Galectin Therapeutics (GALT) Q3 2025 earnings summary

Executive summary

• Focused on developing galectin-3 inhibitors for fibrotic diseases and cancer, with lead candidate belapectin in advanced clinical trials for NASH/MASH cirrhosis and immuno-oncology indications.

• Completed NAVIGATE Phase 2b/3 trial in NASH/MASH cirrhosis; top-line results showed a 49.3% reduction in varices in the per-protocol population, though the primary composite endpoint was not statistically significant in the intent-to-treat group.

• Presented new 18-month biomarker analyses from the NAVIGATE trial at AASLD, reinforcing belapectin's antifibrotic and disease-modifying potential in compensated MASH cirrhosis with portal hypertension.

• Safety profile of belapectin remains favorable, with adverse events comparable to placebo and no drug-related serious adverse events.

• Submitted NAVIGATE data to the FDA, with feedback on next steps expected by year-end; focus remains on advancing FDA dialogue and exploring strategic opportunities.

Financial highlights

• Net loss for the three months ended September 30, 2025 was $8.2 million, or $(0.13) per share, compared to $11.2 million, or $(0.18) per share, for the same period in 2024; net loss for the nine months ended September 30, 2025 was $25.4 million, down from $35.2 million in 2024.

• Research and development expenses decreased 66% year-over-year for the quarter and 51% for the nine months, primarily due to lower NAVIGATE trial costs.

• General and administrative expenses increased 8% for the quarter but decreased 4% for the nine months, reflecting higher legal and investor relations costs offset by lower stock compensation.

• Cash and cash equivalents were $11.5 million as of September 30, 2025, with an additional $10 million line of credit available.

• Net cash used in operations for the nine months was $17.8 million, a decrease from $29.0 million in the prior year period.

Outlook and guidance

• Sufficient cash and credit to fund planned operations and R&D activities through June 30, 2026; additional capital will be required beyond that date.

• Awaiting FDA guidance on belapectin program by year-end and pursuing strategic partnerships for further development and commercialization.