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Galectin Therapeutics will present new clinical findings at American Association for the Study of Liver Diseases (AASLD) Annual Meeting in Denver. These results will be covered in one oral presentation and two posters including a Poster of Distinction.
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Belapectin treatment was associated with lower variceal incidence than placebo across all risk categories, i.e. ANTICIPATE-NASH and Baveno risk categories in the NAVIGATE trial, supporting its potential to reduce portal hypertension–related risk.
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These findings support using baseline noninvasive risk assessments for patient enrichment in the planned Phase 3 registration trial and to better evaluate belapectin’s potential to prevent disease progression in patients with MASH cirrhosis and portal hypertension.
NORCROSS, Ga., Nov. 05, 2026 (GLOBE NEWSWIRE) — Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today announced that it will deliver an oral presentation and present two posters, one of which has been recognized as a Poster of Distinction, at the AASLD Liver Meeting 2026, which is taking place on November 5-9, 2026, in Denver, Colorado.
Oral Presentation: ANTICIPATE-NASH Risk Stratification in the NAVIGATE Trial
This oral presentation will review the potential utility of ANTICIPATE-NASH risk stratification, a validated noninvasive tool to predict variceal development and assess belapectin treatment effect. In the NAVIGATE trial, belapectin treatment was associated with a favorable shift toward lower ANTICIPATE-NASH predicted clinically significant portal hypertension (CSPH) risk at 18 months, with a net 15.9% placebo-adjusted improvement (p=0.04). Variceal incidence increased with higher CSPH probability yet was consistently lower in patients treated with belapectin vs placebo across all baseline risk categories. The findings suggest that belapectin may reduce CSPH risk and potentially future hepatic decompensation.
Poster of Distinction: Baveno and ELF Risk Stratification in the NAVIGATE Trial
Baveno VII criteria and ELF score enable risk stratification for CSPH and risk of decompensation, respectively. This Poster of Distinction highlights the relationship between baseline Baveno VI and ELF risk categories and incidence of varices and belapectin treatment effect. Baveno stratification demonstrated increasing incidence of varices with greater portal hypertension severity. Within each category, incidence of varices was lower in patients treated with belapectin vs placebo. Similarly, higher baseline ELF risk was associated with a stepwise increase in new varices, with highest risk ELF i.e. ≥ 11.3 showing significantly greater incidence than lower-risk categories. These results support utilizing these methods of risk stratification to identify higher-risk patients and potentially improve treatment-effect detection in the planned Phase 3 trial in MASH cirrhosis.
Poster Presentation: Baveno VII and ANTICIPATE-NASH in the Phase 2b GT-026 Trial
This poster presentation provides an overview of the analysis evaluating the correlation between Baveno VII criteria and ANTICIPATE-NASH, two noninvasive tests, with actual HVPG results the invasive gold standard for portal hypertension measurement. Both noninvasive tests showed moderate agreement with HVPG-defined CSPH in patients with compensated MASH cirrhosis. Baveno VII demonstrated slightly better concordance and broader risk stratification than ANTICIPATE-NASH. Together, results suggest that noninvasive tools can be used to identify CSPH and enrich the clinical trial population in MASH cirrhosis.
“Developing varices is an important clinical event in patients with compensated MASH cirrhosis, and these analyses from the NAVIGATE and GT-026 studies provide important insights into how noninvasive tools can identify patients at greater risk of varices development” said Naim Alkhouri, M.D., FAASLD; Chief Medical Officer at Summit Clinical Research and presenting author. “Importantly, across these analyses, belapectin was associated with lower variceal incidence and a favorable shift in predicted CSPH risk, supporting further evaluation of these approaches to enrich patient selection and assess treatment effect in a future Phase 3 trial.”
“These risk stratification analyses strengthen our understanding of how noninvasive risk-stratification tools can be extremely useful to identify patients at greater risk of variceal development and inform our planned Phase 3 design,” stated Khurram Jamil, M.D., Chief Medical Officer at Galectin Therapeutics. “Together with the HVPG analyses, the results give us a rigorous, noninvasive framework that we plan to incorporate in the planned Phase 3 trial, to enrich the patient population and increase our probability of success to detect the effect of belapectin on variceal prevention.”
“We are pleased to present these results at the Liver Meeting this year, demonstrating the depth and scientific value of the NAVIGATE dataset and providing additional insights into the potential of belapectin to modify disease progression in patients with MASH cirrhosis and portal hypertension,” added Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics. “With the recent Phase 3 protocol submission to the FDA, we continue to advance our trial initiation activities while in parallel evaluating strategic partnerships for belapectin’s next phase of development.”
About Galectin Therapeutics
Galectin Therapeutics is dedicated to developing novel therapies to improve the lives of patients with chronic liver disease and cancer. Galectin’s lead drug belapectin is a carbohydrate-based drug that inhibits the galectin-3 protein, which is directly involved in multiple inflammatory, fibrotic, and malignant diseases, for which it has Fast Track designation by the U.S. Food and Drug Administration. The lead development program is in metabolic dysfunction-associated steatohepatitis (MASH, formerly known as nonalcoholic steatohepatitis, or NASH) with cirrhosis and portal hypertension, the most advanced form of MASH-related fibrosis. Liver cirrhosis is one of the most pressing medical needs and a significant drug development opportunity. Additional development programs are in treatment of combination immunotherapy for advanced head and neck cancers and other malignancies. Advancement of these additional clinical programs is largely dependent on finding a suitable partner. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development. Additional information is available at www.galectintherapeutics.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as “may,” “estimate,” “could,” “expect”, “look forward”, “believe”, “hope” and others. They are based on management’s current expectations and are subject to factors and uncertainties that could cause actual results to differ materially from those described in the statements. These statements include those regarding the hope that Galectin’s development program for belapectin will lead to the first therapy for the treatment of MASH, formerly known as NASH, with cirrhosis and those regarding the hope that our lead compounds will be successful in cancer immunotherapy and in other therapeutic indications. Factors that could cause actual performance to differ materially from those discussed in the forward-looking statements include, among others, full analysis of the NAVIGATE trial data may not produce positive data; Galectin may not be successful in developing effective treatments and/or obtaining the requisite approvals for the use of belapectin or any of its other drugs in development; the Company may not be successful in scaling up manufacturing and meeting requirements related to chemistry, manufacturing and control matters; the Company’s current clinical trial and any future clinical studies may not produce positive results in a timely fashion, if at all, and could require larger and longer trials, which would be time consuming and costly; plans regarding development, approval and marketing of any of Galectin’s drugs are subject to change at any time based on the changing needs of the Company as determined by management and regulatory agencies; regardless of the results of any of its development programs, Galectin may be unsuccessful in developing partnerships with other companies or raising additional capital that would allow it to further develop and/or fund any studies or trials. Galectin has incurred operating losses since inception, and its ability to successfully develop and market drugs may be impacted by its ability to manage costs and finance continuing operations. For a discussion of additional factors impacting Galectin’s business, see the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause its views to change, management disclaims any obligation to update forward-looking statements.
Company Contact:
Jack Callicutt, Chief Financial Officer
(678) 620-3186
ir@galectintherapeutics.com
Investors Relations Contact:
Kevin Gardner
kgardner@lifesciadvisors.com
Galectin Therapeutics and its associated logo is a registered trademark of Galectin Therapeutics Inc. Belapectin is the USAN assigned name for Galectin Therapeutics’ galectin-3 inhibitor belapectin.
