GLMD

Results from Study AM-001 mark a pivotal advance through the transition to a once daily lower 400mg dose of AM enabling: Production of GMP clinical batch for Galmed's upcoming clinical trials Solidification and prolongation of Aramchol's IP protection Potential reduction in drug CoGs by ~50% Improvement in patients' convenience and compliance upon potential commercialization RAMAT-GAN, Israel, May 14, 2026 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver disease and GI oncological therapeutics, announced today 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 ~ 600 adults have received single or multiple doses of Aramchol free acid, including ~240 healthy subjects and 360 patients with MASH. Allen Baharaff, Galmed's Co-founder and CEO, commented: "A once daily lower dose of Aramchol meglumine is advantageous for compliance as monotherapy or in combination with other MASH candidates. Aramchol is currently being evaluated in multiple pre-clinical studies to overcome drug resistance and enhance the efficacy o...

TEL AVIV, Israel, March 31, 2026 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, cardiometabolic diseases and GI oncological therapeutics, today announced that it has filed its Annual Report on Form 20-F for the fiscal year ended December 31, 2025, with the U.S. Securities and Exchange Commission (the 'SEC'). The report is available on the SEC's website, at www.sec.gov and Galmed's Investor Relations website, at https://galmedpharma.investorroom.com/sec-filings. Shareholders can obtain copies of Galmed's Annual Report on Form 20-F, free of charge, by making a request within a reasonable period of time to Galmed's Investor Relations Department at [email protected]. About Galmed Pharmaceuticals Ltd. We are a biopharmaceutical company focused on the development of Aramchol. We have focused almost exclusively on developing Aramchol for the treatment of liver diseases, and continue to actively advance Aramchol for the treatment of combination therapy for NASH. We are also seeking to develop Aramchol for certain oncological indications outside of NASH and fibrosis. In addition, as part of our growth strategy, we are actively pursuing opportunities to expand and diversify our product pipeline specifically targeting cardiometabolic indications and other innovative product candidates that align with our core expertise in drug development. Forward-Looking Statements Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to the potential synergistic effect of Aramchol, Stivargaﾮ and Metformin as a new fixed-dose combination treatment, the expected timing of clinical trials, future clinical development and creating value for investors and stakeholders. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not lim...

TEL AVIV, Israel, Nov. 26, 2025 /PRNewswire/ —Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company focused on liver, cardiometabolic, and gastrointestinal oncology indications, reports financial results for the three and nine months ended September 30, 2025 and recent developments. Financial Summary – Third Quarter 2025 vs. Third Quarter 2024 Cash and cash equivalents, short term deposits, restricted cash and marketable debt securities totaled approximately $19.2 million as of September 30, 2025, compared to approximately $15.4 million at December 31, 2024. Net loss amounted to approximately $2.0 million, or $0.33 per share, for the three months ended September 30, 2025, compared to a net loss of approximately $1.9 million, or $2.31 per share, for the three months ended September 30, 2024. Research and development expenses amounted to approximately $1.1 million for the three months ended September 30, 2025, compared to approximately $0.7 million for the three months ended September 30, 2024. The increase resulted primarily from clinical and pre-clinical studies expenses. General and administrative expenses amounted to approximately $1.0 million for the three months ended September 30, 2025, compared to approximately $1.3 million for the three months ended September 30, 2024. The decrease resulted primarily from decrease in salaries and benefit expenses. Financial income, net amounted to approximately $0.2 million for the three months ended September 30, 2025, compared to financial income of $0.1 million for the three months ended September 30, 2024. Recent Business Updates On November 17, 2025, Galmed announced top-line results from its joint research with Virginia Commonwealth University (VCU) evaluating Aramchol's effect on overcoming drug resistance in gastrointestinal (GI) cancers, which showed that a 3-drug combination of Aramchol, Stivarga® and Metformin significantly enhanced gastrointestinal tumor cells, killing in-vivo and in-vitro On November 18, 2025, Galmed announced meaningful top-line results from its AM-001 Study, a Phase 1 bioavailability study of Aramchol Meglumine During 2025, Galmed raised approximately $9.3 million through its equity line and ATM facilities. About Galmed Pharmaceuticals Ltd. We are a biopharmaceutical company focused on the development of Aramchol. We have focu...

