Brainstorm Cell Therapeutics(BCLI) - 2025 Q2 - Quarterly Results

Corporate Update and Highlights Management Commentary The CEO highlights FDA clearance for the NurOwn Phase 3b trial as a key milestone and affirms the company's clinical execution focus - Reached a key milestone in Q2 with FDA clearance to initiate the Phase 3b trial for NurOwn, designed to support a potential Biologics License Application (BLA) submission[2] - Advancing operational activities, including discussions with clinical sites and engagement with CDMO partners to ensure readiness for clinical drug supply[2] - Supports the FDA's consideration of the Citizen Petition, viewing it as a potential opportunity for a fresh, objective evaluation of NurOwn's scientific evidence[2] Recent Highlights The company received FDA clearance for its Phase 3b trial, saw a Citizen Petition filed, and reported positive EAP survival data - The FDA has cleared the company to initiate the Phase 3b clinical trial of NurOwn, known as ENDURANCE, expected to enroll approximately 200 participants[3] - A Citizen Petition was submitted to the FDA by the ALS Community, requesting a new review of the NurOwn data, which the company believes provides a new opportunity to reaffirm NurOwn's potential[7] - New survival data from the NurOwn Expanded Access Program (EAP) showed that 100% of participants (10/10) survived more than 5 years from the onset of ALS symptoms[7] - BrainStorm signed a Letter of Intent (LOI) with Minaris Advanced Therapies, a global CDMO, to manufacture NurOwn for the upcoming Phase 3b clinical trial[7] - New pharmacogenomic data highlighting the impact of the UNC13A genotype on clinical outcomes were selected for presentation at the ISCT 2025 Annual Meeting[7] Financial Performance Second Quarter 2025 Financial Results The company reported a net loss of $2.9 million for Q2 2025, with increased R&D expenses and decreased G&A expenses Q2 2025 Financial Highlights | Financial Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Cash, cash equivalents, and restricted cash | ~$1.03 million | N/A | | Research and development expenditures, net | $1.1 million | $0.9 million | | General and administrative expenses | ~$1.4 million | ~$2.1 million | | Net loss | ~$2.9 million | ~$2.5 million | | Net loss per share | $0.34 | $0.60 | Consolidated Financial Statements The statements show total assets of $2.57 million, a stockholders' deficit of $6.06 million, and a Q2 net loss of $2.90 million Consolidated Balance Sheets As of June 30, 2025, total assets increased to $2.57 million while the total stockholders' deficit improved to $6.06 million Financial Position Comparison | Balance Sheet Item (in thousands) | June 30, 2025 (Unaudited) | December 31, 2024 (Audited) | | :--- | :--- | :--- | | Cash and cash equivalents | $824 | $187 | | Total current assets | $1,515 | $385 | | Total assets | $2,566 | $1,832 | | Total current liabilities | $8,528 | $8,978 | | Total liabilities | $8,623 | $9,596 | | Total stockholders' deficit | $(6,057) | $(7,764) | Consolidated Statements of Comprehensive Loss The company recorded a net loss of $2.90 million for Q2 2025 and $5.77 million for the six months ended June 30, 2025 Three Months Ended June 30 | Statement of Loss (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development, net | $1,120 | $922 | | General and administrative | $1,453 | $2,060 | | Operating loss | $(2,573) | $(2,982) | | Net loss | $(2,903) | $(2,541) | | Basic and diluted net loss per share | $(0.34) | $(0.60) | Six Months Ended June 30 | Statement of Loss (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development, net | $2,424 | $1,883 | | General and administrative | $3,238 | $3,573 | | Operating loss | $(5,662) | $(5,456) | | Net loss | $(5,767) | $(5,942) | | Basic and diluted net loss per share | $(0.77) | $(1.35) | Company and Product Overview About NurOwn® NurOwn® is an investigational autologous stem cell therapy designed to deliver neurotrophic factors to sites of damage - The NurOwn® technology platform uses autologous MSC-NTF cells produced from a patient's own bone marrow-derived mesenchymal stem cells (MSCs)[8] - MSCs are converted into MSC-NTF cells, which are induced to secrete high levels of neurotrophic factors (NTFs)[8] - The therapy aims to deliver NTFs and immunomodulatory cytokines to the site of damage to slow or stabilize disease progression[8] About BrainStorm Cell Therapeutics Inc. BrainStorm is a clinical-stage biotech company developing autologous stem cell therapies for neurodegenerative diseases - BrainStorm is a leading developer of autologous adult stem cell therapies for debilitating neurodegenerative diseases[9] - The lead investigational therapy, NurOwn®, has completed a Phase 3 trial in ALS and is set to launch a Phase 3b trial under a Special Protocol Assessment (SPA) with the FDA[10] - The company is also advancing a proprietary, allogeneic exosome-based platform and recently received a Notice of Allowance for a foundational patent[10] Other Information Conference Call Information The company held a conference call on August 14, 2025, to discuss Q2 results, with a replay available until August 28 - A conference call and webcast were scheduled for 8:30 a.m. Eastern Time on Thursday, August 14, 2025[1][5] - A replay of the conference call will be available until August 28[5][6] Forward-Looking Statements This section cautions that the press release contains forward-looking statements subject to substantial risks and uncertainties - The press release contains forward-looking statements regarding the clinical development of NurOwn, potential regulatory approval, and the future success of the company[11] - These statements are subject to inherent uncertainties, risks, and assumptions that are difficult to predict, including the ability to raise additional capital and continue as a going concern[11]