On November 26, 2025 Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company focused on liver, cardiometabolic, and gastrointestinal oncology indications, reported financial results for the three and nine months ended September 30, 2025 and recent developments.

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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.

(Press release, Galmed Pharmaceuticals, NOV 26, 2025, View Source [SID1234660970])

On November 26, 2025 Leukogene Therapeutics Inc. (LTI), a biopharmaceutical company developing next-generation immunotherapies for hematologic and other malignancies, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the Company’s lead product candidate, M2T-CD33 (LTI-214), for the treatment of Acute Myeloid Leukemia (AML).

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This designation underscores the significant unmet medical need for AML patients and recognizes the therapeutic potential of LTI-214 as a novel and differentiated approach for this aggressive blood cancer. The designation may provide LTI with a range of development incentives, including eligibility for tax credits on qualified clinical trial costs, waiver of certain FDA fees, and U.S. market exclusivity upon approval.

"We are honored that the FDA has recognized the therapeutic promise of LTI-214 by granting Orphan Drug Designation," said Dr. Sandeep Gupta, CEO of Leukogene. "AML remains one of the most challenging hematologic cancers, and outcomes for relapsed or refractory patients remain poor. The LTI-214 program embodies our commitment to advancing new immunotherapy approaches that are both potent and safer for patients. This designation represents an important step toward our goal of transforming the treatment paradigm for AML."

Nathan Dolloff, PhD, Founder and CSO of Leukogene stated, "This is an important step forward for Leukogene and the company’s Major Histocompatibility Complex Class II (MHCII) engager technology. The M2T platform is a completely new approach to cancer immunotherapy and the endorsement from FDA is a testament to its high impact potential."

(Press release, Leukogene Therapeutics, NOV 26, 2025, View Source [SID1234660971])

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On November 26, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that Chirfi Guindo, chief marketing officer, Human Health, and Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, are scheduled to participate in a fireside chat at the 8th Annual Evercore ISI HealthCONx Conference on Tuesday, Dec. 2, 2025, at 9:10 a.m. ET.

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at this weblink.

(Press release, Merck & Co, NOV 26, 2025, View Source [SID1234660973])

On November 26, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that Chirfi Guindo, chief marketing officer, Human Health, and Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, are scheduled to participate in a fireside chat at the Citi 2025 Global Healthcare Conference on Wednesday, Dec. 3, 2025, at 1:00 p.m. ET.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at this weblink.

(Press release, Merck & Co, NOV 26, 2025, View Source [SID1234660974])