As filed with the Securities and Exchange Commission on May 30, 2017September 25, 2020.

Registration No. 333 - 218062

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

333-

 


Amendment No. 1

to

Form S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933


Diffusion Pharmaceuticals Inc.

(Exact name of registrant as specified in its charter)


 

UNITED STATES

Delaware

2020 Avon Court, #4SECURITIES AND EXCHANGE COMMISSION

Charlottesville, VA 22902Washington, D.C. 20549

(434) 220-0718FORM S-3

REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933

 

30-0645032DIFFUSION PHARMACEUTICALS INC.

(Exact Name of Registrant as Specified in Its Charter)

Delaware

(State or Other Jurisdiction
of Incorporation)Incorporation or Organization)

(Address, including zip code, and telephone number, including area code, of30-0645032

registrant’s principal executive offices)

(I.R.S. Employer
Identification No.)Number)

1317 Carlton Avenue
Suite 200
Charlottesville, VA 22902

(434) 220-0718

 

(Address, Including Zip Code, and Telephone Number, Including Area Code,
of Registrant’s Principal Executive Offices)

Robert J. Cobuzzi, Jr.

President and Chief Executive Officer

Diffusion Pharmaceuticals Inc.

1317 Carlton Avenue
Suite 200
Charlottesville, VA 22902

(434) 220-0718

(Name, Address, Including Zip Code, and Telephone Number, Including Area Code,
of Agent for Service)

Copies to:

 


David G. Kalergis
Chief Executive Officer
2020 Avon Court, #4
Charlottesville, VA 22902
(434) 220-0718

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


With a Copy to:

David S. Rosenthal, Esq.

Dechert LLP

Three Bryant Park

1095 Avenue of the Americas

New York, New York 10036

(212) 698-3500

 


Approximate date of commencement of proposed sale to the public:public: From time to time after the effective date of this Registration Statement.registration statement becomes effective.


 

If the only securities being registered on this Formform are being offered pursuant to dividend or interest reinvestment plans, please check the following box.  ☐

 

If any of the securities being registered on this Formform are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, other than securities offered only in connection with dividend or interest reinvestment plans, check the following box.  

 

If this Formform 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 Formform 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 Formform is a registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective upon filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box.  ☐

 

If this Formform is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following box.  ☐

  

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 accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

 

Large Accelerated Filer accelerated filer

  

Accelerated Filer ☐filer

 

Non-Accelerated Filer

Non-accelerated filer

  

Smaller Reporting Company☒reporting company

Emerging Growth Company ☐

(Do

Emerging growth company

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


CALCULATION OF REGISTRATION FEE

Title of each Class of Securities to be Registered

Amount

to be

Registered (1)

Proposed
Maximum
Offering Price
Per unit (1)(2)

Proposed
Maximum
Aggregate
Offering Price (1)(3)

Amount of
Registration Fee (1)

Common Stock, $0.001 par value per share (4)

--

--

--

--

Preferred Stock, $0.001 par value per share (4)

--

--

--

--

Debt Securities (4)

--

--

--

--

Warrants (4)

--

--

--

--

Units (4)

--

--

--

--

Rights to purchase common stock, preferred stock, debt securities or units (4)

--

--

--

--

                TOTAL

$ 75,000,000.00

$  5,970.68 (5)

 

 

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 pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

CALCULATION OF REGISTRATION FEE

Title of Each Class of Securities to be Registered

 

Amount to be
Registered
(1)(3)

  

Proposed Maximum
Offering Price per

Security(2)

  

Proposed Maximum
Aggregate Offering

Price(2)

  

Amount of
Registration Fee

 

Common Stock, $0.001 par value per share

  26,467,801  $2.90  $76,756,622.90  $8,896.10(4)

 


 

(1)

PursuantNot specified as to Rule 416 under the Securities Acteach class of 1933, as amended (the “Securities Act”), the shares beingsecurities to be registered hereunder include such indeterminate number of shares of the Common Stock of the Company as may be issuable with respectpursuant to the shares being registered hereunder as may be issuable as a result of any stock dividend, stock split, recapitalization or other similar transaction.General Instruction II.D. to Form S-3.

 

(2)

The proposed maximum offering price per unit will be determined from time to time by the registrant in connection with the issuance by the registrant of the securities registered hereunder.

(3)

Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(c)457(o) of the Securities Act of 1933, as amended.

(4)

The securities being registered consist of such indeterminate number of shares of common stock and preferred stock, such indeterminate number of warrants, such indeterminate number of units, such indeterminate principal amount of debt securities, and such indeterminate number of rights to purchase common stock, preferred stock, debt securities and units as may be determined from time to time at indeterminate prices. The securities registered also include such indeterminate number of shares of common stock and preferred stock and such indeterminate principal amount of debt securities as may be issued upon conversion of or exchange for preferred stock or debt securities that provide for conversion or exchange, upon exercise of warrants or rights or pursuant to the anti-dilution provisions of any such securities. In no event will the aggregate maximum offering price of all securities issued pursuant to this registration statement exceed $75,000,000, or, if any debt securities are issued at an original issue discount, such greater amount as will result in an aggregate initial offering price of $75,000,000, less the aggregate dollar amount of all securities previously issued hereunder. Any securities registered hereunder may be sold separately or as units with other securities registered hereunder. No separate consideration will be received for any securities registered hereunder that are issued in exchange for, or upon conversion of, as the case may be, the shares of preferred stock, debt securities, warrants or rights.

(5)

On May 16, 2019, the registrant filed a shelf registration statement on Form S-3 (File No. 333-231541) (the “2019 Registration Statement”) to register securities with an aggregate maximum offering price of $50,000,000, and paid a $6,060.00 registration fee in connection therewith. Pursuant to Rule 415(a)(6) under the Securities Act. The offering price per share and aggregate offering price are based upon the averageAct, a portion of the high and low prices per share$6,060.00 registration fee previously paid in connection with the 2019 Registration Statement will continue to be applied to such unsold securities in this registration statement, so no registration fee is required to be paid with this registration statement with respect to those securities because they constitute unsold securities being moved from the 2019 Registration Statement to this registration statement. Accordingly, the amount of the Company’s common stock, $0.001 par value per share, as reported onregistration fee in the NASDAQ Capital Market, on May11, 2017, a date within five business days priorCalculation of Registration Fee table of $5,970.68 relates to the filingadditional aggregate principal amount of $45,999,030 of the registrant’s securities being registered hereunder. Pursuant to Rule 415(a)(6) under the Securities Act, the offering of unsold securities under the 2019 Registration Statement will be deemed terminated as of the date of effectiveness of this registration statement.

 

-2-

 

(3)

Includes (i) 12,376,329 shares issued or issuable upon conversion of the Company’s Series A Convertible Preferred Stock, (ii) 13,555,887 shares issued or issuable upon exercise of the Company’s warrants issued in connection with its private placement of Series A Convertible Preferred Stock and (iii) an estimated 535,585 shares issuable as payment of dividends accruing through October 1, 2017 with respect to the Company’s Series A Convertible Preferred Stock.

(4)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 Section 8(a) of the Securities Act of 1933, as amended, or until the Registration Statementthis registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to saidsuch Section 8(a), may determine.

 
-3-

 

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 these securities and is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.

The information in this prospectus is not complete and may be changed. The Selling Stockholders 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 these securities and is not soliciting an offer to buy or sell these securities in any jurisdiction where the offer or sale is not permitted.

 

SUBJECT TO COMPLETION, DATED MAY 30, 2017

Diffusion Pharmaceuticals Inc.



Common Stock
UpSubject to 26,467,801 Shares of Common Stock
Offered by the Selling StockholdersCompletion, Dated September
25, 2020

 

This prospectus relatesPROSPECTUS

$75,000,000


DIFFUSION PHARMACEUTICALS INC.

Common Stock
Preferred Stock

Debt Securities
Warrants
Units
Rights to the resalePurchase Common Stock, Preferred Stock, Debt Securities or other dispositionUnits


We may offer and sell from time to time by the selling stockholders identified herein (including, except as the context may otherwise require, their donees, pledgees, transferees or other successors-in-interest, the “Selling Stockholders”), of, subject to adjustment, up to26,467,801shares of theour common stock, $0.001 par value per share (the “Common Stock”), of Diffusion Pharmaceuticals Inc. (the “Company”). Of these shares, (a) 12,376,329 are issued and outstanding as a result of, or issuable upon, the conversion of the Company’s outstandingstock; shares of Series A convertibleour preferred stock, $0.001 par value per share (the “Series A Preferred Stock”), (b) 13,555,887 arestock; debt securities, which may be issued in one or more series and outstanding as a result of,which may be senior debt securities or issuable upon, the exercise ofsubordinated debt securities; warrants to purchase shares of Common Stock (the “Warrants”)our common stock, shares of our preferred stock or our debt securities; units that include any of the foregoing securities; and (c)rights to purchase shares of our common stock, shares of our preferred stock, our debt securities or units. We may sell any combination of these securities in one or more offerings with an estimated 535,585 are issuable as paymentaggregate initial offering price of dividends accruing through October 1, 2017up to $75,000,000.

This prospectus provides you with respect to the Series A Preferred Stock. The Selling Stockholders acquired alla general description of the securities covered bywe may offer. Each time we offer securities pursuant to this prospectus, we will provide a prospectus supplement containing specific terms of the particular offering together with this base prospectus. We may also authorize one or more free writing prospectuses to be provided to you in connection with a private placement transaction in which we sold the Series A Preferred Stock and Warrants to accredited investors in closings conducted on March 14, 2017 and March 31, 2017 (or, as applicable, a subsequent donation, pledge or transfer thereof). We are registering the resale or other disposition of the shares of Common Stock to satisfy registration rights we have granted to the Selling Stockholders.

Our registration of the shares of Common Stock covered by this prospectus does not mean that the Selling Stockholders will offer or sell any of the shares.these offerings. The Selling Stockholders(including their donees, pledgees, transferees or other successors-in-interest) may, from time to time, resell or otherwise dispose of any or all of the shares of Common Stock described in this prospectus on any stock exchange, market or trading facility on which the shares are traded or in private transactions. These sales may be at fixed or negotiated prices, and may be to or through underwriters, broker-dealers or agents, who may receive compensation in the form of discounts, concessions or commissions. The Selling Stockholders will pay all underwriting discounts, commissions and any similar expenses it incurs, if any, in connection with the sale of the shares of Common Stock, and any related legal expenses incurred by it. We have agreed to pay certain expenses in connection with this registration statement and to indemnify the Selling Stockholders against certain liabilities. None of our shares of Common Stock may be sold without delivery of the applicable prospectus supplement describing the method and terms of the offering of the Common Stock. See “Plan of Distribution” beginning on page 19 for more information regarding the manners in which Selling Stockholders may sell or dispose of the securities registered hereby.


We are not selling any shares of Common Stock under this prospectus and will not receive any of the proceeds from the sale of shares of Common Stock by the Selling Stockholders. To the extent Warrants are exercised for cash, if at all, we will receive the exercise price thereof.

You should read this prospectus, any applicable prospectus supplement and any related free writing prospectus may also add, update or change information contained in this base prospectus. You should carefully read this base prospectus, the accompanying prospectus supplement and any related free writing prospectus, as well as any documents incorporated by reference herein or therein before you invest.invest in any of our securities. This prospectus may not be used to consummate a sale of securities unless accompanied by the accompanying prospectus supplement.

 

Our Common Stockcommon stock is tradedlisted on the NASDAQ Capital Market under the symbol “DFFN.” On May 26, 2017,September 24, 2020, the last reported sale price of our Common Stockcommon stock was $2.72 per share.$0.01.

 

Investing in our Common Stocksecurities involves a number of significant risks. We strongly recommend that you read carefully the risks we describe in this base prospectus and in any accompanying prospectus supplement, as well as the risk factors that are incorporated by reference into this prospectus from our filings made with the Securities and Exchange Commission. See “Risk Factors” on page7 6 of this prospectus,base prospectus.

We may offer and sell securities to or through underwriting syndicates or dealers, through agents or directly to purchasers. The names of any underwriters, dealers or agents that participate in our most recent Annual Report on Form 10-K, anya sale or offer of our other filings with the Securities and Exchange Commission and in any applicable prospectus supplement. You should readsecurities pursuant to this prospectus, any applicable commissions or discounts, the price to the public of the securities offered or sold, and the net proceeds we expect to receive from such sale will, in each case, be stated in an accompanying prospectus supplement, andsupplement. In addition, the documents incorporated by reference herein and therein carefully before you make your investment decision.underwriters, if any, may over-allot a portion of the securities.

 

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of the Common Stock being offered herebythese securities or passed upon the accuracyadequacy or adequacyaccuracy of this prospectus. Any representation to the contrary is a criminal offense.

 


ThisThe date of this prospectus is                    dated _________, 2017, 2020

 

 
-2-

 

TABLE OF CONTENTS

Page

 

ABOUT THIS PROSPECTUS

1

MARKET AND INDUSTRY DATA

1

PROSPECTUS SUMMARY

2

THE OFFERING

6

RISK FACTORS

7

CAUTIONARY

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

8

8

USE OF PROCEEDS

10

9

THE SELLING STOCKHOLDERSDESCRIPTION OF CAPITAL STOCK

11

10

DESCRIPTION OF DEBT SECURITIES

14

DESCRIPTION OF WARRANTS

20

DESCRIPTION OF RIGHTS

22

DESCRIPTION OF UNITS

24

PLAN OF DISTRIBUTION

25

19

LEGAL MATTERS

27

EXPERTS

27

WHERE YOU CAN FIND MORE INFORMATION

27

22

LEGAL MATTERSINFORMATION INCORPORATED BY REFERENCE

24

EXPERTS

24

PART II   Information Not Required in Prospectus

25

27

 

 

 

ABOUT THIS PROSPECTUS 

 

This prospectus is a part of a registration statement on Form S-3 that we filed with the U.S. Securities and Exchange Commission, or the Commission, usingSEC, utilizing a “shelf” registration process. Under this shelf registration process, the Selling Stockholderswe may sell from time to time any combination of the securities described in this prospectus in one or more offerings up to a total dollar amount of $75,000,000. This prospectus only provides you with a general description of the securities we may offer. Each time we sell securities under this shelf registration, we will provide a prospectus supplement that will contain specific information about the Common Stock describedterms of that offering, including the specific amounts, prices and terms of the securities offered. We may also provide or authorize to be provided one or more free writing prospectuses that may contain material information relating to an offering. The prospectus supplement and any related free writing prospectus that we may provide or authorize to be provided may also add, update or change information contained in this base prospectus or in any documents that we have incorporated by reference into this prospectus. You should read this base prospectus, any accompanying prospectus supplement and any related free writing prospectus prepared by or on behalf of us, together with the additional information described under the heading, “Where You Can Find More Information” and “Information Incorporated by Reference.”

This prospectus may not be used to offer and sell securities unless accompanied by a prospectus supplement.

 

You should rely only on the information that we have provided in this prospectus, the related prospectus supplement, including any informationor incorporated by reference andin this base prospectus, any pricing supplement. No one is authorized to provide you with information different from that which is contained, or deemed to be contained, in the prospectus, the relatedaccompanying prospectus supplement and any pricing supplement. The Selling Stockholders arerelated free writing prospectus that we may provide or authorize to be provided to you. We have not making offersauthorized anyone to provide any information or to make any representation other than those contained or incorporated by reference in this base prospectus, any accompanying prospectus supplement, or any related free writing prospectus. You must not rely upon any information or representation not contained or incorporated by reference in this base prospectus, the accompanying prospectus supplement or related free writing 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 base prospectus, any accompanying prospectus supplement and any related free writing prospectus, if any, do not constitute an offer to sell Common Stockor the solicitation of an offer to buy any securities other than the registered securities to which they relate, nor do this base prospectus, any accompanying prospectus supplement or any related free writing prospectus constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction in which an offer or solicitation is not authorized or in which theto any person making such offer or solicitation is not qualified to do so or to anyone to whom it is unlawful to make ansuch offer or solicitation.solicitation in such jurisdiction.

The information in this base prospectus is accurate as of the date on the front cover. You should not assume that the information contained in this base prospectus, any accompanying prospectus supplement or any documentrelated free writing prospectus is accurate on any date subsequent to the date set forth on the front cover or that any information we have incorporated by reference herein is accurate as ofcorrect on any date other thansubsequent to the date of the document in whichincorporated by reference, even though this base prospectus, any accompanying prospectus supplement or any related free writing prospectus is delivered, or the information is contained or other date referred to in that document, regardless of the time of sale or issuance of the Common Stock.applicable securities are sold, on a later date. 

 

We may sell our securities to or through underwriters, initial purchasers, dealers, or agents, directly to purchasers or through a combination of any of these methods of sale, as designated from time to time. We and our agents, if any, reserve the sole right to accept or reject in whole or in part any proposed purchase of our securities. An accompanying prospectus supplement, which we will provide each time we offer the securities, will set forth the names of any underwriters, initial purchasers, dealers or agents involved in the sale of our securities, and any related fee, commission or discount arrangements. See “Plan of Distribution.”

When used in this prospectus, the terms “Diffusion,” “Diffusion Pharmaceuticals,” the “Company,” “we,” “our” and “us” refer to Diffusion Pharmaceuticals, Inc., unless otherwise specified or the context otherwise requires.

“Diffusion Pharmaceuticals,” the Diffusion logo and other trademarks, trade names or service marks of Diffusion appearing in this prospectus are the property of Diffusion Pharmaceuticals, Inc. Solely for convenience, the trademarks and trade names in this prospectus may be referred to without the ® and ™ symbols, but such references or the omission thereof should not be construed as any indicator that their respective owners will or will not assert their rights thereto.

MARKET AND INDUSTRY DATA 

Certain market and industry data included in this prospectus were obtained from independent third-party surveys, market research, publicly available information, reports of governmental agencies and industry publications and surveys. All of the market and industry data used in this prospectus involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. Although we are responsible for all of the disclosure contained in this prospectus and we believe the information from the industry publications and other third-party sources included in this prospectus is reliable, such information is inherently imprecise. The industry in which we operate is subject to a high degree of uncertainty, volatility, and risk due to a variety of factors, including those described in the section titled “Risk Factors.” These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties and by us.

1

PROSPECTUS SUMMARY

This summary highlights information contained in other parts of this prospectus or incorporated by reference into this prospectus from our filings with the Securities and Exchange Commission (the “SEC”). As it is only a summary, it does not contain all of the information included in the registration statement. For a more complete understanding of the offering of the Common Stock,that you should refer to the registration statement including the exhibits. This prospectus contains summaries of certain provisions contained in some of the documents described herein, but referenceconsider before purchasing our securities and it is made to the actual documents for complete information. All of the summaries are qualified in theirits entirety by, and should be read in conjunction with, the actual documents. Copies of some ofaccompanying prospectus supplement, any related free writing prospectus, and the documents referred to herein have been filed, will be filedmore detailed information appearing elsewhere or will be incorporated by reference as exhibits tointo this prospectus. You should read the entire base prospectus, any accompanying prospectus supplement, the registration statement of which this prospectus is a part, and you may obtain copies of those documents as described belowthe information incorporated by reference herein in their entirety, including the information contained under the heading “Where You Can Find Additional Information.” We further note that the representations, warranties and covenants made by us in any agreement that is filed as an exhibit to any document that is incorporated by reference in this prospectus were made solely for the benefit of the parties to such agreement, including in some cases, for the purpose of allocating risk among the parties to such agreements, and should not be deemed to be a representation, warranty or covenant to you. Moreover, such representations, warranties or covenants were accurate only as of the date when made. Accordingly, such representations, warranties and covenants should not be relied on as accurately representing the current state of our affairs.

