Slide 1: Belapectin for MASH Cirrhosis and Portal Hypertension
Belapectin for MASH Cirrhosis and Portal Hypertension March 10, 2026
Slide 2: Today's Agenda
Today’s Agenda 01 Moderator Michael Cozart, LifeSci Consulting 02 Belapectin as Galectin-3 Inhibitor for MASH cirrhosis & Portal Hypertension Khurram Jamil, M.D. (CMO) 03 Current Landscape & Primary End Point Results Naga Chalasani, M.D. 04 Biomarker Results Naim Alkhouri. M.D. Khurram 05 Closing Re
Slide 3: Belapectin a Galectin-3 Inhibitor for MASH Cirrhosis & Portal Hypertension
Belapectin a Galectin-3 Inhibitor for MASH Cirrhosis & Portal Hypertension Khurram Jamil, M.D. Chief Medical Officer
Slide 4: MASH Cirrhosis with Portal Hypertension Represents a Significant Unmet Need
MASH Cirrhosis with Portal Hypertension Represents a Significant Unmet Need Addressable market in the U.S. Metabolic dysfunction-associated steatohepatitis 100M (MASH), previously known as non-alcoholic Americans have fatty liver disease (most don’t know it)1 steatohepatitis (NASH), is characterized
Slide 5: Belapectin For MASH Cirrhosis and Portal Hypertension
Belapectin For MASH Cirrhosis and Portal Hypertension Belapectin Preclinical Data: Multiple animal models of MASH (streptozotocin High-Fat Diet mice1) and cirrhosis (thioacetamide treated rats2) belapectin was associated with decreased: • Galectin-3 staining and galectin-3 expression in macrophages
Slide 6: Belapectin's Novel Mechanism Positions It to Address MASH Cirrhosis & Portal Hypertension
Belapectin’s Novel Mechanism Positions It to Address MASH Cirrhosis & Portal Hypertension United States Estimates1 $18B 1.7M 5M Patients with compensated Patients with compensated cirrhosis and Peak belapectin sales MASH cirrhosis in 2024 portal hypertension with no varices in 2024 in U.S. 3rd Party
Slide 7: MASH Cirrhosis Landscape Belapectin Program
MASH Cirrhosis Landscape Belapectin Program Naga Chalasani, M.D.
Slide 8: When to Intervene in Cirrhosis- before its too late!
When to Intervene in Cirrhosis- before its too late! Compensated cirrhosis Decompensated cirrhosis No Portal Hypertension Portal Hypertension Varices, Varices Bleeding, ascites, No varices No varices small to large encephalopathy ≥6 ≥10 One year mortality 1-3% One year mortality ~50% There are no ap
Slide 9: Treatment Progression
Current Treatment Paradigm Resmetirom and Semaglutide approved for F2/3 patients; Limited options in Cirrhosis & Portal Hypertension Hepatic Lipid Improved Regressed Goal Reduction MASH Fibrosis Lifestyle interventions are used to promote weight-loss, a key component Lifestyle Interventions ± co-mor
Slide 10: Phase 2b Study of Belapectin in Patients with MASH Cirrhosis: GT-026 Trial
Phase 2b Study of Belapectin in Patients with MASH Cirrhosis: GT-026 Trial HVPG Change at Week 52 Belapectin Reduced Emergence of Second Incidence of Varices at week 52 Varices in Patients with MASH Cirrhosis1,* 15 18 14 16 p = 0.44 13 14 Percent New Varices Formation p = 0.02 12 12 HVPG mean (mm Hg
Slide 11: NAVIGATE Trial Design
NAVIGATE Trial Design Patient Population Trial Design • MASH cirrhosis based on Liver Forum Recommended Criteria for Belapectin 2 mg/Kg LBM Q2W Clinical Trials n = 119 • Diagnosis of Portal Hypertension as (n = 357 1:1:1) Randomize per Baveno VI criteria Screen Belapectin 4 mg/Kg LBM Q2W (via non-in
Slide 12: NAVIGATE Study: Patient Population and Efficacy Endpoints
NAVIGATE Study: Patient Population and Efficacy Endpoints Key inclusion criteria Primary endpoint Composite secondary endpoint MASH cirrhosis Composite primary end point in Hepatic decompensation events No varices on EGD ITT population All-cause mortality CTP Scores <7 Incidence of Varices in per Pr
