GLMD News & Events

Galmed announced the grant of a new Use Patent related to its lead compound, Aramchol. The patent covers the use of a combination therapy of Aramchol and Rezdiffra for the treatment of non-alcoholic steatohepatitis, or NASH, also known as metabolic dysfunction-associated steatohepatitis, or MASH, and liver fibrosis in South Korea. Previously, Galmed announced the grant of new use patent for a combination of Aramchol and Madrigal Pharmaceuticals' Rezdiffra for MASH. The new patent extends Aramchol's patent protection worldwide to July 2042.

Galmed Pharmaceuticals issued a Letter to Shareholders from Allen Baharaff, Chief Executive Officer. "Over the past year, we have successfully expanded our therapeutic focus beyond liver disease, generating compelling new data that supports a broader clinical development path for Aramchol in oncology and cardiometabolic indications... My message to investors is clear: Galmed is well-capitalized, scientifically advancing on multiple fronts, and positioned for meaningful growth opportunities. 1. Strong Cash Position and Prudent Financial Stewardship. Galmed ended the third quarter of 2025 with approximately $19.2 million in cash and practically zero debt on our balance sheet... 2. Significant Clinical Advancements. Aramchol for MASH and liver fibrosis... Aramchol for Gastrointestinal oncology indications... Expansion Potential Beyond MASH and Oncology... Looking Ahead: In summary, I want to emphasize the following: Galmed remains financially strong, with sufficient resources to support our current strategic and clinical plans. Our scientific progress has been exceptional, with multiple breakthroughs validating and expanding the potential of Aramchol across high-value therapeutic areas. We are committed to short and long-term value creation, grounded in disciplined execution, scientific innovation, and responsible financial stewardship. Throughout this process, we aim to maintain transparency, careful capital allocation, and clear communication with our shareholders."

Cash and cash equivalents, short term deposits, restricted cash and marketable debt securities totaled approximately $19.2M as of September 30, 2025, compared to approximately $15.4M at December 31, 2024.

Galmed Pharmaceuticals announced meaningful top-line results from Galmed's AM-001 Study, a Phase 1 Bioavailability Study of Aramchol meglumine. The AM-001 study was designed to help identify the optimal doses for advancing Aramchol meglumine into the upcoming oncology Phase 2 studies planned for H1 2026. The study compared the relative BA of Aramchol meglumine granules to Aramchol free acid tablets in 30 healthy volunteers. The study results demonstrated that the BA of Aramchol from the Aramchol meglumine granules is considerably greater than that from Aramchol free acid tablets. The BA of 400mg and 200mg Aramchol meglumine granules were approximately 5-fold and 3-fold respectively, from that of the Aramchol free acid 300 mg tablets. To date, Galmed has successfully advanced Aramchol through six clinical trials (up to Phase 3) enrolling 661 patients, establishing both its overall excellent tolerability, safety and efficacy in treating NASH under the IND 505(b)1regulatory pathway. In addition, 82 healthy subjects to date have received Aramchol meglumine under a clinical trial application in the United Kingdom.