On December 30, 2024, BrainStorm Cell Therapeutics, Inc. (BCLI) held a conference call to provide a corporate update. The company remains on track to conduct a Phase 3b trial of NurOwn in patients with amyotrophic lateral sclerosis (ALS) to support a potential Biologics License Application (BLA) filing. During 2024, BrainStorm reached agreement with the FDA on a Special Protocol Assessment (SPA) and the CMC aspects of the upcoming trial, which significantly de-risks the regulatory aspects of the program. In addition, the company entered a Memorandum of Understanding with Pluri, Inc. for the clinical manufacturing of NurOwn, which should enable an expedited startup for the Phase 3b trial. The company is continuing to pursue various avenues for funding the trial, and we continue to anticipate the first patient will be enrolled during the first quarter of 2025.
