Core Viewpoint - Galmed Pharmaceuticals Ltd. reported its financial results for the third quarter of 2025, highlighting a net loss and ongoing development of its lead product, Aramchol, for various medical indications, including liver disease and gastrointestinal oncology [1][6]. Financial Summary – Third Quarter 2025 vs. Third Quarter 2024 - Cash and cash equivalents totaled approximately $19.2 million as of September 30, 2025, an increase from $15.4 million at the end of 2024 [6]. - The net loss for the three months ended September 30, 2025, was approximately $2.0 million, or $0.33 per share, compared to a net loss of approximately $1.9 million, or $2.31 per share, for the same period in 2024 [6]. - Research and development expenses rose to approximately $1.1 million in Q3 2025 from $0.7 million in Q3 2024, primarily due to increased clinical and pre-clinical study costs [6]. - General and administrative expenses decreased to approximately $1.0 million in Q3 2025 from $1.3 million in Q3 2024, attributed to lower salaries and benefits [6]. Recent Business Updates - On November 17, 2025, Galmed announced positive results from a joint study with Virginia Commonwealth University, demonstrating that a combination of Aramchol, Stivarga®, and Metformin significantly enhanced the killing of gastrointestinal tumor cells both in vivo and in vitro [6][11]. - On November 18, 2025, the company reported meaningful results from its AM-001 Study, a Phase 1 bioavailability study of Aramchol Meglumine [6][11]. - In 2025, Galmed raised approximately $9.3 million through equity line and ATM facilities [6]. About Galmed Pharmaceuticals Ltd. - Galmed Pharmaceuticals is focused on developing Aramchol primarily for liver disease and is also exploring its potential in oncological indications beyond NASH and fibrosis [4]. - The company aims to expand and diversify its product pipeline, targeting cardiometabolic indications and other innovative drug candidates that align with its expertise in drug development [4].

Core Insights - Galmed Pharmaceuticals has announced positive preliminary results from the AM-001 Study, marking a significant step in the development of Aramchol Meglumine, an improved formulation of its lead compound [1][7] - Aramchol Meglumine is a New Chemical Entity (NCE) with patent protection until 2035, being developed for various indications related to fatty acid metabolism [1][2] - The initial findings indicate that Aramchol Meglumine has higher bioavailability compared to Aramchol free acid, with a once-daily 200 mg dose likely to be optimal for future trials [1][5] Company Development - Galmed has successfully advanced Aramchol acid through six clinical trials, enrolling 661 subjects, establishing its safety and efficacy in treating NASH (MASH) [2] - The transition from Aramchol acid to Aramchol Meglumine was approved by the FDA, requiring only a bioavailability study for comparison [3][4] - The AM-001 study aims to identify optimal doses for advancing Aramchol Meglumine into Phase 2 studies, with Part 2 expected to conclude in the second half of 2025 [4] Clinical Findings - Preliminary results from Part 1 of the AM-001 study show that a 400 mg dose of Aramchol Meglumine achieved an area under the curve (AUC) nearly double that of Aramchol acid tablets [5] - The findings suggest that a once-daily regimen simplifies patient adherence and is expected to lower manufacturing costs [5][7] Strategic Outlook - Galmed's commitment to accelerating the clinical program for Aramchol Meglumine is reinforced by the positive data from the AM-001 study [7] - The company aims to leverage the enhanced bioavailability and robust patent protection of Aramchol Meglumine to drive growth and deliver innovative therapies for unmet medical needs [7][8] - Galmed is also pursuing opportunities to expand its product pipeline, targeting cardiometabolic diseases and gastrointestinal cancers [8]