Galectin Therapeutics Inc. · NASDAQ:GALT
Galectin Therapeutics — Investor Presentation (January 2025)
31 slides from Galectin Therapeutics's investor presentation, Jan 13, 2025
Slide 1: Galectin Therapeutics Corporate Overview January 2025
Galectin TherapeuticsCorporate OverviewJanuary 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 2033 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: 3rd Party Market Opportunity Assessment Suggests Potential 50-100% Adoption Rate
10 3rd Party Market Opportunity Assessment Suggests1 Potential 50-100% 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 It's 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 HVPG 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: Belapectin for Prevention of Varices in MASH Cirrhosis and Portal Hypertension
NAVIGATE Trial: Belapectin for Prevention of Varices in Patients with MASH cirrhosis and Portal Hypertension 15 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) Patient Population MASH cirrhosis Diagnosis of Portal Hypertension u
Slide 16: NAVIGATE Study: Patient Population and Efficacy Endpoints
NAVIGATE Study: Patient Population and Efficacy Endpoints 16 MASH cirrhosis No varices on EGD CTP Scores <7 Portal hypertension: Thrombocytopenia or at least AST/ALT > 1 Spleen ≥ 14 cm Collaterals by imaging Stiffness ≥ 20 kPa Development of new varices (composite strategy) in ITT population- Number
Slide 17: Baseline Demographics and Clinical Characteristics
Baseline demographics Table 14.1.3.1 17 © 2014 Galectin Therapeutics | NASDAQ: GALT Baseline Demographics and Clinical Characteristics (n=355) Placebo (N = 118) 2mg/kg LBM (N = 119) 4mg/kg LBM (N = 118) Mean (Standard Deviation) Mean (Standard Deviation) Mean (Standard Deviation) Age (years) 60.4 (8
Slide 18: NAVIGATE 18-month Primary Analyses Result: ITT
NAVIGATE 18-month Primary Analyses Result 18 © 2014 Galectin Therapeutics | NASDAQ: GALT ITT: All randomized subjects Primary end point composite strategy i.e. new varices and or intercurrent events or drop out ICEs (intercurrent events) include; Liver related clinical events, AE leading to disconti
Slide 19: NAVIGATE 18-month Primary Analyses Result: Per Protocol
NAVIGATE 18-month Primary Analyses Result 19 © 2014 Galectin Therapeutics | NASDAQ: GALT Per protocol population Per Protocol: All ITT subjects who completed 18 months of treatment and an end of treatment (EOT) EDG Overall Target Significance level – 2-sided p value of 0.05; using CMH test, stratifi
Slide 20: Categorical Changes in Liver Stiffness Measure
20 © 2014 Galectin Therapeutics | NASDAQ: GALT Categorical Changes in Liver Stiffness Measure LSM (kPa) Baseline to 18 month Per-Protocol (N = 277)Table 14.2.5.1.1.3 Belapectin Placebo (N = 92) 2mg/kg LBM (N = 93) 4mg/kg LBM (N = 92) Baseline LSM Value (kPA) Mean (SD) 23.3 (11.1) 22.9 (10.6) 24.4 (1
Slide 21: Categorical Changes in ELF Score
Categorical Changes in ELF Score- Baseline to 18 months Per-Protocol Table 14.2.5.1.2.2 (N: 275) 21 © 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 Bel
Slide 22: 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 23: Summary of Safety Results
Summary of safety results Similar proportion of subjects discontinued the study treatment in each arm due to Adverse Events: 7 (5.9%) in the Placebo arm, 6 (5.0%) in the Belapectin 2 mg/Kg arm and 9 (7.5%) in the Belapectin 4 mg/Kg arm. Similar proportion of subjects discontinued the study due to Ad
Slide 24: 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 25: 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. Non-invasive markers provide supportive evidence showing a lower incidence
Slide 26: Cancer Immunotherapy Program (Belapectin + checkpoint inhibitor)
Cancer Immunotherapy Program (Belapectin + checkpoint inhibitor)
Slide 27: Higher Galectin-3 Tumor Levels are Associated with Metastatic Melanoma Progression
27 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 28: 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,* 28 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 29: Belapectin 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 29 Objective response observed in 50% of MM (7/14) and 33% of HNSCC (2/6) patients Extension in more advanced patients showed stable
Slide 30: 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 2033 Only company to exclusively focus on treatment for MASH Cirrhosis and Portal Hypertension Consistent and
Slide 31: Galectin gy
Galectin gy > fo) > =x c © a= E
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