UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
For
the quarterly period ended
For the transition period from _________ to _________
Commission
File No.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or formation) |
(I.R.S. employer identification number) |
(Address of principal executive offices and Zip Code)
(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 | ||
| The
|
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.
☒
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).
☒
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 | ☐ |
| ☒ | 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
As of October 26, 2026, there were shares of the issuer’s common stock, $ par value, outstanding.
Bone Biologics Corporation
- INDEX -
| 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, 2025, filed with the Securities and Exchange Commission (“SEC”) on March 2, 2026 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,” “future,” “plan,” “estimate,” “can,” “could,” “may,” “might,” “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, the success of our patent application, 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
September 30, 2026 | December 31, 2025 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current Assets | ||||||||
| Cash | $ | $ | ||||||
| Advances on research and development contract services | ||||||||
| Prepaid insurance | ||||||||
| Other prepaid expenses | ||||||||
| Deferred offering costs | ||||||||
| Interest receivable | ||||||||
| Total current assets | ||||||||
| Total assets | $ | $ | ||||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current Liabilities | ||||||||
| Accounts payable and accrued expenses | $ | $ | ||||||
| Warrant liability | ||||||||
| Total current liabilities | ||||||||
| Total liabilities | ||||||||
| Commitments and Contingencies | ||||||||
| Stockholders’ Equity | ||||||||
| Preferred Stock, $ par value per share; shares authorized; issued or outstanding at September 30, 2026 and December 31, 2025 | ||||||||
| Common stock, $ par value per share; shares authorized; and shares issued and outstanding at September 30, 2026 and December 31, 2025, respectively | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders’ equity | ||||||||
| Total liabilities and stockholders’ equity | $ | $ | ||||||
See accompanying notes to condensed consolidated financial statements.
| F-1 |
Bone Biologics Corporation
Condensed Consolidated Statements of Operations
(Unaudited)
Three Months Ended September 30, 2026 | Three Months Ended September 30, 2025 | Nine Months Ended September 30, 2026 | Nine Months Ended September 30, 2025 | |||||||||||||
| Revenues | $ | $ | $ | $ | ||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Total operating expenses | ||||||||||||||||
| Loss from operations | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Change in fair value of warrant liability | ||||||||||||||||
| Interest income | ||||||||||||||||
| Total other income | ||||||||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Weighted average shares outstanding – basic and diluted | ||||||||||||||||
| Loss per share – basic and diluted | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
See accompanying notes to condensed consolidated financial statements.
| F-2 |
Bone Biologics Corporation
Condensed Consolidated Statement of Stockholders’ Equity
For the Nine Months ended September 30, 2026
(Unaudited)
| Common Stock | Additional Paid-in | Accumulated | Total Stockholders’ | |||||||||||||||||
| Shares | Amount | Capital | Deficit | Equity | ||||||||||||||||
| Balance at December 31, 2025 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Fair value of vested stock options | - | |||||||||||||||||||
| Options issued to settle accrued bonus | - | |||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Balance at March 31, 2026 | ( | ) | ||||||||||||||||||
| Fair value of vested stock options | - | |||||||||||||||||||
| Issuance of common shares from ATM, net of costs of $ | ||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Balance at June 30, 2026 | ( | ) | ||||||||||||||||||
| Fair value of vested stock options | - | |||||||||||||||||||
| Issuance of pre-funded warrants and warrants in private placement, net of costs of $ | - | |||||||||||||||||||
| Exercise of pre-funded warrants | ||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Balance at September 30, 2026 | $ | $ | $ | ( | ) | $ | ||||||||||||||
See accompanying notes to condensed consolidated financial statements.
| F-3 |
Bone Biologics Corporation
Condensed Consolidated Statement of Stockholders’ Equity
For the Nine Months ended September 30, 2025
(Unaudited)
| Common Stock | Additional Paid-in | Accumulated | Total Stockholders’ | |||||||||||||||||
| Shares | Amount | Capital | Deficit | Equity | ||||||||||||||||
| Balance at December 31, 2024 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Fair value of vested stock options | - | |||||||||||||||||||
| Options issued to settle accrued bonus | - | |||||||||||||||||||
| Issuance of common shares from ATM, net of costs of $ | ||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Balance at March 31, 2025 | ( | ) | ||||||||||||||||||
| Fair value of vested stock options | - | |||||||||||||||||||
| Proceeds from sale of common stock , pre-funded warrants and warrants in public offering, net of
offering costs of $ | ||||||||||||||||||||
| Exercise of pre-funded warrants | ( | ) | ||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Balance at June 30, 2025 | ( | ) | ||||||||||||||||||
| Fair value of vested stock options | - | |||||||||||||||||||
| Exercise of pre-funded warrants | ( | ) | ||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Balance at September 30, 2025 | $ | $ | $ | ( | ) | $ | ||||||||||||||
See accompanying notes to condensed consolidated financial statements.
