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BrainStorm Cell Therapeutics Inc. develops autologous adult stem cell therapeutics for neurodegenerative diseases, with news centered on its investigational NurOwn® platform for amyotrophic lateral sclerosis. NurOwn uses bone marrow-derived mesenchymal stem cells expanded and differentiated ex vivo into neurotrophic factor-secreting MSC-NTF cells designed to deliver neurotrophic factors and immunomodulatory cytokines.
Company updates commonly cover financial results, private placements and working-capital actions, regulatory engagement with the FDA, manufacturing readiness and clinical development activities tied to the Phase 3b ENDURANCE study. Corporate updates also address the completed transition of BCLI common stock from Nasdaq listing to OTCQB quotation.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) has announced a new clinical program to develop NurOwn for treating Alzheimer's disease. A multi-national Phase 2 clinical trial is planned to evaluate the safety and efficacy of NurOwn in patients with prodromal to mild Alzheimer's. The trial will include 40 participants receiving three doses over 52 weeks. The company aims to build on its existing ALS program and believes NurOwn can potentially address various neurodegenerative disorders.
BrainStorm Cell Therapeutics (BCLI) announced its inclusion in the Russell 2000® and Russell 3000® Indexes effective June 29, 2020. This addition is significant as it reflects BrainStorm’s market capitalization and positions the company for greater visibility and investment opportunities. The Russell Indexes are widely used by investment managers and institutional investors, with approximately $9 trillion in assets benchmarked against these indexes.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) reported its Q1 2020 financial results and provided updates on clinical trials amid the COVID-19 pandemic. The Phase 3 ALS trial is on track for Q4 2020 data readout, with patient treatments ongoing. The company signed an agreement for EMEA regulatory guidance and leased a facility in Tel Aviv to enhance manufacturing capacity. Despite challenges, cash reserves increased to $14.5 million but net losses widened to $8.1 million, compared to $5.03 million in Q1 2019.
BrainStorm Cell Therapeutics announced a lease with Tel Aviv Sourasky Medical Center to produce NurOwn® in new cleanrooms, enhancing manufacturing capacity for ALS treatment in Israel and the EU. This collaboration aims to ensure rapid production post-regulatory approval, supporting ongoing clinical demands. The cleanroom facility complies with cGMP standards, indicating a significant step toward scaling up operations. With full enrollment in a Phase 3 ALS trial and recent FDA clearance for a Phase 2 MS trial, BrainStorm is positioned to advance its therapeutic pipeline significantly.
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