Galectin Therapeutics Announces Positive Type C Meeting with the FDA for Belapectin in Patients with MASH Cirrhosis and Portal Hypertension (Form 8-K)

Galectin Therapeutics Announces Positive Type C Meeting with the FDA for Belapectin in Patients with MASH Cirrhosis and Portal Hypertension

NORCROSS, Ga., June 23, 2026 - Galectin Therapeutics Inc. (NASDAQ: GALT), a biotechnology company focused on developing therapies for patients with advanced liver disease, today announced positive feedback from its recent in person Type C meeting with the U.S. Food and Drug Administration (FDA), supporting the advancement of belapectin for the treatment of patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension.

Joel Lewis, Chief Executive Officer of Galectin Therapeutics, said "We are pleased to have reached agreement with FDA on the key elements of our planned Phase 3 program for belapectin. Alignment on the study design, primary endpoint, and regulatory framework provides important clarity, as we advance the program with renewed confidence. We are initiating preparations for the Phase 3 trial and in parallel are evaluating development pathways alongside potential strategic partnership opportunities. We remain committed to patients with MASH cirrhosis and portal hypertension facing the highest risk of life-threatening decompensation events, who currently are excluded from enrolling in other ongoing drug development efforts. Additionally, FDA acknowledged the substantial unmet medical need in this patient population during our meeting, which strengthened our dedication to continuing the development of belapectin and our Phase 3 trial. We look forward to submitting the final Phase 3 protocol in the third quarter of 2026."

The Phase 3 trial will assess the safety and efficacy of belapectin for the prevention of disease progression in a randomized, double-blind, placebo-controlled design in patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension. Alignment was reached on the following:

Primary Endpoint: Alignment was reached on a composite liver outcome as the primary endpoint, including prevention of development of large esophageal varices (>5 mm), a clinically meaningful manifestation of worsening portal hypertension and disease progression in patients with compensated MASH cirrhosis. Importantly, the Company plans to incorporate the development of large esophageal varices as one component of composite clinical outcome endpoints in the planned Phase 3 study.

Central Endoscopy Review Methodology: FDA accepted the Company's proposed blinded central review process for endoscopic assessment of esophageal varices. This methodology builds upon the approach successfully implemented in the global Phase 2b/3 NAVIGATE trial and is designed to ensure standardized, objective, and consistent assessment of endoscopic outcomes across study sites.

Galectin recently published details of the central review methodology and operational framework developed for NAVIGATE, highlighting the rigor and reproducibility of the process in a large multinational clinical trial.

Planned registration trial to evaluate single dose: Based on the robust efficacy observed with the 2 mg dose across prior clinical studies, the Company plans to evaluate a single 2 mg dose of belapectin in its planned Phase 3 trial. The Company believes that the planned Phase 3 study, together with the totality of existing clinical data, has the potential to support a full approval application for belapectin in patients with MASH cirrhosis and portal hypertension.

Given the similarity of the intended study population to the NAVIGATE trial, including patients with MASH cirrhosis and portal hypertension, and the evaluation of a single belapectin dose, the Company currently expects the planned Phase 3 trial to be of a size generally comparable to the NAVIGATE trial.

Regulatory Pathway: Consistent with FDA guidance, the Company understands that approval in the MASH cirrhosis population will require a traditional pathway, unlike earlier-stage MASH populations where accelerated approval based on histologic endpoints may be available. The FDA confirmed that the proposed composite outcome endpoints, including the development of large varices, and study framework are appropriate for a full approval pathway. Based on FDA's recent communication regarding use of a single, adequate and well-controlled confirmatory trial for marketing approval, the Company believes the planned phase 3 trial provides a clear regulatory path toward a broad indication focused on preventing progression of MASH cirrhosis.

Khurram Jamil, M.D., Chief Medical Officer of Galectin Therapeutics, commented "FDA's acceptance of our centralized endoscopy review process underscores the scientific rigor and operational robustness of the methodology that Galectin pioneered, and successfully implemented in the NAVIGATE trial. Standardized, blinded assessment of esophageal varices is critical to ensuring reliable and reproducible endpoint evaluation in global studies. Importantly, the Agency's feedback supports the advancement of belapectin towards full approval, which we believe offers the opportunity to pursue a broad indication focused on preventing disease progression in patients with MASH cirrhosis."

Galectin is advancing Phase 3 planning and is actively pursuing potential strategic and financial partners. Phase 3 protocol submission is anticipated in the third quarter of 2026.

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.