BrainStorm Cell Therapeutics Inc. — Cyborg Score 4/10

Mixed
Biotechnology - Cell & Gene Therapy, Neurodegenerative Diseases

Strategic Profile

The company received FDA clearance for a Phase 3b trial (ENDURANCE) designed to support a potential BLA submission, planning to enroll approximately 200 participants. In February 2026, BrainStorm raised $2 million in strategic private placements to advance its regulatory and clinical objectives.

Cyborg Score Rationale

The company delisted from Nasdaq in July 2025 due to non-compliance with equity requirements and transitioned to OTCQB. Cash position was critically low at $0.23 million as of Q3 2025. However, recent funding raises and FDA-cleared Phase 3b trial provide near-term catalysts.

Top Insights

  • Expanded Access Program showed 100% of participants surviving beyond 5 years from ALS symptom onset with median survival of 6.8 years, providing compelling efficacy signals.
  • Delisted from Nasdaq to OTCQB in July 2025 due to shareholder equity requirements non-compliance.
  • Completed Phase 2 open-label trial in progressive multiple sclerosis supported by National MS Society grant.
  • Developing proprietary allogeneic exosome platform with foundational patent allowance from USPTO for emerging IP portfolio.

Named Competitors

  • Autologous Stem Cell Therapies — Cell therapy competitors in neurodegenerative space
  • ALS Therapeutics Pipeline — Traditional small molecule and biologic ALS treatments

Recent Developments

  • (February 2026) Secured $2 million in strategic private placements at $0.60 per share with 120% warrant coverage
  • (November 2025) FDA cleared Phase 3b ENDURANCE trial for NurOwn in ALS; ALS community filed Citizen Petition for regulatory re-evaluation
  • (July 2025) Delisted from Nasdaq Capital Market, transitioned to OTCQB due to shareholder equity non-compliance

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