GALT

NORCROSS, Ga., Aug. 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”. 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 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. 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: 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. 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. Q2 2026 and Recent Corporate Highlights 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: Upcoming Catalysts Registrational Phase 3 trial protocol submission for belapectin in advanced MASH cirrhosis with portal hypertension is anticipated in 3Q 2026. Q2 2026 Financial Highlights 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. 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. 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. 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. 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 TherapeuticsGalectin 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) [email protected] Investors Relations Contacts:Kevin [email protected] 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. Condensed Consolidated Statements of Operations Condensed Consolidated Balance Sheet Data

NORCROSS, Ga., May 15, 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 March 31, 2026. “We continue to make meaningful progress advancing the belapectin program and further analyzing the NAVIGATE dataset in patients with MASH cirrhosis and portal hypertension. The additional analyses, including biomarker data, continue to support the potential of belapectin to impact disease progression in this high-risk population. We are looking forward to our upcoming data presentations at EASL later this month and our in-person Type-C meeting with FDA this quarter. Additionally, we remain focused on engaging with potential partners and leading experts to help determine the optimal path forward. This is an extremely exciting and consequential time in the Company’s history, and we will share updates as soon as possible.” said Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics. Belapectin Program Highlights Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of MASH and fibrosis. MASH Cirrhosis NAVIGATE Phase 2b/3 trial (NCT04365868) is a global, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of belapectin intravenously either belapectin 2 mg/kg of lean body mass (LBM) (n=119), 4 mg/kg/LBM (n=118) or placebo (n=118) every other week for 18 months for the prevention of esophageal varices in MASH cirrhosis. Additional analyses from the NAVIGATE trial, including biomarker data, continue to support the potential of belapectin to impact disease progression in this high-risk population. Statistically significant reductions in liver stiffness measurements (LSM), assessed by FibroScan®, were observed in the belapectin 2 mg/kg treatment arm at Weeks 26, 52 and 78, based on Mixed Model for Repeated Measures (MMRM) analyses of all clean and verified data collected throughout the study. Treatment with belapectin was associated with a reduction in the proportion of patients experiencing clinically meaningful worsening in liver stiffness compared to placebo, including fewer patients with >30% increases from baseline (11.7% vs. 23.9%; p=0.03) and fewer patients with combined increases of >10 kPa and >30% over the 18-month treatment period. These thresholds are clinically meaningful and associated with increased risk of liver-related complications, and the findings are consistent with a reduction in fibrosis progression, with placebo-treated patients continuing to demonstrate expected disease worsening over time. Q1 2026 Corporate Highlights Announced the appointment of Dr. Henry Brem to its Board of Directors in January 2026, further strengthening governance and strategic oversight. Hosted a virtual key opinion leader (KOL) event in March 2026 focused on MASH cirrhosis and the clinical development of belapectin. Upcoming Catalysts Additional biomarker analyses from the NAVIGATE trial, including evaluation of belapectin’s impact on liver stiffness and fibrogenesis, will be presented in oral and poster presentations at the European Association for the Study of the Liver Congress in Barcelona, Spain: Oral presentation by Mazen Noureddin: “Belapectin reduces varices development in high-risk MASH cirrhosis by modulating fibrogenesis balance as reflected by Pro-C3/CTX-III ratio” (Abstract REG26-611; Saturday, May 30, 2026, 10:15 AM–11:30 AM CET). Poster presentation by Naim Alkhouri: “Risk reduction in clinically significant portal hypertension with belapectin in advanced MASH cirrhosis: results from the NAVIGATE trial” (Abstract REG26-612; Thursday, May 28, 2026, 8:30 AM–5:00 PM CET). Upcoming FDA meeting to align on next steps for advancing the belapectin program and informing future clinical development plans in 2Q 2026. Q1 2026 Financial Highlights As of March 31, 2026, the Company had $14.1 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 May 2027. Research and development expenses for the quarter ended March 31, 2026 were $2.2 million compared with $6.5 million for the same period in 2025. The decrease was primarily due to timing of incurrence of expenditures related to our NAVIGATE clinical trial. General and administrative expenses for the quarter ended March 31, 2026 were $1.8 million, compared to $1.4 million for the quarter ended March 31, 2025. The increase was primarily due to an increase in non-cash, stock-based compensation expense. For the quarter ended quarter ended March 31, 2026, the Company reported a net loss applicable to common stockholders of $5.1 million, or ($0.08) per share, compared to a net loss applicable to common stockholders of $9.6 million, or ($0.15) per share for the quarter ended March 31, 2025. These results are included in the Company's Quarterly Report on Form 10-Q as of and for the period ended March 31, 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, the most advanced form of MASH-related fibrosis. Liver cirrhosis is one of the most pressing medical need 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 [email protected] Investors Relations Contacts: Kevin Gardner [email protected] 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. Condensed Consolidated Statements of Operations Condensed Consolidated Balance Sheet Data