Unless otherwise specified or unless the context requires otherwise, all references in this prospectus to “Diffusion,” the “Company,” “we,” “us,” “our” or similar references mean Diffusion Pharmaceuticals Inc. and its subsidiaries on a consolidated basis.

We have registered trademarks for RestorGenex and Diffusion. All other trade names, trademarks and service marks appearing in this prospectus are the property of their respective owners. Use or display by us of other parties’ trademarks, trade dress or products is not intended to and does not imply a relationship with, or endorsements or sponsorship of, us by the trademark or trade dress owner.


PROSPECTUS SUMMARY

The following is a summary of what we believe to be the most important aspects of our business and the offering of our common stock under this prospectus. This summary does not contain all of the information that should be considered before investing in our common stock. Investors should read the entire prospectus carefully, including the risks related to our business and purchasing our common stock discussed under “Risk Factors” beginning on page 7 of this prospectus, “Special Notes Regarding Forward Looking Statements” and our financial statements and the related notes to those financial statementscontained in and incorporated by reference ininto this prospectus.prospectus, before purchasing our securities.

 

Diffusion Pharmaceuticals Inc.

 

Business Overview

 

We are a clinical stage biotechnologyDiffusion Pharmaceuticals Inc. is an innovative biopharmaceutical company focused on extendingdeveloping novel therapies to improve the life expectancybody’s ability to deliver oxygen to the areas where it is needed most, offering new hope for the treatment of cancer patients by improving the effectiveness of current standard-of-care treatments, including radiation therapy and chemotherapy. We are developing ourlife-threatening medical conditions.

Our lead productdrug candidate,transcrocetinate sodium, also known astrans sodium crocetinate (“TSCTSC”), was originally developed in conjunction with the United States (“U.S.”), Office of Naval Research to treat multiple organ failure and its resulting mortality caused by low oxygen levels due to blood loss on the battlefield. Evolutions in research have led the Company to focus on addressing some of medicine’s most intractable and difficult-to-treat conditions involving cellular oxygen deficiency, or hypoxia, such as COVID-19, stroke, glioblastoma multiforme (“GBM”) brain cancer, and other conditions and diseases in which hypoxia is a critical factor which presents a significant obstacle for medical providers and is the target for TSC’s novel mechanism.

Using principles of physical chemistry, TSC was developed to increase the amount of hydrogen bonding among water molecules. The increased level of hydrogen bonding may increase the level of organization among the water molecules, creating a less dense matrix through which oxygen molecules can move more efficiently from areas of high to low oxygen concentrations. We believe this novel mechanism of action results in an enhancement of the rate of oxygen diffusion from the lungs onto red blood cells and then from red blood cells into body tissue where the oxygen is used to power the cells. This novel diffusion-enhancing mechanism has been observed to affect hypoxic tissue selectively, thus avoiding problems of tissue over-oxygenation and related oxygen toxicity.

COVID-19

We believe TSC’s oxygen-enhancing mechanism could potentially provide an important new treatment option for low oxygen levels and the associated risk of acute respiratory distress syndrome (“ARDS”) and multiple organ failure that can occur in COVID-19 patients.

An open-label Phase 1b lead-in trial of TSC in hospitalized COVID-19 patients was initiated in September 2020 at the Romanian National Institute of Infectious Diseases (“NIID”) to evaluate the safety and tolerability of TSC administered intravenously four-times daily in this patient population. In addition to evaluating safety and tolerability, we will collect preliminary data on TSC’s effects on blood oxygenation, which are sometimes referred to as pharmacodynamic effects, and on certain clinical endpoints related to COVID-19 disease status. Although the study is not powered to detect statistical differences in effect, we believe positive changes from baseline in pharmacodynamic and/or clinical efficacy data will support proof of concept for use of TSC in patients with COVID-19 who suffer from low oxygen level. The safety and tolerability of TSC will be evaluated in this trial at pre-set intervals by a Safety Monitoring Committee (“SMC”).

On September 10, 2020, we announced the first two patients were randomized and began dosing in the many cancer typesPhase 1b lead-in trial. With enrollment now in which tumor oxygen deprivation (“hypoxia”) is knownprogress, we currently expect topline data to diminishbe available in the effectivenessfourth quarter of current treatments.2020. If a safe, well-tolerated dose of TSC is designedidentified at which there is evidence of elevated oxygen levels and/or clinical effect, we will use these data to targetdetermine the cancer’s hypoxic micro-environment, re-oxygenatingappropriate dosing regimen to begin our planned, randomized, controlled Phase 2/3 clinical trial testing TSC in hospitalized COVID-19 patients to evaluate TSC’s effects on certain clinical endpoints.. We intend to incorporate feedback on the program and protocol design from regulatory authorities, including the U.S. Food and Drug Administration (“FDA”). Pending this feedback, we are planning to conduct the study in multiple sites in the U.S., the European Union (“E.U.”) and other non-E.U. Eastern European countries.

In July 2020, we filed an Investigational New Drug (“IND”) application with FDA in connection with the COVID-19 program, which incorporated pre-IND regulatory guidance from the FDA and certain European regulatory agencies. Based on subsequent communications with the FDA, the IND was withdrawn for administrative reasons. We do not anticipate that withdrawal of the IND will have a significant effect on our overall timeline for the program, and we intend to re-submit the IND after data from the Phase 1b study are available.

2

Cancer

Hypoxia is a critical factor in multiple conditions and the resistance of those conditions to treatment, including glioblastoma multiforme (“GBM”), stroke, infections, and other conditions with a significant unmet medical need. In addition to our ongoing COVID-19 program, we have evaluated TSC in preclinical and clinical studies of GBM, acute stroke, acute lung injury and peripheral artery disease (“PAD”).

In GBM, we believe TSC can be used to re-oxygenate treatment-resistant cancerous tissue, and making the cancer cells more susceptible to the therapeutic effects of standard-of-care radiation therapy and chemotherapy.

Our lead development programs target TSC against cancers known to be inherently treatment-resistant, including brain cancers and pancreatic cancer. A Phase 2 clinical program,study was completed in the second quarter of 2015 that evaluated 59 patients with newly diagnosed glioblastoma multiforme (“GBM,”). a particularly deadly form of brain cancer for which TSC has received an Orphan Drug Designation from the FDA. Each year GBM affects approximately 12,000 patients in the U.S. and approximately 35,000 patients worldwide. This open label,open-label, historically controlled study demonstrated a favorable safety and efficacy profile for TSC when combined with standard of care includingtreatment for GBM. Although not prospectively defined, a 37% improvement in overall survival over the control group at two years. A particularly strong efficacy signal was seen in thesubgroup analysis of inoperable patients where survivalsuggested a higher proportion of TSC-treated patients survived at two years was increased by 380% overcompared to those in the controls. At an End-Of-Phasehistorical control group.

Based upon data from the inoperable patient subgroup in the Phase 2 Meeting,study, we initiated the U.S. Food and Drug Administration provided Diffusion with extensive guidance on the design for aINvestigation of TSC Against Cancerous Tumors (“INTACT”) Phase 3 trial of TSC in the newly diagnosed inoperable GBM patients. We believe focusingpatient population in December 2017. The trial was designed to enroll 236 patients in total, with 118 in the treatment arm and 118 in the control arm. The trial began with an FDA-mandated open-label dose-escalation, safety run-in for which enrollment was completed and is now closed. A total of 19 patients were enrolled to ensure that at least 8 completed the FDA-specified 42-month exposure period. At a meeting in the third quarter of 2019, the INTACT Trial Data Safety Monitoring Board (“DSMB”) concluded, based on their analysis, that no adverse safety signal was present and unanimously recommended the inoperable patient groupstudy continue as planned using the highest tested dose of TSC (1.5 mg/kg) during the adjuvant treatment chemotherapy period with temozolomide. Commencement of enrollment in the randomization portion of the INTACT Phase 3 should reduceTrial has been suspended, as the needed number of patients from over 400Company reprioritizes its resources to around 230, which is expectedthe shorter duration COVID-19 studies designed to provide real cost savings, while the strengthdemonstrate TSC’s effectiveness. Restart and completion of the Phase 2 efficacy signal should makeINTACT GBM study is contingent upon the showingavailability of significant additional capital, which would need to be obtained through a financing event, strategic partnership or otherwise.

Stroke

Based upon preclinical safety and efficacy data, as well as certain clinical gainsafety data, we believe TSC also has potential applications in Phase 3 more likely. Assuming FDA sign-off on our final protocol design, focusing onboth ischemic and hemorrhagic stroke. Stroke is the inoperablefifth leading cause of death in the U.S. and the leading cause of adult disability. TSC may enhance the diffusion of oxygen into brain cells in which stroke-induced oxygen-deprivation causes neuronal death. The hypoxic conditions in the brain of stroke patients the study is plannedmay be a significant factor contributing to initiate by the end of 2017. Due to its novel mechanism of action, TSC has safely re-oxygenatedmorbidity and mortality. On October 17, 2019, we began enrolling patients in a range of tumor types in our preclinical and clinical studies. Diffusion believes its therapeutic potential is not limited to specific tumors, thereby making it potentially useful to improve standard-of-care treatments of other life-threatening cancers. Additional planned studies include arandomized Phase 2 trial in pancreatic cancer and a study in brain metastases, with a study initiation subject to receipt of additional funding or collaborative partnering. We also believe that TSC has potential application in other indications involving hypoxia, such as neurodegenerative diseases and emergency medicine. For example, our stroke program is now in advanced discussions with doctors from UCLA and the University of Virginia, with whom we have established a joint team dedicated to developing a program to test TSC in the treatment of stroke,acute ischemic or hemorrhagic stroke. This trial was planned to enroll 160 patients, with an80 in the TSC treatment arm and 80 in the control arm. Patients were to receive treatment while in the ambulance to ensure all eligible patients received treatment as soon as possible after the onset of clinical symptoms. However, the COVID-19 pandemic created logistical problems for the study, including with respect to in-ambulance treatment, and currently enrollment in this trial of TSC in stroke under consideration.is suspended as the Company reprioritizes its resources to the shorter duration COVID-19 studies designed to demonstrate TSC’s effectiveness.

DFN-529 (formerly RES-529)

 

In addition to the TSC, programs, we are exploring alternatives regarding how best to capitalize upon the legacy RestorGenexour product candidate RES-529,DFN-529 is a novel PI3K/Akt/mTOR pathway inhibitor which has completed two Phase I1 clinical trials for age-related macular degeneration and was previously in preclinical development in oncology, specifically for GBM. RES-529 has shown activity in both in vitro and in vivo glioblastoma animal models and has been demonstrated to be orally bioavailable and can crosscapable of crossing the blood brain barrier. We are currently exploring alternatives to best capitalize upon the value of DFN-529 and our related intellectual property, which may include out-licensing or other options.

 

Corporate

Corporation Information

 

We are a Delaware corporation that was incorporated in June 2015. Prior to June 2015, we were a Nevada corporation. We maintain our principal executive offices at 2020 Avon Court,1317 Carlton Avenue, Suite #4,200, Charlottesville, VA 22902. Our telephone number there is (434) 220-0718. The address of our website iswww.diffusionpharma.com. www.diffusionpharma.com. The information set forth on, or connected to, our website is expressly not incorporated by reference into, and does not constitute a part of, this prospectus.

We are a “smaller reporting company” as defined in Rule 12b-2 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and have elected to take advantage of certain of the scaled disclosure available for smaller reporting companies in this prospectus as well as our filings under the Exchange Act. 

 

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Summary of Private PlacementSecurities We May Offer

 

In March 2017, we conducted a private placement (the “Private Placement”), pursuant to which we issued 12,376,329We may offer shares of the Series A Preferred Stock, initially convertible into one shareour common stock and preferred stock, various series of Common Stock,debt securities, warrants and 5-year warrantsrights to purchase 12,376,329 shares of Common Stock at an exercise price equal to $2.22 per share (the “Investor Warrants”). The aggregate gross proceeds from the Private Placement were $25.0 million, prior to deducting placement agent fees and expenses payable by us. Maxim Merchant Capital, a division of Maxim Group LLC (“Maxim”), acted as our sole placement agent in the Private Placement. We issued to Maxim and its designees (who are included as Selling Stockholders) 5-year warrants, to purchase of 1,179,558 shares of Common Stock at an exercise price equal to $2.22 per share, with such warrants containing a cashless exercise provision (the “Maxim Warrants” and, together with the Investor Warrants, the “Warrants”). The securities were issued to accredited investors in reliance upon an exemption pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and the rules and regulations promulgated thereunder. Please see “Description of Capital Stock” for a description of our Common Stock, Series A Preferred Stock and Warrants.

As part of the Private Placement, we entered into registration rights agreements with the investors in the Private Placement and Maxim (the “Registration Rights Agreement”), pursuant to which we agreed to file a registration statement to register for resale the shares of common stock (i) issuedor preferred stock, debt securities or units, as well as units to purchase any of such securities, from time to time under this prospectus, together with any applicable prospectus supplement and outstanding asrelated free writing prospectus, at prices and on terms to be determined by market conditions at the time of offering. This base prospectus provides you with a resultgeneral description of the securities we may offer. Each time we offer a type or issuable upon,series of securities, we will provide a prospectus supplement that will describe the specific amounts, prices and other important terms of the securities, including, to the extent applicable:

designation or classification;

aggregate principal amount or aggregate offering price;

maturity, if applicable;

original issue discount, if any;

rates and times of payment of interest or dividends, if any;

redemption, conversion, exchange or sinking fund terms, if any;

conversion or exchange prices or rates, if any, and, if applicable, any provisions for changes to or adjustments in the conversion or exchange prices or rates and in the securities or other property receivable upon conversion or exchange;

ranking, if any;

restrictive covenants, if any;

voting or other rights, if any; and

important United States federal income tax considerations.

A prospectus supplement and any related free writing prospectus that we may provide or authorize to be provided to you may also add, update, or change information contained in this prospectus or in documents we have incorporated by reference. However, no prospectus supplement or free writing prospectus will offer a security that is not registered and described in this prospectus at the time of the shareseffectiveness of Series A Preferred Stock, (ii) issued and outstanding as a result of, or issuable upon, the exercise of the Warrants sold in the Private Placement and (iii) issuable as payment of dividends accruing on the Series A Preferred Stock. We are required to use our commercially reasonable best efforts to cause the registration statement to be declared effective under the Securities Act, as soon as practicable, but in no event later than 120 days after the final closing of the Private Placement, which occurred on March 31, 2017 (the “Final Closing”). We agreed to keep the registration statement effective until the earlier of (i) 66 months after the Final Closing or (ii) all registrable securities may be sold pursuant to Rule 144 under the Securities Act or another similar exemption under the Securities Act. We also agreed, among other things, to indemnify the investors under the registration statement from certain liabilities and to pay all fees and expenses incident to our performance of or compliance with the Registration Rights Agreement.this prospectus is a part

 

Series A Convertible Preferred Stock

Voting. The holdersWe may sell the securities directly to or through underwriters, dealers or agents. We, and our underwriters or agents, reserve the right to accept or reject all or part of the Series A Preferred Stockany proposed purchase of securities. If we do offer securities through underwriters or agents, we will be entitled to vote with the holders of Common Stock (and any other class or series that may similarly be entitled to vote with the holders of Common Stock as the Board may authorize and issue) and not as a separate class, at any annual or special meeting of stockholders of the Company, and may act by written consentinclude in the same manner as the holders of Common Stock. In the event of any such vote or action by written consent, each holder of shares of Series A Preferred Stock shall be entitled to that number of votes equal to the whole number of shares of Common Stock into which the aggregate number of shares of Series A Preferred Stock held of record by such holder are convertible as of the close of business on the record date fixed for such vote or such written consent based on a conversion price, solely for such purpose, equal to the closing price of our Common Stock on the date such Series A Preferred Stock was issued. In addition, for as long as 50% of the shares of Series A Preferred Stock outstanding immediately after the final closing remain outstanding, without the consent of holders of at least a majority of the then outstanding shares of Series A Preferred Stock, we may not (a) amend our amended and restated certificate of incorporation (the “Certificate of Incorporation”) and amended and restated bylaws (the “Bylaws”)so as to materially and adversely affect any rights of the holders of the Series A Preferred Stock, (b) increase or decrease (other than by conversion of the Series A Preferred Stock) the authorized number of Series A Preferred Stock to be in excess of the number of shares required to satisfy the maximum offering amount of the Private Placement, (c) amend the Certificate of Designation of Preferences, Rights and Limitations of the Series A Convertible Preferred Stock of Diffusion Pharmaceuticals Inc. (the “Certificate of Designation”), (d) repay, repurchase or offer to repay, repurchase or otherwise acquire more than ade minimis number of shares of Common Stock or Common Stock equivalents or (e) enter into any agreement or understanding with respect to (a) through (d).

Dividends. The Series A Preferred Stock will be entitled to an 8.0% cumulative preferred dividend payable semi-annually in shares of Common Stock that will begin accruing on the issue date of the Series A Preferred Stock. The dividend will begin to accrue and be cumulative on the first day of each applicable dividend period and shall remain accumulated dividends with respect to such Series A Preferred Stock until paid; provided, that the first dividend payable with respect to any share of Series A Preferred Stock shall not begin to accrue until the date of original issuance of such share of Series A Preferred Stock. Dividends shall accrue whether or not there are profits, surplus or other funds of the Company legally available for the payment of dividends but shall not be payable until legally permissible, as applicable.prospectus supplement:

 

the names of those underwriters or agents;

applicable fees, discounts and commissions to be paid to them;

details regarding over-allotment options or refreshable options, if any; and

the net proceeds to us.

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Liquidation. The Series A Preferred Stock will rank senior to the Common Stock and each other class of capital stock of the Company or series of Series A Preferred Stock of the Company authorized by the Board in the future that does not expressly provide that such class or series ranks senior to, or on parity with, the Series A Preferred Stock (“Junior Securities”). In the event of a Liquidation Event (as defined in the Certificate of Designation), the holders of the Series A Preferred Stock shall be entitled to receive, out of the assets of the Company or proceeds thereof legally available therefor, an amount in cash equal to 100% of the stated value of the Series A Preferred Stock before any payment or distribution of the assets of the Company is made or set apart for the holders of Junior Securities. In addition, prior to such Liquidation Event, the holders of Series A Preferred Stock shall be entitled to notice so that they

We may exercise their conversion rights prior to such event. If, upon the occurrence of any Liquidation Event, the assets of the Company, or proceeds thereof, distributable after payment in fulloffer shares of our creditors and any securities senior to the Series A Preferred Stock shall be insufficient to pay in full the aggregate amount of 100% of the statedcommon stock, par value to the holders of the Series A Preferred Stock, the assets of the Company, or the proceeds thereof, shall be distributed ratably among the holders of any Series A Preferred Stock and the holders of any security ranked equally with the Series A Preferred Stock.