| F-4 |
Bone Biologics Corporation
Condensed Consolidated Statements of Cash Flows
(Unaudited)
Nine months Ended September 30, 2026 | Nine months Ended September 30, 2025 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation-fair value of vested stock options | ||||||||
| Change in fair value of warrant liability | ( | ) | ( | ) | ||||
| Changes in operating assets and liabilities: | ||||||||
| Advances on research and development contract services | ||||||||
| Prepaid insurance | ||||||||
| Interest receivable | ||||||||
| Accounts payable and accrued expenses | ||||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from financing activities | ||||||||
| Proceeds from issuance of common shares from ATM, net of costs | ||||||||
| Proceeds from sale of common stock, pre-funded warrants and warrants in public offering, net of offering costs | ||||||||
| Proceeds from sale of pre-funded warrants and warrants in private placement, net of offering costs | ||||||||
| Exercise of pre-funded warrants | ||||||||
| Deferred offering costs | ( |
) | ||||||
| Net cash provided by financing activities | ||||||||
| Net increase in cash | ||||||||
| Cash, beginning of period | ||||||||
| Cash, end of period | $ | $ | ||||||
| Supplemental information | ||||||||
| Income taxes paid | $ | $ | ||||||
| Noncash investing and financing activities | ||||||||
| Options issued to settle accrued bonus | $ | $ | ||||||
See accompanying notes to condensed consolidated financial statements.
| F-5 |
Bone Biologics Corporation
Notes to Unaudited Condensed Consolidated Financial Statements
For the Nine Months ended September 30, 2026 and 2025
1. The Company
Bone Biologics Corporation (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.
Going Concern and Liquidity
The
Company has no significant operating history and since inception to September 30, 2026, has incurred accumulated losses of approximately
$
| F-6 |
At
September 30, 2026, the Company had cash of $
Available cash is expected to fund the Company’s operations through the second quarter of 2027.
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.
The Company’s ability to raise additional capital is subject to certain restrictions under the securities purchase agreement entered into in connection with the July 2026 Private Placement (see Note 5). Until July 24, 2027, the Company may not enter into any variable rate transaction, including an equity line of credit or an at-the-market (“ATM”) offering facility, other than sales under an ATM facility with H.C. Wainwright & Co., LLC (“Wainwright”) serving as the sales agent. Until that date, the Company also may not effect a reverse stock split without the consent of the purchaser, unless the Board of Directors determines in good faith that a reverse stock split is required to maintain the listing of the Company’s common stock on Nasdaq. In addition, under its engagement agreement with Wainwright, Wainwright has a right of first refusal to act as the Company’s exclusive placement agent, underwriter or advisor for certain future financings through July 2027. Sales under the ATM facility are also limited by the amount the Company may sell under its shelf registration statement, which depends on the market value of its common stock held by non-affiliates. These restrictions may limit the Company’s ability to raise capital on acceptable terms or in the amounts needed. There can be no assurance that additional financing will be available when needed or on terms acceptable to the Company.
Reverse Stock Split
On
June 5, 2025, the Company filed an amendment to its amended and restated certificate of incorporation, as amended, with the Secretary
of State of the State of Delaware to effect a
All share and per share amounts have been retroactively restated as if the reverse stock split occurred at the beginning of the earliest period presented.
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) which, in the opinion of management, are 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, 2025 was derived from the audited consolidated financial statements included in the Company’s Annual Report on Form 10-K filed with the SEC on March 2, 2026 (the “2025 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, 2025 and notes thereto included in the 2025 Annual Report.
The results of operations for the nine months ended September 30, 2026 are not necessarily indicative of the results to be expected for the entire fiscal year ended December 31, 2026 or for any other period.
Segment Information
The
Company operates and reports in
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. Other segment expenses include all remaining costs necessary to operate our business, which primarily include external professional services and other administrative expenses (see Note 8).
| F-7 |
Use of Estimates
The preparation of the accompanying condensed 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.
Macroeconomic environment and geopolitical events
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.
