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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 March 31, 2025

 

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 Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant 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 filer Accelerated filer
Non-accelerated filer Smaller reporting company
    Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided 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 May 1, 2025, there were 3,271,042 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 Sheets F-1
   
Unaudited Condensed Consolidated Statements of Operations F-2
   
Unaudited Condensed Consolidated Statements of Stockholders’ Equity F-3
   
Unaudited Condensed Consolidated Statements of Cash Flows F-5
   
Notes to Unaudited Condensed Consolidated Financial Statements F-6
   
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 4
   
Item 3. Quantitative and Qualitative Disclosures about Market Risk 6
   
Item 4. Controls and Procedures 6
   
PART II – OTHER INFORMATION: 7
   
Item 1. Legal Proceedings 7
   
Item 1A. Risk Factors 7
   
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 8
   
Item 3. Defaults Upon Senior Securities 8
   
Item 4. Mine Safety Disclosures 8
   
Item 5. Other Information 8
   
Item 6. Exhibits 9
   
Signatures 10

 

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 Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on February 26, 2025 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 “anticipate,” “believe,” “expect,” “intend,” “plan,” “estimate,” “can,” “could,” “may,” “will,” “would,” 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 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/DBM, 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 Form 10-Q 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

 

  

March 31,

2025

   December 31,
2024
 
   (unaudited)     
Assets          
           
Current Assets          
Cash  $2,746,555   $3,325,131 
Advances on research and development contract services   208,972    258,059 
Prepaid insurance   196,533    268,179 
Prepaid expenses   10,000    10,000 
Total current assets  $3,162,060   $3,861,369 
Total assets  $3,162,060   $3,861,369 
           
Liabilities and Stockholders’ Equity          
           
Current Liabilities          
Accounts payable and accrued expenses  $247,843   $373,042 
Warrant liability   3,315    4,670 
           
Total current liabilities   251,158    377,712 
Total liabilities   251,158    377,712 
           
Commitments and Contingencies   -    - 
           
Stockholders’ Equity          
Preferred Stock, $0.001 par value per share; 20,000,000 shares authorized; none issued or outstanding at March 31, 2025 and December 31, 2024   -    - 
Common stock, $0.001 par value per share; 100,000,000 shares authorized; 3,271,042 and 2,953,982 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively   3,270    2,953 
Additional paid-in capital   88,946,102    88,502,082 
Accumulated deficit   (86,038,470)   (85,021,378)
           
Total stockholders’ equity   2,910,902    3,483,657 
           
Total liabilities and stockholders’ equity  $3,162,060   $3,861,369 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

F-1

 

 

Bone Biologics Corporation

 

Condensed Consolidated Statements of Operations

 

  

Three Months

Ended

March 31, 2025

  

Three Months

Ended
March 31, 2024

 
   (unaudited)   (unaudited) 
Revenues  $-   $- 
           
Operating expenses          
Research and development   423,576    245,625 
General and administrative   614,910    657,911 
           
Total operating expenses   1,038,486    903,536 
           
Loss from operations   (1,038,486)   (903,536)
           
Other income          
Change in fair value of warrant liability   1,355    37,311 
Interest income   20,039    255 
Total other income   21,394    37,566 
           
Net loss  $(1,017,092)  $(865,970)
           
Weighted average shares outstanding - basic and diluted   3,183,191    660,928 
           
Loss per share - basic and diluted  $(0.32)  $(1.31)

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

F-2

 

 

Bone Biologics Corporation

 

Consolidated Statement of Stockholders’ Equity

For the Three Months ended March 31, 2025

(unaudited)

 

   Shares   Amount   Capital   Deficit   Equity 
   Common Stock   Additional
Paid-in
   Accumulated   Total Stockholders’ 
   Shares   Amount   Capital   Equity   Equity 
                     
Balance at December 31, 2024   2,953,982   $2,953   $88,502,082   $(85,021,378)  $3,483,657 
                          
Fair value of vested stock options   -    -    50,605    -    50,605 
                          
Options issued to settle accrued bonus   -    -    46,183    -    46,183 
                          
Issuance of common shares from ATM, net of costs of $13,029   317,060    317    347,232    -    347,549 
                          
Net Loss   -    -    -    (1,017,092)   (1,017,092)
                          
Balance at March 31, 2025   3,271,042   $3,270   $88,946,102   $(86,038,470)  $2,910,902 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

F-3

 

 

Bone Biologics Corporation

 

Consolidated Statement of Stockholders’ Equity

For the Three Months ended March 31, 2024

(unaudited)

 

   Common Stock   Additional
Paid-in
   Accumulated   Total Stockholders’ 
   Shares   Amount   Capital   Equity   Equity 
                     
Balance at December 31, 2023   534,238   $534   $83,814,785   $(80,908,958)  $2,906,361 
                          
