Why Did BrainStorm Cell Therapeutics Inc (BCLI) Plunge 11.03% Despite FDA Milestone?

On May 20, 2025, BrainStorm Cell Therapeutics Inc (BCLI) experienced a significant drop of 11.03% in pre-market trading, reflecting investor sentiment and market dynamics.

BrainStorm Cell Therapeutics Inc (BCLI) recently received clearance from the U.S. FDA to initiate a pivotal Phase 3b trial for NurOwn, a significant milestone in their ALS treatment development. The trial design, agreed upon under a special protocol assessment (SPA), de-risks the regulatory pathway for NurOwn. The company has secured a leading U.S. clinical site that has passed FDA inspection, enhancing operational readiness for the upcoming trial. Additionally, BrainStorm is actively engaged in negotiations with approximately 15 leading clinical centers across the United States, indicating strong interest from the ALS research community.

Despite these advancements, BrainStorm faces significant financial constraints, which are common in the biotech industry. Securing proper funding is essential to commence the trial, and the company is pursuing multiple funding avenues, including a promising $15 million non-dilutive grant. The initiation and successful execution of the clinical trial demand a robust and sustainable cash flow, which is currently a challenge for BrainStorm. The company has not yet signed clinical trial agreements (CTAs) with the clinical centers, which could delay the trial's start. Furthermore, the manufacturing capacity at the Tel Aviv facility is limited, and the company is still in the process of expanding its manufacturing footprint to the United States. The exosome program, while promising, is still in the preclinical stage and requires strategic partnerships to advance towards clinical development.