Brainstorm Cell Therapeutics Inc., a company focused on developing cell therapies for neurodegenerative disorders, provided an update on its mid-year corporate status, particularly concerning its NurOwn program. The key points highlighted in the update include:
-
Phase 3b Trial Initiation: The company is prioritizing the initiation of a Phase 3b trial for the treatment of Amyotrophic Lateral Sclerosis (ALS). A constructive face-to-face Type C meeting with the FDA was held on June 24, addressing chemistry, manufacturing, and controls aspects of the trial. The company reports alignment with the FDA on resolving previous concerns and appreciates the agency's input and advice.
-
Clinical Trial Support: A leading Clinical Research Organization (CRO) has been contracted to support the initiation and execution of the Phase 3b trial. This CRO specializes in ALS and cell therapy trials, offering comprehensive services to ensure high-quality and timely execution.
-
Financing: The company recently completed a transaction with a single institutional investor, raising $4 million in gross proceeds. This funding is intended to support near-term milestones but acknowledges the need for additional funding to cover the entire Phase 2b study.
-
Operational Leadership: Dr. Haro Hartounian has been appointed as the Chief Operating Officer, bringing extensive experience in cell and gene therapy product development and operations. He will oversee operational aspects, including chemistry, manufacturing, and commercialization.
-
Strategic Planning: The company continues to explore various financing options, including non-dilutive grants, aiming to secure adequate resources for its ongoing and future trials.
-
Phase 3b Trial Timeline: The Phase 3b trial for NurOwn is expected to begin within the next few months, following the alignment with the FDA and the establishment of a strong foundation for the trial design and efficacy endpoints.
-
Market Impact: Despite the recent fundraising, the company notes that the current market valuation may not fully reflect the potential of a Phase 3b ready company. Strategic actions are being taken to address this discrepancy.
In summary, Brainstorm Cell Therapeutics is progressing with the critical preparations for its Phase 3b trial for ALS, with a focus on securing appropriate funding and leveraging experienced leadership to advance the NurOwn program towards potential approval and commercialization.