Fair value of vested stock options   -    -    52,681    -    52,681 
                          
Options issued to settle accrued bonus   -    -    77,400    -    77,400 
                          
Proceeds from sale of common stock in public offering, net of offering costs of $490,227   344,938    345    1,503,994    -    1,504,339 
                          
Exercise of pre-funded warrants   137,313    137    -    -    137 
                          
Net Loss   -    -    -    (865,970)   (865,970)
                          
Balance at March 31, 2024   1,016,489   $1,016   $85,448,860   $(81,774,928)  $3,674,948 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

F-4

 

 

Bone Biologics Corporation

 

Condensed Consolidated Statements of Cash Flows

 

  

Three Months

Ended

March 31, 2025

   Three Months Ended
March 31, 2024
 
    (unaudited)    (unaudited) 
Cash flows from operating activities          
Net loss  $(1,017,092)  $(865,970)
Adjustments to reconcile net loss to net cash used in operating activities:          
Stock-based compensation   50,605    52,681 
Change in fair value of warrant liability   (1,355)   (37,311)
Changes in operating assets and liabilities:          
Advances on research and development contract services   49,087    - 
Prepaid expenses and other current assets   71,646    99,254 
Accounts payable and accrued expenses   (79,016)   (137,076)
Accrued legal settlement   -    (414,989)
           
Net cash used in operating activities   (926,125)   (1,303,411)
           
Cash flows from financing activities          
Proceeds from issuance of common shares under ATM offering, net of costs   347,549    1,504,476 
           
Net cash provided by financing activities   347,549    1,504,476 
           
Net increase (decrease) in cash   (578,576)   201,065 
           
Cash, beginning of period   3,325,131    3,026,569 
Cash, end of period  $2,746,555   $3,227,634 
           
Supplemental information          
Income taxes paid  $-   $- 
Noncash investing and financing activities          
Options issued to settle accrued bonus  $46,183    77,400 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

F-5

 

 

Bone Biologics Corporation

Notes to Unaudited Condensed Consolidated Financial Statements

For the Three Months ended March 31, 2025 and 2024

 

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 U.S. Food and Drug Administration (“FDA”) that NELL-1/DBM will be classified as a device/drug combination product that will require an FDA-approved pre-market approval (“PMA”) application before it can be commercialized in the United States.

 

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 Federal 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.

 

The Company is also subject to additional risks and uncertainties arising from changes to the macroeconomic environment and geopolitical events. U.S. and global financial markets have experienced volatility and disruption due to macroeconomic and geopolitical events such as the implementation of tariffs, inflation, the risk of a recession and ongoing conflicts in other countries. In addition, if equity and credit markets deteriorate, it may make any future debt or equity financing more difficult to obtain on favorable terms, and potentially more dilutive to existing stockholders. The Company cannot predict at this time to what extent it and its collaborators, employees, suppliers, contract manufacturers and/or vendors could potentially be negatively impacted by these events.

Going Concern and Liquidity

 

The Company has no significant operating history and since inception to March 31, 2025 has incurred accumulated losses of approximately $86.0 million. The Company will continue to incur significant expenses for development activities for their lead product NELL-1/DBM. Operating expenditures for the next twelve months are estimated at $4.9 million. The accompanying consolidated financial statements for the three months ended March 31, 2025 have been prepared assuming the Company will continue as a going concern. As reflected in the financial statements, the Company incurred a net loss of $1.0 million and used net cash in operating activities of $0.9 million during the three months ended March 31, 2025. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. In addition, our independent registered public accounting firm, in its audit report to the financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, expressed substantial doubt about the Company’s 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.

 

F-6

 

 

At March 31, 2025, the Company had cash of $2.7 million. Available cash is expected to fund the Company’s operations up to the fourth quarter of 2025.

 

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, or 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 the Company’s operations, in the case of debt financing, or cause substantial dilution for its stockholders, in the case of equity financing.

 

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, 2024 was derived from the audited consolidated financial statements included in the Company’s Annual Report on Form 10-K filed with the SEC on February 26, 2025 (the “2024 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, 2024 and notes thereto included in the 2024 Annual Report.

 

The results of operations for the three months ended March 31, 2025 are not necessarily indicative of the results to be expected for the entire fiscal year ended December 31, 2025 or for any other period.

 

Segment Information

 

The Company operates and reports in one segment, which focuses on bone regeneration in spinal fusion using the recombinant human protein known as NELL-1. The Company’s operating segment is reported in a manner consistent with the internal reporting provided to the Chief Operating Decision Maker (the “CODM”), which is the Company’s Chief Executive Officer and President (the “CEO”).

 

The CODM uses consolidated net income (loss) as the sole measure of segment profit or loss. Significant segment expenses include research and development, salaries, insurance, and stock-based compensation. Operating expenses include all remaining costs necessary to operate our business, which primarily include external professional services and other administrative expenses (see Note 8).

 

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 accounting 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 the realizability of the Company’s deferred tax assets. Actual results could differ from those estimates.