Cash
Cash
primarily consists of bank demand deposits maintained by a major financial institution. At September 30, 2026, the Company holds $
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”). The Company may periodically have cash balances in financial institutions
in excess of the FDIC insurance limits of $
Deferred Offering Costs
Deferred
offering costs consist of legal, accounting and other fees directly attributable to the Company’s at-the-market (“ATM”)
offering program. These costs are deferred and charged against additional paid-in capital in proportion to the proceeds received as shares
are sold under the ATM. Any remaining deferred costs are expensed if the program is terminated or the related registration statement
expires. As of September 30, 2026, deferred offering costs were $
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: 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.
| F-8 |
The fair value of financial instruments measured on a recurring basis was as follows:
| As of September 30, 2026 | ||||||||||||||||
| Description | Total | Level 1 | Level 2 | Level 3 | ||||||||||||
| Liabilities: | ||||||||||||||||
| Warrant liability | $ | $ | ||||||||||||||
| Total liabilities at fair value | $ | $ | ||||||||||||||
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 nine-month period ended September 30, 2026 as follows:
| September 30, 2026 | ||||
| Warrant liability | ||||
| Balance as of beginning of period – December 31, 2025 | $ | |||
| Change in fair value | ( | ) | ||
| Balance as of September 30, 2026 | $ | |||
The Company believes the carrying amount of certain financial instruments, including cash and accounts payable approximate their fair values based on their short-term nature and are excluded from the fair value tables above.
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.
| F-9 |
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. Shares issuable upon exercise of pre-funded warrants are included in the weighted-average number of shares outstanding from the date of issuance, as the pre-funded warrants are exercisable for nominal consideration. 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, diluted net loss per share is the same as basic net loss per share for the three and nine months ended September 30, 2026 and 2025.
| September 30, | ||||||||
| 2026 | 2025 | |||||||
| Warrants | ||||||||
| Stock options | ||||||||
The
table above excludes pre-funded warrants to purchase
Concentrations
Research
and development costs for the nine months ended September 30, 2026, include charges from three vendors and consultants representing
At
September 30, 2026, accounts payable and accrued expenses include amounts due to two vendors representing
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 the adoption of this ASU to determine its impact on the Company’s disclosures.
In November 2024, the FASB issued ASU 2024-04 “Debt with Conversion and Other Options (Subtopic 470-20)”. This ASU clarifies the requirements related to accounting for the settlement of a debt instrument as an induced conversion. An induced conversion is when a company induces debt holders to convert their debt into equity shares under changed terms and involves additional consideration. The amendments in this ASU are effective for all entities for annual reporting periods beginning January 1, 2026, and interim reporting periods within those annual reporting periods. The adoption of this ASU has not had a material effect on the Company’s financial position, results of operations or cash flows.
In December 2025, the FASB issued ASU No. 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements, which includes amendments to clarify interim reporting requirements and applicability of Topic 270 and codifies a principle requiring disclosure of material events and changes since the most recent annual reporting period. This guidance is effective for the Company for interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The Company is in the process of evaluating the impact of adoption of this ASU on its Condensed Consolidated Financial Statements.
| F-10 |
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.
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 subjects 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, 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. For the nine-month periods ended September 30, 2026 and 2025, research and
development expenses were principally attributable to clinical trials conducted for the Company’s lead product candidate. At September
30, 2026, the estimated remaining commitment under these agreements is approximately $
Research and development costs are summarized below based on the respective geographical regions where such costs are incurred.
Nine Months Ended September 30, | ||||||||
| 2026 | 2025 | |||||||
| United States | $ | $ | ||||||
| Australia | ||||||||
| Singapore | ||||||||
| Total | $ | $ | ||||||
4. Warrant Liability
In October 2022, the Company issued warrants in connection with a public offering. Certain provisions of the warrants require liability classification under ASC 815. The warrants are remeasured at fair value using a Black-Scholes valuation model at each reporting date, with changes in fair value recognized in earnings.
The
fair value of the warrant liability was $
| F-11 |
5. Stockholders’ Equity
Preferred Stock
The Company’s amended and restated certificate of incorporation authorizes the Company to issue a total of shares of preferred stock. shares have been issued.
Common Stock
The Company’s amended and restated certificate of incorporation authorizes the Company to issue a total of shares of common stock. As of September 30, 2026 and December 31, 2025, the Company had an aggregate of and shares of common stock outstanding, respectively.
