Brainstorm Cell Therapeutics Inc. (BCLI): Business Model Canvas [Dec-2025 Updated]

You're digging into the mechanics of a pre-revenue biotech, and honestly, the Business Model Canvas for Brainstorm Cell Therapeutics Inc. right now is a masterclass in high-wire execution under extreme pressure. We're looking at a company betting everything on the Phase 3b ENDURANCE trial for NurOwn, supported by key partners like Minaris, but the runway is razor thin-we're talking just $0.23 million in cash as of September 30, 2025, while Q3 expenses hit $2.0 million between R&D and G&A alone. This model hinges defintely on translating proprietary cell therapy IP into a future revenue stream, balancing the pursuit of a critical FDA Biologics License Application (BLA) with the immediate, desperate need for non-dilutive funding or equity to survive the next few quarters. Dive into the full breakdown below to see exactly how their partnerships, resources, and revenue hopes stack up against this near-term financial reality.

Brainstorm Cell Therapeutics Inc. (BCLI) - Canvas Business Model: Key Partnerships

The ability of Brainstorm Cell Therapeutics Inc. to advance its NurOwn therapy hinges on a network of specialized external partners for manufacturing, clinical execution, and regulatory navigation as of late 2025.

The company has established a dual-site manufacturing strategy to support the pivotal Phase 3b ENDURANCE trial and potential future commercial supply. This strategy diversifies risk and builds U.S.-based capacity.

The regulatory framework for the Phase 3b ENDURANCE trial is anchored by prior agreement with the U.S. Food and Drug Administration (FDA).

• The trial design was agreed upon with the FDA under a Special Protocol Assessment (SPA).
• The SPA confirms the study's endpoints and statistical methodology are appropriate to support a future Biologics License Application (BLA) submission.
• The trial is designed to enroll approximately 200 participants.
• The primary endpoint is the change from baseline to week 24 in the ALSFRS-R score.

The clinical execution relies on a network of sites, with operational readiness being a major focus following FDA clearance in Q2 2025. This readiness is supported by the company's cash position as of the end of Q2 2025, which stood at approximately $1.03 million in cash, cash equivalents, and restricted cash as of June 30, 2025.

Brainstorm Cell Therapeutics Inc. (BCLI) - Canvas Business Model: Key Activities

You're looking at the core engine driving Brainstorm Cell Therapeutics Inc. (BCLI) right now-the essential actions they must execute flawlessly to move NurOwn toward potential approval and keep the lights on. Honestly, for a company at this stage, the key activities are a tightrope walk between clinical execution and financial survival.

Executing the Phase 3b ENDURANCE clinical trial (approx. 200 participants)

The absolute top priority is getting the Phase 3b ENDURANCE study running and completed successfully. This trial is specifically designed to generate the confirmatory data needed to support a Biologics License Application (BLA) submission. The FDA has already cleared the initiation of this trial, which is a huge de-risking step, especially since the design was agreed upon under a Special Protocol Assessment (SPA).

• Trial ID is listed as NCT06973629.
• Expected enrollment target is approximately 200 participants with early-stage ALS.
• The structure involves a 24-week, randomized, double-blind, placebo-controlled period (Part A).
• This is immediately followed by a 24-week open-label extension (Part B).
• The primary efficacy measure focuses on the change from baseline to Week 24 on the ALSFRS-R score.

Research and Development (R&D) of the NurOwn and exosome technology platforms

While the clinical trial is front and center, Brainstorm Cell Therapeutics Inc. must continue advancing its underlying science. This includes optimizing the NurOwn platform and building out the intellectual property around the exosome technology, which represents a separate, potentially scalable asset. You can see the cash burn associated with this work in the quarterly filings.

Here's the quick math on R&D spend, which shows the intensity of this activity:

Also, the company is actively developing a proprietary, allogeneic exosome-based platform. They strengthened their IP position by receiving a Notice of Allowance from the U.S. Patent and Trademark Office for a foundational patent covering this exosome technology.

Regulatory management, including BLA preparation and citizen petition engagement

Managing the relationship with the U.S. Food and Drug Administration (FDA) is a non-negotiable key activity. Success in the ENDURANCE trial's Part A is explicitly designed to support a future BLA submission. Furthermore, Brainstorm Cell Therapeutics Inc. must actively manage external regulatory pressures.

