Galectin Therapeutics Inc. · NASDAQ:GALT
Galectin Therapeutics — Shareholder Meeting (May 2015)
32 slides from Galectin Therapeutics's shareholder meeting presentation, May 21, 2015
Slide 1: Annual Shareholder Presentation
Annual Shareholder Presentation May 21, 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: 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 4: Lead Drug Candidate Targets Galectin-3 Protein
Lead Drug Candidate Targets Galectin-3 Protein • Binds to galactose residues in glycoproteins and promotes Galectin-3 Protein interactions between these proteins Function • High expression in immune cells (macrophages) • Modulates cell signaling and immune cell function • Gal-3 is increased in infla
Slide 5: Lead Indication in Organ Fibrosis: Advanced Fibrosis and Cirrhosis due to NASH
Lead Indication in Organ Fibrosis ADVANCED FIBROSIS AND CIRRHOSIS DUE TO NASH (NON-ALCOHOLIC STEATOHEPATITIS) © 2015 Galectin Therapeutics | NASDAQ:GALT 5
Slide 6: Past Year Accomplishments: Foundation For Phase 2 NASH Fibrosis Program
Past Year Accomplishments: Provide A Strong Foundation For Phase 2 NASH Fibrosis Program • Completed GR-MD-02 Phase 1 study in NASH patients with advanced fibrosis • Safe and well tolerated • Determined dosing for Phase 2 studies • Biomarker and liver stiffness evidence of positive effect • Complete
Slide 7: NASH: An Epidemic With No Approved Therapies
NASH: An Epidemic With No Approved Therapies Estimated prevalence of NASH in U.S. adults1, 2 > 28 million U.S. Prevalence in Asymptomatic Adults (% of population studied)2 Obesity 45% Diabetes 17% Fatty Liver 46% NASH 12% 1 Based on July 2013 US census data for people >20 years old 2 Prospective eva
Slide 8: Morbidity And Mortality In NASH Is Dependent On Degree Of Fibrosis
Morbidity And Mortality In NASH Is Dependent On Degree Of Fibrosis Estimated US prevalence of advanced fibrosis1,2: ~ 6 million Estimated US prevalence of cirrhosis1: ~ 1-2 million Early Disease (low stage fibrosis) Late Disease (advanced fibrosis) Fibrosis Progression Stage 1 Stage 2 Stage 3 Stage
Slide 9: NASH Competitive Landscape
NASH Competitive Landscape* * 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) • Simtuzumab (Gilead) • GFT505 (GenFit) • GR-MD-02 (Galectin) • Liraglutide (
Slide 10: Preclinical Data Shows GR-MD-02 Can Reverse NASH, Fibrosis, and Cirrhosis
Strong Scientific Basis For Development Program: 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 publi
Slide 11: 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 planned cirrhosis trial © 2015 Galectin Therapeutics | NAS
Slide 12: Two Completed Phase 1 Trials Provide Foundation For Entering Phase 2
Two Completed Phase 1 Trials Provide Strong Foundation For Entering Phase 2 • GT-020: Multiple dose escalation, double-blind, placebo controlled trial in NASH patients with advanced fibrosis • GR-MD-02 up to 8 mg/kg IV was safe and well tolerated • 8 mg/kg IV is in the upper range of the targeted th
Slide 13: Significant Reduction In Alpha-2 Macroglobulin At The 8 mg/kg Dose
Highly 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 because
Slide 14: 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) 100% 80% *In cohort 3 there were technically adequate scans at baseline, D
Slide 15: Phase 2 NASH Clinical Development Program In Two Indications
Phase 2 NASH Clinical Development Program Includes Trials In Two Separate Indications In NASH With Advanced Fibrosis Indication Objective Expectation From Successful Study Reduction of portal • Could be a pivotal trial in conjunction NASH with 1 Year of pressure and fibrosis with another P3 trial NA
Slide 16: The NASH-CX Trial (GT-026)
The NASH-CX Trial (GT-026) • Primary Endpoint: • Reduction of hepatic venous pressure gradient (HVPG) as a measure of portal pressure compared to placebo at 1 year of treatment • Secondary Endpoints: • At least one stage change in histopathological fibrosis stage • Liver collagen on liver biopsy (di
Slide 17: Complications of Portal Hypertension in Cirrhosis
Complications of Portal Hypertension in Cirrhosis (Portal Hypertension = High Blood Pressure in Portal Vein) Encephalopathy ↓ Liver Cell Function Shunting Varices Ascites The Goal is to: ↓ Fibrosis → ↓ Portal Pressure → ↓ Complications → ↓ Morbidity and Mortality © 2015 Galectin Therapeutics | NASDA
