UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended JuneSeptember 30, 2023

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from _________ to _________

 

Commission File No. 001-40899

 

Bone Biologics Corporation

(Exact name of registrant as specified in its charter)

 

Delaware 42-1743430

(State or other jurisdiction of

incorporation or formation)

 

(I.R.S. employer

identification number)

 

2 Burlington Woods Drive, Ste 100, Burlington, MA 01803

(Address of principal executive offices and Zip Code)

 

(781) 552-4452

(Registrant’s telephone number, including area code)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class Trading Symbol(s) Name of each exchange on which registered
Common stock, $0.001 par value per share BBLG The Nasdaq Capital Market
Warrants to Purchase Common stock, $0.001 par value per share BBLGW The Nasdaq Capital Market

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the issuer was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

 

Yes ☐ No

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (Section 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).

 

Yes ☐ No

 

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 filerAccelerated filer
Non-accelerated filerSmaller reporting company
  Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

 

☐ Yes ☒ No

 

As of August 11,November 10, 2023, there were 3,134,391 shares of the issuer’s common stock, $0.001 par value, outstanding.

 

 

 

 

 

 

Bone Biologics Corporation

- INDEX -

 

 Page
PART I – FINANCIAL INFORMATION: 
  
Item 1. Financial Statements.F-1
  
Unaudited Condensed Consolidated Financial Statements 
  
Unaudited Condensed Consolidated Balance SheetsF-1
  
Unaudited Condensed Consolidated Statements of OperationsF-2
  
Unaudited Condensed Consolidated StatementStatements of Stockholders’ EquityF-3
  
Unaudited Condensed Consolidated Statements of Cash FlowsF-5
  
Notes to Unaudited Condensed Consolidated Financial StatementsF-6
  
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations4
  
Item 3. Quantitative and Qualitative Disclosures about Market Risk89
  
Item 4. Controls and Procedures89
  
PART II – OTHER INFORMATION:910
  
Item 1. Legal Proceedings910
  
Item 1A. Risk Factors910
  
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds910
  
Item 3. Defaults Upon Senior Securities910
  
Item 4. Mine Safety Disclosures910
  
Item 5. Other Information910
  
Item 6. Exhibits1011
  
Signatures1112

 

2

 

NOTE ON FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q (this “Form 10-Q”) contains forward-looking statements. Such forward-looking statements include those that express plans, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact. These forward-looking statements are based on our current expectations and projections about future events and they are subject to risks and uncertainties known and unknown that could cause actual results and developments to differ materially from those expressed or implied in such statements. These forward-looking statements are subject to a number of risks, uncertainties and assumptions. For a more detailed listing of some of the risks and uncertainties facing the Company, please see our Current Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 30, 2023.2023 and subsequent Quarterly Reports on Form 10-Q or other reports filed with the SEC.

 

All statements other than historical facts contained in this report, including statements regarding our future financial position, capital expenditures, cash flows, business strategy and plans and objectives of management for future operations are forward-looking statements. The words “anticipated,” “believe,” “expect,” “plan,” “intend,” “seek,” “estimate,” “project,” “could,” “may,” and similar expressions are intended to identify forward-looking statements. These statements include, among others, information regarding future operations, future capital expenditures, and future net cash flow. Such statements reflect our management’s current views with respect to future events and financial performance and involve risks and uncertainties, including, without limitation, our ability to raise additional capital to fund our operations, inflation, rising interest rates, governmental responses there to and possible recession caused thereby, obtaining Food and Drug Administration (“FDA”) and other regulatory authorization to market our drug and biological products, successful completion of our clinical trials, our ability to achieve regulatory authorization to market our lead product NELL-1, our reliance on third party manufacturers for our drug products, market acceptance of our products, our dependence on licenses for certain of our products, our reliance on the expected growth in demand for our products, exposure to product liability and defect claims, development of a public trading market for our securities, and various other matters, many of which are beyond our control.

 

Should one or more of these risks or uncertainties occur, or should underlying assumptions prove to be incorrect, actual results may vary materially and adversely from those anticipated, believed, estimated or otherwise indicated. Consequently, all of the forward-looking statements made in this Annual Report are qualified by these cautionary statements and accordingly there can be no assurances made with respect to the actual results or developments. We undertake no obligation to revise or publicly release the results of any revision to these forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements.

 

Unless expressly indicated or the context requires otherwise, the terms “Company,” “we,” “us,” and “our” in this document refer to Bone Biologics Corporation, a Delaware corporation, and, its wholly owned subsidiary as defined under the heading “Management’s Discussion and Analysis” in this Form 10-Q.

 

3

 

PART I – FINANCIAL INFORMATION

 

Item 1. Financial Statements.

Bone Biologics Corporation

 

Condensed Consolidated Balance Sheets

 

      
 June 30, 2023  December 31, 2022  September 30, 2023  December 31, 2022 
 (unaudited)    (unaudited)   
Assets                
                
Current Assets                
Cash $7,007,809  $7,538,312  $4,452,586  $7,538,312 
Prepaid expenses  615,238   956,925   523,758   956,925 
                
Total assets $7,623,047  $8,495,237  $4,976,344  $8,495,237 
                
Liabilities and Stockholders’ Equity                
                
Current Liabilities                
Accounts payable and accrued expenses $1,689,095  $888,461  $1,102,721  $888,461 
Warrant liability  241,160   1,659,468   80,514   1,659,468 
                
Total current liabilities  1,930,255   2,547,929   1,183,235   2,547,929 
                
Total liabilities  1,930,255   2,547,929   1,183,235   2,547,929 
                
Commitments and Contingencies  -   -   -   - 
                
Stockholders’ Equity                
Preferred Stock, $0.001 par value per share; 20,000,000 shares authorized; none issued or outstanding at June 30, 2023 and December 31, 2022  -   - 
Common stock, $0.001 par value per share; 100,000,000 shares authorized; 3,134,391 and 510,065 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively  3,135   510 
Preferred Stock, $0.001 par value per share; 20,000,000 shares authorized; none issued or outstanding at September 30, 2023 and December 31, 2022  -   - 
Common stock, $0.001 par value per share; 100,000,000 shares authorized; 3,134,391 and 510,065 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively  3,135   510 
Additional paid-in capital  83,129,021   77,907,025   83,149,047   77,907,025 
Accumulated deficit  (77,439,364)  (71,960,227)  (79,359,073)  (71,960,227)
                
Total stockholders’ equity  5,692,792   5,947,308   3,793,109   5,947,308 
                
Total liabilities and stockholders’ equity $7,623,047  $8,495,237  $4,976,344  $8,495,237 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

F-1

 

Bone Biologics Corporation

 

Condensed Consolidated Statements of Operations

 

                  
 

Three

Months Ended

June 30, 2023

 Three
Months Ended
June 30, 2022
 

Six

Months Ended

June 30, 2023

 Six
Months Ended
June 30, 2022
  

Three Months Ended

September 30, 2023

 Three Months Ended
September 30, 2022
 

Nine Months Ended

September 30, 2023

 Nine Months Ended
September 30, 2022
 
 (unaudited) (unaudited) (unaudited) (unaudited)  (unaudited) (unaudited) (unaudited) (unaudited) 
Revenues $-  $-  $-  $-  $-  $-  $-  $- 
                                
Cost of revenues  -   -   -   -   -   -   -   - 
                                
Gross profit  -   -   -   -   -   -   -   - 
                                
Operating expenses                                
Research and development  2,295,251   17,600   4,885,896   54,000   1,574,850   769,410   6,460,747   823,410 
General and administrative  744,617   451,704   1,301,509   1,104,803   506,040   449,867   1,807,548   1,554,670 
                                
Total operating expenses  3,039,868   469,304   6,187,405   1,158,803   2,080,890   1,219,277   8,268,295   2,378,080 
                                
Loss from operations  (3,039,868)  (469,304)  (6,187,405)  (1,158,803)  (2,080,890)  (1,219,277)  (8,268,295)  (2,378,080)
                                
Other expenses                                
Change in fair value of warrant liability  1,270,202   -   707,284   -   160,645   -   867,930   - 
Interest income  428   -   984   -   536   -   1,519   - 
                                
Net Loss $(1,769,238) $(469,304) $(5,479,137) $(1,158,803) $(1,919,709) $(1,219,277) $(7,398,846) $(2,378,080)
                                
Weighted average shares outstanding – basic and diluted  1,047,022   345,019   793,537   345,019 
Weighted average shares outstanding – basic  1,047,022   345,019   793,537   345,019 
                
Loss per share – basic and diluted $(1.69) $(1.36) $(6.90) $(3.36) $(0.61) $(3.53) $(4.68) $(6.89)
Loss per share – basic $(1.69) $(1.36) $(6.90) $(3.36)

Weighted average shares outstanding – basic and diluted3,134,391345,0191,582,397345,019

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

F-2

 

 

Bone Biologics Corporation

 

Consolidated Statement of Stockholders’ Equity

For the Three and SixNine Months ended JuneSeptember 30, 2023

(unaudited)

 

            Shares Amount Capital Equity Equity 
 Common Stock  Additional
Paid-in
 Accumulated Total
Stockholders’
  Common Stock  Additional
Paid-in
 Accumulated Total
Stockholders’
 
 Shares Amount Capital Equity Equity  Shares Amount Capital Equity Equity 
                      
Balance at December 31, 2022  510,065  $510  $77,907,025  $(71,960,227) $5,947,308   510,065  $510  $77,907,025  $(71,960,227) $     5,947,308 
                                        
Fair value of vested stock options issued to employees and directors  -   -   44,764   -   44,764   -   -   44,764   -   44,764 
                                        