• Secured FDA clearance to initiate the Phase 3b ENDURANCE trial.
• Achieved alignment with the FDA on Chemistry, Manufacturing, and Controls (CMC) aspects in 2024.
• Engaging with the FDA regarding a Citizen Petition filed by ALS community representatives, which requests a renewed regulatory review of existing NurOwn data.

Manufacturing technology transfer to CDMO partners for drug supply readiness

You can't run a trial without product, so securing a robust, U.S.-based supply chain is critical. This involves complex technology transfer activities with Contract Development and Manufacturing Organizations (CDMOs). They are building redundancy here, which is smart given the complexity of cell therapy manufacturing.

Key manufacturing partners and activities include:

• Signed a Letter of Intent (LOI) with Minaris Advanced Therapies to manufacture NurOwn for the Phase 3b trial.
• Technology transfer has been initiated at Minaris' facility in Allendale, New Jersey.
• This complements the ongoing collaboration and technology transfer with Pluri Inc. in Israel.

Securing non-dilutive and dilutive financing to fund operations

Honestly, liquidity is the gating factor for everything else listed here. The company is pre-revenue, so funding operations requires constant financial maneuvering. The cash position as of late 2025 clearly shows the urgency to secure more capital before enrollment can fully ramp up.

Here are the recent financial markers you need to watch:

• Cash, cash equivalents, and restricted cash stood at approximately $0.23 million as of September 30, 2025.
• The net loss for the third quarter ended September 30, 2025, was approximately $2.1 million.
• Management highlighted pursuing a promising $15 million non-dilutive grant under review (as of Q1 2025).
• The company previously closed a $4.0 million registered direct offering around June 28, 2024.

Finance: draft 13-week cash view by Friday.

Brainstorm Cell Therapeutics Inc. (BCLI) - Canvas Business Model: Key Resources

You're looking at the core assets Brainstorm Cell Therapeutics Inc. (BCLI) relies on to execute its strategy, which is heavily concentrated on advancing its lead candidate, NurOwn®. These resources are the foundation for everything else in their business model, from partnerships to revenue potential.

The primary Key Resource is the NurOwn® technology platform, which is a proprietary autologous MSC-NTF cell therapy. This means the treatment uses the patient's own (autologous) bone marrow-derived mesenchymal stem cells (MSCs) that are expanded and differentiated ex vivo into MSC-NTF cells. These cells are engineered to secrete high levels of neurotrophic factors (NTFs) under patented conditions, aiming to deliver multiple factors directly to the site of damage to slow or stabilize disease progression in neurodegenerative disorders like ALS.

The company's competitive moat is built around its intellectual property and regulatory achievements related to this platform. These are critical, non-physical assets.

• Intellectual Property: Brainstorm Cell Therapeutics Inc. holds exclusive worldwide licensing rights for NurOwn.
• Orphan Drug Designation: This status has been granted by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for ALS, which offers market exclusivity incentives upon approval.

Here's a quick look at the critical dates and the most recent balance sheet snapshot as of the end of the third quarter of 2025. This data shows the immediate liquidity position against the long-term IP protection.

Financially speaking, the immediate resource picture is tight. As of September 30, 2025, Brainstorm Cell Therapeutics Inc.'s Cash, cash equivalents, and restricted cash stood at approximately $0.23 million. This figure underscores the immediate need for capital to fund the planned Phase 3b ENDURANCE study, which is a key next step to generate confirmatory data for a potential Biologics License Application (BLA) submission. The company reported a net loss of approximately $2.1 million for the quarter ended September 30, 2025.

Also, remember that the company transitioned to the OTCQB market, which is a different tier of public trading than NASDAQ. Finance: draft 13-week cash view by Friday.

Brainstorm Cell Therapeutics Inc. (BCLI) - Canvas Business Model: Value Propositions

The core value proposition for Brainstorm Cell Therapeutics Inc. centers on delivering a potentially disease-modifying therapy for devastating neurodegenerative conditions, leveraging proprietary cell and exosome technology.

