Financial Data and Key Metrics Changes - The company is currently trading at close to multi-year highs, indicating a positive market sentiment and performance [18] - The Navigate trial's top-line results were presented, showing a lower rate of new varices with the two-milligram dose of belapectin compared to placebo after 18 months, although not statistically significant in the overall population [24] Business Line Data and Key Metrics Changes - The focus has been on analyzing biomarker data from the Navigate trial to support the efficacy of belapectin in treating MASH cirrhosis and portal hypertension [21][25] - Significant findings include a lower rate of new varices in patients treated with belapectin compared to placebo, particularly in those with advanced fibrosis [26] Market Data and Key Metrics Changes - The company has engaged with key opinion leaders (KOLs) and presented findings at major hepatology conferences, enhancing its visibility and credibility in the market [22] - The Navigate trial enrolled one of the most advanced compensated MASH cirrhosis populations studied to date, which may influence market perception and potential partnerships [29] Company Strategy and Development Direction - The company aims to maximize the value of its program and is exploring strategic opportunities to advance belapectin, which has the potential to change the treatment landscape for patients with no FDA-approved therapies [23] - Continued engagement with clinicians and KOLs is planned to further validate and communicate the clinical findings of belapectin [22] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the company's current position and the extensive data available to support its programs [18] - The company anticipates feedback from the FDA regarding its submitted package and is optimistic about the future of its treatment options [23] Other Important Information - The company has maintained a clean safety profile for belapectin, with no drug-related serious adverse events reported during the Navigate trial [29] - The results from the Navigate trial are expected to lead to further discussions with potential partners committed to advancing belapectin [29] Q&A Session Summary Question: What are the key findings from the Navigate trial? - The two-milligram dose of belapectin showed a lower rate of new varices compared to placebo, particularly in the completer population [24] - Biomarker analyses indicated that belapectin may stabilize MASH cirrhosis over time and reduce key inflammatory pathways [26][27] Question: What are the next steps for the company? - The company is finalizing remaining analyses and looks forward to working with the FDA to determine next steps for the belapectin program [29] - Active discussions with potential partners are ongoing to advance the treatment for patients with no approved options [29]

Core Viewpoint - Galectin Therapeutics reported positive clinical data for belapectin, indicating its potential to slow disease progression in patients with compensated MASH cirrhosis, and submitted the NAVIGATE data package to the FDA for feedback on next steps [2][4]. Clinical Data Summary - The NAVIGATE trial presented at AASLD showed consistent improvements in key biomarkers, including FibroScan, ELF, and PRO-C3, supporting belapectin's antifibrotic activity [2][4]. - Belapectin demonstrated a significant reduction in clinically significant portal hypertension (CSPH) risk categories, with a decrease from 33.3% to 25.9% in the 2 mg/kg group, compared to a smaller decrease from 34.2% to 32.9% in the placebo group [8]. - The treatment also improved the no/low-risk category for CSPH, increasing from 42.0% to 56.8% in the belapectin group versus an increase from 44.7% to 51.3% in the placebo group [8]. Financial Highlights - As of September 30, 2025, the company reported cash and cash equivalents of $11.5 million, with total assets of $12.9 million [14]. - Research and development expenses for Q3 2025 were $2.6 million, a decrease from $7.6 million in Q3 2024, primarily due to the timing of expenditures related to the NAVIGATE trial [6][12]. - The net loss applicable to common stockholders for Q3 2025 was $8.2 million, or ($0.13) per share, compared to a net loss of $11.2 million, or ($0.18) per share in Q3 2024 [12][13].

Core Insights - Galectin Therapeutics Inc. presented findings from the NAVIGATE study, focusing on the efficacy of belapectin, a galectin-3 inhibitor, in treating patients with compensated MASH cirrhosis and portal hypertension [1][2] Study Overview - The NAVIGATE trial was a Phase 2b randomized, double-blind, placebo-controlled study involving 355 patients, assessing the effects of belapectin administered at doses of 2 mg/kg and 4 mg/kg every other week for 18 months [2] - The study aimed to evaluate the impact of belapectin on the incidence of new esophageal varices and liver fibrosis progression [2][4] Efficacy Results - Belapectin 2 mg/kg showed a significantly lower incidence of new varices compared to placebo, particularly in patients with an ELF score >11.3 (22.7% vs 42.9%) [3][4] - At 18 months, patients receiving 2 mg/kg belapectin achieved a mean reduction of 6.4 ng/mL in Pro-C3 levels, indicating over 50% improvement from baseline [3][5] - The treatment also demonstrated a lower incidence of clinically meaningful worsening in liver stiffness compared to placebo, suggesting a slowing of fibrosis progression [4] Biomarker Analysis - Analysis of YKL-40 showed a ≥20% reduction in a higher proportion of patients treated with belapectin 2 mg/kg compared to placebo (33.8% vs 23.1%), supporting its antifibrotic activity [6][7] - PRO-C4 analysis indicated a ≥20% increase from baseline occurred more frequently in placebo-treated patients (13% vs 3%), reinforcing belapectin's potential to modify disease progression [7] Long-term Outcomes - The reduction in new varices observed at 18 months was sustained through 36 months, with cumulative incidences of new varices at 36 months being 23.4% for placebo, 12.4% for 2 mg/kg, and 16.7% for 4 mg/kg cohorts [8] - The safety profile of belapectin remained favorable, with adverse events comparable across treatment groups and no drug-related serious adverse events reported [9] Expert Commentary - Experts highlighted the long-term NAVIGATE data as significant, noting the sustained improvements in liver stiffness and biomarkers, which suggest a consistent antifibrotic effect [10] - The company expressed optimism about advancing regulatory discussions and exploring partnerships to further develop belapectin, emphasizing its potential to address a significant unmet medical need in MASH cirrhosis [10][11]