NORCROSS, Ga., May 11, 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 publication of results from its NAVIGATE Phase 2b clinical trial evaluating belapectin in patients with MASH cirrhosis and portal hypertension in AASLD flagship journal Hepatology. 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 now available online and available as an open-access publication. The NAVIGATE trial evaluated belapectin, a galectin-3 inhibitor, in patients with MASH cirrhosis and portal hypertension without esophageal varices at baseline. Results demonstrated that belapectin 2 mg/kg was associated with a numerical reduction in the development of new varices compared to placebo in the full analysis set, with a statistically significant reduction observed in the per-protocol population. Key markers of fibrosis including Liver Stiffness Measure results were aligned with the clinical finding belapectinwas generally safe and well tolerated. “These findings provide clinically meaningful evidence for the potential role of belapectin in addressing portal hypertension and reducing the risk of clinically significant complications in patients with MASH cirrhosis,” said Prof. Naga Chalasani, David W. Crabb Professor of Gastroenterology and Hepatology at Indiana University School of Medicine and principal investigator for the NAVIGATE program. “The observed reduction in variceal development, together with consistent biomarker findings and a favorable safety profile, supports continued development of belapectin in patients with MASH cirrhosis and portal hypertension—a population with substantial unmet medical need.” “These results further strengthen the clinical and mechanistic profile of belapectin in MASH cirrhosis and portal hypertension,” said Khurram Jamil, M.D., Chief Medical Officer of Galectin Therapeutics. “The consistency across clinical outcomes and noninvasive biomarkers, including signals of reduced risk of clinically significant portal hypertension and variceal development, reinforces our confidence in belapectin’s potential to modify disease progression. We believe these data meaningfully support continued advancement of our program, while positioning belapectin as a differentiated therapeutic candidate in MASH cirrhosis with portal hypertension—a market with significant unmet need and limited treatment options.” The manuscript highlights: Numerical reduction in incidence of new esophageal varices with belapectin 2 mg/kg compared to placebo Statistically significant reduction in the per-protocol population Supportive changes in non-invasive markers of portal hypertension and fibrosis including LSM and ELF. Favorable safety and tolerability profile Belapectin targets galectin-3, a key mediator of fibrosis and inflammation, and is being developed as a potential therapy to address complications of MASH cirrhosis. The full manuscript is available online and can be accessed here freely given its open-access status. About NAVIGATE NAVIGATE was a global, randomized, placebo-controlled Phase 2b trial evaluating belapectin in patients with MASH cirrhosis and portal hypertension without esophageal varices at baseline. The study assessed the development of varices and other clinically relevant outcomes over an 18-month treatment period. 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, the most advanced form of MASH-related fibrosis. Liver cirrhosis is one of the most pressing medical need 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 product 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 [email protected] Investors Relations Contacts: Kevin Gardner [email protected] 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.

NORCROSS, Ga., March 31, 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 year ended December 31, 2025. Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said “We are at an important juncture for the belapectin development program. During 2025, we made meaningful progress advancing the belapectin program and continuing our analysis of the NAVIGATE dataset in patients with MASH cirrhosis and portal hypertension. We are encouraged by the signals observed, including additional biomarkers from the NAVIGATE dataset, and remain focused on evaluating the data as we engage with regulators, potential partners, and leading experts to determine the optimal path forward for the program. Importantly, we also improved the Company’s financial position during the year, including securing an additional $10 million line of credit from our Chairman, Dick Uihlein, to extend our projected cash runway through April 2027. Also, just very recently, we have strengthened our Board with the appointment of Dr. Henry Brem, an internationally recognized neurosurgeon-scientist and leader in translational medicine, whose clinical development experience will be valuable as we advance the program. With no approved therapies currently available for patients with MASH cirrhosis, we believe belapectin has the potential to address a significant unmet medical need and look forward to discussing the program with FDA.” Khurram Jamil, M.D., Chief Medical Officer, added “The NAVIGATE dataset continues to provide encouraging insights supporting belapectin’s potential role in patients with MASH cirrhosis and portal hypertension. In addition to the previously reported clinical finding of reduced varices incidence in the per-protocol population, additional biomarker analyses have demonstrated consistent signals across specialized markers of fibrosis and noninvasive measures of liver stiffness, supporting belapectin’s potential antifibrotic activity and disease-modifying effect. These findings have been well received by the scientific community and were recently discussed by leading hepatology experts during our March 10, 2026 virtual KOL event, where the data were reviewed in the context of disease progression and portal hypertension category risk in MASH cirrhosis. Taken together, these results further strengthen the biological rationale for galectin-3 inhibition and support continued evaluation of belapectin as a potential therapy for patients with MASH cirrhosis, a population for whom there are currently no approved treatment options. We are excited about our upcoming FDA meeting in the second quarter of 2026 to align on the next steps for advancing the program. We are pleased to announce that multiple abstracts from the NAVIGATE program have been accepted for presentations at the upcoming EASL Congress, including one oral presentation. This builds on our momentum from last year’s late-breaker presentation at EASL and oral presentation at AASLD 2025 and reflects the continued interest from the scientific community in our unique and comprehensive dataset.” Belapectin Program Highlights Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein involved in fibrosis and