Company Performance - Galectin Therapeutics Inc. reported a GAAP EPS of -$0.13 for Q3 2025, translating to a net loss of $8.2 million for the quarter [1] - The decline in earnings was primarily attributed to increased research and development and operating expenses [1] Analyst Background - The analyst has a Master's degree in Cell Biology and extensive experience in drug discovery, focusing on cell culture, assay development, and therapeutic research [1] - The analyst has been active in the investing space for five years, with a focus on biotechnology companies that are innovating through novel mechanisms of action and first-in-class therapies [1] - The approach emphasizes evaluating the science behind drug candidates, the competitive landscape, clinical trial design, and potential market opportunities while balancing financial fundamentals and valuation [1]

Financial Data and Key Metrics Changes - The company is currently trading at close to multi-year highs, indicating a positive market sentiment and performance [14] - The results of the stockholder vote showed a plurality of shares voted in favor of all 11 nominees for director, reflecting strong shareholder support [10] Business Line Data and Key Metrics Changes - The Navigate trial results indicated that the two-milligram dose of belapectin showed a lower rate of new varices compared with placebo after 18 months, particularly in the completer population [20] - Belapectin demonstrated a significant reduction in liver stiffness and a lower rate of new varices across various fibrosis levels, indicating its potential effectiveness in treating MASH cirrhosis [22] 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 [18] - The unique nature of the patient population in the Navigate trial has led to groundbreaking discussions regarding treatment options for patients with MASH cirrhosis and portal hypertension [19] Company Strategy and Development Direction - The company aims to maximize the value of its program and believes that belapectin has the potential to change the treatment landscape for patients with no FDA-approved therapy [19] - There is a focus on strengthening, validating, and communicating the evidence supporting belapectin's clinical findings, with plans for additional KOL events and peer-reviewed publications [18][25] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the company's current position and the extensive amount of meaningful information available, indicating a positive outlook for the future [14] - The company anticipates feedback from the FDA regarding its submitted package and is actively discussing potential partnerships to advance belapectin [19][25] Other Important Information - The company has maintained a clean safety profile for belapectin, with no drug-related serious adverse events reported during the trial [24] - The final results of the stockholder vote will be disclosed in a current report on Form 8-K filed with the SEC within four business days [13] 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 [20] - Belapectin demonstrated significant reductions in liver stiffness and lower rates of new varices across various fibrosis levels [22] Question: What is the company's strategy moving forward? - The company aims to maximize the value of its program and believes belapectin can change the treatment landscape for patients with no approved therapies [19] - There are plans for additional KOL events and peer-reviewed publications to strengthen the evidence supporting belapectin [18][25]

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 Insights - Biotech companies often pursue broad indications with complex mechanisms of action, but occasionally a clear mechanistic rationale emerges that targets unmet medical needs [1] Group 1: Company Focus - There is a strong inclination towards high-growth companies in sectors expected to experience exponential expansion [1] - The focus is on understanding and investing in disruptive technologies and forward-thinking enterprises [1] Group 2: Analytical Approach - The investment approach combines fundamental analysis with future trend predictions [1] - There is a belief in the power of innovation to generate substantial returns [1]

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].

Financial Performance - For the quarter ended September 30, 2025, Galectin Therapeutics reported a net loss applicable to common stockholders of $8.2 million, or ($0.13) per share, compared to a net loss of $11.2 million, or ($0.18) per share for the same period in 2024[11]. - Total operating expenses for Q3 2025 were $4.2 million, down from $9.1 million in Q3 2024[15]. - The company reported a total stockholders' deficit of $125.3 million as of September 30, 2025[16]. Research and Development - Research and development expenses for Q3 2025 were $2.6 million, a significant decrease from $7.6 million in Q3 2024, primarily due to the timing of expenditures related to the NAVIGATE clinical trial[9]. - The NAVIGATE trial data presented at the AASLD Annual Meeting showed belapectin's potential to reduce clinically significant portal hypertension (CSPH) from 33.3% to 25.9% (-22.2% change) in the treatment group[5]. - The proportion of patients in the no/low-risk category for CSPH increased from 42.0% to 56.8% (35.2% change) in the belapectin 2 mg/kg group[7]. Financial Position - As of September 30, 2025, the company had $11.5 million in cash and cash equivalents, and a new $10 million line of credit was established to fund operations[9]. - Total liabilities as of September 30, 2025, were $136.4 million, compared to $120.6 million at the end of 2024[16]. Future Outlook - The company anticipates guidance from the FDA regarding the NAVIGATE data package by year-end 2025[9]. - Galectin Therapeutics aims to leverage its expertise and relationships to advance additional development programs in cancer immunotherapy[10].

