Evaluate the exposure of of Aramchol from 2 different single doses of Aramchol meglumine tablet and to compare the exposure of steady state from a selected dose of Aramchol meglumine tablet.

Start Date25 Dec 2025

Sponsor / Collaborator

Galmed Pharmaceuticals Ltd.

NCT06095986

/ WithdrawnPhase 2

A Proof of Concept, Prospective, Randomized, Placebo-controlled, Double-blind, Study to Evaluate the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Patients With Primary Sclerosing Cholangitis

The objectives of this study is to Evaluate the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Patients with Primary Sclerosing Cholangitis

Start Date01 Jun 2025

Sponsor / Collaborator

Galmed Pharmaceuticals Ltd.

[+1]

NCT06502561

/ Active, not recruitingPhase 1

A Phase 1 Relative Bioavailability Study Comparing The Pharmacokinetics Of Aramchol Meglumine Granules For Oral Suspension To Aramchol Free Acid 300 mg Tablets In Healthy Volunteers

This is a Phase 1 Relative Bioavailability Study Comparing The Pharmacokinetics Of Aramchol Meglumine Granules For Oral Suspension To Aramchol Free Acid 300 mg Tablets In Healthy Volunteers

Start Date15 Feb 2025

Sponsor / Collaborator

Galmed Pharmaceuticals Ltd.

100 Clinical Results associated with Icomidocholic acid

100 Translational Medicine associated with Icomidocholic acid

100 Patents (Medical) associated with Icomidocholic acid

Literatures (Medical) associated with Icomidocholic acid

14 Oct 2025·ACS Omega

Targeting Stearoyl-CoA Desaturase-1 (SCD1) by the Drug–Nutraceutical Combination of Montelukast and Bixin in Ameliorating Steatotic NAFLD

Article

Author: Sankaranarayanan, Murugesan ; Sharma, Pankaj Kumar ; Deepa, Perinkulam Ravi ; Puri, Sonakshi ; Dash, Shubhashree ; Kirad, Shivani

Nonalcoholic fatty liver disease (NAFLD) is a hepatic manifestation of metabolic syndrome, which progresses from simple fat accumulation (steatosis) to nonalcoholic steatohepatitis (NASH), fibrosis, and eventually liver cancer. Stearoyl-CoA desaturase 1 (SCD1), a key lipogenic enzyme, plays a significant role in the progression of NAFLD by promoting the accumulation of fat in the liver. This study investigated the drug-nutraceutical combination of Montelukast (a synthetic anti-inflammatory drug) and Bixin (an apo-carotenoid) as SCD1 inhibitors for treating fatty liver disease. Bixin was identified through virtual screening of a curated carotenoid database (carotenoid DB) targeting lipogenic enzyme SCD1. In the in vitro model of steatotic HepG2 cells, the combination treatment of Montelukast and Bixin showed a marked reduction (P < 0.05) in SCD1 gene expression (41%), protein expression (61%), and SCD1 enzyme activity (56.22%). The combination treatment showed a significant reduction of 21.64% (P < 0.05) in lipid accumulation relative to individual treatment with Bixin or Montelukast and was comparable with the reference drug Aramchol (21.83%). The markers of oxidative stress were also significantly reduced (P < 0.05), evidenced by decreased MDA (42.25%), RNS levels (32.59%), and ROS levels (30.72%) in the combination group. These findings suggest that Bixin and Montelukast in combination hold potential for managing the multiple aspects in the pathophysiology of NAFLD development and progression.

