Galectin Therapeutics (GALT) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Program and pipeline overview

• Lead compound belapectin targets MASH cirrhosis and portal hypertension, with a unique galectin-3 inhibition mechanism and Fast Track designation.

• Patent protection extends to 2035, supporting long-term growth and value creation.

• Experienced leadership team with decades of pharma and regulatory expertise drives innovation and execution.

• Discovery group is developing additional galectin-3 inhibitors for fibrosis-related diseases.

• Oncology program explores belapectin as a combination therapy in advanced melanoma and head and neck cancers.

Scientific rationale and preclinical data

• Galectin-3 is implicated in fibrosis across multiple organs; inhibition is a validated anti-fibrotic target.

• Belapectin demonstrated potent anti-fibrotic effects and NAFLD activity score reduction in preclinical studies.

• Preclinical models showed high tolerability and safety at elevated doses.

• Preclinical data support potential applications in pulmonary fibrosis and heart failure.

Clinical development and trial design

• No FDA-approved therapies exist for NASH cirrhosis or portal hypertension, representing a vast unmet need with ~5 million US patients.

• Phase IIb trial showed significant reduction in hepatic vein pressure gradient and varices development in patients without baseline varices at 2 mg/kg dose.

• NAVIGATE adaptive phase IIb/III trial tests 2 and 4 mg/kg doses over 18 months, using clinical criteria and endoscopy-based endpoints.

• FDA agreed to novel, non-invasive primary endpoint (varices via endoscopy) aligned with clinical practice.

• Enrollment for NAVIGATE completed (357 subjects, global sites); interim analysis results expected before year-end.