Exercise of warrants  46,698   47   (47)  -   -   46,698   47   (47)  -   - 
                                        
Extinguishment of warrant liability upon exercise of warrants  -   -   490,226   -   490,226   -   -   490,226   -   490,226 
                                        
Net Loss  -   -   -   (3,709,899)  (3,709,899)  -   -   -   (3,709,899)  (3,709,899)
                                        
Balance at March 31, 2023  556,763   557   78,441,968   (75,670,126)  2,772,399   556,763   557   78,441,968   (75,670,126)  2,772,399 
                                        
Fair value of vested stock options issued to employees and directors  -   -   16,670   -   16,670   -   -   16,670   -   16,670 
                                        
Exercise of warrants  39,506   40   (40)  -   -   39,506   40   (40)  -   - 
                                        
Extinguishment of warrant liability upon exercise of warrants  -   -   220,798   -   220,798   -   -   220,798   -   220,798 
                                        
Proceeds from sale of common stock in public offering, net of offering costs $547,837  2,538,071   2,538   4,449,625   -   4,452,163   2,538,071   2,538   4,449,625   -   4,452,163 
                                        
Share adjustment for stock split rounding  51   -   -   -   -   51   -   -   -   - 
                                        
Net Loss  -   -   -   (1,769,238)  (1,769,238)  -   -   -   (1,769,238)  (1,769,238)
                                        
Balance at June 30, 2023  3,134,391  $3,135  $83,129,021  $(77,439,364) $5,692,792   3,134,391   3,135   83,129,021   (77,439,364)  5,692,792 
                    
Fair value of vested stock options issued to employees and directors  -   -   20,026   -   20,026 
                    
Net Loss  -   -   -   (1,919,709)  (1,919,709) 
                    
Balance at September 30, 2023  3,134,391  $3,135  $83,149,047  $(79,359,073) $3,793,109 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

F-3

 

 

Bone Biologics Corporation

 

Consolidated Statement of Stockholders’ Equity

For the Three and SixNine Months ended JuneSeptember 30, 2022

(unaudited)

 

 Common Stock  Additional
Paid-in
 Accumulated Total
Stockholders’
  Common Stock  Additional
Paid-in
 Accumulated Total
Stockholders’
 
 Shares Amount Capital Deficit Equity  Shares Amount Capital Deficit Equity 
                      
Balance at December 31, 2021  345,019  $345  $77,050,718  $(70,475,607) $6,575,456   10,350,574  $10,350  $77,040,713  $(70,475,607) $     6,575,456 
                                        
Fair value of vested stock options issued to employees and directors  -   -   152,844   -   152,844   -   -   152,844   -   152,844 
                                        
Share adjustment for October 2021 stock split rounding  5   -   -   -   - 
Share adjustment for stock split rounding  5   -   -   -   - 
                    
Net Loss  -   -   -   (689,499)  (689,499)  -   -   -   (689,499)  (689,499)
                                        
Balance at March 31, 2022  345,019  $345   77,203,562  $(71,165,106) $6,038,801   10,350,579   10,350   77,193,557   (71,165,106)  6,038,801 
Balance  345,019  $345   77,203,562   (71,165,106)  6,038,801 
                                        
Fair value of vested stock options issued to employees and directors  -   -   18,748   -   18,748   -   -   18,748   -   18,748 
                                        
Net Loss  -   -   -   (469,304)  (469,304)  -   -   -   (469,304)  (469,304)
                                        
Balance at June 30, 2022  345,019  $345  $77,222,310  $(71,634,410) $5,588,245   10,350,579   10,350   77,212,305   (71,634,410)  5,588,245 
Balance  345,019  $345  $77,222,310  $(71,634,410) $5,588,245   10,350,579   10,350   77,212,305   (71,634,410)  5,588,245 
                    
Fair value of vested stock options issued to employees and directors  -   -   32,534   -   32,534 
                    
Net Loss  -   -   -   (1,219,277)  (1,219,277)
                    
Balance at September 30, 2022  10,350,579  $10,350  $77,244,839  $(72,853,687) $4,401,502 
Balance  10,350,579  $10,350  $77,244,839  $(72,853,687) $4,401,502 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

F-4

 

Bone Biologics Corporation

 

Condensed Consolidated Statements of Cash Flows

 

     
 

Six Months

Ended

June 30, 2023

 Six Months
Ended
June 30, 2022
  

Nine Months Ended

September 30, 2023

 Nine Months Ended
September 30, 2022
 
 (unaudited) (unaudited)  (unaudited) (unaudited) 
Cash flows from operating activities                
Net loss $(5,479,137) $(1,158,803) $(7,398,846) $(2,378,080)
Adjustments to reconcile net loss to net cash used in operating activities:                
Stock-based compensation  61,434   171,592   81,460   204,126 
Change in fair value of warrant liability  (707,284)  -   (867,930)  - 
Changes in operating assets and liabilities:                
Prepaid expenses and other current assets  341,687   (204,359)  433,167   (141,734)
Accounts payable and accrued expenses  800,634   (29,273)  214,260   699,566 
                
Net cash used in operating activities  (4,982,666)  (1,220,843)  (7,537,889)  (1,616,122)
                
Cash flows from financing activities                
Proceeds from sale of common stock in public offering, net of offering costs  4,452,163   -   4,452,163   - 
                
Net cash provided by financing activities  4,452,163   -   4,452,163   - 
                
Net decrease in cash  (530,503)  (1,220,843)  (3,085,726)  (1,616,122)
                
Cash, beginning of period  7,538,312   6,675,365   7,538,312   6,675,365 
Cash, end of period $7,007,809  $5,454,522  $4,452,586  $5,059,243 
                
Supplemental information                
Income taxes paid $-  $-  $-  $- 
                
Non-cash financing activities                
Issuance of shares upon cashless exercise of warrants $-  $- 
Extinguishment of warrant liability upon exercise of warrants $711,024  $- 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

F-5

 

Bone Biologics Corporation

Notes to Unaudited Condensed Consolidated Financial Statements

For the Three and SixNine Months ended JuneSeptember 30, 2023 and 2022

 

1. The Company

 

Bone Biologics Corporation (the “Company”) was incorporated under the laws of the State of Delaware on October 18, 2007 as AFH Acquisition X, Inc. Pursuant to a Merger Agreement, dated September 19, 2014, by and among the Company, its wholly-owned subsidiary, Bone Biologics Acquisition Corp., (“Merger Sub”), and Bone Biologics, Inc., Merger Sub merged with and into Bone Biologics Inc., with Bone Biologics Inc. remaining as the surviving corporation. On September 22, 2014, the Company changed its name to “Bone Biologics Corporation” and Bone Biologics, Inc. became a wholly owned subsidiary of the Company. Bone Biologics, Inc. was incorporated in California on September 9, 2004.

 

The Company is a medical device company that is currently focused on bone regeneration in spinal fusion using the recombinant human protein known as NELL-1. NELL-1 in combination with DBM, demineralized bone matrix, is an osteopromotive recombinant protein that provides target specific control over bone regeneration. The NELL-1 technology platform has been licensed exclusively for worldwide applications to the Company through a technology transfer from the UCLA Technology Development Group on behalf of UC Regents (“UCLA TDG”). UCLA TDG and the Company received guidance from the Food and Drug Administration that NELL-1/DBM will be classified as a device/drug combination product with a pre-market approval filing (“PMA”).

 

The production and marketing of the Company’s products and its ongoing research and development activities are subject to extensive regulation by numerous governmental authorities in the United States. Prior to marketing in the United States, any combination product developed by the Company must undergo rigorous preclinical (animal) and clinical (human) testing and an extensive regulatory approval process implemented by the FDA under the Food, Drug and Cosmetic Act. There can be no assurance that the Company will not encounter problems in clinical trials that will cause the Company or the FDA to delay or suspend clinical trials.

 

The Company’s success will depend in part on its ability to obtain patents and product license rights, maintain trade secrets, and operate without infringing on the proprietary rights of others, both in the United States and other countries. There can be no assurance that patents issued to or licensed by the Company will not be challenged, invalidated, rendered unenforceable, or circumvented, or that the rights granted thereunder will provide proprietary protection or competitive advantages to the Company.

 

On June 5, 2023, an amendment to the Company’s certificate of incorporation for a reverse split of the Company’s outstanding common stock at a ratio of 1-for-30 became effective. All share and per share amounts have been retro-actively restated as if the reverse split occurred at the beginning of the earliest period presented.

 

Going Concern

 

The Company has no significant operating history and since inception to JuneSeptember 30, 2023 has incurred accumulated losses of approximately $77.479.4 million. The Company will continue to incur significant expenses for development activities for its product NELL-1/DBM. Operating expenditures for the next twelve months are estimated at $6.15.1 million. The accompanying unaudited condensed consolidated financial statements for the sixnine months ended JuneSeptember 30, 2023, have been prepared on the basis that the Company will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business. As reflected in the financial statements, during the sixnine months ended JuneSeptember 30, 2023, the Company incurred a net loss of $5.57.4 million, and used net cash in operating activities of $5.07.5 million. These factors raise substantial doubt about the Company’s ability to continue as a going concern within a reasonable period of time, which is considered to be one year from the issuance date of these financial statements. In addition, our independent registered public accounting firm, in its audit report to the financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2022, expressed substantial doubt about our ability to continue as a going concern. The consolidated financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

 

At JuneSeptember 30, 2023, we had cash of $7.04.5 million. Available cash is expected to fund through six month trialour operations until the second quarter of 2024 when we expect to announce data reporting forfrom our pilot clinical study.