Disease-modifying therapy for ALS: NurOwn aims to slow progression and improve quality of life.

The clinical evidence supporting NurOwn (MSC-NTF cells) for Amyotrophic Lateral Sclerosis (ALS) is anchored in long-term survival data from patients treated under expanded access. You should note the stark contrast in survival rates observed in this patient group.

The company is advancing the Phase 3b ENDURANCE study, which is designed to generate the necessary confirmatory data to support a potential Biologics License Application (BLA) submission. This trial is being conducted under an agreement with the U.S. Food and Drug Administration (FDA) via a Special Protocol Assessment (SPA). The primary efficacy measure for the initial randomized, double-blind, placebo-controlled period (Part A) is the change from baseline to Week 24 on the ALS Functional Rating Scale-Revised (ALSFRS-R). This upcoming pivotal trial is expected to enroll approximately 200 participants at leading ALS centers.

Autologous cell therapy: Personalized treatment using the patient's own cells.

Brainstorm Cell Therapeutics Inc. focuses on an autologous approach, meaning the treatment is derived from the patient's own cells. This personalization is inherent to the platform's design.

• The proprietary NurOwn platform uses autologous mesenchymal stem cells (MSCs).
• These MSCs are engineered to produce neurotrophic factor-secreting cells, referred to as MSC-NTF cells.
• NurOwn has secured Orphan Drug designation from both the U.S. FDA and the European Medicines Agency (EMA) for ALS.

Potential for other neurodegenerative diseases: Platform applicability to Progressive MS and Parkinson's.

The underlying technology shows application beyond ALS, though the focus remains on the lead candidate. The platform has been tested in other indications.

• Completed a Phase 2 open-label multicenter trial (NCT03799718) in progressive multiple sclerosis (MS).
• This MS trial was supported by a grant from the National MS Society.

Exosome platform: Scalable, allogeneic delivery system for therapeutic proteins.

A significant secondary value driver is the proprietary exosome technology, which offers a potential shift toward a more scalable, off-the-shelf product. The company has been building its intellectual property fortress here.

The company is actively pursuing strategic collaborations for this exosome platform. Financially, as of the third quarter ended September 30, 2025, Brainstorm Cell Therapeutics Inc. reported cash, cash equivalents, and restricted cash of approximately $0.23 million. For that same quarter, Research and development expenditures, net, were $0.9 million, and General and administrative expenses were approximately $1.1 million, resulting in a net loss of approximately $2.1 million.

Brainstorm Cell Therapeutics Inc. (BCLI) - Canvas Business Model: Customer Relationships

You're looking at how Brainstorm Cell Therapeutics Inc. (BCLI) manages its critical relationships, which are heavily skewed toward the patient and scientific communities given its clinical stage in developing NurOwn for ALS. This is not a typical B2C or B2B model; it's a highly specialized, high-stakes relationship structure.

High-touch engagement with the ALS patient community and advocates

Brainstorm Cell Therapeutics Inc. maintains a close relationship with the ALS community, which is vital for trial recruitment and public support. The company explicitly stated its commitment to working with the ALS community. This engagement is underscored by the acknowledgment of a Citizen Petition filed with the U.S. Food and Drug Administration (FDA) by representatives of the ALS community, requesting a renewed regulatory review of the data supporting NurOwn. The company views this petition as a constructive development that highlights the ongoing interest in NurOwn's potential therapeutic value. The prior Expanded Access Program (EAP) data showed that 10/10 participants in that program survived more than 5 years from the onset of ALS symptoms, a stark contrast to published estimates of approximately 10% survival beyond 5 years for the general ALS population.

• Citizen Petition filed by ALS community representatives with the FDA.
• Commitment to working with the ALS community if NurOwn is approved.
• 100% survival past 5 years for 10 EAP participants.

Direct support and communication with clinical trial participants

The success of the upcoming Phase 3b ENDURANCE study hinges on strong relationships with the participants who will receive the therapy. The company is advancing pre-initiation activities for this trial, which is expected to enroll approximately 200 participants at leading ALS centers. This trial structure includes a 24-week, randomized, double-blind, placebo-controlled period (Part A), followed by a 24-week open-label extension (Part B) where all participants will receive NurOwn. This structure suggests a commitment to providing the therapy to all enrolled patients eventually, which is a key component of participant retention and trust.

