Galectin Therapeutics (GALT) investor relations material

Program overview and clinical rationale

• Focused on belapectin for NASH cirrhosis with portal hypertension, a population with high unmet need and no FDA-approved therapies.

• Chose development of esophageal varices as primary endpoint due to its clinical significance in disease progression.

• Preclinical studies showed belapectin reduced galectin-3, collagen, and portal pressure, supporting clinical development.

• Estimated 1% of the U.S. population may have NASH cirrhosis with portal hypertension, highlighting large market potential.

• Market research suggests multi-billion dollar annual peak sales opportunity for belapectin.

Clinical trial design and execution

• NAVIGATE trial targeted patients with NASH cirrhosis and portal hypertension but no baseline varices, using 2 mg and 4 mg doses over 18 months.

• Central-blinded review ensured robust and consistent assessment of varices at baseline and during the trial.

• Non-invasive methods were used to diagnose portal hypertension across 100+ centers globally.

• Primary endpoint was a composite of varices development, liver complications, adverse events, or use of certain medications.

• Patient population had more advanced disease compared to other recent NASH cirrhosis trials.

Key clinical findings and biomarker data

• 2 mg dose showed 43% lower incidence of varices versus placebo in ITT population, though not statistically significant; per-protocol analysis reached significance.

• Fewer patients on 2 mg developed medium or large varices, which are associated with worse outcomes.

• U.S. patients had lower varices incidence, possibly due to higher GLP-1 and statin use, suggesting potential synergy.

• Biomarkers (LSM, ELF score) showed double-digit improvements with 2 mg dose compared to placebo, with placebo group worsening.

• Sicker patients (higher ELF) benefited most, with nearly twice as many placebo patients developing varices.