Galectin Therapeutics Inc. · NASDAQ:GALT
Galectin Therapeutics — Investor Presentation (February 2018)
22 slides from Galectin Therapeutics's investor presentation, Feb 6, 2018
Slide 1: GR-MD-02 for Indication of NASH Cirrhosis: NASH-CX Clinical Trial Results
GR-MD-02 for Indication of NASH Cirrhosis: NASH-CX Clinical Trial Results Supplemental Information to Corporate Presentation February 6, 2018 NASDAQ: GALT www.galectintherapeutics.com 2017 Galectin Therapeutics | NASDAQ: GALT For more information, see galectintherapeutics.com Exhibit 99.2
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: Developing Treatments Where Galectin-3 Protein is Implicated in Disease
Developing Treatments Where Galectin-3 Protein is Implicated in Disease Clinical Phase Studies With Galectin-3 Inhibitor GR-MD-02 Primary Program is in NASH Cirrhosis (topic of this presentation) Combination Cancer Immunotherapy Investigator initiated phase 1b clinical trial of GR-MD-02 in combinati
Slide 4: NASH Cirrhosis Development Program: Summary
NASH Cirrhosis Development Program: Summary Gal-3 null mice are resistant to development of NASH 1 and liver fibrosis 1, 2 GR-MD-02 is a glycopolymer (polysaccharide), considered a Nonbiological Complex Drug (NBCD) that binds to galectin-3 protein, has strong patent protection, and is administered i
Slide 5: There is no Treatment for NASH Cirrhosis
80 - 100M 24 - 30M 1.5-2.5M 1.5-2.5M Estimated US Prevalence There is no Treatment for NASH Cirrhosis Fatty Liver NASH: Cell Death Inflammation Fibrosis 5 1 Garcia-Tsao, G., Friedman, S., Iredale, J., Prinzani, M. Hepatology. 2010;51:14451449 Compensated Cirrhosis Decompensated Cirrhosis Stage 1 Sta
Slide 6: Critical Importance of Esophageal Varices in NASH Cirrhosis
Critical Importance of Esophageal Varices in NASH Cirrhosis Esophagus: No Varices Esophageal Varices Bleeding Esophageal Varices An important goal of treatment of patients with Stage 1, compensated cirrhosis without esophageal varices is to prevent progression to varices and complications 6
Slide 7: NASH-CX Clinical Trial Design
NASH-CX Clinical Trial Design1 Every other week infusion X 26 Placebo (54) GR-MD-02 2 mg/kg (54) GR-MD-02 8 mg/kg (54) NASH cirrhosis (biopsy) HVPG ≥ 6 mmHg No cirrhosis complications No or small varices HVPG2 Liver Biopsy3 FibroScan MBT4 Complications5 Endoscopy X X X X X X X X X X X X X X 1 All su
Slide 8: Patient Populations: Total Group
Patient Populations: Total Group N = 290 Patients Screened N = 162 Patients Randomized N = 128 Screening Failures N = 54 Placebo (PLB) N = 54 2 mg/kg GR-MD-02 (GR2) N = 54 8 mg/kg GR-MD-02 (GR8) N = 3 Discontinued Treatment AE (1) Lost to follow up (0) Withdrew consent (1) Protocol mandate (1) N = 2
Slide 9: HVPG Primary Endpoint: Total Patient Population
HVPG Primary Endpoint: Total Patient Population HVPG increased in placebo, whereas it decreased in treatment groups by end of study While there was a trend toward benefit with drug, it was not statistically significant
Slide 10: HVPG Primary Endpoint: Mild Portal Hypertension in Total Population Group
HVPG Primary Endpoint: Mild Portal Hypertension in Total Population Group Evaluation of mild portal hypertension was a pre-determined statistical analysis There was a statistically significant effect of both doses of GR-MD-02 There was no effect on those with high portal pressure (data not shown)
Slide 11: Patient Populations Based on Esophageal Varices
Patient Populations Based on Esophageal Varices Patients Screened: N = 290 Screening Failures N = 128 Baseline Esophageal Varices N = 80 (ITT/LOCF) No Baseline Esophageal Varices N = 81 (ITT/LOCF) 1 Discontinued before 1st dose 10 Discontinued during dosing without end of study HVPG CSPH N = 67 MPH
