Galectin Therapeutics Inc. · NASDAQ:GALT
Galectin Therapeutics — Investor Presentation (November 2025)
54 slides from Galectin Therapeutics's investor presentation, Nov 10, 2025
Slide 1: Galectin Therapeutics Corporate Overview November 2025
Galectin TherapeuticsCorporate OverviewNovember 2025
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains, in addition to historical information, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance and use words such as “may,” “
Slide 3: Investment Highlights
Belapectin is a novel, potent, galectin-3 inhibitor with Fast Track Designation Low toxicity as a carbohydrate-based molecule which is degraded by natural processes Patent protection through 2032 Only company to exclusively focus on treatment for MASH cirrhosis and portal hypertension Significant ef
Slide 4: Highly Experienced Leadership Team
4 Highly Experienced Leadership Team Over 32 years of public and private company experience including more than a decade of audit, tax and SEC registrant experience with a major accounting firm. JACK W. CALLICUTT Chief Financial Officer SETH ZUCKERMANSenior Director, Biostatistics JESSICA KOPACZEWSK
Slide 5: Laser-Focused Pipeline
Clinical Program Development Stage Drug Indication Discovery Preclinical Phase 1 Phase 2 Phase 3 Fibrosis Belapectin MASH Cirrhosis and Portal Hypertension Cancer Immunotherapy (Combination therapy) Belapectin + Keytruda Melanoma + Head / Neck Cancer Oral Galectin-3 Inhibitors Discovery program to i
Slide 6: Galectin-3 is a Promising Therapeutic Target in Inflammatory and Fibrotic Diseases
Galectin 3 is part of the galectin family of sugar-binding proteins that act as a “molecular glue”, it is: Predominantly produced by activated macrophages Involved in a wide number of biological and pathological processes Galectin-3 recruits macrophages to injury sites and promotes chronic inflammat
Slide 7: Belapectin: a Proprietary Galectin-3 Inhibitor with Low Toxicity and Anti-fibrotic Activity
Belapectin is a polysaccharide polymer comprising galacturonic acid, galactose, arabinose, rhamnose and smaller amounts of other sugars Belapectin Preclinical Data: In animal models of MASH (streptozotocin High-Fat Diet mice1) and cirrhosis (thioacetamide treated rats2) belapectin was associated wit
Slide 8: MASH Cirrhosis
MASH Cirrhosis 8
Slide 9: MASH disease overview and risk factors
Metabolic dysfunction-associated steatohepatitis (MASH), previously known as non-alcoholic steatohepatitis (NASH), is characterized by fat accumulation, inflammation and fibrosis of the liver1 3%-5% of the global population is estimated to be affected by MASH, though the disease is considered to be
Slide 10: Belapectin First- and Best-in-Class Potential in MASH Cirrhosis
10 Belapectin is a Novel Therapy with First- and Best-in-Class Potential in MASH Cirrhosis 3rd Party Market Opportunity Assessment Suggests1 Potential 35-100% Adoption Rate Limited current treatment options: Cirrhotic management focuses on stabilization and delaying progression Management directed t
Slide 11: When to Intervene in Cirrhosis - Before It's Too Late
HPVG=hepatic venous pressure gradient. There are no approved therapies to reverse portal hypertension once it develops in MASH Cirrhosis 11 When to Intervene in Cirrhosis- before its too late! Compensated cirrhosis Decompensated cirrhosis No Portal Hypertension Portal Hypertension Stage 2 Stage 3 an
Slide 12: Phase 2b Study of Belapectin in Patients with MASH Cirrhosis: GT-026 Trial
12 Phase 2b Study of Belapectin in Patients with MASH Cirrhosis: GT-026 Trial Main inclusion criteria MASH cirrhosis (biopsy) Portal Hypertension: HVPG ≥ 6 mmHg No cirrhosis complications No varices/varices (50:50) Primary endpoint Portal pressure (HPVG) change from baseline to Week 54 Secondary end
