Bone Biologics expects cash to fund operations into second quarter of 2026

Bone Biologics Corporation (Nasdaq: BBLG) said its current cash position should fund planned operations into the second quarter of 2026. The statement appears in a letter to stockholders from President and Chief Executive Officer Jeffrey Frelick, dated September 4, 2025, which the company filed as Exhibit 99.1 to a Form 8-K. The company is based in Burlington, Massachusetts.

The letter says the company completed a public offering on June 30, 2025, raising gross proceeds of $5 million. It gives no share count, offering price or net proceeds for that offering. It does not name any underwriter, placement agent, financial adviser or counsel for the offering.

Enrollment and the pilot

The letter says the company began a pilot study of its NB1 bone graft in Australia last year. The study is multicenter, prospective and randomized, and it evaluates safety and preliminary effectiveness in patients with degenerative disc disease who undergo transforaminal lumbar interbody fusion. It compares two concentrations of NB1 with an autograft control in up to 30 subjects.

The primary clinical endpoints are fusion success at 12 and 24 months after surgery, and the change from baseline on the Oswestry Disability Index, which the letter calls the gold standard for measuring functional disability. Frelick wrote that enrollment "has been slower than anticipated." The company expects to complete enrollment by the end of the year.

The letter also plans an interim update once all patients reach six-month follow-up. The interim update is tied to six-month follow-up, while the primary endpoints are measured at 12 and 24 months.

Product and manufacturing

Third-party stability studies extended the shelf life of the company's protein to 18 months, from 12 months previously. The company plans to expand it to 24 months in preparation for a pivotal study. The letter says a formulation change should make the protein compatible with a scaled, semi-automated fill and finish process that will be required for an upcoming pivotal study. It gives no cost or timeline for that scale-up.

In June, the company filed a U.S. patent application covering rhNELL-1 compositions and their uses for bone conditions. The letter says the application, if approved, would support the company's strategic plan.

The annual report filed on February 26, 2025 describes Bone Biologics as a medical device company focused on spinal fusion. It says FDA guidance indicates that NELL-1 combined with demineralized bone matrix will be classified as a device and drug combination product. That would require an FDA-approved pre-market approval application before U.S. commercialization. The report also says the company's platform is licensed exclusively worldwide from the UCLA Technology Development Group, on behalf of the UC Regents.

Cash and the risks it names

The letter's forward-looking warning lists risks generally associated with an undercapitalized developing company. The same warning refers readers to risk factors in the annual report for the year ended December 31, 2024.

The letter does not give a cash balance, a burn rate or the cost of the pilot, the pivotal study or the scale-up. The only cash figure it gives is the $5 million gross raised in June, and the only runway figure is the statement that cash should fund planned operations into the second quarter of 2026. The letter lists value-creating events expected over the coming year: completing enrollment, the shelf life expansion, a better potency assay and the interim update. It does not quantify the money those events will need.

The annual report also cites a $3 billion global bone graft substitute market, based on an estimate from Fortune Business Insights. That is a third-party estimate the company uses to frame its opportunity, not a forecast of its own sales.

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