As filed with the Securities and Exchange Commission on December 18, 2017

Registration No. 333-220747333-276367

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION
Washington,D.C. 20549

Amendment No. 1

FormS-1/A
(Amendment No. 3)

REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933

SUN BIOPHARMA,PANBELA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware
(State or other jurisdiction of
incorporation or organization)

 

2834
(Primary Standard Industrial
Classification Code Number)
 

87-054392288-2805017
(I.R.S. Employer
Identification No.)

 

712 Vista Blvd, Suite305
Waconia, Minnesota 55387
(952) 479-1196

(Address, including zip code, and telephone number, including area code, of registrants principal executive offices)

David B. KaysenJennifer K. Simpson
President and Chief Executive Officer
712 Vista Blvd, Suite305
Waconia, Minnesota 55387
(952) 479-1196

(Name, address, including zip code, and telephone number, including area code, of agent for service)

 

Copies to:

 

W. Morgan Burns
Joshua L. CColburnolburn
Faegre Baker Daniels LLP

Oded Har-Even, Esq
Robert V. Condon III, Esq.W. Jason Deppen
Zysman, Aharoni, Gayer and
SullivanFaegre Drinker Biddle & WorcesterReath LLP

90 South Seventh Street
2200 Wells Fargo Center
Minneapolis, Minnesota 55402-3901
Telephone: (612) 766-7000

 

1633 Broadway
M. Ali Panjwani

Pryor Cashman LLP

7 Times Square

New York, New York 10019
Telephone: 10036

(212) 660-5000421-4100

 

 

Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this registration statement.

 

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, as amended, check the following box. ☑

 

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

 

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

 

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large“large accelerated filer,” “accelerated filer,” “smaller reporting company”company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐

Accelerated filer ☐

Non-accelerated filer ☐
(Do not check if a smaller reporting company) ☑

Smaller reporting company ☑

Emerging growth company ☑ ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided to Section 7(a)(2)(B) of the Securities Act.


CALCULATION OF REGISTRATION FEE

Title of Each Class of Securities to be Registered

 

Proposed Maximum

Aggregate Offering

Price(1)

  

Amount of

Registration Fee

 

Common stock, $0.001 par value per share(2)

 $11,500,000  $1,332.85 

Common stock purchase warrants(3)

 $115,000  $13.33 

Common Stock, $0.001 par value per share, underlying the common stock purchase warrants(2)

 $7,187,500  $833.03 

Representative’s warrants (4)(5)

 $  $ 

Common stock, $0.001 par value per share, underlying representative’s warrants(2)(5)

 $575,000  $66.64 

TOTAL

 $19,377,500  $2,245.85(6)


(1)

Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(o) of the Securities Act of 1933, as amended (the “Securities Act”). Includes offering price of shares that the underwriters have the option to purchase to cover over-allotments, if any.

(2)

Pursuant to Rule 416 under the Securities Act, the shares of common stock registered hereby also include an indeterminate number of additional shares of common stock as may from time to time become issuable by reason of stock split, stock dividends, recapitalizations, or other similar transactions.

(3)

Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(i) under the Securities Act.

(4)

Represents warrants granted to the representative of the underwriters to purchase shares of common stock in an amount up to 5.0% of the number of shares of common stock sold to the public in this offering, excluding any exercise of the underwriters’ option to cover over-allotments. See “Underwriting” contained within this registration statement for information on underwriting arrangements related to this offering. No registration fee pursuant to Rule 457(g) under the Securities Act.

(5)

Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(g) under the Securities Act based on an estimate of the proposed maximum aggregate offering price. The representative’s warrants are exercisable at a per share exercise price equal to 115% of the public offering price of one share of common stock and warrant. As estimated solely for the purposes of calculating the registration fee pursuant to Rule 457(g) of the Securities Act, the proposed maximum offering price of the representative’s warrants is equal to 115% of $500,000 (5% of $10,000,000).

(6)

Previously paid.

 

The registrantregistrant hereby amends this registration statementregistration statement on such date or dates as may be necessary to delay its effective date until the registrantregistrant shall file a further amendment which specifically states that this registration statementregistration statement shall thereafter become effective in accordance with Section8(a) of the Securities Act of 1933, as amended, or until the registration statementregistration statement shall become effective on such date as the Commission, acting pursuant to said Section8(a), may determine.

 

 

 

 

The information in this prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell securities, and we are not soliciting offers to buy these securities, in any state where the offer or sale is not permitted.

 

PRELIMINARY PROSPECTUS

SUBJECT TO COMPLETION

DATED DECEMBER 18, 2017JANUARY 22, 2024

 

834,028Up to 3,007,519 Shares of Common Stock

Up to 3,007,519 Class E Common Warrants to Purchase 417,014purchase up to 3,007,519 Shares of Common Stock

Up to 3,007,519 Class F Common Warrants to purchase up to 3,007,519 Shares of Common Stock

Up to 3,007,519 Pre-Funded Warrants to purchase up to 3,007,519 Shares of Common Stock

Up to 9,022,557 Shares of Common Stock Underlying Warrants

 

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This is a firm commitmentbest efforts public offering of 834,028(a) up to 3,007,519 shares of our common stock, and warrants$0.001 par value per share, (b) up to 3,007,519 Class E Common Warrants to purchase up to an aggregate of 417,0143,007,519 shares of our common stock (assuming a(the “Class E Warrants”), and (c) up to 3,007,519 Class F Common Warrants to purchase up to 3,007,519 shares of our common stock (the “Class F Warrants” and, together with the Class E Warrants, the “common warrants”) at an assumed combined public offering price of $11.99$6.65 per share based onof common stock and accompanying warrants (equal to the last reported sale price of our common stock as reported by the Nasdaq Capital Market on December 7, 2017, and $0.01 per warrant)January 18, 2024). Each share of our common stock is being sold together with a warrantClass E Warrant to purchase 0.50 sharesone share of our common stock and a Class F Warrant to purchase one share of our common stock. Each common warrant willis assumed to have an exercise price of $15.00$6.65 per share (125%(100% of the public offering price of one share of common stock and warrant assuming a public offering price of $12.00 per share and warrant)common warrants), will be exercisable upon issuance, and will expire five years from the date of issuance. The

We are also offering to those purchasers, if any, whose purchase of common stock in this offering would otherwise result in any such purchaser, together with its affiliates, beneficially owning more than 4.99% (or, at the election of such purchaser, 9.99%) of our outstanding common stock immediately following the consummation of this offering, the opportunity to purchase pre-funded warrants in lieu of shares of our common stock andthat would otherwise result in such purchaser’s beneficial ownership exceeding 4.99% (or, at the warrants are immediately separableelection of such purchaser, 9.99%) of our outstanding common stock. The purchase price for each pre-funded warrant will equal the per share public offering price for the common stock in this offering less the $0.001 per share exercise price of each such pre-funded warrant. Each pre-funded warrant will be exercisable upon issuance and will be issued separately, butnot expire prior to exercise. For each pre-funded warrant we sell, the number of shares of common stock we are offering will be purchaseddecreased on a one-for-one basis.

For purposes of clarity, each share of common stock or pre-funded warrant to purchase one share of common stock is being sold together in this offering.with a Class E Warrant to purchase one share of common stock and a Class F Warrant to purchase one share of common stock.

 

Our common stock is quotedlisted on the OTCQB VentureNasdaq Capital Market operated by OTC Markets Group, Inc. (“OTCQB”) under the ticker symbol “SNBP.“PBLA.” On December 7, 2017,January 18, 2024, the last reported sale price of our common stock on the Nasdaq Capital Market was $11.99$6.65 per share. The price of our common stock as quoted on the OTCQB may not be indicative of the actualcombined public offering price. The actual offering priceprices per share and accompanying warrant or per pre-funded warrant and accompanying warrant will be determined between us and the underwritersinvestors based on market conditions at the time of pricing and may be at a discount to the current market price. We have applied to list the sharesprice of our common stockstock. Therefore, the recent market price and resulting assumed price used throughout this prospectus may differ substantially from the actual offering price. None of the common warrants or pre-funded warrants are listed on a national securities exchange. We do not intend to apply to list the common warrants or pre-funded warrants on any national securities exchange. Without an active trading market, the liquidity of the common warrants and pre-funded warrants may be limited.

Effective January 18, 2024, we effected a 1-for-20 reverse stock split of our outstanding shares of common stock. Unless specifically provided herein, the share and per share information that follows in this prospectus, other than in the historical financial statements and related notes included elsewhere in this prospectus, assumes the effect of the reverse stock split.


We have requested and been granted a hearing to appeal the staff determination letter we received from The Nasdaq Stock Market, LLC (“Nasdaq”) on November 28, 2023, which letter communicated that Nasdaq would suspend trading in our common stock and file a Form 25-NSE with the Securities and Exchange Commission, which would remove our common stock from listing and registration on Nasdaq, unless we appealed its delisting determination by requesting a hearing before the Nasdaq Hearings Panel. The suspension of trading and delisting of the company’s common stock has been stayed pending the conclusion of the hearing process. Consequently, the company’s common stock is expected to remain listed on the Nasdaq Capital Market underat least until the symbols “SNBP” and “SNBPW,” respectively. No assurancepanel renders a decision following the hearing. There can be givenno assurance that the panel will grant the company’s appeal for continued listing on The Nasdaq Capital Market. The determination letter communicated that our applications will becompany (i) has not maintained a minimum closing bid price of $1.00 per share as required by Nasdaq Listing Rule 550(a)(2) (the “Minimum Bid Price Requirement”) and (ii) is not in compliance with the minimum stockholders’ equity requirement for continued listing as required by Nasdaq Listing Rule 5550(b) (the “Minimum Stockholders’ Equity Requirement”). At a special meeting of stockholders held on December 19, 2023, our stockholders approved or that a trading market will develop. Effective November 7, 2017, we implementedproposed amendment to our Amended and Restated Certificate of Incorporation to effect a 1-for-10 reverse stock split of our outstanding common stock at a reverse stock split ratio ranging from any whole number between 1-for-8 and 1-for-50, subject to and as determined by our Board of Directors. Effective January 18, 2024, we effected a 1-for-20 reverse stock split of our outstanding shares of common stock.  The primary reason we effected a reverse stock split was intendedis to potentially increase the per share market price per share of our common stock to a levelsatisfy the Minimum Bid Price Requirement. Additionally, it is our intention that qualifies for listing onthe net proceeds from this public offering will allow us to regain compliance with the Minimum Stockholders’ Equity Requirement. We believe that if we are unable to regain compliance with both the Minimum Bid Price Requirement and the Minimum Stockholders’ Equity Requirement, it is likely that our common stock will be delisted from the Nasdaq Capital Market. We are taking additional actions to meet the remaining listing requirements. Our share price on the OTCQB may not be indicative of the market price on the Nasdaq Capital Market, if we become listed. There is no established public trading market for the warrants.

 

Investing in our securities involves a high degree of risk. You should review carefully the risks and uncertainties described under the heading Risk Factors beginning on page98 of this prospectus, and under similar headings in any amendments or supplements to this prospectus, including our most recent annual report on Form 10-K and any similar section contained in any documents that are incorporated by reference into this prospectus.

 

This offering will terminate on February 15, 2024, unless completed sooner or unless we decide to terminate the offering (which we may do at any time in our discretion) prior to that date, except that the shares of Common Stock underlying the Class E Warrants, Class F Warrants, and the pre-funded warrants will be offered on a continuous basis pursuant to Rule 415 under the Securities Act of 1933, as amended. We will deliver all securities to be issued in connection with this offering delivery versus payment upon receipt of investor funds received by us. Accordingly, there is no arrangement to receive or place investor funds in an escrow, trust or any similar account.

We have engaged Roth Capital Partners, LLC as our exclusive placement agent (“Roth” or the “placement agent”) to use its reasonable best efforts to solicit offers to purchase our securities in this offering. The placement agent has no obligation to purchase any of the securities from us or to arrange for the purchase or sale of any specific number or dollar amount of the securities. Because there is no minimum offering amount required as a condition to closing in this offering the actual public offering amount, placement agent’s fee, and proceeds to us, if any, are not presently determinable and may be substantially less than the total maximum offering amounts set forth above and throughout this prospectus. We have agreed to pay the placement agent the placement agent fees set forth in the table below and to provide certain other compensation to the placement agent. See “Plan of Distribution” beginning on page 27 of this prospectus for more information regarding these arrangements.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.

 

  

Per Share and
Common
Warrant

  

Per Pre-Funded

Warrant and

Common

Warrant

  

Total

 

Public offering price

 

$

   

$

   

$

  

Underwriting discounts and commissions(1)Placement Agent fees

 

$

   

$

   

$

  

ProceedsNet proceeds to us, before expenses(1)

 

$

   

$

   

$

  

 


(1)

The underwriters will receive compensationabove summary of offering proceeds does not give effect to any proceeds from the exercise of the common warrants or pre-funded warrants being issued in addition to the underwriting discount and commissions. See “Underwriting”, beginning on page 90 for a full description of compensation payable to the underwritersthis offering.

 

We have granted a 45-day option toDelivery of the underwriters to purchase up to 125,104 additional shares of our common stock and/orand pre-funded warrants to purchase upcertain of the investors, together with accompanying common warrants, is expected to 62,552 shares of common stock from us solely to cover over-allotments, if any.

The underwriters expect to deliver the shares and warrantsbe made on or about         , 2017.2024, subject to customary closing conditions.

 

Sole Book-Running Manager

AegisRoth Capital Corp

_______________

Co-Manager

Lake Street Capital MarketsPartners

 

The date of thisthis prospectus is          , 20172024

 

 

 

 

Table of ContentsTABLE OF CONTENTS

Page

ABOUT THIS PROSPECTUS

ii

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

iii

PROSPECTUS SUMMARY

1

THE OFFERING

6

SUMMARY CONSOLIDATED FINANCIAL DATA

8

RISK FACTORS

9

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

2410

USE OF PROCEEDS

2522

PRICE RANGE OF COMMON STOCKMARKET INFORMATION

26

23

CAPITALIZATION

3223

DILUTION

3424

DIVIDEND POLICY

35

25

MANAGEMENT’SMANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

36

25

BUSINESS

48

36

MANAGEMENT

69

65

EXECUTIVE COMPENSATION

74

69

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT

79

71

DESCRIPTION OF SECURITIES

80

72

SHARES ELIGIBLE FOR FUTURE SALEPLAN OF DISTRIBUTION

86

UNDERWRITING

88

78

LEGAL MATTERS

97

83

EXPERTS

97

83

WHERE YOU CAN FIND MORE INFORMATION

97

84

FINANCIAL STATEMENTS

F-1

i

ABOUT THIS PROSPECTUS

We incorporate by reference important information into this prospectus. You may obtain the information incorporated by reference without charge by following the instructions under “Where You Can Find More Information.” You should carefully read this prospectus as well as additional information described under “Information Incorporated by Reference,” before deciding to invest in our securities.

 

You should rely only on the information contained in this prospectus. We have not, and the underwriters haveplacement agent has not, authorized anyone to provide you with any information other than that contained in this prospectus. We take no responsibility for and can provide no assurance as to the reliability of any other information that others may give you. This prospectus may only be used where it is legal to offer and sell our securities. The information in this prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or any sale of our securities. Our business, financial condition, results of operations and prospects may have changed since that date. We are not, and the underwriters areplacement agent is not, making an offer of these securities in any jurisdiction where the offer is not permitted.

 

For investors outside the United States: We have not and the underwriters haveplacement agent has not done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United States must inform themselves about, and observe any restrictions relating to, the offering of securities and the distribution of this prospectus outside the United States.

 

This prospectus includes statistical and other industry and market data that we obtained from industry publications and research, surveys and studies conducted by third parties. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. We believe that the data obtained from these industry publications and third-party research, surveys and studies are reliable. We are ultimately responsible for all disclosure included in this prospectus.

 

You should rely only on the information contained in this prospectus, as supplemented and amended. We have not authorized anyone to provide you with information that is different. This prospectus may only be used where it is legal to sell these securities. The information in this prospectus may only be accurate on the date of this prospectus.

 

We urge you to read carefully this prospectus, as supplemented and amended, before deciding whether to invest in any of the securities being offered.

 

iii

 

 

Reverse Stock SplitCAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

Effective November 7, 2017, we implemented a 1-for-10 reverse splitThis prospectus contains forward-looking statements within the meaning of our common stock. No fractional shares were issued in connection with the reverse stock split. Stockholders received a proportionate cash payment for any fractional shares based upon the closing price of our common stock on the effective dateSection 27A of the reverse stock split. The reverse stock split was intendedSecurities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements contained in this prospectus other than statements of historical fact, including statements regarding our future results of operations and financial position, our business strategy and plans, projected costs and our objectives for future operations, are forward-looking statements.

In some cases, you can identify forward-looking statements by the following words: “anticipate,” “assume,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are not a guarantee of future performance or results and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time the statements are made and involve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity, performance or achievements to increasebe materially different from the market price per shareinformation expressed or implied by the forward-looking statements in this prospectus. These factors include:

our lack of diversification and the corresponding risk of an investment in our company;

potential deterioration of our financial condition and results due to failure to diversify;

our ability to successfully complete acquisitions;

our ability to integrate acquired companies and operations for new product candidates;

our ability to obtain additional capital, on acceptable terms or at all, required to implement our business plan;

final results of our Phase I clinical trial;

progress and success of our randomized Phase II/III clinical trial;

our ability to demonstrate safety and effectiveness of our product candidate;

our ability to obtain regulatory approvals for our product candidate in the United States, the European Union, or other international markets;

the market acceptance and future sales of our product candidate;

the cost and delays in product development that may result from changes in regulatory oversight applicable to our product candidate;

the rate of progress in establishing reimbursement arrangements with third-party payors;

the effect of competing technological and market developments;

the costs involved in filing and prosecuting patent applications and enforcing or defending patent claims;

our ability to maintain the listing of our common stock on a national securities exchange; and

other risk factors included under the caption “Risk Factors” starting on page 8 of this prospectus.

You should read the matters described in “Risk Factors” and the other cautionary statements made in this prospectus as being applicable to all related forward-looking statements wherever they appear in this prospectus. We cannot assure you that the forward-looking statements in this prospectus will prove to be accurate and therefore you are encouraged not to place undue reliance on forward-looking statements. You should read this prospectus completely. Other than as required by law, we undertake no obligation to update or revise these forward-looking statements, even though our situation may change in the future.

We caution readers not to place undue reliance on any forward-looking statement that speaks only as of our common stockthe date made and to a levelrecognize that qualifies for listing on the Nasdaq Capital Market. Weforward-looking statements are taking additional actions to meet the remaining listing requirements. Until we meet the criteria for listing and an application for listing is accepted by Nasdaq,predictions of future results, which may not happen within a reasonable time frame, if at all, our common stock will continueoccur as anticipated. Actual results could differ materially from those anticipated in the forward-looking statements and from historical results due to be eligible for quotation on the OTCQB Venture Marketplace tier of the over-the-counter markets administered by the OTC Markets Group, Inc.risks and uncertainties described under the symbol “SNBP”. FINRA has temporarily appended a suffix character, “D,” to our trading symbol to indicate the completion of the reverse stock split. The reverse stock split did not affect the par value of our common stock, however, concurrent with the reverse stock split, the number of shares of common and preferred stock authorized for issuance was reduced by 50% to 100,000,000 and 10,000,000, respectively. Proportional adjustments were also made to our 2016 Omnibus Incentive Plan, outstanding stock options, warrants and outstanding convertible notes payable. The new CUSIP number for our common stock following the reverse stock split is 8666M 206. Unless otherwise indicated, all references to share and per share amounts includedheading “Risk Factors” in this prospectus, have been retroactively adjustedas well as others that we may consider immaterial or do not anticipate at this time. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. Our expectations reflected in our forward-looking statements can be affected by inaccurate assumptions that we might make or by known or unknown risks and uncertainties, including those described under the heading “Risk Factors” in this prospectus. The risks and uncertainties described under the heading “Risk Factors” in this prospectus are not exclusive and further information concerning us and our business, including factors that potentially could materially affect our financial results or condition, may emerge from time to time. We assume no obligation to update forward-looking statements to reflect actual results or changes in factors or assumptions affecting such forward-looking statements. We advise stockholders and investors to consult any further disclosures we may make on related subjects in our subsequent annual reports on Form 10-K, quarterly reports on Form 10-Q, and current reports on Form 8-K that we file with or furnish to the reverse stock split.U.S. Securities and Exchange Commission (the “SEC”).

 

ii
iii

Prospectus SummaryPROSPECTUS SUMMARY

 

This summary highlights information contained elsewhere in this prospectus and does not contain all of the information that you should consider in making your investment decision. Before investing in our securities, you should carefully read this entire prospectus, including our financial statements and the related notes and the information set forth under the headings Risk Factors and Managements Discussion and Analysis of Financial Condition and Results of Operations in each case included elsewhere in this prospectus. Unless otherwise stated or the context requires otherwise, references in this prospectus to Panbela,Sun BioPharma, the Company,, we,, us,, our and similar references refer to Sun BioPharma,Panbela Therapeutics, Inc. and its wholly-owned subsidiary, Sun BioPharma Australia Pty Ltd. (subsidiaries.SBA).

 

Business Overview

 

Sun BioPharma, Inc.Panbela is a clinical stage drug developmentbiopharmaceutical company founded with technology licensed from The University of Florida Research Foundation (“UFRF”). The polyamine analogue compound we have licensed from UFRF, which we refer to as “SBP-101,” exhibits extraordinary specificitydeveloping disruptive therapeutics for the exocrine pancreas,treatment of patients with therapeutic potentialurgent unmet medical needs. We are currently enrolling patients in our randomized double-blind placebo controlled clinical trial for boththe treatment of pancreatic cancer and pancreatitis indications. Xenograft studies of human pancreatic cancer cells transplanted into mice indicate thatwe are a regulatory and commercial collaborator in a Phase III clinical trial funded by the unique specificity of SBP-101National Cancer Institute (the “NCI”) for the exocrine pancreas facilitates suppressionstudy of both primarycolon cancer risk reduction and colon adenoma therapy (“CAT”), a preventative treatment approach for survivors of colorectal cancer or those who have high-risk colon polyps. In addition, the Company is designing a global protocol for a Phase III registration trial for familial adenomatous polyposis (“FAP”), a rare inherited condition that can cause the growth of thousands of colorectal adenomas (i.e., adenomatous polyps), which are recognized as a key risk factor for colon cancer. The global protocol will be submitted to the Federal Drug Administration (FDA) and European Medicines Agency (EMA) for agreement on the registration pathway. By leveraging Panbela’s extensive experience with FAP and in designing global registration trials, the team can develop a high-quality trial protocol that meets the standards of regulatory agencies and is designed to demonstrate the potential safety and efficacy of Flynpovi ™ efficiently and effectively in the treatment of FAP. We also support several investigator initiated trials and company sponsored preclinical trials including: (1) Phase II clinical trial for the treatment of early-onset type 1 diabetes funded by the Juvenile Diabetes Research Foundation; (2) Phase II clinical trial for treatment of gastric cancer funded by the NCI; (3) Phase I/II clinical trial for the treatment of non-small cell lung cancer (NSCLC) possessing the STK11 mutation; (4) Phase II program for the treatment of Metastatic Castration-Resistant Prostate Cancer; and (5) preclinical studies that we have sponsored in the orphan disease and cancer fields.

The Company’s lead assets are ivospemin (SBP-101), FlynpoviTM (eflornithine (CPP-1X) and sulindac), and eflornithine (CPP-1X) which provides a multi-targeted approach to reset dysregulated biology present in many types of diseases such as cancer and autoimmune disorders. Many tumors require greatly elevated levels of polyamines to support their growth and survival. These agents target the polyamine pathway at complementary junctions, which have been shown to be altered in disease. In particular, our lead assets have the potential to suppress and prevent tumor growth, enhance anti-tumor activity of other anti-cancer agents, and modulate the immune system.

Ivospemin is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition. Ivospemin has demonstrated encouraging activity against metastatic disease in a clinical trial of patients with pancreatic cancer. The efficacy and safety results demonstrated in our completed Phase I clinical trial of ivospemin in combination with gemcitabine and nab-paclitaxel in the first line treatment of metastatic pancreatic cancer which is known to originateprovides support for the current randomized, double-blind, placebo-controlled study of ivospemin in the exocrine pancreas. To facilitatecombination with gemcitabine and accelerate the development of this compoundnab-paclitaxel in thepatients previously untreated for metastatic pancreatic cancer indication, we have also acquired data and materials related to this technology from other researchers. Studies in dogs revealed ablation, or “chemical resection,” of the exocrine pancreatic architecture, while leaving the islet cells functionally unchanged. We may refer to this effect as: “pharmaceutical pancreatectomy with islet auto-transplant” (“PP-IAT”).cancer. We believe that SBP-101,ivospemin, if successfully developed, may represent a novel approach that effectively treats patients with pancreatic cancer and pancreatitis, and could become a dominant product in these markets.that market. Only three first-line treatmentstreatment combinations, a single maintenance treatment for a subset (3-7%) of patients, and one second-line drug have been approved by the U.S. Food and Drug Administration (“FDA”) for pancreatic cancer in the last 20 years,25 years. Ivospemin has received Fast Track status and no drugsorphan drug designation status for pancreatic cancer in the United States as well as Europe.

On June 15, 2022 Panbela acquired Cancer Prevention Pharmaceuticals, Inc. (“CPP”), which added the Company’s second lead asset, eflornithine in multiple forms. First, an investigational new drug product, Flynpovi is a combination of the polyamine synthesis inhibitor eflornithine and the non-steroidal anti-inflammatory drug sulindac and then eflornithine as a single agent. Eflornithine is an enzyme-activated, irreversible inhibitor of the enzyme ornithine decarboxylase, the first rate-limiting enzyme in the biosynthesis of polyamines. Sulindac, a non-steroidal anti-inflammatory drug, facilitates the export and catabolism of polyamines. Flynpovi has a unique dual mechanism of action whereby it suppresses the synthesis of new polyamines and increases the export and catabolism of polyamines from the diet and microbiome. We believe Flynpovi is unique in that it is designed to treat the risk factors (e.g., polyps) that are hypothesized to lead to Familial Adenomatous Polyposis (“FAP”) surgeries and colon cancer and therefore may have been approvedthe ability to prevent various types of colon cancer. In the FAP-310 Phase III trial, the efficacy and safety of the combination of Flynpovi (eflornithine and sulindac), as compared with either drug alone, in adults with FAP was conducted. While the study missed the primary composite endpoint (Burke et al. 2020), a post-hoc analysis showed that none of the patients in the combination arm progressed to a need for lower gastrointestinal (“LGI”) surgery for up to 48 months compared to 13.2% and 15.7% of patients in the sulindac and eflornithine arms (Balaguer et al. 2022). This data corresponded to risk reductions for the specificneed for LGI surgery approaching 100% between combination and either monotherapy. Given the statistical significance of the LGI group, a new drug application (“NDA”) was filed with the FDA; however, since this was based on the results of an exploratory analysis, a complete response letter (“CRL”) was issued. To address the CRL, the Company is designing a Phase III registration trial and will advance this program while not increasing our current cash requirements. There are no currently approved pharmaceutical therapies for FAP

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Additional programs are evaluating a single agent tablet eflornithine or high dose powder eflornithine sachet for several indications including prevention of gastric cancer, recent onset Type 1 diabetes, and STK-11 mutant NSCLC. Preclinical studies as well as Phase I or Phase II investigator-initiated trials suggest that eflornithine treatment is well tolerated and has potential activity.In December, US WorldMeds®, a Kentucky-based specialty pharmaceutical company to whom Panbela divested certain assets in its eflornithine pediatric neuroblastoma program, received FDA approval of patients with pancreatitis, other than supportive care.their NDA for the use of eflornithine as a maintenance therapy for neuroblastoma in remission.  This approval marks the first approval for eflornithine and any polyamine targeted therapy in a cancer indication.

Flynpovi has received Fast Track designation in the United States and orphan drug designation status for FAP in the United States and Europe. In addition, we have received orphan drug designation status for eflornithine as a single agent for Neuroblastoma in the United States and Europe and for gastric cancer in the United States.

Clinical Trials

Ivospemin (SBP-101)

 

In August 2015, the FDA accepted our Investigational New Drug (“IND”) application for our SBP-101ivospemin product candidate. We have completed enrollment in aan initial clinical trial of SBP-101ivospemin in patients with previously treated locally advanced or metastatic pancreatic cancer. This iswas a Phase 1,I, first-in-human, dose-escalation, safety study. From January 2016 through September 2017, we enrolled twenty-nine patients into six cohorts, or groups, in the dose-escalation phase of our currentthe Phase 1I trial. Twenty-four of the patients received at least two prior chemotherapy regimens. No drug-related serious adverse events occurred during the first four cohorts.bone marrow toxicity or peripheral neuropathy was observed at any dose level. In cohort five, serious adverse events (klebsiella sepsis with metabolic acidosis in one patient, and renal and hepatic toxicity in one patient) were observed in two of the ten patients, both of whom exhibited progressive disease at the end of their first cycle of treatment, and were determined by the Data Safety Monitoring Board (“DSMB”) to be dose-limiting toxicities (���DLTs”). Consistent with the study protocol, the DSMB recommended continuation of the study by expansion of cohort 4. Four patients were enrolled in this expansion cohort.

In addition to being evaluated for safety, twenty-four23 of the twenty-nine29 patients were evaluable for preliminary signals of efficacy prior to or at the eight-week conclusion of their first cycle of treatment using the Response Evaluation Criteria in Solid Tumors (“RECIST”), the currentcurrently accepted standard for evaluating changeschange in the size of tumors. Eight

In 2018, we began enrolling patients in our second clinical trial, a Phase Ia/Ib study of the twenty-four patients (33%safety, efficacy, and pharmacokinetics of ivospemin administered in combination with two standard-of-care chemotherapy agents, gemcitabine and nab-paclitaxel. A total of 25 subjects were enrolled in four cohorts to evaluate the dosage level and schedule. An additional 25 subjects were enrolled in the expansion phase of the trial. Interim results were presented in January of 2022. Best response in evaluable subjects (cohorts 4 and Ib N=29) was a Complete Response in 1 (3%) had, Partial Response in 13 (45%), Stable Disease (“SD”in 10 (34%) and sixteen of twenty-four (67%) had Progressive Disease (“PD”in 5 (17%). It shouldOne subject did not have post baseline scans with RECIST tumor assessments. Median Progression Free Survival (“PFS”), now final at 6.5 months may have been negatively impacted by drug dosing interruptions to evaluate potential toxicity. Median overall survival in Cohort 4 + Phase Ib was 12.0 months when data was presented in January 2022 and is now final at 14.6 months. Two patients from cohort 2 have demonstrated long term survival. One at 30.3 months (final data) and one at 33.0 months and still alive. Seven subjects are still alive at this time, one from cohort 2 and six from cohort 4 plus Ib.

In January of 2022, the Company announced the initiation of a new pancreatic cancer clinical trial. Referred to as ASPIRE, the trial is a randomized double-blind placebo-controlled trial in combination with gemcitabine and nab-paclitaxel, a standard pancreatic cancer treatment regimen, in patients previously untreated for metastatic pancreatic cancer. The trial will be noted thatconducted globally at approximately 93 sites in the United States, Europe and Asia – Pacific.

The Aspire trial commenced early in 2022, while opening of clinical sites in the US and the rest of the sixteen patients with PD, six came from cohorts one and two and are consideredworld has been slower than originally anticipated, due in part to have received less than potentially therapeutic doses of SBP-101. We also noted that twenty-eight of the twenty-nine patients had follow-up blood tests measuring the Tumor Marker CA 19-9 associated with pancreatic ductal adenocarcinoma. Eleven of these patients (39%) had reductionsresource fatigue in the CA 19-9 levels,medical community, the Company expects all countries and sites to be open by in early 2024.

The trial was originally designed as measureda Phase II/III with a smaller sample size (150) to support the events required for interim analysis based on PFS and a primary endpoint of overall survival. In response to European and FDA regulatory feedback the study was amended to include the total trial sample size (600) and the design modified to utilize overall survival as the primary endpoint to be examined at least once afterinterim analysis. PFS will also be analyzed to provide additional efficacy evidence. This amendment was supported by the baseline assessment. Sevenfinal data from the Phase Ia/b first line metastatic pancreatic cancer trial which completed enrollment in December of 2020. The study will enroll 600 subjects and is anticipated to take 36 months for complete enrollment with the remaining seventeen patients showedinterim analysis available in mid-2024.  The Independent Data Safety Monitoring Board (“DSMB”) has met twice, the most recently in November 2023, which evaluated the safety of 214 patients.  Both meetings resulted in no reductionsafety concerns and the trial continuing without modification.

If we can successfully complete all FDA recommended clinical studies, we intend to seek marketing authorization from the FDA, the European Medicines Agency (“EMA”) (European Union), Ministry of Health and Welfare (Japan) and TGA (Australia). The submission fees may be waived when ivospemin has been designated an orphan drug in CA 19-9 came from cohorts one and two.each geographic region.

 


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Additionally, in early April 2023, the Company announced a poster presentation highlighting the results for ivospemin as a polyamine metabolism modulator in ovarian cancer at the American Association for Cancer Research Annual Conference The best response outcomesposter concludes that the ivospemin treatment of C57Bl/6 mice injected with VDID8+ ovarian cancer cells significantly prolonged survival and survival were observed in the group of thirteen patients who received total cumulative doses between 2.5 mg/kg and 8.0 mg/kg. Twelve of the thirteen patients in this group were evaluable for preliminary signs of efficacy at eight weeks by RECIST. Five patients (42%) showed SD at week eight. Five of the thirteen patients (38%) had reductionsdecreased overall tumor burden. The results suggest that ivospemin may have a role in the CA19-9 levels, as measured at least once afterclinical management of ovarian cancer, and the baseline assessment. Median survivalCompany intends to continue pre-clinical and clinical studies in this group was 3.8 months as of October 2017. To date, nine patients (69%) have exceeded 3 months of overall survival (“OS”), four have exceeded four months of OS and two patients have exceeded 10 months of OS, with some patients continuing to be followed for survival.ovarian cancer.

 

Additional preclinical work is underway evaluating ivospemin (also known as SBP-101) and eflornithine (also known as CPP-1X or DFMO) in multiple myeloma (cell lines). Data published in the November 2023, supplemental issue of the Journal Blood investigated the effects of polyamine inhibition by ivospemin and CPP-1X on myeloma cell lines growth and viability in vitro. Results showed that ivospemin and CPP-1X treatment significantly decreased cell proliferation and induced apoptosis in a panel of multiple myeloma cell lines. When ivospemin and CPP-1X were combined an almost complete abolition of cell growth occurred. These results demonstrate the anti-neoplastic potential of ivospemin and CPP-1X and offer a compelling rationale for its clinical trials will be requireddevelopment as a potentially promising treatment option for FDA approvalmultiple myeloma. The work reflects the Company’s on-going collaboration with researchers from The University of SBP-101Texas MD Anderson Cancer Center for the evaluation of polyamine metabolic inhibitor therapies in pancreatic cancer and pancreatitis. We estimate that the additional time and cost to obtain FDA and European Medicines Agency (“EMA”) approval and to bring SBP-101 to marketcombination with CAR-T cell therapies in these two indications will be 6 to 7 years and cost at least $200 million.preclinical models.

 

With adequate financial resources, clinical development of SBP-101FLYNPOVI

In December 2009, the FDA accepted our IND application for the treatmentcombination product, Flynpovi. Flynpovi showed promising results in an NCI supported randomized, placebo-controlled Phase IIb/III clinical trial to prevent recurrent colon adenomas, particularly high-risk pre-cancerous polyps in which 375 subjects who had resected sporadic adenoma were treated for 3 years with eflornithine (500 mg once a day) + sulindac (150 mg once a day [N = 191]) or matched placebo/placebo (N = 184). Results demonstrated a marked risk reduction (70%) in developing metachronous adenomas, 92% risk reduction in developing advanced adenomas, and 95% risk reduction in developing multiple adenomas with the active combination regimen compared to placebo (Meyskens et al. 2008). This combination regimen was generally well tolerated.

Given the similar mechanism of disease in sporadic and FAP-associated adenomatous polyposis, and the mechanism of action of Flynpovi in prevention of progressive polyposis in both the general population with sporadic adenomas and in patients with pancreatitisFAP, a Phase III program in FAP, and a Phase III program to study colon cancer risk reduction in partnership with the Southwest Oncology Group (SWOG) and the NCI were initiated.

In the FAP-310 Phase III study completed in 2019, the efficacy and safety of the combination of eflornithine and sulindac, as compared with either drug alone, in adults with familial adenomatous polyposis was conducted (Burke et al. 2020). The patients were randomly assigned in a 1:1:1 ratio to receive eflornithine, sulindac, or both once daily for up to 48 months. The primary end point, assessed in a time-to-event analysis, was disease progression, defined as a composite of major surgery, endoscopic excision of advanced adenomas, diagnosis of high-grade dysplasia in the rectum or pouch, or progression of duodenal disease. A total of 171 patients underwent randomization. Disease progression occurred in 18 of 56 patients (32%) in the eflornithine-sulindac group, 22 of 58 (38%) in the sulindac group, and 23 of 57 (40%) in the eflornithine group, with a hazard ratio of 0.71 (95% confidence interval [CI], 0.39 to 1.32) for eflornithine-sulindac as compared with sulindac (P = 0.29) and 0.66 (95% CI, 0.36 to 1.23) for eflornithine-sulindac as compared with eflornithine (Burke et al. 2020). Adverse and serious adverse events were similar across the treatment groups. In a post-hoc analysis, none of the patients in the combination arm progressed to a need for LGI surgery for up to 48 months compared with 7 (13.2%) and 8 (15.7%) patients in the sulindac and eflornithine arms (Balaguer et al. 2022). These data corresponded to risk reductions for the need for LGI surgery approaching 100% between combination and either monotherapy with HR = 0.00 (95% CI, 0.00-0.48; p = 0.005) for combination versus sulindac and HR = 0.00 (95% CI, 0.00-0.44; p = 0.003) for combination versus eflornithine. Given the statistical significance of the LGI group, an NDA was filed with the FDA. As the study failed to meet the primary endpoint, and the NDA was based on the results of an exploratory analysis, a complete response letter was issued. To address this deficiency concern, the Company must submit the results of one or more adequate and well-controlled clinical trials which demonstrate an effect on a clinical endpoint.

In collaboration with the NCI, and SWOG, a Phase III clinical trial has been initiated to study the benefits of Flynpovi as a therapeutic treatment for use by colon cancer survivors. The trial is intendednamed PACES for “Prevention of Adenomas and Cancer with eflornithine and sulindac.” The PACES trial is funded by the NCI and managed by the Southwest Oncology Group (“SWOG”). This is an ongoing double-blind placebo-controlled trial of Flynpovi to beprevent recurrence of high risk adenomas and second primary colorectal cancers in patients with stage 0-III colon or rectal cancer, Phase III – Preventing Adenomas of the Colon With Eflornithine and Sulindac (“PACES”). The purpose of this study is to assess whether Flynpovi (compared to corresponding placebos) has a reduced rate of cancer or high-risk adenoma recurrence compared to comparator arms after three years of daily dosing. We have exclusive rights to the data that comes from the trial for regulatory and commercial purposes. The Company is evaluating its options for CAT in the European Union and Asia.

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In April 2023, the Company announced that it regained the North American rights to develop and commercialize Flynpovi in patients with FAP, as a result of the termination of the license agreement between CPP and One-Two Therapeutics Assets Limited effective July 4, 2023.

Eflornithine (CPP-1X) and eflornithine sachets (CPP-1X-S)

For the single agent eflornithine, there is a Phase I/II trial in STK11 mutation patients with non-small cell lung cancer and Phase II trial in Recent Onset Type I diabetes with eflornithine have been initiated and conducted concurrentlyare enrolling. Recently, a phase II trial evaluating eflornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer started enrolling.  Lastly, a Phase II trial evaluating eflornithine for the prevention of gastric cancer was completed in 2021 with data analysis ongoing.

Recent Developments

Nasdaq Staff Determination Letter

We have requested and been granted a hearing to appeal the staff determination letter we received from The Nasdaq Stock Market, LLC (“Nasdaq”) on November 28, 2023, which letter communicated that Nasdaq would suspend trading in our common stock and file a Form 25-NSE with the pancreatic cancer indication.Securities and Exchange Commission, which would remove our common stock from listing and registration on Nasdaq, unless we appealed its delisting determination by requesting a hearing before the Nasdaq Hearings Panel. The suspension of trading and delisting of the Company’s common stock has been stayed pending the conclusion of the hearing process. Consequently, the Company’s common stock is expected to remain listed on the Nasdaq Capital Market at least until the panel renders a decision following the hearing. There can be no assurance that the panel will grant the Company’s appeal for continued listing on The Nasdaq Capital Market. The determination letter communicated that the Company (i) has not maintained a minimum closing bid price of $1.00 per share as required by Nasdaq Listing Rule 550(a)(2) (the “Minimum Bid Price Requirement”) and (ii) is not in compliance with the minimum stockholders’ equity requirement for continued listing as required by Nasdaq Listing Rule 5550(b) (the “Minimum Stockholders’ Equity Requirement”). Effective January 18, 2024, we completed a 1-for-20 reverse split of our outstanding shares of common stock. The primary reason we effected the reverse stock split is to potentially increase the per share market price of our common stock to satisfy the Minimum Bid Price Requirement. Additionally, it is our intention that the net proceeds from this public offering will allow us to regain compliance with the Minimum Stockholders’ Equity Requirement. We believe that if we are unable to regain compliance with both the Minimum Bid Price Requirement and the Minimum Stockholders’ Equity Requirement, it is likely that our common stock will be delisted from the Nasdaq Capital Market.

 

WithWarrant Exercise Inducements & Private Placement of Class C Warrants

On November 2, 2023, we entered into warrant exercise inducement offer letters with certain holders of existing warrants to purchase our common stock, pursuant to which the holders agreed to exercise for cash their existing warrants to purchase 106,500 shares of our common stock, in the aggregate, at a reduced exercise price of $15.60 per share, in exchange for our agreement to issue new Class C common stock purchase warrants to purchase up to an aggregate of 213,000 shares of our common stock. The Company received aggregate gross proceeds of approximately $17.0$1.9 million raised from the exercise of the existing warrants and purchase of the new warrants. The new warrants had an initial exercise price of $15.60 per share and were exercisable upon the date of stockholder approval through the date that is five years from the date of any stockholder approvals necessary under the listing rules of Nasdaq. Our stockholders approved the issuance of the underlying shares of common stock at a special meeting held on December 19, 2023. We agreed to file a registration statement covering the resale of the shares issued or issuable upon the exercise of the new warrants and a registration statement on Form S-1 (File No. 333-275733) was declared effective by the SEC on December 20, 2023. As of January 18, 2024 there are 75,200 Class C Warrants outstanding.

Reverse Stock Split

Effective January 18, 2024, we completed a 1-for-20 reverse split of our outstanding shares of common stock. Unless specifically provided herein, the share and per-share information that follows in this prospectus, we have:other than in the historical financial statements and related notes included elsewhere in this prospectus, assumes the effect of the reverse stock split.

 

Our primary objective in effecting the reverse stock split has been to attempt to raise the per-share trading price of our common stock to regain compliance with the Minimum Bid Price Requirement.

organized the Company;

 

Because our Company has effectuated reverse stock splits over the prior two-year period with a cumulative ratio in excess of 250 shares to one, we are not eligible for any compliance cure period specified in Nasdaq Marketplace Rule 5810(c)(3)(A) and the Nasdaq staff issued a delisting determination letter in November 2023. While we intend to continue to actively monitor the bid price for our common stock and consider available options regain compliance with the Minimum Bid Price Requirement, there is no assurance that we will not be delisted from Nasdaq even though the reverse stock split has been effected.

evaluated and secured the intellectual property for our core technology;

 

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Although we expect that the reverse stock split will allow us to maintain the bid price per share of our common stock above the $1.00 per share minimum price for any required number of days, thereby regaining compliance with the Minimum Bid Price Requirement, there can be no assurance that any reverse stock split will have that effect, initially or in the future, or that it would enable us to maintain the listing of our common stock on The Nasdaq Capital Market for any particular duration.

There can be no assurance that any reverse stock split will achieve any of the desired results. There also can be no assurance that the price per share of our common stock immediately after any reverse stock split would increase proportionately with the reverse stock split, or that any increase would be sustained for any period of time, as evidenced by the Company’s past reverse stock splits.

Warrant Exercise Inducements & Private Placement of Class D Warrants

On December 21, 2023, we entered into warrant exercise inducement offer letters with certain holders of existing warrants to purchase our common stock, pursuant to which the holders agreed to exercise for cash their existing warrants to purchase 127,800 shares of our common stock, in the aggregate, at their existing exercise price of $15.60 per share, in exchange for our agreement to issue new Class D common stock purchase warrants to purchase up to an aggregate of 255,600 shares of our common stock. The Company received aggregate gross proceeds of approximately $2.0 million from the exercise of the existing warrants. The new warrants had an initial exercise price of $19.00 per share and will only be exercisable contingent upon and after receiving stockholder approval as required by listing rules of Nasdaq and may be exercised until five years from the date of such stockholder approval, if any. The exercise price is separately subject to reduction in the event of certain future dilutive issuances of shares of our common stock by the Company, including pursuant to common stock equivalents and convertible or derivative securities, upon any intervening reverse stock splits, and upon receipt of the stockholder approval. As of January 18, 2024 all of the new warrants remained outstanding but unexercisable pending stockholder approval. We have agreed to call a meeting to seek stockholder approval of the issuance of the shares of our common stock underlying the new warrants within six months and to file a registration statement covering the resale of the shares underlying the new warrants within sixty calendar days of December 21, 2023. Additionally, the Company agreed not to effect or agree to effect any variable rate transaction (as defined in the inducement letters) for one year, other than an at-the-market offering, which may be effected after six months.

Product Developments

Through January 18, 2024, we had: 

completed required pre-clinical steps in the development plan for SBP-101 for pancreatic cancer;

 

 

secured an orphan drug designation for ivospemin from the FDA;

 

 

submitted and received acceptance from the FDA for an IND application tofor ivospemin;

received Country approvals for the FDA (May 18, 2015);ASPIRE Trial in Australia, France, Italy and Spain;

completed a Phase Ia monotherapy safety study of ivospemin in the treatment of patients with metastatic pancreatic ductal adenocarcinoma;

 

 

received an acceptance of an IND application“Fast Track” designation from the FDA (August 21, 2015);for ivospemin for metastatic pancreatic cancer;

completed enrollment and released interim results in our second trial a Phase Ia /Ib clinical study of ivospemin, a first-line study with ivospemin given in combination with a current standard of care in patients with pancreatic ductal adenocarcinoma who were previously untreated for metastatic disease; a total of 50 subjects were enrolled in this study, 25 in the Phase Ia and 25 in the Phase Ib or expansion phase;

secured a two-year research agreement with Johns Hopkins School of Medicine led by Professor Robert Casero, an internationally recognized researcher in polyamine biology;

completed process improvement measures expected to be scalable for commercial use and received issue notification for a patent covering this new shorter synthesis of ivospemin;

initiated a randomized, double-blind, placebo-controlled study with ivospemin given in combination with gemcitabine and nab-paclitaxel in patients with pancreatic ductal adenocarcinoma who are previously untreated for metastatic disease;

completed preclinical evaluation of ivospemin for use as neoadjuvant therapy in resectable pancreatic cancer prior to surgery;

obtained early, preclinical, indication of tumor growth inhibition activity in ovarian cancer and presented the results at ASCO-GI conference;

 

 

received acceptanceUSAN adoption of the nonproprietary name of ivospemin for SBP-101;

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acquired and integrated CPP, adding a Clinical Trial Notification by the Australian Therapeutic Goods Administration (September 23, 2015);second lead asset in multiple forms and an expansive clinical development program ranging from pre-clinical to registration level clinical trials;

 

 

completed enrollmentEuropean Medicines Agency (EMA) Committee for Orphan Medicinal Products issued a positive opinion on Panbela’s application for orphan designation of ivospemin in a phase 1a safety study of SBP-101 for the treatment ofcombination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma; and

 

 

commenced further pre-clinical studiesannounced the initiation of phase II program through Indiana University for early onset Type I diabetes utilizing eflornithine; and;

announced the initiation of the Phase I/II clinical trial for the usetreatment of SBP-101 to treat pancreatitis.non-small lung cancer (NSCLC) possessing the STK11 mutation through Moffitt Cancer Center;

entered into a sponsored research agreement with The University of Texas MD Anderson Cancer Center for the evaluation of polyamine metabolic inhibitor therapies in combination with CAR-T cell therapies in preclinical models;

announced the SWOG Cancer Research Network’s PACES S0820 Phase III trial passed a single planned futility analysis and will continue; and

announced the approval of US WorldMeds NDA Approval for Eflornithine (DFMO) in Pediatric Neuroblastoma, first polyamine approval in oncology.

 

Risks Associated with Our BusinessCompany

 

Our business is subject to many significant risks, as more fully described in the section titled “Risk“Risk Factors” immediately following this prospectus summary. You should read and carefully consider these risks, together with the risks set forth under the section titled “Risk Factors” and all of the other information in this prospectus, including the financial statements and the related notes included elsewhere in this prospectus, before deciding whether to invest in our securities. If any of the risks discussed in this prospectus actually occur, our business, financial condition or operating results could be materially and adversely affected. In particular, our risks include, but are not limited to, the following:

 

 

We are an early stage company and it will take several yearsour ability to haveobtain additional capital, on acceptable terms or at all, required to implement our initial or any of our proposed product candidates approved, assuming such approvals can be obtained at all. We therefore do not expect to generate revenue from product sales for at least the next several years.business plan;

 

 

As a result of the pre-revenue nature of our company and our then current lack of financial liquidity,diversification and the Reportcorresponding risk of Independent Registered Public Accounting Firm foran investment in our 2016 financial statements, which are included as part of this prospectus, contains a statement concerning our ability to continue as a “going concern”.Company;

 

 

Our limited operating history makes it difficult for youour ability to evaluatemaintain our historical business and to assess our future viability.listing on a national securities exchange;

 

 

Our lackprogress and success of diversification increases the risk of an investment in our Company and our financial condition and results of operations may deteriorate if we fail to diversify.randomized Phase II/III clinical trial;

 

 

We may be unable to obtain the additional capital that is required to execute our business plan, which could restrict our ability to grow.


Raising additional capital may cause dilution todemonstrate the safety and effectiveness of our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.candidates: ivospemin ( SBP-101 ), Flynpovi, and eflornithine (CPP-1X);

 

 

The marketour ability to obtain regulatory approvals for our product candidate is highly competitivecandidates, SBP-101, Flynpovi and is subject to rapid scientific change, which could have a material adverse effect on our business, results of operations and financial condition.CPP-1X in the United States, the European Union or other international markets;

 

 

Our product candidate is based on new formulationthe market acceptance and level of an existing technology which has never been approved for the treatment of any cancer and, consequently, is inherently risky. Concerns about the safety and efficacyfuture sales of our product candidate could limit our future success.candidates, SBP-101, Flynpovi and CPP-1X ;

 

 

Clinical trials required forthe cost and delays in product development that may result from changes in regulatory oversight applicable to our product candidate are expensivecandidates, SBP-101, Flynpovi and time-consuming, and their outcome is highly uncertain. If any of our drug trials are delayed or yield unfavorable results, we will have to delay application for or may be unable to obtain regulatory approval for our product candidate.CPP-1X ;

 

 

Due to our reliance on third-parties to conduct our clinical trials, we are unable to directly control the timing, conduct, expense and qualityrate of our clinical trials, which could adversely affect our clinical data and results and related regulatory approvals.progress in establishing reimbursement arrangements with third-party payors;

 

 

We are subject to extensive regulation,the effect of competing technological and if we fail to obtain, or if there are delays in obtaining, required regulatory approvals, we may not be able to commercialize our product candidate, and our ability to generate revenue and the viability of our company may be materially impaired.market developments;

 

 

Our directors, executive officersthe costs involved in filing and significant stockholders have substantial control over usprosecuting patent applications and could limit stockholders’ ability to influence the outcome of key transactions, including changes of control.

Implications of Being an Emerging Growth Company

We qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act (the “JOBS Act”), enacted in April 2012. An emerging growth company may take advantage of reduced reporting requirements that are otherwise applicable to public companies. These provisions include, but are not limited to:

Being required to provide only two years of audited financial statements in addition to any required unaudited interim financial statements, with correspondingly reduced disclosure in the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of this prospectus;

Not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes- Oxley Act of 2002 (“Sarbanes-Oxley Act”);

Reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements;enforcing or defending patent claims; and

 

 

Exemptions fromother risk factors included under the requirementscaption “Risk Factors” starting on page 9 of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.this prospectus. 

 

We may take advantageImplications of these provisions for up to five years after the first sale of our common equity securities pursuant to an effective registration statement under the Securities Act of 1933, as amended (the “Securities Act”). However, if certain events occur prior to the end of such five year period, including if we becomeBeing a “large accelerated filer,” our annual gross revenues exceed $1.07 billion, or we issue more than $1.0 billion of non-convertible debt in any three year period, we would cease to be an emerging growth company prior to the end of such five year period.

We may choose to take advantage of some but not all of these reduced requirements. We have taken advantage of certain of the reduced disclosure obligations, which include reduced executive compensation disclosure in this registration statement and may elect to take advantage of other reduced requirements in future filings. As a result, the information that we provide to our stockholders may be different than you might receive from other public reporting companies in which you hold equity interests.


Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards until such time as those standards apply to private companies. However, we have irrevocably elected not to avail ourselves of this extended transition period for complying with new or revised accounting standards and, therefore, we will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.Smaller Reporting Company

 

We are also a “smaller“smaller reporting company” as defined in Rule 12b-2 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and have elected to take advantage of certain of the scaled disclosure available to smaller reporting companies.

6

Corporate History

 

Reverse Merger and Related Transactions

On The primary business underlying Panbela Therapeutics, Inc., was originally incorporated under the laws of the State of Delaware under the name “Sun BioPharma, Inc.” in September 4,2011. In 2015, we completedit became a reversepublic company by completing a merger transaction in which SB Acquisition Corporation, Inc.,with a Delaware corporation and wholly-ownedwholly owned subsidiary of Cimarron Medical, Inc. (“Merger Sub”), merged with and into our predecessor, Sun BioPharma, Inc., a Delaware corporation (“SBI Delaware”), with SBI Delaware remaining aspublic company then organized under the surviving entity and a wholly-owned operating subsidiary of Cimarron Medical, Inc., a Utah Corporation (“Parent”). This transaction is referred to throughout this prospectus as the “Merger.” In the Merger, each outstanding share of capital stock of SBI Delaware was automatically exchanged for four shares of Parent common stock. As a resultlaws of the Merger,State of Utah. In 2016, it was reincorporated under the former stockholders of SBI Delaware owned approximately 95.0%laws of the sharesState of the outstanding capital stock of Parent. In connectionDelaware via a merger with the Merger, SBI Delawareour operating subsidiary. That company changed its name to “Sun BioPharma“Panbela Therapeutics, Inc.” on December 2, 2020. On June 15, 2022, we became a successor issuer to Panbela Therapeutics, Inc. and adopted its name, pursuant to a holding company reorganization via merger by operation of Rule 12g-3(a) promulgated under the Exchange Act, resulting in our current structure – consisting of two wholly owned subsidiaries: Panbela Research, Inc. and Parent changed its name to “Sun BioPharma,Cancer Prevention Pharmaceuticals, Inc.

 

Concurrent with the Merger, two former directors and then-majority shareholders of Parent, David Fuhrman and Robert Sargent (through his entity, Rare Principle, L.C.), sold (i) an aggregate of 57,126 shares of Parent common stock, and (ii) a $250,000 portion of loan indebtedness they were owed by Parent, to certain parties for total consideration of $250,000 (collectively, the “Stock and Debt Transactions”). The loan indebtedness was not modified from its existing terms and is not convertible into equity. The purchasers under the Stock and Debt Transactions consisted of the Ryan R. Gilbertson 2012 Irrevocable Family Trust, which acquired 47,109 shares and $125,000 principal amount of indebtedness; Douglas M. Polinsky, a then-former director of SBI Delaware, who acquired 21,670 shares and $100,000 principal amount of indebtedness; Providence Investments LLC, which acquired 17,053 shares and $25,000 principal amount of indebtedness; and Clearline Ventures, LLC, which acquired 21,800 shares. The Ryan R. Gilbertson 2012 Irrevocable Family Trust, Douglas M. Polinsky and Providence Investments LLC (or their respective affiliates) held shares of SBI Delaware common stock at the time of the Merger. As a result, the former stockholders of SBI Delaware owned approximately 99.0% of the shares of the outstanding capital stock of Parent after giving effect to both the Merger and the Stock and Debt Transactions.Corporate Information

 

Reincorporation

On May 25, 2016, we completed a reincorporation into the State of Delaware from the State of Utah pursuant to an agreement and plan of merger between Parent and Sun BioPharma Research, Inc. (formerly SBI Delaware). Upon the reincorporation, each outstanding certificate representing shares of Parent’s common stock was deemed, without any action by the holders thereof, to represent the same number and class of shares of our company’s common stock. As of May 25, 2016, the rights of our stockholders began to be governed by Delaware law and our current certificate of incorporation and bylaws.

Nasdaq Listing

We have applied to list our common stock and intend to apply to list the warrants on the Nasdaq Capital Market under the symbols “SNBP” and “SNBPW,” respectively. No assurance can be given that our applications will be approved or that a trading market will develop. Effective November 7, 2017, we implemented a 1-for-10 reverse split of our common stock. The reverse stock split was intended to increase the market price per share of our common stock to a level that qualifies for listing on the Nasdaq Capital Market. We are taking additional actions to meet the remaining listing requirements. Our share price on the OTCQB may not be indicative of the market price on the Nasdaq Capital Market, if we become listed.


Corporate Information

Sun BioPharma, Inc. was originally incorporated in Delaware in September 2011. Our corporate mailing address is 712 Vista Blvd, #305, Waconia, MN 55387. Our telephone number is (952) 479-1196, and our website is www.sunbiopharma.com.www.panbela.com. The information on our website is not part of this prospectus. We have included our website address as a factual reference and do not intend it to be an active link to our website. The information contained in or connected to our website is not incorporated by reference into, and should not be considered part of, this prospectus.

Sun BioPharma™, the Sun BioPharma logo, and other trademarks or service marks of Sun BioPharma, Inc. appearing in this prospectus are our property. Trade The trade names, trademarks, and service marks of other companies appearing in this prospectus are the property of the respective holders.

 


7

The OfferingTHE OFFERING

 

Common stock offered by us

834,028 3,007,519 shares of our common stock, (or 959,132including shares if the underwritersof common stock issuable upon exercise their over-allotment option in full)of pre-funded warrants, plus up to 6,015,038 additional shares of our common stock issuable upon exercise of common warrants.

  

WarrantsCommon warrants offered by us

Class E Common Warrants to purchase up to 417,0143,007,519 shares of our common stock, (or 479,566 shares ifwhich will be exercisable during the underwriters exerciseperiod commencing on the date of their over-allotment option in full)

Each warrant to purchase 0.50 shares of common stock will haveissuance and ending five years from such date at an exercise price of $15.00$     per share (125%of common stock (100% of the public offering price per share and common warrants).

Class F Common Warrants to purchase up to 3,007,519 shares of oneour common stock, which will be exercisable during the period commencing on the date of their issuance and ending five years from such date at an exercise price of $     per share of common stock and warrant to purchase 0.50 shares(100% of common stock and assuming athe public offering price of $12.00 per share and warrant), will be exercisable upon issuance and will expire five years from the date of issuance.common warrants).

  

Over-allotment optionPre-funded warrants offered by us         

We have grantedare also offering to certain purchasers whose purchase of our common stock in this offering would otherwise result in the underwriters an option for a periodpurchaser, together with its affiliates, beneficially owning more than 4.99% (or, at the election of up to 45 days to purchase up to 125,104 additionalthe purchaser, 9.99%) of our outstanding shares of common stock and/or warrantsimmediately following the consummation of this offering, the opportunity to purchase uppre-funded warrants (together with the common warrants, the “Warrants”) in lieu of common stock that would otherwise result in any such purchaser’s beneficial ownership exceeding 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding shares of common stock. Each pre-funded warrant will be exercisable for one share of common stock. The purchase price of each pre-funded warrant and the accompanying common warrants will equal the price at which the common stock and the accompanying common warrants are being sold to 62,552the public in this offering, minus $0.001, and the exercise price of each pre-funded warrant will be $0.001 per share. The pre-funded warrants will be exercisable immediately and may be exercised at any time until exercised in full. For each pre-funded warrant we sell, the number of shares of common stock we are offering will be decreased on a one-for-one basis. Because we will issue common warrants to cover over-allotments, if any.purchase 2 shares of common stock for each share of common stock and for each pre-funded warrant sold in this offering, the number of common warrants sold in this offering will not change as a result of a change in the mix of the shares of our common stock and pre-funded warrants sold.

Assumed public offering price

$6.65 per share of common stock and accompanying common warrant, or $0.914 per pre-funded warrant and accompanying common warrant, as applicable, in each case assuming a public offering price equal to the last sale price of our common stock as reported by the Nasdaq Capital Market on January 18, 2024, which was $6.65.

  

Common stock outstanding before this offering

3,670,432480,244 shares

  

Common stock to be outstanding immediately after this offering

4,504,460 3,487,763 shares (or 4,629,564(assuming we sell only shares ifof common stock and no pre-funded warrants, and none of the underwriters exercise their over-allotment optioncommon warrants issued in full)

this offering are exercised).

8

Use of proceeds

We estimate that the net proceeds from this offering will be up to approximately $8.8$18.3 million, or approximately $10.2 million if the underwriters exercise their over-allotment option in full, atbased on an assumed initialcombined public offering price of $12.00$6.65 per share of common stock and warrant,accompanying common warrants, after deducting the underwriting discounts and commissionsplacement agent fees and estimated offering expenses payable by us. We intend to use the net proceeds from this offering for the continued clinical development of our initial product candidate SBP-101, the repayment of approximately $350,000 of indebtedness,candidates ivospemin and eflornithine and for working capital, and other general corporate purposes.purposes, which may include repayment of debt. Because this is a best efforts offering with no minimum amount as a condition to closing, we may not sell all or any of the securities offered hereby. As a result, we may receive significantly less in net proceeds than we currently estimate. See “Use of Proceeds” on page 25.

21.

Representative’s warrants

The registration statement of which this prospectus is a part also registers for sale warrants to purchase up to 41,701 shares of our common stock to the representative of the underwriters as a portion of the underwriting compensation payable to the underwriters in connection with this offering. The warrants will be exercisable at any time, and from time to time, in whole or in part, during the four-year period commencing one year from the effective date of this offering at an exercise price equal to 115% of the public offering price of one share of common stock and warrant. Please see “Underwriting - Representative’s Warrants” for a description of these warrants.

Risk Factors

You should read the “Risk“Risk Factors” section of this prospectus beginning on page 10 for a discussion of factors to consider carefully before deciding to invest in our securities.

  

OTCQB symbol

SNBP”

Proposed Nasdaq Capital Market trading symbol

We have applied to list our common stock and intend to apply to list the warrants to be issued in this offering on the Nasdaq Capital Market under the symbols “SNBP” and “SNBPW,” respectively. There is no established public trading market for the warrants.“PBLA”


 

The number of shares of our common stock outstanding before and after this offering is based on 3,670,432an estimated 480,244 shares of our common stock outstanding as of December 7, 2017,January 18, 2024 and excludes:

 

 

417,014 all shares issuable upon the exercise of warrants sold in this offering;

pending settlements of fractional shares for cash in connection with the reverse stock split effected as of January 18, 2024;
 

683,960599 shares of common stock issuable upon the exercise of outstanding stock options as of the date of this prospectus at a weighted average exercise price of $9.77$13,297.06 per share; and

 

1,110,400 additional shares of common stock reserved and available for future issuances under our equity plans;

351,500340,952 shares of common stock issuable upon exercise of stock purchase warrants at a weighted average exercise price of $5.93$64.09 per share;

an estimated 315,970 shares of common stock potentially issuable pursuant to convertible promissory notes, including accrued but unpaid interest through December 7, 2017; and

41,701 shares of common stock issuable upon exercise of the warrants issued to the representative at the closing of this offering.share.

 

Unless otherwise indicated, all information in this prospectus assumes no exercise of the outstanding options or warrants or the conversion of shares issuable pursuant to convertible promissory notes.

Except as otherwise stated herein, the information in this prospectus assumes no exercise by the underwriters of their option to purchase up to 125,104 additional shares of common stock and/or warrants to purchase up to 62,552 shares of common stock to cover over-allotments, if any.warrants. 

 


9

SUMMARY CONSOLIDATED FINANCIAL DATA

The following selected historical financial information is derived from our consolidated financial statements appearing elsewhere in this prospectus and should be read in conjunction with our consolidated financial statements, including the accompanying notes thereto, beginning on page F-1. Our historical results for any period are not necessarily indicative of results to be expected in any other period, including the full fiscal year ending December 31, 2017. You should read this information together with the sections titled “Capitalization”, “Dilution” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included elsewhere in this prospectus.

Summary of Consolidated Statements of Operations
(in thousands, except share and per share amounts)

  

Nine months ended September 30,

  

Year ended December 31,

 
  

2017

  

2016

  

2016

  

2015

 
  

(unaudited)

  

(unaudited)

         

Operating Expenses:

                

General and administrative

 $2,252  $1,399  $2,664  $2,592 

Research and development

  1,955   1,657   2,504   2,852 

Total operating expenses

  4,207   3,056   5,168   5,444 

Operating loss

 $(4,207) $(3,056) $(5,168) $(5,444)

Other expense

 $(4,466) $(70) $(285) $(239)

Net loss

 $(8,213) $(2,874) $(5,112) $(4,927)
                 

Net loss per share - basic and diluted

 $(2.33) $(0.94) $(1.65) $(3.50)

Weighted average shares outstanding - basic and diluted

  3,518,839   3,069,195   3,106,846   1,407,293 

Summary Consolidated Balance Sheet Information
(in thousands)

      

December 31,

 
  

September 30,

2017

  

2016

  

2015

 
  

(unaudited)

         

Cash

 $943  $438  $925 

Total assets

 $1,533  $877  $1,732 

Current liabilities

 $2,149  $5,519  $1,375 

Long-term debt, net

 $1,483  $  $3,038 

Stockholders’ deficit

 $(2,099) $(4,642) $(2,681)



 

Risk FactorsRISK FACTORS

 

Any investment in our securities involves a high degree of risk. Investors should carefully consider the risks described below and all of the information contained in this prospectus before deciding whether to purchase our securities. Our business, financial condition or results of operations could be materially adversely affected by these risks if any of them actually occur. This prospectus also contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of certain factors, including the risks we face as described below and elsewhere in this prospectus.

 

Risks Related to Our Business and Financial Position

 

We are a pre-revenue company with limiteda history of negative operating history for you to evaluate our business.cash flow.

We have a limited operating history for you to consider in evaluating our business and prospects. As such, it is difficult for potential investors to evaluate our business.

 

We have experienced negative cash flows for our operating activities since inception, primarily due to the investments required to commercialize our primary drug candidate, SBP-101.candidates. Our financing cash flows historically have been positive due to proceeds from the sale of equity securities and promissory notes issuances. Our net cash used in operating activities was $2.4$15.3 million and $2.6$7.2 million for the yearyears ended December 31, 20162022 and for the nine months ended September 30, 2017,2021, respectively, and we had negative working capital of $4.6$6.0 million on December 31, 2022 and positive working capital of $9.6 million as of December 31, 2016 and $616,000 as of2021. For the quarter ended September 30, 2017.2023 we had approximately $0.9 million in cash and approximately $7.0 million in negative working capital. Working capital is defined as current assets less current liabilities.

 

Our operations are subject to all of the risks, difficulties, complications and delays frequently encountered in connection with the formationdevelopment of any new business,products, as well as those risks that are specific to the pharmaceutical and biotechnology industries in which we compete. Investors should evaluate us in light ofconsidering the delays, expenses, problems and uncertainties frequently encountered by companies developing markets for new products, services and technologies. We may never overcome these obstacles.

 

As a result of our current lack oflimited financial liquidity, we and our auditors have expressed substantial doubt regarding our ability to continue as a going concern.

 

As a result of our current lack oflimited financial liquidity, our auditorsauditors’ report for our 20162022 financial statements, which are included as part of this prospectus,is incorporated by reference herein, contains a statement concerning our ability to continue as a “going concern.” Our lack of sufficientlimited liquidity could make it more difficult for us to secure additional financing or enter into strategic relationships on terms acceptable to us, if at all, and may materially and adversely affect the terms of any financing that we may obtain and our public stock price generally.

 

Our continuation as a “going“going concern” is dependent upon, among other things, achieving positive cash flow from operations and, if necessary, augmenting such cash flow using external resources to satisfy our cash needs. Our plans to achieve positive cash flow primarily include engaging in offerings of securities. Additional potential sources of funds include negotiating up-front and milestone payments on our current and potential future product candidates or royalties from sales of our products that secure regulatory approval and any milestone payments associated with such approved products. These cash sources could, potentially, be supplemented by financing or other strategic agreements. However, we may be unable to achieve these goals or obtain required funding on commercially reasonable terms, or at all, and therefore may be unable to continue as a going concern.

Our lack of diversification increases the risk of an investment in our Company and our financial condition and results of operations may deteriorate if we fail to diversify.

Our Board of Directors has centered our attention on our drug development activities, which are currently focused on our initial product candidate SBP-101, the polyamine analogue compound we licensed from the UFRF. Our ability to diversify our investments will depend on our access to additional capital and financing sources and the availability and identification of suitable opportunities.


Larger companies have the ability to manage their risk by diversification. However, we lack and expect to continue to lack diversification, in terms of both the nature and geographic scope of our business. As a result, we will likely be impacted more acutely by factors affecting pharmaceutical and biotechnology industries in which we compete than we would if our business were more diversified, enhancing our risk profile. If we cannot diversify our operations, our financial condition and results of operations could deteriorate.

 

We may be unable to obtain the additional capital that is required to execute our business plan, which could restrict our ability to grow.

 

OurOur current capital and our other existing resources will be sufficient only to provide a limited amount of working capital and will not be sufficient to fund our expected continuing opportunities. Our capital at the end of the third quarter of 2023 and funds raised subsequent to September 30, 2023 will be sufficient to fund operations into the first quarter of 2024. We will require additional capital to continue to operate our business.business and complete our clinical development plans.

 

Future acquisitions, research and development, andincluding clinical trial cost, capital expenditures as well asand possible acquisitions, and our administrative requirements, such as clinical trial costs, salaries, insurance expenses and general overhead expenses, as well as legal compliance costs and accounting expenses, will require a substantial amount of additional capital and cash flow. There is no guarantee that we will be able to raise additional capital required to fund our ongoing business on commercially reasonable terms or at all.

 

We intend to pursue sources of additional capital through various financing transactions or arrangements, including collaboration arrangements, debt financing, equity financing or other means. We may not be successful in locating suitable financing transactions on commercially reasonable terms, in the time period required or at all, and we may not obtain the capital we require by other means. If we do not succeed in raising additional capital, our resources will not be sufficient to fund our operations going forward.

10

 

Any additional capital raised through the sale of equity may dilute the ownership percentage of our stockholders. This could also result in a decrease in the fair market value of our equity securities because our assets would be owned by a larger pool of outstanding equity. The terms of securities we issue in future capital transactions may be more favorable to our new investors, and may include preferences, superior voting rights and the issuance of warrants or other derivative securities which may have a further dilutive effect.

 

Our ability to obtain needed financing may be impaired by such factors as the capital markets, both generally and in the pharmaceutical and other drug development industries in particular, our status as a new enterprise without a significant demonstrated operating history, the limited diversity of our activities and/or the loss of key personnel. If the amount of capital we are able to raise from financing activities is not sufficient to satisfy our capital needs, even to the extent that we reduce our operations, we may be required to cease our operations.

 

We may incur substantial costs in pursuing future capital financing, including investment banking fees, legal fees, accounting fees, securities law compliance fees, printing and distribution expenses and other costs, which may adversely impact our financial condition.

 

We may not be able to effectively manage our growth, which may harm our profitability.

Our strategy envisions expanding our business. If we fail to effectively manage our growth, our financial results could be adversely affected. Growth may place a strain on our management systems and resources. We must continue to refine and expand our business development capabilities, our systems and processes and our access to financing sources. As we grow, we must continue to hire, train, supervise and manage new employees. We cannot assure you that we will be able to:

expand our systems effectively or efficiently or in a timely manner;

allocate our human resources optimally;

identify and hire qualified employees or retain valued employees; or

incorporate effectively the components of any business that we may acquire in our effort to achieve growth.

If we are unable to manage our growth, our operations and our financial results could be adversely affected by inefficiency, which could diminish our profitability.


Our business may suffer if we do not attract and retain talented personnel.

Our success will depend in large measure on the abilities, expertise, judgment, discretion, integrity and good faith of our management and other personnel in conducting our business. We have a small management team, and the loss of a key individual or inability to attract suitably qualified staff could materially adversely impact our business.

Our success depends on the ability of our management, employees, consultants and joint venture partners, if any, to interpret market data correctly and to interpret and respond to economic market and other conditions in order to locate and adopt appropriate investment opportunities, monitor such investments, and ultimately, if required, to successfully divest such investments. Further, no assurance can be given that our key personnel will continue their association or employment with us or that replacement personnel with comparable skills can be found. We will seek to ensure that management and any key employees are appropriately compensated; however, their services cannot be guaranteed. If we are unable to attract and retain key personnel, our business may be adversely affected.

The marketmarkets for our product candidate iscandidates are highly competitive and isare subject to rapid scientific change, which could have a material adverse effect on our business, results of operations and financial condition.

 

The pharmaceutical and biotechnology industries in which we compete are highly competitive and characterized by rapid and significant technological change. We face intense competition from organizations such as pharmaceutical and biotechnology companies, as well as academic and research institutions and government agencies. Some of these organizations are pursuing products based on technologies similar to our technology. Other of these organizations have developed and are marketing products or are pursuing other technological approaches designed to produce products that are competitive with our product candidates in the therapeutic effect these competitive products have on the diseasediseases targeted by our product candidate.candidates. Our competitors may discover, develop or commercialize products or other novel technologies that are more effective, safer or less costly than any that we may develop. Our competitors may also obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for our product candidate.candidates.

 

Many of our competitors are substantially larger than we are and have greater capital resources, research and development staffs and facilities than we have. In addition, many of our competitors are more experienced in drug discovery, development and commercialization, obtaining regulatory approvals and drug manufacturing and marketing.

 

We anticipate that the competition with our product candidatecandidates and technology will be based on a number of factors including product efficacy, safety, availability and price. The timing of market introduction of our planned future product candidates and competitive products will also affect competition among products. We expect the relative speed with which we can develop our product candidate,candidates, complete the required clinical trials, establish a strategic partnerpartners and supply appropriate quantities of the product candidate for late stage trials, if required, to be important competitive factors. Our competitive position will also depend upon our ability to attract and retain qualified personnel, to obtain patent protection in non-U.S. markets, which we currently do not have, or otherwise develop proprietary products or processes and to secure sufficient capital resources for the period between technological conception and commercial sales or out-license to a pharmaceutical partner.partners. If we fail to develop and deploy oura proposed product candidate in a successful and timely manner, we will in all likelihood not be competitive.

 

Our lack of diversification increases the risk of an investment in our Company and our financial condition and results of operations may deteriorate if we fail to diversify.

Our Board of Directors has centered our attention on our drug development activities, which are currently focused on a limited number of product candidates. Our ability to diversify our investments will depend on our access to additional capital and financing sources and the availability and identification of suitable opportunities.

Larger companies have the ability to manage their risk by diversification. However, we lack and expect to continue to lack diversification, in terms of both the nature and geographic scope of our business. As a result, we will likely be impacted more acutely by factors affecting pharmaceutical and biotechnology industries in which we compete than we would if our business were more diversified, enhancing our risk profile. If we cannot diversify our operations, our financial condition and results of operations could deteriorate.

Our business may suffer if we do not attract and retain talented personnel.

Our success will depend in large measure on the abilities, expertise, judgment, discretion, integrity and good faith of our management and other personnel in conducting our business. We have a small management team, and the loss of a key individual or inability to attract suitably qualified staff could materially adversely impact our business.


11

 

Our success depends on the ability of our management, employees, consultants and strategic partners, if any, to interpret market data correctly and to interpret and respond to economic market and other conditions in order to locate and adopt appropriate investment opportunities, monitor such investments, and ultimately, if required, to successfully divest such investments. Further, no assurance can be given that our key personnel will continue their association or employment with us or that replacement personnel with comparable skills can be found. We will seek to ensure that management and any key employees are appropriately compensated; however, their services cannot be guaranteed. If we are unable to attract and retain key personnel, our business may be adversely affected.

We may be required to defend lawsuits or pay damages for product liability claims.

Product liability is a major risk in testing and marketing biotechnology and pharmaceutical products. We may face substantial product liability exposure in human clinical trials and in the sale of products after regulatory approval. Product liability claims, regardless of their merits, could exceed policy limits, divert management’s attention and adversely affect our reputation and the demand for our product. In any such event, your investment in our securities could be materially and adversely affected.

Risks Related to the Development and Approval of New Drugs

Clinical trials required for our product candidate are expensive and time-consuming, and their outcome is highly uncertain. If any of our drug trials are delayed or yield unfavorable results, we will have to delay or may be unable to obtain regulatory approval for our product candidate.

We must conduct extensive testing of each product candidate before we can obtain regulatory approval to market and sell it. We need to conduct both preclinical animal testing and human clinical trials. Conducting these trials is a lengthy, time-consuming and expensive process. These tests and trials may not achieve favorable results for many reasons, including, among others, failure of the product candidate to demonstrate safety or efficacy, the development of serious or life-threatening adverse events, or side effects, caused by or connected with exposure to the product candidate, difficulty in enrolling and maintaining subjects in the clinical trial, lack of sufficient supplies of the product candidate or comparator drug, and the failure of clinical investigators, trial monitors, contractors, consultants, or trial subjects to comply with the trial protocol. A clinical trial may fail because it did not include a sufficient number of patients to detect the endpoint being measured or reach statistical significance. A clinical trial may also fail because the dose(s) of the investigational drug included in the trial were either too low or too high to determine the optimal effect of the investigational drug in the disease setting. Many clinical trials are conducted under the oversight of Independent Data Monitoring Committees (“IDMCs”) also known as DSMB’s. These independent oversight bodies are made up of external experts who review the progress of ongoing clinical trials, including available safety and efficacy data, and make recommendations concerning a trial’s continuation, modification, or termination based on interim, unblinded data. Any of our ongoing clinical trials may be discontinued or amended in response to recommendations made by responsible IDMCs based on their review of such interim trial results.

We will need to reevaluate our product candidates if they do not test favorably and either conduct new trials, which are expensive and time consuming, or abandon our drug development program. Even if we obtain positive results from preclinical or clinical trials, we may not achieve the same success in future trials. Many companies in the biopharmaceutical industry have suffered significant setbacks in clinical trials, even after promising results have been obtained in earlier trials. The failure of clinical trials to demonstrate safety and effectiveness for the desired indication could harm the development of our product candidate and our business, financial condition and results of operations may be materially harmed.

12

We face significant risks in our product candidate development efforts.

 

Our business depends on the successful development and commercialization of our product candidates.candidates. We are currently focused on developing our initial product candidate, SBP-101,ivospemin, for the treatment of Pancreatic ductal adenocarcinoma (“PDA”)PDA and are not permitted to market it in the United States until we receive approval of a new drug application (“NDA”)an NDA from the FDA, or in any foreign jurisdiction until we receive the requisite approvals from such jurisdiction. The process of developing new drugs and/or therapeutic products is inherently complex, unpredictable, time-consuming, expensive and uncertain. We must make long-term investments and commit significant resources before knowing whether our development programs will result in drugs that will receive regulatory approval and achieve market acceptance. A product candidate that appears to be promising at all stages of development may not reach the market for a number of reasons that may not be predictable based on results and data from the clinical program. A product candidatescandidate may be found ineffective or may cause harmful side effects during clinical trials, may take longer to progress through clinical trials than had been anticipated, may not be able to achieve the pre-defined clinical endpoints even though clinical benefit may have been achieved, may fail to receive necessary regulatory approvals, may prove impracticable to manufacture in commercial quantities at reasonable cost and with acceptable quality, or may fail to achieve market acceptance.

 

We cannot predict whether or when we will obtain regulatory approval to commercialize our initial product candidatecandidates and we cannot, therefore, predict the timing of any future revenues from this or other product candidates, if any. The FDA has substantial discretion in the drug approval process, including the ability to delay, limit or deny approval of a product candidate for many reasons. For example, the FDA:

 

 

could determine that the information provided by us was inadequate, contained clinical deficiencies or otherwise failed to demonstrate the safety and effectiveness of any of our product candidates for any indication;

 

 

may not find the data from clinical trials sufficient to support the submission of an NDA or to obtain marketing approval in the United States, including any findings that the clinical and other benefits of our product candidates outweigh their safety risks;

 

 

may disagree with our trial design or our interpretation of data from preclinical studies or clinical trials or may change the requirements for approval even after it has reviewed and commented on the design for our trials;

 

 

may identify deficiencies in the manufacturing processes or facilities of third-party manufacturers with which we enter into agreements for the manufacturing of our product candidates;

 

 

may approve our product candidates for fewer or more limited indications than we request or may grant approval contingent on the performance of costly post-approval clinical trials;

 

 

may change its approval policies or adopt new regulations; or

 

 

may not approve the labeling claims that we believe are necessary or desirable for the successful commercialization of our product candidates.

 

Any failure to obtain regulatory approval of our initial product candidate or future product candidates we develop, if any, would significantly limit our ability to generate revenues, and any failure to obtain such approval for all of the indications and labeling claims we deem desirable could reduce our potential revenues.

 

Our product candidate iscandidates are based on a new formulation of an existing technology which has never been approved for the treatment of any cancer and, consequently, is inherently risky. Concerns about the safety and efficacy of our product candidate could limit our future success.

 

We are subject to the risks of failure inherent in the development of product candidates based on new technologies. These risks include the possibility that any product candidates we create will not be effective, that our current product candidate will be unsafe, ineffective or otherwise fail to receive the necessary regulatory approvals or that our product candidate will be hard to manufacture on a large scale or will be uneconomical to market.

 


Many pharmaceutical products cause multiple potential complications and side effects, not all of which can be predicted with accuracy and many of which may vary from patient to patient. Long term follow-up data may reveal additional complications associated with our product candidate. The responses of potential physicians and others to information about complications could materially affect the market acceptance of our product candidate, which in turn would materially harm our business.

 

Clinical trials required for our product candidate are expensive and time-consuming, and their outcome is highly uncertain. If any of our drug trials are delayed or yield unfavorable results, we will have to delay application for or may be unable to obtain regulatory approval for our product candidate.

We must conduct extensive testing of our product candidate before we can obtain regulatory approval to market and sell it. We need to conduct both preclinical animal testing and human clinical trials. Conducting these trials is a lengthy, time-consuming and expensive process. These tests and trials may not achieve favorable results for many reasons, including, among others, failure of the product candidate to demonstrate safety or efficacy, the development of serious or life-threatening adverse events, or side effects, caused by or connected with exposure to the product candidate, difficulty in enrolling and maintaining subjects in the clinical trial, lack of sufficient supplies of the product candidate or comparator drug, and the failure of clinical investigators, trial monitors, contractors, consultants, or trial subjects to comply with the trial protocol. A clinical trial may fail because it did not include a sufficient number of patients to detect the endpoint being measured or reach statistical significance. A clinical trial may also fail because the dose(s) of the investigational drug included in the trial were either too low or too high to determine the optimal effect of the investigational drug in the disease setting. Many clinical trials are conducted under the oversight of Independent Data Monitoring Committees (“IDMCs”). These independent oversight bodies are made up of external experts who review the progress of ongoing clinical trials, including available safety and efficacy data, and make recommendations concerning a trial’s continuation, modification, or termination based on interim, unblinded data. Any of our ongoing clinical trials may be discontinued or amended in response to recommendations made by responsible IDMCs based on their review of such interim trial results.

We will need to reevaluate our product candidate if it does not test favorably and either conduct new trials, which are expensive and time consuming, or abandon our drug development program. Even if we obtain positive results from preclinical or clinical trials, we may not achieve the same success in future trials. Many companies in the biopharmaceutical industry have suffered significant setbacks in clinical trials, even after promising results have been obtained in earlier trials. The failure of clinical trials to demonstrate safety and effectiveness for the desired indication could harm the development of our product candidate and our business, financial condition and results of operations may be materially harmed.

The results of pre-clinical studies and completed clinical trials are not necessarily predictive of future results, and our current product candidates may not have favorable results in later studies or trials.

Pre-clinical studies and Phase 1 and Phase 2 clinical trials are not primarily designed to test the efficacy of a product candidate in the general population, but rather to test initial safety, to study pharmacokinetics and pharmacodynamics, to study limited efficacy in a small number of study patients in a selected disease population, and to identify and attempt to understand the product candidate’s side effects at various doses and dosing schedules. Success in pre-clinical studies or completed clinical trials does not ensure that later studies or trials, including continuing pre-clinical studies and large-scale clinical trials, will be successful nor does it necessarily predict future results. Favorable results in early studies or trials may not be repeated in later studies or trials, and product candidates in later stage trials may fail to show acceptable safety and efficacy despite having progressed through earlier trials.


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Due to our reliance on third-partiesthird parties to conduct our clinical trials, we are unable to directly control the timing, conduct, expense and quality of our clinical trials, which could adversely affect our clinical data and results and related regulatory approvals.

 

We extensively outsource our clinical trial activities and expect to directly perform only a small portion of the preparatory stages for planned trials. We rely on independent third-party contract research organizations (“CROs”)CROs to perform most of our clinical trials, including document preparation, site identification, screening and preparation, pre-study visits, training, program management and bio-analytical analysis. Many important aspects of the services performed for us by the CROs are out of our direct control. If there is any dispute or disruption in our relationship with our CROs, our clinical trials may be delayed. Moreover, in our regulatory submissions, we rely on the quality and validity of the clinical work performed by third-party CROs. If a CRO’s processes, methodologies or results are determined to be invalid or inadequate, our own clinical data and results and related regulatory approvals could be adversely affected or invalidated.

Regulatory and legal uncertainties could result in significant costs or otherwise harm our business.

In order to manufacture and sell our product candidate, we must comply with extensive international and domestic regulations. In order to sell our product candidate in the United States, approval from the FDA is required. The FDA approval process is expensive and time-consuming. We cannot predict whether our product candidate will be approved by the FDA. Even if our product candidate is approved, we cannot predict the time frame for such approval. Foreign regulatory requirements differ from jurisdiction to jurisdiction and may, in some cases, be more stringent or difficult to obtain than FDA approval. As with the FDA, we cannot predict if or when we may obtain these regulatory approvals. If we cannot demonstrate that our product candidate can be used safely and successfully in a broad enough segment of the indicated patient population for a satisfactory length of time, our product candidate would likely be denied approval by the FDA and the regulatory agencies of foreign governments.

 

We may be unable to formulate or manufacture our product candidate in a way that is suitablerely on third-party suppliers and other third parties for commercial use.

Changes in product formulations and manufacturing processes may be required as our product candidate progresses in clinical development and is ultimately commercialized. If we are unable to develop suitable product formulations or manufacturing processes to support large scale clinical testingproduction of our product candidate, wecandidates and our dependence on these third parties may be unable to supply necessary materials forimpair the advancement of our clinical trials, which would delayresearch and development programs and the development of our product candidate. Similarly, if we are unable to supply sufficient quantities of our product candidate or develop product formulations suitable for commercial use, we will not be able to successfully commercialize our product candidate.candidates.

 

We lack sales, marketingrely on, and distribution capabilities and currently expect to continue to rely on, third parties for the supply of raw materials and manufacture of drug supplies necessary to marketconduct our preclinical studies and distributeclinical trials. During 2021 the Company, in collaboration with our manufacturing partner confirmed a new shorter and less expensive synthesis of the active drug substance. However, delays in production by third parties could delay our clinical trials or have an adverse impact on any commercial activities. In addition, the fact that we are dependent on third parties for the manufacture of and formulation of our product candidate,candidates means that we are subject to the risk that the products may have manufacturing defects that we have limited ability to prevent or control. Although we oversee these activities to ensure compliance with our quality standards, budgets and timelines, we have had and will continue to have less control over the manufacturing of our product candidates than potentially would be the case if we were to manufacture our product candidates. Further, the third parties we deal with could have staffing difficulties, might undergo changes in priorities or may become financially distressed, which would adversely affect the manufacturing and production of our product candidates.

The results of pre-clinical studies and completed clinical trials are not necessarily predictive of future results, and our current product candidates may harmnot have favorable results in later studies or delay our commercialization efforts.trials.

