Exhibit 99.1 Galectin Therapeutics Reports 2024 Financial Results and Provides Business Update 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 an ...

Clinical Trials and Efficacy - The company has completed randomizations totaling 357 patients in the NAVIGATE trial, a Phase 2b/3 clinical study evaluating the safety and efficacy of belapectin for preventing esophageal varices in NASH cirrhosis patients [97]. - In the intent-to-treat population (N=355), the incidence of varices was reduced by 43.2% in the belapectin 2 mg/kg dose group compared to placebo, although the composite endpoint did not reach statistical significance [98]. - In the per-protocol population (n=287), the incidence of varices was reduced by 49.3% in the belapectin 2 mg/kg dose group, with a p-value of less than 0.05 [98]. - In the U.S. cohort (n=186), the incidence of varices was significantly reduced by 68.1% in patients treated with belapectin 2 mg compared to placebo (4 out of 60 vs 13 out of 62) [98]. - The Phase 2b NASH-CX trial enrolled 162 patients with compensated cirrhosis and portal hypertension, evaluating belapectin's safety and efficacy [113]. - In the NASH-CX trial, the mean change in hepatic venous pressure gradient (HVPG) was -0.37 mm Hg for the 2 mg/kg LBM dose and -0.42 mm Hg for the 8 mg/kg LBM dose, compared to a 0.3 mm Hg change in placebo [114]. - In patients without esophageal varices at baseline, the 2 mg/kg LBM dose of belapectin showed a statistically significant reduction in HVPG of -1.08 mm Hg (p<0.01) [115]. - The NASH-CX trial demonstrated a 0% incidence of new varices in the 2 mg/kg LBM group compared to 18% in the placebo group, indicating a significant clinical benefit [117]. - The NAVIGATE trial reported a 43.2% reduction in the incidence of varices in the belapectin 2 mg/kg group compared to placebo, although the composite endpoint did not reach statistical significance [122]. - In the per-protocol population of the NAVIGATE trial, the incidence of varices was reduced by 49.3% in the belapectin 2 mg/kg group (p<0.05) [122]. - The NAVIGATE trial showed a significant reduction of 68.1% in the incidence of varices in U.S. patients treated with belapectin 2 mg/kg (p=0.02) [122]. Safety Profile - The safety profile of belapectin remains encouraging, with rates of adverse events and serious adverse events comparable to placebo, and no drug-related serious adverse events reported in the NAVIGATE trial [99]. - The safety profile of belapectin in the NAVIGATE trial was comparable to placebo, with no drug-related serious adverse events reported [123]. - The Hepatic Impairment Study indicated that belapectin exposure did not increase with the degree of hepatic insufficiency, supporting its safety profile [130]. Financials and Expenses - Research and development expenses for Q1 2025 were $8,054,000, a decrease of $1,569,000 or 19.5% compared to Q1 2024 [136]. - Clinical activities expenses decreased from $5,872,000 in Q1 2024 to $4,466,000 in Q1 2025, primarily due to the timing of expenditures related to the NAVIGATE clinical trial [137]. - General and administrative expenses decreased by $182,000 or 11.4%, from $1,594,000 in Q1 2024 to $1,412,000 in Q1 2025 [140]. - As of March 31, 2025, the company had $7.4 million in unrestricted cash and cash equivalents, with an additional $11 million available under two lines of credit [141]. - Net cash used in operations decreased by $4,415,000 to $7,689,000 for Q1 2025 compared to $12,105,000 for Q1 2024 [142]. - The company has raised a net total of $314.5 million from public and private offerings since its inception [141]. Product Development and Future Plans - The company has a lead product candidate, belapectin, which has shown promise in treating liver fibrosis, severe skin disease, and cancer, particularly focusing on NASH cirrhosis and head and neck cancer [107]. - The company is pursuing a development pathway for belapectin in immuno-oncology, having filed a new IND with the FDA for advanced or metastatic head and neck cancer in combination with a PD-1 inhibitor [104]. - The company plans to file a Phase 2 trial with the FDA for belapectin in combination with an immune checkpoint inhibitor targeting recurrent or metastatic head and neck cancer [134]. - The company continues to analyze data from approximately 55 patients who completed 36 months of treatment, which may attract interest from potential strategic partners [100]. - The company has established a joint venture subsidiary, Galectin Sciences LLC, to develop small molecules that inhibit galectin-3, potentially expanding the uses of galectin-3 inhibitors beyond belapectin [103]. Combination Therapies - The Phase 1b trial combining belapectin with pembrolizumab (KEYTRUDA) showed a 50% objective response rate in advanced melanoma and a 33% response rate in head and neck cancer patients [133]. - The combination of belapectin with pembrolizumab may reduce autoimmune side effects associated with pembrolizumab [133]. Challenges and Limitations - The company is unable to provide accurate estimates for the costs and timing of bringing a drug candidate to market due to numerous variables [138].