Core Insights - Galectin Therapeutics, Inc. will participate in the H.C. Wainwright 9 Annual MASH Virtual Investor Conference on October 21, 2025 [1][2] - The management team, including CEO Joel Lewis and CMO Khurram Jamil, will be available for one-on-one meetings during the conference [3] Company Overview - Galectin Therapeutics focuses on developing novel therapies for chronic liver disease and cancer, with its lead drug belapectin targeting the galectin-3 protein [4] - Belapectin has received Fast Track designation from the U.S. FDA and is primarily being developed for metabolic dysfunction-associated steatohepatitis (MASH) with cirrhosis [4] - The company is also exploring treatments for advanced head and neck cancers and other malignancies, with further development dependent on finding suitable partners [4]

Core Insights - Galectin Therapeutics Inc. is participating in the AASLD Liver Meeting 2025, presenting data from the NAVIGATE trial on belapectin for MASH cirrhosis treatment [1][2] - The NAVIGATE trial data has been recognized for its significance in addressing the urgent need for therapies in MASH cirrhosis, highlighting belapectin's potential impact on treatment [2] Presentation Details - The oral presentation titled "Belapectin Reduces Liver Stiffness Progression and Prevents Varices at 18 Months in MASH Cirrhosis: Results from the NAVIGATE Trial" will take place on November 10, 2025 [3] - A poster presentation titled "Belapectin Maintains a Favorable Trend in Reducing Variceal Development Over 36 Months in MASH Cirrhosis: Results from the NAVIGATE Trial" is scheduled for November 8, 2025 [3] Company Overview - Galectin Therapeutics focuses on developing therapies for chronic liver disease and cancer, with belapectin as its lead drug targeting galectin-3 [4] - The company has received Fast Track designation from the FDA for belapectin, which is aimed at treating MASH with cirrhosis, a significant medical need [4] - Additional development programs include cancer immunotherapy, with the success of these programs dependent on finding suitable partnerships [4]

Company Participation - Galectin Therapeutics, Inc. will participate in the H.C. Wainwright 27 Annual Global Investment Conference from September 8-10, 2025 in New York, NY [1] - The company presentation is scheduled for September 8, 2025, at 1:00 PM ET, with a live and archived webcast available [2] Management Availability - The management team, including CEO Joel Lewis and CMO Khurram Jamil, will be available for one-on-one meetings during the conference [3] Company Overview - Galectin Therapeutics focuses on developing novel therapies for chronic liver disease and cancer, with its lead drug belapectin targeting the galectin-3 protein [4] - Belapectin has received Fast Track designation from the U.S. FDA and is primarily being developed for metabolic dysfunction-associated steatohepatitis (MASH) with cirrhosis [4] - The company is also exploring treatments for advanced head and neck cancers and other malignancies, with further development dependent on finding suitable partners [4]