RAMAT GAN, Israel (AP) — RAMAT GAN, Israel (AP) — Galmed Pharmaceuticals Ltd. (GLMD) on Wednesday reported a loss of $1.9 million in its third quarter. The Ramat Gan, Israel-based company said it had a loss of 33 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on GLMD at https://www.zacks.com/ap/GLMD

The top-line results showed that bioavailability of Aramchol meglumine 400mg and 200mg granules is considerably greater, higher by 5-fold and 3-fold respectively, that of the Aramchol free acid 300mg tablets The new unexpected PK profile allows for a once daily therapeutic regimen thus potentially improving long term adherence and expected to significantly reduce the drug cost of goods RAMAT-GAN, Israel, Nov. 18, 2025 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company focused on liver, cardiometabolic, and gastrointestinal oncology indications, today 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. Allen Baharaff, President and CEO of Galmed Pharmaceuticals commented: "Aramchol is the most advanced down regulator of SCD-1 (Stearoyl – CoA desaturase) in clinical development. Inhibition of SCD-1 has been recently investigated in multiple indications, re-emphasizing its metabolic master switch potential and importance in multiple organs and indications. Based on these outcomes, 400mg oral once daily administration appears to be the optimal dose for Galmed's subsequent clinical trials. A once-daily administration of Aramchol meglumine in lieu of the twice daily administration of Aramchol is an important milestone in the drug develo...

The top-line results from the study showed that the 3-drugs' synergistic effect has the potential as a new fixed-dose combination treatment, enhancing the effect of Bayer's top selling cancer drug, Stivarga® (regorafenib); such combination could potentially become a life-cycle IP strategy when Stivarga's® main European and U.S. patents expires in August 2028 and July 2032, respectively. New patent applications (US 63/786,370 and US 63/915,832) have been submitted to USPTO. Metformin is typically the first-choice treatment for managing type 2 diabetes and is widely available in generic forms. The combination of Aramchol and Stivarga® is expected to enter phase 1b clinical trials early 2026 in metastatic colorectal cancer (CRC), hepatocellular (HCC) and cholangiocarcinoma patients with a planned expansion cohort including metformin. RAMAT-GAN, Israel, Nov. 17, 2025 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, cardiometabolic diseases and GI oncological therapeutics, announced today results from its joint research with Virginia Commonwealth University (VCU) evaluating Aramchol's effect on overcoming drug resistance in gastrointestinal (GI) cancers. The collaboration is based on breakthrough findings published in Nature Communications linking Aramchol to overcome cancer drug resistance. Previously in May 2025, Galmed announced that Aramchol significantly enhances Bayer's regorafenib effect in GI cancer models to kill GI tumor cells. In that study, Aramchol enhanced both flux and autolysosome formation caused by Regorafenib, activating ATM and AMPK and inactivating mTORC1 and mTORC2 pathways. In addition, Regorafenib and Aramchol interacted to suppress tumor growth in hepatoma models without normal tissue toxicities. Today's announced top line results include new data regarding the synergetic effects of Aramchol and Stivarga® with Metformin. In this latest study, Aramchol demonstrated the mechanism of action of Aramchol's anti-tumor abilities, alone or when combined with the mutli-kinase inhibitor regorafenib and the type 2 diabetes drug, Metformin, suggesting a synergistic effect and potential for fixed dose combination for treatment. Allen Baharaff, President and CEO of Galmed Pharmaceuticals commented: "Stivarga® (regorafenib) is indicated as standard-of-care third...