Slide 18: The NASH-FX Trial (GT-028)
The NASH-FX Trial (GT-028) 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), a multi-parametric MRI protocol. Secondary Endpoints: • To determine the ba
Slide 19: 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 (FibroScan™) Normal Transducter Ribs Probe Vibrator Cirrhosis Whole liver assessment of Whole liver assessment of Regional assessment of fibrosis using multi- stiffness using magnetic l
Slide 20: Summary of NASH Advanced Fibrosis Program
Summary of NASH Advanced Fibrosis Program • Galectin-3 a well-validated target in pre-clinical studies • GR-MD-02 binds gal-3 and is targeted to macrophages • In pre-clinical models GR-MD-02 has multiple effects • Reduces inflammation, fat and ballooning hepatocytes in NASH • Reduces and reverses li
Slide 21: Lead Indication in Cancer Immunotherapy: Advanced Melanoma
Lead Indication in Cancer Immunotherapy ADVANCED MELANOMA © 2015 Galectin Therapeutics | NASDAQ:GALT 21
Slide 22: Cancer Therapy Strategy
Cancer Therapy Strategy • Immunotherapy is a major breakthrough in cancer therapeutics Focus on • Galectin-3 has an important role in reducing the ability Immunotherapy of immune system to fight cancer • GR-MD-02 is efficacious on tumors in combination with other immunotherapies in animal models Adv
Slide 23: 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 24: Checkpoint Inhibitors Plus GR-MD-02 Boosts Anti-Tumor Immunity In Mouse 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 25: GR-MD-02 May Be A Complementary Therapy To Enhance Checkpoint Blockade
GR-MD-02 May Be A Complementary Therapy To Enhance Checkpoint Blockade Therapies Immune checkpoint blockade Patients Alive Plus GR-MD-02 PD-1-blockade (KEYTRUDA®) CTLA-blockade (Yervoy®) Natural History 1 2 3 4 Years Note: these are illustrative curves not representative of actual data; redrawn from
Slide 26: Phase 1b Trial In Advanced Melanoma With GR-MD-02 And Yervoy
Phase 1b Clinical Trial In Patients With Advanced Melanoma Using GR-MD-02 In Combination With Yervoy® Patients Advanced melanoma with indication for Yervoy® treatment Design Three patients per cohort (+3 if serious adverse events) with 10 patients treated with maximum dose achieved Dose GR-MD-02 sta
Slide 27: Phase 1b Trial In Advanced Melanoma With GR-MD-02 And KEYTRUDA
Phase 1b Clinical Trial In Patients With Advanced Melanoma Using GR-MD-02 In Combination With KEYTRUDA® Patients • Patients who have had melanoma progression after Yervoy® and/or BRAF targeted therapy in melanomas with a BRAF mutation • Patients who have had melanoma progression after Keytruda® mono
Slide 28: Summary of Cancer Immunotherapy Program
Summary of Cancer Immunotherapy Program • Collaboration with investigative group at Providence Portland Medical Center (PPMC) who have significant expertise in basic tumor immunology and translational clinical trials • Pre-clinical studies demonstrate in multiple cancers that GR- MD-02 augments the
Slide 29: Other Potential Indications in Inflammatory Disease: Plaque Psoriasis
Other Potential Indications in Inflammatory Disease MODERATE TO SEVERE PLAQUE PSORIASIS © 2015 Galectin Therapeutics | NASDAQ:GALT 29
Slide 30: Exploratory Phase 2a Trial In Moderate to Severe Plaque Psoriasis
Exploratory Phase 2a Trial In Moderate to Severe Plaque Psoriasis • Patient in Phase 1 trial had apparent remission of severe psoriasis while receiving GR-MD-02 • Galectin-3 is increased in skin lesions of patients with psoriasis Primary Endpoint: • Evaluate the number of patients who have 75% impro
Slide 31: Product and Program Pipeline
Product and Program Pipeline Clinical Focus Stage of Development Drug Indication Discovery Preclinical Phase 1 Phase 2 Phase 3 Fibrosis (monotherapy) GR-MD-02 NASH cirrhosis June 2015 NASH advanced fibrosis July 2015 Lung, Kidney, Cardiovascular fibrosis Cancer Immunotherapy (combination therapy) GR
Slide 32: 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); June 2015 End 2017 “NASH-CX” liver biopsy GT-028 NASH with Multi-parametric MRI July 2015 2H 2016 “NASH-FX” advanced fibrosis C
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