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 [113]. - 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 [114]. - 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 < 0.05 [114]. - 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) [114]. - The NASH-FX trial did not meet its primary endpoint, with no significant efficacy results in advanced liver fibrosis patients, although belapectin was found safe and well tolerated [129]. - The NASH-CX trial involved 162 patients and showed a statistically significant reduction in hepatic venous pressure gradient (HVPG) of -1.08 mm Hg (p<0.01) for the 2 mg/kg LBM dose in patients without esophageal varices at baseline [132]. - In the NASH-CX trial, the belapectin 2 mg/kg group had a 0% incidence of new varices compared to 18% in the placebo group, indicating a significant reduction in portal pressure and varice development [134]. - The NAVIGATE trial reported a 43.2% reduction in varices incidence in the intent-to-treat population for the belapectin 2 mg/kg group, although the composite endpoint did not reach statistical significance [139]. - In the per-protocol population of the NAVIGATE trial, the incidence of varices was reduced by 49.3% (p<0.05) in the belapectin 2 mg/kg group [139]. - The NAVIGATE trial showed a significant reduction of 68.1% in varices incidence in U.S. patients treated with belapectin 2 mg/kg (4 out of 60) compared to placebo (13 out of 62) (p=0.02) [139]. - Promising results were reported in the Phase 1b trial combining belapectin with pembrolizumab, showing a 50% objective response rate in advanced melanoma patients [150]. 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 [115]. - The safety profile of belapectin in the NAVIGATE trial was encouraging, with no drug-related serious adverse events reported [140]. - The Company completed a Hepatic Impairment Study involving approximately 40 patients, indicating that belapectin exposure did not increase with the degree of hepatic insufficiency [147]. Financial Performance - Research and development expenses for the three months ended September 30, 2025, were $2,612,000, a decrease of $4,983,000 (66%) compared to $7,595,000 in the same period of 2024 [153]. - For the nine months ended September 30, 2025, research and development expenses totaled $12,358,000, down $13,104,000 (51%) from $25,462,000 in 2024 [153]. - General and administrative expenses for the three months ended September 30, 2025, were $1,587,000, an increase of $116,000 (8%) compared to $1,471,000 in 2024 [157]. - For the nine months ended September 30, 2025, general and administrative expenses decreased by $180,000 (4%) to $4,363,000 from $4,543,000 in 2024 [157]. - Net cash used in operations decreased by $11,143,000 to $17,833,000 for the nine months ended September 30, 2025, compared to $28,976,000 for the same period in 2024 [159]. - Cash provided by financing activities decreased by $16,138,000 to $14,238,000 for the nine months ended September 30, 2025, compared to $30,376,000 in 2024 [159]. - As of September 30, 2025, the company had $11.5 million in unrestricted cash and cash equivalents, along with a $10 million line of credit available [158]. - The NAVIGATE clinical trial expenses decreased significantly, contributing to the overall reduction in research and development costs [154]. - The company anticipates needing additional cash to fund operations beyond June 30, 2026 [158]. Strategic Developments - The company is analyzing data from approximately 55 patients who completed 36 months of treatment, which may attract interest from potential strategic partners [116]. - A new IND for advanced or metastatic head and neck cancer using belapectin in combination with a PD-1 inhibitor has been filed, with the trial commencement dependent on financing [120]. - 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 [119]. - The company is focused on developing belapectin for NASH cirrhosis and head and neck cancer, with ongoing clinical trials and favorable results reported in 2023 [123]. - The company plans to file a phase 2 trial with the FDA for belapectin in combination with an immune checkpoint inhibitor for recurrent or metastatic head and neck cancer [151]. - The Company activated over 150 clinical trial sites in 14 countries for the NAVIGATE trial, although enrollment was impacted by the COVID-19 pandemic [144].

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]

Summary of Galectin Therapeutics Conference Call Company Overview - **Company**: Galectin Therapeutics (NasdaqCM:GALT) - **Event**: Conference at HC Wainwright's Virtual Liver Disease Conference on October 21, 2025 Key Points on MASH Cirrhosis and Palipectin - **Lead Compound**: Palipectin, a proprietary galectin-3 inhibitor, is in development for patients with MASH cirrhosis and portal hypertension [4][5] - **Clinical Need**: MASH cirrhosis with portal hypertension is a serious and underserved condition in hepatology, with no FDA-approved therapies available to reverse portal hypertension once developed [5][6] - **Epidemiology**: Approximately 1% of the U.S. population may have MASH cirrhosis and portal hypertension [5] - **Mechanism of Action**: Palipectin blocks the galectin-3 pathway, which is a key driver of fibrosis, offering antifibrotic activity [4][5] Clinical Trial Insights - **Phase 2B GD26 Study**: Palipectin at 2 mg prevented the development of new varices in patients without varices at baseline, significantly reducing hepatic venous pressure gradient [7][8] - **Navigate Trial**: Enrolled 357 patients with compensated MASH cirrhosis and portal hypertension, assessing the incidence of new varices as the primary endpoint [9][10] - **Results**: In the ITT population, there was a 43% lower incidence of varices in the 2 mg group compared to placebo (12 vs. 21 varices) [11] - **U.S. Subgroup Findings**: Results were more remarkable in the U.S. subgroup, showing significant reduction in varices incidence [12] Safety and Efficacy - **Safety Profile**: Palipectin exhibited a favorable safety profile with low discontinuation rates due to adverse events and no serious drug-related adverse events reported [16][17] - **Biomarker Evidence**: Non-invasive markers showed improvement in liver stiffness and a significant reduction in fibrosis markers in the palipectin group compared to placebo [14][15][17] Market Opportunity - **Strategic Advantage**: Palipectin's unique mechanism positions it favorably against other therapies in development, addressing a critical unmet need in MASH cirrhosis treatment [6][17] - **Combination Potential**: There is potential for synergy between palipectin and metabolic agents, which could expand its therapeutic value [12][17] Conclusion - **Future Directions**: Galectin Therapeutics is focused on advancing discussions with regulatory agencies and identifying partners to move the program forward, aiming to bring meaningful advances to patients with MASH cirrhosis [17]

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]