 

We currently have no sales, marketing, or distribution capabilitiesPre-clinical studies and doPhase I clinical trials are not currently intendprimarily designed to develop such capabilitiestest the efficacy of a product candidate in the foreseeable future. If we are unablegeneral population, but rather to partner withtest initial safety, to study pharmacokinetics and pharmacodynamics, to study limited efficacy in a larger pharmaceutical organization havingsmall number of study patients in a selected disease population, and to identify and attempt to understand the expertiseproduct candidate’s side effects at various doses and capacity to perform these functions, then we maydosing schedules. Success in pre-clinical studies or completed clinical trials does not ensure that later studies or trials, including continuing pre-clinical studies and large-scale clinical trials, will be unable to sell any product that we develop. Wesuccessful nor does it necessarily predict future results. Favorable results in early studies or trials may not be ablerepeated in later studies or trials, and product candidates in later stage trials may fail to enter into any necessary arrangements, including marketing or distribution agreements, onshow acceptable terms, if at all. Should our strategic partners, if any, be unable to effectively sell our products, then our ability to generate revenues will be significantly harmed.safety and efficacy despite having progressed through earlier trials.

 

We may be required to defend lawsuits or pay damages for product liability claims.

Product liability is a major risk in testing and marketing biotechnology and pharmaceutical products. We may face substantial product liability exposure in human clinical trials and in the sale of products after regulatory approval. Product liability claims, regardless of their merits, could exceed policy limits, divert management’s attention, and adversely affect our reputation and the demand for our product. In any such event, your investment in our securities could be materially and adversely affected.


Risks Related to the Regulation of our Business

 

Federal and state pharmaceutical marketing compliance and reporting requirements may expose us to regulatory and legal action by state governments or other government authorities.

 

The Food and Drug Administration Modernization Act (the “FDMA”“FDMA”), established a public registry of open clinical trials involving drugs intended to treat serious or life-threatening diseases or conditions in order to promote public awareness of and access to these clinical trials. Under the FDMA, pharmaceutical manufacturers and other trial sponsors are required to post the general purpose of these trials, as well as the eligibility criteria, location and contact information of the trials. Failure to comply with any clinical trial posting requirements could expose us to negative publicity, fines and other penalties, all of which could materially harm our business.

 

In recent years, several states, including California, Vermont, Maine, Minnesota, New Mexico and West Virginia, have enacted legislation requiring pharmaceutical companies to establish marketing compliance programs and file periodic reports on sales, marketing, pricing and other activities. Similar legislation is being considered in other states. Many of these requirements are new and uncertain, and available guidance is limited. Unless we are in full compliance with these laws, we could face enforcement actions and fines and other penalties and could receive adverse publicity, all of which could harm our business.

 

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If any of the product candidatecandidates we develop becomesbecome subject to unfavorable pricing regulations, third party reimbursement practices or healthcare reform initiatives, our ability to successfully commercialize our product candidatecandidates may be impaired.

 

Our future revenues, profitability and access to capital will be affected by the continuing efforts of governmental and private third partythird-party payors to contain or reduce the costs of health care through various means. We expect a number ofseveral federal, state and foreign proposals to control the cost of drugs through government regulation. We are unsure of the impact recent health care reform legislation may have on our business or what actions federal, state, foreign and private payors may take in response to the recent reforms. Therefore, it is difficult to predict the effect of any implemented reform on our business. Our ability to commercialize our product candidatecandidates successfully will depend, in part, on the extent to which reimbursement for the cost of such product candidate and related treatments will be available from government health administration authorities, such as Medicare and Medicaid in the United States, private health insurers and other organizations. Significant uncertainty exists as to the reimbursement status of newly approved health care products, particularly for indications for which there is no current effective treatment or for which medical care typically is not sought. Adequate third partythird-party coverage may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product research and development. If adequate coverage and reimbursement levels are not provided by government and third partythird-party payors for use of our product candidates, our product candidates may fail to achieve market acceptance and our results of operations will be harmed.

 

Healthcare legislative reform measures may have a material adverse effect on our business and results of operations.

 

Legislative and regulatory actions affecting government prescription drug procurement and reimbursement programs occur relatively frequently. In the United States, therethe ACA was enacted in 2010 to expand healthcare coverage. Since then, numerous efforts have been made to repeal, amend or administratively limit the ACA in whole or in part. For example, the Tax Cuts and continueJobs Act, signed into law by President Trump in 2017, repealed the individual health insurance mandate, which is considered a key component of the ACA. In December 2018, a Texas federal district court struck down the ACA on the grounds that the individual health insurance mandate is unconstitutional, although this ruling has been stayed pending appeal. The ongoing challenges to the ACA and new legislative proposals have resulted in uncertainty regarding the ACA's future viability and destabilization of the health insurance market. The resulting impact on our business is uncertain and could be material.

Efforts to control prescription drug prices could also have a number of legislative initiatives to contain healthcare costs.material adverse effect on our business. For example, in March 2010,2018, President Trump and the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (“PPACA”), was passed, which substantially changed the way health care is financed by both governmental and private insurers, and has significantly impactedSecretary of the U.S. Department of Health and Human Services (“HHS”) released the "American Patients First Blueprint" and have begun implementing certain portions. The initiative includes proposals to increase generic drug and biosimilar competition, enable the Medicare program to negotiate drug prices more directly and improve transparency regarding drug prices and ways to lower consumers' out-of-pocket costs. The Trump administration also proposed to establish an “international pricing index” that would be used as a benchmark to determine the costs and potentially limit the reimbursement of drugs under Medicare Part B. Among other pharmaceutical industry. PPACA, among other things, subjects biologicmanufacturer industry-related proposals, Congress has proposed bills to change the Medicare Part D benefit to impose an inflation-based rebate in Medicare Part D and to alter the benefit structure to increase manufacturer contributions in the catastrophic phase. The volume of drug pricing-related bills has dramatically increased under the current Congress, and the resulting impact on our business is uncertain and could be material.

In addition, many states have proposed or enacted legislation that seeks to regulate pharmaceutical drug pricing indirectly or directly, such as by requiring biopharmaceutical manufacturers to publicly report proprietary pricing information or to place a maximum price ceiling on pharmaceutical products purchased by state agencies. For example, in 2017, California’s governor signed a prescription drug price transparency state bill into law, requiring prescription drug manufacturers to potential competitionprovide advance notice and explanation for price increases of certain drugs that exceed a specified threshold. Both Congress and state legislatures are considering various bills that would reform drug purchasing and price negotiations, allow greater use of utilization management tools to limit Medicare Part D coverage, facilitate the import of lower-priced drugs from outside the United States and encourage the use of generic drugs. The Inflation Reduction Act passed by lower-cost biosimilars, addressesCongress allows Medicare to negotiate the prices of the prescription drugs. Such initiatives and legislation may cause added pricing pressures on our products.

Changes to the Medicaid program at the federal or state level could also have a new methodology by which rebates owed by manufacturersmaterial adverse effect on our business. Proposals that could impact coverage and reimbursement of our products, including giving states more flexibility to manage drugs covered under the Medicaid Drug Rebate Program are calculated for drugsprogram and permitting the re-importation of prescription medications from Canada or other countries, could have a material adverse effect by limiting our products’ use and coverage. Furthermore, state Medicaid programs could request additional supplemental rebates on our products as a result of an increase in the federal base Medicaid rebate. To the extent that are inhaled, infused, instilled, implantedprivate insurers or injected, increases the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extends the rebate program to individuals enrolled in Medicaid managed care organizations, establishes annual feesprograms follow Medicaid coverage and taxespayment developments, they could use the enactment of these increased rebates to exert pricing pressure on our products, and the adverse effects may be magnified by their adoption of lower payment schedules.

Other proposed regulatory actions affecting manufacturers could have a material adverse effect on our business. It is difficult to predict the impact, if any, of certain branded prescription drugsany such proposed legislative and subjects additional drugs to lower pricing underregulatory actions or resulting state actions on the 340B Drug Discount Program by adding new entities touse and reimbursement of our products in the program.United States, but our results of operations may be adversely affected.

 


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Risks Related to Ourour Intellectual Property

UFRF, our sole licensor, may under certain circumstances terminate our license agreement, which is required for us to conduct our proposed business.

Our license agreement with UFRF provides it with the right to terminate our agreement upon written notice to us if we do not meet all of our requirements under the license agreement that requires us to file an IND application with the FDA, have a commercial sale of a licensed product on or before December 31, 2020 and raise certain amounts of capital. If the license or any other agreement we enter into with UFRF is terminated for any reason, our business could be materially adversely affected, and our business would in all likelihood fail.

 

If we are unable to obtain, maintain and enforce our proprietary rights, we may not be able to compete effectively or operate profitably.

 

We have entered intoFor ivospemin, we are party to a license agreement with UFRF.the University of Florida Research Foundation (“UFRF”) and for Flynpovi, we are party to a license agreement with the Arizona Board of Regents of the University of Arizona. The patentpatents underlying the licensed intellectual property and those of other biopharmaceutical companies are generally uncertain and involve complex legal, scientific and factual questions.

 

Our ability to develop and commercialize drugs depends in significant part on our ability to: (i) obtain and/or develop broad, protectable intellectual property; (ii) obtain additional licenses, if required, to the proprietary rights of others on commercially reasonable terms; (iii) operate without infringing upon the proprietary rights of others; (iv) prevent others from infringing on our proprietary rights; and (v) protect our corporate know-how and trade secrets.

 

Patents that we may acquire, and those that might be issued in the future, may be challenged, invalidated or circumvented, and the rights granted thereunder may not provide us with proprietary protection or competitive advantages against competitors with similar technology. Furthermore, our competitors may independently develop similar technologies or duplicate any technology we develop. Because of the extensive time required for development, testing and regulatory review of a potential product candidates, it is possible that, before any of our product candidates can be commercialized, any related patent may expire or remain in force for only a short period following commercialization, thus reducing any advantage of the patent.

 

Because patent applications in the U.S. and many foreign jurisdictions are typically not published until at least 12 months after filing, or in some cases not at all, and because publications of discoveries in the scientific literature often lag behind actual discoveries, neither we nor our licensors can be certain that either we or our licensors were the first to make the inventions claimed in issued patents or pending patent applications, or that we were the first to file for protection of the inventions set forth in these patent applications.

 

Additionally, UFRF previously elected to seek protection for certain elements of the licensed technology only in the United States, and the time to file for international patent protection has expired. This limits the strength of the Company’sCompany’s intellectual property position in certain markets and could affect the overall value of the Company to a potential corporate partner.

Obtaining and maintaining our patent protection depends upon compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

The United States Patent and Trademark Office and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process. There are situations in which noncompliance can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, competitors might be able to enter the market earlier than would otherwise have been the case.

 

We may be exposed to infringement or misappropriation claims by third parties, which, if determined adversely to us, could cause us to pay significant damage awards.

 

There has been substantial litigation and other proceedings regarding patent and other intellectual property rights in the pharmaceutical and biotechnology industries. We may become a party to various types of patent litigation or other proceedings regarding intellectual property rights from time to time even under circumstances where we are not using and do not intend to use any of the intellectual property involved in the proceedings.

 

The cost of any patent litigation or other proceeding, even if resolved in our favor, could be substantial. Some of our competitors may be able to sustain the cost of such litigation or proceedings more effectively than we will be able to because our competitors may have substantially greater financial resources. If any patent litigation or other proceeding is resolved against us, we or our collaborators may be enjoined from developing, manufacturing, selling or importing our drugs without a license from the other party and we may be held liable for significant damages. We may not be able to obtain any required license(s) on commercially acceptable terms or at all.

 


Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace. Patent litigation and other proceedings may also absorb significant management time.

 

Obtaining and maintaining our patent protection depends upon compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

The United States Patent and Trademark Office and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process. There are situations in which noncompliance can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, competitors might be able to enter the market earlier than would otherwise have been the case.

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Confidentiality agreements with employees and others may not adequately prevent disclosure of our know-how, trade secrets and other proprietary information and may not adequately protect our intellectual property, which could impede our ability to compete.

 

Because we operate in the highly technical field of medical technology development, we rely in part on trade secret protection in order to protect our proprietary trade secrets and unpatented know-how. However, trade secrets are difficult to protect, and we cannot be certain that others will not develop the same or similar technologies on their own. We have taken steps, including entering into confidentiality agreements with all of our employees, consultants and corporate partners, to protect our trade secrets and unpatented know-how. These agreements generally require that the other party keep confidential and not disclose to third parties any confidential information developed by the party or made known to the party by us during the course of the party’sparty’s relationship with us. We also typically obtain agreements from these parties which provide that inventions conceived by the party in the course of rendering services to us will be our exclusive property. However, these agreements may not be honored and may not effectively assign intellectual property rights to us. Enforcing a claim that a party illegally obtained and is using our trade secrets or know-how is difficult, expensive and time consuming, and the outcome is unpredictable. In addition, courts outside the United States may be less willing to protect trade secrets or know-how. The failure to obtain or maintain trade secret protection could adversely affect our competitive position.

 

We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.

 

As is common in the biotechnology industry, we employ individuals who were previously employed at other biotechnology companies, including our competitors or potential competitors. Although no claims against us are currently pending, we may be subject to claims that these employees or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.

 


Risks Related toAssociated with this Offering and Ownership of our SecuritiesOur Common Stock

 

Our directors, executive officersWe could be delisted from Nasdaq, which would seriously harm the liquidity of our stock and significant stockholders have substantial control over us and could limit stockholdersour ability to influence the outcome of key transactions, including changes of control.raise capital.

 

AsDuring the first quarter of December 7, 20172023 we cured previously identified minimum bid price and minimum stockholders’ equity deficiencies and regained compliance with all applicable listing standards of Nasdaq. On April 14, 2023, we had received a notification letter from Nasdaq’s Listing Qualifications Department indicating that for 30 consecutive business days our directors and executive officers beneficially owned 30.6%common stock did not maintain a minimum closing bid price of $1.00 per share as required by Nasdaq Listing Rule 5550(a)(2) (“Minimum Bid Price Requirement”). Nasdaq granted us an extension until October 11, 2023 to regain compliance with the Minimum Bid Price Requirement for continued listing on the Nasdaq Capital Market. At our annual meeting of stockholders held on May 25, 2023, stockholders approved an amendment to our Restated Certificate of Incorporation to effect a reverse stock split of our outstanding common stock within a prescribed range. Pursuant to that authority, our Board of Directors approved a 1-for-30 reverse split ratio and together are ableour company effected the reverse stock split on June 1, 2023. The primary reason for the reverse stock split was to influence significantly all matters requiring approvalattempt to increase the per share market price of our common stock to exceed the Minimum Bid Price Requirement for continued listing on the Nasdaq Capital Market. On June 15, 2023, we received a notification letter from the Listing Qualifications Department of Nasdaq indicating that we regained compliance with the Minimum Bid Price Requirement as the closing bid price of our common stock met or exceeded $1.00 per share for a minimum of ten consecutive business days during the 180-calendar day grace period.

Subsequently, we have requested and been granted a hearing to appeal the staff determination letter we received from Nasdaq on November 28, 2023, which letter communicated that Nasdaq would suspend trading in our common stock and file a Form 25-NSE with the Securities and Exchange Commission, which would remove our common stock from listing and registration on Nasdaq, unless we appealed its delisting determination by requesting a hearing before the Nasdaq Hearings Panel. The suspension of trading and delisting of the company’s common stock has been stayed pending the conclusion of the hearing process. Consequently, our stockholders. In addition, four holderscommon stock is expected to remain listed on the Nasdaq Capital Market at least until the panel renders a decision following the hearing. There can be no assurance that the panel will grant the company’s appeal for continued listing on The Nasdaq Capital Market. The determination letter communicated that our company (i) has not maintained a minimum closing bid price of greater than five percent$1.00 per share as required by the Minimum Bid Price Requirement and (ii) is not in compliance with the Minimum Stockholders’ Equity Requirement. Effective January 18, 2024, we completed a 1-for-20 reverse split of our outstanding shares of common stock.  The primary reason we effected a reverse stock split is to potentially increase the per share market price of our common stock beneficially owned 32.7% and, acting together, would be able to influence significantly all matters requiring approval bysatisfy the Minimum Bid Price Requirement. Additionally, it is our stockholders, includingintention that the election of directorsnet proceeds from this public offering will allow us to regain compliance with the Minimum Stockholders’ Equity Requirement. We believe that if we are unable to regain compliance with both the Minimum Bid Price Requirement and the approvalMinimum Stockholders’ Equity Requirement, it is likely that our common stock will be delisted from the Nasdaq Capital Market.

While we have regained compliance in the past, if, for any reason, Nasdaq were to delist our securities from trading on The Nasdaq Capital Market and we were unable to obtain listing on another reputable national securities exchange, a reduction in some or all of mergers or other significant corporate transactions. These stockholdersthe following may occur, each of which could materially adversely affect our stockholders:

the liquidity and marketability of our common stock;

the market price of our common stock;

our ability to obtain financing for the continuation of our operations;

the number of institutional and general investors that will consider investing in our common stock;

the number of market makers in our common stock;

the availability of information concerning the trading prices and volume of our common stock; and

the number of broker-dealers willing to execute trades in shares of our common stock.

In addition, if we cease to be listed on The Nasdaq Capital Market, we may have intereststo pursue trading on a less recognized or accepted market, such as the over the counter markets, our stock may be traded as a “penny stock”, which would make transactions in our stock more difficult and cumbersome, and we may be unable to access capital on favorable terms or at all, as companies trading on alternative markets may be viewed as less attractive investments with higher associated risks, such that differexisting or prospective institutional investors may be less interested in, or prohibited from, investing in our common stock. This may also cause the market price of our common stock to further decline.

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We cannot assure that the reverse stock split, will increase our stock price for the required time period or maintain our listing on Nasdaq.

The reverse stock split has been accompanied by an increase the market price of our common stock; however, the ongoing effect of such a reverse stock split on the market price of our common stock cannot be predicted with any certainty, and the history of reverse stock splits for other stockholders,companies is varied. Some investors may view the recent reverse stock split negatively.

While Nasdaq rules do not impose a specific limit on the number of times a listed company may effect a reverse stock split to maintain or regain compliance with the Minimum Bid Price Requirement, Nasdaq has stated that a series of reverse stock splits may undermine investor confidence in securities listed on Nasdaq, especially where the reverse stock splits follow dilutive transactions. Accordingly, Nasdaq may determine that it is not in the public interest to maintain our listing, even if we regain compliance with the Minimum Bid Price Requirement as a result of any reverse stock split. Because our Company has effectuated reverse stock splits over the prior two-year period with a cumulative ratio in excess of 250 shares to one, and theycommon stock has failed to meet the Minimum Bid Price Requirement, we are not currently eligible for any compliance cure period specified in Nasdaq Marketplace Rule 5810(c)(3)(A) and, as discussed above, the Nasdaq staff has issued a delisting determination for noncompliance with the Minimum Bid Price Requirement.

Furthermore, the reverse stock split may votenot result in a way with which other stockholders disagree andper share price that attracts investors who do not trade in lower priced stocks. Although we believe the reverse stock split may enhance the marketability of our common stock to certain potential investors, we cannot assure you that our common stock will be adversemore attractive to investors following the interests of other stockholders. The concentration of ownershipreverse stock split. Even though we have implemented a reverse stock split, the market price of our common stock may havedecrease due to factors unrelated to the effectreverse stock split, including our future performance or general market trends. If the trading price of delaying, preventing or deterringthe common stock declines, the percentage declines as an absolute number and as a change of controlpercentage of our company, could depriveoverall market capitalization may be greater than would occur in the absence of a reverse stock split.

the recent reverse stock split may decrease the liquidity of our common stock and result in higher transaction costs.

The liquidity of our common stock may be negatively impacted by a reverse stock split, given the reduced number of shares that would be outstanding after such a reverse stock split, particularly if the stock price does not increase as a result of the reverse stock split. Additionally, if the reverse stock split is implemented, it will increase the number of our stockholders who own “odd lots” of an opportunity to receive a premium for theirfewer than 100 shares of common stock. Brokerage commissions and other costs of transactions in odd lots are generally higher than the costs of transactions of more than 100 shares of common stock. Accordingly, the reverse stock split may not achieve the desired results of increasing marketability of our common stock as partdescribed above.

The reverse stock split was not accompanied by a decrease in our authorized shares.

Although the reverse stock split did not have any dilutive effect on our stockholders, the reduction in outstanding shares that resulted from the reverse stock split reduced the proportion of shares owned by our stockholders relative to the number of shares authorized for issuance, giving the Board of Directors an effective increase in the relative number of authorized shares available for issuance, in its discretion. The Board of Directors from time to time may deem it to be in the best interests of the Company and its stockholders to enter into transactions and other ventures that may include the issuance of shares of our common stock. If the Board of Directors authorizes the issuance of additional shares of common stock subsequent to a reverse stock split, the dilution to the ownership interest of our existing stockholders may be greater than would occur had such reverse stock split not been effected.

Raising additional capital may cause dilution to our stockholders or restrict our operations.

To the extent that we raise additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect their rights as stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting our company,ability to take specific actions such as incurring additional debt, making capital expenditures or declaring dividends. Any of these events could adversely affect our ability to achieve our product development and commercialization goals and harm our business. We do not anticipate any adverse effects stemming from the lack of available credit facilities at this time.

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Issuances of common stock in offerings or pursuant to the exercise of rights to purchase shares may cause the price of our common stock to decline and cause investors to lose a significant portion of their investment.

If our stockholders sell substantial amounts of our common stock in the public market or upon the expiration of any statutory holding period under Rule 144, or upon expiration of lock-up periods applicable to outstanding shares or issued upon the exercise of outstanding options or warrants, it could create a circumstance commonly referred to as an “overhang” and in anticipation of which the market price of our common stock could fall. The existence of an overhang, whether sales have occurred or are occurring, also could make our ability to raise additional financing through the sale of equity or equity-related securities in the future at a time and price that we deem reasonable or appropriate more difficult. As of January 18, 2024, we had outstanding options to purchase 599 shares of our common stock at a weighted-average exercise price of $13,297.06 per share with a remaining contractual life of 8.7 years and outstanding warrants to purchase 340,952 of common stock at a weighted-average exercise price of $64.09 per share and an average remaining exercise period of 5.24 years.

Securities analysts may not initiate coverage or continue to cover our common stock, and this may have a negative impact on the market price of our common stock.

Common stock prices are often significantly influenced by the research and reports that securities analysts publish about companies and their business. We do not have any control over these analysts. There is no guarantee that securities analysts will cover, or continue to cover, our common stock. If securities analysts do not cover our common stock, the lack of research coverage may adversely affect the market price of our common stock. This concentration of ownership of our common stock may also have the effect of influencing the completion of a change in control that may not necessarily be in the best interests of all of our stockholders.

Although we intend to apply for listing on the Nasdaq Capital Market,If our common stock is currently eligible for quotationcovered by securities analysts and our stock is downgraded, our stock price will likely decline. If one or more of these analysts ceases to cover us or fails to publish regular reports on the over-the-counter-market but not listed on any national securities exchange.

Our shares of common stock are eligible for quotation on the OTCQB tier of the over-the-counter markets under the symbol “SNBP.” Despite eligibility for quotation, no assuranceus, we can be given that any market for our common stock will develop or, if one develops, that it will be maintained for any period of time. Quotation on the over-the-counter markets is generally understood to be a less active, and therefore less liquid, trading market than other types of markets such as a national securities exchange. In comparison to a listing on a national securities exchange, quotation on the over-the-counter markets is expected to have an adverse effect on the liquidity of shares of our common stock, both in terms of the number of shares that can be bought and sold at a given price, but also through delayslose visibility in the timing of transactions and reduction in analyst and media coverage. This may result in lower prices forfinancial markets, which can cause our common stock than might otherwise be obtained and could also result in a larger spread between the bid and ask prices for our common stock.

Our common stock is currently a “penny stock,” which may make it difficultprice or trading volume to sell shares of our common stock.decline.

Our common stock is currently categorized as a “penny stock” as defined in Rule 3a51-1 of the Exchange Act and is subject to the requirements of Rule 15g-9 of the Exchange Act. Under this rule, broker-dealers who sell penny stocks must, among other things, provide purchasers of these stocks with a standardized risk-disclosure document prepared by the SEC. Under applicable regulations, unless it becomes listed on a national securities exchange, our common stock will generally remain a “penny stock” until such time as its per-share price is $5.00 or more (as determined in accordance with SEC regulations), or until we meet certain net asset or revenue thresholds. These thresholds include the possession of net tangible assets (i.e., total assets less intangible assets and liabilities) in excess of $2 million or average revenues equal to at least $6 million for each of the last three years.

The penny-stock rules significantly limit the liquidity of securities in the secondary market, and many brokers choose not to participate in penny-stock transactions. As a result, there is generally less trading in penny stocks. If you become a holder of our common stock, you may not always be able to resell shares of our common stock in a public broker’s transaction, if at all, at the times and prices that you feel are fair or appropriate.


 

If you purchase shares of common stock in this offering, you will incur immediate and substantial dilution in the book value of the shares of our common stock.

 

The proposed public offering price of the shares of our common stock is substantially higher than the net tangible book value per share of our common stock. Investors purchasing shares of common stock in this offering will pay a price per share that substantially exceeds the book value of our tangible assets after subtracting our liabilities. As a result, investors purchasing shares of common stock in this offering will incur immediate dilution of $10.47$0.701 per share, based on an assumed combined public offering price of $11.99$6.65 per share.share and accompanying common warrants (assuming a public offering price equal to the last sale price of our common stock as reported by the Nasdaq Capital Market on January 18, 2024, which was $6.65). Further, investors purchasing shares of common stock in this offering will contribute approximately 37.2%19% of the total amount invested by shareholders since our inception, but will own, as a result of such investment, only approximately 18.5%86% of the shares of common stock outstanding immediately following this offering. As a result of the dilution to investors purchasing shares of common stock in this offering, investors may receive significantly less than the purchase price paid in this offering, if anything, in the event of our liquidation. Further, because we may need to raise additional capital to fund our anticipated level of operations, we may in the future sell substantial amounts of common stock or securities convertible into or exchangeable for common stock. These future issuances of equity or equity-linked securities, together with the exercise of outstanding options and any additional shares issued in connection with acquisitions, if any, may result in further dilution to investors.

 

Our failure to meet the continued listing requirements of the Nasdaq Capital Market could result in a delisting Holders of our warrants will have no rights as a common stockstockholder until they exercise their warrants and warrants.acquire our common stock.

 

If we are successful in having our common stock and warrants listed on the Nasdaq Capital Market, we will be required to satisfy the continued listing requirements. If we fail to satisfy the continued listing requirements of the Nasdaq Capital Market, such as the minimum stockholders’ equity or minimum closing bid price requirements, Nasdaq may take steps to delist our common stock or warrants. Such a delisting would likely have a negative effect on the price of our common stock or warrants and would impair your ability to sell or purchase our common stock or warrants whenUntil you wish to do so. In the event of a delisting, we would take actions to restore our compliance with Nasdaq’s listing requirements, but we can provide no assurance that any such action taken by us would allow our common stock or warrants to become listed again, stabilize the market price or improve the liquidity of our common stock or warrants, prevent our common stock or warrants from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements.

Trading in our common stock has been minimal and investors may not be able to sell as much stock as they want at prevailing prices.

As of December 7, 2017, the 30-day average daily trading volume in our common stock was less than 250 shares as reported by OTC Markets Group Inc. If trading in our stock continues at that level, it may be difficult for investors to sell or buy substantial quantities of shares in the public market at any given time at prevailing prices as significant price movement can be caused trading a relatively small number of shares. Accordingly, the market price foracquire shares of our common stock may be made more volatile becauseupon exercise of the relatively low volume of trading in our common stock. We cannot guarantee that a more liquid market for our common stockyour warrants, you will develop.


Offers or availability for sale of a substantial number ofhave no rights with respect to shares of our common stock may causeissuable upon exercise of your warrants. Upon exercise of your warrants, you will be entitled to exercise the pricerights of oura common stockstockholder only as to decline and cause investors to lose part or all of their investment.matters for which the record date occurs after the exercise date

The common warrants are speculative in nature.

 

If our stockholders sell substantial amountsThe common warrants offered pursuant to this prospectus do not confer any rights of our common stock inownership on their holders, such as voting rights or the public market or uponright to receive dividends, but rather merely represent the expiration of any statutory holding period under Rule 144, or upon expiration of lock-up periods applicableright to outstanding shares, or issued upon the exercise of outstanding options or warrants, it could create a circumstance commonly referred to as an “overhang” and in anticipation of which the market price of our common stock could fall. The existence of an overhang, whether or not sales have occurred or are occurring, also could make our ability to raise additional financing through the sale of equity or equity-related securities in the future at a time and price that we deem reasonable or appropriate more difficult. As of September 30, 2017, we had outstanding stock options to purchase 683,960acquire shares of our common stock at a weighted-averagefixed price for a limited period of time. Specifically, commencing on the date of issuance, holders of the common warrants may exercise their right to acquire the common stock and pay an exercise price of $9.77$   per share, outstandingprior to five years from the date of issuance, after which date any unexercised common warrants to purchase 351,500 shareswill expire and have no further value. Moreover, following this offering, the market value of the common stock at a weighted-average exercise pricewarrants is uncertain and there can be no assurance that the market value of $5.93 per share and outstanding convertible notes payable convertible into an estimated 315,356 shares at a weighted-average conversion price of $10.10.

Securities analysts may not initiate coveragethe common warrants will equal or continue to cover our common stock, and this may have a negative impact onexceed their public offering price. There can be no assurance that the market price of ourthe common stock.stock will ever equal or exceed the exercise price of the common warrants, and, consequently, whether it will ever be profitable for holders of the common warrants to exercise those warrants.

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There is no established public trading market for the warrants being offered in this offering.

 

Common stock prices are often significantly influenced byThere is no established public trading market for the research and reports that securities analysts publish about companies and their business.common warrants or the pre-funded warrants being offered in this offering. We do not haveintend to apply to list the common warrants or the pre-funded warrants to be issued in this offering on any control over these analysts.national securities exchange or to seek qualification of the common warrants or the pre-funded warrants for quotation on the over-the-counter markets. Without an active trading market, the liquidity of the common warrants and the pre-funded warrants will be limited without first exercising them.

This is a best efforts offering, no minimum amount of securities is required to be sold, and we may not raise the amount of capital we believe is required for our business plans.

The placement agent has agreed to use its reasonable best efforts to solicit offers to purchase the securities being offered in this offering. The placement agent has no obligation to buy any of the securities from us or to arrange for the purchase or sale of any specific number or dollar amount of the securities. This offering will terminate on February 15, 2024, unless completed sooner or unless we decide to terminate the offering (which we may do at any time in our discretion) prior to that date. There is no guaranteerequired minimum number of securities or amount of proceeds that must be sold as a condition to completion of this offering. Because there is no minimum offering amount required as a condition to the closing of this offering, the actual offering amount, placement agent fees and proceeds to us are not presently determinable and may be substantially less than the maximum amounts set forth above. We may sell fewer than all of the securities analystsoffered hereby, which may significantly reduce the amount of proceeds received by us, and investors in this offering will cover our common stock. If securities analystsnot receive a refund in the event that we do not coversell an amount of securities sufficient to fund for our common stock, the lack of research coverage may adversely affect the market price of our common stock. If our common stock is covered by securities analysts and our stock is downgraded, our stock price will likely decline. If one or more of these analysts ceases to cover us or fails to publish regular reports on us, we can lose visibilityoperations as described in the financial markets, which can cause our stock price or trading volume to decline.

We have broad discretion in the use“Use of the net proceeds from this offering, and our use of those proceeds may not yield a favorable return on investment.

We intend to use the net proceeds from this offering for the continued clinical development of our initial product candidate SBP-101 and for working capital and other general corporate purposes. However, our management has broad discretion of how these proceeds are used and could spend the proceeds in ways with which you may not agree. In addition,Proceeds” section herein. Thus, we may not useraise the proceeds from this offering effectively oramount of capital we believe is required for our operations in a manner that increases our market value or results in revenue. We have not established a timetable for the effective deployment of the proceeds,short term and we cannot predict how long it will takemay need to deploy the proceeds.

Raising additional capital may cause dilution to our stockholders or restrict our operations.

To the extent that we raise additional capital through the sale of equityfunds, which may not be available or convertible debt securities, stockholders’ ownership interest will be diluted, and theavailable on terms may include liquidation or other preferences that adversely affect their rights as stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting our abilityacceptable to take specific actions such as incurring additional debt, making capital expenditures or declaring dividends. Any of these events could adversely affect our ability to achieve our product development and commercialization goals and harm our business. We do not anticipate any adverse effects stemming from the lack of available credit facilities at this time.us.

 

Our charter documents and Delaware law may inhibit a takeover that stockholders consider favorable.

 

ProvisionsThe provisions of our certificate of incorporation and bylaws and applicable provisions of Delaware law may make it more difficult for or prevent a third party from acquiring control of us without the approval of our Boardboard of Directors.directors. These provisions:

 

 

set limitations on the removal of directors;

 

 

limit who may call a special meeting of stockholders;

 


 

establish advance notice requirements for nominations for election to our Boardboard of Directorsdirectors or for proposing matters that can be acted upon at stockholder meetings;

 

 

do not permit cumulative voting in the election of our directors, which would otherwise permit less than a majority of stockholders to elect directors;

 

 

establish a classified board of directors limiting the number of directors that are elected each year; and

 

 

provide our Boardboard of Directorsdirectors with the ability to designate the terms of and issue preferred stock without stockholder approval.

 

In addition, Section 203 of the Delaware General Corporation Law generally limits our ability to engage in any business combination with certain persons who own 15% or more of our outstanding voting stock or any of our associates or affiliates who at any time in the past three years have owned 15% or more of our outstanding voting stock unless our Boardboard of Directorsdirectors has pre-approved the acquisitions that lead to such ownership. These provisions may have the effect of entrenching our management team and may deprive stockholders of the opportunity to sell their shares to potential acquirers at a premium over prevailing prices. This potential inability to obtain a control premium could reduce the price of our common stock.

 

If we issue preferred stock, the rights of the holders of our common stock and the value of such common stock could be adversely affected.

 

Our Board of Directors is authorized to issue classes or series of preferred stock, without any action on the part of the stockholders. OurThe Board of Directors also has the power, without stockholder approval, to set the terms of any such classes or series of preferred stock, including voting rights, dividend rights and preferences over the common stock with respect to dividends or upon the liquidation, dissolution or winding-up of our business and other terms. If we issue preferred stock in the future that has a preference over the common stock with respect to the payment of dividends or upon liquidation, dissolution or winding-up, or if we issue preferred stock with voting rights that dilute the voting power of the common stock, the rights of holders of the common stock or the value of the common stock would be adversely affected.

The protection provided by the federal securities laws relating to forward-looking statements does not currently apply to us. The lack of this protection could harm us in the event of an adverse outcome in a legal proceeding relating to forward-looking statements made by us.

Although federal securities laws provide a safe harbor for forward-looking statements made by a public company that files reports under the federal securities laws, this safe harbor is not available to certain issuers, including penny stock issuers. We believe we are not currently eligible for the statutory safe harbor included in the Exchange Act of 1934. As a result, we will not have the benefit of this statutory safe harbor protection in the event of certain legal actions based upon forward-looking statements. The lack of this protection in a contested proceeding could harm our financial condition and, ultimately, the value of our common stock.

We are an emerging growth company and we cannot be certain if reduced disclosure requirements applicable to emerging growth companies will make our common stock less attractive to investors.

We are an emerging growth company under the JOBS Act. For as long as we continue to be an emerging growth company, we intend to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies including, but not limited to, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, exemptions from the requirements of holding a nonbinding advisory stockholder vote on executive compensation and any golden parachute payments not previously approved, exemption from the requirement of auditor attestation in the assessment of our internal control over financial reporting and exemption from any requirement that may be adopted by the Public Company Accounting Oversight Board. If we do, the information that we provide stockholders may be different than what is available with respect to other public companies. We cannot predict if investors will find our common stock less attractive because we will rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.

 


20

 

We have identified a significant deficiency in internal control over financial reporting, ifIf we fail to maintain effective internal controls over financial reporting, the price of our common stock may be adversely affected.

 

We are required to establish and maintain appropriate internal controls over financial reporting. Failure to establish those controls, or any failure of those controls once established, could adversely impact our public disclosures regarding our business, financial condition or results of operations. Any failure of these controls could also prevent us from maintaining accurate accounting records and discovering accounting errors and financial fraud.

In the course of completing its assessment of internal control over financial reporting as of December 31, 2016, management did not identify any material weaknesses but did identify a significant deficiency in the number of personnel available to serve the Company’s accounting function, specifically management believes that we may not be able to adequately segregate responsibility over financial transaction processing and reporting. A significant deficiency is a deficiency, or a combination of deficiencies, in internal control over financial reporting, that is less severe than a material weakness yet important enough to merit attention by those responsible for oversight of the Company’s financial reporting. Although we are unable to remediate the significant deficiency with current personnel, we are mitigating its potential impact, primarily through greater involvement of senior management in the review and monitoring of financial transaction processing and reporting.

In addition, management’s Management’s assessment of internal controls over financial reporting may identify additional weaknesses and conditions that need to be addressed or other potential matters that may raise concerns for investors. Any actual or perceived weaknesses and conditions that need to be addressed in our internal control over financial reporting disclosure of management’s assessment of our internal controls over financial reporting, or disclosure of our public accounting firm’s attestation to or report on management’s assessment of our internal controls over financial reporting may have an adverse impact on the price of our common stock.

 

Holders ofEven if this offering is completed, we will need to raise additional capital in the future to finance our warrants will have no rights as a common stockholder until they exercise their warrants and acquireoperations, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our common stock.product development efforts or other operations.

 

Until you acquire shares of our common stock upon exercise of your warrants, you willWe have no rights with respect to shares of our common stock issuable upon exercise of your warrants. Upon exercise of your warrants, you will be entitled to exercise the rights of a common stockholder only as to matters for which the record date occurs after the exercise date.

The warrants may not have any value.

Each warrant willhad recurring losses from operations, negative operating cash flow and have an exercise price per share of 125% of the public offering price of one share of common stock and warrantaccumulated deficit. We must raise additional funds in order to purchase 0.50 shares ofcontinue financing our common stock in the offering, will be exercisable upon issuance and will expire five years from the date of issuance. In the event the price of our common stock doesoperations. If additional capital is not exceed the exercise price of the warrants during the periodavailable to us when the warrants are exercisable, the warrantsneeded or on acceptable terms, we may not have any value.

There is no established public trading market for the warrants being offered in this offering.

There is no established public trading market for the warrants being offered in this offering. We intend to apply to list the warrants to be issued in this offering on The Nasdaq Capital Market under the symbol “SNBPW.” If we are otherwise unable to obtain listing on a national securities exchange, then we expect to seek qualification of the warrants to be issued in this offering for quotation on the over-the-counter markets. Without an active trading market, the liquidity of the warrants would be limited.


The reverse stock split may not increase the price of our common stock for a sufficient duration to list our common stock or the warrants on a national securities exchange.

On December 7, 2017, the last reported sale price of our common stock on the OTCQB Marketplace was $11.99 per share. We cannot assure you that the reverse stock split, by itself, will be sufficient to allow us to accomplish our objective to obtain a listing on a national securities exchange. While the reduction in the number of outstanding shares of common stock has increased the market price of our common stock, we cannot assure you that the market price of our common stock will not decrease or that we will satisfy the other listing criteria or will be able to obtaincontinue to operate our business pursuant to our business plan or we may have to discontinue our operations entirely. Any additional capital raised through the sale of equity or equity-backed securities may dilute our stockholders’ ownership percentages and could also result in a listing ondecrease in the market value of our equity securities. The terms of any national securities exchange,issued by us in future capital transactions may be more favorable to new investors, and may include preferences, superior voting rights and the issuance of warrants or to maintain such listing for any meaningful period of time. In addition to specific listing and maintenance standards, the Nasdaq Capital Market has broad discretionary authority over the initial and continued listing ofother derivative securities, which it could exercise with respect tomay have a further dilutive effect on the listingholders of any of our common stock. securities then outstanding.

If we are unable to meet the minimum bid price requirement of The Nasdaq Capital Marketsecure additional funds when needed or are otherwise unableon acceptable terms, we may be required to obtain a listing on a national securities exchange, then the common stock to be issued in this offering would continue to be quoted on the over-the-counter markets and we would seek qualification of the warrants to be issued in this offering for quotation on the over-the-counter markets Under applicable regulations, unless our common stock becomes listed on a national securities exchangedefer, reduce or it qualifies for another exception, our common stock will generally remain a “penny stock.”

The priceeliminate significant planned expenditures, restructure, curtail or eliminate some or all of our common stock is dependent upon many factors, including the resultsoperations, dispose of technology or assets, pursue an acquisition of our clinical trials, business and financial performance, general market conditions and prospects for future success. If the per share marketcompany by a third party at a price does not increase proportionately as athat may result of the reverse stock split, then the value of our Company as measured by our market capitalization will be reduced, perhaps significantly.

The reverse stock split may have decreased the liquidity of our stock.

The number of shares held by each individual stockholder was reduced as a result of the reverse stock split. Additionally, the transaction costs to stockholders selling “odd lots” are typically higher on a per share basis. Consequently, the reverse stock split could increase the transaction costs to existing stockholders in the event they wish to sell all or a portion of their shares.

Even after the reverse stock split, the trading price of our common stock may not be high enough to attract new investors, including institutional investors, and may not satisfy the investing requirements of those investors. Consequently, the trading liquidity of our common stock may not improve.

There can be no assurance that the reverse stock split has resulted in a share price that will attract new investors, including institutional investors,loss on investment for our stockholders, file for bankruptcy or that the share price satisfies the investing requirements of those investors. As a result, the trading liquidity of our common stock may not necessarily improve, our share price may decline and you may lose all or part of your investment.


CAUTIONARY Note Regarding Forward-Looking Statements

This prospectus contains forward-looking statements within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negativecease operations altogether. Any of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are not a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time the statements are made and involve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in this prospectus. These factors include:

the fact that we are a company with limited operating history for you to evaluate our business;

our lack of diversification and the corresponding risk of an investment in our Company;

potential deterioration of our financial condition and results due to failure to diversify;

our ability to obtain additional capital required to implement our business plan;

our ability to effectively manage growth and the corresponding impact on our profitability; and

other risk factors included under the caption “Risk Factors” beginning on page 9 of this prospectus.

You should read the matters described in “Risk Factors” and the other cautionary statements made in this prospectus as being applicable to all related forward-looking statements wherever they appear in this prospectus. We cannot assure you that the forward-looking statements in this prospectus will prove to be accurate and therefore prospective investors are encouraged not to place undue reliance on forward-looking statements. You should read this prospectus completely.

This prospectus also contains market data related to our business and industry. These market data include projections that are based on a number of assumptions. If these assumptions turn out to be incorrect, actual results may differ from the projections based on these assumptions. As a result, our markets may not grow at the rates projected by these data, or at all. The failure of these markets to grow at these projected rates mayevents could have a material adverse effect on our business, results of operations, financial condition and the market priceresults of operations. Moreover, if we are unable to obtain additional funds on a timely basis, there will be substantial doubt about our securities.

Other thanability to continue as requireda going concern and increased risk of insolvency and up to a total loss of investment by law, we undertake no obligation to update or revise these forward-looking statements, even though our situation may change in the future.stockholders.

 


21

 

Use of ProceedsUSE OF PROCEEDS

 

We estimate that thewe will receive net proceeds of up to approximately $18.3 million from our issuance andthe sale of sharesthe securities by us in this offering, based on an assumed combined public offering price of $6.65 per share and accompanying common warrants (based on the last sale price of our common stock and warrants in this offering will be approximately $8.8 million, assuming a public offering price of $12.00 per share and warrant,as reported by the Nasdaq Capital Market on January 18, 2024, which was $6.65), after deducting underwriting discounts and commissionsthe placement agent fees and estimated offering expenses payable by us, in this offering. Ifand excluding the underwriters exercise their over-allotment option in full, we estimate thatproceeds, if any, received from the net proceeds from this offering will be approximately $10.2 million.

In addition, if all of the warrants offered pursuant to this prospectus are exercised in full for cash, we will receive approximately an additional $6.2 million in cash. However, the warrants contain a cashless exercise provision that permit exercise of warrants on a cashless basis at any time where there is no effective registration statement under the Securities Act covering the issuance of the underlying shares.

A $1.00 increase or decreaseissued in the assumed public offering price of $12.00 per share and warrant would increase or decrease the net proceeds from this offering by approximately $0.8 million, assuming that the number of shares and warrants offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions. Similarly, each increase (decrease) of 100,000 shares in the number of shares of common stock and warrants offered would increase (decrease) our proceeds by approximately $1.1 million, assuming the assumed public offering price remains the same, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.offering.

 

We intend to use the net proceeds from the sale of any securities for (i) the continued clinical development of our initial product candidate ivospemin, (ii) cost of drug product for use in clinical development with collaboration partners of CPP assets, and (iii) general corporate purposes unless otherwise indicated in the applicable prospectus supplement. General corporate purposes may include the repayment of outstanding indebtedness, working capital, general and administrative expenses. We may also use a portion of the net proceeds to invest in or acquire businesses or technologies that we believe are complementary to our own, although we have no current plans, commitments or agreements with respect to any acquisitions as of the date of this offering as follows:prospectus supplement. We have not yet determined the amount of net proceeds to be used specifically for any of the foregoing purposes. Accordingly, our management will have significant discretion and flexibility in applying the net proceeds from the sale of these securities.

 

We are party to a guaranty (the “Guaranty”) pursuant to which we have agreed to guarantee the payment obligations of CPP, under a promissory note in favor of Sucampo GmbH dated as of June 15, 2022, (the “Note”), which had a principal balance of approximately $5.2 million as of September 30, 2023. CPP is required to make four remaining payments of $1 million, plus accrued but unpaid interest, on January 31st of each of  2024, 2025, 2026, with the remaining balance due on January 31, 2027. The first installment of $1.0 million plus accrued interest was paid on February 1, 2023.

for the continued clinical development of our initial product candidate SBP-101;

for the repayment of approximately $350,000 of principal and accrued interest due to the Institute for Commercialization of Public Research, Inc. (the “Institute”); and

the remainder for working capital, business development and other general corporate purposes.

 

Our expected use of net proceeds from this offering represents our intentions based on our present plans and business conditions, which could change as our plans and business conditions evolve. The amount and timing of our actual expenditures will depend on numerous factors, including the timing and success of clinical studies or clinical studies we may commence in the future, the timing of regulatory submissions and the feedback from regulatory authorities. As a result, our management will have broad discretion over the use of the net proceeds from this offering. Pending our use of the net proceeds from this offering, we may temporarily invest the net proceeds in investment-grade, interest-bearing securities.

 

We anticipate thatcurrently estimate the net proceeds from this offering together with our existing cash and cash equivalentsfunds will be sufficient to enableallow us to fundmake significant progress in the conduct of our operating expenses and capital expenditure requirements throughnew randomized double-blind, placebo-controlled clinical trial (known as the endASPIRE trial) for the treatment of 2019. We currently estimate that these funds will enable us to complete a dose-escalation study of SBP-101 in combination with the current standard of care treatment for patients with pancreatic ductile adenocarcinoma. Continuation of the current trial, if the interim analysis is positive, will be required for FDA or other similar approvals. The cost and timing of additional clinical trials are highly dependent on the number of indications we pursue and the nature and size of the trials. It is estimated that the completion of the randomized clinical trial and other steps in the approval process for ivospemin in pancreatic cancer could cost between $60 and $80 million.

Predicting the cost necessary to develop product candidates can be difficult and we anticipate that we will need additional funds to conduct a larger randomized trial ofcomplete the typedevelopment work generally required for obtaining regulatory approval to commercialize a drug. We have based these estimates on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect.

 


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Price Range of Common StockMARKET INFORMATION

 

Effective as of September 9, 2015, ourOur common stock became quotedis listed on the OTCPink tier of the over-the-counter markets. On September 28, 2016, our common stock became quoted on the OTCQB VentureNasdaq Capital Market both of which are administered by OTC Markets Group, Inc., under the symbol “SNBP.“PBLA. Despite eligibility for quotation, no assurance can be given that any market for our common stock will develop or be maintained. If an “established trading market” ever develops in the future, the sale of shares of our common stock that are deemed to be “restricted securities” pursuant to Rule 144 of the SEC by members of management or others may have a substantial adverse impact on any such market.

Set forth below are the high and low bid prices for our common stock for each quarter of 2015, 2016 and 2017 for which data is available. These bid prices were obtained from OTC Markets Group Inc. All prices listed below reflect inter-dealer prices, without retail mark-up, mark-down or commissions and may not represent actual transactions. Prices prior to November 8, 2017 have been adjusted to reflect the 1-for-10 reverse stock split.

Fiscal 2017

 

High

  

Low

 

Fourth Quarter (through December 7, 2017)

 $18.00  $7.01 

Third Quarter

 $14.50  $5.70 

Second Quarter

 $29.00  $12.50 

First Quarter

 $40.00  $7.80 

Fiscal 2016

 

High

  

Low

 

Fourth Quarter

 $35.00  $5.60 

Third Quarter

 $30.00  $20.10 

Second Quarter

 $35.00  $25.00 

First Quarter

 $60.10  $25.00 

Fiscal 2015

 

High

  

Low

 

Fourth Quarter

 $70.00  $25.00 

Third Quarter

 $25.00  $10.00 

Second Quarter

 $10.00  $6.00 

First Quarter

 $6.00  $6.00 

On December 7, 2017, the last reported sale price of our common stock on the OTCQB Marketplace was $11.99 per share. As of the same date, we had 182January 18, 2024, there were 49 holders of record of our common stock.

 

Equity Compensation Plan Information

The following table provides information as of December 31, 2016 regarding outstanding grants and shares available for grant under our equity compensation plans.

Plan Category

 

Number of securities to be

issued upon exercise of

outstanding options,

warrants and rights

  

Weighted-average exercise

price of outstanding

options, warrants and rights

  

Number of securities

remaining available for

future issuance under

equity compensation plans

 

Equity compensation plans approved by security holders(1)

  701,960(2) $9.50   1,114,400 

Equity compensation plans not approved by security holders

         

Total

  701,960  $9.50   1,114,400 


(1)

Consists of the 2011 Stock Option Plan and 2016 Omnibus Incentive Plan, each described in more detail below.

(2)

Represents 316,360 shares under outstanding options under the 2011 Plan and 385,600 shares under outstanding options under the 2016 Plan.


2011 Stock Option Plan

The Sun BioPharma, Inc. 2011 Stock Option Plan (the “2011 Plan”) was adopted by our Board of Directors in September 2011 and approved by our stockholders in January 2012. In conjunction with stockholder approval of the 2016 Plan, our Board of Directors ceased making grants under the 2011 Plan, although awards outstanding under the 2011 Plan will remain outstanding in accordance with and pursuant to the terms thereof. Options granted under the 2011 Plan have a maximum term of ten years and generally vest over zero to two years for employees. As of December 7, 2017, options to purchase 294,360 shares of common stock remained outstanding under the 2011 Plan with a weighted average price of $2.79 per share.

2016 Omnibus Incentive Plan

The Sun BioPharma, Inc. 2016 Omnibus Incentive Plan (the “2016 Plan”) was adopted by our Board of Directors in March 2016 and approved by our stockholders at our annual meeting of stockholders on May 17, 2016. The 2016 Plan permits the granting of incentive and non-statutory stock options, restricted stock, stock appreciation rights, performance units, performance shares and other stock awards to eligible employees, directors and consultants. We grant options to purchase shares of common stock under the 2016 Plan at no less than the fair market value of the underlying common stock as of the date of grant. Options granted under the Plan have a maximum term of ten years. Under the 2016 Plan, a total of 1,500,000 shares of common stock were initially reserved for issuance. As of December 7, 2017 options to purchase 389,600 shares of our common stock were outstanding under the 2016 Plan with a weighted average price of $15.05 per share. A total of 1,110,400 shares of common stock remained available for future grants under the 2016 Plan as of the same date.

The purpose of the 2016 Plan is to promote the interests of our company and our stockholders by providing key personnel, consultants and advisors of our company and its affiliates with an opportunity to acquire a proprietary interest in our company and thereby develop a stronger incentive to put forth maximum effort for the continued success and growth of our company and our affiliates. In addition, the opportunity to acquire a proprietary interest in our company will aid in attracting and retaining key personnel of outstanding ability. The 2016 Plan is also intended to provide non-employee directors of the company with an opportunity to acquire a proprietary interest in the company, to compensate non-employee directors for their contributions to the company and to aid in attracting and retaining non-employee directors.

Administration

The 2016 Plan is administered by the Compensation Committee of our Board of Directors (“Committee”). The Committee has the authority to adopt, revise and waive rules relating to the 2016 Plan and to determine the timing and identity of participants, the amount of any awards and other terms and conditions of awards. The Committee may delegate its responsibilities under the 2016 Plan to one or more of its members or to one or more directors or executive officers of the company with respect to the selection and grants of awards to employees of the company who are not deemed to be officers, directors or 10% stockholders of the company under applicable securities laws. The independent members of our Board of Directors perform the duties and have the responsibilities of the committee with respect to awards made to non-employee directors.

Eligibility

All employees of our company and its affiliates, non-employee directors of our company and any consultant or advisor who is a natural person and provides services to us or our affiliates are eligible to receive awards under the 2016 Plan at the discretion of the Committee or the independent members of our Board of Directors, as applicable. No awards may be granted under the 2016 Plan in conjunction with a capital-raising transaction or the promotion or maintenance of a market for our securities. Incentive stock options under the 2016 Plan may be awarded to employees of the company. As of December 7, 2017, there were nine employees and five non-employee directors. Such employees, directors and others who currently or may in the future provide services to us and our affiliates may be considered for the grant of awards under the 2016 Plan at the discretion of the Committee or the independent members of our Board of Directors, as applicable.


Shares Available

A total of 1,500,000 shares of our common stock were initially authorized for issuance under the 2016 Plan, subject to adjustment for future stock splits, stock dividends and similar changes in the capitalization of the Company. The shares of our common stock covered by the 2016 Plan may be treasury shares, authorized but unissued shares, or shares purchased in the open market.

Any shares subject to an award under the 2016 Plan that are forfeited, cancelled, returned to the company for failure to satisfy vesting requirements, settled for cash or otherwise terminated without payment being made thereunder shall, to the extent of such expiration, forfeiture, cancellation, return, cash settlement or termination, will remain in the pool of shares available for grant under the 2016 Plan. The following shares will, however, continue to be charged against the foregoing maximum share limitations and will not again become available for grant: (i) shares tendered by the participant or withheld by us in payment of the purchase price of an option, (ii) shares tendered by the participant or withheld by us to satisfy any tax withholding obligation with respect to an Award, (iii) shares subject to a stock appreciation right (“SAR”) that are not issued in connection with the settlement of the SAR upon its exercise and (iv) shares repurchased by us with proceeds received from the exercise of a stock option issued under the 2016 Plan.

Types of Awards

The 2016 Plan allows us to grant stock options, SARs, restricted stock, restricted stock units and other stock-based awards. The Committee may provide that the vesting or payment of any award will be subject to the attainment of certain performance objectives established by the Committee, in addition to completion by the plan participant of a specified period of service. The Committee may amend the terms of any award previously granted, but no amendment may materially impair the rights of any participant with respect to an outstanding award without the participant’s consent, unless such amendment is necessary to comply with applicable laws or stock exchange rules.

Stock Options

Stock options granted under the 2016 Plan may be either incentive stock options (“ISOs”), which are specifically designated as such for purposes of compliance with Section 422 of the Internal Revenue Code of 1986, as amended, or its successor (the “Code”), or non-statutory stock options (“NSOs”). Options will vest as determined by the Administrator, subject to statutory limitations regarding the maximum term of ISOs and the maximum value of ISOs that by vest in a single year. The exercise price of options may not be less than the fair market value of our common stock on the date of grant, which, if our shares or not readily tradable on an established securities market will be determined by the Administrator as the result of a reasonable application of a reasonable valuation method that satisfies the requirements of Section 409A of the Code. The exercise price must be paid in full at the time of exercise and may be paid in cash or such other manner as permitted by the Administrator, including by withholding shares issuable upon exercise or by delivery of shares already owned by a participant.

Stock Appreciation Rights

SARs provide for payment to the participant of all or a portion of the excess of the fair market value of a specified number of shares of our common stock on the date of exercise over a specified exercise price, which may not be less than the fair market value of our common stock on the date of grant. Payment may be made in cash or shares of our common stock or a combination of both, as determined by the Administrator.

Restricted Stock

Restricted stock awards are awards of shares of our common stock that are subject to vesting conditions, and the corresponding lapse or waiver of forfeiture conditions and other restrictions, based on such factors and occurring over such period of time as the Administrator may determine.


Restricted Stock Units

Restricted stock units provide a participant with the right to receive, in cash or shares of our common stock or a combination of both, the fair market value of a specified number of shares of our common stock, and are be subject to such vesting and forfeiture conditions and other restrictions as the Administrator determines.

Other Stock-Based Awards

We may grant other awards under the 2016 Plan that are valued by reference to and/or payable in whole or in part in shares of our common stock.

Cash Incentive Awards

Cash incentive awards permit a participant to receive cash or other forms of awards upon the satisfaction of one or more performance goals over a specified performance cycle as determined by the Administrator.

Terms of Awards and Plan Provisions

Performance-Based Compensation

For purposes of any 2016 Plan awards (other than stock options and SARs) that are intended to qualify as performance-based compensation for Section 162(m) purposes, the lapsing of restrictions, vesting and payment of such awards, as applicable, will be subject to the achievement of one or more performance goals over a specified performance period, all as determined by the Administrator. The vesting and exercisability of stock options and SARs need not be made subject to the achievement of one or more performance goals in order to be considered performance-based compensation for purposes of Code Section 162(m). The performance measures upon which such performance goals will be based on one or a combination of two or more of the business criteria enumerated in the 2016 Plan.

Any performance goal utilized may be expressed in absolute amounts, on a per share basis, relative to one or more other performance measures, as a growth rate or change from preceding periods, or as a comparison to the performance of specified companies or other external measures, and may relate to one or any combination of corporate or business performance criteria. The Committee will specify the manner of calculating the performance goals it establishes for any performance period. The committee will select the applicable performance measures and establish the corresponding performance goals for any performance period, and certify any amount payable in connection with an award intended to qualify as performance-based compensation, within the time periods prescribed by and consistent with the other requirements of Code Section 162(m). The Committee may adjust downward, but not upward, any amount determined to be otherwise payable in connection with such an award.

Maximum Award Amounts

The aggregate number of shares that may be subject to certain awards during any calendar year to any one participant under the 2016 Plan will not exceed 100,000 shares with respect to stock options, SARs and other awards intended to qualify as performance-based compensation for Section 162(m) purposes. The aggregate number of shares that may be subject to full value awards during any calendar year to any one participant under the 2016 Plan also will not exceed 100,000 shares. The maximum amount payable with respect to any cash incentive awards and awards other than stock options and SARs denominated in cash that are granted to any one participant in any calendar year will not exceed $1 million.

Substitute Awards

Awards may be granted under the 2016 Plan in substitution for awards granted by another entity acquired by our company or with which our company combines. The terms and conditions of these substitute awards will be comparable to the terms of the awards replaced, and may therefore differ from the terms and conditions otherwise set forth in the 2016 Plan. Shares subject to substitute awards do not count against the 2016 Plan share reserve.


Repricing of Awards

The Committee may not reduce the exercise price of stock options or SARs granted under the 2016 Plan, exchange outstanding stock options or SARs with new stock options or SARs with a lower exercise price or a new full value award, repurchase underwater stock options or SARs or take any other action that would constitute a “repricing,” unless such action is first approved by our stockholders.

Transferability of Awards

Except as noted below, during the lifetime of a person to whom an award is granted, only that person, or that person’s legal representative, may exercise an option or SAR, or receive payment with respect to performance units or any other award. No award may be sold, assigned, transferred, exchanged or otherwise encumbered other than to a successor in the event of a participant’s death or pursuant to a qualified domestic relations order. However, the Administrator may provide that awards, other than incentive stock options, may be transferable to members of the participant’s immediate family or to one or more trusts for the benefit of such family members or partnerships in which such family members are the only partners, if the participant does not receive any consideration for the transfer.

Termination of Service

Unless otherwise provided in an award agreement, upon termination of a participant’s service with us, all unvested and unexercisable portions of the participant’s outstanding awards will immediately be forfeited. If a participant’s service with us terminates other than for cause (as defined in the 2016 Plan), death or disability, the vested and exercisable portions of the participant’s outstanding stock options and SARs generally will remain exercisable for 90 days after termination. If a participant’s service terminates due to death or disability, the vested and exercisable portions of the participant’s outstanding stock options and SARs generally will remain exercisable for one year after termination. Upon termination for cause, all unexercised stock options and SARs will be forfeited.

Tax Withholding

The 2016 Plan permits us to withhold from cash awards, and to require a participant receiving common stock under the 2016 Plan to pay us in cash, an amount sufficient to cover any required withholding taxes. In lieu of cash, a participant may be permitted to cover withholding obligations through a reduction in the number of shares delivered to such participant or a surrender of shares then owned by the participant.

Change in Control

If a change in control (as defined in the 2016 Plan) that involves a corporate transaction (as defined in the 2016 Plan) occurs and any outstanding award is continued, assumed or replaced by our company or the surviving or successor entity in connection with such change in control, and if within 12 months after the change in control a participant’s employment or other service is terminated without cause or with good reason (as defined in the 2016 Plan), then (i) each of the participant’s outstanding options and SARs will become exercisable in full, and (ii) each of the participant’s unvested full value awards will fully vest. If any outstanding award is not continued, assumed or replaced in connection with such change in control, then the same consequences as specified in the previous sentence will occur in connection with a change in control unless and to the extent the Compensation Committee or Board elects to terminate such award in exchange for a payment in an amount equal to the intrinsic value of the award (or, if there is no intrinsic value, the award may be terminated without payment). The Compensation Committee or Board may, in its discretion, take such other action as it deems appropriate with respect to outstanding awards for a change in control not involving a corporate transaction or may generally provide for different circumstances upon any change in control in an individual award agreement.

If any payments or benefits provided under the 2016 Plan taken together with other payments an individual may receive in connection with a change in control may constitute a “parachute payment” under Code Section 280G, such payments or benefits may be reduced to provide the individual with the best after-tax result. Specifically, the individual will receive either a reduced amount so that the excise tax imposed under Code Section 4999 is not triggered, or the individual will receive the full amount of the payments and benefits and then be liable for any excise tax.


Adjustment of Awards

In the event of an equity restructuring, such as a stock dividend or stock split, that affects the per share value of our Common Stock, the Administrator will make appropriate adjustment to: (i) the number and kind of securities reserved for issuance under the 2016 Plan, (ii) the number and kind of securities subject to outstanding awards under the 2016 Plan, (iii) the exercise price of outstanding options and SARs, and (iv) any maximum limitations prescribed by the 2016 Plan as to grants of certain types of awards. The Administrator may also make similar adjustments in the event of any other change in our company’s capitalization, including a merger, consolidation, reorganization or liquidation.

Amendment and Termination

The 2016 Plan has a term of ten years from its effective date, or the earlier termination of the 2016 Plan by our Board of Directors. Our Board of Directors may amend the 2016 Plan at any time, but no amendment may materially impair the rights of any participant with respect to outstanding awards without the participant’s consent. Stockholder approval of any amendment of the 2016 Plan will be obtained if required by applicable law or the rules of the Nasdaq Stock Market. Awards that are outstanding on the 2016 Plan’s termination date will remain in effect in accordance with the terms of the 2016 Plan and the applicable award agreements.


CAPITALIZATION

 

The following table presents a summary of our cash and cash equivalents and capitalization as of September 30, 2017:2023:

 

 

on an actual basis; as of September 30, 2023;

 

as adjusted for the issuance of 330,470 shares issued for exercises of warrants to purchase shares of common stock, which exercises occurred after September 30, 2023 and 132 shares issued primarily as the result of the cashless exchange for warrants which occurred after September 30, 2023;

on an as adjusted basis to give effect to the issuance and sale of 834,0283,007,519 shares of our common stock and common warrants to purchase up to 417,0146,015,038 shares of our common stock in this offering at thean assumed combined public offering price of $12.00$6.65 per share and warrantaccompanying common warrants less underwriting discounts and commissions and estimated offering expenses payable by us; and

on an as adjusted basis to give effect to (i) the issuance and sale of 834,028 shares of our common stock and warrants to purchase up to 417,014 shares of our common stock in this offering at the assumed public offering price of $12.00 per share and warrant less underwriting discounts and commissionsplacement agent fees and estimated offering expenses payable by us, and (ii) the conversionfor total net proceeds of outstanding convertible promissory notes.

up to approximately $18.3 million (assuming no sale of pre-funded warrants).

 

The unaudited as adjusted information below is prepared for illustrative purposes only and our capitalization following the completion of this offering will be adjusted based on the actual public offering price and other terms of this offering determined at pricing and whether or not the convertible promissory notes are converted.pricing. You should read the following table in conjunction with “Summary Consolidated Financial Data”, “Management’sManagement’s Discussion and Analysis of Financial Condition and Results of Operations”Operations and the historical financial statements and related notes thereto included elsewhere in this prospectus. incorporated herein by reference. 

  

(in thousands)

 

Actual as of

September 30,

2017

(unaudited)

  

Offering

Adjustment

  

Pro Forma as

Adjusted for

Offering

  

Convertible

Notes

Conversion

Adjustment

  

Pro Forma as

Adjusted for

Offering and

Convertible

Notes

Conversion

  

Actual as of

September

30, 2023

(unaudited)

  

As of

September

30, 2023

(after

reflecting
subsequent events)

  

Offering

Adjustment

  

Pro Forma

as

Adjusted

 

Cash

 $943  $8,968  $9,911  $-  $9,911  $907  $5,817  $18,323  $24,140 

Common stock, $0.001 par value, 100,000,000 shares authorized; 3,670,432 shares issued and outstanding; 4,504,460 shares issued and outstanding, pro forma as adjusted for offering; 4,817,594 shares pro forma as adjusted for offering and convertible notes conversion

  4   1   5   -   5 
Common stock, $0.001 par value, 100,000,000 shares authorized; 149,656 shares issued and outstanding, actual; 480,244 shares issued and outstanding, after subsequent events; 3,487,763 shares issued and outstanding, pro forma as adjusted  -   0.4   3.0   3.4 

Additional paid-in capital

  25,059   8,967   34,026   3,189   37,215   106,029   110,939   18,320   129,259 

Accumulated deficit

  (26,992)  -   (26,992)  (1,994)  (28,986)  (109,883

)

  (109,883

)

  -   (109,883

)

Total stockholders’ equity (deficit)

  (2,099)  8,968   6,869   1,195   8,064 

Total capitalization

 $(2,099) $8,968  $6,869  $1,195  $8,064 

Accumulated comprehensive income

  1,371   1,371   -   1,371 

Total stockholders’ equity

 $(2,483

)

 $2,427  $18,323   20,750 

 

Each $1.00$0.25 increase (decrease) in the assumed public offering price of $12.00$6.65 per share and warrantcommon warrants would increase (decrease) each of cash, additional paid-in capital, total shareholders’ equity and total capitalization by approximately $0.8$0.7 million, assuming the number of shares of common stock and common warrants offered, as set forth on the cover page of this prospectus, remains the same, and after deducting estimated underwriting discounts and commissionsplacement agent fees and estimated offering expenses. Similarly, each increase (decrease) of 100,000200,000 shares in the number of shares of common stock and common warrants offered would increase (decrease) cash, additional paid-in capital, total shareholders’ equity and total capitalization by approximately $1.1$1.2 million, assuming the assumed public offering price remains the same, and after deducting estimated underwriting discounts and commissionsplacement agent fees and estimated offering expenses payable by us. The pro forma as adjusted information discussed above is illustrative only and will be adjusted based on the actual public offering price and other terms of this offering determined at pricing.


 

The number of shares of our common stock outstanding before and after this offering is based on 3,670,432149,656 shares of our common stock outstanding as of September 30, 2017,2023, and 330,588 shares issued primarily as the result of the exercise of warrants, primarily for cash, which occurred after September 30, 2023, and excludes:

 

 

417,014all shares issuable upon the exercise of warrants sold in this offering;

pending settlements of fractional shares for cash in connection with the reverse stock split effected as of January 18, 2024;

 

 

683,960599 shares of common stock issuable upon the exercise of outstanding stock options as of September 30, 2017 at a weighted average exercise price of $9.77$13,297.06 per share;

and

 

 

1,110,400 additional shares of common stock reserved and available for future issuances under our 2016 Stock Option Plan;

351,500340,952 shares of common stock issuable upon exercise of outstanding stock purchase warrants, including warrants issued subsequent to September 30, 2023 but not relating to this offering at a weighted average exercise price of $5.93$64.09 per share;

an estimated 315,356 shares of common stock potentially issuable pursuant to convertible promissory notes, including accrued but unpaid interest through September 30, 2017; and

41,701 shares of common stock issuable upon exercise of the warrants issued to the representative at the closing of this offering.share.

 


23

 

DILUTION

 

If you purchase shares and warrants in this offeringof our common stock, your interest will be diluted immediately to the extent of the difference between the assumed public offering price of $12.00per share and warrantyou will pay in this offering and the as adjusted net tangible book value per share of our common stock immediately followingafter this offering. Net tangible book value dilution per share to new investors represents the difference between the amount per share paid by purchasers in this offering and the as adjusted net tangible book value per share of common stock immediately after completion of this offering.

Our net tangible book value as of September 30, 2017 was a deficit of approximately $2.1 million, or approximately $0.57 per share. Net tangible book value per share represents our total tangible assets less total tangible liabilities, excluding goodwill and customer relationship intangibles, divided by the number of shares of our common stock outstanding asoutstanding.

As of September 30, 2017.2023, after giving effect to the issuance of 330,588 issued as the result of the exercise of warrants, primarily for cash, which occurred after September 30, 2023 our net tangible book value was approximately $2.4 million, or $5.054 per share of common stock.

 

After giving effect to the foregoing pro forma adjustments and the sale by us of all 3,007,519 shares of our common stock and warrants in this offering at an assumed public offering price of $12.00$6.65 per share and warrant,accompanying common warrants and after deducting underwriting discounts and commissionsthe placement agent fees and estimated offering expenses payable by us, our as adjusted net tangible book value as of September 30, 2017,2023, would have been $6.7approximately $20.7 million, or $1.50$5.949 per share. This represents an immediate increase in as adjusted net tangible book value of approximately $2.07$0.895 per share to our existing stockholders, and an immediate dilution of $10.49$0.701 per share to purchasers of shares in this offering, as illustrated in the following table:

 

Assumed public offering price per share and warrant

     $12.00 

Net tangible book value (deficit) per share as of September 30, 2017

 $(0.57)    

Increase per share attributable to new investors

 $2.07     

As adjusted net tangible book value per share after this offering

     $1.50 

Dilution per share to new investors in the offering

     $10.49 

If the underwriters exercise their over-allotment option in full, the as adjusted net tangible book value will increase to $1.75 per share, representing an immediate dilution of $10.24 per share to new investors, assuming that the assumed public offering price remains the same and after deducting underwriting discounts and commissions and the estimated offering expenses payable by us.

Assumed public offering price per share

 $6.650 

Pro forma net tangible book value per share as of September 30, 2023

 $5.054 

Increase per share attributable to new investors

 $0.895 

As adjusted net tangible book value per share after this offering

 $5.949 

Dilution per share to new investors in the offering

 $0.701 

 

A $1.00$0.25 increase or decrease in the assumed public offering price of $12.00$6.65 per share and warrantcommon warrants would increase or decrease the net proceeds from thisdilution per share to new investors in the offering by approximately $0.8 million, assuming that$0.05 per share, if the number of shares and warrants offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions. Similarly, each increase (decrease) of 100,000 shares in the number of shares of common stock and warrants offered would increase (decrease) our proceeds by approximately $1.1 million, assuming the assumed public offering price remains the same, and after deducting estimated underwriting discounts and commissionsplacement agent fees and estimated offering expenses payable by us.expenses.

 

The number of shares of our common stock outstanding before and after this offering is based on 3,670,432149,656 shares of our common stock outstanding as of September 30, 2017,2023, and excludes:330,588 shares issued primarily as the result of the exercise of warrants, primarily for cash, which occurred after September 30, 2023:

 

 

417,014all shares issuable upon the exercise of warrants sold in this offering;

 

683,960pending settlements of fractional shares for cash in connection with the reverse stock split effected as of January 18, 2024;

599 shares of common stock issuable upon the exercise of outstanding stock options as of the date of this prospectus at a weighted average exercise price of $9.77$13,297.06 per share; and

 

1,110,400 additional shares of common stock reserved and available for future issuances under our 2016 Stock Option Plan;

351,500340,952 shares of common stock issuable upon exercise of outstanding stock purchase warrants, including warrants issued subsequent to September 30, 2023 but not relating to this offering at a weighted average exercise price of $5.93$64.09 per share;

an estimated 315,356 shares of common stock potentially issuable pursuant to convertible promissory notes, including accrued but unpaid interest through September 30, 2017; and

41,701 shares of common stock issuable upon exercise of the warrants issued to the representative at the closing of this offering.share.

 


24

 

Dividend PolicyDIVIDEND POLICY

 

We have never declared or paid cash dividends on our capital stock. Following the completion of this offering, we intend to retain our future earnings, if any, to finance the further development and expansion of our business and do not expect to pay cash dividends in the foreseeable future. Payment of future cash dividends, if any, will be at the discretion of our Board of Directors after taking into account various factors, including our financial condition, operating results, current and anticipated cash needs, outstanding indebtedness, plans for expansion and restrictions imposed by lenders, if any.


 

Management’s Discussion and Analysis ofMANAGEMENTS DISCUSSION AND ANALYSIS OF
Financial Condition and Results of Operations
FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

The following discussion of our financial condition and results of operations should be read in conjunction with our financial statements and the notes to those financial statements included elsewhere in this prospectus. This discussion contains forward-looking statements, which are based on our assumptions about the future of our business. Our actual results could differ materially from those contained in the forward-looking statements. Please readCautionary Note Regarding Forward-Looking Statements” included elsewhere in this prospectus for additional information regarding forward-looking statements used in this prospectus.

The Management Discussion and Analysis for the three and nine months ended September 30, 2023 versus the three and nine months ended September 30, 2022 and for the fiscal years ended December 31, 2022 and 2021 are historical. Share and per share amounts for three and nine months ended September 30, 2022 have been restated for comparison purposes for the 1-for-40 reverse stock split that was effected on January 13, 2023 or the 1-for-30 reverse stock split that was effected on June 1, 2023. No share or per share amounts for three and nine months ended September 30, 2023 versus the three and nine months ended September 30, 2022 and for the fiscal years ended December 31, 2022 and 2021 or for events which occurred subsequent to September 30, 2023 and included in the Management Discussion and analysis have been restated for the 1-for-20 reverse stock split that was effected on January 18, 2024.

 

Overview

 

Sun BioPharma,Panbela Therapeutics, Inc. (“Panbela” and together with its wholly-owned subsidiary, Sun BioPharma Australia Pty Ltd. (“SBA”) (collectivelydirect and indirect subsidiaries, “we,” “us,” “our,” and the “Company”) exist for the primary purpose of advancing the commercial development ofis a proprietary polyamine analogueclinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with pancreatic cancer andurgent unmet medical needs.

Our lead candidates are ivospemin (SBP-101) for a second indication in chronic pancreatitis. Wewhich we have exclusively licensed the worldwide rights to this compound, which has been designated as SBP-101, from the University of Florida Research Foundation, Inc. (“UFRF”)and Flynpovi (eflornithine (CPP-1X) and Sulindac). Flynpovi is delivered in an oral form. The Company has an exclusive worldwide license to commercialize Flynpovi from the Arizona Board of Regents of the University of Arizona.

 

On September 4, 2015,

As Panbela is focused on utilizing a polyamine platform to develop disruptive therapeutics for the treatment of patients with urgent unmet medical needs, we completed a reverse merger transactionare engaged in which SB Acquisition Corporation, Inc.two sponsored research agreements to evaluate the polyamines individually and combined for various diseases. At present, the collaboration with Johns Hopkins University School of Medicine has been focused on mechanism of action and solid tumors while the MD Anderson Cancer Center has been focused on the hematologic malignancies. An abstract about SBP-101 and CPP-1X (also known as DFMO or Eflornithine) research in multiple myeloma (cell lines), a Delaware corporation and wholly-owned subsidiaryhas been accepted for an online publication on the American Society of Cimarron Medical, Inc. (“Merger Sub”), merged with and into our predecessor, Sun BioPharma, Inc., a Delaware corporation (“SBI Delaware”), with SBI Delaware remaining asHematology (ASH) meeting site in the surviving entity and a wholly-owned operating subsidiary of Cimarron Medical, Inc., a Utah Corporation (“Parent”). This transaction is referred to throughout this prospectus as the “Merger.” In the Merger, each outstanding share of capital stock of SBI Delaware was automatically exchanged for 4 shares of Parent common stock. As a resultNovember 2023 supplemental issue of the Merger, the former stockholders of SBI Delaware owned approximately 95.0% of the shares of the outstanding capital stock of Parent. In connection with the Merger, SBI Delaware changed its name to “Sun BioPharma Research, Inc.” and Parent changed its name to “Sun BioPharma, Inc.”

Under GAAP, SBI Delaware was deemed to be the acquirer for accounting purposes because its former stockholders owned a substantial majority of the issued and outstanding shares of our common stock after the Merger. Further, as Parent’s business operations and net assets, at the time of the Merger, were nominal relative to SBI Delaware’s business operations and net assets, the Merger was accounted for as a capital transaction and the activity presented in these financial statements represents the current and historical operations of Sun BioPharma, Inc.

During the year ended December 31, 2015, we incurred approximately $325,000 of costs associated with the Merger and as of December 31, 2015, assumed $250,000 of demand notes payable, net, after giving effect to the disposition of the legacy business operations of Parent. The transaction costs for the Merger are included in general and administrative expenses in our Consolidated Statements of Operations and Comprehensive Loss. See Note 8 to the Consolidated Financial Statements appearing elsewhere in this prospectus for additional information regarding the Merger.journal Blood.

 


25

 

On May 25, 2016, we completed a reincorporation into the State of Delaware from the State of Utah pursuant to an agreement and plan of merger between Parent and SBI Delaware. Upon the reincorporation, each outstanding certificate representing shares of Parent’s common stock was deemed, without any action by the holders thereof, to represent the same number and class of shares of our company’s common stock. As of May 25, 2016, the rights of our stockholders began to be governed by Delaware law and our current certificate of incorporation and bylaws. The Reincorporation did not result in any change in the name, business, management, fiscal year, accounting, location of the principal executive offices, assets or liabilities of the Company. The current directors of the Company continued as directors of the surviving corporation.

On November 7, 2017, we implemented a reverse stock split and reduction in authorized shares. Without further action on our part or on the part our stockholders, the outstanding shares of common stock held by stockholders of record as of November 7, the effective date of the reverse stock split, were converted into a lesser number of shares of common stock based on the reverse stock split ratio of one-for-ten (1:10). In addition, we amended our Certificate of Incorporation to reduce the shares authorized for issuance by 50%.Ivospemin (SBP-101)

 

In August 2015, the FDA accepted our INDInvestigational New Drug (“IND”) application for our SBP-101ivospemin product candidate. In May of 2022 we were notified that the United States Adopted Names (“USAN”) had adopted ivospemin as a USAN for SBP-101. The USAN information on ivospeminwas posted on the USAN Web site (www.ama-assn.org/go/usan).

We have completed enrollment in aan initial clinical trial of SBP-101ivospemin in patients with previously treated locally advanced or metastatic pancreatic cancer. This iswas a Phase 1,I, first-in-human, dose-escalation, safety study. From January 2016 through September 2017, we enrolled twenty-nine patients into six cohorts, or groups, in the dose-escalation phase of our currentthe Phase 1I trial. Twenty-fourNo drug-related bone marrow toxicity or peripheral neuropathy was observed at any dose level. In addition to being evaluated for safety, 23 of the 29 patients received at least twowere evaluable for preliminary signals of efficacy prior chemotherapy regimens. No drug-related serious adverse events occurred during the first four cohorts. In cohort five, serious adverse events (klebsiella sepsis with metabolic acidosis in one patient, and renal and hepatic toxicity in one patient) were observed in two of the ten patients, both of whom exhibited progressive diseaseto or at the endeight-week conclusion of their first cycle of treatment and were determined byusing the DSMB to be DLTs. Consistent withResponse Evaluation Criteria in Solid Tumors (“RECIST”), the study protocol,currently accepted standard for evaluating change in the DSMB recommended continuationsize of tumors.

In 2018, we began enrolling patients in our second clinical trial, a Phase Ia/Ib study of the study by expansionsafety, efficacy and pharmacokinetics of cohort 4. Four patientsivospemin administered in combination with two standard-of-care chemotherapy agents, gemcitabine and nab-paclitaxel. A total of 25 subjects were enrolled in this expansion cohort. On October 9, 2017, we announced that patient enrollment had been completed for this study and the DSMB has recommended a safe and well-tolerated dose level for use in further clinical development. As a result, we have begun the development of a protocol for a new studyfour cohorts to evaluate the usedosage level and schedule. An additional 25 subjects were enrolled in the expansion phase of SBP-101the trial. Interim results were presented in January of 2022. Best response in evaluable subjects (cohorts 4 and Ib N=29) was a CR in 1 (3%), PR in 13 (45%), SD in 10 (34%) and PD in 5 (17%). One subject did not have post baseline scans with RECIST tumor assessments. Median PFS, now final at 6.5 months, may have been negatively impacted by drug dosing interruptions to evaluate potential toxicity. Median overall survival in cohort 4 + Phase Ib was 12.0 months when data was presented in January 2022 and is now final at 14.6 months. Two patients from cohort 2 have demonstrated long term survival. One at 30.3 months (final data) and one at 33.0 months and still alive at database lock on March 18, 2022. Seven subjects are still alive at database lock, one from cohort 2 and six from cohort 4 plus Phase Ib.

In January of 2022, the Company announced the initiation of a new clinical trial. Referred to as ASPIRE, the trial is a randomized double-blind placebo-controlled trial in combination with gemcitabine and nab-paclitaxel, a standard pancreatic cancer treatment regimen in patients previously untreated patients withfor metastatic pancreatic cancer. The trial will be conducted globally at approximately 94 sites in the United States, Europe and Asia – Pacific. The Company announced the first patient enrolled in the trial in Australia in August of 2022. In September 2022, the company announced that they had obtained regulatory approval to open sites in Spain, France and Italy. On September 30, 2023 there were 81 sites open in 10 countries.

 

This study has been conducted atWhile opening of clinical sites in both Australia and the United States including The Mayo Clinic Scottsdale and HonorHealth in Scottsdale, AZ, the Austin Health Olivia Newton-John Cancer Wellness & Research Centre in Melbourne, Australia and the Ashfordrest of the world has been slower than originally anticipated, due in part to resource fatigue in the medical community, the Company expects all countries and sites to be open by mid-2023.

The trial was originally designed as a Phase II/III with a smaller initial sample size. In response to European and FDA regulatory feedback, the study was amended to include the total trial sample size (600) and the design modified to utilize overall survival (the primary endpoint) to be examined at interim analysis as well. All Countries are open and the full complement of sites is expected to be open by year-end. The independent Data Safety Monitoring Board (DSMB) met for a prespecified safety analysis and recommended the trial continue without modification. The study is anticipated to take 36 months for complete enrollment of 600 subject with the interim analysis available in early 2024.

In early April 2023 the Company announced a poster presentation highlighting the results for ivospemin as a polyamine metabolism modulator in ovarian cancer at the American Association for Cancer CentreResearch Annual Conference. The poster concludes that the ivospemin chemotherapy treatment of C57Bl/6 mice injected with VDID8+ ovarian cancer cells significantly prolonged survival and decreased overall tumor burden. The results suggest that ivospemin in Adelaide, Australia.combination with standard of care chemotherapy may have a role in the clinical management of ovarian cancer, and the Company intends to continue pre-clinical and clinical studies in ovarian cancer.

 

Additional clinical trials willmay be required for FDA or other similar approvals ifcountry approvals. The cost and timing of additional clinical trials are highly dependent on the nature and size of the trials.

Flynpovi (eflornithine (CPP-1X) and sulindac)

In 2009, the FDA accepted our IND application for the combination product, Flynpovi, product candidate.

26

In a Phase III study, the efficacy and safety of the combination of eflornithine and sulindac known as Flynpovi, as compared with either drug eflornithine or sulindac alone, in adults with familial adenomatous polyposis (“FAP”) was conducted. A total of 171 patients underwent randomization. Disease progression occurred in 18 of 56 patients (32%) in the Flynpovi group, 22 of 58 (38%) in the sulindac group, and 23 of 57 (40%) in the eflornithine group, with a hazard ratio of 0.71 (95% confidence interval [CI], 0.39 to 1.32) for Flynpovi as compared with sulindac (p = 0.29) and 0.66 (95% CI, 0.36 to 1.23) for Flynpovi as compared with eflornithine. In a post-hoc analysis, none of the patients in the Flynpovi arm progressed to a need for lower gastrointestinal (“LGI”) surgery for up to 48 months compared with 7 (13.2%) and 8 (15.7%) patients in the sulindac and eflornithine (CPP-1X) arms. These data corresponded to risk reductions for the need for LGI surgery approaching 100% between Flynpovi and either monotherapy with HR = 0.00 (95% CI, 0.00–0.48; p = 0.005) for Flynpovi versus sulindac and HR = 0.00 (95% CI, 0.00–0.44; p = 0.003) for Flynpovi versus eflornithine. Given the statistical significance of the LGI group, a new drug application (“NDA”) was filed with the FDA. As the study failed to meet the primary endpoint, and the NDA was based on the results of an exploratory analysis, a complete response letter was issued. To address this deficiency concern, the firstCompany must submit the results of one or more adequate and well-controlled clinical trials which demonstrate an effect on a clinical endpoint.

In April of 2023 the Company regained the North American rights to develop and commercialize Flynpovi in patients with FAP, as a result of the termination of the licensing agreement between CPP and One-Two Therapeutics Assets Limited. 

We also have an ongoing double-blind placebo-controlled trial of our SBP-101 product candidate justify continued development. We estimateFlynpovi to prevent recurrence of high-risk adenomas and second primary colorectal cancers in patients with stage 0-III colon or rectal cancer, Phase III – Preventing Adenomas of the Colon with Eflornithine and Sulindac (“PACES”). The purpose of this study is to assess whether the combination of eflornithine and sulindac (compared to corresponding placebos) has efficacy against colorectal lesions with respect to high-grade dysplasia, adenomas with villous features, adenomas one cm or greater, multiple adenomas, any adenomas >/= 0.3 cm, total advanced colorectal events, or total colorectal events. The PACES trial is funded by the National Cancer Institute (“NCI”) in collaboration with Southwest Oncology Group (“SWOG”). The Company announced on June 28, 2023 that the additionalPACES trial passed a pre-planned futility analysis.

Eflornithine (CPP-1X)/eflornithine sachets (CPP-1X-S)

In 2009 and 2018, the FDA accepted our IND applications for eflornithine.

There is a trial evaluating eflornithine sachets in STK11 mutation patients with non-small cell lung cancer scheduled to begin this year. For eflornithine tablets, a Phase II trial in early onset Type I diabetes was opened on January 11, 2023 in collaboration with Indiana University and the Juvenile Diabetes Research Foundation (“JDRF”). Two poster presentations were given discussing the Phase I T1D results, one at the Endocrine Society meeting and the other at the Immunology of Diabetes Society Meeting in June 2023. Additionally, eflornithine is being evaluated with high dose testosterone and enzalutamide in metastatic castration-resistant prostate cancer in a Phase II trial.

On July 17, 2023, the Company divested certain rights, titles and interests in its eflornithine pediatric neuroblastoma program. Included in these assets is an ongoing trial evaluating eflornithine sachets in relapsed refractory neuroblastoma supported by the Children’s Oncology Group (“COG”) /NCI Under the terms of the agreement with US World Meds®, the Company is entitled to receive up to approximately $9.5 million in non-dilutive funding in exchange for the sale of these assets. An initial payment of $400,000 was received by the Company at the time and costof closing, remaining payments will be receivable if the acquiring company successfully completes certain milestones related to obtain FDA and European Medicines Agency (“EMA”)clinical development, regulatory approval and to bring our SBP-101 product candidate to market as a treatment for pancreatic cancer could be 6 to 7 years and cost up to $200 million.commercial sales.

 

Financial Overview

On June 1, 2023, we effected a reverse stock split at a ratio of one-for-forty (1:30) shares of the Company’s common stock and on January 13, 2023, we effected a reverse stock split at a ratio of one-for-forty (1:40) shares of the Company’s common stock. All share and per share amounts of our common stock presented have been retroactively adjusted to reflect these reverse stock splits.