Scientific engagement with Key Opinion Leaders (KOLs) and clinical investigators

Engagement with the scientific community, including KOLs and clinical investigators, is managed through rigorous data presentation and collaboration on trial design. Brainstorm Cell Therapeutics Inc. secured U.S. FDA clearance for the planned clinical study and is advancing activities with its network of clinical sites. The company's scientific findings were presented orally at the International Society for Cell & Gene Therapy (ISCT) 2025 Annual Meeting in May 2025, focusing on pharmacogenomic data related to the UNC13A genotype and its impact on clinical outcomes for ALS patients treated with NurOwn. This demonstrates active participation in the scientific discourse.

Investor relations and public updates on regulatory and financial status

Investor relationships are maintained through regular, though sometimes rescheduled, public updates on regulatory milestones and financial health. As of the third quarter ended September 30, 2025, the company reported cash, cash equivalents, and restricted cash of approximately $0.23 million. The net loss for that quarter was approximately $2.1 million, an improvement from the net loss of approximately $2.7 million in the third quarter of 2024. General and administrative expenses for Q3 2025 were approximately $1.1 million, down from approximately $2.0 million in Q3 2024. The company trades on the OTCQB under the ticker BCLI, with a recent quote showing a price of $0.61 USD. Brainstorm is planning to host a conference call and webcast for the investment community later in Q4 2025 or early Q1 2026 to provide further updates on the NurOwn Phase 3 program.

Here's the quick math on the recent financial stability impacting investor confidence:

Finance: draft 13-week cash view by Friday.

Brainstorm Cell Therapeutics Inc. (BCLI) - Canvas Business Model: Channels

You're mapping out how Brainstorm Cell Therapeutics Inc. gets its product, NurOwn, to the patient and how it interfaces with the market and regulators. This isn't about selling widgets off a shelf; it's a highly specialized, clinical-to-regulatory channel strategy.

Specialized Clinical Trial Sites

The primary channel for advancing NurOwn is through the execution of its clinical trials, which rely on a network of specialized centers. The current focus is the Phase 3b ENDURANCE study (ClinicalTrials.gov ID NCT06973629) for Amyotrophic Lateral Sclerosis (ALS).

• The ENDURANCE study is planned to enroll approximately 200 participants.
• This enrollment is taking place across leading academic medical centers.
• The trial has 15 locations in the United States as of May 2025.
• Specific sites include Barrow Neurological Institute in Phoenix, Arizona, and University of California San Diego Medical Center in La Jolla, California.
• The study's estimated start date was June 30, 2025.

This network of sites is the physical channel for drug delivery and data collection, which is critical for the next step in the commercialization path.

Contract Development and Manufacturing Organizations (CDMOs)

Brainstorm Cell Therapeutics Inc. uses external partners for the complex manufacturing of its autologous cell therapy. This outsourcing is a key channel for ensuring clinical supply readiness.

The company stated in August 2025 that it was engaged in ongoing discussions with these selected CDMO partners to ensure readiness for clinical drug supply. Honestly, managing these complex supply chains is a massive operational channel in itself.

Regulatory Pathway

The most crucial channel for Brainstorm Cell Therapeutics Inc. is the direct, formal interaction with the U.S. Food and Drug Administration (FDA). This channel dictates the entire timeline for potential market access.

• The Phase 3b trial design was established under a Special Protocol Assessment (SPA) agreement with the FDA.
• FDA clearance was secured to initiate the Phase 3b trial.
• Data from Part A of the ENDURANCE study is expected to support a future Biologics License Application (BLA) submission.
• A Citizen Petition was filed with the FDA by ALS community representatives, requesting a renewed regulatory review of existing NurOwn data.

The company reported approximately $0.23 million in cash, cash equivalents, and restricted cash as of September 30, 2025, which underscores the financial reality tied to navigating this regulatory channel successfully.

OTCQB Venture Market

For its common stock, the trading channel is the OTCQB Venture Market, following a delisting from NASDAQ. This is the channel for capital raising and investor liquidity.