 

F-7

 

 

Inflation

 

Macroeconomic factors such as inflation, rising interest rates, governmental responses there to and possible recession caused thereby also add significant uncertainty to the Company’s 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.

 

Research and Development Costs

 

Research and development costs include, but are not limited to, payroll and other personnel expenses, consultants, expenses incurred under agreements with contract research and manufacturing organizations and animal clinical investigative sites and the cost to manufacture clinical trial materials. Research and development costs are generally charged to operations ratably over the life of the underlying contracts, unless the achievement of milestones, the completion of contracted work, the termination of an agreement, or other information indicates that a different expensing schedule is more appropriate. However, payments for research and development costs that are contractually defined as non-refundable are charged to operations as incurred.

 

Payments made pursuant to contracts are initially recorded as advances on research and development contract services in the Company’s consolidated balance sheet and are then charged to research and development costs in the Company’s consolidated statement of operations as those contract services are performed. Expenses incurred under contracts in excess of amounts advanced are recorded as research and development contract liabilities in the Company’s consolidated balance sheets, with a corresponding charge to research and development costs in the Company’s consolidated statements of operations. The Company reviews the status of its various clinical trial and research and development contracts on a quarterly basis.

 

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:

 

Description  Total   Level 1   Level 2   Level 3 
   As of March 31, 2025 
Description  Total   Level 1   Level 2   Level 3 
Liabilities:                    
Warrant liability  $3,315           $3,315 
Total liabilities at fair value  $3,315           $3,315 

 

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 three month period ended March 31, 2025 as follows:

 

   March 31, 2025 
Warrant liability     
Balance as of beginning of period – December 31, 2024  $4,670 
Change in fair value   (1,355)
Balance as of March 31, 2025  $3,315 

 

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.

 

F-8

 

 

Stock Based Compensation

 

Accounting Standards Codification (“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.

 

Warrants

 

The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in ASC 480, Distinguishing Liabilities from Equity (“ASC 480”), and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own common stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the time of issuance. For issued or modified warrants that do not meet all of the criteria for equity classification, the warrants are required to be liability classified and recorded at their initial fair value on the date of issuance and remeasured at fair value at each balance sheet date thereafter. Changes in the estimated fair value of the warrants that are liability classified are recognized as a non-cash gain or loss in the statement of operations at each balance sheet date.

 

Net 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 three months ended March 31, 2025 and 2024, 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 March 31, 2025 and 2024:

 

       
   March 31, 
   2025   2024 
Warrants   1,854,096    1,324,970 
Stock options   275,412    74,151 
 Anti dilutive securities   2,129,508    1,399,121 

 

New Accounting Standards

 

In November 2024, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) 2024-03 “Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses.” This ASU requires public business entities to disclose, for interim and annual reporting periods, additional information about certain income statement expense categories. The requirements are effective for fiscal years beginning after December 15, 2026, and for interim periods beginning after December 15, 2027. Entities are permitted to apply either the prospective or retrospective transition methods. The Company is in the process of evaluating this ASU to determine its impact on the Company’s disclosures.

 

The Company’s management has evaluated all other 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.

 

F-9

 

 

3. Research and Development

 

The Company has developed a stand-alone platform technology through significant laboratory and small and large animal research over more than ten years to generate the current applications across broad fields of use, including the completion of two preclinical sheep studies that demonstrated our recombinant NELL-1 (“rhNELL-1”) growth factor effectively promotes bone formation in a phylogenetically advanced spine model.

 

During 2024, the Company announced the treatment of the first patients in the multicenter, prospective, randomized pilot clinical study of our NB1 bone graft device. NB1 is NELL-1 protein combined with demineralized bone matrix (DBM) to provide rapid, specific and guided control over bone regeneration.

 

The pilot clinical study will evaluate the safety and effectiveness, fusion success, pain, function improvement and adverse events of NB1 in up to 30 adult subjects who undergo transforaminal lumbar interbody fusion to treat degenerative disc disease. To be enrolled in the study, subjects must have DDD at one level from L2-S1 and may also have up to Grade 1 spondylolisthesis or Grade 1 retrolisthesis at the involved level. The study is being conducted in Australia. The study design was previously reviewed and agreed upon by the FDA’s Division of Orthopedic Devices in a Pre-submission to support progression to a pivotal clinical trial in the United States.

 

The Company has entered into various agreements with Contract Manufacturing Organizations (“CMOs”), Contract Research Organizations and other third parties related to our pilot clinical study. During the three month period ended March 31, 2025 and 2024, research and development costs primarily associated with clinical trials involving the Company’s lead product candidate, totaled $423,576 and $245,625, respectively. At March 31, 2025, the estimated remaining commitment under these agreements is approximately $304,367.

 

Research and development costs are summarized below based on the respective geographical regions where such costs are incurred.

