Galectin Therapeutics Inc. · NASDAQ:GALT
Galectin Therapeutics — Investor Presentation (May 2025)
38 slides from Galectin Therapeutics's investor presentation, May 12, 2025
Slide 1: Galectin Therapeutics Corporate Overview May 2025
Galectin TherapeuticsCorporate OverviewMay 2025
Slide 2: Forward-Looking Statements
2 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,” “estimate,” “could,” “expe
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
Highly Experienced Leadership Team 4 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 Over 28 years of experience working in the pharmaceutical indus
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: 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 Hi
Slide 8: MASH Cirrhosis
MASH Cirrhosis Galectin gy
Slide 9: MASH Cirrhosis Represents a Significant Market Opportunity in the U.S. with No FDA-Approved Treatment
MASH Cirrhosis Represents a Significant Market Opportunity in the U.S. with No FDA-Approved Treatment 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%
Slide 10: Belapectin is a Novel Therapy with First- and Best-in-Class Potential in MASH Cirrhosis
10 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 towards comorbidities Highly favorable perception of belapectin indication, MoA and safet
Slide 11: When to Intervene in Cirrhosis - before its too late!
HPVG=hepatic venous pressure gradient. There are no approved therapies to reverse portal hypertension once it develops in MASH Cirrhosis When to Intervene in Cirrhosis- before its too late! 11 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
Phase 2b Study of Belapectin in Patients with MASH Cirrhosis: GT-026 Trial 12 Placebo n=54 Screen Belapectin 8 mg/kg/LBM Q2W n=54 52 Weeks Belapectin 2 mg/kg/LBM Q2W n=53 Randomize (N=162 1:1:1) Main inclusion criteria MASH cirrhosis (biopsy) Portal Hypertension: HVPG ≥ 6 mmHg No cirrhosis complicat
Slide 13: Belapectin Impact on HPVG at One Year
Belapectin Impact on HPVG at One Year1,* 13 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 yr Ba
Slide 14: Belapectin Reduces Emergence of Varices in Patients with MASH Cirrhosis
Belapectin Reduces Emergence of Varices in Patients with MASH Cirrhosis1,* 14 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
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 15 Originally the NAVIGATE trial was designed as an adaptive Phase 2b/3 trial for 36-month duration. However, based on FDA feedback, the Company
Slide 16: NAVIGATE Study: Patient Population and Efficacy Endpoints
NAVIGATE Study: Patient Population and Efficacy 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 (comp
Slide 17: Key Populations for Assessment of Varices Outcome
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 th
Slide 18: NAVIGATE Trial: Baseline Demographics
NAVIGATE Trial: Baseline Demographics © 2014 Galectin Therapeutics | NASDAQ: GALT 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)
Slide 19: NAVIGATE 18-Month Primary Analyses Result – ITT Population
Key points 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 discontin
Slide 20: NAVIGATE: Intercurrent Events breakdown by category
NAVIGATE: Intercurrent Events breakdown by category © 2014 Galectin Therapeutics | NASDAQ: GALT n = 118 Subject % Intercurrent Event Category 20 Key points No subject met intercurrent event category for Trans-jugular intrahepatic portosystemic shunt(TIPS) or ≥12-month use of non-selective beta-block
Slide 21: NAVIGATE: Significantly Lower Incidence of Varices in Completers at 18 months
NAVIGATE: Significantly Lower Incidence of Varices in Completers at 18 months © 2014 Galectin Therapeutics | NASDAQ: GALT 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 21 Key points NAVIGATE 18-month Primary Analyses Result; Per protocol populati
Slide 22: NAVIGATE: Incidence of Varices by Size at 18-months
NAVIGATE: Incidence of Varices by Size at 18-months © 2014 Galectin Therapeutics | NASDAQ: GALT Number of subjects with new varices Subjects with new varices New varices at 18 months in Per Protocol Population 22 Key points Placebo Treatment Group: N = 94 2mg/kg Belapectin Treatment Group: N = 97 4m
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. © 2014 Galectin Therapeutics | NASDAQ: GALT 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.
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 (4.6
Slide 25: 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 26: NAVIGATE: Improvement in LSM - Baseline to 18 months
NAVIGATE: Improvement in LSM - Baseline to 18 months © 2014 Galectin Therapeutics | NASDAQ: GALT Per-Protocol (Completers n: 269) 26 N=97 N=96 Liver Stiffness kPa mean change % Belapectin Placebo (N=88) 2mg/kg LBM (N=94) 4mg/kg LBM (N=87) Baseline LSM Value (kPA) Mean (SD) 23.4 (11.46) 23.6 (13.19)
Slide 27: Fewer Subjects Showed Worsening in Liver Stiffness Measure
27 Fewer Subjects Showed Worsening in Liver Stiffness Measure - LSM (kPa) Statistics based on Cochran-Mantel-Haenszel test; differences for placebo vs 4 mg not significant. NASDAQ: GALT Increase in LSM of >30% or >10 kpa from baseline; Per-Protocol (n = 269) Gawrieh S. et al. JHep 2024:81.600-608 p
Slide 28: Fewer Subjects Progressed to High-Risk ELF Category
Key points Fewer Subjects Progressed to High-Risk ELF Category (ELF ≥13)Per-Protocol (n=280) © 2014 Galectin Therapeutics | NASDAQ: GALT 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 t
Slide 29: Subjects Clinical Outcomes or MACE at 18 months
Subjects Clinical Outcomes or MACE at 18 months © 2014 Galectin Therapeutics | NASDAQ: GALT 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 G
Slide 30: 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 31: Assessment of Results
Assessment of Results Belapectin 2 mg reduced varices incidence by 43.2% compared to placebo in the overall population; results were not statistically significant (ITT). In the per-protocol population (18-month treatment + end-of-treatment EGD), the reduction was 48.9%. Initial sample size assumed 5
Slide 32: Key Takeaways and Next Steps
Key Takeaways and Next Steps 2 mg dose demonstrated a meaningful reduction in the development of new esophageal varices in patients with MASH cirrhosis and portal hypertension validating the findings observed in GT-026 trial. Noninvasive markers provide further evidence of efficacy, number of subjec
Slide 33: Cancer Immunotherapy Program (Belapectin + checkpoint inhibitor)
Cancer Immunotherapy Program (Belapectin + checkpoint inhibitor)
Slide 34: Higher Galectin-3 Tumor Levels are Associated with Metastatic Melanoma Progression
34 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 35: Reduced PD-1 Clearance Correlates with Better Survival in Patients with MM and HNSCC
Increased progression-free survival in patients with higher trough level of pembrolizum1,* 35 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 36: Belapectin in Combination with Pembrolizumab Showed Clinical Efficacy and Safety in Phase 1
Phase 1 (Investigator-Initiated) of belapectin + pembrolizumab (Keytruda®) Belapectin in Combination with Pembrolizumab Showed Clinical Efficacy and Safety in Phase 11 36 Objective response observed in 50% of MM (7/14) and 33% of HNSCC (2/6) patients Extension in more advanced patients showed stable
Slide 37: 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 Consistent and
Slide 38: Galectin gy
Galectin gy > fo) > =x c © a= E
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