Bone Biologics Achieves 29-Month Validated Shelf Life for rhNELL-1

Bone Biologics (NASDAQ: BBLG) reported that the validated shelf life of its rhNELL-1 protein product has been extended to 29 months, up from 24 months.

Rhea-AI Summary

Bone Biologics (NASDAQ: BBLG) reported that the validated shelf life of its rhNELL-1 protein product has been extended to 29 months, up from 24 months.

According to Bone Biologics, third-party stability data support this milestone, which is expected to enhance manufacturing flexibility and distribution planning ahead of a future pivotal study of lead candidate NB1.

Positive

• Validated shelf life for rhNELL-1 extended to 29 months from 24 months
• Third-party stability data support the extended rhNELL-1 shelf life
• Longer shelf life expected to improve lot sizing and distribution planning
• Extension moves rhNELL-1 closer to shelf life target for pivotal study manufacturing
• Ongoing multicenter pilot study of NB1 in up to 30 subjects in Australia

Negative

• None.

Argus May 19 session

+0.80% close to close Open Argus

Details

News Market Reaction – BBLG

In the May 19 session, BBLG gained 0.80%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement underscores incremental but tangible progress in product stability, with rhNELL-1’...

Analysis

This announcement underscores incremental but tangible progress in product stability, with rhNELL-1’s validated shelf life extended to 29 months, building on the prior 24‑month milestone. The update supports manufacturing flexibility and planning for a future pivotal study, alongside an ongoing pilot trial of up to 30 subjects. Against this, investors must weigh the company’s continued net losses and cumulative deficit of $87.4 million as disclosed in recent filings.

Key Figures

Validated shelf life: 29 months Prior shelf life: 24 months Pilot study size: up to 30 subjects +5 more

Validated shelf life

29 months

Updated rhNELL-1 stability milestone in May 2026

Prior shelf life

24 months

Previously reported rhNELL-1 milestone in December 2025

Pilot study size

up to 30 subjects

NB1 pilot study in degenerative disc disease

Q3 2025 net loss

$666,737

Quarter ended September 30, 2025

9M 2025 net loss

$2,424,348

Nine months ended September 30, 2025

Cash balance

$6.05 million

As of September 30, 2025

Public offering proceeds

$4,352,792

June 2025 public offering net proceeds

Cumulative losses

$87.4 million

Accumulated deficit disclosed in Q3 2025 10-Q

Historical Context

2 past events · Latest: Jan 08

2 events

1. Jan 08

   Milestones and outlook

   24h Move

   -1.3%

   Outlined 2025 milestones, 2026 outlook, financing and compliance achievements.

2. Dec 23

   Shelf-life extension

   24h Move

   +4.3%

   Validated extension of rhNELL-1 shelf life to 24 months with stability data.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

orthobiologic, pivotal study, demineralized bone matrix, multicenter, +3 more

7 terms

orthobiologic medical

"a developer of orthobiologic products for spine fusion markets"

Orthobiologics are medical products made from natural substances—such as blood, bone, or growth factors—used to help heal bones, joints and soft tissues faster or more effectively. For investors, they matter because they represent a growing segment of healthcare that can offer less invasive, often outpatient treatments with potential for recurring sales, intellectual property, and reimbursement shifts that can affect revenue and valuation in companies developing or commercializing these therapies.

pivotal study medical

"required for a future pivotal study"

A pivotal study is a large, definitive clinical trial designed to show whether a medical product works and is safe enough for regulators to approve and for doctors to use. Think of it as the final exam that determines whether a drug or device moves from testing into the market; its results can dramatically change a company’s approval chances, future sales prospects, and therefore its stock value.

demineralized bone matrix medical

"combines rhNELL-1 protein with demineralized bone matrix to provide controlled"

Demineralized bone matrix is human bone that has had its mineral components removed, leaving a protein-based scaffold that helps the body grow new bone. Think of it as a biological framework or scaffold that surgeons use in orthopedics and dental procedures to support healing and tissue regrowth. For investors, it matters because its clinical utility, regulatory clearance, manufacturing quality, and adoption by surgeons affect product demand, company revenue, and reimbursement dynamics in the medical products market.

multicenter medical

"currently conducting a multicenter, prospective, randomized pilot clinical study"