July 2026 Private Placement
On
July 9, 2026, pursuant to a securities purchase agreement dated July 7, 2026 (the “July 2026 Private Placement”), the Company
sold units to an investor at a purchase price of $ per unit.
The
pre-funded warrants have an exercise price of $
In
addition to the placement agent warrants, the placement agent received compensation consisting of cash fee equal to
During
the three months ended September 30, 2026, the Company issued shares of common stock upon the exercise of pre-funded warrants
for proceeds of $
The Company evaluated the pre-funded warrants, Series F warrants, Series G warrants and placement agent warrants under ASC 480 and ASC 815-40 and concluded that each is indexed to the Company’s own stock and meets the requirements for equity classification. The Series F, Series G and placement agent warrants provide the holder the right, upon certain fundamental transactions within the Company’s control, to receive cash equal to the Black-Scholes value, as defined, of the unexercised warrants.
At the Market (ATM) Offering Program
In September 2024, the Company entered into an
At The Market Offering Agreement (the “ATM Agreement”) with Wainwright, establishing an at-the-market offering program
(the “ATM Facility”) pursuant to which the Company may, from time to time, in its sole discretion, issue and sell shares
of common stock through Wainwright. In September and December 2024, the Company filed prospectus supplements providing for the sale
of up to $
Shares may be sold through the ATM Facility in transactions deemed to be “at the market” offerings under
Rule 415 of the Securities Act. The Company pays Wainwright a commission of
The Company did not sell any shares of common stock through the ATM facility during the three months ended September
30, 2026. During
the nine months ended September 30, 2026, the Company sold shares of common stock through the ATM Facility for net proceeds of
$
The
Company did not sell any shares of common stock through the ATM facility during the three months ended September 30, 2025. During
the nine months ended September 30, 2025, the Company sold
shares of common stock through the ATM Facility for net proceeds of $
June 2025 Public Offering
On
June 27, 2025, the Company issued investors
shares of its common stock and pre-funded warrants to purchase
In
June 2025,
shares of common stock were issued upon the exercise of
In
addition, warrants to purchase
| F-12 |
6. Common Stock Warrants
A summary of warrant activity for the nine months ended September 30, 2026 is presented below:
| Subject to Exercise | Number of Warrants | Weighted Average Exercise Price | Weighted Average Life (Years) | |||||||||
| Outstanding as of December 31, 2025 | $ | |||||||||||
| Issued – 2026 | ||||||||||||
| Forfeited/Expired – 2026 | ( | ) | - | |||||||||
| Exercised – 2026 | ( | ) | - | |||||||||
| Outstanding as of September 30, 2026 | $ | |||||||||||
As of September 30, 2026, the Company had outstanding exercisable, but unexercised common stock warrants as follows:
| Date Issued | Exercise Price | Number of Warrants | Expiration date | |||||||||
| October 2021 | $ | |||||||||||
| October 2022 | $ | |||||||||||
| October 2022 | $ | |||||||||||
| October 2022 | $ | |||||||||||
| November 2023 | $ | |||||||||||
| November 2023 | $ | |||||||||||
| March 2024 | $ | |||||||||||
| August 2024 | $ | |||||||||||
| August 2024 | $ | |||||||||||
| June 2025 | $ | |||||||||||
| June 2025 | $ | |||||||||||
| June 2025 | $ | |||||||||||
| July 2026 | $ | |||||||||||
| July 2026 | $ | |||||||||||
| July 2026 | $ | |||||||||||
| July 2026 | $ | - | ||||||||||
| Total outstanding warrants at September 30, 2026 | ||||||||||||
Based on a fair market value of $ per share on September 30, 2026, there were 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 September 30, 2026 was $.
| F-13 |
2015 Equity Incentive Plan
The Company has shares of common stock authorized and reserved for issuance under its 2015 Equity Incentive Plan, as amended (the “2015 Plan”). The reserve may be increased annually by the Board of Directors up to % of the Company’s outstanding common stock as of the immediately preceding December 31. The 2015 Plan also provides for customary anti-dilution adjustments in the event of stock splits or other changes in the Company’s capital structure.
Shares subject to awards that expire, are forfeited, canceled or repurchased become available for future grant under the 2015 Plan. However, shares withheld for tax withholding purposes and the gross number of shares issued upon the exercise of stock appreciation rights or options through net exercise or tender of previously owned shares are not returned to the share reserve.
