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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 (BCLI) announced the peer-reviewed publication of Phase 2 trial results for its treatment NurOwn in progressive multiple sclerosis (MS) in the Multiple Sclerosis Journal. The study, which included 20 participants, demonstrated NurOwn's safety and showed preliminary efficacy, with 19% of treated patients meeting responder criteria. Key endpoints exhibited significant improvements compared to matched control patients from the CLIMB registry. No major adverse events were reported, confirming NurOwn's favorable safety profile.
BrainStorm Cell Therapeutics (BCLI) has announced plans to submit a Biologics License Application (BLA) to the FDA for NurOwn®, a stem cell therapy aimed at treating amyotrophic lateral sclerosis (ALS). This decision follows new clinical analyses that reinforce the efficacy conclusions from the Phase 3 trial. Financial results for Q2 2022 reveal a net loss of $7.0 million, up from $6.3 million the previous year, with cash reserves decreasing to $12.2 million. The company emphasizes the significance of the upcoming regulatory submission and expresses gratitude towards the ALS community and investors.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) will hold a conference call on August 15, 2022, at 8:00 a.m. Eastern Time to discuss financial results for Q2 2022, ending June 30, 2022. The call will feature CEO Chaim Lebovits, along with other executives, providing a corporate update and answering shareholder questions. Participants can submit questions by August 11, 2022, and access the call by dialing specified numbers or via a webcast. BrainStorm focuses on innovative therapies for neurodegenerative diseases.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced significant presentations at upcoming ALS and MS conferences in June 2022. Key findings from the ALS Phase 3 trial will be shared at the ENCALS meeting in Edinburgh, emphasizing the importance of addressing floor effects in ALSFRS-R outcomes. At the CMSC meeting in Maryland, three posters will discuss the effects of NurOwn therapy on visual outcomes and biomarkers in progressive MS. These insights aim to enhance understanding of NurOwn's potential benefits for patients with neurodegenerative diseases.
BrainStorm Cell Therapeutics Inc. (BCLI) announced financial results for Q1 2022, reporting a net loss of $5.4 million, down from $6.7 million in Q1 2021. Cash and equivalents decreased to $18.4 million from $22.1 million at the end of 2021. The company is enhancing its leadership team with new appointments, focusing on the advancement of its ALS treatment, NurOwn®. Promising Phase 3 data has been shared, indicating significant effects on ALS biomarkers. BrainStorm continues to engage with ALS experts and plans to present at upcoming conferences.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced senior management appointments on May 12, 2022. Netta Blondheim-Shraga, PhD, is the new VP of Research & Development, tasked with advancing the company's pipeline in cellular therapies. Antal Pearl-Lendner, Adv., joins as Chief Legal Counsel, bringing extensive legal experience. CEO Chaim Lebovits emphasized the importance of these roles in preparing for the company's growth and mission to develop innovative therapies for neurodegenerative diseases.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) presented at ISCT 2022 on May 4, 2022, highlighting the superior anti-inflammatory effects of NurOwn-derived exosomes over naïve mesenchymal stem cell-derived exosomes. Preclinical data demonstrated significant reductions in pro-inflammatory cytokines and enhancements in anti-inflammatory cytokines. Notably, treatment with NurOwn-derived exosomes led to a 6.4-fold reduction in MCP-1 and a 3.5-fold increase in IL10. These findings provide critical insights into the potential of NurOwn technology for treating neurodegenerative diseases.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced key presentations at scientific conferences in May 2022, focusing on its MSC-NTF exosome technology. New data will be shared at ISCT 2022 in San Francisco (May 4-7) and ISEV 2022 in Lyon, France (May 25-29). Additionally, an analysis of CSF biomarkers from the NurOwn® Phase 3 trial will be presented at the ALS Drug Development Summit in Boston (May 24-26). These insights aim to advance understanding of neurodegenerative disease therapies, particularly ALS.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) will hold a conference call on May 16, 2022, at 8:00 a.m. ET to discuss first-quarter financial results and provide a corporate update. CEO Chaim Lebovits will lead the call along with key executives, and participant questions will be addressed. Interested parties can submit questions until 5:00 p.m. ET on May 15, 2022. The call can be accessed via phone or webcast. BrainStorm's autologous MSC-NTF technology aims to address neurodegenerative diseases, with recent advances including a completed Phase 3 trial for ALS.
Brainstorm Cell Therapeutics (NASDAQ: BCLI) announced that President and Chief Medical Officer, Ralph Kern, MD MHSc, will present at the 2022 Virtual Growth Conference hosted by Maxim Group LLC from March 28-30, 9:00 a.m. - 5:00 p.m. EDT. This virtual event will feature executives from various sectors and includes presentations, roundtable discussions, and live Q&A sessions. Investors can sign up to attend. Brainstorm focuses on autologous adult stem cell therapies for neurodegenerative diseases.