Galectin Therapeutics Inc. · NASDAQ:GALT
Galectin Therapeutics — Investor Presentation (March 2021)
23 slides from Galectin Therapeutics's investor presentation, Mar 9, 2021
Slide 1: Corporate Overview March 2021
Corporate Overview March 2021 NASDAQ: GALT www.galectintherapeutics.com Exhibit 99.1
Slide 2: 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,” “estimate,” “could,” “expect
Slide 3: Contents
Overview NASH cirrhosis and belapectin NASH-CX results NAVIGATE trial Summary Contents
Slide 4: Phase 2b/3 NAVIGATE trial of belapectin for NASH cirrhosis
Conducting an adaptively-designed Phase 2b/3 trial of belapectin, a potent galectin-3 inhibitor, for the prevention of esophageal varices in NASH cirrhosis (NAVIGATE) First patient randomized August 2020 Belapectin is a novel galectin-3 inhibitor that targets macrophages (a key driver in cirrhosis)
Slide 5: Management team experience
Over 35 years of relevant experience Solvay Pharmaceuticals, CEO Harold H. Shlevin, Ph.D., Former CEO and President, Consultant and Board Member Over 28 years of relevant experience Reach Health, CFO, Vystar Corporation, CFO, Corautus Genetics, Deloitte Jack W. Callicutt, CFO Over 35 years of releva
Slide 6: Contents: NASH cirrhosis and belapectin
Overview NASH cirrhosis and belapectin NASH-CX results NAVIGATE trial Summary Contents
Slide 7: Galectin-3 role in fibrotic disease
Galectin proteins’ ability to dimerize creates the opportunity for galectins to link glycoproteins and form a lattice structure on the cellular surface and to promote cell-cell and cell-matrix interactions Galectin-3 expression is up-regulated in established human fibrotic liver disease, and disrupt
Slide 8: Schematic Representation of Galectin-3: Carbohydrate Recognition Domain and Tail
Schematic Representation of Galectin-3: a Carbohydrate Recognition Domain and a Tail
Slide 9: Schematic Representation of Galectin-3: Unique Conformation
Schematic Representation of Galectin-3: Unique Conformation
Slide 10: NASH cirrhosis progression and unmet need
Fatty Liver NASH: Cell Death Inflammation Fibrosis 1 Garcia-Tsao, G., Friedman, S., Iredale, J., Prinzani, M. Hepatology. 2010;51:14451449 Compensated cirrhosis Decompensated cirrhosis Stage 1 Stage 2 Stage 3 and 4 No varices Varices develop Bleeding, ascites, encephalopathy Low one year mortality (
Slide 11: Contents: NASH-CX results
Overview NASH cirrhosis and belapectin NASH-CX results NAVIGATE trial Summary Contents
Slide 12: NASH-CX Phase 2b trial design
4 Liver-related complications (varices/bleeding, ascites, hepatic encephalopathy, liver-related death, or transplant) Endpoints Baseline Week 54 Primary endpoint Portal pressure: HVPG2 ✔ ✔ Secondary endpoints Liver biopsy3 ✔ ✔ Endoscopy (varices) ✔ ✔ Complications4 ✔ ✔ 1 Subjects were enrolled acros
Slide 13: Effect on HVPG in patients without varices
Placebo belapectin 2 mg/kg.LBM belapectin 8 mg/kg.LBM 13 9 8 10 11 12 n=33 Baseline Week 54 n=31 Baseline n=25 Week 54 n=23 n=23 Baseline n=22 Week 54 HVPG (mmHg) Statistically significant effect of 2 mg/kg.LBM dose on change in HVPG at baseline Mean Change from Baseline to Week 541 0.8 mmHg -1.08 m
Slide 14: New varices formation versus placebo
Trial hit a clinically relevant endpoint related to patient outcomes 1 Chi Square Percent New Varices Formation Placebo belapectin 2 mg/kg.LBM 6/33 0/25 p = 0.021 20 15 10 5 0 18% 0% Significantly fewer new varices developed in treatment groups versus placebo, and no patients in the 2 mg/kg.LBM trea
Slide 15: Portal hypertension and NASH-CX conclusions
Portal hypertension is a deleterious consequence of cirrhosis and responsible for the majority of cirrhotic complications Portal pressure of ≥10 mmHg (HVPG) is associated with increased risk of decompensation and mortality The increase in portal pressure and the development of varices are a continuu
Slide 16: Contents: NAVIGATE trial
Overview NASH cirrhosis and belapectin NASH-CX results NAVIGATE trial Summary Contents
Slide 17: NAVIGATE Overview: Adaptively Designed Phase 2b/3 Study
NASH cirrhosis Patients with NASH cirrhosis have the greatest immediate medical need This population is not being addressed by most drug developers, who focus on the prevention of NASH cirrhosis using liver biopsies as an efficacy endpoint An innovative seamless, adaptive Phase 2b/3 developed with l
Slide 18: Belapectin NAVIGATE: Schematic Study Design
Belapectin NAVIGATE: Schematic Study Design Belapectin 4 mg/kg LBM N = 105 Belapectin 2 mg/kg LBM N = 105 N = 140 new patients switch to 4 mg/kg LBM Placebo N = 105 N = 70 new patients Sample size re-estimation Interim Analysis to Inform Phase 3 1° endpoint: development of new varices Final Analysis
Slide 19: Belapectin NAVIGATE: Summary and key milestones
Key clinical study milestones: First patient randomized August 2020 ~130+ sites, 12 countries in North America, Europe, Asia and Australia; phase 2b part to Interim Analysis will be ~315 patients Initially recruitment period for phase 2b portion estimated: ~ 12 – 14 months. However, COVID-19 impact
Slide 20: NAVIGATE: End of Phase 2b or 3 Accelerated Approval Application
Primary Endpoint Development of new varices Secondary Endpoints Proportion of patients with large varices or red wales Varices requiring treatment Decompensation events All-cause mortality MELD ≥ 15 in patients with baseline MELD<12 Liver transplant Biomarkers Informs Phase 4 features – sizing, dura
Slide 21: Contents: Summary
Overview NASH cirrhosis and belapectin NASH-CX results NAVIGATE trial Summary Contents
Slide 22: 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 reduced development of varices Galectin Therapeutics
Slide 23: Thank you
Thank you
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