Brainstorm Cell Therapeutics I Stock Price, News & Analysis

BrainStorm Cell Therapeutics Inc. (BCLI) is a biotechnology company focused on developing autologous adult stem cell therapies for debilitating neurodegenerative diseases. According to company disclosures and recent press releases, BrainStorm’s work centers on its proprietary NurOwn® technology platform, which uses a patient’s own mesenchymal stem cells (MSCs) to generate neurotrophic factor-secreting cells (MSC‑NTF cells). These cells are designed to deliver targeted biological signals that modulate neuroinflammation and promote neuroprotection in disorders such as amyotrophic lateral sclerosis (ALS) and progressive multiple sclerosis (MS).

BrainStorm’s common stock trades under the symbol BCLI. A Form 25 filed by The Nasdaq Stock Market LLC on October 9, 2025, documents the removal of BrainStorm Cell Therapeutics Inc. from listing on Nasdaq. Subsequent company communications state that the shares are quoted on the OTCQB Venture Market, and an 8‑K dated November 14, 2025, and another dated January 9, 2026, list BCLI as trading on the OTCQB.

NurOwn® platform and core therapeutic focus

The company describes NurOwn® (autologous MSC‑NTF cells) as an investigational therapeutic approach that targets disease pathways important in neurodegenerative disorders. MSC‑NTF cells are produced from autologous, bone marrow‑derived MSCs that are expanded and differentiated ex vivo under patented conditions. These conditions induce the cells to secrete high levels of neurotrophic factors (NTFs) and immunomodulatory cytokines. BrainStorm states that these autologous MSC‑NTF cells are designed to deliver multiple NTFs and immunomodulatory cytokines directly to sites of damage, with the goal of eliciting a desired biological effect and ultimately slowing or stabilizing disease progression.

According to multiple company press releases, NurOwn® is BrainStorm’s lead investigational therapy for ALS. The company reports that NurOwn has received Orphan Drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for ALS. BrainStorm has completed a Phase 3 trial in ALS (ClinicalTrials.gov ID NCT03280056) and is preparing a Phase 3b trial, referred to as the ENDURANCE study, under a Special Protocol Assessment (SPA) agreement with the FDA.

Clinical development in ALS

BrainStorm’s disclosures describe a multi‑stage clinical program in ALS:

• A completed Phase 3 ALS trial (NCT03280056), which generated clinical and biomarker data.
• Plans for a Phase 3b ENDURANCE trial, designed in collaboration with the FDA under an SPA and intended to enroll approximately 200 participants with early‑stage ALS. Company press releases explain that the trial includes a 24‑week randomized, double‑blind, placebo‑controlled period followed by a 24‑week open‑label extension in which all participants receive NurOwn. The primary efficacy endpoint is the change from baseline to week 24 on the ALS Functional Rating Scale‑Revised (ALSFRS‑R). BrainStorm states that successful completion of the double‑blind portion (Part A) is expected to generate data to support a potential Biologics License Application (BLA).
• An Expanded Access Program (EAP) for ALS participants who previously completed the Phase 3 trial. In a June 16, 2025 press release, BrainStorm reports survival data from 10 EAP participants, noting that 9 of 10 survived more than five years from ALS symptom onset, with a median survival of 6.8 years. The company contrasts this with published estimates indicating that approximately 10% of individuals with ALS survive beyond five years, and states that the probability of observing such extended survival purely by chance is extremely low.

BrainStorm also highlights additional analyses from its ALS program, including pharmacogenomic response associated with the UNC13A genotype, biomarker data collected at seven longitudinal time points, and a comprehensive analysis of the so‑called “Floor Effect” in advanced ALS, which it describes as a critical challenge in measuring clinical outcomes. The company notes that these findings have been presented at scientific meetings and published in peer‑reviewed journals.

Additional indications and research platforms

Beyond ALS, BrainStorm reports that it has completed a Phase 2 open‑label multicenter trial (NCT03799718) of MSC‑NTF cells in progressive multiple sclerosis (MS), supported by a grant from the National MS Society. The company also states that it is advancing a proprietary, allogeneic exosome‑based platform designed to deliver therapeutic proteins and nucleic acids. According to company press releases, BrainStorm has received a Notice of Allowance from the U.S. Patent and Trademark Office for a foundational patent covering this exosome technology, which it describes as strengthening its intellectual property portfolio in regenerative medicine.

