Bone Biologics Corporation

What they do

Bone Biologics holds an exclusive worldwide license from UCLA Technology Development Group to develop and commercialize NELL-1 for spinal fusion, osteoporosis and trauma applications. Its lead candidate, NB1, combines NELL-1 protein with demineralized bone matrix in a bone graft device intended to provide targeted control over bone regeneration. The company is running a pilot clinical study of NB1 in up to 30 adult subjects undergoing transforaminal lumbar interbody fusion (TLIF) for degenerative disc disease in Australia. FDA guidance indicates NELL-1/DBM will be regulated as a device/drug combination product requiring a pre-market approval (PMA) application before U.S. commercialization.

Revenue drivers

• NB1 bone graft device (pre-revenue) — Lead product candidate combining NELL-1 with demineralized bone matrix; no commercial sales and no product revenue reported in the filings.
• NELL-1 platform licensing (pre-revenue) — Platform licensed exclusively from UCLA TDG for spinal fusion, osteoporosis and trauma; no licensing revenue disclosed in the provided financials.
• Spinal fusion market opportunity — Development is targeted at spinal fusion surgery, which the 10-K describes as one of the larger segments in the orthopedic market.

Recent performance

The company has no disclosed product revenue; the XBRL annual revenue figures of $1.07B in 2016, 2019 and 2020 do not align with a clinical-stage company and are not explained in the excerpts. Annual net losses were $1.6M in 2021, $1.5M in 2022, $8.9M in 2023, $4.1M in 2024 and $3.1M in 2025. Operating cash flow was negative in each of those years, at $(1.2)M, $(3.6)M, $(9.6)M, $(4.1)M and $(2.7)M respectively. Diluted EPS improved to $(2.65) in 2025 from $(28.96) in 2024. The latest balance sheet (2026-06-30) shows total assets of $4.4M, total liabilities of $512,018 and shareholder equity of $3.9M.

Strategy

The company's stated priority is developing NB1 through clinical testing, having announced treatment of the first subjects in its multicenter, prospective, randomized pilot study in 2024. The pilot study is designed to evaluate safety and effectiveness, fusion success, pain, function improvement and adverse events in up to 30 TLIF patients with degenerative disc disease. The design was reviewed and agreed with the FDA's Division of Orthopedic Devices in a pre-submission intended to support progression to a U.S. pivotal trial. The company is also managing its capital structure and Nasdaq listing status, having completed financings evidenced by Series F, Series G, pre-funded and placement agent warrants dated July 9, 2026.

Risks

• Going concern — The 10-K risk factor summary states recurring operating losses have raised substantial doubt regarding the company's ability to continue as a going concern.
• Nasdaq delisting — The 10-Q states the company is not in compliance with the new Nasdaq MVLS Requirement if it were to come into effect, and failure to meet it for 30 consecutive business days would result in suspension and immediate delisting.
• Early-stage regulatory path — NELL-1/DBM is expected to require an FDA-approved PMA application before U.S. commercialization, and the 10-K notes product candidates are at an early stage and may not be successfully developed.
• Limited resources and trial execution — The 10-K cites limited resources to pursue product candidates and the risk that enrollment in clinical trials may be difficult, which could delay or prevent development.

Outlook

Management's disclosed near-term focus is completing the Australian pilot study of NB1 and using its results to support progression to a pivotal U.S. clinical trial. The 10-K warns that operating expenses are expected to increase in the foreseeable future and that FDA regulation is costly and time consuming. The company also states it cannot assure regaining compliance with the Nasdaq MVLS Requirement if it takes effect, and that delisting could impair its ability to raise equity capital. No product revenue guidance or commercialization timeline is provided in the excerpts.