Announcement • May 15
Galmed Pharmaceuticals Ltd. Announces Results from First-In-Man Pharmacokinetics Study of Oral Formulation of Aramchol Meglumine Galmed Pharmaceuticals Ltd. announced major milestone results from a Phase 1 PK study in healthy subjects (Study AM-001). The overall objective of the study was to identify the dose of Aramchol meglumine (AM) administered once daily that produces similar exposure to Aramchol from 300mg Aramchol free acid (AA) tablets dosed twice daily. Single doses of AM granules for oral suspension of 400 mg and 200mg were evaluated and compared to AA 300mg tablet. The study demonstrated that the bioavailability of Aramchol from the Aramchol meglumine granules for oral suspension is considerably greater (approximately 5-fold and 3-fold respectively) than that from Aramchol free acid tablets. An additional PK study (AM-003) comparing AM 400mg tablets once daily with AA 300mg tablets twice daily is ongoing. Aramchol down-regulates stearoyl CoA desaturase 1 (SCD1) in hepatocytes and in hepatic stellate cells (HSC's) and other tissues including various cancers. Metabolic-dysfunction associated steatohepatitis (MASH) (previously called non-alcoholic steatohepatitis (NASH)) is a common serious type of fatty liver disease often leading to cirrhosis, liver failure and sometimes to hepatocellular carcinoma. In Phase 2 and Phase 3 (open label part) clinical trials 600mg Aramchol reduced liver fat, attenuated steatohepatitis and demonstrated robust anti-fibrotic effects. To date approximately 600 adults have received single or multiple doses of Aramchol free acid, including approximately 240 healthy subjects and 360 patients with MASH. Announcement • Apr 10
Galmed Pharmaceuticals Ltd. Announces Breakthrough Development of Brain Penetrating New Formulation of Aramchol Galmed Pharmaceuticals Ltd. announced the breakthrough development of a brain penetrating new formulation of Aramchol. 98% of drugs do not reach the brain, as the blood–brain barrier (BBB) separates peripheral blood circulation from the central nervous system (CNS). Galmed has developed, in collaboration with Barcode Nanotech, a unique proprietary formulation of Aramchol which targets the brain. By crossing the BBB, this new Aramchol formulation could become a disease modifying therapy for unmet chronic CNS diseases. Stearoyl-CoA desaturase (SCD1) has been identified as an important therapeutic target for CNS diseases (Parkinson disease and dementia) which are characterized by the aggregation of the protein a-synuclein (aSyn). In-vitro studies have demonstrated that Aramchol effectively down-regulated aSyn-aggregation in a dose dependent manner. Crossing of the blood-brain barrier (BBB) is an essential step to achieve effective treatment effects in Parkinson disease (PD) and other CNS diseases. The new Aramchol formulation is characterized by sequestration of the Aramchol in lipid nanoparticles which will be administered by subcutaneous injection for delivery across the BBB. This new Aramchol formulation was co-developed by Galmed and Barcode Nanotech, based on Barcode Nanotech's unique and proprietary platform which enables simultaneous screening of hundreds of different nanoparticle formulations in vivo, coupled with AI analysis tools to select the optimal delivery vehicle to the brain. There are currently no disease-modifying therapies available for treatment of PD or related synucleinopathies such as multiple systems atrophy (MSA) and dementia with Lewy bodies (DLB). These diseases are each characterized by presence of Lewy bodies enriched in aSyn protein and are thus collectively known as synucleinopathies. Recent evidence from cell-based screens of aSyn toxicity has identified stearoyl-CoA desaturase 1 (SCD1) as a potential target for treatment of synucleinopathies. Based on the evidence for the role of SCD1 inhibition in mitigating synucleinopathies, Galmed's breakthrough medicinal chemistry work converting Aramchol into a brain-penetrant SCD1 inhibitor position Aramchol as an attractive therapeutic asset for synucleinopathies such as Parkinson disease, multiple systems atrophy (MSA), dementia and other CNS indications of unmet need. Announcement • Dec 09
Galmed Pharmaceuticals Ltd. Announces Acceptance of Late-Breaking Abstract to Be Presented at HEP-DART 2025 Meeting Galmed Pharmaceuticals Ltd. announced the presentation of a late breaking abstract for its lead drug candidate, Aramchol at HEP-DART 2025 Meeting. Previously, Galmed announced that Aramchol significantly enhances Bayer's regorafenib effect in GI cancer models to kill GI tumor cells. SCD1 inhibition augments regorafenib (Stivarga) activity through ATM-AMPK-autophagy signaling. These findings provide the scientific and translational rationale for the initiation of a Phase 1/2 clinical trial of the combination of standard of care regorafenib with the SCD1 inhibitor Aramchol in HCC and other GI cancers. Once a recommended Phase 2 dose is found, Galmed plans to add a dose expansion cohort that will include Metformin and will evaluate the 3-drugs' combination efficacy. Announcement • Dec 04
