Galectin Therapeutics Inc. · NASDAQ:GALT
Galectin Therapeutics — Investor Presentation (September 2024)
23 slides from Galectin Therapeutics's investor presentation, Sep 9, 2024
Slide 1: Galectin Therapeutics Corporate Overview August 2024
Galectin TherapeuticsCorporate OverviewAugust 2024
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 2035 Only company to exclusively focus on treatment for the cirrhotic stage of MASH Significant efficacy obse
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 Cancer Immunotherapy (Combination therapy) Belapectin + Keytruda Melanoma + Head / Neck Cancer Oral Galectin-3 Inhibitors Discovery program to identify subcutaneous for
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 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: Intervention Before Escalation: When to Intervene in Cirrhosis
Compensated Cirrhosis Decompensated Cirrhosis Decompensated Cirrhosis Liver Function Liver is irreversibly failing Liver is irreversibly failing Symptoms Usually no or minimal symptoms Esophageal Varices (first clinical expression of PH) Varices Bleeding, ascites, encephalopathy Varices Bleeding, as
Slide 12: Belapectin Demonstrated Efficacy and Safety in Clinical Trials
LBM=lean body mass.1. Chalasani N, et al. Gastroentrol 2020;158:1334-45. 2. Curti B. J Immunother Cancer. 2021;9:e002371. Belapectin Demonstrated Efficacy and Safety in Clinical Trials1,2 12 Belapectin was well-tolerated and appeared safe in Phase 1 and Phase 2b clinical studies No adverse safety si
Slide 13: Phase 2b Study of Belapectin in Patients with MASH Cirrhosis: Study Design
Phase 2b Study of Belapectin in Patients with MASH Cirrhosis: Study Design1 13 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 complica
Slide 14: Total Patient Population: Belapectin Impact on HPVG at One Year
Total Patient Population: Belapectin Impact on HPVG at One Year1,* 14 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.
Slide 15: Patients without Varices: Belapectin Significantly Reduced HVPG at One Year
Patients without Varices: Belapectin Significantly Reduced HVPG at One Year1,* 15 HVPG = Hepatic Venous Pressure Gradient; LBM=lean body mass. *ITT with LOCF, ANCOVA with baseline as covariate and treatment varices, and treatment/varices interaction as factors, LOCF, Bonferroni-Holm1. Chalasani N, e
Slide 16: Belapectin Reduces Emergence of Varices
Belapectin Reduces Emergence of Varices1,* 16 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 mass. *Chi square 1. Chalasani N
Slide 17: Next Step: NAVIGATE Belapectin's Seamless, Adaptive Study
Next Step: NAVIGATE Belapectin’s Seamless, Adaptive Study *Minimum number of additional patients in Phase 3, sample size adjusted based on Interim Analysis results. Screen Randomize (1:1:1) Interim analysis to inform potential filling/Phase 3 Final analysis Placebo (minimum additional 70 patients*)
Slide 18: NAVIGATE Study: Patient Population and Efficacy Endpoints
NAVIGATE Study: Patient Population and Efficacy Endpoints 18 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 Hepatic decompensation events All-cause mortal
Slide 19: NAVIGATE Update
NAVIGATE Update 19 No systematic liver biopsies required Pre-screening on portal hypertension clinical criteria Central review of esophago-gastro-endoscopies Interim analysis phase 2b expected December 2024 130+ 15 5 sites countries continents Approximately Recruitment complete 357 patients randomiz
Slide 20: Cancer Immunotherapy Program (Belapectin + checkpoint inhibitor)
Cancer Immunotherapy Program (Belapectin + checkpoint inhibitor)
Slide 21: 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 21 Objective response observed in 50% of MM (7/14) and 33% of HNSCC (2/6) patients Extension in more advanced patients showed stable
Slide 22: 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 2035 Only company to exclusively focus on treatment for the cirrhotic stage of MASH Significant efficacy obse
Slide 23: Galectin gy
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