Slide 13: Belapectin Impact on HVPG at One Year
13 Belapectin Impact on HPVG at One Year1,* HVPG = Hepatic Venous Pressure Gradient; LBM=lean body mass, N.S.=non significant. *ITT with LOCF, ANCOVA with baseline as covariate and treatment as factors, Bonferroni-Holm.1. Chalasani N, et al. Gastroentrol. 2020;158:1334-45. N.S. N.S. Baseline 1 year
Slide 14: Belapectin Reduces Emergence of Varices in Patients with MASH Cirrhosis
14 Belapectin Reduces Emergence of Varices in Patients with MASH Cirrhosis1,* Significantly fewer new varices on belapectin vs placebo No patients on 2 mg/kg/LBM developed new varices Belapectin demonstrated efficacy on a clinically-meaningful endpoint where no current therapies exist LBM=lean body
Slide 15: NAVIGATE Trial Design
15 NAVIGATE Trial Design Placebo n=119 Screen Belapectin 2 mg/kg/LBM Q2W n=119 78 Weeks Belapectin 4 mg/kg/LBM Q2W n=119 Randomize (N=357 1:1:1) Trial Design Patient Population MASH cirrhosis based on Liver Forum Recommended Criteria for Clinical Trials1 Diagnosis of Portal Hypertension as per Baven
Slide 16: NAVIGATE patient population and endpoints
MASH cirrhosis No varices on EGD CTP Scores <7 Evidence of Portal hypertension: Platelet count <150,000/mm3 Or at least two of the following AST/ALT > 1 Spleen ≥ 14 cm Collaterals by imaging Stiffness ≥ 20 kPa Development of new varices (composite strategy) in ITT population Incidence of Varices in
Slide 17: Key Populations for Assessment of Varices Outcome
17 Key Populations for Assessment of Varices Outcome ITT population- All randomized subjects minus two subjects who had varices at baseline; Per-Protocol or completer population- All subjects who completed 18 month of therapy and had an EGD at baseline and 18 months Subject were required to complete
Slide 18: NAVIGATE Trial: Baseline Demographics
18 NAVIGATE Trial: Baseline Demographics Baseline Demographics and Clinical Characteristics (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) Gend
Slide 19: NAVIGATE 18-Month Primary Analyses Result – ITT Population
NAVIGATE 18-Month Primary Analyses Result – ITT Population Intent to Treat (ITT) -All randomized subjects Primary end point composite strategy i.e. new varices and/or intercurrent events or drop out Intercurrent events (ICEs) include; Liver related clinical events, AE leading to discontinuation, TIP
Slide 20: NAVIGATE: Intercurrent Events breakdown by category
Key points 20 NAVIGATE: Intercurrent Events breakdown by category n = 118 Subject % Intercurrent Event Category No subject met intercurrent event category for Trans-jugular intrahepatic portosystemic shunt(TIPS) or ≥12-month use of non-selective beta-blocker NSBB ITT Population 6.3% subjects receive
Slide 21: Significantly Lower Incidence of Varices in Completers at 18 months
Key points NAVIGATE: Significantly Lower Incidence of Varices in Completers at 18 months N = 97 N = 98 N = 95 n = 94 n =97 n = 96 p=0.04 p=0.13 Number of subjects Subjects with new varices NAVIGATE 18-month Primary Analyses Result; Per protocol population n= 287 Completer/Per Protocol: All ITT subje
Slide 22: Incidence of Varices by Size at 18 months
Key points NAVIGATE: Incidence of Varices by Size at 18-months Number of subjects with new varices Subjects with new varices New varices at 18 months in Per Protocol Population Placebo Treatment Group: N = 94 2mg/kg Belapectin Treatment Group: N = 97 4mg/kg Belapectin Treatment Group: N = 96 Varices
Slide 23: Incidence of New Varices was Significantly Lower in Patients in the U.S.
Incidence of New Varices was Significantly Lower in Patients in the U.S. n=13/62 n=4/60 n=8/64 n=8/32 n=7/37 n=5/ 32 p=0.02 p=0.54 p=0.35 NAVIGATE 18-month; Per protocol population (n=287) p=0.2 23
Slide 24: Use of GLP-1 and Statin was Higher in Patients in the U.S.