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) -- ...

NORCROSS, Ga., April 15, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin-3 for patients with MASH cirrhosis and portal hypertension, today announced that it will attend the EASL 2025 meeting and deliver a scientific presentation in the late-breaking oral presentation session. The meeting will be held May 7-10, 2025, in Amsterdam, Netherlands. "We are excited that data from our NAVIGATE study, evaluating belapectin, a galectin-3 in ...

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. Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH and fibrosis. NASH Cirrhosis Full Year 2024 Financial Highlights As of December 31, 2024, the Company had $15.1 million of unrestricte ...

Financial Performance - Net cash used in operations increased by $8,802,000 to $41,767,000 for 2024, compared to $32,965,000 for 2023[188] - Net cash used in operations increased by $1,909,000 to $32,965,000 in 2023 compared to $31,056,000 in 2022, driven by increased research and development expenses[191] - Net cash provided by financing activities was $31,227,000 in 2024, a decrease from $40,033,000 in 2023, primarily due to changes in transactions[190] - In 2023, the company received $40,033,000 in financing, up from $10,000,000 in 2022, with $30,000,000 from a convertible line of credit and $10,000,000 from stock purchase warrants[192] Research and Development - Research and development expenses for 2024 were $36,571,000, a decrease of 13.8% compared to $32,130,000 in 2023[174] - Clinical program expenses increased to $29,079,000 in 2024 from $23,942,000 in 2023, primarily due to NAVIGATE clinical trial activities[175] - Research and development expenses are charged as incurred, with significant costs related to the NAVIGATE clinical trial and third-party contract research organizations[199] Cash Position and Financing - As of December 31, 2024, the company had $15.1 million in unrestricted cash and cash equivalents, plus $6 million available under a line of credit[187] - The company has raised a net total of $314.5 million from public and private offerings since its inception[187] - The company believes it has sufficient cash to fund operations through August 2025, but will require additional financing thereafter[187] Clinical Trials - The NAVIGATE trial is currently the only active clinical trial, with no plans or funding for additional trials at this time[173] - The company has engaged outside vendors for clinical trial services, which are typically cancellable on 30 days notice[195] Operating Expenses - General and administrative expenses decreased by 1.3% to $5,942,000 in 2024 from $5,862,000 in 2023[178] - Stock-based compensation is measured at grant date fair value and recognized over the service period, with estimates for potential forfeitures included[200] - The company entered into an operating lease for office space in Norcross, GA, with an average rate of approximately $4,250 per month, effective from March 1, 2022[193] Market Risks and Losses - The company has incurred significant operating losses since inception and cannot assure future revenue generation[171] - The company is not exposed to significant market risks as of December 31, 2024, and 2023[201] - The company has not created any off-balance sheet entities that could materially affect liquidity or capital resources[196]

