Galectin Therapeutics is a clinical-stage biopharmaceutical company focused on developing new therapies for fibrotic disease and cancer by targeting galectin proteins. The lead drug candidate, belapectin (GR-MD-02), is a galectin-3 inhibitor being developed for MASH (metabolic dysfunction-associated steatohepatitis) with cirrhosis and certain cancer indications. The large, global Phase 2b/3 NAVIGATE clinical trial for the prevention of esophageal varices in MASH cirrhosis patients completed randomization in February 2023, with top-line results presented in December 2024. In the intent-to-treat (ITT) population (N=355), the incidence of varices was 43.2% reduced in the belapectin 2 mg/kg dose group versus placebo, but the composite endpoint did not reach statistical significance. In the pre-defined per-protocol population (PPP, n=287), the incidence of varices was reduced by 49.3% (p-value < 0.05) in the belapectin 2 mg/kg dose group. A further analysis of the US completer patients (n=186) in the NAVIGATE trial showed a significant 68.1% reduction (p=0.02) in the incidence of varices with belapectin 2 mg/kg. Belapectin demonstrated consistent, meaningful effects across multiple key biomarkers in MASH cirrhosis, including fewer patients experiencing clinically significant worsening of liver stiffness (LSM) and improvements in ELF (Enhanced Liver Fibrosis) score. The safety profile of belapectin remained highly encouraging, with adverse events and serious adverse events comparable across all three cohorts in the NAVIGATE trial, and no drug-related SAEs reported. The company incurred a net loss of $30.8 million in 2025, compared to $47.0 million in 2024, and has an accumulated deficit of $431 million as of December 31, 2025. Cash and cash equivalents totaled $17.7 million as of December 31, 2025, with an additional $10 million available under a line of credit from the chairman, expected to fund operations through April 2027. A follow-up Type C meeting with the FDA is planned to finalize the design for the next clinical trial for belapectin in MASH cirrhosis. Development in immuno-oncology for advanced or metastatic head and neck cancer with belapectin in combination with a checkpoint inhibitor is also being pursued, with a proposed Phase 2 trial dependent on financing. A material weakness in internal control over financial reporting was identified related to the valuation of derivative liabilities associated with contingent interest on convertible notes payable.