Galectin Therapeutics Inc. · NASDAQ:GALT
Galectin Therapeutics — Investor Presentation (January 2024)
21 slides from Galectin Therapeutics's investor presentation, January 2024
Slide 1: Galectin Therapeutics Corporate Overview
Galectin Therapeutics Corporate Overview January 2024
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
Investment Highlights Developing galectin-based therapeutics to improve the lives of patients with chronic liver diseases and cancer Belapectin is a novel, potent, galectin-3 inhibitor with Fast Track Designation Focused Pipeline Low toxicity as a carbohydrate-based molecule which is degraded by nat
Slide 4: Highly Experienced Leadership Team
Highly Experienced Leadership Team Highly experienced in pharmaceutical JOEL LEWIS Financial executive with over 25 years JEFF KATSTRA development of novel formulations of management experience in a Chief Executive Officer & taxation, restructuring, acquisition, VP, CMC / Pharmaceutical and medicine
Slide 5: Laser-Focused Pipeline
Laser-Focused Pipeline Clinical Program Development Stage Drug Indication Discovery Preclinical Phase 1 Phase 2 Phase 3 Fibrosis Belapectin NASH Cirrhosis Cancer Immunotherapy (Combination therapy) Belapectin + Keytruda Melanoma + Head / Neck Cancer Oral Galectin-3 Inhibitors Discovery program to id
Slide 6: Galectin-3 is a Promising Therapeutic Target in Inflammatory and Fibrotic Diseases
Galectin-3 is a Promising Therapeutic Target in Inflammatory and Fibrotic Diseases1,2 Galectin-3 drives many pathophysiological process in Galectin 3 is part of the galectin fibrotic diseases and cancer family of sugar-binding proteins Inflammation that act as a “molecular glue”, it is: • Predominan
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 Preclinical Data: In animal models of NASH (streptozotocin High-Fat Diet mice1) and cirrhosis (thioacetamide treated rats2) belapectin was associated with decreased: • Galectin-3 staining and galec
Slide 8: NASH Cirrhosis
NASH Cirrhosis Galectingy
Slide 9: NASH Cirrhosis Represents a Significant Market Opportunity in the U.S. with No FDA-Approved Treatment
NASH Cirrhosis Represents a Significant Market Opportunity in the U.S. with No FDA-Approved Treatment Addressable market in the U.S. Non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction-associated steatohepatitis 100M Americans have fatty liver disease (most don’t know it)1 (MAS
Slide 10: Intervention Before Escalation: When to Intervene in Cirrhosis
Intervention Before Escalation: When to Intervene in Cirrhosis Compensated Decompensated Cirrhosis Cirrhosis Ideal treatment timing Despite histological findings, Liver is Liver Function liver still able to function irreversibly failing Esophageal Varices (first Varices Bleeding, ascites, Symptoms U
Slide 11: Belapectin Demonstrated Efficacy and Safety in Clinical Trials
Belapectin Demonstrated Efficacy and Safety in Clinical Trials1,2 Efficacy Safety The Phase 2b NASH cirrhosis study provided a Belapectin was well-tolerated and appeared safe in proof of concept for: Phase 1 and Phase 2b clinical studies • Efficacy • No adverse safety signal identified • Phase 2 stu
Slide 12: First Phase 2b Study of Belapectin in Patients with NASH Cirrhosis: Study Design
First Phase 2b Study of Belapectin in Patients with NASH Cirrhosis: Study Design1 Belapectin 8 mg/kg/LBM Q2W n=54 (N=162 1:1:1) Randomize Belapectin 2 mg/kg/LBM Q2W Screen Primary endpoint n=53 • Portal pressure (HPVG) change from Placebo baseline to Week 54 n=54 52 Weeks Secondary endpoints at Week
Slide 13: Total Patient Population: Belapectin Reduced HPVG at Week 54
Total Patient Population: Belapectin Reduced HPVG at Week 541 Total Patient Population* mean ± SEM Placebo Belapectin Belapectin 2 mg/kg/LBM 8 mg/kg/LBM HVPG = Hepatic Venous Pressure Gradient; LBM=lean body mass. *ITT with LOCF, ANCOVA with LSD. 1. Chalasani N, et al. Gastroentrol. 2020;158:1334-45
Slide 14: Patients without Varices: Belapectin Significantly Reduced in HVPG at Week 54
Patients without Varices: Belapectin Significantly Reduced in HVPG at Week 54 Statistically significant effect of 2 mg/kg/LBM dose on change in HVPG from baseline at Week 54 Placebo Belapectin Belapectin 2 mg/kg/LBM 8 mg/kg/LBM 14 HVPG = Hepatic Venous Pressure Gradient; LBM=lean body mass. *ITT wit
Slide 15: Belapectin Reduces Emergence of Varices
Belapectin Reduces Emergence of Varices p = 0.02 20 Significantly fewer new Percent New Varices Formation varices on belapectin vs 18% 0% placebo 15 (Chi Square) No patients on 2 mg/kg/LBM 10 developed new varices 5 Belapectin demonstrated efficacy on a clinically- 6/33 0/25 meaningful endpoint wher
Slide 16: Next step: NAVIGATE belapectin's seamless, adaptive study
Next step: NAVIGATE belapectin’s seamless, adaptive study Key inclusion criteria: NASH cirrhosis Belapectin 4 mg/kg/LBM Q2W Belapectin 4 mg/kg/LBM Q2W No varices on EGD n=119 n=119 CTP Scores <7 Randomize Portal hypertension: (1:1:1) Belapectin 2 mg/kg/LBM Q2W Belapectin 2 mg/kg/LBM Q2W Screen • Thr
Slide 17: NAVIGATE Update
NAVIGATE Update Recruitment complete No systematic liver biopsies 357 patients required randomized in Phase 2b portion of trial Pre-screening on portal hypertension clinical criteria Approximately Central review of esophago- gastro-endoscopies 130+ 15 5 Interim analysis phase 2b expected Q4 2024 sit
Slide 18: Cancer Immunotherapy Program (Belapectin + checkpoint inhibitor)
Cancer Immunotherapy Program (Belapectin + checkpoint inhibitor)
Slide 19: Belapectin in Combination with Pembrolizumab Showed Clinical Efficacy and Safety in Phase 1
Belapectin in Combination with Pembrolizumab Showed Clinical Efficacy and Safety in Phase 11 Phase 1 (Investigator-Initiated) of belapectin + pembrolizumab (Keytruda®) ▪ Objective response observed in 50% of MM (7/14) and 33% Objective response to of HNSCC (2/6) patients belapectin+pembrolizumab the
Slide 20: Investment Highlights
Investment Highlights Developing galectin-based therapeutics to improve the lives of patients with chronic liver diseases and cancer Belapectin is a novel, potent, galectin-3 inhibitor with Fast Track Designation Focused Pipeline Low toxicity as a carbohydrate-based molecule which is degraded by nat
Slide 21: Thank you!
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