Galectin Therapeutics Presents New EASL 2026 Oral and Poster Analyses Demonstrating Belapectin’s Potential to Modify Disease Progression in Advanced MASH Cirrhosis

• Data from the NAVIGATE trial presented at EASL 2026 (May 27–30, Barcelona) oral presentation demonstrates belapectin reduces varices development in high-risk MASH cirrhosis by modulating fibrogenesis balance, as reflected by the Pro-C3/CTX-III ratio, with associated improvements in Baveno portal hypertension risk category
  
  
• Poster presentation on risk reduction in clinically significant portal hypertension designated a TOP Poster at EASL 2026 — selected among the best abstracts in the Portal Hypertension session and displayed throughout all four days of the congress
  
  
• Belapectin 2 mg/kg produced a statistically significant reduction in new varices at 18 months in the per-protocol population (p=0.04), with significantly fewer patients experiencing worsening of liver stiffness as measured by FibroScan®
  
  

NORCROSS, Ga., May 27, 2026 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), a clinical-stage biotechnology company developing therapeutics that target galectin-3 for patients with MASH cirrhosis and portal hypertension, today announced the oral and poster presentations of new analyses from its global NAVIGATE trial of belapectin at the European Association for the Study of the Liver (EASL) Congress 2026, taking place May 27–30, 2026, in Barcelona, Spain.

Data from the oral presentation (REG26-611), presented by Mazen Noureddin, M.D., MHSc, Director of Houston Research Institute and Professor of Medicine at Houston Methodist Hospital, demonstrate belapectin’s impact on fibrosis modulation in patients with high-risk MASH cirrhosis, as reflected by changes in the Pro-C3/CTX-III ratio — a marker of fibrogenesis balance. Favorable shifts in this ratio were associated with reduced varices development and improvements in broad markers of fibrosis including liver stiffness measure and other markers of fibrosis including Pro-C3, supporting belapectin’s potential to modify disease progression by targeting underlying fibrotic pathology.

The poster presentation (REG26-612), presented by Dr. Naim Alkhouri, MD, FAASLD, Chief Academic Officer at Summit Clinical Research and Director of the Steatotic Liver Program at North Shore Gastroenterology, presents new analyses from the NAVIGATE trial demonstrating risk reduction in clinically significant portal hypertension. Notably, this abstract has been designated a TOP Poster by EASL, recognizing it among the best abstracts in the Portal Hypertension (cirrhosis and non-cirrhosis) session.

Across the NAVIGATE dataset, belapectin 2 mg/kg demonstrated a statistically significant reduction in new varices at 18 months in the per-protocol population (p=0.04) and statistically significant reductions in liver stiffness at multiple timepoints. Fewer belapectin-treated patients experienced clinically meaningful worsening of liver stiffness (>30% increase) versus placebo (11.7% vs. 23.9%; p=0.03). At 18 months, a greater proportion of belapectin-treated patients improved to the no/low-risk Baveno category relative to baseline compared with placebo (p=0.0073). These data collectively support belapectin’s potential as a disease-modifying therapy in MASH cirrhosis.

These EASL presentations build on results recently published in Hepatology, the AASLD flagship journal. The manuscript, titled “Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in Patients with MASH Cirrhosis: The Randomized, Placebo-Controlled NAVIGATE Trial,” is available as an open-access publication, further validating the clinical and scientific significance of belapectin’s effects in this high-risk population. There are currently no approved therapies for the prevention of varices or treatment of portal hypertension in patients with MASH cirrhosis.

“The analyses presented at EASL 2026 provide important new insight into how belapectin may modify disease progression in patients with advanced MASH cirrhosis and portal hypertension,” said Khurram Jamil, M.D., Chief Medical Officer of Galectin Therapeutics. “The oral presentation demonstrates a mechanistic link between modulation of fibrogenesis balance, as reflected by the Pro-C3/CTX-III ratio, and reduced varices development in high-risk patients (i.e. ELF scores ≥11.3, a threshold consistent with cirrhosis). These findings are consistent with the biologic effect we would expect to observe if belapectin is meaningfully impacting the underlying fibrotic disease process. The poster analyses further support that these biologic effects translate into clinically meaningful reductions in portal hypertension risk, including improvements in liver stiffness and Baveno risk category. Taken together, the consistency of findings across the dataset strengthens the overall evidence supporting belapectin’s disease-modifying potential.”

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 belapectin 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, 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, 2024, 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.

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