Regulatory and community engagement

BrainStorm’s communications emphasize ongoing engagement with regulatory authorities and the ALS community. The company reports:

• FDA clearance to initiate the Phase 3b NurOwn trial in ALS, with the trial design agreed under an SPA.
• Submission of an Investigational New Drug (IND) amendment for NurOwn to the FDA, described as an important step toward initiating the Phase 3b study.
• Recognition of a Citizen Petition submitted by representatives of the ALS community, requesting renewed regulatory review of NurOwn data. BrainStorm states that it did not participate in drafting or submitting the petition but views the FDA’s consideration of the petition as an opportunity for a fresh evaluation of the evidence.

Company press releases also note participation by BrainStorm’s leadership and scientific team in professional meetings, including presentations at the International Society for Cell & Gene Therapy (ISCT) Annual Meeting and the ALS Drug Development Summit, where the company has discussed pharmacogenomic findings and cerebrospinal fluid biomarker pathways associated with NurOwn treatment.

Manufacturing and partnerships

To support its clinical programs, BrainStorm describes several manufacturing‑related arrangements. In May 2025, the company announced a Letter of Intent (LOI) with Minaris Advanced Therapies, a contract development and manufacturing organization specializing in cell and gene therapies, to manufacture NurOwn for an upcoming clinical trial at a facility in Allendale, New Jersey. BrainStorm states that this collaboration is intended to initiate technology transfer of NurOwn and enhance U.S.‑based manufacturing capabilities for its planned multicenter Phase 3b ALS trial.

The company also references a collaboration with Pluri Inc. in Israel to contribute to the production of clinical trial material, describing these relationships as part of a broader effort to build a flexible manufacturing network for NurOwn.

Capital structure, financing, and listing status

BrainStorm’s SEC filings provide insight into its capital structure and financing activities. An 8‑K filed June 25, 2025, notes that stockholders approved amendments to the company’s 2014 Stock Incentive Plan and 2014 Global Share Option Plan, increasing the shared pool of common shares available for issuance under these plans. Subsequent 8‑K filings dated November 6, 2025, November 14, 2025, and January 9, 2026, describe multiple promissory notes and convertible promissory notes issued to institutional investors, including Vanquish Funding Group Inc., Labrys Fund II, L.P., Quick Capital, LLC, and Auctus Fund, LLC. These notes include original issue discounts, specified maturity dates, scheduled amortization payments, and conversion features that may allow holders to convert outstanding amounts into shares of common stock upon certain events, subject to beneficial ownership limitations and other terms.

The Form 25 dated October 9, 2025, filed by Nasdaq Stock Market LLC, confirms the removal of BrainStorm Cell Therapeutics Inc.’s common stock from listing and registration on Nasdaq. In a July 17, 2025 press release, the company states that the delisting resulted from non‑compliance with Nasdaq Listing Rule 5550(b)(1) regarding minimum shareholder equity, and that BrainStorm obtained approval for its common stock to be quoted on the OTCQB Venture Market under the same symbol, BCLI.

Business model context

Based on the company’s own descriptions, BrainStorm’s activities are concentrated in clinical‑stage development of cell‑based therapeutics for neurodegenerative diseases. Its primary assets are its NurOwn autologous MSC‑NTF platform, associated clinical data and regulatory designations in ALS, its early‑stage work in progressive MS, and its allogeneic exosome‑based technology platform. Revenue‑generating commercial products are not described in the provided materials; instead, disclosures focus on clinical trials, regulatory interactions, intellectual property, and financing transactions.