19 Aug 2025·Oncotarget

The SCD1 inhibitor aramchol interacts with regorafenib to kill GI tumor cells in vitro and in vivo

Article

Author: Yue, Yang ; Kinsey, Emily ; Roberts, Jane L. ; Dent, Paul ; Booth, Michael R. ; Poklepovic, Andrew ; Boone, David ; Baharaff, Allen ; Cowhart, L. Ashley ; Booth, Laurence

The anti-tumor actions of the Stearoyl-CoA desaturase (SCD1) inhibitor aramchol in tumor cells remains poorly understood. Aramchol interacted with the multi-kinase inhibitors sorafenib, regorafenib or lenvatinib, to kill GI tumor cells, with regorafenib exhibiting the greatest effect. In HCT116 cells homozygous for the autophagy-regulatory protein ATG16L1 T300, aramchol and regorafenib interacted to activate ATM and the AMPK and to inactivate mTORC1 and mTORC2. As a single agent, regorafenib inactivated eIF2α and it combined with aramchol to elevate GRP78 expression. In HCT116 cells expressing the ATG16L1 A300 isoform the drug-induced dephosphorylation of mTORC1 S2448 and mTORC2 S2481 and the increased phosphorylation of eIF2α S51 were significantly lower than in T300 cells. In cells expressing ATG16L1 T300, but not A300, regorafenib and/or the drug combination inactivated AKT, ERK1/2 and p70 S6K. Regorafenib and aramchol interacted to cause formation of autophagosomes which was significantly greater in cells expressing ATG16L1 T300. Aramchol as a single agent did not stimulate autophagic flux but further enhanced both flux and autolysosome formation caused by regorafenib. Knock down of Beclin1 reduced the lethality of regorafenib and aramchol as single agents and when combined whereas knock down of LAMP2 or BID did not reduce killing caused by aramchol as a single agent but did reduce the lethality of regorafenib alone and regorafenib plus aramchol. In vivo using the HuH7 adult hepatoma cell line, regorafenib and aramchol interacted to suppress tumor growth without normal tissue toxicities.

01 Mar 2025·HEPATOLOGY

Aramchol improves hepatic fibrosis in metabolic dysfunction–associated steatohepatitis: Results of multimodality assessment using both conventional and digital pathology

Article

Author: Friedman, Scott L. ; Eyal, Eli ; Cummings, Oscar W ; Sanyal, Arun J. ; Petitjean, Mathieu ; Chen, Li ; Friedman, Scott L ; Cummings, Oscar W. ; Yilmaz, Yusuf ; Kadosh, Shaul ; Lazas, Don ; Sanyal, Arun J ; Behling, Cynthia ; Gilgun-Sherki, Yossi ; Lackner, Caroline ; Ratziu, Vlad ; Gorfine, Tali

Background and Aims::

Antifibrotic trials rely on conventional pathology despite recognized limitations. We compared single-fiber digital image analysis with conventional pathology to quantify the antifibrotic effect of Aramchol, a stearoyl-CoA desaturase 1 inhibitor in development for metabolic dysfunction–associated steatohepatitis.

Approach and Results::

Fifty-one patients with metabolic dysfunction–associated steatohepatitis enrolled in the open-label part of the ARMOR trial received Aramchol 300 mg BID and had paired pre-post treatment liver biopsies scored by consensus among 3 hepatopathologists, and separately assessed by a digital image analysis platform (PharmaNest) that generates a continuous phenotypic Fibrosis Composite Severity (Ph-FCS) score. Fibrosis improvement was defined as: ≥1 NASH Clinical Research Network (NASH-CRN) stage reduction; “improved” by ranked pair assessment; reduction in Ph-FCS (“any” for ≥0.3 absolute reduction and “substantial” for ≥25% relative reduction). Fibrosis improved in 31% of patients (NASH-CRN), 51% (ranked pair assessment), 74.5% (any Ph-FCS reduction), and 41% (substantial Ph-FCS reduction). Most patients with stable fibrosis by NASH-CRN or ranked pair assessment had a Ph-FCS reduction (a third with substantial reduction). Fibrosis improvement increased with treatment duration: 25% for <48 weeks versus 39% for ≥48 weeks by NASH-CRN; 43% versus 61% by ranked pair assessment, mean Ph-FCS reduction −0.54 (SD: 1.22) versus −1.72 (SD: 1.02); Ph-FCS reduction (any in 54% vs. 100%, substantial in 21% vs. 65%). The antifibrotic effect of Aramchol was corroborated by reductions in liver stiffness, Pro-C3, and enhanced liver fibrosis. Changes in Ph-FCS were positively correlated with changes in liver stiffness.

