Galectin Therapeutics Inc. · NASDAQ:GALT
Galectin Therapeutics — Investor Presentation (February 2016)
35 slides from Galectin Therapeutics's investor presentation, Feb 8, 2016
Slide 1: Corporate Presentation
Corporate Presentation February 8, 2016 NASDAQ: GALT www.galectintherapeutics.com © 2016 Galectin Therapeutics Inc.
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: Company Thesis
Company Thesis • Therapy for unmet medical need that may benefit a large number of people: Fatty liver disease (NASH) with advanced fibrosis/cirrhosis • Novel protein target (galectin-3) and drug compound (GR-MD-02) • Strong pre-clinical and early clinical data • Competitive positioning with near- a
Slide 4: Focused Developing Drugs For Major Unmet Medical Needs
Focused Developing Drugs For Major Unmet Medical Needs • 45% of U.S. deaths estimated to be associated with fibrotic disease1 • Lead indication is liver fibrosis/cirrhosis due to fatty liver disease (75% of all liver disease in U.S.2) Organ Fibrosis • Potentially applicable to other fibrotic disease
Slide 5: Drugs That Target Galectin-3 Protein May Address These Unmet Medical Needs
Drugs That Target Galectin-3 Protein May Address These Unmet Medical Needs • Interactions between sugar-containing proteins Galectin-3 Protein • Modulates cell signaling and immune cell function • Increased in inflammation and fibrogenesis Role in Disease • Critical in liver, lung, kidney and heart
Slide 6: Pipeline of Indications for GR-MD-02
Pipeline of Indications for GR-MD-02 Clinical Focus Stage of Development Drug Indication Discovery Preclinical Phase 1 Phase 2 Phase 3 Fibrosis GR-MD-02 NASH cirrhosis NASH advanced fibrosis Lung, Kidney, Cardiovascular fibrosis Cancer Immunotherapy (combination therapy) GR-MD-02 + Melanoma Yervoy G
Slide 7: Lead Indication in Organ Fibrosis
Lead Indication in Organ Fibrosis ADVANCED FIBROSIS AND CIRRHOSIS DUE TO FATTY LIVER DISEASE NASH: (NON-ALCOHOLIC STEATOHEPATITIS) © 2016 Galectin Therapeutics | NASDAQ:GALT 7
Slide 8: NASH Is An Epidemic With No Approved Drug Therapy
NASH Is An Epidemic With No Approved Drug Therapy • NASH is a chronic inflammatory disease of the liver that leads to progressive scar formation (fibrosis) • Major global problem driven by increasing obesity & diabetes • Affects survival and causes need for liver transplants • Very large number of i
Slide 9: Scarring (Fibrosis) Of The Liver In Advanced NASH Leads To Patient Morbidity and Mortality
Scarring (Fibrosis) Of The Liver In Advanced NASH Leads To Patient Morbidity and Mortality Early Disease (low stage fibrosis) Late Disease (advanced fibrosis) Fibrosis Progression Stage 1 Stage 2 Stage 3 Stage 4 Liver biopsy (Blue = fibrosis) Cirrhosis No increased mortality* Increased mortality* *A
Slide 10: Galectin Therapeutics Is Targeting Late-Stage NASH Which Narrows the Competition
Galectin Therapeutics Is Targeting Late-Stage NASH Which Narrows the Competition in the Disease Area Phase 2/3 Companies with drugs in development for NASH Early Disease (low stage fibrosis) Late Disease (advanced fibrosis) Stage 1 Stage 2 Stage 3 Stage 4 (Cirrhosis) • Phase 3 • Intercept • Phase 2
Slide 11: Why can GR-MD-02 be used in advanced fibrosis?