 

We have incurred losses of $27.0$109.9 million since inception.2011. For the nine months ended September 30, 2017,2023 we incurred a net lossesloss of $8.2 million, which includes a non-cash charge of $3.7 million related to the induced conversions of $2.9 million of convertible promissory notes, including accrued but unpaid interest, originally issued in 2013 and 2014, and $250,000 aggregate principal amount of demand notes originally issued in September 2015.$18.8 million. We also incurred negative cash flows from operating activities of $2.6approximately $21.8 million for this period. For the year ended December 31, 2016, we incurred net losses of $5.1 million, and negative cash flows from operating activities of $2.4 million. We expect to continue to incur substantial losses, which will continue to generate negative net cash flows from operating activities, as we continue to pursue research and development activities and commercialize our SBP-101 product candidate.

During February and March 2017, we issued convertible promissory notes raising gross proceeds of approximately $3.1 million which are convertible into our common stock or other securities upon the completion of a qualified financing of at least $2.0 million on or before the maturity of the notes. In addition, we negotiated the conversion of approximately $3.1 million of previously outstanding debt and accrued interest into 418,332 shares of our common stock. See Note 7 titled “Indebtedness” in the Condensed Consolidated Financial Statements for the period ended September 30, 2017 elsewhere in this prospectus.commercialize.

 


27

In four closings from June through September 2016, we entered into Securities Purchase Agreements pursuant to which we sold an aggregate of 222,100 shares of common stock (the “Purchased Shares”) and warrants (the “Warrants”) to purchase an aggregate of 111,050 shares of common stock (the “Warrant Shares”). We received aggregate gross proceeds of $1.9 million from the Purchase Agreements closings under these private placement transactions and an additional $196,000 was invested by management through the conversion of previously deferred compensation. Pursuant to the Purchase Agreements, we filed a registration statement on Form S-1 with the SEC covering the resale of the Purchased Shares and Warrant Shares. On October 3, 2016, the SEC declared the registration statement effective. See “Private Placement, Resale Registration” in Note 8 to the Consolidated Financial Statements for the period ended December 31, 2016 for additional information included elsewhere in this prospectus.


 

Our cash was $943,000approximately $0.9 million and $1.3 million as of September 30, 2017, compared to $438,000 as of2023 and December 31, 2016. In May 2016, we received a $772,0002022, respectively. A decrease of $0.4 million in cash for the nine months ended September 30, 2023 was due to $21.8 million negative cash flow from operations offset in part to $21.4 million net financing activities. Due to drug shortages of Abraxane, which is utilized in addition to ivospemin for the current randomized clinical trial, the Company has become responsible for procuring this standard of care component to the clinical trial and in the quarter ended approximately $3.1 million was charged to research and development tax incentive payment fromwhen the governmentdrug was made available to our clinical sites. The Company continues to explore all avenues to procure supply and prepayments of Australia related to the research activities of our Australian subsidiary during 2015. In July 2017, we receivedan additional approximately $460,000 related to the research activities of our Australian subsidiary during 2016.

Effective March 1, 2016, we instituted substantial salary deferrals for all senior employees in order to conserve cash. In October 2017, salary deferrals$0.5 million were discontinued as part of amendments to employment agreements for the senior employees which included salary reductions for the Company’s Executive Chairman, Chief Executive Officer and Chief Medical Officer. See Note 10 titled “Subsequent Events”required in the Condensed Consolidated Financial Statements forthird quarter. These prepayments are required well in advance of delivery and will be held on the balance sheet as a prepaid expense and reflected in the periods cash used in operations. Net financing activities included a registered public offering of common stock, pre-funded warrants, and warrants with net proceeds of approximately $23.0 million. The Company also sold common stock through its at-the market sales arrangement, with net proceeds of approximately $1.6 million. In the same period, ended September 30, 2017 elsewherethe Company also recorded $1.6 million in this prospectus.loan repayments.

 

We will need to obtainraise additional fundscapital to continue our operations and execute our current business plans,plan past the third quarter of 2023 including completing our current Phase 1 clinical trial, planning for required future regulatory submissions and trials and pursuing regulatory approvals in the United States, the European Union, and other international markets. We historicallyHistorically we have financed our operations principally from the sale of convertible debtequity securities and equity securities.debt. While we have been successful in the past in obtaining the necessary capital to support our operations and havewe are likely to seek additional financing through similar future plans to obtain additional financing,means, there is no assurance that we will be able to obtain additional financing under commercially reasonable terms and conditions, or at all. This risk would increase if our clinical data is inconclusive orwere not positive or if economic or market conditions worsendeteriorate. The accompanying condensed consolidated financial statements have been prepared assuming that we will continue as a going concern which contemplates the realization of assets and liquidation of liabilities in the market as a whole or in the pharmaceutical or biotechnology markets individually.normal course of business.

 

If we are unable to obtain additional financing when needed, we willwould need to reducescale back our operations, by taking actions thatwhich may include, among other things, reducing use of outside professional service providers, reducing staff or further reducing staff compensation, significantly modifying, or delaying the development of our SBP-101 product candidate,candidates, licensing rights to third parties including the rightrights to commercialize our SBP-101 product candidate for pancreatic cancer, acute pancreatitiscandidates, or other applications that we would otherwise seek to pursue, or discontinue operations entirely.ceasing operations.

 

Key Components of Our Results of Operations

General and Administrative Expenses

Our selling, general and administrative expenses consist primarily of salaries, benefits and other costs, including stock-based compensation, forThe Company did not experience any significant disruptions to our executive and administrative personnel; legal and other professional fees; travel, insurance and other corporate costs. Our general and administrative expenses increased significantlyoperations as a result of becoming a public company in September 2015. These increases include higher costs for insurance, costs related to quarterly, annual and other periodic filings with the SEC and payments to outside consultants, lawyers and accountants.COVID-19 pandemic.


 

Research and Development ExpensesWarrant Exercise Inducements & Private Placement of Class C Warrants

 

Since inception,On November 2, 2023, we have focused our activities on the developmententered into warrant exercise inducement offer letters with certain holders of SBP-101, our initial product candidate, for the treatment of pancreatic cancer. We expense both internal and external research and development costs as incurred. Research and development costs include expenses incurred in the conduct of our Phase 1 human clinical trial, for third-party service providers performing various testing and accumulating data relatedexisting warrants to our preclinical studies; sponsored research agreements; developing and scaling the manufacturing process necessary to produce sufficient amounts of the SBP-101 compound for use in our pre-clinical studies and human clinical trials; consulting resources with specialized expertise related to execution of our development plan for our SBP-101 product candidate; personnel costs, including salaries, benefits and stock-based compensation; and costs to license and maintain our licensed intellectual property. During 2016, research and development expenditures shifted to focus on costs related to the execution of our Phase 1 human clinical trial and related support activities.

We cannot determine with certainty the timing of initiation, the duration or the completion costs of current or future preclinical studies and clinical trials of our product candidates. At this time, due to the inherently unpredictable nature of preclinical and clinical development, we are unable to estimate with any certainty the costs we will incur and the timelines we will require in the continued development of our product candidates and our other pipeline programs. Clinical and preclinical development timelines, the probability of success and development costs can differ materially from expectations. Our future research and development expenses will depend on the preclinical and clinical success of each product candidate that we develop, as well as ongoing assessments of the commercial potential of such product candidates. In addition, we cannot forecast which product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.

Completion of clinical trials may take several years or more, and the length of time generally varies according to the type, complexity, novelty and intended use of a product candidate. The cost of clinical trials may vary significantly over the life of a project as a result of differences arising during clinical development, including, among others:

per patient trial costs;

the number of trials required for approval;

the number of sites included in the trials;

the number of patients that participate in the trials;

the length of time required to enroll suitable patients;

the number of doses that patients receive;

the drop-out or discontinuation rates of patients;

the duration of patient follow-up;

potential additional safety monitoring or other studies requested by regulatory agencies;

the number and complexity of analyses and tests performed during the trial;

the phase of development of the product candidate; and

the efficacy and safety profile of the product candidate.

Our expenses related to clinical trials are based on estimates of the services received and efforts expended pursuant to contracts with multiple clinical trial sites and, for certain trials, contract research organizations, (“CROs”), which administer clinical trials on our behalf. The financial terms of these agreements are subject to negotiation and vary from contract to contract and may result in uneven payment flows. Generally, these agreements set forth the scope of work to be performed at a fixed fee or unit price. Payments under the contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. Expenses related to clinical trials generally are accrued based on contracted amounts and the achievement of milestones, such as number of patients enrolled. If timelines or contracts are modified based upon changes to the clinical trial design or scope of work to be performed, we modify our estimates of accrued expenses accordingly.


Other Income (Expense)

Other income (expense) consists of interest income, cash and non-cash interest expense and transaction gains and losses resulting from transactions denominated in other than our functional currency.

Critical Accounting Policies and Estimates

Our management’s discussion and analysis of financial condition and results of operations is based on our financial statements, which have been prepared in accordance with GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses. On an ongoing basis, we evaluate these estimates and judgments, including those described below. We base our estimates on our historical experience and on various other assumptions that we believe to be reasonable under the circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results and experiences may differ materially from these estimates.

While our significant accounting policies are more fully described in Note 4 to our Consolidated Financial Statements for the period ended December 31, 2016 appearing elsewhere in this prospectus, we believe that the following accounting policies are the most critical to aid you in fully understanding and evaluating our reported financial results and affect the more significant judgments and estimates that we use in the preparation of our financial statements.

Fair Value Estimates of Common Stock

Prior to becoming eligible for quotation on the over-the-counter markets, determining the fair value per share orpurchase our common stock, pursuant to which the holders agreed to exercise for use in estimating the fair values of share based payments required making complex and subjective judgments. The Company used the implied valuations based upon the terms from our sales of convertible notes payablecash their existing warrants to estimate our enterprise value for the dates on which these transactions occurred. The estimated enterprise values considered certain discounts related to control and lack of marketability.

Our Board of Directors also considered the estimated fair valuepurchase 2,130,000 shares of our common stock, in relation tothe aggregate, at a numberreduced exercise price of objective and subjective factors, including external market conditions affecting the biotechnology industry sector. Our Board of Directors also retained an independent financial valuation firm to provide independent estimates of our enterprise value. Until an active trading market develops$0.78 per share, in exchange for our agreement to issue new Class C common stock estimating the fair value per sharepurchase warrants to purchase up to an aggregate of 4,260,000 shares of our common stock will continue to be highly subjective. There is inherent uncertainty in these estimates.

Stock-Based Compensation

In accounting for stock-based incentive awards we measurestock. The Company received aggregate gross proceeds of approximately $1.9 million from the exercise of the existing warrants and recognizepurchase of the costnew warrants. The new warrants had an initial exercise price of employee$0.78 per share and non-employee services received in exchange for awards of equity instruments based on the grant date fair value of those awards. Compensation cost is recognized ratably using the straight-line attribution method over the expected vesting period, which is considered to be the requisite service period. Compensation expense for performance-based stock options is recognized when “performance” has occurred or is probable of occurring. All of our previously awarded options were classified as equity instruments and continue to maintain their equity classification.

The fair value of stock-based awards is estimated atexercisable upon the date of grant usingstockholder approval through the Black-Scholes option pricing model. The determination of the fair value of stock-based awardsdate that is affected by our stock price, as well as assumptions regarding a number of complex and subjective variables. Risk free interest rates are based upon U.S. Treasury rates appropriate for the expected term of each award. Expected volatility rates are based primarily on the volatility rates of a set of guideline companies, which consist of public and recently public biotechnology companies. The assumed dividend yield is zero, as we do not expect to declare any dividends in the foreseeable future. The expected term of options granted is determined using the “simplified” method. Under this approach, the expected term is presumed to be the mid-point between the average vesting date and the end of the contractual term. The model and assumptions also attempt to account for changing employee behavior as the stock price changes and capture the observed pattern of increasing rates of exercise as the stock price increases. The use of different assumptions by management in connection with these assumptions in the Black Scholes option pricing model can produce substantially different results.


We grant options to employees and non-employees, including our directors. Option grants to employees generally vest quarterly over twofive years from the date of grant. Options grantedany stockholder approvals necessary under the listing rules of Nasdaq. Our stockholders approved the issuance of the underlying shares of common stock at a special meeting held on December 19, 2023. We agreed to file a registration statement covering the resale of the shares issued or issuable upon the exercise of the new warrants and a registration statement on Form S-1 (File No. 333-275733) was declared effective by the SEC on December 20, 2023. As of January 18, 2024 there are 1,504,000 Class C Warrants outstanding.

Warrant Exercise Inducements & Private Placement of Class D Warrants

On December 21, 2023, we entered into warrant exercise inducement offer letters with certain holders of existing warrants to purchase our non-employee directors generally vest over one-yearcommon stock, pursuant to which the holders agreed to exercise for cash their existing warrants to purchase 2,556,000 shares of our common stock, in the aggregate, at their existing exercise price of $0.78 per share, in exchange for our agreement to issue new Class D common stock purchase warrants to purchase up to an aggregate of 5,112,000 shares of our common stock. The Company received aggregate gross proceeds of approximately $2.0 million from the exercise of the existing warrants. The new warrants had an initial exercise price of $0.95 per share and will only be exercisable contingent upon and after receiving stockholder approval as required by listing rules of Nasdaq and may be exercised until five years from the date of grant. Options grantedsuch stockholder approval, if any. The exercise price is separately subject to other non-employees generally vest over two years with 50%reduction in the event of certain future dilutive issuances of shares of our common stock by the Company, including pursuant to common stock equivalents and convertible or derivative securities, upon any intervening reverse stock splits, and upon receipt of the totalstockholder approval. As of January 18, 2024 all of the new warrants remained outstanding but unexercisable pending stockholder approval. We have agreed to call a meeting to seek stockholder approval of the issuance of the shares of our common stock underlying the new warrants within six months and to file a registration statement covering the resale of the shares underlying the option vesting onnew warrants within sixty calendar days of December 21, 2023. Additionally, the first and second anniversaries ofCompany agreed not to effect or agree to effect any variable rate transaction (as defined in the date of grant. Options issued to employees and non-employee directors generally have a maximum term of ten years and options issued to non-employees generally have a maximum term of five years.inducement letters) for one year, other than an at-the-market offering, which may be effected after six months.

 

Option grants to non-employees have been made in conjunction with their service as advisors to us. Certain of these advisors have also purchased shares of stock in our private placement offerings, but none beneficially own 5% or more of our outstanding common stock. The fair value of options granted to non-employees is measured at each reporting date until the option, or respective portion of the option, vests and the expense recorded by us is updated accordingly.

Research and development costs

We charge research and development costs, including clinical trial costs, to expense when incurred. Our human clinical trials are, and will be, performed at clinical trial sites and are administered jointly by us with assistance from contract research organizations (“CROs”). Costs of setting up clinical trial sites are accrued upon execution of the study agreement. Expenses related to the performance of clinical trials generally are accrued based on contracted amounts and the achievement of agreed upon milestones, such as patient enrollment, patient follow-up, etc. We monitor levels of performance under each significant contract, including the extent of patient enrollment and other activities through communications with the clinical trial sites and CROs, and adjust the estimates, if required, on a quarterly basis so that clinical expenses reflect the actual effort expended at each clinical trial site and by each CRO.

Results of Operations

Note that the activity presented in financial analyses below represents our current and historical operations. All share and per share amounts included below are presented on an as converted basis, which gives effect to the exchange of common stock in accordance with the Merger and the one-for-ten reverse stock split implemented November 7, 2017.

 

Comparison of the three and nine months ended September 30, 2017 to the three and nine months ended September 30, 2016results of operations (in thousands):

 

  

Three Months Ended September 30,

  

Nine Months Ended September 30,

 
  

2017

  

2016

  

Percent

Change

  

2017

  

2016

  

Percent

Change

 

Operating expenses:

                        

General and administrative

 $515  $499   3.2% $2,252  $1,399   61.0%

Research and development

  530   636   (16.7)  1,955   1,657   18.0 

Total operating expenses

  1,045   1,135   (7.9)  4,207   3,056   37.7 
                         

Other income (expense), net

  (371)  11   nm   (4,466)  (70)  nm 

Income tax benefit

  197   45   337.8   460   252   82.5 
                         

Net loss

 $(1,219) $(1,079)  13.0% $(8,213) $(2,874)  185.8%

“nm” = not meaningful.

  Three Months Ended September 30,     Nine Months Ended September 30,     
  

2023

  

2022

  

Percent

Change

  

2023

  

2022

  

Percent

Change

 

Operating Expenses

                        

General and administrative

 $1,107  $1,294   -14.5% $4,102  $4,349   -5.7%

Research and development

  6,739   2,329   189.4%  14,501   24,563   -41.0%

Total operating expenses

  7,846   3,623   116.6%  18,603   28,912   -35.7%
                         

Other expense, net

  (4)  (835)  -99.5%  (353)  (1,390)  -74.6%

Income tax benefit

  19   56   -66.1%  167   104   60.6%
                         

Net Loss

 $(7,831) $(4,402)  77.9% $(18,789) $(30,198)  -37.8%

 

Research and development (“R&D”) and general and administrative (“G&A”) expenses include non-cash share-based compensation expense as a result ofresulting from our issuance of stock options. We expense the fair value of equity awards over their vesting periods. The terms and vesting schedules for share-based awards vary by type of grant and the employment status of the grantee. The awards granted through September 30, 20172023 vest upon performance andor time-based conditions. We expect to record additional non-cash share-based compensation expense in the future, which may be significant.

 


28

 

The following table summarizes the share-basedstock-based compensation expense in our statements of operations and comprehensive loss for the nineloss:

  

Nine Months Ended September 30,

 
  

2023

  

2022

 

General and administrative

 $554  $697 

Research and development

  145  $160 

Total stock based compensation

 $699  $857 

Three months ended September 30, 2017. No share-based compensation was recorded during the comparable period in 2016. (in thousands):2023 and September 30, 2022

 

  

Nine months ended

September 30, 2017

 

Research and development

 $229 

General and administrative

  938 

Total share-based compensation

 $1,167 

General and administrative expense

 

Our general and administrative (“G&A”)&A expenses increased 3.2%decreased 14.5% to $515,000$1.1 million in the third quarter of 2017 up2023 down from $499,000$1.3 million in the third quarter of 2016. G&A expenses increased 61.0%2022. The decrease is due primarily to $2.3 million in the nine months ended September 30, 2017 up from $1.4 million in the comparable period of 2016. These increases resulted primarily from increases in non-cash, share-based compensation expense during the current year partially offset current year reductions inreduced legal and accounting costs.other professional services.

 

Research and development expense

 

Our research and development (“R&D”)&D expenses decreased 16.7%increased 189.4% to $530,000$6.7 million in the third quarter of 2017, down2023 up from $636,000$2.3 million in the third quarter of 2016. R&D expenses increased 18.0%2022. The increase is primarily due to $2.0the cost of approximately $3.2 million foror approximately 6 months’ supply of Abraxane a standard of care drug used in the nineASPIRE clinical trial and first made available to the clinical sites during the three months ended September 30, 2017, up from $1.7 million in2023. The ASPIRE trial, and the nine months ended September 30, 2016. The current quarter decrease in R&D expense was due primarilyneed to reduced costssupply standard of manufacturing and manufacturing process development, which was materially completed in 2016, and fewer study patient enrollments in the third quarter of 2017, partially offset by contract research costs incurred in conjunction with our NIH sponsored pancreatitis study. Thecare drug to many sites, will continue to drive increased costs forversus the nine months ended September 30, 2017 resulted primarily from the costs of our Phase 1 clinical trial and non-cash share-based compensation expense recorded during the currentprior year. There was no share-based compensation expense recorded during the first nine months of 2016.

 

Other income (expense),expense, net

 

Other expense, net, was $371,000 in the current quarter compared to other income, net, of $11,000 in the third quarter of 2017. Other expense, net, increased to $4.5 millionapproximately $4,000 for the ninethree months ended September 30, 2017, up2023. Other expense for this period of $0.4 million from $70,000foreign currency exchange loss on the intercompany receivable balance and interest expense on one promissory note, was nearly offset by $0.4 million of other income from the gain on sale of assets and interest income on a money market account. Other expense, net, was approximately $0.9 million for the three months ended September 30, 2022. Other expense in the same period ofthree months ended September 30, 2022, is related to foreign currency exchange loss on the prior year. The increase in the current quarter was primarily due to increasedintercompany receivable balance and interest expense resulting from the amortization of the discount on the 2017 convertible notes payable, partially offset by grant income earned during the current year received under a research grant awarded to the Company in 2016. On a year-to-date basis, the increase was due primarily to charges recorded related to the induced conversion of debt and increased interest expense resulting from the amortization of the discount on the 2017 convertible notes payable. These expenses were partially offset by a foreign currency transaction gains recognized by our Australian subsidiary and grant income earned during the current year period.two promissory notes.

 


Income tax benefit

 

Income tax benefit increased 337.8%decreased to $197,000 and 82.5% to $460,000$19,000 for the three and nine months ended September 30, 2017, respectively.2023 down from $56,000 for the three months ended September 30, 2022. Our income tax benefit is derived primarily from refundable tax credits associated with our R&D activities conducted in Australia. The ASPIRE trial is being conducted in several countries across the world, including five clinical sites in Australia as of September 30, 2023. Costs incurred to do research in Australia are available for this refundable credit.

Nine months ended September 30, 2023 and September 30, 2022

General and administrative expense

Our G&A expenses decreased 5.7% to $4.1 million in the nine months ended September 30, 2023 down from $4.3 million in the nine months ended September 30, 2022. The decrease is due primarily to professional services incurred in connection with the acquisition of CPP incurred in the nine months ended September 30, 2022.

29

Research and development expense

Our R&D expenses decreased 41.0% to $14.5 million in the nine months ended September 30, 2023 down $10.1 million from the nine months ended September 30, 2022. The decrease is primarily due to a $17.7 million IPR&D write-off in the second quarter of 2022 for the CPP acquisition. Exclusive of this one-time write-off, R&D increased $7.6 million in the first nine months of 2023 related to the cost of Abraxane and increased sites and subject enrollments in the ASPIRE trial. The ASPIRE trial will continue to drive increased costs versus the prior year.

Other expense, net

Other expense, net, was approximately $0.4 million for the nine months ended September 30, 2023. Other expenses for this period are related to foreign currency exchange loss on the intercompany receivable balance and interest expense on two promissory notes, partially offset by gain on sale of fixed assets and interest income on a money market account.

Other expense, net, was approximately $1.4 million for the nine months ended September 30, 2022, it is related to foreign currency exchange loss on the intercompany receivable balance.

Income tax benefit

Income tax benefit increased to $167,000 for the nine months ended September 30, 2023 up from $104,000 for the nine months ended September 30, 2022. Our income tax benefit is derived primarily from refundable tax credits associated with our R&D activities conducted in Australia which have started to increase versus last year due to the ASPIRE trial.

 

Comparison of the YearResults of Operations (in thousands) for the Years Ended December 31, 2022 and 2021December 31, 2016 to the Year Ended December 31, 2015

 

(in thousands)

 

Year Ended December 31,

     
 

2016

  

2015

  Percent Change  Year Ended December 31,     

Operating expenses:

            
 

2022

  

2021

  

Percent Change

 

Operating Expenses

            

General and administrative

 $2,664  $2,592   2.8% $6,044  $4,587   31.8%

Research and development

  2,504   2,852   (12.2)  28,049   5,423   417.2%

Total operating expenses

  5,168   5,444   (5.1)  34,093   10,010   240.6%
                        

Other expense, net

  (285)  (239)  19.2 

Other (expense) income, net

  (956)  (613)  56.0%

Income tax benefit

  341   756   (54.9)  116   488   -76.2%
                        

Net loss

 $(5,112) $(4,927)  39.5%

Net Loss

 $(34,933) $(10,135)  244.7%

30

 

General and administrative (“G&A”) and research and development (“R&D”) expenses include non-cash stock-based compensation expense as a result of our issuance of stock options. The terms and vesting schedules for stock-based awards vary by type of grant and the employment status of the grantee. The awards granted through December 31, 20162022 vest based upon time-based and performance conditions. We expect to record additional non-cash compensation expense in the future, which may be significant. The following table summarizes the stock-based compensation expense in our statement of Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 20162022 and 2015:2021 (in thousands):

 

(in thousands)

 

Year Ended December 31,

 
 

Year Ended December 31,

 
 

2016

  

2015

  

2022

  

2021

 

General and administrative

 $810  $759  $889  $1,083 

Research and development

  92   217   199   204 

Total stock-based compensation

 $902  $976 

Total stock based compensation

 $1,088  $1,287 

 

General and administrative expense

 

G&A expenses increased 2.8%31.8% to $2.7$6.0 million in 2016,2022, up from $2.6$4.6 million in 2015. This2021. The increase was due to a combinationin G&A expenses is primarily the result of factors including salary increases implemented in the fourth quarter of 2015, increased reporting and compliance costs associated with being a public company during 2016 and increased stock based compensation costs, offset by decreased legal and accounting fees relating to the Merger.financial advisor expenses.

 

Research and product development expense

 

Our R&D expenses decreased 12.2%increased 417.2% to $2.5$28.0 million in 2016, down2022, up from $2.9$5.4 million in 2015. The decrease in R2021. After considering the non-cash write off of approximately $17.7 million of IPR&D, expenses resulted from decreased costs of preclinical studies and other product development projects, which completed in 2015, along with decreased stock-based compensation, partially offset bythe remaining increase is due primarily to increased clinical trial andcosts related costs forto our Phase 1ivospemin (SBP-101) randomized trial. As we expand our clinical trial.studies it is expected that R&D expenses will continue to increase. The write off of IPR&D is a one-time occurrence.

 

Other expense,income (expense), net

 

Other expense, net, increased 19.2% to $285,000 inwas $1.0 million and $0.6 million for the current year up from $239,000 in the prior year. Other expense, net, consistsended December 31, 2022 and 2021 respectively and was composed primarily of interest expense on convertible promissory notes and term debt in addition to foreign currency transaction losses. The current year increases are primarily due to increases in losses associated with transactions in foreign currencies.loss.

 


Income tax benefit

 

Income tax benefit decreased to $341,000$116,000 in 2016,2022, down from $756,000$488,000 in 2015.2021. Our income tax benefit is derived primarily from refundable tax creditsincentives associated with our R&D activities conducted in Australia. The current year decrease reflects an reductionAustralia which have significantly curtailed in 2022 as the costs eligiblePhase Ia/Ib trial completed and the ASPIRE trial had not yet opened all sites planned for the Australian R&D tax credit.in Australia.

 

Liquidity and Capital Resources

 

The following table summarizes our liquidity and capital resources as of September 30, 20172023 and December 31, 20162022, and our cash flow data for the nine months ended September 30, 20172023 and 2016 and2022. It is intended to supplement the more detailed discussion that follows (in thousands):

 

Liquidity and Capital Resources

 

September 30, 2017

  

December 31, 2016

         
 

September 30, 2023

  

December 31, 2022

 

Cash

 $943  $438  $907  $1,285 

Working capital deficit

 $616  $4,642 

Working capital (deficit)

 $(7,031) $(6,056)

 

  

Nine months Ended September 30,

 

Cash Flow Data

 

2017

  

2016

 

Cash provided by (used in):

        

Operating activities

 $(2,619) $(1,570)

Financing activities

  3,106   1,873 

Effect of exchange rate changes on cash and cash equivalents

  18   1 

Net increase (decrease) in cash and cash equivalents

 $505  $304 

Cash Flow Data

 

Nine Months Ended September 30,

 
  

2023

  

2022

 

Cash Provided by (Used in):

        

Operating Activities

 $(22,169) $(10,273)

Investing Activities

  400   (656)

Financing Activities

  21,393   5 

Effect of exchange rate changes on cash

  (2)  (2)

Net increase (decrease) in cash

 $(378) $(10,926)

31

 

Working Capital

 

Our total cash was $943,000and cash equivalents were $0.9 million and $1.3 million as of September 30, 2017, compared to $438,000 as of2023, and December 31, 2016.2022, respectively. We had $2.1 million in current liabilities, and negative working capital of $616,000 as of September 30, 2017, compared to $5.5$8.9 million in current liabilities and a working capital deficit of $4.6$7.0 million as of September 30, 2023, compared to $7.8 million in current liabilities and working capital deficit of $6.1 million as of December 31, 2016.2022. Working capital is defined as current assets less current liabilities.

 

Cash Flows

 

Net Cash Used in Operating Activities

 

Net cash used in operating activities was $2.6approximately $21.8 million in the nine months ended September 30, 20172023, compared to $1.6approximately $10.3 million in the nine months ended September 30, 2016.2022. The net cash used in each of these periods primarily reflects the net loss for these periods and is partially offset by the effects of changes in operating assets and liabilities. For the nine months ended September 30, 2023, cash used in operating activities also included $5.5 million to fund long term deposits held by the CRO leading our randomized trial, offset in part by an increase in Accounts Payable as we slowed payments to the CRO for these Deposits. Also reflected in the increased cash used in operations is approximately $3.2 million to provide standard of care drug supply to the sites to support the Aspire Trial, and $0.5 million for prepayment of standard of care drug supply.

Net Cash Provided by Investing Activities

Cash provided by investing activities included the proceeds from the sale of intellectual property in the nine months ended September 30, 2023. In the nine months ended September 30, 2017,2022, the net loss is also offset by a non-cash charge of $3.7 millioncash incurred was related to banker and legal costs to acquire the induced conversions of $2.9 million of convertible promissory notes, including accrued but unpaid interest,in process research and $250,000 aggregate principal amount of demand notes and a non-cash charge of $961,000 related to the amortization of the discount on the 2017 convertible notes payable.development from CPP.

 

Net Cash Provided by Financing Activities

 

Net cash provided by financing activities was $3.1approximately $21.4 million for the nine months ended September 30, 2017, which was comprised primarily of net proceeds from the sale of convertible promissory notes. During the nine months ended September 30, 2016, net cash2023 with $5,000 provided by financing activities was $1.9 million which resultedfor the nine months ended September 30, 2022. The cash provided for the nine months ended September 30, 2023 represents the proceeds from net proceeds received in the sale of common stock, pre-funded warrants and warrants, partially offset by the payments made on promissory notes. The cash provided for the nine months ended September 30, 2022 represents the proceeds from exercise of stock purchase warrants.


 

Capital Requirements

 

WeAs we continue to pursue our operations and execute our business plan, including the completion of the clinical development plan for our initial product candidate, ivospemin, in pancreatic cancer, and pursuing regulatory approvals in the United States, the European Union and other international markets, we expect to continue to incur substantial and increasing losses, which will continue to generate negative net cash flows from operating activities, as we continue to pursue research and development activities and commercialize our SBP-101 product candidate.activities.

 

Our future capital uses and requirements depend on numerous current and future factors. These factors include, but are not limited to, the following:

 

 

the progress of clinical trials required to support our applications for regulatory approvals, including the completion of our global, randomized Phase 1II/III trial initiated in January of 2022;

our ability to negotiate payment terms with critical vendors;

the cost to implement development efforts for ivospemin in ovarian cancer and expand development efforts for assets acquired as the result of the acquisition of CPP;

the cost, if any, to develop our product candidate, Flynpovi;

the cost to develop eflornithine in various indications if early clinical trial, a human clinical trial in Australiatrials underway now, and the United States;funded through third party collaborations, are successful;

 

 

our ability to demonstrate the safety and effectiveness of our SBP-101 product candidate;candidates;

 

 

our ability to obtain regulatory approval of our SBP-101 product candidatecandidates in the United States, the European Union or other international markets;

 

 

the cost and delays in product development that may result from changes in regulatory oversight applicable to our product candidates;

32

the market acceptance and level of future sales of our SBP-101 product candidate;candidates;

 

 

the rate of progress in establishing reimbursement arrangements with third-party payors;

 

 

the effect of competing technological and market developments;

the cost and delays in product development that may result from changes in regulatory oversight applicable to our SBP-101 product candidate; and

 

 

the costs involved in filing and prosecuting patent applications and enforcing or defending patent claims.

 

Through the date of this prospectus, we have used primarily convertible debt and equity financings to fund our ongoing business operations and short-term liquidity needs, and we expect to continue this practice for the foreseeable future.

Although we do not have any current capital commitments, we expect that we will increase our projected expenditures once we have additional capital on hand in order to continue our efforts to grow our business and continue to conduct clinical trials for our SBP-101 product candidate. Accordingly, we expect to make additional expenditures in completing our Phase 1 clinical trial, preparing for our next clinical trial and related support activities. With sufficient capital, we also expect to invest in research and development efforts of follow-on indications, such as pancreatitis. However, we do not have any definitive plans as to the exact amounts or particular uses at this time, and the exact amounts and timing of any expenditure may vary significantly from our current intentions.

As of September 30, 2017,2023, we did not have any existing credit facilities under which we could borrow funds. Historically we have financed our operations principally from the sale of equity securities and debt. While we have been successful in the past in obtaining the necessary capital to support our operations and we are likely to seek additional financing through similar means, there is no assurance that we will be able to obtain additional financing under commercially reasonable terms and conditions, or at all.

 

During FebruaryIndebtedness

CPP issued to Sucampo GmbH (“Lender”) an Amended and March 2017, we issued convertible promissory notes raising gross proceedsRestated Promissory Note (the “Note”) on June 15, 2022 for the principal sum of approximately $3.1$6.2 million which are convertible into our common stock or other securities upon the completion(the “Principal”). The note bears simple interest on any outstanding Principal at a rate of a qualified financing of at least $2.05% per annum. All unpaid Principal, together with any then unpaid and accrued interest, is payable as follows: (i) $1.0 million, plus all interest accrued but unpaid on or before each of January 31, 2024, January 31, 2025 and January 31, 2026; and (ii) all remaining Principal plus accrued but unpaid interest on or before January 31, 2027. The Company made the maturityscheduled January 31, 2023 payment of $1.0 million plus accrued interest. The outstanding principal balance on September 30, 2023 was approximately $5.2 million. Accrued and unpaid interest as of September 30, 2023 totaled approximately $172,000.

Panbela has provided a Guarantee of payment in favor of the notes. In addition, we negotiatedLender for the conversionfull amount of approximately $3.1 million of previously outstanding debt and accrued interest into 418,332 shares of our common stock. Seethe Note 7 titled “Indebtedness” inissued to the Condensed Consolidated Financial Statements elsewhere in this prospectus.Lender.

 

In four closings from June through September 2016, we entered into Securities Purchase Agreements pursuant to which we soldIssuances of Common Stock and warrants during 2022 and 2021

On October 4, 2022, the Company completed a registered public offering and issued an aggregate of 222,100177,175 shares of its common stock, pre-funded warrants to purchase up to an aggregate of 325,325 shares of common stock (the “Purchased Shares”)at an exercise price of $0.001 per shares and warrants (the “Warrants”) to purchase up to an aggregate of 111,050753,749 shares of its common stock. The exercise price on these warrants were repriced after a dilutive public offering that closed on January 30, 2023 to $1.51 per share. The securities were issued for a combined offering price of $12.00 per share of common stock and 1.5 warrants, or $11.999 per pre-funded warrant and 1.5 warrants. Net proceeds from the offering totaled approximately $5.3 million. All pre-funded warrants were exercised by December 31, 2022. The securities were offered pursuant to an effective registration statement on Form S-1.

33

On July 19, 2022, Panbela Therapeutics, Inc. (the “Company”), entered into a Sales Agreement with Roth Capital Partners, LLC (the “Agent”) to sell shares of the Company’s common stock having an aggregate gross sales price of up to $8,400,000, from time to time, through an “at-the-market” equity offering program (the “ATM Program”). During the last month of the year ended December 31, 2022, the Company sold 28,343 shares of common stock (the “Warrant Shares”). We receivedunder the ATM Offering and generated approximately $93,000 in gross proceeds. The Company incurred financing costs of approximately $44,000, which were charged to additional paid in capital in December 2022 when the Company began selling shares under the ATM Offering. Under the ATM Program, the Company pays the Agent a commission equal to 3.0% of the aggregate gross proceeds of $1.9 million fromany sales of common stock under the Purchase Agreements closings under these private placement transactions and an additional $196,000ATM Program. Net proceeds for the year ended December 31, 2022 was invested by management through the conversion of previously deferred compensation. Pursuant to the Purchase Agreements, we filed a registration statement on Form S-1 with the SEC covering the resale of the Purchased Shares and Warrant Shares. On October 3, 2016, the SEC declared the registration statement effective. See “Private Placement, Resale Registration” in Note 8 to the Consolidated Financial Statements for additional information included elsewhere in this prospectus.approximately $46,000.


 

On March 1, 2016, we instituted substantial salary deferralsJuly 2, 2021, the Company completed an underwritten public offering of 83,333 shares of its common stock for all senior employees in order to conserve cash. In October 2017, salary deferrals were discontinued as parta purchase price of amendments to employment agreements for$120.00 per share. The gross proceeds from the senior employees which included salary reductions foroffering was approximately $10.0 million. The net proceeds, after deducting the Company’s Executive Chairman, Chief Executive Officerunderwriter’s discount and Chief Medical Officer. See Note 10 titled “Subsequent Events” in the Condensed Consolidated Financial Statements elsewhere in this prospectus.other offering costs, was approximately $9.1 million.

Future Capital Requirements

 

We will need to obtainrequire additional funds to continue our operations and execute our business plans,plan, including completing our current Phase 1 clinical trial, preparing for our next trial, planning forcompletion of required future trials and pursuing regulatory approvals in the United States, the European Union and other international markets. We historically have financed our operations principally from the sale of convertible debtequity securities and equity securities.debt. While we have been successful in the past in obtaining the necessary capital to support our operations and havewe are likely to seek additional financing through similar future plans to obtain additional financing,means, there is no assurance that we will be able to obtain additional financing under commercially reasonable terms and conditions, or at all. This risk would increase ifWe believe that our clinical data is inconclusive or not positive or economic conditions worsenexisting cash and cash raised through public offerings in January 2023 will be sufficient to fund our operating expenses into the market as a whole or in the pharmaceutical or biotechnology markets individually.third quarter of 2023.

 

If we are unable to obtain additional financing when needed, we willwould need to reducescale back our operations, by taking actions which may include, among other things, reducing use of outside professional service providers, reducing staff or further reduce staff compensation, significantly modifying or delaying the development of our SBP-101 product candidate,candidates, licensing rights to third parties including the rightrights to commercialize our SBP-101 product candidate for pancreatic cancer acute pancreatitis or other applications that we would otherwise seek to pursue, or discontinuing operations entirely.suspending operations.

 

To the extent that we raise additional capital through the sale of equity or convertible debt securities, the interests of our current stockholders would be diluted, and the terms may include liquidation or other preferences that adversely affect the rights of our current stockholders. If we issue preferred stock, it could affect the rights of our stockholders or reduce the value of our common stock. In particular, specific rights granted to future holders of preferred stock may include voting rights, preferences as to dividends and liquidation, conversion and redemption rights, sinking fund provisions, and restrictions on our ability to merge with or sell our assets to a third party. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Any of these events could adversely affect our ability to achieve our regulatory approvals and commercialization goals and harm our business.

 

Our future success is dependent upon our ability to obtain additional financing, the success of our current Phase 1II/III clinical trialtrials and required future trials, and our ability to obtain marketing approval for our SBP-101 product candidatecandidates in the United States, the European Union and other international markets. If we are unable to obtain additional financing when needed, if our Phase 1II/III clinical trial is not successful, if we do not receive regulatory approval required for future trials or if once these studies are concluded, we do not receive marketing approval for our SBP-101 product candidate, we would not be able to continue as a going concern and would be forced to cease operations. The interim financial statements included in this prospectus have been prepared assuming that we will continue as a going concern and do not include any adjustments relating to the recoverability or classification of assets or the amounts of liabilities that might result from the outcome of these uncertainties.

Indebtedness

As of September 30, 2017 we had $3.1 million aggregate principal amount of convertible promissory notes outstanding. Of this amount, $3,076,000 aggregate principal amount was outstanding under the 2017 Notes, which accrue interest at 5.0% per year and are convertible into common stock or other securities upon the completion of a qualified financing of at least $2.0 million on or before the maturity of the 2017 Notes, or upon the request of a holder at a fixed conversion rate of $10.10 per share. The 2017 Notes mature in December 2018 at which time all principal and interest are payable. One 2013 Note remains outstanding in a principal amount of $25,000, which accrues interest of 5% per year, payable quarterly, and is convertible into common stock at $11.25 per share. The 2013 Note matures in December 2018. We also had $300,000 outstanding in an unsecured loan that accrues annual interest of 4.125%. The terms of this loan were amended in October 2017 to extend the maturity date to May 1, 2019 with monthly payments of $10,000 commencing on May 1, 2018. See Note 10 titled “Subsequent Events.” in the Condensed Consolidated Financial Statements elsewhere in this prospectus.

 


34

 

License Agreement

 

On December 22, 2011, we entered into anPursuant to our exclusive license agreement with UFRF, which was acquired in exchange for $15,000 in cash and the issuance of 10% of our common stock. Upon executing the license agreement, 80,000 shares of common stock were issued to UFRF which was determined to have a fair value of $20,000 based upon an estimated fair value of our predecessor’s common stock of $0.25 per share. The license agreement also contained an anti-dilution provision whichlast amended on October 4, 2019, we are required us to issue additional shares to UFRF sufficient for UFRF to maintain its 10% ownership interest in our predecessor entity until it secured an addition $2.0 million external investment. This investment was received during 2012.

The license agreement requires us to pay royalties to UFRF ranging from 2.5% to 5% of net sales of licensed products developed from the licensed technology. Minimum annual royalties are required after the initial occurrence of a commercial sale of a marketed product. Royalties are payabletechnology for the longer of (i) the last to expire of the claims in the licensed patents or (ii)shorter of: ten (10) years from the first commercial sale of a licensed product in each country in which licensed product is sold.or the period of market exclusivity on a country-by-country basis. The minimum annual royalties are as follows:

$50,000 is due 270 days after occurrence of first commercial sale;

$100,000 is due on the first anniversary date of the first payment;

$100,000 is due on the second anniversary date of the first payment; and

$300,000 is due on the third anniversary date of the first payment and subsequent anniversary dates thereafter, continuing for the life of the license agreement.

latest amendment eliminated all future milestone payments. The Company is subject to six different milestone payments under the license agreement.

$50,000 is due upon enrollment of the first subject in a Phase I clinical trial;

$300,000 is due upon enrollment of the first subject in a Phase II clinical trial;

$3,000,000 is due upon approval of a New Drug Application;

$2,000,000 is due upon approval to manufacture and market in either the European Union or Japan (one time only);

$1,000,000 is due upon the first time annual net sales of licensed product or licensed process by the Company reaches $100,000,000; and

$3,000,000 is due upon the first time annual net sales of licensed product or licensed process by the Company reaches $500,000,000.

On January 4, 2016, we enrolled the first patient in our Phase 1 clinical trial of SBP-101 in patients with previously treated pancreatic cancer. Accordingly, we recorded a milestone obligation of $50,000 as a license expense as of this date. As of September 30, 2017, no royalty or milestone payments were due. We are alsoremains committed to pay an annual license maintenance fee of $10,000.

 

Off-Balance Sheet Arrangements

We have no off-balance sheet arrangements.

Recent Accounting Pronouncements

 

See Note 4 to the Consolidated Financial Statements included hereinfor the fiscal years ended December 31, 2021 and 2022 beginning on page F-16 below for a discussion of recent accounting pronouncements.

 


35

 

BUSINESS

PART I

Item 1.

Business

Panbela Therapeutics, Inc. and its wholly owned subsidiaries Panbela Research, Inc., Cancer Prevention Pharma Limited (Ireland)  and Cancer Prevention Pharmaceuticals, Inc. (collectively “we,” “us,” “our,” “Panbela” and the “Company”) exist for the primary purpose of developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs. Panbela Therapeutics Pty Ltd is a wholly owned subsidiary of Panbela Research, Inc. Cancer Prevention Pharmaceuticals, LLC., and Cancer Prevention Pharma Limited (UK and Wales) are wholly owned subsidiaries of Cancer Prevention Pharmaceuticals Inc. The original business entity predecessor to our Company was incorporated under the laws of the State of Delaware in 2011. The term “common stock” refers to our common stock, par value $0.001 per share.

BusinessCancer Prevention Pharmaceuticals, Inc. (CPP) Acquisition

 

On June 15, 2022, Panbela acquired CPP, a private clinical stage company developing therapeutics to reduce the risk and recurrence of cancer and rare diseases, via merger for consideration consisting of (a) 164,689 shares of common stock, (b) 18,298 shares of common stock that remained subject to a holdback escrow (as defined in the Merger Agreement), (c) replacement options to purchase up to 39,918 shares of common stock at a weighted average exercise price of $14.00 per share, and (d) replacement warrants to purchase up to 8,451 shares of common stock at a weighted average exercise price of $165.80 per share, and post-closing contingent payments up to a maximum of $60 million, subject to satisfaction of milestones.

Holding Company Reorganization

Effective June 15, 2022, Panbela became a successor issuer to Panbela Research, Inc. (formerly known as Panbela Therapeutics, Inc., the “Predecessor”) pursuant to a holding company reorganization in which the Predecessor became a direct, wholly-owned subsidiary of Panbela. Panbela became a successor issuer to the Predecessor by operation of Rule 12g-3(a) promulgated under the Securities Exchange Act of 1934, as amended the (“Exchange Act”).

Business Overview

 

We arePanbela is a clinical stage drug developmentbiopharmaceutical company foundeddeveloping disruptive therapeutics for the treatment of patients with technology licensed from urgent unmet medical needs. We are currently enrolling patients in our randomized double blind placebo controlled clinical trial for the treatment of pancreatic cancer  a Phase III clinical trial funded by the National Cancer Institute (the “NCI”) for the study of colon cancer risk reduction and colon adenoma therapy (“CAT”), a preventative treatment approach for survivors of colorectal cancer or those who have high-risk colon polyps. In addition, we are   designing a Phase III registration trial for familial adenomatous polyposis (“FAP”), a rare inherited condition that can cause the growth of thousands of colorectal adenomas (i.e., adenomatous polyps), which are recognized as a key risk factor for colon cancer. We also support several investigator initiated trials and company sponsored preclinical trials including: (1) Phase I and Phase II clinical trials for the treatment of early-onset type 1 diabetes funded by the Juvenile Diabetes Research Foundation; (2) Phase II clinical trial for the treatment of gastric cancer funded by the NCI; (3) Phase I/II clinical trial for the treatment of non-small cell lung cancer (NSCLC) possessing the STK11 mutation; and (4) preclinical studies that we have sponsored in the orphan disease and cancer fields.

The UniversityCompany’s lead assets are ivospemin (SBP-101), FlynpoviTM (eflornithine (CPP-1X) and sulindac), and eflornithine (CPP-1X), which provide a multi-targeted approach to reset dysregulated biology present in many types of Florida Research Foundation (“UFRF”). Thediseases such as cancer and autoimmunity. Many tumors require greatly elevated levels of polyamines to support their growth and survival. These agents target the polyamine pathway at complementary junctions, which have been shown to be altered in disease. In particular, our lead assets have the potential to suppress and prevent tumor growth, enhance anti-tumor activity of other anti-cancer agents, and modulate the immune system.

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Ivospemin is a proprietary polyamine analogue compound we have licensed from UFRF, which we referdesigned to as “SBP-101,” exhibits extraordinary specificity forinduce polyamine metabolic inhibition. Ivospemin has demonstrated encouraging activity against metastatic disease in a clinical trial of patients with pancreatic cancer. The efficacy and safety results demonstrated in our completed Phase I clinical trial of ivospemin in combination with gemcitabine and nab-paclitaxel in the exocrine pancreas, with therapeutic potential for both pancreatic cancer and pancreatitis indications. Xenograft studiesfirst line treatment of human pancreatic cancer cells transplanted into mice indicate that the unique specificity of SBP-101 for the exocrine pancreas facilitates suppression of both primary and metastatic pancreatic cancer which is known to originateprovide support for the current randomized, double-blind, placebo-controlled study of ivospemin in the exocrine pancreas. To facilitatecombination with gemcitabine and accelerate the development of this compoundnab-paclitaxel in thepatients previously untreated for metastatic pancreatic cancer indication, we have also acquired data and materials related to this technology from other researchers. Studies in dogs revealed ablation, or “chemical resection,” of the exocrine pancreatic architecture, while leaving the islet cells functionally unchanged. We may refer to this effect as: “pharmaceutical pancreatectomy with islet auto-transplant” (“PP-IAT”).cancer. We believe that SBP-101,ivospemin, if successfully developed, may represent a novel approach that effectively treats patients with pancreatic cancer and pancreatitis, and could become a dominant product in these markets.that market. Only three first-line treatment combinations, a single maintenance treatment for a subset (3-7%) of patients, and one second-line drug have been approved by the U.S. Food and Drug Administration (“FDA”(the “FDA”) for pancreatic cancer in the last 20 years,25 years. Ivospemin has received Fast Track status and no drugsorphan drug designation status for pancreatic cancer in the United States and we have been approvedalso received orphan drug designation in Europe.

Our June 2022 acquisition of CPP added the Company’s second lead asset, eflornithine, in multiple forms. First, an investigational new drug product, Flynpovi is a combination of the polyamine synthesis inhibitor eflornithine and the non-steroidal anti-inflammatory drug sulindac and then secondly, eflornithine as a single agent. Eflornithine is an enzyme-activated, irreversible inhibitor of the enzyme ornithine decarboxylase (“ODC”), the first rate-limiting enzyme in the biosynthesis of polyamines. Sulindac, a non-steroidal anti-inflammatory drug (“NSAID”), facilitates the export and catabolism of polyamines. Flynpovi has a unique dual mechanism of action whereby it suppresses the synthesis of new polyamines and increases the export and catabolism of polyamines from the diet and microbiome. We believe Flynpovi is unique in that it is designed to treat the risk factors (e.g., polyps) that are hypothesized to lead to FAP surgeries and colon cancer and therefore may have the ability to prevent various types of colon cancer. In the FAP-310 Phase III trial, the efficacy and safety of Flynpovi (eflornithine (CPP-1X) and sulindac), as compared with either drug alone, in adults with FAP was conducted. While the study missed the primary composite endpoint (Burke et al. 2020), a post-hoc analysis showed that none of the patients in the combination arm progressed to a need for lower gastrointestinal (“LGI”) surgery for up to 48 months compared to 13.2% and 15.7% of patients in the sulindac and eflornithine arms (Balaguer et al. 2022). These data corresponded to risk reductions for the specificneed for LGI surgery approaching 100% between combination and either monotherapy. Given the statistical significance of the LGI group, a new drug application (“NDA”) was filed with the FDA; however, since this was based on the results of an exploratory analysis, a complete response letter (“CRL”) was issued. To address this deficiency concern, the Company must submit the results of one or more adequate and well-controlled clinical trials which demonstrate an effect on a clinical endpoint. There are no currently approved pharmaceutical therapies for FAP.

Additional programs are evaluating a single agent tablet eflornithine or high dose powder eflornithine sachets for several indications including prevention of gastric cancer,  recent onset Type 1 diabetes, Metastatic Castration-Resistant Prostate Cancer and STK-11 mutant NSCLC. Preclinical studies as well as Phase I or Phase II investigator-initiated trials suggest that eflornithine treatment of patients with pancreatitis, other than supportive care.is well tolerated and has potential activity.

Flynpovi has received Fast Track designation in the United States and orphan drug designation status for FAP in the United States and Europe. In addition, we have received orphan drug designation status for eflornithine as a single agent for neuroblastoma in the United States and Europe and for gastric cancer in the United States.

Clinical Trials

Ivospemin (SBP-101)

 

In August 2015, the FDA accepted our INDInvestigational New Drug (“IND”) application for our SBP-101ivospemin (SBP-101) product candidate. We have completed enrollment in aan initial clinical trial of SBP-101ivospemin in patients with previously treated locally advanced or metastatic pancreatic cancer. This iswas a Phase 1,I, first-in-human, dose-escalation, safety study. From January 2016 through September 2017, we enrolled twenty-nine patients into six cohorts, or groups, in the dose-escalation phase of our currentthe Phase 1I trial. Twenty-four of the patients received at least two prior chemotherapy regimens. No drug-related serious adverse events occurred during the first four cohorts.bone marrow toxicity or peripheral neuropathy was observed at any dose level. In cohort five, serious adverse events (klebsiella sepsis with metabolic acidosis in one patient, and renal and hepatic toxicity in one patient) were observed in two of the ten patients, both of whom exhibited progressive disease at the end of their first cycle of treatment, and were determined by the DSMB to be DLTs. Consistent with the study protocol, the DSMB recommended continuation of the study by expansion of cohort 4. Four patients were enrolled in this expansion cohort.

In addition to being evaluated for safety, twenty-four23 of the twenty-nine29 patients were evaluable for preliminary signals of efficacy prior to or at the eight-week conclusion of their first cycle of treatment using RECIST, the currentResponse Evaluation Criteria in Solid Tumors (“RECIST”), the currently accepted standard for evaluating changeschange in the size of tumors. EightA summary of both the safety and preliminary signals of efficacy for this completed clinical trial is contained later in this “Business” section under ivospemin (SBP-101) Clinical Development Pancreatic Cancer, Phase I Clinical Trial Design and Completion (ivospemin Monotherapy).

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In 2018, we began enrolling patients in our second clinical trial, a Phase Ia/Ib study of the twenty-four patients (33%) had SDsafety, efficacy and sixteenpharmacokinetics of twenty-four (67%) had PD. It should be noted thativospemin administered in combination with two standard-of-care chemotherapy agents, gemcitabine and nab-paclitaxel. A total of 25 subjects were enrolled in 4 cohorts to evaluate the dosage level and schedule. An additional 25 subjects were enrolled in the expansion phase of the sixteentrial. Interim results were presented in January of 2022. Best response in evaluable subjects (cohorts 4 and Ib N=29) was a Complete Response (“CR”) in 1 (3%), Partial Response (“PR”) in 13 (45%), Stable Disease (“SD”) in 10 (34%) and Progressive Disease (“PD”) in 5 (17%). One subject did not have post baseline scans with RECIST tumor assessments. Median Progression Free Survival (“PFS”), now final at 6.5 months, may have been negatively impacted by drug dosing interruptions to evaluate potential toxicity. Median overall survival in Cohort 4 + Phase Ib was 12.0 months when data was presented in January 2022 and is now final at 14.6 months. Two patients with PD,from cohort 2 have demonstrated long term survival: one at 30.3 months (final data) and one at 33.0 months and still alive as of March 18, 2022. Seven subjects were still alive at the data cutoff date of March 18, 2022, one from cohort 2 and six came from cohorts onecohort 4 plus Ib. Further details regarding the study design, safety and two andinterim signals of efficacy are considered to have received less than potentially therapeutic doses of SBP-101. We also noted that twenty-eight of the twenty-nine patients had follow-up blood tests measuring the Tumor Marker CA 19-9 associated with pancreatic ductal adenocarcinoma. Eleven of these patients (39%) had reductionscontained later in the CA 19-9 levels, as measured at least once after the baseline assessment. Seven of the remaining seventeen patients showed no reduction in CA 19-9 came from cohorts one and two.this “Business” section under ivospemin (SBP-101) Clinical Development Pancreatic Cancer, Phase Ia/Ib Clinical Trial Interim Results (First Line Combination Therapy).

 

The best response outcomessafety results and survival were observedtumor growth inhibition demonstrated in our Phase Ia/b study provides support for the randomized study of SBP-101 initiated in January of 2022. The trial, referred to as the ASPIRE trial, is a randomized double-blind placebo controlled trial in combination with gemcitabine and nab-paclitaxel in patients previously untreated for metastatic pancreatic cancer. The trial is being conducted globally at approximately 95 sites in the groupUnited States, Europe and Asia-Pacific. The ASPIRE trial commenced in 2022 and, while opening of thirteen patients who received total cumulative doses between 2.5 mg/kgclinical sites in the U.S. and 8.0 mg/kg. Twelvethe rest of the thirteen patientsworld has been slower than originally anticipated, due in part to resource fatigue in the medical community, the Company expects all countries and sites to be open by mid-2023.

The trial was originally designed as a Phase II/III with a smaller sample size (150) to support the events required for interim analysis based on PFS and a primary endpoint of overall survival. In response to European and FDA regulatory feedback, the study was amended to include the total trial sample size (600) and the design modified to utilize overall survival as the primary endpoint to be examined at interim analysis. PFS will also be analyzed to provide additional efficacy evidence. This amendment was supported by the final data from the Phase Ia/Ib first line metastatic pancreatic cancer trial which completed enrollment in December of 2020. The study will enroll 600 subjects and is anticipated to take 36 months for complete enrollment with the interim analysis available in mid- 2024. The Independent Data Safety Monitoring Board (“DSMB”) has met twice, the most recently in November 2023, which evaluated the safety of 214 patients.  Both meetings resulted in no safety concerns and the trial continuing without modification. Further details regarding the study design and anticipated timing are contained later in this group were evaluable“Business” section under ivospemin (SBP-101) Clinical Development Pancreatic Cancer, Randomized Clinical Trial design and anticipated timing (ASPIRE trial).

If we can successfully complete all FDA recommended clinical studies, we intend to seek marketing authorization from the FDA, the European Medicines Agency (“EMA”) (European Union), and TGA (Australia). The submission fees may be waived when ivospemin has been designated an orphan drug in each geographic region.

In early April 2022, the Company announced a poster presentation highlighting the results for preliminary signs of efficacyivospemin (also known as SBP-101) as a polyamine metabolism modulator in ovarian cancer at eight weeks by RECIST. Five patients (42%) showed SD at week eight. Five of the thirteen patients (38%) had reductionsAmerican Association for Cancer Research Annual Conference which was subsequently published in June 2022 in the CA19-9 levels, as measured at least once afterInternational Journal of Molecular Sciences (Holbert et al. 2022). The poster and publication conclude that the baseline assessment. Medianivospemin treatment of C57Bl/6 mice injected with VDID8+ ovarian cancer cells significantly prolonged survival and decreased overall tumor burden. The results suggest that ivospemin may have a role in this group was 3.8 months asthe clinical management of October 2017. To date, nine patients (69%)ovarian cancer, and the Company intends to continue pre-clinical and clinical studies in ovarian cancer.  In April 2023, the Company announced a poster presentation highlighting additional preclinical work in ovarian cancer.  The poster highlights the efficacy of SBP-101 in combination with standard of care chemotherapy agents used to treat platinum-resistant ovarian cancer. Treatment with gemcitabine, topotecan, and doxorubicin have exceeded 3 monthsbeen shown to significantly increase the in vitro toxicity of SBP-101 in both cisplatin-sensitive and cisplatin-resistant ovarian cancer cell lines. Paclitaxel and docetaxel have been shown to not have any added benefit in vitro to SBP-101 alone. The poster concludes that the treatment of C57Bl/6 mice containing VDID8+ ovarian cancer with SBP-101 in combination with doxorubicin significantly prolonged survival and decreased overall survival OS, four have exceeded four months of OS and two patients have exceeded 10 months of OS, with some patients continuing to be followed for survival. tumor burden.

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Additional preclinical work is underway evaluating ivospemin and eflornithine (also known as CPP-1X or DFMO) in multiple myeloma (cell lines). Data published in the November supplemental issue of the Journal Blood investigated the effects of polyamine inhibition by ivospemin and CPP-1X on myeloma cell lines growth and viability in vitro. Results showed that ivospemin and CPP-1X treatment significantly decreased cell proliferation and induced apoptosis in a panel of multiple myeloma cell lines. When ivospemin and CPP-1X were combined an almost complete abolition of cell growth occurred. These results demonstrate the anti-neoplastic potential of ivospemin and CPP-1X and offer a compelling rationale for its clinical trials will be requireddevelopment as a potentially promising treatment option for FDA approvalmultiple myeloma. The work reflects the company’s on-going collaboration with researchers from The University of SBP-101Texas MD Anderson Cancer Center for the evaluation of polyamine metabolic inhibitor therapies in pancreatic cancer and pancreatitis. We estimate that the additional time and cost to obtain FDA and European Medicines Agency (“EMA”) approval and to bring SBP-101 to marketcombination with CAR-T cell therapies in these two indications will be six to seven years and cost at least $200 million.preclinical models.

 

WithFlynpovi

December 2009, the approximately $17.0 million raised throughFDA accepted our IND application for the datecombination product, Flynpovi. Flynpovi showed promising results in an NCI supported randomized, placebo-controlled Phase IIb/III clinical trial to prevent recurrent colon adenomas, particularly high-risk pre-cancerous polyps in which 375 subjects who had resected sporadic adenoma were treated for 3 years with eflornithine (500 mg once a day) + sulindac (150 mg once a day [N = 191]) or matched placebo/placebo (N = 184). Results demonstrated a marked risk reduction (70%) in developing metachronous adenomas, 92% risk reduction in developing advanced adenomas, and 95% risk reduction in developing multiple adenomas with the active combination regimen compared to placebo (Meyskens et al. 2008). This combination regimen was generally well tolerated.

Given the similar mechanism of disease in sporadic and FAP-associated adenomatous polyposis, and the mechanism of action of Flynpovi in prevention of progressive polyposis in both the general population with sporadic adenomas and in patients with FAP, a Phase III program in FAP and a Phase III program to study colon cancer risk reduction in partnership with the Southwest Oncology Group (“SWOG”) and the NCI were initiated.

In the FAP-310 Phase III study completed in 2019, the efficacy and safety of the combination of eflornithine and sulindac, as compared with either drug alone, in adults with familial adenomatous polyposis was conducted (Burke et al. 2020). The patients were randomly assigned in a 1:1:1 ratio to receive eflornithine, sulindac, or both once daily for up to 48 months. The primary end point, assessed in a time-to-event analysis, was disease progression, defined as a composite of major surgery, endoscopic excision of advanced adenomas, diagnosis of high-grade dysplasia in the rectum or pouch, or progression of duodenal disease. A total of 171 patients underwent randomization. Disease progression occurred in 18 of 56 patients (32%) in the eflornithine-sulindac group, 22 of 58 (38%) in the sulindac group, and 23 of 57 (40%) in the eflornithine group, with a hazard ratio of 0.71 (95% confidence interval [CI], 0.39 to 1.32) for eflornithine-sulindac as compared with sulindac (P = 0.29) and 0.66 (95% CI, 0.36 to 1.23) for eflornithine-sulindac as compared with eflornithine (Burke et al. 2020). Adverse and serious adverse events were similar across the treatment groups. In a post-hoc analysis, none of the patients in the combination arm progressed to a need for lower gastrointestinal (“LGI”) surgery for up to 48 months compared with 7 (13.2%) and 8 (15.7%) patients in the sulindac and eflornithine arms (Balaguer et al. 2022). These data corresponded to risk reductions for the need for LGI surgery approaching 100% between combination and either monotherapy with HR = 0.00 (95% CI, 0.00-0.48; p = 0.005) for combination versus sulindac and HR = 0.00 (95% CI, 0.00-0.44; p = 0.003) for combination versus eflornithine. Given the statistical significance of the LGI group, an NDA was filed with the FDA. As the study failed to meet the primary endpoint, and the NDA was based on the results of an exploratory analysis, a complete response letter was issued. To address this deficiency concern, the Company must submit the results of one or more adequate and well-controlled clinical trials which demonstrate an effect on a clinical endpoint.

In collaboration with the NCI, and SWOG, a Phase III clinical trial has been initiated to study the benefits of Flynpovi as a therapeutic treatment for use by colon cancer survivors. The trial is named PACES for “Prevention of Adenomas and Cancer with eflornithine and sulindac.” The PACES trial is funded by the NCI and managed by SWOG. This is an ongoing Phase III double blind placebo-controlled trial of Flynpovi to prevent recurrence of high risk adenomas and second primary colorectal cancers in patients with stage 0-III colon or rectal cancer.  The purpose of this prospectus, we have:study is to assess whether Flynpovi (compared to corresponding placebos) has a reduced rate of cancer or high-risk adenoma recurrence compared to comparator arms after three years of daily dosing. We have exclusive rights to the data that comes from the trial for regulatory and commercial purposes. The Company is evaluating its options for colorectal adenoma therapy (CAT) in the European Union and Asia.

 

In April 2023, the Company announced that it regained the North American rights to develop and commercialize Flynpovi in patients with FAP, as a result of the termination of the licensing agreement between CPP and with One-Two Therapeutics Assets Limited effective July 4, 2023.

Eflornithine (CPP-1X) and eflornithine sachets (CPP-1X-S)

Forthe single agent eflornithine, there is a trial ongoing evaluating eflornithine sachets (CPP-1X-S) in a Phase I/II trial in STK11 mutation patients with non-small cell lung cancer and Phase II trial in Recent Onset Type I diabetes with eflornithine are  began this year. Lastly, a Phase II trial evaluating eflornithine for the prevention of gastric cancer was completed in 2021 with data analysis ongoing.

organized the Company;

 


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Through January 18, 2024, we had:

evaluated and secured the intellectual property for our core technology;

completed required pre-clinical steps in the development plan for SBP-101 for pancreatic cancer;

 

 

secured an orphan drug designation for ivospemin from the FDA;

 

 

submitted and received acceptance from the FDA for an IND application to the FDA (May 18, 2015);for ivospemin;

 

 

received an acceptanceCountry approvals for the Aspire Trial in Australia, France, Italy and Spain;

completed a Phase Ia monotherapy safety study of an IND application fromivospemin in the FDA (August 21, 2015);treatment of patients with metastatic pancreatic ductal adenocarcinoma;

 

 

received acceptance of a Clinical Trial Notification by“Fast Track” designation from the Australian Therapeutic Goods Administration (September 23, 2015);FDA for ivospemin for metastatic pancreatic cancer;

 

 

substantially completed enrollment and released interim results in our second trial a phase 1a safetyPhase Ia /Ib clinical study of SBP-101inivospemin, a first-line study with ivospemin given in combination with a current standard of care in patients with pancreatic ductal adenocarcinoma who were previously untreated for metastatic disease; a total of 50 subjects were enrolled in this study, 25 in the Phase Ia and 25 in the Phase Ib or expansion phase;

secured a two-year research agreement with Johns Hopkins School of Medicine led by Professor Robert Casero, an internationally recognized researcher in polyamine biology;

completed process improvement measures expected to be scalable for commercial use and received issue notification for a patent covering this new shorter synthesis of ivospemin;

initiated a randomized, double-blind, placebo-controlled study with ivospemin given in combination with gemcitabine and nab-paclitaxel in patients with pancreatic ductal adenocarcinoma who are previously untreated for metastatic disease;

completed preclinical evaluation of ivospemin for use as neoadjuvant therapy in resectable pancreatic cancer prior to surgery;

obtained early, preclinical, indication of tumor growth inhibition activity in ovarian cancer and presented the results at ASCO-GI conference;

received USAN adoption of the nonproprietary name of ivospemin for SBP-101;

acquired and integrated CPP, adding a second lead asset in multiple forms and an expansive clinical development program ranging from pre-clinical to registration level clinical trials;

European Medicines Agency (“EMA”) Committee for Orphan Medicinal Products issued a positive opinion on Panbela’s application for orphan designation of ivospemin in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma;

announced the initiation of phase II program through Indiana University for early onset Type I diabetes utilizing eflornithine;

announced the initiation of the Phase I/II clinical trial for the treatment of pancreatic ductal adenocarcinoma;non-small lung cancer (“NSCLC”) possessing the STK11 mutation through Moffitt Cancer Center;

entered into a sponsored research agreement with The University of Texas MD Anderson Cancer Center for the evaluation of polyamine metabolic inhibitor therapies in combination with CAR-T cell therapies in preclinical models;

announced the SWOG Cancer Research Network’s PACES S0820 Phase III trial passed a single planned futility analysis and will continue; and

 

 

commenced further pre-clinical studiesannounced the approval of US WorldMeds NDA Approval for the use of SBP-101 to treat pancreatitis.Eflornithine (“DFMO”) in Pediatric Neuroblastoma, first polyamine approval in oncology.

 

IntroductionPancreatic Cancer

 

An effective treatment for pancreaticPancreatic cancer remains a major unmet medical need. Adenocarcinoma of the pancreas, which accounts for approximately 95% of all cases of pancreatic cancer, has a median overall survival of 8 to 11 months in clinical studies of patients with favorable prognostic signs and optimal chemotherapy. Adenocarcinoma of the pancreas afflicts approximately 83,000151,000 people in the European Union (Eurostat 2014)Europe (Epidemiology in Europe and Recommendations for Screening in High-Risk Populations, Partyka, et al July 2023) , over 53,000approximately 64,000 people in the United States annually (https://seer.cancer.gov/statfacts/html/pancreas.html),(American Cancer Society. Cancer Facts & Figures 2023. Atlanta, GA: American Cancer Society; 2023 and 337,000Overview of Pancreatic Cancer)  and 293,000 people worldwide (World Health Organization 2014, NIH/NCI). Pancreatic cancer is now the third most common cause of cancer death in the– excluding Europe and United States (SEER Cancer Statistics Factsheets 2016)(GLOBOCAN 2020). A recent report from the Pancreatic Cancer Action Network states that pancreatic cancer deaths in the United States have surpassed those from breast cancer and will soon surpass deaths from colorectal cancer to rank number two in deaths, behind only lung cancer in 2020. The five-year survival rate remains less than 3% for patients diagnosed with metastatic pancreatic cancer and approximately 7.7% across all pancreatic stages, and thereIt has been little significant improvement in survival since gemcitabine was approved inidentified as the United States in 1996.

Pancreatic cancer is generally not diagnosed early because the initial clinical signs and symptoms are vague and non-specific. By the time of diagnosis, the cancer is most often locally advanced or metastatic, having spread to regional lymph nodes, liver, lung and/or peritoneum, and is seldom amenable to surgical resection, or removal, with curative intent. Currently, surgical resection offers the only potentially curative therapy, although only 15-20% of patients are candidates for surgical resection at the time of the diagnosis. Patients who undergo radical surgery still have a limited survival rate, averaging 23 months (Macarulla T, et al Clin Transl Oncol 2017).

The prognosis for patients diagnosed with pancreatic cancer is poor and most die from complications related to progression of the disease. The primary treatment for metastatic disease is chemotherapy. Current first-line chemotherapy treatment regimens vary from single agent gemcitabine and various gemcitabine combinations to the multi-chemotherapy drug combination, FOLFIRINOX, defined below, (Conroy NEJM 2011), frequently supplemented with white blood cell (“WBC”) growth factors. These combination therapies deliver median survival benefits ranging from 7 weeks (Von Hoff NEJM 2013) to 4 months (Conroy NEJM 2011) for selected patients with good performance status, meaning that they are in relatively good physical condition at the time of diagnosis, when compared with gemcitabine alone. In 2015 the FDA approved Onivyde® (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with metastatic pancreatic cancer who have been previously treated with a gemcitabine-based chemotherapy. Because most patients with good performance status receive variations of the FOLFIRINOX (generic), defined below, regimen second-line, Onivyde is not widely prescribed as indicated.

University laboratory studies have demonstrated that SBP-101 induces programmed cell death, or “apoptosis,” in the acinar and ductal cells of the pancreas by activation of caspase 3 and poly(adenosine diphosphate-ribose) polymerase (“PARP”) cleavage. In animal models at two independent laboratories, SBP-101, alone or in combination, has demonstrated nearly complete suppression of transplanted human pancreatic cancer, including metastases. SBP-101 has demonstrated both superior and additive efficacy to gemcitabine and nab-paclitaxel in laboratory models of pancreatic cancer. We intend to develop SBP-101 as a unique and novel targeted approach to treating patients with pancreatic cancer. We intend to develop SBP-101 in combination with existing standard chemotherapy agents. With adequate funding, we also expect to continue evaluation of the potential value of SBP-101 in the treatment of patients with recurrent acute or chronic pancreatitis.


Pancreatic Cancer

Adenocarcinoma of the pancreas afflicts approximately 83,000 people in the European Union (Eurostat 2014), over 53,000 people in the United States annually (https://seer.cancer.gov/statfacts/html/pancreas.html), and 337,000 people worldwide (World Health Organization 2014, NIH/NCI). It is the seventhfourth leading cause of death from cancer in Europe (GLOBOCAN 2012)2020) and the third leading cause of death from cancer in the United States (SEER Cancer Statistics Factsheets 2016)2021). PDAOn average, Pancreatic Ductal Adenocarcinoma (“PDA”) represents approximately 95% of all pancreatic cancers.cancers diagnosed in a given calendar year. Considering that the median overall survival for previously untreated patients with good performance status is between 8.5 months (Von Hoff 2013) and 11.1 months (Conroy 2011) with the besttwo most commonly available treatment regimens, effective treatment for PDA remainshas remained a major unmet medical need.

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Pancreatic cancer is generally not diagnosed early because the initial clinical signs and symptoms are vague and non-specific. The most common presenting symptoms include weight loss, epigastric (upper central region of the abdomen) and/or back pain, and jaundice. The back pain is typically dull, constant, and of visceral origin radiating to the back, in contrast to the epigastric pain which is vague and intermittent. Less common symptoms include nausea, vomiting, diarrhea, anorexia, and new onset diabetes (which can be an early signal) or glucose intolerance (Hidalgo 2010).

 

Surgery remains the only treatment option with curative intent, although only 15-20%about 20% of patients are candidates for surgical resection at the time of the diagnosis. Patients who undergo radical surgery still have a limited survival rate, averaging 23 months (Macarulla T, et al Clin Transl Oncol 2017).

 

For the minority of patients who present with resectable disease, surgery is the treatment of choice. Depending on the location of the tumor, the operative procedures may involve cephalic pancreatoduodenectomy, referred to as a “Whipple“Whipple procedure”, distal pancreatectomy or total pancreatectomy. Pancreatic enzyme deficiency and diabetes are frequent complications of both the disease and these surgical procedures. Up to 70% of patients with pancreatic cancer present with biliary obstruction that can be relieved by percutaneous or endoscopic stent placement. However, even if the tumor is fully resected, the outcome in patients with pancreatic cancer ishas been disappointing (Hidalgo 2010, Seufferlein 2012). Post-operative administration of chemotherapy improved progression-free and overall survival in three large randomized clinical trials (Hidalgo 2010), but median post-surgical survival in patients treated in all three trials was similar:similar, only 20-22 months. Pre-operative (neo-adjuvant) chemotherapy is of increasing interest, with the goal of improved successful resections and long-term outcomes.

 

For the majority of patients who present with unresectable, locally advanced or metastatic disease, which represent a majority of PDA patients, management options range from chemotherapy alone to combined forms of treatment with radiation therapy and chemotherapy. However, due to the increased toxicity of combined treatment, randomized trials of such combined regimens have had low enrollment, precluding a firm conclusion as to any advantage of adding radiation to chemotherapy (Hidalgo 2010).

 

Gemcitabine was the first chemotherapeutic agent approved for the treatment of patients with PDA in the modern regulatory era, providing a median survival duration of 5.65 months (Burris 1997). Gemcitabine monotherapy was the standard of care for patients with metastatic pancreatic cancer until combination therapy with gemcitabine plus erlotinib (Tarceva®) was shown to increase median survival by 2two weeks. This modest benefit was tempered by a significant side effect profile and high cost, limiting its adoption as a standard treatment regimen. More recently,Subsequently, the multidrug chemotherapy combination of leucovorin, fluorouracil, irinotecan, and oxaliplatin, or FOLFIRINOX was shown to provide a median survival benefit of 4.3 months (OS = 11.1 months) over gemcitabine alone (6.8 months), but its significant side effect profile limits the regimen to select patients with a good performance status and often requires supplementation with WBC growth factor therapy. Nab-paclitaxel (Abraxane®) received marketing authorization for use in combination with gemcitabine (FDA approved 2013) after showing an increase in overall survival of 7seven weeks compared to gemcitabine alone (Von Hoff 2013). Thus, combination therapies have demonstrated a modest survival benefit compared to gemcitabine alone as summarized in the table below (Thota 2014).

 


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Current First-Line Treatment Approaches: Survival & Toxicity Profiles Across Three Major Positive Clinical Trials

 

 

Gemcitabine vs.

Gemcitabine/Erlotinib

Phase 3 trial

  

ACCORD 11 Trial

  

Metastatic Pancreatic

Adenocarcinoma Clinical

Trial (MPACT)

  

Gemcitabine vs.

Gemcitabine/Erlotinib

Phase 3 trial

  

ACCORD 11 Trial

  

Metastatic Pancreatic

Adenocarcinoma Clinical

Trial (MPACT)

 
 

Gemcitabine

  

Gemcitabine/

Erlotinib

  

Gemcitabine

  

FOLFIRINOX1

  

Gemcitabine

  

Gemcitabine/

Nab-Paclitaxel

  

Gemcitabine

  

Gemcitabine/

Erlotinib

  

Gemcitabine

  

FOLFIRINOX

  

Gemcitabine

  

Gemcitabine/

Nab-Paclitaxel

 

One-Year Survival

  17%  23%  20.6%  48.4%  22%  35%  17%   23%   20.6%   48.4%   22%   35% 

Median Overall Survival

 

5.91 mo

  

6.24 mo

  

6.8 mo

  

11.1 mo

  

6.7 mo

  

8.5 mo

 

Median Progression-Free Survival

 

3.55 mo

  

3.75 mo

  

3.3 mo

  

6.4 mo

  

3.7 mo

  

5.5 mo

 

Median Overall Survival (months)

  5.91   6.24   6.8   11.1   6.7   8.5 

Median Progression-Free Survival (months)

  3.55   3.75   3.3   6.4   3.7   5.5 

Overall Response Rate

  8%  8.6%  9.4%  31.6%  7%  23%  8%   8.6%   9.4%   31.6%   7%   23% 

Toxicity

                                                

Neutropenia

        21%  45.7%  27%  38%        21%   45.7%   27%   38% 

Febrile neutropenia

        1.2%  5.4%  1%  3%        1.2%   5.4%   1%   3% 

Thrombocytopenia

        3.6%  9.1%  9%  13%        3.6%   9.1%   9%   13% 

Diarrhea

  2%  6%  1.8%  12.7%  1%  6%  2%   6%   1.8%   12.7%   1%   6% 

Sensory neuropathy

        0%  9%  1%  17%        0%   9%   1%   17% 

Fatigue

  15%  15%  17.8%  23.6%  7%  17%  15%   15%   17.8%   23.6%   7%   17% 

Rash

  6%  1%              6%   1%             

Stomatitis

 

<1

%  0%             

<1%

   0%             

Infection

  17%  16%              17%   16%             

Source: Thota R et al., Oncology 2014; Jan 28(1):7074

 

Other drugs are currently under investigation, but none have received marketing authorization as a first-line treatment of PDA since the approval of Abraxane. Most notably, Jameson et al presented preliminary resultsAbraxane,Lynparza® (olaparib) was approved in December 2019 for maintenance therapy of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a Phase 1b/2 pilot studyfirst-line platinum-and chemotherapy regimen.

Familial adenomatous polyposis

Familial adenomatous polyposis (“FAP”) is a rare and potentially life threatening genetic condition occurring in approximately one in 10,000 individuals in the United States. FAP is caused primarily by mutations in the adenomatous polyposis coli (APC) tumor suppressor gene. APC mutations are usually inherited as autosomal dominant genetic traits, but as many as 25% of those afflicted with FAP with an identical germline mutation have no family history. Only 1 in 10,000 people will develop FAP. Estimated annual prevalence in the U.S. is approximately 30,000 and in Europe approximately 50,000. If untreated, patients will develop hundreds to thousands of polyps throughout the colon and rectum. FAP often develops in the early teens and results in a nearly 100% lifetime risk of colorectal cancer by age forty if untreated. No approved FAP drug is on the market.

Most patients are asymptomatic for years until the adenomas are large and numerous, and cause rectal bleeding or even anemia, or cancer develops. Generally, cancers start to develop a decade after the appearance of the polyps. Nonspecific symptoms may include constipation or diarrhea, abdominal pain, palpable abdominal masses and weight loss.

Cancer prevention and maintaining a good quality of life are the main goals of management of patients with FAP. By the late teens or early twenties, colorectal cancer prophylactic surgery is advocated. Prophylactic surgery often requires total abdominal colectomy with ileal-rectal anastomoses (“IRA”) and subsequent frequent endoscopic surveillance, with polypectomy and cautery/laser ablation as needed. Patients with extensive rectal involvement must undergo total proctocolectomy with ileal pouch-anal reconstruction. Despite this, approximately 50% of patients who have had total proctocolectomy with ileal pouch-anal reconstruction will develop adenomatous polyps in the neo-rectum (ileal pouch). Duodenal cancer and desmoids are the two main causes of mortality after total colectomy; they need to be identified early and treated. Upper endoscopy is necessary for surveillance to reduce the risk of ampullary and duodenal cancer. Patients with progressive tumors and unresectable disease may respond or stabilize with a combination of gemcitabine, nab-paclitaxelcytotoxic chemotherapy and cisplatin insurgery (when possible, to perform). Individuals with FAP carry a 100% risk of CRC; however, this risk is reduced significantly when patients with stage 4 pancreatic cancer. Although adverse events were frequent and severe, the response rate was encouraging (Jameson ASCO GI 2017).

Pancreatitis

Additional potential indications for SBP-101 are the treatment of patients with the serious and potentially life-threatening conditions of acute/recurrent acute and chronic pancreatitis, which hasenter a mortality rate of between two and five percent. In the United States, acute pancreatitis occurs in approximately 300,000 patients per year, with approximately 50% of those cases considered to be recurrent acute pancreatitis. Approximately 30,000 patients progress to chronic pancreatitis each year. The direct costs associated with pancreatitis are estimated to be approximately $3 billion annually.

Patients with chronic pancreatitis endure repeated episodes of abdominal pain, often with progression to narcotic dependency and to pancreatic enzyme deficiency, as well as insulin dependent diabetes mellitus as a consequence of the ultimate destruction of pancreatic function. Once a patient has suffered from repeated painful bouts of chronic pancreatitis they may be offered a total pancreatectomy. A total pancreatectomy is a surgical procedure resulting in the resection, or removal, of the pancreas (guaranteeing both pancreatic enzyme deficiency as well as insulin-dependent diabetes mellitus), and often includes the spleen, gall bladder and appendix. The operation is both extensive, requiring 8+ hours in the operating room, and expensive. While the goal of a total pancreatectomy in patients with chronic pancreatitis is pain relief, as many as 60% remain narcotic dependent, and even with the isolation and reintroduction of any of the patient’s remaining functional insulin producing islet cells, or islet auto-transplant, over 70% of patients remain insulin dependent. The combination of a total pancreatectomy and islet auto transplant (“TP & IAT”) represents a small subset of the current surgical approaches to patients with chronic pancreatitis. Thus, a patient with chronic pancreatitis may face months of abdominal pain, narcotic dependence, the onset of diabetes mellitus, the requirement for both insulin and pancreatic enzyme replacement, and finally, an extensive and expensive surgical procedure which may not materially improve any of their symptoms.


1 FOLFIRINOX represents leucovirin, fluorouracil, irinotecan, and oxaliplatin.screening-treatment program.

 


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Patients with acute pancreatitis experience abdominal pain, which can be severe and even life threatening. Acute pancreatitis occurs most often in adults aged 30-40 years, and is associated in some cases with increased consumption of alcohol and tobacco, and in other cases, with the presence of stones in the bile or pancreatic duct system. In a small minority of cases the disease may be hereditary, but many affected patients have no clear precipitating cause. There are no specific agents approved for treatment of acute or chronic pancreatitis, as such, current treatment is limited to supportive care with intravenous fluids, narcotics and the avoidance of oral intake.

SBP-101, which has demonstrated the specificity to target the acinar and ductal cells of the pancreas, and if successfully developed, may represent an opportunity for up to 30,000 US patients presenting annually with chronic pancreatitis to receive an early, non-surgical intervention into the natural history of their disease, with the potential to avoid narcotic dependency, insulin dependency, surgery and months or years of chronic pain. Patients would still require pancreatic enzyme replacement. We believe that our consultations with pancreatitis experts at Harvard University, the Ohio State University, the University of Minnesota, Cedars Sinai Medical Center, the University of Miami, the University of Florida and the National Institute of Health (“NIH”) have resulted in enthusiastic endorsement of the study of SBP-101A major unmet need in the treatment of patients with pancreatitis.FAP is a therapeutic means to defer or obviate the need for major surgical interventions, particularly colectomy with IRA or proctocolectomy with an ileal surgical pouch (IPAA). Such interventions often require temporary or permanent ileostomy, and with it, long-term or permanent quality of life (QoL) deficits such as frequent bowel movements (average 6 per day), nocturnal fecal incontinence and, in female patients, reduced reproductive potential. It is critical to find non-surgical alternatives that will delay or obviate the need of repeated endoscopic and surgical procedures to maintain patient QoL. For those patients who have an intact colon in particular, pharmacotherapy offers the opportunity to meaningfully control or delay polyposis progression and offer a greater choice over when or if they undergo prophylactic colectomy/proctocolectomy in order to optimize QoL.

 

Clinical developmentThis potential benefit is in fact likely the most powerful potential benefit possible since the long-term course of SBP-101FAP essentially mandates ultimate colectomy for most patients. The value to a younger patient in safely delaying such a radical procedure by years cannot be overstated.

There are currently no approved and marketed pharmacotherapeutic treatments for patients with FAP. While in 1999 celecoxib was conditionally approved by the FDA for the treatment of FAP based on reductions of polyp number observed in a randomized double-blind placebo controlled study conducted in patients with pancreatitisFAP, it was subject to the marketing authorization holder, Pfizer, providing additional data. In 2011, the FDA requested that Pfizer voluntarily withdraw the FAP indication for CELEBREX (celecoxib) Capsules from the market because the post-marketing study intended to verify clinical benefit and required as a condition of approval under subpart H was never completed. In a letter in 2011, Pfizer requested that the FDA withdraw the FAP indication for CELEBREX (celecoxib) Capsules from the market. Effective in 2012, the approval for the FAP indication for CELEBREX (celecoxib) Capsules was withdrawn. Celecoxib was also authorized for FAP treatment centrally by the European Commission after the EMA’s scientific review in October 2003 under “exceptional circumstances”. Authorization was granted subject to specific obligations during product life-cycle, chiefly to provide further data on its efficacy and safety; however, the applicant/authorization holder could not fulfill this central post-authorization obligation. According to publicly available information, the post- authorization study was initiated in the first quarter of 2004 and the EU Centralized Marketing Authorisation was withdrawn because the holder was unable to provide the data as required.

Ovarian Cancer

Worldwide Ovarian Cancer has annual incidence of approximately 314,000 and annual deaths of approximately 207,000 (Globocan 2020). In the United States, Ovarian represents approximately 1% of all new cancer cases at approximately 22,000 (American Cancer Society. Cancer Facts & Figures 2021. Atlanta, GA: American Cancer Society; 2021) and the five year survival rate for metastatic disease is expectedapproximately 29% (SEER fact sheet Ovarian 2022). According to proceed following the pancreaticAmerican Cancer Society, ovarian cancer indication,is the fifth leading cause of cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system.

Nearly 70 % of the patients are diagnosed with FDA consultation in a pre-IND meeting,advanced-stage due to the failure of screening methods for detecting early-stage disease (Giornelli 2016; Partridge et al. 2009; Bast et al. 2007; Gohagan et al. 2000; Chudecka-Głaz 2015). Thus, most patients will relapse within the first 2 years after diagnosis, even after an optimal primary cytoreductive surgery and six cycles of the standard adjuvant chemotherapy with carboplatin/paclitaxel.

The second line chemotherapy depends mainly on the disease-free interval (“DFI”) (time between completion of first line chemotherapy and clinical relapse); or progression-free interval (“PFI”) (time between the last chemotherapy given for relapsed disease and progression). There are three classifications: Platinum-refractory/resistant with relapse during platinum treatment (refractory) or with a seriesDFI/PFI <6 months (resistant), Platinum-sensitive relapse occurring >12 m of IND-enabling nonclinical toxicologylast platinum-based chemotherapy, or partially sensitive to platinum with disease-free survival (“DFS”)/ PFS between 6 and pharmacology studies,12 months from the last platinum-based chemotherapy.

According to Pignata et al. 2017, in platinum-sensitive patients, treatment with platinum-based combinations is associated with a PFS advantage compared with single agents or non-platinum combinations. For patients with partially sensitive relapse (PFI between 6 and submission12 months), two options are available: platinum doublets or non-platinum therapy (single agent or combination). Last, patients with resistant or refractory relapse (PFI < 6 months) disease there are few options. For these patients, monotherapy with a non-platinum drug or participation in clinical trials is indicated.

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Colorectal Cancer

According to United States Cancer Statistics published by the American Cancer Society, in the United States in 2022, it is estimated that CRC will be the third most commonly occurring cancer among males and females and the third leading cause of cancer-related deaths. High-risk adenomatous polyps are considered the key risk factor for CRC. In 2015, the disease will be responsible for an IND packageestimated 52,000 deaths in the United States. An even higher rate of incidence occurs in the European Union, where approximately 255,000 people per year die from CRC according to the FDA. Clinical developmentGlobocan 2020 Fact Sheets.

Globally, there are approximately 1,931,000 new diagnoses each year (approximately 180,000 expected in North America in 2020). Rates of SBP-101presentation are also becoming significant in Asia (China and Japan). Colorectal adenomas (or “polyps”) are considered the key risk factor for pancreatitisCRC. The general consensus in the medical and scientific communities is also contingentthat these polyps are the precursors to more than 90% of all colorectal cancers.

