Company Overview - BrainStorm Cell Therapeutics Inc. is a leading developer of autologous adult stem cell therapies for neurodegenerative diseases, utilizing its proprietary NurOwn® platform to produce neurotrophic factor-secreting cells [5] - The company focuses on therapies for conditions such as amyotrophic lateral sclerosis (ALS) and progressive multiple sclerosis (MS) [6] Upcoming Conference Call - A conference call is scheduled for August 14, 2025, at 8:30 AM Eastern Time to update shareholders on the financial results for the second quarter of 2025 [1] - Key executives participating in the call include President and CEO Chaim Lebovits, COO Hartoun Hartounian, CMO Bob Dagher, and Interim CFO Alla Patlis [2] Clinical Development - NurOwn® has received Orphan Drug designation from both the U.S. FDA and the European Medicines Agency (EMA) for ALS treatment [6] - A Phase 3 trial for ALS has been completed, and a second Phase 3b trial is set to launch under a Special Protocol Assessment (SPA) agreement with the FDA [6] - The clinical program has provided insights into ALS disease biology, including pharmacogenomic responses and biomarker data [6] Intellectual Property - BrainStorm has received a Notice of Allowance from the U.S. Patent and Trademark Office for a foundational patent covering its exosome technology, enhancing its intellectual property portfolio in regenerative medicine [6]

Core Viewpoint - BrainStorm Cell Therapeutics Inc. is committed to advancing its investigational therapy NurOwn for amyotrophic lateral sclerosis (ALS) and welcomes the FDA's review of the data supporting this treatment [1][2][3] Company Commitment and Regulatory Engagement - The company supports the integrity and scientific validity of its data and emphasizes the importance of a comprehensive review of evidence as the regulatory landscape for rare diseases evolves [2][3] - BrainStorm is proceeding with its Phase 3b ENDURANCE trial of NurOwn under an FDA Special Protocol Assessment (SPA) to generate additional data on efficacy and safety for early-stage ALS patients [3][11] Clinical Data and Outcomes - New survival data from 10 participants in the Expanded Access Program (EAP) indicates that they survived more than five years from ALS symptom onset, with a median survival of 6.8 years, significantly higher than the estimated 10% of ALS patients reaching this benchmark [5][6] - In a subgroup with baseline ALSFRS-R scores of 35 and above, NurOwn demonstrated statistically significant functional improvement compared to placebo, with treated participants retaining an average of two more ALSFRS-R points [7] Technology and Research Advancements - NurOwn technology utilizes autologous mesenchymal stem cells (MSCs) to produce neurotrophic factor-secreting cells (MSC-NTF cells), aimed at delivering therapeutic signals to modulate neuroinflammation and promote neuroprotection [9][10] - The clinical program has provided valuable insights into ALS biology, including pharmacogenomic responses and biomarker data collected over time [11] Community and Advocacy Engagement - The ALS community plays a crucial role in advocating for new treatment approaches, and the company aligns with these efforts to prioritize data-driven decision-making and urgency for patients [4][8]

