Galectin Therapeutics(GALT) - 2025 Q2 - Quarterly Results

Report Overview Introduction and Key Business Updates Galectin Therapeutics reported Q2 2025 financial results, highlighted positive NAVIGATE trial data, and secured debt financing for operations through H2 2026 - Galectin Therapeutics reported financial results and provided a business update for the three and six months ended June 30, 2025[1] - Continued analysis of data from the NAVIGATE trial further supports the clinical profile of belapectin in patients with MASH cirrhosis[2] - An additional $10 million debt financing, announced in early July, is expected to fund current planned operations through the second half of 2026[4] Clinical Development and Business Strategy NAVIGATE Trial Data Analysis and Efficacy Belapectin's NAVIGATE trial data shows sustained efficacy in reducing liver stiffness progression and varices in MASH cirrhosis - The 18-month analysis showed a lower incidence of both liver stiffness progression and varices in the 2 mg belapectin arm compared to placebo[4] - These effects were maintained in patients who continued into the second 18-month treatment period, confirming less progression in the belapectin group using LOCF methodology[5] - Fibroscan® data outcomes support the NAVIGATE trial's primary endpoint, the prevention of esophageal varices after 18 months of treatment with belapectin[2] Recent Clinical and Corporate Highlights Galectin hosted a June KOL event on NAVIGATE data and MASH, and presented EASL 2025 results showing belapectin's sustained efficacy - In June, Galectin hosted a KOL event featuring Dr. Naga Chalasani and Dr. Naim Alkhouri, who discussed NAVIGATE trial results and the unmet need in MASH cirrhosis[5] - In May, Galectin presented NAVIGATE trial results at the European Association for the Study of the Liver (EASL) 2025 Congress, showing sustained efficacy in reducing liver stiffness and fewer patients experiencing clinically meaningful worsening[6] - Updated FibroScan® findings mirror previously reported reductions in esophageal varices, supporting belapectin's potential to reduce portal hypertension-related complications[6] Strategic Outlook and Funding Galectin plans FDA engagement for belapectin, explores partnerships, and secured $10 million debt financing to fund operations through H2 2026 - Galectin remains focused on engaging with the U.S Food and Drug Administration later this year to discuss potential next steps for its program[3] - The company continues to explore strategic partnership opportunities[3] - Additional $10 million debt financing announced in early July is expected to fund current planned operations through the second half of 2026[4] Financial Review Q2 2025 Financial Highlights Galectin reported an improved Q2 2025 net loss due to decreased R&D, securing $10 million debt financing, bringing cash to $13.8 million Q2 2025 Key Financials (in thousands): | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :--------------------- | :------ | :------ | :----------- | | R&D Expenses | $3,261 | $9,813 | -$6,552 (↓66.8%) | | G&A Expenses | $1,364 | $1,478 | -$114 (↓7.7%) | | Net Loss | $(7,521) | $(12,371) | +$4,850 (↓39.2%) | | Net Loss per Share | $(0.12) | $(0.20) | +$0.08 (↓40.0%) | - As of June 30, 2025, the Company had $13.8 million of cash and cash equivalents[8] - On July 8, 2025, the Company entered into a new $10 million line of credit provided by its chairman of the board to fund operations through June 30, 2026[8] Condensed Consolidated Statements of Operations Galectin reported a Q2 2025 net loss of $7.521 million, significantly reduced from prior year due to decreased R&D, with the six-month period also showing a reduced net loss Condensed Consolidated Statements of Operations (Three Months Ended June 30, in thousands): | Operating Expenses | 2025 | 2024 | Change (YoY) | | :-------------------------------- | :--- | :--- | :----------- | | Research and development | $3,261 | $9,813 | -$6,552 (↓66.8%) | | General and administrative | $1,364 | $1,478 | -$114 (↓7.7%) | | Total operating expenses | $4,625 | $11,291 | -$6,666 (↓59.0%) | | Net loss | $(7,521) | $(12,371) | +$4,850 (↓39.2%) | | Basic and diluted net loss per share | $(0.12) | $(0.20) | +$0.08 (↓40.0%) | Condensed Consolidated Statements of Operations (Six Months Ended June 30, in thousands): | Operating Expenses | 2025 | 2024 | Change (YoY) | | :-------------------------------- | :--- | :--- | :----------- | | Research and development | $9,746 | $17,867 | -$8,121 (↓45.5%) | | General and administrative | $2,776 | $3,072 | -$296 (↓9.6%) | | Total operating expenses | $12,522 | $20,939 | -$8,417 (↓40.2%) | | Net loss | $(17,152) | $(23,860) | +$6,708 (↓28.1%) | | Basic and diluted net loss per share | $(0.27) | $(0.39) | +$0.12 (↓30.8%) | Condensed Consolidated Balance Sheet Data As of June 30, 2025, Galectin reported cash and equivalents of $13.771 million, a decrease from year-end 2024, with total liabilities increasing to $132.769 million and stockholders' equity deficit widening to $(118.890) million Condensed Consolidated Balance Sheet Data (in thousands): | Metric | June 30, 2025 | December 31, 2024 | Change | | :-------------------- | :------------ | :---------------- | :----- | | Cash and cash equivalents | $13,771 | $15,120 | -$1,349 | | Total assets | $15,602 | $17,495 | -$1,893 | | Total current liabilities | $10,774 | $35,409 | -$24,635 | | Total liabilities | $132,769 | $120,565 | +$12,204 | | Total stockholders' equity (deficit) | $(118,890) | $(104,793) | -$14,097 | Company Profile and Disclosures About Galectin Therapeutics Galectin Therapeutics develops novel therapies for chronic liver disease and cancer, focusing on belapectin for MASH cirrhosis, with cancer programs dependent on partnerships - Galectin Therapeutics is dedicated to developing novel therapies to improve the lives of patients with chronic liver disease and cancer[10] - Galectin's lead drug belapectin, a carbohydrate-based galectin-3 inhibitor, has Fast Track designation by the U.S. FDA for its lead development program in MASH with cirrhosis[10] - Additional development programs in combination immunotherapy for advanced head and neck cancers and other malignancies are largely dependent on finding a suitable partner[10] Forward-Looking Statements This section contains forward-looking statements, highlighting uncertainties and risks in clinical trials, regulatory approvals, funding, and partnerships that could impact actual results - Statements relate to future events or future financial performance and are based on management's current expectations, subject to factors and uncertainties that could cause actual results to differ materially[11] - Risks include, but are not limited to, the NAVIGATE trial data not producing positive results, failure to develop effective treatments or obtain requisite approvals, challenges in manufacturing, and inability to secure partnerships or raise additional capital[11] Company Contacts Contact information for Galectin Therapeutics' CFO, Jack Callicutt, and Investor Relations, Kevin Gardner, is provided - Company Contact: Jack Callicutt, Chief Financial Officer, (678) 620-3186, ir@galectintherapeutics.com[12] - Investors Relations Contacts: Kevin Gardner, kgardner@lifesciadvisors.com[12]