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 ...

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 ...