Key points for BCLI stock research

• Sector and industry: BrainStorm is classified in Biological Product (except Diagnostic) Manufacturing within the broader manufacturing/biotechnology space.
• Lead program: NurOwn autologous MSC‑NTF cells for ALS, with Orphan Drug designations from FDA and EMA, a completed Phase 3 trial, and a planned Phase 3b trial under an SPA.
• Additional programs: Phase 2 open‑label multicenter trial completed in progressive MS; development of an allogeneic exosome‑based platform for delivery of therapeutic proteins and nucleic acids.
• Listing status: Common stock delisted from Nasdaq via Form 25 on October 9, 2025; company reports quotation on the OTCQB Venture Market under symbol BCLI.
• Financing: Use of promissory and convertible promissory notes with institutional investors, and equity incentive plans as described in SEC filings.

Frequently asked questions (FAQ)

What does BrainStorm Cell Therapeutics Inc. do?
According to its press releases, BrainStorm Cell Therapeutics Inc. develops autologous adult stem cell therapies for debilitating neurodegenerative diseases. Its proprietary NurOwn platform uses a patient’s own mesenchymal stem cells to produce neurotrophic factor‑secreting cells designed to modulate neuroinflammation and promote neuroprotection.

What is NurOwn® and how is it described?
NurOwn is BrainStorm’s lead investigational therapy, based on autologous MSC‑NTF cells produced from bone marrow‑derived mesenchymal stem cells. The company states that these cells are grown under patented conditions to secrete high levels of neurotrophic factors and immunomodulatory cytokines, with the intent to deliver these factors directly to sites of damage in neurodegenerative diseases such as ALS.

Which diseases is BrainStorm targeting with NurOwn?
Company communications identify amyotrophic lateral sclerosis (ALS) as the lead indication for NurOwn, with Orphan Drug designation from both the FDA and EMA. BrainStorm also reports a completed Phase 2 open‑label multicenter trial of MSC‑NTF cells in progressive multiple sclerosis (MS).

What stage is BrainStorm’s ALS program in?
BrainStorm reports that it has completed a Phase 3 trial in ALS (NCT03280056) and is preparing a Phase 3b trial, referred to as ENDURANCE, under a Special Protocol Assessment agreement with the FDA. The company states that the Phase 3b trial is designed to enroll approximately 200 participants with early‑stage ALS and to generate confirmatory data to support a potential BLA submission.

Has NurOwn received any regulatory designations?
Yes. The company states that NurOwn has received Orphan Drug designation for ALS from the U.S. Food and Drug Administration and the European Medicines Agency.

What is known about BrainStorm’s listing status?
A Form 25 filed on October 9, 2025, documents the removal of BrainStorm Cell Therapeutics Inc.’s common stock from listing and registration on Nasdaq. Subsequent press releases and 8‑K filings describe BCLI as trading on the OTCQB Venture Market.

Does BrainStorm describe any exosome‑based programs?
Yes. BrainStorm reports that it is advancing a proprietary, allogeneic exosome‑based platform designed to deliver therapeutic proteins and nucleic acids. The company states that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a foundational patent covering this exosome technology.

What partnerships support BrainStorm’s manufacturing plans?
In May 2025, BrainStorm announced a Letter of Intent with Minaris Advanced Therapies to manufacture NurOwn for an upcoming clinical trial, including technology transfer to a Minaris facility in Allendale, New Jersey. The company also references a collaboration with Pluri Inc. in Israel for production of clinical trial material.

How does BrainStorm describe its ALS Expanded Access Program results?
In a June 16, 2025 press release, BrainStorm reports that 9 of 10 ALS participants in its Expanded Access Program survived more than five years from symptom onset, with a median survival of 6.8 years. The company notes that this survival pattern differs from published estimates in ALS and states that the probability of observing such outcomes by chance alone is extremely low.

Where is BrainStorm headquartered?
SEC filings list BrainStorm Cell Therapeutics Inc.’s principal executive offices in New York, New York. Specific street addresses are provided in those filings but are not necessary for understanding the company’s business.

How does BrainStorm fund its operations?
Based on recent 8‑K filings, BrainStorm has entered into several promissory note and convertible promissory note arrangements with institutional investors and has expanded the share pool available under its 2014 equity incentive plans. These filings describe terms such as original issue discounts, maturity dates, amortization schedules, and conversion features into common stock upon certain events.