 

We anticipate that we will require approximately $8.65.9 million to complete first in man studies, and an estimated additional $27 million to achieve FDA approval for a spine interbody fusion indication.

 

On June 16, 2023, the Company completed a public offering generating net proceeds to the Company of $4.5 million.

 

The Company will continue to attempt to raise additional debt and/or equity financing to fund future operations and to provide additional working capital. However, there is no assurance that such financing will be consummated or obtained in sufficient amounts necessary to meet the Company’s needs. If cash resources are insufficient to satisfy the Company’s on-going cash requirements, the Company will be required to scale back or discontinue its product development programs, or obtain funds if available (although there can be no certainties) through strategic alliances that may require the Company to relinquish rights to its technology, substantially reduce or discontinue its operations entirely. No assurance can be given that any future financing will be available or, if available, that it will be on terms that are satisfactory to the Company. Even if the Company is able to obtain additional financing, it may contain undue restrictions on our operations, in the case of debt financing, or cause substantial dilution for our stockholders, in the case of equity financing.

 

F-6

 

2. Summary of Significant Accounting Policies

 

Basis of Presentation

 

The interim condensed consolidated financial statements included herein reflect all material adjustments (consisting of normal recurring adjustments and reclassifications and non-recurring adjustments) which, in the opinion of management, are ordinary and necessary for a fair presentation of results for the interim periods. Certain information and footnote disclosures required under the accounting principles generally accepted in the United States of America (“GAAP”) have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). The Company believes that the disclosures are adequate to make the information presented not misleading. The condensed consolidated balance sheet information as of December 31, 2022 was derived from the audited consolidated financial statements included in the Company’s Annual Report on Form 10-K filed with the SEC on March 30, 2023 (the “2022 Annual Report”). These condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2022 and notes thereto included in the 2022 Annual Report.

 

The results of operations for the sixnine months ended JuneSeptember 30, 2023 are not necessarily indicative of the results to be expected for the entire fiscal year ended December 31, 2023 or for any other period.

 

Use of Estimates

 

The preparation of the accompanying consolidated financial statements in conformity with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of expenses during the reporting period.

 

Significant estimates include the assumptions used in the accrual for potential liabilities, the valuation of the warrant liability, the valuation of debt and equity instruments, the valuation of stock options and warrants issued for services, and deferred tax valuation allowances. Actual results could differ from those estimates.

Novel Coronavirus (COVID-19)

On May 11, 2023, the United States Department of Health and Human Services declared the end of the COVID-19 Pandemic nationwide health emergency. While the Company’s operations have not been materially disrupted to date from the pandemic, the coronavirus impact on economic conditions nationally continues to be uncertain and could affect the Company’s results of operations, financial condition and liquidity in the future.

The coronavirus pandemic presents a challenge to medical facilities worldwide. As the Company’s clinical trials are conducted on an outpatient basis, there could be delays in and increased costs of such clinical trials as a result of the coronavirus pandemic.

 

Inflation

 

Macroeconomic factors such as inflation, rising interest rates, governmental responses there to and possible recession caused thereby also add significant uncertainty to our operations and possible effects to the amount and type of financing available to the Company in the future.

 

Cash

 

Cash primarily consists of bank demand deposits maintained by a major financial institution. The Company’s policy is to maintain its cash balances with financial institutions with high credit ratings and in accounts insured by the Federal Deposit Insurance Corporation (the “FDIC”) and/or by the Securities Investor Protection Corporation (the “SIPC”). The Company may periodically have cash balances in financial institutions in excess of the FDIC and SIPC insurance limits of $250,000 and $500,000, respectively. The Company has not experienced any losses to date resulting from this policy.

While the Company and its bank has not been directly affected by the recent failures of certain banks, the banking industry overall has experienced disruption and uncertainty, which could put additional pressures on the Company’s bank and other banks, and may negatively impact the availability and costs for various banking and investment offerings. The failure of a bank, or other adverse conditions in the financial or credit markets impacting financial institutions at which we maintain balances, could adversely impact our liquidity and financial performance. There can be no assurance that our deposits in excess of the FDIC or other comparable insurance limits will be backstopped by the U.S., or that any bank or financial institution with which we do business will be able to obtain needed liquidity from other banks, government institutions or by acquisition in the event of a failure or liquidity crisis.

 

F-7

 

 

Fair Value of Financial Instruments

 

Accounting standards require certain assets and liabilities be reported at fair value in the financial statements and provide a framework for establishing that fair value. The Company defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy is based on three levels of inputs that may be used to measure fair value, of which the first two are considered observable and the last is considered unobservable:

 

Level 1: Quoted prices in active markets for identical assets or liabilities.

 

Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

 

Level 3 assumptions: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities including liabilities resulting from embedded derivatives associated with certain warrants to purchase common stock.

 

The fair value of financial instruments measured on a recurring basis was as follows as of JuneSeptember 30, 2023:

Schedule of Fair Value Liabilities Measured on Recurring Basic 

                        
 As of June 30, 2023  As of September 30, 2023 
Description Total  Level 1  Level 2  Level 3  Total  Level 1  Level 2  Level 3 
Liabilities:                                
Warrant liability $241,160        $241,160  $80,514        $80,514 
Total liabilities at fair value $241,160        $241,160  $80,514        $80,514 

 

The following table provides a roll-forward of the warrant liability measured at fair value on a recurring basis using unobservable level 3 inputs for the sixnine period ended JuneSeptember 30, 2023 as follows:

Schedule of Warrant Liability Measured Fair Value on a Recurring Basic Using Unobservable 

 June 30, 2023  September 30, 2023 
Warrant liability        
Balance as of beginning of period – December 31, 2022 $1,659,468  $1,659,468 
Extinguishment of warrant liability upon exercise of warrants  (711,024)  (711,024)
Change in fair value  (707,284)  (867,930)
Balance as of June 30, 2023 $241,160 
Balance as of September 30, 2023 $80,514 

 

The Company believes the carrying amount of certain financial instruments, including cash and accounts payable approximate their values based on their short-term nature and are excluded from the fair value tables above.

 

Prepaid Expenses

 

At JuneSeptember 30, 2023, prepaid expenses consist of prepaid insurance and prepaid services. Prepaid expenses are amounts paid to secure the use of assets or the receipt of services at a future date or continuously over one or more future periods. When the prepaid expenses are eventually consumed, they are charged to expense. The Company had $615,238523,758 and $956,925 in prepaid expenses as of JuneSeptember 30, 2023 and December 31, 2022, respectively.

 

Stock Based Compensation

 

ASC 718, Compensation – Stock Compensation, prescribes accounting and reporting standards for all share-based payment transactions to employees and non-employees. Transactions include incurring liabilities, or issuing or offering to issue shares, options, and other equity instruments such as employee stock ownership plans and stock appreciation rights. Share-based payments to employees, including grants of employee stock options, are recognized as compensation expense in the consolidated financial statements based on their fair values. That expense is recognized over the period during which an employee is required to provide services in exchange for the award, known as the requisite service period (usually the vesting period). Recognition of compensation expense for non-employees is in the same period and manner as if the Company had paid cash for the services.

 

F-8

 

 

Loss per Common Share

 

Basic loss per share is computed by dividing the loss available to common shareholders by the weighted-average number of common shares outstanding during the period. Diluted loss per share is computed similar to basic loss per share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive. Diluted loss per common share reflects the potential dilution that could occur if options and warrants were to be exercised or converted or otherwise resulted in the issuance of common stock that then shared in the earnings of the entity.

 

Since the effects of outstanding options and warrants are anti-dilutive for the sixnine months ended JuneSeptember 30, 2023 and 2022, shares of common stock underlying these instruments have been excluded from the computation of loss per common share.

 

The following sets forth the number of shares of common stock underlying outstanding options and warrants as of JuneSeptember 30, 2023 and 2022:

Schedule of Anti Dilutive Securities Excluded from Computation of Earnings Per Share 

       2023  2022 
 June 30,  September 30, 
 2023  2022  2023  2022 
Warrants  375,296   60,922   375,296   60,922 
Stock options  16,995   11,410   274,284   15,094 
Anti dilutive securities  392,291   72,332   649,580   76,016 

 

New Accounting Standards

 

The Company’s management has evaluated all the recently issued, but not yet effective, accounting standards and guidance that have been issued or proposed by the FASB or other standards-setting bodies through the filing date of these financial statements and does not believe the future adoption of any such pronouncements will have a material effect on the Company’s financial position and results of operations.operations.

 

3. Warrant Liability

 

In October 2022, the Company completed a public equity offering, which included the issuance of 433,382 warrants. Upon the occurrence of certain transactions (“Fundamental Transactions,” as defined in the warrant agent agreement), the warrants provide for a value determined using a Black Scholes model with inputs calculated as described in the warrant agreement which includes a 100% floor on the volatility input to be utilized. The Company has determined that this provision introduces leverage to the holders of the warrants that could result in a value that would be greater than the settlement amount of a fixed-for-fixed option on the Company’s own equity shares. Accordingly, pursuant to ASC 815, the Company has classified the fair value of the warrants as a liability to be re-measured at the end of every reporting period with the change in value reported in the statement of operations.

 

F-9

 

 

The warrant liability was valued at the following dates using a Black-Scholes model with the following assumptions:

Schedule of Warrant Liability Black-Scholes Model 

 June 30, 2023  December 31, 2022  September 30, 2023  December 31, 2022 
Warrant liability:                
Risk-free interest rate  4.31%  4.26%  4.74%  4.26%
Expected volatility  142.57%  112.58%  134.17%  112.58%
Expected life (in years)  4.29   4.78   4.03   4.78 
Expected dividend yield  -   -   -   - 
                
Fair Value of warrant liability $241,160  $1,659,468  $80,514  $1,659,468 

 

The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant. We determine expected volatility based upon the historical volatility of our common stock since listing on The Nasdaq Capital Market. We do not believe that the future volatility of our common stock over an option’s expected term is likely to differ significantly from the past. The expected term of the warrants granted are determined based on the duration of time the warrants are expected to be outstanding. The dividend yield on the Company’s warrants is assumed to be zero as the Company has not historically paid dividends.