 

       
  

Three Months Ended

March 31,

 
   2025   2024 
         
United States  $337,647   $175,048 
Australia   85,929    70,577 
Total  $423,576   $245,625 

 

4. Warrant Liability

 

In October 2022, the Company completed a public equity offering, which included the issuance of 54,174 warrants. The warrants provide for a Black Scholes value calculation, as defined, in the event of certain transactions (“Fundamental Transactions,” as defined), which includes a floor on volatility utilized in the Black Scholes value calculation at 100% or greater. 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.

 

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

 

  

March 31,

2025

  

December 31,

2024

 
Warrant liability:          
Risk-free interest rate   4.35%   4,28%
Expected volatility   148.83%   146.75%
Expected life (in years)   2.53    2.78 
Expected dividend yield   -    - 
           
Fair Value of warrant liability  $3,315   $4,670 

 

The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant. The Company determines expected volatility based upon the historical volatility of the Company’s common stock. The Company does not believe that the future volatility of its 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.

 

F-10

 

 

5. 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.

 

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 March 31, 2025 and December 31, 2024, the Company had an aggregate of 3,271,042 and 2,953,982 shares of common stock outstanding, respectively.

 

2025 transactions

 

At the Market (ATM) Offering Program

 

In September 2024, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”). Under the ATM Agreement, the Company may, from time to time, in its sole discretion, issue and sell through Wainwright up to $1,143,121 of shares of its common stock. In December 2024, the Company filed a prospectus supplement and increased the aggregate offering that can be sold under the ATM Agreement by $535,000 (the “ATM Facility”).

 

Pursuant to the ATM Agreement, the Company may sell the shares by any method permitted that is deemed an “at the market” offering as defined in Rule 415 under the Securities Act. The Company will pay Wainwright a commission of 3.0% of the gross sales price per share sold under the ATM Agreement.

 

During the three months ended March 31, 2025, the Company sold 317,060 shares of common stock through the ATM Facility for net proceeds of $347,549, after deducting $13,029 in offering costs.

 

2024 transactions

 

March 2024 Offering

 

On March 6, 2024, the Company sold 119,000 shares of common stock together with warrants to purchase 119,000 shares of common stock (exercise price of $2.43 per share), expiring on March 6, 2029, at a combined public offering price of $2.56. In addition, the Company sold pre-funded warrants to purchase 662,251 shares of common stock together with warrants to purchase 662,251 shares of common stock, for a combined price of $2.559. The net proceeds received from the sale of common stock, pre-funded warrants and warrants, net of cash costs of $495,227, was $1,504,113.

 

The 781,251 warrants have an exercise price of $2.43 per share, and were exercisable immediately for a term of five years. The 662,251 pre-funded warrants have an exercise price of $0.001 per share and were exercisable immediately until fully exercised.

 

During the three months ended March 31, 2024, 363,251 pre-funded warrants were exercised and 363,251 shares of common stock were issued. During the three months ended June 30, 2024, the balance of 299,000 pre-funded warrants were exercised and 299,000 shares of common stock were issued.

 

In addition, warrants to purchase 46,875 shares of common stock were issued to the placement agent, in connection with the March 2024 offering. The placement agent warrants have an exercise price of $3.20 per share and were exercisable immediately upon issuance for a term of five years.

 

F-11

 

 

6. Common Stock Warrants

 

A summary of warrant activity for the three months ended March 31, 2025 is presented below:

 

Subject to Exercise 

Number of

Warrants

  

Weighted Average

Exercise Price

  

Weighted Average

Life (Years)

 
Outstanding as of December 31, 2024   1,854,096   $15.49    3.04 
Granted – 2025   -    -    - 
Forfeited/Expired – 2025   -    -    - 
Exercised – 2025   -    -    - 
Outstanding as of March 31, 2025   1,854,096   $15.49    2.79 

 

As of March 31, 2025, the Company had outstanding exercisable, but unexercised common stock warrants as follows:

  

Date Issued  Exercise Price   Number of
Warrants
   Expiration date
October 2021  $1,512.00    7,620   October 13, 2026
October 2022  $388.80    18,058   October 12, 2027
October 2022  $324.00    18,846   October 12, 2027
October 2022  $0.00    2,393   October 12, 2027
November 2023  $6.40    8,543   November 16, 2028
November 2023  $4.16    142,384   May 21, 2029
March 2024  $3.20    46,875   March 6, 2029
August 2024  $2.00    781,251   February 2, 2026
August 2024  $2.00    781,251   August 2, 2029
August 2024  $3.35    46,875   August 2, 2029
Total outstanding warrants at March 31, 2025        1,854,096    

 

Based on a fair market value of $0.80 per share on March 31, 2025, there were 2,393 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 March 31, 2025 was $1,914.

 

7. Stock-based Compensation

 

2015 Equity Incentive Plan

 

The Company has 629,489 shares of common stock authorized and reserved for issuance under its 2015 Equity Incentive Plan for option awards. This reserve may be increased by the Board of Directors 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. Appropriate adjustments will be made in the number of authorized shares and other numerical limits in the Company’s 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 the Company’s capital structure. Shares subject to awards granted under the 2015 Equity Incentive Plan which expire, are repurchased or are cancelled or forfeited will again become available for issuance under the 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 the 2015 Equity Incentive Plan.