Conclusions::

Continuous fibrosis scores generated in antifibrotic trials by digital image analysis quantify antifibrotic effects with greater sensitivity and a larger dynamic range than conventional pathology.

News (Medical) associated with Icomidocholic acid

17 Nov 2025

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Galmed Announces Top-line Results in Oncology MoA Studies: A 3-drug combination of Aramchol, Stivarga® and Metformin Significantly Enhanced GI Tumor Cells, Killing In-vivo and In-vitro

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 line treatment in metastatic colorectal cancer (CRC), as well as advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST), and hepatocellular carcinoma. Monoclonal antibodies (MABs), such as atezolizumab & bevacizumab, are the first-line therapy for these patients. However, it is estimated that since around 75% of patients develop resistance or intolerance to MABs and because of their high cost, the cost effectiveness is limited. Stivarga® is Bayer's top selling cancer drug, which generated €458 million (~$500 million) in the first nine months of 2022, up 28% from 2021. The main patent protection for regorafenib is expected to expire in August 2028 in Europe and July 2032 in the U.S., potentially resulting in generic versions of regorafenib becoming available, which could significantly affect Bayer's market share. Based on the top-line results, a fixed dose combination with Aramchol has shown that such combination could potentially become a life-cycle IP strategy for regorafenib to help delay the generic competition." Mr. Baharaff continued "We are looking forward to initiating our Phase 1b study at VCU Massey Comprehensive Cancer Center, which is expected to commence in early 2026. This Phase 1b study will also serve as a proof-of-concept on Aramchol's efficacy in an oncology clinical setting. Positive findings could lay the groundwork for subsequent accelerated clinical development of Aramchol in key three GI cancers, which if successful, could potentially expand Galmed's pipeline and create value for investors and stakeholders." 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 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, Stivarga® and Metformin as a new fixed-dose combination treatment, how such 3-drug combination could potentially become a life-cycle IP strategy, 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 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, or MASH, and fibrosis or in combination therapy; the timing and cost of any pre-clinical or clinical trials of Aramchol or any other product candidate we develop; completion and receiving favorable results of any pre-clinical or clinical trial; regulatory action with respect to Aramchol or any other product candidate by the U.S. Food and Drug Administration, or the FDA, or the European Medicines Authority, or EMA, including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling; the commercial launch and future sales of Aramchol and any future product candidates; our ability to comply with all applicable post-market regulatory requirements for Aramchol, or any other product candidate in the countries in which we seek to market the product; our ability to achieve favorable pricing for Aramchol, or any other product candidate; third-party payor reimbursement for Aramchol, or any other product candidate; our estimates regarding anticipated capital requirements and our needs for additional financing; market adoption of Aramchol or any other product candidate by physicians and patients; the timing, cost or other aspects of the commercial launch of Aramchol or any other product candidate; our ability to obtain and maintain adequate protection of our intellectual property; the possibility that we may face third-party claims of intellectual property infringement; our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; our ability to establish adequate sales, marketing and distribution channels; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; our expectations regarding licensing, acquisitions and strategic operations; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; our ability to maintain the listing of our ordinary shares on The Nasdaq Capital Market; the security, political and economic instability in the Middle East that could harm our business, including due to the current security situation in Israel, risks relating to our 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 our Report of Foreign Private Issuer on Form 6-K filed with the Securities and Exchange Commission ("SEC") on August 25, 2025. We believe these forward-looking statements are reasonable; however, these statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in our Annual Report on Form 20-F for the year ended December 31, 2024, filed with the SEC on April 2, 2025 in greater detail under the heading "Risk Factors." Given these uncertainties, you should not rely upon forward-looking statements as predictions of future events. All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date hereof and are expressly qualified in their entirety by the cautionary statements included in this report. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties. Logo: SOURCE Galmed Pharmaceuticals Ltd. 21% more press release views with Request a Demo

