Brainstorm Cell Therapeutics(BCLI) - 2024 Q2 - Quarterly Results

Executive Summary & Corporate Update BrainStorm provided Q2 2024 financial results and corporate updates, highlighting NurOwn Phase 3b trial preparation Second Quarter 2024 and Recent Highlights BrainStorm announced Q2 2024 results, emphasizing regulatory alignment and trial site establishment for NurOwn Phase 3b trial - CEO Chaim Lebovits stated that regulatory aspects of the program have been substantially derisked, having secured agreement with the FDA on a Special Protocol Assessment and also reached alignment on the CMC aspects[2] - A leading Clinical Research Organization (CRO) has been selected, and the company is actively working to establish multiple trial sites for the Phase 3b trial[2] Clinical and Regulatory Milestones BrainStorm achieved key regulatory milestones for NurOwn, including FDA alignment on CMC and SPA for the Phase 3b trial - In June 2024, BrainStorm reached alignment with the U.S. Food and Drug Administration (FDA) on the Chemistry, Manufacturing, and Controls (CMC) aspects of its planned Phase 3b clinical trial for NurOwn® in ALS[3] - In April 2024, the FDA granted BrainStorm a Special Protocol Assessment (SPA) agreement for the Phase 3b trial, validating the clinical trial protocol and statistical analysis for a future BLA[3] - New biomarker data on NurOwn from the prior Phase 3 study and Expanded Access Program (EAP) were featured at the 3rd Annual ALS Drug Development Summit in May 2024, suggesting continued benefits for patients with extended treatment[5] Corporate Developments BrainStorm completed a $4.0 million registered direct offering and strengthened its leadership with key appointments - In June 2024, BrainStorm completed a successful registered direct offering, raising gross proceeds of $4.0 million from a single institutional investor[6] - In June 2024, Hartoun Hartounian Ph.D. was appointed as EVP and Chief Operating Officer, bringing over 32 years of experience in the biopharmaceutical industry, with a focus on cell and gene therapy[6] - In April 2024, Dr. Bob Dagher was promoted to Executive Vice President and Chief Medical Officer, with over 20 years of experience in clinical research and development[6] Financial Performance BrainStorm's Q2 2024 financial performance showed reduced net loss and improved cash, driven by decreased operating expenses Second Quarter 2024 Financial Summary BrainStorm reported a Q2 2024 net loss of $2.5 million, a significant reduction from $5.3 million in Q2 2023 due to decreased expenses - Cash, cash equivalents, and restricted cash amounted to approximately $3.65 million as of June 30, 2024[6] Key Financials (Q2 2024 vs Q2 2023) | Metric | Q2 2024 (USD millions) | Q2 2023 (USD millions) | Change (YoY) | | :-------------------------- | :--------------------- | :--------------------- | :----------- | | Research & Development, net | $0.9 | $2.8 | -67.9% | | General & Administrative | $2.0 | $2.7 | -25.9% | | Net Loss | $2.5 | $5.3 | -52.8% | | Net Loss Per Share | $0.04 | $0.13 | -69.2% | Interim Condensed Consolidated Balance Sheets As of June 30, 2024, BrainStorm's total assets increased to $5.683 million from $4.208 million at year-end 2023, driven by cash increase Balance Sheet Highlights (USD thousands) | Metric | June 30, 2024 (Unaudited) | December 31, 2023 (Audited) | Change | | :----------------------------------- | :------------------------ | :-------------------------- | :------ | | Cash and cash equivalents | $3,469 | $1,300 | +$2,169 | | Total current assets | $3,816 | $1,899 | +$1,917 | | Total assets | $5,683 | $4,208 | +$1,475 | | Total current liabilities | $7,691 | $7,800 | -$109 | | Total liabilities | $9,210 | $9,066 | +$144 | | Total stockholders' deficit | $(3,527) | $(4,858) | +$1,331 | Interim Condensed Consolidated Statements of Comprehensive Loss For Q2 2024, BrainStorm reported a net loss of $2.541 million, a substantial improvement from $5.329 million in the prior year Comprehensive Loss Highlights (USD thousands) | Metric | Three months ended June 30, 2024 | Three months ended June 30, 2023 | Six months ended June 30, 2024 | Six months ended June 30, 2023 | | :----------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development, net | $922 | $2,794 | $1,883 | $5,718 | | General and administrative | $2,060 | $2,655 | $3,573 | $4,882 | | Operating loss | $(2,982) | $(5,449) | $(5,456) | $(10,600) | | Net loss | $(2,541) | $(5,329) | $(5,942) | $(10,388) | | Basic and diluted net loss per share | $(0.04) | $(0.13) | $(0.09) | $(0.27) | | Weighted average shares outstanding | 71,215,481 | 39,696,665 | 67,977,012 | 38,224,230 | Conference Call and Webcast Information Details for BrainStorm's conference call and webcast to discuss Q2 2024 results and recent progress were provided Conference Call and Webcast Details BrainStorm provided conference call and webcast details for Q2 2024 results, including dial-in numbers and webcast URL - A conference call and webcast for the investment community was scheduled for 8:30 AM ET on August 14, 2024, to discuss second quarter results and recent progress[1][9] - Access details include Toll Free: 877-545-0523, International: 973-528-0016, Participant Access Code: 308245, and Webcast URL: **https://www.webcaster4.com/Webcast/Page/2354/51009**[8](index=8&type=chunk) - A replay of the conference call is available for 14 days via Toll Free: 877-481-4010, International: 919-882-2331, and Replay Passcode: 51009[9] Company Overview and Disclosures BrainStorm Cell Therapeutics develops autologous adult stem cell therapeutics for neurodegenerative diseases, with forward-looking statement disclosures About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics is a leading developer of autologous adult stem cell therapeutics for neurodegenerative diseases, holding NurOwn® rights - BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases[10] - The company holds exclusive, worldwide licensing agreement for the NurOwn® technology platform, which produces autologous MSC-NTF cells[10] - Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. FDA and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS)[10] Notice Regarding Forward-Looking Statements The press release contains forward-looking statements subject to substantial risks and uncertainties, including regulatory approvals and clinical development - This press release contains "forward-looking statements" regarding future events such as FDA meetings, SPA, ADCOM, PDUFA action dates, clinical development of NurOwn, and the future success of BrainStorm[11] - These statements are subject to substantial risks and uncertainties, including management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, and prospects for future regulatory approval of NurOwn[11] - Readers should not place undue reliance on BrainStorm's forward-looking statements, which are based on the beliefs, expectations, and opinions of management as of the date of this press release[11] Contacts Contact information for media and investor relations inquiries is provided - Media Contact: Lisa Guiterman, Phone: +1 202-330-3431, Email: lisa.guiterman@gmail.com[12] - IR Contact: Michael Wood, Phone: +1 646-597-6983, Email: mwood@lifesciadvisors.com[12]