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Bone Biologics Achieves 32-Month Validated Shelf Life for rhNELL-1

Key Takeaway: Bone Biologics Corporation has successfully extended the validated shelf life of its rhNELL-1 protein to 32 months. This achievement allows for improved manufacturing, storage, and distribution processes as the company prepares for pivotal studies. The extension builds on previous milestones and is expected to enhance overall operational efficiency as the lead product candidate, NB1, progresses through clinical trials.

Market Sentiment Analysis

POSITIVE FACTORS

  • Extended shelf life enhances manufacturing and distribution flexibility.
  • Achieved stability milestones on timeline communicated to shareholders.
  • Supports efficient lot sizing and inventory management.
  • Advances the development of rhNELL-1 towards clinical studies.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Cash runway
~14 mo
Low dilution risk
Lead asset
ALLOB cells with ceramic scaffold
Phase 2 · Degenerative Disc Disease

Full Press Release Details

BURLINGTON, Mass, Aug. 12, 2026 (GLOBE NEWSWIRE) -- Bone Biologics Corporation ("Bone Biologics" or the "Company") (NASDAQ: BBLG, BBLGW), a developer of orthobiologic products for spine fusion markets, today announces that the validated shelf life of its rhNELL-1 protein has been extended to 32 months.
“Reaching a 32-month validated shelf life gives us greater flexibility in how we manufacture, store and distribute rhNELL-1 as we prepare for pivotal-study scale,” said Jeff Frelick, Chief Executive Officer. “We have achieved each stability milestone on the timeline communicated to shareholders. By extending the period the product can be held before use, we believe this milestone supports more efficient lot sizing, inventory management and distribution planning as our first-in-human NB1 study advances toward completion of enrollment.”
The extension is supported by third-party stability data and builds on the 29-month milestone announced in May 2026 and the 24-month milestone achieved in December 2025, continuing a progression from the Company's earlier validated 12- and 18-month shelf-life milestones. A 32-month validated shelf life is expected to further enhance manufacturing efficiency, lot sizing, inventory management, distribution planning, and supply-chain flexibility as the Company advances rhNELL-1 through development.
NB1, the Company’s lead product candidate, combines rhNELL-1 protein with demineralized bone matrix to provide controlled bone regeneration. Bone Biologics is currently conducting a multicenter, prospective, randomized pilot clinical study evaluating NB1 in up to 30 subjects with degenerative disc disease undergoing transforaminal lumbar interbody fusion in Australia.
About Bone Biologics Bone Biologics was founded to pursue regenerative medicine for bone. The Company is undertaking work with select strategic partners that builds on the preclinical research of the NELL-1 protein. Bone Biologics is focusing development efforts for its bone graft substitute product on bone regeneration in spinal fusion procedures, while additionally having rights to trauma and osteoporosis applications. For more information, please visit www.bonebiologics.com.
Forward-Looking Statements Certain statements contained in this press release, including, without limitation, statements regarding the timing, implementation, and success of the Company's pilot clinical study, the Company’s development of rhNELL-1 and achievement of operational milestones, the ability of the Company’s lead product candidate NB1 to provide rapid, specific and guided control over bone regeneration and show fusion success in humans, the ability of NB1 to compete in global markets, as well as statements containing the words "may," "believe," "expect," and words of similar import, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including, but not limited to, market and other conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under "Risk Factors" and "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 and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

CORE IR (212) 655-0924 investors@bonebiologics.com

Frequently Asked Questions

What is the new shelf life for rhNELL-1?

The validated shelf life for rhNELL-1 has been extended to 32 months.

How does the shelf life extension benefit Bone Biologics?

It enhances manufacturing flexibility, inventory management, and distribution planning.

What is NB1 in relation to rhNELL-1?

NB1 is Bone Biologics' lead product candidate combining rhNELL-1 with demineralized bone matrix.

Where is the clinical study for NB1 being conducted?

The clinical study is being conducted in Australia with subjects undergoing spinal fusion.

Last updated: Aug 12, 2026