This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as "may," "estimate," "could," "expect", "look forward", "believe", "hope" and others. They are based on NORCROSS, Ga., July 09, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of galectin-3-targeted therapeutics for patients with metabolic dysfun ...

Belapectin for MASH Cirrhosis and Portal Hypertension 2 Company introduction Joel Lewis CEO & President June 2025 Today's Agenda | 01 | Moderator Michael Cozart, LifeSci Consulting | | --- | --- | | 02 | Galectin Company Introduction Joel Lewis (CEO & President) | | 03 | Belapectin as Galectin-3 Inhibitor for MASH cirrhosis & Portal Hypertension Khurram Jamil, M.D. (CMO) | | 04 | Unmet Need & Patient Landscape Naga Chalasani, M.D. | | 05 | Khurram | | | Clinical Results – NAVIGATE Trial design & Results Nai ...

Summary of Galectin Therapeutics (GALT) Update / Briefing Company Overview - **Company**: Galectin Therapeutics (GALT) - **Focus**: Development of belapectin as a treatment for NASH cirrhosis and portal hypertension, addressing a significant unmet medical need [2][4] Industry Context - **Condition**: NASH cirrhosis is a leading cause of liver transplantation in the US, with an estimated 5 million adults affected, including 3.3 million with portal hypertension [8][9] - **Market Opportunity**: Belapectin is positioned as a first-in-class therapy for NASH cirrhosis, with peak sales potential estimated at $18 billion [15] Clinical Trial Insights - **Clinical Trials**: Multiple Phase IIb trials conducted, including the NAVIGATE trial, which focused on patients with NASH cirrhosis and portal hypertension [5][19] - **Mechanism of Action**: Belapectin is a Galectin-3 inhibitor, which has shown anti-inflammatory and anti-fibrotic effects in preclinical studies [5][6] NAVIGATE Trial Findings - **Patient Population**: Included patients with compensated NASH cirrhosis and portal hypertension, with no baseline varices [20][21] - **Primary Endpoint**: Focused on the development of esophageal varices and other hepatic decompensation events [22][36] - **Results**: - Statistically significant reduction in new varices in the belapectin 2 mg/kg group (11.3% vs. 22.3% in placebo) [27] - Reduction in liver stiffness observed, indicating less disease progression [28][30] - Safety profile comparable to placebo, with no significant adverse events reported [31][37] Key Opinion Leaders' Perspectives - **Expert Opinions**: KOLs emphasized the urgent need for effective therapies in the NASH cirrhosis population, highlighting belapectin's potential to fill this gap [8][9][12] - **Market Feedback**: Positive responses from payers and physicians regarding the clinical and economic benefits of belapectin [14] Additional Insights - **Endoscopic Endpoint**: The NAVIGATE trial utilized centrally adjudicated endoscopy videos to track variceal development, enhancing the reliability of results [39][41] - **Comparison with Other Therapies**: Belapectin targets a more advanced patient population compared to other investigational therapies, which often select for less severe cases [62][63] Conclusion - **Future Outlook**: Belapectin shows promise in addressing the unmet needs of patients with advanced NASH cirrhosis and portal hypertension, with a favorable safety profile and significant market potential [36][60]

NORCROSS, Ga., June 10, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin-3 for patients with MASH cirrhosis and portal hypertension, today announced that it will host a virtual key opinion leader (KOL) event on Monday, June 16, 2025 at 12:00 PM ET. To register, click here. The event will focus on the unmet need and current treatment landscape for metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertens ...

Core Viewpoint - Galectin Therapeutics reported promising results for its lead drug belapectin in treating MASH-associated liver cirrhosis and portal hypertension, highlighting significant clinical efficacy and potential as a new treatment option [2][3][4]. Financial Highlights - As of March 31, 2025, the company had $7.4 million in cash and cash equivalents and $11 million available under credit lines [12]. - Research and development expenses for Q1 2025 were $6.5 million, down from $8.1 million in Q1 2024, primarily due to timing of expenditures related to the NAVIGATE clinical trial [12]. - General and administrative expenses decreased to $1.4 million in Q1 2025 from $1.6 million in Q1 2024 [12]. - The net loss applicable to common stockholders for Q1 2025 was $9.6 million, or ($0.15) per share, compared to a net loss of $11.5 million, or ($0.19) per share in Q1 2024 [12][20]. Clinical Trial Results - The NAVIGATE trial demonstrated that the 2 mg/kg dose of belapectin significantly reduced the incidence of new varices compared to placebo, validating earlier Phase 2 findings [2][3]. - Liver stiffness measurements (LSM) showed statistically significant reductions in the belapectin 2 mg/kg treatment arm at Weeks 26, 52, and 78 [11][20]. - The analysis indicated that 64% more patients in the placebo group experienced an absolute increase in LSM of >10 kPa compared to the 2 mg/kg group, reinforcing the treatment's efficacy [8][11]. Belapectin Program Highlights - Belapectin targets galectin-3, a protein involved in the pathogenesis of MASH and fibrosis, and has received Fast Track Designation from the FDA [5][16]. - The NAVIGATE trial is a global, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of belapectin for preventing esophageal varices in MASH cirrhosis [7][20]. Company Overview - Galectin Therapeutics focuses on developing therapies for chronic liver disease and cancer, with belapectin as its lead drug targeting MASH-related fibrosis [16].

Data presentation included efficacy and biomarker analyses from the NAVIGATE trial (n=287). Belapectin 2 mg/kg demonstrated a statistically significant reduction in new varices at 18 months in the per-protocol population (p=0.04). Significantly fewer patients in the belapectin treatment arms experienced worsening of liver stiffness as measured by FibroScan®, reinforcing the potential beneficial effect of belapectin in halting the progression of MASH cirrhosis. NORCROSS, Ga., May 12, 2025 (GLOBE NEWSWIRE) -- ...

Core Insights - Galectin Therapeutics Inc. is set to present data from its NAVIGATE study on belapectin, a galectin-3 inhibitor, at the EASL 2025 meeting, highlighting its significance in the hepatology community [1][2] - The NAVIGATE study focuses on patients with MASH cirrhosis and portal hypertension, conditions that have been historically overlooked despite their severe impact on patients [2] - The company is also analyzing biomarker data from the NAVIGATE study, with additional results expected to be shared in the second quarter of 2025 [2] Company Overview - Galectin Therapeutics is dedicated to developing therapies for chronic liver disease and cancer, with its lead drug belapectin targeting galectin-3, which is involved in various inflammatory and fibrotic diseases [3] - Belapectin has received Fast Track designation from the U.S. FDA and is primarily focused on treating metabolic dysfunction-associated steatohepatitis (MASH) with cirrhosis, representing a significant drug development opportunity [3] - The company is also exploring additional development programs in cancer immunotherapy, contingent on finding suitable partnerships for efficient development [3]