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]

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]

Clinical Trials - The NAVIGATE trial for belapectin is on track for top-line results expected in December 2024, involving 357 patients across 14 countries[1][5] - Three abstracts from the NAVIGATE trial have been accepted for presentation at the AASLD 2024 meeting, highlighting key clinical data[3][5] - The NAVIGATE trial aims to evaluate the efficacy and safety of belapectin for the prevention of esophageal varices in patients with MASH cirrhosis[5] Financial Performance - As of September 30, 2024, the company reported cash and cash equivalents of $27.1 million, with an additional $6 million available under a new line of credit[7] - Research and development expenses for Q3 2024 were $7.6 million, slightly down from $7.7 million in Q3 2023[8] - The net loss applicable to common stockholders for Q3 2024 was $11.2 million, or ($0.18) per share, compared to a net loss of $14.0 million, or ($0.24) per share in Q3 2023[9] Liabilities and Equity - Total liabilities increased to $121.5 million as of September 30, 2024, compared to $88.4 million in December 2023[14] - Total stockholders' equity (deficit) was reported at $(94.2) million as of September 30, 2024, compared to $(61.9) million in December 2023[14] Corporate Events - The company plans to hold its 2024 Annual Meeting of Stockholders on January 23, 2025, following the expected top-line results of the NAVIGATE trial[6] Company Focus - Galectin Therapeutics is focused on developing therapies for chronic liver disease and cancer, with belapectin being a key drug in their pipeline[11]