Why can GR-MD-02 be used in advanced fibrosis? Because it can reverse NASH, fibrosis, and cirrhosis in preclinical models • Mouse model of NASH • Reduces inflammation, fat, and cell death • Prevents as well as reverses fibrosis • Targets macrophages and reduces galectin-3 • Peer-reviewed publication
Slide 12: GR-MD-02 Reversed Cirrhosis In Rat Model
GR-MD-02 Reversed Cirrhosis In Rat Model Toxin induced cirrhosis in rats Toxin continued during GR-MD-02 treatment Vehicle-Treated (control) GR-MD-02-Treated (4 weekly doses) Reduces portal pressure which correlates with primary endpoint in cirrhosis trial © 2016 Galectin Therapeutics | NASDAQ:G
Slide 13: Successful Phase 1 Trial In NASH Patients With Advanced Fibrosis
Successful Phase 1 Trial In NASH Patients With Advanced Fibrosis • Fast Track designation from FDA • Four dose, double-blind, placebo-controlled, dose escalation trial in NASH patients with advanced fibrosis • GR-MD-02 was safe and well tolerated • Reached targeted doses without adverse effects • Hi
Slide 14: Statistically Significant Reduction In Alpha-2 Macroglobulin Serum Levels
Statistically Significant Reduction In Alpha-2 Macroglobulin (A2M) Serum Levels Seen At The 8 mg/kg Dose A2M is involved in fibrogenesis and correlates to degree of liver fibrosis ns4 Legend and Notes: ns3 1. Mean ± standard deviation 2. Placebo values were combined p < 0.055 for all three cohorts b
Slide 15: Evidence Of Reduced FibroScan Scores In Cohort 3 Patients
Evidence Of Reduced FibroScan® Scores In Cohort 3 Patients Treated With GR-MD-02 3 of 5 patients treated with GR-MD-02 had reduction in liver stiffness to below 80% of baseline values (red squares)* Placebo GR-MD-02 (8 mg/kg) 120% 80% *FS added during cohort 2, but only available at most centers for
Slide 16: Phase 2 Clinical Trials Underway: NASH-FX
Phase 2 Clinical Trials Underway (Details in Appendix) Indication Objective Expectation From Successful Study Reduction in Reduction of liver NASH with fibrosis 4 Months fibrosis as Advanced NASH-FX of Therapy assessed using 3 Fibrosis Basis for future non-invasive tests (Stage 3) Phase 2b or Phase
Slide 17: Non-Invasive Assessments Of Liver Fibrosis In NASH-FX Trial
Non-Invasive Assessments Of Liver Fibrosis In NASH-FX Trial LiverMultiScan* MR-Elastography Transient Elastography Normal (FibroScan™) Transducter Ribs Probe Vibrator Cirrhosis Whole liver assessment of Whole liver assessment of Regional assessment of liver for fibrosis using multi-parametric stiffn
Slide 18: Phase 2 Clinical Trials Underway: NASH-CX
Phase 2 Clinical Trials Underway (Details in Appendix) Indication Objective Expectation From Successful Study Reversal or NASH with Reduction of improvement of 1 Year of NASH-CX Cirrhosis portal pressure cirrhosis Therapy and liver fibrosis (Stage 4) Has potential to be a pivotal trial • 156 patient
Slide 19: Important NASH Milestones: Top Line Data Expectations
Important NASH Milestones: Top Line Data Expectations* 2016 2017 2018 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Stage 3 Fibrosis Galectin (NASH-FX) Gilead (Simtuzimab) Stage 4 (Cirrhosis) Galectin (NASH-CX) Gilead (Simtuzimab) • GR-MD-02 and simtuzimab have different mechanism of action • Simtuzimab has f
Slide 20: NASH Advanced Fibrosis Program with GR-MD-02: Summary
NASH Advanced Fibrosis Program with GR-MD-02: Summary • Unmet medical need with a very large potential market • Competitively well positioned in NASH with advanced fibrosis and cirrhosis • Reversal of fibrosis/cirrhosis in preclinical models • In human Phase 1, GR-MD-02 is safe and well tolerated wi
Slide 21: Potential as a Platform Technology for other Diseases
Potential as a Platform Technology for other Diseases • Cancer • Skin inflammatory disease: psoriasis • Other areas of organ fibrosis where positive effects have been shown with GR-MD-02 in preclinical studies • Lung fibrosis • Kidney fibrosis • Heart and vascular fibrosis © 2016 Galectin Therapeuti
Slide 22: Lead Indication in Cancer Immunotherapy
Lead Indication in Cancer Immunotherapy ADVANCED MELANOMA © 2016 Galectin Therapeutics | NASDAQ:GALT 22
Slide 23: Cancer Immunotherapy Opportunity
