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 ...

Conference call and webcast at 8:00 a.m. Eastern Time today NEW YORK, April 9, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS).  The SPA agreement with the FDA validates the cl ...

Core Viewpoint - BrainStorm Cell Therapeutics Inc. is set to provide an update on its NurOwn® program during a conference call scheduled for April 9, 2024, at 8:00 AM Eastern Time, aimed at informing shareholders and the investment community about recent developments [1]. Group 1: Company Overview - BrainStorm Cell Therapeutics Inc. specializes in developing innovative autologous adult stem cell therapies for neurodegenerative diseases [2]. - The company holds exclusive rights to the NurOwn® technology platform, which produces autologous MSC-NTF cells, and has received Orphan Drug designation from both the U.S. FDA and the European Medicines Agency for treating amyotrophic lateral sclerosis (ALS) [2]. - BrainStorm has completed a Phase 3 pivotal trial for ALS, which investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells, supported by a grant from the California Institute for Regenerative Medicine [2]. Group 2: Upcoming Events - The conference call will feature presentations from key executives, including the President and CEO, Co-CEO, and Chief Development Officer, followed by a Q&A session with the investment community [1]. - Participants can join the call via a provided link or by dialing specific toll-free and international numbers [1]. Group 3: Additional Information - A replay of the conference call will be available until April 24, 2024, allowing interested parties to listen to the discussion at a later time [1][2].

Table of Contents IdentificationNo.) UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ⌧ ANNUAL REPORT UNDER SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2023 ☐ TRANSITION REPORT UNDER 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 its charter) Delaw ...

[Corporate Update and Strategic Outlook](index=1&type=section&id=Corporate%20Update%20and%20Strategic%20Outlook) BrainStorm's primary focus for 2024 is advancing a confirmatory Phase 3b trial for its ALS treatment, NurOwn - The company's **main priority** for 2024 is to initiate a **confirmatory Phase 3b trial** for NurOwn to support a new Biologics License Application (BLA)[2](index=2&type=chunk) - BrainStorm is seeking a **Special Protocol Assessment (SPA) agreement** with the FDA to ensure alignment on the study design, which is believed to substantially de-risk the regulatory process[2](index=2&type=chunk) [Clinical and Regulatory Highlights](index=1&type=section&id=Clinical%20and%20Regulatory%20Highlights) In early 2024, BrainStorm submitted a Special Protocol Assessment (SPA) request to the FDA for its planned Phase 3b study of NurOwn - Submitted a **Special Protocol Assessment (SPA) request** to the FDA in February 2024 for a **Phase 3b study** of NurOwn, with a response expected soon after the 45-day review cycle[3](index=3&type=chunk) - The proposed **Phase 3b trial** is a two-part, multicenter study designed to assess NurOwn's efficacy and safety in ALS participants earlier in their disease progression[3](index=3&type=chunk) - In October 2023, the company **withdrew its Biologics License Application (BLA)** for NurOwn without prejudice, following an FDA Advisory Committee vote that it did not demonstrate substantial evidence of effectiveness[4](index=4&type=chunk) [Corporate Highlights](index=2&type=section&id=Corporate%20Highlights) In October 2023, BrainStorm executed a strategic realignment to prioritize the development of NurOwn for ALS - Announced a **strategic realignment** in October 2023 to accelerate the development of NurOwn for ALS treatment[5](index=5&type=chunk) - The company streamlined clean room operations and implemented a **targeted headcount reduction of about 30%** to refocus resources[5](index=5&type=chunk) [Financial Performance for Fiscal Year 2023](index=2&type=section&id=Financial%20Performance%20for%20Fiscal%20Year%202023) For the full year 2023, BrainStorm reported a net loss of $17.2 million, a reduction from the $24.3 million net loss in 2022 [Key Financial Results Summary](index=2&type=section&id=Key%20Financial%20Results%20Summary) BrainStorm's net loss per share improved to $0.40 in 2023 from $0.66 in 2022, supported by decreased R&D expenses and stable G&A expenses Key Financial Results | Metric | 2023 | 2022 | | :--- | :--- | :--- | | Cash, cash equivalents, and restricted cash | $1.45 million | $3.0 million | | Research and development expenses | $10.8 million | $14.0 million | | General and administrative expenses | $10.7 million | $10.9 million | | Net loss | $17.2 million | $24.3 million | | Net loss per share | $0.40 | $0.66 | [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) As of December 31, 2023, BrainStorm's total assets decreased to $4.2 million from $8.5 million, resulting in an increased stockholders' deficit of $4.9 million Consolidated Balance Sheet Summary (U.S. dollars in thousands) | Balance Sheet Item | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Total current assets | $1,899 | $3,106 | | Total assets | $4,208 | $8,451 | | Total current liabilities | $7,800 | $8,800 | | Total liabilities | $9,066 | $11,466 | | Total stockholders' equity (deficit) | $(4,858) | $(3,015) | [Consolidated Statements of Comprehensive Loss](index=5&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Loss) The company's operating loss narrowed to $21.4 million in 2023, primarily due to reduced R&D spending and a significant non-operating gain from warrant liability fair value Consolidated Statements of Comprehensive Loss (U.S. dollars in thousands) | Income Statement Item | Year ended Dec 31, 2023 | Year ended Dec 31, 2022 | | :--- | :--- | :--- | | Research and development, net | $10,746 | $13,956 | | General and administrative | $10,693 | $10,866 | | Operating loss | $(21,439) | $(24,822) | | Net loss | $(17,192) | $(24,277) | - The company recognized a **gain of $4.694 million** from the change in fair value of warrants liability in 2023, which significantly reduced the net loss compared to 2022[15](index=15&type=chunk) [About BrainStorm Cell Therapeutics Inc.](index=2&type=section&id=About%20BrainStorm%20Cell%20Therapeutics%20Inc.) BrainStorm Cell Therapeutics Inc. is a clinical-stage biotechnology company developing autologous adult stem cell therapies for neurodegenerative diseases, with NurOwn® technology holding Orphan Drug designation for ALS - The company develops **innovative autologous adult stem cell therapeutics** for neurodegenerative diseases[8](index=8&type=chunk) - Its **NurOwn® technology platform** has received **Orphan Drug designation** from the FDA and EMA for treating ALS[8](index=8&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements regarding the company's clinical development plans and regulatory interactions, subject to substantial risks including capital raising and going concern ability - The report contains **forward-looking statements** about the clinical development of NurOwn, FDA interactions (including the SPA), and future success, which are subject to **significant risks and uncertainties**[9](index=9&type=chunk) - Key risks highlighted include the company's ability to **raise additional capital**, its ability to **continue as a going concern**, and prospects for future regulatory approval of NurOwn[9](index=9&type=chunk)

