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]