Board Change • May 20
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 4 highly experienced directors. Independent Director Rick Zordani was the last director to join the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. 공시 • May 12
Galectin Therapeutics Inc Announces Publication of Navigate Phase 2B Trial Results for Belapectin Galectin Therapeutics Inc. announced the publication of results from its NAVIGATE Phase 2b clinical trial evaluating belapectin in patients with MASH cirrhosis and portal hypertension in AASLD flagship journal Hepatology. The manuscript, titled “Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in Patients with MASH Cirrhosis: The Randomized, Placebo-Controlled NAVIGATE Trial,” is now available online and available as an open-access publication. The NAVIGATE trial evaluated belapectin, a galectin-3 inhibitor, in patients with MASH cirrhosis and portal hypertension without esophageal varices at baseline. Results demonstrated that belapectin 2 mg/kg was associated with a numerical reduction in the development of new varices compared to placebo in the full analysis set, with a statistically significant reduction observed in the per-protocol population. Key markers of fibrosis including Liver Stiffness Measure results were aligned with the clinical finding belapectin was generally safe and well tolerated. The manuscript highlights: Numerical reduction in incidence of new esophageal varices with belapectin 2 mg/kg compared to placebo; Statistically significant reduction in the per-protocol population; Supportive changes in non-invasive markers of portal hypertension and fibrosis including LSM and ELF; Favorable safety and tolerability profile. Belapectin targets galectin-3, a key mediator of fibrosis and inflammation, and is being developed as a potential therapy to address complications of MASH cirrhosis. The full manuscript is available online and can be accessed freely given its open-access status. NAVIGATE was a global, randomized, placebo-controlled Phase 2b trial evaluating belapectin in patients with MASH cirrhosis and portal hypertension without esophageal varices at baseline. The study assessed the development of varices and other clinically relevant outcomes over an 18-month treatment period. 공시 • Mar 18
Galectin Therapeutics Inc. Appoints Henry Brem, M.D. as Independent Director to Board of Directors Galectin Therapeutics Inc. on March 17, 2026 announced it has appointed Henry Brem, M.D., as an independent director to its Board of Directors. Dr. Brem is an internationally recognized neurosurgeon-scientist and leader in translational medicine. He serves as the Henry Brem Professor of Neurosurgery at Johns Hopkins University and previously served as Director of the Department of Neurosurgery and Neurosurgeon-in-Chief at The Johns Hopkins Medical Institutions. He is also Co-Director of the Brain Cancer Program at the Sidney Kimmel Comprehensive Cancer Center. Dr. Brem has helped transform neurosurgical oncology through the development of image-guided surgical techniques and localized drug delivery systems, including Gliadel wafers for brain tumors. He has published more than 416 peer-reviewed papers, holds multiple patents, and has been continuously funded by the NIH for over four decades. He is a member of the National Academy of Medicine and has received numerous honors recognizing his contributions to clinical excellence and translational research. 공시 • Jan 14
Galectin Therapeutics Inc Announces Resignation Of Director Marc Rubin On January 10, 2026, Marc Rubin resigned from the Board of Directors of Galectin Therapeutics Inc. (the “Company”). Mr. Rubin’s resignation is not the result of any disagreement with the Company on any matter relating to its operations, policies or practices. 공시 • Dec 19
Galectin Therapeutics Inc. Provides Regulatory Update Following FDA Written Response and Announces an Additional $10 Million Line of Credit from Richard E. Uihlein Sufficient to Cover Expected Expenditure Through March 2027 Galectin Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has provided a written response, and subsequent communications, to the Company's previously submitted Type C meeting request regarding the development program for belapectin, its investigational galectin-3 inhibitor. The FDA converted the Company's initial request for an in-person or teleconference meeting to a written response. Based on FDA's written feedback, the Company believes there is alignment with the Agency on the patient population proposed for enrollment in a registration trial. In addition, Galectin Therapeutics had previously reached an agreement with the FDA on the use of a centralized, blinded endoscopy review for esophageal variceal assessment and plans to apply a similar approach for variceal evaluation in its next study. Pursuant to the written response from FDA, Galectin Therapeutic will pursue a follow-up Type C meeting to finalize remaining components of the next clinical trial design that were not fully