 

4. Stockholders’ Equity

 

Preferred Stock

 

The Company’s amended and restated certificate of incorporation authorizes the Company to issue a total of 20,000,000 shares of preferred stock. No shares have been issued as of JuneSeptember 30, 2023 and December 31, 2022.

 

Common Stock

 

The Company’s amended and restated certificate of incorporation authorizes the Company to issue a total of 100,000,000 shares of common stock. As of JuneSeptember 30, 2023 and December 31, 2022, the Company had an aggregate of 3,134,391 and 510,065 shares of common stock outstanding, respectively.

 

In February 2023, 46,698 Series C warrants were exchanged for 46,698 shares of common stock.

 

In May 2023, 39,506 Series C warrants were exchanged for 39,506 shares of common stock.

 

On June 14, 2023, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with EF Hutton, division of Benchmark Investments, LLC (“EF Hutton”) acting as representatives of the several underwriters in connection with a public offering (the “Offering”) of an aggregate of 2,538,071 shares of its common stock. The public offering price was $1.97 per share and the underwriters agreed to purchase 2,538,071 shares at a 7% discount to the public offering price. The Company granted EF Hutton a 45-day option to purchase up to 380,710 additional shares, to cover over-allotments, if any.any, which was not exercised. The Offering closed on June 16, 2023, resulting in gross proceeds of $5 million, before deducting underwriting discounts and commissions and other offering expenses. The net proceeds in relation to the Offering were $4,452,163.

5. Common Stock Warrants

 

A summary of warrant activity for the sixnine months ended JuneSeptember 30, 2023 is presented below:

Schedule of Warrant Activity 

Subject to Exercise Number of
Warrants
 Weighted
Average
Exercise Price
 Weighted
Average Life
(Years)
  Number of
Warrants
 Weighted
Average
Exercise Price
 Weighted
Average Life
(Years)
 
Outstanding as of December 31, 2022  461,500  $53.40   4.65   461,500  $53.40   4.65 
Granted – 2023  -   -   -   -   -   - 
Forfeited/Expired – 2023  -   -   -   -   -   - 
Exercised – 2023  (86,204)  -   4.29   (86,204)  -   4.29 
Outstanding as of June 30, 2023  375,296  $65.66   4.13 
Outstanding as of September 30, 2023  375,296  $65.66   3.87 

 

F-10

 

 

As of JuneSeptember 30, 2023, the Company had outstanding vested and unexercised Common Stock Warrants as follows:

Schedule of Outstanding Vested and Unexercised Common Stock Warrants

Date Issued Exercise Price Number of
Warrants
 Expiration date Exercise Price Number of
Warrants
 Expiration date
October 2021 $189.00   60,934  October 13, 2026 $189.00   60,934  October 13, 2026
October 2022 $48,60   144,464  October 12, 2027 $48,60   144,464  October 12, 2027
October 2022 $40.50   150,761  October 12, 2027 $40.50   150,761  October 12, 2027
October 2022 $0.00   19,137  October 12, 2027 $0.00   19,137  October 12, 2027
Total outstanding warrants at June 30, 2023      375,296   
Total outstanding warrants at September 30, 2023      375,296   

 

Based on a fair market value of $1.430.71 per share on JuneSeptember 30, 2023, there 19,137 exercisable but unexercised in-the-money common stock warrants on that date. Accordingly, the intrinsic value attributed to exercisable but unexercised common stock warrants at JuneSeptember 30, 2023 was $27,36613,587.

 

6. Stock-based Compensation

 

2015 Equity Incentive Plan

 

The Company has 35,9185,035,918 shares of Common Stock authorized and reserved for issuance under our 2015 Equity Incentive Plan for option awards. This reserve may be increased by the Board each year by up to the number of shares of stock equal to 5% of the number of shares of stock issued and outstanding on the immediately preceding December 31. In JulySeptember 2023, the Company’s board of directorsstockholders approved an amendment to the 2015 Equity Incentive Plan that, among other items, would increaseincreased the number of shares available under the 2015 Equity Incentive Plan by 5,000,000 shares, subject to approval by the Company’s stockholders at the 2023 annual meeting of stockholders.shares. Appropriate adjustments will bewere made in the number of authorized shares and other numerical limits in our 2015 Equity Incentive Plan and in outstanding awards to prevent dilution or enlargement of participants’ rights in the event of a stock split or other change in our capital structure. Shares subject to awards granted under our 2015 Equity Incentive Plan which expire, are repurchased or are cancelled or forfeited will again become available for issuance under our 2015 Equity Incentive Plan. The shares available will not be reduced by awards settled in cash. Shares withheld to satisfy tax withholding obligations will not again become available for grant. The gross number of shares issued upon the exercise of stock appreciation rights or options exercised by means of a net exercise or by tender of previously owned shares will be deducted from the shares available under our 2015 Equity Incentive Plan.

 

Awards may be granted under our 2015 Equity Incentive Plan to our employees, including officers, director or consultants, and our present or future affiliated entities. While we may grant incentive stock options only to employees, we may grant non-statutory stock options, stock appreciation rights, restricted stock purchase rights or bonuses, restricted stock units, performance shares, performance units and cash-based awards or other stock based awards to any eligible participant.

 

The 2015 Equity Incentive Plan is administered by our compensation committee. Subject to the provisions of our 2015 Equity Incentive Plan, the compensation committee determines, in its discretion, the persons to whom, and the times at which, awards are granted, as well as the size, terms and conditions of each award. All awards are evidenced by a written agreement between us and the holder of the award. The compensation committee has the authority to construe and interpret the terms of our 2015 Equity Incentive Plan and awards granted under our 2015 Equity Incentive Plan.

 

A summary of stock option activity for the sixnine months ended JuneSeptember 30, 2023 is presented below:

Schedule of Stock Option Activity 

Subject to Exercise Number of
Options
 Weighted Average
Exercise
Price
 Weighted
Average
Life (Years)
 Aggregate
Intrinsic
Value
  Number of
Options
 

Weighted

Average
Exercise
Price

 Weighted
Average
Life (Years)
 Aggregate
Intrinsic
Value
 
Outstanding as of December 31, 2022  15,106  $505.20   5.60  $-   15,106  $505.20   5.60  $- 
Granted – 2023  1,889   7.20   2.00   -   259,178   0.68   9.94   18,010 
Forfeited/Expired – 2023  -   -   -   -   -   -   -   - 
Exercised – 2023  -   -   -   -   -   -   -   - 
Outstanding as of June 30, 2023  16,995  $459.70   4.57  $- 
Options vested and exercisable at June 30, 2023  16,074  $483.26   4.31  $- 
Outstanding as of September 30, 2023  274,284  $29.08   8.62  $18,010 
Options vested and exercisable at September 30, 2023  16,995  $459.70   4.32  $- 

 

F-11

 

 

As of JuneSeptember 30, 2023, the Company had outstanding stock options as follows:

Schedule of Outstanding Stock Options 

Date Issued Exercise Price Number of
Options
 Expiration date Exercise Price Number of
Options
 Expiration date
August 2015 $1,192.50   1,387  December 27, 2025 $1,192.50   1,387  December 27, 2025
September 2015 $1,192.50   268  December 27, 2025 $1,192.50   268  December 27, 2025
November 2015 $1,192.50   1,634  December 27, 2025 $1,192.50   1,634  December 27, 2025
December 2015 $1,192.50   75  December 27, 2025 $1,192.50   75  December 27, 2025
January 2016 $1,192.50   1,701  January 9, 2026 $1,192.50   1,701  January 9, 2026
May 2016 $1,537.50   359  May 26, 2026 $1,537.50   359  May 26, 2026
September 2016 $1,537.50   135  May 31, 2026 $1,537.50   135  May 31, 2026
January 2017 $1,537.50   72  January 1, 2027 $1,537.50   72  January 1, 2027
January 2018 $1,477.50   53  January 1, 2028 $1,477.50   53  January 1, 2028
January 2019 $70.50   732  January 1, 2029 $70.50   732  January 1, 2029
October 2021 $157.50   1,630  October 26, 2031 $157.50   1,630  October 26, 2031
January 2022 $105.60   873  January 1, 2032 $105.60   873  January 1, 2032
January 2022 $111.60   1,667  January 1, 2024 $111.60   1,667  January 1, 2024
January 2022 $111.60   833  January 3, 2024 $111.60   833  January 3, 2024
August 2022 $48.30   3,687  August 23, 2032 $48.30   3,687  August 23, 2032
January 2023 $7.20   1,889  January 25, 2025 $7.20   1,889  January 25, 2025
September 2023 $0.64   257,289  September 12, 2033
                    
Total outstanding options at June 30, 2023      16,995   
Total outstanding options at September 30, 2023      274,284   

 

Based on a fair value of $1.430.71 per share on JuneSeptember 30, 2023. There were no exercisable but unexercised in-the-money common stock warrants on that date.

 

There were 1,889259,178 options granted during the sixnine months ended JuneSeptember 30, 2023 with a fair value of $11,948161,948. Vesting of options differs based on the terms of each option. During the sixnine months ended JuneSeptember 30, 2023 and 2022, the Company had stock-based compensation expense of $61,43481,460 and $171,592204,126, respectively, related to the vesting of stock options granted to the Company’s employees and directors included in our reported net loss. Our policy is to account for forfeitures of the unvested portion of option grants when they occur; therefore, these forfeitures are recorded as a reversal to expense, which can result in a credit balance in the statement of operations.

