Galectin Therapeutics Reports Financial Results for the quarter ended September 30, 2025, and Provides Business Update (Form 8-K)

Earlier in November, at the 2025 AASLD Annual Meeting, Galectin presented new 18-month biomarker analyses from the NAVIGATE trial, further supporting the antifibrotic and disease-modifying potential of belapectin in patients with compensated MASH cirrhosis and portal hypertension. The updated results reinforce and extend previously reported findings.

Belapectin demonstrated consistent, meaningful effects across multiple key biomarkers in MASH cirrhosis. Fewer patients experienced clinically significant worsening of liver stiffness (LSM), while improvements in the ELF (Enhanced Liver Fibrosis) score suggested reduced fibrosis risk and potential improvement in liver function. Notably, the strongest impact was observed in the subgroup with the highest baseline risk (ELF score 11.3), underscoring belapectin's potential to benefit patients with advanced MASH cirrhosis. FibroScan® derived liver stiffness measurement (LSM) and the ELF test are the most widely used noninvasive markers to assess fibrosis severity and the risk of complications in patients with MASH and MASH cirrhosis. PRO-C3 (which indicates active fibrosis) levels showed marked reductions, reflecting decreased fibrogenesis and aligning with observed reductions in new varices. Mechanistic support was provided by YKL-40 (a marker of inflammation), with a greater proportion of patients achieving significant reductions, consistent with Galectin-3 modulation. PRO-C4 data further indicated reduced fibrotic activity, distinguishing belapectin's impact versus placebo across both overall and completer populations. Together, these findings reinforce belapectin's antifibrotic mechanism of action in a very high-risk patient population.

We also present new data showing that, using the validated Baveno VII criteria for portal hypertension, treatment with belapectin was associated with a reduced presence of clinically significant portal hypertension (CSPH) and a lower risk of hepatic decompensation at 18 months.

Belapectin reduced clinically significant portal hypertension category and risk of hepatic decompensation. Using Baveno VII criteria incorporating liver stiffness measurement (LSM) by transient elastography (FibroScan®) and platelet count, belapectin treatment reduced the presence of clinically significant portal hypertension (CSPH) and lowered the risk of hepatic decompensation in patients with MASH cirrhosis. Notably, among recent MASH cirrhosis trials reported, NAVIGATE enrolled one of the most advanced patient populations, as evidenced by the high proportion of subjects meeting CSPH criteria at baseline.

All portal hypertension risk categories were improved comparing belapectin to placebo. Over 18 months, a higher proportion of patients treated with belapectin transitioned from the CSPH or probable CSPH categories to the no/low-risk category, compared to placebo.

CSPH category for placebo decreased from 34.2% to 32.9% (-3.8% change) while belapectin 2 mg/kg decreased 33.3% to 25.9% (-22.2% change).

Probable category for CSPH decreased for placebo from 21.1% to 15.8% (-25.1% change) while belapectin 2 mg/kg probable category for CSPH decreased from 24.7% to 17.3% (-30% change),

No/low-risk category for CSPH for placebo increased from 44.7% to 51.3% (14.8% change) while belapectin 2 mg/kg no/low-risk category for CSPH increased from 42.0% to 56.8% (35.2% change).

Belapectin improved composite liver risk scores based on AGILE-4 assessment. Using AGILE-4, a validated composite marker incorporating liver enzymes, FibroScan® measurements, gender, and diabetes status, patients treated with belapectin demonstrated favorable outcomes relative to placebo. At 18 months, ~32% fewer subjects in the belapectin 2 mg/kg group experienced a ≥20% worsening in AGILE-4 score, a threshold indicative of increased risk for liver complications. This improvement reflects a meaningful reduction in disease progression and is consistent with the clinical endpoint findings of a lower incidence of new varices in the NAVIGATE trial.

The company has submitted the NAVIGATE data package to the FDA and requested feedback on proposed next steps, with guidance anticipated by year-end.

The management team participated in H.C. Wainwright Investor Meeting in New York (September) and the H.C. Wainwright MASH Conference (October), where NAVIGATE data were presented, including new analyses on fibrosis biomarkers.

As of September 30, 2025, the Company had $11.5 million of cash and cash equivalents. Additionally, on July 8, 2025, the Company entered into a new $10 million line of credit provided by its chairman of the board to fund operations. The Company believes it has sufficient cash to fund currently planned operations and research and development activities through June 30, 2026.

Research and development expenses for the quarter ended September 30, 2025 were $2.6 million compared with $7.6 million for the same period in 2024. The decrease was primarily due to timing of incurrence of expenditures related to our NAVIGATE clinical trial which ended in the first quarter of 2025.

General and administrative expenses for the quarter ended September 30, 2025 were $1.6 million, compared to $1.5 million for the quarter ended quarter ended September 30, 2024.

For the quarter ended September 30, 2025, the Company reported a net loss applicable to common stockholders of $8.2 million, or ($0.13) per share, compared to a net loss applicable to common stockholders of $11.2 million, or ($0.18) per share for the quarter ended September 30, 2024.

These results are included in the Company's Quarterly Report on Form 10-Q as of and for the period ended September 30, 2025, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.