BrainStorm Advances with Phase 3b Trial of NurOwn® in ALS and Secures New Patent for Exosome Technology

On December 3, 2024, BrainStorm Cell Therapeutics announced a significant milestone with the U.S. Patent and Trademark Office (USPTO) issuing a Notice of Allowance for its patent application covering the company's proprietary exosome technology. This technology involves the production of exosomes from MSC-NTF cells, which contain neurotrophic factors and are isolated using a unique method developed by BrainStorm. The patent is expected to offer protection until April 10, 2039.

In financial news, BrainStorm reported its third-quarter results for 2024, revealing no revenues but a notable decrease in net R&D expenses to $1.0 million from $3.3 million in the same quarter of the previous year. This reduction was attributed to lower costs associated with the Phase 3 clinical trial and payroll expenses. Similarly, G&A expenses decreased to $2.0 million from $2.7 million, primarily due to reduced payroll, stock-based compensation, and other costs. The company ended the quarter with approximately $0.35 million in cash, cash equivalents, and short-term deposits.

BrainStorm is making strides towards initiating the Phase 3b trial of NurOwn® in ALS patients, with regulatory aspects of the program being de-risked through alignment with the FDA on the CMC aspects of the trial and the establishment of a SPA. The company is also exploring the potential for nondilutive funding as it moves closer to trial initiation. Following a reverse stock split, BrainStorm's valuation stands at $9.00 per share.