Galectin Therapeutics (GALT) 9th Annual MASH Investor Conference summary

Strategic focus and leadership

• Focused on developing galectin-3 inhibitors for chronic liver disease and cancer, with belapectin as the lead compound.

• Fast-track FDA designation and patent protection through 2035 support long-term growth.

• Leadership team has extensive experience in pharma, biotech, and regulatory approvals.

• Pipeline targets critical unmet needs in MASH cirrhosis and oncology.

• Discovery program is expanding galectin-3 therapies for additional indications.

Clinical development and trial progress

• Belapectin inhibits galectin-3, reducing fibrosis and inflammation in preclinical and clinical studies.

• Demonstrated favorable safety profile and efficacy in reducing portal pressure and preventing varices in MASH cirrhosis.

• Phase IIb trial showed significant benefit in patients without varices at baseline; ongoing NAVIGATE trial is a seamless phase IIb/III registration study.

• NAVIGATE trial has completed phase IIb enrollment with 357 subjects; interim analysis scheduled for December.

• Five DSMB reviews have affirmed safety, with lower discontinuation rates than comparable trials.

Market opportunity and unmet need

• MASH cirrhosis affects over five million in the U.S., with no FDA-approved therapies and limited liver transplant availability.

• Belapectin could be first-to-market for cirrhosis with portal hypertension, addressing a multibillion-dollar market.

• Market research indicates strong physician and peer support for belapectin's potential.

• Economic burden and rising prevalence of MASH cirrhosis underscore urgent need for new treatments.