TEL AVIV, Israel, Aug. 28, 2025 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for cardiometabolic diseases and GI oncological indications, reports financial results for the three and six months ended June 30, 2025 and recent developments. Recent Business Updates In August 2025, Galmed announced that it has adopted a digital asset management strategy as part of a new treasury investment policy and capital allocation initiative to enhance capital efficiency and drive shareholder value. Accordingly, the Company established a Crypto Committee of the Board, which is evaluating and, if appropriate, will oversee the implementation of any crypto investing related activities, including a potential allocation of up to 50% of the Company's cash reserves to be used for the purchase of digital assets, which is currently about $10 million, to be deployed in execution of active digital asset management strategy which may include covered call options, staking, lending, and yield-generating protocols. To pursue the new strategy, Galmed is in the process of engaging Tectona Ltd. (TASE:TECT), a specialized crypto treasury management service provider, to advise and implement digital asset strategy by Galmed. Also in August 2025, Galmed entered into a termination agreement of a previously announced binding term sheet that was entered into with Entomus s.r.o. for an exclusive license to develop and commercialize a Self-Emulsifying Drug Delivery System (SEDDS) formulation. Following additional due diligence and discussions between the parties, the Company has decided to modify and de-risk the structure of its participation so that the Company will not lead the project. Instead, a new UK-based company has been established by Allen Baharaff, the Galmed CEO, for the development and commercialization of the SEDDS formulation in which it is contemplated that Galmed will acquire up to 20% of its share capital through an investment of up to $2 million, subject to execution of definitive documentation and approval of Galmed's board of directors. Financial Summary – Second Quarter 2025 vs. Second Quarter 2024 Cash and cash equivalents, short term deposits, restricted cash and marketable debt securities totaled approximately $20.7 million as of June 30, 2025, compared to approximately $15.4 million at Decem...

RAMAT GAN, Israel (AP) — RAMAT GAN, Israel (AP) — Galmed Pharmaceuticals Ltd. (GLMD) on Thursday reported net income of $2.5 million in its second quarter. On a per-share basis, the Ramat Gan, Israel-based company said it had net income of 63 cents. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on GLMD at https://www.zacks.com/ap/GLMD

TEL AVIV, Israel, May 22, 2025 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for cardiometabolic diseases and GI oncological indications, reports financial results for the three months ended March 31, 2025 and recent developments. Key Recent Developments Announced First Time Results in Oncology Studies: Aramchol Significantly Enhances Bayer's Regorafenib Effect in GI Cancer Models Signed Term Sheet for the Development of Novel Semaglutide Sublingual Formulation Raised $6.5 million since the beginning of 2025. Company's current cash balance is $20.1 million Financial Summary – First Quarter 2025 vs. First Quarter 2024*: Cash and cash equivalents, short term deposits, restricted cash and marketable debt securities totaled approximately $15.9 million as of March 31, 2025, compared to approximately $15.4 million at December 31, 2024. During May 2025, the Company raised an additional $5.0 million. As a result, as of the date hereof, the Company's current cash balance is approximately $20.1 million. Net loss amounted to approximately $1.1 million, or $0.62 per share, for the three months ended March 31, 2025, compared to a net loss of approximately $1.3 million, or $2.76 per share, for the three months ended March 31, 2024. Research and development expenses amounted to approximately $0.6 million for the three months ended March 31, 2025, compared to approximately $0.6 million for the three months ended March 31, 2024. General and administrative expenses amounted to approximately $0.6 million for the three months ended March 31, 2025, compared to approximately $0.8 million for the three months ended March 31, 2024. The decrease in general and administrative expenses for the three months ended March 31, 2023 resulted primarily from a decrease in professional services expenses. Financial income, net amounted to approximately $0.2 million for the three months ended March 31, 2025, compared to financial income of $0.1 million for the three months ended March 31, 2024. About Galmed Pharmaceuticals Ltd. We are a biopharmaceutical company focused on the development of Aramchol. We have focused almost exclusively on developing Aramchol for the treatment of liver disease and we are currently seeking to advance the development of Aramchol for oncological indications outside of NASH and fibro...

