Brainstorm Cell Therapeutics Q4 2024: Unpacking Contradictions in Trial Timelines, Funding Strategies, and Manufacturing Readiness

These are the key contradictions discussed in Brainstorm Cell Therapeutics' latest 2024 Q4 earnings call, specifically including: Phase 3b trial timeline and funding, and manufacturing capabilities and alignment with the FDA:



Phase 3b Trial and NurOwn Treatment:
- BrainStorm Cell Therapeutics is preparing for the initiation of its Phase 3b trial for NurOwn, an investigational treatment for ALS.
- The trial aims to confirm NurOwn's potential to slow disease progression in early-stage patients, generating robust data for a successful BLA.
- The company is focused on regulatory compliance, clinical trial agreements, and manufacturing arrangements to support the trial.

Financial Position and Funding Strategy:
- The company reported a net loss of approximately $11.6 million for the 12 months ended December 31, 2024, compared to $17.2 million in 2023.
- BrainStorm is actively pursuing multiple funding avenues, including warrant inducement agreements and non-dilutive financing opportunities, to secure necessary funds for the trial.
- Approximately $20 million to $30 million annually is anticipated for trial execution.

Regulatory and Clinical Progress:
- BrainStorm has secured a special protocol assessment from the FDA, derisking the regulatory pathway for NurOwn.
- The company is negotiating clinical trial agreements with approximately 15 leading clinical centers across the US, emphasizing strong interest from ALS experts.
- Collaborations with IQVIA and Pluri Inc. are in place to support clinical research and manufacturing needs.

Manufacturing and Supply Chain:
- BrainStorm has established a robust manufacturing strategy for Phase 3b trial support, including partnerships with Pluri Inc. and a leased facility in Tel Aviv.
- Plans are in place to bring an additional US-based manufacturing center online to meet broader production needs and facilitate future commercialization.
- The goal is to ensure a consistent and reliable supply of NurOwn for clinical trials and beyond.