24 Use of GLP-1 and Statin was Higher in Patients in the U.S. 24 Treatment Group Placebo Belapectin 2mg/kg LBM Belapectin 4mg/kg LBM Total U.S. (N=62) (N=60) (N=64) (N=186) Concomitant Use of GLP-1 n (%) 28 (45.2%) 22 (36.7%) 18 (28.1%) 68 (36.6%) Concomitant Use of NSBBs n (%) 5 (7.9%) 3 (5.0%) 3 (
Slide 25: Impact of Concomitant Use of GLP-1 and Statins
25 Impact of Concomitant Use of GLP-1 and Statins Per-Protocol (n = 287) New Varices at 18 months ≥ 0.5pt ELF Increase YES (n=57) NO (n=229) ≥ 5 kPa LSM Increase Placebo 2mg/kg LBM 4mg/kg LBM Total Yes 18 19 20 57 No 75 78 76 229
Slide 26: Liver Related Outcomes/MACE
26 Liver Related Outcomes/MACE at 18 months Belapectin Placebo (N = 95) n (%) 2mg/kg LBM (N = 97) n (%) 4mg/kg LBM (N = 98) n (%) Subjects with Composite Clinical Outcomes, n (%) 4 (4.2) 3 ( 3.1) 7 (7.1) Varices (Esophageal or Gastric) Requiring Treatment 3 (3.2) 3 ( 3.1) 3 (3.1) Variceal Bleed Requ
Slide 27: Lack of Dose Response at Higher Doses of Belapectin
Lack of Dose Response at Higher Doses of Belapectin in GT-026 were also observed in NAVIGATE trial Based on findings from preclinical and clinical trials to date, Belapectin likely demonstrates target-mediated drug disposition (TMDD) Once Galectin-3 binding sites within macrophages are saturated, ad
Slide 28: Reference Guide: Biomarkers and Non-Invasive Scores in MASH Cirrhosis
28 Reference Guide: Biomarkers and Non-Invasive Scores in MASH Cirrhosis Biomarker Target Biological Process LSM by VCTE Measures fibrosis via transient elastography (ultrasound-based) Non-invasive quantification of liver stiffness reflecting fibrosis severity; used for diagnosis, prognosis, and tre
Slide 29: NAVIGATE: Improvement in LSM - Full Analysis Set
29 NAVIGATE: Improvement in LSM - Baseline to 18 monthsFull Analysis Set-FAS ITT Population (n: 315) N=97 N=96 Liver Stiffness kPa mean change % Belapectin Placebo 2mg/kg LBM 4mg/kg LBM (N=102) (N=107) (N=106) Baseline LSM Value (kPA) Mean (SD) 23.6 (11.44) 25.1 (15.04) 25.8 (12.91) Median 22.5 21.8
Slide 30: NAVIGATE: Improvement in LSM - Per-Protocol
NAVIGATE: Improvement in LSM - Baseline to 18 monthsPer-Protocol– Subjects with all available valid LSM Per-Protocol (Completers n: 234) N=97 N=96 Liver Stiffness kPa mean change % Belapectin Placebo 2mg/kg LBM 4mg/kg LBM (N=76) (N=81) (N=77) Baseline LSM Value (kPA) Mean (SD) 22.6 (10.31) 24.6 (13.