Conversion Rate: Each share of Series A Preferred Stock is convertible into a share of Common Stock at a conversion price equal to the $2.02, subject to adjustment as provided in the Certificate of Designation and summarized herein (the “Conversion Price”), at any time after the final closing date at the holder’s sole and absolute discretion. Holders may immediately convert their Series A Preferred Stock prior to the occurrence of certain Liquidation Events. Each share of Series A Preferred Stock will automatically convert, initially, into a share of Common Stock (a) on any date that is more than thirty (30) trading days after the original issued date of such share Series A Preferred Stock that the 30 day moving average of the closing price of the Common Stock on the NASDAQ Capital Market (or any other exchange where the Common Stock is traded) exceeds $8.00$0.001 per share, (subject to adjustment in the event of a stock dividendeither alone or split), (b) upon a financing of at least $10 million or (c) upon the majority vote of the voting power of the then outstanding shares of Series A Preferred Stock. We are not required to issue any fractional shares of Series A Preferred Stock or Common Stock in connection with the conversion of Series A Preferred Stock and may, in each case, at our discretion, pay the holder such amount in cash or deliver an additional whole share in lieu thereof.

Limitations of Conversion: The number of shares of Common Stock issuable upon a conversion of the Series A Preferred Stock that may be acquired by a holder shall be limited to the extent necessary to ensure that, following such conversion (orunderlying other issuance), the total number of shares of Common Stock then beneficially owned by such holder and its affiliates and any other persons whose beneficial ownership of Common Stock would be aggregated with the Holder's for purposes of Section 13(d) of the Exchange Act, does not exceed 4.99% of the total number of issued and outstanding shares of Common Stock (including for such purpose the shares of Common Stock issuable upon such conversion). However, any holder may increase or decrease such percentage to any other percentage not in excess of 9.99% of the total number of shares of Common Stock then issued and outstanding provided that such increase in percentage shall not be effective until sixty-one (61) days after notice to the Company.

Dilution Protection. In the event we, at any time after the first date of issue of the Series A Preferred Stock and while at least one share of Series A Preferred Stock is outstanding: (a) pay a dividend or otherwise make a distribution or distributions on shares of its Common Stock or any other equity or equity equivalent securities payable in shares of Common Stock (which, for avoidance of doubt, shall not include any shares of Common Stock issued by the Company upon conversion of the Series A Preferred Stock or any debt securities), (b) subdivide outstanding shares of Common Stock into a larger number of shares, (c) combine (including by way of reverse stock split) outstanding shares of Common Stock into a smaller number of shares or (d) issue by reclassification of shares of Common Stock any shares of capital stock of the Company, then in each case the conversion price shall be multiplied by a fraction of which (x) the numerator shall be the number of shares of Common Stock (excluding treasury shares, if any) outstanding immediately before such event and (y) the denominator shall be the number of shares of Common Stock outstanding immediately after such event. Any adjustment made pursuant to this section shall become effective immediately after the effective date of the applicable event described in subsections (a) through (d) above.

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Make-Whole Adjustment. In the event we, during the three years immediately following the Initial Closing, subject to certain exceptions, issue in an offering at least $10 million of Common Stock orregistered securities convertible into or exercisable for Common Stock at a per share price less than $2.02 (the “Make-Whole Price”), we will be requiredour common stock. Holders of our common stock are entitled to issuedividends as our board of directors may declare from time to time out of legally available funds, subject to the preferential rights of the holders of Series A Preferred Stock a number ofany shares of our preferred stock that we may issue in the future. Currently, we do not pay any dividends and we do not have any issued and outstanding preferred stock. Each holder of our common stock is entitled to one vote per share. In this prospectus, we provide a general description of, among other things, our dividend policy and the rights and restrictions that apply to holders of our common stock. Our common stock is described in greater detail in this prospectus under “Description of Capital Stock—Common Stock.”

Preferred Stock equal

We may issue shares of preferred stock in one or more classes or series. Our board of directors or a committee designated by our board of directors will determine the dividend, voting and conversion rights and other provisions at the time of sale. The particular terms of each class or series of preferred stock, including redemption privileges, liquidation preferences, voting rights, dividend rights and/or conversion rights, will be more fully described in the accompanying prospectus supplement relating to the additional numberpreferred stock offered thereby. Our preferred stock is described in greater detail in this prospectus under “Description of sharesCapital Stock—Preferred Stock.”

Debt Securities

We may offer debt securities from time to time, in one or more series, as either senior or subordinated debt or as senior or subordinated convertible debt. The senior debt securities will rank equally with any other unsubordinated debt that we may have and may be secured or unsecured. The subordinated debt securities will be subordinate and junior in right of Common Stockpayment, to the extent and in the manner described in the instrument governing the debt, to all or some portion of our indebtedness. Any convertible debt securities that such shares of Series A Preferred Stock wouldwe issue will be convertible into ifor exchangeable for our common stock or other securities of ours. Conversion may be mandatory or at the holder’s option and would be at prescribed conversion pricerates.

The debt securities will be issued under one or more documents called indentures, which are contracts between us and a trustee for the holders of the Series A Preferred Stock was equal to 105%debt securities. In this prospectus, we have summarized certain general features of the Make-Whole Price (the “Make-Whole Adjustmentdebt securities under “Description of Debt Securities.). We are only obligatedurge you, however, to issue sharesread the prospectus supplements and any free writing prospectus that we may provide or authorize to be provided to you related to the series of debt securities being offered, as well as the complete indentures that contain the terms of the debt securities. A form of an indenture has been filed as an exhibit to the registration statement of which this prospectus is a part, and supplemental indentures and forms of debt securities containing the terms of debt securities being offered will be incorporated by reference into the registration statement of which this prospectus is a part from reports we file with respect to a Make-Whole Adjustment in the first such subsequent offering, if any, following the Private Placement.SEC. 

 

Warrants Issued in the Private Placement

 

AsWe may from time to time offer warrants for the purchase of May 5, 2017 there were 13,555,887 Warrantsour common stock, preferred stock and/or debt securities in one or more series. We may issue warrants independently or together with common stock, preferred stock and/or debt securities, and the warrants may be attached to or separate from those securities.

The warrants will be evidenced by warrant certificates issued under one or more warrant agreements, which are contracts between us and outstanding. The Warrantsan agent for the holders of the warrants. In this prospectus, we have an exercise price $2.22 per share, are immediately exercisablesummarized certain general features of the warrants under “Description of Warrants.” We urge you, however, to read the prospectus supplements and are subjectany free writing prospectus that we may provide or authorize to customary anti-dilution adjustments. The Warrants are exercisable until March 31, 2022. The Warrants are subjectbe provided to a provision prohibiting the exercise of such Warrantsyou related to the extentseries of warrants being offered, as well as the complete warrant agreements and warrant certificates that after giving effectcontain the terms of the warrants. Specific warrant agreements will contain additional important terms and provisions and will be incorporated by reference as an exhibit to such exercise, the holderregistration statement which includes this prospectus.

Rights

We may from time to time issue rights to purchase shares of such Warrant (togetherour common stock or preferred stock, debt securities or units. The rights may be issued independently or together with other securities and may or may not be transferable by the holder’s affiliates, andpersons purchasing or receiving the rights. In connection with any rights offering, we may enter into a standby underwriting or other arrangement with one or more underwriters or other persons acting aspursuant to which such underwriters or other persons would purchase any offered securities remaining unsubscribed for after such rights offering. In connection with a group together withrights offering to our stockholders, we would make available a prospectus supplement to our stockholders on or about the holder or any of the holder’s affiliates), would beneficially ownrecord date that we set for receiving rights in excess of 19.99% of the outstanding Common Stock. In addition, the Maxim Warrants contain a cashless exercise provision.such rights offering.

 

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THE OFFERINGIn this prospectus, we have summarized certain general features of the rights under “Description of Rights.” We urge you, however, to read the prospectus supplements and any free writing prospectus that we may provide or authorize to be provided to you related to the series of rights being offered. 

 

Selling Stockholders

Units

We may offer units consisting of common stock, preferred stock, debt securities and/or warrants to purchase any of such securities in one or more series. In this prospectus, we have summarized certain general features of the units under “Description of Units.” We urge you, however, to read the prospectus supplements and any free writing prospectus that we may provide or authorize to be provided to you related to the series of units being offered, as well as the unit agreements that contain the terms of the units. We will file as exhibits to the registration statement of which this prospectus is a part, or will incorporate by reference from a current report on Form 8-K that we file with the SEC, the form of unit agreement and any supplemental agreements that describe the terms of the series of units we are offering before the issuance of the related series of units.

We will evidence each series of units by unit certificates that we will issue under a separate agreement. We will enter into the unit agreements with a unit agent. Each unit agent will be a bank or trust company that we select. We will indicate the name and address of the unit agent in the accompanying prospectus supplement relating to a particular series of units.

Accredited investors who purchased shares of Series A Preferred Stock and Warrants the Private Placement conducted in March 2017, the placement agent for the Private Placement, Maxim, and its designees, and their respective donees, pledges, transferees and other successors-in-interest.

Common Stock offered by

the Selling Stockholders

Subject to adjustment, up to 26,467,801 shares of Common Stock, which includes (a) 12,376,329 shares issued and outstanding as a result of, or issuable upon, the conversion of the Series A Preferred Stock, (b) 13,555,887 shares issued and outstanding as a result of, or issuable upon, the exercise of the Warrants and (c) an estimated 535,585 issuable as payment of dividends accruing through October 1, 2017 with respect to the Series A Preferred Stock.

Use of proceeds

We are not selling any shares of Common Stock under this prospectus and will not receive any of the proceeds from the sale of shares of Common Stock by the Selling Stockholders. To the extent Warrants are exercised for cash, we will receive the exercise price thereof.

Risk factors

Investing in our Common Stock involves a high degree of risk. See “Risk Factors” beginning on page 7 of this prospectus, and any other risk factors described in the documents incorporated by reference in this prospectus or in any accompanying prospectus supplement, for a discussion of factors that you should carefully consider before deciding to invest in our Common Stock.

NASDAQ Capital Market symbol

DFFN

 

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RISK FACTORS

 

Investing in our Common Stocksecurities involves a high degree of risk. Prior to making anya decision to investabout investing in our securities, you should consider carefully considerall of the information containedincluded and incorporated by reference or deemed to be incorporated by reference in this base prospectus or the applicable prospectus supplement, including the risk factors below and the risk factors incorporated by reference herein from our Annual Report on Form 10-K for the year ended December 31, 2019, as updated by annual, quarterly and other reports and documents we file with the SEC after the date of this prospectus and that are incorporated by reference herein, or in the applicable prospectus supplement. Each of these risk factors could have a material and adverse effect on our business, results of operations, financial position, or cash flows, which may result in the loss of all or part of your investment.

The Bylaws of the Company include a forum selection clause, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, employees, or agents.

Our Bylaws, as amended (the “Bylaws”), require that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware shall be the sole and exclusive forum for (i) any derivative action or proceeding brought on our behalf, (ii) any action asserting a claim for breach of a fiduciary duty owed by any of our directors, officers, employees or agents to us or our stockholders, (iii) any action asserting a claim arising pursuant to any provision of the Delaware General Corporation Law, our Certificate of Incorporation or our Bylaws or (iv) any action asserting a claim governed by the internal affairs doctrine, in each case subject to said Court of Chancery having personal jurisdiction over the indispensable parties named as defendants therein.

This exclusive forum provision will not apply to claims under the Exchange Act, but will apply to other state and federal law claims including actions arising under the Securities Act (although our stockholders will not be deemed to have waived our compliance with the federal securities laws and the rules and regulations thereunder). Section 22 of the Securities Act, however, creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder. Accordingly, there is uncertainty as to whether a court would enforce such a forum selection provision as written in connection with claims arising under the Securities Act. Any person or entity purchasing or otherwise acquiring any interest in shares of our capital stock is deemed to have notice of and consented to the foregoing provisions. This forum selection provision in our Bylaws may limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, employees, or agents, which may discourage lawsuits against us and such persons. It is also possible that, notwithstanding the forum selection clause included in our Bylaws, a court could rule that such a provision is inapplicable or unenforceable.

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus and the other information and documents incorporated by reference herein include forward-looking statements. We may, in some cases, use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements appear in and are incorporated by reference into a number of places throughout this prospectus and include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, our intellectual property position, the degree of clinical utility of our products, particularly in specific patient populations, expectations regarding clinical trial data, our ability to commercialize our product candidates, our results of operations, cash needs, financial condition, liquidity, prospects, growth and strategies, the industry in which we operate and the trends that may affect the industry or us.

By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics and industry change, and depend on the economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. Although we believe that we have a reasonable basis for each forward-looking statement contained in or incorporated by reference into this prospectus, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in and incorporated by reference into this prospectus. In addition, even if our results of operations, financial condition and liquidity, and the development of the industry in which we operate are consistent with the forward-looking statements contained in and incorporated by reference into this prospectus, they may not be predictive of results or developments in future periods.

Actual results could differ materially from our forward-looking statements due to a number of factors, including risks related to:

our ability to obtain additional financing;

our estimates regarding expenses, capital requirements and needs for additional financing;

the success and timing of our preclinical studies and clinical trials;

the difficulties in obtaining and maintaining regulatory approval of our products and product candidates, and the labeling under any approval we may obtain;

our plans and ability to develop and commercialize our product candidates;

our failure to recruit or retain key scientific or management personnel or to retain our executive officers;

the accuracy of our estimates of the size and characteristics of the potential markets for our product candidates and our ability to serve those markets;

regulatory developments in the United States and foreign countries;

the rate and degree of market acceptance of any of our product candidates;

obtaining and maintaining intellectual property protection for our product candidates and our proprietary technology;

our ability to operate our business without infringing the intellectual property rights of others;

recently enacted and future legislation regarding the healthcare system;

our ability to satisfy the continued listing requirements of the Nasdaq Capital Market or any other exchange that our securities may trade on in the future;

our ability to continue as a going concern;

the success of competing products that are or may become available; and

the performance of third parties, including contract research organizations and manufacturers.

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You should also read carefully the factors described in the “Risk Factors” section contained in this prospectus, any accompanying prospectus supplement including, without limitation,and any related free writing prospectus, and incorporated by reference herein from our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as updated by annual, quarterly and other reports and documents we file with the SEC after the date of this prospectus and that are incorporated by reference herein to better understand the risks describedand uncertainties inherent in our business and underlying any forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements contained in or incorporated by reference into this prospectus will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all.

Any forward-looking statements that we make in or incorporate by reference into this prospectus speak only as of the date of such statement, and, except as required by applicable law, we undertake no obligation to update such statements to reflect events or circumstances after the date of this prospectus or to reflect the occurrence of unanticipated events. Comparisons of results for current and any prior periods are not intended to express any future trends or indications of future performance, unless expressed as such, and should only be viewed as historical data.

For all forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

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 USE OF PROCEEDS 

Unless otherwise indicated in any applicable prospectus supplement and in any free writing prospectuses in connection with a specific offering, we currently intend to use the net proceeds from the sale of securities offered hereby, if any, to fund research and development of our lead product candidate, TSC, including clinical trial activities, and for general corporate purposes. See “Risk Factors” in this prospectus and in our Annual Report on Form 10-K for the fiscal year ended December 31, 2016,2019, which is incorporated by reference herein, as updated by annual, quarterly and other reports and documents we file with the SEC after the date of this prospectus and that are incorporated by reference herein, for a discussion of certain risks that may affect our intended use of the net proceeds from the sale of securities offered hereby, including that we will need to raise additional capital in the future to complete the development of TSC and our other product candidates. Pending these uses, we intend to invest the net proceeds of any offering under this prospectus in short-term, investment-grade, interest-bearing securities, or certificates of deposit.

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DESCRIPTION OF CAPITAL STOCK

Company Capitalization

Our authorized capital stock consists of 1,000,000,000 shares of common stock and 30,000,000 shares of preferred stock, $0.001 par value, all of which remains undesignated. The following summary is qualified in its entirety by reference to our Certificate of Incorporation, as amended, a copy of which is filed as an exhibit to our previous filings with the SEC and incorporated herein by reference,reference.

Common Stock

Authorized. We are authorized to issue 1,000,000,000 shares of common stock, of which 63,998,298 shares were issued and outstanding as of August 5, 2020. We may amend from time to time our Certificate of Incorporation to increase the risk factors describednumber of authorized shares of common stock. Any such amendment would require the approval of the holders of a majority of the voting power of the shares entitled to vote thereon.

Voting Rights. For all matters submitted to a vote of stockholders, each holder of common stock is entitled to one vote for each share registered in the holder’s name on our books. Our common stock does not have cumulative voting rights. At all meetings of the stockholders, except where otherwise provided by law, the Certificate of Incorporation or Bylaws, the presence, in person or by proxy duly authorized, of the holders of a majority of the outstanding shares of common stock entitled to vote constitutes a quorum for the transaction of business. Except as otherwise provided by law or by the Certificate of Incorporation or Bylaws, in all matters other than the election of directors, the affirmative vote of the majority of shares of common stock present in person or represented by proxy at the meeting and entitled to vote generally on the subject matter shall be the act of the stockholders. Except as otherwise provided by law, the Certificate of Incorporation or Bylaws, directors are elected by a plurality of the votes of the shares of common stock present in person or represented by proxy at the meeting and entitled to vote generally on the election of directors.

Dividends. Subject to limitations under Delaware law and any preferences that may be applicable to any then outstanding preferred stock, holders of common stock are entitled to receive ratably those dividends, if any, as may be declared by our Board out of legally available funds.

Liquidation. Upon our liquidation, dissolution or winding up, the holders of common stock will be entitled to share ratably in the net assets legally available for distribution to stockholders after the payment of all of our debts and other liabilities of our company, subject to any prior rights of any preferred stock then outstanding.

Fully Paid and Non-assessable. All shares of our outstanding common stock are fully paid and non-assessable and any additional shares of common stock that we issue will be fully paid and non-assessable.

Other Rights and Restrictions. Holders of common stock do not have preemptive or subscription rights, and they have no right to convert their common stock into any other securities. There are no redemption or sinking fund provisions applicable to common stock. The rights, preferences and privileges of common stockholders are subject to the rights of the stockholders of any series of preferred stock which we may designate in the future. Our Certificate of Incorporation and Bylaws do not restrict the ability of a holder of common stock to transfer the holder’s shares of common stock.

Listing. Our common stock is quoted on the Nasdaq Capital Market under the caption “Risk Factors”symbol “DFFN.” As of March 10, 2020, there were 480 record holders of our common stock.

Transfer Agent and Registrar. The transfer agent and registrar for common stock is Computershare Investor Services, LLC, 250 Royall Street, Canton, Massachusetts, telephone number: 1-800-942-5909.

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Preferred Stock

As of September 25, 2020, no shares of preferred stock of the Company were issued or outstanding. Our Certificate of Incorporation authorizes our board of directors to provide for the issuance of up to 30,000,000 shares of preferred stock in one or more series. Our board is authorized to classify or reclassify any unissued portion of our authorized shares of preferred stock to provide for the issuance of shares of other classes or series, including preferred stock in one or more series. We may issue preferred stock from time to time in one or more classes or series, with the exact terms of each class or series established by our board. Without seeking stockholder approval, our board may issue preferred stock with voting and other rights that could adversely affect the voting power of the holders of our common stock. Additionally, the issuance of preferred stock may have the effect of decreasing the market price of the common stock.

The rights, preferences, privileges and restrictions of the preferred stock of each series will be fixed by the certificate of designation relating to each series. A prospectus supplement relating to each series will specify the terms of the preferred stock, including, but not limited to:

the distinctive designation and the maximum number of shares in the series;

the terms on which dividends, if any, will be paid;

the voting rights, if any, on the shares of the series;

the terms and conditions, if any, on which the shares of the series shall be convertible into, or exchangeable for, shares of any other class or classes of capital stock;

the terms on which the shares may be redeemed, if at all;

the liquidation preference, if any; and

any or all other preferences, rights, restrictions, including restrictions on transferability, and qualifications of shares of the series.