inflammation associated with MASH and portal hypertension. MASH Cirrhosis NAVIGATE Phase 2b/3 trial (NCT04365868) is a global, randomized, double-blind, placebo-controlled study evaluating belapectin administered intravenously at 2 mg/kg or 4 mg/kg of lean body mass (LBM) versus placebo every two weeks for 18 months for the prevention of esophageal varices in patients with MASH cirrhosis. The NAVIGATE trial demonstrated: In the intent-to-treat population (n=355), the incidence of varices at 18 months was 43.2% lower in patients treated with belapectin 2 mg/kg compared with placebo, although the composite endpoint did not reach statistical significance. In the per-protocol population (n=287), belapectin 2 mg/kg reduced the incidence of varices by 49.3% versus placebo (nominal p = 0.04). In U.S. patients within the per-protocol population (n=186), belapectin 2 mg/kg reduced the incidence of varices by 68.1% compared with placebo (p = 0.02). Safety results showed a similar proportion of treatment-emergent adverse events, serious adverse events, and discontinuations across treatment groups, with no drug-related serious adverse events observed. Additional 18-month NAVIGATE biomarker analyses presented in 2025 demonstrated consistent effects across multiple non-invasive markers of fibrosis and disease progression, including FibroScan® liver stiffness measurement, ELF score, and PRO-C3, further supporting belapectin’s potential antifibrotic and disease-modifying activity in patients with compensated MASH cirrhosis and portal hypertension. Additional mechanistic analyses, including YKL-40 and PRO-C4, further supported belapectin’s biological activity, with findings consistent with reduced inflammation and fibrogenesis. Analyses using validated Baveno VII criteria suggested belapectin treatment was associated with improvements in portal hypertension risk categories and a reduced risk of hepatic decompensation compared with placebo. In March 2026, the Company hosted a virtual KOL event featuring leading hepatology experts who reviewed additional NAVIGATE biomarker findings and discussed their implications for disease progression and portal hypertension risk in MASH cirrhosis. The Company will present new NAVIGATE trial analyses at EASL 2026 (May 27–30, 2026), including an oral presentation on reduced varices based on favorable changes in markers of fibrosis formation and resolution (PRO-C3/CTX-III), and a poster presentation on risk reduction in clinically significant portal hypertension in advanced MASH cirrhosis. Full Year 2025 Financial Highlights As of December 31, 2025, the Company had $17.7 million of unrestricted cash and cash equivalents in addition to $10 million available under a line of credit provided by our chairman to fund future operations. The Company believes it has sufficient cash to fund currently planned operations and research and development activities through April 2027. Research and development expenses for the year ended December 31, 2025 were $14.3 million compared with $36.6 million for the year ended December 31, 2024. The decrease was primarily due to costs related to our NAVIGATE clinical trial and other supportive activities. General and administrative expenses for the year ended December 31, 2025 were $5.8 million, compared to $5.9 million for the year ended December 31, 2024. For the year ended December 31, 2025, the Company reported a net loss applicable to common stockholders of $31.0 million, or ($0.48) per share, compared to a net loss applicable to common stockholders of $47.2 million, or ($0.76) per share, for the year ended December 31, 2024. The decrease is largely due to a decrease in research and development costs due to the conclusion of the NAVIGATE trial. These results are included in the Company's Annual Report on Form 10-K, 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, the most advanced form of MASH-related fibrosis. Liver cirrhosis is one of the most pressing medical need 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 [email protected] Investors Relations Contacts: Kevin Gardner [email protected] 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. Condensed Consolidated Statements of Operations Condensed Consolidated Balance Sheet Data

NORCROSS, Ga., Nov. 14, 2025 (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 and nine months ended September 30, 2025. “The new NAVIGATE data presented at AASLD further strengthen the clinical and mechanistic profile of belapectin. We continue to see encouraging consistency across key biomarkers—including FibroScan®, ELF, and PRO-C3—all supporting belapectin’s durable antifibrotic activity and potential to slow disease progression in patients with compensated MASH cirrhosis. We submitted the NAVIGATE data package to the FDA and requested feedback on proposed next steps, with guidance anticipated by year-end. As we move forward, our focus remains on advancing dialogue with FDA and exploring strategic opportunities to maximize the value of this promising program,” said Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics. Khurram Jamil, M.D., Chief Medical Officer, added, “Importantly, the concordant biomarker data across independent measures support the mechanistic rationale for Galectin-3 inhibition and highlight belapectin’s potential to favorably alter disease trajectory in patients with advanced, high-risk MASH cirrhosis. From a clinical and mechanistic standpoint, these biomarker analyses provide compelling evidence of belapectin’s biological activity and durability of effect. The data demonstrating reductions in Baveno VII defined portal hypertension risk categories are particularly encouraging, as they come from the sickest MASH cirrhosis patients studied to date. The results were consistent across both the overall and completer populations, with a clear dose-response observed, reinforcing the biological rationale. Taken together, these findings strengthen our confidence in belapectin’s mechanism of action and its potential to positively impact disease progression in this high-risk population.” Recent Highlights 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. 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. Q3 2025 Financial Highlights 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. 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) 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 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 [email protected] Investors Relations Contacts: Kevin Gardner [email protected] 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.

