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 ...

Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI) Q2 2023 Earnings Conference Call August 14, 2023 8:00 AM ET Company Participants Michael Wood - LifeSci Advisors Chaim Lebovits - President and Chief Executive Officer Stacy Lindborg - Co-Chief Executive Officer Alla Patlis - Interim Chief Financial Officer Kirk Taylor - Executive Vice President and Chief Medical Officer Conference Call Participants Jason McCarthy - Maxim Group Operator Greetings, and welcome to the Brainstorm Cell Therapeutics Second Quarter ...

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 June 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 specified in ...

Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI) Q1 2023 Earnings Conference Call May 15, 2023 8:00 AM ET Company Participants Michael Wood - LifeSci Advisors Chaim Lebovits - President and CEO Stacy Lindborg - Co-CEO Alla Patlis - Interim CFO Kirk Taylor - EVP and Chief Medical Officer Conference Call Participants David Bautz - Zacks Small-Cap Operator Greetings, and welcome to the Brainstorm Cell Therapeutics First Quarter 2023 Earnings Call. At this time, participants are in a listen-only mode. As a remin ...

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, 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 specified in ...

Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI) Q4 2022 Earnings Conference Call March 30, 2023 8:00 AM ET Company Participants Michael Wood - LifeSci Advisors Chaim Lebovits - President and Chief Executive Officer Stacy Lindborg - Co-Chief Executive Officer Alla Patlis - Interim Chief Financial Officer David Setboun - Chief Operating Officer Conference Call Participants Jason McCarthy - Maxim Group David Bautz - Zacks Small-Cap Research Operator Greetings, and welcome to the Brainstorm Cell Therapeutics Fo ...