Brainstorm Cell Therapeutics Inc.

Brainstorm Cell Therapeutics Inc. is a biotechnology company focused on developing and selling personalized cell therapies for neurodegenerative diseases. The company's main product is NurOwn®, a cell therapy platform that uses a patient's own bone marrow-derived mesenchymal stem cells. These cells are processed to produce high levels of neurotrophic factors, which are intended to influence neuroinflammatory and neurodegenerative disease processes, support the survival of nerve cells, and improve neurological function. NurOwn® is being developed for conditions such as amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), progressive multiple sclerosis (PMS), and Alzheimer's disease (AD). The company has completed Phase 3 clinical trials for ALS and Phase 2 clinical trials for PMS. Top-line data from the Phase 3 ALS trial was announced on November 17, 2020, and positive top-line data from the Phase 2 PMS trial, which involved three intrathecal administrations of NurOwn® given 2 months apart, was announced on March 24, 2021. A new clinical program for NurOwn® as a treatment for AD was announced on June 24, 2020. On August 15, 2022, the company decided to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for NurOwn® for ALS, which was filed on September 9, 2022. On November 10, 2022, the FDA issued a refusal to file (RTF) letter regarding the BLA. The company submitted a Type A meeting request with the FDA on December 12, 2022, which was granted on December 27, 2022, to discuss the RTF letter. This Type A Meeting was held on January 11, 2023.