Galectin Therapeutics Inc.

08/14/2026 | Press release | Distributed by Public on 08/14/2026 05:56

Galectin Therapeutics Reports June 30, 2026 Financial Results and Provides Business Update (Form 8-K)

Galectin Therapeutics Reports June 30, 2026 Financial Results and Provides Business Update
NORCROSS, Ga., August 14, 2026 (GLOBE NEWSWIRE) - Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the three months ended June 30, 2026.

"We had a very productive second quarter. Importantly, we reached an agreement with the FDA on the key elements of our planned Phase 3 trial of belapectin in MASH cirrhosis and portal hypertension and aligned on the regulatory path forward. We are working diligently and expect to submit the registrational Phase 3 protocol in the third quarter," said Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics.
Mr. Lewis continued, "the strength of our NAVIGATE trial dataset was further validated and continued to gain momentum within the scientific community. New analyses were presented at EASL and the results of the trial and our novel central endoscopy review process were published in Hepatology and Gastro Hep Advances, respectively. Also in June 2026, we hosted an advisory committee meeting with several leading key opinion leaders at the inaugural SOLAR conference.
Finally, the recent issuance of common stock converting approximately $105.8 million in debt and accrued interest from our chairman, Mr. Uihlein, significantly enhanced our capital structure by strengthening the balance sheet. We will share additional updates when they become available".
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Belapectin Program Highlights

Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of Metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis.

MASH Cirrhosis


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Reached agreement with the U.S. Food and Drug Administration (FDA) on the path forward for the potential full approval of belapectin. Alignment was reached with the agency on the key elements of the planned Phase 3 trial design, including the primary endpoint of composite liver outcome, blinded central review process for endoscopic assessment of esophageal varices, and the use of a single, 2 mg/kg LBM dose of belapectin.


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Presented oral and poster presentations of new analyses from its global NAVIGATE Phase 2b/3 trial of belapectin at the European Association for the Study of the Liver (EASL) Congress 2026:


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The oral presentation, presented by Mazen Noureddin, MD, MHSc, Director of Houston Research Institute and Professor of Medicine at Houston Methodist Hospital, showed 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 measurement and other markers of fibrosis including Pro-C3, supporting belapectin's potential to modify disease progression by targeting underlying fibrotic pathology.

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The poster presentation, presented by Naim Alkhouri, MD, FAASLD, Chief Academic Officer at Summit Clinical Research and Director of the Steatotic Liver Program at North Shore Gastroenterology, included 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.


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Published in AASLD flagship journal Hepatology a manuscript titled "Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in Patients with MASH Cirrhosis: The Randomized, Placebo-Controlled NAVIGATE Trial". The publication highlights the results from the NAVIGATE Phase 2b clinical trial evaluating belapectin in patients with MASH cirrhosis and portal hypertension.


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Published in Gastro Hep Advances a manuscript titled "Assessment of Esophageal and Gastric Varices in Patients With Cirrhosis for Clinical Trials: A Centralized Blinded Evaluation System". The publication describes Galectin's novel central endoscopy review process used in the NAVIGATE trial that will also be utilized in the planned registrational Phase 3 study.

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Q2 2026 and Recent Corporate Highlights

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Richard E. Uihlein, the Company's Chairman of the Board and largest stockholder, has converted all outstanding principal and accrued interest under five of the Company's line of credit facilities into shares of the Company's common stock, effective July 31, 2026. The transaction simplifies Galectin's capital structure and strengthens its balance sheet. Terms of the transaction include:

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Elimination of approximately $105.8 million in total debt, consisting of $91.0 million in principal and $14.8 million in accrued interest


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Issuance of 34,376,167 shares of common stock to Mr. Uihlein upon conversion


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Conversion covers all notes under five of six credit facilities; the December 2025 facility remains undrawn and available
Upcoming Catalysts


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Registrational Phase 3 trial protocol submission for belapectin in advanced MASH cirrhosis with portal hypertension is anticipated in 3Q 2026.

Q2 2026 Financial Highlights

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As of June 30, 2026, the Company had $13.2 million of cash and cash equivalents. Additionally, the Company has $10 million remaining available under a 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 2027.


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Research and development expenses for the quarter ended June 30, 2026 were $2.1 million compared with $3.3 million for the same period in 2025. The decrease was primarily due to timing of incurrence of expenditures related to our NAVIGATE clinical trial.


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General and administrative expenses for the quarter ended June 30, 2026 were $1.8 million, compared to $1.4 million for the quarter ended June 30, 2025. The increase was primarily due to an increase in non-cash, stock-based compensation expense.

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For the quarter ended June 30, 2026, the Company reported a net loss applicable to common stockholders of $9.2 million, or ($0.14) per share, compared to a net loss applicable to common stockholders of $7.6 million, or ($0.12) per share for the quarter ended June 30, 2025. The increase in net loss applicable to common stockholders was primarily due to the charge for change in fair value of derivative liabilities of $3.2 million in the quarter ended June 30, 2026.


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These results are included in the Company's Quarterly Report on Form 10-Q as of and for the period ended June 30, 2026, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.

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.

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