Slide 31: Fewer Subjects Showed Worsening in Liver Stiffness Measure
Gawrieh S. et al. JHep 2024:81.600-608 Belapectin N Placebo 2mg/kg LBM 4mg/kg LBM Total 77 84 79 240 31 Fewer Subjects Showed Worsening in Liver Stiffness Measure - LSM (kPa) FAS with all available data (n = 240)
Slide 32: Fewer Subjects Showed Worsening in Liver Stiffness Measure - Per-Protocol
32 Fewer Subjects Showed Worsening in Liver Stiffness Measure - LSM (kPa) Per-Protocol with all LSM (n = 234) Gawrieh S. et al. JHep 2024:81.600-608 p 0.09 p 0.03 Belapectin Placebo 2mg/kg LBM 4mg/kg LBM Total N 76 81 77 234
Slide 33: Improvement in Portal Hypertension Risk Category (FAS)
33 Belapectin Led to Improvement in Portal Hypertension Risk Category Full Analysis Set- FAS (n :240) Probable CSPH LSM ≥20 & platelet <150 or LSM 15-20 & platelet <110; no/low CSPH LSM≤ 15 and platelet≥ 150; Baveno VII Guidelines de Franchis 2022 Jhep FAS with all available data Belapectin 2mg/kg L
Slide 34: Improvement in Portal Hypertension Risk Category in Completer Population
34 Belapectin Led to Improvement in Portal Hypertension Risk Category in Completer Population Placebo (N:76) Belapectin 2mg/kg LBM (N:81) Belapectin 4mg/kg LBM (N:77) Per Protocol Population (n :234) Probable CSPH LSM ≥20 & platelet <150 or LSM 15-20 & platelet <110; no/low CSPH LSM≤ 15 and platelet
Slide 35: Increase in AGILE-4 score ≥ 20%
35 Increase in AGILE-4 score ≥ 20% Per protocol population n= 287 N = 95 n = 12 n = 9 n = 9 N = 94 N = 97 N = 96 n = 9
Slide 36: Incidence of Varices by Baseline ELF Categories
Incidence of Varices at 18 Months by Baseline ELF Categories Per protocol population (n = 279) N = 30 N = 25 N = 25 n = 3/18 n = 3/19 n = 3/17 n = 1/21 n = 3/19 n = 9/50 n = 5/53 n = 6/53 n = 9/21 n = 5/22 n = 4/23 36
Slide 37: Fewer Subjects Progressed to High-Risk ELF Category
Key points 37 Fewer Subjects Progressed to High-Risk ELF Category (ELF ≥13) ELF Enhanced Liver Fibrosis Score- combined for HA, PIIINP and TIMP-1 ELF: Risk of disease progression. < 9.8 Low risk, ≥11.3 mid risk, highest risk ≥13 Baseline to 18 months Per-Protocol (n=280) Belapectin Baseline ELF Valu
Slide 38: NAVIGATE - Pro-C3 change from Baseline
38 NAVIGATE- Pro-C3 change from Baseline at 78 Weeks Per Protocol Population (n: 243) Belapectin Placebo 2mg/kg LBM 4mg/kg LBM (N=79) (N=81) (N=83) Baseline Mean 50.19 45.91 43.39 Standard Deviation 38.45 31.58 17.42 Per protocol population with all available Pro-C3 data
Slide 39: NAVIGATE - Pro-C4 change (Per Protocol)
39 NAVIGATE- Pro-C4 change at 18 month Per Protocol Set (n: 201) Percentage Change in Pro-C4 (Baseline to Week 78) n= 61 n= 73 Belapectin Placebo 2mg/kg LBM 4mg/kg LBM (N=61) (N=73) (N=67) Baseline Mean 8.6 8.6 8.6 Standard Deviation 0.21 0.20 0.23 n= 67
Slide 40: NAVIGATE: Change in Pro-C4
40 NAVIGATE: Change in Pro-C4 at 18 Month Full Analysis Population (n :204) | Per Protocol Population (n :201) n=8 n=2 n=5 n=8 n=2 n=5 Belapectin Placebo 2mg/kg LBM 4mg/kg LBM Total N, FAS 63 73 68 204 N, PPP 61 73 67 201
Slide 41: Percentage Change from Baseline in YKL-40 (FAS)
Percentage Change from Baseline in YKL-40 Full Analysis Set (n = 187) n=13 n=23 n=23 n=23 n=23 n=19 Belapectin Placebo 2mg/kg LBM 4mg/kg LBM YKL-40 at Baseline 56.0 68.0 63.0 Mean 5.14 5.02 5.00 Standard Deviation 0.92 0.82 0.78 41
Slide 42: Percentage Change from Baseline in YKL-40 (Per Protocol)
Percentage Change from Baseline in YKL-40 Per Protocol Set (n = 179) n=21 n=22 n=19 n=12 n=22 n=22 Belapectin Placebo 2mg/kg LBM 4mg/kg LBM YKL-40 at Baseline 52.0 65.0 62.0 Mean 5.11 4.95 4.92 Standard Deviation 0.95 0.94 0.74 42
Slide 43: Belapectin consistently reduced Pro-Inflammatory Markers at 18 months
