Bone Biologics Corporation (BBLG): Business Model Canvas [Dec-2025 Updated]

You're digging into how a clinical-stage orthobiologics firm actually operates, and for Bone Biologics Corporation, it boils down to a high-stakes bet on proprietary science. Right now, the entire model hinges on successfully navigating the NB1 pilot trial in Australia using their NELL-1 protein technology, all while keeping the lights on through equity raises-they secured about $5 million in gross proceeds in June 2025 to fund operations until roughly Q2 2026. Honestly, seeing a company with zero current revenue but a clear path toward the multi-billion dollar spinal fusion market, supported by key partnerships like the one with Johnson & Johnson MedTech, is fascinating; let's break down the nine essential blocks of the Bone Biologics Corporation business model below to see exactly where the risk and reward lie.

Bone Biologics Corporation (BBLG) - Canvas Business Model: Key Partnerships

You're looking at the core relationships that let Bone Biologics Corporation (BBLG) move its NELL-1 technology from the lab bench toward commercial reality. These aren't just vendor agreements; they are essential conduits for R&D, clinical validation, and future market access. Honestly, for a clinical-stage company, these partnerships define the near-term risk profile.

Exclusive worldwide license for NELL-1 from UCLA TDG.

The foundation of Bone Biologics Corporation's entire pipeline rests on the intellectual property secured from the University of California, Los Angeles Technology Development Group (UCLA TDG). Bone Biologics Corporation holds an exclusive worldwide license for the recombinant human protein NELL-1. This license covers the manufacture, composition, and use of NELL-1. While the focus is currently on the bone graft substitute product NB1 for spinal fusion, the rights extend to trauma and osteoporosis applications as well. The initial agreement was an option agreement for osteoporosis use, with the broader exclusive license secured between 2011 and 2014. This IP ownership is critical for protecting the technology as the company advances its NB1 product, which combines NELL-1 with demineralized bone matrix (DBM).

Contract Research Organizations (CROs) like Avania for clinical trial execution.

To execute the necessary human trials, Bone Biologics Corporation engaged specialized external expertise. Specifically, the company engaged Avania as the contract research organization (CRO) responsible for managing the pilot clinical trial involving their lead product, NB1. Avania brings specialized expertise in medical devices and drug-device combination products. This engagement is a direct use of capital raised; for instance, the $5 million in gross proceeds from the June 30, 2025, public offering is planned to fund operations, including retaining CROs, into the second quarter of 2026. The trial itself is designed to evaluate safety and effectiveness in up to 30 subjects undergoing Transforaminal Lumbar Interbody Fusion (TLIF).

Collaboration with Johnson & Johnson MedTech on bone allograft products.

A significant strategic alliance involves Johnson & Johnson MedTech, which is noted for reducing commercialization risk should the NB1 trial prove successful. The collaboration is specifically reported in connection with the launch of the PliaFX Pak bone allograft gel. To be fair, another source mentions LifeNet Health and Johnson & Johnson MedTech co-launching PliaFX Flo. This positions Bone Biologics Corporation to potentially enter the $1.5 billion demineralized bone matrix (DBM) market as of 2025. The potential market scope for their technology is vast, with the established global market for bone graft substitutes in spine fusion estimated at $3 billion annually.

Here's a quick look at the market context these partnerships aim to penetrate:

Clinical trial sites and principal investigators in Australia.

The initial human testing for the NB1 device is being conducted as a multicenter, prospective, randomized pilot clinical study in Australia, which commenced in 2024. The company expects to complete enrollment by the end of 2025. The structure of this trial relies on securing specific clinical sites and investigators:

• Monash Health was approved as the first of the planned multicenter pilot trial sites by the Human Research Ethics Committee (HREC).
• As of early 2024 reports, three hospital sites had been engaged to participate in the pilot trial.
• The trial is comparing two concentrations of NB1 against an autograft control in up to 30 subjects.
• The company has milestones planned to include adding more hospital sites in Australia in the coming year.