 

Awards may be granted under the 2015 Equity Incentive Plan to the Company’s employees, including officers, director or consultants, and its present or future affiliated entities. While the Company may grant incentive stock options only to employees, it 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.

 

F-12

 

 

The 2015 Equity Incentive Plan is administered by the Company’s compensation committee. Subject to the provisions of the 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 the Company and the holder of the award. The compensation committee has the authority to construe and interpret the terms of the 2015 Equity Incentive Plan and awards granted under the 2015 Equity Incentive Plan.

 

A summary of stock option activity for the three months ended March 31, 2025 is presented below:

 

Subject to Exercise  Number of
Options
   Weighted
Average
Exercise
Price
   Weighted
Average
Life (Years)
   Aggregate
Intrinsic
Value
 
Outstanding as of December 31, 2024   194,484   $42.14    7.25   $- 
Granted – 2025   81,165    0.97    10.00    - 
Forfeited/Expired – 2025   237    57.60    -    - 
Exercised – 2025   -    -    -    - 
Outstanding as of March 31, 2025   275,412   $29.99    5.47   $- 
Options vested and exercisable at March 31, 2025   215,248   $37.88    4.55   $- 

 

As of March 31, 2025, the Company had outstanding stock options as follows:

 

Date Issued  Exercise Price   Number of
Options
   Expiration date
August 2015  $9,540.00    174   December 27, 2025
September 2015  $9,540.00    36   December 27, 2025
November 2015  $9,540.00    205   December 27, 2025
December 2015  $9,540.00    12   December 27, 2025
January 2016  $9,540.00    213   January 9, 2026
May 2016  $12,300.00    45   May 26, 2026
September 2016  $12,300.00    21   May 31, 2026
January 2017  $12,300.00    10   January 1, 2027
January 2018  $11,820.00    8   January 1, 2028
January 2019  $564.00    92   January 1, 2029
October 2021  $1,260.00    207   October 26, 2031
January 2022  $844.80    111   January 1, 2032
August 2022  $387.26    462   August 23, 2032
September 2023  $5.12    26,803   September 12, 2033
January 2024  $4.68    8,015   January 8, 2034
January 2024  $3.61    37,500   January 17, 2026
September 2024  $1.73    92,139   September 17, 2034
October 2024  $1.88    28,194   October 16, 2034
January 2025  $0.97    81,165   January 15, 2027
              
Total outstanding options at March 31, 2025        275,412    

 

Based on a fair value of $0.80 per share on March 31, 2025, there were no exercisable but unexercised in-the-money common stock warrants on that date.

 

During the three months ended March 31, 2025, options exercisable into 237 shares of common stock expired. Vesting of options differs based on the terms of each option. During the three months ended March 31, 2025 and 2024, the Company had stock-based compensation expense of $50,605 and $52,681, respectively, related to the vesting of stock options granted to the Company’s employees and directors included in our reported net loss. In addition, during the three months ended March 31, 2025 and 2024, options exercisable into 81,165 and 37,500, shares of common stock respectively, were issued to employees in settlement of previously accrued bonuses of $46,183 and $77,400, respectively.

 

The Company utilized the Black-Scholes option-pricing model. The assumptions used for the three months ended March 31, 2025 are as follows:

 

   March 31, 2025 
Risk free interest rate   3.96%
Expected Volatility   141.95%
Expected life (in years)   5.00 
Expected dividend yield   0%

 

F-13

 

 

The expected volatility is a measure of the amount by which the Company stock price is expected to fluctuate during the expected term of options granted. The Company determines the expected volatility based upon the historical volatility of our common stock since listing on The Nasdaq Capital Market. The Company does not believe that the future volatility of its 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 the Company settles these obligations by issuing shares of its common stock from its authorized shares instead of settling such obligations with cash payments.

 

As of March 31, 2025, total unrecognized compensation cost related to unvested stock options was $37,511. The cost is expected to be recognized over a weighted average period of 0.42 years.

 

8. Segment information

 

The CODM has been identified as the CEO. The Company’s CODM evaluates performance and makes operating decisions about allocating resources based on financial data presented on a consolidated basis. Because the CODM evaluates financial performance on a consolidated basis, the Company has determined that it has a single operating segment composed of the consolidated financial results of Bone Biologics Corporation.

