#Israel #Tel Aviv #Galmed Pharmaceuticals #Aramchol #Allen Baharaff

CEO Letter Overview from Galmed Pharmaceuticals

On December 1, 2025, Allen Baharaff, the Chief Executive Officer of Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD), addressed shareholders in a detailed letter highlighting the company's current status and exciting prospects for growth. Galmed, a clinical-stage biopharmaceutical firm, focuses on developing treatments for liver diseases, cardiometabolic disorders, and gastrointestinal oncology.

Recent Progress and Future Ambitions

Baharaff emphasized the importance of transparency and maintaining a strong connection with shareholders while outlining the significant advancements Galmed has made in recent months. The letter served as a platform for portraying Galmed's vision for a transformative future marked by scientific innovation and value creation.

Over the past year, Galmed has broadened its therapeutic targets beyond liver disease, strengthening the clinical development pathway for its drug, Aramchol. This compound is positioned to address several conditions, including oncology and cardiometabolic diseases, which opens up new avenues for potential revenue.

Strong Financial Position

One of the key highlights from the letter is the company’s strong cash position. As of the end of the third quarter of 2025, Galmed reported approximately $19.2 million in cash reserves with virtually no debt. This financial stability has allowed the company to invest in research and development while maintaining a minimal cash burn rate of around $1.5 million per quarter. This prudent financial management assures stakeholders that Galmed can pursue its short and long-term goals without resorting to unhealthy capital raises.

Clinical Advancements

Baharaff provided an update on Aramchol's progress, particularly its application for treating metabolic dysfunction-associated steatohepatitis (MASH). MASH represents a substantial unmet medical need, with estimates projecting that approximately 22 million Americans are affected. The market potential for treatments targeting MASH could reach $16 billion by 2033.

Galmed’s ARMOR study has shown promising results, with a significant percentage of participants experiencing improvement in liver fibrosis after treatment with Aramchol. The results were significant enough to be published in the highly regarded Journal of Hepatology, underlining the scientific community's confidence in the drug's efficacy.

Plans for Combination Therapy

Baharaff also discussed the need for combination therapies in treating complex conditions like MASH. He noted that addressing the condition effectively will require multi-faceted treatment strategies. Galmed is currently working on a new sublingual formulation of Aramchol that would allow for its combination with other metabolic agents, paving the way for future clinical studies.

Oncology Development

In terms of oncology, preliminary pre-clinical studies have indicated that Aramchol could enhance the efficacy of existing cancer treatments, such as Stivarga and metformin. The plans include advancing Aramchol to Phase 1/2 clinical trials for various cancers, which may help secure FDA approval sooner, especially for less common cancer types.

Broader Applications and Biomarkers

In addition to liver and cancer applications, Galmed is exploring the broader clinical utility of Aramchol, including potential applications in cardiometabolic diseases. The identification of blood-based biomarkers has strengthened the hypothesis about Aramchol's usefulness across several conditions.

The development of a subcutaneous formulation of Aramchol aims to improve drug delivery, particularly to the heart, enhancing its therapeutic effects. This advancement is expected to create new clinical opportunities and substantial market potential.

Concluding Thoughts

In summary, Baharaff’s letter encapsulates Galmed's current achievements and its strategic vision. The company is well-positioned not only in terms of financial health but also in its scientific pursuits, which have led to numerous breakthroughs over the past year.

With a clear focus on short and long-term value creation, Galmed expresses commitment to transparent communication and responsible financial management. Stakeholders can anticipate further updates as the company reaches key milestones. The entire Galmed team is enthusiastic about the opportunities that lie ahead and strives to deliver substantial benefits to patients, partners, and shareholders alike.

About Galmed Pharmaceuticals Ltd.

Galmed Pharmaceuticals is dedicated to developing Aramchol, primarily for liver disease treatments, while seeking out opportunities for expansion into oncological therapies and other unmet medical needs. As part of its growth strategy, the company is diversifying its product pipeline, focusing on innovative candidates that align with its strengths in drug development.