Phase 1Clinical ResultPatent Expiration

28 Aug 2025

·www.prnewswire.com

Galmed Pharmaceuticals Reports Second Quarter 2025 Financial Results and Provides Business Update

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 December 31, 2024. As of June 30, 2025, the Company raised $7.6 million during 2025, mostly through its ATM facility. Net loss amounted to approximately $2.5 million, or $0.63 per share, for the three months ended June 30, 2025, compared to a net loss of approximately $1.1 million, or $2.16 per share, for the three months ended June 30, 2024. Research and development expenses amounted to approximately $1.1 million for the three months ended June 30, 2025, compared to approximately $0.5 million for the three months ended June 30, 2024. The increase resulted primarily from clinical and pre-clinical studies expenses. General and administrative expenses amounted to approximately $1.1 million for the three months ended June 30, 2025, compared to approximately $0.7 million for the three months ended June 30, 2024. The increase resulted primarily from an increase in salaries and benefit expenses. Financial income, net amounted to approximately $0.2 million for the three months ended June 30, 2025, compared to financial income of $0.1 million for the three months ended June 30, 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 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 our product development efforts, business, financial condition, results of operations, strategies or prospects, and our plans to implement a digital asset management strategy and prospects of our digital asset management strategy, as well as statements, other than historical facts, that address activities, events or developments that we intend, expect, project, believes or anticipate will or may occur in the future. 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 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, or MASH, and fibrosis or in combination therapy; the timing and cost of any pre-clinical or clinical trials of Aramchol or any other product candidate we develop; completion and receiving favorable results of any pre-clinical or clinical trial; regulatory action with respect to Aramchol or any other product candidate by the U.S. Food and Drug Administration, or the FDA, or the European Medicines Authority, or EMA, including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling; the commercial launch and future sales of Aramchol and any future product candidates; our ability to comply with all applicable post-market regulatory requirements for Aramchol, or any other product candidate in the countries in which we seek to market the product; our ability to achieve favorable pricing for Aramchol, or any other product candidate; third-party payor reimbursement for Aramchol, or any other product candidate; our estimates regarding anticipated capital requirements and our needs for additional financing; market adoption of Aramchol or any other product candidate by physicians and patients; the timing, cost or other aspects of the commercial launch of Aramchol or any other product candidate; our ability to obtain and maintain adequate protection of our intellectual property; the possibility that we may face third-party claims of intellectual property infringement; our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; our ability to establish adequate sales, marketing and distribution channels; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; our expectations regarding licensing, acquisitions and strategic operations; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; our ability to maintain the listing of our ordinary shares on The Nasdaq Capital Market; and security, political and economic instability in the Middle East that could harm our business, including due to the current security situation in Israel. We believe these forward-looking statements are reasonable; however, these statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in our Annual Report on Form 20-F for the year ended December 31, 2024 filed with the SEC on April 2, 2025 in greater detail under the heading "Risk Factors." Given these uncertainties, you should not rely upon forward-looking statements as predictions of future events. All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date hereof and are expressly qualified in their entirety by the cautionary statements included in this report. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties. express an opinion or any other form of assurance with respect thereto. This preliminary financial information is not a comprehensive statement of the company's financial results for this period. Logo - SOURCE Galmed Pharmaceuticals Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Financial StatementLicense out/in