RAMAT GAN, Israel (AP) — RAMAT GAN, Israel (AP) — Galmed Pharmaceuticals Ltd. (GLMD) on Thursday reported a loss of $1.1 million in its first quarter. On a per-share basis, the Ramat Gan, Israel-based company said it had a loss of 62 cents. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on GLMD at https://www.zacks.com/ap/GLMD

Results from studies at Virginia Commonwealth University (VCU) show that an Aramchol and Bayer's Regorafenib drug combination significantly reduced hepatic tumor growth in mice models. The cell killing effect in-vitro and in-vivo was due to increased autophagy and death receptor signaling. A Phase 1b Study of the addition of Aramchol to Regorafenib in patients with advanced GI cancers is planned to be initiated at VCU's Massey Cancer Center in Q4 2025. Leveraging on its long-standing experience in liver and metabolic diseases, Galmed plans to advance the novel combination oncology program in parallel to the recently announced Semaglutide GLP-1 development. TEL AVIV, Israel, May 6, 2025 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for cardiometabolic diseases and GI oncological therapeutics, announced today that the first set of oncology studies has shown that Aramchol enhances the liver / colorectal cancer-approved therapeutic Regorafenib effects in liver and colon cancers in-vitro and in-vivo models. Aramchol interacted with the multi-kinase inhibitors Sorafenib, Regorafenib and Lenvatinib, to kill GI tumor cells, with Regorafenib exhibiting the greatest effect. Aramchol enhanced both flux and autolysosome formation caused by Regorafenib, activating ATM and AMPK and inactivating mTORC1 and mTORC2 pathways. In addition, Regorafenib and Aramchol interacted to suppress tumor growth in hepatoma models without normal tissue toxicities. Paul Dent, Ph.D. Professor School of Medicine Biochemistry and Molecular Biology Virginia Commonwealth University commented: "The key molecular mechanisms by which Aramchol and Regorafenib killed GI tumor cells were defined in the study. Aramchol acts to enhance autophagy through mechanisms that are different to those of Regorafenib. The interaction between Aramchol and Regorafenib, causing more autophagic flux and autolysosome formation, is required for the enhanced killing of tumor cells by the drug combination." Allen Baharaff, President and CEO of Galmed Pharmaceuticals commented: "Targeting lipid metabolism with Aramchol, a potent SCD1 inhibitor, is a promising emerging strategy to overcome TKIs, such as Sorafenib, Regorafenib or Lenvatinib, for therapy resistance in HCC and colorectal cancers. A combination of Bayer's Regorafenib and Aramch...

– AM-001 Study represents a pivotal milestone in Galmed's transition to Aramchol Meglumine, an improved formulation of its lead compound in advanced clinical development – Aramchol Meglumine, a New Chemical Entity (NCE) protected by patents until 2035, is being developed both as a standalone agent and in novel drug combinations for multiple indications influenced by fatty acid metabolism – Initial findings suggest that the new Aramchol Meglumine formulation offers higher bioavailability than Aramchol free acid and that a once-daily, oral 200 mg dose is likely to be optimal for future trials, supporting improved patient compliance and potentially lowering manufacturing costs TEL AVIV, Israel, April 10, 2025 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company focused on liver, cardiometabolic, and gastrointestinal oncology indications, today announced positive preliminary results from Part 1 of the Ph1 Bioavailability AM-001 Study of Aramchol Meglumine. Galmed has successfully advanced Aramchol acid through six clinical trials (up to Ph3) enrolling 661 subjects, establishing both its overall safety and its efficacy in treating NASH (MASH). The N-methylglucamine (meglumine) salt of Aramchol exhibits notable advantages over Aramchol acid, including enhanced solubility, absorption, and systemic exposure, translating to higher bioavailability. In recognition of these benefits, Aramchol Meglumine received NCE patent protection extending until 2035. Previously, the FDA approved the transition from Aramchol acid to Aramchol Meglumine under a new IND, leveraging cross-reference to the substantial preclinical and clinical data amassed in recent years for Aramchol. The only requirement for this transition was a bioavailability study to compare the two formulations. The AM-001 study was conducted in response to that FDA request and is also designed to help identify the doses best suited for advancing Aramchol Meglumine into Phase 2 studies. It consists of two parts, comparing single doses of Aramchol acid and Aramchol Meglumine in healthy volunteers. Part 2 of the study is anticipated to conclude in the second half of 2025. In Part 1 of AM-001, preliminary results demonstrate that a 400 mg dose of Aramchol Meglumine suspension achieved an area under the curve (AUC) nearly double that of Aramch...