The 2015 Plan permits the grant of incentive stock options to employees and non-statutory stock options, stock appreciation rights, restricted stock, restricted stock units, performance awards, cash-based awards and other stock-based awards to employees, directors, consultants and certain affiliated service providers. The 2015 Plan is administered by the Compensation Committee of the Board of Directors, which has the authority to determine award recipients and the terms and conditions of awards, subject to the provisions of the plan.
| Subject to Exercise | Number of Options | Weighted Average Exercise Price | Weighted Average Life (Years) | Aggregate Intrinsic Value | ||||||||||||
| Outstanding as of December 31, 2025 | $ | $ | ||||||||||||||
| Granted – 2026 | - | |||||||||||||||
| Forfeited/Expired – 2026 | ( | ) | - | - | ||||||||||||
| Exercised – 2026 | - | - | ||||||||||||||
| Outstanding as of September 30, 2026 | $ | $ | ||||||||||||||
| Options vested and exercisable at September 30, 2026 | $ | $ | ||||||||||||||
| F-14 |
| Date Issued | Exercise Price | Number of Options | Expiration date | |||||||
| January 2017 | $ | |||||||||
| January 2018 | $ | |||||||||
| January 2019 | $ | |||||||||
| October 2021 | $ | |||||||||
| January 2022 | $ | |||||||||
| August 2022 | $ | |||||||||
| September 2023 | $ | |||||||||
| January 2024 | $ | |||||||||
| September 2024 | $ | |||||||||
| October 2024 | $ | |||||||||
| January 2025 | $ | |||||||||
| June 2025 | $ | |||||||||
| January 2026 | $ | |||||||||
| September 2026 | $ | |||||||||
| Total outstanding options at September 30, 2026 | ||||||||||
Based on a fair value of $ per share on September 30, 2026, there were no exercisable but unexercised in-the-money common stock options on that date.
During
the nine months ended September 30, 2026 and 2025, the Company had stock-based compensation expense of $ and $, respectively,
related to the vesting of stock options granted to the Company’s employees and directors and included in our reported net loss.
Vesting of options differs based on the terms of each option. In addition, during the nine months ended September 30, 2026 and 2025,
options exercisable into and shares of common stock, respectively, were issued to employees in settlement of previously
accrued bonuses of $
| September 30, 2026 | ||||
| Risk free interest rate | % | |||
| Expected Volatility | % | |||
| Expected life (in years) | ||||
| Expected dividend yield | % | |||
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. The expected life of options granted was determined using the simplified method, under which the expected term is the average of the vesting period and the contractual term of the option. 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.
| F-15 |
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. Other segment 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:
| Nine months ended September 30, | ||||||||
| 2026 | 2025 | |||||||
| Revenue | $ | $ | ||||||
| Less: | ||||||||
| Research and development | ||||||||
| Salaries | ||||||||
| Insurance | ||||||||
| Stock-based compensation | ||||||||
| Other segment expenses | ||||||||
| Change in fair value of warrant liability | ( |
) | ( |
) | ||||
| Interest income | ( | ) | ( | ) | ||||
| Net loss | $ | $ | ||||||
9. Commitments and Contingencies
UCLA TDG Exclusive License Agreement
Effective April 9, 2019, the Company entered into an Amended and Restated Exclusive License Agreement (the “License Agreement”) with the University of California, Los Angeles Technology Development Group (“UCLA TDG”), which amended and restated the parties’ prior license agreement. Under the License Agreement, UCLA TDG granted the Company exclusive rights to develop and commercialize NELL-1 technology for spinal fusion, osteoporosis and trauma applications.
The
Company is required to pay UCLA TDG an annual maintenance fee of $
The
License Agreement also requires milestone payments of $
In
addition, the Company is obligated to pay aggregate diligence fees of up to $
The Company is required to use commercially reasonable efforts to develop and commercialize licensed products, reimburse UCLA TDG for patent-related costs, and indemnify UCLA TDG against certain third-party claims. UCLA TDG may terminate or convert the license to a non-exclusive license if specified diligence requirements are not met.
Payments
to UCLA TDG under the Amended License Agreement for the nine months ended September 30, 2026 and 2025 were $
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 the date which the consolidated financial statements were issued. There were no subsequent events noted that would require adjustment to or disclosure in these consolidated financial statements.
| F-16 |
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
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, 2025 and 2024 and the related notes included in our Annual Report on Form 10-K filed for the fiscal year ended December 31, 2025, with the SEC on March 2, 2026. 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. In the second quarter of 2025, we submitted a patent application with the United States Patent and Trademark Office (“USPTO”) regarding proprietary compositions of rhNELL-1 polypeptide for treating bone conditions. There can be no assurance that the USPTO will approve our patent application or that the 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 subjects 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. Six hospital sites in Australia are now under agreement to participate in the study.