22 May 2025

·www.prnewswire.com

Galmed Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides Business Update

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 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 our product development efforts, business, financial condition, results of operations, strategies or prospects, as well as statements, other than historical facts, that address activities, events or developments that we intend, expect, project, believes or anticipate will or may occur in the future. 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 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, or MASH, and fibrosis or in combination therapy; the timing and cost of any pre-clinical or clinical trials of Aramchol or any other product candidate we develop; completion and receiving favorable results of any pre-clinical or clinical trial; regulatory action with respect to Aramchol or any other product candidate by the U.S. Food and Drug Administration, or the FDA, or the European Medicines Authority, or EMA, including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling; the commercial launch and future sales of Aramchol and any future product candidates; our ability to comply with all applicable post-market regulatory requirements for Aramchol, or any other product candidate in the countries in which we seek to market the product; our ability to achieve favorable pricing for Aramchol, or any other product candidate; third-party payor reimbursement for Aramchol, or any other product candidate; our estimates regarding anticipated capital requirements and our needs for additional financing; market adoption of Aramchol or any other product candidate by physicians and patients; the timing, cost or other aspects of the commercial launch of Aramchol or any other product candidate; our ability to obtain and maintain adequate protection of our intellectual property; the possibility that we may face third-party claims of intellectual property infringement; our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; our ability to establish adequate sales, marketing and distribution channels; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; our expectations regarding licensing, acquisitions and strategic operations; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; our ability to maintain the listing of our ordinary shares on The Nasdaq Capital Market; and security, political and economic instability in the Middle East that could harm our business, including due to the current security situation in Israel. We believe these forward-looking statements are reasonable; however, these statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in our Annual Report on Form 20-F for the year ended December 31, 2024 filed with the SEC on April 2, 2025 in greater detail under the heading "Risk Factors." Given these uncertainties, you should not rely upon forward-looking statements as predictions of future events. All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date hereof and are expressly qualified in their entirety by the cautionary statements included in this report. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties. * This unaudited preliminary financial information regarding the company's financial results for the three months and quarter ended March 31, 2025, is based upon the estimates and subject to completion of the company's quarter-end financial results. Moreover, this financial information has been prepared solely on the basis of currently available information by, and is the responsibility of, management. The company's independent registered public accounting firm has not audited, reviewed or performed any procedures with respect to such preliminary estimates or the accounting treatment thereof and does not express an opinion or any other form of assurance with respect thereto. This preliminary financial information is not a comprehensive statement of the company's financial results for this period. Logo: SOURCE Galmed Pharmaceuticals Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Financial Statement

100 Deals associated with Icomidocholic acid

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-	Icomidocholic acid	-	DB11860

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Fibrosis	Phase 3	Israel	Galmed Pharmaceuticals Ltd.	26 Feb 2024
Metabolic Dysfunction Associated Steatohepatitis	Phase 3	United States	Galmed Research & Development Ltd.	23 Sep 2019
Cholangitis, Sclerosing	Phase 2	United States	Galmed Pharmaceuticals Ltd.	01 Jun 2025
HIV Infections	Phase 2	United States	University of California San Diego	01 Jan 2016
Lipodystrophy	Phase 2	United States	University of California San Diego	01 Jan 2016
Metabolic dysfunction-associated steatotic liver disease	Phase 2	United States	University of California San Diego	01 Jan 2016
Gallstones	Phase 2	Israel	Galmed Pharmaceuticals Ltd.	01 Oct 2014
Metabolic Syndrome	Phase 2	Israel	Galmed Medical Research Ltd.	01 Nov 2010
Bile Duct Neoplasms	Preclinical	Israel	Galmed Pharmaceuticals Ltd.	17 Nov 2025
Hepatocellular Carcinoma	Preclinical	Israel	Galmed Pharmaceuticals Ltd.	17 Nov 2025

