Galectin Therapeutics Inc. · NASDAQ:GALT
Galectin Therapeutics — Investor Presentation (September 2020)
23 slides from Galectin Therapeutics's investor presentation, Sep 29, 2020
Slide 1: Corporate Overview September 2020
Corporate Overview September 2020 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 NASH-RX trial Summary Contents
Slide 4: Introduction by Joel Lewis
Introduction by Joel Lewis
Slide 5: Belapectin Phase 2b/3 NASH-RX trial and key highlights
Conducting an adaptively-designed Phase 2b/3 trial of belapectin, a potent galectin-3 inhibitor, for the prevention of esophageal varices NASH cirrhosis (NASH-RX) First patient enrolled June 2020, first patient randomized August 2020 NASH market opportunity estimated to reach $35 - $40 billion/year
Slide 6: 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 7: Contents
Overview NASH cirrhosis and belapectin NASH-CX results NASH-RX trial Summary Contents
Slide 8: Galectin-3 role in fibrosis and belapectin mechanism
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 9: NASH progression and unmet need in cirrhosis
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 10: Contents
Overview NASH cirrhosis and belapectin NASH-CX results NASH-RX trial Summary Contents
Slide 11: 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 12: 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 13: New varices formation endpoint
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 = 0.02 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 treat
Slide 14: Portal hypertension and safety of belapectin
Portal hypertension (PH) is a critical, clinically important consequence of cirrhosis and responsible for the majority of associated complications Portal pressures of ≥10 mmHg (HVPG) are associated with increased risk of decompensation and mortality For patients with compensated cirrhosis and PH wit
Slide 15: Summary of NASH-CX trial
NASH-CX is the first clinical trial to show positive results in compensated NASH cirrhosis without esophageal varices Reduction of portal pressure in a relevant subgroup of patients Improvement in liver cell death, a key component of NASH Prevention of new esophageal varices Belapectin was safe and
Slide 16: Contents
Overview NASH cirrhosis and belapectin NASH-CX results NASH-RX trial Summary Contents
Slide 17: NASH-RX Trial Overview
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 clinical trial d
Slide 18: Belapectin Phase 2b/3 adaptively designed trial
Belapectin Phase 2b/3 Adaptively Designed Trial 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 Anal
Slide 19: NASH-RX summary and key milestones
Key clinical study milestones: First patient enrolled June 2020, first patient randomized August 2020 Global study: overall ~500 patients, ~130+ sites, 12 countries in North America, Europe, Asia and Australia; First segment before Interim Analysis will be ~315 patients Recruitment period for phase
Slide 20: NASH-RX endpoints and accelerated approval
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
Overview NASH cirrhosis and belapectin NASH-CX results NASH-RX trial Summary Contents
Slide 22: Summary of drug development program
NASH Cirrhosis is a major unmet medical need with a large potential market NASH-CX trial is first positive phase 2 clinical data in a subset of patients without esophageal varices Belapectin was safe and well-tolerated and improved portal pressure and reduced development of varices GALT is competiti
Slide 23: Thank you
Thank you
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