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, 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.
| 4 |
July 2026 Private Placement
On July 9, 2026, pursuant to a securities purchase agreement dated July 7, 2026 (the “July 2026 Private Placement”), the Company sold 2,112,677 units to an investor at a purchase price of $1.419 per unit. Each unit consisted of one pre-funded warrant, one Series F warrant and one Series G warrant, each to purchase one share of common stock. The Company received gross proceeds of $2,997,888, and net proceeds of $2,639,667 after deducting offering costs of $358,221. In connection with the July 2026 Private Placement, the Company also issued warrants to the placement agent to purchase 126,761 shares of common stock.
The pre-funded warrants have an exercise price of $0.001 per share, are immediately exercisable and do not expire. The Series F and Series G warrants each have an exercise price of $1.42 per share, while the placement agent warrants have an exercise price of $1.775 per share. These warrants became exercisable on September 28, 2026, following stockholder approval of the issuance of the underlying shares. The Series F and placement agent warrants expire on September 28, 2031, while the Series G warrants expire on March 28, 2028.
In addition to the placement agent warrants, the placement agent received compensation consisting of cash fee equal to 7.0% and a management fee equal to 1.0% of the aggregate gross proceeds from the private placement. We also reimbursed the placement agent for non-accountable expenses in an amount of $35,000, and its legal fees and expenses and other out-of-pocket expenses in the amount of $50,000.
During the three months ended September 30, 2026, the Company issued 1,578,677 shares of common stock upon the exercise of pre-funded warrants for proceeds of $1,579. As of September 30, 2026, 534,000 pre-funded warrants remained outstanding.
ATM Offering
In September 2024, we entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC, establishing an at-the-market offering program (the “ATM Facility”) pursuant to which we may, from time to time, in its sole discretion, issue and sell shares of common stock through Wainwright. In September and December 2024, we filed prospectus supplements providing for the sale of up to $1,143,121 and $832,009, respectively, of common stock under the ATM Agreement. In March 2026, after selling approximately $1.7 million of shares of common stock pursuant to the ATM Facility, we filed a new prospectus supplement under our current shelf registration statement providing for the sale of up to $1,064,000 of common stock under the ATM Agreement.
Shares may be sold through the ATM Facility in transactions deemed to be “at the market” offerings under Rule 415 of the Securities Act. We pay Wainwright a commission of 3.0% of the gross sales price per share sold under the ATM Agreement.
During the three months ended September 30, 2026, we did not sell any shares of common stock through the ATM Facility. During the nine months ended September 30, 2026, we sold 15,120 shares of common stock through the ATM Facility for net proceeds of $20,180, after deducting $2,090 in offering costs.
Nasdaq Compliance
On September 10, 2026, we received a letter from the Listing Qualifications Staff (the “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 March 9, 2027, 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.
The notification has no immediate effect on the listing of our common stock on Nasdaq. At our 2026 annual meeting of stockholders, we received stockholder approval for a reverse stock split of our outstanding common stock in the range of not less than 1-for-2 and not more than 1-for-10, at the discretion of our Board of Directors. Accordingly, our Board of Directors may authorize a reverse stock split to attempt to increase the per share price of the common stock and regain compliance with the Nasdaq Listing Standards.
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 September 30, 2026 compared to the Three months ended September 30, 2025
Three
months September 30, 2026 | Three-months ended September 30, 2025 | % Change | ||||||||||
| Operating expenses | ||||||||||||
| Research and development | $ | 242,569 | $ | 187,808 | 29.16 | % | ||||||
| General and administrative | 423,771 | 527,466 | (19.66 | )% | ||||||||
| Total operating expenses | 666,340 | 715,274 | (6.84 | )% | ||||||||
| Loss from operations | (666,340 | ) | (715,274 | ) | (6.84 | )% | ||||||
| Change in fair value of warrant liability | 348 | 1,212 | (71.29 | )% | ||||||||
| Interest income | 48,341 | 47,325 | 2.15 | % | ||||||||
| Net loss | $ | (617,651 | ) | $ | (666,737 | ) | (7.36 | )% | ||||
Research and Development
Our research and development expenditures increased from $187,808 for the three months ended September 30, 2025, to $242,569 for the same period in 2026, marking an increase of $54,761. The increase in costs can be attributed to our development activities to extend the shelf-life of our protein. 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 expenses decreased by $103,695, from $527,466 for the three months ended September 30, 2025, to $423,771 for the same period in 2026. The decrease was primarily due to the timing of director compensation expense recognition, which is tied to the annual meeting. The 2026 annual meeting was held in September, compared to May 2025, resulting in lower compensation expense recognized during the current quarter.
| 5 |
Change in fair value of warrant liability
The change in fair value of warrant liability represents the re-measurement of the outstanding warrants at September 30, 2026.
