Accessibility StatementSkip Navigation TEL AVIV, Israel, Nov. 26, 2025 /PRNewswire/ —Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company focused on liver, cardiometabolic, and gastrointestinal oncology indications, reports financial results for the three and nine months ended September 30, 2025 and recent developments. Financial Summary – Third Quarter 2025 vs. Third Quarter 2024 Recent Business Updates About Galmed Pharmaceuticals Ltd. We are a ...

The top-line results showed that bioavailability of Aramchol meglumine 400mg and 200mg granules is considerably greater, higher by 5-fold and 3-fold respectively, that of the Aramchol free acid 300mg tablets The new unexpected PK profile allows for a once daily therapeutic regimen thus potentially improving long term adherence and expected to significantly reduce the drug cost of goods RAMAT-GAN, Israel , Nov. 18, 2025 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a ...

Accessibility StatementSkip Navigation RAMAT-GAN, Israel, Nov. 17, 2025 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, cardiometabolic diseases and GI oncological therapeutics, announced today results from its joint research with Virginia Commonwealth University (VCU) evaluating Aramchol's effect on overcoming drug resistance in gastrointestinal (GI) cancers. The collaboration is based on breakthrough findings pub ...

Core Viewpoint - Galmed Pharmaceuticals Ltd. has approved a digital asset management strategy to diversify its balance sheet and enhance capital efficiency, potentially allocating up to 50% of its cash reserves, approximately $10 million, for digital asset investments [1][2][8] Group 1: Digital Asset Management Strategy - The new treasury investment policy aims to leverage blockchain-based assets for growth and liquidity opportunities [2] - A Crypto Committee has been established to oversee the management of crypto holdings, including portfolio rebalancing, liquidity provisioning, yield-generating protocols, and risk-adjusted hedging strategies [2] - The company has entered into a non-binding letter of intent with Tectona, a crypto treasury management service provider, for advisory and operational services related to digital asset management [3] Group 2: Share Capital Increase - The authorized share capital has been increased from 50,000,000 to 900,000,000 ordinary shares following shareholder approval on August 15, 2025 [4][8] - This increase is intended to provide greater flexibility for the company to raise capital and pursue strategic opportunities [5] Group 3: Management Commentary - The CEO emphasized that integrating digital assets into the treasury management program reflects a proactive approach to financial management and innovation [5] - The strategy aims to optimize liquidity and support the company's mission of advancing transformative therapies [5]

Core Insights - Galmed Pharmaceuticals has achieved a significant milestone with the discovery of a proprietary pharmacodynamic blood-based biomarker signature for its lead candidate, Aramchol, which is the most advanced SCD1 inhibitor in the industry [1][2] Group 1: Biomarker Discovery and Implications - The newly characterized biomarker profile from the Phase 3 ARMOR study indicates Aramchol's therapeutic potential extends beyond liver applications, suggesting broader disease-modifying capabilities in cardiometabolic and inflammatory conditions [2][3] - The biomarker insights are expected to facilitate regulatory discussions and inform future clinical trials targeting liver fibrosis, heart failure, and other cardiometabolic indications [3] Group 2: Clinical and Commercial Potential - The analysis from the ARMOR study shows significant reductions in inflammation, cardiac stress, and atherosclerotic drivers, indicating new commercial and clinical pathways for Aramchol [6] - A validated decrease in Atrial Natriuretic Peptide (ANP), a key marker for heart failure, highlights the potential for expanding into broader cardiometabolic markets [6][7] Group 3: Strategic Positioning and Future Growth - Galmed's proprietary biomarker tools enhance its lifecycle management of Aramchol and open up high-return expansion pathways into multi-billion-dollar markets beyond MASH [8] - The collaboration with Proteas Health positions Galmed at the forefront of AI-driven biomarker-guided therapeutics, strengthening its readiness for potential strategic partnerships, licensing, or M&A opportunities [8][9]

Core Insights - Galmed Pharmaceuticals announced positive results from initial oncology studies showing that Aramchol enhances the effects of Regorafenib, a therapeutic approved for liver and colorectal cancers, in both in-vitro and in-vivo models [1][6] - The combination of Aramchol and Regorafenib demonstrated significant tumor growth suppression in hepatoma models without causing toxicity to normal tissues [2][6] - A Phase 1b clinical trial is planned to evaluate the combination of Aramchol and Regorafenib in patients with advanced gastrointestinal cancers, set to begin in Q4 2025 [6] Company Overview - Galmed Pharmaceuticals is focused on developing Aramchol primarily for liver disease and is now expanding its applications to oncological indications beyond non-alcoholic steatohepatitis (NASH) [4] - The company aims to diversify its product pipeline by targeting cardiometabolic indications and other innovative drug candidates that align with its expertise in drug development [4] Scientific Mechanisms - The study identified key molecular mechanisms by which Aramchol and Regorafenib kill gastrointestinal tumor cells, highlighting that Aramchol enhances autophagy through different mechanisms than Regorafenib [3] - The interaction between Aramchol and Regorafenib leads to increased autophagic flux and autolysosome formation, which is essential for the enhanced efficacy of the drug combination [3]