New biomarker analyses from the NAVIGATE trial demonstrated consistent antifibrotic effects of belapectin 2 mg/kg Using established criteria for clinically meaningful worsening, a lower proportion of patients treated with belapectin 2 mg/kg experienced ≥30% or ≥5 kPa increases in liver stiffness (LSM) by FibroScan® compared with placebo, indicating slowing of fibrosis progression and stabilization of liver function Across all ELF fibrosis risk categories, belapectin 2 mg/kg showed a lower incidence of new varices compared with placebo, with the largest benefit in patients with ELF > 11.3 (22.7% vs 42.9%), representing those at highest risk for liver complications Pro-C3 biomarker analysis demonstrated a >50% reduction from baseline at 18 months with belapectin 2 mg/kg versus placebo, supporting the therapy’s antifibrotic and disease-modifying potential in compensated MASH cirrhosis with portal hypertension. Analysis of YKL-40, a biomarker associated with Galectin-3 upregulation in fibrotic liver disease, demonstrated a ≥20% reduction in a higher proportion of patients treated with belapectin 2 mg/kg compared with placebo, providing additional mechanistic evidence of belapectin’s antifibrotic activity. Analysis of PRO-C4, a key biomarker of liver injury and fibrogenesis, showed a ≥20% increase in a higher proportion of placebo-treated patients compared with those receiving belapectin 2 mg/kg, consistent with ongoing fibrotic progression and further supporting belapectin’s disease-modifying potential For available patients who completed 36 months of therapy, belapectin maintained the sustained reduction in new variceal development seen at 18 months NORCROSS, Ga., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of galectin-3-targeted therapeutics for patients with MASH cirrhosis and portal hypertension, presented a poster and will deliver an oral presentation of the NAVIGATE study analysis at the AASLD 2025 Annual Meeting. The Phase 2 NAVIGATE trial evaluated belapectin, a proprietary galectin-3 inhibitor, in patients with compensated MASH cirrhosis and portal hypertension. The global Phase 2b NAVIGATE trial (NCT04365868) was a randomized, double-blind, placebo-controlled study evaluating the galectin-3 inhibitor belapectin in 355 patients with compensated MASH cirrhosis and portal hypertension confirmed by non-invasive markers and baseline endoscopy. Patients were randomized 1:1:1 to receive intravenous belapectin at 2 mg/kg or 4 mg/kg of lean body mass or placebo every other week for 18 months (78 weeks). When patients were stratified using FDA-approved Enhanced Liver Fibrosis (ELF) score cutoffs, belapectin 2 mg/kg demonstrated a consistently lower incidence of new varices across all fibrosis categories, with the largest reduction observed among patients with ELF >11.3, representing those at highest risk for liver complications (22.7% vs 42.9% for placebo). Incidences across ELF strata were as follows: Note: ELF: Risk of disease progression. < 9.8 Low risk, ≥11.3 mid risk, highest risk ≥13 Additionally, analysis of the Pro-C3 fibrosis biomarker showed that baseline levels were comparable across all groups (placebo: 50.2 ng/mL; 2 mg/kg: 45.9 ng/mL; 4 mg/kg: 43.4 ng/mL). At 78 weeks, patients receiving 2 mg/kg belapectin achieved a mean –6.4 ng/mL reduction in Pro-C3, representing >50% improvement from baseline compared with placebo (–4.5 ng/mL), while the 4 mg/kg dose showed a –1.7 ng/mL change. These biomarker findings were consistent with the clinical outcome of reduction in development of new varices, further supporting the antifibrotic and disease-modifying potential of belapectin in patients with compensated MASH cirrhosis and portal hypertension. Baseline YKL-40 levels were comparable across treatment groups (placebo: 5.11 ng/mL; 2 mg/kg: 4.95 ng/mL; 4 mg/kg: 4.92 ng/mL). At 18 months, a greater proportion of patients receiving belapectin 2 mg/kg achieved a ≥ 20% reduction in YKL-40 compared with placebo (33.8% vs 23.1%), while fewer belapectin-treated patients experienced increases from baseline. These findings provide additional mechanistic evidence of galectin-3 pathway modulation and support belapectin’s antifibrotic biological activity in patients with MASH cirrhosis and portal hypertension. Analysis of PRO-C4, a key biomarker associated with liver injury and fibrogenesis, showed that a ≥ 20% increase from baseline occurred at a higher rate in placebo-treated subjects compared with those receiving belapectin 2 mg/kg (13% vs 3%). This pattern, consistent across both the full analysis and per-protocol populations, indicates ongoing fibrotic progression in the placebo arm and further reinforces belapectin’s potential to modify disease progression in compensated MASH cirrhosis with portal hypertension. Separately, a poster presentation at AASLD over the weekend showed that reduction in the development of esophageal varices observed at 18 months was sustained through 36 months in patients with MASH cirrhosis and portal hypertension. A total of 57 subjects completed 36 months of therapy in NAVIAGTE. At 36 months, the cumulative incidence of new varices in the study was 23.4%, 12.4% and 16.7% respectively, in placebo, 2 mg/kg, and 4 mg/kg cohorts. As in prior trials, the safety profile of belapectin remains highly encouraging with incidence of adverse events and serious adverse events comparable across the three cohorts. Rates of discontinuation, adverse events (AEs), and serious adverse events (SAEs) were comparable to placebo, with no drug-related SAEs reported in the NAVIGATE trial. Raj Vuppalanchi, M.D., serves as Professor of Medicine and Director of Hepatology at Indiana University School of Medicine, stated “The long-term NAVIGATE data presented at AASLD provide important insights into the potential of Galectin-3 inhibition in advanced fibrosis. The sustained improvements in liver stiffness and multiple serum biomarkers, including ELF, PRO-C3, and YKL-40, are particularly noteworthy, as they collectively suggest a consistent antifibrotic effect and stabilization of disease. These results are encouraging for patients with MASH cirrhosis and portal hypertension, a population with few effective therapeutic options.” Dr. Khurram Jamil, Chief Medical Officer at Galectin Therapeutics, stated, “The consistency we observed across both clinical and biomarker endpoints reinforces belapectin’s potential as a disease-modifying therapy for patients with compensated MASH cirrhosis and portal hypertension. The 2 mg/kg dose demonstrated a clear and clinically meaningful reduction in the incidence of new varices across all ELF risk categories, with the strongest effect seen in patients at highest risk for liver complications. In addition, the more than 50% greater reduction in Pro-C3 levels versus placebo further supports belapectin’s antifibrotic activity and alignment between biomarker and clinical outcomes.” Joel Lewis, Chief Executive Officer at Galectin Therapeutics, added, “We are very encouraged to see the robust effects of belapectin maintained over 36 months of therapy. These results represent an important milestone for the belapectin program and for patients living with MASH cirrhosis, a population with no approved therapeutic options today. With a solid foundation of clinical and biomarker evidence, we are focused on advancing regulatory discussions and exploring strategic partnerships to accelerate the next phase of development. We are deeply encouraged by the potential of belapectin to make a meaningful difference for patients and families affected by this serious disease.” 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, the most advanced form of MASH-related fibrosis. Liver cirrhosis is one of the most pressing medical need 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 [email protected] Investors Relations Contacts: Kevin Gardner [email protected] 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.