Colon cancer represents nearly three-fourths of all colorectal cancers in the U.S. Despite potentially curative treatment with surgery (with or without adjuvant chemotherapy), local stage and locally advanced stage colon cancer patients remain at considerable risk for colorectal adenomas, distant recurrence, secondary colonic tumor formation, and colorectal cancer related mortality. Polypectomy appears to be an effective way to decrease mortality from colon cancer but widespread adoption of this approach is limited by both cost and patient acceptability (Newcomb et al. 1992; Selby et al. 1992). Certain types of colorectal polyps have increased risk of progression to colorectal cancer. High-risk polyps (polyps with villous histology, size ≥ 1 cm, high grade dysplasia, or multiple adenomas defined as 3 or more) have become the focus of colorectal tumorigenesis research due to the higher rate of malignant potential for these lesion (Lotfi et al. 1986; Spencer et al. 1984; Winawer et al. 1993; Martinez et al. 2009). The current standard of care for resected colon cancer patient (beyond surgery, and adjuvant chemotherapy when indicated) is surveillance monitoring with clinical exams, laboratory analyses, and colonoscopic evaluation. However, data suggest that colonoscopy does not predict death from colorectal cancer uniformly throughout the colon – in fact, right-sided colorectal cancers were not observed to gain any mortality benefit from colonoscopy (Baxter et al. 2009). Other potential problems with colonoscopy include (rarely) perforations, infection, bleeding, and non-adherence with current recommendations. Safe and effective chemopreventive interventions, therefore, offer great potential to complement and improve upon raising additional funds beyond the raise contemplated by this offering.current colon cancer surveillance paradigm.Unlike other therapies used to treat CAT, Flynpovi is a non-surgical and non-invasive option that has the potential to both improve patient quality of life and reduce higher healthcare system-wide expense burdens.

Proprietary Technology

 

Proprietary Technology

Function and Characteristics of Polyamines

 

Polyamines are metabolically distinct entities within human cells that bind to and facilitate DNA replication, RNA transcription and processing, and protein (such as pancreatic enzymes) synthesis. Human cells contain three essential and naturally occurring polyamines - putrescine, spermidine, and spermine - that, in contrast to cell building blocks such as amino acids and sugars, remain as metabolically distinct entities inside the cell.spermine. Polyamines perform many functions necessary for cellular proliferation, apoptosis and protein synthesis. The critical balance of polyamines within cells is maintained by several enzymes such as ornithine decarboxylase ((“ODC”) and spermidine/spermine N1 acetyl transferase (“SSAT”). All of these homeostatic enzymes are short-lived, rapidly inducible intracellular proteins that serve to tightly and continuously regulate native polyamine pools.pools tightly and continuously. These enzymes constantly maintain polyamines within a very narrow range of concentration inside the cell.

44

Polyamine metabolism and cancer

 

Polyamine AnaloguesPolyamines are required for cell proliferation. It is believed that many cancers, especially oncogene-driven cancers, might be sensitive to interference with polyamine metabolism. The natural polyamines putrescine, spermidine and spermine are intimately involved in growth-related processes, wound healing, and the development of cancer. Under normal conditions, the pool of polyamines is tightly controlled through regulation of synthesis, catabolism, and transport mechanisms (Gerner and Meyskens 2004). The loss of this tight control can result in an excessive accumulation of polyamines, which favors malignant transformation of cells. Consequently, with the loss of growth control in cancer cells, the transformed cells may be more sensitive to polyamine depletion than normal cells. Thus, the polyamine metabolic pathway is a rational target for therapeutic intervention (Casero 2018).

 

Immune systems require multiple soluble and cellular components, including polyamines, for a normal immune function. As such, polyamines are important modulators of the immune response, particularly in the tumor microenvironment where they are found in high concentrations. High levels of polyamines are present in tumor cells and in autoreactive B- and T-cells in autoimmune diseases. Dysregulation of polyamines can result in tumor immune evasion, elevated cell stress, and increased autoimmunity. By resetting the polyamine pathway through therapeutic interventions, there is the potential to restore normal immune functions.

Pharmacotherapeutic Approaches to Reset the Polyamine Pathway

The Company’s lead assets are ivospemin and Flynpovi, which provide a multi-targeted approach to reset dysregulated biology present in many types of diseases such as cancer and autoimmunity. For instance, many tumors require greatly elevated levels of polyamines to support their growth and survival. These agents target the polyamine pathway at complementary junctions which have been shown to be altered is disease. In particular, these agents have the potential to suppress and prevent tumor growth, enhance anti-tumor activity of other anti-cancer agents, and modulate the immune system.

45

image01.jpg

Polyamine Analogue - ivospemin (SBP-101)

Many tumors, including pancreatic cancer, display an increased uptake rate of polyamines. Polyamine analogues such as SBP-101ivospemin are structurally similar to naturally occurring polyamines and are recognized by the cell’s polyamine uptake system, allowing these compounds to gain rapidready entrance to the cell. We believe that pancreatic acinar cells, because of their extraordinary protein synthesis capacity, exhibit enhanced uptake of polyamines and polyamine analogues such as SBP-101.analogues. Because of this preferential uptake by pancreatic acinar cells, polyamine analogiesanalogues such as SBP-101ivospemin disrupt the cell’s polyamine balance and biosynthetic network, and induce programmed cell death, or apoptosis, via processes including caspase 3 activation and PARPpoly ADP ribose polymerase (PARP) cleavage. Proof of concept has been demonstrated in multiple human pancreatic cancer models, both in vivo and in vitro, that pancreatic ductal adenocarcinoma exhibits sensitivity to SBP-101. Many tumors, including pancreatic cancer, display an increased uptake rate of polyamines and polyamine analogues.ivospemin.

 

SBP-101

SBP-101Ivospemin is a proprietary polyamine analogue, which we believe accumulates in the exocrine pancreas acinar cells due to its unique chemical structure alterations. SBP-101structure. ivospemin was discovered and extensively studied by Professor Raymond J. Bergeron at the University of Florida College of Pharmacy. In a key, independent, pre-clinical study we observed the accumulation of SBP-101 in the acinar cells of the beagle pancreas causing a complete pharmaceutical resection of the exocrine tissues of the pancreas and notably, without producing an inflammatory response. We believe that SBP-101,when administered in a sufficiently high pharmacologic dosage, disrupts the normal metabolic process of acinar cells and pancreatic adenocarcinoma cells, which exhibit similar responses, including programmed cell death, or apoptosis. Importantly, pancreatic islet cells, which secrete insulin, are structurally and functionally dissimilar to acinar cells and are not impacted by SBP-101.

 


TheAs laboratory studies suggest, the primary mechanism of action for SBP-101ivospemin has been demonstrated to include the enhanced uptake of the compound in the exocrine pancreas. This effectpancreas; therefore, pancreatic cancer was logical for the initial development of this compound. Sufficiently high dosing in animal models leads to correspondingcorrespondingly depressed levels of native polyamines, with caspase 3 activation, PARP cleavage and apoptotic destruction (programmed cell death) of the exocrine pancreatic acinar and ductal cells without an inflammatory response. Importantly, pancreatic islet cells, which secrete insulin, are structurally and functionally dissimilar to acinar cells and are not impacted by ivospemin. In animal models at two independent laboratories, SBP-101ivospemin has demonstrated significant suppression of transplanted human pancreatic cancer cells, including metastatic pancreatic cancer growth. See “Proof of Principle” below.

46

 

We believe that SBP-101 will have a distinct advantage over current pancreatic cancer therapies in that it specifically targetsivospemin exploits the natural affinity of the exocrine pancreas, the liver and may cause ablation, or pharmaceutical resection, of the acinarkidney, and pancreatic ductal adenocarcinoma cells as well as the primary and metastatic pancreatic cancer, while leaving the insulin-producing islet cells and most non-pancreatic tissue unharmed. Most current cancer therapies, including chemotherapy, radiation, and surgery, are associated with significant side effects that further reduce the patient’spatient’s quality of life. However, based on data evaluated from clinical studies to date, we believe that the adverse effects of SBP-101 willivospemin in causing bone marrow suppression or peripheral neuropathy do not overlap with or exacerbate those seen with typical chemotherapy options. It is expected that SBP-101 may produce exocrine pancreatic insufficiency and, potentially, other GI adverse events, many of which are generally expected to occur as common complications of advanced pancreatic cancer and part of the natural history/progression of the disease. The dose-limiting toxicities observed in cohort five of our first Phase 1aI study, as noted above,below, were not observed at lower doses. Exocrine pancreatic insufficiencydoses and are not expected to overlap with the adverse events of bone marrow suppression and peripheral neuropathy commonly associated with standard chemotherapy. The dose and dosing schedule evaluated in the expansion phase of the recently completed Phase Ia/Ib is a common complication of pancreatic cancerbelow the maximum tolerable dose (MTD) and is treatable with currently marketed digestive enzyme replacement capsules, such as Creon® (AbbVie). Asat this dose level, neither the exocrine nor the endocrine human pancreas is expected to be unaffectedaffected by SBP-101,ivospemin, resulting in no treatment impact on pancreatic enzyme or insulin levels. This dose level and dosing schedule in the new requirement for insulin is expected.ASPIRE trial will be the same as evaluated in the expansion phase of the Ia/Ib study.

 

Proof of PrincipleOrnithine Decarboxylase Inhibitor - eflornithine (CPP-1X)

 

SBP-101Ornithine decarboxylase is the first and rate-limiting enzyme in the biosynthesis of polyamines which catalyzes the conversion of ornithine to putrescine and regulates the biosynthesis of polyamines in mammalian as well as many other eukaryotic cells. Eflornithine, also known as α-difluoromethylornithine (DFMO), is an ornithine analogue. Eflornithine irreversibly binds to ODC1 and prevents the natural ODC1 substrate, ornithine, from accessing the active site of the enzyme (Meyskens and Gerner 1999). The administration of eflornithine decreases both ODC activity and polyamine concentrations. In genetic mouse models with an APC gene mutation, the administration of eflornithine reduces intestinal carcinogenesis, decreasing the concentration of polyamines through transport and catabolism and inhibiting tumor development (Babbar et al. 2003).

Treatment of animals with eflornithine results in inhibition of ODC activity, especially in tissues and organs with rapidly dividing cells. Polyamine biosynthesis has been testedshown to be critical for eukaryotic cellular growth and differentiation, and inhibition of polyamine biosynthesis can stimulate or inhibit cellular differentiation depending on the model studied (Gerner and Meyskens 2004). Accordingly, eflornithine has promoted or inhibited cell differentiation in a variety of models.

Polyamine biosynthesis is also a critical step in experimental chemical-induced carcinogenesis, cell transformation, and tumor cell proliferation, and there is a growing body of evidence that eflornithine's inhibitory effect on cell proliferation and tumorigenesis may involve a complex inter-relationship between oncogenes, polyamine metabolism, and ODC activity. MYC is an oncogene that encodes a transcription factor that is required for the proliferation of normal cells but when overexpressed can lead to aberrant cell growth (Gerner and Meyskens 2004). Additionally, c-Myc is a transcriptional activator of the ODC gene (Pena et al. 1993) (Bello-Fernandez, Packham, and Cleveland 1993). Furthermore, eflornithine has been shown to decrease N-Myc mRNA in neuroblastoma cells and c-Myc mRNA in human colon carcinoma cells (Celano et al. 1988) and spermidine preferentially stimulated transcription and expression of c-Myc, but not c-Fos (Tabib and Bachrach 1999). Taken together, these results suggest that polyamines play a feedback role in the regulation of expression of certain oncogenes at the level of transcription.

Mice with a mutation of the adenomatous polyposis coli (Apc) tumor suppressor gene develop intestinal tumors in numbers similar to those found in patients with FAP. Mutations of the Apc gene increases the activity of ODC and leads to increased intestinal polyamine levels. Studies in animal models of FAP indicate that eflornithine alone is effective in reducing pancreaticthe number of intestinal tumors (Erdman et al. 1999b) and colonic tumor growthburden (Yerushalmi et al. 2006). Eflornithine may lower polyamine levels in multiple separate in vivo models of human pancreatic cancer. SBP-101 was used to treat mice subcutaneously implanted with human pancreatic cancer cell line PANC-1 tumor fragments. A dose-response for efficacy was demonstrated with a 26 mg/kg daily injection resulting in near complete suppression of the transplanted tumor, as shown in Figure 1.

Figure 1.

Impact of SBP-101 on PANC-1 Tumor Burden in a Murine Xenograft Model

Source: Study BERG20100R1a(MIR1581)


A separate orthotopic xenograft study, in which human pancreatic cancer tumorcolorectal mucosa and skin cells are implanted directly into the pancreas of the mouse, employed a particularly aggressive human pancreatic cancer cell line, L3.6pl, that is known to metastasize from the pancreas to the liver(Gerner and the peritoneum in mice. These mice were treated with SBP-101 and the results were compared with saline-treated control mice, with mice treated with gemcitabine alone (Gemzar®, the “gold standard” treatment at that time), and the combination of both drugs. Both gemcitabine and SBP-101 significantly reduced tumor volume compared to the control group, but the combination of SBP-101 and gemcitabine was significantly better than gemcitabine alone as shown in Figure 2.

Figure 2Meyskens 2004).

L3.6pl Orthotopic Xenograft Dose-response Study - Mean (+SD) Tumor Volume after Treatment with SBP-101, Gemcitabine (Gemzar) or Both

Source: Study101-Biol-101-001

 

The major clinical evidence for benefit of eflornithine derives from prospective, randomized, placebo-controlled clinical studies of eflornithine monotherapy in patients with elevated risk for developing certain forms of cancer (prostate and basal cell skin cancer). In a randomized, placebo-controlled, clinical study in subjects with a history of resected colon polyps, eflornithine reduced polyamines in rectal mucosal tissue. This marker study is especially relevant to patients with FAP, in whom target tissues include intestinal and colonic mucosa (Meyskens et al. 1998).

Eflornithine has received regulatory approvals as a high dose, intravenously delivered medication for the treatment of a form of African sleeping sickness, and as a topical agent for the treatment of hirsutism (excess hair growth on body parts where hair growth is usually absent or minimal). No oral dosage form of eflornithine has ever received regulatory approval in any indication.

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Activator of Spermidine/Spermine N-Acetyltransferase (SSAT1) Sulindac

Transport of polyamines is maintained by the peroxisome-proliferator activated receptor-g (“PPARg”). This receptor positively regulates SSAT transcription facilitating polyamine acetylation and transport of polyamines out of the cell. Under normal conditions, the K-Ras molecule has no activity on PPARg. However, mutation of the K-Ras gene produces a product that inhibits PPARg’s effect on SSAT translation resulting in elevated polyamine pools and tumorigenesis (Babbar et al. 2003). NSAIDs, such as sulindac, act through PPARg to enhance transcriptional of SSAT which increases catabolism and export of polyamines.

Sulindac is a member of the arylalkanoic acid class of NSAIDs and is a non-selective inhibitor of cyclooxygenases involved in prostaglandin synthesis. To understand potential mechanisms of action of sulindac, patterns of gene expression resulting from treatment with sulindac sulfone, a sulindac metabolite lacking cyclooxygenase inhibitory activity, were measured in human colon tumor-derived cells (Babbar et al. 2003). Sulindac sulfone inhibited cell growth, and induced apoptosis and the expression of spermidine/spermine N-acetyltransferase (SSAT1), a polyamine catabolic enzyme implicated in polyamine export (Xie, Gillies, and Gerner 1997). Sulindac sulfone induction of SAT1 expression occurs via a cyclooxygenase-independent transcriptional activation of SAT1 at a specific peroxisomal proliferator activated receptor gamma (PPARγ) responsive element (“PPRE”) in the SAT1 gene. Treatment of cells with sulindac sulfone induces SAT1 expression and stimulates polyamine export.

Experimental findings in human cell and mouse models indicate that sulindac and other NSAIDS activate polyamine catabolism (Gerner and Meyskens 2009). Thus, NSAIDs complement inhibitors of polyamine synthesis, like eflornithine, to reduce tissue polyamine levels. In cell culture, sulindac metabolites reduce cell survival in vitro in a dose-dependent manner at doses above 150 µM at 24-hour exposure times (Lawson et al. 2000).

Experiments in both mouse and rat models of colon cancer have demonstrated a preventative effect for SBP-101 assulindac (Babbar et al. 2003). Sulindac blocked tumor formation in the multiple intestinal neoplasia (Min) mouse, a murine model of APC mutation-associated intestinal carcinogenesis, mimicking FAP. In the Min mouse, tumor-preventing doses of sulindac inhibited tissue levels of prostaglandin-E2 and COX-2 (Boolbol et al. 1996). In other nonclinical studies, sulindac had an effective therapyinhibitory effect on bladder, lung, and forestomach tumor formation in rat and mouse models (Kelloff, Boone, et al. 1994, Kelloff, Crowell, et al. 1994).

Dual Targeting - Flynpovi

The ability to decrease the polyamine pools by a dual mechanism of action, i.e., suppressed synthesis and enhanced catabolism and export, led to the hypothesis that Flynpovi would complement one another in the prevention of tumor development in a patient population where elevated polyamine pools lead to enhanced tumorigenesis. Eflornithine is the irreversible inhibitor of ODC which is responsible for pancreatic cancerde novo synthesis of polyamines and sulindac regulates SSAT which plays a role in polyamine export and catabolism. Hence the combination, Flynpovi, inhibits the generation of new polyamines and also removes polyamines obtained from the diet and microbiome.

The ability of Flynpovi to reduce polyamines in the GI tract has therefore been demonstrated in vivoboth the preclinical and clinical settings. In the study by separate investigators, in different human pancreatic cancer cell linesIgantenko et al, the effect of eflornithine alone and in twocombination with NSAIDs sulindac or celecoxib on intestinal tumor number and grade and polyamine content was evaluated in ApcMin/+ mice (Ignatenko et al. 2008). Administration of eflornithine in combination with sulindac was superior to each single agent at significantly (P< 0.05) decreasing putrescine, spermidine, and total intestinal polyamine concentrations to below baseline levels in the ApcMin/+ mice. Additionally, in this study with the exception of the 0.5% eflornithine treatment group, all treatment groups developed significantly (P<0.05) fewer tumors/animal than the control group. The combination treatment of 2% eflornithine and sulindac suppressed intestinal tumorigenesis to a level that was not statistically significantly different animal models, using SBP-101 synthesized by two different routes, confirming nearly equal,from that for sulindac alone. Although sulindac alone produced a significant decrease in the number of intestinal tumors in ApcMin/+ mice, it did not reduce the percentage of high‑grade adenomas. However, the combination of eflornithine and remarkably effective, dosessulindac significantly (P<0.05) decreased the number of 25high-grade adenomas compared to the sulindac alone group.

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The ability of the eflornithine and 26 mg/kg, respectively.sulindac treatment group to suppress high grade adenomas is a key finding as it is the high grade adenomas in this model which correlate to the high grade adenomas seen in FAP patients that are indicators for excisional and surgical events clinically. These data support the rationale for treatment of FAP patients with eflornithine combined with sulindac to reduce intestinal polyamine contents and the incidence of high-grade intestinal adenomas.

 

Additionally, whenMore importantly, combination treatment with Flynpovi dramatically reduces the incidence of metachronous colorectal adenomas in patients with prior sporadic adenomas (Meyskens et al. 2008). Meyskens and colleagues performed a Phase IIb/III, double-blind pharmacoprevention of Sporadic Colorectal Adenomas Study (PSCA Study) in which 375 subjects who had resected sporadic adenoma were treated for 3 years with eflornithine (500 mg once a day) + sulindac (150 mg once a day [N = 191]) or matched placebo/placebo (N = 184). Results demonstrated a marked risk reduction (70%) in developing metachronous adenomas, 92% risk reduction in developing advanced adenomas, and 95% risk reduction in developing multiple adenomas with the active combination regimen compared in vitro to existing therapies, SBP-101 produced superior results in suppressing growth of pancreatic cancer cells.placebo. This combination regimen was generally well tolerated.

 

The mechanism of disease in sporadic and FAP-associated adenomatous polyposis, and the mechanism of eflornithine and NSAID action in prevention of progressive polyposis in both the general population with sporadic adenomas and in patients with FAP, led to the development of the FAP-310 trial in patients with FAP associated with APC germline mutations.

The FAP-310 Phase III study that evaluated the efficacy and safety of the combination of eflornithine and sulindac, as compared with either drug alone, in adults with familial adenomatous polyposis was conducted (Burke et al. 2020). The patients were randomly assigned in a 1:1:1 ratio to receive eflornithine, sulindac, or both once daily for up to 48 months. In a post-hoc analysis, none of the patients in the combination arm progressed to a need for lower gastrointestinal (LGI) surgery for up to 48 months compared with 7 (13.2%) and 8 (15.7%) patients in the sulindac and eflornithine arms (Balaguer et al. 2022). These data corresponded to risk reductions for the need for LGI surgery approaching 100% between combination and either monotherapy with HR = 0.00 (95% CI, 0.00-0.48; P= 0.005) for combination versus sulindac and HR = 0.00 (95% CI, 0.00-0.44; P= 0.003) for combination versus eflornithine.

Development Plan for SBP-101Ivospemin (SBP-101)

 

Development of SBP-101ivospemin for the pancreatic cancer indication includeshas included a pre-clinical and a clinical phase. The pre-clinical phase, which was substantially completed during 2015, consistsconsisted of four primary components: chemistry, manufacturing and controls ((“CMC”), preclinical (laboratory and animal) pharmacology studies, preclinical toxicology studies, and regulatory submissions in Australia and the United States.

Preparation of the ivospemin IND for pancreatic cancer required collaboration by our manufacturing, preclinical toxicology, pharmacokinetic, and metabolism experts, our regulatory affairs project management, and our in-house clinical expertise. In August 2015, the FDA accepted our application.

In Australia, a Human Research Ethics Committee (“HREC”) application was submitted with subsequent Clinical Trial Notification (“CTN”) to the Therapeutic Goods Administration (“TGA”). Complementing the Australian initiative, a similar, but considerably more extensive, preclinical package has been submitted to the FDA in support of an IND application.

Our initial clinical trial in previously treated patients with locally advanced or metastatic pancreatic cancer was a Phase 1,I, first-in-human, dose-escalation, safety study conducted at clinical sites in both Australia and the United States. We engaged expert clinicians who treat pancreatic cancer at major cancer treatment centers in Melbourne and Adelaide, Australia as well as the Mayo Clinic Scottsdale and HonorHealth in Scottsdale, Arizona. These Key Opinion Leaders, (“KOLs”), with proven performance in pancreatic cancer studies, enthusiastically agreed to participate as investigators for our Phase 1I First-in-Human study.

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Enrollment in ourour initial Phase 1I safety trial of SBP-101ivospemin in previously treated pancreatic cancer patients commenced in January 2016 and was completed in September 2017. This study was a dose-escalation study with 8-week treatment/observation cycles at each dose level. Preliminary resultsResults from this trial are discussed in ivospemin (SBP-101) Clinical Development Pancreatic Cancer, Phase I Clinical Trial Design and Completion (ivospemin Monotherapy)below.


 

We anticipate initiationcompleted enrollment of patient enrollmentpatients in our nextsecond clinical trial in the first quarter of 2018. OurDecember 2020. This second clinical trial will bewas a Phase 1a/1bIa/Ib study of the safety, efficacy and efficacypharmacokinetics of SBP-101ivospemin administered in combination with two standard-of-care chemotherapy agents, gemcitabine and nab-paclitaxel,nab-paclitaxel. A total of 25 subjects were enrolled in four cohorts of Phase Ia and we plan to conduct the trial at four study sites (three in Australia and onean additional 25 subjects were enrolled in the United States). In theexpansion Phase 1a portionIb by December of 2020. Safety and interim efficacy results from this trial are discussed in ivospemin (SBP-101)Clinical Development - Pancreatic Cancer, Phase Ia/Ib Clinical Trial Interim Results (First Line Combination Therapy) below.

In January of 2022, we expect to enroll three cohortsinitiated our third clinical trial. This new trial is a randomized, double blind, placebo controlled study of 3-6 patients with increased dosage levelssafety and efficacy of SBP-101ivospemin administered in the secondcombination with two standard-of-care chemotherapy agents, gemcitabine and third cohorts. Demonstration of adequate safetynab-paclitaxel. Trial design and expected timing are discussed in the Phase 1a portion of the trial is expected to lead to the Phase 1b exploration of efficacy, in which we plan to enroll ten patients using the recommended dosage level determined in the Phase 1a portion of the trial. We believe that meeting the primary endpoint in Phase 1b would predict a successful randomized Phase 3 trial. Early results from the Phase 1a portion are expected to be available in late 2018. Early results from the Phase 1b expansion could become available as soon as the second half of 2019.Clinical Development - Pancreatic Cancer, Randomized Clinical Trial Design and Anticipated Timing (ASPIRE trial).

 

With additional funding SBP-101 may also be exploredIn addition, we are exploring ivospemin for use as aneoadjuvant treatment for recurrent acute and chronic pancreatitis and maintenance therapy in patients responding to first line treatment and/or for adjuvant treatment after surgery in appropriate pancreatic cancer patients. There is also preclinical data to suggest that SBP-101ivospemin may have potential therapeutic uses for cancers other than pancreatic. In February 2021, we entered into a research agreement with the Johns Hopkins University School of Medicine. The collaboration has focused on the further development of Panbela’s investigative agent ivospemin, including activity in cell lines outside of the pancreas, but due to the current focus on pancreatic cancer, biomarkers informing diagnostics and pancreatitis, none have been formally explored.potential combination with checkpoint inhibitors. In December 2021, the Company announced positive preclinical data supporting the activity of ivospemin in ovarian cancer cell lines which was presented and published in 2022 (Holbert et al. 2022). Further data resulting from the ongoing relationship with Johns Hopkins University School of Medicine is expected.

 

PreclinicalIvospemin (SBP-101) Clinical Development Pancreatic Cancer

 

To enable IND and HREC/CTN submission and as part of our pharmacology work, we conducted plasma and urine assayOur clinical development and validation in animals, in vitro metabolism studies in liver microsomes and hepatocytes, in vitro interaction studies with hepatic and renal transporters, a protein binding study, animal pharmacokinetic and metabolism/mass balance studies, and human plasma and urine assay development and validation. As a part of the pharmacology evaluation, we conducted an in vitro pharmacology screen profiling assay, a study in six human pancreatic cell lines, and studies in tumor xenograft models in mice using human pancreatic cancer PANC-1 tumor fragments, human pancreatic cancer BxPC-3 tumor fragments and human pancreatic cancer cells (L3.6pl) injected orthotopically in the tail of the pancreas of nude mice.

To meet regulatory requirements and to establish the safety profile of SBP-101, we conducted, in rodents and non-rodents, toxicology dose-ranging studies, IND-enabling general toxicology studies, and genetic toxicology studies, including an Ames test. Exploratory studies in mice and rats and a Good Laboratory Practice (“GLP”)-compliant dog toxicology study have also been completed. The relationship between dose and exposure (pharmacokinetics) has been described for three animal species. We have also completed a preclinical hERG assay to detect any electrocardiographic QTc interval effects (IKr potassium ion channel testing).

In anticipation of the potential for using SBP-101 in combination therapy with gemcitabine and/or nab-paclitaxel (Abraxane®), we also conducted appropriate nonclinical studies which confirmed the potential value of such combinations, including assessing the comparative efficacy of SBP-101, gemcitabine and nab-paclitaxel in various combinations as shown in Figure 3.


Figure 3.

Evaluation of SBP-101 alone and in combination with gemcitabine and nab-paclitaxel in 6 human pancreatic cancer cell lines

Note that maximum percent growth inhibition (mean ± SE) at 96 hours was observed with 10 µM SBP-101 alone and in combination with gemcitabine and/or nab-paclitaxel in 6 human pancreatic cancer cell lines.

We have met FDA-mandated Chemistry, Manufacturing and Control (“CMC”) requirements with a combination of in-house expertise and contractual arrangements. To date, preparation of anticipated metabolites and an internal standard, as a prerequisite for analytical studies, have been completed through a Sponsored Research Agreement with the University of Florida and a contract manufacturer. We have Service Agreements with Syngene International Ltd. (“Syngene”) for the manufacture and supply of specific quantities of Good Manufacturing Practice (“GMP”)-compliant SBP-101 active pharmaceutical ingredient (“API”) and for the development of synthetic process improvements. Investigational product (IP or clinical trial supply) has been made and tested at Albany Molecular Research Inc. (“AMRI”) in Burlington, MA. Initial lots of GMP-compliant API were prepared by Syngene and released for conversion into supply dosage form. Two clinical trial supply lots have been successfully prepared and released by AMRI. In addition, efforts continue to refine both the synthetic process at Syngene and to prepare improved formulations of the clinical supply.

Pancreatic Cancer Investigational New Drug (“IND”) – Form 1571 Submission.

The preclinical work to support the IND submission has been completed. Our IND application package contained the following:thus far includes:

 

 

Investigator’s Brochure;a Phase I SBP-101 Monotherapy study completed in 2017;

 

 

Statement of general investigative plans;

Proposeda Phase 1 pancreatic cancer Ia/Ib SBP-101 First Line Combination Therapy study, protocol;

Data management and statistical plan;

CMC data;which completed enrollment in late 2020; and

 

 

Pharmacology, absorption, distribution, metabolism and excretion (“ADME”), and toxicology data.a Randomized, Double Blind Placebo Controlled First Line Combination Therapy study was initiated in January of 2022.

 


Details of these programs follow.

 

Preparation of the SBP-101 IND for pancreatic cancer required collaboration by our manufacturing, preclinical toxicology, pharmacokineticPhase I Clinical Trial Design and metabolism experts, our regulatory affairs project management, and our in-house clinical expertise. In August 2015, the FDA accepted our application and in January 2016 we commenced patient enrollment in our Phase 1Completion (ivospemin Monotherapy)

We have completed an initial clinical trial which was a safety and tolerability studyof ivospemin in patients with previously treated locally advanced or metastatic pancreatic ductal adenocarcinoma.cancer. This is further discussed in “Clinical Development” below.

Clinical Development – Pancreatic Cancer

was a Phase 1 Clinical Trial

Our initial Phase 1 study in patients with pancreatic cancer commenced the enrollment of patients inI, first-in-human, dose-escalation, safety study. From January 2016 andthrough September 2017, we expectenrolled twenty-nine patients into six cohorts, or groups, in the dose-escalation phase of the Phase I trial. No drug-related bone marrow toxicity or peripheral neuropathy was observed at any dose level. In addition to complete on study follow-upbeing evaluated for safety, 23 of allthe 29 patients were evaluable for preliminary signals of efficacy prior to or at the eight-week conclusion of their first cycle of treatment using the Response Evaluation Criteria in September 2017. This study was a dose-escalation study with 8-week cyclesSolid Tumors (“RECIST”), the currently accepted standard for evaluating change in the size of treatment/observation at each dose level.tumors.

 

The absenceabsence of adverse events which could potentially overlap with adverse events typically observed in the use of conventional chemotherapeutic agents, supports the case for combination of SBP-101ivospemin with conventional chemotherapeutic agents, such as gemcitabine, nab-paclitaxel, or even FOLFIRINOX.

 

A favorable characteristic of the pancreatic action of SBP-101 is the lack of an effect on the normal insulin-producing islet cells. Preservation of islet cell function implies the likely absence of diabetes as a complication of SBP-101 therapy. It is important to note that diabetes is a common co-morbidity in patients with pancreatic cancer, but it is not expected to be an adverse effect of treatment with SBP-101. The potential adverse effect of exocrine pancreatic insufficiency is mitigated by the observation that many patients with pancreatic ductal adenocarcinoma require pancreatic enzyme replacement as a feature of their underlying disease, a complication so common that pancreatic enzyme replacement with one of several commercially available products is typically covered by United States and Australian health care plans. Patients with cystic fibrosis, chronic pancreatitis and pancreatic cancer are the populations most often treated with pancreatic enzyme replacement.

Patients in our Phase 1 trial underwent regular pancreatic and hepatic enzyme evaluation, and obtained periodic chest and abdominal CT follow-up. Patients were also carefully monitored for clinical signs of GI adverse events.Ia/Ib Clinical Trial Interim Results (First Line Combination Therapy)

 

In August 2015, the FDA accepted our IND application for our SBP-101 product candidate. We have completed enrollment in a clinical trial of SBP-101 in patients with previously treated locally advanced or metastatic pancreatic cancer. This is a Phase 1, first-in-human, dose-escalation, safety study. From January 2016 through September 2017,2018, we enrolled twenty-nine patients into six cohorts, or groups, in the dose-escalation phase of our current Phase 1 trial. Twenty-four of the patients received at least two prior chemotherapy regimens. No drug-related serious adverse events occurred during the first four cohorts. In cohort five, serious adverse events (klebsiella sepsis with metabolic acidosis in one patient, and renal and hepatic toxicity in one patient) were observed in two of the ten patients, both of whom exhibited progressive disease at the end of their first cycle of treatment, and were determined by the DSMB to be DLTs. Consistent with the study protocol, the DSMB recommended continuation of the study by expansion of cohort 4. Four patients were enrolled in this expansion cohort.

In addition to being evaluated for safety, twenty-four of the twenty-nine patients were evaluable for preliminary signals of efficacy prior to or at the eight-week conclusion of their first cycle of treatment using RECIST, the current standard for evaluating changes in the size of tumors. Eight of the twenty-four patients (33%) had SD and sixteen of twenty-four (67%) had PD. It should be noted that of the sixteen patients with PD, six came from cohorts one and two and are considered to have received less than potentially therapeutic doses of SBP-101. We also noted that twenty-eight of the twenty-nine patients had follow-up blood tests measuring the Tumor Marker CA 19-9 associated with pancreatic ductal adenocarcinoma. Eleven of these patients (39%) had reductions in the CA 19-9 levels, as measured at least once after the baseline assessment. Seven of the remaining seventeen patients showed no reduction in CA 19-9 came from cohorts one and two. 


The best response outcomes and survival were observed in the group of thirteen patients who received total cumulative doses between 2.5 mg/kg and 8.0 mg/kg. Twelve of the thirteenbegan enrolling patients in this group were evaluable for preliminary signs of efficacy at eight weeks by RECIST. Five patients (42%) showed SD at week eight. Five of the thirteen patients (38%) had reductions in the CA19-9 levels, as measured at least once after the baseline assessment. Median survival in this group was 3.8 months as of October 2017. To date, nine patients (69%) have exceeded 3 months of overall survival OS, four have exceeded four months of OS and two patients have exceeded 10 months of OS, with some patients continuing to be followed for survival.

Given the life-threatening nature of pancreatic ductal adenocarcinoma, the limited efficacy of current treatment options, and the long history of failures in pancreatic ductal adenocarcinoma developmental therapeutics, we will attempt to evaluate SBP-101 expeditiously as noted below.

We anticipate initiation of patient enrollment in our next clinical trial in the first quarter of 2018. Our second clinical trial, will be a Phase 1a/1bIa/Ib study of the safety, efficacy and efficacypharmacokinetics of SBP-101ivospemin administered in combination with two standard-of-care chemotherapy agents, gemcitabine and nab-paclitaxel,nab-paclitaxel. A total of 25 subjects were enrolled in 4 cohorts to evaluate the dosage level and we planschedule. An additional 25 subjects were enrolled in the expansion phase of the trial. Interim results were presented in January of 2022. Best response in evaluable subjects (cohorts 4 and Ib N=29) was a CR in 1 (3%), PR in 13 (45%), SD in 10 (34%) and PD in 5 (17%). One subject did not have post baseline scans with RECIST tumor assessments. Median PFS, now final at 6.5 months, may have been negatively impacted by drug dosing interruptions to conductevaluate potential toxicity. Median overall survival in Cohort 4 + Phase Ib was 12.0 months when data was presented in January 2022 and is now final at 14.6 months. Two patients from cohort 2 have demonstrated long term survival: one at 30.3 months (final data) and one at 33.0 months and still alive.

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Figure 4.Evaluation of SBP 101 Phase Ib First-line combo-therapy Safety Trial
Best Overall Response

image02.jpg

Source: Singhal, N., Poster Presentation, ASCO GI 2022

Randomized Clinical Trial design and anticipated timing (ASPIRE trial)

In January of 2022, the Company announced the initiation of a new clinical trial. Referred to as ASPIRE, the trial is a randomized double-blind placebo-controlled trial in combination with gemcitabine and nab-paclitaxel, a standard pancreatic cancer treatment regimen in patients previously untreated for metastatic pancreatic cancer. The trial will be conducted globally at four studyapproximately 95 sites (three in Australia and one in the United States)States, Europe and Asia - Pacific.

While opening of clinical sites in the United States and the rest of the world has been slower than originally anticipated, due in part to resource fatigue in the medical community, the Company expects all countries and sites to be open by early -2024.

The trial was originally designed as a Phase II/III trial with a smaller sample size (150) to support the events required for interim analysis based on PFS and a primary endpoint of overall survival (OS). In response to European and FDA regulatory feedback, the Phase 1a portion of thisstudy was amended to include the total trial we expectsample size (600) and the design modified to enroll three cohorts of 3-6 patients with increased dosage levels of SBP-101 administered in the second and third cohorts. Demonstration of adequate safety in the Phase 1a portion of the trial is expected to lead to the Phase 1b exploration of efficacy, in which we plan to enroll ten patients using the recommended dosage level determined in the Phase 1a portion of the trial. We believe that meetingutilize overall survival as the primary endpoint in Phase 1b would predict a successful randomized Phase 3 trial. Early resultsto be examined at interim analysis. PFS will also be analyzed to provide additional efficacy evidence. This amendment was supported by the final data from the Phase 1a portion are expectedIa/Ib first line metastatic pancreatic cancer trial which completed enrollment in December of 2020. The study will enroll 600 subjects and is anticipated to betake 36 months for complete enrollment with the interim analysis available in late 2018. Early results from the Phase 1b expansion could become available as soon as the second half of 2019.

Phase 2 Clinical Trial

A Phase 2 study of SBP-101 in combination with two standard chemotherapy agents, gemcitabine and nab-paclitaxel, is expected to directly extend from the Phase 1 safety study with an exploration of efficacy and may result in an expedited development pathway, leading toward a randomized pivotal trial.

If the results of our planned Phase 2 combination clinical trial demonstrate safety and sufficiently successful efficacy results, we intend to meet with the FDA to obtain advice on potential breakthrough therapy designation, fast track designation (to both provide guidance to facilitate development and expedite review) and an accelerated approval strategy.mid-2024.

 

If we are able tocan successfully complete all FDA recommended clinical studies, we intend to seek marketing authorization from the FDA, the EMA (European Union), Ministry of Health and Welfare (Japan) and TGA (Australia). The submission fees may be waived when SBP-101ivospemin (SBP-101) has been designated an orphan drug in each geographic region, as described under “Orphan“Orphan Drug Status.”

 

Development Plan for Flynpovi and Eflornithine (CPP-1X)

In December 2009, the FDA accepted CPP’s IND application for the combination product, Flynpovi, product candidate and in November 2009 and August 2018, the FDA accepted IND applications for eflornithine.

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The Development plan executed by CPP of Flynpovi for FAP and colon cancer prevention has included both a pre-clinical/non-clinical and a clinical phase. The non-clinical phase consisted of four primary components: CMC, preclinical (laboratory and animal) pharmacology studies, preclinical toxicology studies, and regulatory submissions in the U.S. and Europe. Similarly, the development plan for eflornithine and eflornithine sachets in several different indications included much of the same primary components and regulatory submission in the U.S.

Clinical Development Flynpovi

Our clinical development of Flynpovi thus far includes:

The FAP-310 Phase III

The PACES Phase III Trial

FAP-310 Phase III Trial

In the FAP-310 Phase III study, the efficacy and safety of the combination of Flynpovi (ES combo), as compared with either drug eflornithine or sulindac alone, in adults with FAP was conducted. A total of 171 patients underwent randomization. Disease progression occurred in 18 of 56 patients (32%) in the Flynpovi, 22 of 58 (38%) in the sulindac group, and 23 of 57 (40%) in the eflornithine group, with a hazard ratio of 0.71 (95% CI, 0.39 to 1.32) for Flynpovi as compared with sulindac (P = 0.29) and 0.66 (95% CI, 0.36 to 1.23) for Flynpovi as compared with eflornithine. In a post-hoc analysis, none of the patients in the combination arm progressed to a need for LGI surgery for up to 48 months compared with 7 (13.2%) and 8 (15.7%) patients in the sulindac and eflornithine arms. These data corresponded to risk reductions for the need for LGI surgery approaching 100% between combination and either monotherapy with HR = 0.00 (95% CI, 0.00–0.48; P= 0.005) for combination versus sulindac and HR = 0.00 (95% CI, 0.00–0.44; P= 0.003) for combination versus eflornithine.

image03.jpg

Given the statistical significance of the LGI group, an NDA was filed with the FDA. As the study failed to meet the primary endpoint, and the NDA was based on the results of an exploratory analysis, a complete response letter was issued. To address this deficiency concern, the Company must submit the results of one or more adequate and well-controlled clinical trials which demonstrate an effect on a clinical endpoint.

Phase III Clinical Trial in Colon Cancer Survivors

In collaboration with the NCI, and SWOG, a Phase III clinical trial has been initiated to study the benefits of Flynpovi as a therapeutic treatment for use by colon cancer survivors. The trial is named PACES for “Prevention of Adenomas and Cancer with eflornithine and sulindac.” The PACES trial is funded by the NCI and managed by SWOG. This is an ongoing double blind placebo-controlled trial of Flynpovi to prevent recurrence of high risk adenomas and second primary colorectal cancers in patients with stage 0-III colon or rectal cancer, Phase III PACES. The purpose of this study is to assess whether the Flynpovi, combination of eflornithine and sulindac, (compared to corresponding placebos) has a reduced rate of cancer or high-risk adenoma recurrence compared to comparator arms after three years of daily dosing. We have exclusive rights to the data that comes from the trial for regulatory and commercial purposes.

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Clinical Development Eflornithine (CPP 1X)

Our clinical development of eflornithine thus far includes:

Phase II Gastric Cancer Prevention Trial

Phase I and Phase II Recent Onset Type 1 Diabetes Trials

Phase I/II STK-11 Mutant NSCLC Trial

Phase II Gastric Cancer Prevention Trial

H. pylori is the most common bacterial infection in humans and causes gastritis in all individuals. Gastritis progresses along the “Correa cascade” from gastritis to the precancerous stages of atrophic gastritis (loss of specialized gastric epithelium) and intestinal metaplasia (“IM”), to gastric adenocarcinoma (Correa 1992). In response to H. pylori infection the host elicits a robust innate and adaptive immune response, which results in mucosal inflammation but fails to eradicate the organism. Several studies have demonstrated that the failure of the immune response may be related to dysregulated L-arginine metabolism and polyamines including the upregulation of ornithine decarboxylase (“ODC”) by macrophages (Chaturvedi et al. 2010; Chaturvedi, de Sablet, Coburn, et al. 2012) (Chaturvedi, de Sablet, Peek, et al. 2012), (Chaturvedi et al. 2011) (Xu et al. 2004) (Chaturvedi et al. 2014) (Chaturvedi et al. 2004). Levels of polyamines are increased in H. pylori-induced gastritis in mice, and oralDFMO treatment reduces gastric polyamine levels, and severity of both H. pylori colonization and gastritis (Chaturvedi et al. 2010). In the gerbil model of H. pylori-induced gastric cancer, polyamine levels correlate with levels of gastritis, DNA damage, and progression to dysplasia/carcinoma. In this model, eflornithine reduces polyamine levels and DNA damage, and reduces rates of dysplasia and carcinoma by >50% (Chaturvedi et al. 2014).

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In collaboration with investigators at Vanderbilt University and funding by the NCI, the investigator-initiated Phase II trial performed in Honduras and Puerto Rico was a randomized, double-blinded study comparing once daily eflornithine versus placebo for an up to 18-month treatment period in patients with gastric premalignant lesions. This trial has completed and is undergoing data analysis. The Company has received orphan drug designation for the use of eflornithine for the treatment of gastric cancer in the United States.

Phase I and II Recent Onset Type 1 Diabetes (T1D) Trials

T1D is an organ-specific autoimmune disease characterized by chronic immune-mediated destruction of pancreatic β-cells, leading to partial, or in most cases, absolute insulin deficiency. The majority of cases result from autoimmune mediated pancreatic β-cell destruction, which occurs at a variable rate. Patients become clinically symptomatic when approximately 90% of pancreatic β-cells are destroyed. Therefore, preserving β-cell function is a target for promising treatments (Couper et al. 2014). The activity of ODC is upregulated in early diabetic kidney disease, contributing to renal hypertrophy and hyperfiltration (Pedersen et al. 1992; Deng et al. 2003). In vivo studies in experimental models of recent-onset T1D evaluating eflornithine demonstrate roles in suppressing the development of renal hypertrophy and hyperplasia, decreasing the incidence of diabetes, augmenting the survival and regeneration of β-cell populations, decreasing insulinitis, and maintaining an immune-tolerant balance of T-cell subpopulations.

The Company collaborated with investigators at Indiana University on a JDRF funded Phase I study to evaluate the safety and efficacy of increasing doses of eflornithine in patients with recent onset Type 1 diabetes. The completed Phase I trial demonstrated that a 3-month course of oral eflornithine was well tolerated with a favorable adverse event profile in children and adults with recent-onset T1D. Urinary polyamine data showed that eflornithine treatment inhibited ornithine decarboxylase activity effectively, reflected by a dose dependent reduction in urinary putrescine values. Furthermore, although not powered to detect metabolic efficacy, subjects treated with 750 mg/m2/day and 1000 mg/m2/day of eflornithine exhibited higher C-peptide AUC 6 months after treatment indicative of improved β cell function compared to placebo. These data suggest that eflornithine may improve β cell function alone and in combination regimens to treat or prevent type 1 diabetes that also include immunotherapy. A larger Phase II study fully powered to detect an effect of eflornithine treatment on maintenance of C-peptide is being planned with the goal of initiating in early 2023.

Phase I/II STK-11 Mutant NSCLC Trial

STK11 is the fourth-most frequently mutated gene in lung adenocarcinoma, with loss of function occurring in up to 30% of all cases (Laderian et al. 2020). Patients with LKB1 loss have reduced infiltrates of cytotoxic T-cells and respond poorly to anti PD1 or anti-PDL-1 therapies regardless of the PDL-1 status. CheckMate-057 trial lung tumors harboring co-mutations in KRAS and STK11 had an inferior response to PD-1 axis inhibitors (Skoulidis et al. 2018). These results suggest that STK11-mutated tumors were found to have a cold immune microenvironment regardless of KRAS status.

Bioinformatic analyses using two well-annotated lung adenocarcinoma datasets identified upregulation of ornithine decarboxylase (the target for eflornithine). Additionally, LKB1-loss tumors show a significant up-regulation of several solute transporters (SLC7A2, SLC14A2, and SLC16A4). SLC7A2 is known to be responsible for the membrane transport of cationic amino acids arginine, lysine, and ornithine. Furthermore, LKB1 loss the arginine pathway in which arginine is converted to ornithine and urea (by arginase) and ornithine is converted to putrescine (by ODC1). Together, the results suggested that ODC1 may be a key metabolic driver in LKB1-loss lung cancer.

In other model systems eflornithine treatment has been shown to modulate the tumor microenvironment. A previously studied cohort revealed that ODC1 may be instrumental to immune suppression (Chamaillard et al. 1997). Since eflornithine is an ODC1 inhibitor, it is hypothesized that inhibiting the metabolic enzyme ODC1 using eflornithine will increase the number of tumor-infiltrating lymphocytes (“TILs”) in LKB1-loss tumors and restore benefit of PD(L)-1 blockade to these patients.

The Company is currently planning a Phase I/II investigator-initiated trial to assess eflornithine in patients with STK-11 mutant NSCLC with the goal of starting in early 2023.

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Neuroblastoma Trial

Neuroblastoma, a rare cancer originating from immature nerve cells, contributes to nearly 15% of pediatric cancer deaths.[1] Panbela Therapeutics' subsidiary, Cancer Prevention Pharmaceuticals, has extensively collaborated with leading neuroblastoma research groups such as the Neuroblastoma Medulloblastoma Translational Research Consortium (“NMTRC”) (now Beat Childhood Cancer), New Advances in Neuroblastoma Therapy (“NANT”), the Children’s Oncology Group (“COG”), and the National Cancer Institute (NCI) in the clinical development of eflornithine as a treatment for neuroblastoma

In July of 2023 the Company announced it had divested certain assets in its eflornithine pediatric neuroblastoma program to US WorldMeds®1(“USWM”), a Kentucky-based specialty pharmaceutical company. Under the terms of the agreement, Panbela is entitled to receive up to approximately $9.5 million non-dilutive funding in exchange for the sale of certain assets within its pediatric neuroblastoma program for eflornithine. Panbela will receive payments upon USWM’s successful completion of milestones related to eflornithine's clinical development, regulatory approval, and commercial sales.

In December of 2023 the Company announced the USWM received FDA approval of their NDA for the use of eflornithine as a maintenance therapy for neuroblastoma in remission.  

Total Development Costs

 

The development of SBP-101ivospemin involves a preclinical and a clinical development phase. We believe that we have completed our initial preclinical development work for pancreatic cancer and are concluding our initialas well as two Phase I clinical trials. The Phase II/III trial in pancreatic cancer. We have accomplished this using the approximately $17.0 million of capital raised through the date of this prospectus and we believe that our current capital will fund our operations through the end of 2017.has just been initiated. Additional clinical trials will likely be required. We estimaterequired for FDA or other approvals in foreign jurisdictions if the total timeresults of the first-line clinical trial of our ivospemin product candidate justify continued development. The cost and costtiming of additional clinical trials is highly dependent on the nature and size of the trials.

The development of Flynpovi also has involved preclinical and clinical development work for FAP and colon cancer prevention. The Company intends to obtain FDA and EU approval and bring SBP-101 to market is 6 to 7 years and up to two hundred million dollars ($200 million), although this process could be accelerated and less funds may be needed if SBP-101 qualifies for Breakthrough Status. A breakthrough therapy designation conveys fast track program features, more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers atsecure consensus from the FDA and eligibility for rolling review and priority review of an NDA submission.the European Medicines Agency (“EMA”) on a global registration trial.


 

Orphan Drug Status

 

The Orphan Drug Act (“ODA”) provides special status to drugs which are intended for the safe and effective treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people in the United States, or that affect more than 200,000 persons but for which a manufacturer is not expected to recover the costs of developing and marketing such a drug. Orphan drug designation has the advantage of reducing drug development costs by: (i) streamlining the FDA’s approval process, (ii) providing tax breaks for expenses related to the drug development, (iii) allowing the orphan drug manufacturer to receive assistance from the FDA in funding the clinical testing necessary for approval of an orphan drug, and (iv) facilitating drug development efforts. More significantly, the orphan drug manufacturer’s ability to recover its investment in developing the drug is also greatly enhanced by the FDA granting the manufacturer seven years of exclusive USU.S. marketing rights upon approval. Designation of a drugproduct candidate as an orphan drug therefore providesmay provide its sponsor with the opportunity to adopt a faster and less expensive pathway to commercializing its product. We obtained US Orphan Drug Status in 2014 and we intend to submit an application for Orphan Drug Status in Europe, Japan and Australia when we have further clinical data. Depending on certain factors, including the timing and progression of our second clinical trial, we expect to obtain Orphan Drug status in Europe during the fourth quarter of 2018.

 

In 2014, the FDA granted SBP-101We obtained U.S. Orphan Drug Status for ivospemin in 2014. On December 14, 2022, we announced that the EMA Committee for Orphan Medicinal Products issued a positive opinion on Panbela’s application for orphan designation of ivospemin (SBP-101) in combination with gemcitabine and nab Paclitaxel in patients with metastatic pancreatic cancer which may provide seven years of market exclusivity if SBP-101 is approved for this indication.

Intellectual Property Status

Intellectual property licensed by us from the University of Florida includes U.S. Patent No. 6,160,022 covering the methods of using SBP-101 for the chemical reaction of the exocrine portion of the pancreas, which expires in 2019.

In addition, we have filed International Application No. PCT/US2016/055888 in September 2016, which takes priority from US Provisional Patent Application No. 62/238,916, which was filed in October 2015. This application covers the use of SBP-101 to treat patients suffering from pancreatitis.

Development Project Managers

Project managers have been hired or contracted to coordinate all the functions identified in our Development Plan for SBP-101. The personnel responsible for overseeing critical functions of the Development Plan are as follows:

Our CMC program is under the direction of Dr. Thomas Neenan, Ph.D., a highly experienced pharmaceutical industry synthetic chemist, who is a founding member of Sun BioPharma, Inc. and our Chief Scientific Officer. Dr. Neenan has commissioned Contract Manufacturing Organizations (“CMOs”), which have improved the process for synthesis of SBP-101, and have produced high-quality compound, chemically identical to that synthesized by Dr. Bergeron at the University of Florida. Dr. Neenan’s completed work includes development, confirmation and documentation of the synthetic chemistry process, analytical purity, reproducibility, stability (shelf-life), degradation products and pharmaceutical formulation and packaging. This work has culminated in a supply of drug to support preclinical work and human clinical trials. Dr. Neenan also leads our preclinical group.

Dr. Ajit Shah, Ph.D., is our Vice President of Clinical Pharmacology. Dr. Shah has extensive prior experience with numerous compounds at both large and mid-size sponsoring companies, including Pfizer and MGI Pharma. His completed work includes development of analytical methods to quantify levels of drug and characterization of metabolites in plasma, urine and tissues, plus distribution of the compound in living tissues, metabolic pathways and products, anticipated drug blood levels, half-life in the organism, and excretion pathways. Dr. Shah’s work has enabled informed dose and schedule planning for human clinical trials. Dr. Shah currently manages pharmacokinetic analyses in support of the Phase 1 study.

Dr. Anthony Kiorpes, Ph.D., D.V.M., is a long-term consultant with the Company. Dr. Kiorpes has responsibility for our toxicology program, a role he has assumed previously for many preclinical projects at other companies. His studies have determined single- and multiple-dose safety profiles in rodent and non-rodent species, enabling improved safety monitoring in the design of clinical trials for SBP-101. Dr. Kiorpes’ results have helped management to predict and prevent potential side effects in humans.

Dr. Michael Cullen, M.D., M.B.A, is our founder and Executive Chairman. Dr. Cullen is an experienced drug development specialist with 10 prior NDA approvals and has led our overall Clinical, Regulatory Affairs and Project Management effort, including timeline and budget management, critical path timeline synchronization, IND/HREC/CTN package submissions, management of industry partner collaborative efforts, initial EU Regulatory Affairs planning, and collaboration on oversight of outsourced CMC efforts. Dr. Cullen has recruited additional experienced and talented staff in the positions of statistical analyses, manufacturing operations, clinical operations, clinical research and non-clinical studies.


Dr. Suzanne Gagnon, M.D., is our Chief Medical Officer and a member of our Board of Directors. Dr. Gagnon is an experienced CMO, having served in that capacity for several private and public companies, including BioPharm/IBAH/Omnicare, ICON, Idis, NuPathe, Luitpold (Daiichi-Sankyo), and Rhone-Poulenc and Rorer (Sanofi) where she helped develop docetaxel, still an important chemotherapy agent. Dr. Gagnon assumed the lead in the design and implementation of our clinical trials, recruiting investigators, monitoring the safety of the patients and reporting the findings to the FDA, EMA and TGA, and in medical literature.ductal adenocarcinoma.

 

We have engaged Courante Oncology, an experienced clinical Contract Research Organization (“CRO”), to manage clinical operationsobtained orphan drug designation status for Flynpovi and eflornithine for FAP in the United States (2013 and 2011 respectively) and Europe (2013 and 2011 respectively). In addition, we have engaged Novotech Ptyreceived orphan drug designation status for eflornithine as a single agent for neuroblastoma in the United States (2010) and Europe (2011) and for gastric cancer (2015) in the United States.

Fast Track

In June 2020, we received Fast Track Designation from the FDA for development of ivospemin for the treatment of first-line patients with metastatic PDA when administered in combination with gemcitabine and nab-paclitaxel.

Additionally, in September 2017, we received Fast Track Designation from the FDA for the development of Flynpovi for the treatment of FAP.

With the designation of Fast Track Designation, we, or our North American partners, may engage in more frequent interactions with the FDA, and the FDA may review sections of a New Drug Application (“NDA”) before the application is complete. This rolling review is available if we provide, and the FDA approves, a schedule for the submission of the remaining information and the applicant pays applicable user fees. However, the FDA’s time period goal for reviewing an application does not begin until the last section of the NDA is submitted. Additionally, Fast Track Designation may be withdrawn by the FDA if the FDA believes that the designation is no longer supported by data emerging in the clinical trial process.

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Intellectual Property

As the result of efforts at our contract manufacturer Syngene International Ltd another experienced CROto refine the synthetic process, a new shorter synthetic process has been developed on which a patent (US 11,098,005 B2) “METHODS FOR PRODUCING (65,155)-3,8,13,18-TETRAAZAICOSANE-6, 15-DIOL” issued on Aug. 24, 2021 and was assigned to Panbela. The patent claims cover a novel process for the production of ivospemin and reduces the number of synthetic steps from nineteen to six.

For Flynpovi, there is a composition of matter patent for the fixed dose combination of eflornithine and sulindac that is broadly nationalized, providing potential protection through 2037. Additionally, we hold several Method of Use patents for Flynpovi and/or eflornithine for the treatment of Familial Adenomatous Polyposis, neuroblastoma, and the Treatment of Recent Onset Type 1 Diabetes.

We are evaluating other opportunities to provide additional intellectual property.

Human Capital Management

As of January 18, 2024, we had eight employees, seven of which were full time. None of our Australian operations. These two CROs will provide regulatory documentation for HREC/CTN and Investigational Review Board (“IRB”) submissions, FDA 1571 regulation compliance, and informed consents, as well as clinical study site qualification, contracting and payment, study conduct monitoring, data collection, analysis and reporting.employees are represented by a labor union or covered by a collective bargaining agreement. We believe our relationship with our employees is good.

 

Our other collaboratorshuman capital resources objectives include, Dr. James Abbruzeese, M.D.as applicable, identifying, recruiting, retaining, incentivizing, and Dr. David Goldstein, M.D., who currently serve as co-chairsintegrating our existing and new employees, advisors, and consultants. The principal purposes of our DSMB, Dr. Steve Pandol, M.D., Ashok Saluja, Ph.D.,equity and Dr. Dan Von Hoff, M.D.cash incentive plans are to attract, retain and reward personnel through the granting of stock-based and cash-based compensation awards, in order to motivate such individuals to perform to the best of their abilities and achieve our objectives and lead to the success of the Company and increase value to our stockholders.

We value diversity of backgrounds and perspectives in our workforce and our policy is that we do not discriminate based on race, religion, creed, color, national origin, ancestry, physical disability, mental disability, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, military and veteran status, sexual orientation or any other protected characteristic as established by federal, state or local laws.

We believe that operational responsibilities can be handled by our current employees, independent consultants and our global CRO. We have historically used the services of independent consultants and contractors to perform various professional services. We believe that this use of third-party service providers enhances our ability to minimize general and administrative expenses. We intend to periodically evaluate our staffing and talent requirements and expect to add employees if that becomes a more appropriate resourcing alternative.

 

Competition

 

The development and commercialization of new products to treat cancer is intensely competitive and subject to rapid and significant technological change. While we believe that our knowledge, experience and scientific resources provide us with competitive advantages, we face substantial competition from major pharmaceutical companies, specialty pharmaceutical companies, and biotechnology companies worldwide. Many of our competitors have significantly greater financial, technical, and human resources. Smaller and early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. As a result, our competitors may discover, develop, license or commercialize products before or more successfully than we do.

 

We face competition with respect to our current product candidates and will face competition with respect to future product candidates, from segments of the pharmaceutical, biotechnology and other related markets that pursue approaches to targeting molecular alterations and signaling pathways associated with cancer. Our competitors may obtain regulatory approval of their products more rapidly than we do or may obtain patent protection or other intellectual property rights that limit our ability to develop or commercialize our product candidates. Our competitors may also develop drugs that are more effective, more convenient, less costly, or possessing better safety profiles than our products, and these competitors may be more successful than us in manufacturing and marketing their products.

 

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In addition, we may need to develop our product candidates in collaboration with diagnostic companies, and we will face competition from other companies in establishing these collaborations. Our competitors will also compete with us in recruiting and retaining qualified scientific, management and commercial personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

 

Furthermore, we also face competition more broadly across the market for cost-effective and reimbursable cancer treatments. The most common methods of treating patients with cancer are surgery, radiation and drug therapy, including chemotherapy, immunotherapy, hormone therapy and targeted drug therapy or a combination of such methods. There are a variety of available drug therapies marketed for cancer. In many cases, these drugs are administered in combination to enhance efficacy. While our product candidates, if any are approved, may compete with these existing drug and other therapies, to the extent they are ultimately used in combination with or as an adjunct to these therapies, our product candidates may be approved as companion treatments and not be competitive with current therapies. Some of these drugs are branded and subject to patent protection, and others are available on a generic basis. Insurers and other third-party payors may also encourage the use of generic products or specific branded products. We expect that if our product candidates are approved, they will be priced at a premium over competitive generic, including branded generic, products. As a result, obtaining market acceptance of, and gaining significant share of the market for, any of our product candidates that we successfully introduce to the market will pose challenges. In addition, many companies are developing new therapeutics and we cannot predict what the standard of care will be as our product candidate progressesprogresses through clinical development.


SBP-101

 

Commercialization

 

We have not established a sales, marketing or product distribution infrastructure nor have we devoted significant management resources to planning such an infrastructure because our lead product candidate is still in early clinical development. We currently anticipate that we will partner with a larger pharmaceutical organization having the expertise and capacity to perform these functions.

 

Flynpovi will be commercialized, if approved, in North America by One-Two.

Manufacturing and Suppliers

 

We do not own or operate, and currently have no plans to establish, any manufacturing facilities. We currently rely, and expect to continue to rely, on third parties for the manufacture of our product candidates for preclinical and clinical testing as well as for commercial manufacture of any products that we may commercialize. If needed, we intend to engage, by entering into a supply agreement or through another arrangement, third partythird-party manufacturers to provide us with additional SBP-101 clinical supply. We identified and qualified manufacturers to provide the active pharmaceutical ingredient and fill-and-finish services for our initial product candidate prior to our submission of an NDA to the FDA and expect to continue utilizing this approach for any future product candidates.

 

EmployeesSecuring the manufacture of Flynpovi for further clinical studies and for commercialization in North America, if the product is approved, is the responsibility of One-Two, who was granted a non-exclusive license to manufacture for North America.

 

As of December 7, 2017, we had nine employees, six of whom were full-time employees and three of whom were part-time employees. We may hire additional employees to support the growth of our businesses. We believe that operational responsibilities can be handled by our current employees and independent consultants. We have historically used, and expect to continue to use, the services of independent consultants and contractors to perform various professional services. We believe that this use of third-party service providers enhances our ability to minimize general and administrative expenses. None of our employees is represented by a labor union, and we consider our relationship with our employees to be good.

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Properties

Our primary business functions, including research and development, are conducted by our employees and independent contractors on a remote basis. Accordingly, we do not currently own or lease any real property. Our corporate mailing address is 712 Vista Blvd. #305, Waconia, Minnesota 55387.

Material Agreements

 

The Standard Exclusive License Agreement (“License Agreement”) dated December 22, 2011, between us and UFRF grants us an exclusive license to the proprietary technology covered by issued United States Patents Nos. US 5,962,533, which expired in February 2016, and US 6,160,022 which expiresexpired in July 2019,2020 and Know-How as defined by the License Agreement, with reservations by UFRF for academic or government uses. Under this agreement, we agreehad agreed to pay various royalties, expenses and milestone payments to UFRF. Additionally, pursuant to this agreement, we initially issued to UFRF 80,000 shares of common stock. Anti-dilution protection for UFRF pursuant to this agreement required us to issue additional sharesThe License Agreement was amended in order for UFRF to maintain its ownership stake at ten percent (10%December 2016 (“First Amendment”) ofand again in October 2019 (“Second Amendment”). Under the total number of issuedSecond Amendment all minimum royalty payments and outstanding shares of our common stock, calculated on a fully diluted basis, until such time as we had received a total of two million dollars ($2,000,000)milestone payments defined in exchange for our issuance of equity securities. This requirement was met in 2012, and UFRF is therefore afforded no further anti-dilution protection. Pursuant to this anti-dilution provision, we issued an additional 34,423 shares of common stock to UFRF increasing the total shares of common stock issued to UFRF to 114,423 shares.


Under the License Agreement We have a numberwere eliminated. In addition, the period for payment of performance related milestones we must meet in orderroyalties was changed to retain our rights tobe the technology. Included in such milestones is the commitment to have ourshorter of (i) ten (10) years from first commercial sale or (ii) the period of market exclusivity on a product incorporating the technology by the end of 2020. Also, in the event that we are not actively pursuing commercialization of the technology in any country or territory other than the United States and certain other countries by the end of 2014, UFRF may terminate the license as to that country or territory under certain circumstances.country-by-country basis. UFRF may also terminate this license for standard and similar causes such as material breach of the agreement, bankruptcy, failure to pay royalties and other customary conditions.

The foregoing description ofagreement allows for UFRF to terminate if the material terms of the License Agreementfirst commercial sale is qualifiednot made by the full text of the License Agreement, a copy of which was filed as Exhibit 10.5 to our current report on Form 8-K filed on September 11, 2015 and is incorporated herein by reference.December 31, 2025.

 

Government Regulation

 

FDA Approval Process

 

In the United States, pharmaceutical products are subject to extensive regulation by the FDA. The Federal Food, Drug and Cosmetic Act and other federal and state statutes and regulations govern, among other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling and import and export of pharmaceutical products. Failure to comply with applicable USU.S. requirements may subject a company to a variety of administrative or judicial sanctions, such as FDA refusal to approve pending NDAs, warning or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties and criminal prosecution.

 

Pharmaceutical product development for a new product or certain changes to an approved product in the United States typically involves preclinical laboratory and animal tests, the submission to the FDA of an IND which must become effective before clinical testing may commence, and adequate and well-controlled clinical trials to establish the safety and effectiveness of the drug for each indication for which FDA approval is sought. Satisfaction of FDA pre-market approval requirements typically takes many years and the actual time required may vary substantially based upon the type, complexity and novelty of the product or disease.

 

Preclinical tests include laboratory evaluation of product chemistry, formulation and toxicity, as well as animal trials to assess the characteristics and potential safety and efficacy of the product. The conduct of the preclinical tests must comply with federal regulations and requirements, including good laboratory practices. The results of preclinical testing are submitted to the FDA as part of an IND along with other information, including the Investigator’s Brochure, information about product chemistry, manufacturing and controls, potential perceived side effects and risks, and a proposed clinical trial protocol. Long-term preclinical tests, such as animal tests of reproductive toxicity and carcinogenicity, may continue after the IND is submitted.

 

A 30-day waiting period after the submission of each IND is required prior to the commencement of clinical testing in humans. If the FDA has neither commented on nor questioned the IND within this 30-day period, the clinical trial proposed in the IND may begin.

 

Clinical trials involve the administration of the investigational new drug to healthy volunteers or patients under the supervision of a qualified investigator. Clinical trials must be conducted: (i) in compliance with federal regulations; (ii) in compliance with good clinical practice (“GCP”), an international standard meant to protect the rights and health of patients and to define the roles of clinical trial sponsors, administrators and monitors; as well as (iii) under protocols detailing the objectives of the trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. Each protocol involving testing on USU.S. patients and subsequent protocol amendments must be submitted to the FDA as part of the IND.

 

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The FDA may order the temporary, or permanent, discontinuation of a clinical trial at any time, or impose other sanctions, if it believes that the clinical trial either is not being conducted in accordance with FDA requirements or presents an unacceptable risk to the clinical trial patients. The study protocol and informed consent information for patients in clinical trials must also be submitted to an institutional review board (“IRB”) for approval. An IRB may also require the clinical trial at the site to be halted, either temporarily or permanently, for failure to comply with the IRB’s requirements, or may impose other conditions.


 

Clinical trials to support NDAs for marketing approval are typically conducted in three sequential phases, but the phases may overlap. In Phase 1,I, the initial introduction of the drug into healthy human subjects/patients, the drug is tested to assess metabolism, pharmacokinetics, pharmacological actions, side effects associated with increasing doses, and, if possible, early evidence of effectiveness. Phase 2II usually involves trials in a limited patient population to determine the effectiveness of the drug for a particular indication, dosage tolerance and optimum dosage, and to identify common adverse effects and safety risks. If a compound demonstrates evidence of effectiveness and an acceptable safety profile in Phase 2II evaluations, pivotal, or Phase 3III trials are undertaken to obtain the additional information about clinical efficacy and safety in a larger number of patients, typically at geographically dispersed clinical trial sites, to permit the FDA to evaluate the overall benefit-risk relationship of the drug and to provide adequate information for the labeling of the drug. In many cases the FDA requires two adequate and well-controlled Phase 3III clinical trials to demonstrate the efficacy of the drug. A single Phase 3III trial with other confirmatory evidence may be sufficient in instances where the study is a large multicenter trial demonstrating internal consistency and a statistically very persuasive finding of a clinically meaningful effect on mortality, irreversible morbidity or prevention of a disease with a potentially serious outcome, and confirmation of the result in a second trial would be practically or ethically impossible. After an NDA is approved, a Phase IV trial may be undertaken to evaluate safety over a long period of time, quality of life or cost effectiveness.

 

After completion of the required clinical testing, an NDA is prepared and submitted to the FDA. FDA approval of the NDA is required before marketing of the product may begin in the United States. The NDA must include the results of all preclinical, clinical and other testing and a compilation of data relating to the product’sproduct’s pharmacology, chemistry, toxicology, manufacture, controls and controls.any proposed labeling. The cost of preparing and submitting an NDA is substantial, and the fees are typically increased annually.

 

The FDA has 60 days from its receipt of an NDA to determine whether the application will be accepted for filing based on the agency’sagency’s threshold determination that it is sufficiently complete to permit substantive review. Once the submission is accepted for filing, the FDA begins an in-depth review. The FDA has agreed to certain performance goals in the review of new drug applicationsNDAs to encourage timeliness. Most applications for standard review drug products are reviewed within twelve months from submission; most applications for priority review drugs are reviewed within eight months from submission. Priority review can be applied to drugs that the FDA determines offer major advances in treatment or provide a treatment where no adequate therapy exists. If priority review is achieved, the FDA’s goal is to act on the application within six months. The review process for both standard and priority review may be extended by the FDA for three additional months to consider certain late-submitted information, or information intended to clarify information already provided in the submission.

The FDA may also refer applications for novel drug products, or drug products that present difficult questions of safety or efficacy, to an outside advisory committeecommittee—typically a panel that includes clinicians and other experts—for review, evaluation and a recommendation as to whether the application should be approved. The FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations.

 

Before approving an NDA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP. Additionally, the FDA will inspect the facility or the facilities at which the drug is manufactured. The FDA will not approve the product unless compliance with current good manufacturing practice (“cGMP”), a quality system regulating manufacturing, is satisfactory and the NDA contains data that provide substantial evidence that the drug is safe and effective in the indication studied.

 

After the FDA evaluates the NDA and the manufacturing facilities, it issues either an approval letter or a complete response letter. A complete response letter generally outlines the deficiencies in the submission and may require substantial additional testing, or information, in order for the FDA to reconsider the application. If, or when, those deficiencies have been addressed to FDA’sthe FDA’s satisfaction in a resubmission of the NDA, the FDA will issue an approval letter. The FDA has committed to reviewing such resubmissions in two or six months depending on the type of information included.

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An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications. As a condition of NDA approval, the FDA may require a risk evaluation and mitigation strategy (“REMS”) to help ensure that the benefits of the drug outweigh the potential risks. REMS can include medication guides, communication plans for healthcare professionals, and elements to assure safe use (“ETASU”). ETASU can include, but are not limited to, special training or certification for prescribing or dispensing, dispensing only under certain circumstances, special monitoring and the use of patient registries. The requirement for a REMS can materially affect the potential market and profitability of the drug. Moreover, product approval may require substantial post-approval testing and surveillance to monitor the drug’s safety or efficacy. Once granted, product approvals may be withdrawn if compliance with regulatory standards is not maintained or problems are identified following initial marketing.


 

Changes to some of the conditions established in an approved application, including changes in indications, labeling, or manufacturing processes or facilities, require submission and FDA approval of a new NDA or NDA supplement before the change can be implemented. An NDA supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA uses the same procedures and actions in reviewing NDA supplements as it does in reviewing NDAs.

 

Fast Track Designation and Accelerated Approval

 

The FDA is required to facilitate the development, and expedite the review, of drugs that are (1) intended for the treatment of a serious or life-threatening disease or (2) condition for which there is no effective treatment and which demonstrate the potential to address unmet medical needs for the condition. Under the Fast Track program, the sponsor of a new product candidate may request that the FDA designate the product candidate for a specific indication as a Fast Track drug concurrent with, or after, the filing of the IND for the product candidate. The FDA must determine if the product candidate qualifies for Fast Track Designation within 60 days of receipt of the sponsor’ssponsor’s request.

 

Under the Fast Track program and FDA’sthe FDA’s accelerated approval regulations, the FDA may approve a drug for a serious or life-threatening illness that provides meaningful therapeutic benefit to patients over existing treatments based upon a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments.

 

In clinical trials, a surrogate endpoint is a measurement of laboratory or clinical signs of a disease or condition that substitutes for a direct measurement of how a patient feels, functions, or survives. Surrogate endpoints can often be measured more easily or more rapidly than clinical endpoints. A product candidate approved on this basis is subject to rigorous post-marketing compliance requirements, including the completion of Phase 4IV or post-approval clinical trials to confirm the effect on the clinical endpoint. Failure to conduct required post-approval studies, or confirm a clinical benefit during post-marketing studies, will allow the FDA to withdraw the drug from the market on an expedited basis. All promotional materials for product candidates approved under accelerated regulations are subject to priority review by the FDA.

 

If a submission is granted Fast Track Designation, the sponsor may engage in more frequent interactions with the FDA, and the FDA may review sections of the NDA before the application is complete. This rolling review is available if the applicant provides, and the FDA approves, a schedule for the submission of the remaining information and the applicant pays applicable user fees. However, FDA’sthe FDA’s time period goal for reviewing an application does not begin until the last section of the NDA is submitted. Additionally, Fast Track Designation may be withdrawn by the FDA if the FDA believes that the designation is no longer supported by data emerging in the clinical trial process.

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Breakthrough Therapy Designation

 

The FDA is also required to expedite the development and review of the application for approval of drugs that are intended to treat a serious or life-threatening disease or condition where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Under the Breakthrough Therapy program, the sponsor of a new product candidate may request that the FDA designate the product candidate for a specific indication as a breakthrough therapy concurrent with, or after, the filing of the IND for the product candidate.therapy. The FDA must determine if the product candidate qualifies for Breakthrough Therapy designation within 60 days of receipt of the sponsor’ssponsor’s request.


 

Orphan Drug Designation and Exclusivity

 

The Orphan Drug Act provides incentives for the development of products intended to treat rare diseases or conditions. Under the Orphan Drug Act, the FDA may grant orphan designation to a drug intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States and for which there is no reasonable expectation that the cost of developing and making a drug available in the United States for this type of disease or condition will be recovered from sales of the product. If a sponsor demonstrates that a drug is intended to treat a rare disease or condition, the FDA will grant orphan designation for that product for the orphan disease indication, assuming that the same drug has not already been approved for the indication for which the sponsor is seeking orphan designation. If the same drug has already been approved for the indication for which the sponsor is seeking orphan designation, the sponsor must present a plausible hypothesis of clinical superiority in order to obtain orphan designation. Orphan designation must be requested before submitting an NDA. After the FDA grants orphan designation, the FDA discloses the identity of the therapeutic agent and its potential orphan use.

 

Orphan designation may provide manufacturers with benefits such as research grants, tax credits, PDUFAPrescription Drug User Fee Act (“PDUFA”) application fee waivers and eligibility for orphan drug exclusivity. If a product that has orphan designation subsequently receives the first FDA approval of the active moiety for that disease or condition for which it has such designation, the product is entitled to orphan drug exclusivity, which for seven years prohibits the FDA from approving another product with the same active ingredient for the same indication, except in limited circumstances. Orphan drug exclusivity will not bar approval of another product under certain circumstances, including if a subsequent product with the same active ingredient for the same indication is shown to be clinically superior to the approved product on the basis of greater efficacy or safety, or providing a major contribution to patient care, or if the company with orphan drug exclusivity is not able to meet market demand. Further, the FDA may approve more than one product for the same orphan indication or disease as long as the products contain different active ingredients. Moreover, competitors may receive approval of different products for the indication for which the orphan drug has exclusivity or obtain approval for the same product but for a different indication for which the orphan drug has exclusivity.

 

In the European Union, orphan drug designation also entitles a party to financial incentives such as reduction of fees or fee waivers and 10 years of market exclusivity is granted following drug or biological product approval. This period may be reduced to 6 years if the orphan drug designation criteria are no longer met, including where it is shown that the product is sufficiently profitable not to justify maintenance of market exclusivity.

 

Orphan drug designation must be requested before submitting an application for marketing approval. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.

 

Post-Approval Requirements

 

Once an NDA is approved, a product will be subject to certain post-approval requirements. For instance, the FDA closely regulates the post-approval marketing and promotion of drugs, including standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational activities and promotional activities involving the internet. Drugs may be marketed only for the approved indications and in accordance with the provisions of the approved labeling.

 

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Adverse event reporting and submission of periodic reports are required following FDA approval of an NDA. The FDA also may require post-marketing testing, known as Phase 4IV testing, risk evaluation and mitigation strategies, or REMS, and surveillance to monitor the effects of an approved product, or the FDA may place conditions on an approval that could restrict the distribution or use of the product. In addition, quality control, drug manufacture, packaging and labeling procedures must continue to conform to current good manufacturing practices, or cGMPs, after approval. Drug manufacturers and certain of their subcontractors are required to register their establishments with the FDA and certain state agencies. Registration with the FDA subjects entities to periodic unannounced inspections by the FDA, during which the Agency inspects manufacturing facilities to assess compliance with cGMPs. Accordingly, manufacturers must continue to expend time, money and effort in the areas of production and quality-control to maintain compliance with cGMPs. Regulatory authorities may withdraw product approvals or request product recalls if a company fails to comply with regulatory standards, if it encounters problems following initial marketing, or if previously unrecognized problems are subsequently discovered.


 

Additional Regulations and Environmental Matters

 

In the United States, our activities are potentially subject to regulation by various federal, state and local authorities in addition to the FDA, restrictions onincluding but not limited to, the Centers for Medicare and Medicaid Services, or CMS, other divisions of the U.S. Department of Health and Human Services (e.g., the Office of Inspector General), the U.S. Department of Justice, or DOJ, and individual U.S. Attorney offices within the DOJ, and state and local governments. For example, sales, marketing and scientific/educational grant programs must comply with the anti-fraud and abuse provisions of pharmaceutical products, we are subject to additional healthcare regulation and enforcement by the federal government and by authorities inSocial Security Act, the states and foreign jurisdictions in which we conduct our business. These laws, which generally will not be applicable to us or our product candidates unless and until we obtain FDA marketing approval for any of our product candidates, include transparency laws, anti-kickback statutes, false claims statuteslaws, and regulation regarding providing drug samples, among others.our activities may implicate the privacy provisions of the Health Insurance Portability and Accountability Act (“HIPAA”) and similar state laws, each as amended.

 

The federal Anti-Kickback Statute prohibits, among other things, individuals and entitiesany person or entity, from knowingly and willfully offering, paying, soliciting or receiving any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or in return for purchasing, leasing, ordering or arranging for the purchase, lease or order of any healthcare item or service reimbursable under Medicare, Medicaid or other federally financedfederal healthcare programs. ViolationsThe term remuneration has been interpreted broadly to include anything of value. The Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers, and formulary managers on the other. There are statutory exceptions and regulatory safe harbors protecting some common activities from prosecution. The exceptions and safe harbors are drawn narrowly and practices that involve remuneration that may be alleged to be intended to induce prescribing, purchasing or recommending may be subject to scrutiny if they do not qualify for an exception or safe harbor. Failure to meet all the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the Anti-Kickback Statute. Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all its facts and circumstances. While we reasonably believe our practices to be in compliance with the Anti-Kickback Statute, our practices may not in all cases meet all the criteria for protection under a statutory exception or regulatory safe harbor.

Additionally, the intent standard under the Anti-Kickback Statute was amended by the Affordable Care Act (“ACA”) to a stricter standard such that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it to have committed a violation. In addition, the ACA codified case law that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute are punishable by imprisonment, criminal fines, civil monetary penalties and exclusion from participation inconstitutes a false or fraudulent claim for purposes of the federal healthcare programs.

Federal false claims laws and civil monetary penalties, including the False Claims Act prohibit,(as further discussed below).

The Civil Monetary Penalties statute authorizes the imposition of severe financial penalties against any person or entity who, among other things, is determined to have presented or caused to be presented a claim to a federal health program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent.

The federal False Claims Act prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, a false claim for payment to, or approval by, the federal government or knowingly making, using, or causing to be made or used, a false record or statement material to have a false or fraudulent claim paid.to the federal government. As a result of a modification made by the Fraud Enforcement and Recovery Act of 2009, a claim includes “any request or demand” for money or property presented to the U.S. government. Recently, several pharmaceutical and other healthcare companies have been prosecuted under these laws for allegedly inflating drug prices they report to pricing services, which in turn were used by the government to set Medicare and Medicaid reimbursement rates, and for allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product. In addition, certain marketing practices, including off-label promotion, may also violateOther companies have been prosecuted for causing false claims laws.to be submitted because of the companies’ marketing of the product for unapproved, and thus non-reimbursable, uses.

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HIPAA imposescreated new federal criminal statutes that prohibit knowingly and civil liability for, among other things,willfully executing, or attempting to execute, a scheme to defraud or to obtain, by means of false or fraudulent pretenses, representations or promises, any money or property owned by, or under the control or custody of, any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying, concealing or covering up by trick, scheme or device, a material fact or making any materially false, statements relating tofictitious or fraudulent statement in connection with the delivery of, or payment for, healthcare matters.benefits, items or services.

 

HIPAA, as amended by the HITECH ActAlso, many states have similar fraud and its implementing regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information. Many states and foreign jurisdictions also have laws and regulations that govern the privacy and security of individually identifiable health information, and such laws often vary from one another and from HIPAA.

The federal Physician Payment Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to CMS, information related to payments or other transfers of value made to physicians and teaching hospitals, and ownership and investment interests held by the physicians and their immediate family members.

The majority of states also haveabuse statutes or regulations similar to the federal Anti-Kickback Law and false claims laws, whichthat apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor. Our activities

We may be subject to data privacy and security regulations by both the federal government and the states in which we conduct our business. HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”) and its implementing regulations, imposes requirements relating to the privacy, security and transmission of individually identifiable health information. Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable to business associates, independent contractors or agents of covered entities that receive or obtain protected health information in connection with providing a service on behalf of a covered entity. HITECH also be certaincreated four new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions. In addition, state laws regardinggovern the privacy and security of health information thatin specified circumstances, many of which differ from each other in significant ways and may not be preemptedhave the same effect, thus complicating compliance efforts.

Additionally, the federal Physician Payments Sunshine Act within the ACA, and its implementing regulations, require that certain manufacturers of drugs, devices, biological and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) report information related to certain payments or other transfers of value made or distributed to physicians, other specified health care professionals and teaching hospitals, or to entities or individuals at the request of, or designated on behalf of, the physicians, other specified health care professionals and teaching hospitals and report annually certain ownership and investment interests held by HIPAA,physicians and other specified health care professionals and their immediate family members. Some states have analogous laws requiring manufacturers to report certain transfers of value to covered individuals and entities. To distribute products commercially, we must comply with state laws that require the registration of manufacturers and wholesale distributors of drug and biological products in a state, including, in certain states, manufacturers and distributors who ship products into the state even if such manufacturers or distributors have no place of business within the state. Some states also impose requirements on manufacturers and distributors to establish the pedigree of product in the chain of distribution, including some states that require manufacturers and others to adopt new technology capable of tracking and tracing product as it moves through the distribution chain. Several states have enacted legislation requiring pharmaceutical and biotechnology companies to establish marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing, clinical trials and other activities, and/or register their sales representatives, as well as additional trackingto prohibit pharmacies and reporting obligations regarding paymentsother healthcare entities from providing certain physician prescribing data to healthcare providerspharmaceutical and biotechnology companies for use in sales and marketing, expenditures.and to prohibit certain other sales and marketing practices. All our activities are potentially subject to federal and state consumer protection and unfair competition laws.

 

In additionIf our operations are found to regulatory schemesbe in violation of any of the federal and state healthcare laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including without limitation, civil, criminal and/or mayadministrative penalties, damages, fines, disgorgement, exclusion from participation in government programs, such as Medicare and Medicaid, injunctions, private “qui tam” actions brought by individual whistleblowers in the name of the government, or refusal to allow us to enter into government contracts, contractual damages, reputational harm, administrative burdens, diminished profits and future apply,earnings, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business we are or may become subject to various environmental, health and safety laws and regulations governing, among other things, laboratory procedures and any use and disposal by usour results of hazardous or potentially hazardous substances in connection with our research and development activities. We do not presently expect such environmental, health and safety laws or regulations to materially impact our present or planned future activities.operations.

 


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Coverage and Reimbursement

 

SalesSignificant uncertainty exists as to the coverage and reimbursement status of any of our product candidates that may be approvedfor which we obtain regulatory approval. In the United States and markets in other countries, sales of any products for which we receive regulatory approval for commercial sale will depend, in part, on the extent to which third-party payors provide coverage and establish adequate reimbursement levels for such products. In the costUnited States, third-party payors include federal and state healthcare programs, privately managed care providers, health insurers and other organizations. The process for determining whether a third-party payor will provide coverage for a product may be separate from the process for setting the price of a product or for establishing the productreimbursement rate that such a payor will be covered by third party payors. Third partypay for the product. Third-party payors may limit coverage to specific products on an approved list, of products, oralso known as a formulary, which might not include all drugthe FDA-approved products approved byfor a particular indication. Third-party payors are increasingly challenging the price, examining the medical necessity and reviewing the cost-effectiveness of medical products, therapies and services, in addition to questioning their safety and efficacy. We may need to conduct expensive pharmaco-economic studies to demonstrate the medical necessity and cost-effectiveness of our products, in addition to the costs required to obtain the FDA for an indication.approvals. Our product candidates may not be considered medically necessary or cost-effective. A payor’spayor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved. Further, one payor’s determination to provide coverage for a drug product does not assure that other payors will also provide coverage for the drug product. This is also true of Medicare reimbursement, where different vendors process payments, so that coverage by one vendor does not assure that all other vendors will provide coverage. Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development. In addition, the United States federal government position on matters related to drug pricing is evolving and uncertain, and any changes could have a material impact on drug pricing generally in the United States, including for our product candidates if approved.

 

AnyDifferent pricing and reimbursement schemes exist in other countries. In the EU, governments influence the price of pharmaceutical products through their pricing and reimbursement rules and control of national health care systems that fund a large part of the cost of those products to consumers. Some jurisdictions operate positive and negative list systems under which products may only be marketed once a reimbursement price has been agreed. To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare the cost-effectiveness of a particular product candidate to currently available therapies. Other member states allow companies to fix their own prices for medicines but monitor and control company profits. The National Institute for Health and Care Excellence (“NICE”) in the United Kingdom also requires consideration of cost-benefit analysis. The downward pressure on health care costs has become very intense. As a result, increasingly high barriers are being erected to the entry of new products. In addition, in some countries, cross-border imports from low-priced markets exert a commercial pressure on pricing within a country.

The marketability of any product candidates for which we obtain marketingreceive regulatory approval for commercial sale may not be considered medically necessary or cost-effective by third partysuffer if the government and third-party payors fail to provide adequate coverage and we may need to conduct expensive pharmacoeconomic studies in the future to demonstrate the medical necessity and/or cost effectiveness of any such product. Nonetheless, our product candidates may not be considered medically necessary or cost effective. The US government, state legislatures and foreign governments have shown increased interest in implementing cost containment programs to limit government-paid healthreimbursement. In addition, emphasis on managed care costs, including price controls, restrictions on reimbursement and requirements for substitution of generic products. Continued interest in and adoption of such controls and measures, and tightening of restrictive policies in jurisdictions with existing controls and measures, could limit payments for pharmaceuticals such as the product candidates we are developing.

Health Reform

The United States and some foreign jurisdictions are considering or have enacted a number of legislative and regulatory proposals to change the healthcare system in ways that could affect our ability to sell our products profitably. Among policy makers and payors in the United States has increased and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives. By way of example, in March 2010, the ACA was signed into law, which intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add transparency requirements for the healthcare and health insurance industries, impose taxes and fees on the health industry and impose additional health policy reforms. With regard to pharmaceutical products, among other things, the ACA expanded and increased industry rebates for drugs covered under Medicaid programs and made changes to the coverage requirements under the Medicare prescription drug benefit. Wewe expect will continue to evaluateincrease the effect thatpressure on healthcare pricing. Coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the ACA has on our business.future.