Core Viewpoint - BrainStorm Cell Therapeutics Inc. is making significant progress in the development of its NurOwn® therapy for ALS, with plans for a Phase 3b trial aimed at confirming efficacy in early-stage ALS patients and supporting a new Biologics License Application (BLA) [2][4]. Financial Results - As of March 31, 2025, the company reported cash, cash equivalents, and restricted cash of approximately $1.8 million [4]. - Research and development expenditures for Q1 2025 were $1.3 million, an increase from $1.0 million in Q1 2024 [4]. - General and administrative expenses for Q1 2025 were approximately $1.8 million, compared to $1.5 million in Q1 2024 [4]. - The net loss for Q1 2025 was approximately $2.9 million, an improvement from a net loss of approximately $3.4 million in Q1 2024 [4][14]. - Net loss per share for Q1 2025 was $0.45, compared to $0.75 for Q1 2024 [4][14]. Corporate Updates - The company submitted an IND amendment for NurOwn to the FDA, which is a critical step for the upcoming Phase 3b trial [4]. - The Phase 3b trial, named ENDURANCE, is designed to enroll approximately 200 early-stage ALS participants and will assess changes in ALSFRS-R scores [4]. - NurOwn data was selected for presentation at the ISCT 2025 Meeting, highlighting the impact of the UNC13A genotype on clinical outcomes for ALS patients [4]. - Insights on biomarkers related to NurOwn treatment were presented at the 2025 ALS Drug Development Summit [4]. About NurOwn® - NurOwn® is an investigational therapy utilizing autologous MSC-NTF cells, which are derived from bone marrow and designed to deliver neurotrophic factors to slow or stabilize neurodegenerative diseases [6][8]. - The therapy has received Orphan Drug designation from both the FDA and EMA, and a Phase 3 trial has been completed [8]. Company Overview - BrainStorm Cell Therapeutics Inc. focuses on developing autologous adult stem cell therapies for neurodegenerative diseases, with its proprietary NurOwn® platform aimed at modulating neuroinflammation and promoting neuroprotection [7].

Core Viewpoint - BrainStorm Cell Therapeutics Inc. has rescheduled the release of its financial results for Q1 2025 and an investor conference call, indicating ongoing engagement with investors and stakeholders [1][2]. Company Overview - BrainStorm Cell Therapeutics Inc. is a leading developer of adult stem cell therapies targeting neurodegenerative diseases, utilizing its proprietary NurOwn® platform to produce neurotrophic factor-secreting cells [5]. - The company's lead investigational therapy, NurOwn®, has received Orphan Drug designation from both the FDA and EMA, and a Phase 3 trial for ALS has been completed [6]. Upcoming Events - The financial results will be released post-market on May 15, 2025, and the investor conference call is scheduled for May 19, 2025, at 8:30 a.m. Eastern Time [1][2]. - Participants are encouraged to submit questions in advance, with specific contact details provided for access to the conference call [3]. Clinical Development - BrainStorm has completed a Phase 2 trial of MSC-NTF cells in progressive multiple sclerosis, supported by a grant from the National MS Society [6]. - The company is advancing an allogeneic exosome-based platform for delivering therapeutic proteins and nucleic acids, with a foundational patent recently allowed by the U.S. Patent and Trademark Office [6].

Company Overview - BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) is a leading developer of adult stem cell therapeutics aimed at treating neurodegenerative diseases [3][4] - The company's proprietary NurOwn® platform utilizes autologous mesenchymal stem cells (MSCs) to create neurotrophic factor-secreting cells (MSC-NTF cells) [3][4] Upcoming Conference Call - A conference call is scheduled for May 15, 2025, at 8:30 a.m. Eastern Time to discuss the financial results for Q1 2025 and provide a corporate update [1][2] - The call will feature BrainStorm's President & CEO Chaim Lebovits, along with Dr. Bob Dagher, Chief Medical Officer, and Alla Patlis, Interim CFO [2] Clinical Development - NurOwn® is the lead investigational therapy for amyotrophic lateral sclerosis (ALS) and has received Orphan Drug designation from both the FDA and EMA [4] - A Phase 3 trial for ALS has been completed, and a confirmatory Phase 3b trial is set to launch under a Special Protocol Assessment (SPA) agreement with the FDA [4] - The clinical program has provided insights into ALS disease biology, including pharmacogenomic responses and biomarker data [4] Additional Research and Development - BrainStorm has completed a Phase 2 open-label multicenter trial of MSC-NTF cells in progressive multiple sclerosis (MS), supported by a grant from the National MS Society [4] - The company is also advancing an allogeneic exosome-based platform for delivering therapeutic proteins and nucleic acids, with a foundational patent recently allowed by the U.S. Patent and Trademark Office [4]