The issuance of preferred stock may delay, deter or prevent a change in control.

We will describe the specific terms of a particular series of preferred stock in the prospectus supplement relating to that series. The description of preferred stock above and the description of the terms of a particular series of preferred stock in the prospectus supplement are not complete. You should refer to the applicable certificate of designation for complete information. The prospectus supplement will contain a description of U.S. federal income tax consequences relating to the preferred stock.

Anti-Takeover Provisions

Delaware Anti-Takeover Law

We are subject to Section 203 of the DGCL. Section 203 generally prohibits a public Delaware corporation from engaging in a “business combination” with an “interested stockholder” for a period of three years after the date of the transaction in which the person became an interested stockholder, unless:

prior to the date of the transaction, the board of directors of the corporation approved either the business combination or the transaction that 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 number of shares outstanding (a) shares owned by persons who are directors and also officers of the corporation and (b) shares issued under employee stock plans under which employee participants do not have the right to determine whether shares held subject to the plan will be tendered in a tender or exchange offer; or

on or subsequent to the date of the transaction, the business combination is approved by the board and authorized at an annual or special meeting of stockholders, and not by written consent, by the affirmative vote of at least 66 2⁄3% of the outstanding voting stock that is not owned by the interested stockholder.

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Section 203 defines a business combination to include:

any merger or consolidation involving the corporation and the interested stockholder;

any sale, transfer, pledge or other disposition involving the interested stockholder of 10% or more of the assets of the corporation;

subject to exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder;

any transaction involving the corporation that has the effect of increasing the proportionate share of its stock owned by the interested stockholder; or

the receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits provided by or through the corporation.

In general, Section 203 defines an interested stockholder as any entity or person beneficially owning 15% or more of the outstanding voting stock of the corporation and any entity or person affiliated with or controlling or controlled by the entity or person.

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DESCRIPTION OF DEBT SECURITIES

The following description, together with the additional information we include in any applicable prospectus supplementsupplements or free writing prospectuses, summarizes the material terms and any risk factors set forth in our other filings with the Commission, pursuant to Sections 13(a), 13(c), 14, or 15(d)provisions of the Securities Exchange Act of 1934,debt securities that we may offer under this prospectus. We may issue debt securities, in one or more series, as amended,either senior or subordinated debt or as senior or subordinated convertible debt. While the Exchange Act, before making an investment decision. The occurrenceterms we have summarized below will apply generally to any future debt securities we may offer under this prospectus, we will describe the particular terms of any of these risks might cause you to lose all or a part of your investmentdebt securities that we may offer in more detail in the offered securities. See “Where You Can Find More Information.”

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus, any applicable prospectus supplement and the documents incorporated by reference herein contain forward-looking statements within the meaning of Section 21E of the Exchange Act and Section 27A of the Securities Act, and are subject to the safe harbor created by those sections. We have identified some of these forward-looking statements with words like “believe,” “may,” “could,” “would,” “might,” “possible,” “potential,” “will,” “should,” “expect,” “intend,” “plan,” “predict,” “anticipate,” “estimate” and “continue”, the negative of these words, other words andor free writing prospectus. The terms of similar meaning and the use of future dates. Forward-looking statements involve risks and uncertainties. These uncertainties include factors that affect all businesses as well as matters specific to us. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause our actual results to be materially different than those expressed in or implied by our forward-looking statements. For us, particular uncertainties and risks include, among others, our history of operating losses and negative cash flow, uncertainties regarding clinical testing, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance and other risks and uncertainties described in our filings with the Commission, including:

our estimates regarding expenses, future revenues, capital requirements and needs for additional financing;

our ability to continue asany debt securities we offer under a going concern;

the success and timing of our preclinical studies and clinical trials;

the difficulties in obtaining and maintaining regulatory approval of our products and product candidates, and the labeling under any approval we may obtain;

our plans and ability to develop and commercialize our product candidates;

our failure to recruit or retain key scientific or management personnel or to retain our executive officers;

the accuracy of our estimates of the size and characteristics of the potential markets for our product candidates and our ability to serve those markets;

regulatory developments in the United States and foreign countries;

the rate and degree of market acceptance of any of our product candidates;

our ability to obtain additional financing;

obtaining and maintaining intellectual property protection for our product candidates and our proprietary technology;

our ability to operate our business without infringing the intellectual property rights of others;

recently enacted and future legislation regarding the healthcare system;

the success of competing products that are or become available; and

the performance of third parties, including contract research organizations and manufacturers.

All forward-looking statements in this prospectus, any applicable prospectus supplement andmay differ from the documents incorporated by reference herein speak only asterms we describe below. As of the date of this prospectus, orwe have no outstanding registered debt securities. Unless the context requires otherwise, whenever we refer to the “indenture,” we also are referring to any applicable prospectus supplement and are based on our current beliefs and expectations. We undertake no obligation to update or revise any forward-looking statement, whether assupplemental indentures that specify the terms of a resultparticular series of new information, future events or otherwise, except as otherwise required by law.

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USE OF PROCEEDSdebt securities.

 

We may offer senior debt securities or subordinated debt securities under the indenture and any supplemental indentures that we will receive no proceeds fromenter into with the saletrustee named in the indenture. We have filed a form of the Common Stock by the Selling Stockholders. To the extent Warrants are exercised for cash, we will receive the exercise price thereof.

The Selling Stockholders will pay any underwriting discounts and commissions and any similar expenses they incur in disposing of the Common Stock, if any, and any related legal expenses incurred by them. We will bear all other costs, fees and expenses incurred in effecting the registration of the Common Stock covered by this prospectus, including all registration and filing fees, fees and expenses of compliance with securities or “blue sky” laws, listing application fees, printing expenses, transfer agent’s and registrar’s fees, costs of distributing prospectuses in preliminary and final formindenture as well as any supplements thereto, and fees and disbursements of counsel for the Company and all independent certified public accountants and other persons retained by the Company.

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THE SELLING STOCKHOLDERS

This prospectus relatesan exhibit to the resale or other disposition from time to time by the Selling Stockholders identified herein (including their donees, pledgees, transferees or other successors-in-interest) of, subject to adjustment, up to26,467,801shares of Common Stock. Of these shares, (a) 12,376,329 are issued and outstanding as a result of, or issuable upon, the conversion of the Series A Preferred Stock, (b) 13,555,887 are issued and outstanding as a result of, or issuable upon, the exercise of the Warrants (including the Maxim Warrants) and (c) an estimated 535,585 are issuable as payment of dividends accruing through October 1, 2017 with respect to the Series A Preferred Stock. We entered into subscription agreements on March 14, 2017 and March 31, 2017 for the sale of an aggregate of 12,376,329 shares of the Series A Preferred Stock for aggregate gross proceeds of approximately $25.0 million in the Private Placement to the investors therein. In addition, each such investor received a Warrant to purchase one share of Common Stock for each share of Series A Preferred Stock purchased by such investor in the Private Placement. In connection with the Private Placement, we entered into the Registration Rights Agreement with such investors. The filing of the registration statement, of which this prospectus is a part, and supplemental indentures and forms of debt securities containing the terms of the debt securities being offered will be filed as exhibits to the registration statement of which this prospectus is a part or will be incorporated by reference from reports that we file with the SEC.

The indenture will be qualified under the Trust Indenture Act of 1939, as amended (the “Trust Indenture Act”).

The following summaries of material provisions of the indenture are subject to, and qualified in their entirety by reference to, all of the provisions of the indenture and any supplemental indentures applicable to a particular series of debt securities. We urge you to read the applicable prospectus supplements and any related free writing prospectuses related to the debt securities that we may offer under this prospectus, as well as the complete indenture that contains the terms of the debt securities.

General

The terms of each series of debt securities will be established by or pursuant to a resolution of our board of directors and set forth or determined in the manner provided in an officer’s certificate or by a supplemental indenture. Debt securities may be issued in separate series without limitation as to aggregate principal amount. We may specify a maximum aggregate principal amount for the debt securities of any series. We will describe in the applicable prospectus supplement the terms of the series of debt securities being offered, including:

the title;

the principal amount being offered, and if a series, the total amount authorized and the total amount outstanding;

any limit on the amount that may be issued;

whether or not we will issue the series of debt securities in global form, and, if so, the terms and who the depositary will be;

the maturity date;

whether and under what circumstances, if any, we will pay additional amounts on any debt securities held by a person who is not a United States person for tax purposes, and whether we can redeem the debt securities if we have to pay such additional amounts;

the annual interest rate, which may be fixed or variable, or the method for determining the rate and the date interest will begin to accrue, the dates interest will be payable and the regular record dates for interest payment dates or the method for determining such dates;

whether or not the debt securities will be secured or unsecured, and the terms of any secured debt;

the terms of the subordination of any series of subordinated debt;

the place where payments will be made;

restrictions on transfer, sale or other assignment, if any;

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our right, if any, to defer payment of interest and the maximum length of any such deferral period;

the date, if any, after which, and the price at which, we may, at our option, redeem the series of debt securities pursuant to any optional or provisional redemption provisions and the terms of those redemption provisions;

provisions for a sinking fund purchase or other analogous fund, if any, including the date, if any, on which, and the price at which we are obligated, pursuant thereto or otherwise, to redeem, or at the holder’s option, to purchase, the series of debt securities and the currency or currency unit in which the debt securities are payable;

whether the indenture will restrict our ability or the ability of our subsidiaries to:

incur additional indebtedness;

issue additional securities;

create liens;

pay dividends or make distributions in respect of our capital stock or the capital stock of our subsidiaries;

redeem capital stock;

place restrictions on our subsidiaries’ ability to pay dividends, make distributions or transfer assets;

make investments or other restricted payments;

sell or otherwise dispose of assets;

enter into sale-leaseback transactions;

engage in transactions with stockholders or affiliates;

issue or sell stock of our subsidiaries; or

effect a consolidation or merger;

whether the indenture will require us to maintain any interest coverage, fixed charge, cash flow-based, asset-based or other financial ratios;

a discussion of certain material or special United States federal income tax considerations applicable to the debt securities;

information describing any book-entry features;

the applicability of the provisions in the indenture on discharge;

whether the debt securities are to be offered at a price such that they will be deemed to be offered at an “original issue discount” as defined in paragraph (a) of Section 1273 of the Internal Revenue Code of 1986, as amended;

the denominations in which we will issue the series of debt securities, if other than denominations of $1,000 and any integral multiple thereof;

the currency of payment of debt securities if other than U.S. dollars and the manner of determining the equivalent amount in U.S. dollars; and

any other specific terms, preferences, rights or limitations of, or restrictions on, the debt securities, including any additional events of default or covenants provided with respect to the debt securities, and any terms that may be required by us or advisable under applicable laws or regulations.

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Conversion or Exchange Rights

We will set forth in the applicable prospectus supplement the terms under which a series of debt securities may be convertible into or exchangeable for our common stock, our preferred stock or other securities (including securities of a third party). We will include provisions as to whether conversion or exchange is mandatory, at the option of the holder or at our option. We may include provisions pursuant to which the number of shares of our common stock, our preferred stock or other securities (including securities of a third party) that the holders of the series of debt securities receive would be subject to adjustment.

Consolidation, Merger or Sale

Unless we provide otherwise in the prospectus supplement applicable to a particular series of debt securities, the indenture will not contain any covenant that restricts our ability to merge or consolidate, or sell, convey, transfer or otherwise dispose of all or substantially all of our assets. However, any successor to or acquirer of such assets must assume all of our obligations under the indenture or the debt securities, as appropriate. If the debt securities are convertible into or exchangeable for our other securities or securities of other entities, the person with whom we consolidate or merge or to whom we sell all of our property must make provisions for the conversion of the debt securities into securities that the holders of the debt securities would have received if they had converted the debt securities before the consolidation, merger or sale.

Events of Default under the Indenture

Unless we provide otherwise in the prospectus supplement applicable to a particular series of debt securities, the following are events of default under the indenture with respect to any series of debt securities that we may issue:

if we fail to pay interest when due and payable and our failure continues for 90 days and the time for payment has not been extended;

if we fail to pay the principal, premium or sinking fund payment, if any, when due and payable at maturity, upon redemption or repurchase or otherwise, and the time for payment has not been extended;

if we fail to observe or perform any other covenant contained in the debt securities or the indenture, other than a covenant specifically relating to another series of debt securities, and our failure continues for 90 days after we receive notice from the trustee or we and the trustee receive notice from the holders of at least 25% in aggregate principal amount of the outstanding debt securities of the applicable series; and

if specified events of bankruptcy, insolvency or reorganization occur.

We will describe in each applicable prospectus supplement any additional events of default relating to the relevant series of debt securities.

If an event of default with respect to debt securities of any series occurs and is continuing, other than an event of default specified in the last bullet point above, the trustee or the holders of at least 25% in aggregate principal amount of the outstanding debt securities of that series, by notice to us in writing, and to the trustee if notice is given by such holders, may declare the unpaid principal, premium, if any, and accrued interest, if any, due and payable immediately. If an event of default arises due to the occurrence of certain specified bankruptcy, insolvency or reorganization events, the unpaid principal, premium, if any, and accrued interest, if any, of each issue of debt securities then outstanding shall be due and payable without any notice or other action on the part of the trustee or any holder.

The holders of a majority in principal amount of the outstanding debt securities of an affected series may waive any default or event of default with respect to the series and its consequences, except defaults or events of default regarding payment of principal, premium, if any, or interest, unless we have cured the default or event of default in accordance with the indenture. Any waiver shall cure the default or event of default.

Subject to the terms of the indenture, if an event of default under the indenture shall occur and be continuing, the trustee will be under no obligation to exercise any of its rights or powers under the indenture at the request or direction of any of the holders of the applicable series of debt securities, unless such holders have offered the trustee reasonable indemnity or security satisfactory to it against any loss, liability or expense. The holders of a majority in principal amount of the outstanding debt securities of any series will have the right to direct the time, method and place of conducting any proceeding for any remedy available to the trustee, or exercising any trust or power conferred on the trustee, with respect to the debt securities of that series, provided that:

the direction so given by the holder is not in conflict with any law or the indenture; and

subject to its duties under the Trust Indenture Act, the trustee need not take any action that might involve it in personal liability or might be unduly prejudicial to the holders not involved in the proceeding.

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The indenture provides that if an event of default has occurred and is continuing, the trustee will be required in the exercise of its powers to use the degree of care that a prudent person would use in the conduct of its own affairs. The trustee, however, may refuse to follow any direction that conflicts with law or the indenture, or that the trustee determines is unduly prejudicial to the rights of any other holder of the relevant series of debt securities, or that would involve the trustee in personal liability. Prior to taking any action under the indenture, the trustee will be entitled to indemnification against all costs, expenses and liabilities that would be incurred by taking or not taking such action.

Unless we provide otherwise in the prospectus supplement applicable to a particular series of debt securities, a holder of the debt securities of any series will have the right to institute a proceeding under the indenture or to appoint a receiver or trustee, or to seek other remedies only if:

the holder has given written notice to the trustee of a continuing event of default with respect to that series;

the holders of at least 25% in aggregate principal amount of the outstanding debt securities of that series have made a written request and such holders have offered reasonable indemnity to the trustee or security satisfactory to it against any loss, liability or expense or to be incurred in compliance with instituting the proceeding as trustee; and

the trustee does not institute the proceeding, and does not receive from the holders of a majority in aggregate principal amount of the outstanding debt securities of that series other conflicting directions within 90 days after the notice, request and offer.

These limitations do not apply to a suit instituted by a holder of debt securities if we default in the payment of the principal, premium, if any, or interest on, the debt securities, or other defaults that may be specified in the applicable prospectus supplement.

We will periodically file statements with the trustee regarding our compliance with specified covenants in the indenture.

Modification of Indenture; Waiver

Subject to the terms of the indenture for any series of debt securities that we may issue, we and the trustee may change the indenture without the consent of any holders with respect to the following specific matters:

to fix any ambiguity, defect or inconsistency in the indenture;

to comply with the provisions described above under “Description of Debt Securities—Consolidation, Merger or Sale;”

to comply with any requirements of the SEC in connection with the qualification of any indenture under the Trust Indenture Act;

to add to, delete from or revise the conditions, limitations and restrictions on the authorized amount, terms or purposes of issue, authentication and delivery of debt securities, as set forth in the indenture;

to provide for the issuance of, and establish the form and terms and conditions of, the debt securities of any series as provided under “Description of Debt Securities—General,” to establish the form of any certifications required to be furnished pursuant to the terms of the indenture or any series of debt securities, or to add to the rights of the holders of any series of debt securities;

to evidence and provide for the acceptance of appointment hereunder by a successor trustee;

to provide for uncertificated debt securities and to make all appropriate changes for such purpose;

to add such new covenants, restrictions, conditions or provisions for the benefit of the holders, to make the occurrence, or the occurrence and the continuance, of a default in any such additional covenants, restrictions, conditions or provisions an event of default or to surrender any right or power conferred to us in the indenture; or

to change anything that does not adversely affect the interests of any holder of debt securities of any series in any material respect.

In addition, under the indenture, the rights of holders of a series of debt securities may be changed by us and the trustee with the written consent of the holders of at least a majority in aggregate principal amount of the outstanding debt securities of each series that is affected.

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However, subject to the terms of the indenture for any series of debt securities that we may issue or otherwise provided in the prospectus supplement applicable to a particular series of debt securities, we and the trustee may only make the following changes with the consent of each holder of any outstanding debt securities affected:

extending the stated maturity of the series of debt securities;

reducing the principal amount, reducing the rate of or extending the time of payment of interest, or reducing any premium payable upon the redemption or repurchase of any debt securities; or

reducing the percentage of debt securities, the holders of which are required to consent to any amendment, supplement, modification or waiver.

Discharge

The indenture may provide that, subject to the terms of the indenture and any limitation otherwise provided in the prospectus supplement applicable to a particular series of debt securities, we may elect to be discharged from our obligations with respect to one or more series of debt securities, except for specified obligations, including obligations to:

register the sharestransfer or exchange of Common Stockdebt securities of the series;

replace stolen, lost or mutilated debt securities of the series;

maintain paying agencies;

hold monies for payment in trust;

recover excess money held by the trustee;

compensate and indemnify the trustee; and

appoint any successor trustee.

In order to exercise our rights to be discharged, we must deposit with the trustee money or government obligations sufficient to pay all the principal of, and any premium and interest on, the debt securities of the series on the dates payments are due.

Form, Exchange and Transfer

Unless we provide otherwise in the prospectus supplement applicable to a particular series of debt securities, we will issue the debt securities of each series only in fully registered form without coupons and, unless we otherwise specify in the applicable prospectus supplement, in denominations of $1,000 and any integral multiple thereof. The indenture provides that we may issue debt securities of a series in temporary or permanent global form and as book-entry securities that will be deposited with, or on behalf of, The Depository Trust Company or another depositary named by us and identified in a prospectus supplement with respect to that series. To the Selling Stockholders underextent the Registration Rights Agreement. All expenses incurreddebt securities of a series are issued in global form and as book-entry, a description of terms related to any book-entry securities will be set forth in the applicable prospectus supplement.

At the option of the holder, subject to the terms of the indenture and the limitations applicable to global securities described in the applicable prospectus supplement, the holder of the debt securities of any series can exchange the debt securities for other debt securities of the same series, in any authorized denomination and of like tenor and aggregate principal amount.