 

In addition, other legislative changes have been proposed and adopted since the ACA was enacted. These changes included aggregate reductions to Medicare payments to providers of up to 2% per fiscal year effective April 1, 2013 and, due to subsequent legislative amendments to the statute, will stay in effect through 2024 unless additional Congressional action is taken. In January 2013, President Obama signed into law the American Taxpayer Relief Act of 2012, which, among other things, reduced Medicare payments to several providers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. These new laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on customers for our drugs, if approved, and, accordingly, our financial operations.Available Information

 

In the coming years, additional legislativeOur website is located at www.Panbela.com. The information contained on or connected to our website is not a part of this prospectus. We have included our website address as a factual reference and regulatory changes coulddo not intend it to be madean active link to governmental health programs that could significantly impact pharmaceutical companies and the success of our product candidates.

Legal Proceedingswebsite.

 

We make available, free of charge, through our website materials we file or furnish to the SEC pursuant to Section 13(a) or 15(d) of the Exchange Act, including our annual report on Form 10-K, our quarterly reports on Form 10-Q, our current reports on Form 8-K and amendments to those reports. These materials are not currently partyposted to our website as soon as reasonably practical after we electronically file them with or furnish them to the SEC.

Members of the public may read and copy any material legal proceedings. From time to time,materials we may be named asfile with the SEC at its Public Reference Room at 450 Fifth Street, NW, Washington, DC 20549. Information on the operation of the Public Reference Room is available by calling the SEC at 1-800-SEC-0330. The SEC maintains a defendant in legal actions arising from our normal business activities. We believewebsite that we have obtained adequate insurance coverage or rights to indemnification in connection with potential legal proceedingscontains reports, proxy and information statements and other information about us and other issuers that may arise.file electronically at http://www.sec.gov.

 


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Accounting MattersMANAGEMENT

 

Cherry Bekaert LLPInformation about our Executive Officers

Jennifer K. Simpson, Ph.D., MSN, CRNP, age 55, has been engaged byserved as President and Chief Executive Officer and as a director of our Company since July 2020. Prior to joining the auditCompany, Dr. Simpson served as President and Chief Executive Officer and as a member of the board of directors of Delcath Systems, Inc. (Nasdaq: DCTH) from 2015 to June 2020. She had previously held various other leadership roles at Delcath since 2012. From 2011 to 2012, Dr. Simpson served as Vice President, Global Marketing, Oncology Brand Lead at ImClone Systems, Inc. (a wholly owned subsidiary of Eli Lilly and Company), where she was responsible for all product commercialization activities and launch preparation for one of the late-stage assets. From 2009 to 2011, Dr. Simpson served as Vice President, Product Champion and from 2008 to 2009 as the Associate Vice President, Product Champion for ImClone’s product Ramucirumab. From 2006 to 2008, Dr. Simpson served as Product Director, Oncology Therapeutics Marketing at Ortho Biotech (now Janssen Biotech), a Pennsylvania-based biotech company that focuses on innovative solutions in immunology, oncology and nephrology. Earlier in her career, Dr. Simpson spent over a decade as a hematology/oncology nurse practitioner and educator. Dr. Simpson has served on the board of directors and nominating and corporate governance committee of Eagle Pharmaceuticals, Inc. since August 2019 and on the board of Directors of CytRx Corporation since July 2021. Dr. Simpson earned a Ph.D. in Epidemiology from the University of Pittsburgh, an M.S. in Nursing from the University of Rochester, and a B.S. in Nursing from the State University of New York at Buffalo.

Susan Horvath, age 64, has served as our Vice President and Chief Financial Officer since April 2018. Ms. Horvath has held both finance and operating positions within pharmaceutical, healthcare and consumer organizations. In addition to her position with the Company, Ms. Horvath sits on the board of directors and provides financial consulting services for Photonic Pharma, LLC, a privately held company focused on efficiencies in early stage drug discovery. Prior to joining the Panbela team, Ms. Horvath served as Chief Financial Officer of Eyebobs, LLC, a private company focused on eyewear for corrective vision, from 2016 to January 2018; Vice President and Chief Financial Officer of Tenacious Holdings, Inc. (d/b/a ergodyne), a privately held, safety products company, from 2014 to 2016; Chief Financial Officer and Vice President of Human Resources at Healthsense, Inc., a next generation technology (SaaS) and remote monitoring company focused on providing safety and improving quality of life while reducing overall costs of healthcare for seniors and fragile adults, from 2011 to 2014; Chief Financial Officer, Vice President of Operations & Human Resources of Hemosphere, Inc., an early commercialization stage medical device company, from 2008 to 2010; and Vice President & Team Leader International of CNS, Inc, a publicly traded consumer health care products company focused on the development and marketing of strong consumer brands, from 2004 to 2007. Ms. Horvath holds a Bachelor of Science degree in Accounting from the University of Illinois, Champaign, and is a Certified Management Accountant and Certified Public Accountant, inactive.

Information about our Board of Directors

Our business is overseen by a Board of Directors divided into three classes as nearly equal in number as possible, and directors typically are elected to serve as our independent registered public accounting firma designated class for fiscal 2017, and our stockholders ratified such engagement ata term of three years. The following sets forth certain information regarding the annual meeting held on June 6, 2017. Notwithstanding the ratification by our stockholders, the audit committee, in its discretion, may appoint another independent registered public accounting firm at any time during the year if the committee believes that such a change would be in the best interestscurrent members of our company and its stockholders.Board of Directors:

 

As a result of the Merger, our Company was deemed to have changed its independent registered public accounting firm. Accordingly, on September 4, 2015, the Company’s Board ofClass II Directors effectively discharged Mantyla McReynolds LLP (“MMR”) as its independent registered public accounting firm. With the exception of a “going concern” modification, the report of MMR on the financial statements of the Company for its two most recent fiscal years prior to the Merger contained no adverse opinion or disclaimer of opinion, and was not qualified or modified as to uncertainty, audit scope or accounting principle. In connection with MMR’s audit for the fiscal years ended December 31, 2013 and 2014, and through the date of dismissal, there were no disagreements with MMR on any matter of accounting principles or practices, financial statement disclosure or auditing scope or procedure, which disagreements if not resolved to the satisfaction of MMR would have caused them to make reference thereto- Term Expiring in its report on the financial statements for such years.

During the two most recent completed fiscal years prior to the Merger and through the date of dismissal, none of the events specified in Item 304(a)(1)(iv) of Regulation S-K had occurred, with the exception of material weaknesses identified in the Company’s internal control over financial reporting prior to the Merger.

On September 4, 2015, the Company retained Cherry Bekaert LLP to serve as its principal independent registered public accounting firm. During the two most recent fiscal years and to the date of this prospectus, the Company has not consulted with Cherry Bekaert LLP regarding either: (i) the application of accounting principles to a specified transaction, either completed or proposed; or the type of audit opinion that might be rendered on the Company’s financial statements, and either a written report was provided to the Company or oral advice was provided that Cherry Bekaert LLP concluded was an important factor considered by the Company in reaching a decision as to the accounting, auditing or financial reporting issue; or (ii) any matter that was the subject of a disagreement and required to be reported under Item 304(a)(1)(iv) of Regulation S-K and the related instructions thereto.

We previously provided MMR with a copy of the foregoing disclosure and requested that it furnish us with a letter addressed to the SEC stating whether it agrees with the above statements. A copy of the letter from MMR was filed with the SEC as Exhibit 16.1 to a current report on Form 8-K filed September 11, 2015 (File No. 000-55242).


Management2024

The name, age and position of each of our directors and executive officers as of the date of this prospectus are as follows:

Name

Age

Position

Michael T. Cullen

71

Executive Chairman of the Board and Director

Suzanne Gagnon

61

Chief Medical Officer and Director

Dalvir S. Gill

59

Director

David B. Kaysen

68

President, Chief Executive Officer and Director

Scott B. Kellen

52

Chief Financial Officer and Vice President of Finance

Jeffrey S. Mathiesen

57

Director

J. Robert Paulson, Jr.

61

Director

Paul W. Schaffer

74

Director

D. Robert Schemel

62

Director

Executive Officers

 

Michael T. Cullen, M.D., M.B.A., co-founded Sun BioPharma, Inc. in November 2011 andage 77, has continuously served as Chairman of its boardthe Board and a non-employee director of directorsour Company since that date. He previouslyhis retirement as an employee of the Company in May 2021. Dr. Cullen had served as Executive Chairman and as a director of our Company since its Chief Executive Officer and Presidentco-founding in 2015.November 2011. Dr. Cullen brings 2533 years of pharmaceutical experience to our Company, including expertise in working with development-stage companies in planning, designing and advancing drug candidates from preclinical through clinical development. Dr. Cullen served as our President and Chief Executive Officer between October 2018 and July 2020. He previously served as our Chief Medical Officer and President from November 2011 to June 2015. Dr. Cullen provided due diligence consulting to the pharmaceutical industry from 2009 to 2011, after one year in transition consulting to Eisai Co., Ltd.Pharmaceuticals. He developed several oncology drugs as Chief Medical Officer for MGI Pharma Inc. from 2000 to 2008, and previously at G.D. Searle, SunPharm Corporation, and as Vice President for Clinical Consulting at IBAH Inc., the world’s fifth largest contract research organization, where he provided consulting services on business strategy, creating development plans, regulatory matters and designing clinical trials for several development stage companies in the pharmaceutical industry. Dr. Cullen was also a co-founder and Chief Executive Officer of IDD Medical, a pharmaceutical start-up company. Dr. Cullen joined 3M Pharmaceuticals in 1988 and contributed to the development of cardiovascular, pulmonary, rheumatology and immune-response modification drugs. Over the course of his career Dr. Cullen has been instrumental in obtaining the approval of ten drugs, including three (3) since 2004: Aloxi®, Dacogen® and Lusedra®. Board-certified in Internal Medicine, Dr. Cullen practiced from 1977 to 1988 at Owatonna Clinic, Owatonna, MN, where he served as president. Dr. Cullen earned his M.D.MD and B.S.BS degrees from the University of Minnesota and his M.B.A. from the University of St. Thomas and completed his residency and Board certification in Internal Medicine through the University of North Carolina in Chapel Hill and Wilmington, NC. We believe Dr. Cullen’s role in the development of our business since inception, including his past and current positions with our Company, and extensive experience with pharmaceuticals generally make him a valuable member of our Board of Directors.

David B. Kaysen has served as our President since August 2015 and as Chief Executive Officer and as a director of our Company since July 2015. Prior to joining the Company, Mr. Kaysen was a self-employed medical technology consultant since April 2013. Mr. Kaysen previously was the President, Chief Executive Officer and a board member of Uroplasty, Inc. (now Cogentix Medical, Inc.), a publicly traded medical device company, from May 2006 through April 2013. Prior to that, Mr. Kaysen served as President and CEO and as a director of Diametrics Medical, a publicly traded diagnostics company, and Rehabilicare Inc. (now Compex Technologies), a publicly traded neuromodulation medical device company. Mr. Kaysen holds a B.S. in Business Administration from the University of Minnesota. Mr. Kaysen’s experience with publicly traded companies and within the Life Sciences industry generally, in addition to his perspective as our current President and Chief Executive Officer, uniquely qualify him for service on our Board of Directors.

Scott Kellen has served as our Vice President and Chief Financial Officer since October 1, 2015. Prior to joining Sun BioPharma, Inc., Mr. Kellen was the Chief Financial Officer of Kips Bay Medical, Inc. from 2010 through 2015 originally joining to help lead them through their initial public offering and multiple follow-on offerings. In March 2012, Mr. Kellen also became their Chief Operating Officer. From 2007 to 2009, Mr. Kellen served as Director of Finance for Transoma Medical, Inc., during which time Transoma prepared for its proposed initial public offering, which was withdrawn in February 2008 due to deteriorated market conditions. From 2005 to 2007, Mr. Kellen served as the Corporate Controller for ev3 Inc. during that company’s initial public offering and during additional follow-on offerings. From 2003 to 2005, he served as Senior Audit Manager of Deloitte & Touche, LLP (now Deloitte LLP), providing auditing and consulting services to mid-size public companies adjusting to the requirements of the Sarbanes-Oxley Act. Altogether, Mr. Kellen has spent more than 20 years in the medical device industry, serving early stage and growth companies that produced Class II and III devices. Mr. Kellen holds a B.S. in Business Administration from the University of South Dakota and is a Certified Public Accountant (inactive).

 


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Other Directors

Suzanne Gagnon, M.D. has served as our Chief Medical Officer since January 2015 and as a director of our Company since June 2015. Previously, Dr. Gagnon served as the Lead Clinical Consultant to the Company. Prior to working for the Company, Dr. Gagnon was the President of Gagnon Consulting LLC from July 2014 through December 2014 consulting on medical, safety and regulatory matters. From December 2001 through July 2014, Dr. Gagnon had acted as the Chief Medical Officer for three companies, ICON Clinical Research, Nupathe, Inc. and Idis, Inc. Dr. Gagnon received her medical degree from Boston University School of Medicine, became Board Certified in Internal Medicine at Boston City Hospital and spent several years on faculty at the University of Miami School of Medicine where she published independently conducted clinical research in the New England Journal of Medicine prior to joining the industry. She is an international editorial advisor to Elsevier Publishing, the author or co-author of numerous publications, abstracts and book chapters and a frequent international speaker. She currently holds a position as adjunct Professor in Pharmaceutical Product Development at West Chester University of Pennsylvania. Dr. Gagnon brings deep experience in pharmaceutical development and a key perspective in the ongoing development of SBP-101 to our Board of Directors.

Dalvir S. Gill, Ph.D. has served as a director of our Company since March 2016. Mr. Gill has served as the Chief Executive Officer and a director of TransCelerate BioPharma, Inc., a nonprofit organization focused on improving the health of people around the world by simplifying and enhancing the research and development of innovative new therapies since January 2013. Previously, he was the President of Phase II-IV Drug Development at PharmaNet-i3, an international contract research organization, from July to December 2012. Dr. Gill earned his B.Sc. in Applied Biology from the University of Hertfordshire and his Ph.D. in Pathobiology from the Royal Free Hospital School of Medicine, University of London. He also holds a diploma in the health economics of pharmaceuticals from the executive program of the Stockholm School of Economics. Dr. Gill has more than 25 years of drug development experience. We believe that Dr. Gill brings strategic insight and leadership and a wealth of experience in the pharmaceutical industry to our Board of Directors, as well as knowledge of the regulatory and clinical requirements associated with the development of new drug compounds.

Jeffrey S. Mathiesen has served as a director of our Company since September 2015. He has served as Chief Financial Officer of Gemphire Therapeutics Inc., a publicly held biopharmaceutical company since January 2015. Previously, he served as Chief Financial Officer of Sunshine Heart, Inc., a publicly traded medical device company, from March 2011 to January 2015. From December 2005 to April 2010, Mr. Mathiesen served as Vice President and Chief Financial Officer of Zareba Systems, Inc., a manufacturer and marketer of medical products, perimeter fencing and security systems that was purchased by Woodstream Corporation in April 2010. Mr. Mathiesen has held executive positions with publicly traded companies dating back to 1993, including vice president and chief financial officer positions. Mr. Mathiesen holds a B.S. in Accounting from the University of South Dakota and is also a Certified Public Accountant. We believe that Mr. Mathiesen brings financial insight and leadership and a wealth of experience in capital markets to our Board of Directors, as well as knowledge of public company accounting and financial reporting requirements.

J. Robert Paulson, Jr., M.B.A. has served as a director of our Company since September 2015. Mr. Paulson has served as President, CEO, and a director of NxThera, Inc., a venture-funded medical device company developing a novel convective water vapor energy system to treat a variety of endourological conditions, including benign prostatic hyperplasia and prostate cancer since 2009. Previously, he was President, CEO and a director of Restore Medical Inc. from 2005 until its acquisition by Medtronic in July 2008. He was CFO and VP of Global Marketing for Endocardial Solutions, which was acquired by St. Jude Medical in 2005. Before that, he was the Sr. VP/General Manager of Advanced Bionics, and held several executive positions with Medtronic, including VP/General Manager of the Surgical Navigation Technologies business, VP Corporate Strategy, and Director of Corporate Development. Mr. Paulson has held senior positions in marketing, corporate development, legal and finance at General Mills, and practiced corporate, M&A and securities law with the Minneapolis law firm of Lindquist & Vennum. He has served as a director of Veran Medical since 2008, and is a former director of Ablation Frontiers, Vascular Solutions and Medical CV. Mr. Paulson received a J.D. from the Vanderbilt University School of Law, an M.B.A. from the University of St. Thomas, and a B.A. in accounting, economics & political science from Luther College. We believe that Mr. Paulson brings strategic insight and leadership and a wealth of experience in healthcare to our Board of Directors, as well as knowledge of capital markets and early stage companies.



 

Paul W. SchafferD. Robert Schemel, age 68, has served as a director since January 2014.September 2015. Mr. Schaffer graduated from Minnesota Pharmacy School in 1966. He owned and operated a compounding pharmacy, Bloomington Drug, for 42 years. Mr. Schaffer is an experienced biotech investor. We believe that Mr. Schaffer brings a wealth of experience in pharmaceutical development and manufacturing to our Board of Directors, as well as knowledge of regulations and issues facing pharmaceutical companies.

D. Robert Schemel has had previously served as a director of Sun BioPharma Research, Inc. since March 2012. Mr. Schemel has over 39 years’ experience in the agriculture industry. From 1973-2005, Mr. Schemel owned and operated a farming operation in Kandiyohi County, Minnesota, building a 5,000-acre operation producing corn, soybeans and sugar beets. Mr. Schemel has extensive experience in serving on boards of directors. From 1992-1996 he served as a board member for ValAdCo and then from 1996-2003 he served as the Chairman of the Board for Phenix Biocomposites.

Class III Directors -Terms Expiring in 2025

Arthur J. Fratamico, age 58, has served as a director of our Company since December of 2019. He is currentlya registered pharmacist with over 30 years of experience in the pharmaceutical industry and has been the Chief Executive Officer of Radiant Biotherapeutics, which is advancing a novel antibody platform that is focused on the development of Multabodies, which are multi-valent and multi-specific antibodies since May 2021. Prior to Radiant, Mr. Fratamico served as Chief Business Officer at Galera Therapeutics, Inc., a biopharmaceutical company dedicated to discovering and developing novel dismutase mimetics with the goal of transforming cancer radiotherapy, since January 2017. Prior to joining Galera, Mr. Fratamico served as Chief Business Officer of Vitae Pharmaceuticals, Inc., a Nasdaq-listed clinical-stage biotechnology company, from May 2014 until its sale to Allergan in December 2016. Prior to Vitae Pharmaceuticals, he held similar executive roles with a number of biotechnology companies leading their business development efforts, including facilitating the sales of Gemin X Pharmaceuticals, Inc. and MGI Pharma, Inc. In addition to being responsible for numerous licensing transactions and acquisitions, he also directed corporate strategy and managed external corporate communications. He also served in several senior marketing, product planning and new product development positions. Mr. Fratamico earned a bachelor’s degree in pharmacy from the Philadelphia College of Pharmacy and Science and an M.B.A. from Drexel University.

Jeffrey S. Mathiesen, age 63, has served as a director of our Company since September 2015. Mr. Mathiesen also serves as a director and audit committee chairman of NeuroOne Medical Technologies Corporation, a publicly traded medical device company. Since June 2021, Mr. Mathiesen has served as Chief Financial Officer, Treasurer and Secretary of Helius Medical Technologies, Inc. (Nasdaq: HSDT), a publicly traded medical device company, developing noninvasive platform technologies focused on neurological wellness, and he served as director since May 2022 and previously served as director and Audit Committee Chair from June 2020 through June 2021. Additionally, Mr. Mathiesen previously served as a director and Audit Committee Chair of Healthcare Triangle, Inc. (Nasdaq: HCTI), a publicly traded provider of cloud and data transformation platform and solutions for healthcare and life sciences, from March 2022 to December 2022 and as a director and audit committee chairman of eNeura, Inc., a privately held medical technology company providing therapy for both acute treatment and prevention of migraine, from July 2018 to February 2020. Mr. Mathiesen has served as Advisor to the CEO of Teewinot Life Sciences, a privately held biopharmaceutical company focused on the biosynthetic production of pure pharmaceutical grade cannabinoids from October 2019 to December 2019, and as Chief Financial Officer from March 2019 to October 2019. In August 2020, Teewinot Life Sciences filed a voluntary petition under Chapter 11 of the United States Bankruptcy Code. Previously he served as Chief Financial Officer of Gemphire Therapeutics Inc., a publicly traded biopharmaceutical company from September 2015 to September 2018. From August 2015 to September 2015, he was a consultant to Gemphire. He served as Chief Financial Officer of Sunshine Heart, Inc., a publicly traded medical device company, from March 2011 to January 2015. Mr. Mathiesen has held executive positions with publicly traded companies dating back to 1993, including vice president and chief financial officer positions. Mr. Mathiesen holds a B.S. in Accounting from the University of South Dakota and is also a Certified Public Accountant.

Class I Directors -Terms Expiring in 2026

Daniel J. Donovan, age 59, has served as a director since June 2022. He had served as a director and Chief Business Officer, a non-employee position, of CPP from 2011 until immediately before the completion of its acquisition by Panbela in June 2022. He has served as chief executive officer of rareLife Solutions, Inc., a private company since he founded it in 2014. He served on the Board of Directors at Intensity Therapeutics since January of 2023 and is a member of the Southern Minnesota Beet Sugar Co-op which oversees the operationaudit committee. Before rareLife, Mr. Donovan founded Envision Pharma in 2001, serving as managing director then president until 2011. Envision Pharma was acquired by United BioSource Corporation in 2008, where Mr. Donovan served as Senior Vice President Strategy and Market Development and was a member of the largest US sugar processing facilityleadership team. Mr. Donovan began his career at Pfizer serving in a variety of positions of increasing responsibility, ranging from sales to market research and marketing in the U.S. and internationally, culminating in his position as Director and European Team Leader. During his time at Pfizer, he played a pivotal role in the commercialization of some of the pharmaceutical industry’s most successful product launches.

Jeffrey E. Jacob, age 62, has served as a director since June 2022. He served as Chief Executive Officer of CPP from 2009 until immediately before the completion of its acquisition by Panbela in June 2022. He is also the principal of Tucson Pharma Ventures LLC, an Arizona-based biopharmaceutical consulting and investment firm, a role he’s held since 2004. In 2004, Mr. Jacob founded Systems Medicine Inc., a startup company applying systems biology, predictive pharmacogenomics, and clinical trial design innovations to the development of new cancer drugs and served as its chief executive officer until its sale in 2007, after which he served as a divisional chief executive officer until late 2008. Between 1987 and 2004, Mr. Jacob was employed by Research Corporation Technologies, most recently as Senior Vice President. During that time, he led the transformation of Research Corporation Technologies from a patent development and licensing organization to an early stage-technology incubation and venture deployment firm. He has served as a member of the board of directors of Research Corporation Technologies and currently serves as its chair. He is also a founding board member and previously served as the chief program officer of Critical Path Institute. Mr. Jacob holds a master’s degree in engineering and a molasses desugarization facilitymaster’s degree in Renville, Minnesota, which hastechnology and policy from the Massachusetts Institute of Technology and a total economic benefit currently exceeding $180 million annually. We believe that Mr. Schemel brings business insight and leadership as well as significant experiencebachelor’s degree in engineering from the development and growthUniversity of early stage companies.Arizona.

 

66

Jennifer K. Simpson Ph.D., MSN, CRNP, has served as our President and Chief Executive Officer and as a director of our Company since July 2020. See “Information about our Executive Officers” above for further information regarding Dr. Simpson’s background and experience.

Director Independence

 

Our Board of Directors consists of eight directors. Five of our directors are independent directors, as defined under the applicableThe continued listing rules of The Nasdaq Stock Market, which we have voluntarily adopted as our standard for director independence. These independent directors are Messrs. Gill, Mathiesen, Paulson, Schaffer and Schemel. There is no familial relationship among anyLLC (the “Nasdaq Rules”) require that a majority of our directors or executive officers.

Committees of the Board of Directors

Our Board of Directors has established three standing committees: Audit, Compensation, and Nominating and Governance. The membership of each committee is as follows:

 

 

Committees

 

 

Director

 

Audit

 

Compensation

 

Nominating and

Governance

 

Independent

Directors

Michael T. Cullen

 

 

 

  

Suzanne Gagnon

 

 

 

  

Dalvir S. Gill

 

 

 

Member

 

 ✓

David B. Kaysen

 

 

 

  

Jeffrey S. Mathiesen

 

Chair

 

 

Member

 

J. Robert Paulson, Jr.

 

 

Member

 

Chair

 

 

Paul W. Schaffer

 

Member

 

Member

 

 

D. Robert Schemel

 

Member

 

Chair

 

 

Audit Committee

The Audit Committee’s primary functions, among others, are to: (a) assist our Board of Directors in discharging its statutory and fiduciary responsibilities with regard to audits of the books and records of our Company and the monitoring of its accounting and financial reporting practices; (b) carry on appropriate oversight to determine that our Company and its subsidiaries have adequate administrative and internal accounting controls and that they are operating in accordance with prescribed procedures and codes of conduct; and (c) independently review our Company’s financial information that is distributed to shareholders and the general public. The Audit Committee operates pursuant to a written, which is available on our website at www.sunbiopharma.com.


All of the members of the Audit Committee meet the requirements for financial literacy under the applicable rules and regulations of the SEC. Our Board of Directors has determined that Jeffrey S. Mathiesen is qualified to serve as an audit committee financial expert, as that term is defined under the applicable rules of the SEC. Each member of the Audit Committee is anbe “independent director,”directors” as that term is defined in the rulesNasdaq Rules. Our Board has determined that each of the Nasdaq Stock Market,our non-employee directors, namely Messrs. Donovan, Fratamico, Mathiesen, and satisfies the independence requirements of Rule 10A-3(b)(1) of the Exchange Act.Schemel, are “independent directors.”

 

67

Compensation Committee

DIRECTOR COMPENSATION

 

The Compensation Committee reviews and recommends to our Board of Directors on an annual basis the goals and objectives relevant to the annualfollowing table sets forth certain information regarding compensation of our executive officers in light of their respective performance evaluations. Our Compensation Committee is responsible for reviewing and approving the compensation of our executive officers and administering our equity incentive plans, including approval of individual grants of stock options and other awards to persons other than non-employee directors. In fulfilling its duties, the Compensation Committee has the authority to retain and has, from time to time, retained an outside compensation consultant to provide advice and reference materials on compensation matters. The Compensation Committee operates pursuant to a written charter, which is available on our website at www.sunbiopharma.com.

Each member of the Compensation Committee is an “independent director,”who served as that term is defined in the rules of the Nasdaq Stock Market, a “non-employee director” pursuant to Rule 16b-3 of the Exchange Act.

Nominating and Governance Committee

The Nominating and Governance Committee is primarily responsible for identifying individuals qualified to serve as members of our Board of Directors, recommending individuals to our Board of Directors for nomination as directors and committee membership, reviewing the compensation paid to our non-employee directors and recommending adjustments in director compensation, as necessary, in addition to overseeing the annual evaluation of our Board of Directors. The Nominating and Governance Committee operates pursuant to a written charter, which is available on our website at www.sunbiopharma.com.

Each member of the Nominating and Governance Committee is an “independent director,” as that term is defined in the rules of the Nasdaq Stock Market.

Compensation Committee Interlocks and Insider Participation

None of the members of the compensation committee nor any director nominee proposed to become a member of the compensation committee is or has at any time during the last completed fiscal year been an officer or employee of our Company. None of our executive officers has served as a member of our Board of Directors or as a member of the compensation or similar committee, of any entity that has one or more executive officers who served on our Board of Directors during the lastmost recently completed fiscal year. Share amounts have been restated for the historical 1-for-30 and the 1-for-40 reverse splits.

 

Name

 

Fees Earned

or
Paid in Cash
($)

  

Option

Awards

($)

  

Total
($)

 

Michael T. Cullen (a)

  72,500   3,642   76,142 

Arthur J. Fratamico (b)

  49,000   3,642   52,642 

Jeffrey S. Mathiesen (c)

  81,500   3,642   85,142 

D. Robert Schemel (d)

  57,500   3,642   61,142 
Daniel J. Donovan (e)  52,500   3,642   56,142 

Jeffrey J. Jacob (f)

  40,000   3,642   43,642 

None of the members of the compensation committee is or has at any time during the last completed fiscal year been an officer or employee of our Company. None of our executive officers has served as a member of the Board of Directors, or as a member of the compensation or similar committee, of any entity that has one or more executive officers who served on our Board of Directors or compensation committee during the last completed fiscal year.


(a)

Dr. Cullen held options to purchase an aggregate of 27 shares as of December 31, 2023.

(b)

Mr. Fratamico held options to purchase an aggregate of 14 shares as of December 31, 2023.

(c)

Mr. Mathiesen held options to purchase an aggregate of 14 shares as of December 31, 2023.

(d)

Mr. Schemel held options to purchase an aggregate of 14 shares as of December 31, 2023.

(e)

Mr. Donovan held options to purchase an aggregate of 14 shares as of December 31, 2023.

(f)

Mr. Jacob held options to purchase an aggregate of 24 shares as of December 31, 2023.

 

Director Compensation

Directors who are also our employees receive no additional compensation for serving on our Board of Directors. During 2016, our Company2023, Panbela reimbursed non-employee directors for out-of-pocket expenses incurred in connection with attending meetings of our Board of Directors and its committees.

 

Directors who are also our employees or service providers receive no additional cash compensation for service on our Board of Directors. Dr. Simpson served as President and Chief Executive Officer throughout fiscal 2022.

In February 2022, the Compensation Committee approved an update to the cash compensation for non-employee directors. The annual amounts described below were effective January 1, 2022 and remain in place unless and until they are changed by the committee.

Annual Retainers
(all amounts in $)

 

General

  

Audit Committee

  

Nominating &

Governance

Committee

  

Compensation

Committee

 

Nonemployee director

  40,000             

Chair(a)

  32,500             

Lead independent director(a)

  22,500             

Committee chair

      15,000   7,500   10,000 

Committee member

      7,500   4,000   5,000 


(a)

Paid in addition to nonemployee director retainer.


68

 

Non-Employee Director EXECUTIVE COMPENSATION

Compensation for 2016of Named Executive Officers

 

The following table sets forth information concerning annual compensation fordisclosure focuses on our non-employee directors during the year ended December 31, 2016:

Name

Option Awards(1) ($)

Total ($)

Dalvir S. Gill

198,000(2)

198,000

Jeffrey S. Mathiesen

198,000(3)

198,000

J. Robert Paulson, Jr.

198,000(4)

198,000

Paul W. Schaffer

198,000(5)

198,000

D. Robert Schemel

198,000(6)

198,000


(1)

Amounts shown in the “Option Awards” column represent the aggregate grant date fair value of these awards computed in accordance with FASB ASC Topic 718. For additional information regarding the calculation of grant date fair value of options granted during 2016, see Note 9 to the consolidated financial statements appearing in our annual report on Form 10-K for the fiscal year ended December 31, 2016.

(2)

Represents, a non-qualified stock option to purchase 208,000 shares of common stock granted in December 2016.

(3)

Represents, a non-qualified stock option to purchase 208,000 shares of common stock granted in December 2016.

(4)

Represents, a non-qualified stock option to purchase 208,000 shares of common stock granted in December 2016.

(5)

Represents, a non-qualified stock option to purchase 208,000 shares of common stock granted in December 2016.

(6)

Represents, a non-qualified stock option to purchase 208,000 shares of common stock granted in December 2016.


Executive Compensation named executive officers. For fiscal 2023, our “named executive officers” consisted of our only executive officers, Dr. Simpson and Ms. Horvath.

 

Base salaries for each of our named executive officers were initially established based on arm’s-lengtharm’s-length negotiations with the applicable executive. OurThe Compensation Committee of our Board of Directors reviews our executive officers’ salaries annually. When negotiating or reviewing base salaries, the Compensation Committee expects to considerconsiders market competitiveness based on their marketthe experience of its members, the executive’s expected future contribution to our success and the relative salaries and responsibilities of our other executives. All three of our Company’s continuing executive officers were employed by the Company during the most recent completed fiscal year.

 

Summary Compensation Table

 

The following table provides information regarding the compensation earned during fiscal year 2016 and fiscal year 2015 by our named executive officers:officers for the periods presented (collectively referred to as the “Executives”):

 

Name and principal position

 

Fiscal Year

 

Salary
($)

  

Option awards
($)
(1)

  

Total
($)

 

Michael T. Cullen

 

2016

  199,364   145,248   344,612 

Executive Chairman

 

2015

  90,000   140,000   230,000 

David B. Kaysen

 

2016

  248,859   1,016,736   1,265,595 

President and
Chief Executive Officer

 

2015

  77,955      78,000 

Scott Kellen

 

2016

  209,046   435,744   644,790 

Chief Financial Officer and

Vice President of Finance
 

2015

  50,000      50,000 

Name and Principal Positions

 

Year

 

Salary
($)

  

Option

Awards(a)
($)

 

Stock

Awards
($)

 

Nonequity

Incentive Plan

Compensation

(b)
($)

  

Total
($)

 
                    

Jennifer K. Simpson

 

2023

  527,000   44,921 

 

   571,921 

President and Chief Executive Officer

 

2022

  506,000  

 

  188,324   694,324 
                    

Susan Horvath

 

2023

  333,000   15,535 

 

   348,535 

Chief Financial Officer and Vice President of Finance

 

2022

  320,200  

 

  103,459   423,459 

 


(1)(a)

The values of option awards in this table represent the fair value of such awards granted during the fiscal year, as computed in accordance with FASB ASCFinancial Accounting Standards Board Accounting Standards Codification Topic 718. The assumptions used to determine the valuation of the awards are discussed in Note 9 to ourthe consolidated financial statements, includedstatements. No equity awards were awarded for fiscal 2022.

(b)

Represents payments made in our annual report on Form 10-K2023 under Panbela’s 2022 Cash Incentive Programs as described further below. The Compensation Committee has not certified actual performance for purposes of determining the fiscal year ended December 31, 2016.cash incentive payments earned under the 2023 Cash Incentive Program.

 

Cash Incentive Compensation

For 2023, the Compensation Committee established performance objectives for each of the Executives based on clinical development and financial milestones. Each Executive’s potential payment upon satisfaction of the objectives was equal to the target set forth in the Executive’s employment agreement as described further below. The 2023 incentive, if any, is expected to be paid in the first quarter of 2024, subject to a final determination by the Compensation Committee.

Outstanding Equity Awards at as of December 31, 20162023 (Adjusted for the 1 for 20, 1 for 30 and 1 for 40 reverse stock splits)

 

 

 

Option Awards

Name 

Number of securities

underlying

unexercised options

(#) exercisable

 

Number of securities

underlying unexercised

options (#)

unexercisable

 

Option exercise price

($)

 

Option expiration

Date

Michael T. Cullen

 

80,000

 

–   

 

3.175

 

3/5/25

  

1,875

 

13,125(1)

 

15.10

 

12/12/26

David B. Kaysen

 

17,600

 

62,400(2)

 

15.10

 

12/12/26

  

3,125

 

21,875(1)

 

15.10

 

12/12/26

Scott Kellen

 

6,600

 

23,400(2)

 

15.10

 

12/12/26

  

1,875

 

13,125(1)

 

15.10

 

12/12/26

    

Option Awards

Name

 

Grant

Date

 

Number of

securities

underlying

unexercised

options (#)

exercisable

  

Number of

securities

underlying

unexercised

options (#) un-

exercisable

  

Option

exercise

price
($)

 

Option

expiration

Date

Jennifer K. Simpson

 

7/17/2020

  8      239,760 

7/17/2030

  

3/30/2021

  4  

2(a)

   98,160 

3/30/2031

  

3/27/2023

    165(b)   300 

3/27/2033

                

Susan Horvath

 

4/17/2018

  1      138,000 

4/17/2028

  

5/21/2019

  2      70,800 

5/21/2029

  

9/24/2019

  1      120,000 

9/24/2029

  

6/24/2020

  1      119,520 

6/24/2030

  

3/30/2021

  1  

   98,160 

3/30/2031

  

3/27/2023

    57(b)   300 

3/27/2033

 


(1)(a)

Scheduled to vest in eight equal installmentswith respect to all remaining shares on the last day of each calendar quarter, starting March 31, 2017.30, 2024.

(2)(b)

Vests proportionately basedScheduled to vest in three substantially equal installments on cash proceeds received by, or contractually obligated to be remitted to, the Company after June 1, 2016March 27 in each of 2024, 2025 and before December 31, 2018 from any transaction, excluding operating-related cash flows. Gross proceeds resulting from a closing of the Offering would result in additional vesting under this award.

2026.

 


69

 

EmploymentEmployment Agreements

 

We are party to employment agreements with our Executive Chairman, President and Chief Executive Officer, and Chief Financial Officer (collectively,each of the “Executives”).Executives. In addition to the specific terms summarized below, each of the ExecutivesExecutive is eligible to participate in the other compensation and benefit programs generally available to our employees, including our other executive officers.officers, if any. Each such employment agreement also includes customary confidentiality, non-competition and non-solicitation covenants.covenants and a requirement that the Executive sign a supplemental agreement regarding confidentiality and assignment of intellectual property.

 

In accordance with the employment agreements, the base salary of each Executive is reviewed annually by the Compensation Committee of our Board of Directors. ThePursuant to the employment agreements, the committee may authorize an increase for the applicable year but may not reduce an Executive’s base salary below its then-current level other than with the Executive’s consent or pursuant to a general wage reduction in respect of substantially all of our executive officers.

In October 2017, we further amended the employment agreements with the Executives. For Dr. Cullen and Mr. Kaysen, the amendments established new annual base salaries representing a 25% reduction from prior levels, each effective as of October 1, 2017. Mr. Kellen’s annual base salary remained unchanged. Each Amendment further discontinued the “accrued compensation” provision that had been introduced in earlier amendments to the Executives’ employment agreements.

As a result of the amendments, each of the Executives continues to be eligible to receive a cash payment in an amount equal to the amount that previously accumulated under the “accrued compensation” provision through September 30, 2017. The cash payment would become due upon a change of control (as defined in each employment agreement) or our issuance of equity securities (including any securities that are convertible into or exercisable for equity securities) resulting in gross cash proceeds of $10,000,000 or more (a “Qualified Offering”). If neither a change of control nor a Qualified Offering occurs on or before June 30, 2018, then the right to cash payment will be forfeited.

If, on or before June 30, 2018, the Company closes an underwritten public offering of its securities that includes shares of common stock (whether or not such offering is a Qualified Offering), including the offering contemplated by this prospectus, then each of the Executives will, in lieu of cash payment, instead receive one or more equity awards under the 2016 Plan. The equity awards would be in the form of an option to purchase shares of common stock and a potential additional award of shares of common stock. Pursuant to the amendments, each Executive has agreed to automatically waive their rights to the cash payment discussed above in exchange for the equity awards. The number of shares underlying the potential stock option will be determined at the time the Company closes an underwritten public offering and is to be based on the amount of each Employee’s potential cash payment amount (identified above) divided by the value of an option to purchase a single share of common stock determined using a Black-Scholes option valuation model. The exercise price for each option award will equal “fair market value” as of the grant date determined in accordance with the 2016 Plan. If the number of shares underlying the option award is limited by the 2016 Plan, then the remainder will be issued in the form of a stock award.

 

President and Chief Executive ChairmanOfficer

 

Under hisher employment agreement, Dr. Cullen was entitledSimpson is eligible to receive an initial annualized base salary equal to $384,000. As discussed above, the latest amendment to Dr. Cullen’s employment agreement reduced his annualized base salary to $288,000, effective as of October 1, 2017. Notwithstanding the foregoing, Dr. Cullen received a portion of his monthly salary in cash and the remainder was accrued between October 1, 2015 and September 30, 2017. In lieu of the accrued amount, Dr. Cullen’s employment agreement entitles him to a potential cash payment of $410,136 as a result of any change of control or Qualified Offering on or before June 30, 2018, as discussed in more detail above.

Starting with the fiscal year ended December 31, 2016, Dr. Cullen has been eligible for an annual performance-based cash bonus with a target amount equal to no less than 45%50% of hisher base salary. Payment of the bonus amount will beis subject to achievement of metrics to be established by our Board of Directors and Dr. Cullen’sher continued employment with the CompanyPanbela through the end of the applicable cash bonus period. Neither our Board of Directors nor its Compensation Committee established such performance criteria for 2016 and therefore no cash bonus was paid.


President and Chief Executive Officer

Under his employment agreement, Mr. Kaysen was entitled to receive an initial annualized base salary equal to $420,000. Through June 15, 2016, Mr. Kaysen continued to serve as a part-time employee, pursuant to which he was entitled to receive a reduced monthly salary of $17,500. Since June 16, 2016, Mr. Kaysen has served as a full-time employee. Notwithstanding the foregoing, Mr. Kaysen received a portion of his monthly salary in cash and the remainder was accrued between March 1, 2016 and September 30, 2017. In lieu of the accrued amount, Mr. Kaysen’s employment agreement entitles him to a potential cash payment of $201,599 as a result of any change of control or Qualified Offering on or before June 30, 2018, as discussed in more detail above.

Starting with the fiscal year ended December 31, 2016, Mr. Kaysen has been eligible for an annual performance-based cash bonus with a target amount equal to no less than 60% of his base salary. Payment of the bonus amount will be subject to achievement of metrics to be established by our Board of Directors and Mr. Kaysen’s continued employment with the Company through the end of the applicable cash bonus period. Neither our Board of Directors nor its Compensation Committee established such performance criteria for 2016 and therefore no cash bonus was paid. Mr. Kaysen is also eligible to receive cash bonuses of (i) $260,000 upon the completion of a Qualified Financing and (ii) $36,000 upon the completion of certain other objectives specified in his employment agreement. Mr. Kaysen had satisfied the objectives of the bonus amount of $36,000 during the first quarter of 2016, payment of which has also been deferred until the completion of a Qualified Financing.

In place of the option award that his employment agreement would have required upon the completion of a Qualified Financing, on December 12, 2016, Mr. Kaysen received an option to purchase an aggregate of 80,000 shares of our common stock at an exercise price of $1.51 per share. Such option, vests proportionately based on cash proceeds received by, or contractually obligated to be remitted to, the Company after June 1, 2016 and before December 31, 2018 from any transaction, excluding certain internal operating-related cash flows. The performance criteria was 22% satisfied on the date of grant, resulting in vesting of the option as to 17,600 shares. On March 17, 2017, the Compensation Committee certified the further satisfaction of the performance criteria as a result of the sale of convertible promissory notes in February and March 2017 resulting in gross proceeds of $3.1 million. Upon completion of the sale of those convertible promissory notes, the option became exercisable for a total of 42,400 shares or 53% of the total underlying shares.

 

Vice President of Finance and Chief Financial Officer

 

Under hisher employment agreement, Mr. KellenMs. Horvath is entitledeligible to receive an initial annualized base salary equal to $240,000. Notwithstanding the foregoing, Mr. Kellen received a portion of his monthly salary in cash and the remainder was accrued between March 1, 2016 and September 30, 2017. In lieu of the accrued amount, Mr. Kaysen’s employment agreement entitles him to a potential cash payment of $97,208 as a result of any change of control or Qualified Offering on or before June 30, 2018, as discussed in more detail above.

Starting with the fiscal year ended December 31, 2016, Mr. Kellen has been eligible for an annual performance-based cash bonus with a target amount equal to no less than 40% of hisher base salary. Payment of the bonus amount will beis subject to achievement of metrics to be established by our Board of Directors and Mr. Kellen’sher continued employment with the CompanyPanbela through the end of the applicable cash bonus period. Neither our Board of Directors nor its Compensation Committee established such performance criteria for 2016 and therefore no cash bonus was paid.

 

In place of the option award that his employment agreement would have required upon the completion of a Qualified Financing, on December 12, 2016, Mr. Kellen received an option to purchase an aggregate of 30,000 shares of our common stock at an exercise price of $1.51 per share. Such option, vests proportionately based on cash proceeds received by, or contractually obligated to be remitted to, the Company after June 1, 2016 and before December 31, 2018 from any transaction, excluding certain internal operating-related cash flows. The performance criteria was 22% satisfied on the date of grant, resulting in vesting of the option as to 6,600 shares. On March 17, 2017, the Compensation Committee certified the further satisfaction of the performance criteria as a result of the sale of convertible promissory notes in February and March 2017 resulting in gross proceeds of $3.1 million. Upon completion of the sale of those convertible promissory notes, the option became exercisable for a total of 15,900 shares or 53% of the total underlying shares.


Potential Payments uponUpon Termination or Change-in-Control

 

Under their respective employment agreements, if an ExecutivesDr. Simpson’s or Ms. Horvath’s employment is terminated by us for any reason other than for “cause” (as defined in the applicable employment agreement) or by the Executiveher for “good reason” (as defined in the applicable employment agreement), then the Executiveeither Dr. Simpson or Ms. Horvath will be eligible to receive an amount equal to histheir respective annualized salary plus an amount equal to a prorated portion of histheir cash bonus target, if any, for the year in which the termination occurred, in addition to other amounts accrued on or before the date of termination. If any such termination occurs within six months prior or two years after a “change of control” (as defined in the applicable employment agreement), then Dr. Cullen and Mr. KellenSimpson or Ms. Horvath, as applicable, would instead receive an amount equal to hisher respective annualized salary, plus an amount equal to hisher full cash bonus target for the year in which the termination occurred. Upon a similar termination, Mr. Kaysen would receive an amount equal to 1.5 times his annualized salary, plus an amount equal to his full cash bonus target. As discussed above, the employment agreements with Dr. Cullen, Mr. Kellen and Mr. Kaysen would entitled each of them to receive a cash payments for previously accrued salaries in the amount of $410,136; $201,599; and $97,208, respectively, upon a change of control.

Certain Relationships and Related Party Transactions

The following is a summary of transactions since January 1, 2015 to which our company has been a party and in which the amount involved exceeded $13,000, which is approximately 1% of the average of our total assets as of December 31, 2016, and in which any of our directors, executive officers, or beneficial holders of more than 5% of our capital stock had or will have a direct or indirect material interest, other than compensation arrangements that are described under the heading “Executive Compensation: Employment Agreements” and “Director Compensation” above.

Our Chief Medical Officer, Suzanne Gagnon, is also a member of our Board of Directors. We are party to an employment agreement with Ms. Gagnon in substantially the same form as the employment agreements with the Executives described above under the heading “Employment Agreements.” Ms. Gagnon is eligible to participate in the other compensation and benefit programs generally available to our employees. Her employment agreement also includes customary confidentiality, non-competition and non-solicitation covenants. During 2015 and 2016, Ms. Gagnon received compensation from the Company amounting to $110,000 and $177,000, respectively. Under her employment agreement, Ms. Gagnon was entitled to receive an initial annualized base salary equal to $360,000. Pursuant to the latest amendment to her employment agreement, her annualized base salary was reduced to $270,000, effective as of October 1, 2017. Ms. Gagnon’s employment agreement would entitle her to a potential cash payment of $385,036 as a result of any change of control or Qualified Offering, which amount was based on the amount of compensation that she had accrued prior to September 30, 2017.

During 2015, Ryan R. Gilbertson received $34,417 in cash compensation for his service as SBI Delaware’s Executive Vice President of Business Development. As additional compensation for his service, on March 6, 2015, Mr. Gilbertson received options to purchase the equivalent of 40,000 shares of our common stock at $3.175 per share. Mr. Gilbertson is a beneficial holder of more than 5% of our capital stock.

During 2015, Christopher R. Johnson received $35,400 in cash compensation for his service to SBI Delaware and on March 6, 2015, he received options to purchase the equivalent of 40,000 shares of our common stock at $3.175 per share. At the time, Mr. Johnson was a beneficial holder of more than 5% of our capital stock.

In March 2017, Northern Capital Partners I, LP, of which Mr. Gilbertson is the chief manager, purchased $200,000 original principal amount of 2017 Notes. As a result of this investment, Northern Capital Partners I, LP is a party to both a Note Purchase Agreement and a Participation Agreement with the Company.

In March 2017, Douglas M. Polinsky purchased $150,000 original principal amount of 2017 Notes. As a result of this investment, Mr. Polinsky is a party to both a Note Purchase Agreement and a Participation Agreement with the Company.

In March 2017, Christopher R. Johnson purchased an aggregate of $75,000 original principal amount of 2017 Notes through various affiliated entities. As a result of these investments, the affiliated entities are party to both Note purchase Agreements and Participation Agreements with the Company.

In March 2017, Paul W. Schaffer, a director of the Company, purchased $50,000 original principal amount of 2017 Notes. As a result of this investment, he is party to both a Note Purchase Agreement and a Participation Agreement with the Company.

On December 17, 2017, the Company entered into a standstill agreement with Ryan R. Gilbertson, pursuant to which he has agreed not to acquire securities of the Company that would result in him having ownership (beneficial or otherwise) of greater than 16.4% of the outstanding common stock of the Company or any of its subsidiaries or, other than pursuant to rights existing as December 17, 2017, participate in any future financing involving the Company.  The standstill period will continue until the earliest of (i) the date the Company, after a class of its securities has commenced trading on a national securities exchange, ceases to have a class of its securities listed on a national securities exchange, (ii) the date that Mr. Gilbertson’s beneficial ownership of our common stock has remained below 5% for 90 consecutive days, and (iii) unless the Company has obtained approval for the listing of a class of its equity securities on a national securities exchange and commenced trading on such national securities exchange, March 31, 2018.

 


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Recent Equity Issuances to Directors, Executive Officers and 5% Stockholders

The following table shows all issuances of common stock since the beginning of January 1, 2015 to directors, executive officers and holders of more than 5% of our capital stock.

Director Executive Officer

or Stockholder

Date

Shares Issued

Consideration

Michael T. Cullen

4/28/2015

60,000

$112,500 in connection with exercise of warrants

Michael T. Cullen

6/24/2016

5,000

$50,000 pursuant to Securities Purchase Agreement

Michael T. Cullen

12/31/2014

2,000

$1,750 in connection with exercise of options

Suzanne Gagnon

5/6/2014

40,000

Services rendered as an employee.

Suzanne Gagnon

6/24/2016

3,000

$30,000 pursuant to Securities Purchase Agreement

Ryan R. Gilbertson

12/31/2014

36,360

$99,990 in connection with option exercise

Ryan R. Gilbertson

2/19/2015

36,360

$99,990 in connection with option exercise

David B. Kaysen

6/24/2016

5,000

$50,000 pursuant to Securities Purchase Agreement

Scott Kellen

6/24/2016

3,500

$35,000 pursuant to Securities Purchase Agreement

Douglas M. Polinsky

12/31/2014

40,000

$100,000 in connection with option exercise

Douglas M. Polinsky

2/19/2015

40,000

$100,000 in connection with option exercise

Paul W. Schaffer

12/31/2014

8,000

$18,200 in connection with option exercise

Paul W. Schaffer

4/18/2015

20,000

$37,500 in connection with warrant exercise

Paul W. Schaffer

5/22/2015

8,000

$25,400 in connection with option exercise

Paul W. Schaffer

6/24/2016

10,000

$100,000 pursuant to Securities Purchase Agreement

Paul W. Schaffer Trust

4/17/2015

8,909

$100,000 principal amount of converted indebtedness

D. Robert Schemel

5/20/2015

100,000

$187,500 in connection with warrant exercise

D. Robert Schemel

12/31/2014

32,000

$51,200 in connection with option exercise

D. Robert Schemel

5/20/2015

6,000

$19,050 in connection with option exercise

D. Robert Schemel

5/20/2015

40,000

$127,000 in connection with option exercise

Douglas M. Polinsky

3/31/17

83,332

$625,000 in connection with conversion of promissory notes

Ryan R. Gilbertson

3/31/17

98,000

$735,000 in connection with conversion of promissory notes, including $210,000 through Total Depth Foundation

Ryan R. Gilbertson12/13/1768,488Net exercise of stock purchase warrant

Promoters and Certain Control Persons

Michael T. Cullen, a founder of Sun Biopharma, Inc., received an option to purchase the equivalent of 2,000 shares of our common stock at $0.875 per share on December 29, 2011, as compensation for his service as its Chief Medical Officer. During 2012 and 2013, Dr. Cullen received cash compensation for his service as Chief Medical Officer in the amounts of $22,500 and $90,000, respectively. See the disclosure in the “Summary Compensation Table” above for Dr. Cullen’s compensation during 2015 and under the heading “Employment Agreements” above for additional information regarding the terms of his employment.

Paul M. Herron, a founder of Sun BioPharma, Inc., received an option to purchase the equivalent of 2,000 shares of our common stock at $0.875 per share on December 29, 2011, as compensation for his service as its President and Chief Executive Officer. During 2012, 2013 and 2014, Mr. Herron received cash compensation for his service as Chief Executive Officer in the amounts of $22,500, $90,000 and $105,000, respectively.

Clifford F. McCurdy, III, a founder of Sun BioPharma, Inc., received an option to purchase the equivalent of 2,000 shares of our common stock at $0.875 per share on December 29, 2011, as compensation for his service as its Chief Operating Officer. During 2012 and 2013, Mr. McCurdy received cash compensation for his service as Chief Operating Officer in the amounts of $11,250 and $90,000, respectively. See the disclosure in the “Summary Compensation Table” above for Mr. McCurdy’s compensation during 2015.

Thomas X. Neenan, a founder of Sun BioPharma, Inc., received cash compensation for service as a consultant in the amounts of $15,000; $60,000; and $84,000 during 2012, 2013 and 2014, respectively. As additional compensation for his service as a consultant, Dr. Neenan received an option to purchase the equivalent of 4,000 shares of our common stock at $1.10 per share on June 13, 2013, an option to purchase the equivalent of 4,000 shares of our common stock at $2.50 per share on January 22, 2014 and an option to purchase the equivalent of 6,000 shares of our common stock at $2.275 per share on July 31, 2014. During 2015, Dr. Neenan received cash compensation in the amount of $93,000 and an option to purchase the equivalent of 30,000 shares of our common stock at $3.175 per share granted on March 5, 2015 as compensation for his service as Chief Scientific Officer.


Security Ownership of Certain Beneficial OwnersSECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND ManagementMANAGEMENT

 

The following table sets forth certain information with respect to the beneficial ownership of our outstanding common stock as of December 15, 2017January 18, 2024 by (i) each of our named executive officers identified in the Summary Compensation Table below; (ii) each of our directors,directors; (iii) all of our executive officerofficers, directors and directorsdirector nominees as a group,group; and (iv) each person known to us to beneficially ownother beneficial owner of 5% or more than five percent of our outstanding shares of common stock. The rightmost columns present numbers andOwnership percentages ofare based on an estimated 480,244 shares of common stock that would be beneficially owned afteroutstanding as of the saleclose of shares of common stock and warrants in this offering andbusiness on the conversion of convertible promissory notes, including accrued but unpaid interest, into an estimated 316,304 shares of common stock. The information presented in the table is based on 3,841,652 shares of our common stock outstanding on December 15, 2017 and excludes any shares that may be purchased through the offering by the persons listed below.

same date. Beneficial ownership is determined in accordance with the rules of the SEC and generally includes voting or investment power with respect to securities. Unless otherwise indicated below, toSEC. To our knowledge and subject to applicable community property laws, each of the persons and entities named in the table haveholders of stock listed below has sole voting and investment power with respectas to all shares beneficiallythe stock owned subject to community property laws where applicable. For purposes of theunless otherwise noted. The table below includes the number of shares ofunderlying rights to acquire common stock issuable pursuant to options and warrants that can be acquiredare exercisable within 60 days of December 15, 2017, are deemed to be outstanding and to be beneficially owned by such person holding the securities but are not treated as outstanding for the purpose of computing the percentage ownership of any other person.from January 18, 2024. Except as otherwise noted below, the address for each persondirector or officer listed in the table is c/o Sun BioPharma,Panbela Therapeutics, Inc., 712 Vista Blvd #305, Waconia, Minnesota 55387.

 

 

 

Shares Beneficially Owned

  

Shares Beneficially Owned After

Offering and Conversion of

Convertible Promissory Notes

 
Name 

Number

  

Percentage

  

Number

  

Percentage

 

Executive Officers and Directors:

                

Michael T. Cullen(1)

  441,576   11.2%  441,576   8.7%

David B. Kaysen(2)

  62,400   1.6%  62,400   1.2%

Scott Kellen(3)

  28,650   *   28,650   * 

Suzanne Gagnon(4)

  93,000   2.4%  93,000   1.8%

Dalvir S. Gill(5)

  20,800   *   20,800   * 

Jeffrey S. Mathiesen(5)

  20,800   *   20,800   * 

J. Robert Paulson, Jr. (5)

  20,800   *   20,800   * 

Paul W. Schaffer(6)(7)

  147,265   3.8%  147,265   2.9%

D. Robert Schemel(8)

  392,882   10.2%  392,882   7.8%

All directors and current executive officers as a group (9 persons)(9)

  1,228,173   29.3%  1,228,173   23.0%
                 

5% Stockholders:

                

Ryan R. Gilbertson(7)(10)
1675 Neal Ave
Delano, MN 55328

  604,081   15.6%  604,081   12.1%

Paul M. Herron(11)
105 Cypress Lagoon Court
Ponte Vedra Beach, FL 32082

  245,486   6.4%  242,608   4.8%

Douglas M. Polinsky(7)(12)
328 Barry Ave S. #210
Wayzata, MN 55391

  200,424   5.2%  200,424   4.0%

Clifford F. McCurdy III(13)
15625 West Hwy 318
Williston, Florida 32696

  184,000   4.8%  184,000   3.7%

Nam e

Amount and

Nature
of

Beneficial
Ownership

Percentage of
Outstanding

Shares*

Executive Officers and Directors

Jennifer K. Simpson

33

(a)

*

Susan Horvath

27

(b)

*

Michael T. Cullen

60

(c)

*

Daniel J. Donovan

25

(d)

*

Arthur J. Fratamico

14

(e)

*

Jeffrey E. Jacob

27

(f)

*

Jeffrey S. Mathiesen

14

(g)

*

D. Robert Schemel

48

(h)

*

All directors and current executive officers as a group (8 persons)

248

(i)

*

 


*

Less than one percent.1.0%.

(1)(a)

Includes 189,576 shares held by the Cullen Living Trust, 87,50012 shares subject to stock options and 2,50014 shares subject to warrants.

(2)(b)

Includes 2,5006 shares subject to stock options and 14 shares subject to warrants.

(c)

Includes 27 shares subject to stock options, and 1 shares subject to warrants. Also includes 147 shares and 10 shares subject to warrants and 54,900in each case held by the Cullen Living Trust.

(d)

Includes 14 shares subject to stock options.

Also includes 3 shares held by Westport Boys, LLC (“Westport”), 6 shares held by GDB Investments, LLP (“GDB”). Mr. Donovan is a managing member of Westport and a designated member of GDB. Mr. Donovan disclaims beneficial ownership of the securities owned by Westport and GDB except to the extent of his pecuniary interest therein.

(3)(e)

Includes 1,75014 shares subject to stock options.

(f)

Includes 24 shares subject to options, 2 shares subject to warrants and 23,400held jointly with spouse.

(g)

Includes 14 shares subject to options.

(h)

Includes 14 shares subject to stock options.

(4)

Includes 1,000 shares held by the Gagnon Family Trust, 1,500 shares subject to warrants and 47,500 shares subject to stock options.

(5)

Includes 20,800 shares subject to stock options.

(6)

Includes 18,909options, 19 shares and 5,00012 shares subject to warrants held by the Paul Shaffer Trust, 28,800spouse

(i)

Includes 125 shares subject to stock options and an estimated 5,136 shares issuable upon the holder’s election pursuant to a convertible promissory note.

(7)

Upon a “qualified financing,” the convertible promissory note(s) beneficially owned would instead automatically convert into common stock at price of $10.10 per share or (if less) a price representing a 33% discount from either (a) the price per share of common stock (if any) offered in such financing or (b) the closing price of our common stock on the date the material terms of such financing are first publicly announced, subject to the holder’s right to elect an alternate conversion into the securities then offered at a 10% discount to the price paid in such financing. Upon a corporate transaction, the convertible promissory note would automatically convert into common stock at a price equal to $30 million divided by the number of shares then outstanding (calculated on a fully-diluted basis).

(8)

Includes 282,654 shares held by spouse and 20,80053 shares subject to stock options.

warrants.

(9)

Includes 325,000 shares subject to stock options, 13,200 shares subject to warrants and an estimated 5,136 shares issuable upon the holder’s election pursuant to a convertible promissory note.

(10)

Based on Amendment No. 1 on Schedule 13D/A filed with the SEC on April 14, 2017, reflecting beneficial ownership as of March 31, 2017. Includes an estimated 20,543 shares issuable upon the holder’s election pursuant to convertible promissory notes. $200,000 principal amount of the convertible promissory notes are held by Northern Capital Partners I, LP. As chief manager of Northern Capital Partners I, LP, Mr. Gilbertson reported sharing voting and dispositive power with respect to the shares of common stock beneficially owned by Northern Capital Partners I, LP. Also includes 28,000 shares held by Total Depth Foundation.

(11)

Based on Schedule 13G filed with the SEC on September 14, 2015, reflecting the stockholder’s beneficial ownership as of September 4, 2015. Includes 41,486 shares held jointly with spouse and 20,000 shares subject to warrants.

(12)

Includes 10,170 shares held jointly with spouse and an estimated 15,421 shares issuable upon the holder’s election pursuant to a convertible promissory note.

(13)

Based on Schedule 13G filed with the SEC on September 14, 2015, reflecting the stockholder’s beneficial ownership as of September 4, 2015.


71

 

DESCRIPTION OF SecuritiesSECURITIES

 

The following is a summary description of our securities. Itthe general terms and provisions of the common stock, par value $0.001 per share (“Common Stock”), of Panbela set forth below does not purport to be complete and is subject to and is qualified in its entirety by reference to the Corporation’s Restated Certificate of Incorporation, as amended (the “Certificate”), and Restated Bylaws of the Corporation, as amended (the “Bylaws”). For additional information, please read the Certificate, Bylaws and the applicable provisions of our certificatethe General Corporation Law of incorporation and bylaws, copiesDelaware (the “DGCL”).

Authorized Shares

The Corporation is authorized to issue up to 110,000,000 shares of capital stock, of which are attached hereto and incorporated herein by reference.

Authorized Capital Stock

Our authorized capital stock consists of: (1) 100,000,000 constitute shares of common stock, $0.001 par value per share,Common Stock and (2) 10,000,000 constitute shares of preferred stock, $0.001 par value $0.001 per share. As of December 7, 2017, there were approximately 182 holders of record of our common stock and no holders of preferred stock. As of the same date, we had 3,670,432 shares of common stock outstanding and no shares of preferred stock outstanding.share (“Preferred Stock”).

 

Common Stock

 

Voting Rights

Each share of common stock entitles the holder to one vote for all purposes and cumulative voting is not permitted in the election of directors. Significant corporate transactions, such as amendments to the certificate of incorporation, mergers, sales of assets and dissolution or liquidation, require approval by the affirmative vote of the majority of theNo outstanding shares of common stock. Other mattersstock is entitled to be voted upon by the holderspreference over any other share, and each share is equal to any other share in all respects. Holders of common stock normally require the affirmative vote of a majority of the shares present at the particular stockholders meeting.

Dividend Rights

Holders of common stock are entitled to receive such dividends as may be declared by our Boardone vote for each share held of Directors outrecord at each meeting of assets legally available therefore, and to share ratably in the assetsshareholders. Holders of our Company available upon liquidation. However, we do not anticipate paymentshares of any dividends in the foreseeable future. See “Dividend Policy.”

Liquidation and Preemptive Rights

In the event of liquidation, dissolution or winding-up, holders of our common stock are not entitled to share ratably in the assets of our Company available upon liquidation. There are noany preemptive, subscription, conversion, redemption or redemption rights pertaining to our common stock.sinking fund rights. The absence of preemptive rights could result in a dilution of the interest of investorsshareholders should additional common shares be issued.

Subject to any prior rights of any Preferred Stock then outstanding, holders of common stock are entitled to receive dividends in the form of cash, property or shares of capital stock of the Corporation, when and as declared by the board of directors, provided there are sufficient net profits or surplus legally available for that purpose. In any distribution of capital assets, such as liquidation, whether voluntary or involuntary, holders of shares of common stock be issued.are entitled to receive pro rata the assets remaining after creditors have been paid in full. All of the issued and outstanding shares of common stock are non-assessable.

Anti-Takeover Provisions

The Charter Documents and the DGCL contain certain provisions that may discourage an unsolicited takeover of the Company or make an unsolicited takeover of the Company more difficult. The following are some of the more significant anti-takeover provisions that are applicable to the Company:

 

National Exchange ListingDelaware Anti-Takeover Law

 

We intend to applyIn general, Section 203 of the DGCL prohibits a Delaware corporation with a class of voting stock listed on a national securities exchange or held of record by 2,000 or more stockholders from engaging in a Business Combination (as defined below) with an Interested Stockholder (as defined below) for a listingthree-year period following the time that this stockholder becomes an interested stockholder, unless the Business Combination is approved in a prescribed manner. A “Business Combination” includes, among other things, a merger, asset or stock sale or other transaction resulting in a financial benefit to the Interested Stockholder. An “Interested Stockholder” is a person who, together with affiliates and associates, owns, or did own within three years prior to the determination of our commonInterested Stockholder status, 15% or more of the corporation’s voting stock. Under Section 203, a Business Combination between a corporation and an Interested Stockholder is prohibited for three years unless it satisfies one of the following conditions:

Before the stockholder became an Interested Stockholder, the board of directors approved either the Business Combination or the transaction which resulted in the stockholder becoming an Interested Stockholder;

Upon consummation of the transaction which resulted in the stockholder becoming an Interested Stockholder, the Interested Stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining the voting stock outstanding, shares owned by persons who are directors and also officers, and employee stock plans, in some instances; or

At or after the time the stockholder became an Interested Stockholder, the Business Combination was approved by the board of directors of the corporation and authorized at an annual or special meeting of the stockholders by the affirmative vote of at least two-thirds of the outstanding voting stock which is not owned by the Interested Stockholder.

Requirements for Advance Notification of Stockholder Nominations and Proposals

The Bylaws establish advance-notice procedures with respect to stockholder proposals to be brought before a stockholder meeting and the warrantsnomination of candidates for election as directors, other than nominations made by or at the direction of the board of directors.

72

Special Meetings of Stockholders

The Certificate and Bylaws provide that a special meeting of stockholders may be called only by the board of directors, the Chairman of the Board or the Chief Executive Officer of the Corporation.

Classified Board of Directors

The Certificate provides that directors are divided into three classes and elected for staggered terms. At each annual meeting, approximately one third of the directors will be elected to be issued in this offering on the Nasdaq Capital Market under the symbols “SNBP” and “SNBPW,” respectively. No assuranceserve a three-year term. Directors serving staggered terms can be given thatremoved from office only for cause and only by the affirmative vote of the holders of 75% or more of the outstanding shares of stock then entitled to vote at an election of directors.

Authority of the Board of Directors

The board of directors has the power to issue any or all of the shares of the Corporation’s capital stock, including the authority to establish one or more series of Preferred Stock and to fix the powers, preferences, rights and limitations of such listing will be approvedclass or that a trading market will develop.series, without seeking stockholder approval. The board of directors has the authority to adopt and change Bylaws, subject to the right of holders of at least 66.67% of the voting power of all then-outstanding shares entitled to vote generally in the election of directors to adopt, amend or repeal Bylaws.

 

Preferred Stock

 

Our Board of Directors has the authority, without first obtaining the approval of our stockholders, to establish one or more series of preferred stock and to fix:

 

 

the number of shares of such series;

 

 

the designations, preferences and relative rights, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences; and

 

 

any qualifications, limitations or restrictions.

 

We believe that the ability of our Board of Directors to issue one or more series of preferred stock provides flexibility in structuring possible future financings and acquisitions, and in meeting other corporate needs that may arise. The authorized shares of preferred stock, as well as authorized and unissued shares of common stock, are available for issuance without action by the holders of common stock, unless such action is required by applicable law or the rules of any stock exchange or automated quotation system on which our securities may be listed or traded.


 

Our Board of Directors may authorize, without stockholder approval, the issuance of preferred stock with voting and conversion rights that could adversely affect the voting power and other rights of holders of common stock. Although our Board of Directors has no current intention of doing so, it could issue a series of preferred stock that could, depending on the terms of such series, impede the completion of a merger, tender offer or other takeover attempt of our Company. Our Board of Directors could also issue preferred stock having terms that could discourage an acquisition attempt through which an acquirer may be able to change the composition of our Board of Directors, including a tender offer or other transaction that some, or a majority, of the stockholders might believe to be in their best interests or in which stockholders might receive a premium for their stock over the then-current market price. Any issuance of preferred stock therefore could have the effect of decreasing the market price of our common stock.

 

Our Board of Directors will make any determination to issue such shares based on its judgment as to the best interests of our Company and stockholders. We have no current plans to issue any preferred stock.

 

Options

 

The 2016 Plan initially authorized the issuance of up to 1,500,000116 shares of our common stock pursuant to awards granted thereunder.thereunder and 164,246 shares have been added pursuant to its annual evergreen feature. As of December 7, 2017,January 18, 2024, options to purchase 389,600553 shares of our common stock were outstanding under the 2016 Plan with a weighted average price of $15.05$13,297.06 per share. A total of 1,110,400Approximately 163,757 shares of common stock remained available for future grants under the 2016 Plan as of the same date.

 

As of December 7, 2017,January 18, 2024, options to purchase 294,3605 shares of our common stock remained outstanding under the 2011 Plan with a weighted average price of $2.79$76,200.00 per share. We ceased making awards under the 2011 Plan upon stockholder approval of the 2016 Plan.

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As of January 18, 2024, options to purchase 41 shares of our common stock remained outstanding under CPP’s 2010 Equity Incentive Plan with a weighted average price of $6,743.41, all of which were assumed by us in connection with the acquisition of CPP.

 

Warrants Outstanding

 

As of December 7, 2017,January 18, 2024, we had issued and outstanding warrants to purchase 351,500340,952 shares of common stock and no warrants to purchase shares of preferred stock outstanding. OfAs of the same date, the outstanding warrants had a weighted average exercise price of $64.09 per share and an average remaining exercise period of 5.24 years. To the extent the offering is deemed to involve a sale of Common Stock at a price less than the exercise price of any of the following warrants, then each such warrant’s exercise price will be adjusted according to its respective terms. Under no circumstances (other than a forward stock split) will any outstanding warrants be exercisable for a greater number of shares of Common Stock.

October 2022 Warrants

In October 2022, we issued common stock purchase warrants to purchase 242,500up to an aggregate of 1,256 shares of our Common Stock (the “October 2022 Warrants”) in connection with a public offering of shares of our Common Stock and warrants. The October 2022 Warrants had an initial exercise price of $108,960.00 per share (after adjusting for subsequent reverse stock splits), were exercisable upon issuance and through October 4, 2027. The exercise price is separately subject to reduction in the event of certain future dilutive issuances of shares of Common Stock by the Company, including pursuant to common stock equivalents and convertible or derivative securities. As of January 18, 2024 there remained 285 shares underlying outstanding October 2022 Warrants, each having an adjusted exercise price of $12.39 per share.

January 2023 Warrants

In January 2023, we issued common stock purchase warrants to purchase up to an aggregate of 3,091 shares of our Common Stock (the “January 2023 Warrants”) in connection with a public offering of shares of our Common Stock and warrants. The January Warrants had an initial exercise price of $1,650.00 per share (after adjusting for subsequent reverse stock splits), were exercisable upon issuance and through January 30, 2028. The exercise price is separately subject to reduction in the event of certain future dilutive issuances of shares of Common Stock by the Company, including pursuant to common stock equivalents and convertible or derivative securities. On or after the thirty-day anniversary of their issuance, a holder of common warrants may also provide notice and elect an “alternative cashless exercise” pursuant to which they would receive an aggregate number of shares equal to the product of (x) the aggregate number of shares of common stock are exercisable atthat would be issuable upon a cash exercise and (y) 0.75. As of January 18, 2024 there remained 128 shares underlying outstanding January 2023 Warrants, each having an adjusted cash exercise price of $1.875$12.39 per share.

Class A and B Warrants

In June 2023, we issued Class A common stock purchase warrants to purchase up to an aggregate of 113,500 shares of our Common Stock (the “Class A Warrants”) and Class B common stock purchase warrants to purchase up to an aggregate of 113,500 shares of our Common Stock (the “Class B Warrants” and, together with the Class A Warrant, the “June Warrants”) in connection with a public offering of shares of our Common Stock and warrants. The June Warrants had an initial exercise price of $15.60 per share (after adjusting for upthe subsequent reverse stock split), were exercisable upon issuance and through June 16, 2028. The exercise price is separately subject to ten (10) yearsreduction in the event of certain future dilutive issuances of shares of Common Stock by the Company, including pursuant to common stock equivalents and convertible or derivative securities. With respect to the Class A Warrants only, on or after the datethirty-day anniversary of their issuance, (or earlier upon a changeholder of control orcommon warrants may also provide notice and elect an initial public offering, each as defined in“alternative cashless exercise” pursuant to which they would receive an aggregate number of shares equal to the warrants). Warrants to purchase 108,550product of (x) the aggregate number of shares of common stock that would be issuable upon a cash exercise and (y) 0.24. As of January 18, 2024 there remained 2,595 shares underlying outstanding Class A Warrants and 7,000 shares underlying outstanding Class B Warrants, each having an adjusted cash exercise price of $12.39 per share.

Class C Warrants

On November 2, 2023, we issued Class C common stock purchase warrants to purchase up to an aggregate of 213,000 shares of our Common Stock (the “Class C Warrants”) in connection with the inducement of exercises of existing warrants to purchase shares of our Common Stock. The Class C Warrants had an initial exercise price of $15.60 per share (after adjusting for the subsequent reverse stock split) and were issued pursuant toexercisable upon the Purchase Agreements and are exercisable for a perioddate of stockholder approval through the date that is five years from the date of any stockholder approvals necessary under the listing rules of Nasdaq. Our stockholders approved the issuance of the underlying shares of Common Stock at ana special meeting held on December 19, 2023. The exercise price is separately subject to reduction in the event of certain future dilutive issuances of shares of Common Stock by the Company, including pursuant to common stock equivalents and convertible or derivative securities. As of January 18, 2024 there remained 75,200 shares underlying outstanding Class C Warrants, each having a cash exercise price of $15.00$15.60 per share. The remaining

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We agreed to file a registration statement covering the resale of the shares underlying the Class C Warrants issued or issuable upon the exercise of the Class C Warrants and a registration statement on Form S-1 (File No. 333-275733) was declared effective by the SEC on December 20, 2023.

Class D Warrants

On December 21, 2023, we issued Class D common stock purchase warrants to purchase 450up to an aggregate of 255,600 shares of commonour Common Stock (the “Class D Warrants”) in connection with the inducement of exercises of existing Class C Warrants. The Class D Warrants had an initial exercise price of $19.00 per share (after adjusting for the subsequent reverse stock were issued to a private individualsplit)  and arewill only be exercisable for a periodcontingent upon and after receiving stockholder approval as required by listing rules of Nasdaq and may be exercised until five years from the date of issuance at ansuch stockholder approval, if any. The exercise price is separately subject to reduction in the event of $2.50.certain future dilutive issuances of shares of Common Stock by the Company, including pursuant to common stock equivalents and convertible or derivative securities, upon any intervening reverse stock splits, and upon receipt of the stockholder approval. As of January 18, 2024 all of the Class D Warrants remained outstanding and unexercisable pending stockholder approval.

We have agreed to file a registration statement covering the resale of the shares underlying the Class D Warrants within sixty (60) calendar days of December 21, 2023. Additionally, the Company agreed not to effect or agree to effect any variable rate transaction (as defined in the inducement letters) for one year, other than an at-the-market offering, which may be effected after six months.

 

Class E and F Warrantsto be Issued in this Offering

 

See the description under the heading “Common Warrants” below for a discussion of certain terms of the Class E and F Warrants proposed for issuance pursuant to this offering.

Pre-Funded Warrants

The following is a brief summary of certain terms and conditionsprovisions of pre-funded warrants that are being offered hereby is not complete and is subject to, and qualified in its entirety by, the provisions of the warrants to be issued in connection with this offering and are subject in all respects to the provisions contained in the warrants.

Form

The warrants will be issued in electronic book-entry form to the investors. You should review a copy ofpre-funded warrant, the form of warrant, which is filed as an exhibit to the registration statement of which this prospectus forms a part,part. Prospective investors should carefully review the terms and provisions of the form of pre-funded warrant for a complete description of the terms andand conditions applicable toof the pre-funded warrants.


Exercisability

 

Duration and Exercise Price. Each pre-funded warrant offered hereby will have an initial exercise price per share equal to $0.001. The pre-funded warrants arewill be immediately exercisable and may be exercised at any time after their original issuance, expecteduntil the pre-funded warrants are exercised in full. The exercise price and number of shares of common stock issuable upon exercise is subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting our common stock and the exercise price. The pre-funded warrants will be          , 2017,issued separately from the accompanying common warrants and at any time up to the date that is five years after their original issuance.may be transferred separately immediately thereafter.

Exercisability. The pre-funded warrants will be exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executed exercise notice accompanied by payment in full for the number of shares of our common stock purchased upon such exercise (except in the case of a cashless exercise as discussed below). Purchasers of the pre-funded warrants in this offering may elect to deliver their exercise notice following the pricing of the offering and at any time a registration statement registeringprior to the issuance of the pre-funded warrants at closing to have their pre-funded warrants exercised immediately upon issuance and receive shares of common stock underlying the pre-funded warrants under the Securities Act is effective and available for the issuanceupon closing of such shares, or an exemption from registration under the Securities Act is available for the issuance of such shares, by payment in full in immediately available funds for the number of shares of common stock purchased upon such exercise. If a registration statement registering the issuance of the shares of common stock underlying the warrants under the Securities Act is not effective or available and an exemption from registration under the Securities Act is not available for the issuance of such shares, the holder may, in its sole discretion, elect to exercise the warrant through a cashless exercise, in which case the holder would receive upon such exercise the net number of shares of common stock determined according to the formula set forth in the warrant. No fractional shares of common stock will be issued in connection with the exercise of a warrant. In lieu of fractional shares, we will pay to the holder an amount in cash equal to the fractional amount multiplied by the exercise price or round up to the next whole share.

Exercise Limitation

this offering. A holder will(together with its affiliates) may not have the right to exercise any portion of the pre-funded warrant ifto the extent that the holder (together with its affiliates) would beneficially own in excessmore than 4.99% of 4.99%the outstanding common stock immediately after exercise, except that upon at least 61 days’ prior notice from the holder to us, the holder may increase the amount of ownership of outstanding stock after exercising the holder’s pre-funded warrants up to 9.99% of the number of shares of our common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the pre-funded warrants. However, any holderPurchasers of pre-funded warrants in this offering may increase or decrease such percentagealso elect prior to any other percentage not in excessthe issuance of the pre-funded warrants to have the initial exercise limitation set at 9.99% upon at least 61 days’ prior notice from the holder to us.

Exercise Price

The exercise price per whole shareof our outstanding common stock. No fractional shares of common stock purchasable uponwill be issued in connection with the exercise of a pre-funded warrant. In lieu of fractional shares, we will round down to the next whole share.

Cashless Exercise. If, at the time a holder exercises its pre-funded warrants, is expected to be $15.00 per share, which is equal to 125%a registration statement registering the issuance of the public offering price of one shareshares of common stock and warrant. Theunderlying the pre-funded warrants under the Securities Act is not then effective or available, then in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, is subjectthe holder may elect instead to appropriate adjustmentreceive upon such exercise (either in whole or in part) the net number of shares of common stock determined according to a formula set forth in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting our common stock and also upon any distributions of assets, including cash, stock or other property to our stockholders.pre-funded warrants.

 

TransferabilityTransferability.

Subject to applicable laws, the warrantsa pre-funded warrant may be offeredtransferred at the option of the holder upon surrender of the pre-funded warrant to us together with the appropriate instruments of transfer.

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Exchange Listing. There is no trading market available for sale, sold, transferredthe pre-funded warrants on any securities exchange or assigned without our consent.nationally recognized trading system. We do not intend to list the pre-funded warrants on any securities exchange or nationally recognized trading system.

 

Fundamental TransactionsRight as a Stockholder. Except as otherwise provided in the pre-funded warrants or by virtue of such holder’s ownership of shares of our common stock, the holders of the pre-funded warrants do not have the rights or privileges of holders of our common stock, including any voting rights, until they exercise their pre-funded warrants.

 

Fundamental Transaction.In the event of a fundamental transaction, as described in the pre-funded warrants and generally including any reorganization, recapitalization or reclassification of our common stock, the sale, transfer or other disposition of all or substantially all of our properties or assets, our consolidation or merger with or into another person, the acquisition of more than 50% of our outstanding common stock, or any person or group becoming the beneficial owner of 50% of the voting power represented by our outstanding common stock, the holders of the pre-funded warrants will be entitled to receive upon exercise of the pre-funded warrants the kind and amount of securities, cash or other property that the holders would have received had they exercised the pre-funded warrants immediately prior to such fundamental transaction.

 

Common Warrants

The following summary of certain terms and provisions of the common warrants that are being offered hereby is not complete and is subject to, and qualified in its entirety by, the provisions of the common warrants, the form of which is filed as an exhibit to the registration statement of which this prospectus forms a part. Prospective investors should carefully review the terms and provisions of the form of common warrants for a complete description of the terms and conditions of the common warrants.

Duration and Exercise Price. Each common warrant offered hereby will have an initial exercise price per share equal to $      . The common warrants will be immediately exercisable and will expire on the fifth anniversary of the original issuance date. The exercise price and number of shares of common stock issuable upon exercise is subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting our common stock and the exercise price. The exercise price is separately subject to reduction in the event of (i) certain future dilutive issuances of shares of common stock by us, including pursuant to common stock equivalents and convertible or derivative securities and (ii) any reverse stock split. The common warrants will be issued separately from the common stock and will be held separately immediately thereafter. One Class E Warrant to purchase one share of our common stock and One Class F Warrant to purchase one share of our common stock will be issued for every share of common stock or pre-funded warrant to purchase one share purchased in this offering.

Exercisability. The common warrants will be exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executed exercise notice accompanied by payment in full for the number of shares of our common stock purchased upon such exercise (except in the case of a cashless exercise as discussed below). A holder (together with its affiliates) may not exercise any portion of the common warrant to the extent that the holder would own more than 4.99% of the outstanding common stock immediately after exercise, except that upon at least 61 days’ prior notice from the holder to us, the holder may increase the amount of ownership of outstanding stock after exercising the holder’s common warrants up to 9.99% of the number of shares of our common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the common warrants. No fractional shares of common stock will be issued in connection with the exercise of a common warrant. In lieu of fractional shares, we will round down to the next whole share.

Cashless Exercise. If, at the time a holder exercises its common warrants, a registration statement registering the issuance of the shares of common stock underlying the common warrants under the Securities Act is not then effective or available and an exemption from registration under the Securities Act is not available for the issuance of such shares, then in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of shares of common stock determined according to a formula set forth in the common warrants.

Alternative Cashless Exercise. On or after the thirty-day anniversary of their issuance, a holder of Class E Warrants may also provide notice and elect an “alternative cashless exercise” pursuant to which they would receive an aggregate number of shares equal the product of (x) the aggregate number of shares of common stock that would be issuable upon a cash exercise and (y) 0.24.

Transferability. Subject to applicable laws, a common warrant in book entry form may be transferred at the option of the holder through the facilities of the Depository Trust Company and common warrants in physical form may be transferred upon surrender of the common warrant to the warrant agent together with the appropriate instruments of transfer. Pursuant to a warrant agency agreement between us and VStock Transfer, as warrant agent, the common warrants initially will be issued in book-entry form and will be represented by one or more global certificates deposited with The Depository Trust Company (“DTC”) and registered in the name of Cede & Co., a nominee of DTC, or as otherwise directed by DTC.

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Anti-Takeover Provisions

The Charter Documents and the DGCL contain certain provisions that may discourage an unsolicited takeover of the Company or make an unsolicited takeover of the Company more difficult. The following are some of the more significant anti-takeover provisions that are applicable to the Company:

Exchange ListingDelaware Anti-Takeover Law

 

There is no established public trading market forIn general, Section 203 of the warrants. We intend to apply to list the warrants on The Nasdaq Capital Market under the symbol “SNBPW.” If we are unable to obtain listingDGCL prohibits a Delaware corporation with a class of voting stock listed on a national securities exchange then we intendor held of record by 2,000 or more stockholders from engaging in a Business Combination (as defined below) with an Interested Stockholder (as defined below) for a three-year period following the time that this stockholder becomes an interested stockholder, unless the Business Combination is approved in a prescribed manner. A “Business Combination” includes, among other things, a merger, asset or stock sale or other transaction resulting in a financial benefit to seek qualificationthe Interested Stockholder. An “Interested Stockholder” is a person who, together with affiliates and associates, owns, or did own within three years prior to the determination of Interested Stockholder status, 15% or more of the warrants to be issued in this offeringcorporation’s voting stock. Under Section 203, a Business Combination between a corporation and an Interested Stockholder is prohibited for quotation onthree years unless it satisfies one of the over-the-counter markets.following conditions:

Before the stockholder became an Interested Stockholder, the board of directors approved either the Business Combination or the transaction which resulted in the stockholder becoming an Interested Stockholder;

Upon consummation of the transaction which resulted in the stockholder becoming an Interested Stockholder, the Interested Stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining the voting stock outstanding, shares owned by persons who are directors and also officers, and employee stock plans, in some instances; or

At or after the time the stockholder became an Interested Stockholder, the Business Combination was approved by the board of directors of the corporation and authorized at an annual or special meeting of the stockholders by the affirmative vote of at least two-thirds of the outstanding voting stock which is not owned by the Interested Stockholder.

 

Warrant AgentRequirements for Advance Notification of Stockholder Nominations and Proposals

 

The Bylaws establish advance-notice procedures with respect to stockholder proposals to be brought before a stockholder meeting and the nomination of candidates for election as directors, other than nominations made by or at the direction of the board of directors.

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Special Meetings of Stockholders

The Certificate and Bylaws provide that a special meeting of stockholders may be called only by the board of directors, the Chairman of the Board or the Chief Executive Officer of the Corporation.

Classified Board of Directors

The Certificate provides that directors are divided into three classes and elected for staggered terms. At each annual meeting, approximately one third of the directors will be elected to serve a three-year term. Directors serving staggered terms can be removed from office only for cause and only by the affirmative vote of the holders of 75% or more of the outstanding shares of stock then entitled to vote at an election of directors.

Authority of the Board of Directors

The board of directors has the power to issue any or all of the shares of the Corporation’s capital stock, including the authority to establish one or more series of Preferred Stock and to fix the powers, preferences, rights and limitations of such class or series, without seeking stockholder approval. The board of directors has the authority to adopt and change Bylaws, subject to the right of holders of at least 66.67% of the voting power of all then-outstanding shares entitled to vote generally in the election of directors to adopt, amend or repeal Bylaws.

Preferred Stock

Our Board of Directors has the authority, without first obtaining the approval of our stockholders, to establish one or more series of preferred stock and to fix:

the number of shares of such series;

the designations, preferences and relative rights, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences; and

any qualifications, limitations or restrictions.

We believe that the ability of our Board of Directors to issue one or more series of preferred stock provides flexibility in structuring possible future financings and acquisitions, and in meeting other corporate needs that may arise. The authorized shares of preferred stock, as well as authorized and unissued shares of common stock, are available for issuance without action by the holders of common stock, unless such action is required by applicable law or the rules of any stock exchange or automated quotation system on which our securities may be listed or traded.

Our Board of Directors may authorize, without stockholder approval, the issuance of preferred stock with voting and conversion rights that could adversely affect the voting power and other rights of holders of common stock. Although our Board of Directors has no current intention of doing so, it could issue a series of preferred stock that could, depending on the terms of such series, impede the completion of a merger, tender offer or other takeover attempt of our Company. Our Board of Directors could also issue preferred stock having terms that could discourage an acquisition attempt through which an acquirer may be able to change the composition of our Board of Directors, including a tender offer or other transaction that some, or a majority, of the stockholders might believe to be in their best interests or in which stockholders might receive a premium for their stock over the then-current market price. Any issuance of preferred stock therefore could have the effect of decreasing the market price of our common stock.

Our Board of Directors will make any determination to issue such shares based on its judgment as to the best interests of our Company and stockholders. We have no current plans to issue any preferred stock.

Options

The 2016 Plan initially authorized the issuance of up to 116 shares of our common stock pursuant to awards granted thereunder and 164,246 shares have been added pursuant to its annual evergreen feature. As of January 18, 2024, options to purchase 553 shares of our common stock were outstanding under the 2016 Plan with a weighted average price of $13,297.06 per share. Approximately 163,757 shares of common stock remained available for future grants under the 2016 Plan as of the same date.

