Brainstorm Cell Therapeutics(BCLI) - 2023 Q4 - Annual Results

Corporate Update and Strategic Outlook 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] - 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] Clinical and Regulatory Highlights 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] - 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] - 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] Corporate Highlights 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] - The company streamlined clean room operations and implemented a targeted headcount reduction of about 30% to refocus resources[5] Financial Performance for Fiscal Year 2023 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 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 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 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] About BrainStorm Cell Therapeutics Inc. 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] - Its NurOwn® technology platform has received Orphan Drug designation from the FDA and EMA for treating ALS[8] Forward-Looking Statements 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] - 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]