Slide 13: Key Populations for Assessment of Varices Outcome
Key Populations for Assessment of Varices Outcome • ITT All randomized subjects minus two subjects who had varices at baseline; • Per Protocol All subjects who completed 18 month of therapy and had an EGD at baseline and 18 month • Subject were required to complete the study even after development o
Slide 14: NAVIGATE Trial: Baseline Demographics
NAVIGATE Trial: Baseline Demographics n = 355 Placebo (n = 118 Belapectin 2 mg (n = 119) Belapectin 4 mg (n = 118) Mean (Standard Deviation) Mean (Standard Deviation) Mean (Standard Deviation) Age (years) 60.4 (8.50) 60.6 (8.82) 59.0 (9.14) Gender (female), n 72 (61.0) 75 (63.0) 83 (70.3) Ethnicity
Slide 15: NAVIGATE: Composite Primary End Point Results
NAVIGATE: Composite Primary End Point Results Intent to Treat Key points 60 56 (47.5%) 51 • Intent to Treat (ITT) -All randomized (43.2%) subjects 50 45 Number of subjects with new varices (37.8%) • Primary end point composite strategy i.e. new varices and/or intercurrent 40 events or drop out 29 30
Slide 16: NAVIGATE: Significantly Lower Incidence of Varices in Completer Population
NAVIGATE: Significantly Lower Incidence of Varices in Completer Population Per Protocol 25 21 (22.3%) Key points 20 • NAVIGATE 18-month Primary Analyses p = 0.04 p = 0.12 Number of subjects Result; Per protocol population n= 287 15 13 (13.5%) • Per Protocol Population: All ITT subjects who 11 comple
Slide 17: NAVIGATE: Reduced Incidence of Medium/Large Varices with Belapectin
NAVIGATE: Reduced Incidence of Medium/Large Varices with Belapectin Per Protocol 30 p = 0.04 Key points 25 Placebo Treatment Group: n = 94 Number of subjects with new varices 21 (22.3%) 2 mg/kg LBM Belapectin Treatment Group: n = 97 20 4 mg/kg LBM Belapectin Treatment Group: n = 96 13 13 Varices gra
Slide 18: Lowest Rates of Liver-Related Events and MACE Observed with the 2 mg Dose
Lowest Rates of Liver-Related Events and MACE Observed with the 2 mg Dose Per Protocol Belapectin Placebo 2mg/kg LBM 4mg/kg LBM (n = 94) (n = 97) (n = 96) n (%) n (%) n (%) Subjects with Composite Clinical Outcomes, n (%) 5 (5.3) 3 (3.1) 9 (9.4) Varices (Esophageal or Gastric) Requiring Treatment 3
Slide 19: Safety Summary
Safety Summary Discontinuation of the study due to Adverse Events was similar across 3 cohorts: Adverse Events − 7 (5.9%) in the Placebo − 5 (4.2%) in 2 mg/kg LBM Belapectin − 8 (6.7%) in 4 mg/kg LBM Belapectin − One subject in each of the three cohorts discontinued the study due to death • No drug
Slide 20: NAVIGATE Biomarker Results at 18 Months
NAVIGATE Biomarker Results at 18 Months Naim Alkhouri, M.D.
Slide 21: NAVIGATE Enrolled Subject with Advanced Cirrhosis & Portal Hypertension
NAVIGATE Enrolled Subject with Advanced Cirrhosis & Portal Hypertension Key Baseline Characteristics, Per Protocol Placebo (n = 94) Belapectin 2 mg (n = 97) Mean (Standard Deviation) Mean (Standard Deviation) Platelets (per µL) 132.3 (40.73) 125.8 (48.52) Liver Stiffness Measurement (kPa) 23.4 (11.3
Slide 22: NAVIGATE: Belapectin Treatment Associated with Decreased Liver Stiffness
NAVIGATE: Belapectin Treatment Associated with Decreased Liver Stiffness Per Protocol Liver Stiffness kPa Mean Change Percentage 15 10 Percentage Change from Baseline 5 1.7% 0 Belapectin Placebo 2 mg/kg LBM -5 (n = 76) (n = 81) Mean 22.6 24.6 -10 -8.4% Standard Deviation 10.31 13.971 Median 22.4 21.