The product's stability is also being managed through partnerships, with recent studies extending the shelf life to 18 months from the previous 12 months, with a goal of reaching 24 months. This is defintely a key operational metric tied to site logistics.

Bone Biologics Corporation (BBLG) - Canvas Business Model: Key Activities

Conducting the NB1 pilot clinical trial in Australia.

• The multicenter, prospective, randomized pilot clinical study evaluates NB1 bone graft in patients undergoing transforaminal lumbar interbody fusion (TLIF) for degenerative disc disease (DDD).
• The study is assessing two concentrations of NB1 relative to autograft control in up to 30 subjects.
• The Human Research Ethics Committee (HREC) approved Monash Health as the first site.
• The company expected to complete enrollment by the end of 2025.
• Primary clinical endpoints include fusion success at 12 and 24 months after surgery.
• The estimated global market for bone graft substitutes in spine fusion is $3 billion annually.

Research and development (R&D) for NELL-1 protein technology.

Bone Biologics Corporation reported a net loss of $1.0 million for the three months ending March 31, 2025, driven by increased research and development costs.

• For the nine months ended September 30, 2025, the net loss was $2.42 million.
• The trailing 12 months ending September 30, 2025, showed earnings of $-3.9M.
• The company planned on developing a more robust potency assay to better measure NB1's biological activity.

Managing and expanding the intellectual property (IP) portfolio.

• Bone Biologics Corporation filed a patent application for bone regeneration technology on June 27, 2025.
• The company holds an exclusive worldwide license for the NELL-1 technology from UCLA TDG.
• Planned product improvements included expanding shelf life to 24 months from 18-months.

Securing capital through public offerings to fund operations.

Bone Biologics Corporation announced the closing of a public offering on June 30, 2025, raising gross proceeds of $5.0 million.

Bone Biologics Corporation (BBLG) - Canvas Business Model: Key Resources

You're looking at the core assets Bone Biologics Corporation (BBLG) is relying on to drive value, which are heavily weighted toward intellectual property and clinical progress right now. These are the tangible and intangible things the company must have to make its business model work.

The most critical resource is the underlying science, centered on the NELL-1 protein. Bone Biologics Corporation is focusing development efforts for its bone graft substitute product on bone regeneration in spinal fusion procedures, while additionally holding rights to trauma and osteoporosis applications. The company is building on preclinical research of the NELL-1 protein. This technology is positioned to compete in the estimated $3 billion global spine fusion segment.

The company has taken concrete steps to lock down this technology:

• Proprietary NELL-1 protein technology, which is a recombinant human protein growth factor essential for normal bone development.
• Exclusive license rights, building on UCLA-licensed research.

Securing the intellectual property is a major focus, evidenced by the recent filing:

The U.S. patent application filed in June 2025 sought to secure rights for the recombinant human NELL-1 (rhNELL-1) protein compositions and their use in treating bone conditions. This announcement caused BBLG shares to surge by over 100% in pre-market trading following the June 27, 2025 news.

Clinical validation is the next major resource being built. The first-in-human NB1 study is the current proof point:

The NB1 device, which combines the rhNELL-1 protein with demineralized bone matrix (DBM), is being evaluated in a pilot clinical trial in Australia. Here are the key statistics for this ongoing resource:

Finally, the financial runway dictates how long Bone Biologics Corporation has to convert these scientific and clinical assets into commercial value. The company bolstered its position recently:

Bone Biologics Corporation completed a public offering on June 30, 2025, raising gross proceeds of $5 million. This capital infusion is expected to fund planned operations into the second quarter of 2026. For context, as of the Q3 2025 earnings report on November 14, 2025, the actual reported EPS was -$0.37.

You should track the cash burn rate closely.

Bone Biologics Corporation (BBLG) - Canvas Business Model: Value Propositions

NB1 offers guided bone regeneration with a unique mechanism of action.

The core component, rhNELL-1, is a recombinant human protein combined with demineralized bone matrix (DBM) to form the NB1 bone graft device. This mechanism involves classic receptor binding and intracellular signaling transduction to the nucleus to promote osteogenic gene expression and bone formation. This provides rapid, specific, and guided control over bone regeneration.