Subject to the terms of the indenture and the limitations applicable to global securities set forth in the applicable prospectus supplement, holders of the debt securities may present the debt securities for exchange or for registration of transfer, duly endorsed or with the form of transfer endorsed thereon duly executed if so required by us or the security registrar, at the office of the security registrar or at the office of any transfer agent designated by us for this purpose. Unless otherwise provided in the debt securities that the holder presents for transfer or exchange, we will make no service charge for any registration of the Common Stock owned by the Selling Stockholders will be borne by us. This prospectus will not cover subsequent salestransfer or exchange, but we may require payment of Common Stock purchased from a Selling Stockholder named in this prospectus.any taxes or other governmental charges.

 

We cannot predict whenwill name in the applicable prospectus supplement the security registrar, and any transfer agent in addition to the security registrar, that we initially designate for any debt securities. We may at any time designate additional transfer agents or whetherrescind the designation of any transfer agent or approve a change in the office through which any transfer agent acts, except that we will be required to maintain a transfer agent in each place of payment for the debt securities of each series.

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If we elect to redeem the debt securities of any series, we will not be required to:

issue, register the transfer of, or exchange any debt securities of that series during a period beginning at the opening of business 15 days before the day of mailing of a notice of redemption of any debt securities that may be selected for redemption and ending at the close of business on the day of the mailing; or

register the transfer of or exchange any debt securities so selected for redemption, in whole or in part, except the unredeemed portion of any debt securities we are redeeming in part.

Information Concerning the Trustee

The trustee, other than during the occurrence and continuance of an event of default under the indenture, undertakes to perform only those duties as are specifically set forth in the indenture and is under no obligation to exercise any of the Selling Stockholderspowers given it by the indenture at the request of any holder of debt securities unless it is offered reasonable security and indemnity against the costs, expenses and liabilities that it might incur. However, upon an event of default under the indenture, the trustee must use the same degree of care as a prudent person would exercise or use in the conduct of his or her own affairs.

Payment and Paying Agents

Unless we otherwise indicate in the applicable prospectus supplement, we will convertmake payment of the interest on any debt securities on any interest payment date to the person in whose name the debt securities, or one or more predecessor securities, are registered at the close of business on the regular record date for the interest payment.

We will pay principal of and any premium and interest on the debt securities of a particular series at the office of the paying agents designated by us, except that unless we otherwise indicate in the applicable prospectus supplement, we will make interest payments by check that we will mail to the holder or by wire transfer to certain holders. Unless we otherwise indicate in the applicable prospectus supplement, we will designate the corporate trust office of the trustee as our sole paying agent for payments with respect to debt securities of each series. We will name in the applicable prospectus supplement any other paying agents that we initially designate for the debt securities of a particular series. We will maintain a paying agent in each place of payment for the debt securities of a particular series.

All money we pay to a paying agent or the trustee for the payment of the principal of or any premium or interest on any debt securities that remains unclaimed at the end of two years after such principal, premium or interest has become due and payable will be repaid to us, and the holder of the debt security thereafter may look only to us for payment thereof.

Governing Law

The indenture and the debt securities will be governed by and construed in accordance with the laws of the State of New York, except to the extent that the Trust Indenture Act is applicable.

Ranking Debt Securities

The subordinated debt securities that we may offer will be unsecured and will be subordinate and junior in priority of payment to certain other indebtedness to the extent described in a prospectus supplement.

The senior debt securities that we may offer will be unsecured and will rank equally in right of payment to all our other senior unsecured debt.

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DESCRIPTION OF WARRANTS

The following description, together with the additional information we may include in any applicable prospectus supplements and free writing prospectuses, summarizes the material terms and provisions of the warrants that we may offer under this prospectus, which may consist of warrants to purchase common stock, preferred stock or debt securities and may be issued in one or more series. Warrants may be offered independently or together with common stock, preferred stock or debt securities offered by any prospectus supplement, and may be attached to or separate from those securities. While the terms we have summarized below will apply generally to any warrants that we may offer under this prospectus, we will describe the particular terms of any series of warrants that we may offer in more detail in the applicable prospectus supplement and any applicable free writing prospectus. The terms of any warrants offered under a prospectus supplement may differ from the terms described below.

We will file as exhibits to the registration statement of which this prospectus is a part, or will incorporate by reference from a current report on Form 8-K that we file with the SEC, the form of warrant agreement, if any, including a form of warrant certificate, if any, that describes the terms of the particular series of warrants we are offering before the issuance of the related series of warrants. The following summaries of material provisions of the warrants and the warrant agreements are subject to, and qualified in their Series A Preferred Stockentirety by reference to, all the provisions of the warrant agreement and warrant certificate applicable to a particular series of warrants. We urge you to read the applicable prospectus supplement and any applicable free writing prospectus related to the particular series of warrants that we sell under this prospectus, as well as the complete warrant agreements and warrant certificates that contain the terms of the warrants.

General

We will describe in the applicable prospectus supplement the terms relating to a series of warrants, including:

the offering price and aggregate number of warrants offered;

the currency for which the warrants may be purchased;

if applicable, the designation and terms of the securities with which the warrants are issued and the number of warrants issued with each such security or each principal amount of such security;

if applicable, the date on and after which the warrants and the related securities will be separately transferable;

in the case of warrants to purchase debt securities, the principal amount of debt securities purchasable upon exercise their Warrantsof one warrant and even if they do, we do not know how long the Selling Stockholders will holdprice at, and currency in which, this principal amount of debt securities may be purchased upon such exercise;

in the case of warrants to purchase common stock or preferred stock, the number of shares of Common Stock acquiredcommon stock or preferred stock, as the case may be, purchasable upon conversion orthe exercise as applicable, before selling them,of one warrant and we currently have no agreements, arrangements or understandings with the Selling Stockholders regarding price at which these shares may be purchased upon such exercise;

the effect of any merger, consolidation, sale or other disposition of our business on the warrant agreements and the warrants;

the terms of any rights to redeem or call the warrants;

any provisions for changes to or adjustments in the exercise price or number of securities issuable upon exercise of the shares. The shares of Common Stock covered herebywarrants;

the dates on which the right to exercise the warrants will commence and expire;

the manner in which the warrant agreements and warrants may be offeredmodified;

United States federal income tax consequences of holding or exercising the warrants;

the terms of the securities issuable upon exercise of the warrants; and

any other specific terms, preferences, rights or limitations of or restrictions on the warrants.

Exercise of Warrants

Each warrant will entitle the holder to purchase the securities that we specify in the applicable prospectus supplement at the exercise price that we describe in the applicable prospectus supplement. Unless we otherwise specify in the applicable prospectus supplement, holders of the warrants may exercise the warrants at any time up to the specified time on the expiration date that we set forth in the applicable prospectus supplement. After the close of business on the expiration date, unexercised warrants will become void.

20

Holders of the warrants may exercise the warrants by delivering the warrant certificate or agreement representing the warrants to be exercised together with specified information, and paying the required amount to the warrant agent in immediately available funds, as provided in the applicable prospectus supplement. We will set forth on the reverse side of the warrant certificate or agreement and in the applicable prospectus supplement the information that the holder of the warrant will be required to deliver to the warrant agent.

Upon receipt of the required payment and the warrant certificate or agreement properly completed and duly executed at the corporate trust office of the warrant agent or any other office indicated in the applicable prospectus supplement, we will issue and deliver the securities purchasable upon such exercise. If fewer than all of the warrants represented by the warrant certificate or agreement are exercised, then we will issue a new warrant certificate or agreement for the remaining amount of warrants. If we so indicate in the applicable prospectus supplement, holders of the warrants may surrender securities as all or part of the exercise price for warrants.

Enforceability of Rights by Holders of Warrants

Each warrant agent will act solely as our agent under the applicable warrant agreement and will not assume any obligation or relationship of agency or trust with any holder of any warrant. A single bank or trust company may act as warrant agent for more than one issue of warrants. A warrant agent will have no duty or responsibility in case of any default by us under the applicable warrant agreement or warrant, including any duty or responsibility to initiate any proceedings at law or otherwise, or to make any demand upon us. Any holder of a warrant may, without the consent of the related warrant agent or the holder of any other warrant, enforce by appropriate legal action its right to exercise, and receive the securities purchasable upon exercise of, its warrants.

21

DESCRIPTION OF RIGHTS

The following is a general description of the terms of the rights we may issue from time to time byunless we provide otherwise in the Selling Stockholders.applicable prospectus supplement. Particular terms of any rights we offer will be described in the prospectus supplement relating to such rights.

 

Furthermore, we do not know whenGeneral

We may issue rights to purchase common stock, preferred stock, debt securities or in what amounts the Selling Stockholdersunits. Rights may sellbe issued independently or otherwise dispose of the shares covered hereby. The Selling Stockholders might not sell any or all of the shares covered by this prospectustogether with other securities and may or may sellnot be transferable by the person purchasing or disposereceiving the rights. In connection with any rights offering to our stockholders, we may enter into a standby underwriting, backstop or other arrangement with one or more underwriters or other persons pursuant to which such underwriters or other persons would purchase any offered securities remaining unsubscribed for after such rights offering. In connection with a rights offering to our stockholders, we would distribute certificates evidencing the rights and a prospectus supplement to our stockholders on or about the record date that we set for receiving rights in such rights offering.

The applicable prospectus supplement will describe the following terms of any rights we may issue, including some or all of the shares other than pursuant to this prospectus. Because following:

the Selling Stockholders may not sell or otherwise dispose of some or alltitle and aggregate number of the rights;

the subscription price or a formula for the determination of the subscription price for the rights and the currency or currencies in which the subscription price may be payable;

if applicable, the designation and terms of the securities with which the rights are issued and the number of rights issued with each such security or each principal amount of such security;

the number or a formula for the determination of the number of the rights issued to each stockholder;

the extent to which the rights are transferable;

in the case of rights to purchase debt securities, the principal amount of debt securities purchasable upon exercise of one right;

in the case of rights to purchase common stock or preferred stock, the type of stock and number of shares covered by this prospectusof stock purchasable upon exercise of one right;

the date on which the right to exercise the rights will commence, and because there are currently no agreements, arrangementsthe date on which the rights will expire (subject to any extension);

if applicable, the minimum or understandingsmaximum amount of the rights that may be exercised at any one time;

the extent to which such rights include an over-subscription privilege with respect to unsubscribed securities;

if applicable, the procedures for adjusting the subscription price and number of shares of common stock or preferred stock purchasable upon the exercise of each right upon the occurrence of certain events, including stock splits, reverse stock splits, combinations, subdivisions or reclassifications of common stock or preferred stock;

the effect on the rights of any merger, consolidation, sale or other disposition of our business;

the terms of any rights to redeem or call the rights;

information with respect to book-entry procedures, if any;

the terms of the securities issuable upon exercise of the rights;

if applicable, the material terms of any standby underwriting, backstop or other purchase arrangement that we may enter into in connection with the rights offering;

22

if applicable, a discussion of certain U.S. Federal income tax considerations; and

any other terms of the rights, including terms, procedures and limitations relating to the exchange and exercise of the rights.

Exercise of Rights

Each right will entitle the holder to purchase for cash or other consideration such shares of stock or principal amount of securities at the subscription price as shall in each case be set forth in, or be determinable as set forth in, the prospectus supplement relating to the rights offered thereby. Rights may be exercised as set forth in the applicable prospectus supplement beginning on the date specified therein and continuing until the close of business on the expiration date set forth in the prospectus supplement relating to the rights offered thereby. After the close of business on the expiration date, unexercised rights will become void.

Upon receipt of payment and a subscription certificate properly completed and duly executed at the corporate trust office of the subscription agent or any other office indicated in the prospectus supplement, we will, as soon as practicable, forward the securities purchasable upon such exercise. If less than all of the rights represented by such subscription certificate are exercised, a new subscription certificate will be issued for the remaining rights. If we so indicate in the applicable prospectus supplement, holders of the rights may surrender securities as all or part of the exercise price for rights.

We may determine to offer any unsubscribed offered securities directly to stockholders, persons other than stockholders, to or through agents, underwriters or dealers or through a combination of such methods, including pursuant to standby underwriting, backstop or other arrangements, as set forth in the applicable prospectus supplement.

Prior to exercising their rights, holders of rights will not have any of the shares, we cannot estimate the numberrights of holders of the shares that will be held bysecurities purchasable upon subscription, including, in the Selling Stockholders after completioncase of rights to purchase common stock or preferred stock, the offering. For purposesright to receive dividends, if any, or payments upon our liquidation, dissolution or winding up or to exercise any voting rights or, in the case of rights to purchase debt securities, the table below, we have assumed thatright to receive principal, premium, if any, or interest payments, on the Selling Stockholders will have sold all of the shares covered by this prospectusdebt securities purchasable upon completion ofexercise or to enforce covenants in the applicable offering.indenture.

23

DESCRIPTION OF UNITS

 

The tablefollowing description, together with the additional information we may include in any applicable prospectus supplements and free writing prospectuses, summarizes the material terms and provisions of the units that we may offer under this prospectus. While the terms we have summarized below presents information regardingwill apply generally to any units that we may offer under this prospectus, we will describe the Selling Stockholdersparticular terms of any series of units in more detail in the applicable prospectus supplement. The terms of any units offered under a prospectus supplement may differ from the terms described below. However, no prospectus supplement will fundamentally change the terms that are set forth in this prospectus or offer a security that is not registered and described in this prospectus at the time of its effectiveness.

We will file as exhibits to the registration statement of which this prospectus is a part, or will incorporate by reference from a current report on Form 8-K that we file with the SEC, the form of unit agreement that describes the terms of the series of units we are offering, and any supplemental agreements, before the issuance of the related series of units. The following summaries of material terms and provisions of the units are subject to, and qualified in their entirety by reference to, all the provisions of the unit agreement and any supplemental agreements applicable to a particular series of units. We urge you to read the applicable prospectus supplements related to the particular series of units that we sell under this prospectus, as well as the complete unit agreement and any supplemental agreements that contain the terms of the units.

General

We may issue units comprised of one or more debt securities, shares of common stock, shares of preferred stock and warrants in any combination. Each unit will be issued so that the holder of the unit is also the holder of each security included in the unit. Thus, the holder of a unit will have the rights and obligations of a holder of each included security. The unit agreement under which a unit is issued may provide that the securities included in the unit may not be held or transferred separately, at any time or at any time before a specified date.

We will describe in the applicable prospectus supplement the terms of the series of units, including:

the designation and terms of the units and of the securities comprising the units, including whether and under what circumstances those securities may be held or transferred separately;

any provisions of the governing unit agreement that differ from those described below; and

any provisions for the issuance, payment, settlement, transfer or exchange of the units or of the securities comprising the units.

The provisions described in this section, as well as those described under “Description of Capital Stock,” “Description of Debt Securities” and “Description of Warrants” will apply to each unit and to any common stock, preferred stock, debt security or warrant included in each unit, respectively.

Issuance in Series

We may issue units in such amounts and in numerous distinct series as we determine.

Enforceability of Rights by Holders of Units

Each unit agent will act solely as our Common Stockagent under the applicable unit agreement and will not assume any obligation or relationship of agency or trust with any holder of any unit. A single bank or trust company may act as unit agent for more than one series of units. A unit agent will have no duty or responsibility in case of any default by us under the applicable unit agreement or unit, including any duty or responsibility to initiate any proceedings at law or otherwise, or to make any demand upon us. Any holder of a unit may, without the consent of the related unit agent or the holder of any other unit, enforce by appropriate legal action its rights as holder under any security included in the unit.

We, the unit agents and any of their agents may treat the registered holder of any unit certificate as an absolute owner of the units evidenced by that theycertificate for any purpose and as the person entitled to exercise the rights attaching to the units so requested, despite any notice to the contrary.

24

PLAN OF DISTRIBUTION

We may sell or otherwise dispose ofthe securities, from time to time, under this prospectus. The percentageto or through underwriters or dealers, through agents or remarketing firms, or directly to one or more purchasers pursuant to:

underwritten public offerings;

negotiated transactions;

block trades;

“At the Market Offerings,” within the meaning of beneficial ownership is based upon 10,345,637 shares of Common Stock issued and outstanding as of May 5, 2017. Beneficial ownership is determined under Section 13(d) of the Exchange Act and generally includes voting or investment power with respect to securities and includes any securities that grant the Selling Stockholders the right to acquire Common Stock within 60 days of May 5, 2017. Information in the table below is based on information provided by or on behalf of the Selling Stockholders. Since the date on which they provided us with the information below, the Selling Stockholders may have sold, transferred or otherwise disposed of some or all of the shares in transactions exempt from the registration requirementsRule 415(a)(4) of the Securities Act.Act, into an existing trading market, at prevailing market prices; or

 

-10-

Name of Selling Stockholders(1)

 

Shares of Common Stock
Beneficially Owned

Before this Offering(2)

  

Estimated

Shares of

Common

Stock to be

Issuable as

Dividends

on the

Series A

Preferred

Stock at

10/1/2017

  

Number of

Shares of

Common

Stock Being

Offered

Pursuant to

this

Prospectus(3)

  

Shares of Common Stock

Beneficially To Be Owned

Upon Completion of this

Offering(4)

 
  

Number

  

Percentage(5)

  

Number

  

Number

  

Number

  

Percentage(5)

 

ABG – USL1 Limited(6)

  1,127,182   9.9

%

  21,210   970,892   177,500   1.7

%

ACNYC, LLC

  607,550   4.6

%

  11,056   506,106   112,500   1.1

%

Adam Lipson

  99,010   *   2,211   101,221       

Adam T Drobot & Lucy S. Drobot JT Ten

  27,254   *   553   25,307   2,500   * 

Adolfo Carmona & Donna Carmona JT TEN

  93,170   *   1,857   85,027   10,000   * 

Advanced Ambulatory ANES LLC Defined Benefit Plan

  272,526   2.6

%

  5,528   253,054   25,000   * 

Albert Gentile & Heidi Lyn Gentile JT TEN

  41,604   *   884   40,488   2,000   * 

Alva Terry Staples

  24,952   *   557   25,509       

Alyson D. Schlosser

  37,154   *   774   35,428   2,500   * 

Andrew Schwartzberg

  455,446   4.2

%

  9,311   464,757       

Andy Entertainment Limited

  49,506   *   1,106   50,612       

Angelo Moesslang & Monika Moesslang JT TEN

  69,308   *   1,548   70,856       

Anthony Daulerio

  49,506   *   1,106   50,612       

AR Properties C/O Dennis Repp

  300,196   2.9

%

  3,354   153,550   150,000   1.4

%

Arnold E. Spangler

  101,510   *   2,211   101,221   2,500   * 

Arnold T Hagler Separate Trust U/A/D 9/17/97 Arnold T Hagler TTEE

  27,754   *   553   25,307   3,000   * 

Barclay Armitage

  89,160   *   1,880   86,040   5,000   * 

Ben Crown

  208,020   1.3

%

  4,422   202,442   10,000   * 

Benjamin King

  24,754   *   506   25,260       

Benjamin L. Padnos

  160,398   1.5

%

  3,279   163,677       

Benjamin R. Hasty

  27,254   *   506   25,260   2,500   * 

BES Investments, LLC

  133,812   1.3

%

  2,653   121,465   15,000   * 

Bigger Capital Fund, L.P.

