Galectin Therapeutics Inc. · NASDAQ:GALT
Galectin Therapeutics — Investor Presentation (January 2016)
32 slides from Galectin Therapeutics's investor presentation, Jan 8, 2016
Slide 1: Corporate Presentation
Corporate Presentation January 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: 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 4: Experienced Executive Leadership Team
Experienced Executive Leadership Team Marc Rubin, M.D. • Oncology and infectious disease specialty certifications Chairman of the Board • Current Chairman and previously CEO of Titan Pharmaceuticals • Head Global Research Bayer Schering Pharmaceuticals • Executive Committee of Bayer Healthcare • Boa
Slide 5: Developing Products For Major Unmet Medical Needs
Developing Products 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 Organ Fibrosis disease (75% of all liver disease in U.S.2) • Potentially applicable to other fibrotic diseases bas
Slide 6: Drugs That Target Galectin-3 Protein May Address These Unmet Medical Needs
Drugs That Target Galectin-3 Protein May Address These Unmet Medical Needs • Binds to galactose residues (sugars) in glycoproteins and promotes interactions between these proteins Galectin-3 Protein • High expression in immune cells (macrophages) • Modulates cell signaling and immune cell function •
Slide 7: 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 8: 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 8
Slide 9: Fatty Liver Disease (NASH) Is An Epidemic With No Approved Therapies
Fatty Liver Disease (NASH) Is An Epidemic With No Approved Therapies Extracted from Deutsche Bank Markets Research1 • Estimates for number of people with NASH is 18-30M in the US • 5-9M people in U.S. may have NASH AND advanced fibrosis (Stage 2/3). 1-2M people may have cirrhosis (stage 4), the most
Slide 10: 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 11: Galectin Therapeutics Is Targeting Late-Stage NASH
Galectin Therapeutics Is Targeting Late-Stage NASH Companies in Phase 2; multiple other companies in discovery and Phase 1 Early Disease (low stage fibrosis) Late Disease (advanced fibrosis) Stage 1 Stage 2 Stage 3 Stage 4 (Cirrhosis) • Obeticholic Acid (Intercept) • GR-MD-02 (Galectin) • GFT505 (Ge
Slide 12: Fundamental Science on Target is Strong: Galectin-3 Is Critically Important In Fibrosis
Fundamental Science on Target is Strong: Galectin-3 Is Critically Important In Development Of Fibrosis • Galectin-3 null mice (no galectin-3) are resistant to fibrosis due to toxin-induced liver toxicity Mice treated with liver toxin to induce fibrosis Red stain is collagen, Normal mouse No gal-3 mo
Slide 13: Preclinical Data Shows That GR-MD-02 Can Reverse NASH, Fibrosis, and Cirrhosis
Preclinical Data Shows That GR-MD-02 Can Reverse NASH, Fibrosis, and Cirrhosis • 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: • Traber PG and Zomer E. Therapy of Exper
Slide 14: 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:GALT
Slide 15: Galectin-3 is at the nexus of multiple pathophysiological processes in NASH and fibrogenesis
Galectin-3 is at the nexus of multiple pathophysiological processes in NASH and fibrogenesis Metabolic Syndrome Cause of Liver Injury Glucose Fat Accumulation Impaired Lipid Intolerance Metabolism Potential sites of Mediators Hyperglycemia Adipo-Cytokines Free Fatty Acids anti-galectin activity Adva
Slide 16: Phase 1 Trial of GR-MD-02 In NASH Patients With Advanced Fibrosis
Phase 1 Trial of GR-MD-02 In NASH Patients With Advanced Fibrosis: Foundation For Phase 2 Program • Performed under IND for NASH patients with advanced fibrosis which received Fast Track designation from FDA • Multiple dose escalation, double-blind, placebo-controlled trial in NASH patients with adv
Slide 17: Statistically Significant Reduction In Alpha-2 Macroglobulin Serum Levels At 8 mg/kg
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 18: Evidence Of Reduced FibroScan Scores In Cohort 3 Patients Treated With GR-MD-02
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 19: Phase 2 Clinical Trials Focus On Two Indications In NASH Patients
Phase 2 Clinical Trials Focus On Two Indications In NASH Patients With Advanced Fibrosis Indication Objective Expectation From Successful Study Reduction of portal Has potential to be a NASH with 1 Year of pressure and liver pivotal trial NASH-CX Cirrhosis (Stage Therapy fibrosis 4) NASH with Reduct
Slide 20: 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 21: 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
Slide 22: 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 23: Summary of NASH Advanced Fibrosis Program
Summary of NASH Advanced Fibrosis Program • Preclinical studies show galectin-3 to be a well-validated target that is inhibited by GR-MD-02 • In preclinical models GR-MD-02 has multiple effects • Reduces inflammation, fat and ballooning hepatocytes in NASH • Reduces and reverses liver fibrosis and c
Slide 24: Lead Indication in Cancer Immunotherapy: Advanced Melanoma
Lead Indication in Cancer Immunotherapy ADVANCED MELANOMA © 2016 Galectin Therapeutics | NASDAQ:GALT 24
Slide 25: Cancer Therapy Strategy
Cancer Therapy Strategy • Immunotherapy is a major breakthrough in cancer Focus on • Galectin-3 plays an important role in reducing the Immunotherapy ability of immune system to fight cancer Advanced • In U.S. 76,000 new diagnoses and 9,100 deaths per year* Melanoma as • Even with newly approved dru
Slide 26: Potential Sites Of Action For Galectin Inhibition In Tumor Immunology
Potential Sites Of Action For Galectin Inhibition In Tumor Immunology Immunotherapies CD8+ 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 27: Checkpoint Inhibitors Plus GR-MD-02 Boosts Anti-Tumor Immunity In Mouse Cancer Models
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 28: PPMC Conducting Two Melanoma Phase 1b Clinical Trials With GR-MD-02
PPMC Conducting Two Melanoma Phase 1b Clinical Trials With GR-MD-02 • Phase 1b Clinical Trial In 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
Slide 29: 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 30: Exploratory Indication
Exploratory Indication • Moderate-to-severe plaque psoriasis • Patient in Phase 1 trial had apparent remission of severe psoriasis while receiving 4 mg/kg of GR-MD-02 • Galectin-3 plays important role in skin and there is increase in skin vessels of patients with psoriasis1,2 • Open-label, single-si
Slide 31: 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 advanced Multi-parametric MRI Underway End Q3 2016 “NASH-FX” fibrosis
Slide 32: Company Blog: CEO Perspectives
Company Blog: CEO Perspectives • Communication feature to provide in depth information on clinical development programs and other news • http://perspectives.galectintherapeutics.com/ • Please sign up on web site to receive notification of blog articles © 2016 Galectin Therapeutics | NASDAQ: GALT 32
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