Galmed Issues CEO Letter to Shareholders

Core Insights - Galmed Pharmaceuticals is focused on expanding its therapeutic focus beyond liver disease, with promising data supporting its clinical development in oncology and cardiometabolic indications [2][4] - The company maintains a strong cash position of approximately $19.2 million and minimal debt, allowing for continued investment in R&D while keeping operational costs low [3][4] - Galmed's lead compound, Aramchol, shows significant clinical advancements, particularly in treating metabolic dysfunction-associated steatohepatitis (MASH) and liver fibrosis, with a projected market value of $16 billion by 2033 [5][6] Financial Position - As of Q3 2025, Galmed has approximately $19.2 million in cash and negligible debt, providing a solid financial foundation for ongoing development [3] - The company has increased its R&D investment while maintaining a minimal burn rate of approximately $1.5 million per quarter [4] Clinical Advancements - Aramchol has demonstrated robust fibrosis improvement in patients, with 65% and 100% of patients showing improvement in liver biopsies at week 48 [6] - The company is developing a new sublingual formulation of Aramchol to facilitate combination therapy for MASH, aiming to initiate a Phase 2 clinical study [9] - Early findings indicate that Aramchol enhances the efficacy of standard treatments for gastrointestinal cancers, supporting plans for a Phase 1/2 trial in collaboration with VCU Massey Comprehensive Cancer Center [10][11] Expansion Potential - Galmed is exploring the use of Aramchol in broader therapeutic areas, including cardiometabolic diseases, by developing a proprietary subcutaneous formulation to increase drug exposure [14][15] - The identification of systemic blood-based biomarkers broadens Aramchol's potential clinical utility beyond liver-focused applications [14] Future Outlook - The company emphasizes transparency and disciplined capital allocation as it progresses towards key milestones and growth stages [16][17] - Galmed is committed to delivering value to patients and shareholders through scientific innovation and responsible financial management [17]