GR-MD-02 (belapectin) - (NAVIGATE)

Aug. 14, 2026: Galectin Therapeutics (NASDAQ: GALT) said it reached agreement with FDA on the key elements and regulatory path for a registrational Phase 3 trial of belapectin in advanced MASH cirrhosis with portal hypertension, supporting potential full approval. The agreed design includes a composite liver outcome primary endpoint, blinded central review for endoscopic assessment of esophageal varices, and a single 2 mg/kg lean body mass dose. Protocol submission is anticipated in 3Q 2026.

For belapectin/NAVIGATE, the company reported new analyses presented at EASL 2026: an oral presentation linked favorable changes in the Pro-C3/CTX-III ratio with reduced varices development and improvements in fibrosis markers including liver stiffness; a poster showed risk reduction in clinically significant portal hypertension and was designated a TOP Poster by EASL. Galectin also said Hepatology published NAVIGATE Phase 2b results in patients with MASH cirrhosis and portal hypertension, and Gastro Hep Advances published its centralized blinded endoscopy review method to be used in Phase 3.

Separately, effective July 31, 2026, the chairman converted about $105.8 million of debt and accrued interest into 34,376,167 common shares, eliminating five credit-facility notes and strengthening the balance sheet.