Core Insights - Galmed Pharmaceuticals has signed a binding term-sheet with Entomus for a license agreement to develop and commercialize a proprietary Self-Emulsifying Drug Delivery System (SEDDS) for sublingual administration of peptides like GLP-1 [1] - The global GLP-1 market is projected to exceed $120 billion by 2030, with peak sales outside the US expected to reach approximately $20 billion by 2032 [3] - The new sublingual formulation aims to enhance bioavailability, reduce side effects, and improve patient compliance compared to existing injectable and oral forms of semaglutide [6][9] Company Developments - The definitive agreement with Entomus will outline milestone payments and future royalty payments, expected to be finalized within 90 days [1] - The sublingual semaglutide formulation is anticipated to be approved through the expedited 505(b)(2) regulatory pathway [5][6] - Galmed aims to initially target markets with high rates of type 2 diabetes and obesity, such as India, Brazil, and the GCC region, where patent protections for semaglutide are less stringent [4][5] Industry Context - The first-pass effect in oral medications can reduce efficacy, while sublingual administration offers a non-invasive alternative that allows direct entry into the bloodstream [2] - The increasing prevalence of type 2 diabetes and obesity in various global markets creates a favorable environment for GLP-1 therapies [4] - Semaglutide, as a GLP-1 receptor agonist, has shown significant efficacy in managing blood glucose levels and promoting weight loss, positioning it as a transformative treatment option [7]

Core Viewpoint - Galmed Pharmaceuticals has initiated a research collaboration with Virginia Commonwealth University to explore the potential of Aramchol in overcoming drug resistance in gastrointestinal cancers, particularly colorectal and hepatocellular cancers, aiming to enhance treatment efficacy against these aggressive tumors [1][5]. Group 1: Collaboration Details - The collaboration involves VCU scientists studying Aramchol in preclinical models, focusing on its ability to prevent or reverse resistance to standard therapies such as targeted kinase inhibitors and chemotherapies [1][2]. - The project is based on recent research highlighting the role of lipid metabolic pathways, specifically Stearoyl-CoA Desaturase 1 (SCD1), in driving drug resistance in GI tumors [2][5]. - Galmed will provide funding and Aramchol materials, while VCU will conduct the studies, leveraging its expertise in cancer biology and drug resistance [7]. Group 2: Market Implications - This partnership marks a strategic expansion for Galmed beyond its historical focus on fibrotic liver diseases into oncology, targeting a significant market with high unmet needs [4][5]. - Aramchol is the most clinically advanced SCD1 inhibitor, with a strong safety profile demonstrated in previous trials, presenting a unique opportunity in cancer treatment [4][5]. - The collaboration aims to generate proof-of-concept data that could lead to further clinical development in oncology, potentially expanding Galmed's pipeline and enhancing its commercial prospects [6][7]. Group 3: Clinical Context - A significant proportion of patients with advanced hepatocellular carcinoma (HCC) do not benefit from current second-line therapies due to drug resistance, with most developing resistance within six months [3][6]. - Targeting lipid metabolism with Aramchol is seen as a promising strategy to overcome resistance to tyrosine kinase inhibitors (TKIs), which are pivotal in treating advanced HCC [6][3]. - The collaboration aims to develop safe drug combinations that can block and circumvent drug resistance in HCC, addressing a critical need in cancer treatment [3][6].

Core Insights - Galmed Pharmaceuticals has unveiled novel pharmacodynamic blood markers for its lead compound, Aramchol, which is the most clinically advanced SCD1 inhibitor in the industry, indicating potential applications beyond NASH therapy [1][3] - The collaboration with Proteas Health has led to the identification of a panel of 70 plasma proteins that can track Aramchol's therapeutic impact, providing a single blood-based pharmacodynamic signature for monitoring patient response [2][5] - The findings suggest that Aramchol may reduce chronic systemic inflammation, oxidative stress, and atherosclerotic plaque pathogenesis, highlighting its broad therapeutic relevance in cardiometabolic diseases [3][8] Company Developments - Galmed is focusing on expanding its clinical pipeline to include additional cardiometabolic and potentially oncological indications, leveraging the insights gained from the pharmacodynamic markers [3][9] - The company aims to develop a cost-effective, high-throughput assay to measure Aramchol's unique pharmacodynamic signature, which could enhance clinical trials and drug response evaluation [5][6] - CEO Allen Baharaff emphasized that the newly discovered markers could serve as early indicators of Aramchol's efficacy, opening avenues for future research in cardiovascular diseases [4][6] Industry Context - The collaboration with Proteas Health is positioned to reduce clinical trial risks and accelerate commercialization pathways for Aramchol, addressing the global burden of cardiometabolic and fibro-inflammatory conditions [6][10] - The ability to demonstrate and monitor Aramchol's impact through a single blood test is expected to transform clinical development and create new commercialization opportunities [6][10]

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]