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Bone Biologics Corp

For the period ended Dec 31, 2024. Filed Feb 26, 2025.

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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2024 · Filed Feb 26, 2025

BBLG$0.33+3.0%Stored close · as of Nov 6, 2026
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

For the fiscal year ended: December 31,2024

☐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)

Delaware42-1743430
(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 classTrading Symbol(s)Name of each exchange on which registered
Common stock, $0.001 par value per shareBBLGThe Nasdaq Capital Market
Warrants to Purchase Common stock, $0.001 par value per shareBBLGWThe 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, 2024, was $1,565,909.

As of February 19, 2025, there were 3,271,042 shares of common stock, par value $0.001, outstanding.

TABLE OF CONTENTS

Page
Part I
Item 1.Business5
Item 1A.Risk Factors14
Item 1B.Unresolved Staff Comments44
Item 1C.Cybersecurity44
Item 2.Properties45
Item 3.Legal Proceedings45
Item 4.Mine Safety Disclosures45
Part II
Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities46
Item 6.[Reserved]46
Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations46
Item 7A.Quantitative and Qualitative Disclosures About Market Risk49
Item 8.Financial Statements and Supplementary Data49
Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure49
Item 9A.Controls and Procedures49
Item 9B.Other Information50
Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections50
Part III
Item 10.Directors, Executive Officers and Corporate Governance51
Item 11.Executive Compensation54
Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters58
Item 13.Certain Relationships and Related Transactions, and Director Independence59
Item 14.Principal Accountant Fees and Services60
Part IV
Item 15.Exhibits and Financial Statement Schedules61
Signatures64
Power of Attorney65
Index to Consolidated Financial StatementsF-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
ACAAffordable Care Act
BMPBone Morphogenic Protein
CDMOContract Development and Manufacturing Organization
cGMPcurrent Good Manufacturing Practice
CROContract Research Organization
DBMDemineralized bone matrix is allograft bone that has had the inorganic mineral removed
DDDDegenerative disc disease
FDAU.S. Food and Drug Administration
HIPAAHealth Insurance Portability and Accountability Act of 1996
IDEInvestigational Device Exemption
IRBInstitutional Review Board
MTFMusculoskeletal Transplant Foundation
NB1 DeviceProduct combination kit that includes vial of NELL-1 recombinant protein and demineralized bone matrix
NDANew Drug Application
NELL-1Neural epidermal growth factor-like 1 protein (NELL-1)
NOLNet Operating Loss
PMAPre-market approval
rhBMP-2Recombinant Bone Morphogenic Protein
rhNELL-1Recombinant NELL-1
UCLA TDGUCLA Technology Development Group on behalf of UC Regents
USPTOThe United States Patent and Trademark Office
Defined Terms
Alkaline phosphatase assayAlkaline 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 modelA mouse that provides an experiment model for conducting research because it mounts no rejection response.
Demineralized BoneBone that has had the calcium removed.
OsteopromotiveA material that promotes the de novo formation of bone.
OsteostimulativeStimulates bone growth.
OsteosyntheticThe reduction and fixation of a bone fracture with implantable devices.
Phylogenetically advanced spine modelEvolutionary advancement of spine systems that exist in large animal models.
RecombinantRelating to or denoting an organism, cell, or genetic material formed by recombination.
RetrolisthesisA medical condition in which a vertebra in the spine becomes displaced and moves forward or backward.
SpondylolisthesisA spinal disorder in which one vertebra (spinal bone) slips onto the vertebra below it.
ContentsView on SEC.gov

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