Bone Biologics Corp
For the period ended Dec 31, 2025. Filed Mar 2, 2026.
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FY2025 · Filed Mar 2, 2026
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
For the fiscal year ended: December 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 Number:001-40899
(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) (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 if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐No ☒
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐No ☒
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 during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the Company is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):
| 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 has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.☐
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark whether the Company is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No☒
The approximate aggregate market value of the registrant’s common equity held by non-affiliates of the registrant at the close of business on June 30, 2025, was $7,232,186.
As of February 23, 2026, there were 1,795,260 shares of common stock, par value $0.001, outstanding.
TABLE OF CONTENTS
| Page | ||
|---|---|---|
| Part I | ||
| Item 1. | Business | 5 |
| Item 1A. | Risk Factors | 14 |
| Item 1B. | Unresolved Staff Comments | 44 |
| Item 1C. | Cybersecurity | 44 |
| Item 2. | Properties | 45 |
| Item 3. | Legal Proceedings | 45 |
| Item 4. | Mine Safety Disclosures | 45 |
| Part II | ||
| Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 46 |
| Item 6. | [Reserved] | 46 |
| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 46 |
| Item 7A. | Quantitative and Qualitative Disclosures About Market Risk | 49 |
| Item 8. | Financial Statements and Supplementary Data | 49 |
| Item 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 49 |
| Item 9A. | Controls and Procedures | 49 |
| Item 9B. | Other Information | 50 |
| Item 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 50 |
| Part III | ||
| Item 10. | Directors, Executive Officers and Corporate Governance | 51 |
| Item 11. | Executive Compensation | 54 |
| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 58 |
| Item 13. | Certain Relationships and Related Transactions, and Director Independence | 59 |
| Item 14. | Principal Accountant Fees and Services | 60 |
| Part IV | ||
| Item 15. | Exhibits and Financial Statement Schedules | 61 |
| Signatures | 64 | |
| Power of Attorney | 65 | |
| Index to Consolidated Financial Statements | F-1 | |
Cautionary Note on Forward-Looking Statements
This annual report on form 10-K (“Annual Report”) 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.
All statements other than historical facts contained in this Annual 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,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “project,” “seek,” “should,” “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, obtaining U.S. 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 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,” “Bone Biologics,” “we,” “us,” and “our” in this document refer to Bone Biologics Corporation, a Delaware corporation, and, our wholly owned subsidiary, as defined under Part I, Item 1-”Business” in this Annual Report.
Glossary of Abbreviations and Defined Terms
| Abbreviations | |
|---|---|
| ACA | Affordable Care Act |
| BMP | Bone Morphogenic Protein |
| CDMO | Contract Development and Manufacturing Organization |
| cGMP | current Good Manufacturing Practice |
| CRO | Contract Research Organization |
| DBM | Demineralized bone matrix is allograft bone that has had the inorganic mineral removed |
| DDD | Degenerative disc disease |
| FDA | U.S. Food and Drug Administration |
| HIPAA | Health Insurance Portability and Accountability Act of 1996 |
| IDE | Investigational Device Exemption |
| IRB | Institutional Review Board |
| MTF | Musculoskeletal Transplant Foundation |
| NB1 Device | Product combination kit that includes vial of NELL-1 recombinant protein and demineralized bone matrix |
| NDA | New Drug Application |
| NELL-1 | Neural epidermal growth factor-like 1 protein (NELL-1) |
| NOL | Net Operating Loss |
| PMA | Pre-market approval |
| rhBMP-2 | Recombinant Bone Morphogenic Protein |
| rhNELL-1 | Recombinant NELL-1 |
| UCLA TDG | UCLA Technology Development Group on behalf of UC Regents |
| USPTO | The United States Patent and Trademark Office |
| Defined Terms | |
|---|---|
| Alkaline phosphatase assay | Alkaline phosphatase is an enzyme that is found throughout your body. ALP blood tests measure the level of ALP in your blood that comes from your bones. |
| Athymic mouse model | A mouse that provides an experiment model for conducting research because it mounts no rejection response. |
| Demineralized Bone | Bone that has had the calcium removed. |
| Osteopromotive | A material that promotes the de novo formation of bone. |
| Osteostimulative | Stimulates bone growth. |
| Osteosynthetic | The reduction and fixation of a bone fracture with implantable devices. |
| Phylogenetically advanced spine model | Evolutionary advancement of spine systems that exist in large animal models. |
| Recombinant | Relating to or denoting an organism, cell, or genetic material formed by recombination. |
| Retrolisthesis | A medical condition in which a vertebra in the spine becomes displaced and moves forward or backward. |
| Spondylolisthesis | A spinal disorder in which one vertebra (spinal bone) slips onto the vertebra below it. |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.