NORCROSS, Ga., Aug. 14, 2025 (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 and six months ended June 30, 2025. Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, stated “We are encouraged by the continued analysis of data from our NAVIGATE trial , which further supports the clinical profile of belapectin in patients with MASH cirrhosis. At the European Association for the Study of the Liver (EASL) in May, we presented a clinically significant response in Fibroscan® (a key biomarker in MASH) and additional Fibroscan® data outcomes supporting the NAVIGATE trial’s primary endpoint, the prevention of esophageal varices after 18 months of treatment with belapectin. We believe it is especially promising that these findings remain robust in patients who received belapectin beyond 18 months, reinforcing our belief in the potential of belapectin to modify disease progression in this high-risk population. We are also analyzing additional biomarkers and expect to present those results later this year.” “In June, we hosted a webcast featuring two prominent key opinion leaders, Dr. Naga Chalasani and Dr. Naim Alkhouri, who provided valuable insight into the NAVIGATE data and evolving treatment landscape. Looking ahead, we remain focused on engaging with the U.S Food and Drug Administration later this year to discuss potential next steps for our program, while also continuing to explore strategic partnership opportunities. As stated previously, we continue to believe that belapectin has the potential to offer a much-needed new treatment option for the growing number of patients with MASH-associated liver cirrhosis and portal hypertension — a significant area of unmet medical need. Lastly, I again thank Mr. Richard E. Uihlein, our chairman, for his continued support through the additional $10 million debt financing announced in early July, which is expected to fund our current planned operations through second half of 2026.” Khurram Jamil, M.D., Chief Medical Officer, added, “The 18-month analysis showed a lower incidence of both liver stiffness progression and varices in the 2 mg belapectin arm compared to placebo — an encouraging signal, given that increasing liver stiffness is a well-established predictor of liver-related complications. We are pleased that these effects were maintained in patients who continued into the second 18-month treatment period. Using all available data and LOCF (Last Observation Carried Forward) methodology, the updated analysis confirms less progression in the belapectin group, further supporting FibroScan® as a meaningful predictive biomarker in this setting.” Recent Highlights In June, Galectin hosted a KOL event featuring two key opinion leaders, Dr. Naga Chalasani and Dr. Naim Alkhouri, who discussed NAVIGATE trial results and the unmet need and current treatment landscape for metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension. In May, Galectin presented NAVIGATE trial results at the European Association for the Study of the Liver (EASL) 2025 Congress. The updated analysis includes subjects who completed the 18 months of treatment, had an endoscopy assessment (i.e., completers) and had at least one FibroScan® assessment during the stage 2 portion of the study. As a reminder, while endoscopy assessments were conducted at months 18 and 36, FibroScan® evaluations were performed every six months throughout the study. Belapectin shows sustained efficacy in reducing liver stiffness: In patients who entered the second 18 months of treatment, belapectin 2 mg continued to significantly reduce progression in liver stiffness compared to placebo. Using the LOCF (Last Observation Carried Forward) method, the analysis confirms the durability of effect beyond the initial 18-month period. Fewer patients experienced clinically meaningful worsening: A lower proportion of patients in the belapectin arm had >5 kPa or >30% increases in liver stiffness from baseline, reinforcing the drug’s ability to slow disease progression. This was consistent across both thresholds, as assessed using LOCF. Liver stiffness outcomes align with reduced varices incidence: The updated FibroScan® findings mirror previously reported reductions in esophageal varices, supporting belapectin’s potential to reduce the risk of portal hypertension-related complications. Longitudinal FibroScan® data strengthens clinical confidence: Regular assessments every six months, combined with LOCF methodology, provided a robust dataset across both phases of treatment, enhancing confidence in the consistency and durability of the observed biomarker trends. Q2 2025 Financial Highlights As of June 30, 2025, the Company had $13.8 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 June 30, 2025 were $3.3 million compared with $9.8 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 June 30, 2025 were $1.4 million, compared to $1.5 million for the quarter ended quarter ended June 30, 2024. For the quarter ended June 30, 2025, the Company reported a net loss applicable to common stockholders of $7.6 million, or ($0.12) per share, compared to a net loss applicable to common stockholders of $12.4 million, or ($0.20) per share for the quarter ended March 31, 2024. These results are included in the Company's Quarterly Report on Form 10-Q as of and for the period ended June 30, 2025, 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) 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 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 [email protected] Investors Relations Contacts: Kevin Gardner [email protected] 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. Condensed Consolidated Statements of Operations Condensed Consolidated Balance Sheet Data

