On August 14, 2025, BrainStorm Cell Therapeutics, Inc. (BCLI) announced financial results for the second quarter of 2025 and provided a business update. The company continues to be focused on initiating the Phase 3b ENDURANCE trial of NurOwn for the treatment of amyotrophic lateral sclerosis (ALS). Following the filing of the Citizen's Petition in July 2025, we await a decision from the FDA regarding that petition and whether the agency will invite BrainStorm to resubmit the Biologics License Application (BLA) for NurOwn in ALS. In the meantime, BrainStorm is continuing to evaluate its funding options. A financing was delayed in July 2025 following the filing of the Citizen's Petition, which also affected the ability of the company to be eligible for the non-dilutive funding it had applied for, which required a committed secondary funding source. Thus, the company appears to be in a holding pattern until any action is taken regarding the Citizen's Petition, however key operational activities are continuing, including discussions with clinical sites along with ongoing engagement with the CDMO partners.