Here's the quick math on the stock as of late 2025:

• Stock Symbol: BCLI.
• Trading Price as of Dec 04, 2025: $0.609.
• Day's Range on Dec 04, 2025: $0.600 to $0.630.
• 52-Week Range (as of early Dec 2025): Spans from a low of $0.521 to a high of $2.500.
• Market Capitalization as of Nov 29, 2025: $7.02M (though a figure of $12.91 MM was noted on Nov 24, 2025).

The company reported a net loss for the third quarter ended September 30, 2025, of approximately $2.1 million, which is the financial context for the capital raised through this market channel. Finance: draft 13-week cash view by Friday.

Brainstorm Cell Therapeutics Inc. (BCLI) - Canvas Business Model: Customer Segments

You're looking at the core group Brainstorm Cell Therapeutics Inc. (BCLI) is laser-focused on right now: patients in the very specific window of early-stage Amyotrophic Lateral Sclerosis (ALS) eligible for their pivotal Phase 3b trial, the ENDURANCE study. This isn't a broad market play yet; it's a precise clinical target.

The immediate, most critical customer segment is defined by the trial enrollment target. The upcoming Phase 3b ENDURANCE study is expected to enroll approximately 200 participants at leading ALS centers. These individuals must meet the criteria for early symptomatic ALS and moderate disease presentation. The success of this group directly dictates the next step: supporting a potential Biologics License Application (BLA) submission based on data from the initial 24-week, randomized, double-blind, placebo-controlled period.

To give you a sense of the broader patient pool they are addressing, consider the incidence rate: as of May 2025, the ALS Association noted that a person is diagnosed with this progressive neurodegenerative disease every 90 minutes. That scale underscores the urgency for the entire ALS community, which is a key secondary segment.

The company's operational capacity, which underpins its ability to manage these patient relationships and trials, is reflected in its recent financial standing. Here's the quick math on their late 2025 financial footing:

The next customer group involves the professionals and organizations that facilitate access and provide support to the patients. Brainstorm Cell Therapeutics Inc. is actively working with its network of clinical sites, which are described as leading ALS centers, to ensure operational readiness for the trial. This group is essential for patient recruitment and trial execution.

The engagement with the broader ALS ecosystem is also a defined segment, especially given the recent Citizen Petition filed with the FDA by community representatives requesting a renewed regulatory review of NurOwn's data. This shows a high level of vested interest from the community itself.

• Neurologists and clinicians specializing in neurodegenerative diseases.
• Leading academic medical centers for trial site activation.
• ALS patient advocacy groups and supporting organizations.
• The ALS community, which has actively petitioned for regulatory review.

Looking ahead, the business model anticipates expansion into adjacent, high-need patient populations. This future segment is currently less defined in terms of immediate trial numbers but represents significant long-term opportunity. The company is exploring potential applications of its cell therapy platform in these areas, which means these patients will become active customers if pipeline progression is successful.

• Patients with Progressive MS (PMS).
• Patients with Parkinson's disease.
• Patients with Alzheimer's Disease (AD).

If onboarding takes 14+ days, churn risk rises, even in a trial setting.

Finance: draft 13-week cash view by Friday.

Brainstorm Cell Therapeutics Inc. (BCLI) - Canvas Business Model: Cost Structure

The Cost Structure for Brainstorm Cell Therapeutics Inc. (BCLI) is heavily weighted toward the clinical development and regulatory pathway for its lead candidate, NurOwn. As a pre-revenue biotechnology company, operating expenses are the primary cost drivers, reflecting the intensive nature of late-stage cell therapy development.

The primary operating expenses for the third quarter ended September 30, 2025, are detailed below. You'll note the company achieved expense discipline year-over-year, narrowing its net loss to approximately $2.1 million for the quarter.

The R&D spend is directly tied to advancing the NurOwn program. This includes significant, though not explicitly itemized for Q3 2025, costs associated with the Phase 3b ENDURANCE trial.

Clinical Trial Costs are a major component of the R&D expenditure. The ENDURANCE study is a critical, high-cost activity:

• The trial is designed to enroll up to approximately 200 participants at leading ALS centers.
• It follows a two-part structure: a 24-week randomized, double-blind, placebo-controlled period (Part A), followed by a 24-week open-label extension (Part B).
• The trial protocol is being executed under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).

