Galectin Therapeutics Inc. · NASDAQ:GALT
Galectin Therapeutics — Investor Presentation (February 2018)
26 slides from Galectin Therapeutics's investor presentation, Feb 6, 2018
Slide 1: Corporate Presentation
CORPORATE PRESENTATION February 6, 2018 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,” “expec
Slide 3: Galectin is a Development Stage 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: Addressing Important Unmet Medical Needs
Addressing Important Unmet Medical Needs 4 Advanced Fatty Liver Disease (NASH Cirrhosis) NASH global annual market could be $35-40 Billion by 2025 Competitively well positioned as one of the few companies focused on the most advanced form of NASH Our target indication of NASH cirrhosis may have 2.5M
Slide 5: Primary Program is in NASH Cirrhosis
Primary Program is in NASH Cirrhosis Positive efficacy in compensated NASH cirrhosis without varices Combination Cancer Immunotherapy Encouraging early clinical data in combination with KEYTRUDA with 5 of 8 objective responses (2 complete responses (CR) and 3 partial responses (PR)) in advanced mela
Slide 6: 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 6 Many companies with clinical development programs Few companies with clinical development programs 1 Garcia-Tsao, G., Friedman, S., Iredale, J.,
Slide 7: 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 7
Slide 8: NASH-CX Clinical Trial Design
4 Liver-related complications (varices/bleeding, ascites, hepatic encephalopathy, liver-related death, or transplant) NASH-CX Clinical Trial Design Baseline Week 54 Primary Endpoint Portal Pressure: HVPG2 X X Secondary Endpoints Liver Biopsy3 X X Endoscopy (varices) X X Complications4 X X 1 All subj
Slide 9: NASH Cirrhosis Without Esophageal Varices at Baseline
NASH Cirrhosis Without Esophageal Varices at Baseline Placebo GR-MD-02 2 mg/kg GR-MD-02 8 mg/kg 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 dose on change in HVPG at baseline Mean Change from
Slide 10: Responder Analysis in Patients Without Varices at Baseline
Responder Analysis in Patients Without Varices at Baseline p = 0.011 Placebo GR-MD-02 2 mg/kg 50% 10% 0% 4/31 20% 30% 40% 10/23 13% 43% 1 Chi Square Rigorous definition of efficacy because it requires a clinically important reduction in HVPG from baseline Percentage of Patients Who Had a Clinically
Slide 11: Statistically Significant Improvement of Liver Cell Death on Liver Biopsy
Statistically Significant Improvement of Liver Cell Death on Liver Biopsy 1 ITT population Ordinal Logistic Regression Analysis Placebo GR-MD-02 2 mg/kg GR-MD-02 8 mg/kg p = 0.03 p = 0.09 0.4 0.2 0.0 -0.2 n=54 n=54 Mean ± SEM n=53 Change in Hepatocyte Ballooning Score at Week 54 1 11 In the total po
Slide 12: Significantly Fewer New Varices Developed in Treatment Groups Versus Placebo
Significantly Fewer New Varices Developed in Treatment Groups Versus Placebo Percent New Varices Formation Placebo GR-MD-02 2 mg/kg 6/33 0/25 p = 0.02 20 15 10 5 0 Trial hit a clinically relevant endpoint related to patient outcomes 1 Chi Square
Slide 13: 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 14: Summary of GR-MD-02 in NASH Cirrhosis
Summary of GR-MD-02 in NASH Cirrhosis 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 o
Slide 15: Primary Program is in NASH Cirrhosis
Primary Program is in NASH Cirrhosis Combination Cancer Immunotherapy Encouraging early clinical data in combination with KEYTRUDA with 5 of 8 objective responses (2 complete responses and 3 partial responses) in advanced melanoma Psoriasis and Atopic Dermatitis Small open label studies show clinica
Slide 16: Cancer Immunotherapy
Galectin-3 secreted by cancer cells into the tumor microenvironment reduces the ability of immune system to fight cancer Even with newly approved drugs, a substantial unmet medical need remains in melanoma and multiple other cancers Cancer Immunotherapy 16 - Providence Cancer Center in Portland, Ore
Slide 17: Phase 1B Trial of GR-MD-02 Plus Pembrolizumab (KEYTRUDA)
Phase 1B Trial of GR-MD-02 Plus Pembrolizumab (KEYTRUDA) in Patients with Metastatic Melanoma and Other Cancers 17 GR-MD-02 used in combination with a flat dose (200 mg) of pembrolizumab in the following patients: Metastatic melanoma with progression after other treatment including pembrolizumab alo
Slide 18: Clinical Results of GR-MD-02 plus Pembrolizumab (KEYTRUDA)
Clinical Results of GR-MD-02 plus Pembrolizumab (KEYTRUDA) Waterfall plot of best objective clinical response post treatment (RECIST 1.1) 18 * * Head and Neck CA Response rate of 62.5% in melanoma compares favorably to best response of KEYTRUDA alone of 33%
Slide 19: CT Scan Showing Resolution of a Large Intramuscular Melanoma Deposit
CT Scan Showing Resolution of a Large Intramuscular Melanoma Deposit Baseline Day 85 19
Slide 20: Multiple PET Scan Detected Melanoma Deposits Resolved
Multiple PET Scan Detected Melanoma Deposits Resolved 20 Baseline Day 169 Multiple tumors in legs All tumors resolved
Slide 21: Multiple PET Scan Detected Melanoma Deposits Resolved
Multiple PET Scan Detected Melanoma Deposits Resolved 21 Baseline Day 169 Multiple tumors throughout body (red arrows) All tumors resolved: normal contrast seen in heart, kidneys and bladder
Slide 22: GR-MD-02 in Combination Cancer Immunotherapy
GR-MD-02 in Combination Cancer Immunotherapy Many combination approaches are under investigation using marketed and experimental cancer immunotherapy drugs As a galectin-3 inhibitor, GR-MD-02 represents a novel mechanism of action, differentiated from the many other drugs that being tested Potential
Slide 23: 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 Combination Cancer Immunotherapy Psoriasis and Atopic Dermatitis Small open label studies show clinically significant effect, demonst
Slide 24: Activity of GR-MD-02: Moderate-to-Severe Plaque Psoriasis
Activity of GR-MD-02: Moderate-to-Severe Plaque Psoriasis Psoriasis is immune-mediated chronic skin inflammation associated with NASH All 5 patients treated in Phase 2a open label trial showed improvement in disease activity by an average of 50% (one improved by 82%) Additional evidence that drug is
Slide 25: Summary of Drug Development Program
25 Summary of Drug Development Program GR-MD-02 is a novel antigalectin-3 drug that can modulate the immune system and may improve multiple diseases NASH Cirrhosis is a major unmet medical need with a large potential market Galectin-3 is important in development of NASH cirrhosis NASH-CX trial is fi
Slide 26: Thank you!
Thank you!
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