 

Significant segment expenses include research and development, salaries, insurance, and stock-based compensation. Operating expenses include all remaining costs necessary to operate our business, which primarily include external professional services and other administrative expenses. The following table presents the significant segment expenses and other segment items regularly reviewed by our CODM:

 

       
   Three months ended
March 31,
 
   2025   2024 
Revenue  $-   $- 
           
Less:          
Research and development   423,577    245,625 
Salaries   125,000    125,000 
Insurance   71,646    99,254 
Stock-based compensation   50,605    52,681 
Operating expenses   367,659    380,976 
Other income   (21,395)   (37,566)
Net loss  $(1,017,092)  $(865,970)

 

9. Commitments and Contingencies

 

UCLA TDG Exclusive License Agreement

 

Effective April 9, 2019, the Company entered into an Amended and Restated Exclusive License Agreement, 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 the Company 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.

 

The Company has 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. The Company must pay the royalties to UCLA TDG on a quarterly basis. Upon a first commercial sale, the Company 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 the Company is required to pay a third party any royalties as a result of it making use of UCLA TDG patents, then it may reduce the royalty owed to UCLA TDG by 0.333% for every percentage point paid to a third party. If the Company grants sublicense rights to a third party to use the UCLA TDG patent, then it will pay UCLA TDG 10% to 20% of the sublicensing income it receives from such sublicense.

 

The Company is 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.

 

F-14

 

 

The Company is 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.

 

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

 

The Company is 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 (i) $500,000; or (ii) 2% of all proceeds in connection with a Change of Control Transaction.

 

During 2024, the first patients were treated in the multicenter, prospective, randomized pilot clinical study of the Company’s NB1 bone graft device, triggering the payment of the initial $100,000 Feasibility Study milestone.

 

The Company is obligated to diligently proceed with developing and commercializing licensed products under UCLA TDG patents set forth in the Amended License Agreement. UCLA TDG has the right to either terminate the license or reduce the license to a non-exclusive license if it does not meet certain diligence milestone deadlines set forth in the Amended License Agreement.

 

The Company must reimburse or pre-pay UCLA TDG for patent prosecution and maintenance costs incurred during the term of the Amended License Agreement. The Company has 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 the Company’s expense, be joined involuntarily to the action. The Company is required to indemnify UCLA TDG against any third-party claims arising out of its exercise of the rights under the Amended License Agreement or any sublicense.

 

Payments to UCLA TDG under the Amended License Agreement for the three months ended March 31, 2025 and 2024 were $10,000 and $30,845, respectively.

 

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.

 

10. Subsequent Events

 

The Company has evaluated subsequent events through May 1, 2025, 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-15

 

 

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, 2024 and 2023 and the related notes included in our Annual Report on Form 10-K filed for the fiscal year ended December 31, 2024, with the SEC on February 26, 2025. This discussion contains forward-looking statements reflecting our current expectations that involve risks and uncertainties. See “Note On 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.

 

Company 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 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 that will require an FDA-approved PMA before it can be commercialized in the United States.

 

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 platform technology. Our platform technology 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 clinical-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 Federal 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 clinical trials.

 

Our success will depend in part on our ability to obtain and retain 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.

 

During 2024, we announced the treatment of the first patients in the multicenter, prospective, randomized pilot clinical study of our NB1 bone graft device. NB1 is NELL-1 protein combined with demineralized bone matrix (DBM) to provide rapid, specific and guided control over bone regeneration.

 

The pilot clinical study will evaluate the safety and effectiveness, fusion success, pain, function improvement and adverse events of NB1 in up to 30 adult subjects who undergo transforaminal lumbar interbody fusion to treat degenerative disc disease (DDD). To be enrolled in the study, patients must have DDD at one level from L2-S1 and may also have up to Grade 1 spondylolisthesis or Grade 1 retrolisthesis at the involved level. The study is being conducted in Australia. The study design was previously reviewed and agreed upon by the FDA’s Division of Orthopedic Devices in a Pre-submission to support progression to a pivotal clinical trial in the United States.

 

4

 

 

Recent Developments

 

Nasdaq Deficiency Notice

 

On April 7, 2025, we received a letter from the Listing Qualifications Staff of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, based on the closing bid price of our common stock for 30 consecutive business days, we no longer meet Nasdaq Listing Rule 5550(a)(2), which requires listed companies to maintain a minimum bid price of at least $1 per share (the “Bid Price Rule”). The Nasdaq Listing Rules provide a compliance period of 180 calendar days, or until October 6, 2025, in which to regain compliance with the Bid Price Rule. If we evidence a closing bid price of at least $1 per share for a minimum of 10 consecutive business days during the 180-day compliance period, we will automatically regain compliance. If we fail to regain compliance with the Bid Price Rule, Nasdaq will provide notice that our common stock will be subject to delisting. We would then be entitled to appeal that determination to a Nasdaq hearings panel. This notification has no immediate effect on the listing of our common stock on Nasdaq.

 

The notification has no immediate effect on the listing of our common stock on Nasdaq. We intend to seek stockholder approval of a reverse stock split of our outstanding common stock in a range of 1-for-2.5 to 1-for-10, at the discretion of our Board of Directors (the “Reverse Stock Split”) at our upcoming annual meeting of stockholders to be held on May 30, 2025.