Manufacturing and Technology Transfer Costs are being managed through external partnerships. Brainstorm Cell Therapeutics Inc. signed a Letter of Intent (LOI) with Minaris Advanced Therapies, a global contract development and manufacturing organization (CDMO), specifically to manufacture NurOwn for this Phase 3b trial. While the specific Q3 2025 charge for this partnership isn't itemized separately from R&D, cash used in operating activities for the six months ended June 30, 2025, was $5,133,000, which was primarily attributed to costs including clinical trials, rent of clean room, and materials for clinical trials.

Legal and Regulatory Costs are ongoing as the company prepares for a potential Biologics License Application (BLA) submission based on Part A data. The company has been engaging with regulatory authorities, including following up on a Citizen Petition filed by the ALS community requesting a renewed review of NurOwn data. For context on legal spend, the SEC filing for the period ended June 30, 2025, noted that cash used for operating activities included outside legal fee expenses.

• The company reached alignment with the FDA on Chemistry, Manufacturing, and Controls (CMC) aspects of the Phase 3b trial in June 2024.
• The trial's primary efficacy measure is the change from baseline to Week 24 on the ALSFRS-R scale.

Brainstorm Cell Therapeutics Inc. (BCLI) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Brainstorm Cell Therapeutics Inc. as of late 2025. For a pre-revenue biotech, the current picture is stark, but the potential future streams are what drive the valuation. Honestly, the focus right now is entirely on clinical execution to unlock the first real revenue source.

Current Financial State and Pre-Revenue Status

As of the first quarter of 2025, Brainstorm Cell Therapeutics Inc. reported $0 in revenue. This is typical for a company deep in clinical development, as the primary focus is on generating the confirmatory data needed for regulatory submission, not sales. For the quarter ended March 31, 2025, the company reported a net loss of approximately $2.9 million. This loss reflects the ongoing Research and Development expenditures necessary to advance the NurOwn program.

Here's a quick look at the Q1 2025 financial context:

Future Product Sales

The primary, most significant revenue stream hinges on the successful commercialization of NurOwn for Amyotrophic Lateral Sclerosis (ALS). This requires clearing the Phase 3b ENDURANCE study, which is designed to enroll approximately 200 participants. The successful completion of the double-blind portion (Part A) is targeted to generate the clinical data necessary to support a Biologics License Application (BLA) submission. Direct sales revenue would commence only upon potential FDA approval for NurOwn.

Licensing/Partnership Revenue

Beyond the lead candidate, Brainstorm Cell Therapeutics Inc. has a secondary, high-potential revenue avenue in its proprietary, allogeneic exosome-based platform. This technology is being advanced to deliver therapeutic proteins and nucleic acids. Securing a foundational patent covering this technology strengthens the IP portfolio, making potential out-licensing deals more attractive. Strategic collaborations and expanded IP filings are currently in progress to build value in this platform.

Non-Dilutive Funding

To bridge the gap until potential product sales, the company actively pursues non-dilutive funding sources. You should note the pursuit of grants, which do not require giving up equity. Specifically, there is mention of a promising $15 million grant under review, which is critical for supporting operations and trial initiation. The company has a history of such support, including a $16 million grant from the California Institute for Regenerative Medicine (CIRM) awarded in 2017 to support a Phase 3 trial.

• Pursuit of a promising $15 million non-dilutive grant.
• Historical CIRM grant for Phase 3 support: $16 million (awarded 2017).
• Past support from Israel's OCS, including approximately $4.1 million cumulatively through 2014.

Equity Financing

Since operational funding is essential for clinical progression, capital raised through equity markets is a current, though dilutive, source of cash flow. In the period leading up to the first quarter of 2025, Brainstorm Cell Therapeutics Inc. secured capital through at-the-market offerings and warrant exercises. This financing activity contributed a total of $3.086 million to the company's cash position. This type of funding is a necessary mechanism to sustain operations while awaiting value inflection points from clinical milestones.

Finance: draft 13-week cash view by Friday.