Belapectin consistently reduced Pro-Inflammatory Markers at 18 months FAS population N: 143 N = 38 SD = 19.95 N = 58 SD = 10.65 N = 47 SD = 12.61 N = 38 SD = 95.52 N = 58 SD = 84.55 N = 47 SD = 95.80 N = 38 SD = 49.83 N = 58 SD = 39.60 N = 47 SD = 11.79 N = 38 SD = 1.96 N = 58 SD = 1.64 N = 47 SD =
Slide 44: Inflammatory Biomarkers: Role and Function
44 Inflammatory Biomarkers: Role and Function Biomarker Primary Cellular Source(s) Pathophysiologic Role in MASH / Cirrhosis Fibrosis Association Expected Modulation with Gal-3 Inhibition IL-1β (Pro-inflammatory) Kupffer cells, macrophages, stellate cells Activates inflammasome, promotes hepatocyte
Slide 45: Subjects Clinical Outcomes or MACE (Per Protocol)
Subjects Clinical Outcomes or MACE at 18 months Per Protocol population Belapectin Placebo (N = 95) n (%) 2mg/kg LBM (N = 97) n (%) 4mg/kg LBM (N = 98) n (%) Subjects with Composite Clinical Outcomes, n (%) 4 (4.2) 3 ( 3.1) 7 (7.1) Varices (Esophageal or Gastric) Requiring Treatment 3 (3.2) 3 ( 3.1)
Slide 46: Safety Summary
Safety Summary Discontinuation of the study due to Adverse Events was similar across 3 cohorts: 7 (5.9%) in the Pbo 5 (4.2%) in 2 mg/kg Belapectin 8 (6.7%) in 4 mg/kg Belapectin One subject in each of the three cohorts discontinued the study due to death No drug related SAE reported in the entire tr
Slide 47: Assessment of Results
Assessment of Results Belapectin 2 mg reduced varices incidence by 43.2% compared to placebo in the overall population(ITT); results were not statistically significant. In the per-protocol population/completer (18-month treatment + end-of-treatment EGD), the reduction was 48.9%. Initial sample size
Slide 48: Key Takeaways and Next Steps
Key Takeaways and Next Steps NAVIGATE enrolled the most advanced patients of recent MASH trials, requiring both MASH cirrhosis and portal hypertension. A robust reduction in new varices was observed in both ITT and completer populations after 18 months of treatment. Non-invasive biomarkers results,
Slide 49: Cancer Immunotherapy Program (Belapectin + checkpoint inhibitor)
Cancer Immunotherapy Program (Belapectin + checkpoint inhibitor)
Slide 50: Higher Galectin-3 Tumor Levels are Associated with Metastatic Melanoma Progression
50 Higher Galectin-3 Tumor Levels are Associated with Metastatic Melanoma Progression **p<0.01, ***p<0.001. CR=complete response; HNSCC=head and neck squamous cell carcinoma; MM=metastatic melanoma; PD=progressive disease; PR=partial response; SD=stable disease. 1. Greisen SR, et al. J Immunother Ca
Slide 51: Increased progression-free survival in patients with higher trough level of pembrolizumab
Increased progression-free survival in patients with higher trough level of pembrolizum1,* 51 Reduced PD-1 Clearance Correlates with Better Survival in Patients with MM and HNSCC Serum trough levels of pembrolizumab in patients with disease control or progressive disease1 Increased trough levels of
Slide 52: Belapectin with Pembrolizumab Showed Clinical Efficacy and Safety in Phase 1
Phase 1 (Investigator-Initiated) of belapectin + pembrolizumab (Keytruda®) 52 Belapectin in Combination with Pembrolizumab Showed Clinical Efficacy and Safety in Phase 11 Objective response observed in 50% of MM (7/14) and 33% of HNSCC (2/6) patients Extension in more advanced patients showed stable
Slide 53: Investment Highlights
Belapectin is a novel, potent, galectin-3 inhibitor with Fast Track Designation Low toxicity as a carbohydrate-based molecule which is degraded by natural processes Patent protection through 2032 Only company to exclusively focus on treatment for MASH cirrhosis and portal hypertension Significant ef
Slide 54: Thank You!
Thank You!
Galectin Therapeutics — Investor Presentation (November 2025) on 6ix