resolved in the written response. This follow-up meeting will also provide an opportunity to present recently generated biomarker data, including findings highlighted at last month's American Association for the Study of Liver Diseases (AASLD) meeting, which could not be incorporated in the original submission due to stated objective of obtaining FDA feedback before the end of 2025. The Company views this next FDA interaction as an important step toward ensuring full clarity as it advances belapectin towards subsequent clinical development in a pivotal Phase 3 clinical trial. Galectin Therapeutics is also encouraged that the planned meeting will allow participation from prominent key opinion leaders, whose insights could not be integrated into the prior written-only exchange. Galectin Therape therape remains committed to advancing belapectin's development for patients with advanced fibrotic liver disease and continues to engage constructively with the FDA as it progresses the program. In connection with this agreement, the maturity dates of all of the Company's convertible lines of credit and convertible notes payable to its chairman have been extended through June 30, 2027. The Company now believes that its cash resources, together with availability under these credit facilities, are sufficient to fund currently expected expenditures through at least March 2027. 공시 • Nov 11
Galectin Therapeutics Presented Navigate Trial Results At the American Association for the Study of Liver Diseases (Aasld) 2025 Annual Meeting Galectin Therapeutics Inc. announced new biomarker analyses from the NAVIGATE trial demonstrated consistent antifibrotic effects of belapectin 2 mg/kg. Using established criteria for clinically meaningful worsening, a lower proportion of patients treated with belapectin 2 mg /kg experienced 30% or 5 kPa increases in liver stiffness (LSM) by FibroScan®? compared with placebo, indicating slowing of fibrosis progression and stabilization of liver function. Across all ELF fibrosis risk categories, belapectin2 mg/kg showed a lower incidence of new varices compared with placebo, with the largest benefit in patients with ELF > 11.3 (22.7% vs 42.9%), representing those at highest risk for liver complications. Pro-C3 biomarker analysis demonstrated a >50% reduction from baseline at 18 months with belapectin 2 u/kg compared with placebo, supporting the therapy's antifibrotic and disease-modifying potential in compensated MASH cirrhosis with portal hypertension. Analysis of YKL-40, a biomarker associated with Galectin-3 upregulation in fibrotic liver disease, demonstrated a 20% reduction in a higher proportion of patients treated with bel apectin 2 mg/kg compared with placebo, providing additional mechanistic evidence of belapectin's antifibrotic activity. Patients were randomized 1:1:1 to receive intravenous belapectin at 2 mg/kg or 4 mg/kg of lean body mass or placebo every other week for 18 months (78 weeks). When patients were stratified using FDA-approved Enhanced Liver Fibrosis (ELF) score cutoffs, belapectin 2 mg-kg demonstrated a consistently lower incidence of new varices across all fibrosis categories, with the largest reduction observed among patients with ELF >11.3, representing those at highest risk for Liver complications (22.7% vs42.9% for placebo). A total of 57 subjects completed 36 months of therapy in NAVIAGTE. At 36 months, the cumulative incidence of new varices in the study was 23.4%, 12.4% and 16.7% respectively, in placebo, 2 mg/kg, and 4 mg/kg cohorts. As in prior trials, the safety profile of belapectin remains highly encouraging with incidence of adverse events and serious adverse events comparable across the three cohorts. As in prior trials. Raj Vuppalanchi, M.D., serves as Professor of Medicine and Director of Hepatology at Indiana University School of Medicine, stated "The long-term NAVIGATE data presented at AASLD provide important insights into the potential of Galectin-3 inhibition in advanced fibrosis. Galectin's lead drug belapectin is a carbohydrate-based drug that inhibits thegalectin-3 protein, which is directly involved in multiple inflammatory, fibrotic, and malignant diseases, for which it has Fast Track designation by the U.S. Food and Drug Administration. Galectin may not be successful in developing effective treatments and/or obtaining the requisite approvals for the use of belapectin or any of its other drugs in development; the Company may not be successful in scaling up manufacturing and meeting requirements related to chemistry, manufacturing and control matters; the Company's current clinical trial and any future clinical studies may not produce positive results in a timely fashion, if at all, and could require larger and longer trials, which would be time consuming and costly; plans regarding development, approval and marketing of any of Galectin's drugs are subject to change at any time based on the changing needs of the Company's current clinical trial; and the Company's current clinical trial. 
