GLMD

Xtandi® (enzalutamide) is indicated as monotherapy for the treatment of patients with non-metastatic prostate cancer (nmCSPC) at high risk of metastasis and for the treatment of patients with metastatic prostate cancer (mCSPC) who are maintaining treatment with a GnRH analogue. Global sales for Xtandi® (marketed by Astellas Pharma and Pfizer) reached approximately $8 billion and $6 billion globally in 2024 and 2025, respectively.

Aramchol meglumine is the only SCD1 inhibitor with an established clinical safety profile and confirmed blood-brain barrier (BBB) penetration. In order to improve patient convenience and long-term treatment adherence by Parkinson patients affected by dysphagia, an ODF formulation was developed demonstrating ~150% higher systemic bioavailability and ~300% significant increase in CNS exposure than conventional oral administration.

Galmed has developed, in collaboration with Barcode Nanotech, a unique proprietary lipid nanoparticles (LPNs) novel formulation of Aramchol that penetrates the heart tissue and redirects Aramchol's biodistribution away from liver-hepatocytes to the heart's muscle. Cardiac fibrosis is a major driver of chronic heart failure, the leading cause of death globally, responsible for an estimated 20.5 million deaths in 2025.

Colospan Ltd. ("Colospan") provides Galmed Pharmaceuticals Ltd.

- Tissue Dynamics identified a previously unrecognized metabolic mechanism driving cardiac fibrosis using a human cardiac organoid model, revealing disease biology that is not accessible through conventional animal models. - In inflammatory human cardiac organoids, the combination of Aramchol Meglumine and a selective PPARα agonist reduced fibrotic burden by approximately 4-fold (p

Results from Study AM-001 mark a pivotal advance through the transition to a once daily lower 400mg dose of AM enabling: Production of GMP clinical batch for Galmed's upcoming clinical trials Solidification and prolongation of Aramchol's IP protection Potential reduction in drug CoGs by ~50% Improvement in patients' convenience and compliance upon potential commercialization RAMAT-GAN, Israel, May 14, 2026 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver disease and GI oncological therapeutics, announced today major milestone results from a Phase 1 PK study in healthy subjects (Study AM-001).

Novel vascularized, sensor-embedded cardiac organoid model will focus on chronic post-MI remodeling and HFpEF, linking lipid metabolism, SCD1 activity, fibrosis, and impaired tissue repair REHOVOT, Israel and RAMAT-GAN, Israel, May 6, 2026 /PRNewswire/ -- Tissue Dynamics Ltd. and Galmed Pharmaceuticals Ltd.

Recently, Galmed announced breakthrough medicinal chemistry work converting Aramchol into a brain-penetrant SCD1 inhibitor, potentially positioning Aramchol as a first-in-class therapy for synucleinopathies and other CNS diseases. Among CNS unmet conditions, brain metastasis (BM) remains a lethal progression of the primary cancer in urgent need of novel and effective therapies.