Galmed Pharmaceuticals EOCN

Galmed Pharmaceuticals Ltd. is a biopharmaceutical company focused on the development of Aramchol a first in class oral SCD1 modulator. Aramchol is a synthetic conjugate of 3-amino cholic acid a modified bile acid and arachidic acid a saturated fatty acid. The molecule modulates the SCD1 enzyme reducing fat accumulation in the liver improving fatty acid oxidation and regulating cholesterol transport. This mechanism may also reduce inflammation and fibrosis in the liver and lower cardiovascular risks associated with NASH. The company historically concentrated on liver disease indications particularly nonalcoholic steatohepatitis or NASH. Galmed believes Aramchol can treat all stages of NASH in patients who are overweight or obese and have prediabetes or type II diabetes mellitus. In September 2019 the company initiated the Phase 3 ARMOR Study to evaluate Aramchol's efficacy and safety in NASH patients with fibrosis. In May 2023 Galmed initiated a new clinical program to evaluate Aramchol for primary sclerosing cholangitis a rare disease with no approved treatment. During 2024 the company entered a collaboration with the Massy Cancer Center at Virginia Commonwealth University to investigate Aramchol's role in preventing drug resistance to standard of care oncology agents in hepatoma cholangiocarcinoma and colorectal cancer. In April 2025 Galmed entered a sponsored research collaboration with VCU to study Aramchol's potential in overcoming drug resistance in gastrointestinal cancers. The company has recently reinitiated evaluating strategic options to optimize resources and enhance shareholder value. Galmed is currently seeking to advance Aramchol for combination therapy in gastrointestinal oncological indications while pursuing opportunities in biotech and medtech to expand its pipeline targeting gastrointestinal cardiometabolic and other indications.

Galmed Pharmaceuticals Ltd. generates revenue primarily through royalties and milestone payments from licensing agreements as it does not currently sell any commercial products. The company's main revenue source is its license agreement with Samil Pharma Co. Ltd. for the commercialization of Aramchol in South Korea for fatty liver indications including NASH. Under this agreement signed in July 2016 Samil paid an upfront fee of approximately two point one million dollars. In September 2018 Galmed received a milestone payment of one point five million dollars. The agreement provides for additional clinical and regulatory based milestone payments which may aggregate to four point five million dollars. Galmed is also entitled to receive tiered double digit royalties on sales of Aramchol in South Korea. The company has stated that it does not expect to generate revenue from other sources beyond royalties and milestones from the Samil Agreement. This expectation stems from the discontinuation of the open label part of the ARMOR Study which the company determined had reached its objectives. Following this decision Galmed does not currently anticipate initiating the second part of the ARMOR Study in the near term. At present Aramchol remains under clinical development and has not received regulatory approval for commercial sale in any jurisdiction.

Galmed Pharmaceuticals Ltd. operates in the competitive NASH treatment landscape which has seen increased activity in recent years. The company competes with firms such as Novo Nordisk which markets Wegovy for NASH treatment Madrigal Pharmaceuticals which markets Rezdiffra resmetirom for NASH with moderate to advanced liver fibrosis and Viking Therapeutics which has advanced clinical programs in the NASH space. According to epidemiological data nonalcoholic fatty liver disease affects approximately twenty five percent of the general population globally with much higher prevalence in high risk groups. In the United States alone eighty to one hundred million people are affected by NAFLD. Nonalcoholic steatohepatitis impacts an estimated three to five percent of the US population and two to four percent of the global population. NASH is associated with increased risk of liver cirrhosis liver failure hepatocellular carcinoma and cardiovascular diseases. Despite the significant patient population there were no approved therapeutic treatments for NASH until recent approvals. Grand View Research estimated the global NASH treatment market at seven point seven two billion dollars in 2024 projecting growth to thirty three point eight billion dollars by 2030 representing a compound annual growth rate of twenty eight point one percent from 2025 to 2030. Galmed's competitive advantage derives from Aramchol's unique mechanism as a partial SCD1 inhibitor which modulates rather than completely inhibits the enzyme. This approach avoids certain safety concerns observed with complete SCD1 inhibition such as atherosclerosis and skin disorders. The company has strengthened its position through a robust patent portfolio covering Aramchol and related compounds. Key patents include United States patent 10 849 911 B2 for low dose Aramchol composition with expected term until December 2034 United States patent 11 197 870 B2 for hepatic fibrosis treatment with expected term until 2037 and patents covering dysbiosis modulation and cancer treatment combinations. Galmed has also secured Fast Track designation from the FDA for Aramchol which facilitates expedited development and review processes.

Galmed Pharmaceuticals Ltd. currently serves research collaborators and licensing partners rather than direct patient customers as its products remain under development and have not received regulatory approval for commercial sale. The company's primary collaborative relationship is with Virginia Commonwealth University specifically through its Massey Cancer Center. In 2024 Galmed entered a collaboration agreement with VCU to investigate Aramchol's effect in preventing drug resistance to standard of care oncology agents in the treatment of hepatoma hepatocellular carcinoma cholangiocarcinoma and colorectal cancer. This collaboration was expanded in April 2025 with a sponsored research agreement focused on Aramchol's potential in overcoming drug resistance in gastrointestinal cancers. Galmed maintains a licensing agreement with Samil Pharma Co. Ltd. for the commercialization of Aramchol in South Korea covering fatty liver indications including NASH. The company has previously worked with the Hebrew University of Jerusalem on the development of Amilo 5MER a therapeutic candidate for inflammatory diseases though it is not actively pursuing clinical development of this asset and is seeking to out license it. For clinical trial execution Galmed relies on contract research organizations and has conducted studies across multiple regions including the United States Latin America Europe and Israel as evidenced by the geographic distribution of patients in the ARMOR Study. Upon successful regulatory approval Galmed anticipates serving patients diagnosed with NASH primary sclerosing cholangitis gastrointestinal cancers and other indications where Aramchol demonstrates therapeutic benefit. The company's customer base will also include healthcare providers and payors who will facilitate access to its approved therapies.