Galmed's Strategic Pivot: Fueling an Oncology Push with New Capital

TEL AVIV, Israel – November 26, 2025 – In the high-stakes world of clinical-stage biotechnology, a company’s survival often hinges on its ability to adapt and pivot. Galmed Pharmaceuticals Ltd. appears to be executing just such a maneuver, moving decisively beyond its historical focus on liver disease to tackle the complex challenges of gastrointestinal oncology and cardiometabolic disorders. The company’s third-quarter financial report, while seemingly routine, serves as the backdrop for a far more compelling narrative of strategic realignment, underpinned by promising new scientific data, a strengthened capital position, and the development of a more potent drug formulation.

For investors and industry observers, Galmed is no longer just a company developing a treatment for non-alcoholic steatohepatitis (NASH). It is now positioning its lead asset, Aramchol, as a platform therapeutic with the potential to become a cornerstone of combination therapies in some of medicine’s most difficult-to-treat areas. This is a capital move that signals not just ambition, but a calculated strategy to unlock significant future value.

A Calculated Leap into Oncology

The most significant development driving this strategic shift is the promising preclinical data emerging from Galmed’s oncology program. In a joint research effort with Virginia Commonwealth University (VCU), the company demonstrated that Aramchol could play a pivotal role in overcoming drug resistance in gastrointestinal (GI) cancers—a critical unmet need that plagues current treatment regimens.

The research highlighted a powerful synergistic effect when Aramchol was used in a three-drug combination with metformin and Bayer's established cancer drug, Stivarga® (regorafenib). This cocktail significantly enhanced the killing of GI tumor cells in both laboratory and animal models. The underlying mechanism is tied to Aramchol's function as a first-in-class Stearoyl-CoA desaturase 1 (SCD1) inhibitor. By inhibiting SCD1, a key enzyme in lipid metabolism, Aramchol appears to reprogram the metabolic processes within cancer cells, effectively lowering their defenses and re-sensitizing them to attack. This process involves modulating critical cellular pathways—including ATM, AMPK, and mTOR—that govern cell growth and survival.

The strategic brilliance of this move is multifaceted. First, it targets a major clinical problem; resistance to targeted therapies and immunotherapies is a primary cause of treatment failure in advanced GI cancers. Second, it employs a combination strategy with an existing blockbuster drug, Stivarga®. With Stivarga's patents set to expire in the coming years, a novel fixed-dose combination with Aramchol could represent a clever intellectual property life-cycle extension, creating a new, protected therapeutic with an established safety and efficacy profile. Galmed is wasting no time in advancing this program, with plans to initiate a Phase 1b clinical trial for patients with advanced GI cancers in late 2025 or early 2026.

The Financial Backbone for a Bold Expansion

A strategic pivot of this magnitude is impossible without a solid financial foundation. Galmed's latest financial disclosures reveal a deliberate and successful effort to fortify its balance sheet to fund this expanded ambition. The company reported a cash position of approximately $19.2 million as of September 30, 2025, a healthy increase from $15.4 million at the end of 2024. This was largely fueled by the raising of approximately $9.3 million in capital during 2025 through its at-the-market (ATM) and equity line facilities.

While R&D expenses predictably increased to $1.1 million for the quarter, reflecting the ramp-up in clinical and preclinical work, the company demonstrated fiscal prudence by simultaneously reducing its general and administrative expenses to $1.0 million. This disciplined approach to capital management is critical for investor confidence. Based on its current quarterly burn rate of approximately $1.5 million, Galmed now possesses a cash runway projected to last well into early 2029.

This multi-year runway is a crucial strategic asset. It provides the company with the stability and time needed to see its new oncology and cardiometabolic programs through key clinical milestones without the immediate pressure of seeking dilutive financing. For a clinical-stage biotech, this level of financial security allows management to focus on execution and value creation, a signal that savvy investors will not overlook.

A More Potent, Defensible Asset

Complementing the strategic and financial moves is a critical product development advancement: a new and improved formulation of its lead drug. The company recently announced positive top-line results from a Phase 1 bioavailability study of Aramchol Meglumine, a salt formulation designed to be superior to the original Aramchol free acid.

The results were significant, showing that the new meglumine granules demonstrated approximately three-to-five times higher bioavailability. This enhancement is not merely an incremental improvement; it is a game-changer for the drug's therapeutic and commercial profile. The increased absorption enables a convenient once-daily dosing regimen, a major factor in ensuring long-term patient adherence in chronic diseases and complex cancer treatment protocols. Furthermore, Galmed anticipates this new formulation could slash drug manufacturing costs by as much as 50%.

Perhaps most importantly from a strategic investment perspective, Aramchol Meglumine is protected as a New Chemical Entity (NCE), with patent protection extending until 2035. This secures a longer period of market exclusivity, dramatically enhancing the long-term value proposition of the entire Aramchol platform and making it a more attractive asset for potential partnerships or future commercialization across all its target indications.

A Broader Vision Beyond the Liver

Taken together, these developments paint a clear picture of a company undergoing a fundamental transformation. Galmed is leveraging Aramchol's unique mechanism as a "metabolic master switch" to build a diversified pipeline from a single asset. The strategic expansion into oncology, enabled by a stronger drug formulation and backed by a solid financial runway, repositions the company from a niche player in the crowded liver disease space to a contender in multiple high-value therapeutic areas.

This diversification strategy also extends to cardiometabolic diseases, where SCD1 inhibition is increasingly recognized as a promising therapeutic target for conditions like cardiac fibrosis. By pursuing multiple indications in parallel, Galmed is not only increasing its shots on goal but also mitigating the inherent risks of biopharmaceutical development. This is a sophisticated capital move that looks beyond a single clinical trial outcome and focuses on building a resilient, platform-based company poised for long-term growth.