As of January 18, 2024, options to purchase 5 shares of our common stock remained outstanding under the 2011 Plan with a weighted average price of $76,200.00 per share. We ceased making awards under the 2011 Plan upon stockholder approval of the 2016 Plan.

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As of January 18, 2024, options to purchase 41 shares of our common stock remained outstanding under CPP’s 2010 Equity Incentive Plan with a weighted average price of $6,743.41, all of which were assumed by us in connection with the acquisition of CPP.

Warrants Outstanding

As of January 18, 2024, we had issued and outstanding warrants to purchase 340,952 shares of common stock and no warrants to purchase shares of preferred stock outstanding. As of the same date, the outstanding warrants had a weighted average exercise price of $64.09 per share and an average remaining exercise period of 5.24 years. To the extent the offering is deemed to involve a sale of Common Stock at a price less than the exercise price of any of the following warrants, then each such warrant’s exercise price will be adjusted according to its respective terms. Under no circumstances (other than a forward stock split) will any outstanding warrants be exercisable for a greater number of shares of Common Stock.

October 2022 Warrants

In October 2022, we issued common stock purchase warrants to purchase up to an aggregate of 1,256 shares of our Common Stock (the “October 2022 Warrants”) in connection with a public offering of shares of our Common Stock and warrants. The October 2022 Warrants had an initial exercise price of $108,960.00 per share (after adjusting for subsequent reverse stock splits), were exercisable upon issuance and through October 4, 2027. The exercise price is separately subject to reduction in the event of certain future dilutive issuances of shares of Common Stock by the Company, including pursuant to common stock equivalents and convertible or derivative securities. As of January 18, 2024 there remained 285 shares underlying outstanding October 2022 Warrants, each having an adjusted exercise price of $12.39 per share.

January 2023 Warrants

In January 2023, we issued common stock purchase warrants to purchase up to an aggregate of 3,091 shares of our Common Stock (the “January 2023 Warrants”) in connection with a public offering of shares of our Common Stock and warrants. The January Warrants had an initial exercise price of $1,650.00 per share (after adjusting for subsequent reverse stock splits), were exercisable upon issuance and through January 30, 2028. The exercise price is separately subject to reduction in the event of certain future dilutive issuances of shares of Common Stock by the Company, including pursuant to common stock equivalents and convertible or derivative securities. On or after the thirty-day anniversary of their issuance, a holder of common warrants may also provide notice and elect an “alternative cashless exercise” pursuant to which they would receive an aggregate number of shares equal to the product of (x) the aggregate number of shares of common stock that would be issuable upon a cash exercise and (y) 0.75. As of January 18, 2024 there remained 128 shares underlying outstanding January 2023 Warrants, each having an adjusted cash exercise price of $12.39 per share.

Class A and B Warrants

In June 2023, we issued Class A common stock purchase warrants to purchase up to an aggregate of 113,500 shares of our Common Stock (the “Class A Warrants”) and Class B common stock purchase warrants to purchase up to an aggregate of 113,500 shares of our Common Stock (the “Class B Warrants” and, together with the Class A Warrant, the “June Warrants”) in connection with a public offering of shares of our Common Stock and warrants. The June Warrants had an initial exercise price of $15.60 per share (after adjusting for the subsequent reverse stock split), were exercisable upon issuance and through June 16, 2028. The exercise price is separately subject to reduction in the event of certain future dilutive issuances of shares of Common Stock by the Company, including pursuant to common stock equivalents and convertible or derivative securities. With respect to the Class A Warrants only, on or after the thirty-day anniversary of their issuance, a holder of common warrants may also provide notice and elect an “alternative cashless exercise” pursuant to which they would receive an aggregate number of shares equal to the product of (x) the aggregate number of shares of common stock that would be issuable upon a cash exercise and (y) 0.24. As of January 18, 2024 there remained 2,595 shares underlying outstanding Class A Warrants and 7,000 shares underlying outstanding Class B Warrants, each having an adjusted cash exercise price of $12.39 per share.

Class C Warrants

On November 2, 2023, we issued Class C common stock purchase warrants to purchase up to an aggregate of 213,000 shares of our Common Stock (the “Class C Warrants”) in connection with the inducement of exercises of existing warrants to purchase shares of our Common Stock. The Class C Warrants had an initial exercise price of $15.60 per share (after adjusting for the subsequent reverse stock split) and were exercisable upon the date of stockholder approval through the date that is five years from the date of any stockholder approvals necessary under the listing rules of Nasdaq. Our stockholders approved the issuance of the underlying shares of Common Stock at a special meeting held on December 19, 2023. The exercise price is separately subject to reduction in the event of certain future dilutive issuances of shares of Common Stock by the Company, including pursuant to common stock equivalents and convertible or derivative securities. As of January 18, 2024 there remained 75,200 shares underlying outstanding Class C Warrants, each having a cash exercise price of $15.60 per share.

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We agreed to file a registration statement covering the resale of the shares underlying the Class C Warrants issued or issuable upon the exercise of the Class C Warrants and a registration statement on Form S-1 (File No. 333-275733) was declared effective by the SEC on December 20, 2023.

Class D Warrants

On December 21, 2023, we issued Class D common stock purchase warrants to purchase up to an aggregate of 255,600 shares of our Common Stock (the “Class D Warrants”) in connection with the inducement of exercises of existing Class C Warrants. The Class D Warrants had an initial exercise price of $19.00 per share (after adjusting for the subsequent reverse stock split)  and will only be exercisable contingent upon and after receiving stockholder approval as required by listing rules of Nasdaq and may be exercised until five years from the date of such stockholder approval, if any. The exercise price is separately subject to reduction in the event of certain future dilutive issuances of shares of Common Stock by the Company, including pursuant to common stock equivalents and convertible or derivative securities, upon any intervening reverse stock splits, and upon receipt of the stockholder approval. As of January 18, 2024 all of the Class D Warrants remained outstanding and unexercisable pending stockholder approval.

We have agreed to file a registration statement covering the resale of the shares underlying the Class D Warrants within sixty (60) calendar days of December 21, 2023. Additionally, the Company agreed not to effect or agree to effect any variable rate transaction (as defined in the inducement letters) for one year, other than an at-the-market offering, which may be effected after six months.

Class E and F Warrants

See the description under the heading “Common Warrants” below for a discussion of certain terms of the Class E and F Warrants proposed for issuance pursuant to this offering.

Pre-Funded Warrants

The following summary of certain terms and provisions of pre-funded warrants that are being offered hereby is not complete and is subject to, and qualified in its entirety by, the provisions of the pre-funded warrant, the form of which is filed as an exhibit to the registration statement of which this prospectus forms a part. Prospective investors should carefully review the terms and provisions of the form of pre-funded warrant for a complete description of the terms and conditions of the pre-funded warrants.

Duration and Exercise Price. Each pre-funded warrant offered hereby will have an initial exercise price per share equal to $0.001. The pre-funded warrants will be immediately exercisable and may be exercised at any time until the pre-funded warrants are exercised in full. The exercise price and number of shares of common stock issuable upon exercise is subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting our common stock and the exercise price. The pre-funded warrants will be issued separately from the accompanying common warrants and may be transferred separately immediately thereafter.

Exercisability. The pre-funded warrants will be exercisable, at the option of each holder, in registered formwhole or in part, by delivering to us a duly executed exercise notice accompanied by payment in full for the number of shares of our common stock purchased upon such exercise (except in the case of a cashless exercise as discussed below). Purchasers of the pre-funded warrants in this offering may elect to deliver their exercise notice following the pricing of the offering and prior to the issuance of the pre-funded warrants at closing to have their pre-funded warrants exercised immediately upon issuance and receive shares of common stock underlying the pre-funded warrants upon closing of this offering. A holder (together with its affiliates) may not exercise any portion of the pre-funded warrant to the extent that the holder would own more than 4.99% of the outstanding common stock immediately after exercise, except that upon at least 61 days’ prior notice from the holder to us, the holder may increase the amount of ownership of outstanding stock after exercising the holder’s pre-funded warrants up to 9.99% of the number of shares of our common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the pre-funded warrants. Purchasers of pre-funded warrants in this offering may also elect prior to the issuance of the pre-funded warrants to have the initial exercise limitation set at 9.99% of our outstanding common stock. No fractional shares of common stock will be issued in connection with the exercise of a pre-funded warrant. In lieu of fractional shares, we will round down to the next whole share.

Cashless Exercise. If, at the time a holder exercises its pre-funded warrants, a registration statement registering the issuance of the shares of common stock underlying the pre-funded warrants under the Securities Act is not then effective or available, then in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of shares of common stock determined according to a formula set forth in the pre-funded warrants.

Transferability. Subject to applicable laws, a pre-funded warrant agency agreement between VStock Transfer, asmay be transferred at the option of the holder upon surrender of the pre-funded warrant agent, and us.to us together with the appropriate instruments of transfer.

 


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RightsExchange Listing. There is no trading market available for the pre-funded warrants on any securities exchange or nationally recognized trading system. We do not intend to list the pre-funded warrants on any securities exchange or nationally recognized trading system.

Right as a Stockholder

. Except as otherwise provided in the pre-funded warrants or by virtue of such holder’s ownership of shares of our common stock, the holderholders of a warrant doesthe pre-funded warrants do not have the rights or privileges of a holderholders of our common stock, including any voting rights, until the holder exercises the warrant.they exercise their pre-funded warrants.

 

Representatives Warrants to be IssuedFundamental Transaction. In the event of a fundamental transaction, as described in this Offering

We have agreed to issue to Aegis Capital Corp., the representative of underwriters in this offering,pre-funded warrants to purchase up to 5.0% of the sharesand generally including any reorganization, recapitalization or reclassification of our common stock, issued in the offering (exclusive of any shares to be issued pursuant to the exercise of the over-allotment option or the exercise of any warrants sold in this offering). Please see “Underwriting – Representative’s Warrants” for a description of the warrants we have agreed to issue to the representative of the underwriters , subject to the completion of the offering. We expect to enter into a warrant agreement in respect of the Representative’s Warrants prior to the closing of this offering.

2017 Convertible Notes

As of September 30, 2017 we had outstanding $3,076,000 aggregate principal amount of convertible promissory notes (the “2017 Notes”). The 2017 Notes are scheduled to mature on December 1, 2018 and bear interest at a rate of 5.0% per year. Principal and interest on the 2017 Notes are payable at maturity. We may prepay the 2017 Notes in whole or in part at any time without penalty or premium. The 2017 Notes are convertible into shares of our common stocksale, transfer or other securities upon the occurrence of a Qualified Financing, including the sale of equity securities or a strategic partnership, raising gross proceeds of at least $2.0 million on or before the maturity of the 2017 Notes or upon the request of a holder of any 2017 Note at a fixed conversion rate of $10.10 per share. Upon issuance, the 2017 Notes were convertible into our common stock at a conversion rate of $10.10 per share. The fair market value of our stock on the dates of issuance ranged from $15.00 to $39.00 per share. Therefore the 2017 Notes contained a beneficial conversion feature with an aggregate intrinsic value of approximately $3.0 million, which was recorded as a debt discount and is presented as a direct deduction from the carrying value of the 2017 Notes and will be amortized through interest expense over the life of the 2017 Notes. Upon the occurrence of certain events of default, the 2017 Notes require the Company to repay the unpaid principal amount of the Notes and any unpaid accrued interest. If all of the outstanding Notes, including accrued but unpaid interest, had converted into shares of common stock as of September 30, 2017, the holders would have received an estimated total of 313,134 shares of common stock.

Term Debt

As of September 30, 2017 we had an outstanding term note of $300,000 at a fixed interest rate of 4.125% held by the Institute. No principal or interest payments are due until the maturity date, October 26, 2017, unless a mandatory repayment event occurs. A mandatory repayment event includes, (i) a liquidity event defined as a saledisposition of all or substantially all of our assets; aproperties or assets, our consolidation or merger consolidation, share exchangewith or similar transaction as a resultinto another person, the acquisition of whichmore than 50% of our outstanding common stock, or any person or group becoming the persons holding our equity constituting a majoritybeneficial owner of 50% of the outstanding equity by voting power represented by our outstanding common stock, the holders of the pre-funded warrants will be entitled to receive upon exercise of the pre-funded warrants the kind and amount of securities, cash or economic participationother property that the holders would have received had they exercised the pre-funded warrants immediately prior to such fundamental transaction.

Common Warrants

The following summary of certain terms and provisions of the transaction hold less than a majoritycommon warrants that are being offered hereby is not complete and is subject to, and qualified in its entirety by, the provisions of such voting power or economic participation immediately after such transaction; or a sale or transfer of outstanding equity in a transaction as a resultthe common warrants, the form of which is filed as an exhibit to the persons holding our equity constitutingregistration statement of which this prospectus forms a majoritypart. Prospective investors should carefully review the terms and provisions of the outstanding equity by voting power or economic participation immediately prior to the transaction hold less than a majority of such voting power or economic participation immediately after such transaction, (ii) an event of default, (iii) a failure to maintain a Florida base of operations for more than 6 months, (iv) a sale or transfer of licensed technology, (v) any false representation to the Institute, (vi) a violation of law by us or one of our principal officers, or (vii) an achievement of aggregate revenues during any fiscal year of more than $4,000,000 from sales of products and/or services.


2013 Convertible Note

As of September 30, 2017, we had outstanding a convertible promissory note in the principal amount of $25,000 (the “2013 Note”). This note bears 5.0% simple interest per annum on its unpaid principal balance. All unpaid principal and unpaid and accrued interest is due and payable on the earlier to occur of (i) written demand of the holder after December 27, 2018 (the “Maturity Date”), (ii) the initial public offering of our Common Stock, (iii) a Change of Control (as defined in the 2013 Note), or (iv) the continuance of an Event of Default that is not cured within the cure period (as defined in the 2013 Note). Prior to the Maturity Date, any or all of the outstanding principal amount and accrued and unpaid interest of the 2013 Note may, upon written election of the holder, be converted into fully paid and nonassessable shares of our commons stock at a rate of $11.25 per share. If the 2013 Note had converted into sharesform of common stock aswarrants for a complete description of September 30, 2017, the holder would have received an estimated total of 2,222 shares of common stock, excluding accrued interest, which we have historically paid in cash on a quarterly basis.

Participation Rights

On March 27, 2017, we entered into a Participation Agreement (collectively, the “Participation Agreements”) with each holder of the 2017 Notes (the “Participants”), pursuant to which the Participants have a right to purchase his, her, or its pro rata portion of any future equity issuances in the Company (based on the Company equity securities shares held by the Participant immediately prior to the subject issuance), subject to certain exceptions described therein. Prior to any proposed issuance or sale of new equity securities, we will give the Participants written notice thereof pursuant to the terms and conditions of the Participation Agreement.common warrants.

 

UnderDuration and Exercise Price. Each common warrant offered hereby will have an initial exercise price per share equal to $      . The common warrants will be immediately exercisable and will expire on the Participation Agreements, we are obligated to give each participant noticefifth anniversary of the proposedoriginal issuance date. The exercise price and number of shares of common stock issuable upon exercise is subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting our common stock and the exercise price. The exercise price is separately subject to reduction in the event of (i) certain future dilutive issuances of shares of common stock by us, including pursuant to common stock equivalents and convertible or derivative securities and (ii) any reverse stock split. The common warrants will be issued separately from the common stock and will be held separately immediately thereafter. One Class E Warrant to purchase one share of our common stock and One Class F Warrant to purchase one share of our common stock will be issued for every share of common stock or pre-funded warrant to purchase one share purchased in this offeringoffering.

Exercisability. The common warrants will be exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executed exercise notice accompanied by payment in full for the number of shares of our common stock purchased upon such exercise (except in the case of a cashless exercise as promptly as is reasonably practical and prudent in lightdiscussed below). A holder (together with its affiliates) may not exercise any portion of the timing and naturecommon warrant to the extent that the holder would own more than 4.99% of the offering andoutstanding common stock immediately after exercise, except that upon at least 61 days’ prior notice from the holder to use commercially reasonable efforts to causeus, the underwriters to allow (but not obligate) each participant to participate inholder may increase the offering in an amount of ownership of outstanding stock after exercising the holder’s common warrants up to their respective pro rata portion on9.99% of the same terms, conditions and price to be providednumber of shares of our common stock outstanding immediately after giving effect to the public. Our obligations remain subject to each participant’s compliance with any timing, indication, eligibility and documentation requirements imposed by the underwriters.

Registration Rights

The shares underlying the 2017 Notes are subject to certain demand registration rights. After the closing of a Qualified Financing (defined below) and prior to the date on which the underlying securities may be sold without registration and without restriction orexercise, as such percentage ownership is determined in accordance with Rule 144 promulgatedthe terms of the common warrants. No fractional shares of common stock will be issued in connection with the exercise of a common warrant. In lieu of fractional shares, we will round down to the next whole share.

Cashless Exercise. If, at the time a holder exercises its common warrants, a registration statement registering the issuance of the shares of common stock underlying the common warrants under the Securities Act is not then effective or available and an exemption from registration under the Securities Act is not available for the issuance of such shares, then in a single transaction, holderslieu of at least 75%making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of shares underlyingof common stock determined according to a formula set forth in the outstanding 2017 Notes (the “Note Shares”)common warrants.

Alternative Cashless Exercise. On or after the thirty-day anniversary of their issuance, a holder of Class E Warrants may demandalso provide notice and elect an “alternative cashless exercise” pursuant to which they would receive an aggregate number of shares equal the product of (x) the aggregate number of shares of common stock that would be issuable upon a cash exercise and (y) 0.24.

Transferability. Subject to applicable laws, a common warrant in book entry form may be transferred at the Company register their Note Shares. For purposesoption of the demand registration rights, a “Qualified Financing” meansholder through the first transaction or seriesfacilities of related transactionsthe Depository Trust Company and common warrants in whichphysical form may be transferred upon surrender of the Company (i) sells any of its Equity Securities, (ii) receives a cash infusion relatedcommon warrant to the negotiationwarrant agent together with the appropriate instruments of transfer. Pursuant to a warrant agency agreement between us and VStock Transfer, as warrant agent, the common warrants initially will be issued in book-entry form and will be represented by one or entering into,more global certificates deposited with The Depository Trust Company (“DTC”) and registered in the name of Cede & Co., a strategic partnership, (iii) onnominee of DTC, or before the maturity of the 2017 Notes and (iv) with gross proceeds to the Company of at least $2 million (excluding the amount attributable to the conversion of the 2017 Notes).as otherwise directed by DTC.

 

Although this offering is likely to constitute a Qualified Financing, we may postpone for up to 90 days the filing or effectiveness of a registration statement pursuant to the foregoing demand registration rights if our Board of Directors determines that such registration would among other things, materially interfere with any securities offering, including this offering.

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Anti-Takeover Provisions

 

ProvisionsThe Charter Documents and the DGCL contain certain provisions that may discourage an unsolicited takeover of our certificatethe Company or make an unsolicited takeover of incorporation and amended and restated bylaws may delaythe Company more difficult. The following are some of the more significant anti-takeover provisions that are applicable to the Company:

Delaware Anti-Takeover Law

In general, Section 203 of the DGCL prohibits a Delaware corporation with a class of voting stock listed on a national securities exchange or discourage transactions involvingheld of record by 2,000 or more stockholders from engaging in a Business Combination (as defined below) with an actual or potential changeInterested Stockholder (as defined below) for a three-year period following the time that this stockholder becomes an interested stockholder, unless the Business Combination is approved in our control or change in our management, including transactions in which stockholders might otherwise receive a premium for their shares, or transactions that our stockholders might otherwise deem to be in their best interests. Therefore, these provisions could adversely affect the price of our common stock. Amongprescribed manner. A “Business Combination” includes, among other things, our certificatea merger, asset or stock sale or other transaction resulting in a financial benefit to the Interested Stockholder. An “Interested Stockholder” is a person who, together with affiliates and associates, owns, or did own within three years prior to the determination of incorporationInterested Stockholder status, 15% or more of the corporation’s voting stock. Under Section 203, a Business Combination between a corporation and amended and restated bylaws:an Interested Stockholder is prohibited for three years unless it satisfies one of the following conditions:

 

 

provide that all vacancies, including newly created directorships, may, except as otherwise required by law, be filled byBefore the affirmative vote of a majoritystockholder became an Interested Stockholder, the board of directors thenapproved either the Business Combination or the transaction which resulted in office, even if less than a quorum;the stockholder becoming an Interested Stockholder;

 

 

authorizes our BoardUpon consummation of Directors to issue onethe transaction which resulted in the stockholder becoming an Interested Stockholder, the Interested Stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining the voting stock outstanding, shares owned by persons who are directors and also officers, and employee stock plans, in some instances; or more classes or series of preferred stock without stockholder approval;


require that any action to be taken by our stockholders must be effected at a duly called annual or special meeting of stockholders and not be taken by written consent;

 

 

provide for a classified BoardAt or after the time the stockholder became an Interested Stockholder, the Business Combination was approved by the board of Directors,directors of the corporation and authorized at an annual or special meeting of the stockholders by the affirmative vote of at least two-thirds of the outstanding voting stock which means that our directors are divided into three classes that are elected to three-year terms on a staggered basis andis not owned by the entireInterested Stockholder.

Requirements for Advance Notification of Stockholder Nominations and Proposals

The Bylaws establish advance-notice procedures with respect to stockholder proposals to be brought before a stockholder meeting and the nomination of candidates for election as directors, other than nominations made by or at the direction of the board of directors.

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Special Meetings of Stockholders

The Certificate and Bylaws provide that a special meeting of stockholders may be called only by the board of directors, the Chairman of the Board or the Chief Executive Officer of the Corporation.

Classified Board of Directors

The Certificate provides that directors are divided into three classes and elected for staggered terms. At each annual meeting, approximately one third of the directors will be elected to serve a three-year term. Directors serving staggered terms can be removed from office only for cause and only by the affirmative vote of the holders of 75% or more of the outstanding shares of stock then entitled to vote at an election of directors.

Authority of the Board of Directors

The board of directors has the power to issue any or all of the shares of the Corporation’s capital stock, including the authority to establish one or more series of Preferred Stock and to fix the powers, preferences, rights and limitations of such class or series, without seeking stockholder approval. The board of directors has the authority to adopt and change Bylaws, subject to the right of holders of at least 66.67% of the voting power of all then-outstanding shares entitled to vote generally in the election of directors to adopt, amend or repeal Bylaws.

Preferred Stock

Our Board of Directors has the authority, without first obtaining the approval of our stockholders, to establish one or more series of preferred stock and to fix:

the number of Directors cannot be replaced in any one year;shares of such series;

 

 

provide that stockholders seeking to present proposals before a meeting of stockholders or to nominate candidates for election as directors at a meeting of stockholders must provide notice in writing in a timely manner,the designations, preferences and also specify requirements as to the formrelative rights, including voting rights, dividend rights, conversion rights, redemption privileges and content of a stockholder’s notice;liquidation preferences; and

 

 

do not provide for cumulative voting rights (therefore allowing the holders of a majority of the shares of common stock entitled to vote in any election of directors to elect all of the directors standing for election, if they should so choose);

provide that special meetings of our stockholders may be called only by the Chairman of the Board, our Chief Executive Officerqualifications, limitations or by our Board of Directors pursuant to a resolution adopted by a majority of the total number of authorized directors; and

provide that stockholders will be permitted to amend our amended and restated bylaws only upon receiving at least 66.67% of the votes entitled to be cast by holders of all outstanding shares then entitled to vote generally in the election of directors, voting together as a single class.restrictions.

 

Limitation on LiabilityWe believe that the ability of our Board of Directors to issue one or more series of preferred stock provides flexibility in structuring possible future financings and Indemnificationacquisitions, and in meeting other corporate needs that may arise. The authorized shares of preferred stock, as well as authorized and unissued shares of common stock, are available for issuance without action by the holders of common stock, unless such action is required by applicable law or the rules of any stock exchange or automated quotation system on which our securities may be listed or traded.

 

Our certificateBoard of incorporation limitsDirectors may authorize, without stockholder approval, the liabilityissuance of preferred stock with voting and conversion rights that could adversely affect the voting power and other rights of holders of common stock. Although our Board of Directors has no current intention of doing so, it could issue a series of preferred stock that could, depending on the terms of such series, impede the completion of a merger, tender offer or other takeover attempt of our Company. Our Board of Directors could also issue preferred stock having terms that could discourage an acquisition attempt through which an acquirer may be able to change the composition of our Board of Directors, including a tender offer or other transaction that some, or a majority, of the directorsstockholders might believe to be in their best interests or in which stockholders might receive a premium for their stock over the fullest extent permitted by Delaware law. Delaware law provides that directorsthen-current market price. Any issuance of a corporation will not be personally liable for monetary damages for breachpreferred stock therefore could have the effect of their fiduciary duties as directors, except for liability for any:

breach of their duty of loyalty to us or our stockholders;

act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;

unlawful payment of dividends or redemption of shares as provided in Section 174 of the Delaware General Corporation Law; or

transaction from which the directors derived an improper personal benefit.

These limitationsdecreasing the market price of liability do not apply to liabilities arising under federal securities laws and do not affect the availability of equitable remedies such as injunctive relief or rescission.our common stock.

 

Our bylaws provide that weBoard of Directors will indemnify our directors and executive officers, and may indemnify other officers, employees and other agents,make any determination to issue such shares based on its judgment as to the fullest extent permittedbest interests of our Company and stockholders. We have no current plans to issue any preferred stock.

Options

The 2016 Plan initially authorized the issuance of up to 116 shares of our common stock pursuant to awards granted thereunder and 164,246 shares have been added pursuant to its annual evergreen feature. As of January 18, 2024, options to purchase 553 shares of our common stock were outstanding under the 2016 Plan with a weighted average price of $13,297.06 per share. Approximately 163,757 shares of common stock remained available for future grants under the 2016 Plan as of the same date.

As of January 18, 2024, options to purchase 5 shares of our common stock remained outstanding under the 2011 Plan with a weighted average price of $76,200.00 per share. We ceased making awards under the 2011 Plan upon stockholder approval of the 2016 Plan.

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As of January 18, 2024, options to purchase 41 shares of our common stock remained outstanding under CPP’s 2010 Equity Incentive Plan with a weighted average price of $6,743.41, all of which were assumed by law. Our amended and restated bylaws also permit us to secure insurance on behalf of any officer, director, employee or other agent for any liability arising out of his or her actions in connection with the acquisition of CPP.

Warrants Outstanding

As of January 18, 2024, we had issued and outstanding warrants to purchase 340,952 shares of common stock and no warrants to purchase shares of preferred stock outstanding. As of the same date, the outstanding warrants had a weighted average exercise price of $64.09 per share and an average remaining exercise period of 5.24 years. To the extent the offering is deemed to involve a sale of Common Stock at a price less than the exercise price of any of the following warrants, then each such warrant’s exercise price will be adjusted according to its respective terms. Under no circumstances (other than a forward stock split) will any outstanding warrants be exercisable for a greater number of shares of Common Stock.

October 2022 Warrants

In October 2022, we issued common stock purchase warrants to purchase up to an aggregate of 1,256 shares of our Common Stock (the “October 2022 Warrants”) in connection with a public offering of shares of our Common Stock and warrants. The October 2022 Warrants had an initial exercise price of $108,960.00 per share (after adjusting for subsequent reverse stock splits), were exercisable upon issuance and through October 4, 2027. The exercise price is separately subject to reduction in the event of certain future dilutive issuances of shares of Common Stock by the Company, including pursuant to common stock equivalents and convertible or derivative securities. As of January 18, 2024 there remained 285 shares underlying outstanding October 2022 Warrants, each having an adjusted exercise price of $12.39 per share.

January 2023 Warrants

In January 2023, we issued common stock purchase warrants to purchase up to an aggregate of 3,091 shares of our Common Stock (the “January 2023 Warrants”) in connection with a public offering of shares of our Common Stock and warrants. The January Warrants had an initial exercise price of $1,650.00 per share (after adjusting for subsequent reverse stock splits), were exercisable upon issuance and through January 30, 2028. The exercise price is separately subject to reduction in the event of certain future dilutive issuances of shares of Common Stock by the Company, including pursuant to common stock equivalents and convertible or derivative securities. On or after the thirty-day anniversary of their servicesissuance, a holder of common warrants may also provide notice and elect an “alternative cashless exercise” pursuant to us, regardlesswhich they would receive an aggregate number of whethershares equal to the product of (x) the aggregate number of shares of common stock that would be issuable upon a cash exercise and (y) 0.75. As of January 18, 2024 there remained 128 shares underlying outstanding January 2023 Warrants, each having an adjusted cash exercise price of $12.39 per share.

Class A and B Warrants

In June 2023, we issued Class A common stock purchase warrants to purchase up to an aggregate of 113,500 shares of our amendedCommon Stock (the “Class A Warrants”) and restated bylaws permit indemnification. Class B common stock purchase warrants to purchase up to an aggregate of 113,500 shares of our Common Stock (the “Class B Warrants” and, together with the Class A Warrant, the “June Warrants”) in connection with a public offering of shares of our Common Stock and warrants. The June Warrants had an initial exercise price of $15.60 per share (after adjusting for the subsequent reverse stock split), were exercisable upon issuance and through June 16, 2028. The exercise price is separately subject to reduction in the event of certain future dilutive issuances of shares of Common Stock by the Company, including pursuant to common stock equivalents and convertible or derivative securities. With respect to the Class A Warrants only, on or after the thirty-day anniversary of their issuance, a holder of common warrants may also provide notice and elect an “alternative cashless exercise” pursuant to which they would receive an aggregate number of shares equal to the product of (x) the aggregate number of shares of common stock that would be issuable upon a cash exercise and (y) 0.24. As of January 18, 2024 there remained 2,595 shares underlying outstanding Class A Warrants and 7,000 shares underlying outstanding Class B Warrants, each having an adjusted cash exercise price of $12.39 per share.

Class C Warrants

On November 2, 2023, we issued Class C common stock purchase warrants to purchase up to an aggregate of 213,000 shares of our Common Stock (the “Class C Warrants”) in connection with the inducement of exercises of existing warrants to purchase shares of our Common Stock. The Class C Warrants had an initial exercise price of $15.60 per share (after adjusting for the subsequent reverse stock split) and were exercisable upon the date of stockholder approval through the date that is five years from the date of any stockholder approvals necessary under the listing rules of Nasdaq. Our stockholders approved the issuance of the underlying shares of Common Stock at a special meeting held on December 19, 2023. The exercise price is separately subject to reduction in the event of certain future dilutive issuances of shares of Common Stock by the Company, including pursuant to common stock equivalents and convertible or derivative securities. As of January 18, 2024 there remained 75,200 shares underlying outstanding Class C Warrants, each having a cash exercise price of $15.60 per share.

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We have obtainedagreed to file a directors’registration statement covering the resale of the shares underlying the Class C Warrants issued or issuable upon the exercise of the Class C Warrants and officers’ liability insurance policy.a registration statement on Form S-1 (File No. 333-275733) was declared effective by the SEC on December 20, 2023.

Class D Warrants

On December 21, 2023, we issued Class D common stock purchase warrants to purchase up to an aggregate of 255,600 shares of our Common Stock (the “Class D Warrants”) in connection with the inducement of exercises of existing Class C Warrants. The Class D Warrants had an initial exercise price of $19.00 per share (after adjusting for the subsequent reverse stock split)  and will only be exercisable contingent upon and after receiving stockholder approval as required by listing rules of Nasdaq and may be exercised until five years from the date of such stockholder approval, if any. The exercise price is separately subject to reduction in the event of certain future dilutive issuances of shares of Common Stock by the Company, including pursuant to common stock equivalents and convertible or derivative securities, upon any intervening reverse stock splits, and upon receipt of the stockholder approval. As of January 18, 2024 all of the Class D Warrants remained outstanding and unexercisable pending stockholder approval.

 

We have entered,agreed to file a registration statement covering the resale of the shares underlying the Class D Warrants within sixty (60) calendar days of December 21, 2023. Additionally, the Company agreed not to effect or agree to effect any variable rate transaction (as defined in the inducement letters) for one year, other than an at-the-market offering, which may be effected after six months.

Class E and intendF Warrants

See the description under the heading “Common Warrants” below for a discussion of certain terms of the Class E and F Warrants proposed for issuance pursuant to continuethis offering.

Pre-Funded Warrants

The following summary of certain terms and provisions of pre-funded warrants that are being offered hereby is not complete and is subject to, enter, into separate indemnification agreements with our executive officers,and qualified in additionits entirety by, the provisions of the pre-funded warrant, the form of which is filed as an exhibit to the indemnification providedregistration statement of which this prospectus forms a part. Prospective investors should carefully review the terms and provisions of the form of pre-funded warrant for a complete description of the terms and conditions of the pre-funded warrants.

Duration and Exercise Price. Each pre-funded warrant offered hereby will have an initial exercise price per share equal to $0.001. The pre-funded warrants will be immediately exercisable and may be exercised at any time until the pre-funded warrants are exercised in full. The exercise price and number of shares of common stock issuable upon exercise is subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting our certificatecommon stock and the exercise price. The pre-funded warrants will be issued separately from the accompanying common warrants and may be transferred separately immediately thereafter.

Exercisability. The pre-funded warrants will be exercisable, at the option of incorporation and bylaws. These agreements, among other things, requireeach holder, in whole or in part, by delivering to us to indemnify our executive officersa duly executed exercise notice accompanied by payment in full for certain expenses, including attorneys’ fees, judgments, fines and settlement amounts incurred by an executive officer in any action or proceeding arising outthe number of their services as oneshares of our executive officers, orcommon stock purchased upon such exercise (except in the case of a cashless exercise as discussed below). Purchasers of the pre-funded warrants in this offering may elect to deliver their exercise notice following the pricing of the offering and prior to the issuance of the pre-funded warrants at closing to have their pre-funded warrants exercised immediately upon issuance and receive shares of common stock underlying the pre-funded warrants upon closing of this offering. A holder (together with its affiliates) may not exercise any portion of the pre-funded warrant to the extent that the holder would own more than 4.99% of the outstanding common stock immediately after exercise, except that upon at least 61 days’ prior notice from the holder to us, the holder may increase the amount of ownership of outstanding stock after exercising the holder’s pre-funded warrants up to 9.99% of the number of shares of our subsidiaries or any other company or enterprisecommon stock outstanding immediately after giving effect to which the person provides servicesexercise, as such percentage ownership is determined in accordance with the terms of the pre-funded warrants. Purchasers of pre-funded warrants in this offering may also elect prior to the issuance of the pre-funded warrants to have the initial exercise limitation set at 9.99% of our request.outstanding common stock. No fractional shares of common stock will be issued in connection with the exercise of a pre-funded warrant. In lieu of fractional shares, we will round down to the next whole share.

 

Except as described above under “Certain Relationships and Related Party Transactions,”Cashless Exercise. If, at present there is no pending litigation or proceeding involving anythe time a holder exercises its pre-funded warrants, a registration statement registering the issuance of the current or former directors or officers as to which indemnification is required or permitted, and we are not awareshares of any threatened litigation or proceeding that may result in a claim for indemnification.


Insofar as indemnification for liabilities arisingcommon stock underlying the pre-funded warrants under the Securities Act is not then effective or available, then in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of shares of common stock determined according to a formula set forth in the pre-funded warrants.

Transferability. Subject to applicable laws, a pre-funded warrant may be permitted to directors, officers and controlling personstransferred at the option of the registrant pursuantholder upon surrender of the pre-funded warrant to us together with the foregoing provisions,appropriate instruments of transfer.

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Exchange Listing. There is no trading market available for the pre-funded warrants on any securities exchange or nationally recognized trading system. We do not intend to list the pre-funded warrants on any securities exchange or nationally recognized trading system.

Right as a Stockholder. Except as otherwise the registrant has been advised thatprovided in the opinionpre-funded warrants or by virtue of such holder’s ownership of shares of our common stock, the holders of the SEC this indemnification is against public policy as expressed inpre-funded warrants do not have the Securities Act and is therefore unenforceable. rights or privileges of holders of our common stock, including any voting rights, until they exercise their pre-funded warrants.

Fundamental Transaction.In the event of a fundamental transaction, as described in the pre-funded warrants and generally including any reorganization, recapitalization or reclassification of our common stock, the sale, transfer or other disposition of all or substantially all of our properties or assets, our consolidation or merger with or into another person, the acquisition of more than 50% of our outstanding common stock, or any person or group becoming the beneficial owner of 50% of the voting power represented by our outstanding common stock, the holders of the pre-funded warrants will be entitled to receive upon exercise of the pre-funded warrants the kind and amount of securities, cash or other property that a claim for indemnification againstthe holders would have received had they exercised the pre-funded warrants immediately prior to such liabilities (other thanfundamental transaction.

Common Warrants

The following summary of certain terms and provisions of the paymentcommon warrants that are being offered hereby is not complete and is subject to, and qualified in its entirety by, the registrant of expenses incurred or paid by a director, officer or controlling personprovisions of the registrantcommon warrants, the form of which is filed as an exhibit to the registration statement of which this prospectus forms a part. Prospective investors should carefully review the terms and provisions of the form of common warrants for a complete description of the terms and conditions of the common warrants.

Duration and Exercise Price. Each common warrant offered hereby will have an initial exercise price per share equal to $      . The common warrants will be immediately exercisable and will expire on the fifth anniversary of the original issuance date. The exercise price and number of shares of common stock issuable upon exercise is subject to appropriate adjustment in the successful defenseevent of stock dividends, stock splits, reorganizations or similar events affecting our common stock and the exercise price. The exercise price is separately subject to reduction in the event of (i) certain future dilutive issuances of shares of common stock by us, including pursuant to common stock equivalents and convertible or derivative securities and (ii) any action, suitreverse stock split. The common warrants will be issued separately from the common stock and will be held separately immediately thereafter. One Class E Warrant to purchase one share of our common stock and One Class F Warrant to purchase one share of our common stock will be issued for every share of common stock or proceeding)pre-funded warrant to purchase one share purchased in this offering.

Exercisability. The common warrants will be exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executed exercise notice accompanied by payment in full for the number of shares of our common stock purchased upon such exercise (except in the case of a cashless exercise as discussed below). A holder (together with its affiliates) may not exercise any portion of the common warrant to the extent that the holder would own more than 4.99% of the outstanding common stock immediately after exercise, except that upon at least 61 days’ prior notice from the holder to us, the holder may increase the amount of ownership of outstanding stock after exercising the holder’s common warrants up to 9.99% of the number of shares of our common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is asserted by such director, officer or controlling persondetermined in accordance with the terms of the common warrants. No fractional shares of common stock will be issued in connection with the securities being registered,exercise of a common warrant. In lieu of fractional shares, we will round down to the registrant will, unless innext whole share.

Cashless Exercise. If, at the opiniontime a holder exercises its common warrants, a registration statement registering the issuance of its counsel the matter has been settled by controlling precedent, submit to a courtshares of appropriate jurisdictioncommon stock underlying the question whether such indemnification by it is against public policy as expressed incommon warrants under the Securities Act is not then effective or available and an exemption from registration under the Securities Act is not available for the issuance of such shares, then in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of shares of common stock determined according to a formula set forth in the common warrants.

Alternative Cashless Exercise. On or after the thirty-day anniversary of their issuance, a holder of Class E Warrants may also provide notice and elect an “alternative cashless exercise” pursuant to which they would receive an aggregate number of shares equal the product of (x) the aggregate number of shares of common stock that would be issuable upon a cash exercise and (y) 0.24.

Transferability. Subject to applicable laws, a common warrant in book entry form may be transferred at the option of the holder through the facilities of the Depository Trust Company and common warrants in physical form may be transferred upon surrender of the common warrant to the warrant agent together with the appropriate instruments of transfer. Pursuant to a warrant agency agreement between us and VStock Transfer, as warrant agent, the common warrants initially will be issued in book-entry form and will be governedrepresented by one or more global certificates deposited with The Depository Trust Company (“DTC”) and registered in the final adjudicationname of Cede & Co., a nominee of DTC, or as otherwise directed by DTC.

76

Exchange Listing. There is no established public trading market for the common warrants, and we do not expect a market to develop. In addition, we do not intend to list the common warrants on any securities exchange or nationally recognized trading system. Without an active trading market, the liquidity of the common warrants will be limited.

Right as a Stockholder. Except as otherwise provided in the common warrants or by virtue of such issue.holder’s ownership of shares of our common stock, the holders of the common warrants do not have the rights or privileges of holders of our common stock, including any voting rights, until they exercise their common warrants.

Fundamental Transaction. In the event of a fundamental transaction, as described in the form of common warrant, and generally including any reorganization, recapitalization or reclassification of our common stock, the sale, transfer or other disposition of all or substantially all of our properties or assets, our consolidation or merger with or into another person, the acquisition of more than 50% of our outstanding common stock, or any person or group becoming the beneficial owner of 50% of the voting power represented by our outstanding common stock, the holders of the common warrants will be entitled to receive upon exercise of the common warrants the kind and amount of securities, cash or other property that the holders would have received had they exercised the common warrants immediately prior to such fundamental transaction.

 

Transfer Agent, Registrar, and RegistrarWarrant Agent

 

The transfer agent and registrar for our common stock, warrant agent for the October 2022 Warrants, January 2022 Warrants, and Class A and B Warrants, and the proposed warrant agent for the Class E and F Warrants is VStock Transfer, which can be contacted at 18 Lafayette Place, Woodmere, New York, 11598, info@vstocktransfer.com, or +1 (212) 828-8436. VStock Transfer will also act as the warrant agent for the warrants.828-8436.

 

Electronic Distribution

77

 

This prospectus in electronic format may be made available on websites or through other online services maintained by the underwriter, or by its affiliates. Other than this prospectus in electronic format, the information on the underwriter’s website and any information contained in any other website maintained by the underwriter is not part of this prospectus or the registration statement of which this prospectus forms a part, has not been approved and/or endorsed by us or the underwriter in its capacity as underwriter, and should not be relied upon by investors.

SHARES ELIGIBLE FOR FUTURE SALE

 

Future sales of substantial amounts of our common stock in the public market, including shares issued upon exercise of outstanding options and warrants, or the anticipation of these sales, could adversely affect prevailing market prices from time to time and could impair our ability to raise equity capital in the future.

 

Upon the closing of this offering, we will have a total of 4,820,4303,487,763 shares of our common stock outstanding (or 4,945,534 shares if the underwriters exercise their option to purchase additional shares of common stock in full), and a total of 5,237,4449,502,401 shares of our common stock outstanding if the warrants sold in this offering are exercised for cash in full, (or 5,425,100 shares if the underwriters exercise their option to purchase additional shares of common stock and additional warrants in full and the warrants are exercised) based on the 3,670,432480,244 shares of our common stock outstanding as of December 7, 2017 and an estimated 315,970 shares of common stock issuable pursuant to the conversion of promissory notes as a result of the offering.January 18, 2024. Of these outstanding shares, all of the shares sold in the offering will be freely tradable, except that any shares purchased in this offering by our affiliates, as that term is defined in Rule 144 under the Securities Act, would only be able to be sold in compliance with the limitations described below. In addition, we expect that the warrants and the shares issued upon exercise of the warrants issued in this offering will be freely tradeable except for any such warrants or shares issued to our affiliates, which would also only be able to be sold in compliance Rule 144.

 

Rule144

 

In general, under Rule 144 as currently in effect, once we have been subject to public company reporting requirements for at least 90 days, a person who is not deemed to have been one of our affiliates for purposes of the Securities Act at any time during the 90 days preceding a sale and who has beneficially owned the shares proposed to be sold for at least six months, including the holding period of any prior owner other than our affiliates, is entitled to sell those shares without complying with the manner of sale, volume limitation or notice provisions of Rule 144, subject to compliance with the public information requirements of Rule 144. If such a person has beneficially owned the shares proposed to be sold for at least one year, including the holding period of any prior owner other than our affiliates, then that person would be entitled to sell those shares upon expiration of the lock-up agreements described below, without complying with any of the requirements of Rule 144.

 


In general, under Rule 144, as currently in effect, our affiliates or persons selling shares on behalf of our affiliates are entitled to sell upon expiration of the lock-up agreements described below, within any three-month period, a number of shares that does not exceed the greater of:

 

 

1% of the number of shares of our common stock then outstanding, which will equal approximately 45,04434,878 shares immediately after this offering; or

 

 

if and when our common stock is listed on the Nasdaq Capital Market, the average weekly trading volume of our common stock on such market during the four calendar weeks preceding the filing of a notice on Form 144 with respect to the sale.

 

Sales under Rule 144 by our affiliates or persons selling shares on behalf of our affiliates are also subject to certain manner of sale provisions and notice requirements and to the availability of current public information about us.

 

Rule 701

 

Rule 701 generally allows a stockholder who purchased shares of our common stock pursuant to a written compensatory plan or contract and who is not deemed to have been an affiliate of our company during the immediately preceding 90 days to sell these shares in reliance upon Rule 144, but without being required to comply with the public information or holding period provisions of Rule 144. Rule 701 also permits affiliates of our company to sell their Rule 701 shares under Rule 144 without complying with the holding period requirements of Rule 144. All holders of Rule 701 shares, however, are required by that rule to wait until 90 days after the date of this prospectus before selling those shares pursuant to Rule 701, subject to the market standoff agreements and lock-up agreements described below.

 

Stock Options and Warrants

 

AsSee “Description of December 7, 2017, options to purchaseSecurities” above for a total of 683,960 shares of common stock were outstanding, of which 490,410 were vested. Of the total number of shares of our common stock issuable under these options, approximately 70% were subject to contractual lock-up agreements with the underwriter described below, and will become eligible for sale, subject to any applicable limitations of Rule 144, at the expiration of those agreements.

As of December 7, 2017, warrants to purchase a total of 351,500 shares of common stock were outstanding. In addition, warrants to purchase 458,714 shares of common stock are being offered hereby or will be issued to the underwriter upon the closing of the offering. Upon the exercise of outstanding warrants, and the warrants offered hereby and otherwise issuable as a result of the offering, 789,365 shares underlying these warrants will become eligible for sale, subject to any applicable limitations of Rule 144.

Convertible Promissory Notes

As of December 7, 2017, promissory notes representing the right to receive an estimated 315,970 shares of common stock (representing the conversion of principal and accrued interest through that date) were outstanding. If and when issued, all of the shares underlying the promissory notes will become eligible for sale, subject to any applicable limitations of Rule 144.

Lock-Up Agreements

We, our officers and directors and each of our stockholders who hold 5% or morediscussion of our outstanding common stock expectand options warrant to enter into lock up agreements with the underwriter prior to the commencement of this offering. See “Underwriting – Lock-up Agreements” for additional information regarding the terms of these agreements. Following the expiration of the lock-up agreements, covered shares will become eligible for sale, subject to any applicable limitations of Rule 144.


UNDERWRITING

Aegis Capital Corp. is acting as the representative of the underwriters of the offering. We have entered into an underwriting agreement dated              , 2017 with the representative. Subject to the terms and conditions of the underwriting agreement, we have agreed to sell to each underwriter named below and each underwriter named below has agreed, severally but not jointly, to purchase from us, at the public offering price less the underwriting discount set forth on the cover page of this prospectus, the number of shares of common stock and warrants listed next to its name in the following table:

Underwriters

Number of
Shares

Number of

Warrants

Aegis Capital Corp.

Lake Street Capital Markets, LLC

TOTAL

The underwriters are committed to purchase all the shares of common stock and warrants offered by us other than those covered by the option to purchase additional shares of common stock and/or warrants described below, if they purchase any shares of common stock and warrants. The obligations of the underwriters may be terminated upon the occurrence of certain events specified in the underwriting agreement. Furthermore, pursuant to the underwriting agreement, the underwriters’ obligations are subject to customary conditions, representations and warranties contained in the underwriting agreement, such as receipt by the underwriters of officers’ certificates and legal opinions.

We have agreed to indemnify the underwriters against specified liabilities, including liabilities under the Securities Act, and to contribute to payments the underwriters may be required to make in respect thereof.

The underwriters are offering the shares of common stock and warrants, subject to prior sale, when, as and if issued to and accepted by them, subject to approval of legal matters by their counsel and other conditions specified in the underwriting agreement. The underwriters reserve the right to withdraw, cancel or modify offers to the public and to reject orders in whole or in part.

Over-allotment Option

We have granted the underwriters an over-allotment option. This option, which is exercisable for up to 45 days after the date of this prospectus, permits the underwriters to purchase a maximum of 125,104 additional shares of common stock (15% of the shares sold in this offering) and/or warrants to purchase up to 62,552 shares of common stock (15% of the warrants sold in this offering) from us to cover over-allotments, if any. If the underwriters exercise all or part of this option, they will purchase shares of common stock and/or warrants covered

PLAN OF DISTRIBUTION

Pursuant to a placement agency agreement, dated as of           , 2024, we have engaged Roth Capital Partners, LLC to act as our lead placement agent to solicit offers to purchase the securities offered by the option at the public offering price per share and/or warrant that appears on the cover page of this prospectus lesson a reasonable best efforts basis. The placement agent is not purchasing or selling any securities, nor is it required to arrange for the underwriting discount. Ifpurchase and sale of any specific number or dollar amount of securities, other than to use its “reasonable best efforts” to arrange for the sale of the securities by us. Therefore, we may not sell the entire amount of securities being offered, or any at all. The placement agent may engage one or more subagents or selected dealers in connection with this option is exercised in full, the gross proceeds from the public will be approximately $1.5 million and the total net proceeds, before expenses, to us will be approximately $1.4 million.offering.

 


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DiscountWe expect to enter into a securities purchase agreement directly with the institutional investors, at the investor’s option, who purchase our securities in this offering. Investors who do not enter into a securities purchase agreement shall rely solely on this prospectus in connection with the purchase of our securities in this offering.

The placement agency agreement provides that the placement agent’s obligations are subject to the conditions contained in the placement agency agreement.

We will deliver the securities being issued to the investors upon receipt of investor funds for the purchase of the securities offered pursuant to this prospectus. We expect to deliver the securities being offered pursuant to this prospectus on or about          , 2024. There is no minimum number of securities or amount of proceeds that is a condition to closing of this offering.

Placement Agent Fees, Commissions and Expenses

Upon the closing of this offering, we will pay the placement agent a cash transaction fee equal to 7.0% of the aggregate gross proceeds to us from the sale of the securities in the offering. In addition, we will reimburse the placement agent for its out-of-pocket expenses incurred in connection with this offering, including the fees and expenses of the counsel for the placement agent, up to $100,000.

 

The following table shows the public offering price, underwriting discount, non-accountable expense allowanceplacement agent fees and proceeds,, before expenses, to us. The information assumes either no exercise or full exercise byus, assuming the underwriterspurchase of all the over-allotment option.securities we are offering.

 

  

Per Share and

Common
Total(1)

Per ShareWarrant

  

Per Pre-Funded

Warrant(1)

Without Over- and

Common
Allotment Option

With Over-

Allotment OptionWarrant

 

Public offering price

 

$

   

$

Placement Agent fees

$

   

$

$

Underwriting discount (7%)

$$$$

Non-accountable expense allowance (1%)

$$$$  

Proceeds to us, before expenses to us

 

$

   

$

$$

  


(1)

Does not include warrants to purchase shares of common stock equal to 5% of the number of the common stock sold in the offering to be issued to the underwriter at the closing.

The underwriters propose to offer the shares of common stock and warrants directly to the public at the public offering price set forth on the cover page of this prospectus. In addition, the underwriters may offer some of the common stock and warrants to other securities dealers at such price less a concession of $      per share of common stock. After this offering, this offering price and concessions and discounts to brokers and dealers and other selling terms may from time to time be changed by the underwriters.

We have agreed to pay the representative of the underwriters a non-accountable expense allowance of 1% of the public offering price at the closing.

We have paid an expense deposit of $20,000 to the representative of the underwriters for out-of-pocket accountable expenses, which will be applied against the accountable expenses (in compliance with the Financial Industry Regulatory Authority (“FINRA”) Rule 5110(f)(2)(C)) that will be paid by us to the underwriters in connection with this offering.

We have also agreed to pay the underwriters’ expenses relating to the offering, including: (a) all filing fees and communication expenses relating to the registration of the shares of common stock to be sold in this offering (including any shares sold upon exercise of the over-allotment option) with the SEC; (b) all filing fees associated with the review of the offering by FINRA; (c) all fees and expenses relating to the listing of such shares of common stock and warrants sold in this offering on the Nasdaq Capital Market, the Nasdaq Global Market, Nasdaq Global Select Market, or the NYSE American and on such other stock exchanges as we and the representative together determine; (d) all fees, expenses and disbursements relating to background checks of the Company’s officers and directors in an amount not to exceed $4,000 per individual and $15,000 in the aggregate; (e) all fees, expenses and disbursements relating to the registration or qualification of such shares of common stock and warrants sold in this offering under the “blue sky” securities laws of such states and other jurisdictions (including without limitation, all filing and registration fees, and the reasonable fees and disbursements of “blue sky” counsel); (f) all fees, expenses and disbursements relating to the registration, qualification or exemption of such shares of common stock and warrants to be sold in this offering under the securities laws of such foreign jurisdiction as the representative and we mutually designate; (g) the costs of all mailing and printing of the underwriting documents (including, without limitation, the underwriting agreement, any blue sky surveys and, if appropriate, any agreement among underwriters, selected dealers’ agreement, underwriters’ questionnaire and power of attorney), registration statements, prospectuses and all amendments, supplements and exhibits thereto and as many preliminary and final prospectuses as the representative may reasonably deem necessary; (h) the costs of preparing printing and delivering certificates representing the shares of common stock and warrants to be sold in this offering; (i) fees and expenses of the transfer agent for the common stock and warrants; (j) stock transfer and/or stamp taxes, if any, payable upon the transfer of securities from the Company to the representative; (k) the fees and expenses of the Company’s accountants; (l) the fees and expenses of the Company’s legal counsel and other agents and representatives; (m) the fees and expenses of the underwriter’s legal counsel not to exceed $75,000; (n) the $25,000 cost associated with the use of Ipreo’s book building, prospectus tracking and compliance software for the offering; (o) the costs associated with post-closing advertising the offering in the national editions of the Wall Street Journal and New York Times; (p) the costs associated with bound volumes of the public offering materials as well as commemorative mementos and lucite tombstones not to exceed $2,500; and (q) up to $20,000 of the representative’s actual accountable “road show” expenses for the offering.


 

We estimate that the total expenses of thisthe offering, including registration, filing and listing fees, printing fees and legal and accounting expenses, but excluding the underwriting discount and the non-accountable expense allowance,placement agent fees, will be approximately $372,000.$     , all of which are payable by us. This figure includes the placement agent’s accountable expenses, including, but not limited to, legal fees for placement agent’s legal counsel, that we have agreed to pay at the closing of the offering up to an aggregate expense reimbursement of $100,000.

 

Lock-Up Agreements

 

We and our executive officers and directors and each of our stockholders who hold 5% or more of our outstanding common stock expect to enter into lock up agreements with the representative prior to the commencement of this offering pursuant to which each of these persons or entities, for a period of 90 days from the effective date of the registration statement of which this prospectus forms a part, without the prior consent of the representative, agree not to (1)(a) offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, lend,hypothecate, pledge or otherwise transferdispose of (or enter into any transaction which is designed to, or dispose of,might reasonably be expected to, result in the disposition (whether by actual disposition or effective economic disposition due to cash settlement or otherwise), directly or indirectly, or establish or increase a put equivalent position or liquidate or decrease a call equivalent position within the meaning of Section 16 of the Exchange Act, any shares of our capitalcommon stock or any securities convertible, into or exercisable or exchangeable forinto, shares of our capital stock;common stock;; (b) file or cause to be filed any registration statement with the SEC relating to the offering of any shares of our capital stock or any securities convertible into or exercisable or exchangeable for shares of our capital stock;stock or issue, enter into any agreement to issue, or announce the issuance or any proposed issuance of, any of the foregoing; or (c) enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of our capital stock, whether any such transaction described in (a), (b) or (c) above is to be settled by delivery of shares of our capital stock or such other securities, in cash or otherwise.

 

Representatives Warrants

Indemnification

 

We have agreed to issueindemnify the placement agent against certain liabilities, including liabilities under the Securities Act, and to contribute to payments that the placement agent may be required to make for these liabilities.

Determination of Offering Price and Warrant Exercise Price

The actual public offering price of the securities we are offering, and the exercise price of the common warrants and pre-funded warrants that we are offering, will be negotiated between us, the placement agent and the investors in the offering based on the trading price of our common stock prior to the representative warrants to purchase up to a total of 41,701 shares of common stock (5% of the shares of common stock sold in this offering, exclusive of any shares to be issued pursuant to the exercise of the over-allotment option or the exercise of any warrants sold in this offering. The warrantsamong other things. Other factors that will be exercisable at any time, and from time to time,considered in whole or in part, during the four-year period commencing one year from the effective date of this offering and ending five years from the effective date of the offering in compliance with FINRA Rule 5110(f)(2)(G)(i). The warrants are exercisable at a per share price equal to $13.80 per share, or 115% ofdetermining the public offering price of one sharethe securities we are offering, as well as the exercise price of the common stockwarrants and warrant inpre-funded warrants that we are offering include our history and prospects, the stage of development of our business, our business plans for the future and the extent to which they have been implemented, an assessment of our management, the general conditions of the securities markets at the time of the offering (assuming a public offering priceand such other factors as are deemed relevant, including the Nasdaq Minimum Price (as defined in Nasdaq Listing Rule 5635(d)).

79

Other Compensation

If within six (6) months following the termination or expiration of $12.00 per share and warrant). Theour engagement with the placement agent, we complete any sale of equity or equity-linked securities for which the placement agent is not acting as underwriter or placement agent (other than the exercise by any person or entity of any options, warrants have been deemed compensation by FINRA and are thereforeor other convertible securities) to any of the investors that the placement agent introduced to us or with which the placement agent conducted discussions on our behalf, subject to specified exceptions, then we are required to pay to the placement agent a 180 day lock-up pursuantcommission as described in this section, in each case only with respect to FINRA Rule 5110(g)(1). the portion of such financing received from such investors.

Regulation M

The representative (or permitted assignees under FINRA Rule 5110(g)(1)) will not sell, transfer, assign, pledge, or hypothecate these warrants orplacement agent may be deemed to be an underwriter within the meaning of Section 2(a)(11) of the Securities Act, and any commissions received by it and any profit realized on the resale of the securities underlyingsold by it while acting as principal might be deemed to be underwriting discounts or commissions under the Securities Act. As an underwriter, the placement agent would be required to comply with the requirements of the Securities Act and the Exchange Act, including, without limitation, Rule 10b-5 and Regulation M under the Exchange Act. These rules and regulations may limit the timing of purchases and sales of our securities by the placement agent acting as principal. Under these warrants, nor will theyrules and regulations, the placement agent (i) may not engage in any hedging, short sale, derivative, put,stabilization activity in connection with our securities and (ii) may not bid for or call transaction that would resultpurchase any of our securities or attempt to induce any person to purchase any of our securities, other than as permitted under the Exchange Act, until it has completed its participation in the effective economic disposition of the warrants or the underlying securities for a period of 180 days from the effective date of the offering. In addition, the warrants provide for registration rights upon request, in certain cases. The demand registration right provided will not be greater than five years from the effective date of the offering in compliance with FINRA Rule 5110(f)(2)(G)(iv). The piggyback registration right provided will not be greater than seven years from the effective date of the offering in compliance with FINRA Rule 5110(f)(2)(G)(v). We will bear all fees and expenses attendant to registering the securities issuable on exercise of the warrants other than underwriting commissions incurred and payable by the holders. The exercise price and number of shares issuable upon exercise of the warrants may be adjusted in certain circumstances including in the event of a stock dividend, extraordinary cash dividend or our recapitalization, reorganization, merger or consolidation. However, the warrant exercise price or underlying shares will not be adjusted for issuances of shares of common stock at a price below the warrant exercise price.distribution.

Right of First Refusal

For a period of 24 months from the closing of this offering, the representative will have an irrevocable right of first refusal to act as sole investment banker, sole book-runner, and/or sole placement agent, at the representative’s sole and exclusive discretion, for each and every future public and private equity and debt offering, including all equity linked financings of the Company (or any successor or subsidiary of the Company), on terms customary to the representative.


 

Electronic Offer, Sale and Distribution of Securities

 

A prospectus in electronic format may be made available on the websitesa website maintained by onethe placement agent. In connection with the offering, the placement agent or more of the underwriters or selling group members, if any, participating in this offering and one or more of the underwriters participating in this offeringselected dealers may distribute prospectuses electronically. The representative may agree to allocate a numberNo forms of shares and warrants to underwriters and selling group members for sale to their online brokerage account holders. Internet distributionselectronic prospectus other than prospectuses that are printable as Adobe® PDF will be allocated by the underwriters and selling group members that will make internet distributions on the same basis as other allocations. used in connection with this offering.

Other than the prospectus in electronic format, the information on these websitesthe placement agent’s website and any information contained in any other website maintained by the placement agent is not part of nor incorporated by reference into, thisthe prospectus or the registration statement of which this prospectus forms a part, has not been approved and/or endorsed by us or any underwriterthe placement agent in its capacity as underwriter,placement agent and should not be relied upon by investors.

 

Stabilization

In connection with this offering, the underwriters may engage in over-allotment transactions, syndicate-covering transactions, stabilizing transactions, penalty bids and purchases to cover positions created by short sales.

Stabilizing transactions permit bids to purchase securities, so long as the stabilizing bids do not exceed a specified maximum and are engaged in for the purpose of preventing or retarding a decline in the market price of the securities while the offering is in progress.

Over-allotment transactions involve sales by the underwriters of securities in excess of the number of securities the underwriters are obligated to purchase. This creates a syndicate short position, which may be either a covered short position or a naked short position. In a covered short position, the number of securities over-allotted by the underwriters is not greater than the number of securities that they may purchase in the over-allotment option. In a naked short position, the number of securities involved is greater than the number of securities in the over-allotment option. The underwriters may close out any covered short position by either exercising their over-allotment option or purchasing shares of securities in the open market.

Syndicate covering transactions involve the purchase of securities in the open market after the distribution has been completed in order to cover syndicate short positions. In determining the source of securities to close out the short position, the underwriters will consider, among other things, the price of securities available for purchase in the open market as compared to the price at which they may purchase securities through the exercise of the over-allotment option. If the underwriters sell more shares of securities than could be covered by the exercise of the over-allotment option, creating a naked short position, the position can be closed out only by buying securities in the open market. A naked short position is more likely to be created if the underwriters are concerned that after pricing there could be downward pressure on the price of the securities in the open market that could adversely affect investors who purchase in this offering.

Penalty bids permit the representative to reclaim a selling concession from a syndicate member when the securities originally sold by the syndicate member are purchased in stabilizing or syndicate covering transactions to cover syndicate short positions.

These stabilizing transactions, syndicate covering transactions and penalty bids may have the effect of raising or maintaining the market price of our securities or preventing or retarding a decline in the market price of our securities. As a result, the price of our securities in the open market may be higher than it would be otherwise in the absence of these transactions.

Neither we nor the underwriters make any representation or prediction as to the effect that the transactions described above may have on the prices of our securities. These transactions may occur on the Nasdaq Capital Market or on any other trading market. If any of these transactions are commenced, they may be discontinued without notice at any time.


Passive Market Making

In connection with this offering, the underwriters and selling group members, if any, may engage in passive market making transactions in our common stock in accordance with Rule 103 of Regulation M under the Exchange Act, during a period before the commencement of offers or sales of the shares and warrants and extending through the completion of the distribution. A passive market maker must display its bid at a price not in excess of the highest independent bid of that security. However, if all independent bids are lowered below the passive market maker’s bid, then that bid must then be lowered when specified purchase limits are exceeded.

OtherCertain Relationships

 

The underwritersplacement agent and theirits affiliates have provided, or may in the future provide, variousfrom time to time, investment banking commercial banking,and financial advisory brokerage and other services to us and our affiliatesin the ordinary course of business, for which services they have received, and may in the future receive customary fees and reimbursement of expenses. In the ordinary course of their various business activities, the underwriters and their affiliates may make or hold a broad array of investments and actively trade debt and equity securities (or related derivative securities) and financial instruments (including bank loans) for their own accounts and for the accounts of their customers and such investment and securities activities may involve securities and/or instruments of our Company. The underwriters and their affiliates may also make investment recommendations and/or publish or express independent research views in respect of such securities or instruments and may at any time hold, or recommend to clients that they acquire, long and/or short positions in such securities and instruments.commissions.

 

The Nasdaq Capital Market Listing

Our common stock is listed on The Nasdaq Capital Market under the symbol “PBLA.”

Offer Restrictions Outside the United States

 

Other than in the United States, no action has been taken by us or the underwriters that would permit a public offering of the securities offered by this prospectus in any jurisdiction where action for that purpose is required. The securities offered by this prospectus may not be offered or sold, directly or indirectly, nor may this prospectus or any other offering material or advertisements in connection with the offer and sale of any such securities be distributed or published in any jurisdiction, except under circumstances that will result in compliance with the applicable rules and regulations of that jurisdiction. Persons into whose possession this prospectus comes are advised to inform themselves about and to observe any restrictions relating to the offering and the distribution of this prospectus. This prospectus does not constitute an offer to sell or a solicitation of an offer to buy any securities offered by this prospectus in any jurisdiction in which such an offer or a solicitation is unlawful.European Economic Area

 

Australia

This prospectus is not a disclosure document under Chapter 6D of the Australian Corporations Act, has not been lodged with the Australian Securities and Investments Commission and does not purportIn relation to include the information required of a disclosure document under Chapter 6D of the Australian Corporations Act. Accordingly, (1) the offer of the securities under this prospectus is only made to persons to whom it is lawful to offer the securities without disclosure under Chapter 6D of the Australian Corporations Act under one or more exemptions set out in section 708 of the Australian Corporations Act, (2) this prospectus is made available in Australia only to those persons as set forth in clause (1) above, and (3) the offeree must be sent a notice stating in substance that by accepting this offer, the offeree represents that the offeree is such a person as set forth in clause (1) above, and, unless permitted under the Australian Corporations Act, agrees not to sell or offer for sale within Australia any of the securities sold to the offeree within 12 months after its transfer for the offeree under this prospectus.


Canada

The securities may be sold in Canada only to purchasers purchasing, or deemed to be purchasing, as principal that are accredited investors, as defined in National Instrument 45-106 Prospectus Exemptions or subsection 73.3(1) of the Securities Act (Ontario), and are permitted clients, as defined in National Instrument 31-103 Registration Requirements, Exemptions and Ongoing Registrant Obligations. Any resale of the securities must be made in accordance with an exemption from, or in a transaction not subject to, the prospectus requirements of applicable securities laws.

Securities legislation in certain provinces or territories of Canada may provide a purchaser with remedies for rescission or damages if this prospectus (including any amendment thereto) contains a misrepresentation, provided that the remedies for rescission or damages are exercised by the purchaser within the time limit prescribed by the securities legislation of the purchaser’s province or territory. The purchaser should refer to any applicable provisions of the securities legislation of the purchaser’s province or territory for particulars of these rights or consult with a legal advisor.

Pursuant to section 3A.3 of National Instrument 33-105 Underwriting Conflicts (NI 33-105), the underwriters are not required to comply with the disclosure requirements of NI 33-105 regarding underwriter conflicts of interest in connection with this offering.

China

The information in this document does not constitute a public offer of the securities, whether by way of sale or subscription, in the People’s Republic of China (excluding, for purposes of this paragraph, Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan). The securities may not be offered or sold directly or indirectly in the PRC to legal or natural persons other than directly to “qualified domestic institutional investors.”

European Economic Area - Belgium, Germany, Luxembourg and the Netherlands

The information in this document has been prepared on the basis that all offers of securities will be made pursuant to an exemption under the Directive 2003/71/EC (“Prospectus Directive”), as implemented in Member Stateseach member state of the European Economic Area, (each, a “Relevant Member State”), fromno offer of securities which are the requirement to produce a prospectus for offerssubject of securities.

An offerthe offering has been, or will be made to the public of securities has not been made, and may not be made, in a Relevantthat Member State, except pursuant to one ofother than under the following exemptions under the Prospectus Directive as implemented in that Relevant Member State:Directive:

 

 

(a)

to any legal entities that are authorized or regulated to operateentity which is a qualified investor as defined in the financial markets or, if not so authorized or regulated, whose corporate purpose is solely to invest in securities;Prospectus Directive;

 

 

to any legal entity that has two or more of (i) an average of at least 250 employees during its last fiscal year; (ii) a total balance sheet of more than €43,000,000 (as shown on its last annual unconsolidated or consolidated financial statements) and (iii) an annual net turnover of more than €50,000,000 (as shown on its last annual unconsolidated or consolidated financial statement);

(b)

to fewer than 100150 natural or legal persons (other than qualified investors withinas defined in the meaning of Article 2(1)I of the Prospectus Directive), subject to obtaining the prior consent of the company or any underwriterRepresentatives for any such offer; or

80

 

 

(c)

in any other circumstances falling within Article 3(2) of the Prospectus Directive, provided that no such offer of securities shall result in a requirement for the publication by the company of a prospectus pursuant to Article 3 of the Prospectus Directive.

 


Franceprovided that no such offer of securities referred to in (a) to (c) above shall result in a requirement for the Company or the placement agent to publish a prospectus pursuant to Article 3 of the Prospectus Directive or supplement a prospectus pursuant to Article 16 of the Prospectus Directive.

 

This document is not being distributedEach person located in the context of a public offering of financial securities (offre au public de titres financiers) in France within the meaning of Article L.411-1 of the French Monetary and Financial Code (Code monétaire et financier) and Articles 211-1 et seq. of the General Regulation of the French Autorité des marchés financiers (“AMF”). The securities have not been offered or sold and will not be offered or sold, directly or indirectly,Member State to the public in France.

This document andwhom any other offering material relating to the securities has not been, and will not be, submitted to the AMF for approval in France and, accordingly, may not be distributed or caused to distributed, directly or indirectly, to the public in France.

Such offers, sales and distributions have been and shall only be made in France to (i) qualified investors (investisseurs qualifiés) acting for their own account, as defined in and in accordance with Articles L.411-2-II-2° and D.411-1 to D.411-3, D. 744-1, D.754-1 and D.764-1 of the French Monetary and Financial Code and any implementing regulation and/or (ii) a restricted number of non-qualified investors (cercle restreint dinvestisseurs non-qualifiés) acting for their own account, as defined in and in accordance with Articles L.411-2-II-2° and D.411-4, D.744-1, D.754-1 and D.764-1 of the French Monetary and Financial Code and any implementing regulation.

Pursuant to Article 211-3 of the General Regulation of the AMF, investors in France are informed that the securities cannot be distributed (directly or indirectly) to the public by the investors otherwise than in accordance with Articles L.411-1, L.411-2, L.412-1 and L.621-8 to L.621-8-3 of the French Monetary and Financial Code.

Ireland

The information in this document does not constitute a prospectus under any Irish laws or regulations and this document has not been filed with or approved by any Irish regulatory authority as the information has not been prepared in the context of a public offeringoffer of securities is made or who receives any communication in Irelandrespect of an offer of securities, or who initially acquires any shares of our securities will be deemed to have represented, warranted, acknowledged and agreed to and with the placement agent and the Company that (1) it is a “qualified investor” within the meaning of the Irishlaw in that Member State implementing Article 2(1)(e) of the Prospectus (Directive 2003/71/EC) Regulations 2005 (the Directive; and (2) in the case of any shares of our securities acquired by it as a financial intermediary as that term is used in Article 3(2) of the Prospectus Regulations”). TheDirective, the securities acquired by it in the offer have not been offeredacquired on behalf of, nor have they been acquired with a view to their offer or sold, and will not be offered, sold or delivered directly or indirectlyresale to, persons in Ireland by way of a public offering, except to (i)any Member State other than qualified investors, as that term is defined in Regulation 2(l)the Prospectus Directive, or in circumstances in which the prior consent of the placement agent has been given to the offer or resale; or where our securities have been acquired by it on behalf of persons in any Member State other than qualified investors, the offer of those securities to it is not treated under the Prospectus Regulations and (ii) fewer than 100 natural or legal persons who are not qualified investors.

IsraelDirective as having been made to such persons. 

 

The securities offered by this prospectus have not been approved or disapproved byCompany, the Israeli Securities Authority (the ISA), or ISA, nor have such securities been registered for sale in Israel. The sharesplacement agent and warrants may not be offered or sold, directly or indirectly, totheir respective affiliates will rely upon the public in Israel, absent the publication of a prospectus. The ISA has not issued permits, approvals or licenses in connection with the offering or publishing the prospectus; nor has it authenticated the details included herein, confirmed their reliability or completeness, or rendered an opinion as to the qualitytruth and accuracy of the securities being offered. Any resale in Israel, directly or indirectly, to the public of the securities offered by this prospectus is subject to restrictions on transferabilityforegoing representations, acknowledgments and must be effected only in compliance with the Israeli securities laws and regulations.


Italyagreements.

 

The offeringThis prospectus has been prepared on the basis that any offer of the our securities in the Republic of Italy has not been authorized by the Italian Securities and Exchange Commission (Commissione Nazionale per le Società e la Borsa, “CONSOB”) pursuant to the Italian securities legislation and, accordingly, no offering material relating to the securities mayany Member State will be distributed in Italy and such securities may not be offered or sold in Italy in a public offer within the meaning of Article 1.1(t) of Legislative Decree No. 58 of 24 February 1998 (“Decree No. 58”), other than:

to Italian qualified investors, as defined in Article 100 of Decree no. 58 by reference to Article 34-ter of CONSOB Regulation no. 11971 of 14 May 1999 (“Regulation no. 1197l”) as amended (“Qualified Investors”); and

in other circumstances that are exempt from the rules on public offer pursuant to Article 100 of Decree No. 58 and Article 34-ter of Regulation No. 11971 as amended.

Any offer, sale or delivery of the securities or distribution of any offer document relating to the securities in Italy (excluding placements where a Qualified Investor solicits an offer from the issuer) under the paragraphs above must be:

made by investment firms, banks or financial intermediaries permitted to conduct such activities in Italy in accordance with Legislative Decree No. 385 of 1 September 1993 (as amended), Decree No. 58, CONSOB Regulation No. 16190 of 29 October 2007 and any other applicable laws; and

in compliance with all relevant Italian securities, tax and exchange controls and any other applicable laws.

Any subsequent distribution of the securities in Italy must be made in compliance with the public offer and prospectus requirement rules provided under Decree No. 58 and the Regulation No. 11971 as amended, unless an exception from those rules applies. Failure to comply with such rules may result in the sale of such securities being declared null and void and in the liability of the entity transferring the securities for any damages suffered by the investors.

Japan

The securities have not been and will not be registered under Article 4, paragraph 1 of the Financial Instruments and Exchange Law of Japan (Law No. 25 of 1948), as amended (the “FIEL”) pursuant to an exemption under the Prospectus Directive from the registration requirements applicablerequirement to publish a privateprospectus for offers of shares. Accordingly, any person making or intending to make an offer in that Member State of our securities which are the subject of the offering contemplated in this prospectus may only do so in circumstances in which no obligation arises for the Company or the placement of securitiesagent to Qualified Institutional Investors (as defined in and in accordance withpublish a prospectus pursuant to Article 2, paragraph 3 of the FIEL andProspectus Directive in relation to such offer. Neither the regulations promulgated thereunder). Accordingly,Company nor the securities may not be offered or sold, directly or indirectly, in Japan or to, or forplacement agent have authorized, nor do they authorize, the benefitmaking of any resident of Japan other than Qualified Institutional Investors. Any Qualified Institutional Investor who acquires securities may not resell them to any person in Japan that is not a Qualified Institutional Investor, and acquisition by any such person of securities is conditional upon the execution of an agreement to that effect.

Portugal

This document is not being distributed in the context of a public offer of financial securities (oferta pública de valores mobiliários) in Portugal, within the meaning of Article 109 of the Portuguese Securities Code (Código dosValores Mobiliários). The securities have not been offered or sold and will not be offered or sold, directly or indirectly, to the public in Portugal. This document and any other offering material relating to the securities have not been, and will not be, submitted to the Portuguese Securities Market Commission (Comissão do Mercado de Valores Mobiliários) for approval in Portugal and, accordingly, may not be distributed or caused to distributed, directly or indirectly, to the public in Portugal, other than under circumstances that are deemed not to qualify as a public offer under the Portuguese Securities Code. Such offers, sales and distributions of securities in Portugal are limitedcircumstances in which an obligation arises for the Company or the placement agent to publish a prospectus for such an offer.

For the purposes of this provision, the expression an “offer of our securities to the public” in relation to any of our securities in any Member State means the communication in any form and by any means of sufficient information on the terms of the offer and the securities to be offered so as to enable an investor to decide to purchase or subscribe for the securities, as the same may be varied in that Member State by any measure implementing the Prospectus Directive in that Member State, the expression “Prospectus Directive” means Directive 2003/71/EC (as amended) and includes any relevant implementing measure in each Member State. The above selling restriction is in addition to any other selling restrictions set out below.

Notice to Prospective Investors in the United Kingdom

In addition, in the United Kingdom, this document is being distributed only to, and is directed only at, and any offer subsequently made may only be directed at persons who are “qualified investors” (as defined in the Portuguese Securities Code)Prospectus Directive) (i) who have professional experience in matters relating to investments falling within Article 19 (5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”) and/or (ii) who are high net worth companies (or persons to whom it may otherwise be lawfully communicated) falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). Only such investors may receive this document and they may not distribute it or the information contained in it to any other person.


Sweden

This document has not been, and willmust not be registered withacted on or approvedrelied on in the United Kingdom byFinansinspektionen (the Swedish Financial Supervisory Authority). Accordingly, this document may not be made available, nor may the securities be offered for sale in Sweden, other than under circumstances that are deemed not to require a prospectus under the Swedish Financial Instruments Trading Act (1991:980) (Sw. lag (1991:980) om handel med finansiella instrument). Any offering of securities in Sweden is limited to persons who are “qualified investors” (as defined innot relevant persons. In the Financial Instruments Trading Act). Only such investors may receiveUnited Kingdom, any investment or investment activity to which this document relates is only available to, and they may not distribute it or the information containedwill be engaged in it to any other person.with, relevant persons.

 

Notice to Prospective Investors in Switzerland

 

The securities may not be publicly offered in Switzerland and will not be listed on the SIX Swiss Exchange (“SIX”) or on any other stock exchange or regulated trading facility in Switzerland. This document has been prepared without regard to the disclosure standards for issuance prospectuses under art. 652a or art. 1156 of the Swiss Code of Obligations or the disclosure standards for listing prospectuses under art. 27 ff. of the SIX Listing Rules or the listing rules of any other stock exchange or regulated trading facility in Switzerland. Neither this document nor any other offering or marketing material relating to our securities or the securitiesoffering may be publicly distributed or otherwise made publicly available in Switzerland.

 

Neither this document nor any other offering or marketing material relating to the offering, the Company or our securities have been or will be filed with or approved by any Swiss regulatory authority. In particular, this document will not be filed with, and the offer of our securities will not be supervised by, the Swiss Financial Market Supervisory Authority (“FINMA”FINMA (FINMA), and the offer of our securities has not been and will not be authorized under the Swiss Federal Act on Collective Investment Schemes ("CISA"). The investor protection afforded to acquirers of interests in collective investment schemes under the CISA does not extend to acquirers of our securities.

 

This document is personal to the recipient only and not for general circulation in Switzerland.

81

 

UnitedArab Emirates

Neither this document nor the securities have been approved, disapproved or passed on in any way by the Central Bank of the United Arab Emirates or any other governmental authority in the United Arab Emirates, nor have we received authorization or licensing from the Central Bank of the United Arab Emirates or any other governmental authority in the United Arab EmiratesNotice to market or sell the securities within the United Arab Emirates. This document does not constitute and may not be used for the purpose of an offer or invitation. No services relating to the securities, including the receipt of applications and/or the allotment or redemption of such shares, may be rendered within the United Arab Emirates by us.

No offer or invitation to subscribe for securities is valid or permittedProspective Investors in the Dubai International Financial Centre.Centre

 

UnitedKingdom

NeitherThis prospectus relates to an Exempt Offer in accordance with the information in this document nor any other document relating toOffered Securities Rules of the offer has been delivered for approval to theDubai Financial Services Authority (“DFSA”). This prospectus is intended for distribution only to persons of a type specified in the United Kingdom and no prospectus (within the meaning of section 85Offered Securities Rules of the Financial ServicesDFSA. It must not be delivered to, or relied on by, any other person. The DFSA has no responsibility for reviewing or verifying any documents in connection with Exempt Offers. The DFSA has not approved this prospectus nor taken steps to verify the information set forth herein and Markets Act 2000, as amended (“FSMA”))has no responsibility for the prospectus. The securities to which this prospectus relates may be illiquid and/or subject to restrictions on their resale. Prospective purchasers of the securities offered should conduct their own due diligence on the securities. If you do not understand the contents of this prospectus, you should consult an authorized financial advisor.

Notice to Prospective Investors in Australia

No placement document, prospectus, product disclosure statement or other disclosure document has been publishedlodged with the Australian Securities and Investments Commission (“ASIC”), in relation to the offering. This prospectus does not constitute a prospectus, product disclosure statement or is intendedother disclosure document under the Corporations Act 2001 (the “Corporations Act”) and does not purport to include the information required for a prospectus, product disclosure statement or other disclosure document under the Corporations Act.

Any offer in Australia of our securities may only be published in respect of the securities. This document is issued on a confidential basismade to “qualifiedpersons (the “Exempt Investors”) who are “sophisticated investors” (within the meaning of section 86(7)708(8) of FSMA)the Corporations Act), “professional investors” (within the meaning of section 708(11) of the Corporations Act) or otherwise pursuant to one or more exemptions contained in section 708 of the Corporations Act so that it is lawful to offer the securities without disclosure to investors under Chapter 6D of the Corporations Act.

The securities applied for by Exempt Investors in Australia must not be offered for sale in Australia in the United Kingdom,period of 12 months after the date of allotment under the offering, except in circumstances where disclosure to investors under Chapter 6D of the Corporations Act would not be required pursuant to an exemption under section 708 of the Corporations Act or otherwise or where the offer is pursuant to a disclosure document which complies with Chapter 6D of the Corporations Act. Any person acquiring our securities must observe such Australian on-sale restrictions.

This prospectus contains general information only and does not take account of the investment objectives, financial situation or particular needs of any particular person. It does not contain any securities mayrecommendations or financial product advice. Before making an investment decision, investors need to consider whether the information in this prospectus is appropriate to their needs, objectives and circumstances, and, if necessary, seek expert advice on those matters.

Notice to Prospective Investors in Hong Kong

The securities have not been offered or sold and will not be offered or sold in the United KingdomHong Kong, by means of any document, other than (a) to “professional investors” as defined in the Securities and Futures Ordinance (Cap. 571) of Hong Kong and any rules made under that Ordinance; or (b) in other circumstances which do not result in the document being a “prospectus” as defined in the Companies Ordinance (Cap. 32) of Hong Kong or which do not constitute an offer to the public within the meaning of that Ordinance. No advertisement, invitation or document relating to the securities has been or may be issued or has been or may be in the possession of any person for the purposes of issue, whether in Hong Kong or elsewhere, which is directed at, or the contents of which are likely to be accessed or read by, the public of Hong Kong (except if permitted to do so under the securities laws of Hong Kong) other than with respect to securities which are or are intended to be disposed of only to persons outside Hong Kong or only to “professional investors” as defined in the Securities and Futures Ordinance and any rules made under that Ordinance.

Notice to Prospective Investors in Japan

The securities have not been and will not be registered under the Financial Instruments and Exchange Law of Japan (Law No. 25 of 1948, as amended) and, accordingly, will not be offered or sold, directly or indirectly, in Japan, or for the benefit of any Japanese Person or to others for re-offering or resale, directly or indirectly, in Japan or to any Japanese Person, except in compliance with all applicable laws, regulations and ministerial guidelines promulgated by relevant Japanese governmental or regulatory authorities in effect at the relevant time. For the purposes of this document,paragraph, “Japanese Person” shall mean any accompanying letterperson resident in Japan, including any corporation or other entity organized under the laws of Japan.

Notice to Prospective Investors in Singapore

This prospectus has not been registered as a prospectus with the Monetary Authority of Singapore. Accordingly, this prospectus and any other document except in circumstances that do not require the publication of a prospectus pursuant to section 86(1) FSMA. This document should not be distributed, published or reproduced, in whole or in part, nor may its contents be disclosed by recipients to any other person in the United Kingdom.

Any invitation or inducement to engage in investment activity (within the meaning of section 21 of FSMA) receivedmaterial in connection with the issueoffer or sale, or invitation for subscription or purchase, of securities may not be circulated or distributed, nor may the securities be offered or sold, or be made the subject of an invitation for subscription or purchase, whether directly or indirectly, to persons in Singapore other than (i) to an institutional investor under Section 274 of the securities have only been communicatedSecurities and Futures Act, Chapter 289 of Singapore (the “SFA”), (ii) to a relevant person pursuant to Section 275(1), or causedany person pursuant to be communicatedSection 275(1A), and will only be communicatedin accordance with the conditions specified in Section 275, of the SFA, or caused(iii) otherwise pursuant to, be communicatedand in accordance with the United Kingdom in circumstances in which section 21(1)conditions of, FSMA does not apply to us.any other applicable provision of the SFA.

 


82

 

InWhere the United Kingdom, this document is being distributed only to, and is directed at, persons (i) who have professional experience in matters relating to investments falling within Article 19(5) (investment professionals)securities are subscribed or purchased under Section 275 of the Financial Services and Markets Act 2000 (Financial Promotions) Order 2005 (“FPO”), (ii) who fall within the categories of persons referred to in Article 49(2)(a) to (d) (high net worth companies, unincorporated associations, etc.) of the FPO or (iii) to whom it may otherwise be lawfully communicated (together “relevant persons”). The investments to which this document relates are available only to, and any invitation, offer or agreement to purchase will be engaged in only with, relevant persons. Any person who is notSFA by a relevant person shouldwhich is:

(a)

a corporation (which is not an accredited investor (as defined in Section 4A of the SFA)) the sole business of which is to hold investments and the entire share capital of which is owned by one or more individuals, each of whom is an accredited investor; or

(b)

a trust (where the trustee is not an accredited investor) whose sole purpose is to hold investments and each beneficiary of the trust is an individual who is an accredited investor,

securities (as defined in Section 239(1) of the SFA) of that corporation or the beneficiaries’ rights and interest (howsoever described) in that trust shall not actbe transferred within six months after that corporation or rely on this document or anythat trust has acquired the securities pursuant to an offer made under Section 275 of its contents.the SFA except:

(a)

to an institutional investor or to a relevant person defined in Section 275(2) of the SFA, or to any person arising from an offer referred to in Section 275(1A) or Section 276(4)(i)(B) of the SFA;

(b)

where no consideration is or will be given for the transfer;

(c)

where the transfer is by operation of law;

(d)

as specified in Section 276(7) of the SFA; or

(e)

as specified in Regulation 32 of the Securities and Futures (Offers of Investments) (Shares and Debentures) Regulations 2005 of Singapore.

Notice to Prospective Investors in Canada

 

The securities may be sold only to purchasers purchasing, or deemed to be purchasing, as principal that are accredited investors, as defined in National Instrument 45-106 Prospectus Exemptions or subsection 73.3(1) of the Securities Act (Ontario), and are permitted clients, as defined in National Instrument 31-103 Registration Requirements, Exemptions and Ongoing Registrant Obligations. Any resale of the securities must be made in accordance with an exemption from, or in a transaction not subject to, the prospectus requirements of applicable securities laws.

Securities legislation in certain provinces or territories of Canada may provide a purchaser with remedies for rescission or damages if this prospectus (including any amendment thereto) contains a misrepresentation, provided that the remedies for rescission or damages are exercised by the purchaser within the time limit prescribed by the securities legislation of the purchaser’s province or territory. The purchaser should refer to any applicable provisions of the securities legislation of the purchaser’s province or territory for particulars of these rights or consult with a legal advisor.

Pursuant to section 3A.3 (or, in the case of securities issued or guaranteed by the government of a non-Canadian jurisdiction, section 3A.4) of National Instrument 33-105 Underwriting Conflicts (Legal Matters NI 33-105), the placement agent is not required to comply with the disclosure requirements of NI 33-105 regarding underwriter conflicts of interest in connection with this offering

LEGAL MATTERS

 

The validity of the shares of common stock beingsecurities offered by this prospectus has beenwill be passed upon for us by Faegre Baker DanielsDrinker Biddle & Reath LLP. Pryor Cashman LLP Minneapolis, Minnesota. Certain legal mattersis acting as counsel for the placement agent in connection with certain legal matters related to this offering will be passed upon for the underwriters by Zysman, Aharoni, Gayer and Sullivan & Worcester LLP, New York, New York.offering.

 

Experts EXPERTS

 

The financial statements of Panbela as of December 31, 20162022 and 20152021 and for the two years in the period ended December 31, 2016 included2022 incorporated in this prospectus by reference from the Company's Annual Report on Form 10-K have been so included in reliance on the report ofaudited by Cherry Bekaert LLP, an independent registered public accounting firm, appearing elsewhereas stated in their report, which is incorporated herein by reference. Such financial statements have been so incorporated in reliance upon the report of such firm given on theupon their authority of said firm as experts in auditingaccounting and accounting.auditing.

