Galmed CEO outlines drug development plans in shareholder letter

Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) issued a shareholder letter from Chief Executive Officer Allen Baharaff outlining the company's clinical development strategy and financial position.

The Tel Aviv-based biopharmaceutical company reported $19.2 million in cash at the end of the third quarter of 2025 with a quarterly burn rate of approximately $1.5 million. The company has expanded its therapeutic focus beyond liver disease to include oncology and cardiometabolic indications for its drug candidate Aramchol.

In its Phase 3 ARMOR study, Aramchol demonstrated fibrosis improvement in liver patients. At week 48, paired and AI evaluations showed 65% and 100% of patients respectively experiencing fibrosis improvement. The results were published in the Journal of Hepatology in March 2025.

Galmed announced plans to advance Aramchol into a Phase 1/2 clinical trial for metastatic colorectal cancer, hepatocellular carcinoma, and cholangiocarcinoma in collaboration with VCU Massey Comprehensive Cancer Center in early 2026. Pre-clinical studies showed Aramchol enhanced the activity of Stivarga (regorafenib) and potentially overcame drug resistance in gastrointestinal tumor models.

The company is developing new formulations of Aramchol, including a sublingual version for combination therapy with approved metabolic agents and a subcutaneous formulation for higher blood exposure.

Baharaff stated the company aims to pursue combination therapies for MASH treatment, noting that 22 million Americans live with the condition. The MASH market is expected to reach $16 billion by 2033 according to analysts cited in the letter.

The company discontinued its ARMOR study following the COVID-19 pandemic, though Baharaff stated this was not due to safety or efficacy concerns. Galmed is working on initiating a Phase 2 MASH clinical study with its new formulation approach.

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