 

The Company utilized the Black-Scholes option-pricing model. The assumptions used for the sixnine months ended JuneSeptember 30, 2023 are as follows:

Schedule of Assumptions Using Black-Scholes Option Pricing Mode

  JuneSeptember 30, 2023 
Risk free interest rate  4.674.39%
Expected Volatility  136.03135.49%
Expected life (in years)  15.86 
Expected dividend yield  0%

 

The expected volatility is a measure of the amount by which our stock price is expected to fluctuate during the expected term of options granted. We determine the expected volatility based upon the historical volatility of our common stock since listing on The Nasdaq Capital Market. We do not believe that the future volatility of our common stock over an option’s expected term is likely to differ significantly from the past. The risk-free interest rate used in the calculations is based on the implied yield available on U.S. Treasury issues with an equivalent term approximating the expected life of the options as calculated using the simplified method. The expected life of the options used was based on the contractual life of the option granted. Stock-based compensation is a non-cash expense because we settle these obligations by issuing shares of our common stock from our authorized shares instead of settling such obligations with cash payments.

 

As of JuneSeptember 30, 2023, total unrecognized compensation cost related to unvested stock options was $5,471135,445. The cost is expected to be recognized over a weighted average period of 0.150.38 years.

 

F-12

 

7. Commitments and Contingencies

 

UCLA TDG Exclusive License Agreement

 

Effective April 9, 2019, we entered into an Amended and Restated Exclusive License Agreement dated as of March 21, 2019, which was subsequently amended through three sets of amendments (as so amended the “Amended License Agreement”) with the UCLA TDG. The Amended License Agreement amends and restates the Amended and Restated Exclusive License Agreement, dated as of June 19, 2017 (the “2017 Agreement”). The 2017 Agreement amended and restated the Exclusive License Agreement, effective March 15, 2006, between the Company and UCLA TDG, as amended by ten amendments. Under the terms of the Amended License Agreement, the Regents have continued to grant us exclusive rights to develop and commercialize NELL-1 (the “Licensed Product”) for spinal fusion by local administration, osteoporosis and trauma applications. The Licensed Product is a recombinant human protein growth factor that is essential for normal bone development.

 

We have agreed to pay an annual maintenance fee to UCLA TDG of $10,000 as well as pay certain royalties to UCLA TDG under the Amended License Agreement at the rate of 3.0%3.0% of net sales of licensed products or licensed methods. We must pay the royalties to UCLA TDG on a quarterly basis. Upon a first commercial sale, we also must pay a minimum annual royalty between $50,000 and $250,000, depending on the calendar year which is after the first commercial sale. If we are required to pay any third party any royalties as a result of us making use of UCLA TDG patents, then we may reduce the royalty owed to UCLA TDG by 0.333% for every percentage point paid to a third party. If we grant sublicense rights to a third party to use the UCLA TDG patent, then we will pay UCLA TDG 10% to 20% of the sublicensing income we receive from such sublicense.

 

We are obligated to make the following milestone payments to UCLA TDG for each Licensed Product or Licensed Method:

 

 $100,000 upon enrollment of the first subject in a Feasibility Study;
   
 $250,000 upon enrollment of the first subject in a Pivotal Study:
   
 $500,000 upon Pre-Market Approval of a Licensed Product or Licensed Method; and
   
 $1,000,000 upon the First Commercial Sale of a Licensed Product or Licensed Method.

 

We are also obligated pay to UCLA TDG a fee (the “Diligence Fee”) of $8,000,000 upon the sale of any Licensed Product (the “Triggering Sale Date”) in accordance with the payment schedule below:

 

 Due upon cumulative Net Sales equaling $50,000,000 following the Triggering Sale Date - $2,000,000;
   
 Due upon cumulative Net Sales equaling $100,000,000 following the Triggering Sale Date - $2,000,000; and
   
 Due upon cumulative Net Sales equaling $200,000,000 following the Triggering Sale Date - $4,000,000$4,000,000..

 

Our obligation to pay the Diligence Fee will survive termination or expiration of the Amended License Agreement and we are prohibited from assigning, selling, or otherwise transferring any of its assets related to any Licensed Product unless our Diligence Fee obligation is assigned, sold, or transferred along with such assets, or unless we pay UCLA TDG the Diligence Fee within ten (10) days of such assignment, sale or other transfer of such rights to any Licensed Product.

 

We are also obligated to pay UCLA TDG a cash milestone payment within thirty (30) days of a Liquidity Event (including a Change of Control Transaction and a payment election by UCLA TDG exercisable after December 22, 2016) such payment to equal the greater of:

 

 $500,000; or
   
 2% of all proceeds in connection with a Change of Control Transaction.

 

F-13

 

 

As of JuneSeptember 30, 2023, none of the above milestones have been met.

 

We are obligated to diligently proceed with developing and commercializing licensed products under UCLA TDG patents set forth in the Amended License Agreement. We are required to meet certain diligence milestone deadlines pursuant to the Amended License Agreement. Applicable for the current year, we are required to spend at least $1,000,000 per calendar year on pre-clinical or clinical development until the date that we complete a Phase III pivotal study. If we fail to meet this or the other diligence milestone deadlines, UCLA TDG has the right to either terminate the license or reduce the license to a non-exclusive license.

We must reimburse or pre-pay UCLA TDG for patent prosecution and maintenance costs incurred during the term of the Amended License Agreement. We have the right to bring infringement actions against third party infringers of the Amended License Agreement, UCLA TDG may join voluntarily, at its own expense, or, at our expense, be joined involuntarily to the action. We are required to indemnify UCLA TDG against any third party claims arising out of our exercise of the rights under the Amended License Agreement or any sublicense.

 

Payments to UCLA TDG under the Amended License Agreement for the sixnine months ended JuneSeptember 30, 2023 and 2022 were $20,11223,238 and $29,05935,235, respectively.

 

Development Contracts

 

The Company has two contracts with one vendor for development activities of NELL-1. As of JuneSeptember 30, 2023, there were no prepaid expenses and $877,428955,076 in accounts payable for this vendor. Amounts remaining for services contained within the contracts was $1,738,539487,640 as of JuneSeptember 30, 2023.

 

At JuneSeptember 30, 2023 there exists a concentration of payables to two vendorsone vendor of approximately 8798% of the Company’s payables.

 

Contingencies

 

The Company is subject to claims and assessments from time to time in the ordinary course of business. The Company’s management does not believe that any such matters, individually or in the aggregate, will have a material adverse effect on the Company’s business, financial condition, results of operations or cash flows.

 

In July 2019, Dr. Bessie (Chia) Soo and Dr. Kang (Eric) Ting (“Plaintiffs”) filed a complaint (the “Complaint”) in federal court in Massachusetts against the Company, Bruce Stroever (“Stroever”), John Booth (“Booth”), Stephen LaNeve (“LaNeve”, and together with Stroever and Booth, the “Individual Defendants”), and MTF Biologics (f/k/a The Musculoskeletal Transplant Foundation, Inc.) (“MTF”). The Complaint alleges claims for breach of contract against the Company and tortious interference with contract against the Individual Defendants and MTF arising from the termination of the Professional Service Agreements, dated as of January 8, 2016, between the Company and each of the Plaintiffs. The Individual Defendants have been sued for actions taken by them in connection with their service to the Company as directors and/or officers of the Company. As such, the Company has certain indemnification obligations to the Individual Defendants. The Company and the Individual Defendants intend to vigorously defend against the allegations in the Complaint. Although the Complaint was filed several years ago, due to the Covid-19 Pandemic and long delays in the court ruling on various motions to dismiss, in terms of case progression the case is still in its early stages with the claims in the case not being set until April 2022 and preliminary discovery starting since then. Based on the early stage of the litigation, it is not possible to estimate the amount or range of any possible loss arising from the expenditure of defense fees, a judgment or settlement of the matter.

 

NASDAQ NoticeNotices

 

On June 28, 2023, Bone Biologics Corporation (the “Company”)November 17, 2022, the Company received a deficiency letter (the “Letter”) from the Hearings Advisor in the Nasdaq Office of General Counsel confirming the decision of The Nasdaq Stock Market LLC’s (“Nasdaq”) Hearings Panel (the “Panel”),notifying it that, because the Company currently demonstratesbid price of its common stock closed below $1.00 per share for 30 consecutive business days, it was no longer in compliance with the requirementsNasdaq’s minimum bid price rule, which is a requirement for continued listing on Thethe Nasdaq Capital Market forMarket. On June 28, 2023, the Company received a letter from Nasdaq confirming the decision of a Nasdaq Hearings Panel, that while the Company demonstrated compliance with the minimum bid price as outlined in Listing Rule 5550(a)(2).

F-14

Pursuant toat that time, based on its recent bid price history the Letter, the Company will be subject topanel imposed a “Panel Monitor,” as defined by Nasdaq Listing Rule 5815(d)(4)(A), through June 27, 2024.

On September 27, 2023, the Company received a written notice (the “Notice”) from the staff of Nasdaq notifying the Company that it failed to comply with the $1.00 per share minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2). As a result of the imposition of a mandatory Panel Monitor, the Company is not eligible for a compliance period to regain compliance with the minimum bid price requirement. Accordingly, the Nasdaq staff has determined to delist the Company’s securities from Nasdaq (the “Staff Determination”).