Potential for improved safety profile versus existing bone growth factors.

• The pilot clinical study in Australia is evaluating safety and preliminary effectiveness in up to 30 subjects undergoing transforaminal lumbar interbody fusion (TLIF).
• Primary clinical endpoints include fusion success at 12 and 24 months after surgery.
• Enrollment in the first-in-human study is anticipated to complete by the end of 2025.

Alternative bone graft for patients with hard-to-heal spinal fusions.

The scientific basis for developing NB1 is the potential for increased safety and better fusion rates, making it especially useful among so-called "hard healers."

Targeting the multi-billion dollar global spinal fusion market.

Bone Biologics Corporation is focusing development efforts for NB1 on spinal fusion procedures, aiming to compete in a substantial market segment.

The company secured gross proceeds of $5.0 million from a public offering in June 2025, which it expects will fund planned operations into the second quarter of 2026.

Bone Biologics Corporation (BBLG) - Canvas Business Model: Customer Relationships

High-touch, collaborative relationship with clinical investigators.

Bone Biologics Corporation (BBLG) is conducting a multicenter, prospective, randomized pilot clinical study for its NB1 bone graft product in Australia, which began last year. This study is evaluating the safety and preliminary effectiveness of NB1 in patients with degenerative disc disease undergoing transforaminal lumbar interbody fusion. The relationship involves assessing two concentrations of NB1 against autograft control in up to 30 subjects. Enrollment completion is anticipated by the end of 2025. The company is also planning to add additional hospital sites in Australia. Furthermore, stability studies have achieved an 18-month shelf life for the protein, an improvement from the prior 12 months, with a goal to expand this to 24 months. The company reports having 2 total employees.

Key operational and financial metrics underpinning these relationships as of late 2025 include:

Investor relations focused on communicating clinical milestones and funding.

The President and CEO, Jeffrey Frelick, issued a letter to stockholders on September 4, 2025, detailing progress and outlook. The company communicated the completion of a public offering on June 30, 2025, which raised gross proceeds of $5 million. This offering included common stock, Series D warrants, and Series E short-term warrants, priced at $4.00 per share. The company's stock trades on Nasdaq under the symbol BBLG, with a price of $1.60 as of November 14, 2025. The company executed a 1-for-6 reverse stock split on June 10, 2025, to regain Nasdaq compliance. Bone Biologics Corporation (BBLG) has never declared or paid cash dividends.

Investor engagement activities included:

• Participation in the H.C. Wainwright 27th Annual Global Investment Conference on September 8-10, 2025.
• Communication of expected cash position funding operations into Q2 2026.
• Filing of a U.S. patent application on June 27, 2025.
• Regaining compliance with Nasdaq minimum bid price requirement on June 24, 2025.

Regulatory engagement with the FDA for future PMA submission.

The current pilot clinical study design for NB1 has been previously reviewed by the U.S. Food and Drug Administration's (FDA's) Division of Orthopedic Devices in a Pre-submission. This engagement is intended to support progression to a pivotal clinical trial in the United States. The company's strategic plan to advance its clinical development program is supported by this filing.

Bone Biologics Corporation (BBLG) - Canvas Business Model: Channels

You're looking at how Bone Biologics Corporation gets its product, NB1, from development to the surgeon's hand. For a clinical-stage company, the channels are heavily weighted toward clinical validation right now, but the groundwork for commercial scale is being laid with partners.

Clinical trial sites (hospitals in Australia) for current product testing

The NB1 first-in-human, multicenter, prospective, randomized pilot clinical trial is the immediate channel for product testing. This study, which began in Australia, is designed to evaluate safety and preliminary effectiveness in patients undergoing transforaminal lumbar interbody fusion for degenerative disc disease.

The company expects to complete enrollment in this trial by the end of 2025. The trial is assessing two concentrations of NB1 against autograft control in up to 30 subjects. The CEO noted an anticipated milestone of adding more hospital sites in Australia in the near term.