  247,600   2.3

%

  5,062   252,662       

Bowling Family Trust

  55,446   *   1,238   56,684       

Bradley Cuvelier

  99,010   *   2,211   101,221       

Brian Potiker Revocable Trust UAD 8/7/96 Brian Potiker TTEE

  62,006   *   1,012   50,518   12,500   * 

 -11-

Bruce D. Goethe & Laura K. Goethe COMM PROP WROS

  30,224   *   619   28,343   2,500   * 

Bruce Inglis & Nancy Inglis JT TEN

  27,254   *   553   25,307   2,500   * 

Bryan Ezralow 1994 Trust UTD 12/22/1994 U/A/D 12/22/94 Bryan Ezralow TTEE AMD 12/01/12

  198,020   1.9

%

  4,422   202,442       

C. Barnes Darwin II

  99,110   *   1,990   91,100   10,000   * 

Carleen Tufo DTD 2/21/2017

  27,254   *   553   25,307   2,500   * 

Charles Brinkley

  27,254   *   506   25,260   2,500   * 

Chitayat Holdings, LLC

  99,010   *   2,211   101,221       

Ciro Giuseppe Randazzo

  49,506   *   1,012   50,518       

CJ Biotech II, LLC

  222,774   2.1

%

  4,554   227,328       

Clay Struve

  109,010   1.0

%

  2,211   101,221   10,000   * 

Craig Geers

  38,154   *   708   35,362   3,500   * 

Daniel P. Petro

  32,254   *   553   25,307  

7,500

   * 

David Abel

  29,704   *   663   30,367       

David Abraham & Joann Abraham JT TEN

  133,714   1.2

%

  2,875   131,589   5,000   * 

David D. Shively Rev Wealth Preservation Trust UAD 7/21/04 David D. Shively TTEE

  99,010   *   2,211   101,221       

David E. Schwartz

  83,708   *   1,548   70,856   14,400   * 

David E.I. Pyott Revocable Living Trust U/A/D 4/18/14 David E.I. Pyott TTEE

  495,050   4.6

%

  10,121   505,171       

David Frydrych

  505,546   4.7

%

  9,109   454,655   60,000   * 

David G. Schmidt

  1,169,643   10.6

%

  14,373   657,939   526,077   4.9

%

David Pouland

  99,010   *   2,211   101,221       

David R. Victor Revocable Trust UAD 3/29/00 David R. Victor TTEE

  54,506   *   1,106   50,612   5,000   * 

David S. Nagelberg 2003 Rev TR U/A/D 07/02/03 David S. Nagelberg TTEE A/M/D 12/11/07

  247,526   2.3

%

  5,528   253,054       

David Schneider

  218,020   2.1

%

  4,422   202,442   20,000   * 

David Y. Norton

  49,704   *   663   30,367   20,000   * 

David Young & Karen Plaisance JT TEN

  49,506   *   1,106   50,612       

Dennis Shasha

  114,010   1.1

%

  2,211   101,221   15,000   * 

DJ&J, LLC

  218,020   2.1

%

  4,422   202,442   20,000   * 

Dominick Abel TOD

  38,154   *   774   35,428   3,500   * 

Donald E. Hinkle

  32,664   *   662   30,326   3,000   * 

Donald Sesterhenn

  24,754   *   553   25,307       

Douglas J. Gold

  24,754   *   506   25,260       

Dyke Rogers

  207,920   2.0

%

  4,422   202,442   9,900   * 

-12- 

E.L. Property Trust UAD 7/01/83 Robert C. Kopple TTEE

  990,100   8.7

%

  22,112   1,012,212       

Edgar D. Jannotta JR Exempt Family Trust U/A/D 10/02/1998 Erika Pearsall TTEE

  247,526   2.3

%

  5,061   252,587       

Eldar Investments, LLC

  24,754   *   506   25,260       

Elevado Investments Company, LLC

  208,020   2.0

%

  4,422   202,442   10,000   * 

Eric Prescott Campbell

  44,556   *   911   45,467       

Erick Richardson

  148,516   1.4

%

  3,036   151,552       

Ernest W. Moody Revocable Trust U/A/D 01/14/09 Ernest W. Moody TTEE

  1,215,100   10.7

%

  20,242   1,010,342   225,000   2.1

%

EZ Colony Partners, LLC

  208,020   2.0

%

  4,422   202,442   10,000   * 

EZ MM & B Holdings, LLC

  208,020   2.0

%

  4,422   202,442   10,000   * 

G. Jan Van Heek

  27,254   *   553   25,307   2,500   * 

Garfinkle Revocable Trust UAD 5/15/08 Morris Garfinkle & Stephanie Garfinkle TTEES

  106,510   1.0

%

  2,211   101,221   7,500   * 

Gary M. Ferman

  35,625   *   613   30,613   5,625   * 

Gary W. Jaster

  55,446   *   1,238   56,684       

Graham Burton

  990,100   8.7

%

  20,242   1,010,342       

Graham R. Smith

  54,506   *   1,106   50,612   5,000   * 

Greenway Capital, L.P.

  198,020   1.9

%

  4,048   202,068       

Gregory L. Storm

  123,764   1.2

%

  2,530   126,294       

Henry Herzing Revocable Living Trust U/A/D 10/27/93 Henry Herzing TTEE AMD 05/22/00

  475,842   4.4

%

  9,287   425,129   60,000   * 

Howard J. Worman

  27,254   *   553   25,307   2,500   * 

IRA FBO Kristian Weinman Pershing LLC as Custodian Roth

  20,000   *   409   20,409       

IRA FBO Marhsall S Ezralow Pershing LLC as Custodian Roth Account

  208,020   2.0

%

  4,422   202,442   10,000     

IRA FBO Robin J. Steele Pershing LLC as Custodian Rollover Account

  99,010   *   2,024   101,034       

IRA FBO Stephen R. Meyer Pershing LLC as Custodian Rollover Account

  98,110   *   1,990   91,100   9,000   * 

IRA FBO Steven Yost Pershing LLC as Custodian Roth Conversion Account #2

  29,664   *   662   30,326       

 -13-

IRA FBO: Peter J. Spengler Pershing LLC as Custodian

  99,010   *   2,211   101,221       

IRA FBO: Roger L. Hawley Pershing LLC as Custodian

  198,020   1.9

%

  4,422   202,442       

Irrevocable Aloha Trust UAD 5/1/02 Marianne Schmitt Hellauer TTEE

  198,020   1.9

%

  4,422   202,442       

Irwin Blitt Revocable Trust UAD 1/28/78 Irwin Blitt TTEE AMD 1/11/07

  54,506   *   1,106   50,612   5,000   * 

Isymax Corp

  22,000   *   491   22,491       

Jack Cavin Holland 1979 Trust U/A/D 2/14/79 Jack Cavin Holland TTEE

  49,506   *   1,012   50,518       

Jack R. Frank II

  27,254   *   506   25,260   2,500   * 

Jacob D. Wiznitzer

  34,654   *   708   35,362       

James A. Kluge

  31,754   *   553   25,307   7,000   * 

James B. and Karen A Glavin Family Trust U/A/D 10/30/98 James B. and Karen A. Glavin TTEES

  54,506   *   1,106   50,612   5,000   * 

James Diasio

  33,724   *   619   28,343   6,000   * 

James F. Winschel, JR

  49,506   *   1,106   50,612       

James L. Dritz

  36,496   *   681   31,177   6,000   * 

James L. Payne & Arlene H. Payne TEN COMM

  247,526   2.3

%

  5,528   253,054       

James R. Hollingshead and Amita Hollingshead Revocable Living Trust 5/30/08 James and Amita Hollingshead TTEES

  49,506   *   1,012   50,518       

James W. Thomas

  11,402   *   202   10,104   1,500   * 

Jason Schmidt

  49,506   *   1,106   50,612       

Jay & Jennifer Ferguson JT TEN

  99,010   *   2,024   101,034       

Jayant Aphale

  99,010   *   2,024   101,034       

Jeff Kurtz

  27,254   *   553   25,307   2,500   * 

Jeffrey & Margaret Padnos 2010 Generation Trust F/B/O Benjamin Padnos

  50,000   *   1,022   51,022       

Jeffrey Bacha

  24,750   *   506   25,256       

Jeffrey S. Padnos & Margaret Mais Padnos JT TEN

  100,000   *   2,044   102,044       

Jeffrey Wren & Shannon Wren TEN COMM

  24,754   *   506   25,260       

Joel L. Hochman Revocable Trust UAD 12/08/94 Joel L. Hochman TTEE

  81,758   *   1,658   75,916   7,500   * 

Joel Yanowitz

  19,802   *   405   20,207       

 -14-

John Florsheim

  24,754   *   553   25,307       

John Ford

  24,754   *   506   25,260       

John V. Wagner

  54,506   *   1,106   50,612   5,000   * 

Jonathan Gilliland

  29,802   *   405   20,207   10,000   * 

Jonathan Patronik

  25,600   *   470   23,470   2,600   * 

Joshua Gregg Berkowitz

  148,516   1.4

%

  3,317   151,833       

Juan Carlos Alzate Tejada

  49,506   *   1,106   50,612       

Juli-Ann Cialone

  15,248   *   341   15,589       

Karen Shasha

  24,754   *   553   25,307       

Keith Gelles

  163,516   1.6

%

  3,317   151,833   15,000   * 

Keller Enterprises, LLC

  695,050   6.4

%

  10,121   505,171   200,000   1.9

%

Kenmont Capital Private Equity Partners III

  148,516   1.4

%

  3,317   151,833       

Kenneth F. Buechler Trust 9/24/2007 UAD 9/24/07 Kenneth F. Buechler TTEE

  24,754   *   506   25,260       

Kevin Gabrik

  19,802   *   405   20,207       

Lambda IV, LLC

  247,526   2.3

%

  5,528   253,054       

Leonite Capital, LLC

  74,258   *   1,518   75,776       

Leslie Rudes Grandchildren Trust UAD 2/27/03 Lis Rudes Sandel TTEE

  260,026   2.5

%

  5,061   252,587   12,500   * 

Leipman Trust UAD 5/08/1984 Holger A Liepmann & Loraine Liepmann TTEES AMD 4/22/12

  44,556   *   957   45,513       

Lisa Rudes Grandchildren Trust UAD 2/13/03 Lis Rudes Sandel TTEE

  260,026   2.5

%

  5,060   252,586   12,500   * 

Loeb Holding Corporation

  99,010   *   2,211   101,221       

Louis Vigden

  109,010   *   2,024   101,034   10,000   * 

Lundring Family Trust U/A/D 2/13/02 Eric Lundring and Lori Yost Lundring TTEES

  29,704   *   663   30,367       

Mai 2, LLC

  346,536   3.2%  7,739   354,275       

Marc Cohen

  39,904   *   774   35,428   5,250   * 

Marc R. Jalbert

  49,506   *   1,106   50,612       

Mark Grinbaum and Tatyana Grinbaum JT TEN

  74,308   *   1,548   70,856   5,000   * 

Mark H. Rubin

  64,358   *   1,316   65,674       

Mark Ravich

  24,754   *   506   25,260       

Marsha K. Ederer

  74,258   *   1,518   75,776       

Mayhar Eidgah

  24,754   *   553   25,307       

Maxim Merchant Capital(7)

 

1,377,695

  

4.9

     1,179,558  

198,137

  

1.9

Michael Cohn & Paula Cohn JT TEN

  27,452   *   557   25,509   2,500   * 

Michael P. Ross

  203,020   1.9

%

  4,422   202,442   5,000   * 

 -15-

Monte D. Anglin & Janet S. Anglin JT TEN

  27,254   *   553   25,307   2,500   * 

Neil H. Wasserman

  29,704   *   663   30,367       

OSI Holdings, LLC

  29,754   *   553   25,307   5,000   * 

OSPREY I, LLC

  81,758   *   1,658   75,916   7,500   * 

Panella Living Trust U/A/D 05/11/04 Joseph Panella and Pan Panella TTEES

  14,144   *   260   11,904   2,500   * 

Patrick Lin

  49,506   *   1,012   50,518       

Peter B. Rauenbuehler & Mary L. Mines Living Trust U/A/D 09/26/05 Peter B. Rauenbuehler & Mary MinesTTEES

  99,802   *   2,229   102,031       

Peter D. Schiffrin

  49,506   *   1,106   50,612       

Peter john Freix

  24,754   *   506   25,260       

Pura Vida Master Fund, LTD

  165,632   1.6

%

  3,386   169,018       

Rande R Willison

  29,754   *   506   25,260   5,000   * 

Richard D. Cohen

  150,892   1.4

%

  2,477   113,369   40,000   * 

Richard Dvorak

  29,324   *   619   28,343   1,600   * 

Richard F. Braun

  115,010   1.1

%

  2,211   101,221   16,000   * 

Richard Martin Reiter

  27,254   *   553   25,307   2,500   * 

Richman Trust DTD 6/02/1983 UAD 6/02/83 Douglas Richman & Eva Richman TTEES AMD 1/6/14

  29,704   *   663   30,367       

Rick D. Mace & Karen Mace JT TEN

  34,654   *   774   35,428       

Robert C. Monks

  26,000   *   409   20,409   6,000   * 

Robert Charles Bourge

  109,010   1.0

%

  2,211   101,221   10,000   * 

Robert Giesen

  13,402   *   221   10,123   3,500   * 

Robert Kantor

  54,506   *   1,106   50,612   5,000   * 

Robert N Garff

  57,050   *   1,166   58,216       

Robin J. Steele Trust DTD 1/30/2015 Robin J. Steele TTEE AMD 05/04/15

  99,010   *   2,211   101,221       

Robin Rothstein & Jeffery Rothstein COMM PROP WROS

  49,506   *   1,106   50,612       

Ron Eller & Beth Eller JT TEN

  32,724   *   619   28,343   5,000   * 

RP Capital, LLC

  455,446   4.2

%

  9,311   464,757       

Russell Nowak

  49,506   *   1,012   50,518       

Russell S. Dritz

  9,518   *   186   8,504   1,200   * 

Ryan Miller & Gail Miller

  29,704   *   663   30,367       

Sean Janzer

  24,754   *   553   25,307       

Shamus, LLC

  489,132   4.6

%

  5,765   263,897   231,000   2.2

%

Sherry Casali

  24,754   *   506   25,260       

Shiloh Produce, Inc.

  191,388   1.8

%

  3,913   195,301       

Stanley M. Marks

  54,506   *   1,106   50,612   5,000   * 

Stephen Bender

  109,010   1.0

%

  2,211   101,221   10,000   * 

 -16-

Stephen Dwayne Richards

  49,506   *   1,106   50,612       

Stephen J. Meringoff

  495,050   4.6

%

  10,121   505,171       

Stephen M. Payne

  59,506   *   1,106   50,612   10,000   * 

Stephen Mut

  24,754   *   553   25,307       

Steve Goodman & Helane Goodman JT TEN

  39,604   *   884   40,488       

Steven and Kaye Yost Family Trust U/A/D 02/07/92 AMD 6/04/97 Steven A. Yost and Kate Yost TTEES

  59,902   *   1,114   51,016   10,000   * 

Steven F. White

  51,393   *   531   26,521   25,403   * 

Steven Glassman

  27,254   *   553   25,307   2,500   * 

Steven H. Oram Revocable Trust UAD 5/17/06 Steven H. Oram & Terri Oram TTEES

  54,506   *   1,106   50,612   5,000   * 

Steven K. Luminais & Elizabeth Kindwall Luminais JT TEN

  54,506   *   1,106   50,612   5,000   * 

Steven M. Nelson

  26,827   *   557   25,509   1,875   * 

Swift Run Capital

  990,100   8.7

%

  22,112   1,012,212       

Terrence E. Troy

  86,210   *   1,769   80,979   7,000   * 

The A.C. Trust (Delaware) UAD 8/21/08 Seth Lapidow TTEE

  495,050   4.6

%

  11,056   506,106       

The Bahr Family Limited Partnership

  119,912   1.1

%

  2,432   111,344   11,000   * 

The Kentor Trust U/A/D 9/18/02 Eric Kentor and Adrienne Kentor TTEES

  24,754   *   553   25,307       

The Notas Family Trust UAD 8/13/1997 Bernard Notas & Eve Notas TTEES

  69,308   *   1,548   70,856       

The Oberkfell Living Trust U/A/D 12/18/02 HF Oberkfell & VA Oberkfell TTEES AMD 06/29/10

  55,446   *   1,238   56,684       

The R Scott Greer and Michelle Greer Revocable Trust U/A/D 10/01/00 R. Scott Greer and Michelle Greer TTEES

  49,506   *   1,106   50,612       

The Robert L. Bahr Revocable Trust UAD 3/14/85 Robert Bahr TTEE

  89,110   *   1,990   91,100       

The Stanford Baratz Revocable Trust U/A/D 09/07/94 Stanford Baratz & Amy Baratz TTEES

  21,875   *   409   20,409   1,875   * 

Thomas L. Eisenberg

  28,754   *   553   25,307   4,000   * 

Thomas L. Kempner

  99,010   *   2,211   101,221       

Thomas M Vertin

  49,506   *   1,012   50,518       

Timothy Michael Cicchese

  99,010   *   2,211   101,221       

Timothy P. Hanley & Monica Hanley JTWROS

  99,010   *   2,211   101,221       

Tom Sego

  99,010   *   2,024   101,034       

Trust of David Benaderet U/A/D 1/15/13 David Benaderet TTEE

  54,506   *   1,106   50,612   5,000   * 

Trust U/W Renee Weiss DTD 5/9/90 Peter H. Weiss TTEE

  23,552   *   442   20,244   3,750   * 

William Filon

  21,802   *   442   20,244   2,000   * 

William H. Costigan

  24,754   *   506   25,260       

William Huff

  51,956   *   1,105   50,561   2,500   * 

William Kadi & Sandra Marie Kadi JT TEN

  24,754   *   506   25,260       

William Krywicki & Nancie Krywicki JT TEN

  49,506   *   1,106   50,612       

William Strawbridge

  24,754   *   553   25,307       

Wilson Wilson & Wilson

  44,556   *   910   45,466       

Zhe Qiu

  99,012   *   2,117   101,129       

-17-


* Less than 1%

(1)

All information contained as of May 5, 2017.

(2)

Includes (a) shares of our Common Stock held by the applicable Selling Stockholder, (b) shares of Common Stock issuable upon exercise or conversion of convertible securities that are currently exercisable or convertible or are exercisable or convertible within 60 days of May 5, 2017 beneficially owned by the applicable Selling Stockholder outside of the Private Placement and (c) shares of Common Stock issuable to the applicable Selling Stockholder upon the conversion of the Series A Preferred Stock or the exercise of the Warrants sold in the Private Placement.

(3)

Consists only of (a) shares of Common Stock issuable to the applicable Selling Stockholder upon the conversion of the Series A Preferred Stock or the exercise of the Warrants sold in the Private Placement and (b) shares of Common Stock issuable to the applicable Selling Stockholder as dividends on the Series A Preferred Stock.

(4)

For purposes of this table, the Company assumes that all of the shares covered by this prospectus will be sold by the Selling Stockholders.

(5)

Based on a denominator equal to the sum of (a) 10,345,637 shares of our Common Stock outstanding on May 5, 2017, and (b) the number of shares of Common Stock issuable upon exercise or conversion of convertible securities that are currently exercisable or convertible or are exercisable or convertible within 60 days of May 5, 2017 beneficially owned by the applicable Selling Stockholder.

(6)

Shares beneficially owned is based solely on the Schedule 13G/A filed with the SEC on April 6, 2017 by Ally Bridge Group Capital Partners II, L.P. (“Ally Bridge”). The address of Ally Bridge is Unit 3002-3004, 30th Floor, Gloucester Tower, The Landmark, 15 Queen’s Road Central, Hong Kong. Amounts reported do not include 6,099 shares of Common Stock held by ABG II - SO Limited, as reported on the Schedule 13G/A filed with the SEC on April 6, 2017 by Ally Bridge. The conversion of the Series A Preferred Stock and the exercise of certain warrants held by this Selling Stockholder are subject to a 9.99% ownership blocker.

