Galectin Therapeutics - to file Phase 3 protocol for belapectin in Q3 2026 - SEC filing

Galectin Therapeutics, Inc. (NASDAQ: GALT) has announced plans to file a Phase 3 clinical trial protocol for its lead drug candidate, belapectin, in the third quarter of 2026, according to recent SEC filings and company disclosures. The announcement follows continued positive data from the NAVIGATE Phase 2b/3 trial, which evaluated belapectin in MASH cirrhosis.

The NAVIGATE trial, a global, randomized, double-blind, placebo-controlled study, demonstrated statistically significant reductions in liver stiffness measurements (LSM) in the belapectin 2 mg/kg treatment arm at Weeks 26, 52, and 78. These findings, based on Mixed Model for Repeated Measures (MMRM) analyses, suggest a potential reduction in fibrosis progression among high-risk patients. Additional biomarker data from the trial, including the Pro-C3/CTX-III ratio and ELF (Enhanced Liver Fibrosis) scores, further support the drug’s antifibrotic activity.

The company has also scheduled presentations at the European Association for the Study of the Liver (EASL) Congress in May 2026, where it will share belapectin’s impact on fibrogenesis and portal hypertension. These presentations are expected to provide further clarity on the drug’s mechanism of action and its potential to alter disease progression in advanced MASH cirrhosis.

In terms of financial performance, Galectin reported a net loss of $5.1 million, or ($0.08) per share, for the quarter ended March 31, 2026, compared to a net loss of $9.6 million, or ($0.15) per share, for the same period in 2025. The reduction in net loss was attributed to lower research and development expenses, primarily due to the timing of expenditures related to the NAVIGATE trial. As of March 31, 2026, the company held $14.1 million in cash and cash equivalents and had access to an additional $10 million through a line of credit provided by its chairman.

The company’s cash runway extends through May 2027, based on current operational and research and development plans. This financial position supports the anticipated Phase 3 filing and continued development of belapectin, which has Fast Track designation from the FDA for the treatment of MASH with cirrhosis.

Galectin also plans to hold an in-person Type-C meeting with the FDA in the second quarter of 2026 to align on the next steps for the belapectin program. The meeting is expected to inform the design and regulatory strategy for the upcoming Phase 3 trial.

Overall, the company’s recent progress, combined with its financial stability and regulatory engagement, positions Galectin to advance belapectin into the next phase of clinical development. Investors and stakeholders will be closely watching the outcomes of the EASL presentations and the FDA meeting for further clarity on the drug’s path forward.