BrainStorm CEO issues letter to shareholders

Chaim Lebovits, President and CEO of BrainStorm Cell Therapeutics, issued the following letter to shareholders. “We remain steadfast in our commitment to advancing NurOwn as a promising treatment for ALS patients. Recognizing the challenges faced in our recent BLA submission, we are ambitiously pursuing a Phase 3b trial, aligning with our dedication to the ALS community and our goal of making NurOwn commercially available. Despite the setbacks with the ADCOM’s unfavorable vote, our focus remains to align with the FDA on a phase 3b trial design, as we acknowledge that this represents the most expedient pathway to approval. We are exploring various strategies to secure the necessary funding. We intend to seek a Special Protocol Assessment, which, when agreed with the FDA, could significantly de-risk the regulatory aspects of the NurOwn program. We are very encouraged by the FDA’s ongoing engagement, including the opportunity provided by the expedited in-person Type A meeting on December 6, a rare occurrence in today’s regulatory environment. We appreciate the Agency’s feedback, comments and other regulatory accommodations, signaling its recognition for the unmet need in ALS and its willingness to reach alignment with Brainstorm on our new clinical strategy. Our team is diligently preparing to submit a clinical protocol, and Statistical Analysis Plan, for the FDA’s review. Following alignment with the FDA’s expectations, we will formally submit our SPA request. We anticipate making this submission in February 2024. The FDA’s response is expected within 45 days of submission. We believe that agreement on an SPA would open a broad spectrum of financing options for the trial. Concurrently, we are committed to maintaining our NASDAQ listing status. Our strategy focuses on enhancing the value of our assets, thereby garnering market support that is crucial for our stock price to reach its requisite level by April. We prefer this approach over a reverse stock split, as it aligns more closely with our long-term goals and shareholder interests. We thank you for your continued support. Your faith in our mission fuels our determination to overcome the recent challenges and ultimately deliver groundbreaking treatments that will help patients in need and create value for our stakeholders.”