Brainstorm Cell Therapeutics Inc.

Brainstorm Cell Therapeutics Inc. is a U.S.-based biotechnology company focused on developing autologous cell therapies for neurodegenerative diseases. Its core platform, NurOwn®, uses patients’ own bone marrow-derived mesenchymal stem cells that are induced to secrete neurotrophic factors intended to modulate neuroinflammation and support neuronal survival. The company’s most advanced program is a Phase 3b trial in ALS, and it also has research efforts in progressive multiple sclerosis, Alzheimer’s disease, and exosome-based technologies. Brainstorm is still in the development stage and has not generated operating revenue, so its business is centered on clinical development, regulatory progress, manufacturing readiness, and intellectual property protection.

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— Brainstorm Cell Therapeutics Inc.
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Autologous cell therapy platform70% Patient-derived MSC-NTF cell therapy designed to treat neurodegenerative disease.
Clinical development programs20% Late-stage clinical trials and regulatory work for ALS and other indications.
Exosome-based therapeutics5% Preclinical and patent-protected exosome technologies derived from the core platform.
Manufacturing and supply capabilities5% Centralized GMP production and distribution of NurOwn® for trials and potential commercialization.

Brainstorm does not sell a commercial product today; its current 'customers' are primarily clinical trial participants,...

  • ALS clinical trial participantsprimary

    Patients with ALS enrolled in Phase 3b studies who receive NurOwn® to evaluate safety and efficacy.

  • Clinical investigators and trial sitesprimary

    Hospitals and research centers in the U.S. that run the late-stage trials and administer the therapy.

  • Regulatory agenciesprimary

    FDA and other regulators that review trial design, CMC controls, and potential approval pathways.

  • Future commercial neurology providerssecondary

    Specialty physicians and treatment centers that would use NurOwn® if it reaches market approval.

  • Potential partners and licensorssecondary

    Organizations that may fund, license, or co-develop the platform and exosome technologies.

Brainstorm is incorporated in Delaware and has its principal executive offices in New York, with additional operations...

  • •Headquartered in New York, United States
  • •R&D center in Petach Tikva, Israel
  • •GMP manufacturing center in Tel Aviv, Israel
  • •Late-stage ALS and PMS trial sites are all in the United States
  • •Patent coverage across the U.S., Europe, Israel, Australia, and other markets
  • •Manufacturing footprint supports potential EU and Israeli supply

Brainstorm’s strategy is to advance NurOwn® through late-stage clinical development and regulatory engagement, with the...

01
Complete and de-risk the Phase 3b ALS programshort-term

Clinical success is the main path to value creation and future commercialization.

02
Strengthen manufacturing and CMC readinessshort-term

Cell therapies require reliable, scalable, and stable production to support trials and eventual launch.

03
Expand and defend intellectual propertymedium-term

Patent protection is essential for exclusivity in a platform-based biotech business.

04
Broaden the platform into additional neurodegenerative and exosome applicationslong-term

A broader pipeline can reduce dependence on a single indication and increase long-term optionality.

Brainstorm faces the classic risks of a development-stage biotech company: clinical failure, regulatory delays, and...

critical

Clinical development failure

NurOwn® is still in late-stage testing, so efficacy or safety shortfalls could prevent approval and commercialization.

Scope
Phase 3b ALS program
Materiality
high
high

Capital and liquidity constraints

The company has no operating revenue and has relied on short-term borrowing and equity markets to fund operations.

Scope
Working capital and R&D funding
Materiality
high
high

Regulatory and CMC execution risk

Cell therapy approval depends on manufacturing controls, comparability, and FDA alignment on trial design.

Scope
Phase 3b trial and future BLA pathway
Materiality
high
high

Nasdaq delisting and market access

OTCQB trading can reduce liquidity, investor demand, and the company’s ability to raise capital efficiently.

Scope
Public market financing
Materiality
high
medium

Intellectual property dependence

Commercial rights depend on patents and a licensing agreement with Ramot for NurOwn® technology.

Scope
Core platform and exosome portfolio
Materiality
medium
medium

Internal control weakness

A reported material weakness in internal controls increases the risk of financial reporting errors.

Scope
Financial reporting and compliance
Materiality
medium
Stock-based compensation valuation
Affects operating loss and earnings per share
R&D expense recognition
Affects comparability of operating results
Internal control weakness
Affects reliability of reported numbers
Liquidity and debt classification
Affects solvency and financing assessment

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: 11/08/2026