 

Results of Operations

 

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 March 31, 2025 compared to the Three months ended March 31, 2024

 

  

Three-months
ended

March 31, 2025

   Three-months
ended
March 31, 2024
   % Change 
Operating expenses               
Research and development  $423,576   $245,625    72.45%
General and administrative   614,910    657,911    (6.54)%
                
Total operating expenses   1,038,486    903,536    14.94%
                
Loss from operations   (1,038,486)   (903,536)   14.94%
                
Change in fair value of warrant liability   1,355    37,311    (96.37)%
                
Interest income   20,039    255    7758.43%
                
Net loss  $(1,017,092)  $(865,970)   17.45%

 

Research and Development

 

Our research and development expenditures increased from $245,625 for the three months ending March 31, 2024, to $423,576 for the same period in 2025, marking an increase of $177,951. The increase in costs can be attributed to formulation processes completed with our Contract Development and Manufacturing Organization. Moving forward, we anticipate continued substantial investment in development activities for NELL-1 as we prepare for our pivotal clinical study in the future.

 

General and Administrative

 

Our general and administrative costs decreased $43,001 from $657,911 for the three months ending March 31, 2024, to $614,910 for the corresponding period in 2025.

 

Change in fair value of warrant liability

 

In October 2022, we completed a public equity offering, which included the issuance of 54,174 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 March 31, 2025.

 

Liquidity and Capital Resources

 

Going Concern and Liquidity

 

We have no significant operating history and since inception to March 31, 2025 have incurred accumulated losses of approximately $86.0 million. We will continue to incur significant expenses for development activities for our lead product NELL-1/DBM. Operating expenditures for the next twelve months are estimated at $4.9 million. The accompanying consolidated financial statements for the three months ended March 31, 2025 have been prepared assuming we will continue as a going concern. As reflected in the financial statements, we incurred a net loss of $1.0 million, and used net cash in operating activities of $0.9 million during the three months ended March 31, 2025. These factors raise substantial doubt about our ability to continue as a going concern within a reasonable period of time, which is considered to be one year after the date that the financial statements are issued. In addition, our independent registered public accounting firm, in their report on the Company’s December 31, 2024, audited financial statements, 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.

 

5

 

 

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.

 

At March 31, 2025 and December 31, 2024, we had cash of $2,746,555 and $3,325,131, respectively.

 

Available cash is expected to fund our operations into the fourth quarter of 2025.

 

Cash Flows

 

Operating activities

 

During the three months ended March 31, 2025 and 2024, cash used in operating activities was $926,125 and $1,303,411, respectively. Cash expenditures for the three months ended March 31, 2025 decreased due to the legal settlement payment in January 2024 that did not reoccur during the current period.

 

Financing activities

 

During the three months ended March 31, 2025, cash provided by financing activities was $347,549 from the net proceeds of the ATM Offering.

 

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, 2024 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 (the “Exchange Act”)) as of March 31, 2025. Based upon that evaluation, our Chief Financial Officer and Chief Executive Officer concluded that as of March 31, 2025, 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 March 31, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

6

 

 

PART II – OTHER INFORMATION

 

Item 1. Legal Proceedings.

 

In the normal course of our business, we may periodically become subject to various lawsuits. We are not presently a party to any legal proceedings that, if determined adversely to us, would individually or taken together have a material adverse effect on our business, results of operations, financial condition or cash flows. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

 

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, 2024, 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, 2024 except as noted herein.

 

We are not currently in compliance with the Nasdaq continued listing requirements. If we are unable to regain compliance with Nasdaq’s listing requirements, our securities will be delisted, which would negatively impact our common stock’s market price and liquidity and reduce our ability to raise capital.

 

On April 7, 2025, we received a deficiency letter from 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 the Nasdaq’s minimum bid price rule, which is a requirement for continued listing on Nasdaq (the “Minimum Bid Price Rule”).

 

We cannot assure you that we will be able to regain compliance with the Minimum Bid Price Rule and maintain compliance with Nasdaq’s other continued listing standards. Accordingly, our common stock and certain warrants could be delisted from Nasdaq. We and holders of our securities could be materially adversely impacted if our securities are delisted from Nasdaq. In particular:

 

  we may be unable to raise equity capital on acceptable terms or at all;
  we may lose the confidence of our business partners, which would jeopardize our ability to continue our business as currently conducted;
  the price of our common stock will likely decrease as a result of the loss of market efficiencies associated with Nasdaq and the loss of federal preemption of state securities laws;
  holders may be unable to sell or purchase our securities when they wish to do so;
  we may become subject to stockholder litigation;
  we may lose the interest of institutional investors in our common stock;
  we may lose media and analyst coverage;
  our common stock could be considered a “penny stock,” which would likely limit the level of trading activity in the secondary market for our common stock; and
  we would likely lose any active trading market for our common stock, as it may only be traded on one of the over-the-counter markets, if at all.