The Company timely requested a hearing before a Nasdaq Hearings Panel (the “Panel”), to appeal the Staff Determination, which request stayed any delisting action pending the issuance of the Panel’s determination. The Panel hearing is scheduled for November 30, 2023.

At the hearing, the Company expects to present its plan for regaining and sustaining compliance with all applicable requirements for continued listing on The Nasdaq Capital Market. There can be no assurance that the Panel will grant the Company any additional time to regain compliance or that the Company will ultimately regain and sustain compliance for listing of its securities on Nasdaq. In the event the Company fails to satisfy a continued listing requirement during the one year monitoring period,Company’s securities are delisted from Nasdaq, the Company will notexpects that its securities should be provided witheligible to trade on the opportunity to present a compliance plan to Nasdaq’s Listing Qualifications Department (the “Department”) and the Department will not be permitted to grant additional time for theover-the-counter OTC Markets platform. The Company is evaluating several alternatives to regain compliance with respect to that deficiency, nor will the Company be afforded an applicable cure or compliance period pursuant to Rule 5810(c)(3), which process might otherwise be available under the Nasdaq Listing Rules but would instead have an opportunity to request an appeal of the determination pursuant to Listing Rule 5815(d)(4)(C). The Company’s securities may at that time be delisted from Nasdaq.minimum bid price requirement.

 

8. Subsequent Events

 

The Company has evaluated subsequent events through August 11,November 14, 2023, the date which the consolidated financial statements were available to be issued. There were no additional subsequent events noted that would require adjustment to or disclosure in these consolidated financial statements.

 

F-15F-14

 

Item 2. Management’s Discussion and Analysis.

 

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the condensed consolidated financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q and audited consolidated financial statements for the years ended December 31, 2022 and 2021 and the related notes included in our Annual Report on Form 10-K filed for the fiscal year ended December 31, 2022, with the SEC on March 30, 2023. This discussion contains forward-looking statements reflecting our current expectations that involve risks and uncertainties. See “Note Regarding Forward-Looking Statements” for a discussion of the uncertainties, risks and assumptions associated with these statements. Actual results and the timing of events could differ materially from those discussed in our forward-looking statements as a result of many factors.

 

Overview

 

We are a medical device company that is currently focused on bone regeneration in spinal fusion using the recombinant human protein known as NELL-1. NELL-1 in combination with DBM, demineralized bone matrix, is an osteopromotive recombinant protein that provides target specific control over bone regeneration. The NELL-1 technology platform has been licensed exclusively for worldwide applications to us through a technology transfer from the UCLA Technology Development Group on behalf of UC Regents (“UCLA TDG”). UCLA TDG and the Company received guidance from the FDA that NELL-1/DBM will be classified as a device/drug combination product with a pre-market approval filing (“PMA”).

 

We were founded by University of California professors in collaboration with an Osaka University professor and a University of Southern California surgeon in 2004 as a privately-held company with proprietary, patented technology that has been validated in sheep and non-human primate models to facilitate bone growth. We believe our platform technology has application in delivering improved outcomes in the surgical specialties of spinal, orthopedic, general orthopedic, plastic reconstruction, neurosurgery, interventional radiology, and sports medicine. Lead product development and clinical studies are targeted on spinal fusion surgery, one of the larger segments in the orthopedic market.

 

We are a development stage entity. The production and marketing of our products and ongoing research and development activities are subject to extensive regulation by numerous governmental authorities in the United States. Prior to marketing in the United States, any combination product developed by us must undergo rigorous preclinical (animal) and clinical (human) testing and an extensive regulatory approval process implemented by the FDA under the Food, Drug and Cosmetic Act. There can be no assurance that we will not encounter problems in clinical trials that will cause us or the FDA to delay or suspend the clinical trials.

 

Our success will depend in part on our ability to obtain patents and product license rights, maintain trade secrets, and operate without infringing on the proprietary rights of others, both in the United States and other countries. There can be no assurance that patents issued to or licensed by us will not be challenged, invalidated, rendered unenforceable, or circumvented, or that the rights granted thereunder will provide proprietary protection or competitive advantages to us.

 

4

 

 

UCLA TDG Exclusive License Agreement

 

Effective April 9, 2019, we entered into an Amended and Restated Exclusive License Agreement dated as of March 21, 2019, which was subsequently amended through three sets of amendments (as so amended the “Amended License Agreement”) with the UCLA TDG. The Amended License Agreement amends and restates the Amended and Restated Exclusive License Agreement, dated as of June 19, 2017 (the “2017 Agreement”). The 2017 Agreement amended and restated the Exclusive License Agreement, effective March 15, 2006, between the Company and UCLA TDG, as amended by ten amendments. Under the terms of the Amended License Agreement, the Regents have continued to grant us exclusive rights to develop and commercialize NELL-1 (the “Licensed Product”) for spinal fusion by local administration, osteoporosis and trauma applications. The Licensed Product is a recombinant human protein growth factor that is essential for normal bone development.

 

We have agreed to pay an annual maintenance fee to UCLA TDG of $10,000 as well as pay certain royalties to UCLA TDG under the Amended License Agreement at the rate of 3.0% of net sales of licensed products or licensed methods. We must pay the royalties to UCLA TDG on a quarterly basis. Upon a first commercial sale, we also must pay a minimum annual royalty between $50,000 and $250,000, depending on the calendar year which is after the first commercial sale. If we are required to pay any third party any royalties as a result of us making use of UCLA TDG patents, then we may reduce the royalty owed to UCLA TDG by 0.333% for every percentage point paid to a third party. If we grant sublicense rights to a third party to use the UCLA TDG patent, then we will pay UCLA TDG 10% to 20% of the sublicensing income we receive from such sublicense.

 

We are obligated to make the following milestone payments to UCLA TDG for each Licensed Product or Licensed Method:

 

 $100,000 upon enrollment of the first subject in a Feasibility Study;
   
 $250,000 upon enrollment of the first subject in a Pivotal Study:
   
 $500,000 upon Pre-Market Approval of a Licensed Product or Licensed Method; and
   
 $1,000,000 upon the First Commercial Sale of a Licensed Product or Licensed Method.

 

We are also obligated pay to UCLA TDG a fee (the “Diligence Fee”) of $8,000,000 upon the sale of any Licensed Product (the “Triggering Sale Date”) in accordance with the payment schedule below:

 

 Due upon cumulative Net Sales equaling $50,000,000 following the Triggering Sale Date - $2,000,000;
   
 Due upon cumulative Net Sales equaling $100,000,000 following the Triggering Sale Date - $2,000,000; and
   
 Due upon cumulative Net Sales equaling $200,000,000 following the Triggering Sale Date - $4,000,000.

 

Our obligation to pay the Diligence Fee will survive termination or expiration of the Amended License Agreement and we are prohibited from assigning, selling, or otherwise transferring any of its assets related to any Licensed Product unless our Diligence Fee obligation is assigned, sold, or transferred along with such assets, or unless we pay UCLA TDG the Diligence Fee within ten (10) days of such assignment, sale or other transfer of such rights to any Licensed Product.

 

5

 

 

We are also obligated to pay UCLA TDG a cash milestone payment within thirty (30) days of a Liquidity Event (including a Change of Control Transaction and a payment election by UCLA TDG exercisable after December 22, 2016) such payment to equal the greater of:

 

 $500,000; or
   
 2% of all proceeds in connection with a Change of Control Transaction.

 

As of JuneSeptember 30, 2023, none of the above milestones have been met.

 

We are obligated to diligently proceed with developing and commercializing licensed products under UCLA TDG patents set forth in the Amended License Agreement. We are required to meet certain diligence milestone deadlines pursuant to the Amended License Agreement. Applicable for the current year, we are required to spend at least $1,000,000 per calendar year on pre-clinical or clinical development until the date that we complete a Phase III pivotal study. If we fail to meet this or the other diligence milestone deadlines, UCLA TDG has the right to either terminate the license or reduce the license to a non-exclusive license.

We must reimburse or pre-pay UCLA TDG for patent prosecution and maintenance costs incurred during the term of the Amended License Agreement. We have the right to bring infringement actions against third party infringers of the Amended License Agreement, UCLA TDG may join voluntarily, at its own expense, or, at our expense, be joined involuntarily to the action. We are required to indemnify UCLA TDG against any third party claims arising out of our exercise of the rights under the Amended License Agreement or any sublicense.

 

Payments to UCLA TDG under the Amended License Agreement for the sixnine months ended JuneSeptember 30, 2023 and 2022 were $20,112$ $23,238 and $29,059,$35,235, respectively.

 

NASDAQ NoticeNotices

 

On June 28, 2023, Bone Biologics Corporation (the “Company”)November 17, 2022, we received a deficiency letter (the “Letter”) from the Hearings Advisor in the Nasdaq Office of General Counsel confirming the decision of The Nasdaq Stock Market LLC’s (“Nasdaq”) Hearings Panel (the “Panel”),notifying us that, because the Company currently demonstratesbid price of our common stock closed below $1.00 per share for 30 consecutive business days, we were no longer in compliance with the requirementsNasdaq’s minimum bid price rule, which is a requirement for continued listing on Thethe Nasdaq Capital Market forMarket. On June 28, 2023, the Company received a letter from Nasdaq confirming the decision of a Nasdaq Hearings Panel that while the Company demonstrated compliance with the minimum bid price as outlined in Listing Rule 5550(a)(2).