Core Viewpoint - BrainStorm Cell Therapeutics Inc. is focused on advancing the NurOwn program, particularly through a confirmatory Phase 3b trial aimed at supporting a new Biologics License Application (BLA) for ALS treatment [2][3]. Clinical and Regulatory - The company submitted a Special Protocol Assessment (SPA) request to the FDA for the Phase 3b study of NurOwn, which is currently under review with an expected response soon [3]. - The planned Phase 3b trial will be a two-part, multicenter study assessing the efficacy and safety of NurOwn in ALS patients earlier in the disease [3]. - In October 2023, BrainStorm withdrew its previous BLA for NurOwn after the FDA advisory committee indicated insufficient evidence of effectiveness for mild to moderate ALS [3]. Corporate Developments - In October 2023, BrainStorm announced a strategic realignment, reducing resources and headcount by approximately 30% to accelerate the development of NurOwn for ALS [4]. - The company is committed to conducting the upcoming Phase 3b trial with high scientific standards, reflecting its dedication to the ALS community [2]. Financial Results - As of December 31, 2023, BrainStorm reported cash and cash equivalents of $1.45 million, down from $3 million in 2022 [5]. - Research and development expenses decreased to approximately $10.8 million in 2023 from $14 million in 2022 [5]. - The net loss for the year ended December 31, 2023, was $17.2 million, an improvement from a net loss of $24.3 million in 2022, with net loss per share decreasing from $0.66 to $0.40 [6][15].

NEW YORK, Feb. 23, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it has submitted a Special Protocol Assessment (SPA) request to the U.S. Food and Drug Administration (FDA) for a Phase 3b study of NurOwn®, its investigational treatment for amyotrophic lateral sclerosis (ALS). The submission follows an in-person meeting that BrainStorm held with the FDA in December 2023. The inter ...

NEW YORK, Feb. 13, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it will provide a corporate update at the 17th Annual European Life Sciences CEO Forum to take place 28 - 29 of February, 2024 in Zurich, Switzerland. Presentation DetailsPresentation Date: Wednesday, 28th FebruaryTime: 13:40h CETLocation: Panorama Room (Track C), Hilton Zurich Airport Hotel Dr. Stacy Lindborg, Co-C ...

Start Time: 08:30 January 1, 0000 8:58 AM ET BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI) Q3 2023 Earnings Conference Call November 14, 2023, 08:30 AM ET Company Participants Chaim Lebovits - President and CEO Stacy Lindborg - Co-CEO Alla Patlis - Interim CFO Michael Wood - LifeSci Advisors Conference Call Participants David Bautz - Zacks Small-Cap Research Operator Greetings, and welcome to the BrainStorm Cell Therapeutics Third Quarter 2023 Earnings Call. At this time, participants are in a listen-only ...

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 September 30, 2023. 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 specifie ...