 

We cannot assure you that the proposed Reverse Stock Split will increase the price of our common stock.

 

We have scheduled our 2025 annual meeting of stockholders (“2025 Annual Meeting”) to be held on May 30, 2025, at which our stockholders will vote on whether to approve an amendment to our amended and restated certificate of incorporation to effect a reverse stock split of our common stock in a range of 1-for-2.5 to 1-for-10, at the discretion of the Board of Directors (the “Reverse Stock Split”). We expect that the Reverse Stock Split will increase the market price of our common stock. However, the effect of the Reverse Stock Split on the market price of our common stock cannot be predicted with any certainty, and the history of reverse stock splits for other companies of similar size to us is varied, particularly because investors may view a reverse stock split negatively. We have effected reverse stock splits in the past, however, the price of our common stock did not remain at the elevated price for an extended period of time following the reverse stock split. It is possible that the per share price of our common stock after the Reverse Stock Split will not increase in the same proportion as the reduction in the number of outstanding shares of common stock following the Reverse Stock Split, and the Reverse Stock Split may not result in a per share price that would attract investors who do not trade in lower-priced securities. In addition, we cannot assure you that our common stock will be more attractive to investors. Even if we implement the Reverse Stock Split, the market price of our common stock may decrease due to factors unrelated to the Reverse Stock Split, including our future performance, similar to the prior reverse stock split by the Company. If the Reverse Stock Split is consummated and the trading price of our common stock declines, the percentage decline as an absolute number and as a percentage of our overall market capitalization may be greater than would occur in the absence of the Reverse Stock Split.

 

7

 

 

The proposed Reverse Stock Split may decrease the liquidity of our common stock and result in higher transaction costs.

 

The Reverse Stock Split may decrease the liquidity of our common stock because fewer shares would be outstanding after the Reverse Stock Split. In addition, if the Board of Directors implements the Reverse Stock Split, more stockholders may own “odd lots” of fewer than 100 shares of common stock, which may be more difficult to sell. Brokerage commissions and other costs of transactions in odd lots are generally higher than the costs of transactions of more than 100 shares or multiples of 100 shares of common stock. Accordingly, the Reverse Stock Split may not achieve the desired results of increasing marketability of the common stock as described above.

 

If the Reverse Stock Split is approved and effected, the resulting per-share market price may not attract institutional investors or investment funds and may not satisfy the investing guidelines of such investors and, consequently, the trading liquidity of our common stock may not improve.

 

While the Board of Directors believes that a higher stock price may help generate investor interest, there can be no assurance that the Reverse Stock Split will result in a per-share market price that will attract institutional investors or investment funds or that such share price will satisfy the investing guidelines of institutional investors or investment funds. As a result, the trading liquidity of our common stock may not necessarily improve.

 

A decline in the market price of our common stock after the Reverse Stock Split is approved and effected may result in a greater percentage decline than would occur in the absence of the Reverse Stock Split.

 

If the Reverse Stock Split is approved and effected and the market price of our common stock declines, the percentage decline may be greater than would occur in the absence of the Reverse Stock Split. The market price of our common stock will, however, also be based upon our performance and other factors, which are unrelated to the number of shares of common stock outstanding.

 

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.

 

Insider Trading Arrangements

 

During the three months ended March 31, 2025, 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.

 

Annual Meeting Date Change

 

As disclosed on our Current Report on Form 8-K filed with the SEC on April 21, 2025 (the “Form 8-K”), our Board of Directors determined on March 26, 2025 that the 2025 Annual Meeting will be held on May 30, 2025. The 2025 Annual Meeting date, the record date for the 2025 Annual Meeting and detailed information regarding the proposals to be presented at the 2025 Annual Meeting are set forth in our Definitive Proxy Statement on Schedule 14A filed with the SEC on April 23, 2025. Because the 2025 Annual Meeting will take place more than 30 days before the anniversary of our last annual meeting of stockholders, the due dates for the submission of any qualified shareholder proposal or qualified shareholder nominations under applicable SEC rules and our Amended and Restated Bylaws, as amended, listed in our Definitive Proxy Statement on Schedule 14A for our last annual meeting of stockholders, filed with the SEC on August 8, 2024, became no longer applicable. Such nominations or proposals, including any notice on Schedule 14N, were due to be received by the Company no later than Friday April, 11, 2025, which was ten calendar days following the disclosure of the 2025 Annual Meeting date on the Form 8-K.

 

8

 

 

Item 6. Exhibits.

 

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

 

        Incorporated by reference
Exhibit       (unless otherwise indicated)
Number   Exhibit Title   Form   File   Exhibit   Filing date
                     
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 March 31, 2025.        
                     
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 March 31, 2025.        
                     
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

 

9

 

 

SIGNATURES

 

Pursuant to the requirements 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: May 12, 2025 By: /s/ Jeffrey Frelick
  Name: Jeffrey Frelick
  Title: Chief Executive Officer

 

10