Company Overview - Galectin Therapeutics Inc. is focused on developing therapeutics targeting galectin-3 for patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension [1][8] - The lead drug, belapectin, is a carbohydrate-based drug that inhibits galectin-3, which is involved in inflammatory, fibrotic, and malignant diseases [8] Upcoming Event - A virtual key opinion leader (KOL) event is scheduled for June 16, 2025, to discuss the unmet needs and treatment landscape for MASH cirrhosis and portal hypertension [1][2] - The event will feature results from the NAVIGATE Phase 3 clinical trial evaluating belapectin for MASH cirrhosis and portal hypertension, highlighting its potential as the first treatment for this condition [2] Clinical Significance - There are currently no approved therapies to prevent or treat varices in MASH cirrhosis, making belapectin a significant potential treatment option [2] - The event will include a live Q&A session following the presentations, allowing for further discussion on the findings [3] Key Opinion Leaders - Featured KOLs include Dr. Naga P. Chalasani, a prominent figure in gastroenterology and hepatology, and Dr. Naim Alkhouri, an expert in MASH therapeutics [4][5][7] - Both KOLs have extensive backgrounds in research and clinical practice, contributing to the credibility of the event and the findings presented [4][5] Research and Development Focus - Galectin Therapeutics is dedicated to addressing significant medical needs in chronic liver disease and cancer, with belapectin being central to its development program [8] - The company is also exploring additional development programs in combination immunotherapy for advanced cancers, dependent on finding suitable partnerships [8]

Core Viewpoint - Galectin Therapeutics reported promising results for its lead drug belapectin in treating MASH-associated liver cirrhosis and portal hypertension, highlighting significant clinical efficacy and potential as a new treatment option [2][3][4]. Financial Highlights - As of March 31, 2025, the company had $7.4 million in cash and cash equivalents and $11 million available under credit lines [12]. - Research and development expenses for Q1 2025 were $6.5 million, down from $8.1 million in Q1 2024, primarily due to timing of expenditures related to the NAVIGATE clinical trial [12]. - General and administrative expenses decreased to $1.4 million in Q1 2025 from $1.6 million in Q1 2024 [12]. - The net loss applicable to common stockholders for Q1 2025 was $9.6 million, or ($0.15) per share, compared to a net loss of $11.5 million, or ($0.19) per share in Q1 2024 [12][20]. Clinical Trial Results - The NAVIGATE trial demonstrated that the 2 mg/kg dose of belapectin significantly reduced the incidence of new varices compared to placebo, validating earlier Phase 2 findings [2][3]. - Liver stiffness measurements (LSM) showed statistically significant reductions in the belapectin 2 mg/kg treatment arm at Weeks 26, 52, and 78 [11][20]. - The analysis indicated that 64% more patients in the placebo group experienced an absolute increase in LSM of >10 kPa compared to the 2 mg/kg group, reinforcing the treatment's efficacy [8][11]. Belapectin Program Highlights - Belapectin targets galectin-3, a protein involved in the pathogenesis of MASH and fibrosis, and has received Fast Track Designation from the FDA [5][16]. - The NAVIGATE trial is a global, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of belapectin for preventing esophageal varices in MASH cirrhosis [7][20]. Company Overview - Galectin Therapeutics focuses on developing therapies for chronic liver disease and cancer, with belapectin as its lead drug targeting MASH-related fibrosis [16].

