Brainstorm Cell Therapeutics (BCLI) Status Update summary

2024 achievements and operational progress

• Secured a special protocol assessment (SPA) with the FDA for the planned phase 3B trial in ALS, ensuring regulatory alignment and de-risking the clinical program.

• Achieved FDA alignment on the CMC plan, establishing a robust, high-quality manufacturing process for NurOwn.

• Strengthened manufacturing capabilities through partnerships with Pluri and Ichilov Medical Center, and are onboarding a U.S.-based manufacturing center for scalability.

• Biomarker data showed NurOwn reduced neurofilament light levels, indicating a positive impact on neurodegeneration in ALS.

• Leadership team enhanced with new COO and CMO, bringing expertise in cell therapy and clinical development.

Financial and funding update

• Raised approximately $8 million in a challenging biotech financing environment.

• Actively pursuing non-dilutive grants and strategic partnerships to support ongoing operations and the phase 3B trial.

• CRO and vendors have supported technical and operational readiness despite funding constraints.

Clinical and regulatory strategy

• Phase 3B trial for NurOwn in early-stage ALS patients is on track to initiate in Q1 2025, with no delay due to financing.

• Trial preparation includes updating IND modules, site activation, and regulatory submissions, progressing well.

• Regulatory strategy centers on close FDA collaboration, proactive communication, and compliance with SPA agreement.

• Engaging top-tier CROs and medical centers to ensure trial quality and compliance.