Galectin Therapeutics Inc. · NASDAQ:GALT

Galectin Therapeutics — Investor Presentation (May 2015)

32 slides from Galectin Therapeutics's investor presentation, May 11, 2015

  1. Slide 1: Corporate Presentation

    Exhibit 99.1 Corporate Presentation May 11, 2015 NASDAQ: GALT www.galectintherapeutics.com © 2015 Galectin Therapeutics Inc.

  2. 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,”

  3. 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 1 fibrotic disease • Lead indication is liver fibrosis/cirrhosis due to fatty liver 2 disease (75% of all liver disease in U.S. ) Organ Fibrosis • Potentially applicable to other fibrotic diseases

  4. Slide 4: Experienced Leadership Team

    Experienced Leadership Team © 2015 Galectin Therapeutics | NASDAQ:GALT 4

  5. Slide 5: 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

  6. Slide 6: 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 6

  7. 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 ev

  8. Slide 8: End-Stage Fibrosis (Cirrhosis) Is When Patients With NASH Experience Symptoms And Complications

    End-Stage Fibrosis (Cirrhosis) Is When Patients With NASH Experience Symptoms And Complications Estimated US prevalence of advanced fibrosis1,2: ~ 6 million 1 Estimated US prevalence of cirrhosis : ~ 1-2 million Early Disease (low stage fibrosis) Late Disease (advanced fibrosis) Fibrosis Progression

  9. Slide 9: NASH Stage Competitive Landscape

    NASH Stage 2 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 • Obeticholic Acid (Intercept) • Simtuzumab (Gilead) • GFT505 (GenFit) • Emricasan (Conatus) • Liraglutide (Novo

  10. Slide 10: Published Preclinical Data Shows That GR-MD-02 Can Reverse NASH, Fibrosis, and Cirrhosis

    Published 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. Therap

  11. 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 GR-MD-02-Treated (4 weekly doses) Reduces portal pressure which correlates with primary endpoint in planned cirrhosis trial *Traber PG, Chou H, Zomer E, Hong F, Klyoso

  12. Slide 12: Phase 1 Trial Completed December 2014

    Phase 1 Trial Completed December 2014 • 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 therapeutic window for drug administration • The

  13. Slide 13: Highly Significant Reduction In Alpha-2 Macroglobulin Serum Levels Seen At The 8 mg/kg Dose

    Highly Significant Reduction In Alpha-2 Macroglobulin Serum Levels Seen At The 8 mg/kg Dose A reduction in serum alpha-2-macroglobulin accounted for the reduction in FibroTest ® ns4 Legend and Notes: 3 ns 1. Mean ± standard deviation 2. Placebo values were combined p < 0.055 for all three cohorts be

  14. Slide 14: 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) 100% 80% *In cohort 3 there were technically adequate scans at baseline, D

  15. Slide 15: Phase 2 NASH Clinical Development Program Includes Trials In Two Separate 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

  16. 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

  17. 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 | NASDAQ: GALT 17

  18. 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

  19. 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 Whole liver assessment of Whole liver assessment of Regional assessment of fibrosis using multi- stiffness using magnetic liver for t

  20. 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

  21. Slide 21: Lead Indication in Cancer Immunotherapy: Advanced Melanoma

    Lead Indication in Cancer Immunotherapy ADVANCED MELANOMA © 2015 Galectin Therapeutics | NASDAQ:GALT 21

  22. Slide 22: 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 Tumor Vaccines Clonal Cells Galectin-3 Expansion CD8+ T-Cells T-Cells Cytokines (kill tumor cells) Potential for galectin Potential f

  23. Slide 23: 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 of Immunotherapy immune system to fight cancer • GR-MD-02 is efficacious on tumors in combination with other immunotherapies in animal models Adv

  24. Slide 24: GR-MD-02 May Be A Complementary Therapy To Enhance Efficacy Of Immune Checkpoint Blockade Therapies

    GR-MD-02 May Be A Complementary Therapy To Enhance Efficacy Of Immune Checkpoint Blockade Therapies Immune checkpoint blockade Plus GR-MD-02 PD-1-blockade (KEYTRUDA®) CTLA-blockade (Yervoy®) Natural History 1 2 3 4 Years Note: these are illustrative curves not representativeof actual data; redrawn f

  25. Slide 25: 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

  26. Slide 26: Phase 1b Clinical Trial In Advanced Melanoma Using GR-MD-02 With 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 s

  27. Slide 27: Phase 1b Clinical Trial In Advanced Melanoma Using GR-MD-02 With 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® mon

  28. 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

  29. Slide 29: Other Potential Indications in Inflammatory Disease: Moderate to Severe Plaque Psoriasis

    Other Potential Indications in Inflammatory Disease MODERATE TO SEVERE PLAQUE PSORIASIS © 2015 Galectin Therapeutics | NASDAQ:GALT 29

  30. 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

  31. 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 Q2 2015 NASH advanced fibrosis Q2 2015 Lung, Kidney, Cardiovascular fibrosis Cancer Immunotherapy (combination therapy) GR-MD-

  32. 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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