Galectin Therapeutics(GALT) - 2025 Q4 - Annual Results

Financial Performance - For the year ended December 31, 2025, Galectin Therapeutics reported a net loss applicable to common stockholders of $31.0 million, or ($0.48) per share, compared to a net loss of $47.2 million, or ($0.76) per share for 2024, reflecting a decrease in losses due to reduced research and development costs [9]. - Research and development expenses for 2025 were $14.3 million, a significant decrease from $36.6 million in 2024, primarily due to costs related to the NAVIGATE clinical trial [9]. - Total operating expenses for 2025 were $20.1 million, down from $42.4 million in 2024, indicating improved cost management [13]. Cash Position - As of December 31, 2025, the company had $17.7 million in unrestricted cash and cash equivalents, along with an additional $10 million available under a line of credit, providing sufficient cash to fund operations through April 2027 [7]. Clinical Trial Results - The NAVIGATE Phase 2b/3 trial showed that in the per-protocol population, belapectin 2 mg/kg reduced the incidence of varices by 49.3% compared to placebo, with a nominal p-value of 0.04 [6]. - In U.S. patients within the per-protocol population, belapectin 2 mg/kg reduced the incidence of varices by 68.1% compared to placebo, with a p-value of 0.02 [6]. Future Plans and Developments - The company plans to present new analyses from the NAVIGATE trial at the EASL Congress in May 2026, including an oral presentation on reduced varices and a poster presentation on risk reduction in portal hypertension [8]. - Galectin Therapeutics is focused on evaluating the NAVIGATE dataset and engaging with regulators and potential partners to determine the optimal path forward for the belapectin program [2]. - The company anticipates an upcoming FDA meeting in Q2 2026 to discuss the next steps for advancing the belapectin program, which targets a significant unmet medical need in MASH cirrhosis [4]. Board and Management - The company strengthened its Board with the appointment of Dr. Henry Brem, enhancing its clinical development expertise as it advances the belapectin program [3].