A multicenter study or trial is conducted at several independent locations or clinics rather than a single site, so researchers collect data from diverse groups and settings. For investors, multicenter designs matter because they increase the credibility and generalizability of results, reduce the risk that findings are due to one local population or practice, and often speed enrollment — all factors that can affect regulatory outcomes, market confidence and commercial prospects.

prospective medical

"conducting a multicenter, prospective, randomized pilot clinical study"

Prospective means relating to the future or to something expected to happen; in finance and regulatory contexts it describes forward-looking information, planned actions, or studies that follow events or people over time rather than looking back. For investors it matters because prospective data—such as forecasts, planned transactions, or prospective clinical trials—helps anticipate risks and opportunities, similar to using a weather forecast to decide whether to carry an umbrella.

randomized medical

"multicenter, prospective, randomized pilot clinical study evaluating NB1"

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

transforaminal lumbar interbody fusion medical

"degenerative disc disease undergoing transforaminal lumbar interbody fusion in Australia"

A transforaminal lumbar interbody fusion is a type of spine surgery that stabilizes two adjacent lower-back vertebrae by reaching the disc space through the natural side opening where spinal nerves exit, removing damaged disc material, and placing bone graft and an implant to fuse the bones together. Investors care because the procedure drives demand for spinal implants, surgical devices, hospital services, rehabilitation and insurance payments, so trends in its use, outcomes and reimbursement affect medical device makers, hospitals and payers much like sales trends affect any product line.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

Milestone advances commercial and manufacturing readiness ahead of anticipated pivotal study scale-up

BURLINGTON, Mass, May 19, 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 product has been further extended to 29 months, building on the 24-month milestone the Company reported in December 2025.

The updated shelf life is supported by continued third-party stability data. The additional five months of validated product life is expected to provide greater flexibility in lot sizing and distribution planning as the Company progresses rhNELL-1 toward the manufacturing scale required for a future pivotal study.

"Reaching 29 months is a direct result of the ongoing stability work our team has been executing," said Jeffrey Frelick, Bone Biologics President and Chief Executive Officer. "Beyond the incremental operational benefit, this result gives us increased confidence in the robustness of our rhNELL-1 formulation as we continue to prepare for the next phase of development. We believe a longer validated shelf life translates to more efficient use of manufactured material and greater scheduling latitude across our clinical and supply chain operations."

The Company previously stated its objective of achieving a shelf life sufficient to support scaled manufacturing ahead of a pivotal study. The 29-month validation is expected to bring the program meaningfully closer to that threshold.

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 a clinical study in Australia 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, 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," “continue,” "expect," “objective,” 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.

Contacts

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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Bone Biologics (NASDAQ: BBLG) announce about rhNELL-1 shelf life on May 19, 2026?

Bone Biologics announced that the validated shelf life of its rhNELL-1 protein product has increased to 29 months. According to Bone Biologics, this builds on a prior 24-month milestone and supports future manufacturing and clinical planning.

How does the 29-month rhNELL-1 shelf life affect Bone Biologics (BBLG) manufacturing plans?

The 29-month validated shelf life is expected to provide greater flexibility in lot sizing and distribution planning. According to Bone Biologics, this supports scaling rhNELL-1 manufacturing for a potential future pivotal study of its NB1 product candidate.

Why is the extended rhNELL-1 shelf life important for Bone Biologics BBLG investors?

The longer 29-month shelf life moves the rhNELL-1 program closer to the company’s shelf-life objective for scaled manufacturing ahead of a pivotal study. According to Bone Biologics, this may improve material use and scheduling across clinical and supply chain operations.

What is Bone Biologics’ NB1 product candidate and current clinical status for BBLG?

NB1 combines rhNELL-1 protein with demineralized bone matrix for controlled bone regeneration. According to Bone Biologics, NB1 is being evaluated in a multicenter, prospective, randomized pilot clinical study in up to 30 degenerative disc disease subjects in Australia.

How was the 29-month rhNELL-1 shelf life validation supported for Bone Biologics (BBLG)?

The 29-month shelf life validation is supported by continued third-party stability data. According to Bone Biologics, ongoing stability work by its team contributed to this milestone, reinforcing confidence in the robustness of its rhNELL-1 formulation.