NORCROSS, Ga., May 15, 2025 (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 March 31, 2025. Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, stated “This quarter, we remained laser-focused on advancing additional analyses for belapectin. I was extremely encouraged by the feedback we received last week at the European Association for the Study of the Liver (EASL), specifically that we successfully demonstrated a clinically significant response in a key biomarker (Fibroscan®) that is used to support outcomes in MASH trials at every stage of disease progression. In December 2024, as part of the topline results from the NAVIGATE trial, we reported that the 2 mg/kg dose of belapectin led to a significantly lower incidence of new varices compared to placebo in the per protocol population—validating the findings from our earlier Phase 2 study where 2 mg/kg dose showed significant reduction in portal pressure and new varices in cohort of patients without varices at baseline. Based on these results from the NAVIGATE trial presented at EASL, we continue to believe that belapectin has the potential to offer a much-needed new treatment option for the growing number of patients with MASH-associated liver cirrhosis and portal hypertension — a significant area of unmet medical need.” Khurram Jamil, M.D., Chief Medical Officer, added “We were pleased to present the analysis of the NAVIGATE trial coupled with biomarker analysis to the scientific community and industry stakeholders at EASL. We are particularly encouraged by the liver stiffness measure (LSM), which showed that approximately double the number of patients demonstrated worsening of liver stiffness on placebo compared to on belapectin. We also showed that the difference in new varices between the 2 mg/kg dose and placebo was primarily driven by a reduction in medium and large varices, rather than small ones. This is relevant for clinicians since it’s medium or large size varices that are more likely to bleed and or require additional treatment. We also demonstrated that the proportion of patients who experienced a significant worsening of LSM were significantly higher in the placebo group compared to the 2 mg/kg belapectin group, thus reinforcing the relationship between disease progression and development of varices. These findings further support the potential clinical efficacy of belapectin.   With Fast Track Designation in place, we are hopeful that the belapectin program will ultimately deliver the first targeted treatment for patients with MASH cirrhosis and portal hypertension.” Mr. Lewis added, “We are pleased to share that after a complete analysis of all existing valid Fibroscan data, we observed several important findings. First, the total baseline Fibroscan data was normally distributed (n=269). Additionally, the 2 mg/kg population (n=94) and the 4 mg/kg population (n=87) showed statistically significant changes from baseline on Fibroscan data, while the placebo population (n=88) did not show a statistically significant change from baseline. Most importantly, on several clinical endpoints indicating increased severity of LSM worsening, the 2 mg/kg population significantly outperformed the placebo group (see below). We look forward to sharing more biomarker data as it becomes available.” Belapectin Program Highlights Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of MASH and fibrosis. MASH Cirrhosis NAVIGATE Phase 2b/3 trial (NCT04365868) is a global, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of belapectin intravenously either belapectin 2 mg/kg of lean body mass (LBM) (n=119), 4 mg/kg/LBM (n=118) or placebo (n=118) every other week for 18 months for the prevention of esophageal varices in MASH cirrhosis. Following the topline data announced in December 2024, the NAVIGATE trial data and additional biomarker data were presented at the European Association for the Study of the Liver (EASL) Congress on May 10, 2025. Liver stiffness measurements (LSM), assessed using FibroScan®, were analyzed using a commonly used analytical method for this test (i.e. Mixed Model for Repeated Measures (MMRM)), incorporating all clean and verified assessments collected throughout NAVIGATE.Statistically significant reductions in liver stiffness from baseline were observed in the belapectin 2 mg/kg treatment arm at Week 26, Week 52 and Week 78: Belapectin 2 mg/kg (absolute kPa change from baseline) • Week 26 - LSM Mean Change from Baseline = -3.48; p = 0.005• Week 52 - LSM Mean Change from Baseline = -4.60; p = < 0.0001• Week 78 - LSM Mean Change from Baseline = -2.72; p = 0.0197 This finding indicates that belapectin treatment may lead to regression of liver stiffness in this high-risk population, while placebo-treated patients continued to show no improvement. In addition, significantly fewer patients with >30% worsening in liver stiffness were observed in the 2 mg/kg belapectin groups compared to placebo: • Placebo: 21/88 (23.9%) patients• Belapectin 2 mg/kg: 11/94 (11.7%) patients (51% fewer cases than placebo; p=0.03)• Belapectin 4 mg/kg: 13/87 (14.9%) patients Further, compared to the 2 mg/kg group, 64% more patients in the placebo group experienced an absolute increase in LSM of >10 kPa (p=0.02). Additionally, 62.5% more patients in the placebo group experienced both worsening of >10 kPa and >30% increase (p=0.04) over 18 months, thus reinforcing the progression of disease in the absence of treatment. These thresholds of increases are clinically meaningful since they are based on published trials in MASH populations where categorical increases meeting these thresholds result in significantly increased rates of liver complications.1 Q1 2025 Financial Highlights As of March 31, 2025, the Company had $7.4 million of cash and cash equivalents. Additionally, the Company has $11 million remaining available under two lines 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 August 2025. Research and development expenses for the quarter ended March 31, 2025 were $6.5 million compared with $8.1 million for the same period in 2024. The decrease was primarily due to timing of incurrence of expenditures related to our NAVIGATE clinical trial. General and administrative expenses for the quarter ended March 31, 2025 were $1.4 million, compared to $1.6 million for the quarter ended quarter ended March 31, 2024. For the quarter ended quarter ended March 31, 2025, the Company reported a net loss applicable to common stockholders of $9.6 million, or ($0.15) per share, compared to a net loss applicable to common stockholders of $11.5 million, or ($0.19) per share for the quarter ended March 31, 2024. These results are included in the Company's Quarterly Report on Form 10-Q as of and for the period ended March 31, 2025, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov. 1  Gawrieh S, Vilar-Gomez E, Wilson LA, Pike F, Kleiner DE, Neuschwander-Tetri BA, Diehl AM, Dasarathy S, Kowdley KV, Hameed B, Tonascia J, Loomba R, Sanyal AJ, Chalasani N; NASH Clinical Research Network. Increases and decreases in liver stiffness measurement are independently associated with the risk of liver-related events in NAFLD. J Hepatol. 