Pursuant torule at that time, based on our recent bid price history the Letter, the Company will be subject topanel imposed a “Panel Monitor,” as defined by Nasdaq Listing Rule 5815(d)(4)(A), through June 27, 2024. In the event

On September 27, 2023, the Company fails to satisfyreceived a continued listing requirement duringwritten notice (the “Notice”) from the one year monitoring period,staff of Nasdaq notifying the Company will not be providedthat it failed to comply with the opportunity to present$1.00 per share minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2). As a result of the imposition of a mandatory Panel Monitor, the Company is not eligible for a compliance plan to Nasdaq’s Listing Qualifications Department (the “Department”) and the Department will not be permitted to grant additional time for the Companyperiod to regain compliance with respect to that deficiency, nor will the Company be afforded an applicable cure or compliance period pursuant to Rule 5810(c)(3), which process might otherwise be available underminimum bid price requirement. Accordingly, the Nasdaq Listing Rules but would instead have an opportunitystaff has determined to request an appeal ofdelist the determination pursuant to Listing Rule 5815(d)(4)(C). The Company’s securities may at that time be delisted from Nasdaq.

Results of Operations

Impact of the Novel Coronavirus (COVID-19) on the Company’s Business OperationsNasdaq (the “Staff Determination”).

 

The global outbreakCompany timely requested a hearing before a Nasdaq Hearings Panel (the “Panel”), to appeal the Staff Determination, which request stayed any delisting action pending the issuance of the novel coronavirus (COVID-19) has led to severe disruptions in general economic activities worldwide, as businesses and governments have taken broad actions to mitigate this public health crisis. In light of the uncertain and continually evolving situation relating to the spread of COVID-19, this pandemic could pose a risk to the Company.Panel’s determination. The extent to which the coronavirus may impact the Company’s business operations will depend on future developments, which are highly uncertain and cannot be predicted at this time. The Company intends to continue to monitor the situation and may adjust its current business plans as more information and guidance become available.Panel hearing is scheduled for November 30, 2023.

 

At the hearing, the Company expects to present its plan for regaining and sustaining compliance with all applicable requirements for continued listing on The coronavirus pandemic presents a challengeNasdaq Capital Market. There can be no assurance that the Panel will grant the Company any additional time to medical facilities worldwide. Asregain compliance or that the Company will ultimately regain and sustain compliance for listing of its securities on Nasdaq. In the event the Company’s clinical trials will be conducted on an outpatient basis, it is not currently possible to predict the full impact of this developing health crisis on such clinical trials, which could include delays in and increased costs of such clinical trials. Current indicationssecurities are delisted from the clinical research organizations conducting the clinical trials forNasdaq, the Company areexpects that such clinical trials are being delayed or extended forits securities should be eligible to trade on the over-the-counter OTC Markets platform. The Company is evaluating several months as a result ofalternatives to regain compliance with the coronavirus pandemic.minimum bid price requirement.

 

6

 

 

Results of Operations

The spread of the coronavirus, which has caused a broad impact globally, including restrictions on travel and quarantine policies put into place by businesses and governments, may have a material economic effect on our business. While the potential economic impact brought by and the duration of the pandemic may be difficult to assess or predict, it has already caused, and is likely to result in further, significant disruption of global financial markets, which may reduce our ability to access capital either at all or on favorable terms. In addition, a recession, depression or other sustained adverse market event resulting from the spread of the coronavirus could materially and adversely affect our business and the value of our common stock.

Since our inception, we devoted substantially all of our efforts and funding to the development of the NELL-1 protein and raising capital. We have not yet generated revenues from our planned operations.

 

Three Months ended JuneSeptember 30, 2023 compared to the Three Months ended JuneSeptember 30, 2022

 

 

Three-months

ended

June 30, 2023

 Three-months
ended
June 30, 2022
 % Change  

Three-months ended

September 30, 2023

 Three-months ended
September 30, 2022
 % Change 
Operating expenses                        
Research and development $2,295,251  $17,600   12941.20% $1,574,850  $769,410   104.68%
General and administrative  744,617   451,704   64.85%  506,040   449,867   12.49%
                        
Total operating expenses  3,039,868   469,304   547.74%  2,080,890   1,219,277   70.67%
                        
Loss from operations  (3,039,868)  (469,304)  547.74%  (2,080,890)  (1,219,277)  70.67%
                        
Change in fair value of warrant liability  1,270,202   -   100.00%  160,645   -   100.00%
                        
Interest income  428   -   100.00%  536   -   100.00%
                        
Net loss $(1,769,238) $(469,304)  276.99% $(1,919,709) $(1,219,277)  57.45%

 

Research and Development

 

Our research and development costs increased from $17,600$769,410 during the three months ended JuneSeptember 30, 2022 to $2,295,251$1,574,850 during the three months ended JuneSeptember 30, 2023. The increase of $2,277,651$805,440 is primarily due to development activities for our Nell-1 protein as we prepare for our pilot clinical study. We will continue to incur significant expenses for development activities for NELL-1 in the future.

 

General and Administrative

 

Our general and administrative expenses increased from $451,704$449,867 during the three months ended JuneSeptember 30, 2022 to $744,617$506,040 during the three months ended JuneSeptember 30, 2023. The $292,913$56,173 increase was primarily due to consultants for the estimated annual incentive bonus accrualproxy and increased legal expenditures.to assist with the NASDAQ notice. The incentive bonus accruals were based on performance targets established for each fiscal year.

 

Change in fair value of warrant liability

 

In October 2022, we completed a public equity offering, which included the issuance of 433,382 warrants. The warrants provide for a Black Scholes value calculation in the event of certain transactions (“Fundamental Transactions,” as defined), which includes a floor on volatility utilized in the value calculation at 100% or greater. We have determined that this provision introduces leverage to the holders of the warrants that could result in a value that would be greater than the settlement amount of a fixed-for-fixed option on the Company’s own equity shares. Accordingly, pursuant to ASC 815, we have classified the fair value of the warrants as a liability to be re-measured at the end of every reporting period with the change in value reported in the statement of operations.

 

The change in fair value of warrant liability represents the re-measurement of the outstanding warrants at JuneSeptember 30, 2023.

 

7

SixNine Months ended JuneSeptember 30, 2023 compared to the SixNine Months ended JuneSeptember 30, 2022

 

 

Six-months

Ended

June 30, 2023

 Six-months
Ended
June 30, 2022
 % Change  

Nine-months Ended

September 30, 2023

 Nine-months Ended
September 30, 2022
 % Change 
Operating expenses                        
Research and development $4,885,896  $54,000   8947.96% $6,460,747  $823,410   684.63%
General and administrative  1,301,509   1,104,803   17.80%  1,807,548   1,554,670   16.27%
                        
Total operating expenses  6,187,405   1,158,803   433.95%  8,268,295   2,378,080   247.69%
                        
Loss from operations  (6,187,405)  (1,158,803)  433.95%  (8,268,295)  (2,378,080)  247.69%
                        
Change in fair value of warrant liability  707,284   -   100.00%  867,930   -   100.00%
                        
Interest income  984   -   100.00%  1,519   -   100.00%
                        
Net loss $(5,479,137) $(1,158,803)  372.83% $(7,398,846) $(2,378,080)  211.13%

 

Research and Development

 

Our research and development costs increased from $54,000$823,410 during the sixnine months ended JuneSeptember 30, 2022 to $4,885,896$6,460,747 during the sixnine months ended JuneSeptember 30, 2023. The increase of $4,831,896$5,637,337 is primarily due to development activities for our Nell-1 protein as we prepare for our pilot clinical study. We will continue to incur significant expenses for development activities for NELL-1 in the future.

 

General and Administrative

 

Our general and administrative expenses increased from $1,104,803$1,554,670 during the sixnine months ended JuneSeptember 30, 2022 to $1,301,509$1,807,548 during the sixnine months ended JuneSeptember 30, 2023. The $196,706$252,878 increase was due to increased legal expenditures offset by a decrease in the fair value of options issued in 2023 verses 2022.

 

Change in fair value of warrant liability

 

In October 2022, we completed a public equity offering, which included the issuance of 433,382 warrants. The warrants provide for a Black Scholes value calculation in the event of certain transactions (“Fundamental Transactions,” as defined), which includes a floor on volatility utilized in the value calculation at 100% or greater. We have determined that this provision introduces leverage to the holders of the warrants that could result in a value that would be greater than the settlement amount of a fixed-for-fixed option on the Company’s own equity shares. Accordingly, pursuant to ASC 815, we have classified the fair value of the warrants as a liability to be re-measured at the end of every reporting period with the change in value reported in the statement of operations.

 

The change in fair value of warrant liability represents the re-measurement of the outstanding warrants at JuneSeptember 30, 2023.

Liquidity and Capital Resources

 

Since inception to JuneSeptember 30, 2023 we have incurred accumulated losses of approximately $77.4$79.4 million. We will continue to incur significant expenses for development activities for its product NELL-1/DBM. Operating expenditures for the next twelve months are estimated at $6.1$5.1 million. The accompanying consolidated financial statements for the sixnine months ended JuneSeptember 30, 2023 have been prepared assuming the Company will continue as a going concern. As reflected in the financial statements, we incurred a net loss of $5.5$7.4 million, and used net cash in operating activities of $5.0$7.5 million during the sixnine months ended JuneSeptember 30, 2023. These factors raise substantial doubt about the Company’s ability to continue as a going concern within a reasonable period of time, which is considered to be one year from the issuance date of these financial statements. In addition, our independent registered public accounting firm, in its audit report to the financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2022, expressed substantial doubt about our ability to continue as a going concern. The consolidated financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

 

78

 

 

We will continue to attempt to raise additional debt and/or equity financing to fund future operations and to provide additional working capital. However, there is no assurance that such financing will be consummated or obtained in sufficient amounts necessary to meet our needs. If cash resources are insufficient to satisfy our on-going cash requirements, we will be required to scale back or discontinue our product development programs, or obtain funds if available (although there can be no certainties) through strategic alliances that may require us to relinquish rights to our technology or substantially reduce or discontinue our operations entirely. No assurance can be given that any future financing will be available or, if available, that it will be on terms that are satisfactory to us. Even if we are able to obtain additional financing, it may contain undue restrictions on our operations, in the case of debt financing, or cause substantial dilution for our stockholders, in the case of equity financing.

