Galectin Therapeutics(GALT) - 2025 Q3 - Quarterly Report

Clinical Trials and Efficacy - The company has completed randomizations totaling 357 patients in the NAVIGATE trial, a Phase 2b/3 clinical study evaluating the safety and efficacy of belapectin for preventing esophageal varices in NASH cirrhosis patients [113]. - In the intent-to-treat population (N=355), the incidence of varices was reduced by 43.2% in the belapectin 2 mg/kg dose group compared to placebo, although the composite endpoint did not reach statistical significance [114]. - In the per-protocol population (n=287), the incidence of varices was reduced by 49.3% in the belapectin 2 mg/kg dose group, with a p-value < 0.05 [114]. - In the U.S. cohort (n=186), the incidence of varices was significantly reduced by 68.1% in patients treated with belapectin 2 mg compared to placebo (4 out of 60 vs 13 out of 62) [114]. - The NASH-FX trial did not meet its primary endpoint, with no significant efficacy results in advanced liver fibrosis patients, although belapectin was found safe and well tolerated [129]. - The NASH-CX trial involved 162 patients and showed a statistically significant reduction in hepatic venous pressure gradient (HVPG) of -1.08 mm Hg (p<0.01) for the 2 mg/kg LBM dose in patients without esophageal varices at baseline [132]. - In the NASH-CX trial, the belapectin 2 mg/kg group had a 0% incidence of new varices compared to 18% in the placebo group, indicating a significant reduction in portal pressure and varice development [134]. - The NAVIGATE trial reported a 43.2% reduction in varices incidence in the intent-to-treat population for the belapectin 2 mg/kg group, although the composite endpoint did not reach statistical significance [139]. - In the per-protocol population of the NAVIGATE trial, the incidence of varices was reduced by 49.3% (p<0.05) in the belapectin 2 mg/kg group [139]. - The NAVIGATE trial showed a significant reduction of 68.1% in varices incidence in U.S. patients treated with belapectin 2 mg/kg (4 out of 60) compared to placebo (13 out of 62) (p=0.02) [139]. - Promising results were reported in the Phase 1b trial combining belapectin with pembrolizumab, showing a 50% objective response rate in advanced melanoma patients [150]. Safety Profile - The safety profile of belapectin remains encouraging, with rates of adverse events and serious adverse events comparable to placebo, and no drug-related serious adverse events reported in the NAVIGATE trial [115]. - The safety profile of belapectin in the NAVIGATE trial was encouraging, with no drug-related serious adverse events reported [140]. - The Company completed a Hepatic Impairment Study involving approximately 40 patients, indicating that belapectin exposure did not increase with the degree of hepatic insufficiency [147]. Financial Performance - Research and development expenses for the three months ended September 30, 2025, were $2,612,000, a decrease of $4,983,000 (66%) compared to $7,595,000 in the same period of 2024 [153]. - For the nine months ended September 30, 2025, research and development expenses totaled $12,358,000, down $13,104,000 (51%) from $25,462,000 in 2024 [153]. - General and administrative expenses for the three months ended September 30, 2025, were $1,587,000, an increase of $116,000 (8%) compared to $1,471,000 in 2024 [157]. - For the nine months ended September 30, 2025, general and administrative expenses decreased by $180,000 (4%) to $4,363,000 from $4,543,000 in 2024 [157]. - Net cash used in operations decreased by $11,143,000 to $17,833,000 for the nine months ended September 30, 2025, compared to $28,976,000 for the same period in 2024 [159]. - Cash provided by financing activities decreased by $16,138,000 to $14,238,000 for the nine months ended September 30, 2025, compared to $30,376,000 in 2024 [159]. - As of September 30, 2025, the company had $11.5 million in unrestricted cash and cash equivalents, along with a $10 million line of credit available [158]. - The NAVIGATE clinical trial expenses decreased significantly, contributing to the overall reduction in research and development costs [154]. - The company anticipates needing additional cash to fund operations beyond June 30, 2026 [158]. Strategic Developments - The company is analyzing data from approximately 55 patients who completed 36 months of treatment, which may attract interest from potential strategic partners [116]. - A new IND for advanced or metastatic head and neck cancer using belapectin in combination with a PD-1 inhibitor has been filed, with the trial commencement dependent on financing [120]. - The company has established a joint venture subsidiary, Galectin Sciences LLC, to develop small molecules that inhibit galectin-3, potentially expanding the uses of galectin-3 inhibitors beyond belapectin [119]. - The company is focused on developing belapectin for NASH cirrhosis and head and neck cancer, with ongoing clinical trials and favorable results reported in 2023 [123]. - The company plans to file a phase 2 trial with the FDA for belapectin in combination with an immune checkpoint inhibitor for recurrent or metastatic head and neck cancer [151]. - The Company activated over 150 clinical trial sites in 14 countries for the NAVIGATE trial, although enrollment was impacted by the COVID-19 pandemic [144].