Slide 12: NASH Cirrhosis Without Varices at Baseline
NASH Cirrhosis Without Varices at Baseline (50% of total population) Drug effect was significantly dependent on dose*varices in total group (p<0.04) Presence or absence of esophageal varices is an important clinical finding Statistically significant effect of 2 mg/kg dose on absolute and percent cha
Slide 13: Responder Analysis in Patients Without Varices at Baseline
Responder Analysis in Patients Without Varices at Baseline 1 Chi Square Percentage of Patients Who Had a Clinically Relevant Reduction in HVPG With: ≥ 2 mmHg Decrease From Baseline AND ≥ 20% Decrease From Baseline Rigorous definition of efficacy because it requires a clinically important reduction i
Slide 14: Statistically Significant Improvement of Hepatocyte Ballooning on Liver Biopsy
Statistically Significant Improvement of Hepatocyte Ballooning on Liver Biopsy Change in hepatocyte ballooning score at week 54 Mean ± SEM n=54 n=54 n=53 Total Study Patient Population2 2 ITT with LOCF (161) 1 Traber PG and Zomer E. PLOS ONE 2013;8:e83481 3 Ordinal Logistic Regression Analysis p = 0
Slide 15: Cirrhosis Complications
Cirrhosis Complications1 Patients with at least one complication PLB GR2 GR8 Comments Intention to Treat Group (n=161) 11 (54) 8 (53) 7 (54) No difference between groups No Baseline Esophageal Varices (n=81) 7 (33) 3 (25) 2 (23) No difference between groups New Esophageal Varices 6 0 1 p = 0.022, PL
Slide 16: Significantly Fewer New Varices Developed in Treatment Groups Versus Placebo
Significantly Fewer New Varices Developed in Treatment Groups Versus Placebo Placebo GR-MD-02 2 mg/kg GR-MD-02 8 mg/kg 2 mg/kg plus 8 mg/kg 6/33 1/23 0/25 1/48 Percent New Varices Formation p = 0.02 p = 0.12 p = 0.01 Chi Square
Slide 17: Safety Results
Safety Results Total (n=162) PLB (n=54) GR2 (n=54) GR8 (n=54) All adverse events 1422 464 541 417 Grade 3-4 (patients (total events)) 31 (69) 10 (19) 10 (22) 11 (28) SAE1 (patients (total events)) 25 (39) 9 (13) 5 (10) 11 (16) Rx stopped due to AE 5 0 0 52 Death 1 0 13 0 Grade 3/4 lab (patients (tot
Slide 18: GR-MD-02 Was Safe and Well Tolerated
GR-MD-02 Was Safe and Well Tolerated No differences between treatment groups in the number of patients with treatment emergent adverse events (AEs), grade 3/4 AEs, serious adverse events (SAE), or grade 3/4 laboratory abnormalities All but 2 SAEs were unrelated to study drug; 2 patients in 8 mg/kg g
Slide 19: Major Conclusions from NASH-CX Clinical Trial Results
Major Conclusions from NASH-CX Clinical Trial Results GR-MD-02 had a statistically significant and clinically meaningful effect in improving HVPG versus placebo in patients with NASH cirrhosis who did not have baseline esophageal varices Important drug effect in the total study population on liver b
Slide 20: Summary Conclusions and Next Steps
Summary Conclusions and Next Steps NASH-CX is the first clinical trial to show positive results in compensated NASH cirrhosis without esophageal varices Clinically meaningful effect in reducing portal pressure Improvement in liver cell death, a key component of NASH Reduction in the development of n
Slide 21: Appendix
Appendix NASDAQ: GALT www.galectintherapeutics.com 2017 Galectin Therapeutics | NASDAQ: GALT For more information, see galectintherapeutics.com
Slide 22: Appendix 1: Deep Gratitude to Patient Volunteers and Clinical Study Sites
22 Appendix 1: Deep Gratitude to Patient Volunteers and Clinical Study Sites
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