Core Viewpoint - BrainStorm Cell Therapeutics Inc. is making progress in stabilizing its financial situation and advancing the Phase 3b study of its investigational therapy NurOwn for ALS, with FDA clearance obtained for the clinical study [2][8]. Financial Results - As of September 30, 2025, the company reported cash, cash equivalents, and restricted cash of approximately $0.23 million [7]. - Research and development expenditures for Q3 2025 were $0.9 million, a decrease from $1 million in Q3 2024 [7]. - General and administrative expenses for Q3 2025 were approximately $1.1 million, down from approximately $2.0 million in Q3 2024 [7]. - The net loss for Q3 2025 was approximately $2.1 million, compared to a net loss of approximately $2.7 million in Q3 2024 [7]. NurOwn Therapy Development - NurOwn is designed to deliver neurotrophic factors and immunomodulatory cytokines to slow disease progression in ALS [6][8]. - The upcoming Phase 3b ENDURANCE study will enroll about 200 participants and will include a 24-week randomized, double-blind, placebo-controlled period followed by a 24-week open-label extension [7]. - The primary efficacy measure will be the change from baseline to Week 24 on the ALSFRS-R scale [7]. Regulatory Engagement - The company is actively engaging with regulatory authorities and has received FDA clearance for the planned clinical study [2][8]. - A Citizen Petition was filed with the FDA by ALS community representatives, requesting a renewed review of NurOwn's data, which the company views as a constructive development [7]. Future Communications - BrainStorm plans to host a conference call and webcast for the investment community later in Q4 2025 or early Q1 2026 to provide further updates on the NurOwn Phase 3 program [4].

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]