 

On June 14, 2023, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with EF Hutton, division of Benchmark Investments, LLC (“EF Hutton”) acting as representatives of the several underwriters in connection with a public offering (the “Offering”) of an aggregate of 2,538,071 shares of its common stock. The public offering price was $1.97 per share and the underwriters agreed to purchase 2,538,071 shares at a 7% discount to the public offering price. The Company granted EF Hutton a 45-day option to purchase up to 380,710 additional shares, to cover over-allotments, if any.any, which was not exercised. The Offering closed on June 16, 2023, resulting in gross proceeds of $5 million, before deducting underwriting discounts and commissions and other offering expenses. The net proceeds in relation to the Offering were $4,452,163 thousand.

At JuneSeptember 30, 2023 and December 31, 2022, we had cash of $7,007,809$4,452,586 and $7,538,312, respectively.

 

Available cash is expected to fund through six month trial data reporting for our pilot clinical study, which results we expect duringoperations through the second quarter of 2024.

 

We anticipate that we will require approximately $8.6$5.9 million to complete first in man studies, and an estimated additional $27 million to achieve FDA approval for a spine interbody fusion indication.

 

Cash Flows

 

Operating activities

 

During the sixnine months ended JuneSeptember 30, 2023 and 2022, cash used in operating activities was $4,982,666$7,537,889 and $1,220,843,$1,616,122, respectively. Cash expenditures for the sixnine months ended JuneSeptember 30, 2023 increased primarily due to development activities for our Nell-1 protein as we prepare for our pilot clinical study.

 

Financing activities

During the sixnine months ended JuneSeptember 30, 2023, cash provided by financing activities of $4,452,163 resulted from the net proceeds of our June 14, 2023 public offering of common stock.

Off-Balance Sheet Arrangements

 

The Company does not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on the Company’s financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.

 

Critical Accounting Policies and Use of Estimates

See our most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2022 for a discussion of our critical accounting policies and use of estimates. There have been no material changes to our critical accounting policies and use of estimates discussed in such report.

 

Item 3. Quantitative and Qualitative Disclosures about Market Risk

 

Not applicable.

 

Item 4. Controls and Procedures.

 

Evaluation of Disclosure Controls and Procedures

 

Under the supervision and with the participation of our management, including our Chief Financial Officer and Chief Executive Officer, we evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (Exchange Act)) as of JuneSeptember 30, 2023. Based upon that evaluation, our Chief Financial Officer and Chief Executive Officer concluded that as of JuneSeptember 30, 2023, our disclosure controls and procedures were effective.

 

Changes in Internal Controls

 

There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(d) and 15d-15(d) under the Exchange Act) that occurred during the quarter ended JuneSeptember 30, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

89

 

PART II – OTHER INFORMATION

 

Item 1. Legal Proceedings.

 

There have been no material developments with respect to the information previously reported under Part I, Item 3 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2022.

 

Item 1A. Risk Factors.

 

For a discussion of the Company’s potential risks or uncertainties, please see “Part I—Item 1A—Risk Factors” and “Part II—Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC, and “Part I—Item 2—Management’s Discussion and Analysis of Financial Condition and Results of Operations” herein. There have been no material changes from the risk factors as previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2022, and subsequent Quarterly Reports on Form 10-Q, except as noted herein.

The Nasdaq Hearings Panel has imposed on us a Panel Monitor until June 27, 2024. If we failWe ceased to continue to complybe in compliance with the Nasdaq minimum bid price rule orwhile subject to a Nasdaq Panel Monitor and have requested a hearing with any othera Nasdaq Hearing Panel in response to a delisting notice. If the Hearing Panel does not grant us additional time to regain compliance with the minimum bid price rule,, and if we are unable to regain and maintain compliance with the Nasdaq listing requirement,rules, our common stock may be delisted from trading on the Nasdaq Stock Market, which could have a material adverse effect on us and our stockholders.

On November 17, 2022, we received a deficiency letter from the Nasdaq notifying us that, because the bid price of our common stock closed below $1.00 per share for 30 consecutive business days, we were no longer in compliance with Nasdaq’s minimum bid price rule, which is a requirement for continued listing on the Nasdaq Capital Market. Nasdaq’s rules require that we would need to regain compliance with this rule by May 16, 2023. We were not eligible to obtain an additional second 180 calendar period to regain compliance because as of March 31, 2023, the Company did not meet the initial listing standard for stockholders’ equity and subsequently, on May 18, 2023, the Company was notified by the Staff that, based upon the Company’s non-compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) as of May 30, 2023, the Company’s securities, common stock and publicly traded warrants, were subject to delisting unless the Company timely appealed the Staff’s determination by requesting a hearing before the Nasdaq Hearings Panel (the “Panel”). We filed an expedited review request and on May 26, 2023 which included the June 2023 one-for-thirty reverse stock split described in Note 1 to our condensed consolidated financial statements included in this report. On June 20, 2023, we received a temporary extension until June 21, 2023 to regain compliance.

On June 28, 2023, we received a letter from the Hearings Advisor in the Nasdaq Office of General Counsel confirming the decision of thea Nasdaq Hearing Panel that while the Company currently demonstratesdemonstrated compliance with the requirements for continued listing on The Nasdaq Capital Market for the minimum bid price as outlined in Listing Rule 5550(a)(2). However,rule at that time, based on our recent bid price history, the Nasdaq Hearings Panel haspanel imposed a “Panel Monitor,” as defined by Nasdaq Listing Rule 5815(d)(4)(A), through June 27, 2024. In the event

On September 27, 2023, the Company fails to satisfyreceived a continued listing requirement duringwritten notice (the “Notice”) from the one year monitoring period,staff of Nasdaq notifying the Company will not be providedthat it failed to comply with the opportunity to present$1.00 per share minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2). As a result of the imposition of a mandatory Panel Monitor, the Company is not eligible for a compliance plan to Nasdaq’s Listing Qualifications Department (the “Department”) and the Department will not be permitted to grant additional time for the Companyperiod to regain compliance with respect to that deficiency, nor will the Company be afforded an applicable cure or compliance period pursuant to Rule 5810(c)(3), which process might otherwise be available underminimum bid price requirement. Accordingly, the Nasdaq Listing Rules but would instead have an opportunitystaff has determined to delist the Company’s securities from Nasdaq (the “Staff Determination”).

The Company timely requested a hearing before a Nasdaq Hearings Panel (the “Panel”), to appeal the Staff Determination, which request an appealstayed any delisting action pending the issuance of the determination pursuant to Listing Rule 5815(d)(4)(C).Panel’s determination. The Company’s securities may at that time be delisted from Nasdaq.Panel hearing is scheduled for November 30, 2023.

If the Company is delisted from Nasdaq, its common stock may be eligible for trading on an over-the-counter market. If the Company is not able to obtain a listing on another stock exchange or quotation service for its common stock, it may be extremely difficult or impossible for stockholders to sell their shares of common stock. Moreover, if the Company is delisted from Nasdaq, but obtains a substitute listing for its common stock, it will likely be on a market with less liquidity, and therefore experience potentially more price volatility than experienced on Nasdaq. Stockholders may not be able to sell their shares of common stock on any such substitute market in the quantities, at the times, or at the prices that could potentially be available on a more liquid trading market. As a result of these factors, if the Company’s common stock is delisted from Nasdaq, the value and liquidity of the Company’s common stock, warrants and pre-funded warrants would likely be significantly adversely affected. A delisting of the Company’s common stock from Nasdaq could also adversely affect the Company’s ability to obtain financing for its operations and/or result in a loss of confidence by investors, employees and/or business partners.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

 

None

 

Item 3. Defaults Upon Senior Securities.

 

None

 

Item 4. Mine Safety Disclosures.

 

Not Applicable

 

Item 5. Other Information.

 

During the three months ended JuneSeptember 30, 2023, no director or officer of the Company adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.

 

910

 

 

Item 6. Exhibits.

 

(a) Exhibits required by Item 601 of Regulation S-K.

 

Exhibit Description
3.110.1Certificate ofFirst Amendment to Amended and Restated Certificate of Incorporation ofthe Bone Biologics Corporation (incorporated herein2015 Equity Incentive Plan (Incorporated by reference to Exhibit 3.1Annex B to current reportthe registrant’s Proxy Statement on Form 8-K, File No. 001-40899,Schedule 14A filed June 6,August 3, 2023).
31.1 Certification of the Company’s Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, with respect to the registrant’s Report on Form 10-Q for the quarter ended JuneSeptember 30, 2023.*
   
31.2 Certification of the Company’s Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, with respect to the registrant’s Report on Form 10-Q for the quarter ended JuneSeptember 30, 2023.*
   
32.1 Certification of the Company’s Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.**
   
32.2 Certification of the Company’s Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.**
   
101.INS Inline XBRL Instance Document*
101.SCH Inline XBRL Taxonomy Extension Schema Document*
101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document*
101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document*
101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document*
101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document*
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

* Filed Herewith

** Furnished Herewith

 

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SIGNATURES

 

In accordance with Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 BONE BIOLOGICS CORPORATION
   
Dated: AugustNovember 14, 2023By:/s/ Jeffrey Frelick
 Name:Jeffrey Frelick
 Title:Chief Executive Officer

 

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