2024 Oct;81(4):600-608. doi: 10.1016/j.jhep.2024.05.008. Epub 2024 May 16. PMID: 38762169; PMCID: PMC11410523. Loomba R, Huang DQ, Sanyal AJ, et al Liver stiffness thresholds to predict disease progression and clinical outcomes in bridging fibrosis and cirrhosis Gut 2023;72:581-589. van Doorn DJ, Holleboom AG, Takkenberg RB, Verheij J, Lantinga MA. Can liver stiffness measurement accurately predict disease progression and clinical outcome in patients with metabolic dysfunction-associated steatotic liver disease and bridging fibrosis or cirrhosis? Hepatobiliary Surg Nutr. 2023 Dec 1;12(6):912-915. doi: 10.21037/hbsn-23-445. 2023 Oct 30. PMID: 38115935; PMCID: PMC10727830. About Galectin TherapeuticsGalectin 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) with cirrhosis, the most advanced form of MASH-related fibrosis. Liver cirrhosis is one of the most pressing medical need 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 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 product 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) [email protected] Investors Relations Contacts:Kevin [email protected] 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.

Data presentation included efficacy and biomarker analyses from the NAVIGATE trial (n=287). Belapectin 2 mg/kg demonstrated a statistically significant reduction in new varices at 18 months in the per-protocol population (p=0.04). Significantly fewer patients in the belapectin treatment arms experienced worsening of liver stiffness as measured by FibroScan®, reinforcing the potential beneficial effect of belapectin in halting the progression of MASH cirrhosis. NORCROSS, Ga., May 12, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of galectin-3-targeted therapeutics for patients with MASH cirrhosis and portal hypertension, presented a late-breaking oral presentation of the NAVIGATE study analysis at the EASL 2025 Congress, on May 10, 2025, in Amsterdam, Netherlands. The NAVIGATE study evaluated belapectin, a galectin-3 inhibitor, in patients with MASH cirrhosis and portal hypertension. The NAVIGATE trial (NCT04365868) is a global, multicenter, randomized, double-blind, placebo-controlled study. A total of 355 patients were randomized in a 1:1:1 ratio to receive intravenous belapectin at either 2 mg/kg of lean body mass (LBM) (n=119), 4 mg/kg LBM (n=118), or placebo (n=118) every other week for 18 months. The primary endpoint was the prevention of varices, assessed as a composite clinical outcome that included patients who developed any varices, experienced intercurrent events, or lacked an endoscopy or intercurrent events at 18 months. The study evaluated both the intent-to-treat (ITT) population (N=355) and a pre-defined per-protocol population or completer population (PPP, N=287), the latter comprising patients who completed 18 months of treatment with upper endoscopies performed at both baseline and after 18 months of treatment. In the PPP population, the incidence of varices was 11.3% in the belapectin 2 mg/kg group and 13.5% in the 4 mg/kg group, compared to 22.3% in the placebo group. The 2 mg/kg dose demonstrated a 49.3% reduction in incidence of new varices compared to placebo (p=0.04), whereas the 4 mg/kg dose showed a 39.5% reduction in new varices compared to placebo (not statistically significant). These clinical findings were further supported by non-invasive assessments. Specifically, liver stiffness, measured via FibroScan®, showed a notably lower proportion of patients with worsening in liver stiffness. Notably, the 2mg/kg group significantly outperformed placebo by 66% (p=0.02) and 51% (p=0.03) respectively in each category as shown below: As in prior trials, the safety profile of belapectin remains highly encouraging with incidence of adverse events and serious adverse events comparable across the three cohorts. Rates of discontinuation, adverse events (AEs), and serious adverse events (SAEs) were comparable to placebo, with no drug-related SAEs reported in the NAVIGATE trial. Dr. Naim Alkhouri, MD, FAASLD, DABOM, Chief Academic Officer of Summit Clinical Research and the Director of the Steatotic Liver Program at the Clinical Research Institute of Ohio, commented: "We are excited to have presented results from the NAVIGATE study, which reinforces belapectin’s potential in addressing a significant unmet need in patients with MASH cirrhosis and clinically significant portal hypertension. Galectin Therapeutics was among the first to pursue prevention of esophageal varices as a clinical endpoint—an approach now gaining broader interest across the field. It’s encouraging to see the consistency in benefit with the 2 mg dose in this global study." Dr. Naga Chalasani, David W. Crabb Professor of Gastroenterology and Hepatology and Adjunct Professor of Anatomy, Cell Biology & Physiology at Indiana University School of Medicine, stated: "The NAVIGATE study contributes meaningful new evidence supporting belapectin’s therapeutic potential in MASH cirrhosis. In addition to reducing varices development, the data show that fewer patients experienced worsening in liver stiffness measure by Fibroscan, a key biomarker of clinical outcomes. These liver stiffness thresholds are well established as being associated with poorer clinical outcomes, so this trend is particularly encouraging as the review of the full dataset continues. Belapectin clearly is showing benefit evidence across several clinically important endpoints and should be continued in clinical development as there is a significant unmet need for patients with MASH cirrhosis."About Galectin TherapeuticsGalectin 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, the most advanced form of MASH-related fibrosis. Liver cirrhosis is one of the most pressing medical need 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 product 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 [email protected] Investors Relations Contacts: Kevin Gardner [email protected] 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.