(7)

Maxim Merchant Capital, a division of Maxim Group LLC, a FINRA member broker-dealer, acted as our sole placement agent in the Private Placement. In connection with the Private Placement, we issued to Maxim and its designees 5-year warrants to purchase of 1,179,558 shares of Common Stock at an exercise price equal to $2.22 per share, with such warrants containing a cashless exercise provision. The exercise of certain warrants held by this Selling Stockholder are subject to a 4.99% ownership blocker.

Each time the Selling Stockholders sell any sharesthrough a combination of Common Stock offered by this prospectus, they are required to provide you with this prospectus and the related prospectus supplement, if any, containing specific information about the Selling Stockholders and the terms of the shares of Common Stock being offered in the manner required by the Securities Act.these methods.

No offer or sale may occur unless the registration statement that includes this prospectus has been declared effective by the Commission and remains effective at the time the Selling Stockholders offer or sell shares of Common Stock. We are required, under certain circumstances, to update, supplement or amend this prospectus to reflect material developments in our business, financial position and results of operations and may do so by an amendment to this prospectus, a prospectus supplement or a future filing with the Commission incorporated by reference in this prospectus.

This prospectus also covers any additional shares of Common Stock that become issuable in connection with the shares being registered by reason of any stock dividend, stock split, recapitalization or other similar transaction effected without the receipt of consideration which results in an increase in the number of our outstanding shares of Common Stock.

-18-

PLAN OF DISTRIBUTION

 

We are registering the shares of Common Stock issuable to the Selling Stockholders upon conversion of the Series A Preferred Stock or exercise of the Warrants issued to the Selling Stockholders to permit the resale of these shares of Common Stock by the holders thereof from time to time after the date of this prospectus, pursuant to the provisions of the Registration Rights Agreement. As used in this prospectus, “Selling Stockholders” includes donees, pledgees, transferees or other successors-in-interest selling shares received after the date of this prospectus from a selling stockholder as a gift, pledge, partnership distribution or other permitted transfer.

We will not receive any of the proceeds from the sale by the Selling Stockholders of the shares of Common Stock. We will bear all fees and expenses incident to our obligation to register the shares of Common Stock.

The Selling Stockholders may sell all or a portion of the shares of Common Stock beneficially owned by them and offered hereby from timesecurities to time directly or through one or more underwriters broker-dealers or agents. Ifdealers (acting as principal or agent), through agents, or directly to one or more purchasers.

We may distribute securities from time to time in one or more transactions:

at a fixed price or prices, which may be changed;

at market prices prevailing at the sharestime of Common Stocksale;

at prices related to such prevailing market prices; or

at negotiated prices.

A prospectus supplement or supplements (and any related free writing prospectus that we may authorize to be provided to you) will describe the terms of the offering of the securities, including, to the extent applicable:

the name or names of the underwriters, dealers or agents, if any;

if the securities are soldto be offered through the selling efforts of brokers or dealers, the plan of distribution and the terms of any agreement, arrangement, or understanding entered into with broker(s) or dealer(s) prior to the effective date of the registration statement, and, if known, the identity of any broker(s) or dealer(s) who will participate in the offering and the amount to be offered through each;

the purchase price of the securities or other consideration therefor, and the proceeds, if any, we will receive from the sale;

if any of the securities being registered are to be offered otherwise than for cash, the general purposes of the distribution, the basis upon which the securities are to be offered, the amount of compensation and other expenses of distribution, and by whom they are to be borne;

any delayed delivery arrangements;

any over-allotment or other options under which underwriters may purchase additional securities from us;

any agency fees or broker-dealers, the Selling Stockholders will be responsible for underwriting discounts and other items constituting agents’ or underwriters’ compensation;

any public offering price;

any discounts, commissions or concessions allowed or reallowed or paid to dealers;

the identity and relationships of any similar expenses it incurs in disposing of the Common Stock,finders, if applicable; and

any and any related legal expenses incurred by it. The shares of Common Stock may be sold on any national securities exchange or quotation servicemarket on which the securities may be listedlisted.

25

In compliance with the guidelines of the Financial Industry Regulatory Authority, the maximum compensation to the underwriters or quoted atdealers in connection with the timesale by the Company of sale,its securities pursuant to this prospectus and the accompanying supplement to this prospectus may not exceed 8% of the aggregate offering price of the securities as set forth on the cover page of any prospectus supplement.

Only underwriters named in the over-the-counter market or in transactions otherwise than on these exchanges or systems orprospectus supplement will be underwriters of the securities offered by the prospectus supplement.

If underwriters are used in the over-the-counter marketsale, they will acquire the securities for their own account and may resell the securities from time to time in one or more transactions at a fixed prices, at prevailing market prices at the time of the sale,public offering price or at varying prices determined at the time of sale, or at negotiated prices. These sales may be effected in transactions, which may involve crosses or block transactions. In addition, the Selling Stockholders may use any one or moresale. The obligations of the following methods when selling shares:

ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;

block trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block as principal to facilitate the transaction;

purchases by a broker-dealer as principal and resale by the broker-dealer for its account;

an exchange distribution in accordance with the rules of the applicable exchange;

privately negotiated transactions;

settlement of short sales entered into after the effective date of the registration statement of which this prospectus is a part;

broker-dealers may agree with the Selling Stockholders to sell a specified number of such shares at a stipulated price per share;

through the writing or settlement of options or other hedging transactions, whether such options are listed on an options exchange or otherwise;

a combination of any such methods of sale; and

any other method permitted pursuant to applicable law.

The Selling Stockholders also may resell all or a portion ofunderwriters to purchase the shares in open market transactions in reliance upon Rule 144 under the Securities Act, as permitted by that rule, or Section 4(a)(1) under the Securities Act, if available, rather than under this prospectus, provided that they meet the criteria and conformsecurities will be subject to the requirements of those provisions.

-19-

Broker-dealers engaged by the Selling Stockholders may arrange for other broker-dealers to participate in sales. If the Selling Stockholders effect such transactions by selling shares of Common Stock to or through underwriters, broker-dealers or agents, such underwriters, broker-dealers or agents may receive commissions in the form of discounts, concessions or commissions from the Selling Stockholders or commissions from purchasers of the shares of Common Stock for whom they may act as agent or to whom they may sell as principal. Such commissions will be in amounts to be negotiated, but, except asconditions set forth in the applicable underwriting agreement. We may offer the securities to the public through underwriting syndicates represented by managing underwriters or by underwriters without a supplement to this prospectus,syndicate. Unless otherwise indicated in the caseprospectus supplement, subject to certain conditions, the underwriters will be obligated to purchase all of an agency transactionthe securities offered by the prospectus supplement, other than securities covered by any over-allotment option. Any public offering price and any discounts or concessions allowed or reallowed or paid to dealers may change from time to time. We may use underwriters, dealers or agents with whom we have a material relationship. We will not be in excess of a customary brokerage commission in compliance with FINRA Rule 2121; anddescribe in the caseprospectus supplement, naming the underwriter, dealer or agent, the nature of a principal transaction a markup or markdown in compliance with FINRA Rule 2121.01.any such relationship.

 

In connection with sales ofWe may use a remarketing firm to offer the shares of Common Stock or otherwise, the Selling Stockholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of the shares of Common Stock in the course of hedging in positions they assume. The Selling Stockholders may also sell shares of Common Stock short and if such short sale shall take place after the date that this Registration Statement is declared effective by the Commission, the Selling Stockholders may deliver shares of Common Stock covered by this prospectus to close out short positions and to return borrowed sharessecurities in connection with such short sales.a remarketing arrangement upon their purchase. Remarketing firms will act as principals for their own account or as agents for us. These remarketing firms will offer or sell the securities pursuant to the terms of the securities. A prospectus supplement will identify any remarketing firm and the terms of its agreement, if any, with us and will describe the remarketing firm’s compensation. Remarketing firms may be deemed to be underwriters in connection the securities they remarket.

If we offer and sell securities through a dealer, we or an underwriter will sell the securities to the dealer, as principal. The Selling Stockholdersdealer may also loan or pledge sharesthen resell the securities to the public at varying prices to be determined by the dealer at the time of Common Stock to broker-dealers thatresale. The name of the dealer and the terms of the transaction will be set forth in turnthe applicable prospectus supplement.

We may sell such shares, to the extent permitted by applicable law. The Selling Stockholders may also enter into optionsecurities directly or other transactions with broker-dealers or other financial institutions or the creation of one or more derivative securities which require the delivery to such broker-dealer or other financial institution of shares offered by this prospectus, which shares such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction). Notwithstanding the foregoing, the Selling Stockholders have been advised that they may not use shares registered on this registration statement to cover short sales of our common stock made prior to the date the registration statement, of which this prospectus forms a part, has been declared effective by the Commission.

The Selling Stockholders may,through agents we designate from time to time, pledge or grant a security interest in some or all of the Warrants or shares of Series A Preferred Stock or Common Stock owned by them and, if they defaulttime. We will name any agent involved in the performanceoffering and sale of their secured obligations,securities and we will describe any commissions payable to the pledgees or secured parties may offer and sellagent in the sharesprospectus supplement. Unless the prospectus supplement states otherwise, the agent will act on a best-efforts basis for the period of Common Stock from time to time pursuant to this prospectus or any amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act amending, if necessary, the list of Selling Stockholders to include the pledgee, transferee or other successors in interest as Selling Stockholders under this prospectus. The Selling Stockholders also may transfer and donate the shares of Common Stock in other circumstances in which case the transferees, donees, pledgees or other successors in interest will be the selling beneficial owners for purposes of this prospectus.its appointment.

 

The Selling StockholdersDealers and any broker-dealer or agents participatingsparticipating in the distribution of the shares of Common Stocksecurities may be deemed to be “underwriters” within the meaning of Section 2(a)(11) of the Securities Act in connection with such sales. In such event, any commissions paid, or any discounts or concessions allowed to, any such broker-dealer or agentunderwriters, and any profitcompensation received by them on the resale of the shares purchased by themsecurities may be deemed to be underwriting commissionsdiscounts. If such dealers or discountsagents were deemed to be underwriters, they may be subject to statutory liabilities under the Securities Act. Selling Stockholders who are "underwriters" within the meaning of Section 2(a)(11) of the Securities Act will be subject to the applicable prospectus delivery requirements of the Securities Act including Rule 172 thereunder and may be subject to certain statutory liabilities of, including but not limited to, Sections 11, 12 and 17 of the Securities Act and Rule 10b-5 under the Exchange Act.

 

Except as set forth herein, each Selling Stockholder has informed the CompanyWe may sell securities directly to one or more purchasers without using underwriters or agents. Underwriters, dealers and agents that it is not a registered broker-dealer and does not have any written or oral agreement or understanding, directly or indirectly, with any person to distribute the Common Stock. Upon the Company being notified in writing by a Selling Stockholder that any material arrangement has been entered into with a broker-dealer for the sale of common stock through a block trade, special offering, exchange distribution or secondary distribution or a purchase by a broker or dealer, a supplement to this prospectus will be filed, if required, pursuant to Rule 424(b) under the Securities Act, disclosing (i) the name of each such Selling Stockholder and of the participating broker-dealer(s), (ii) the number of shares of Common Stock involved, (iii) the price at which such the shares of Common Stock were sold, (iv) the commissions paid or discounts or concessions allowed to such broker-dealer(s), where applicable, (v) that such broker-dealer(s) did not conduct any investigation to verify the information set out or incorporated by reference in this prospectus, and (vi) other facts material to the transaction. In no event shall any broker-dealer receive fees, commissions and markups, in the aggregate, in excess of eight percent (8.0%) of any offering.

-20-

Under the securities laws of some states, the shares of Common Stock may be sold in such states only through registered or licensed brokers or dealers. In addition, in some states the shares of Common Stock may not be sold unless such shares have been registered or qualified for sale in such state or an exemption from registration or qualification is available and is complied with. Subject to the terms of the Registration Rights Agreement, the Company has no obligation to qualify the resale of any shares in any particular state.

There can be no assurance that any Selling Stockholder will sell any or all of the shares of Common Stock registered pursuant to the shelf registration statement, of which this prospectus forms a part.

Each Selling Stockholder and any other person participating in such distribution will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder, including, without limitation, to the extent applicable, Regulation M of the Exchange Act, which may limit the timing of purchases and sales of any of the shares of Common Stock by the Selling Stockholder and any other participating person. To the extent applicable, Regulation M may also restrict the ability of any person engagedparticipate in the distribution of the shares of Common Stock to engagesecurities may be underwriters as defined in market-making activities with respect to the shares of Common Stock. AllSecurities Act, and any discounts or commissions they receive from us and any profit on their resale of the foregoingsecurities may affect the marketability of the shares of Common Stock and the ability of any person or entity to engage in market-making activities with respect to the shares of Common Stock.

We will pay all expenses of the registration of the shares of Common Stock pursuant to the registration rights agreement, including, without limitation, Commission filing fees and expenses of initial compliance with state securities or “blue sky” laws;provided,however, that each selling stockholder will pay allbe treated as underwriting discounts commissions and any similar expenses it incurs in disposing of the Common Stock, if any, and any related legal expenses incurred by it. We will indemnify the Selling Stockholders against certain liabilities, including some liabilitiescommissions under the Securities Act, in accordance with the Registration Rights Agreements, or the Selling Stockholders will be entitled to contribution. Act.

We may be indemnifiedauthorize agents or underwriters to solicit offers by certain types of institutional investors to purchase securities from us at the Selling Stockholderspublic offering price set forth in the prospectus supplement pursuant to delayed delivery contracts providing for payment and delivery on a specified date in the future. We will describe the conditions to these contracts and the commissions we must pay for solicitation of these contracts in the prospectus supplement.

We may provide agents, underwriters, and dealers with indemnification against civil liabilities, including liabilities under the Securities Act, or contribution with respect to payments that the agents, underwriters, or dealers may arise frommake with respect to these liabilities. Agents, underwriters and dealers, or their respective affiliates, may engage in transactions with, or perform services for, us in the ordinary course of business.

The securities we offer may be new issues of securities and may have no established trading market. The securities may or may not be listed on a securities exchange. Underwriters may make a market in these securities, but will not be obligated to do so and may discontinue any written information furnishedmarket making at any time without notice. We can make no assurance as to us by the Selling Stockholders specificallyliquidity of, or the existence of trading markets for, useany of the securities.

Any underwriter may engage in this prospectus,over-allotment, stabilizing transactions, short-covering transactions and penalty bids in accordance with Regulation M under the related Registration Rights AgreementsExchange Act. Over-allotment involves sales in excess of the offering size, which create a short position. Stabilizing transactions permit bids to purchase the underlying security so long as the stabilizing bids do not exceed a specified maximum price. Syndicate-covering or weother short-covering transactions involve purchases of the securities, either through exercise of the over-allotment option or in the open market after the distribution is completed, to cover short positions. Penalty bids permit the underwriters to reclaim a selling concession from a dealer when the securities originally sold by the dealer are purchased in a stabilizing or covering transaction to cover short positions. Those activities may cause the price of the securities to be higher than it would otherwise be. If commenced, the underwriters may discontinue any of the activities at any time.

Any underwriters that are qualified market makers on the Nasdaq Global Select Market may engage in passive market making transactions in the common stock on the Nasdaq Global Select Market in accordance with Regulation M under the Exchange Act, during the business day prior to the pricing of the offering, before the commencement of offers or sales of the common stock. Passive market makers must comply with applicable volume and price limitations and must be identified as passive market makers. In general, a passive market maker must display its bid at a price not in excess of the highest independent bid for such security; if all independent bids are lowered below the passive market maker’s bid, however, the passive market maker’s bid must then be lowered when certain purchase limits are exceeded. Passive market making may stabilize the market price of the securities at a level above that which might otherwise prevail in the open market and, if commenced, may be entitled to contribution.discontinued at any time.

 

26
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WHERE YOU CAN FIND MORE INFORMATION LEGAL MATTERS 

 

Available Information

We file annual, quarterly and current reports, proxy statements and other information withDechert LLP will pass for us upon the Commission. You may read and copy any of this information at the Commission’s public reference room at 100 F Street, N.E., Washington, D.C. 20549. Please call the Commission at (800) SEC-0330 or (202) 942-8090 for further information on the public reference room. The Commission also maintains an Internet website that contains reports, proxy statements and other information regarding issuers, including us, who file electronically with the Commission. The address of that site iswww.sec.gov.

We also maintain an Internet website atwww.diffusionpharma.com, which can be used to access free of charge, through the investor relations section, our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, current reports on Form 8-K and any amendments to those reports, as soon as reasonably practicable after we electronically file such material with or furnish it to the Commission and all such reports of ours going forward. The information set forth on, or connected to, our website is expressly not incorporated by reference into, and does not constitute a part of, this prospectus.

This prospectus is part of a registration statement on Form S-3 that we have filed with the Commission under the Securities Act, for the registration under the Securities Actvalidity of the securities offered hereby. This prospectus does not contain all the information set forth in the registration statement, parts of which are omitted in accordance with the rules and regulations of the Commission. Reference is hereby made to the registration statement which contains further information with respect to our company and our securities. Statements herein concerning the provisions of documents filed as exhibits to the registration statement are necessarily summaries of such documents, and each such statement is qualified by reference to the copy of the applicable document filed with the Commission.

Incorporation of Documents by Reference

The Commission allows us to incorporate by reference information into this prospectus. This means we can disclose information to you by referring you to another document we filed with the Commission. We will make those documents available to you without charge upon your oral or written request. Requests for those documents should be directed to Investor Relations Department, Diffusion Pharmaceuticals Inc., 2020 Avon Court, Suite 4, Charlottesville, Virginia 22902, Attention: Secretary, telephone: (434) 220-0718. This prospectus incorporates by reference the following documents (other than any portion of the respective filings furnished, rather than filed, under the applicable Commission rules) that we have filed with the Commission but have not included or delivered with this prospectus:

Our Annual Report on Form 10-K for the fiscal year ended December 31, 2016, as amended, filed with the Commission on March 31, 2017.

Our Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2017, filed with the Commission on May 15, 2017.

Our Current Reports on Form 8-K filed on January 9, 2017, January 26, 2017 (to the extent not furnished), March 15, 2017, April 3, 2017, April 11, 2017 and May 26, 2017.

Our Definitive Proxy Statement on Schedule 14A filed on May 12, 2016.

The description of our Common Stock included in our amended registration statements on Form 8-A filed on November 8, 2016 under the Exchange Act, and any amendment or report we may file with the Commission for the purpose of updating such description.

We also incorporate by reference into this registration statement and prospectus any future filings we will make with the Commission under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act prior to the termination of the offering of the securities covered by this prospectus (other than current reports or portions thereof furnished under Item 2.02 or Item 7.01 of Form 8-K).This additional information is a part of this prospectus from the date of filing of those documents.

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Any statements made in this prospectus or in a document incorporated or deemed to be incorporated by reference into this prospectus will be deemed to be modified or superseded for purposes of this prospectus to the extent that a statement contained in this prospectus or in any other subsequently filed document, which is also incorporated or deemed to be incorporated into this prospectus, modifies or supersedes the statement. Any statement so modified or superseded will not be deemed, except as so modified or superseded, to constitute a part of this prospectus. The information relating to us contained in this prospectus should be read together with the information in the documents incorporated by reference.