Nine months ended September 30, 2026 compared to the Nine months ended September 30, 2025
Nine-months September 30, 2026 | Nine-months ended September 30, 2025 | % Change | ||||||||||
| Operating expenses | ||||||||||||
| Research and development | $ | 692,914 | $ | 802,994 | (13.71 | )% | ||||||
| General and administrative | 1,586,587 | 1,698,843 | (6.61 | )% | ||||||||
| Total operating expenses | 2,279,501 | 2,501,837 | (8.89 | )% | ||||||||
| Loss from operations | (2,279,501 | ) | (2,501,837 | ) | (8.89 | )% | ||||||
| Change in fair value of warrant liability | 505 | 3,469 | (85.44 | )% | ||||||||
| Interest income | 121,655 | 74,020 | 64.35 | % | ||||||||
| Net loss | $ | (2,157,341 | ) | $ | (2,424,348 | ) | (11.01 | )% | ||||
Research and Development
Our research and development expenditures decreased from $802,994 for the nine months ended September 30, 2025, to $692,914 for the same period in 2026, marking a decrease of $110,080. The decrease in costs can be attributed to timing of our clinical trial. 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 expenses decreased by $112,256, from $1,698,843 for the nine months ended September 30, 2025, to $1,586,587 for the same period in 2026. The decrease was primarily due to the timing of director compensation expense recognition, which is tied to the annual meeting. The 2026 annual meeting was held in September, compared to May 2025, resulting in lower compensation expense recognized during the current quarter.
Change in fair value of warrant liability
The change in fair value of warrant liability represents the re-measurement of the outstanding warrants at September 30, 2026.
| 6 |
Liquidity and Capital Resources
Going Concern and Liquidity
We have no significant operating history and since inception to September 30, 2026 have incurred accumulated losses of approximately $90.3 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 $6.0 million. The accompanying consolidated financial statements for the nine months ended September 30, 2026 have been prepared assuming we will continue as a going concern. As reflected in the financial statements, we incurred a net loss of $2.2 million and used net cash in operating activities of $1.9 million during the nine months ended September 30, 2026. 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 audited financial statements for the year ended December 31, 2025, included an explanatory paragraph regarding 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.
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.
The Company’s ability to raise additional capital is subject to certain restrictions under the securities purchase agreement entered into in connection with the July 2026 Private Placement. Until July 24, 2027, the Company may not enter into any variable rate transaction, including an equity line of credit or an at-the-market (“ATM”) offering facility, other than sales under an ATM facility with Wainwright serving as sales agent. Until that date, the Company also may not effect a reverse stock split without the consent of the purchaser, unless the Board of Directors determines in good faith that a reverse stock split is required to maintain the listing of the Company’s common stock on Nasdaq. In addition, under its engagement agreement with Wainwright, Wainwright has a right of first refusal to act as the Company’s exclusive placement agent, underwriter or advisor for certain future financings through July 2027. Sales under the ATM facility are also limited by the amount the Company may sell under its shelf registration statement, which depends on the market value of its common stock held by non-affiliates. These restrictions may limit the Company’s ability to raise capital on acceptable terms or in the amounts needed. There can be no assurance that additional financing will be available when needed or on terms acceptable to the Company.
At September 30, 2026 and December 31, 2025, we had cash of $6,088,085 and $5,334,322, respectively. On July 9, 2026, we completed the July 2026 Private Placement and after deducting cash costs of approximately $358,000, we received net proceeds of approximately $2.6 million from the offering.
Available cash is expected to fund our operations through the second quarter of 2027.
Cash Flows
Operating activities
For the nine months ended September 30, 2026 and 2025, cash used in operating activities totaled $1,854,997 and $1,976,388, respectively.