The company raised gross proceeds of $5 million in a public offering on June 30, 2025, which they expect will fund planned operations into the second quarter of 2026, supporting the continuation of these clinical channels.

Future strategic distribution partners for commercialization

Bone Biologics Corporation is running an extremely lean operation, relying on vendors, partners, and contractors to manage manufacturing and distribution logistics for the NB1 product candidate. They are undertaking work with select strategic partners to build on the NELL-1 protein research.

A key element in the commercialization channel is the strategic partnership with Johnson & Johnson MedTech, which is noted for providing distribution muscle. This partnership is cited as potentially providing immediate access to 85% of US hospitals upon successful trial results and FDA approval.

• Partner for Contract Development Manufacturing (CDMO) for protein production.
• Partner for Fill/Finish operations (drug substance to drug product).
• Strategic partner for US distribution access.

The potential entry point into the demineralized bone matrix (DBM) market is estimated at $1.5 billion as of 2025.

Direct engagement with key opinion leaders (KOLs) and spinal surgeons

Direct engagement channels focus on the clinical community that will ultimately adopt NB1 for spinal fusion procedures. The company's focus is on spine fusion, which represents an estimated global market of $3 billion annually for bone graft substitutes.

The clinical trial itself serves as a primary engagement tool, involving surgeons at the participating Australian centers. The primary clinical endpoints for the study include fusion success at 12 and 24 months post-surgery, which directly speaks to the data KOLs and spinal surgeons require for adoption. The company also has rights to trauma and osteoporosis applications, suggesting broader future engagement targets beyond the initial spine focus.

The company structure includes personnel with deep industry experience, such as a team member with 15 years of musculoskeletal R&D experience, including successfully commercialized orthopedic medical devices.

Bone Biologics Corporation (BBLG) - Canvas Business Model: Customer Segments

You're looking at the initial target market for Bone Biologics Corporation (BBLG) as they push their lead candidate, NB1, through clinical validation. Since the company is still pre-revenue as of September 30, 2025, the customer segments are currently defined by the clinical trial participants and the specialists involved in that process, rather than broad commercial sales figures.

Spinal surgeons and orthopedic specialists are the key gatekeepers. They are the ones using the NB1 bone graft device, which combines the recombinant human protein NELL-1 with demineralized bone matrix (DBM), in procedures like transforaminal lumbar interbody fusion (TLIF). These specialists are being engaged through the multicenter, prospective, randomized pilot clinical study initiated in Australia. The study is designed to evaluate safety and preliminary effectiveness, with primary clinical endpoints set at fusion success at 12 and 24 months post-surgery. The company is also focused on product improvements relevant to their use, such as extending the product's shelf life from 12 months to 18 months, with plans to reach 24 months in preparation for larger studies.

Hospitals and surgical centers performing interbody fusion (TLIF) are the institutional customers. Currently, the focus is on the sites participating in the NB1 first-in-human study. This study involves up to 30 subjects across multiple Australian hospital sites. The company's ability to scale up its customer base depends heavily on the successful completion of this trial, which management expected to complete enrollment by the end of 2025. The financial reality of Bone Biologics Corporation-reporting a net loss of $4.1 million for the fiscal year 2024 and cumulative losses of approximately $87.4 million-highlights that these centers are currently engaging with the product in a research capacity, not a standard procurement one. The company secured net proceeds of $4,352,792 from a June 2025 public offering to fund operations, which they expected would last into the second quarter of 2026.

Patients with degenerative disc disease requiring spinal fusion represent the ultimate end-user segment. The NB1 product is specifically being evaluated in patients diagnosed with degenerative disc disease who require TLIF. The value proposition for this segment centers on enhanced clinical outcomes, targeted guided bone growth, and improved fusions and healing, potentially offering an alternative for so-called "hard healers." The study measures patient outcomes using the Oswestry Disability Index change from baseline, which directly reflects the functional disability experienced by these patients. As of September 30, 2025, the company had no revenue from commercial sales, meaning these patients are participating in a trial setting.