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LEGAL MATTERS 

The validity of the issuance of the Common Stockbeing offered by this prospectus and applicable prospectus supplement, and counsel named in the applicable prospectus supplement will be passedpass upon legal matters for us by Dechert LLP, New York, New York. Any underwriterany underwriters, dealers or agent will be advised about other issues relating to any offering by its own legal counsel.agents.

 

EXPERTS 

 

The consolidated financial statements of Diffusion Pharmaceuticals Inc. as of and for the years ended December 31, 20162019 and 2015,2018, have been incorporated by reference herein and in the registration statement in reliance upon the report of KPMG LLP, independent registered public accounting firm, incorporated by reference herein, and upon the authority of said firm as experts in accounting and auditing. The audit report covering the December 31, 20162019 consolidated financial statements contains an explanatory paragraph that states that the Company has suffered recurring losses from operations, has limited resources available to fund current research and development activities, and will require substantial additional financing to continue to fund its research and development activities whichthat raise substantial doubt about its ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

WHERE YOU CAN FIND MORE INFORMATION 

We have filed with the SEC a registration statement on Form S-3 under the Securities Act, with respect to the securities being offered by this prospectus. This prospectus does not contain all of the information in the registration statement and its exhibits. For further information with respect to us and the securities offered by this prospectus, we refer you to the registration statement and its exhibits. Statements contained in this prospectus as to the contents of any contract or any other document referred to are not necessarily complete, and in each instance, we refer you to the copy of the contract or other document filed as an exhibit to the registration statement. Each of these statements is qualified in all respects by this reference.

We file electronically with the SEC annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy statements and other information and amendments to those reports filed or furnished pursuant to Section 13 or 15(d) of the Exchange Act. The SEC maintains an Internet site (www.sec.gov) that uncertainty.contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC. Copies of these reports, proxy and information statements and other information may be obtained by electronic request at the following e-mail address: publicinfo@sec.gov.

We make available, free of charge and through our Internet web site at www.diffusionpharma.com, our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and any amendments to any such reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC. We also make available, free of charge and through our Internet web site, to any stockholder who requests, the charters of our board committees, our Corporate Governance Guidelines and our Code of Business Conduct and Ethics. Requests for copies can be directed to Investor Relations at (434) 220-0718. The information set forth on, or connected to, our website is expressly not incorporated by reference into, and does not constitute a part of, this prospectus.

INFORMATION INCORPORATED BY REFERENCE 

The SEC allows us to incorporate by reference information into this prospectus. This means we can disclose information to you by referring you to another document we filed with the SEC. We will make those documents available to you without charge upon your oral or written request. Requests for those documents should be directed to Investor Relations Department, Diffusion Pharmaceuticals Inc., 1317 Carlton Avenue, Suite 200, Charlottesville, Virginia 22902, Attention: Secretary, telephone: (434) 220-0718. This prospectus incorporates by reference the following documents (other than any portion of the respective filings furnished, rather than filed, under the applicable SEC rules) that we have filed with the SEC but have not included or delivered with this prospectus:

our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, filed with the SEC on March 17, 2020;

our Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, 2020 and June 30, 2020 filed with the SEC on May 1, 2020 and August 7, 2020, respectively;

our Current Reports on Form 8-K filed with the SEC on January 13, 2020, February 6, 2020, March 18, 2020, March 24, 2020, April 1, 2020, April 29, 2020, May 6, 2020, May 8, 2020, May 20, 2020, May 20, 2020, May 26, 2020, June 1, 2020, June 12, 2020, June 17, 2020, July 7, 2020, July 29, 2020, September 4, 2020, September 9, 2020 and September 10, 2020;

27

our Definitive Proxy Statement on Schedule 14A filed with the SEC on April 29, 2020; and

the description of our common stock included in our amended registration statement on Form 8-A filed on November 8, 2016 under the Exchange Act, and any amendment or report we may file with the SEC for the purpose of updating such description.

In addition, all documents subsequently filed by us pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act, prior to the termination of the offering shall be deemed to be incorporated by reference into this prospectus (other than current reports or portions thereof furnished under Item 2.02 or Item 7.01 of Form 8-K).

You may request a free copy of any or all of the documents incorporated by reference in this prospectus by writing or telephoning us at the following address:

Diffusion Pharmaceuticals Inc.

1317 Carlton Avenue, Suite 200

Charlottesville, Virginia 22902

(434) 220-0718

Attention: Investor Relations

In accordance with Rule 412 of the Securities Act, any statement contained in a document incorporated by reference herein shall be deemed modified or superseded to the extent that a statement contained herein or in any other subsequently filed document which also is or is deemed to be incorporated by reference herein modifies or supersedes such statement.

28



$ 75,000,000  

Common Stock
Preferred Stock
Debt Securities
Warrants

Units
Rights to Purchase Common Stock, Preferred Stock, Debt Securities or Units


P R O S P E C T U S


                   , 2020

 

 

 
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PART II

Information Not Required in Prospectus

 

INFORMATION NOT REQUIRED IN PROSPECTUS

Item 14.Other Expenses of Issuance and Distribution

 

The following is a statement oftable sets forth the various expenses (all of which are estimated) to be incurred by us in connection with a distributionthe registration of the Common Stocksecurities being registered under this registration statement:hereby, all of which will be borne by the registrant.

 

SEC registration fee

 $8,896 

Securities and Exchange Commission registration fee

 $5,970.68 

Transfer agent’s and trustee’s fees and expenses

   *

Printing and engraving expenses

    *

Legal fees and expenses

 35,000     *

Accounting fees and expenses

 $7,050     *

Printing fees

   *

Miscellaneous

   *

Miscellaneous expenses

    *

FINRA filing fee (if applicable)

    *

Total

 $50,946

 

 $  *

 

 

*

TheThese fees cannot be estimated at this time, as they are calculated based on the securities offered and the number of issuances. In accordance with Rule 430B, an estimate of the aggregate expenses are presently indeterminablein connection with the sale and distribution of the securities being offered will be set forthincluded in the applicable prospectus supplement with respect to any offering of the Common Stock registered hereunder.supplement.

 

Item 15.Indemnification of Directors and Officers

The summary set forth below does not purport to be complete and is subject to and qualified in its entirety by reference to our Certificate of Incorporation and Bylaws, each of which is incorporated by reference as an exhibit to the registration statement of which this prospectus is a part, and the applicable provisions of the Delaware General Corporation Law.

 

We are incorporated under the laws of the State of Delaware. Section 145 of the Delaware General Corporation Law (“DGCL”) provides that a Delaware corporation may indemnify any persons who are, or are threatened to be made, parties to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of such corporation), by reason of the fact that such person was an officer, director, employee or agent of such corporation, or is or was serving at the request of such person as an officer, director, employee or agent of another corporation or enterprise. The indemnity may include expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person in connection with such action, suit or proceeding, provided that such person acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the corporation’s best interests and, with respect to any criminal action or proceeding, had no reasonable cause to believe that his or her conduct was illegal. A Delaware corporation may indemnify any persons who are, or are threatened to be made, a party to any threatened, pending or completed action or suit by or in the right of the corporation by reason of the fact that such person was a director, officer, employee or agent of such corporation, or is or was serving at the request of such corporation as a director, officer, employee or agent of another corporation or enterprise. The indemnity may include expenses (including attorneys’ fees) actually and reasonably incurred by such person in connection with the defense or settlement of such action or suit provided that such person acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the corporation’s best interests except that no indemnification is permitted without judicial approval if the officer or director is adjudged to be liable to the corporation. Where an officer or director is successful on the merits or otherwise in the defense of any action referred to above, the corporation must indemnify him or her against the expenses which such officer or director has actually and reasonably incurred. OurArticle V of our restated certificate of incorporation and bylaws provideprovides for the indemnification of our directors and officers, and Article X of our amended and restated bylaws provides for indemnification of our directors, officers, employees and other agents, to the fullestmaximum extent permitted underby the Delaware General Corporation Law.DGCL. We have entered into indemnification agreements with our officers and directors. In addition, we maintain a policy providing directors’ and officers’ liability insurance.

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Section 102(b)(7)102 of the Delaware General Corporation LawDGCL permits a corporation to provide in its certificate of incorporation that a director of the corporation shall not be personally liable to the corporation or its stockholders for monetary damages for breach of fiduciary duties as a director, except for liability for any:liability:

 

transaction from which the director derives an improper personal benefit;

for any breach of the director’s duty of loyalty to the corporation or its stockholders;

 

act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;

for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law;

 

unlawful payment of dividends or redemption of shares; or

for acts related to unlawful stock repurchases, redemptions or other distributions or payment of dividends; or

 

breach of a director’s duty of loyalty to the corporation or its stockholders.

for any transaction from which the director derived an improper personal benefit.

 

Our restated certificate of incorporation includesand amended and restated bylaws include such a provision. Expenses incurred by any officer or director in defending any such action, suit or proceeding in advance of its final disposition shall be paid by us upon delivery to us of an undertaking, by or on behalf of such director or officer, to repay all amounts so advanced if it shall ultimately be determined that such director or officer is not entitled to be indemnified by the Company.us.

II-1

Item 16. Exhibits

 

As permittedThe following documents are filed as exhibits to this registration statement, including those exhibits incorporated herein by the Delaware General Corporation Law, we have entered into and intendreference to enter into indemnification agreements with eachone of our directors and executive officers. These agreements, among other things, require us to indemnify each director and officer to the fullest extent permitted by law and advance expenses to each indemnitee in connection with any proceeding in which indemnification is available.

We have an insurance policy covering our officers and directors with respect to certain liabilities, including liabilities arisingprior filing under the Securities Act or otherwise.

Item 16.  Exhibits

The exhibits to this registration statement are listedthe Exchange Act as indicated in the exhibit index that immediately precedes such exhibits and is incorporated herein by reference.

Item 17.  Undertakingsparentheses:

 

(a)Exhibit
Number

The undersigned

Document

1.1*

Form of underwriting agreement

3.1

Certificate of Incorporation of Diffusion Pharmaceuticals Inc., as amended (incorporated by reference to Exhibit 3.1 to Diffusion Pharmaceuticals Inc.’s Form 10-K for the year ended December 31, 2019).

3.2

By-Laws of Diffusion Pharmaceuticals Inc., as amended (incorporated by reference to Exhibit 3.4 to Diffusion Pharmaceuticals Inc.'s Form 10-K for the year ended December 31, 2015).

4.1

Specimen Stock Certificate representing shares of Diffusion Pharmaceuticals Inc.’s $0.001 par value Common Stock (incorporated by reference to Exhibit 4.1 to Diffusion Pharmaceutical Inc.’s Registration Statement on Form S-3 filed May 16, 2019).

4.2*

Form of certificate of designation with respect to any preferred stock issued hereunder and the related form of preferred stock certificate.

4.3

Form of indenture to be entered into between registrant hereby undertakes:and a trustee acceptable to the registrant.

4.4*

Form of warrant agreement.

4.5*

Form of warrant certificate.

4.6*

Form of debt security.

4.7*

Form of rights certificate.

4.8*

Form of unit agreement.

4.9*

Form of unit certificate.

5.1

Opinion of Dechert LLP.

23.1

Consent of KPMG LLP.

23.2

Consent of Dechert LLP (included in its Opinion filed as Exhibit 5.1 hereto).

24.1

Powers of Attorney (included on signature page).

25.1**

Statement of Eligibility of Trustee on Form T-1 under Trust Indenture Act of 1939.


*

To be filed, if applicable, by amendment or as an exhibit to a document filed under the Securities Exchange Act of 1934, as amended, and incorporated by reference herein.

 

(1)**

To file, during any period in which offers or sales are being made, a post-effective amendmentbe filed separately pursuant to this registration statement:Section 305(b)(2) of the Trust Indenture Act of 1939, as amended, and the appropriate rules and regulations thereunder.

 

(i)

To 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 percent change in the maximum aggregate offering price set forth in the “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 the registration statement or any material change to such information in the registration statement;

II-2

 

Item 17. Undertakings

The undersigned 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)    To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;

(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 20 percent change in the maximum aggregate offering price set forth in the “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 the registration statement or any material change to such information in the registration statement;

provided, however, that paragraphs (a)(1)(i), (1)(ii) and (1)(iii) above do not apply if the registration statement is on Form S-1, Form S-3, Form SF-3 or Form F-3 and 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 sectionSection 13 or sectionSection 15(d) of the Exchange Act that are incorporated by reference in the registration statement, or is contained in a form of prospectus filed pursuant to Rule 424(b) that is part of the registration statement.

(2) That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment 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.

(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 of 1933 to any purchaser:

(i)   Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and

(ii)  Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information required by section 10(a) of the Securities Act shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of this registration statement or made in a document incorporated or deemed incorporated by reference into this registration statement or prospectus that is part of this registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in this registration statement or prospectus that was part of this registration statement or made in any such document immediately prior to such effective date.

(5) That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:

(i)    Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424;

 

II-3
-26-

 

(2)

(ii)   Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant;

That, for 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 therein, and the offering of such securities at that time shall be deemed to be the initialbona fide offering thereof.

 

(3)

(iii)  The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and

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)

(iv)  Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.

That, for the purpose of determining liability under the Securities Act to any purchaser:

 

(i)

The undersigned hereby undertakes that, for purposes of determining any liability under the Securities Act of 1933, each filing of the registrant’s annual report pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Securities Exchange Act of 1934) 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.

Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and

  

(ii)

The undersigned registrant hereby undertakes that:

Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information required by section 10(a) of the Securities Act shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initialbona fide offering thereof.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 effective date, 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 effective date.

 

(b)

(1)    For purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filed as a 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 a part of this registration statement as of the time it was declared effective.

The undersigned registrant hereby undertakes 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 section 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 initialbona fide offering thereof.

 

(c)

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 Commission such indemnification is against public policy as expressed in the 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 Act and will be governed by the final adjudication of such issue

(ii)   For the purpose of determining any liability under the Securities Act of 1933, 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.

Insofar as indemnification for liabilities arising under the Securities Act of 1933 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 of 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.

The undersigned registrant hereby undertakes to file an application for the purpose of determining the eligibility of the trustee to act under subsection (a) of section 310 of the Trust Indenture Act (“Act”) in accordance with the rules and regulations prescribed by the Commission under section 305(b)(2) of the Act. 

 

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-27-

 

SIGNATURES

 

Pursuant to the requirements of the Securities Act of 1933, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-3 and has duly caused this Amendment No. 1 to the Registration Statementregistration statement on Form S-3 to be signed on its behalf by the undersigned, thereunto duly authorized, in Charlottesville, VA on the city of Charlottesville, Commonwealth of Virginia, on this 30th25th day of May, 2017.September, 2020.

 

 

DIFFUSION PHARMACEUTICALS INC.   Diffusion Pharmaceuticals Inc.

 

By:

/s/ Robert J. Cobuzzi, Jr.

Robert J. Cobuzzi, Jr.

President and Chief Executive Officer

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POWER OF ATTORNEY

KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Robert J. Cobuzzi, Jr. and William K. Hornung, and each of them, as his true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for him and in his name, place and stead, in any and all capacities, to sign any and all amendments (including post-effective amendments) and exhibits to this registration statement and sign any registration statement for the same offering covered by the registration statement that is to be effective upon filing pursuant to Rule 462 promulgated under the Securities Act of 1933, as amended, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith and about the premises, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or any of them, or their or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.

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.

Name and Signature

Title

Date

/s/ Robert J. Cobuzzi, Jr.

President, Chief

Robert J. Cobuzzi, Jr.

Executive Officer and Director

(Principal Executive Officer)

 September 25, 2020

/s/ William K. Hornung

Chief Financial Officer

September 25, 2020

William K. Hornung

(Principal Financial and Accounting Officer)

/s/ David G. Kalergis

Chairman of the Board of Directors

September 25, 2020

David G. Kalergis

 

 

 

 

 

 

 

 

/s/ Robert Adams

 

By:Director

/s/ David G. Kalergis

September 25, 2020

Robert Adams

 

 

 

David G. Kalergis

/s/ John L. Gainer, Ph.D.

Director

September 25, 2020

John L. Gainer, Ph.D.

 

 

 

Chief Executive Officer
(Principal Executive Officer)

 

 

Pursuant to the requirements of the Securities Act of 1933, as amended, this Amendment No. 1 to the Registration Statement has been signed by the following persons in the capacities and the dates indicated.

Signature

Title

Date

/s/ David G. KalergisMark T. Giles

Chief Executive Officer and Chairman

May 30, 2017

David G. Kalergis

/s/ Ben L. Shealy

Senior Vice President – Finance, Treasurer and

Secretary (Principal Financial Officer)

May 30, 2017

Ben L. Shealy

*

Vice Chairman, Board of Directors

May 30, 2017

Isaac Blech

*

Director

May 30, 2017

John L. Gainer, Ph.d.

*

Director

May 30, 2017

Robert Adams

*

Director

May 30, 2017September 25, 2020

Mark T. Giles

*

Director

May 30, 2017

Alan Levin

*By:

 

/s/ David G. Kalergis

David G. Kalergis
Attorney-in-fact

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EXHIBIT INDEX

 

 

 

Exhibit No.

 

Description

3.1*

 

Certificate of Incorporation of Diffusion Pharmaceuticals Inc., as amended (incorporated by reference to Exhibit 3.1 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2016 (File No. 001-37942), filed March 31, 2017).

3.2*/s/ Jane H. Hollingsworth

 

Bylaws of Diffusion Pharmaceuticals Inc., as amended (incorporated by reference to Exhibit 3.4 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2015 (File No. 001-24477), filed March 25, 2016).

3.3*Director

 

Certificate of Designations for Series A Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37942), filed March 15, 2017).September 25, 2020

3.4*Jane H. Hollingsworth

 

Certificate of Conversion, as filed with the Secretary of State of the State of Delaware on June 18, 2015 (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K (File No. 001-24477), filed June 18, 2015).

4.1*

 

Form of Warrant issued to Investors in the 2017 Private Placement by Diffusion Pharmaceuticals Inc. (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37942), filed March 15, 2017).

4.2*

 

Form of Registration Rights Agreement entered into by and among the Company and Investors in the 2017 Series A Private Placement (incorporated by reference to Exhibit 4.2 to the Registrant’s Quarterly Report on Form 10-Q for the period ended March 31, 2017 (File No. 001-37942), filed May 15, 2017).

4.3*

Form of Diffusion Pharmaceuticals Inc. Convertible Note Agreement (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37942), filed October 3, 2016).

4.4*

Form of Diffusion Pharmaceuticals LLC Convertible Note Agreement (incorporated by reference to Exhibit 4.7 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2015 (File No. 001-24477), filed March 25, 2016).

5.1*

 

Opinion of Dechert LLP regarding validity

10.1*

Placement Agency Agreement, dated January 27, 2017, by and between Diffusion Pharmaceuticals Inc. and Maxim Merchant Capital, a division of Maxim Group LLC (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37942), filed March 15, 2017).

10.2*

Form of 2017 Private Placement Subscription Agreement (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K (File No. 001-37942), filed March 15, 2017).

10.3*

Amendment to the Placement Agency Agreement, dated March 14, 2017, by and between Diffusion Pharmaceuticals Inc. and Maxim Merchant Capital, a division of Maxim Group LLC (incorporated by reference to Exhibit 10.17 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2016 (File No. 001-37942), filed March 31, 2017).

23.1

 

Consent of KPMG LLP

23.2*/s/ Alan Levin

 

Consent of Dechert LLP (included in Exhibit 5.1)

24.1*Director

 

Powers of Attorney (included on signature page of the Registration Statement)September 25, 2020

Alan Levin

 

*    -    Previously filed.  

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