Company Overview - Brainstorm Cell Therapeutics Inc.

What the company does:
Brainstorm Cell Therapeutics Inc. is a biotechnology company focused on developing and commercializing autologous cellular therapies for neurodegenerative diseases. Their main platform technology is NurOwn®, which utilizes a proprietary manufacturing process to turn the patient’s own bone marrow-derived mesenchymal stem cells (MSCs) into cells that secrete neurotrophic factors (NTFs). These NTFs aim to modulate neuroinflammation, promote neuronal survival, and improve neurological functions in diseases such as ALS, progressive multiple sclerosis (PMS), Alzheimer’s disease (AD), and other neurodegenerative conditions.

Key aspects of their technology and operations:

• NurOwn® platform: Induces autologous MSCs to produce high levels of neurotrophic factors including GDNF, BDNF, VEGF, HGF, and Galectin-1.
• Manufacturing process: Involves harvesting bone marrow, processing, cryopreserving MSCs, differentiating them into MSC-NTF cells, and administering via intrathecal lumbar puncture.
• Mechanism of Action: Provides neuroprotection, promotes neuronal repair, reduces neuroinflammation, and supports neuronal survival.
• Clinical Trials:
  • Completed Phase 3 ALS trial (top-line data announced November 17, 2020, indicating the therapy was generally well tolerated but did not demonstrate statistically significant efficacy for the primary endpoints).
  • Ongoing or planned clinical development includes additional trials such as a Phase 3b protocol, and expanded access programs.
  • Also conducted Phase 2 trials for PMS and a new program for AD.

Intellectual Property and Regulatory Status:

• Holds approximately 30 granted patents and multiple pending applications globally, including in the US, Europe, Japan, Canada, and Israel.
• Received Fast Track designation and Orphan Drug status from the FDA and EMA for ALS.
• Their proprietary therapeutic product NurOwn® has been designated an Advanced Therapy Medicinal Product (ATMP) by the EMA.

Business Operations:

• Employs 29 employees in the US and Israel (most senior management based in the US).
• Has a GMP manufacturing center in Tel Aviv at Sourasky Medical Center.
• Has strategic manufacturing partnerships, including with Catalent and Pluri Inc. for production capabilities.

Financials & Market Data:

• As of March 27, 2025, 6,522,350 shares of common stock are outstanding.
• The approximate market value of non-affiliate held common equity as of June 30, 2024, was $25,547,414.
• Health care costs for ALS are estimated at $100,000-$200,000 annually per patient, with an estimated 450,000 patients worldwide.
• The company has no operational revenues from product sales (development stage).
• The company has a history of losses, with ongoing expenses related to R&D and clinical trials.

Summary:
Brainstorm Cell Therapeutics develops autologous stem cell therapies for neurodegenerative diseases, leveraging its NurOwn® platform to induce MSCs to secrete therapeutic neurotrophic factors. Its focus is on gaining regulatory approval for ALS, with ongoing clinical trials and strategic partnerships to enhance manufacturing and clinical development. The company employs 29 people, has no current revenues, and is valued at over $25 million based on non-affiliate market valuation as of mid-2024.