Here's a quick look at the operational scale relevant to these segments as of late 2025:

The immediate focus for Bone Biologics Corporation's commercial readiness is tied to these clinical milestones. You can see the company is still heavily in the investment phase, with operating expenses totaling $4.2 million in the last full fiscal year, and the Q3 2025 net loss was $666,737.

The key characteristics defining the current customer segments include:

• Spinal surgeons: Involved in the Australian multicenter study.
• Surgical Centers: Participating sites for the first-in-human trial.
• Patients: Diagnosed with degenerative disc disease undergoing TLIF.
• Value Focus: Improved safety profile and better fusion rates than existing options.
• Product Status: NB1 is a pre-revenue, clinical-stage asset.

The company's market capitalization stood at $2.87M as of November 14, 2025, which reflects the pre-commercial valuation tied to these early-stage customer interactions. Finance: draft 13-week cash view by Friday.

Bone Biologics Corporation (BBLG) - Canvas Business Model: Cost Structure

The Cost Structure for Bone Biologics Corporation is heavily weighted toward the pre-commercial, clinical-stage development of its regenerative platform.

Heavy investment in Research and Development (R&D) remains a primary cost driver, reflecting the ongoing scientific and clinical advancement required for its NELL-1 technology. For the Trailing Twelve Months (TTM) ending September 2025, R&D expenses were reported at approximately $1.91 million.

General and Administrative (G&A) expenses, which cover overhead, executive functions, and general corporate operations, were reported at about $2.15 million for the TTM period ending September 2025. This figure suggests a stable corporate infrastructure supporting the clinical efforts.

The costs associated with clinical trial execution and Contract Research Organizations (CROs) are embedded within the broader R&D expenditure. For instance, the Q3 2025 report indicated that R&D spending eased with clinical timing, suggesting variable costs tied directly to trial milestones.

Patent maintenance and intellectual property legal fees represent a recurring, though smaller, component of the cost structure. A specific annual maintenance fee related to the licensed technology was noted at $10,000, payable to UCLA TDG.

Here's a breakdown of the key operating expenses for Bone Biologics Corporation as of TTM September 2025:

The overall cost profile is typical for a clinical-stage medical device company with no current revenue stream. The focus is on managing these operating expenses against available capital resources.

• R&D spending eased in Q3 2025 compared to prior periods due to clinical timing.
• G&A expenses remained stable across recent reporting periods.
• The company reported a net loss of $2,424,348 for the nine months ending September 2025.
• Cumulative losses since inception were approximately $87.4 million as of late 2025 filings.

Bone Biologics Corporation (BBLG) - Canvas Business Model: Revenue Streams

As of late 2025, Bone Biologics Corporation is a pre-commercial, clinical-stage company, meaning current revenue from product sales is $0.

The company's primary financial support comes from capital raised through financing activities, not sales. For example, Bone Biologics Corporation closed a public offering on June 30, 2025, securing $5.0 million in gross proceeds before placement agent fees and expenses. This offering involved 1,250,000 shares of common stock and accompanying warrants. The President and CEO stated this cash position is expected to fund planned operations into the second quarter of 2026.

You can see a snapshot of recent financial metrics below, which underscore the reliance on financing:

Future revenue potential is entirely contingent upon regulatory success for its lead product candidate, NB1, which combines the recombinant human protein NELL-1 with demineralized bone matrix (DBM). Bone Biologics is currently focused on its pilot clinical study in Australia for use in spinal fusion procedures.

The anticipated future revenue streams include:

• Future potential revenue from NB1 product sales following necessary regulatory approval, such as the planned U.S. pivotal clinical trial supporting a Class III medical device PMA application.
• Future potential royalty or licensing income derived from NELL-1 applications beyond spinal fusion, specifically including rights for trauma and osteoporosis indications.

The current analyst revenue forecast for the fiscal year ending 2026-12-31 remains 0MM.

Finance: draft 13-week cash view by Friday.