Galectin Therapeutics (GALT) investor relations material

Clinical development update

• Lead compound belapectin targets galectin-3, implicated in chronic fibrotic and inflammatory conditions, with focus on MASH cirrhosis and portal hypertension.

• Two phase II-B studies showed belapectin improved portal pressure, reduced new varices, and had favorable biomarker changes; also showed promise in metastatic cancer when combined with PD-1 inhibitor.

• Market research indicates a multibillion-dollar opportunity due to high unmet need and lack of FDA-approved therapies for MASH cirrhosis with portal hypertension.

• Preclinical and clinical data support belapectin’s mechanism, showing reduction in portal pressure and collagen buildup.

NAVIGATE trial design and results

• NAVIGATE trial tested 2 mg and 4 mg doses of belapectin versus placebo in patients with MASH cirrhosis and portal hypertension over 18 months.

• Primary endpoint was composite of new varices and other liver complications, adjudicated by central blinded review.

• 2 mg belapectin dose reduced new varices incidence by 43.2% compared to placebo (10.1% vs 17.8%), with statistical significance in per-protocol population.

• Greatest benefit observed in reduction of large varices, which are more likely to cause complications.

• Safety profile was strong, with no drug-related serious adverse events or drug-induced liver injury.

Biomarker and mechanistic data

• Belapectin showed placebo-adjusted improvement in liver stiffness and prevented progression of key biomarkers (LSM, ELF score, Pro-C3, Pro-C4, YKL-40, NIS4).

• Sicker patients (higher baseline LSM) experienced greater benefit from belapectin.

• Twice as many patients on belapectin moved from high to low portal hypertension risk compared to placebo.

• Biomarker data consistently corroborated clinical outcomes, supporting belapectin’s mechanism of action.

• 2 mg dose will be used in the upcoming phase III registration trial.