Galectin Therapeutics Inc. · NASDAQ:GALT
Galectin Therapeutics — Conference Presentation (January 2018)
25 slides from Galectin Therapeutics's conference presentation, Jan 4, 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 San Francisco, CA January 8-11, 2018 NASDAQ: GALT www.galectintherapeutics.com 2017 Galectin Therapeutics | NASDAQ: GALT For more information, see galectintherapeutics.com Exhibit 99.1
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 performance and use words such as “may,” “estimate,”
Slide 3: Galectin is a Development Phase Biotech Company with an Experienced Team
Recognized leader in gastroenterology and hepatology University of Pennsylvania Chief of Gastroenterology; Chairman of Internal Medicine; CEO of Health System, Dean of Medicine Baylor College of Medicine, President and CEO GlaxoSmithKline, Senior Vice President and Chief Medical Officer Over 34 year
Slide 4: 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 5: Targeting NASH Cirrhosis
Targeting NASH Cirrhosis Progression to Cirrhosis (5%) Fatty Liver NASH: Cell Death Inflammation Fibrosis 80-100M 24-30M 3-5M Estimated US Prevalence 1.5-2.5M 1.5-2.5M Clinical Hemodynamic (HVPG, mmHg) Biological Compensated Compensated Decompensated No varices or complications Varices present Compl
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
Slide 7: 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 8: 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 9: Patient Populations
Patient Populations 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 N = 13 CSPH N = 41 MPH N = 4
Slide 10: HVPG Primary Endpoint: Total Patient Population
n=54 HVPG Primary Endpoint: Total Patient Population Placebo GR-MD-02 2 mg/kg Mean ± SEM HVPG (mmHg) n=52 n=53 n=50 n=54 n=49 Mean Change From Baseline to Week 541 0.3 -0.37 -0.42 p=0.45 p=0.49 Baseline Week 54 Overall mean baseline HVPG=12.22 mmHg (No significant difference between groups at baseli
Slide 11: NASH Cirrhosis Without Varices at Baseline
n=33 NASH Cirrhosis Without Varices at Baseline (50% of total population) Placebo GR-MD-02 2 mg/kg Mean ± SEM HVPG (mmHg) n=31 n=25 n=23 n=23 n=22 Mean Change From Baseline to Week 541 0.8 -1.08 0.15 p < 0.01 p = 0.36 Baseline Week 54 Overall mean baseline HVPG=10.6 mmHg (No significant difference b
Slide 12: No Varices at Baseline: Mild Portal Hypertension
n=16 No Varices at Baseline: Mild Portal Hypertension (≥ 6 and <10 mmHg) Placebo GR-MD-02 2 mg/kg Mean ± SEM HVPG (mmHg) n=15 n=12 n=10 n=12 n=12 Mean Change From Baseline to Week 541 1.8 -0.3 -0.4 p=0.07 p=0.04 Baseline Week 54 Overall mean baseline HVPG=7.8 mmHg (No significant difference between
Slide 13: No Varices at Baseline: Clinically Significant Portal Hypertension
n=17 No Varices at Baseline: Clinically Significant Portal Hypertension Placebo GR-MD-02 2 mg/kg Mean ± SEM HVPG (mmHg) n=16 n=13 n=13 n=11 n=10 Mean Change From Baseline to Week 541 -0.1 -1.8 0.7 P = 0.06 ns Baseline Week 54 Overall mean baseline HVPG=13.4 mmHg (No significant difference between gr
Slide 14: Responder Analysis in Patients Without Varices at Baseline
Responder Analysis in Patients Without Varices at Baseline 1 Chi Square Percent 16% 43% 18% p = 0.031 5/31 10/23 4/22 Placebo GR-MD-02 2 mg/kg GR-MD-02 8 mg/kg Percentage of Patients Who Had a Clinically Relevant Reduction in HVPG With ≥ 2 mmHg Decrease From Baseline Rigorous definition of efficacy
Slide 15: Responder Analysis in Patients Without Varices at Baseline
Percent 67% 88% 72% p < 0.021 21/31 20/23 16/22 1 Chi Square Responder Analysis in Patients Without Varices at Baseline Placebo GR-MD-02 2 mg/kg GR-MD-02 8 mg/kg Percentage of Patients Who Had a Clinically Relevant Reduction in HVPG with ≥ 2 mmHg Decrease From Baseline PLUS No Change From Baseline D
Slide 16: 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 17: Cirrhosis Complications
7 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,
Slide 18: 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 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 Effect was seen regardless of the severity of the patient’s ba
Slide 20: Discussion of Key Questions Raised by the Study Results
Discussion of Key Questions Raised by the Study Results Why is there a differential effect of GR-MD-02 therapy in patients with and without esophageal varices? Liver biopsy showed an effect in all patients, so GR-MD-02 had a therapeutic benefit regardless of varices The sensitivity and variability o
Slide 21: NASH-CX Trial: Next Steps
NASH-CX Trial: Next Steps The trial results identify a significant patient population who may benefit from treatment with GR-MD-02 Patients with well-compensated NASH cirrhosis without esophageal varices (Stage 1 cirrhosis) Patients are readily identifiable since upper endoscopy for varices is recom
Slide 22: Appendix
Appendix NASDAQ: GALT www.galectintherapeutics.com 2017 Galectin Therapeutics | NASDAQ: GALT For more information, see galectintherapeutics.com
Slide 23: Appendix 1: Deep Gratitude to Patient Volunteers and Clinical Study Sites
23 Appendix 1: Deep Gratitude to Patient Volunteers and Clinical Study Sites
Slide 24: Appendix 2: Study Demographics
Appendix 2: Study Demographics1 Total (FAS2) (162) PLB3 (n=54) GR23 (n=54) GR83 (n=54) Age, years; Median (IQR) 59 (52, 65) 59 (53, 64) 60 (53, 65) 58 (51, 63) Female, n (%) 113 (70) 36 (67) 34 (63) 43 (79) White, n (%) 132 (81) 46 (85) 46 (85) 40 (74) Hispanic/Latino, n (%) 28 (17) 8 (15) 7 (13) 13
Slide 25: Appendix 3: HVPG at Baseline are Comparable Between Treatment Groups
Appendix 3: HVPG at Baseline are Comparable Between Treatment Groups1 Mean ± SD (n) Total PLB GR2 GR8 Hepatic Venous Pressure Gradient HVPG (mm Hg) 12.2 ± 4.1 (162) 11.6 ± 3.9 (54) 12.3 ± 4.3 (54) 12.7 ± 4.2 (54) CSPH2 (mm Hg) 14.3 ± 3.4 (109) 13.8 ± 3.1 (34) 14.2 ± 3.9 (37) 14.8 ± 3.1 (38) MPH3 (mm
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