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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.
Catalent and BrainStorm Cell Therapeutics have announced a collaboration to manufacture NurOwn®, BrainStorm's cellular therapy for amyotrophic lateral sclerosis (ALS). This partnership will facilitate the transfer of the manufacturing process to Catalent's new facility in Houston, Texas, which spans 32,000 square feet. NurOwn has received Fast Track status from the U.S. FDA and Orphan Drug Status for ALS. Currently, BrainStorm is finalizing a Phase 3 clinical trial with 200 patients. The companies plan to expand their collaboration for commercial supply post-trial success.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced the presentation of a scientific poster on NurOwn® exosomes for treating ARDS at the NYSCF Conference on October 20, 2020. The study demonstrated significant improvements in lung function and reduced inflammation in a mouse model of ARDS, suggesting NurOwn exosomes may be a viable therapy for COVID-19 related lung complications. CEO Chaim Lebovits reaffirmed the company's commitment to advancing their therapeutic pipeline while preparing for the pivotal Phase 3 ALS clinical trial data release.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) reported its third quarter financial results for 2020, highlighting a net loss of $4.49 million, improved from $5.63 million in Q3 2019. The company has approximately $36 million in funding, with significant upcoming events including the NurOwn® Phase 3 trial data readout for ALS expected in November. Additionally, management updates include new appointments to enhance regulatory and commercial strategy, and plans for further clinical trials in progressive multiple sclerosis and Alzheimer's disease.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced that Stacy Lindborg, Ph.D., will present at the 2020 Cell & Gene Meeting on the Mesa, held virtually from October 12-16, 2020. The presentation is available on-demand for registered participants. The conference will showcase over 80 presentations by various companies highlighting advancements in cell therapy and gene therapy. BrainStorm’s NurOwn technology is focused on treating neurodegenerative diseases, including a Phase 3 trial for ALS and a Phase 2 trial for progressive MS, supported by FDA approvals.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) will hold a conference call on October 15, 2020, at 8:00 a.m. EDT to discuss third-quarter financial results for the period ending September 30, 2020, and provide a corporate update. The call will feature CEO Chaim Lebovits, alongside key executives who will answer shareholder questions. Participants can submit questions until October 13, 2020. The company is noted for its NurOwn technology, which targets neurodegenerative diseases and has several ongoing clinical trials.
On September 30, 2020, BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) presented a poster on the Phase 3 clinical trial design of NurOwn® for ALS at the virtual Annual Northeast ALS Meeting. The trial is designed to evaluate the effects of NurOwn® on rapidly progressing ALS patients, building on promising Phase 2 results. The study aims to confirm the efficacy of NurOwn® and assess its duration through repeated administrations. Topline data from the trial is expected in Q4 2020, marking a significant step towards potential FDA approval.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced the appointment of William K. White as Senior Vice President, Head of Market Access and Pricing. With over 25 years of experience in product commercialization, White aims to ensure market access for NurOwn®, currently in a Phase 3 trial for ALS. CEO Chaim Lebovits emphasized the importance of White's background in securing patient access to innovative therapies, crucial for the potential FDA approval of NurOwn®. The company is focused on bringing revolutionary stem cell treatments to patients suffering from neurodegenerative diseases.
Brainstorm Cell Therapeutics (NASDAQ: BCLI) announced the granting of a new patent by the Japanese Patent Office for its method of generating mesenchymal stem cells secreting neurotrophic factors, crucial for treating neurodegenerative diseases. The patent covers key neurotrophic factors such as BDNF, GDNF, HGF, and VEGF. This development strengthens Brainstorm’s intellectual property portfolio, enhances its ability to secure commercial partnerships in Japan, and supports its ongoing Phase 3 trial for ALS treatment. The company aims to leverage this patent for strategic growth and market presence.
On August 25, 2020, BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced the acceptance of a clinical abstract showcasing a correlation between MRI measures and functional improvements in patients with progressive multiple sclerosis (MS). This data will be presented at the MSVirtual2020 meeting on September 11-13. The analysis involved 48 participants and revealed significant differences in MRI data between those with improved versus stable or worsening function, specifically using the 9-hole peg test and timed-25-foot-walk metrics. CEO Chaim Lebovits emphasized the potential implications for clinical outcomes in their ongoing Phase 2 trial of NurOwn®.
On August 19, 2020, BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced the publication of a manuscript regarding the effects of its NurOwn stem cell therapy on T and B regulatory cells in ALS. The research highlighted significant findings, including a notable reduction in inflammatory biomarkers and increased circulating T regulatory cells in previous clinical studies. The preclinical experiments demonstrated a decrease in interferon-g secretion and induction of regulatory cells, which may support NurOwn's therapeutic potential in ALS and other neuroinflammatory diseases.