Core Insights - Galectin Therapeutics, Inc. reported financial results and business updates for the second quarter and first half of 2025, highlighting progress in its NAVIGATE trial for belapectin, a treatment for MASH cirrhosis [1][2]. Financial Performance - As of June 30, 2025, the company had cash and cash equivalents of $13.8 million and a new $10 million line of credit to fund operations through mid-2026 [9]. - Research and development expenses for Q2 2025 were $3.3 million, a decrease from $9.8 million in Q2 2024, primarily due to the timing of expenditures related to the NAVIGATE trial [9]. - General and administrative expenses for Q2 2025 were $1.4 million, slightly down from $1.5 million in the same period last year [9]. - The net loss applicable to common stockholders for Q2 2025 was $7.6 million, or ($0.12) per share, compared to a net loss of $12.4 million, or ($0.20) per share for Q1 2024 [9][11]. Clinical Development - The NAVIGATE trial data indicates that belapectin shows a clinically significant response in Fibroscan® results, supporting its primary endpoint of preventing esophageal varices after 18 months of treatment [2][4]. - The 18-month analysis demonstrated a lower incidence of liver stiffness progression and varices in the belapectin 2 mg arm compared to placebo, suggesting its potential to modify disease progression in patients with MASH cirrhosis [3][4]. - The updated analysis confirmed that the effects of belapectin were maintained in patients who continued treatment into the second 18-month period, reinforcing its efficacy [4][5]. Strategic Initiatives - The company is focused on engaging with the U.S. Food and Drug Administration to discuss potential next steps for the belapectin program and is exploring strategic partnership opportunities [2][3]. - A KOL event in June featured discussions on the NAVIGATE trial results and the treatment landscape for MASH cirrhosis, indicating ongoing efforts to raise awareness and support for the treatment [4]. Market Position - Galectin Therapeutics aims to address the significant unmet medical need for patients with MASH-associated liver cirrhosis and portal hypertension, positioning belapectin as a potential new treatment option [3][4]. - The company is also developing additional programs for cancer treatment, indicating a broader therapeutic focus [7].

Core Viewpoint - Galectin Therapeutics Inc. has secured a new $10 million unsecured line of credit from Richard E. Uihlein, the Chairman and largest individual stockholder, to support its MASH cirrhosis program and ongoing operations [1][2]. Financial Details - The new credit line allows borrowings at the company's discretion until April 30, 2026, with an interest rate of 6.05% (4.05% plus 2%) [2]. - Principal and interest are due on September 30, 2026, and can be converted into shares at a minimum price of $3.00 per share [2]. - Up to 200,000 stock purchase warrants will be issued to Mr. Uihlein, with exercise prices ranging from $3.00 to $10.00 per share [2]. Existing Financial Obligations - The maturity dates for three existing $10 million convertible notes payable to Mr. Uihlein and $81 million in borrowings under other lines of credit have been extended to September 30, 2026 [3]. Company Strategy and Development - The financing is expected to cover projected expenditures through June 2026, allowing the company to focus on its NAVIGATE trial and potential FDA presentations [4]. - The company is actively seeking partnerships to support the development and commercialization of its lead drug, belapectin, for MASH cirrhosis and portal hypertension [4][5]. Product Information - Galectin Therapeutics is focused on developing therapies for chronic liver disease and cancer, with belapectin being its lead drug targeting galectin-3, which is involved in various diseases [5]. - The company has received Fast Track designation from the FDA for belapectin, which is aimed at treating MASH cirrhosis, a significant unmet medical need [5].

Summary of Galectin Therapeutics (GALT) Update / Briefing Company Overview - **Company**: Galectin Therapeutics (GALT) - **Focus**: Development of belapectin as a treatment for NASH cirrhosis and portal hypertension, addressing a significant unmet medical need [2][4] Industry Context - **Condition**: NASH cirrhosis is a leading cause of liver transplantation in the US, with an estimated 5 million adults affected, including 3.3 million with portal hypertension [8][9] - **Market Opportunity**: Belapectin is positioned as a first-in-class therapy for NASH cirrhosis, with peak sales potential estimated at $18 billion [15] Clinical Trial Insights - **Clinical Trials**: Multiple Phase IIb trials conducted, including the NAVIGATE trial, which focused on patients with NASH cirrhosis and portal hypertension [5][19] - **Mechanism of Action**: Belapectin is a Galectin-3 inhibitor, which has shown anti-inflammatory and anti-fibrotic effects in preclinical studies [5][6] NAVIGATE Trial Findings - **Patient Population**: Included patients with compensated NASH cirrhosis and portal hypertension, with no baseline varices [20][21] - **Primary Endpoint**: Focused on the development of esophageal varices and other hepatic decompensation events [22][36] - **Results**: - Statistically significant reduction in new varices in the belapectin 2 mg/kg group (11.3% vs. 22.3% in placebo) [27] - Reduction in liver stiffness observed, indicating less disease progression [28][30] - Safety profile comparable to placebo, with no significant adverse events reported [31][37] Key Opinion Leaders' Perspectives - **Expert Opinions**: KOLs emphasized the urgent need for effective therapies in the NASH cirrhosis population, highlighting belapectin's potential to fill this gap [8][9][12] - **Market Feedback**: Positive responses from payers and physicians regarding the clinical and economic benefits of belapectin [14] Additional Insights - **Endoscopic Endpoint**: The NAVIGATE trial utilized centrally adjudicated endoscopy videos to track variceal development, enhancing the reliability of results [39][41] - **Comparison with Other Therapies**: Belapectin targets a more advanced patient population compared to other investigational therapies, which often select for less severe cases [62][63] Conclusion - **Future Outlook**: Belapectin shows promise in addressing the unmet needs of patients with advanced NASH cirrhosis and portal hypertension, with a favorable safety profile and significant market potential [36][60]

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]