 

83

Where You Can Find More Information 

WHERE YOU CAN FIND MORE INFORMATION

 

We have filed with the SEC a registration statement on Form S-1 under the Securities Act that registers the distribution of the securities offered under this prospectus. The registration statement, including the attached exhibits and schedules, contains additional relevant information about us and the securities. The rules and regulations of the SEC allow us to omit from this prospectus certain information included in the registration statement.

 

We are subject to the informational requirements of the Securities Exchange Act and are required to file annual, quarterly and current reports, proxy statements and other information with the SEC. You may read and copy this information and the registration statement at the SEC public reference room located at 100 F Street, N.E., Room 1580, Washington D.C. 20549. You may obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. Any information we file with the SEC, including the documents incorporated by reference into this prospectus, is also available on the SEC’s website at http://www.sec.gov. We also make these documents publicly available, free of charge, on our website at www.sunbiopharma.comwww.panbela.com as soon as reasonably practicable after filing such documents with the SEC. The information contained in, or that can be accessed through, our website is not part of this prospectus.

 


84

 

IndexThe Financial Statements the three and nine months ended September 30, 2023 versus the three and nine months ended September 30, 2022 and for the fiscal years ended December 31, 2022 and 2021 are historical. Share and per share amounts have been restated for comparison purposes for the 1-for-40 reverse stock split that was effected on January 13, 2023 or the 1-for-30 reverse stock split that was effected on June 1, 2023. No share or per share amounts for three and nine months ended September 30, 2023 versus the three and nine months ended September 30, 2022 and for the fiscal years ended December 31, 2022 and 2021 have been restated for the 1-for-20 reverse stock split that was effected on January 18, 2024.

 

Item 1.     Financial Statements.

Consolidated Balance Sheets

F-2

Consolidated Statements of Operations and Comprehensive Loss

F-3

Consolidated Statements of Stockholders’ Deficit

F-4

Consolidated Statements of Cash Flows

F-5

Notes to Consolidated Financial Statements

F-6

 


Sun BioPharma,Panbela Therapeutics, Inc.
Condensed Consolidated Balance Sheets

(In thousands, except share amounts)

 

  

September 30, 2017

  

December 31, 2016

 

 

 

(Unaudited)

     

ASSETS

        

Current assets:

        

Cash and cash equivalents

 $943  $438 

Prepaid expenses and other current assets

  250   118 

Income tax receivable

  340   321 

Total current assets

  1,533   877 
         

Total assets

 $1,533  $877 
         

LIABILITIES AND STOCKHOLDERS’ DEFICIT

        

Current liabilities:

        

Accounts payable

 $874  $1,245 

Accrued expenses

  1,218   842 

Convertible notes payable - current portion, net

     2,733 

Term debt

     294 

Demand notes payable

     250 

Accrued interest

  57   155 

Total current liabilities

  2,149   5,519 
         

Long-term liabilities:

        

Convertible notes payable, net

  1,096    

Term debt

  300    

Accrued interest

  87    

Total long-term liabilities

  1,483    
         

Commitments and contingencies (Note 7)

        
         

Stockholders’ deficit:

        

Preferred stock, $0.001 par value; 10,000,000 authorized; no shares issued or outstanding as of September 30, 2017 and December 31, 2016

      

Common stock, $0.001 par value; 100,000,000 authorized; 3,670,432 and 3,220,100 shares issued and outstanding, as of September 30, 2017 and December 31, 2016, respectively

  4   3 

Additional paid-in capital

  25,059   14,058 

Accumulated deficit

  (26,992)  (18,779)

Accumulated comprehensive gain (loss), net

  (170)  76 

Total stockholders’ deficit

  (2,099)  (4,642)

Total liabilities and stockholders’ deficit

 $1,533  $877 
  

September 30, 2023

  

December 31, 2022

 
  

(Unaudited)

     

ASSETS

 

 

     

Current assets:

        

Cash and cash equivalents

 $907  $1,285 

Prepaid expenses and other current assets

  824   443 

Income tax receivable

  155   49 

Total current assets

  1,886   1,777 

Other non-current assets

  8,742   3,201 

Total assets

 $10,628  $4,978 
         

LIABILITIES AND STOCKHOLDERS' DEFICIT

        

Current liabilities:

        

Accounts payable

 $6,612  $2,865 

Accrued expenses

  1,133   2,993 

Accrued interest payable

  172   325 

Note payable

  -   650 

Debt, current portion

  1,000   1,000 

Total current liabilities

  8,917   7,833 
         

Debt, net of current portion

  4,194   5,194 

Total non-current liabilities

  4,194   5,194 
         

Total liabilities

  13,111   13,027 
         
Stockholders' deficit:        

Preferred stock, $0.001 par value; 10,000,000 authorized; no shares issued or outstanding as of September 30, 2023 and December 31, 2022

  -   - 

Common stock, $0.001 par value; 100,000,000 authorized; 2,996,753 and 34,761 shares issued, and 2,996,334 and 34,761 outstanding as of September 30, 2023 and December 31, 2022, respectively

  3   - 

Treasury Stock at cost; 419 and 0 shares as of September 30, 2023 and December 31, 2022, respectively

  -   - 

Additional paid-in capital

  106,026   82,286 

Accumulated deficit

  (109,883)  (91,094)

Accumulated comprehensive income

  1,371   759 

Total stockholders' deficit

  (2,483)  (8,049)

Total liabilities and stockholders' deficit

 $10,628  $4,978 

 

SeeShare and per share data have been adjusted for all periods presented to reflect the one-for-thirty reverse stock split effective June 1, 2023 and the one-for-forty reverse stock split effective January 13, 2023.

The accompanying notes to condensed consolidated financial statements are an integral part of these statements.

 


F-1

 

Sun BioPharma, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)

(Unaudited)

  

Three Months Ended September 30,

  

Nine Months Ended September 30,

 
  

2017

  

2016

  

2017

  

2016

 

Operating expenses:

                

General and administrative

 $515  $499  $2,252  $1,399 

Research and development

  530   636   1,955   1,657 

Operating loss

  (1,045)  (1,135)  (4,207)  (3,056)
                 

Other income (expense):

                

Interest income

  1      1   2 

Grant income

  27      110    

Interest expense

  (474)  (45)  (1,145)  (135)

Loss on induced debt conversions

        (3,696)   

Other income

  75   56   264   63 

Total other income (expense)

  (371)  11   (4,466)  (70)
                 

Loss before income tax benefit

 $(1,416) $(1,124) $(8,673) $(3,126)
                 

Income tax benefit

  197   45   460   252 
                 

Net loss

  (1,219)  (1,079)  (8,213)  (2,874)

Foreign currency translation adjustment loss

  (62)  (61)  (246)  (94)

Comprehensive loss

 $(1,281) $(1,140) $(8,459) $(2,968)
                 

Basic and diluted net loss per share

 $(0.33) $(0.34) $(2.33) $(0.94)

Weighted average shares outstanding – basic and diluted

  3,670,432   3,201,689   3,518,828   3,069,184 

See accompanying notes to condensedconsolidated financial statements.


Sun BioPharma,Panbela Therapeutics, Inc.

Condensed Consolidated Statements of Operations and Comprehensive LossStockholders’ Deficit


(In thousands, except share and per share amounts)

(Unaudited)

 

  

Three Months Ended September 30,

  

Nine Months Ended September 30,

 
  

2023

  

2022

  

2023

  

2022

 

Operating expenses:

                

General and administrative

 $1,107  $1,294  $4,102  $4,349 

Research and development

  6,739   2,329   14,501   24,563 

Operating loss

  (7,846)  (3,623)  (18,603)  (28,912)
                 

Other income (expense):

                

Interest income

  49   6   114   10 

Gain on sale of intellectual property

  400   -   400   - 

Interest expense

  (71)  (87)  (245)  (107)

Other expense

  (382)  (754)  (622)  (1,293)

Total other expense

  (4)  (835)  (353)  (1,390)
                 

Loss before income tax benefit

  (7,850)  (4,458)  (18,956)  (30,302)
                 

Income tax benefit

  19   56   167   104 
                 

Net loss

  (7,831)  (4,402)  (18,789)  (30,198)

Foreign currency translation adjustment

  381   727   612   1,240 

Comprehensive loss

 $(7,450) $(3,675) $(18,177) $(28,958)
                 

Basic and diluted net loss per share

 $(2.69) $(257.36) $(14.35) $(2,255.96)

Weighted average shares outstanding - basic and diluted

  2,914,600   17,107   1,309,137   13,386 

 

                  

Accumulated

     
          

Additional

      

Other

  

Total

 
  

Common Stock

  

Paid-In

  

Accumulated

  

Comprehensive

  

Stockholders

 
  

Shares

  

Amount

  

Capital

  

Deficit

  

Gain (Loss)

  

Deficit

 

Balances at December 31, 2016

  3,220,100  $3  $14,058  $(18,779) $76  $(4,642)

Conversion of convertible promissory notes

  385,000   1   5,840         5,841 

Conversion of demand notes

  33,332      993         993 

Charge for fair market value of beneficial conversion feature

        2,954         2,954 

Share-based compensation

        1,167         1,167 

Exercise of common stock options

  22,000      28         28 

Exercise of stock purchase warrants

  10,000      19         19 

Net loss

           (8,213)     (8,213)

Foreign currency translation adjustment, net of taxes of $0

              (246)  (246)

Balances at September 30, 2017

  3,670,432  $4  $25,059  $(26,992) $(170) $(2,099)

Share and per share data have been adjusted for all periods presented to reflect the one-for-thirty reverse stock split effective June 1, 2023 and the one-for-forty reverse stock split effective January 13, 2023.

 

SeeThe accompanying notes to condensed consolidated financial statements are an integral part of these statements.

 

F-2

Panbela Therapeutics, Inc.

Condensed Consolidated Statements of Stockholders (Deficit) Equity

(In thousands, except share amounts)

(Unaudited)

                 

For the Nine Months Ended September 30, 2023

 
  Common Stock  Treasury Stock  

Additional Paid-In

  

Accumulated

  

Accumulated Other

  

Total Stockholders'

 
  

Shares

  

Amount

  

Shares

  

Amount

  

Capital

  

Deficit

  

Comprehensive Income

  

(Deficit) Equity

 

Balance as of January 1, 2023

  34,761  $-   -   -  $82,286  $(91,094) $759  $(8,049)

Proceeds from sale of Common Stock

  237,191   -   -   -   15,359   -   -   15,359 

Cash paid for fractional shares

  -   -   -   -   (4)  -   -   (4)

Warrant exchange cashless

  264,124   1   -   -   (1)  -   -   - 

Stock-based compensation

  -   -   -   -   180   -   -   180 

Net loss

  -   -   -   -   -   (5,125)  -   (5,125)

Foreign currency translation adjustment

  -   -   -   -   -   -   164   164 

Balance as of March 31, 2023

  536,076  $1   -  $-  $97,820  $(96,219) $923  $2,525 
                                 

Proceeds from sale of Common Stock

  2,008,881  $2   -   -  $7,711   -   -  $7,713 

Cash paid for fractional shares

  -   -   -   -   (5)  -   -   (5)

Warrant exchange cashless

  67,694   -   -   -   -   -   -   - 

Adjustment for fractional shares

  (613)  -   -   -   -   -   -   - 

Stock-based compensation

  -   -   -   -   329   -   -   329 

Net loss

  -   -   -   -   -   (5,833)  -   (5,833)

Foreign currency translation adjustment

  -   -   -   -   -   -   67   67 

Balance as of June 30, 2023

  2,612,038  $3   -  $-  $105,855  $(102,052) $990  $4,796 
                                 

Proceeds from sale of Common Stock

  3,017  $-   -   -  $3           3 

Incremental offering costs

  -   -   -   -   (22)  -   -   (22)

Prefunded warrants exercised

  165,000   -   -   -   -   -   -   - 

Prefunded warrant exchange cashless

  95,954   -   -   -   -   -   -   - 

Warrant exchange cashless

  120,744   -   -   -   -   -   -   - 

Treasury Stock

  (419)  -   419   -   -   -   -   - 

Stock-based compensation

  -   -   -   -   190   -   -   190 

Net loss

  -   -   -   -   -   (7,831)  -   (7,831)

Foreign currency translation adjustment

  -   -   -   -   -   -   381   381 

Balance as of September 30, 2023

  2,996,334  $3   419  $-  $106,026  $(109,883) $1,371  $(2,483)

Share and per share data have been adjusted for all periods presented to reflect the one-for-thirty reverse stock split effective June 1, 2023 and the one-for-forty reverse stock split effective January 13, 2023.

The accompanying notes to condensed consolidated financial statements are an integral part of these statements.

F-3

Panbela Therapeutics, Inc.

Condensed Consolidated Statements of Stockholders (Deficit) Equity

(In thousands, except share amounts)

(Unaudited)

         

For the Nine Months Ended September 30, 2022

 
  Common Stock  Treasury Stock  

Additional Paid-In

  

Accumulated

  

Accumulated Other

  

Total Stockholders'

 
  Shares  

Amount

  

Shares

  

Amount

  

Capital

  

Deficit

  

Comprehensive Income

  

Equity (Deficit)

 

Balance as of January 1, 2022

  10,995  $-   -   -  $66,240  $(56,160) $133  $10,213 

Vesting of restricted stock

  4   -   -   -   -   -   -   - 

Stock-based compensation

  -   -   -   -   334   -   -   334 

Net loss

  -   -   -   -   -   (3,666)  -   (3,666)

Foreign currency translation adjustment

  -   -   -   -   -   -   (299)  (299)

Balance as of March 31, 2022

  10,999  $-   -  $-  $66,574  $(59,826) $(166) $6,582 
                                 

Issuance of common stock - CPP

  6,099  $-   -   -  $9,605   -   -  $9,605 

Vesting of restricted stock

  4   -   -   -   -   -   -   - 

Stock-based compensation

  -   -   -   -   293   -   -   293 

Net loss

  -   -   -   -   -   (22,130)  -   (22,130)

Foreign currency translation adjustment

  -   -   -   -   -   -   812   812 

Balance as of June 30, 2022

  17,102  $-   -  $-  $76,472  $(81,956) $646  $(4,838)
                                 

Exercise of options, cashless

  12  $-   -   -  $-   -   -  $- 

Exercise of warrants for cash

  -   -   -   -   5   -   -   5 

Stock-based compensation

  -   -   -   -   230   -   -   230 

Net loss

  -   -   -   -   -   (4,402)  -   (4,402)

Foreign currency translation adjustment

  -   -   -   -   -   -   727   727 

Balance as of September 30, 2022

  17,114  $-   -  $-  $76,707  $(86,358) $1,373  $(8,278)

Share and per share data have been adjusted for all periods presented to reflect the one-for-thirty reverse stock split effective June 1, 2023 and the one-for-forty reverse stock split effective January 13, 2023.

The accompanying notes to condensed consolidated financial statements are an integral part of these statements.

F-4

Panbela Therapeutics, Inc.

Condensed Consolidated Statements of Cash Flows
(In thousands)

(Unaudited)

  

Nine Months Ended September 30,

 
  

2023

  

2022

 

Cash flows from operating activities:

        

Net loss

 $(18,789) $(30,198)

Adjustments to reconcile net loss to net cash used in operating activities:

        

Write off of in process research and development (IPR&D)

  -   17,737 

Stock-based compensation

  699   857 

Non-cash interest expense

  172   97 

Gain on sale of intellectual property

  (400)  - 

Changes in operating assets and liabilities:

        

Income tax receivable

  (112)  302 

Prepaid expenses and other current assets

  (381)  (451)

Other non-current assets

  (5,541)  (2,561)

Accounts payable

  4,370   5,392 

Accrued liabilities

  (2,187)  (1,448)

Net cash used in operating activities

  (22,169)  (10,273)
         

Cash flows from investing activities:

        

Investment in IPR&D

  -   (660)

Proceeds from sale of intellectual property

  400   - 

Cash acquired in merger

  -   4 

Net cash provided by (used) in investing activities

  400   (656)

Cash flows from financing activities:

        

Proceeds from sale of common stock and warrants, net of $2.1 million of offering costs

  23,052.00   - 

Cash paid for fractional shares

  (9.00)  - 

Proceeds from exercise of stock purchase warrants

  -   5 

Principal payments on notes

  (1,650)  - 

Net cash provided by financing activities

  21,393   5 
         

Effect of exchange rate changes on cash

  (2)  (2)
         

Net change in cash

  (378)  (10,926)

Cash and cash equivalents at beginning of period

  1,285   11,867 

Cash and cash equivalents at end of period

 $907  $941 
         

Supplemental disclosure of cash flow information:

        

Cash paid during period for interest

 $398  $9 
         

Supplemental disclosure of non-cash transactions:

        

Fair value of common stock, stock options and stock warrants issued as consideration for asset acquisition

 $-  $9,605 

Share and per share data have been adjusted for all periods presented to reflect the one-for-thirty reverse stock split effective June 1, 2023 and the one-for-forty reverse stock split effective January 13, 2023.

The accompanying notes to condensed consolidated financial statements are an integral part of these statements.

F-5

 

Sun BioPharma, Inc.

Condensed Consolidated Statements of Cash Flows
(In thousands)

(Unaudited)

  

Nine Months Ended September 30,

 
  

2017

  

2016

 

Cash flows from operating activities:

        

Net loss

 $(8,213) $(2,874)

Adjustments to reconcile net loss to net cash used in operating activities:

        

Loss on induced debt conversions

  3,696    

Share-based compensation

  1,167    

Amortization of debt discount

  961    

Amortization of debt issuance costs

  53   21 

Non-cash interest expense

  87   9 

Changes in operating assets and liabilities:

        

Income and other tax receivables

  9   512 

Prepaid expenses and other current assets

  (131)  (25)

Accounts payable

  (654)  377 

Accrued liabilities

  406   410 

Net cash used in operating activities

  (2,619)  (1,570)
         

Cash flows from financing activities:

        

Proceeds from the sale of convertible promissory notes, net of offering costs of $16

  3,059    

Proceeds from the exercise of stock options

  28    

Proceeds from the exercise of stock purchase warrants

  19    

Proceeds from issuance of common stock and warrants, net of offering costs of $152

     1,873 

Net cash provided by financing activities

  3,106   1,873 
         

Effect of exchange rate changes on cash and cash equivalents

  18   1 
         

Net increase in cash and cash equivalents

  505   304 

Cash and cash equivalents at beginning of period

  438   925 

Cash and cash equivalents at end of period

 $943  $1,229 
         

Supplemental disclosure of cash flow information:

        

Cash paid during period for interest

 $5  $70 
         

Supplemental disclosure of non-cash transactions:

        

Conversion of promissory notes and accrued interest into common stock

  2,888    

Intrinsic value of beneficial conversion feature in convertible notes

  2,954    

Conversion of demand notes into common stock

  250    

Deferred compensation exchanged for common stock and warrants

     196 

Issuance of common stock for services

 $   75 

See accompanying notes to condensed consolidated financial statements.


Sun BioPharma,Panbela Therapeutics, Inc.
Notes toCondensed Consolidated Financial Statements

 

1.Business

Business

 

Sun BioPharma,Panbela Therapeutics, Inc. (“Panbela”) and its wholly-owneddirect wholly owned subsidiaries: Panbela Research, Inc. (“Panbela Research”) Cancer Prevention Pharmaceuticals, Inc. (“CPP”) and Cancer Prevention Pharma (Ireland) Limited exist for the primary purpose of developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs. Panbela Therapeutics Pty Ltd is a wholly owned subsidiary Sun BioPharma Australia Pty Ltd. (collectivelyof Panbela Research organized under the laws of Australia. Cancer Prevention has two wholly owned dormant subsidiaries: Cancer Prevention Pharma Limited, a United Kingdom entity, and Cancer Prevention Pharmaceuticals, LLC, an Arizona limited liability company. Panbela Therapeutics, Inc., together with its direct and indirect subsidiaries is referred to as “we,” “us,” “our,” and the “Company”) exist“Company.”

The primary objective of our pipeline is the utilization of pharmacotherapies to reduce or normalize increased disease-associated polyamines using complementary pharmacotherapies. Our lead candidates are ivospemin (SBP-101) for the primary purpose of advancing the commercial development of a proprietary polyamine analogue for pancreatic cancer and for a second indication in chronic pancreatitis. Wewhich we have exclusively licensed the worldwide rights to this compound, which has been designated as SBP-101, from the University of Florida Research Foundation, Inc. (“UFRF”)., Flynpovi™ a combination of eflornithine (CPP-1X) and sulindac and eflornithine (CPP-1X) alone in tablet or sachet form. We have exclusively licensed rights from the Arizona Board of Regents of the University of Arizona to commercialize Flynpovi, and a sublicense agreement to develop and commercialize Flynpovi in North America was terminated by the licensee on April 4,2023.

 

Reverse stock splits

Effective June 1,2023, Panbela effected a 1-for-30 reverse stock split of its outstanding shares of common stock. Effective January 13,2023, Panbela effected a 1-for-40 reverse stock split of its outstanding shares of common stock. Unless specifically provided otherwise herein, all share and per share amounts of our common stock presented have been retroactively adjusted to reflect the reverse stock splits. See Note 7 for more information.

2.Risks and Uncertainties

Risks and Uncertainties

 

The Company operates in a highly regulated and competitive environment. The development, manufacturing and marketing of pharmaceutical products require approval from, and are subject to ongoing oversight by, the Food and Drug Administration (“FDA”(the “FDA”) in the United States, the Therapeutic Goods Administration (“TGA”) in Australia, the European Medicines Agency (“EMA”) in the European Union, and comparable agencies in other countries. Obtaining approval for a new pharmaceutical product is never certain, may take many years, and is normally expected to involve substantial expenditures.

 

We have incurred losses of $27.0 $109.9million since our inception in 2011.2011. For the nine months ended September 30, 2017,2023, we incurred a net loss of $8.2 $18.8million which includes a non-cash charge of $3.7 million related to the induced conversion of $2.9 million of convertible promissory notes and accrued interest, originally issued in 2013 and 2014, and $250,000 of demand notes, originally issued in September 2015, into shares of our common stock.. We also incurred negative cash flows from operating activities of $2.6 approximately $22.2million for this period. WeAs we continue to pursue development activities and seek commercialization, we expect to incur substantial losses, for the foreseeable future, which will continueare likely to generate negative net cash flows from operating activities. We generated approximately $21.4million positive cash flows from financing activities as we continuerelated to pursue development activitiesproceeds from the sale of common stock, pre-funded warrants, and seek to commercialize our initial product candidate, SBP-101.warrants, partially offset by the payments made on two promissory notes. As of September 30, 2017,2023, we had cash and cash equivalents of $943,000, negativeapproximately $0.9million, working capital deficit of $616,000$7.0million, (working capital is defined as current assets less current liabilities), and a stockholders’ deficit of $2.1 million.$2.5million. The Company’s principal sources of cash have historically included the issuance of convertible debt and equity securities.

 

The accompanying condensed consolidated financial statements have been prepared assuming that we will continue as a going concern which contemplates the realization of assets and liquidation of liabilities in the normal course of business. The condensed consolidated financial statements do not include any adjustments relating to the recoverability or classification of assets or the amounts of liabilities that might result from the outcome of these uncertainties. Our current independent registered public accounting firm included a paragraph emphasizing this going concern uncertainty in their audit report coveringregarding our 20162022 financial statements dated March 30, 2017.16,2023. Our ability to continue as a going concern, realize the carrying value of our assets and discharge our liabilities in the ordinary course of business is dependent upon a number of factors, including our ability to obtain additional financing, the success of our development efforts, our ability to obtain marketing approval for our SBP-101 product candidatecandidates in the United States, Australia, the European Union or other markets and ultimately our ability to market and sell our SBP-101 product candidate.candidates. These factors, among others, raise substantial doubt about our ability to continue operations as a going concern. See Note 4 titled Liquidity“Liquidity and Management’s Plans.Business Plan.

 

F-6

In January of 2022, the Company announced the opening of a global randomized Phase II/III clinical trial, which is being conducted in the United States, Europe and Asia Pacific (APAC). The Company does not expect any disruption to the conduct of this new clinical trial associated with COVID-19. The trial is reliant on adequate supply of gemcitabine and Abraxane (nab-paclitaxel) which can be subject to supply shortages.

3.Basis of Presentation

Basis of Presentation

 

We have prepared the accompanying interim condensed consolidated financial statements in accordance with US accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Regulation S-X of the Securities and Exchange Commission (“SEC”). Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. These interim condensed consolidated financial statements reflect all adjustments consisting of normal recurring accruals, which, in the opinion of management, are necessary to present fairly our consolidated financial position, consolidated results of operations and consolidated cash flows for the periods and as of the dates presented. Our fiscal year ends on December 31.31. The condensed consolidated balance sheet as of December 31, 20162022, was derived from audited consolidated financial statements but does not include all disclosures required by U.S. GAAP. These interim condensed consolidated financial statements should be read in conjunction with the annual consolidated financial statements and the notes thereto included in our most recent filed Annual Report on Form 10-K filed with the SEC on March 30, 2017 and our othersubsequent filings with the SEC. The nature of our business is such that the results of any interim period may not be indicative of the results to be expected for the entire year.


Effective November 7, 2017, we implemented a 1-for-10 reverse split of our common stock. As previously announced, the reverse stock split was approved by our stockholders as of September 12, 2017, and was intended to increase the market price per share of our common stock to a level that qualifies for listing on the Nasdaq Capital Market. Concurrent with the reverse stock split, there was a 50% reduction in the number of shares authorized for issuance by the Company. All references to share and per share amounts included in these condensed consolidated financial statements have been retroactively restated to reflect the reverse split. See Note 10 titled “Subsequent Events” for additional information.

 

Recently 4.aLiquidity and Business Plandopted accounting pronouncement

 

In March 2016,On June 21,2023, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2016-09, Improvements to Employee Share-Based Payment Accounting. The guidanceCompany completed a registered public offering of common stock, pre-funded warrants and warrants which resulted in ASU 2016-09 is intended to simplify aspectsnet proceeds of the accounting for employee share-based payments, including the accounting for income taxes, forfeitures, statutory withholding requirements, and classification on the statement of cash flows. The standard is effective for interim and annual periods beginning after December 15, 2016, with early adoption permitted. The adoption of this standard did not have a material impact on our financial condition and results of operations.approximately $7.7million.

 

In July 2017,On January 30,2023, the FASB issued ASU 2017-11, Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480)Company completed a registered public offering of common stock, pre-funded warrants and Derivatives and Hedging (Topic 815): I. Accounting for Certain Financial Instruments with Down Round Features; and II. Replacementwarrants which resulted in net proceeds of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Non-controlling Interests with a Scope Exception. Part I of this update addresses the complexity of accounting for certain financial instruments with down round features. Down round features are features of certain equity-linked instruments (or embedded features) that resultapproximately $13.8million. Also, in the strike price being reduced onfirst quarter of 2023, the basisCompany received net proceeds of approximately $1.6million from the pricingsale of future equity offerings. Current accounting guidance creates cost and complexity for entities that issue financial instruments (such as warrants and convertible instruments) with down round features that require fair value measurement ofcommon stock via the entire instrument or conversion option. Part II of this update addressesCompany’s ATM Program (See Note 7). No sales occurred under the difficulty of navigating Topic 480, Distinguishing Liabilities from Equity, because of the existence of extensive pending content in the FASB Accounting Standards Codification. This pending content is the result of the indefinite deferral of accounting requirements about mandatorily redeemable financial instruments of certain nonpublic entities and certain mandatorily redeemable non-controlling interests. The amendments in Part II of this update do not have an accounting effect. This ASU is effective for fiscal years, and interim periods within those years, beginning after December 15, 2018, with early adoption permitted. The adoption of ASU 2017-11,ATM Program during the nine months ended September 30, 2017, did not have any impact on the condensed consolidated financial statements and related disclosures.second quarter of 2023.

4.

Liquidity and Management Plans

 

We will need to obtainraise additional fundscapital to continue our operations and executesupport our current business plans. We may seek to raise additional funds through various sources, such as equity and debt financings,financing, or through strategic collaborations and license agreements. We can give no assurances that we will be able to secure additional sources of funds to support our operations, or if such funds are available to us, that such additional financing will be sufficient to meet our needs or on terms acceptable to us. This risk would increase if our clinical data is inconclusive orwere not positive or economic and market conditions worsen in the market as a whole or in the pharmaceutical or biotechnology markets individually.

On July 3, 2017, we received a research and development tax incentive payment from the government of Australia related to the research activities of our Australian subsidiary during 2016. The incentive payment received was approximately $460,000.


During February and March 2017, we issued convertible promissory notes raising gross proceeds of approximately $3.1 million which are convertible into our common stock or other securities upon the completion of a qualified financing of at least $2.0 million on or before the maturity of the notes. In addition we negotiated the conversion of approximately $3.1 million of previously outstanding debt and accrued interest into 418,332 shares of our common stock. See Note 7 titled “Indebtedness.”

If we are unable to obtain additional financing when needed, we will need to reduce our operations by taking actions that may include, among other things, reducing use of outside professional service providers, reducing staff or further reducing staff compensation, significantly modifying or delaying the development of our SBP-101 product candidate, licensing rights to third parties, including the right to commercialize our SBP-101 product candidate for pancreatic cancer, acute pancreatitis or other applications that we would otherwise seek to pursue, or discontinuing operations entirely.deteriorate.

 

Our future success is dependent upon our ability to obtain additional financing, the success of our development efforts, our ability to obtain marketing approval for our SBP-101 product candidatecandidates ivospemin, Flynpovi and eflornithine in the United States or other markets and ultimately our ability to market and sell our SBP-101 product candidate.candidates. If we are unable to obtain additional financing when needed, if our clinical trials are not successful or if we are unable to obtain marketing approval, we would not be able to continue as a going concern and would be forced to cease operations and liquidate our company.

 

There can be no assurances that we will be able to obtain additional financing on commercially reasonable terms, or at all. The sale of additional convertible debt or equity securities would likely result in dilution to our current stockholdersstockholders.

 

5

5.Summary of Significant Accounting Policies.

Summary of Significant Accounting Policies

 

Principles of consolidation

 

The accompanying condensed consolidated financial statements include the assets, liabilities, and expenses of Sun BioPharma, Inc. and our wholly-owned subsidiary.the Company. All significant intercompany transactions and balances have been eliminated in consolidation.

F-7

 

Use of estimates

 

The preparation of condensed consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amount of expenses during the reporting period. Actual results could differ from those estimates.

Beneficial conversion feature

For convertible debt whereestimates, particularly given the rate of conversion is below fair market value for our common stock, the Company records a "beneficial conversion feature (“BCF“)significant social and related debt discount which is presented as a direct deduction from the carrying amount of the related debt. The discount is amortized to interest expense over the life of the debt.

Debt issuance costs

Costs associatedeconomic disruptions and uncertainties with the issuance of debt instruments are capitalizedongoing pandemic and presented as a direct deduction from the carrying amount of the related debt liability. These costs are amortized through interest expense over the life of the related debt.control responses.


 

Research and development costs

 

Research and development costs include expenses incurred in the conduct of our Phase 1 human clinical trial,trials; for third-party service providers performing various testing and accumulating data related to our preclinical studies;studies; sponsored research agreements;agreements; developing and scaling the manufacturing process necessary to produce sufficient amounts of the SBP-101 compounddrug product for our product candidates for use in our pre-clinical studies and human clinical trials;trials; consulting resources with specialized expertise related to execution of our development plan for our SBP-101 product candidate;candidates; personnel costs, including salaries, benefits and share-based compensation;compensation; and costs to license and maintain our licensed intellectual property.

 

We charge research and development costs, including clinical trial costs, to expense when incurred. Our human clinical trials are, and will be, performed at clinical trial sites and are administered jointly by us with assistance from contract research organizations (“CROs”). Costs of setting up clinical trial sites are accrued upon execution of the study agreement. Expenses related to the performance of clinical trials generally are accrued based on contracted amounts and the achievement of agreed upon milestones, such as patient enrollment, patient follow-up, etc. We monitor levels of performance under each significant contract, including the extent of patient enrollment and other activities through communications with the clinical trial sites and CROs, and adjust the estimates, if required, on a quarterly basis so that clinical expenses reflect the actual effort expended at each clinical trial site and by each CRO. CRO.

The cost to secure certain third-party drug product for the clinical trials, which is often paid for in advance of delivery, is charged to research and development when it is received and available to be shipped to clinical sites.

Research and development costs for 2022 include IPR&D. This asset was acquired from the security holders of CPP and written off to research and development immediately subsequent to the asset acquisition.

All material CRO contracts are terminable by us upon written notice, and we are generally only liable for actual effort expended by the CROs and certain non-cancelable expenses incurred at any point of terminationtermination.

 

We expense costs associated with obtaining licenses for patented technologies when it is determined there is no alternative future use of the intellectual property subject to the license.

 

Share-basedStock-based compensation

 

In accounting for share-basedstock-based incentive awards, we measure and recognize the cost of employee and non-employee services received in exchange for awards of equity instruments based on the grant date fair value of those awards.awards on the grant date. Calculating share-basedstock-based compensation expense requires the input of highly subjective assumptions, which represent our best estimates and involve inherent uncertainties and the application of management’s judgment. Compensation cost is recognized ratably using the straight-line attribution method over the vesting period, which is considered to be the requisite service period. The performance date for non-employee awards is generally not met until the individual award vests. Accordingly we re-measure the current fair value each quarter until the award vests. Compensation expense for performance-based stock option awards is recognized when “performance” has occurred or is probable of occurring.

 

The fair value of share-basedstock-based awards is estimated at the date of grant using the Black-Scholes option pricing model. The determination of the fair value of share-basedstock-based awards is affected by our stock price, as well as assumptions regarding a number of complex and subjective variables. Risk free interest rates are based upon U.S. Treasury rates appropriate for the expected term of each award. Expected volatility rates are based primarily on the volatility rates of a set of guideline companies, which consist of public and recently public biotechnology companies.historical company share price volatility. The assumed dividend yield is zero, as we do not expect to declare any dividends in the foreseeable future. The expected term of options granted is determined using the “simplified” method. Under this approach, the expected term is presumed to be the mid-point between the average vesting date and the end of the contractual term.

F-8

 

Foreign currency translation adjustments

 

The functional currency of Sun BioPharma AustraliaPanbela Therapeutics Pty Ltd is the Australian Dollar (“AUD”).Dollar. Accordingly, assets and liabilities, and equity transactions of Sun BioPharmaPanbela Therapeutics Australia Pty Ltd, are translated into U.S. dollars at period-end exchange rates. Revenues and expenses are translated at the average exchange rate in effect for the period. The resulting translation gains and losses are recorded as a component of accumulated comprehensive loss presented within the stockholders’ deficit.equity. During the three and nine monthnine-month periods ended September 30, 20172023 and 2016,2022, any reclassification adjustments from accumulated other comprehensive loss to operations waswere inconsequential.

Grant Income

Grant income is derived from a one-time grant awarded to the Company by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health “Grant Agreement”. The total grant awarded under the Grant Agreement was $225,000 and is intended to fund studies of SBP-101 as a potential treatment for pancreatitis. Grant income is recognized as a non-operating income when the related research and development expenses are incurred, terms of the grant have been complied with and the Company is eligible for reimbursement under the Grant Agreement.


 

Comprehensive loss

 

Comprehensive loss consists of our net loss and the effects of foreign currency translation.

 

Net loss per share

 

Basic net loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding during the period. Diluted net loss per share is based on the weighted-averageweighted average of common shares outstanding during the period plus dilutive potential common shares calculated using the treasury stock method. Such potentially dilutive shares are excluded when the effect would be is anti-dilutive or reduce a net loss per share. The Company’s potentialpotentially dilutive shares, which include outstanding common stock options, and warrants, have not been included in the computation of diluted net loss per share for all periods as the result would be anti-dilutive.

 

The following table summarizes the calculation of basic and diluted net loss per share for each of the periods presented (in thousands, except share and per share data):

  

Three Months Ended September 30,

  

Nine Months Ended September 30,

 
  

2017

  

2016

  

2017

  

2016

 

Net loss

 $(1,219) $(1,079) $(8,213) $(2,874)

Weighted average shares outstanding—basic and diluted

  3,670,432   3,201,689   3,518,828   3,069,184 

Basic and diluted net loss per share

 $(0.33) $(0.34) $(2.33) $(0.94)

The following table sets forth the potential shares of common stock that were not included in the calculation of diluted net loss per share as their effects would have been anti-dilutive:anti-dilutive as of the dates indicated:

 

  

Three Months Ended September 30,

  

Nine Months Ended September 30,

 
  

2017

  

2016

  

2017

  

2016

 

Employee and non-employee stock options

  683,960   316,360   683,960   316,360 

Common shares issuable upon conversion of notes payable and accrued interest

  315,356   246,667   315,356   246,667 

Common shares issuable under common stock purchase warrants

  351,500   366,050   351,500   366,050 

6.

Accrued Liabilities

  

September 30,

 
  

2023

  

2022

 

Employee and non-employee stock options

  13,455   3,352 

Common stock issuable under common stock purchase warrants

  4,068,826   4,538 
   4,082,281   7,890 

 

Accrued liabilities consist of the following (in thousands):

  

September 30, 2017

  

December 31, 2016

 

Accrued compensation and related expenses

 $1,094  $637 

Clinical trial related expense

  65   97 

Professional services

  55   70 

Product and process development expenses

     29 

Other

  4   9 

Total accrued liabilities

 $1,218  $842 

Effective October 1, 2017, we amended the previously disclosed employment agreements, as amended, with our Executive Chairman, President and Chief Executive Officer, Chief Financial Officer and Chief Medical Officer (the “Employees”). These amendments discontinued the “accrued compensation” provision that was introduced with the prior amendments to the employment agreements between the Company and each of the Employees dated September 12, 2016. These amendments also include a provision whereby if the Company closes an underwritten public offering of its securities that include shares of common stock, then each of these Employees will, in lieu of cash payment for the previously accrued compensation, instead receive one or more equity awards under the Company’s 2016 Omnibus Equity Incentive plan. See Note 10 titled “Subsequent Events.”


7.6.Notes Payable

Indebtedness

 

2017 Sucampo promissory noteConvertible notes payable

 

On eachAs of February 17, March 3, March 10 and March 17, 2017, we entered into Note Purchase Agreements (the “Note Agreements”) withSeptember 30,2023, CPP had a number of accredited investors in private transactions. Pursuant to these Note Agreements, we sold convertible promissory notes (the “2017 Notes”) raising gross proceedsbalance outstanding of approximately $3.1 million.$5.4million for principal and interest under an amended and restated promissory note (the “Sucampo Note). The 2017 Notes are scheduled to mature on December 1, 2018 and bearnote was issued with an initial principal amount of approximately $6.2million in favor of Sucampo GmbH dated as of June 15,2022. The principal balance outstanding as of September 30,2023 of approximately $5.2million under the Sucampo Note bears simple interest at a rate of 5.0%5% per year. Principalannum. All unpaid principal, together with any then unpaid and accrued interest is payable as follows: (i) $1.0million, plus all interest accrued but unpaid on or before each of January 31,2024, January 31,2025, and January 31, 2026; and (ii) all remaining principal plus accrued but unpaid interest on or before January 31,2027. On February 1,2023, Panbela paid the balance due of $1.0million plus accrued and unpaid interest of approximately $295,000. As of September 30,2023, the Company was current in all payments due under the Sucampo Note and the accrued and unpaid interest on this note was approximately $172,000. Panbela has agreed to guarantee CPP’s payment obligations under the Sucampo Note pursuant to a Guaranty dated as of June 15,2022.

F-9

Tillotts promissory note

As of December 31,2022, CPP had a balance outstanding of approximately $0.7million representing principal and interest under an amended promissory note issued with an initial principal amount of approximately $650,000 in favor of Tillotts Pharma AG. The principal balance and accrued and unpaid interest were paid in full on the 2017 Notes are payable at maturity. The Company may prepay the 2017 Notes in whole or in part at any time without penalty or premium. The 2017 Notes are convertible into sharesJanuary 31,2023.

7.Stockholders Equity

Public offering of common stock or other securities ofand warrants June 2023

On June 21,2023, the Company upon the occurrencecompleted a registered public offering and issued an aggregate of a Qualified Financing, including the sale586,000 shares of equity securities or a strategic partnership, raising gross proceeds of at least $2.0 million on or before the maturity of the 2017 Notes or upon the request of a holder of any 2017 Note at a fixed conversion rate of $10.10 per share. Upon issuance, the 2017 Notes were convertible into ourits common stock, at a conversion rate of $10.10 per share. The fair market value of our stock on the dates of issuance ranged from $15.00pre-funded warrants to $39.00 per share. Therefore the 2017 Notes contained a beneficial conversion feature withpurchase up to an aggregate intrinsic value of approximately $3.0 million, which is recorded as a debt discount and is presented as a direct deduction from the carrying value of the 2017 Notes and will be amortized through interest expense over the life of the 2017 Notes. Upon the occurrence of certain events of default, the 2017 Notes require the Company to repay the unpaid principal amount of the Notes and any unpaid accrued interest. The Company expects to use the net proceeds from the sales of the Notes for working capital and general corporate purposes. One of our stockholders, who beneficially owns more than 10% of our common stock, purchased $200,000 of the 2017 Notes.

2013 Convertible notes payable

In 2013, we initiated an offering of convertible promissory notes (the “2013 Notes”). In total, gross proceeds raised were $3.1 million. The 2013 Notes accrue interest at 5% per year, payable quarterly, are convertible into1,684,000 shares of common stock at $11.25an exercise price of $0.001 per share at the optionand warrants to purchase up to an aggregate of the holder and mature in December 2018. The Company had not paid the required quarterly interest for the 2013 Notes since the quarter ended March 31, 2016. This constituted an event of default under which the note holders could have demanded immediate payment of the outstanding principal and accrued but unpaid interest.

In March 2017, we offered to all holders of outstanding 2013 Notes, who were accredited investors, an opportunity to convert all outstanding principal and accrued interest through March 31, 2017 into4,540,000 shares of ourits common stock at a ratean exercise price of $7.50$3.75 per share. The offered conversion rate representedsecurities were issued for a $3.75,combined offering price of $3.75 per share of common stock and warrants to purchase two shares, or 33.3%, discount$3.749 per pre-funded warrant and warrants to purchase two shares. Net proceeds from the rate stated inoffering totaled approximately $7.7million. As of September 30,2023, all pre-funded warrants had been exercised. The securities were offered pursuant to an effective registration statement on Form S-1.

Of the terms of the 2013 Notes, which at the time was $11.25 per share. Holders of $2,750,000 aggregate principal amount of the 2013 Notes accepted the offerremaining warrants, warrants to convert and on March 31, 2017 we issued 385,000purchase 2,270,000 shares of common stock, in exchangehave an alternative cashless exercise provision pursuant to which the holder may provide notice and receive an aggregate number of shares equal to the product of (x) the aggregate number of shares of common stock that would be issuable upon a cash exercise and (y) 0.24. This feature became available on June 28,2023 and as of June 30,2023no shares were issued with this alternative cashless exercise. As of September 30,2023120,744 shares of common stock had been issued for the surrenderwarrants to purchase 503,100 shares of common stock.

As of the 2013 Notessame date warrants to purchase up to an aggregate of 4,036,900 shares of common stock remained outstanding with an exercise price of $3.75 per shares, of which included $138,000warrants to purchase 1,766,900 were eligible for alternative cashless exercise.

Public offering of accrued but unpaid interest.common stock and warrants January 2023

On January 30,2023, the Company completed a registered public offering and issued an aggregate of 161,407 shares of its common stock, pre-funded warrants to purchase up to an aggregate of 61,090 shares of common stock at an exercise price of $0.001 per share and warrants to purchase up to an aggregate of 444.999 shares of its common stock at an exercise price as adjusted, of $2.239 per share. The fair market valuesecurities were issued for a combined offering price of $67.50 per share of common stock and warrants to purchase two shares, or $67.47 per pre-funded warrant and warrants to purchase two shares. Net proceeds from the offering totaled approximately $13.8million. The securities were offered pursuant to an effective registration statement on Form S-1.

All of the pre-funded warrants were exercised by February 3,2023. The remaining warrants have an alternative cashless exercise provision pursuant to which the holder may provide notice and receive an aggregate number of shares equal to the product of (x) the aggregate number of shares of common stock that would be issuable upon a cash exercise and (y) 0.75. This feature became available on March 1,2023 and as of as of September 30,2023,331,824 shares of common stock had been issued was $11.5 million, comparedfor warrants to $8.5 purchase 442,434 shares. Warrants to purchase 2,566 shares of common stock remained outstanding with an exercise price as adjusted,  of $2.239 per share.

At-the-market program

We are party to a Sales Agreement dated July 29,2022, pursuant to which Roth Capital Partners, LLC (the “Agent”) may sell shares of the Company’s common stock having an aggregate gross sales price of up to $8.4million, from time to time, through an “at-the-market” equity offering program (the “ATM Program”). Under the Sales Agreement, Roth is entitled to a commission equal to 3.0% of the aggregate gross proceeds of any sales of common stock under the original conversion terms, resultingATM Program.

F-10

During January 2023, the Company sold 14,694 shares of common stock under the ATM Program for approximately $1.6million in gross proceeds.

During September 2023, the Company sold 3,017 shares of common stock under the ATM program for approximately $3,900 in gross proceeds.

In connection with the warrant transactions that occurred subsequent to the end of the period, the Company is restricted from selling under the ATM Program until at least May 2,2024 (See Note 10).

Reverse stock splits

On May 25,2023, the Company held a lossspecial meeting of its stockholders at which the stockholders approved a proposal to effect an amendment to the Company's certificate of incorporation, as amended, to implement a reverse stock split within a range of a ratio of one-for-five (1:5) up to a ratio of one-for-onehundred (1:100). On June 1,2023, the Company's Board of Directors approved the implementation of the reverse stock split of the Company's Common Stock at a ratio of one-for-thirty (1:30). As a result of the reverse stock split, every thirty(30) shares of the Company's Common Stock either issued and outstanding immediately prior to the effective time was, automatically and without any action on the induced debt conversionpart of approximately $3.0 million. Onethe respective holders thereof, combined and converted into one(1) share of our stockholders, who beneficially owns more than 10% of our common stock, converted $700,000 aggregate principal amount of 2013 Notes, along with $35,000 of accrued but unpaid interest, into 98,000 shares of ourthe Company's common stock. TheNo fractional shares were issued in relianceconnection with the reverse stock split. Stockholders who otherwise were entitled to receive a fractional share in connection with the reverse stock split instead were eligible to receive a cash payment, which was not material in the aggregate, instead of shares. On June 1,2023, the Company filed a Certificate of Amendment of its Certificate of Incorporation, as amended with the Secretary of State of Delaware effecting a one-for-thirty (1:30) reverse stock split of the shares of the Company’s common stock, issued and outstanding, effective June 1,2023.

On November 29,2022, the Company held a special meeting of its stockholders at which the stockholders approved a proposal to effect an amendment to the Company's certificate of incorporation, as amended, to implement a reverse stock split at a ratio of one-for-forty (1:40). On January 13,2023, the Company's Board of Directors approved the implementation of the reverse stock split of the Company's Common Stock. As a result of the reverse stock split, every forty(40) shares of the Company's Common Stock either issued and outstanding immediately prior to the effective time was, automatically and without any action on the exemption from registration set forth in Section 3(a)(9)part of the Securities Actrespective holders thereof, combined and converted into one(1) share of the Company's common stock. No fractional shares were issued in connection with the reverse stock split. Stockholders who otherwise were entitled to receive a fractional share in connection with the reverse stock split instead were eligible to receive a cash payment, which was not material in the aggregate, instead of shares. On January 13,2023, the Company filed a Certificate of Amendment of its Certificate of Incorporation, as securities exchanged by an issueramended with existing security holders where no commission or other remuneration is paid or given directly or indirectly by the issuer for soliciting such exchange.Secretary of State of Delaware effecting a one-for-forty (1:40) reverse stock split of the shares of the Company’s common stock, issued and outstanding, effective January 13,2023.

 

Demand notes payableShares reserved

 

In September 2015, we assumed $250,000 of unsecured demand notes in conjunction with our merger with Cimarron Medical, Inc. that were previously issued by Cimarron (the “Demand Notes”).


We included the holders of Demand Notes in our offer to convert all outstanding principal into shares of our common stock at a rate of $7.50 per share. The Demand Notes had no conversion feature. The holders of all $250,000 aggregate principal amount of the Demand Notes accepted the offer to convert and on March 31, 2017 we issued 33,332following shares of common stock in exchange for the surrender of all Demand Notes. The fair market value of the shares issued was $1.0 million resulting in a loss on induced debt conversion of $700,000. The shares were issued in reliance on the exemption from registration set forth in Section 3(a)(9) of the Securities Act as securities exchanged by an issuer with existing security holders where no commission or other remuneration is paid or given directly or indirectly by the issuer for soliciting such exchange.

The following table sets forth the changes in convertible and demand notes payable during the nine months ended September 30 2017 (in thousands):

  

Convertible Notes Payable

     
  

Principal

  

Accrued Interest

  

Demand Notes

 

Principal value at December 31, 2016

 $2,775  $105  $250 

Accrued interest

     120    

Aggregate principal value of 2017 Notes sold

  3,076       

Aggregate principal value of 2013 Notes and accrued interest converted into common stock

  (2,750)  (138)   

Aggregate principal value of Demand Notes converted into common stock

        (250)

Principal value at September 30, 2017

 $3,101  $87  $ 

Term debt

On October 26, 2012, we entered into an unsecured loan agreement (the “Agreement”) with the Institute for Commercialization of Public Research, Inc. (the "Institute"). Under the terms of the agreement, we borrowed $300,000 at a fixed interest rate of 4.125%. No principal or interest payments were due until the maturity date, October 26, 2017, unless a mandatory repayment event occurred.

Effective October 26, 2017, we entered into an amendment to our unsecured loan agreement with the Institute for Commercialization of Public Research, Inc. Under the terms of the amendment the maturity date of the note was extended to May 1, 2019 with monthly payments of $10,000 to begin on May 1, 2018 with the remaining balance due in full on May 1, 2019. The monthly payments will apply first to accrued and unpaid interest. Accordingly, the outstanding principal is presented as a long term liability in the September 30, 2017 balance sheet.

Debt issuance costs and discount

The following table summarizes the deferred financing costs which are presented as a direct deduction from the carrying amount of their related debt liabilities (in thousands):

  

September 30, 2017

  

December 31, 2016

 
  

Convertible

Notes Payable

  

Term Debt

  

Convertible

Notes Payable

  

Long-Term Debt

 

Loan principal amount

 $3,101  $300  $2,775  $300 

Deferred financing costs

  16   37   105   37 

Accumulated amortization

  (4)  (37)  (63)  (31)

Unamortized balance

  12      42   6 

Discount on debt

  2,954             

Accumulated amortization

  (961)            

Unamortized balance

  1,993             

Loan carrying amounts, net

 $1,096  $300  $2,733  $294 


8.

Stockholders’ Deficit

Shares reserved

Shares of common stock reserved for future issuance are as follows:of the date indicated:

 

  

September 30,, 2017 2023

 

Stock options outstanding

  683,96013,455 

Shares available for grant under equity incentive plan

  1,110,400- 

Estimated common shares issuable upon conversion of notes payable and accrued interestWarrants outstanding

  315,3564,068,826 

Common shares issuable under common stock purchase warrants

  351,500

Total

2,461,2164,082,281 

 

8.Stock-based Compensation

9.

Share-based Compensation

 

2016 Omnibus Incentive Plan

 

The Sun BioPharma,Panbela Therapeutics, Inc. 2016 Omnibus Incentive Plan (the “2016 Plan”) was adopted by our Board of Directors in March 2016 and approved by our stockholders at our annual meeting of stockholders onin May 17, 2016.2016. The 2016 Plan permits the granting of incentive and non-statutory stock options, restricted stock, stock appreciation rights, performance units, performance shares and other stock awards to eligible employees, directors and consultants. We grant options to purchase shares of common stock under the 2016 Plan at no less than the fair market value of the underlying common stock as of the date of grant. Options granted under the 2016Plan have a maximum term of ten years. Under the Plan, a total of 1,500,000 shares of common stock are reserved for issuance. As of September 30, 2017,2023, options to purchase 389,60012,054 shares of common stock were outstanding under the 2016 Plan. Plan and no shares remained available for future awards. The weighted average exercise price is $1,105.88 and the average remaining life is approximately 9.0 years.

F-11

 

2011 Stock Option Plan

 

The Sun BioPharma,Our Board of Directors ceased making awards under the Panbela Therapeutics, Inc. 2011 Stock Option Plan (the “2011 Plan”) was terminated in conjunction withupon the original receipt of stockholder approval offor the 2016 Plan although awardsin May 2016. Awards outstanding under the 2011 Plan will remain outstanding in accordance with and pursuant to the terms thereof. Options granted under the 2011 Plan have a maximum term of ten years and generally vest over zero to two years for employees. As of September 30, 2017,2023, options to purchase 294,360171 shares of common stock remained outstanding under the 2011 Plan. The weighted average exercise price is $3,721.58 and the average remaining life is approximately 1.3 years.

 

Share-basedCPPs 2010 Equity Incentive Plan

The Company has assumed all remaining rights and obligations with respect to CPP’s 2010 Equity Incentive Plan (the “CPP Plan”) through the issuance of replacement options. As of September 30,2023, options to purchase 1,230 shares of common stock remained outstanding under the CPP Plan, with a weighted average exercise price of $361.56 per share, and the average remaining contractual life was 6.8 years.

Stock-based compensation expense

General and administrative (“G&A”) and research and development (“R&D”) expenses include non-cash stock-based compensation expense as a result of our issuance of stock options. The terms and vesting schedules for stock-based awards vary by type of grant and the employment status of the grantee. The awards granted through September 30,2023 vest based upon time-based and performance conditions. There was approximately $0.2million unamortized stock-based compensation expense related to options granted to employees, directors, and consultants as of September 30,2023. The unamortized expense will be recognized over the next 12 months.

Stock-based compensation expense for each of the periods presented is as follows (in thousands):

 

  

Nine months Ended

 
  

September 30, 2017

  

September 30, 2016

 

Research and development

 $229  $ 

General and administrative

  938    

Total share-based compensation

 $1,167  $ 
  

Nine Months Ended September 30,

 
  

2023

  

2022

 

General and Administrative

 $554  $697 

Research and Development

  145   160 
  $699  $857 

 

A summaryDetails of option activity is asoptions granted, exercised, cancelled, or forfeited during the nine months ended September 30,2023 follows:

 

 

Shares

Available for

Grant

  

Shares

Underlying

Options

  

Weighted

Average

Exercise Price

Per Share

  

Aggregate

Intrinsic

Value

  

Shares Underlying

Options

  

Weighted

Average

Exercise Price

Per Share

  

Aggregate

Intrinsic Value

 

Balances at December 31, 2016

  1,114,400   701,960  $9.50  $3,896,235 

Balance at January 1, 2023

  3,287  $4,369  $- 

Granted

  (4,000)  4,000   10.10       10,240   15     

Exercised

     (22,000)  1.25       -   -     

Cancelled

               (72)  1,424     

Balances at September 30, 2017

  1,110,400   683,960  $9.77  $2,121,985 

Forfeitures or expirations

  -   -     

Balance at September 30, 2023

  13,455  $1,071  $- 

 


F-12

 

Information about stock options outstanding, vested and expected to vest as of September 30, 2017,2023 is as follows:

 

     

Outstanding, Vested and Expected to Vest

  

Options Vested and Exercisable

 
         

Weighted Average

          

Weighted Average

 
         

Remaining

  

Weighted

      

Remaining

 

Per Share

      

Contractual

  

Average

  

Options

  

Contractual

 

Exercise Price

  

Shares

  

Life (Years)

  

Exercise Price

  

Exercisable

  

Life (Years)

 

$0.88

1.10   38,360   5.08  $1.00   38,360   5.08 

2.28

2.50   42,000   6.37   2.47   42,000   6.37 
 3.18    214,000   7.42   3.18   214,000   7.42 
 10.10    4,000   4.28   10.10       
 15.10    385,600   8.76   15.10   196,050   9.11 
      683,960   7.96  $9.77   490,410   7.83 
     Outstanding, Vested and Expected to Vest  Options Vested and Exercisable 
                        

Per Share Exercise Price

  

Shares

  

Weighted Average

Remaining

Contractual Life

(Years)

  

Weighted

Average

Exercise Price

  

Options

Exercisable

  

Weighted Average

Remaining

Contractual Life

(Years)

 
                        
 $15    10,240   9.50  $15   1,662   9.50 
 $264    1,150   7.26  $264   1,150   7.26 
$1,764-$3,540   582   5.01  $3,215   569   4.94 
$3,810-$4,908   498   5.57  $4,493   398   5.08 
$5,004-$7,320   428   6.14  $6,102   428   6.14 
$9,720-$18,120   557   4.81  $12,987   557   4.81 
                        

Totals

   13,455   8.66  $1,071   4,764   7.19 

 

AsAssumptions used to calculate the fair market value of options granted in the nine month period ended September 30, 2017 total compensation expense related to unvested employee stock options not yet recognized was $1.1 million, which is expected to be allocated to expenses over a weighted-average period2023 include:

2023

Common stock fair value

$15.00

Risk-free interest rate

3.59%-3.60%

Expected dividend yield

Expected Option life

5.08-5.50

Expected stock price volatility

131.0%-138.0%

9.Gain on Sale of approximately 1.2 years.Intellectual Property

 

Nonemployee share-based compensation

We account for stock options granted to nonemployeesOn July 17,2023, the Company divested certain rights, titles and interests in accordance with FASB ASC 505. In connection with stock options granted to nonemployees, we recorded $397,000 and $0 for nonemployee share-based compensation duringits eflornithine pediatric neuroblastoma program. Under the nine months ended September 30, 2017 and 2016, respectively. These amounts were based upon the fair valuesterms of the vested portionagreement, the Company is entitled to receive up to approximately $9.5million in non-dilutive funding in exchange for the sale of these assets. An initial payment of $400,000 was received by the grants. Amounts expensed during the remaining vesting period will be determined based on the fair valueCompany at the time of vesting.closing, remaining payments will be receivable if the acquiring company successfully completes certain milestones related to clinical development, regulatory approval and commercial sales. At the time of closing, the successful completion of these milestones is not probable and the Company did not recognize these future payments on the date of the sale as they did not have any realized or realizable value. It was determined that the contract was not with a customer and did not represent the sale of a business and therefore the initial payment was recognized as a gain on sale of intellectual property which was reflected in other income during the three months ended September 30,2023.

10.Subsequent Events

On November 2,2023, the Company entered into warrant exercise inducement offer letters (the “Inducement Letters”) with certain holders (the “Holders”) of its existing warrants to purchase shares of common stock (the “Existing Warrants”), pursuant to which the Holders agreed to exercise for cash their Existing Warrants to purchase 2,130,000 shares of the Company’s common stock, in the aggregate, at a reduced exercise price of $0.78 per share, in exchange for the Company’s agreement to issue new warrants (the “Inducement Warrants”) on substantially the same terms as the Existing Warrants described below, to purchase up to 4,260,000 shares of the Company’s common stock (the “Inducement Warrant Shares”) and a cash payment of $0.125 per Existing Warrant Share which was paid in full upon the exercise of the Existing Warrants. The Company received aggregate gross proceeds of approximately $1.9million from the exercise of the Existing Warrants by the Holders and the sale of the Inducement Warrants. The Company incurred $115,659 in investment banking fees relating to the transaction, in addition to reimbursement for certain expenses.

 

The estimated fair valuesCompany has agreed to file a registration statement on Form S-3 covering the resale of the stock optionsInducement Warrants Shares issued to employees and non-employees were calculated using the Black-Scholes valuation model, based on the following assumptions for the nine months ended September 30, 2017 and 2016:

  

2017

  

2016

 

Common stock fair value

  $10.00$29.80   n/a 

Risk-free interest rate

  1.43%1.93%   n/a 

Expected dividend yield

   0%    n/a 

Expected option life (in years)

  2.25  5.0   n/a 

Expected stock price volatility

  75.078.0%   n/a 

10.

Subsequent Events

Reverse stock split

Effective November 7, 2017, we implemented a 1-for-10 reverse split of our common stock. No fractional shares were issued in connection with the reverse stock split. Stockholders received a proportionate cash payment for any fractional shares basedor issuable upon the closing priceexercise of our common stock on the effectiveInducement Warrants (the “Resale Registration Statement”) within twenty(20) calendar days of the date of the reverse stock split. The reverse stock split was intended to increaseInducement Letters. In the market price per share of our common stock to a level that qualifies for listing on the Nasdaq Capital Market. The Company is taking additional actions to meet the remaining listing requirements. UntilInducement Letters, the Company meets the criteria for listing and an application for listing is accepted by Nasdaq, which mayagreed not happen within a reasonable time frame, if at all, its common stock will continue to be eligible for quotation on the OTCQB Venture Marketplace tier of the over-the-counter markets administered by the OTC Markets Group, Inc. under the symbol ”SNBP“. The reverse stock split did not affect the par value of our common stock, however, concurrent with the reverse stock split, the number ofissue any shares of common and preferred stock authorized for issuance byor common stock equivalents or to file any other registration statement with the SEC (in each case, subject to certain exceptions) until the Company was reduced by 50%receives stockholder approval. The Company also has agreed not to 100,000,000 and 10,000,000, respectively. Proportional adjustments were also madeeffect or agree to effect any variable rate transaction (as defined in the Company’s 2016 Omnibus Incentive Plan, outstanding stock options, warrants and outstanding convertible notes payable. The new CUSIP number for our common stock followingInducement Letters) until one year from the reverse stock splitdate of the Inducement Letters, other than an at-the-market offering, which may be effected after the date that is 8666M 206. All references to share and per share amounts included in these condensed consolidated financial statements have been retroactively restated to reflectsix months from the reverse split.date of the Inducement Letters.

 


F-13

Index

Report of Independent Registered Public Accounting Firm

F-16

Consolidated Balance Sheets

F-17

Consolidated Statements of Operations and Comprehensive Loss

F-18

Consolidated Statements of Stockholders’ Deficit

F-19

Consolidated Statements of Cash Flows

F-20

Notes to Consolidated Financial Statements

F-21

Share and per share amounts included in these consolidated financial statements have not been restated to reflect the 1-for-10 reverse stock split implemented on November 7, 2017



 

Report of Independent Registered Public Accounting Firm

 

To the Board of Directors and Stockholders of
Sun BioPharma,

Panbela Therapeutics, Inc.

Waconia, MN

 

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheets of Sun BioPharma,Panbela Therapeutics, Inc. and Subsidiaries (the “Company”) as of December 31, 20162022 and 20152021, and the related consolidated statements of operations and comprehensive loss, stockholders’ deficitstockholders’ (deficit) equity, and cash flows for each of the years then ended. These financial statements areended, and the responsibility ofrelated notes (collectively referred to as the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.

We conducted our audits in accordance with standards of the Public Company Accounting Oversight Board (United States of America)“financial statements”). Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis of designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Sun BioPharma, Inc. atthe Company as of December 31, 20162022 and 20152021, and the results of its operations and its cash flows for each of the years then ended in conformity with accounting principles generally accepted in the United States of America.

 

Substantial Doubt about the Company's Ability to Continue as a Going Concern

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company has recurring losses and negative cash flows from operations that raise substantial doubt about its ability to continue as a going concern. Management’sManagement’s evaluations of the events and conditions and management’s plans in regard to theseregarding those matters are described in Note 3 to the financial statements.3. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

Basis for Opinion

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

Critical Audit Matter Asset Purchase

The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the Company’s Audit Committee and that: (i) relates to accounts or disclosures that are material to the financial statements and (ii) involved especially challenging, subjective, or complex judgements. The communication of critical audit matters does not alter, in any way, our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.

F-14

Critical Audit Matter Description

As described in Note 6 to the financial statements, on June 15, 2022, the Company completed an acquisition of Cancer Prevention Pharmaceuticals, Inc. (“CPP”) in a transaction accounted for as an asset purchase (the “Transaction”). The net assets acquired were recorded at fair value and included acquired in-process research and development (“IPR&D”) associated with CPP’s product candidates and was recorded as a research and development expense in the Company’s consolidated statement of operations.

Auditing the Company’s accounting for the Transaction was complex because of the judgment involved in evaluating whether the Transaction met the criteria of a business combination or an asset acquisition among other accounting considerations. The subjective considerations included whether substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets, the most significant of which is the IPR&D asset.

How the Critical Audit Matter Was Addressed in the Audit

To test the Company’s accounting for the Transaction, we performed the following audit procedures:

We evaluated the Company's application of the relevant accounting guidance as defined in ASC Topic 805 – Business Combinations.

We assessed the completeness and accuracy of the net asset acquired, including the evaluation of any implied goodwill.

We recalculated the fair value of the non-cash consideration paid in the Transaction, including the common stock options.

We also assessed the appropriateness of the related disclosures in the consolidated financial statements.

We have served as the Company’s auditors since 2014.

/s/ Cherry Bekaert

 

Tampa, Florida

March 30, 201716, 2023

 


F-15

 

Sun BioPharma,Panbela Therapeutics, Inc.
Consolidated Balance Sheets

(In thousands, except share amounts)

 

 

 

December 31,

 

 

 

2016

 

 

2015

 

ASSETS

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash

 

$

438

 

 

$

925

 

Prepaid expenses and other current assets

 

 

118

 

 

 

74

 

Income tax receivable

 

 

321

 

 

 

733

 

Total current assets

 

 

877

 

 

 

1,732

 

 

 

 

 

 

 

 

 

 

Total assets

 

$

877

 

 

$

1,732

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ DEFICIT

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,245

 

 

$

585

 

Accrued expenses

 

 

842

 

 

 

505

 

Convertible notes payable

 

 

2,733

 

 

 

 

Term debt

 

 

294

 

 

 

 

Demand notes payable

 

 

250

 

 

 

250

 

Accrued interest

 

 

155

 

 

 

35

 

Total current liabilities

 

 

5,519

 

 

 

1,375

 

 

 

 

 

 

 

 

 

 

Long-term liabilities:

 

 

 

 

 

 

 

 

Convertible notes payable

 

 

 

 

 

2,712

 

Term debt

 

 

 

 

 

287

 

Accrued interest

 

 

 

 

 

39

 

Total long-term liabilities

 

 

 

 

 

3,038

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies (Note 7)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ deficit:

 

 

 

 

 

 

 

 

Preferred stock, $0.001 par value; 20,000,000 and 10,000,000 authorized as of December 31, 2016 and 2015, respectively; no shares issued or outstanding as of December 31, 2016 and 2015

 

 

 

 

 

 

Common stock, $0.001 par value; 200,000,000 and 100,000,000 authorized as of December 31, 2016 and 2015, respectively; 32,201,306 and 29,892,806 shares issued and outstanding, as of December 31, 2016 and 2015, respectively

 

 

32

 

 

 

30

 

Additional paid-in capital

 

 

14,029

 

 

 

10,943

 

Accumulated deficit

 

 

(18,779

)

 

 

(13,667

)

Accumulated other comprehensive gain, net

 

 

76

 

 

 

13

 

Total stockholders’ deficit

 

 

(4,642

)

 

 

(2,681

)

Total liabilities and stockholders’ deficit

 

$

877

 

 

$

1,732

 

  

December 31, 2022

  

December 31, 2021

 

ASSETS

        

Current assets:

        

Cash and cash equivalents

 $1,285  $11,867 

Prepaid expenses and other current assets

  443   91 

Income tax receivable

  49   321 

Total current assets

  1,777   12,279 

Other noncurrent assets

  3,201   593 

Total assets

 $4,978  $12,872 
         

LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY

        

Current liabilities:

        

Accounts payable

 $2,865  $640 

Accrued expenses

  2,993   2,020 

Accrued interest payable

  325   - 

Note payable

  650   - 

Debt, current portion

  1,000   - 

Total current liabilities

  7,833   2,660 
         

Debt, net of current portion

  5,194   - 

Total non current liabilities

  5,194   - 
         

Total liabilities

  13,027   2,660 
         

Stockholders' (deficit) equity:

        

Preferred stock, $0.001 par value; 10,000,000 authorized; no shares issued or outstanding as of December 31, 2022 and December 31, 2021

  -   - 

Common stock, $0.001 par value; 100,000,000 authorized; 1,049,644 and 335,961 shares issued and outstanding, as of December 31, 2022 and December 31, 2021, respectively

  1   - 

Additional paid-in capital

  82,285   66,240 

Accumulated deficit

  (91,094)  (56,161)

Accumulated comprehensive income

  759   133 

Total stockholders' (deficit) equity

  (8,049)  10,212 

Total liabilities and stockholders' (deficit) equity

 $4,978  $12,872 

 

SeeShare and per share data have been adjusted for all periods presented to reflect the one-for-forty reverse stock split effective January 13, 2023.

The accompanying notes to the consolidated financial statements are an integral part of these statements.

 


F-16

 

Sun BioPharma,Panbela Therapeutics, Inc.

Consolidated Statements of Operations and Comprehensive Loss


(In thousands, except share and per share amounts)

 

 

Year Ended December 31,

  

Year Ended December 31,

 
 

2016

  

2015

  

2022

  

2021

 

Operating expenses:

                

General and administrative

 $2,664  $2,592  $6,044  $4,587 

Research and development

  2,504   2,852   28,049   5,423 

Operating loss

  (5,168

)

  (5,444

)

  (34,093)  (10,010)
                

Other income (expense):

        

Other (expense) income:

        

Interest income

  2   8   14   1 

Interest expense

  (180

)

  (183

)

  (288)  (12)

Other expense

  (107

)

  (64

)

  (682)  (602)

Total other expense

  (285

)

  (239

)

  (956)  (613)
                

Loss before income tax benefit

  (5,453

)

  (5,683

)

  (35,049)  (10,623)
                

Income tax benefit

  341   756   116   488 
                

Net loss

  (5,112

)

  (4,927

)

  (34,933)  (10,135)

Foreign currency translation adjustment gain

  63   30 

Foreign currency translation adjustment

  626   517 

Comprehensive loss

 $(5,049

)

 $(4,897

)

 $(34,307) $(9,618)
                

Basic and diluted net loss per share

 $(0.16

)

 $(0.35

)

 $(67.91) $(34.64)

Weighted average shares outstanding – basic and diluted

  31,068,765   14,073,174 

Weighted average shares outstanding - basic and diluted

  514,369   292,607 

 

SeeShare and per share data have been adjusted for all periods presented to reflect the one-for-forty reverse stock split effective January 13, 2023.

The accompanying notes to the consolidated financial statements are an integral part of these statements.

 


F-17

 

Sun BioPharma,Panbela Therapeutics, Inc.

Consolidated Statements of Stockholders Deficit Equity (Deficit)

(In thousands, except share amounts)

  For the Years ended December 31, 2022 and 2021 
  

 

  

Additional

  

 

  

Accumulated

  

Total

 
  Common Stock  Paid in  Accumulated  Comprehensive  Stockholders' 
  

Shares

  

Amount

  

Capital

  

Deficit

  

Loss

  

Equity (Deficit)

 
                         

Balance at January 1, 2021

  241,495  $-  $54,857  $(46,026) $(384) $8,447 

Public Offering - Issuance of common stock

  83,319   -   9,054   -   -   9,054 

Exercise of warrants for cash

  5,723   -   1,042   -   -   1,042 

Exercise of warrants, cashless

  4,763   -   -   -   -   - 

Vesting of restricted stock

  557   -   -   -   -   - 

Exercise of options, cashless

  104   -   -   -   -   - 

Stock-based compensation

  -   -   1,287   -   -   1,287 

Net loss

  -   -   -   (10,135)  -   (10,135)

Foreign currency translation adjustment

  -   -   -   -   517   517 

Balance at December 31, 2021

  335,961   -   66,240   (56,161)  133   10,212 
                         
Issuance of common stock, options and warrants - CPP acquisition  182,988   -   9,605   -   -   9,605 

Public offering - issuance of common stock and warrants

  502,500   1   5,302   -   -   5,303 

Sale of common stock

  28,345   -   46   -   -   46 

Vesting of restricted stock

  269   -   -   -   -   - 

Exercise of options, cashless

  372   -   -   -   -   - 

Exercise of warrants for cash

  25   -   5   -   -   5 

Share Based Compensation

  -   -   1,088   -   -   1,088 

Net Loss

  -   -   -   (34,933)  -   (34,933)

Adjustment for fractional shares not issued, stock split

  (816)  -   (1)  -   -   (1)

Foreign Currency translation adjustment

  -   -   -   -   626   626 

Balance at December 31, 2022

  1,049,644  $1  $82,285  $(91,094) $759  $(8,049)

Share and per share amounts)data have been adjusted for all periods presented to reflect the one-for-forty reverse stock split effective January 13, 2023.

 

                  

Accumulated

     
          

Additional

      

Other

  

Total

 
  

Common Stock

  

Paid-In

  

Accumulated

  

Comprehensive

  

Stockholders

 
  

Shares

  

Amount

  

Capital

  

Deficit

  

Gain (Loss)

  

Deficit

 

Balances at December 31, 2014

  5,688,927  $6  $7,264  $(8,569

)

 $(17

)

 $(1,316

)

Exercise of stock options

  647,634   1   692         693 

Exercise of stock warrants

  500,000      375         375 

Conversion of convertible notes payable and accrued interest into common stock

  50,194      226         226 

Issuance of common stock in a private offering, net of issuance costs of $12

  190,625      1,513         1,513 

Issuance of common stock for services

  33,241      42         42 

Stock-based compensation expense

        933         933 

Exercise price modification of common stock warrants

        171   (171

)

      

Merger transaction – See Note 8

  22,782,185   23   (273

)

        (250

)

Net loss

           (4,927

)

     (4,927

)

Foreign currency translation adjustment, net of taxes of $0

              30   30 

Balances at December 31, 2015

  29,892,806  $30  $10,943  $(13,667

)

 $13  $(2,681

)

Issuance of common stock and warrants, net of offering costs of $152

  2,221,000   2   2,067         2,069 

Issuance of common stock for services

  37,500      75         75 

Exercise of stock warrants

  50,000      42         42 

Stock-based compensation expense

          902           902 

Net loss

           (5,112

)

     (5,112

)

Foreign currency translation adjustment, net of taxes of $0

              63   63 

Balances at December 31, 2016

  32,201,306  $32  $14,029  $(18,779

)

 $76  $(4,642

)

SeeThe accompanying notes to the consolidated financial statements are an integral part of these statements.

 


F-18

 

Sun BioPharma,Panbela Therapeutics, Inc.

Consolidated Statements of Cash Flows
(In thousands)

 

 

 

Year Ended December 31,

 

 

 

2016

 

 

2015

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(5,112

)

 

$

(4,927

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Amortization of debt issuance costs

 

 

28

 

 

 

28

 

Non-cash interest expense

 

 

12

 

 

 

10

 

Stock-based compensation

 

 

902

 

 

 

976

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Income and other tax receivables

 

 

426

 

 

 

(610

)

Prepaid expenses and other assets

 

 

19

 

 

 

(45

)

Accounts payable

 

 

726

 

 

 

252

 

Accrued liabilities

 

 

601

 

 

 

419

 

Net cash used in operating activities

 

 

(2,398

)

 

 

(3,897

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Proceeds from sales and maturities of short-term investments

 

 

 

 

 

500

 

Net cash provided by investing activities

 

 

 

 

 

500

 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Proceeds from issuance of common stock and warrants, net of offering costs of $152

 

 

1,873

 

 

 

 

Proceeds from issuance of common stock, net of selling costs of $12

 

 

 

 

 

1,513

 

Proceeds from the exercise of stock options

 

 

 

 

 

762

 

Proceeds from the exercise of stock purchase warrants

 

 

42

 

 

 

400

 

Net cash provided by financing activities

 

 

1,915

 

 

 

2,675

 

 

 

 

 

 

 

 

 

 

Effect of exchange rate changes on cash

 

 

(4

)

 

 

(7

)

 

 

 

 

 

 

 

 

 

Net decrease in cash

 

 

(487

)

 

 

(729

)

Cash at beginning of year

 

 

925

 

 

 

1,654

 

Cash at end of year

 

$

438

 

 

$

925

 

 

 

 

 

 

 

 

 

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

 

 

 

Cash paid during year for interest

 

$

57

 

 

$

145

 

 

 

 

 

 

 

 

 

 

Supplemental disclosure of non-cash transactions:

 

 

 

 

 

 

 

 

Deferred compensation exchanged for common stock and warrants

 

$

196

 

 

$

 

Issuance of common stock for services

 

$

75

 

 

$

 

Conversion of notes payable and accrued interest into common stock

 

$

 

 

$

226

 

Notes payable assumed in merger (Note 6)

 

$

 

 

$

250

 

  

Year Ended December 31,

 
  

2022

  

2021

 

Cash flows from operating activities:

        

Net loss

 $(34,933) $(10,135)

Adjustments to reconcile net loss to net cash used in operating activities:

        

Write off of in process research and development (IPR&D)

  17,737   - 

Stock-based compensation

  1,088   1,287 

Non-cash interest expense

  273   - 

Changes in operating assets and liabilities:

        

Income tax receivable

  212   51 

Prepaid expenses and other current assets

  (127)  247 

Deposits held for clinical trial costs

  (2,561)  (540)

Accounts payable

  2,249   631 

Accrued liabilities

  786   1,214 

Net cash used in operating activities

  (15,276)  (7,245)

Cash flows from investing activities:

        

Investment in IPR&D

  (660)  - 

Cash acquired in merger

  4   - 

Net cash used in investing activities

  (656)  - 

Cash flows from financing activities:

        
Proceeds from sale of common stock, net of fees and offering costs of $44  46   - 

Proceeds from public offering of common stock and warrants net of underwriters discount and offering costs of $727

  5,303   - 

Proceeds from public offering of common stock net of underwriters discount and offering costs of $946

  -   9,054 

Proceeds from exercise of warrants

  5   1,042 

Net cash provided by financing activities

  5,354   10,096 

Effect of exchange rate changes on cash

  (4)  (6)

Net change in cash

  (10,582)  2,845 

Cash and cash equivalents at beginning of year

  11,867   9,022 

Cash and cash equivalents at end of year

 $1,285  $11,867 

Supplemental disclosure of cash flow information:

        

Cash paid during period for interest

 $15  $12 

Supplemental disclosure of non-cash transactions:

        

Fair value of common stock, stock options and stock warrants issued as consideration for asset acquisition

 $9,605  $- 

 

SeeThe accompanying notes to the consolidated financial statements are an integral part of these statements.

 


F-19

 

Sun BioPharma,Panbela Therapeutics, Inc.
Notes to Consolidated Financial Statements

 

1.     Business

Business

 

Sun BioPharma,Panbela Therapeutics, Inc. (“Panbela”) and its direct wholly-owned subsidiaries: Cancer Prevention Pharmaceuticals, Inc. (“CPP”) and Panbela Research, Inc. (“Panbela Research”) and their respective subsidiaries, all of which are wholly owned exist for the primary purpose of developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs. Panbela Therapeutics Pty Ltd is a wholly-owned subsidiary Sun BioPharma Australia Pty Ltd. (collectivelyof Panbela Research organized under the laws of Australia. CPP has two wholly owned dormant subsidiaries: Cancer Prevention Pharma Limited, a United Kingdom entity, and Cancer Prevention Pharmaceuticals, LLC, an Arizona limited liability company. Panbela, together with its direct and indirect subsidiaries is referred to as “we,” “us,” “our,” and the “Company”) exist“Company.”

The primary objective of our pipeline is the utilization of pharmacotherapies to reduce or normalize increased disease-associated polyamines using complementary pharmacotherapies. Our lead candidates are ivospemin (SBP-101) for the primary purpose of advancing the commercial development of a proprietary polyamine analogue for pancreatic cancer and for a second indication in chronic pancreatitis. Wewhich we have exclusively licensed the worldwide rights to this compound, which has been designated as SBP-101, from the University of Florida Research Foundation, Inc. (“UFRF”). SBR was incorporated underand Flynpovi™ a combination of eflornithine (CPP-1X) and sulindac. We have exclusively licensed rights from the lawsArizona Board of Regents of the StateUniversity of Delaware on September 21, 2011. Sun BioPharma Australia Pty Ltd was established on May 24, 2013,Arizona to commercialize Flynpovi, these rights are subject to a sublicense agreement to develop and incorporated under the lawscommercialize Flynpovi in North America.

Acquisition of Australian Securities and Investments Commission.CPP

 

On September 4, 2015, Sun BioPharmaJune 15, 2022, we completed the previously announced strategic business reorganization and acquisition of CPP pursuant to the agreement and plan of merger, dated as of February 21, 2022 (the “Merger Agreement”), by and among Panbela, CPP, Panbela Research, Canary Merger Subsidiary I, Inc. (“SBR”Merger Sub I”), our predecessor company, executed anand Canary Merger Subsidiary II, Inc. (“Merger Sub II”). Pursuant to the terms of the Merger Agreement, (i) Merger Sub I, then a wholly-owned subsidiary of Panbela, which was itself a wholly-owned subsidiary of Panbela Research, merged with and Plan of Merger with Cimarron Medical, Inc., (“Cimarron”into Panbela Research (the “First Merger”), with Panbela Research surviving the First Merger, and (ii) Merger Sub II, then a Utah corporation,wholly-owned subsidiary of Panbela, merged with and SB Acquisition Corporation,into CPP (the “Second Merger” and, together with the First Merger, the “Mergers”), with CPP surviving the Second Merger. As a result of the Mergers, each of Panbela Research and CPP became a wholly owned subsidiary of Cimarron (the “Merger”). The merger of SB Acquisition CorporationPanbela. In addition, in connection with and into SBR resulted in allthe consummation of the issuedMergers, then “Panbela Therapeutics, Inc.” was renamed to “Panbela Research, Inc.” and outstanding common stock of SBR being converted into the rightthen “Canary Merger Holdings, Inc.” was renamed to receive an aggregate of 28,442,484 shares of Cimarron’s common stock, representing four shares of Cimarron common stock for every one share of SBR common stock cancelled in the Merger. As a result of this transaction, former SBR stockholders owned approximately 98.8% of the outstanding capital stock of Cimarron. Concurrent with the completion of the Merger, Cimarron’s name was changed to “Sun BioPharma,“Panbela Therapeutics, Inc.” See Note 86, “Asset Acquisition,” for additional information regarding the Merger.

On May 17, 2016, our stockholders approved the changing the domicile of Sun BioPharma, Inc., formerly known as Cimarron, from the State of Utah to the State of Delaware through a merger with SBR (the “Reincorporation”). Upon the reincorporation, each outstanding certificate representing shares of the Utah corporation’s common stock was deemed, without any action by the holders thereof, to represent the same number and class of shares of our company’s common stock. As of May 25, 2016, the completion of the Merger, the rights of our stockholders began to be governed by Delaware law and our current certificate of incorporation and bylaws.information.

 

2.     RisksReverse Stock Split

Effective January 13, 2023, Panbela effected a 1-for-40 reverse stock split of its outstanding shares of common stock. Unless specifically provided otherwise herein, all share and Uncertaintiesper share amounts of our common stock presented have been retroactively adjusted to reflect the reverse stock split. See Note 9 for more information.

2.

Risks and Uncertainties

 

The Company operates in a highly regulated and competitive environment. The development, manufacturing and marketing of pharmaceutical products require approval from, and are subject to ongoing oversight by, the Food and Drug Administration (“FDA”) in the United States, the Therapeutic Goods Administration (“TGA”) in Australia, the European Medicines Agency (“EMA”) in the European Union, and comparable agencies in other countries. Obtaining approval for a new pharmaceutical product is never certain, may take many years, and is normally expected to involve substantial expenditures.expenditure.

F-20

 

We have incurred losses of $18.8$91.1 million since our inception in 2011. For the year ended December 31, 2016,2022, we incurred a net loss of $34.9 million. Included in the net loss for the year ended December 31, 2022 was $17.7 million of in-process research and development (“IPR&D”) written off as research and development (“R&D”) expense as the result of the acquisition of CPP. We incurred negative cash flows from operating activities of $5.1approximately $15.3 million for this period. As we continue to pursue development activities and $2.4 million, respectively. Weseek commercialization of our lead assets, we expect to incur substantial losses, for the foreseeable future, which will continueare likely to generate negative net cash flows from operating activities, as we continue to pursue research and development activities and seek to commercialize our primary product candidate, SBP-101.activities. As of December 31, 2016,2022, we had cash of $438,000,$1.3 million, negative working capital of $4.6$6.0 million (current assets less current liabilities), and stockholdersstockholders’ deficit of $4.6$8.0 million. In addition, as of December 31, 2016, the Company had not paid the required quarterly interest payments for its convertible notes payable for the second, third and fourth quarters of 2016. This constitutes an event of default under which the note holders may demand immediate payment of the outstanding principal and accrued but unpaid interest. See Note 6 entitled “Indebtedness.” The Company’s principal sources of cash have historically included the issuance of equity securities and convertible debt. CPP’s principal sources of cash have historically also included issuance of equity securities, convertible debt and equity securities.development partners.


 

The accompanying Consolidated Financial Statements have been prepared assuming that we will continue as a going concern which contemplates the realization of assets and liquidation of liabilities in the normal course of business and do not include any adjustments relating to the recoverability or classification of assets or the amounts of liabilities that might result from the outcome of these uncertainties. Our ability to continue as a going concern, realize the carrying value of our assets and discharge our liabilities in the ordinary course of business is dependent upon a number of factors, including our ability to obtain additional financing, the success of our development efforts, our ability to obtain marketing approval for our initialivospemin (SBP-101), eflornithine (CPP-1X) and eflornithine sachets (CPP-1X-S) product candidate, SBP-101,candidates in the United States, Australia, the European Union or other markets, and Flynpovi outside of North America and ultimately our ability to market and sell our initial product candidate.candidates. These factors, among others, raise substantial doubt about our ability to continue operations as a going concern. See Note 3 entitledtitled “Liquidity and Management’s Plans.Business Plan.

 

3.     LiquidityDecember 2023 marked 33 months since the World Health Organization declared the spread of a novel strain of coronavirus (“COVID-19”) a global pandemic. While there is still some uncertainty of the situation, we continue to be unable to make any prediction as to the ultimate impact COVID-19 will have on the Company's business, financial condition, results of operation and Management Planscash flows. During the spring of 2021, the Company also experienced a delay in the manufacturing of the active product substance, which is manufactured in India. There was also a delay in the final manufacturing steps which are completed in the United States, in part related to COVID-19. To date there has been no disruption in supply for our clinical or preclinical testing. In January of 2022, the Company announced the opening of a global randomized Phase II/III clinical trial, which is expected to be conducted in the United States, Europe and Australia. While regulatory approval and site openings have been slower than expected the Company does not expect any significant delays in enrollment or data. The Company’s administrative operations have been decentralized since inception so the Company experienced no administrative disruptions or additional costs due to the pandemic or related restrictions.

3.

Liquidity and Management Plans

 

We will need to seek additional sources of funds to support our current business plans. We may seek to raise additional funds through various sources, such as equity and debt financings, or through strategic collaborations and license agreements. We can give no assurances that we will be able to secure additional sources of funds to support our operations, or if such funds are available to us, that such additional financing will be sufficient to meet our needs or on terms acceptable to us. This risk would increase if our clinical data iswere not positive or economic and market conditions deteriorate.

 

On March 1, 2016 we instituted substantial salary deferrals for our four full-time senior officers in order to conserve cash. If we are unable to obtain additional financing when needed, we would need to scale back our operations taking actions that may include, among other things, reducing use of outside professional service providers, reducing staff or staff compensation, significantly modify or delay the development of our SBP-101 product candidate,candidates, license to third parties the rights to commercialize our SBP-101 product candidate for pancreaticcandidates as therapies in cancer pancreatitisor auto-immune diseases or other applications that we would otherwise seek to pursue, or cease operations.

 

Subsequent to December 31, 2022, the endCompany completed a registered public offering of 2016, On each of February 17, March 3, March 10 and March 17, 2017, we entered into Note Purchase Agreements (the “Note Agreements”) with a number of accredited purchasers in private transactions. Pursuant to these Note Agreements we sold convertible promissory notes payable (the “2017 Notes”) raising gross proceeds of $3.1 million. See Note 11 entitled “Subsequent Events”.

In March 2017, we offered to all holders of outstanding 2013 Convertible Notes and to all holders of the demand notes payable (collectively the “Notes”) who were accredited investors an opportunity to convert all outstanding principal and accrued interest through March 31, 2017 into shares of our common stock at a rate of $0.75 per share. The offered conversion rate represents a $0.375, or 33.3%, discount from the rate stated in the terms of the 2013 Convertible Notes, which at the time was $1.125 per share. The eligible holders had until March 27, 2017and warrants to accept the offer and holders of $3,000,000 aggregate principle amount of the Notes accepted the offer. Accordingly, on March 31, 2017 our Company will issue 4,183,333purchase shares of common stock for gross proceeds of approximately $15.0 million. See Note 13 for additional information regarding the offering.

