Bone Biologics Corp

Bone Biologics Corporation is a clinical-stage medical device company focused on bone regeneration, specifically in spinal fusion, utilizing its proprietary recombinant human protein, NELL-1. The company's core technology, NELL-1 in combination with demineralized bone matrix (DBM), is an osteopromotive recombinant protein designed to provide target-specific control over bone regeneration. This technology platform is exclusively licensed worldwide from the UCLA Technology Development Group (UCLA TDG) ¹. The company's business model is centered on the development and eventual commercialization of this combination product, classified by the FDA as a device/drug combination product requiring Pre-Market Approval (PMA) ². The primary customer segments are spine surgeons and patients with skeletal bone defects or bone-related conditions in their spine, particularly those undergoing spinal fusion procedures ³.

The company's lead product candidate, NB1, is a NELL-1/DBM Fusion Device. It is comprised of a single dose vial of freeze-dried NELL-1 recombinant protein mixed with DBM, and will be sold in a convenience kit with a diluent and a syringe of 510(k)-cleared DBM Putty manufactured by MTF Biologics ⁴. NB1 is initially targeted at the lumbar spinal fusion market, addressing degenerative disc disease (DDD) at one level from L2-S1, potentially with up to Grade 1 spondylolisthesis or Grade 1 retrolisthesis ⁵. The company believes NELL-1's characteristics, target-specific mechanism of action, efficacy, safety, and affordability position it for broader applications, including the global bone graft substitute market, estimated at $3 billion ⁶, non-union trauma cases, representing an $8 billion global market opportunity ⁷, and the global osteoporosis market, an $11.2 billion opportunity ⁸.

For the fiscal year ended December 31, 2025, Bone Biologics reported no revenues ⁹. The company incurred a net loss of $3,108,991 ¹⁰, which is a 24.40% decrease from the net loss of $4,112,420 in the prior year ¹¹. Total operating expenses for 2025 were $3,234,942 ¹², a 23.33% decrease from $4,219,161 in 2024 ¹³. Research and development expenses decreased by $1,070,194, from $2,130,385 in 2024 to $1,060,191 in 2025 ¹⁴. General and administrative expenses increased by $85,975, from $2,088,776 in 2024 to $2,174,751 in 2025 ¹⁵. The change in fair value of warrant liability resulted in a gain of $3,967 in 2025, compared to a gain of $51,081 in 2024 ¹⁶. Interest income increased by 119.16% to $121,984 in 2025 from $55,660 in 2024 ¹⁷. The diluted loss per share was $(2.65) in 2025, a significant improvement from $(28.96) in 2024 ¹⁸. Cash used in operating activities was $2,691,150 in 2025, down from $4,124,935 in 2024 ¹⁹. As of December 31, 2025, the company had cash of $5,334,322 ²⁰, compared to $3,325,131 at December 31, 2024 ²¹. Total liabilities were $418,587 in 2025, up from $377,712 in 2024 ²². The company has an accumulated deficit of approximately $88.1 million as of December 31, 2025 ²³.

During 2024, the company initiated a first-in-man pilot clinical study of its NB1 bone graft device in Australia, which triggered a $100,000 milestone payment to UCLA TDG ²⁴. This study is evaluating the safety and effectiveness of NB1 in up to 30 adult subjects undergoing transforaminal lumbar interbody fusion (TLIF) for degenerative disc disease ²⁵. In June 2025, the company completed a public offering, issuing 793,750 shares of common stock and pre-funded warrants to purchase 456,250 shares of common stock for $4.00 per share, along with Series D and E warrants to purchase 1,250,000 shares each, resulting in net proceeds of $4,352,792 ²⁶. Additionally, 456,250 pre-funded warrants were exercised in June and July 2025 ²⁷. The company also sold 52,843 shares of common stock through its At The Market (ATM) Facility for net proceeds of $347,549 in 2025 ²⁸. A 1-for-6 reverse stock split was effected on June 10, 2025 ²⁹.

Bone Biologics Corporation anticipates continued significant investment in NELL-1 development as it prepares for a pivotal clinical study ³⁰. The company expects its available cash of $5.3 million ³¹ to fund operations into the fourth quarter of 2026 ³². Operating expenditures for the next twelve months are estimated at $4.9 million ³³. The company plans to raise additional equity or debt capital to fund future operations and provide working capital, though there is no assurance such financing will be successful or on satisfactory terms ³⁴.

The primary growth area for the company is the advancement of its lead product candidate, NB1, through clinical studies to achieve FDA approval for lumbar spinal fusion ³⁵. The ongoing first-in-man pilot clinical study in Australia, which enrolled its first subjects in 2024, is evaluating the safety and effectiveness of NB1 in up to 30 adult subjects with degenerative disc disease undergoing transforaminal lumbar interbody fusion ³⁶. The primary endpoint for this study is fusion success at 12 months and change from baseline in the Oswestry Disability Index pain score ³⁷. The company anticipates completing this trial 12 months after enrolling the 30th patient ³⁸. The data from this pilot study will be used to enable a future, larger U.S. pivotal clinical study, prior to submission of a PMA to the FDA ³⁹.

Beyond lumbar spinal fusion, the company believes NELL-1 has potential applications in a variety of other spine and orthopedic procedures, non-union trauma cases, and osteoporosis ⁴⁰. The global bone graft substitute market is estimated at $3 billion ⁴¹, the global non-union trauma market at $8 billion ⁴², and the global osteoporosis market at $11.2 billion ⁴³. The systemic use of NELL-1 to stimulate bone regeneration throughout the body to increase bone density is seen as a significant potential impact on osteoporosis treatment ⁴⁴. A cervical indication for the NELL-1/DBM Fusion Device is also currently under consideration ⁴⁵.

