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]

Core Viewpoint - Inventiva announced the publication of preclinical study results indicating that lanifibranor may reduce Portal Hypertension (PH), a significant complication of chronic liver diseases, including MASH and cirrhosis [1][5][6]. Group 1: Study Overview - The study was a collaboration with Ghent University Hospital and evaluated lanifibranor's effects on PH independent of hepatic conditions [2]. - Two distinct mouse models were used: Partial Portal Vein Ligation (PPVL) and common Bile Duct Ligation (cBDL) [3]. Group 2: Results from PPVL Model - In the PPVL model, lanifibranor reduced portal pressure by 28% at 10 mg/kg (p=0.03) and 39% at 30 mg/kg (p=0.001) in a dose-dependent manner [3]. - Improvements were linked to vascular changes in the splanchnic compartment, including reduced blood flow in the superior mesenteric artery (p=0.07) and decreased endothelial cell staining [3]. Group 3: Results from cBDL Model - In the cBDL model, lanifibranor also reduced portal pressure and spleen weight while improving fibrosis [4]. - The treatment decreased dysfunction in Liver Sinusoidal Endothelial Cells (LSEC) and hepatic angiogenesis associated with fibrotic PH [4]. Group 4: Implications for Treatment - The study suggests that lanifibranor could be a therapeutic option for patients with clinically significant PH, addressing both intra-hepatic and extra-hepatic conditions [5][6]. - Prof. Sven Francque highlighted the potential of lanifibranor in managing complications related to portal hypertension in chronic liver diseases [6]. Group 5: About Lanifibranor - Lanifibranor is an orally available small molecule that activates all three PPAR isoforms, designed to induce anti-fibrotic, anti-inflammatory, and beneficial vascular changes [8]. - It is the only pan-PPAR agonist in clinical development for MASH, with Breakthrough Therapy and Fast Track designations from the FDA [8]. Group 6: About Inventiva - Inventiva is focused on developing oral small molecule therapies for MASH and other diseases with significant unmet medical needs [9]. - The company is currently evaluating lanifibranor in the NATiV3 pivotal Phase 3 clinical trial for MASH treatment [9].