Galmed Announces Grant of New Use Patents for the Combination of Aramchol and Madrigal Pharmaceuticals' Rezdiffra (Resmetirom) for Mash Galmed announced Grant of New Use Patents for the combination of Aramchol and Madrigal Pharmaceuticals' Rezdiffra (Resmetirom) for MASH. The new patent granted in South Korea is added to earlier patents already granted by the United States Patent and Trademark Office (USPTO), Europe, Canada and other jurisdictions and will expire in the U.S. in July 2042. Aramchol is a first-in-class, Phase 3 ready, drug candidate, that showed robust fibrosis improvement in advanced clinical studies. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause the actual results to differ materially from any future results expressed or implied by the forward-looking statements, including, but not limited to, the development and approval of the use of Aramchol or any other product candidate for indications outside of non-alcoholic steatohepatitis, or NASH, also known as metabolic dysfunction-associated steatohepatitis, and fibrosis or in combination therapy; the timing and cost of any pre-clinical or clinical trials of Aramchol or any Other product candidate by physicians and patients; the timing, cost or other aspects of the commercial launch of Aramchol and any other product candidate; ability to obtain and maintain adequate protection of intellectual property; the possibility that they may face third-party claims of intellectual property infringement; ability to manufacture product candidates in commercial quantities, at an adequate quality or at an acceptable cost; ability to establish adequate sales, marketing and distribution channels; intense competition in industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than the expectations regarding licensing, acquisitions and strategic operations; current or future favorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; the security, political and economic instability in the Middle East that could harm its business, including due to the current security situation in Israel, risks relating to digital asset management strategy, including the highly volatile nature of the price of cryptocurrencies and other digital assets, the risk that our share price may be highly correlated to the price of the cryptocurrencies and other digital assets that we may hold, risks related to increased competition in the industries in which we do and will operate, risks relating to significant legal, commercial, regulatory and technical uncertainty regarding cryptocurrencies and other digital assets generally, risks relating to the treatment of crypto assets for U.S. and foreign tax purposes and those risks and uncertainties identified in Exhibit 99.2 to Report of Foreign Private Issuer on Form 6-K filed with the Securities and Exchange Commission ("SEC") on August 25, 2025. Announcement • Nov 19
Galmed Pharmaceuticals Ltd. Announces Meaningful Top Line Results from AM-001 Study of Aramchol Meglumine Galmed Pharmaceuticals Ltd. announced meaningful top-line results from Galmed's AM-001 Study, a Phase 1 Bioavailability (BA) Study of Aramchol meglumine. The AM-001 study was designed to help identify the optimal doses for advancing Aramchol meglumine into the upcoming oncology Phase 2 studies planned for H1 2026. The study compared the relative BA of Aramchol meglumine granules to Aramchol free acid tablets in 30 healthy volunteers. The study results demonstrated that the BA of Aramchol from the Aramchol meglumine granules is considerably greater than that from Aramchol free acid tablets. The BA of 400mg and 200mg Aramchol meglumine granules were approximately 5-fold and 3-fold respectively, from that of the Aramchol free acid 300 mg tablets. To date, Galmed has successfully advanced Aramchol through six clinical trials (up to Phase 3) enrolling 661 patients, establishing both its overall excellent tolerability, safety and efficacy in treating NASH (MASH) under the IND 505(b)1regulatory pathway. In addition, 82 healthy subjects to date have received Aramchol meglumine under a clinical trial application (CTA) in the United Kingdom. Announcement • Sep 22
Galmed Pharmaceuticals Ltd., Annual General Meeting, Oct 28, 2025 Galmed Pharmaceuticals Ltd., Annual General Meeting, Oct 28, 2025. Location: 16 abba hillel silver rd ramat gan, 5250608, Israel 