[Executive Summary and Business Update](index=1&type=section&id=Executive%20Summary%20and%20Business%20Update) Galectin Therapeutics reported Q1 2025 financial results and a business update, highlighting positive clinical findings for belapectin from the NAVIGATE trial [Report Overview](index=1&type=section&id=Report%20Overview) Galectin Therapeutics reported its financial results and provided a business update for the three months ended March 31, 2025, focusing on the advancement of its lead therapeutic, belapectin - Galectin Therapeutics (NASDAQ: GALT) reported **Q1 2025 financial results** and a business update[1](index=1&type=chunk) - The company is a leading developer of therapeutics targeting **galectin proteins**[1](index=1&type=chunk) [CEO and CMO Commentary](index=1&type=section&id=CEO%20and%20CMO%20Commentary) CEO Joel Lewis and CMO Khurram Jamil highlighted positive feedback and significant clinical findings for belapectin from the NAVIGATE trial, presented at EASL. Key results include a clinically significant response in liver stiffness (Fibroscan®) and a reduction in new varices, particularly medium and large ones, reinforcing belapectin's potential as a treatment for MASH-associated liver cirrhosis and portal hypertension - CEO Joel Lewis emphasized continued focus on advancing belapectin analyses and **positive feedback from EASL**[2](index=2&type=chunk) - CMO Khurram Jamil noted that approximately **double the number of patients on placebo showed worsening liver stiffness** compared to belapectin[4](index=4&type=chunk) - The **2 mg/kg dose of belapectin** led to a significantly lower incidence of new varices compared to placebo, primarily driven by a reduction in **medium and large varices**[2](index=2&type=chunk)[4](index=4&type=chunk) - Belapectin has **Fast Track Designation**, supporting its potential as the first targeted treatment for **MASH cirrhosis and portal hypertension**[5](index=5&type=chunk) [Belapectin Program Details](index=3&type=section&id=Belapectin%20Program%20Details) This section details belapectin's mechanism of action, the design of the NAVIGATE Phase 2b/3 trial, and comprehensive clinical results demonstrating its efficacy [Drug Mechanism and Development Status](index=3&type=section&id=Drug%20Mechanism%20and%20Development%20Status) Belapectin is a carbohydrate-based drug designed to inhibit galectin-3, a protein central to the pathogenesis of MASH and fibrosis. It holds Fast Track designation from the FDA for MASH with cirrhosis - Belapectin is a complex carbohydrate drug targeting **galectin-3**, a protein critical in **MASH and fibrosis pathogenesis**[6](index=6&type=chunk) - Belapectin has **Fast Track designation** by the U.S. Food and Drug Administration for **MASH with cirrhosis**[15](index=15&type=chunk) [NAVIGATE Phase 2b/3 Trial Design](index=3&type=section&id=NAVIGATE%20Phase%202b%2F3%20Trial%20Design) The NAVIGATE trial (NCT04365868) is a global, randomized, double-blind, placebo-controlled Phase 2b/3 study. It evaluates the efficacy and safety of intravenous belapectin (2 mg/kg or 4 mg/kg LBM) administered every other week for 18 months to prevent esophageal varices in MASH cirrhosis patients - NAVIGATE is a **global, randomized, double-blind, placebo-controlled Phase 2b/3 trial**[7](index=7&type=chunk) - The trial evaluates belapectin (**2 mg/kg or 4 mg/kg LBM**) every other week for **18 months** for the prevention of **esophageal varices in MASH cirrhosis**[7](index=7&type=chunk) [Detailed Clinical Results](index=3&type=section&id=Detailed%20Clinical%20Results) Detailed analysis of the NAVIGATE trial, including biomarker data presented at EASL, showed statistically significant reductions in liver stiffness (LSM) from baseline in the belapectin 2 mg/kg arm at Weeks 26, 52, and 78. The 2 mg/kg group also demonstrated significantly fewer patients experiencing worsening liver stiffness compared to placebo, with a notable reduction in the incidence of new varices - **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**[7](index=7&type=chunk) - Belapectin **2 mg/kg treatment** may lead to **regression of liver stiffness** in high-risk MASH populations, while placebo-treated patients showed no improvement[8](index=8&type=chunk) - Significantly fewer patients (**51% fewer**) in the **belapectin 2 mg/kg group** experienced **>30% worsening in liver stiffness** compared to placebo (p=0.03)[10](index=10&type=chunk) Liver Stiffness Worsening (NAVIGATE Trial) | | placebo | 2 mg/kg belapectin | 4mg/kg belapectin | |---|---|---|---| | N= | 88 | 94 | 87 | | >10 increase in kPa from baseline | 11 (12.5%) | 4 (4.3%) | 9 (10.3%) | | >30% increase from baseline | 21 (23.9%) | 11 (11.7%) | 13 (14.9%) | | >10 kPa + 30% increase from baseline | 10 (11.4%) | 4 (4.3%) | 9 (10.3%) | LSM Mean Change from Baseline (Belapectin 2 mg/kg) | Time Point | LSM Mean Change from Baseline | p-value | |---|---|---| | Week 26 | -3.48 | 0.005 | | Week 52 | -4.60 | < 0.0001 | | Week 78 | -2.72 | 0.0197 | [Financial Performance](index=5&type=section&id=Financial%20Performance) This section provides an overview of Galectin Therapeutics' Q1 2025 financial results, including a reduced net loss, detailed statements of operations, and key balance sheet data [Q1 2025 Financial Summary](index=5&type=section&id=Q1%202025%20Financial%20Summary) Galectin Therapeutics reported a net loss