NORCROSS, Ga., March 31, 2025 (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 year ended December 31, 2024. Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said “In the U.S. approximately 5 million adults are affected by MASH cirrhosis and clinically significant portal hypertension. The need for new treatments that can prevent disease progression is more urgent than anticipated. The NAVIGATE trial’s per-protocol analysis in U.S. patients revealed a remarkable 68% reduction in the incidence of new varices, underscoring belapectin’s potential as a treatment for MASH cirrhosis and portal hypertension. The statistically significant results in per protocol population at 18 months are further reinforced by the favorable trend observed in available 36 month data. We look forward to sharing additional results, including specialized biomarkers analyses results, in the second quarter of 2025, and collaborating with potential partners and leading medical experts to define the optimal next steps in belapectin’s development. Finally, I want to thank Richard Uihlein, our chairman, for providing an additional $5 million line of credit this month that will allow us to extend our cash runway as we continue to analyze NAVIGATE results and prepare to discuss them with potential partners and the FDA.” Khurram Jamil, M.D., Chief Medical Officer added “I am encouraged by the 2 mg belapectin data, which demonstrated an approximately 49% reduction in varices incidence in the per-protocol population and a 68% reduction in the per-protocol population of U.S. patients, further validating the findings of our previous Phase 2b (GT-026) trial. Additionally, a total of 57 subjects completed 36 months of treatment and the positive trend that was observed at 18 months for the belapectin 2 mg cohort was sustained at 36 months, with a lower incidence of varices compared to placebo (13.0% vs. 20.0%). These results further support the potential of the 2 mg dose in preventing varices in MASH cirrhosis patients with portal hypertension. I believe the results warrant further clinical development as belapectin could become a pivotal therapeutic option for these patients who currently do not have any treatment options. Our hope is that belapectin MASH program, which has a Fast Track Designation, will ultimately provide the first targeted treatment option for the increasing number of patients affected by MASH-associated liver cirrhosis.” Belapectin Program Highlights Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH and fibrosis. NASH Cirrhosis NAVIGATE Phase 2b/3 trial (NCT04365868) is global, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of belapectin intravenously either belapectin 2mg/kg of lean body mass (LBM) (n=119), 4 mg/kg/LBM (n=118) or placebo (n=118) every other week for 18 months for the prevention of esophageal varices in MASH cirrhosis. Topline data from the NAVIGATE trial showed that the incidence of varices at 18 months was 43.2% lower in patients treated with belapectin 2 mg vs placebo; however, the composite endpoint did not reach statistical significance in the intent-to-treat population (n=355). In the per-protocol population (n=287), the incidence of varices was reduced by 49.3% in patients treated with belapectin 2 mg vs placebo (nominal p-value = 0.04). The incidence of varices was significantly reduced by 68.1% (p=0.02) in the per-protocol patients enrolled in the U.S. treated with belapectin 2 mg vs placebo (n=186). Patients in the U.S. had a higher percentage use of GLP-1 and statins than the rest of the world across three cohorts, and the belapectin cohorts performed much better than placebo in the U.S. Similar proportion of subjects reported Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TEASEs), and discontinuation across the 3 cohorts. No drug related Serious Adverse Events (SAE) were observed in NAVIGATE. The Company is currently conducting the full analysis of the NAVIGATE trial data and anticipates having additional biomarker data in the second quarter of 2025. Full Year 2024 Financial Highlights As of December 31, 2024, the Company had $15.1 million of unrestricted cash and cash equivalents in addition to $6 million available under a line of credit provided by our chairman available to fund future operations. Additionally, in March 2025, we signed a new supplemental line of credit agreement with our chairman for an additional $5 million of available borrowings. The Company believes it has sufficient cash to fund currently planned operations and research and development activities through August 2025. Research and development expenses for the year ended December 31, 2024 were $36.6 million compared with $32.1 million for the year ended December 31, 2023. The increase was primarily due to costs related to our NAVIGATE clinical trial and other supportive activities. General and administrative expenses for the year ended December 31, 2024 were $5.9 million, compared to $5.9 million for the year ended December 31, 2023. For the year ended December 31, 2024, the Company reported a net loss applicable to common stockholders of $47.2 million, or ($0.76) per share, compared to a net loss applicable to common stockholders of $44.5 million, or ($0.74) per share for the year ended December 31, 2023. The increase is largely due to an increase in noncash interest expense of $2.7 million and a increase in research and development costs due to the NAVIGATE trial. These results are included in the Company's Annual Report on Form 10-K, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov. About Galectin TherapeuticsGalectin 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, the most advanced form of MASH-related fibrosis. Liver cirrhosis is one of the most pressing medical need 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 product 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) [email protected] Investors Relations Contacts:Kevin [email protected] 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.