Regarding operational outlook, research and development expenses decreased in 2025 due to lower protein needs during the pilot clinical study, but significant investment is expected as the company prepares for its pivotal clinical study ⁴⁶. The company relies on independent organizations, advisors, and consultants for substantially all aspects of regulatory approval, clinical management, manufacturing, marketing, and sales, and expects this reliance to continue ⁴⁷. The company currently has two full-time employees and will need to grow its organization size to support continued development and potential commercialization ⁴⁸.

Planned capital allocation includes continued funding for research and development programs ⁴⁹. The company is obligated to make milestone payments to UCLA TDG, including $250,000 upon enrollment of the first subject in a Pivotal Study, $500,000 upon Pre-Market Approval, and $1,000,000 upon the First Commercial Sale of a Licensed Product ⁵⁰. Additionally, a Diligence Fee of $8,000,000 is due upon cumulative net sales reaching $50,000,000, $100,000,000, and $200,000,000, with payments of $2,000,000, $2,000,000, and $4,000,000 respectively ⁵¹. The company does not intend to pay cash dividends on its common stock, with any future earnings to be retained for business development, operation, and expansion ⁵².

The company explicitly flagged several structural headwinds and execution risks. These include the need to raise substantial additional funds to achieve FDA approval for a spine interbody fusion indication, including costs for a pivotal clinical trial ⁵³. There is no assurance that such financing will be available or on satisfactory terms, and insufficient cash resources may require scaling back or discontinuing product development programs ⁵⁴. The company's recurring operating losses raise substantial doubt about its ability to continue as a going concern ⁵⁵. The development and regulatory approval process is costly and time-consuming, with no guarantee of success or timely approval ⁵⁶. Clinical trials may cause unacceptable adverse events, face delays in enrollment or completion, or be suspended or terminated ⁵⁷. Operating in foreign countries, such as Australia for the pilot study, exposes the company to differing regulatory requirements, economic weakness, political instability, foreign currency fluctuations, and other risks ⁵⁸. Failure to obtain regulatory approval in international jurisdictions would prevent product marketing abroad ⁵⁹.

Bone Biologics faces material risks across several categories. Operationally, the company has a limited operating history and has incurred accumulated losses of approximately $88.1 million since inception to December 31, 2025 ⁶⁰, raising substantial doubt about its ability to continue as a going concern ⁶¹. The company anticipates needing substantial additional funds for FDA approval and a pivotal clinical trial, with no assurance of successful financing ⁶². Product development is in an early stage, requiring significant capital, testing, and regulatory clearances, and there is no guarantee of successful development or commercialization ⁶³. Clinical trials are subject to risks of unacceptable adverse events, delays in commencement or completion, and difficulties in subject enrollment, which could increase costs or prevent regulatory approval ⁶⁴. The company relies heavily on third parties for raw materials, manufacturing, and clinical trials, and disruptions in these relationships could impair development and marketing ⁶⁵. Competitively, the orthobiologic and orthopedic industries are characterized by rapidly advancing technologies and intense competition from larger, well-resourced companies ⁶⁶. Competitors may develop safer, more effective, or less expensive products, or obtain regulatory approval more rapidly ⁶⁷. Intellectual property risks include the uncertainty of patent protection, the potential for challenges, invalidation, or circumvention of existing patents, and the high costs of litigation ⁶⁸. The company's five currently issued patents expire between 2026 and 2033 ⁶⁹, potentially limiting protection before commercialization ⁷⁰. Regulatory risks are significant, as the NELL-1/DBM product is classified as a Class III medical device requiring extensive FDA PMA approval, a process that is costly, time-consuming, and uncertain ⁷¹. Post-approval, products are subject to pervasive and continuing regulation, including potential restrictions, recalls, fines, or withdrawal from the market if compliance is not maintained or new problems arise ⁷². Healthcare legislative measures aimed at reducing costs, such as the Affordable Care Act, could negatively impact reimbursement and profitability ⁷³.

Management's message to shareholders emphasizes the company's focus on bone regeneration in spinal fusion using its recombinant human protein, NELL-1, in combination with DBM, highlighting its osteopromotive properties and target-specific control over bone regeneration. They underscore the exclusive worldwide license from UCLA TDG for this technology. A key strategic priority is advancing the lead product candidate, NB1, through clinical studies to achieve FDA approval, with initial focus on lumbar spinal fusion. Management noted the initiation of the first-in-man pilot clinical study in Australia in 2024, which will evaluate NB1's safety and effectiveness in up to 30 adult subjects with degenerative disc disease, with the primary endpoint being fusion success at 12 months and improvement in the Oswestry Disability Index pain score. This pilot study data is intended to enable a future, larger U.S. pivotal clinical study. Management also highlighted the broader potential applications of NELL-1 in the global bone graft substitute, non-union trauma, and osteoporosis markets, citing market opportunities of $3 billion ⁷⁴, $8 billion ⁷⁵, and $11.2 billion ⁷⁶ respectively. They explicitly stated the need for continued capital funding to facilitate the development of NELL-1 technology through the clinical regulatory path, acknowledging that operating expenditures for the next twelve months are estimated at $4.9 million ⁷⁷ and that available cash is expected to fund operations into the fourth quarter of 2026 ⁷⁸.