Galectin Therapeutics Inc. · NASDAQ:GALT
Galectin Therapeutics — Rodman & Renshaw 17th Annual Global Investment Conference (September 2015)
25 slides from Galectin Therapeutics's conference presentation, Sep 10, 2015
Slide 1: Rodman & Renshaw 17th Annual Global Investment Conference
Exhibit 99.1 Rodman & Renshaw 17 th Annual Global Investment Conference September 10, 2015 NASDAQ: GALT www.galectintherapeutics.com © 2015 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: Experienced Executive Leadership Team
Experienced Executive Leadership Team James Czirr, Executive Chairman Peter G. Traber, M.D. President, CEO, CMO Harold H. Shlevin, Ph.D. COO & Corporate Secretary Jack W. Callicutt CFO © 2015 Galectin Therapeutics | NASDAQ:GALT 3
Slide 4: 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 disease 1 • 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 b
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 • 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 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) © 2015 Galectin Therapeutics | NASDAQ:GALT 7
Slide 8: 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 Research 1 • 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 mos
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
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 11: Strong Scientific Basis For GR-MD-02 Development
Strong Scientific Basis For GR-MD-02 Development Published in Peer-Reviewed Scientific Journals • Mouse model of NASH • Reduces inflammation, fat, and cell death • Prevents as well as reverses fibrosis • Rat model of liver cirrhosis • Reduces inflammation and cell death • Reverses fibrosis and cirrh
Slide 12: Two Completed Phase 1 Trials Provide Strong Foundation For Phase 2 Clinical Program
Two Completed Phase 1 Trials Provide Strong Foundation For Phase 2 Clinical Program • Study GT-020: Multiple dose escalation, double-blind, placebo- controlled trial in NASH patients with advanced fibrosis • GR-MD-02 was safe and well tolerated • Doses in targeted therapeutic window for drug adminis
Slide 13: 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 14: Phase 2 Clinical Trials Focus On Two Indications In NASH Patients With Advanced Fibrosis
Phase 2 Clinical Trials Focus On Two Indications In NASH Patients With Advanced Fibrosis Indication Objective Expectation From Successful Study Reduction of Has potential to be NASH with 1 Year of portal pressure a pivotal trial NASH-CX Cirrhosis Therapy and liver fibrosis (Stage 4) NASH with Reduct
Slide 15: 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 16: Lead Indication in Cancer Immunotherapy: Advanced Melanoma
Lead Indication in Cancer Immunotherapy ADVANCED MELANOMA © 2015 Galectin Therapeutics | NASDAQ:GALT 16
Slide 17: 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 18: GR-MD-02 May Be Used In Combination With Other Immunotherapies To Enhance Patient Survival
GR-MD-02 May Be Used In Combination With Other Immunotherapies To Enhance Patient Survival PPMC preclinical studies in mice demonstrated that GR-MD-02 has a synergistic effect on multiple tumors in combination with other immunotherapies Note: these are illustrative curves not representative of actua
Slide 19: 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 tumo
Slide 20: 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 21: Exploratory Indication: Plaque Psoriasis
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 22: 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 Sept. 2015 2H 2016 “NASH-FX” advanced fibrosis C
Slide 23: Program Summary
Program Summary • NASH (non alcoholic steatohepatitis) is an unmet medical need with a very large potential global market • Late-stage NASH, with advanced fibrosis/cirrhosis is desirable from regulatory and commercial perspectives • Preclinical studies with GR-MD-02 indicated positive effects on mul
Slide 24: Company Blog: CEO Perspectives
Company Blog: CEO Perspectives • New communication feature to provide in depth information on clinical development programs and other news • http://perspectives.galectintherapeutics.com/ • Most recent posts • The Potential for Treatment of Liver Fibrosis With Galectin’s Drug Candidate GR-MD-02 • Cli
Slide 25: Thank You
Thank You NASDAQ: GALT www.galectintherapeutics.com © 2015 Galectin Therapeutics Inc.