Galectin Therapeutics Inc. · NASDAQ:GALT
Galectin Therapeutics — Investor Presentation (August 2023)
20 slides from Galectin Therapeutics's investor presentation, August 2023
Slide 1: Corporate Overview
Corporate Overview August 2023 2022 Galectin Therapeutics | NASDAQ: GALT www.galectintherapeutics.com
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: Galectin Overview
Galectin Overview Dozens of companies are working at various stages of drug development, but Galectin Therapeutics is the only one exclusively focused on treatment at the cirrhotic stage. • Galectin is conducting an adaptively-designed Phase 2b/3 trial of belapectin, a potent galectin-3 inhibitor, f
Slide 4: Passionate and experienced leadership
Passionate and experienced leadership Joel Lewis Pol F. Boudes, M.D. Jessica Kopaczewski CEO and President Chief Medical Officer Senior Director Clinical Operations Over 23 years of executive management Over 35 years experience in drug development An accomplished clinical operations professional wit
Slide 5: NASH Cirrhosis – The Silent Killer
NASH Cirrhosis – The Silent Killer An estimated Of those, 5 million may progress 100 million Americans to NASH cirrhosis. The only have a fatty liver, and curative treatment available for most don’t know it. cirrhosis is a liver transplant. Nearly 30% of those There is currently no listed will die w
Slide 6: Liver Cirrhosis and Liver Transplantations (2017)
Liver Cirrhosis1 and Liver Transplantations2, 3 (2017) Country Population Cirrhosis Total Cirrhosis Liver Decompensated Transplantations USA 325,100,000 2,180,847 513,134 8,082 Mexico 124,800,000 3,790,183 281,656 180 Globally: Hepatitis C 27%, Hepatitis B 24%, Alcohol 21%, Other 17%, NASH 11% There
Slide 7: INNOVATE OR STAGNATE: pre-cirrhotic NASH and NASH cirrhosis are different fields
INNOVATE OR STAGNATE: For a drug developer pre-cirrhotic NASH and NASH cirrhosis are different fields Most drug developers focus on pre- Galectin Therapeutics focuses on NASH cirrhosis cirrhotic NASH Fatty Liver NASH NAFLD CIRRHOSIS Focus on histology Focus on histology Focus on late decompensation
Slide 8: Portal Hypertension As a Complication of Liver Cirrhosis
Portal Hypertension As a Complication of Liver Cirrhosis Diaphragm Portal Vein 8 2022 Galectin Therapeutics | NASDAQ: GALT www.NAVIGATE.com
Slide 9: Intervention Before Escalation: When to Intervene in Cirrhosis
Intervention Before Escalation: When to Intervene in Cirrhosis Compensated Decompensated cirrhosis cirrhosis No Portal Hypertension Portal Hypertension No varices No varices Varices, small to large Varices Bleeding, ascites, encephalopathy ≥6 HVPG1 mm Hg >10 One year mortality 1-3% One year mortalit
Slide 10: The galectin-3 'fibrosome' and the role of activated macrophages
The galectin-3 ‘fibrosome’ and the role of activated macrophages Galectin-3 binds to glycoproteins and form a lattice structure on cell surface and the inflammatory tissue microenvironment Central role of Gal-3 in multiple pathological processes Galectin-3 expression is up-regulated in human fibroti
Slide 11: Belapectin is a complex carbohydrate drug that inhibits galectin-3
Belapectin is a complex carbohydrate drug that inhibits galectin-3 ▪ In animal models of NASH (streptozotocin High-Fat Diet mice1) and fibrosis (thioacetamide treated rats2) belapectin was associated with: • Decreased galectin-3 staining and galectin-3 expression in macrophages • Decreased NAFLD Act
Slide 12: Randomized, double-blind, placebo-controlled phase 2b NASH cirrhosis patients
Randomized, double-blind, placebo-controlled phase 2b 162 NASH cirrhosis patients1 Dosing and administration Major inclusion criteria ○ NASH cirrhosis (biopsy) ○ No cirrhosis complications ○ Portal Hypertension: HVPG2 ≥ 6 mmHg ○ No varices/varices (50:50) Every other week infusion x 26 Endpoints Bas
Slide 13: Belapectin reduced HVPG in patients without varices
In patients without varices, belapectin 2 mg/kg LBM showed a statistically significant reduction in HVPG from baseline to week 54 Mean Change from 0.8 mmHg -1.08 mmHg 0.15 mmHg Baseline to Week 541 p = 0.01 ns 13 12 HVPG (mmHg) Statistically significant effect of 2 mg/kg/LBM 11 dose on change in HVP
Slide 14: Belapectin Reduces Emergence of Varices Significantly
Belapectin Reduces Emergence of Varices 20 p = 0.02 Significantly 18% 0% 15 Percent New Varices fewer new varices on belapectin vs placebo Formation 10 No patients on 2 mg/kg.LBM developed 5 new varices 6/33 0/25 0 Placebo Belapectin 2 mg/kg.LBM 1 Chi Square 14 2022 Galectin Therapeutics | NASDAQ: G
Slide 15: Belapectin: Bridging the Existing Treatment Gap
Belapectin: Bridging the Existing Treatment Gap • Belapectin demonstrated efficacy on a clinically-meaningful endpoint where no current therapies exist • Portal hypertension caused by cirrhosis is associated with increased risk of decompensation and mortality • Esophageal varices are the first clini
Slide 16: Next step: NAVIGATE belapectin's seamless, adaptive study
Next step: NAVIGATE belapectin’s seamless, adaptive study Key Eligibility Criteria: Belapectin 4 mg/kg LBM N = 105 1). Nash cirrhosis 2). No varices on EGD N = 140 new patients 3). CTP Scores <= 7 4). Portal hypertension: Belapectin 2 mg/kg LBM N = 105 switch to 4 mg/kg LBM ● Thrombocytopenia Or at
Slide 17: NAVIGATE update
NAVIGATE update • No systematic liver biopsies required • Pre-screening on portal hypertension clinical Recruitment complete Approximately criteria 357 patients 130+ sites, • Central review of esophago-gastro- randomized in 15 countries, endoscopies Phase 2b portion 5 continents • Interim analysis p
Slide 18: Belapectin Oncology Data Overview
Belapectin Oncology Data Overview ▪ Belapectin activity demonstrated in tumor-bearing mice models (sarcoma, mammary carcinoma, and prostate adenocarcinoma)1 ▪ Belapectin good tolerance, apparent safety, and encouraging efficacy demonstrated in a phase 1 study2 and a phase 1 extension study in metast
Slide 19: Summary of Belapectin Drug Development Program
Summary of Belapectin Drug Development Program ▪ NASH Cirrhosis is a major unmet medical need with a large potential market • NASH-CX is the first positive phase 2 clinical data in a subset of patients without esophageal varices • Belapectin was safe and well-tolerated, improved portal pressure, and
Slide 20: THANK YOU
THANK YOU 20 2022 Galectin Therapeutics | NASDAQ: GALT www.NAVIGATE.com
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