applicable to common stockholders of $9.6 million, or ($0.15) per share, for Q1 2025, an improvement from $11.5 million, or ($0.19) per share, in Q1 2024. The company had $7.4 million in cash and equivalents and access to an additional $11 million in credit, sufficient to fund operations through August 2025. Research and development expenses decreased due to the timing of NAVIGATE trial expenditures Q1 2025 Financial Highlights (in millions) | Metric | Q1 2025 (in millions) | Q1 2024 (in millions) | Change | |---|---|---|---| | Cash and Cash Equivalents | $7.4 | N/A | N/A | | R&D Expenses | $6.5 | $8.1 | -$1.6 (Decrease) | | G&A Expenses | $1.4 | $1.6 | -$0.2 (Decrease) | | Net Loss Applicable to Common Stockholders | $9.6 | $11.5 | -$1.9 (Improvement) | | Basic and Diluted Net Loss Per Share | ($0.15) | ($0.19) | $0.04 (Improvement) | - The company believes it has sufficient cash to fund planned operations and R&D activities through **August 2025**, supplemented by **$11 million available under lines of credit**[11](index=11&type=chunk) - The decrease in R&D expenses was primarily due to the **timing of expenditures related to the NAVIGATE clinical trial**[11](index=11&type=chunk) [Condensed Consolidated Statements of Operations](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The condensed consolidated statements of operations show a reduced net loss for Q1 2025 compared to Q1 2024, driven by lower operating expenses and a decrease in interest expense and change in fair value of derivatives Condensed Consolidated Statements of Operations (Three Months Ended March 31, in thousands) | Metric (in thousands) | 2025 | 2024 | |---|---|---| | Research and development | $6,485 | $8,054 | | General and administrative | $1,412 | $1,594 | | Total operating expenses | $7,897 | $9,648 | | Total operating loss | ($7,897) | ($9,648) | | Interest income | $35 | $80 | | Interest expense | ($1,744) | ($869) | | Change in fair value of derivatives | ($25) | ($1,052) | | Total other income (expense) | ($1,734) | ($1,841) | | Net loss | ($9,631) | ($11,489) | | Preferred stock dividends | $26 | ($8) | | Net loss applicable to common stock | ($9,605) | ($11,497) | | Basic and diluted net loss per share | ($0.15) | ($0.19) | | Shares used in computing basic and diluted net loss per share | 63,204 | 61,976 | [Condensed Consolidated Balance Sheet Data](index=9&type=section&id=Condensed%20Consolidated%20Balance%20Sheet%20Data) As of March 31, 2025, the company's cash and cash equivalents decreased significantly from December 31, 2024. Total assets also declined, while total current liabilities saw a substantial increase Condensed Consolidated Balance Sheet Data (in thousands) | Metric | March 31, 2025 | December 31, 2024 | |---|---|---| | Cash and cash equivalents | $7,431 | $15,120 | | Total assets | $9,528 | $17,495 | | Total current liabilities | $110,840 | $35,409 | | Total liabilities | $121,789 | $120,565 | | Total redeemable, convertible preferred stock | $1,723 | $1,723 | | Total stockholders' equity (deficit) | ($113,984) | ($104,793) | [Corporate Information](index=6&type=section&id=Corporate%20Information) This section provides an overview of Galectin Therapeutics, outlines the nature of forward-looking statements, and lists key company contacts [About Galectin Therapeutics](index=6&type=section&id=About%20Galectin%20Therapeutics) Galectin Therapeutics is dedicated to developing novel therapies for chronic liver disease and cancer, with belapectin as its lead drug targeting galectin-3 for MASH cirrhosis. The company seeks partnerships for its additional clinical programs in cancer immunotherapy - Galectin Therapeutics focuses on developing therapies for **chronic liver disease and cancer**[15](index=15&type=chunk) - Belapectin, the lead drug, inhibits the **galectin-3 protein** involved in inflammatory, fibrotic, and malignant diseases[15](index=15&type=chunk) - Additional development programs in **cancer immunotherapy** are largely dependent on finding suitable partners[15](index=15&type=chunk) [Forward-Looking Statements](index=7&type=section&id=Forward-Looking%20Statements) The report contains forward-looking statements regarding future events and financial performance, which are subject to risks and uncertainties. These include the potential for belapectin to become the first MASH cirrhosis therapy, success in cancer immunotherapy, and the ability to secure partnerships or additional capital. Actual results may differ materially due to various factors, and management disclaims any obligation to update these statements - Statements regarding future events and financial performance are **forward-looking** and subject to **risks and uncertainties**[17](index=17&type=chunk) - Factors that could cause actual performance to differ include **trial data not being positive, failure to obtain approvals, manufacturing challenges, and inability to secure partnerships or capital**[17](index=17&type=chunk) [Company Contacts](index=8&type=section&id=Company%20Contacts) Contact information for the company's Chief Financial Officer and Investor Relations is provided for inquiries - Company contact: **Jack Callicutt, Chief Financial Officer** (678) 620-3186, ir@galectintherapeutics.com[18](index=18&type=chunk) - Investor Relations contact: **Kevin Gardner**, kgardner@lifesciadvisors.com[18](index=18&type=chunk)

