Core Insights - Galectin Therapeutics Inc. is set to present data from its NAVIGATE study on belapectin, a galectin-3 inhibitor, at the EASL 2025 meeting, highlighting its significance in the hepatology community [1][2] - The NAVIGATE study focuses on patients with MASH cirrhosis and portal hypertension, conditions that have been historically overlooked despite their severe impact on patients [2] - The company is also analyzing biomarker data from the NAVIGATE study, with additional results expected to be shared in the second quarter of 2025 [2] Company Overview - Galectin Therapeutics is dedicated to developing therapies for chronic liver disease and cancer, with its lead drug belapectin targeting galectin-3, which is involved in various inflammatory and fibrotic diseases [3] - Belapectin has received Fast Track designation from the U.S. FDA and is primarily focused on treating metabolic dysfunction-associated steatohepatitis (MASH) with cirrhosis, representing a significant drug development opportunity [3] - The company is also exploring additional development programs in cancer immunotherapy, contingent on finding suitable partnerships for efficient development [3]

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]

Core Insights - Galectin Therapeutics, Inc. announced the presentation of top-line results from the NAVIGATE trial at the 2025 MASH-TAG Conference, focusing on patients with MASH cirrhosis and portal hypertension [1] - The company is also engaging with stakeholders during the JP Morgan Healthcare Conference to discuss the NAVIGATE trial results and the belapectin program [1] Company Overview - Galectin Therapeutics is focused on developing therapies for chronic liver disease and cancer, with its lead drug belapectin targeting the galectin-3 protein, which is involved in inflammatory and fibrotic diseases [2] - Belapectin has received Fast Track designation from the U.S. FDA and is primarily aimed at treating metabolic dysfunction-associated steatohepatitis (MASH) with cirrhosis, representing a significant medical need and drug development opportunity [2] - The company is also exploring additional development programs for combination immunotherapy in advanced head and neck cancers and other malignancies, contingent on finding suitable partnerships [2]

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]

Core Insights - Galectin Therapeutics is focused on advancing the NAVIGATE trial of belapectin for MASH cirrhosis, with top-line results expected in December 2024 [2][3] - The company reported a net loss of $11.2 million for Q3 2024, an improvement from a net loss of $14.0 million in Q3 2023 [7][12] - As of September 30, 2024, Galectin had $27.1 million in cash and cash equivalents, with additional funding available through a line of credit [5][13] NAVIGATE Trial Update - The NAVIGATE trial is evaluating belapectin's efficacy and safety in preventing esophageal varices in MASH patients, involving 357 participants across 14 countries [3] - The trial's stage 1 results will be analyzed as a stand-alone trial, with full results expected after the Data Safety Monitoring Board meeting in December 2024 [3][4] Financial Performance - For Q3 2024, research and development expenses were $7.6 million, slightly down from $7.7 million in Q3 2023, while general and administrative expenses increased to $1.5 million from $1.4 million [6][12] - The total operating loss for the quarter was $9.1 million, compared to $9.2 million in the same quarter of the previous year [12] Stockholder Meeting - The 2024 Annual Meeting of Stockholders is scheduled for January 23, 2025, coinciding with the anticipated top-line results of the NAVIGATE trial [4] Company Overview - Galectin Therapeutics is dedicated to developing therapies for chronic liver disease and cancer, with belapectin being its lead drug targeting galectin-3 [9] - The company aims to address significant medical needs in liver cirrhosis and is exploring additional development programs in cancer immunotherapy [9]

Drug Development and Clinical Trials - The company is focused on developing belapectin, a galectin-3 inhibitor, for treating liver fibrosis and cirrhosis in NASH patients, with significant preclinical evidence supporting its efficacy [87]. - A total of 357 patients were randomized in the NAVIGATE trial, which is designed to evaluate the safety and efficacy of belapectin for preventing esophageal varices in MASH cirrhosis patients [88]. - The Phase 2b NASH-CX trial aims to assess the safety and efficacy of belapectin in patients with compensated cirrhosis and portal hypertension, with top-line results expected in December 2024 [97]. - The company has completed two Phase 1 clinical studies and a Phase 2 clinical study in MASH patients with advanced fibrosis, demonstrating the safety of belapectin [87]. - The company is pursuing a development pathway for belapectin in immuno-oncology, having filed a new IND for advanced head and neck cancer in combination with a PD-1 inhibitor [90]. - Belapectin has shown a significant therapeutic effect on liver fibrosis in preclinical models, reducing liver fat, inflammation, and portal pressure [99]. - The Phase 2 NASH-FX trial did not meet its primary endpoint but demonstrated that belapectin was safe and well tolerated [103]. - The NASH-CX trial involved 162 patients with well-compensated MASH cirrhosis and portal hypertension, randomized to receive either belapectin or placebo [104]. - In the total patient population, 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 of belapectin, compared to a 0.3 mm Hg change in placebo [105]. - 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) [106]. - The belapectin 2 mg/kg LBM group had a significantly lower incidence of new varices (0%) compared to placebo (18%) over the 54-week treatment period [107]. - Belapectin demonstrated a statistically significant improvement in hepatocyte ballooning and a reduction in the development of new esophageal varices (p=0.02) compared to placebo [108]. - The NAVIGATE Trial is a Phase 2b/3 study evaluating belapectin for the prevention of esophageal varices in patients with MASH cirrhosis, targeting a population with unmet medical needs [111]. - The NAVIGATE trial will compare two belapectin doses (2 mg/kg LBM and 4 mg/kg LBM) against placebo, with an interim analysis planned after 18 months of treatment [111]. - The Company activated over 150 clinical trial sites in 14 countries for the NAVIGATE trial, although patient enrollment faced challenges due to the COVID-19 pandemic [120]. - A Hepatic Impairment Study involving approximately 40 patients indicated that belapectin exposure did not increase with the degree of hepatic insufficiency [122]. - Promising results from a Phase 1b trial combining belapectin with KEYTRUDA showed a 50% objective response rate in advanced melanoma patients [125]. Financial and Regulatory Aspects - The company has incurred significant operating losses since inception and relies on additional outside capital for its development programs [86]. - The company is subject to extensive regulation by the FDA, which could impact the commercialization of its product candidates [86]. Insider Trading - Jack Callicutt adopted a Rule 10b5-1 trading plan for the sale of up to 627,456 shares of the Company's common stock until December 31, 2025 [155]. - Khurram Jamil adopted a Rule 10b5-1 trading plan for the sale of shares needed to cover taxes related to a 30,000 RSU grant, plus up to 60% of remaining shares, and an additional 25,000 shares from stock options until December 31, 2025 [156].

Core Insights - Galectin Therapeutics, Inc. announced that three abstracts from its ongoing Phase 2b/3 NAVIGATE trial have been accepted for presentation at the AASLD's annual meeting in November 2024 [1][2] Group 1: Clinical Data Presentation - The three posters will be presented during the "Portal Hypertension and Other Complications of Cirrhosis" session on November 18, 2024 [2] - The titles of the abstracts include evaluations of esophageal and gastric varices, baseline patient characteristics from the NAVIGATE trial, and findings related to esophageal varices in patients with compensated MASH cirrhosis [2] Group 2: Company Overview - Galectin Therapeutics focuses on developing therapies for chronic liver disease and cancer, with its lead drug belapectin targeting galectin-3 protein [4] - The company is advancing its lead development program in metabolic dysfunction-associated steatohepatitis (MASH) with cirrhosis, which represents a significant medical need and drug development opportunity [4] - Additional development programs include combination immunotherapy for advanced head and neck cancers, with progress dependent on finding suitable partnerships [4]