BrainStorm Cell Therapeutics Inc. announced a strategic realignment to enable accelerated development of NurOwn®? for the treatment of amyotrophic lateral sclerosis (ALS). This realignment is designed to 1) support the company plans to conduct a double-blind, placebo-controlled Phase 3b U.S. clinical trial for NurOwn in ALS with an open-label extension and 2) continue to publish data from NurOwn's Phase 3 clinical trial on: biomarkers, long-term safety and survival, and the Expanded Access Program, providing transparency around NurOwn data and progressing ALS drug development.

In preparation for the trial design and subsequent meeting with FDA, BrainStorm is consulting with the NurOwn Principal Investigators, who are most familiar with NurOwn, an additional panel of independent ALS experts, and a patient advisory group. To fund the Phase 3b study and ALS priorities, BrainStorm is actively exploring various options to raise capital including non-dilutive grants and capitalizing on its exosome technology. At the same time, the company will reduce and refocus resources by streamlining clean room operations and undertaking a targeted reduction in headcount of approximately 30%.

Positions most critical to the implementation of the Phase 3b trial and regulatory submission and review will be retained. The strategic realignment will cut total resource consumption by approximately half.