Financing activities
During the nine months ended September 30, 2026, cash provided by financing activities was $2,608,760 compared to $4,700,341 for the nine months ended September 30, 2025, primarily from the net proceeds of the ATM Facility, net proceeds of the July 2026 Private Placement and exercise of pre-funded warrants. During the nine months ended September 30, 2025, cash provided by financing activities was from the net proceeds of the ATM Facility, the net proceeds of a public offering completed in June 2025 and the exercise of pre-funded warrants.
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, 2025 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 September 30, 2026. Based upon that evaluation, our Chief Financial Officer and Chief Executive Officer concluded that as of September 30, 2026, 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 September 30, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
| 7 |
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, 2025, 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, 2025 except as noted herein.
There can be no assurance that our shares will continue to be listed on the Nasdaq Capital Market (“Nasdaq”), which would affect our common stock’s liquidity and reduce our ability to raise capital.
On September 10, 2026, we received a letter from the Staff of Nasdaq indicating that, based upon the closing bid price of our common stock for the last 30 consecutive business days, we no longer meet the Bid Price Rule.
Nasdaq Listing Rule 5810(c)(3)(A) provides a compliance period of 180 calendar days, or until March 9, 2027, 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 regain compliance. In the event we do not regain compliance with the Bid Price Rule by March 9, 2027, we may be eligible for consideration of a second 180-day compliance period if we meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for Nasdaq’s Capital Market, other than the Bid Price Rule, and notify Nasdaq of our intent to cure the minimum bid price deficiency.
If we fail to regain compliance with the Nasdaq continued listing standards, 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.
The notification has no immediate effect on the listing of our common stock on Nasdaq. We intend to monitor the closing bid price of our common stock and consider our available options in the event the closing bid price of our common stock remains below $1 per share. At our 2026 annual meeting of stockholders, we received stockholder approval for a reverse stock split of our outstanding common stock in the range of not less than 1-for-2 and not more than 1-for-10, at the discretion of our Board of Directors (the “Reverse Stock Split”). Accordingly, our Board of Directors may authorize a reverse stock split to attempt to increase the per share price of the common stock and regain compliance with the Nasdaq Listing Standards.
On July 22, 2026, the SEC approved a new continued listing requirement codified as Nasdaq Listing Rule 5550(a)(6) that requires companies to maintain a market value of listed securities of at least $5 million (the “MVLS Requirement”). On July 29, 2026, the SEC provided notice that the order approving the MVLS Requirement was stayed pending a petition for review of the action. On September 11, 2026, the SEC announced that the petitions for review of the approval of the MVLS Requirement were granted and that the implementation of the MVLS Requirement would remain stayed until the SEC orders otherwise. As of the date hereof, we are not in compliance with the MVLS Requirement if it were to come into effect. Under Nasdaq Listing Rule 5810(c)(1), if the MVLS Requirement comes into effect and we fail to meet the MVLS Requirement for 30 consecutive business days, our securities will be suspended and immediately delisted from the Nasdaq Capital Market, even if we are appealing a delisting determination to a Nasdaq Listing Qualifications Panel (the “Panel”), and the Panel will have limited discretion to reverse the delisting determination if it was issued in error or grant an exception for up to 180 days for us to demonstrate compliance with all requirements for initial listing on Nasdaq.
| 8 |
There can be no assurance that we will be able to regain compliance with the Bid Price Rule and maintain compliance with Nasdaq’s other continued listing standards. In addition, if the MVLS Requirement comes into effect, we cannot assure you that we will be able to regain compliance with the MVLS Requirement. Accordingly, our common stock 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 Reverse Stock Split will increase the price of our common stock.
We may need to effect the Reverse Stock Split to regain compliance with the Bid Price Rule. We expect that the Reverse Stock Split, if effected, 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 our prior reverse stock split. 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.
The Reverse Stock Split may decrease the liquidity of our common stock and result in higher transaction costs.
The Reverse Stock Split, if effected, 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 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 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 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.
During the three months ended September 30, 2026, we did not issue any shares in reliance on Section 4(a)(2) of the Securities Act, as amended as a transaction not involving a public offering which have not previously been reported in a Current Report on Form 8-K.
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 September 30, 2026, no director or officer of the Company
| 9 |
Item 6. Exhibits.
| (a) | Exhibits required by Item 601 of Regulation S-K. |
* Filed Herewith
** Furnished Herewith
| 10 |
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: October 26, 2026 | By: | /s/ Jeffrey Frelick |
| Name: | Jeffrey Frelick | |
| Title: | Chief Executive Officer | |
| (on behalf of the registrant and as principal executive officer) | ||
| 11 |