Core Insights - Galectin Therapeutics, Inc. reported financial results and business updates for the second quarter and first half of 2025, highlighting progress in its NAVIGATE trial for belapectin, a treatment for MASH cirrhosis [1][2]. Financial Performance - As of June 30, 2025, the company had cash and cash equivalents of $13.8 million and a new $10 million line of credit to fund operations through mid-2026 [9]. - Research and development expenses for Q2 2025 were $3.3 million, a decrease from $9.8 million in Q2 2024, primarily due to the timing of expenditures related to the NAVIGATE trial [9]. - General and administrative expenses for Q2 2025 were $1.4 million, slightly down from $1.5 million in the same period last year [9]. - The net loss applicable to common stockholders for Q2 2025 was $7.6 million, or ($0.12) per share, compared to a net loss of $12.4 million, or ($0.20) per share for Q1 2024 [9][11]. Clinical Development - The NAVIGATE trial data indicates that belapectin shows a clinically significant response in Fibroscan® results, supporting its primary endpoint of preventing esophageal varices after 18 months of treatment [2][4]. - The 18-month analysis demonstrated a lower incidence of liver stiffness progression and varices in the belapectin 2 mg arm compared to placebo, suggesting its potential to modify disease progression in patients with MASH cirrhosis [3][4]. - The updated analysis confirmed that the effects of belapectin were maintained in patients who continued treatment into the second 18-month period, reinforcing its efficacy [4][5]. Strategic Initiatives - The company is focused on engaging with the U.S. Food and Drug Administration to discuss potential next steps for the belapectin program and is exploring strategic partnership opportunities [2][3]. - A KOL event in June featured discussions on the NAVIGATE trial results and the treatment landscape for MASH cirrhosis, indicating ongoing efforts to raise awareness and support for the treatment [4]. Market Position - Galectin Therapeutics aims to address the significant unmet medical need for patients with MASH-associated liver cirrhosis and portal hypertension, positioning belapectin as a potential new treatment option [3][4]. - The company is also developing additional programs for cancer treatment, indicating a broader therapeutic focus [7].

Core Insights - Galectin Therapeutics reported significant progress in its belapectin program, particularly in treating MASH cirrhosis and portal hypertension, with a 68% reduction in new varices incidence in U.S. patients [2][6] - The company has sufficient cash to fund operations through August 2025, bolstered by a $5 million line of credit from its chairman [5][7] - Financial results for 2024 show a net loss of $47.2 million, an increase from $44.5 million in 2023, primarily due to rising research and development costs [11][13] Financial Highlights - As of December 31, 2024, the company had $15.1 million in unrestricted cash and cash equivalents, with an additional $6 million available under a line of credit [5][14] - Research and development expenses for 2024 were $36.6 million, up from $32.1 million in 2023, driven by costs associated with the NAVIGATE clinical trial [11][13] - The total net loss applicable to common stockholders for 2024 was $47.2 million, or ($0.76) per share, compared to a net loss of $44.5 million, or ($0.74) per share in 2023 [11][13] Belapectin Program Highlights - Belapectin targets galectin-3, a protein involved in the pathogenesis of NASH and fibrosis, and has received Fast Track designation from the FDA [3][8] - The NAVIGATE trial demonstrated a 49% reduction in varices incidence in the per-protocol population and a 68% reduction in U.S. patients treated with belapectin 2 mg compared to placebo [6][11] - The company plans to share additional results and biomarker analyses in the second quarter of 2025 [2][6]