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].

Core Insights - Galectin Therapeutics Inc. presented the NAVIGATE study analysis at the EASL 2025 Congress, highlighting the efficacy of belapectin in treating patients with MASH cirrhosis and portal hypertension [1][5] Study Design and Results - The NAVIGATE trial was a global, multicenter, randomized, double-blind, placebo-controlled study involving 355 patients, who were assigned to receive either belapectin at 2 mg/kg, 4 mg/kg, or placebo for 18 months [2] - The primary endpoint was the prevention of varices, with the 2 mg/kg group showing a 49.3% reduction in new varices compared to placebo (p=0.04), while the 4 mg/kg group showed a 39.5% reduction, which was not statistically significant [3][6] Efficacy and Biomarker Analysis - In the per-protocol population, the incidence of varices was 11.3% in the 2 mg/kg group and 13.5% in the 4 mg/kg group, compared to 22.3% in the placebo group [3] - Non-invasive assessments indicated that the 2 mg/kg group had a 66% lower rate of worsening liver stiffness compared to placebo (p=0.02) [4][6] Safety Profile - The safety profile of belapectin was encouraging, with adverse events and serious adverse events rates comparable across all treatment groups, and no drug-related serious adverse events reported [4][6] Expert Commentary - Experts highlighted the significance of the NAVIGATE study results, emphasizing belapectin's potential to address unmet needs in MASH cirrhosis and its consistent benefits observed in the 2 mg dose [5][7] Company Overview - Galectin Therapeutics focuses on developing therapies for chronic liver disease and cancer, with belapectin being its lead drug targeting galectin-3, which is involved in various diseases [8]

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]

Core Insights - Galectin Therapeutics reported significant progress in its belapectin program, particularly in treating MASH cirrhosis and portal hypertension, with a 68% reduction in new varices incidence in U.S. patients [2][6] - The company has sufficient cash to fund operations through August 2025, bolstered by a $5 million line of credit from its chairman [5][7] - Financial results for 2024 show a net loss of $47.2 million, an increase from $44.5 million in 2023, primarily due to rising research and development costs [11][13] Financial Highlights - As of December 31, 2024, the company had $15.1 million in unrestricted cash and cash equivalents, with an additional $6 million available under a line of credit [5][14] - Research and development expenses for 2024 were $36.6 million, up from $32.1 million in 2023, driven by costs associated with the NAVIGATE clinical trial [11][13] - The total net loss applicable to common stockholders for 2024 was $47.2 million, or ($0.76) per share, compared to a net loss of $44.5 million, or ($0.74) per share in 2023 [11][13] Belapectin Program Highlights - Belapectin targets galectin-3, a protein involved in the pathogenesis of NASH and fibrosis, and has received Fast Track designation from the FDA [3][8] - The NAVIGATE trial demonstrated a 49% reduction in varices incidence in the per-protocol population and a 68% reduction in U.S. patients treated with belapectin 2 mg compared to placebo [6][11] - The company plans to share additional results and biomarker analyses in the second quarter of 2025 [2][6]

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]