Slide 23: Significantly Less Progression of Liver Stiffness on Belapectin
Significantly Less Progression of Liver Stiffness on Belapectin Per Protocol p = 0.03 p = 0.09 17 17 18 (22.4%) (22.4%) 16 14 12 10 Number of Subjects (12.3%) 10 8 (9.9%) 8 6 Belapectin 4 Placebo 2mg/kg LBM 2 76 81 0 > 30% increase from baseline > 5 point kPa increase from baseline Placebo Belapecti
Slide 24: ELF Score Stratification Reveals Greater Variceal Benefit of Belapectin in Highest-Risk Patients
ELF Score Stratification Reveals Greater Variceal Benefit of Belapectin in Highest-Risk Patients Per Protocol Incidence of Varices by Baseline ELF Categories 50% 45% n = 19 42.9% Percent of Subjects with New Esophageal Varices 40% 35% 30% 25% 22.7% 20% 17.6% 18.0% 15% 9.4% 10% 4.8% 5% 0% ELF < 9.8 E
Slide 25: Concordant Fibrosis Biomarkers Support Belapectin's Effect on Stopping Disease Progression
Concordant Fibrosis Biomarkers Support Belapectin's Effect on Stopping Disease Progression Per Protocol 16% 14.3% 14% 12% 10.7% 10% Percent Increase 8.2% 8% 6% 4.1% 4% Belapectin Placebo 2mg/kg LBM 2% n=8 n=6 n=6 n=3 56 73 0% ≥ 30% Increase and Post-Baseline LSM > 25 kPa LSM Increase ≥ 30% kpa and E
Slide 26: Belapectin Drives Meaningful Improvement in Portal Hypertension Risk Category
Belapectin Drives Meaningful Improvement in Portal Hypertension Risk Category Per Protocol Placebo Belapectin 2 mg/kg LBM (n = 76) (n = 81) 25.9% 34.2% 32.9% 33.3% 17.3% 15.8% 21.1% 24.7% CSPH Probably CSPH No/low CSPH 56.8% 51.3% 44.7% 42.0% Baseline Week 78 Baseline Week 78 CSPH LSM ≥ 25 kPa; Prob
Slide 27: Belapectin Reduces Worsening in AGILE-4 Score Across Treated Patients
Belapectin Reduces Worsening in AGILE-4 Score Across Treated Patients Per Protocol Percentage of Subjects with ≥ 20% Increase in AGILE-4 Score 18% 16.9% 16% 14% 11.5% Percentage of Subjects 12% 10% 8% 6% Belapectin Placebo 2mg/kg LBM 4% n = 71 n = 78 2% Baseline Mean 0.66 0.68 n = 12 n=9 0% Standard
Slide 28: Belapectin Treatment Associated with Meaningful Changes in YKL-40
Belapectin Treatment Associated with Meaningful YKL-40 is a circulating Changes in YKL-40 marker of inflammation, Per Protocol also part of NIS-4 ≥ 20% Change from Baseline 45% 40.4% 40% 35% 33.8% 33.8% Percentage of Subjects 30% 25% 23.1% 20% 15% Belapectin Placebo 2mg/kg LBM 10% (n = 52) (n = 65)
Slide 29: Trend Toward Reduced Pro-C3 with Belapectin
Trend Toward Reduced Pro-C3 with Belapectin Pro-C3 is a marker fibrosis or scar tissue Per Protocol build up 3 2 1 Mean Change from Baseline 0 -1 -2 -3 -4 Belapectin -4.5 Placebo 2mg/kg LBM -5 n = 79 n = 81 -6 Baseline Mean 50.19 45.91 -6.4 Standard Deviation 38.45 31.58 -7 Placebo Belapectin 2mg/kg
Slide 30: Belapectin Reduces Fibrogenesis in Highest-Risk Patients (ELF ≥ 11.3)
Belapectin Reduces Fibrogenesis in Highest-Risk Patients (ELF ≥ 11.3) Change in Pro-C3 Change in Pro-C3/CTX-III ratio 0 0 -2 -0.1 -4 -0.2 Mean Change from Baseline (SD) Mean Change from Baseline (SD) -6 -0.2 (3.64) -0.3 -8 -7.3 (22.83) -0.4 -10 -0.5 -12 -0.6 -14 -16 -0.7 -0.7 (2.47) -18 -0.8 -20 -18
Slide 31: Lower Rate of Pro-C4 Worsening with Belapectin Treatment
Lower Rate of Pro-C4 Worsening with Belapectin Treatment Pro-C4 is a marker of type-IV collagen build-up Per Protocol indicates increase in fibrosis and disease ≥ 20% Increase from Baseline in Pro-C4 progression 14% 13.1% 12% 10% Percentage of Subjects 8% 6% Belapectin 4% 2.7% Placebo 2mg/kg LBM n =
Slide 32: Key Takeaways
Key Takeaways Belapectin 2 mg/kg LBM significantly reduced Favorable safety profile with adverse events, 01 the incidence of new esophageal varices at 18 04 serious adverse events, and discontinuation months in patients with MASH cirrhosis and rates comparable to placebo. portal hypertension Biomark
Slide 33: Thank you!
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