Galectin Therapeutics (NasdaqCM:GALT) Conference Transcript

Summary of Galectin Therapeutics Conference Call Company Overview - Company: Galectin Therapeutics (NasdaqCM:GALT) - Event: Conference at HC Wainwright's Virtual Liver Disease Conference on October 21, 2025 Key Points on MASH Cirrhosis and Palipectin - Lead Compound: Palipectin, a proprietary galectin-3 inhibitor, is in development for patients with MASH cirrhosis and portal hypertension [4][5] - Clinical Need: MASH cirrhosis with portal hypertension is a serious and underserved condition in hepatology, with no FDA-approved therapies available to reverse portal hypertension once developed [5][6] - Epidemiology: Approximately 1% of the U.S. population may have MASH cirrhosis and portal hypertension [5] - Mechanism of Action: Palipectin blocks the galectin-3 pathway, which is a key driver of fibrosis, offering antifibrotic activity [4][5] Clinical Trial Insights - Phase 2B GD26 Study: Palipectin at 2 mg prevented the development of new varices in patients without varices at baseline, significantly reducing hepatic venous pressure gradient [7][8] - Navigate Trial: Enrolled 357 patients with compensated MASH cirrhosis and portal hypertension, assessing the incidence of new varices as the primary endpoint [9][10] - Results: In the ITT population, there was a 43% lower incidence of varices in the 2 mg group compared to placebo (12 vs. 21 varices) [11] - U.S. Subgroup Findings: Results were more remarkable in the U.S. subgroup, showing significant reduction in varices incidence [12] Safety and Efficacy - Safety Profile: Palipectin exhibited a favorable safety profile with low discontinuation rates due to adverse events and no serious drug-related adverse events reported [16][17] - Biomarker Evidence: Non-invasive markers showed improvement in liver stiffness and a significant reduction in fibrosis markers in the palipectin group compared to placebo [14][15][17] Market Opportunity - Strategic Advantage: Palipectin's unique mechanism positions it favorably against other therapies in development, addressing a critical unmet need in MASH cirrhosis treatment [6][17] - Combination Potential: There is potential for synergy between palipectin and metabolic agents, which could expand its therapeutic value [12][17] Conclusion - Future Directions: Galectin Therapeutics is focused on advancing discussions with regulatory agencies and identifying partners to move the program forward, aiming to bring meaningful advances to patients with MASH cirrhosis [17]