Summary of Brainstorm Cell Therapeutics Inc. Mid-Year Update on NurOwn Program Company Overview - **Company**: Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) - **Focus**: Development of NurOwn, a cell therapy for neurodegenerative disorders, particularly ALS (Amyotrophic Lateral Sclerosis) Key Developments 1. **Phase 3b Trial Initiation**: - Priority is to initiate the Phase 3b trial for ALS, with a constructive Type C meeting held with the FDA on June 24, 2024, to discuss chemistry, manufacturing, and controls (CMC) aspects [6][8] - The FDA has shown continued support, and the company is aligned with the agency on resolving outstanding CMC questions [6][7] 2. **Clinical Research Organization (CRO) Engagement**: - A contract has been signed with a leading CRO recognized for expertise in ALS and cell therapy to support the Phase 3b trial [9] - The CRO is preparing clinical sites and project plans to begin dosing the first patient before the end of 2024 [9] 3. **Funding and Financial Strategy**: - The company raised $4 million through the sale of common stock and warrants, which will support near-term milestones but is not sufficient for the entire Phase 2b study [10] - Additional financing options, including non-dilutive grants, are being explored [10][19] 4. **Leadership Changes**: - Dr. Haro Hartounian has been appointed as Chief Operating Officer, bringing over 32 years of experience in biopharmaceuticals, particularly in cell and gene therapy [11] 5. **Regulatory Strategy**: - The company is committed to conducting the Phase 3b trial to gather robust data for a future Biologics License Application (BLA) submission [28] - The decision to conduct an additional Phase 3b trial was made to align with FDA expectations and to provide comprehensive data for ALS treatment approval [28][29] Clinical Trial Details 1. **Trial Design and Objectives**: - The Phase 3b trial will have a shorter screening period of about eight weeks, focusing on patients diagnosed within two years and with preserved respiratory function [42][37] - Entry criteria will ensure patients are in the early stages of ALS, aiming for a higher baseline ALSFRS score than in previous trials [42][37] 2. **Manufacturing and BLA Readiness**: - Securing a commercial manufacturing partner early is crucial for BLA filing readiness and reducing time to market [24] - The manufacturing process is well-defined, and the company is prepared for the FDA inspection as part of the BLA approval process [24][33] Market and Competitive Landscape - The company believes that positive results from the Phase 3b trial will lead to a reevaluation of its market value, allowing for future financing on more favorable terms [20][22] - The focus on early intervention in ALS treatment aligns with emerging trends in neurodegenerative disease therapies [52] Additional Insights - The complexity of cell therapy manufacturing was emphasized, with a focus on the unique aspects of NurOwn's production process [49] - The company is committed to transparency regarding challenges and is focused on developing NurOwn as a potential treatment for ALS [29] Conclusion - Brainstorm Cell Therapeutics is poised to advance its NurOwn program with a clear strategy for trial initiation, regulatory engagement, and financial planning, while addressing the urgent need for effective ALS treatments.

Core Viewpoint - BrainStorm Cell Therapeutics Inc. is set to hold a mid-year corporate update on July 8, 2024, to discuss positive developments in the NurOwn® program for neurodegenerative diseases [1] Company Overview - BrainStorm Cell Therapeutics is a leading developer of autologous adult stem cell therapeutics targeting neurodegenerative diseases [3] - The company holds exclusive rights to the NurOwn® technology platform, which produces autologous MSC-NTF cells, and has received Orphan Drug designation from the FDA and EMA for ALS treatment [3] - BrainStorm has completed a Phase 3 trial for ALS (NCT03280056) and a Phase 2 trial for progressive MS (NCT03799718), both supported by grants from various organizations [3] Conference Call Details - The conference call will feature presentations from the President and CEO, Chaim Lebovits, and the newly appointed COO, Hartoun Hartounian, along with a Q&A session [1] - Participants can submit questions in advance until July 5, 2024 [1] - The call can be accessed via toll-free and international numbers, with a replay available until July 22, 2024 [2]

NEW YORK, June 27, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) (the "Company"), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it has entered into a securities purchase agreement with a single institutional investor (the "Holder") for the purchase and sale of 11,111,111 shares of the Company's common stock (or prefunded warrants in lieu thereof) at a purchase price of $0.36 per share in a registered direct offering.In a conc ...

