BCLI News & Events

Lunai Bioworks' (LNAI) wholly owned subsidiary BioSymetrics and BrainStorm (BCLI) announced a strategic collaboration and Letter of Intent to jointly discover, validate, and advance novel therapeutic targets for neurological diseases. The collaboration is supported by a newly awarded grant from the LouLou Foundation. The collaboration combines BioSymetrics' AI-driven target discovery and in vivo zebrafish validation platform with BrainStorm Therapeutics' proprietary human-derived organoid systems to create an integrated translational engine for neurology drug discovery. The companies intend to generate high-confidence therapeutic programs designed for pharmaceutical partnering, licensing, and downstream development. Initial efforts will focus on rare genetic epilepsies and neurodegenerative diseases, including Parkinson's disease. As part of the collaboration, the companies are integrating BrainStorm's Parkinson's disease midbrain organoid foundation model with BioSymetrics' proprietary analysis of the Parkinson's Progression Markers Initiative dataset, to identify progression-associated biomarkers and high-confidence therapeutically actionable targets. The program is intended to support precision medicine strategies and accelerate the development of differentiated CNS therapeutics.

BrainStorm Cell Therapeutics announced that it has received a delisting notification from The Nasdaq Stock Market, informing the company that its common stock will be delisted from the Nasdaq Capital Market. Trading of BrainStorm's common stock on Nasdaq will be suspended at the open of trading on July 18. The delisting is a result of the company's non-compliance with Nasdaq Listing Rule 5550(b)(1), pertaining to its minimum shareholder equity requirement. BrainStorm has already secured approval for its common stock to be quoted on the OTCQB Venture Market, a U.S. trading platform operated by OTC Markets Group. The company anticipates its shares will begin trading on the OTCQB under the same symbol, BCLI, beginning at the open of trading on July 18, or as soon as possible thereafter.

BrainStorm Cell Therapeutics announced new survival data from 10 participants in its Expanded Access Program for NurOwn in amyotrophic lateral sclerosis. The EAP enrolled 10 participants who had previously completed the Phase 3 clinical trial. The analysis reviewed survival from the time of first symptom onset through participation in the Phase 3 trial, EAP Periods 1 and 2, followed by additional survival data collected through publicly available records. EAP participants presented at the start of the Phase 3 trial relatively early in their disease course, with Mean ALSFRS-R at Baseline of 35.8, followed by Mean ALSFRS-R at the start of the EAP of 31.4. Key findings include: 90% of participants survived more than five years from the onset of ALS symptoms, compared to published estimates indicating that approximately 10% of individuals with ALS survive beyond five years. Notably, the single death in the cohort occurred following elective euthanasia. The median survival observed in the EAP cohort was 6.8 years from symptom onset. Given that approximately 10% of individuals with ALS survive beyond five years[1], the probability of observing such extended survival in 9 out of 10 participants purely by chance is extremely low. This strongly suggests that the survival outcomes in this cohort are unlikely to be the result of random variation alone. "These survival data provide encouraging real-world insights into the long-term experience of ALS patients treated with NurOwn under expanded access," said Chaim Lebovits, President and CEO of BrainStorm Cell Therapeutics. "We believe these findings add further evidence to support the upcoming Phase 3b clinical trial of NurOwn, to be conducted under an FDA Special Protocol Assessment (SPA). Our goal remains to generate high quality and conclusive data to demonstrate the benefit of NurOwn in people living with ALS."