Cancer Immunotherapy Opportunity Focus on • Galectin-3 plays an important role in reducing Immunotherapy the ability of immune system to fight cancer Advanced • Even with newly approved drugs, a substantial Melanoma as unmet medical need remains Initial Indication • Providence Cancer Center, Portlan
Slide 24: Potential Sites Of Action For Galectin Inhibition In Tumor Immunology
Potential Sites Of Action For Galectin Inhibition In Tumor Immunology CD8+ Immunotherapies T-Cells Checkpoint Inhibitor Blockage: anti-CTLA4 anti-PD1 + Galectin-3 Tumor Clonal Cells Galectin-3 Expansion CD8+ T-Cells T-Cells Cytokines (kill tumor cells) Potential for galectin inhibitors Potential for
Slide 25: Checkpoint Inhibitors Plus GR-MD-02 Boosts Anti-Tumor Immunity
Checkpoint Inhibitors Plus GR-MD-02 Boosts Anti- Tumor Immunity, Reduces Tumor Size And Increases Survival In Mouse Cancer Models These data are on TC-1 prostate cancer cells (also effective in breast cancer, melanoma, and sarcoma) *p<0.05 aCTLA-4 = anti-CTLA-4 mAb [ipilimumab in humans (Yervoy®, BM
Slide 26: Investigator Initiated Trials: Melanoma
Investigator Initiated Trials: Melanoma • Patients With Advanced Melanoma Using GR-MD-02 In Combination With Yervoy® • Advanced melanoma with indication for Yervoy® treatment • Dose escalation with GR-MD-02 plus standard Yervoy ® • Measure tumor and immune system response • Two dosing groups complet
Slide 27: Summary of Cancer Immunotherapy Program
Summary of Cancer Immunotherapy Program • Collaboration with investigative group at PPMC who have significant expertise in basic tumor immunology and translational clinical trials • Preclinical studies demonstrate in multiple cancers that GR-MD- 02 augments the anti-tumor effects of monoclonal antib
Slide 28: Exploratory Indication: Moderate-to-Severe Psoriasis
Exploratory Indication: Moderate-to-Severe Psoriasis • Patient in Phase 1 trial had apparent remission • Galectin-3 plays important role in skin and there is increase in skin vessels of patients with psoriasis1,2 • Open-label, single-site, 10-patient, 3 months of therapy • Data report in September 2
Slide 29: Expected Development Program Milestones
Expected Development Program Milestones Advanced Liver Fibrosis/Cirrhosis Study Indication Endpoints Start Data Reporting GT-026 NASH with cirrhosis Portal pressure (HVPG); Underway End 2017 “NASH-CX” liver biopsy GT-028 NASH with Multi-parametric MRI Underway End Q3 2016 “NASH-FX” advanced fibrosis
Slide 30: Experienced Executive Leadership Team
Experienced Executive Leadership Team Marc Rubin, M.D. Chairman of the Board Peter G. Traber, M.D. President, CEO, CMO Harold H. Shlevin, Ph.D. COO Corporate Secretary Jack W. Callicutt CFO © 2016 Galectin Therapeutics | NASDAQ:GALT 30
Slide 31: Program Summary
Program Summary • Lead drug (GR-MD-02) targets liver fibrosis associated with NASH (non alcoholic steatohepatitis) • Unmet medical need with a very large potential global market • Targeting late-stage NASH, with advanced fibrosis/cirrhosis, which is desirable from regulatory and commercial perspecti
Slide 32: Information for Prospective Investors
Information for Prospective Investors • Strong risk--reward investment thesis • Easily accessible, in depth information on clinical development programs: http://perspectives.galectintherapeutics.com/ • Newsweek feature article: online now and in print on Feb 15 © 2016 Galectin Therapeutics | NASDAQ:
Slide 33: Appendix
APPENDIX © 2014 Galectin Therapeutics | NASDAQ:GALT 33
Slide 34: The NASH-CX Trial (GT-026) Design
The NASH-CX Trial (GT-026) Design ↓ Fibrosis → ↓ Portal Pressure → ↓ Complications → ↓ Morbidity and Mortality CRO: PPD Sites: 45-60 U.S only Underway Top line: End 2017 • Primary Endpoint: • Reduction of hepatic venous pressure gradient (HVPG) as a measure of portal pressure compared to placebo at
Slide 35: The NASH-FX Trial (GT-028) Design
The NASH-FX Trial (GT-028) Design Reduction of liver fibrosis as assessed using three non-invasive tests Primary Endpoint: • Difference between placebo and GR-MD-02 in the baseline adjusted mean change in liver fibrosis as measured by corrected T1 (cT1) mapping as determined from LiverMultiScan (LMS
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