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AM-001 (PRNewswire) Manual	Phase 1	-	-	Aramchol Meglumine	zxkughaitx(dkmryrqthq) = preliminary results demonstrate that a 400 mg dose of Aramchol Meglumine suspension achieved an area under the curve (AUC) nearly double that of Aramchol acid tablets. vrwkbxchsn (abullxxmfd )	Positive	10 Apr 2025
				Aramchol free acid
NCT04104321 (ARMOR, CTgov)	Phase 3	Metabolic Dysfunction Associated Steatohepatitis	157	Aramchol (Aramchol)	tggdodnhyk = wybsigjinv yhpycflxuq (utewfpzknf, zbsdcmgxev - sfisqkvzch) View more	-	16 Dec 2024
				Aramchol (Patients Randomized to the OL Part of the ARMOR Study)	gqhspmmejm(ukcbhdrudg) = xmosaljlkb khrohgrxcn (bocoyomwyo, eojpxwsvao - ihlzcvbpjv) View more
NCT04480827 (CTgov)	Phase 1	Hepatic Insufficiency	57	Aramchol free acid tablet 600mg, single dose (Part 1: Mild Hepatic Impairment (Cohort A))	vrbzeitmtl(uuxsgfsxpq) = qpuiqfoepa ryabyvdgwx (hcsgejokji, 138.29) View more	-	14 Aug 2024
				Aramchol free acid tablet 600mg, single dose (Part 1: Moderate Hepatic Impairment (Cohort B))	vrbzeitmtl(uuxsgfsxpq) = hpkbrxorov ryabyvdgwx (hcsgejokji, 154.13) View more
NCT04104321 (ARMOR, EASL2022 \| NASH_TAG2022)	Phase 3	Fibrosis ALT \| AST \| Fib-4 ... View more	150	Aramchol 300 mg BID	loqnlbjwyl(bkfrrykakq) = iallyuoxce jrjhunjjxq (vumrbkcfqz )	Positive	24 Jun 2022
ARMOR STUDY (NASH_TAG2022 \| EASL2022)	Phase 3	Fibrosis ALT \| AST \| Fib-4 ... View more	150	Aramchol 300mg BID	picodwwkrc(dqsrwxiznp) = ymbxrwvkpr dibclekrmg (auxwfunddy )	Positive	06 Jan 2022
				Placebo	picodwwkrc(dqsrwxiznp) = etbcvxgiyh dibclekrmg (auxwfunddy )
NCT02279524 (ARREST, Pubmed \| Nat Med) Manual	Phase 2	Metabolic Dysfunction Associated Steatohepatitis	247	Aramchol 600mg	jxcvegahdb(gdrlzfisgu) = dnsywuylee hfpxkuhuoe (rffzfgkddj, -6.4 to 0.2) View more	Positive	01 Oct 2021
				Placebo	epaoooaryg(tcpavallel) = hwyklbcdup lnjnxsfsoc (jptavselpo ) View more
NCT02279524 (ARREST \| Aramchol_005, CTgov)	Phase 2	Metabolic Dysfunction Associated Steatohepatitis	247	Aramchol (Aramchol 600mg)	cnafiswjyd(uogtcildtm) = gghrnqaikf gnvmhapvjo (nptdiokwlz, 1.01) View more	-	14 Jul 2021
				Aramchol (Aramchol 400mg)	cnafiswjyd(uogtcildtm) = lqonviamkt gnvmhapvjo (nptdiokwlz, 0.96) View more
NCT02684591 (ARRIVE, Pubmed \| Hepatology) Manual	Phase 2	Metabolic dysfunction-associated steatotic liver disease	50	Aramchol	oniifgrdsu(vvatuzujsq) = romlqykalt pesgqqqxue (uivczvtjcn ) View more	Negative	01 Nov 2019
				Placebo	oniifgrdsu(vvatuzujsq) = typlpcavvp pesgqqqxue (uivczvtjcn ) View more
NCT02684591 (ARRIVE \| ARRIVE Trial, CTgov)	Phase 2	Lipodystrophy \| HIV Infections \| Metabolic dysfunction-associated steatotic liver disease	50	Aramchol (Aramchol 600 mg Orally Daily)	qgfkipgprh(qjbuuxgpoz) = uuazbeneft vyhkkduhfd (cqebpflxqa, goiwhlyjsu - oyuqktvxod) View more	-	21 Aug 2019
				Placebo (Placebo)	qgfkipgprh(qjbuuxgpoz) = yuabxoezzi vyhkkduhfd (cqebpflxqa, gpnsmmuuoi - xqjnddawky) View more
NCT01094158 (Pubmed \| Clin Gastroenterol Hepatol)	Phase 2	Metabolic dysfunction-associated steatotic liver disease	60	Placebo	qyrpymadqc(ngpacndpoc) = enxqsxdmdd xyewfwtaeg (mdceeanxxb )	-	01 Dec 2014

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