F-21

The company also sold shares of common stock via an At the Market (ATM) facility. During the quarter ended December 31, 2022, 28,343 shares were sold for gross proceeds of approximately $93,000. Subsequent to December 31, 2022 the Company completed the additional sale of common stock via the ATM for gross proceeds of approximately $1.6 million. See Note 13 for additional information regarding the offering.

On October 4, 2022, the Company completed a registered public offering and issued an aggregate of 177,175 shares of its common stock, pre-funded warrants to purchase up to an aggregate of 325,325 shares of common stock at an exercise price of $0.001 per share and warrants to purchase up to an aggregate of 753,749 shares of its common stock at an exercise price of $12.00 per share. The securities were issued for a combined offering price of $12.00 per share of common stock and 1.5 warrants, or $11.999 per pre-funded warrant and 1.5 warrants. Net proceeds from the offering totaled approximately $5.3 million. All pre-funded warrants were exercised by December 31, 2022 for additional proceeds of $13,000.

Much of the development efforts under way regarding the asset acquired in exchangethe CPP acquisition are funded by a licensing partner, see Note 8, “License Agreement for the surrenderDevelopment and Commercialization of Flynpovi”, or collaborations with outside organizations including National Cancer Institute (“NCI”) and the Notes representing $3,000,000Juvenile Diabetes Research Foundation (“JDRF”).

On July 2, 2021, the Company completed an underwritten public offering of principal amount and $137,50083,333 shares of accrued but previously unpaid interest. See Note 11 entitled “Subsequent Events”.common stock at $120.00 per share which resulted in net proceeds of approximately $9.1 million. In the first quarter of 2021, the Company received net proceeds of approximately $1.0 million from the exercise of common stock warrants; a total 5,598 shares of common stock were issued

It is expected that our cash will last into the third quarter of 2023.

 

Our future success is dependent upon our ability to obtain additional financing, the success of our development efforts, our ability to obtain marketing approval for our SBP-101 product candidateivospemin (SBP-101), eflornithine (CPP-1X) and eflornithine sachets (CPP-1X-S) in the United States or other markets and Flynpovi outside of the United States and ultimately our ability to market and sell our SBP-101 product candidate.candidates. If we are unable to obtain additional financing when needed, if our clinical trials are not successful or if we are unable to obtain marketing approval, we would not be able to continue as a going concern and would be forced to cease operations and liquidate our company.

 

There can be no assurances that we will be able to obtain additional financing on commercially reasonable terms, or at all. The sale of additional equity securities or convertible debt or equity securities would likely result in dilution to our current stockholders.

 


4.     Summary of Significant Accounting Policies

Summary of Significant Accounting Policies

 

Basis of presentation

 

We have prepared the accompanying Consolidated Financial Statements in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Our fiscal year ends on December 31.

 

Principles of consolidation

 

The accompanying Consolidated Financial Statements include the assets, liabilities and expenses of Sun BioPharma,Panbela Therapeutics, Inc. and our wholly-owned subsidiary.direct and indirect subsidiaries. All significant intercompany transactions and balances have been eliminated in consolidation.

 

Use of estimates

 

The preparation of Consolidated Financial Statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the Consolidated Financial Statements and the reported amount of revenues and expenses during the reporting period. Actual results could differ from those estimates.

 

F-22

Business Combinations and Asset Acquisition

We account for acquired businesses using the acquisition method of accounting, which requires that the assets acquired, and liabilities assumed be recorded at the date of acquisition at their respective fair values if the acquisition meets the definition of a business combination. If the acquisition does not meet the definition of a business combination, then it is accounted for as an asset acquisition and the purchase consideration is allocated to the acquired assets.

ASC 805, Business Combinations, provides a model for determining whether an acquisition represents a business combination. In order to be a business, the integrated set of activities of the acquired entity needs to have an input and a substantive process that together significantly contribute to the ability to create outputs. The acquired entity must also pass the “Screen Test” which involves determining whether the acquisition represents an in-substance asset acquisition based on whether the fair value of the gross assets acquired is “substantially all” concentrated in a single asset or group of similar assets. This evaluation excludes certain acquired assets such as cash, deferred taxes, and goodwill associated with deferred taxes, but includes all other gross assets, including any consideration transferred in excess of the identified assets.

Concentration of credit risk

 

Financial instruments that potentially subject the companyCompany to significant concentrations of credit risk consist primarily of cash. Cash is deposited in demand accounts at commercial banks. At times, such deposits may be in excess of insured limits. As of December 31, 2022, $1.0 million of the Company’s cash was in excess of insured limits. The Company has not experienced any losses on its deposits of cash.

 

Debt issuance costsCash and cash equivalents

 

Costs associatedCash equivalents include short-term, highly liquid investments with maturities of three months or less.

Other noncurrent assets

Other noncurrent assets are comprised primarily of long-term deposits with contract research organizations (“CROs”). These amounts are recognized as operating expenses or research and development expense as the issuance of debt instruments are capitalized. These costs are amortized on a straight-line basis, which approximates the effective interest method, over the term of the debt agreements and are included in interest expense. The unamortized balance of debt issuance coststrial is presented as a direct reduction of the carrying amount of the related debt.completed.

 

Research and development costs

 

Research and development costs include expenses incurred in the conduct of our Phase 1 human clinical trial,trials, for third-party service providers performing various testing and accumulating data related to our preclinical studies;studies; sponsored research agreements;agreements; developing and scaling the manufacturing process necessary to produce sufficient amounts of the SBP-101, compoundFlynpovi and CPP-1X compounds for use in our pre-clinical studies and human clinical trials;trials; consulting resources with specialized expertise related to execution of our development plan for our SBP-101 product candidate;candidates; personnel costs, including salaries, benefits and stock-based compensation;share-based compensation; and costs to license and maintain our licensed intellectual property. During 2016, research and development expenditures shifted to focus on costs related to the execution of our Phase 1 human clinical trial and related efforts to obtain regulatory approval for SBP-101.

 

We charge research and development costs, including clinical trial costs, to expense when incurred. Our human clinical trials are and will be, performed at clinical trial sites and are administered jointly by us with assistance from contract research organizations (“CROs”).CROs. Costs of setting up clinical trial sites are accrued upon execution of the study agreement. Expenses related to the performance of clinical trials generally are accrued based on contracted amounts and the achievement of agreed upon milestones, such as site openings, patient enrollment, patient follow-up, etc. We monitor levels of performance under each significant contract, including the extent of patient enrollment and other activities through communications with the clinical trial sites and CROs, and adjust the estimates, if required, on a quarterly basis so that clinical expenses reflect the actual effort expended at each clinical trial site and by each CRO.

 

F-23

Research and development costs also include IPR&D. This asset was acquired from the security holders of CPP and written off to research and development expense immediately subsequent to the asset acquisition.

We expense costs associated with obtaining licenses for patented technologies when it is determined there is no alternative future use of the intellectual property subject to the license.

 


Fair value determination of the company’s common stockClinical Trial Accruals

 

PriorCosts for preclinical studies and clinical trial activities are recognized based on an evaluation of the vendors’ progress towards completion of specific tasks, using data such as clinical site activations, patient enrollment or information provided to becoming a public company, determining the fair value per share or our common stockCompany by its vendors regarding their actual costs incurred. Payments for usethese activities are based on the terms of individual contracts and payment timing may differ significantly from the period in estimatingwhich the fair values of share based payments required making complex and subjective judgments.services are performed. The Company useddetermines accrual estimates through reports from and discussions with applicable personnel and outside service providers as to the implied valuations based uponprogress or state of completion, or the terms from our sales of convertible notes payable to estimate our enterprise value for the dates on which these transactions occurred.services completed. The estimated enterprise values considered certain discounts related to control and lack of marketability.

Our Board of Directors also considered the estimated fair value of our common stock in relation to a number of objective and subjective factors, including external market conditions affecting the biotechnology industry sector. Our board of directors also retained an independent financial valuation firm to provide independentCompany’s estimates of our enterprise value. Until an active trading market develops for our common stock, estimatingaccrued expenses as of each balance sheet date are based on the fair value per share of our common stock will continue to be highly subjective. There is inherent uncertainty in these estimates.facts and circumstances known at the time.

 

Stock-based compensation

 

In accounting for stock-based incentive awards, we measure and recognize the cost of employee and non-employee services received in exchange for awards of equity instruments based on the grant date fair value of those awards. Compensation cost is recognized ratably using the straight-line attribution method over the vesting period, which is considered to be the requisite service period. We estimate pre-vesting awardrecord forfeitures when calculatingin the compensation costs and revise those estimatesperiods in subsequent periods if actual forfeitures differ from those estimates. Compensationwhich they occur. The compensation expense for performance-based stock option awards is recognized when “performance” has occurred or is probable of occurring.

 

The fair value of stock-based awards is estimated at the date of grant using the Black-Scholes option pricing model. The determination of the fair value of stock-based awards is affected by our stock price, as well as assumptions regarding a number of complex and subjective variables. Risk free interest rates are based upon U.S. Treasury rates appropriate for the expected term of each award. Expected volatility rates are based primarily on the volatility rates of a set of guideline companies, which consist of public and recently public biotechnology companies.the Company’s common stock. The assumed dividend yield is zero, as we do not expect to declare any dividends in the foreseeable future. The expected term of options granted is determined using the “simplified” method. Under this approach, the expected term is presumed to be the mid-point between the average vesting date and the end of the contractual term.

The fair value of restricted stock units is calculated as the fair value of the underlying common stock as of the date of grant.

 

Income taxes

 

Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the Consolidated Financial Statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carry-forwards.carryforwards. Deferred tax assets and liabilities are measured using enacted rates, for each of the jurisdictions in which the Company operates, expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. Valuation allowances are established when necessary to reduce deferred tax assets to the amount that is more likely than not to be realized. The Company has provided a full valuation allowance against the gross deferred tax assets as of December 31, 20162022 and 2015. See Note 10 for additional information.2021. The Company’sCompany’s policy is to classify interest and penalties related to income taxes as income tax expense in the Consolidated Statements of Operations and Comprehensive Loss.

F-24

 

Foreign currency translation

 

The functional currency of Sun BioPharma AustraliaPanbela Therapeutics Pty Ltd is the Australian Dollar (“AUD”). Accordingly, assets and liabilities, and equity transactions of Sun BioPharma AustraliaPanbela Therapeutics Pty Ltd are translated into U.S. dollars at period-end exchange rates. Expenses are translated at the average exchange rate in effect for the period. The resulting translation gains and losses are recorded as a component of accumulated comprehensive gain (loss) in the Consolidated Statements of Operations and Comprehensive Loss. During the years ended December 31, 20162022 and 2015,2021, any reclassification adjustments from accumulated other comprehensive gain to operations were inconsequential.

 


Comprehensive loss

Comprehensive loss consists of our net lossThe Company records transactions denominated in foreign currencies at the exchange rate in effect on that date. Fluctuations between the transaction date and the effects of foreign currency translation.settlement date are recognized as transaction gain/loss.

 

Net loss per share

 

We compute net loss per share by dividing our net loss (the numerator) by the weighted-average number of common shares outstanding (the denominator) during the period. Shares issued during the period and shares reacquired during the period, if any, are weighted for the portion of the period that they were outstanding. The computation of diluted earnings per share, or EPS, is similar to the computation of basic EPS except that the denominator is increased to include the number of additional common shares that would have been outstanding if the dilutive potential common shares had been issued. Our diluted EPS is the same as basic EPS due to common equivalent shares being excluded from the calculation, as their effect is anti-dilutive.

 

The following table summarizes our calculation of net loss per common share for the periods (in thousands, except share and per share data):

 

 

December 31,

 

 

 

2016

 

 

2015

 

Net loss

 

$

(5,112

)

 

$

(4,927

)

Weighted average shares outstanding—basic and diluted

 

 

31,068,765

 

 

 

14,073,174

 

Basic and diluted net loss per share

 

$

(0.16

)

 

$

(0.35

)

The following outstanding potential common shares were not included in the diluted net loss per share calculations as their effects were not dilutive:

 

 

 

Year Ended December 31,

 

 

 

2016

 

 

2015

 

Employee and non-employee stock options

 

 

7,019,600

 

 

 

3,463,600

 

Estimated common shares issuable upon conversion of notes payable

 

 

2,466,667

 

 

 

2,466,667

 

Common shares issuable under common stock purchase warrants

 

 

3,615,000

 

 

 

2,550,000

 

 

 

 

13,101,267

 

 

 

8,480,267

 

  

December 31,

 
  

2022

  

2021

 

Employee and non-employee stock options

  100,556   61,582 

Restricted stock units

  -   269 

Common stock issuable under common stock purchase warrants

  889,910   127,710 
   990,466   189,561 

 

Recently adopted accounting pronouncementAdopted Accounting Pronouncements

 

In April 2015, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2015-03, Interest - Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs. This ASU requires debt issuance costs to be presented as a direct deduction from the carrying amount of the related debt rather than as an asset. In 2016, the Company retrospectively adopted this update, as required, and the amounts reclassified from other assets to a reduction of the carrying amount of the related debt in the accompanying Consolidated Balance Sheets. These reclassifications did not impact net loss.

Recently issued accounting pronouncements

In February 2016,August 2020, the FASB issued ASU No. 2016-02, Leases.2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which simplifies accounting for convertible instruments by removing major separation models required under current U.S. GAAP. The guidanceASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception and it also simplifies the diluted earnings per share calculation in certain areas. This ASU 2016-02 supersedes the lease recognition requirements in the Accounting Standards Codification Topic 840, Leases. ASU 2016-02 requires an entity to recognize assets and liabilities arising from a lease for both financing and operating leases, along with additional qualitative and quantitative disclosures. The new standard requires the immediate recognition of all excess tax benefits and deficiencies in the income statement, and requires classification of excess tax benefits as an operating activity as opposed to a financing activity in the statements of cash flows. ASU 2016-02 is effective for fiscal years beginning after December 15, 2018, with early adoption permitted. The Company does not expect the adoption of ASU 2016-02 to have a material impact on its Consolidated Financial Statements.


In March 2016, the FASB issued ASU No. 2016-09, Improvements to Employee Stock-Based Payment Accounting. The guidance in ASU 2016-09 is intended to simplify certain aspects of the accounting for employee stock-based payments, including the accounting for income taxes, forfeitures, statutory withholding requirements, and classification on the statement of cash flows. The standard is effective for interim and annual reporting periods beginning after December 15, 2016, with early adoption permitted.2021, including interim periods within those fiscal years. The Company doeshas adopted the ASU for the year ended December 31, 2022. This update permits the use of either the modified retrospective or fully retrospective method of transition. The Company has determined that the impact this ASU did not expect the adoption of ASU 2016-09 to have a material impacteffect on its Consolidated Financial Statements.consolidated financial statements.

 

F-25

5.     Accrued liabilities

5.

Accrued Expenses

 

Accrued liabilitiesexpenses consisted of the following (in thousands):

 

 

December 31, 2016

  

December 31, 2015

  

December 31,

 

Deferred payroll and related expenses

 $637  $169 

Clinical trial related expense

  97    
 

2022

  

2021

 

Clinical trial and related expenses

 $1,760  $992 

Incentive compensation

  550   434 

Severance pay and related payroll taxes

  448   - 

Professional services

  70   75   147   235 

Product and process development expenses

  29   259 

Other

  9   2   88   359 

Total accrued liabilities

 $842  $505  $2,993  $2,020 

 

6.     Indebtedness

Term debt

Asset Acquisition

 

On October 26, 2012, we entered into an unsecured loan agreement (the “Agreement”) withJune 15, 2022, the Institute for CommercializationCompany completed the previously announced strategic business reorganization and acquisition of Public Research, Inc. (the “Institute”).CPP through the Mergers. Under the terms of the agreement, we borrowed $300,000 at a fixed interest rateMerger Agreement, the holders of 4.125%. No principal or interest payments are due untilCPP’s outstanding capital stock immediately prior to the maturity date, October 26, 2017, unless a mandatory repayment event occurs. A mandatory repayment event includes, (i) a liquidity event defined as a saleMerger received shares of all or substantially allcommon stock of our assets; a merger, consolidation, share exchange or similar transaction as a resultPanbela upon closing of which the persons holding our equity constitutingMerger. The stockholders of Panbela Research retained a majority of the outstanding shares of Panbela, the post-merger holding company. CPP stockholders will be eligible to receive contingent payments totaling a maximum of $60 million from milestone and royalty payments associated with the potential approval and commercialization of eflornithine, the lead asset.

We performed the “screen test,” to determine if substantially all of the fair value of the gross assets acquired in the Mergers is concentrated in a single identifiable asset or group of similar identifiable assets. CPP’s lead asset, eflornithine in three forms, including Flynpovi (eflornithine (CPP-1X) and sulindac), eflornithine (CPP-1X), and eflornithine sachets (CPP-1X-S), were identified as the single identifiable asset consisting of IPR&D. Accordingly, our acquisition of CPP has been recorded as an asset acquisition.

The contract consideration for the assets acquired includes certain contingent consideration which at the acquisition date is neither probable of occurring nor reasonably estimable. As such, the value of this contingent consideration has been excluded from the allocation of the purchase price below. Acquisition-related transaction costs incurred have been recorded as additional investment in IPR&D.

The following is a summary of the purchase consideration and the allocation of that purchase consideration in connection with the CPP asset acquisition:

  

Shares

  

Value (in thousands)

 
         

Common stock issued to CPP shareholders

  182,978  $7,839 

Common stock underlying options continued

  39,904   1,637 

Common stock underlying warrants replaced

  8,452   129 

Total non cash consideration

     $9,605 

Transaction costs incurred

     $658 
         

Total Consideration

     $10,263 

F-26

In process research and development *

 $17,737 

Cash

  4 

Other current assets

  230 

Accounts payable and accrued expenses

  (811)

Accrued interest and notes payable

  (6,897)
  $10,263 

* In accordance with FASB ASC Topic 730, Research and Development this asset was immediately expensed upon the closing of the merger.

7.

Notes Payable

Sucampo Promissory Note

As of December 31, 2022, CPP had a balance outstanding of approximately $6.4 million principal and interest under an amended and restated promissory note (the “Sucampo Note”) issued with an initial principal amount of approximately $6.2 million in favor of Sucampo GmbH dated as of June 15, 2022. The principal balance outstanding under the Sucampo Note bears simple interest at a rate of 5% per annum. All unpaid principal, together with any then unpaid and accrued interest is payable as follows: (i) $1.0 million, plus all interest accrued but unpaid on or before each of January 31,2023, January 31, 2024, January 31, 2025 and January 31, 2026; and (ii) all remaining principal plus accrued but unpaid interest on or before January 31, 2027. If CPP or its parent, Panbela, receives cash proceeds from any issuance or offering of debt or equity by voting power or economic participation immediately priorbefore January 31, 2023, then CPP will be required to make a concurrent mandatory prepayment from such cash proceeds in an amount equal to the transaction hold less than a majoritylesser of (i) $1.0 million plus all interest accrued but unpaid on the Sucampo Note through the date of payment; and (ii) 10% of such voting power or economic participation immediately aftercash proceeds. The amount payable by CPP on January 31, 2023 would have been reduced on a dollar-for-dollar basis by the amount of any such transaction; or a sale or transfer of our outstandingprepayment. The Company completed an equity in a transaction as a result ofraise on October 4, 2022 which the persons holding our equity constituting a majoritythen gave rise to an obligation to pay 10% of the outstanding equity$6.0 million gross proceeds or $600,000, which was due by voting power or economic participation immediately prior to the transaction hold less than a majority of such voting power or economic participation immediately after such transaction, (ii) an event of default, (iii) a failure to maintain a Florida base of operations for more than 6 months, (iv) a sale or transfer of licensed technology, (v) any false representation to the Institute, (vi) a violation of law byNovember 4, 2022. As the Company or one of its principal officers, or (vii) an achievement of aggregate revenues during any fiscal year of more than $4,000,000 from sales of products and/or services. Based upon its maturity date,had not made this term debt was reclassified to a current liabilitypayment as of December 31, 2016.

Demand notes payable

In conjunction with2022, the Merger, and after giving effect to the dispositionnote was in default as of the nominal business operations of Cimarron on September 28, 2015, we assumed $250,000 of unsecured demand notes that were previously issued by Cimarron. These demand notes have no stated interest rate or maturitypayment date and accordingly are reportedbegan incurring a penalty interest of an additional 5% as of November 4, 2022. On February 1, 2023 Panbela paid the balance due of $1.0 million plus accrued and unpaid interest of approximately $295,000. As a result of this payment the Company is now current liabilitieswith all payments due and is no longer in our Consolidated Balance Sheet. One of our stockholders, who beneficially owns more than 10% of our common stock, holds $125,000 of these notes. See Note 8 below for additional information regarding the Merger.

Convertible notes payable

In the fourth quarter of 2013, we initiated an offering of convertible promissory notes (the “2013 Convertible Notes”). In total, gross proceeds raised were $3.1 million. The 2013 Convertible Notes accrue interest at 5% per year, payable quarterly, are convertible into shares of common stock at $1.125 per share at the option of the holder and mature in December 2018. One of our stockholders, who beneficially owns more than 10% of our common stock, holds $700,000 of these notes.default. As of December 31, 2016,2022, the Company had not paid the required quarterly interest payments for the 2013 Convertible Notes for the second, thirdaccrued and fourth quarters of 2016. This constitutes an event of default under which the note holders may demand immediate payment of the outstanding principal and accrued but unpaid interest and accordingly,on this note was approximately $243,000. Panbela has agreed to guarantee CPP’s payment obligations under the 2013 Convertible Notes and $105,000Sucampo Note pursuant to a Guaranty dated as of accrued, unpaid interest are presented as current obligations in our Consolidated Balance Sheet. As of the date of this report, no note holder has made such a demand.


In 2015, holders of the 2013 Convertible Notes converted $225,000, plus accrued interest, into 200,776 shares of our common stock.June 15, 2022.

 

Debt issuance costsTillotts Promissory Note

 

As of December 31, 2022, CPP had a balance outstanding of approximately $0.7 million representing principal and interest under an amended promissory note (the “Tillotts Note”) issued with an initial principal amount of approximately $650,000 in favor of Tillotts Pharma AG. The following table summarizesprincipal balance outstanding under the deferred financing costs which are presentedTillotts Note bears simple interest at a rate of 4% per annum. Accrued and unpaid interest as of December 31, 2022 was approximately $82,000. All outstanding amounts under the amended Tillotts Note matured and were paid in full on January 31, 2023.

8.

License Agreement for the Development and Commercialization of Flynpovi

CPP is party to a direct reductionlicense agreement with One-Two Therapeutics Assets Limited (“One-Two”) dated as of July 16, 2021. Under the agreement, One-Two has licensed CPP’s North American development and commercialization rights for Flynpovi. The agreement also calls for CPP to receive a milestone payment upon regulatory approval of Flynpovi by the U.S. Food and Drug Administration (“FDA”) and royalties on net sales of Flynpovi in the licensed territories. Payment of the carrying amountmilestone payment and net sales royalties shall be reduced on a dollar-for-dollar basis by amounts funded by One-Two for One-Two’s direct employee, clinical and regulatory costs associated with any development activities necessary to secure FDA approval. The Company is not responsible for any costs, as they are incurred, associated with the development and regulatory approval of their related debt liabilities (in thousands):Flynpovi in North America.

 

 

 

December 31, 2016

 

 

December 31, 2015

 

 

 

Convertible

Notes Payable

 

 

Long-Term

Debt

 

 

Convertible

Notes Payable

 

 

Long-Term

Debt

 

Loan principal amount

 

$

2,775

 

 

$

300

 

 

$

2,775

 

 

$

300

 

Deferred financing costs

 

 

105

 

 

 

37

 

 

 

105

 

 

 

37

 

Accumulated Amortization

 

 

(63

)

 

 

(31

)

 

 

(42

)

 

 

(24

)

Unamortized balance

 

 

42

 

 

 

6

 

 

 

63

 

 

 

13

 

Loan amount, net

 

$

2,733

 

 

$

294

 

 

$

2,712

 

 

$

287

 

F-27

 

We recorded amortization of debt issuance costs of $28,000 for both of the years ended December 31, 2016 and 2015, which is included in interest expense in the accompanying Consolidated Statements of Operations and comprehensive loss.

7.     Commitments and Contingencies

9.

Commitments and Contingencies

 

License agreement with the University of Florida Research Foundation

 

On December 22, 2011, we entered into an exclusive license agreement with the University of Florida researchResearch Foundation (“UFRF”). This license agreement was amended on December 12, 2016 (“First Amendment”) and again on October 3, 2019 (“Second Amendment”). The license agreement requires the companyCompany to pay royalties to UFRF ranging from 2.5% to 5% of net sales of licensed products developed from the licensed technology. MinimumThe Second Amendment eliminated all minimum annual royalties are required afterand modified the initial occurrenceduration of a commercial saleroyalty payments to the shorter of a marketed product. Royalties are payable for the longer of (i) the last to expire of the claims in the licensed patents or (ii)(1) ten (10) years from the first commercial sale of licensed products or (2) the expiration of the period of regulatory exclusivity on a licensed product in each country in which licensed product is sold. The minimum annual royalties are as follows:

$50,000 is due 270 days after occurrence of first commercial sale;

$100,000 is due on the first anniversary date of the first payment;

$100,000 is due on the second anniversary date of the first payment; and

$300,000 is due on the third anniversary date of the first payment and subsequent anniversary dates thereafter, continuing for the life of the license agreement.

In addition, the company is subject to six differentcountry-by-country basis. All future milestone payments undercontemplated in the license agreement. original agreement were eliminated in the Second Amendment.

$50,000 is due upon enrollment of the first subject in a Phase 1 clinical trial;

$300,000 is due upon enrollment of the first subject in a Phase ii clinical trial;

$3,000,000 is due upon approval of a new drug application;

$2,000,000 is due upon approval to manufacture and market in either the European Union or Japan (one time only);

$1,000,000 is due upon the first time annual net sales of licensed product or licensed process by the Company reaches $100,000,000; and

$3,000,000 is due upon the first time annual net sales of licensed product or licensed process by the Company reaches $500,000,000.


 

The amended license agreement isremains subject to customary and usual termination provisions. The Company must also pay an annual license maintenance fee of $10,000.

 

On January 4, 2016, we enrolledLicense Agreement with the first patient in our Phase 1 clinical trialUniversity of SBP-101 in patients with previously treated pancreatic cancer. Accordingly, we recorded a milestone obligation of $50,000 as a license expense as of this date.

Clinical trialsArizona

 

WeCPP is party to a license agreement with the Arizona Board of Regents of the University of Arizona (the “University”). Pursuant to an Inter-institutional Agreement, the Regents of the University of California on behalf of the University of California, Irvine, has agreed to license certain patents, provisional patents, clinical trial data and other intellectual property related to the chemoprevention of cancer, the prevention of polyps and other technologies to CPP. The University has the right to administer the joint patent rights held between the University and the University of California, Irvine. The license agreement gives CPP exclusive rights to commercialize products based on intellectual property. In exchange for the intellectual property, CPP paid the University certain fees and reimbursements of patent costs and granted the university a warrant to acquire shares of CPP. As a result of the Mergers, the warrant was replaced with a warrant to purchase 2,772 shares of common stock of Panbela at a price of $11.20 per share.

CPP also agreed to pay the University additional milestone payments totaling up to $90,000 upon the achievement of certain research, development and regulatory milestones. Future milestone payments are currently conducting a Phase 1 study in patients with previously treated pancreatic cancer, for a duration of approximately 24 - 36 months. The first patient was enrolled in January 2016. This study is expectedconsidered to include a dose-escalation phase with 8-week cycles of treatment at each dose level. At least two cycles of therapy at each dose level are anticipated in this trial, with continued treatment permitted for patients with clinical responses or stable disease. The projected safety profile, which is supported by early results from the Phase 1 study, suggests that repeat cycles would be well tolerated. Additional clinical trialscontingent consideration and will be subsequently required if the resultsaccrued when probable of the Phase 1 pancreatic cancer trial are positive. We estimate the total time and cost to obtain FDA and EU approval and bring SBP-101 to market is 5 to 7 years and up to two-hundred million dollars ($200 million). Clinical trial costs are expensed as incurred.being paid. As of December 31, 2022, no milestone payments were probable of being paid.

10.

Stockholders Equity

 

IndemnificationPublic offering of directorscommon stock and officers

The Company, as permitted under Delaware law and in accordance with its bylaws, will indemnify and advance expenses to its directors and officers to the fullest extent permitted by law or, if applicable, pursuant to indemnification agreements. They further provide that we may choose to indemnify other employees or agents of our Company from time to time. The Company has secured insurance on behalf of any officer, director, employee or other agent for any liability arising out of his or her actions in connection with their services to the Company as of December 31, 2016 there was no pending litigation or proceeding involving any director or officer of the Company as to which indemnification is required or permitted, and we are not aware of any threatened litigation or proceeding that may result in a claim for indemnification. Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the Company, the Company has been advised that, in the opinion of the SEC, such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable.

The Company believes the fair value of these indemnification agreements is minimal. Accordingly, the Company had not recorded any liabilities for these obligations as of December 31, 2016 or 2015.

8.     Stockholders’ Deficit

Private placement, resale registrationwarrants

 

On each of June 10, June 24, August 11October 4, 2022, the Company completed a registered public offering and September 2, 2016, we entered into Securities Purchase Agreements (the “Purchase Agreements”) with the purchasers named therein, pursuant to which we soldissued an aggregate of 2,221,000177,175 shares of its common stock, pre-funded warrants to purchase up to an aggregate of 325,325 shares of common stock (the “Purchased Shares”)at an exercise price of $0.001 per share and warrants (the “Warrants”) to purchase up to an aggregate of 1,110,500753,749 shares of its common stock (the “Warrant Shares”).at an exercise price of $12.00 per share. The purchasesecurities were issued for a combined offering price for each unit, consisting of one$12.00 per share of common stock and 1.5 warrants, or $11.999 per pre-funded warrant and 1.5 warrants. Net proceeds from the offering totaled approximately $5.3 million. All pre-funded warrants were exercised by December 31, 2022. The securities were offered pursuant to an effective registration statement on Form S-1.

F-28

At-the-Market Program

On July 19, 2022, Panbela Therapeutics, Inc. (the “Company”), entered into a warrantSales Agreement with Roth Capital Partners, LLC (the “Agent”) to purchase one-half sharesell shares of the Company’s common stock having an aggregate gross sales price of up to $8,400,000, from time to time, through an “at-the-market” equity offering program (the “ATM Program”).

During the last month of the year ended December 31, 2022, the Company sold 28,343 shares of common stock was $1.00. The Warrants are exercisable for a period of five years from their respective date of issuance at an exercise price of $1.50 per share.under the ATM Offering and generated approximately $93,000 in gross proceeds. The Company receivedincurred financing costs of approximately $44,000, which were charged to additional paid in capital December 2022 when the Company began selling shares under the ATM Offering. Under the ATM Program, the Company pays Roth a commission equal to 3.0% of the aggregate gross proceeds of $1.9 million fromany sales of common stock under the Purchase Agreements closings under these private placement transactions and an additional $196,000 was invested by management throughATM Program. Net proceeds for the conversion of previously deferred compensation. As ofyear ended December 31, 2016, 1,085,500 of the Warrants remained outstanding.


Pursuant to the Purchase Agreements, we filed a registration statement on Form S-1 with the SEC covering the resale of the Purchased Shares and Warrant Shares. On October 3, 2016, the SEC declared the registration statement effective. We have also agreed, among other things, to indemnify the selling stockholders under the registration statements from certain liabilities and to pay all fees and expenses (excluding underwriting discounts and selling commissions and legal fees) incident to our obligations under the Purchase Agreements.2022 was approximately $46,000.

 

Cimarron Medical, Inc. merger transactionPublic offering of common stock

 

On June 12, 2015, SBR entered intoJuly 2, 2021, the Company completed an Agreement and Planunderwritten public offering of Merger (the “Merger”) with Cimarron and SB Acquisition Corporation, a wholly owned subsidiary of Cimarron. The resulting merger of SB Acquisition Corporation with and into SBR on September 4, 2015, resulted in all of the issued and outstanding common stock of SBR being converted into the right to receive an aggregate of 28,442,484 shares of Cimarron’s common stock, representing four shares of Cimarron common stock for every one share of SBR common stock cancelled in the Merger. All of the shares of common stock issued pursuant to the Merger were “restricted securities” under Rule 144. As a result of this transaction, former SBR stockholders owned approximately 98.8% of the outstanding capital stock, giving SBR’s former stockholders substantial control of Cimarron. In connection with the Merger, Cimarron’s Board of Directors and management team were replaced by members of SBR’s Board of Directors and management team and Cimarron’s name was changed to “Sun BioPharma, Inc.”

In addition, outstanding options and warrants to purchase SBR common stock before the Merger were converted into options and warrants to purchase an aggregate of 5,043,600 shares and 2,550,000 shares, respectively, of Cimarron’s common stock. Approximately $2.8 million aggregate principal amount of SBR outstanding convertible promissory notes were converted into convertible promissory notes payable by Cimarron and convertible into shares of Cimarron common stock at a rate of $1.125 per share. Immediately prior to the Merger, Cimarron had 1,450,322 shares of common stock outstanding with no other capital stock or rights to acquire additional shares outstanding.

Under GAAP, SBR was deemed to be the acquirer for accounting purposes because its former stockholders owned a substantial majority of the issued and outstanding shares of Cimarron’s common stock after the Merger. Further, as Cimarron’s business operations and net assets, at the time of the Merger, were nominal relative to SBR’s business operations and net assets, we have accounted for the Merger as a capital transaction.

SBR incurred approximately $325,000 of costs associated with the Merger and assumed $250,000 of demand notes payable, net, after giving effect to the disposition of the legacy business operations of Cimarron, discussed below. The transaction costs for the Merger are included in general and administrative expenses in our Consolidated Statements of Operations and Comprehensive Loss.

Sale of legacy Cimarron Medical business operations

On September 28, 2015, we sold all of our ownership interest in the legacy business operations of Cimarron, which previously had been contributed to our then wholly owned subsidiary, Cimarron Medical Software, Inc., to Sampleminded, Inc. In exchange, Sampleminded, Inc. agreed to assume our payment obligations under approximately $305,000 of aggregate principal amount of outstanding promissory notes.

Private placement

Pursuant to the June 12, 2015 Agreement and Plan of Merger, SBR was obligated to undertake efforts to engage in a private placement of its common stock. On September 4, 2015, immediately prior to the closing of the Merger, SBR sold83,333 shares of its common stock for totala purchase price of $120.00 per share. The gross proceeds of $1,513,000,from the offering were approximately $10.0 million. The net ofproceeds, after deducting the underwriter’s discount and other offering costs, which shares ultimately resulted in the issuance ofwere approximately $9.1 million. The securities were offered pursuant to an incremental 762,500 shares of Cimarron common stock in the Merger.effective registration statement on Form S-3.


 

Exercise of Warrants to purchase common stock

 

In April 2015, ourDuring the year ended December 31, 2021 the company issued 25 shares for a total of approximately $4,500 in proceeds resulting from the exercise of warrants at 181.60 per share.

During the year ended December 31, 2021, the Company issued a total of 5,723 shares of common stock for a total of approximately $1.0 million in proceeds, resulting from exercises of outstanding warrants. Most of the warrants exercised, a total of 5,598, were exercised at $181.60 per share and the shares of common stock were issued pursuant to an effective registration on Form S-1.

During the same period, the Company issued an additional 4,762 shares of common stock resulting from the net, cashless, exercise of outstanding warrants to purchase 13,403 shares. Warrants to purchase a total of 14,333 shares of common stock, all having an exercise price of $5.00 per share, expired during the year ended December 31, 2021. Additionally, warrants to purchase 2,714 shares of common stock, with an exercise price of $15.00 expired during the year ended December 31, 2021.

Reverse Stock Split

On November 29, 2022, the Company held a special meeting of its stockholders at which the stockholders approved a proposal to effect an amendment to the Company's certificate of incorporation, as amended, to implement a reverse stock split at a ratio of one-for-forty (1:40). On January 13, 2023, the Company's Board of Directors agreedapproved the implementation of the reverse stock split of the Company's Common Stock. As a result of the reverse stock split, every forty (40) shares of the Company's Common Stock either issued and outstanding immediately prior to reduce the exercise priceeffective time was, automatically and without any action on the part of outstanding warrantsthe respective holders thereof, combined and converted into one (1) share of the Company's common stock. No fractional shares were issued in connection with certain notes payable from $0.25 perthe reverse stock split. Stockholders who otherwise were entitled to receive a fractional share in connection with the reverse stock split instead were eligible to $0.1875 per share. This exercise price modification resultedreceive a cash payment, which was not material in the recognitionaggregate, instead of a deemed dividend of $170,625, which was charged to accumulated deficit and credited to additional paid-in-capital. In 2015, we received $375,000 from warrant holders who exercised warrants atshares. On January 13, 2023, the reduced price. As of December 31, 2016, warrants exercisable for 2,450,000 shares remain outstanding.

Authorized capital stock

The total number of shares of capital stock that the Company is authorized to issue is 220,000,000 shares, with 200,000,000 shares designated as common stock and 20,000,000 shares undesignated stock issuable as preferred stock. On May 17, 2016, a regular meeting of our stockholders was held during which the stockholders approved an amendment to our Certificate of Incorporation which increased the number of authorized shares of common stock from 100,000,000 to 200,000,000 and the number of authorized shares of undesignated stock from 10,000,000 to 20,000,000. We filed a Certificate of Amendment to ourof its Certificate of Incorporation, as amended with the Secretary of State of Delaware effecting a one-for-forty (1:40) reverse stock split of the Stateshares of Utahthe Company’s common stock, issued and outstanding, effective January 13, 2023. The Company’s common stock began trading on May 18, 2016 to effect this amendment.a reverse split adjusted basis when the market opened Friday, January 13, 2023.

F-29

 

Shares reserved

 

Shares of common stock reserved for future issuance are as follows:

Shares of common stock reserved for future issuance were as follows as of December 31, 2022:

  

December 31, 2016

 

Stock options outstanding

  7,019,600100,556 

Shares available for grant under equity incentive plan

  11,144,000

Estimated common shares issuable upon conversion of notes payable

2,466,66750,511 

Common shares issuable under outstanding common stock purchase warrants

  3,615,000889,910 

Total

  24,245,2671,040,977 

 

9.     Stock-Based Compensation

11.

Stock-Based Compensation

 

2016 Omnibus Incentive Plan

 

The Sun BioPharma, Inc. 2016 Omnibus Incentive Plan, as last amended effective April 9, 2020 (the “2016 Plan”) was adopted, has been approved by our Board of Directors in March 2016 and approvedratified by our stockholders at our annual meeting of stockholders on May 17, 2016.stockholders. The 2016 Plan permits the granting of incentive and non-statutory stock options, restricted stock, stock appreciation rights, performance units, performance shares and other stock awards to eligible employees, directors and consultants. We grant options to purchase shares of common stock under the 2016 Plan atwith an exercise price no less than the fair market value of the underlying common stock as of the date of grant. Options granted under the 2016 Plan have a maximum term of ten years. Under the 2016 Plan, a total of 15,000,000106,825 shares of common stock arehave been reserved for issuance. As of December 31, 2016,2022, options to purchase 3,856,00055,495 shares of common stock were outstanding under the 2016 Plan.Plan, with a weighted average exercise price of $241.65 per share, and the average remaining contractual life was approximately 6.5 years. At the same date 50,511 shares remained available for future awards.

 

2011 Stock Option Plan

 

The Sun BioPharma, Inc.Prior to approval of the 2016 Plan, stock-based awards were granted under the 2011 Stock Option Plan (the “2011 Plan”) was adopted by our Board of Directors in September 2011 and approved by our stockholders in January 2012.. In conjunction with stockholder approval of the 2016 Plan, the Board terminated the 2011 Plan, although awards outstanding under the 2011 Plan will remain outstanding in accordance with and pursuant to the terms thereof. Options granted under the 2011 Plan have a maximum term of ten years and generally vest over zero to two years for employees. As of December 31, 2016,2022, options to purchase 3,163,6005,600 shares of common stock remained outstanding under the 2011 Plan.Plan, with a weighted average exercise price of $118.92 per share, and the average remaining contractual life was approximately 2.0 years.

CPPs 2010 Equity Incentive Plan

As a result of the Mergers, the Company has assumed all remaining rights and obligations with respect to CPP’s 2010 Equity Incentive Plan (the “CPP Plan”) through the issuance of replacement options. As of December 31, 2022, options to purchase 39,461 shares of common stock remained outstanding under the CPP Plan, with a weighted average exercise price of $14.013 per share, and the average remaining contractual life was 7.2 years.

 

We recognize stock-based compensation based on the fair value of each award as estimated using the portion of awards that are ultimately expected to vest. Guidance requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. The term “forfeitures” is distinct from “cancellations” or “expirations” and represents only the unvested portion of a surrendered option. We re-evaluate this estimate periodically and adjust the forfeiture rate on a prospective basis as necessary.Black-Scholes option valuation model. Ultimately, the actual expense recognized over the vesting period will only be for those shares that actually vest.

 


F-30

 

A summary of option activity is as follows:

 

 

Shares Underlying

Options

  

Weighted Average

Exercise Price

Per Share

  

Shares Underlying

Options

  

Weighted

Average

Exercise Price

Per Share

  

Aggregate

Intrinsic Value

 

Options outstanding at December 31, 2014

  5,487,752  $0.24 

Balance at January 1, 2021

  53,438  $270.92  $388,461 

Granted

  5,340,000   0.32   13,851   154.55     

Exercised

  (2,590,536

)

  0.20   (197)  35.20     

Cancelled

  (4,773,616

)

  0.22   -   -     

Forfeitures

        (5,510)  410.75     

Options outstanding at December 31, 2015

  3,463,600  $0.27 

Granted

  3,856,000   1.51 
            

Balance at December 31, 2021

  61,582  $233.00  $8,821 

Options continued from CPP plan

  39,904   14.00     

Exercised

        (443)  8.80     

Cancelled

  (300,000

)

  0.32   -   -     

Forfeitures

        (487)  562.97     

Options outstanding at December 31, 2016

  7,019,600  $0.95 
                    

Options exercisable at December 31, 2016

  4,035,600  $0.54 

Balance at December 31, 2022

  100,556  $145.50  $- 

Stock-based compensation expense for each of the periods presented is as follows (in thousands):

  Year ended December 31,
  

2022

  

2021

 
General and administrative $889  $1,083 

Research and development

  199   204 

Total stock based compensation

 $1,088  $1,287 

F-31

 

A summary of the status of our unvested shares during the yeartwo years ended and as of December 31, 20162022 is as follows:

 

 

Shares Under

Option

  

Weighted Average

Grant-Date

Fair Value

  

Shares Under

Option

  

Weighted Average

Grant Date Fair Value

 

Unvested at December 31, 2015

    $ 

Unvested at January 1, 2021

  12,653  $166.80 

Granted

  3,856,000   0.95   13,851   118.93 

Vested

  (872,000

)

  0.95   (7,153)  144.41 

Forfeitures

        (1,250)  119 

Unvested at December 31, 2016

  2,984,000  $0.95 

Unvested at December 31, 2021

  18,101  $137.41 

Granted

  -   - 

Vested

  (8,184)  135.03 

Forfeitures

  (487)  562.93 

Unvested at December 31, 2022

  9,430  $139.04 

 

Information about stock options outstanding, vested and expected to vest as of December 31, 2016,2022, is as follows:

 

 

 

 

 

 

 

Outstanding, Vested and Expected to Vest

 

 

Options Vested and Exercisable

 

 

 

 

 

 

 

 

 

 

 

Weighted Average

 

 

 

 

 

 

 

 

 

 

Weighted Average

 

 

 

 

 

 

 

 

 

 

 

Remaining

 

 

Weighted

 

 

 

 

 

 

Remaining

 

Per Share

 

 

 

 

 

 

Contractual

 

 

Average

 

 

Options

 

 

Contractual

 

Exercise Price

 

 

Shares

 

 

Life (Years)

 

 

Exercise Price

 

 

Exercisable

 

 

Life (Years)

 

 

$ 0.09

0.11

 

 

 

563,600

 

 

 

5.85

 

 

$

0.10

 

 

 

563,600

 

 

 

5.85

 

 

0.23

0.25

 

 

 

460,000

 

 

 

7.11

 

 

 

0.25

 

 

 

460,000

 

 

 

7.11

 

 

 

0.32

 

 

 

 

2,140,000

 

 

 

8.17

 

 

 

0.32

 

 

 

2,140,000

 

 

 

8.17

 

 

 

1.51

 

 

 

 

3,856,000

 

 

 

9.51

 

 

 

1.51

 

 

 

872,000

 

 

 

9.75

 

 

 

 

 

 

 

 

7,019,600

 

 

 

8.07

 

 

$

0.95

 

 

 

4,035,600

 

 

 

8.07

 

The cumulative grant date fair value of employee options vested during the years ended December 31, 2016 and 2015 was $336,000 and $933,000, respectively. Total proceeds received for options exercised during the years ended December 31, 2016 and 2015 were $0 and $693,000, respectively. On an aggregated basis, as of December 31, 2016, the intrinsic value of our total outstanding options and outstanding options which are exercisable was $3.9 million.

     

Outstanding, Vested and Expected to Vest

  

Options Vested and Exercisable

 

Per Share Exercise Price

  

Shares

  

Weighted

Average

Remaining

Contractual

Life (Years)

  

Weighted

Average

Exercise Price

  

Options

Exercisable

  

Weighted

Average

Remaining

Contractual Life

(Years)

 
                        
$8.80

-

$58.80   39,810   7.12  $14.31   39,810   7.12 
$90.40

-

$91   1,578   8.02  $90.46   625   6.99 
$100-166.80   30,595   6.38  $135.94   24,383   5.90 
$180

-

$244   11,676   5.94  $208.29   10,738   5.81 
$324

-

$404   12,051   6.19  $365.14   10,724   6.02 
$604   4,846   3.95  $604.00   4,846   3.95 
                        

Totals

   100,556   6.62  $145.50   91,126   6.34 

 

As of December 31, 2016 and 2015,2022, total compensation expense related to unvested employee stock options not yet recognized was $1.9$0.8 million, and $0, respectively, which is expected to be allocated to expenses over a weighted-average period of 1.95 and 0 years, respectively.1.1 years.

 


The assumptions used in calculatingNo new options were granted during the fair value under the Black-Scholes option valuation model are set forth in the following table for options issued by the Company for the yearsyear ended December 31, 2016 and 2015:2022. On June 15, 2022, as a component of the purchase consideration for the acquisition of CPP the Company provided fully vested replacement options to purchase up to 39,904 shares of common stock at a weighted average exercise price of $14.00 per share.

 

 

2016

 

 

2015

 

Common stock fair value

 

 

 

$1.51

 

 

 

 

 

$0.32

 

 

Risk-free interest rate

 

 

1.56%

-

2.04%

 

 

 

1.57%

-

1.61%

 

Expected dividend yield

 

 

 

0%

 

 

 

 

 

0%

 

 

Expected option life (years)

 

 

3.5

-

5.75

 

 

 

 

5.0

 

 

Expected stock price volatility

 

 

 

75.0%

 

 

 

 

62.60%

 -

64.59%

 

 

NonemployeeNon-employee stock-based compensation

 

We account for stock options granted to nonemployees in accordance with FASB ASC 505.Accounting Standards Update (“ASU”) 2019-07, “Compensation – Stock Compensation (Topic 718). In connection with stock options granted to nonemployees, we recorded $557,000$281,000 and $70,000$222,000 for nonemployee stock-based compensation during 2022 and 2021, respectively.

F-32

Restricted stock units

The number and weighted average grant date fair value of restricted non vested common stock for the most recent completed fiscal years is as follows:

  

Number of

Restricted Shares

  

Weighted Average

Grant Date Fair

Value

 

Restricted nonvested at January 1, 2021

  287  $138.00 

Granted in 2021

  539   166.80 

Vested in 2021

  (557)  152.00 

Restricted nonvested at December 31, 2021

  269  $138.00 

Granted in 2022

  -   - 

Vested in 2022

  (269)  67.60 

Restricted nonvested at December 31, 2022

  -  $- 

As of December 31, 2022, there was no compensation expense yet to be recognized related to unvested restricted stock units.

Stock compensation expense includes expense related to restricted stock units of approximately $43,000 and $106,000 during the years ended December 31,2022 and December 31, 2016 and 2015,2021, respectively. These amounts were based upon the fair values of the vested portion of the grants. Amounts expensed during the remaining vesting period will be determined based on the fair value at the time of vesting.

 

Stock-based payments

In the first quarter of 2016, our Board of Directors authorized the issuance of 37,500 shares of our common stock to two vendors who agreed to provide services to the Company upon terms that provided for a portion of their consideration to be paid in shares of our common stock. The fair value of each share of common stock was determined by our Board of Directors, and accordingly, we recorded a charge of $75,000.

In the first quarter of 2015, our Board of Directors authorized the issuance of 132,964 shares of our common stock to two vendors who agreed to provide services to the Company upon terms that provided for a portion of their consideration to be paid in shares of our common stock. The fair value of each share of common stock was determined by our Board of Directors, and accordingly, we recorded an expense of $42,000.

10.     Income Taxes

12.

Income Taxes

 

We have incurred net operating losses since our inception. We have not reflected the benefit of net operating loss carryforwards in the accompanying financial statements and have established a full valuation allowance against our deferred tax assets.

 

AtOn December 31, 20162022 and 2015,2021, the Company had an income tax receivable of $321,000approximately $49,000 and $733,000,$321,000 respectively, comprised of refundable tax creditsincentives related to research and development activities of our subsidiary Sun BioPharma AustraliaPanbela Therapeutics Pty Ltd.

 

Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes andas well as operating losses and tax credit carryforwards.


 

The significant components of our deferred tax assets and liabilities are as follows (in thousands):

 

 

 

December 31,

 

 

 

2016

 

 

2015

 

Deferred tax assets:

 

 

 

 

 

 

 

 

Net operating loss carryforwards

 

$

3,550

 

 

$

3,395

 

Research credit carryforwards

 

 

235

 

 

 

236

 

Accrued expenses

 

 

188

 

 

 

 

Stock-based compensation

 

 

420

 

 

 

148

 

Other

 

 

79

 

 

 

32

 

Total deferred tax assets

 

 

4,472

 

 

 

3,811

 

Valuation allowance

 

 

(4,472

)

 

 

(3,811

)

Net deferred tax asset

 

$

 

 

$

 

2022

Tax Expense:

Current

(116)

Deferred

-

Noncurrent

-
(116)

F-33

  December 31, 

Deferred tax assets (liabilities)

 

2022

  

2021

 
         

Net operating loss carryforwards

 $17,564  $9,986 

Research credit carryforwards

  338   235 

Stock-based compensation

  1,928   1,734 

Section 174 amortization

  1,921   - 

Other

  68   66 

Deferred tax assets

  21,819   12,021 

Valuation allowance

  (21,819)  (12,021)

Net deferred tax asset

 $-  $- 

 

Realization of the future tax benefits is dependent on our ability to generate sufficient taxable income within the carry-forward period. Because of our history of operating losses, management believes that the deferred tax assets arising from the above-mentioned future tax benefits are currently not likely to be realized and, accordingly, we have provided a full valuation allowance.

 

A reconciliation of the statutory tax rates and the effective tax rates is as follows:

 

 

Year Ended December 31,

 

  

Year Ended December 31,     

 

 

2016

 

 

2015

 

 

2022

  

2021

 

Statutory rate

 

34.0

%

 

34.0

%

  21.0%  21.0%

Permanent differences

 

(4.0

)

 

(10.3

)

  (10.8)  2.1 

State tax rate true-up

 

0.6

 

 

5.3

 

Change in effective tax rate

  0.0   (0.4)

States

  0.1   - 

Valuation allowance

 

(30.7

)

 

(29.0

)

  (13.0)  (24.3)

Foreign research incentives

  0.1   3.1 

Other

 

(0.1

)

 

(0.1

)

  2.9   1.6 

State and local income taxes

 

 

 

 

 

0.1

 

Effective rate

 

 

0.0

%

 

 

0.0

%

  0.3%  3.1%

 

Net operating losses and tax credit carryforwards as of December 31, 2016,2022, are as follows:

 

 

 

Amount

(In thousands)

 

Expiration Years

Net operating losses—federal

 

$

10,441

 

Beginning 2031

Tax credits—federal

 

 

235

 

Beginning 2041

(In Thousands)

Amount

Expiration Years

Net operating losses--federal

23,068

Expires beginning 2031

2018 to 2022 net operating losses -- federal

23,977

Never expires

Tax credits--federal

338

Beginning 2041

 

Utilization of the net operating loss carryforwards and credits may be subject to a substantial annual limitation due to the ownership change limitations provided by the Internal Revenue Code of 1986, as amended (the “IRC”),IRC, and similar state provisions. We have not performed a detailed analysis to determine whether an ownership change under Section 382 of the IRC has occurred. The effect of an ownership change would be the imposition of an annual limitation on the use of net operating loss carryforwards attributable to periods before the change.

F-34

 

The Company is subject to taxation in the United States and Australia. Tax returns sincefor the inception of Sun BioPharma, Inc. in 2011year ended December 31, 2017 and thereafter are subject to examinations by federal and state tax authorities and may change upon examination.authorities. Tax returns of Sun BioPharma AustraliaPanbela Therapeutics Pty Ltd.Ltd for the year ended December 31, 20132015 and thereafter are subject to examination by the Australian tax authorities.

 


13.

Subsequent Events

 

11.     Subsequent Events

SalesDuring the month of convertible promissory notes

On each of February 17, March 3, March 10 and March 17, 2017, we entered into Note Purchase Agreements (the “Note Agreements”) with a number of accredited purchasers in private transactions. Pursuant to these Note Agreements weJanuary 2023, the Company sold convertible promissory notes payable (the “2017 Convertible Notes”) raising gross proceeds of $3.1 million.

The 2017 Convertible Notes are scheduled to mature on December 1, 2018 and bear interest at a rate of 5.0% per annum. Principal and interest on the Notes are payable at maturity. The Company may prepay the Notes in whole or in part at any time without penalty or premium. The Notes may be converted into440,830 shares of common stock or other securities ofunder the ATM Program. Net proceeds were approximately $1.6 million.

On January 30, 2023, the Company upon certain triggering events as described in the Notes, including certain transactionscompleted a registered public offering and upon the requestissued an aggregate of a holder4,842,224 shares of any Note. Upon the occurrence of certain events of default, the Notes require the Company to repay the unpaid principal amount of the Notes and any unpaid accrued interest. The Company expects to use the net proceeds from the sales of the Notes for working capital and general corporate purposes. One of our stockholders, who beneficially owns more than 10% of ourits common stock, purchased $200,000pre-funded warrants to purchase up to an aggregate of these notes.

Conversion of convertible notes payable

In March 2017, we offered to all holders of outstanding 2013 Convertible Notes and to all holders of the demand notes payable (collectively the “Notes”) who were accredited investors an opportunity to convert all outstanding principal and accrued interest through March 31, 2017 into shares of our common stock at a rate of $0.75 per share. The offered conversion rate represents a $0.375, or 33.3%, discount from the rate stated in the terms of the 2013 Convertible Notes, which at the time was $1.125 per share. The eligible holders had until March 27, 2017 to accept the offer and holders of $3,000,000 aggregate principle amount of the Notes accepted the offer. Accordingly, on March 31, 2017 our Company will issue 4,183,3331,832,776 shares of common stock in exchange for the surrenderat an exercise price of the Notes representing $3,000,000$0.001 per share and warrants to purchase up to an aggregate of principal amount and $137,50013,350,000 shares of accrued but previously unpaid interest.its common stock at an exercise price of $2.75 per share. The sharessecurities were issued in reliancefor a combined offering price of $2.25 per share of common stock and 2 warrants, or $2.249 per pre-funded warrant and 2 warrants. Net proceeds from the offering totaled approximately $13.7 million. All pre-funded warrants were exercised by February 2, 2023. The securities were offered pursuant to an effective registration statement on the exemption from registration set forth in Section 3(a)(9) of the Securities Act as securities exchanged by an issuer with existing security holders where no commission or other remuneration is paid or given directly or indirectly by the issuer for soliciting such exchange.Form S-1.

 


F-35

 



 

834,028

Up to 3,007,519 Shares of Common Stock


Up to 3,007,519 Class E Common Warrants to Purchase 417,014purchase up to 3,007,519 Shares of Common Stock
Up to 3,007,519 Class F Common Warrants to purchase up to 3,007,519 Shares of Common Stock
Up to 3,007,519 Pre-Funded Warrants to purchase up to 3,007,519 Shares of Common Stock
Up to 9,022,557
Shares of Common Stock Underlying Warrants

Panbela Therapeutics, Inc.

 

 

 

Sun Biopharma, Inc.

 _________________________ 


 

PROSPECTUS

_________________________ 

Sole Book-Running Manager

Aegis Capital Corp

________________

Co-Manager

Lake Street Capital Markets

   , 2017

 

 

 


Roth Capital Partners

, 2024



 


 


PARTII

 

INFORMATION NOT REQUIRED IN PROSPECTUS

 

ItemItem 13.     Other Expenses of Issuance and Distribution.

Other Expenses of Issuance and Distribution.

 

The following table sets forth the costs and expenses other than the underwriting discounts and commissions and non-accountable expense allowance, payable by Sun BioPharma,Panbela Therapeutics, Inc. (the “Company”) in connection with the offering and sale of itsthe common stock being registered. All amounts shown are estimates, except the Securities and Exchange Commission (the “Commission”) registration fee and the Financial Industry Regulatory Authority (“FINRA”) filing fee.

 

U.S. Securities and Exchange Commission registration fee

 $2,246 

Nasdaq Listing application fee

 $50,000 

FINRA filing fee

 $2,000 

Accounting fees and expenses

 $30,000 

Legal fees and expenses

 $175,000 

Transfer agent and registrar fees

 $9,050 

Printing expenses

 $13,330 

Miscellaneous

 $90,000 

Total

 $371,626 
 

U.S. Securities and Exchange Commission registration fee

 

$

8,856 

FINRA filing fee

 

$

10,000 

Accounting fees and expenses

 

$

40,000

 

Legal fees and expenses

 

$

200,000

 

Transfer agent, registrar, and warrant agent fees

 

$

20,000

 

Printing expenses

 

$

10,000

 

Miscellaneous

 

$

11,144

 

Total

 

$

300,000

 

Item 14.     Indemnification of Directors and Officers.

Item14.

Indemnification of Directors and Officers.

 

Section 145 of the Delaware General Corporation Law provides that a corporation may indemnify any person made a party to an action by reason of the fact that he or she was a director, executive officer, employee or agent of the corporation or is or was serving at the request of the corporation against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by him or her in connection with such action if he or she acted in good faith and in a manner he or she reasonably believed to be in, or not opposed to, the best interests of the corporation and, with respect to any criminal action or proceeding, had no reasonable cause to believe his or her conduct was unlawful, except that, in the case of an action by or in right of the corporation, no indemnification may generally be made in respect of any claim as to which such person is adjudged to be liable to the corporation.

 

The Company’sCompany’s certificate of incorporation and amended and restated bylaws limit the liability of its directors to the fullest extent permitted by Delaware law. Delaware law provides that directors of a corporation will not be personally liable for monetary damages for breach of their fiduciary duties as directors, except for liability for any:

 

 

breach of their duty of loyalty to the Company or its stockholders;

 

 

act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;

 

 

unlawful payment of dividends or redemption of shares as provided in Section 174 of the Delaware General Corporation Law; or

 

 

transaction from which the directors derived an improper personal benefit.

 

These limitations of liability do not apply to liabilities arising under federal securities laws and do not affect the availability of equitable remedies such as injunctive relief or rescission. The Company’s amended and restated bylaws provide that it will indemnify its directors and executive officers, and may indemnify other officers, employees and other agents, to the fullest extent permitted by law.

As permitted by the Delaware General Corporation Law, the Company has entered into indemnification agreements with each of the Company’s directors and executive officers that require the Company to indemnify such persons against expenses, judgments, penalties, fines, settlements and other amounts actually and reasonably incurred, including expenses of a derivative action, in connection with an actual or threatened proceeding if any of the Company’s directors or executive officers may be made a party because he or she is or was one of the Company’s directors. The Company will be obligated to pay such amounts only if the director acted in good faith and in a manner that he or she reasonably believed to be in or not opposed to the Company’s best interests. With respect to any criminal proceeding, the Company will be obligated to pay such amounts only if the director had no reasonable cause to believe his or her conduct was unlawful. The indemnification agreements also set forth certain procedures that will apply in the event of a claim for indemnification.

 

II-1

 

 

Section 145(g) of the Delaware General Corporation Law permits a corporation to purchase and maintain insurance on behalf of any person who is or was a director, officer, employee, or agent of the corporation arising out of his or her actions in connection with their services to the Company, regardless of whether its amended and restated bylaws permit indemnification. The Company has purchased and intends to maintain insurance on behalf of any person who is or was a director or officer against any loss arising from any claim asserted against him or her and incurred by him or her in any such capacity, subject to certain exclusions.

Item15.

Recent Sales of Unregistered Securities.

During the six months ended June 30, 2021, the Company issued 162 shares of Common Stock as a result of exercises of outstanding warrants. Of the shares of Common Stock issued, 158 shares were issued pursuant to net, cashless, exercises of warrants to purchase 5446 shares and the remaining 5 shares were issued for $25,000 cash. We relied on exemptions from registration set forth in Section 4(a)(2) of the Securities Act, without the use of any general solicitations or advertising to market or otherwise offer the securities for sale and all participants were “accredited investors,” as defined in Rule 501 of Regulation D as promulgated by the SEC under the Securities Act.

 

Item 15.     Recent SalesOn June 15, 2022, pursuant to an agreement and plan of Unregistered Securities.merger dated as of February 21, 2022 (the “Merger Agreement”), the Company sold and issued the following securities to the holders of CPP securities: (a) 5,489 shares of Common Stock, (b) 609 shares of Common Stock that remained subject to a holdback escrow (as defined in the Merger Agreement), (iv) replacement options to purchase up to 1,330 shares of Common Stock at a weighted average purchase price of $420.00 per share, and (v) replacement warrants to purchase up to 2810 shares of Common Stock at a weighted average purchase price of $4974.00 per share. Effective June 15, 2023, all of the shares in the holdback escrow were released to the sellers. We relied on exemptions from registration set forth in Section 4(a)(2) of the Securities Act, without the use of any general solicitations or advertising to market or otherwise offer the securities for sale and all participants were “accredited investors,” as defined in Rule 501 of Regulation D as promulgated by the SEC under the Securities Act.

 

All share and per share amounts included in this Item 15On November 2, 2023, the Company entered into warrant exercise inducement offer letters with respectcertain holders of its existing warrants to transactions on or before September 4, 2015, have been adjusted to give effect to the exchange ofpurchase shares of common stockCommon Stock, pursuant to the merger transaction to which the Company washolders agreed to exercise for cash their existing warrants to purchase 2,130,000 shares of Common Stock, in the aggregate, at a party and that closedreduced exercise price of $0.78 per share, in exchange for the Company’s agreement to issue new Class C Warrants on that date (the “Merger”). The same amounts with respect to transactions on or before November 7, 2017 are also adjusted to give effect to the 1-for-10 reverse stock split effected as of the close of business onsubstantially the same date.

Common Stock

During 2014, terms as the Company issued an aggregate of 214,360existing warrants, to purchase up to 4,260,000 shares of common stockCommon Stock (the “Class C Warrant Shares”) and a cash payment of $0.125 per existing warrant share which was paid in connection withfull upon the exercise of stock options for aggregate proceedsthe existing warrants. The terms of approximately $493,000. During the same period, the Company issued 10,000 shares of common stock in connection with the exercise of warrants for aggregate proceeds of $25,000. The proceeds for the foregoing exercises were used primarily to fund company operations.

In May 2014, the Company issued 40,000 shares of its common stock in exchange for services rendered and to be rendered by a consultant.

In March 2015, the Company issued 4,000 shares of its common stock in exchange for services rendered and to be rendered by an employee.

In April 2015, the Company sold an aggregate of 17,500 shares of common stock to certain “accredited investors” as defined in Regulation D promulgatedClass C Warrants are further described under the heading “Description of Securities Act of 1933, as amended, for aggregate proceeds of $350,000. The proceeds were used primarily to fund company operations.

In September 2015, the Company sold an aggregate of 58,750 shares of common stock to certain “accredited investors” for aggregate proceeds of $1,175,000. The proceeds were used primarily to fund company operations.

Also during 2015, but prior to the Merger, the Company issued 259,053 shares of common stock in connection with the exercise of stock options for aggregate proceeds of approximately $693,000. During the same period, the Company issued 200,000 shares of common stock in connection with the exercise of warrants for aggregate proceeds of $375,000. The proceeds from the foregoing exercises were used primarily to fund company operations. The Company also issued 20,077 shares of common stock during 2015 in connection with the conversion of $225,000 aggregate principal amount of convertible promissory notes.

In February 2016, the Company issued an aggregate of 3,750 shares of its common stock to two vendors who agreed to provide services to the Company upon terms that provided for a portion of their consideration to be paid in shares of its common stock.

In June through September 2016, the Company sold an aggregate of 222,100 shares of common stock and warrants to purchase an aggregate of 111,050 additional shares of common stock pursuant to a series of purchase agreements. The purchase price for each unit, consisting of one share of common stock and a warrant to purchase one-half shares of common stock, was $10.00.– Warrants Outstanding – Class C Warrants” above. The Company received aggregate gross proceeds of approximately $1.9 million and an additional $196,000 was investedfrom the exercise of the existing warrants by management through the conversion of previously accrued compensation. The Company has and plans to continue to use the cash proceeds from these transactions fund the continuing Phase 1 clinical trial of SPB-101 for pancreatic cancer as well as preclinical efforts to further study the impact of SBP-101 on pancreatitis. The underlying common stock was registered for resale pursuant to a registration statement on Form S-1 declared effective on September 30, 2016 (file no. 333-213687).

II-2

In March 2017, the Company entered into Debt-For-Equity Exchange Agreements with the holders of promissory notes payable by the Company named therein pursuant to which the Company agreed to convert all outstanding principal and accrued interest through March 31, 2017 into shares of common stock at a rate of $7.50 per share. In accordance with the exchange agreements, the Company issued an aggregate of 418,332 shares of common stock in exchange for the cancellation of promissory notes amounting to $3,000,000 principal amount and $137,500 accrued but previously unpaid interest. The shares were issued in reliance on the exemption from registration set forth in Section 3(a)(9) of the Securities Act as securities exchanged by an issuer with existing security holders where no commission or other remuneration is paid or given directly or indirectly by the issuer for soliciting such exchange.

On December 13, 2017, the Company issued an aggregate of 171,220 shares of common stock as a result of the cashless exercise of outstanding warrants to purchase 200,000 shares of common stock at an exercise price of $1.875 per share. The cashless exercise was based on a per share value of $13.03, which represented the average closing bid and ask prices of the Company’s common stock for the ten trading day period ending five trading days prior to the exercise date. On the same date, the Company received notice for the cashless exercise of a similar warrant for an additional 20,000 shares of common stock, which exercise is conditioned upon and will be effective immediately prior to the completion of the offering.  The conditional warrant exercise is expected to result in the issuance of 17,122 additional shares of common stock based on the same exercise price and value per share. The Company does not receive cash proceeds from cashless exercises.

Stock Options

All of the Stock Options granted prior to the Merger were awarded under the Sun BioPharma, Inc. 2011 Stock Option Plan and include a ten year term from the date of their respective grant dates.

In January 2015, the Company granted options to purchase an aggregate of 22,000 shares of its common stock with an exercise price of $3.175 per share to its directors in exchange for services rendered.

In March 2015, the Company granted options to purchase an aggregate of 512,000 shares of its common stock with an exercise price of $3.175 per share to its employees, consultants and directors in exchange for services rendered.

Promissory notes

In February through March 2017, the Company sold $3,076,000 original principal amount of convertible promissory notes (the “2017 Notes”) pursuant to a series of note purchase agreements. The 2017 Notes may be converted into shares of common stock or other securities of the Company upon certain triggering events as described in the 2017 Notes, including certain transactions and upon the request of a holder of any note. In the absence of an event triggering another conversion method, the holders of the 2017 Notes are entitled to convert them into shares of common stock at a conversion price of $10.10 per share. If all of the outstanding 2017 Notes, including accrued but unpaid interest, had converted into shares of common stock as of September 30, 2017, the holders would have received an estimated total of 313,134 shares of common stock. The Company has used and expect to use the net proceeds from the sales of the 2017 Notes for continued clinical development of its initial product candidate, SBP-101, and for working capital and general corporate purposes.

Warrants

In June through September 2016, in conjunction with the sale of equity securitiesthe Class C Warrants. The Company issued the Class C Warrants pursuant to the Purchase Agreements, the Company issued warrants to purchase the Warrant Shares, consisting of an aggregate of 111,050 additional shares of common stock, exercisable for five years after the date of issuance, at an exercise price of $15.00 per share.

Exemption(s) from Registration

None of the foregoing transactions involved any underwriters, underwriting discounts or commissions, or any public offering, and, unless specifically stated otherwise above, the Company believes that the transactions were exemptexemption from the registration requirements of the Securities Act in reliance on Sectionsavailable under Section 4(a)(2) or 4(a)(6) thereof,and Rule 506(b) of Regulation D promulgated thereunder and the rules and regulations promulgated thereunder,Class C Warrant Shares have been or Rule 701 thereunder, as transactions by an issuer not involving a public offering or transactions pursuant to compensatory benefit plans and agreements relating to compensation as provided under such Rule 701. The recipients of securities in such transactions represented their intention to acquire the securities for investment only and not with a view to or for sale in connection with any distribution thereof, and appropriate legends were affixed to the share certificates and instrumentswill be issued in such transactions.

II-3

Item 16.                 Exhibits and Financial Statement Schedules.

(a) Exhibits.

Unless otherwise indicated, all documents incorporated into this registration statement by reference to a document filed with the SEC pursuant to the Exchangesame exemption or pursuant to the exemption provided by Section 3(a)(9) of the Securities Act.

On December 21, 2023, the Company entered into warrant exercise inducement offer letters with the holders of its existing Class C Warrants, pursuant to which the holders agreed to exercise for cash their existing Class C Warrants to purchase an aggregate of 2,556,000 shares of Common Stock, in the aggregate, at the existing exercise price of $0.78 per share, in exchange for the Company’s agreement to issue new Class D Warrants on substantially the same terms as the Class C Warrants, to purchase up to 5,112,000 shares of Common Stock (the “Class D Warrant Shares”). The terms of exercise of the Class D Warrants are further described under the heading “Description of Securities – Warrants Outstanding – Class D Warrants” above. The Company received aggregate gross proceeds of approximately $2.0 million from the exercise of the Class C Warrants by the holders. The Company issued the Class C Warrant Shares and the Class D Warrants pursuant to the exemption from the registration requirements of the Securities Act are locatedavailable under SEC file number 000-55242.Section 4(a)(2) and Rule 506(b) of Regulation D promulgated thereunder and the Class D Warrant Shares have been or will be issued pursuant to the same exemption or pursuant to the exemption provided by Section 3(a)(9) of the Securities Act.

 

Item16.

Exhibits and Financial Statement Schedules.

(a)Exhibits

Exhibit

No.

 

Description

1.1+

Form of Underwriting Agreement

2.1

Agreement and Plan of Merger, dated June 12, 2015, by and among Sun BioPharma, Inc. (f/k/a Cimarron Medical, Inc.), Sun BioPharma Research, Inc. (f/k/a Sun BioPharma, Inc.), and SB Acquisition Corporation (incorporated by reference to Exhibit 2.1 to current report on Form 8-K filed June 18, 2015)

2.2

Amendment No. 1 to Agreement and Plan of Merger, dated August 3, 2015 (incorporated by reference to Exhibit 2.1 to current report on Form 8-K filed August 5, 2015)

2.3

Agreement and Plan of Merger dated May 25, 2016 (incorporated by reference to Exhibit 2.1 to quarterly report on Form 10-Q for the quarter ended June 30, 2016)

3.1

 

Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to current report on Form 8-K filed on November 15, 2017)January 17, 2023)

3.2

 

Certificate of Amendment to Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to current report on Form 8-K filed May 31, 2023)

3.3

Amended and Restated Bylaws (incorporated by reference to Exhibit 3.23.1 to quarterlycurrent report on Form 10-Q for the quarter ended June 30, 2016)8-K filed April 18, 2023)

3.4Certificate of Amendment to Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to current report on Form 8-K filed January 19, 2024)

4.1+4.1

 

Description of Securities (incorporated by reference to Exhibit 4.1 to annual report on Form of Warrant Agreement10-K for fiscal year ended December 31, 2020)

II-2

Exhibit

No.

 Description

4.2+4.2

 

Form of Representative’sCommon Stock Warrant issued December 2018 and January 2019 (incorporated by reference to Exhibit 10.3 to current report on Form 8-K filed December 28, 2018)

5.1+4.3

 

OpinionForm of Faegre Baker Daniels LLPCommon Stock Warrant issued August through October 2019 (incorporated by reference to Exhibit 10.2 to current report on Form 8-K filed August 29, 2019)

10.14.4

 

Form of Warrants issued May 22, June 5, June 15, and June 22, 2020 (incorporated by reference to Exhibit 10.2 to current report on Form 8-K filed June 11, 2020)

4.5

Warrant Agency Agreement with VStock Transfer, LLC dated September 1, 2020 (incorporated by reference to Exhibit 4.1 to current report on Form 8-K filed September 1, 2020)

4.6

Form of Common Stock Purchase SharesWarrant (included in Exhibit 4.6)

4.7

Warrant Agency Agreement with VStock Transfer, LLC dated as of October 4, 2022 (incorporated by reference to Exhibit 4.1 to current report on Form 8-K filed on October 4, 2022)

4.8

Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.3 to current report on Form 8-K filed September 11, 2015)October 4, 2022)

10.24.9

 

FormWarrant Agency Agreement with VStock Transfer, LLC dated as of Convertible Promissory NoteJanuary 30, 2023 (incorporated by reference to Exhibit 4.24.1 to current report on Form 8-K filed September 11, 2015)on January 31. 2023)

10.3*4.10

 

Warrant Agency Agreement with VStock Transfer, LLC dated as of June 21, 2023 (incorporated by reference to Exhibit 4.1 to current report on Form 8-K filed on June 21, 2023)

4.11

Form of Class A Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.3 to current report on Form 8-K filed on June 21, 2023)

4.12

Form of Class B Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.4 to current report on Form 8-K filed on June 21, 2023)

4.13

Form of Class C Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 to current report on Form 8-K filed on November 3, 2023)

4.14

Form of Class D Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 to current report on Form 8-K filed on December 21, 2023)

4.15+

Form of Warrant Agency Agreement with VStock Transfer, LLC

4.16+

Form of Pre-Funded Warrant

4.17+

Form of Class E Common Stock Purchase Warrant

4.18+

Form of Class F Common Stock Purchase Warrant

5.1+

Opinion of Faegre Drinker Biddle & Reath LLP

10.1*

2011 Stock Option Plan, as amended through January 1, 2015 (incorporated by reference to Exhibit 10.1 to current report on Form 8-K filed September 11, 2015)

10.4*10.2*

 

Form of Incentive Stock Option Agreement for awards under 2011 Stock Option Plan as amended (incorporated by reference to Exhibit 10.2 to current report on Form 8-K filed September 11, 2015)

10.5*10.3*

 

Form of Non-Qualified Stock Option Agreement for awards under 2011 Stock Option Plan as amended (incorporated by reference to Exhibit 10.3 to current report on Form 8-K filed September 11, 2015)

10.6*10.4*

 

Indemnification Agreement, dated September 4, 20152016 Omnibus Incentive Plan as amended and restated through April 9, 2020 (incorporated by reference to Exhibit 10.499.1 to current report on Form 8-K filed September 11, 2015)May 26, 2020)

10.7**10.5*

 

Standard Exclusive License Agreement by and between the University of Florida Research Foundation, Inc. and Sun BioPharma, Inc., dated December 22, 2011 (incorporated by reference to Exhibit 10.5 to current report on Form 8-K filed September 11, 2015)

10.8*

2016 Omnibus Incentive Plan (incorporated by reference to Appendix E to definitive proxy statement on Schedule 14A filed April 11, 2016)

10.9*

Form of Incentive Stock Option Agreement for awards under 2016 Omnibus Incentive Plan (incorporated by reference to Exhibit 10.4 to quarterly report on Form 10-Q for the quarter ended June 30, 2016)

10.10*10.6*

 

Form of Non-Qualified Stock Option Agreement for awards under 2016 Omnibus Incentive Plan (incorporated by reference to Exhibit 10.510.5 to quarterly report on Form 10-Q for the quarter ended June 30, 2016)

10.11*10.7*

 

Form of Performance-Based Stock Option Agreement for awards under 2016 Omnibus Incentive Plan (incorporated by reference to Exhibit 10.7 to annual report on Form 10-K for thefiscal year ended December 31, 2016)

10.8**

Standard Exclusive License Agreement with University of Florida Research Foundation, Inc., dated December 22, 2011 (incorporated by reference to Exhibit 10.5 to current report on Form 8-K filed September 11, 2015)

10.9

Form of First Amendment to License Agreement with University of Florida Research Foundation, Inc. dated December 12, 2016 (incorporated by reference to Exhibit 10.10 to annual report on Form 10-K for fiscal year ended December 31, 2019)

10.10

Second Amendment to License Agreement with University of Florida Research Foundation, Inc., dated October 3, 2019 (incorporated by reference to Exhibit 10.1 to current report on Form 8-K filed October 9, 2019)

II-3

Exhibit

No.

Description

10.11*

Employment Agreement with Susan Horvath, dated April 17, 2018 (incorporated by reference to Exhibit 10.4 to quarterly report on Form 10-Q for quarter ended March 31, 2018)

10.12*

 

Employment Agreement with Michael T. Cullen,Jennifer K. Simpson, dated July 15, 2020 (incorporated by reference to Exhibit 10.1 to current report on Form 8-K filed July 16, 2020)

10.13

First Amendment to Seed Capital Accelerator Loan Agreement and Seed Capital Loan Note dated October 13, 2017 (incorporated by reference to Exhibit 10.1 to quarterly report on Form 10-Q for quarter ended March 31, 2019)

10.14

Second Amendment to Seed Capital Accelerator Loan Agreement and Seed Capital Loan Note dated April 5, 2019 (incorporated by reference to Exhibit 10.2 to quarterly report on Form 10-Q for quarter ended March 31, 2019

10.15

Third Amendment to Seed Capital Accelerator Loan Agreement and Seed Capital Loan Noted dated December 2, 201531,2019 (incorporated by reference to Exhibit 10.25 to annual report on Form 10-K for fiscal year ended December 31, 2019)

10.16

Form of Securities Purchase Agreement, dated December 21 and 31, 2018, January 14, 25, and 31, 2019 (incorporated by reference to Exhibit 10.1 to current report on Form 8-K filed December 4, 2015)28, 2018)

II-4

Exhibit

No.

Description

10.13*10.17*

 

First Amendment to Employment Agreement with Michael T. Cullen, dated September 12, 2016Cancer Prevention Pharmaceuticals, Inc. 2010 Equity Incentive Plan, as amended (incorporated by reference to Exhibit 10.1710.1 to registration statementcurrent report on Form S-18-K filed SeptemberJune 16, 2016, file no. 333-213687)2022)

10.14*10.18*

 

Employment Agreement with David B. Kaysen, dated December 2, 2015Form of Stock Option Assumption Notice (incorporated by reference to Exhibit 10.2 to current report on Form 8-K filed December 4, 2015)June 16, 2022)

10.15*10.19

 

First Amendment to Employment Agreement with David B. Kaysen, dated September 12, 2016 (incorporated by reference to Exhibit 10.18 to registration statement on Form S-1 filed September 16, 2016, file no. 333-213687)

10.16*

Employment Agreement with Scott Kellen, dated December 2, 2015of Replacement Warrant (incorporated by reference to Exhibit 10.3 to current report on Form 8-K filed December 4, 2015)June 16, 2022)

10.17*10.20

 

First Amendment to Employment Agreement with Scott Kellen,Convertible Promissory Note in favor of Sucampo GmbH (f/k/a Sucampo AG), dated as of September 12, 20166, 2017, as amended through April 7, 2022 (incorporated by reference to Exhibit 10.1910.4 to registration statementcurrent report on Form S-18-K filed SeptemberJune 16, 2016, file no. 333-213687)2022)

10.18*10.21

 

Employment Agreement with Suzanne Gagnon,Guaranty in favor of Sucampo GmbH (f/k/a Sucampo AG), dated December 2, 2015June 15, 2022 (incorporated by reference to Exhibit 10.910.5 to annualcurrent report on Form 10-K for the year ended December 31, 2015)8-K filed June 16, 2022)

10.19*10.22

 

First Amendment to EmploymentSeparation and Release Agreement with Suzanne Gagnon,Jeffrey E. Jacobs, dated September 12, 2016June 15, 2022 (incorporated by reference to Exhibit 10.2010.6 to registration statementcurrent report on Form S-18-K filed SeptemberJune 16, 2016, file no. 333-213687)2022)

10.2010.23

 

Form of Securities Purchase Agreement (incorporated by reference to Exhibit 10.2 to current report on Form 8-K filed on October 4, 2022)

10.24

Placement Agency Agreement with Roth Capital Partners, LLC dated as of September 29, 2022 (incorporated by reference to Exhibit 10.1 to current report on Form 8-K filed June 14, 2016)on October 4, 2022)

10.2110.25

 

Placement Agency Agreement with Roth Capital Partners, LLC dated as of June 16, 2023 (incorporated by reference to Exhibit 10.1 to current report on Form 8-K filed June 21, 2023)

10.26

Form of Warrant toSecurities Purchase Shares of StockAgreement by and between Panbela Therapeutics, Inc. and the purchasers named therein (incorporated by reference to Exhibit 10.2 to current report on Form 8-K filed June 14, 2016)21, 2023)

10.2210.27

 

Form of Note Purchase Agreements,Inducement Letters dated February 17, 2017, March 3, 2017, March 10, 2017 and March 17, 2017, by and among the Company and the purchasers identified thereinNovember 2, 2023 (incorporated by reference to Exhibit 10.1 to current report on Form 8-K filed March 6, 2017)November 3, 2023).

10.2310.28

 

Form of Convertible Promissory Notes, dated February 17, 2017, March 3, 2017, March 10, 2017 and March 17, 2017 (incorporated by reference to Exhibit 10.2 to current report on Form 8-K filed March 6, 2017)

10.24

Form of Debt-for-Equity Exchange Agreement, dated March 27, 2017 (incorporated by reference to Exhibit 10.1 to current report on Form 8-K filed March 31, 2017)

10.25

Form of Participation Rights Agreement, dated March 27, 2017 (incorporated by reference to Exhibit 10.2 to current report on Form 8-K filed March 31, 2017)

10.26*

Second Amendment to Employment Agreement with Michael T. Cullen, dated October 1, 2017 (incorporated by reference to Exhibit 10.1 to current report on Form 8-K filed October 13, 2017)

10.27*

Second Amendment to Employment Agreement with David B. Kaysen, dated October 1, 2017 (incorporated by reference to Exhibit 10.2 to current report on Form 8-K filed October 13, 2017)

10.28*

Second Amendment to Employment Agreement with Scott Kellen, dated October 1, 2017 (incorporated by reference to Exhibit 10.3 to current report on Form 8-K filed October 13, 2017)

10.29*

Second Amendment to Employment Agreement with Suzanne Gagnon, dated October 1, 2017 (incorporated by reference to Exhibit 10.4 to current report on Form 8-K filed October 13, 2017)

10.30Standstill Agreement with Ryan R. Gilbertson,Inducement Letters dated December 17, 201721, 2023 (incorporated by reference to Exhibit 10.1 to current report on Form 8-K filed December 18, 2017)21, 2023)

10.29+

 

21.1Form of Placement Agency Agreement with Roth Capital Partners, LLC

10.30+

Form of Securities Purchase Agreement

21.1+

 

List of Subsidiaries (incorporated by reference to Exhibit 21.1 to annual report on Form 10-K for the year ended December 31, 2016)

23.1++ 

Consent of Independent Registered Public Accounting Firm

23.2+

 

Consent of Faegre Baker DanielsDrinker Biddle & Reath LLP (included in Exhibit 5.1)

24.1++24.1+

 

Powers of Attorney (see signature page)

107+

 

101+

Financial statements for the years ended December 31, 2016 and 2015 and for the nine months ended September 30, 2017 and 2016, formatted in XBRL: (i) the Balance Sheets, (ii) the Statements of Operations and Comprehensive Loss, (iii) the Statements of Cash Flows, and (iv) the Notes to Financial Statements.Filing Fee Table

 


+

Filed herewithPreviously filed.

++

Previously filed.Filed herewith.

*

Management compensatory plan or arrangement required to be filed as an exhibit to this prospectus.

**

Portions of exhibit omitted pursuant to order granting confidential treatment issued by the Securities and Exchange Commission.

 

II-5
II-4

 

((b)b)Financial Statement Schedules.

 

All schedules are omitted as the required information is inapplicable or the information is presented in the financial statements or related notes.

 

Schedule II. Valuation and Qualifying Accounts

 

All other schedules are omitted as the required information is inapplicable or the information is presented in the financial statements or related notes.

 

ItemItem 17.              Undertakings.

Undertakings.

 

The registrant hereby undertakes:

 

 

(1)

To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:

 

 

(i)

ToTo include any prospectus required by Section 10(a)(3) of the Securities Act;

 

 

(ii)

To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering price set forth in the “Calculation“Calculation of Registration Fee” table in the effective registration statement; and

 

 

(iii)

To include any material information with respect to the plan of distribution not previously disclosed in thisthe registration statement or any material change to such information in this registration statement.statement;

provided, however, that paragraphs (a)(1)(i), (ii) and (iii) do not apply if the information required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the Registrant pursuant to Section 13 or Section 15(d) of the Exchange Act, that are incorporated by reference in the registration statement.

 

 

(2)

That, forfor the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered herein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

 

 

(3)

To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.

 

 

(4)

That, for the purpose of determining liability under the Securities Act to any purchaser: each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included in the registration statement as of the date it is first used after effectiveness; provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such date of first use.

 

II-6

 

(5)

That, for purposes of determining any liability under the Securities Act, each filing of the registrant’s annual report pursuant to Section 13(a) or 15(d) of the Exchange Act (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Exchange Act) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

(6)

That, for the purpose of determining liability under the Securities Act to any purchaser the information omitted from the form of prospectus filed as part of this Registration Statement in reliance upon Rule 430A and contained in a form of prospectus filed by the Registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this Registration Statement as of the time it was declared effective; and for the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

II-5

 

 

(7)(6)

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that, in the opinion of the Securities and Exchange Commission, such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

 

II-7II-6

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Act of 1933, as amended, the registrant has duly caused this registration statement on Form S-1 to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Minneapolis, State of Minnesota on this 18th day of December 2017.January 22, 2024.

 

SUN BIOPHARMA,PANBELA THERAPEUTICS, INC.

By:

/s/ David B. Kaysen

Jennifer K. Simpson

Jennifer K. Simpson

David B. Kaysen

President and Chief Executive Officer

 

Power ofof Attorney

 

Pursuant to the requirements of the Securities Act of 1933, this registration statement has been signed by the following persons in the capacities and on the dates indicated.

 

Signature

Title

Date

     

/s/ David B. Kaysen Jennifer K. Simpson

 

President and Chief Executive Officer and Director

January 22, 2024

Jennifer K. Simpson

 

December 18, 2017(PrincipalExecutiveOfficer), and Director

David B. Kaysen

(principal executive officer)  
     

/s/ Scott Kellen Susan Horvath

 

Chief Financial Officer & Vice President of Finance, Chief Financial Officer, Treasurer

January 22, 2024

Susan Horvath

 

December 18, 2017

Scott Kellen

(principal financial and accounting officer)Secretary (PrincipalFinancialandAccountingOfficer)

  
     
*

*Chair of the Board and Director

 

Executive Chairman and Director

December 18, 2017

January 22, 2024

Michael T. Cullen

    
     
*

*Director

 

Director

December 18, 2017

January 22, 2024

Suzanne GagnonDaniel J. Donovan

    
     
*

*Director

 

Director

December 18, 2017

January 22, 2024

Dalvir S. GillArthur J. Fratamico

    
     
*

*Director

 January 22, 2024

DirectorJeffrey E. Jacob

 
*

December 18, 2017Director

January 22, 2024

Jeffrey S. Mathiesen

    
     
*

*Director

 

Director

December 18, 2017

J. Robert Paulson, Jr.

*

Director

December 18, 2017

Paul W. Schaffer

*

Director

December 18, 2017

January 22, 2024

D. Robert Schemel

    

 


*

David B. Kaysen, by signing his name hereto, does hereby sign this document on behalf of each of the above-named directors of the Registrant

* Jennifer K. Simpson, by signing her name hereto, does hereby sign this document on behalf of each of the above-named directors of the registrant pursuant to powers of attorney duly executed by such persons.

By:       

/s/ Jennifer K. Simpson
Jennifer K. Simpson

Attorney-in-Fact

 

By:

/s/ David B. Kaysen

David B. Kaysen

Attorney-in-Fact

II-7