Core Insights - Galectin Therapeutics, Inc. announced significant results from the NAVIGATE trial, showing a statistically significant reduction in new varices in patients with MASH cirrhosis and portal hypertension treated with belapectin [1][4][8] Group 1: Trial Results - The NAVIGATE trial indicated a 43.2% lower incidence of varices at 18 months for patients treated with belapectin 2 mg compared to placebo, although this was not statistically significant in the intent-to-treat population [2] - In the completer population of 287 patients, the incidence of varices was reduced by 49.3% with belapectin 2 mg versus placebo, achieving a nominal p-value of 0.04 [2] - Further analysis of U.S. completers (n=186) showed a significant 68.1% reduction in varices incidence (p=0.02) for belapectin 2 mg compared to placebo [3][8] Group 2: Market Need and Future Plans - The prevalence of MASH cirrhosis and clinically significant portal hypertension in the U.S. is estimated at around 3 million adults, highlighting the urgent need for new treatments [4][8] - The company is continuing to analyze data from the NAVIGATE trial, including results from approximately 50 patients who completed 36 months of therapy, with additional updates expected in Q1 2025 [4][8] - Galectin Therapeutics is exploring next steps for belapectin development in collaboration with potential partners as ongoing analyses are completed [4]

NORCROSS, Ga., Jan. 10, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today announced that the top-line results of the NAVIGATE trial in patients with MASH cirrhosis and portal hypertension will be presented during the 2025 MASH-TAG Conference, being held January 9-11, 2025 in Park City, Utah. Additionally, Company’s executive leadership will be hosting one-on-one meetings in San Franscico January 13-16, 2025, during ...

Core Insights - The NAVIGATE trial results indicate that belapectin, at a dose of 2 mg/kg, showed a statistically significant reduction of 48.9% in the incidence of varices in the per-protocol population compared to placebo, although the primary composite endpoint did not achieve statistical significance in the intent-to-treat population [1][4][15] - Galectin Therapeutics is focused on developing belapectin as a treatment for patients with Metabolic Dysfunction-Associated Steatohepatitis (MASH) cirrhosis, which currently lacks effective treatment options [2][9] - The company plans to present additional data from the NAVIGATE trial in early 2025, including results from approximately 50 patients who have completed 36 months of treatment [4][10] Company Overview - Galectin Therapeutics is dedicated to developing novel therapies targeting galectin proteins, with belapectin being its lead drug, which has received Fast Track designation from the FDA [2][8] - The company is also exploring additional development programs for cancer immunotherapy and other malignancies, contingent on finding suitable partnerships [2][9] Clinical Trial Details - The NAVIGATE trial was a global, multicenter, randomized, double-blind, placebo-controlled study involving 355 patients across 130 sites in 15 countries [15] - The trial assessed the prevention of varices as a composite clinical outcome, with intercurrent events defined as liver-related complications or treatment discontinuation due to adverse events [15] Safety Profile - Belapectin demonstrated a favorable safety profile, with the incidence of adverse events and serious adverse events comparable to placebo, and no drug-related serious adverse events reported [11]

Core Insights - The NAVIGATE trial is focused on patients with MASH cirrhosis and portal hypertension, utilizing non-invasive tests and clinical criteria based on the latest treatment guidelines [1][2] - A significant finding from the trial indicates that approximately one-third of patients screened have detectable esophageal varices, emphasizing the necessity for screening in this population [2][4] - The trial's readout is anticipated in December 2024, with clinical data being presented at the AASLD annual meeting [1][2] Company Overview - Galectin Therapeutics is dedicated to developing therapies for chronic liver disease and cancer, with its lead drug belapectin targeting galectin-3 protein involved in various diseases [5][6] - The company is focusing on metabolic dysfunction-associated steatohepatitis (MASH) with cirrhosis, which represents a significant medical need and drug development opportunity [5] - Galectin is also exploring additional development programs in combination immunotherapy for advanced cancers, contingent on finding suitable partnerships [5][6]