Core Viewpoint - BrainStorm Cell Therapeutics Inc. has appointed Dr. Hartoun Hartounian as the new EVP and COO, which is expected to enhance the company's operational efficiency and support the commercial readiness of its ALS treatment, NurOwn® [1][2] Company Overview - BrainStorm Cell Therapeutics is a developer of autologous adult stem cell therapeutics aimed at treating neurodegenerative diseases, particularly ALS [4] - The company holds exclusive rights to the NurOwn® technology platform, which has received Orphan Drug designation from the FDA and EMA for ALS treatment [4] Leadership Appointment - Dr. Hartounian has over 32 years of experience in the biopharmaceutical industry, particularly in cell and gene therapy [1][2] - His previous achievements include founding BioCentriq, which was acquired for $73 million in 2022, and leading multiple biotechnology companies [1][2] Responsibilities and Expectations - In his new role, Dr. Hartounian will oversee all operational aspects, including CMC and commercialization, to streamline logistics and navigate complexities [2] - The company anticipates that Dr. Hartounian's expertise will be crucial in advancing NurOwn and achieving strategic objectives [2] Clinical Development - BrainStorm has completed a Phase 3 trial for NurOwn in ALS, which investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells [4][5] - The company has also conducted a Phase 2 trial for progressive MS, supported by grants from relevant organizations [5]

FROM ACF EQUITY RESEARCH HEALTHCARE TEAMNASDAQ: BCLIREAD ACF EQUITY RESEARCH'S INITIATION NOTE HERE READ ACF EQUITY RESEARCH'S RELATED THEMATIC RESEARCH NOTE ON REGENERATIVE MEDICINE – NEURODEGENERATIVE DISEASE STEM CELLS & ALS/MND/LOU GEHRIG'S HERELONDON, June 14, 2024 /PRNewswire/ -- INITIATION NOTE: BrainStorm Cell Therapeutics Inc. (Nasdaq: BCLI) is focused on developing autologous mesenchymal stem cell (MSC) therapies for the treatment of neurodegenerative diseases (NDDs) – BCLI's primary target is the ...

The data will be presented at the Annual ALS Drug Development Summit, which is focused on identifying transformative ALS targets, seeking translational biomarkers and propelling more clinical approvalsNEW YORK, May 20, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, will present new biomarker data suggesting that ALS patients may benefit from longer-term treatment with debamestrocel (NurOwn®). The Comp ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024. or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to _____________ Commission File Number 001-36641 BRAINSTORM CELL THERAPEUTICS INC. (Exact name of registrant as specified in ...

Core Points - BrainStorm Cell Therapeutics Inc. announced the promotion of Dr. Bob Dagher to Executive Vice President and Chief Medical Officer, while Dr. Stacy Lindborg steps down as Co-CEO to join the Board of Directors [1][2] - The management changes are strategic as the company prepares for a registrational Phase 3b trial for NurOwn®, its investigational cell therapy for amyotrophic lateral sclerosis (ALS) [1][2] - Dr. Dagher has over 20 years of experience in clinical research and development, previously serving as Chief Medical Officer at Enveric Biosciences and holding leadership roles at GSK, Sanofi/Genzyme, and LabCorp/Covance [2][3] Company Overview - BrainStorm Cell Therapeutics is a developer of autologous adult stem cell therapeutics for neurodegenerative diseases, specifically focusing on ALS [4] - The company holds rights to the NurOwn® technology platform, which has received Orphan Drug designation from the FDA and EMA for ALS treatment [4] - BrainStorm has completed a Phase 3 trial for ALS, supported by grants from the California Institute for Regenerative Medicine and the ALS Association [4][5]

NEW YORK, April 11, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI, "the Company"), a leading developer of cellular therapies for neurodegenerative diseases, today announced that it received a notification letter (the "Notification Letter on Compliance") on April 10, 2024 from the Listing Qualifications Department of The Nasdaq Stock Market ("Nasdaq"), indicating that the Company has regained compliance with the minimum market value of listed securities requirement set forth under Nasd ...

NurOwn treatment resulted in a positive impact on important CSF biomarkers relevant to ALS compared to placebo.Significant changes in multiple ALS disease pathways support NurOwn's mechanism of action and complement clinical effects observed in ALS. NEW YORK, April 10, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced the peer-reviewed publication of Phase 3 biomarker data in Muscle and Nerve. The ...