v3.26.3
The Company
9 Months Ended
Sep. 30, 2026
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
The Company

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 $90.3 million. The Company will continue to incur significant expenses for development activities for their lead product NELL-1/DBM. Operating expenditures for the next twelve months are estimated at $6.0 million. The accompanying consolidated financial statements for the nine months ended September 30, 2026 have been prepared assuming the Company will continue as a going concern. As reflected in the accompanying financial statements, the Company 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 the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. In addition, our independent registered public accounting firm, in its audit report on the financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, included an explanatory paragraph regarding substantial doubt about the Company’s ability to continue as a going concern. The consolidated financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

 

  

At September 30, 2026, the Company had cash of $6.1 million.

 

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 1-for-6 reverse stock split of its outstanding common stock and warrants. The amendment was authorized by the Company’s stockholders on May 30, 2025, and was effective on June 10, 2025.

 

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.