Galectin Therapeutics Inc. · NASDAQ:GALT

Galectin Therapeutics — Investor Presentation (February 2015)

38 slides from Galectin Therapeutics's investor presentation, Feb 24, 2015

  1. Slide 1: Corporate Presentation

    Exhibit 99.1 Corporate Presentation February 24, 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 are associated with fibrotic disease 1 • 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 diseases • Phase 1 cli

  4. Slide 4: Investment Highlights

    Investment Highlights • Expertise with complex carbohydrate drugs that promote galectin-3 Knowledge inhibition, with applicability to large patient populations Strong Intellectual • Multiple composition-of-matter patents and method patents Property • Initial focus on the treatment of NASH with advan

  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 Function • High expression in immune cells (macrophages) • Modulates cell signaling and immune cell function • Gal-3 is increased in inflammation and fibrogenesi

  6. Slide 6: Deep Product Pipeline

    Deep Product Pipeline *Galectin Sciences, LLC © 2015 Galectin Therapeutics | NASDAQ:GALT 6

  7. Slide 7: 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 7

  8. Slide 8: 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, Middle-Aged Adults (% of population)2 Obesity 45% Diabetes 16.5% Fatty Liver 46% NASH 12.2% 1 Based on July 2013 US census data for people >20 years old (233,880

  9. Slide 9: 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 prevalence of advanced fibrosis1,2: ~ 6 million Estimated prevalence of cirrhosis 1: ~ 1-2 million Approximately one-third will advance to Stage 3/4 fibrosis 3 Complications (variceal bleeding,

  10. Slide 10: Robust Preclinical Data: Therapeutic Effect On NASH With Fibrosis In Mouse Model

    Robust Preclinical Data: GR-MD-02 Has Therapeutic Effect On NASH With Fibrosis In Mouse Model* GR-MD-02 reduces Gal-3, which results in reduction in liver inflammation and fibrosis *Traber PG and Zomer E. Therapy of Experimental NASH and Fibrosis with Galectin Inhibitors. PLOS ONE 2013;8:e83481 10

  11. Slide 11: Robust Preclinical Data: Reversed Cirrhosis In Rat Model

    Robust Preclinical Data: GR-MD-02 Reversed Cirrhosis And Improved Portal Hypertension In Rat Model* *Traber PG, Chou H, Zomer E, Hong F, Klyosov A Fiel M-I, Friedman, SL. Therapy of Regression of fibrosis and reversal of 11 cirrhosis in rats by galectin inhibitors in thioacetamide-induced liver dise

  12. Slide 12: Phase 1 Clinical Trial (GT-020): Completed December 2014

    Phase 1 Clinical Trial (GT-020): Completed December 2014 • Subjects: Biopsy proven NASH with Brunt Stage 3 fibrosis • Design: • Blinded, placebo controlled, sequential dose escalation • Three cohorts: Four doses over 6-7 weeks of 2, 4, and 8 mg/kg lean body weight administered by IV infusion over on

  13. Slide 13: Phase 1 Trial: GR-MD-02 Was Found To Be Safe And Well Tolerated

    Phase 1 Trial: GR-MD-02 Was Found To Be Safe And Well Tolerated Cohort 1 Cohort 2 Cohort 3 (2 mg/kg) (4 mg/kg) (8 mg/kg) Active Placebo Active Placebo Active Placebo Completed protocol 6 2 7 2 7 6 SUSAR (Suspected 0 0 0 0 0 0 unexpected serious adverse reactions) Serious Adverse Events 0 0 1* 0 0 0

  14. Slide 14: Pharmacokinetics Indicates 8 mg/kg Dose Is Within Targeted Therapeutic Window

    Pharmacokinetics Indicates 8 mg/kg Dose Is Within The Upper Range Of The Targeted Therapeutic Window • The best therapeutic dose in mouse NASH was between 10 and 30 mg/kg • Relationship between AUC and dose shows mouse and human equivalency © 2015 Galectin Therapeutics | NASDAQ:GALT 14

  15. Slide 15: Significant Reduction In FibroTest Scores At The 8 mg/kg Dose

    A Significant Reduction In FibroTest ® Scores Were Seen At The 8 mg/kg Dose FibroTest ® scores are calculated from age, gender, alpha-2-macroglobulin, haptoglobin, apolipoprotein A1, gamma-glutamyl transpeptidase (GGT), and total bilirubin Legend and Notes: 1. Mean ± Standard Deviation 2. Placebo va

  16. Slide 16: Highly Significant Reduction In Alpha-2 Macroglobulin 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 ® Legend and Notes: 1. Mean ± standard deviation 2. Placebo values were combined for all three cohorts because there were no

  17. Slide 17: FibroScan Is A Non-Invasive Method For Assessing Liver Stiffness

    FibroScan® Is A Non-Invasive, Ultrasound-Based Method For Assessing Liver Stiffness, Which Correlates With Liver Fibrosis • FibroScan uses an electromechanical vibrator and pulse-echo ultrasound to evaluate the elastic shear wave in liver tissue • The volume of liver tissue assessed is ~100-times gr

  18. 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)* *In cohort 3 there were technically adequate scans at baseline, Day 38 and Day 63 in 5 patients admin

  19. Slide 19: Results Of Phase 1 Trial Provide Foundation For Entry Into Phase 2

    Results Of Phase 1 Trial Provide Firm Foundation For Entry Into A Phase 2 Development Program • GR-MD-02 at doses up to 8 mg/kg IV is safe and well tolerated in NASH patients with advanced fibrosis • A dose of 8 mg/kg IV is in the upper range of the targeted therapeutic window for drug administratio

  20. Slide 20: Phase 2 NASH Clinical Development Program

    Phase 2 NASH Clinical Development Program Patient Objective Expectation From Population Successful Study NASH-CX Reduction of portal Could serve as a Cirrhosis due 1 Year of Therapy pressure as a result pivotal trial for to NASH of reversing fibrosis marketing approval NASH-FX Reduction of liver NAS

  21. Slide 21: The NASH-CX Trial (GT-026)

    The NASH-CX Trial (GT-026) Patients Portal hypertension with NASH cirrhosis Design • Randomized, controlled, blinded, multicenter trial • Three groups of 52 subjects for a total of 156 subjects Dose & • Placebo and two doses of GR-MD-02 (2 mg/kg and 8 mg/kg) Duration • Randomized 1:1:1 • 52 week tre

  22. Slide 22: Complications of Portal Hypertension in Cirrhosis

    Complications of Portal Hypertension in Cirrhosis (Portal Hypertension = High Blood Pressure in Portal Vein) The Goal is to: © 2015 Galectin Therapeutics | NASDAQ: GALT

  23. Slide 23: Assessment Methods for Liver Fibrosis in NASH-CX Trial

    Assessment Methods for Liver Fibrosis in NASH-CX Trial © 2014 Galectin Therapeutics | NASDAQ:GALT 23

  24. Slide 24: Key Points of NASH-CX Clinical Trial

    Key Points of NASH-CX Clinical Trial • FDA in agreement with endpoint of HVPG • Reduction in HVPG is reasonably likely to predict clinical benefit and therefore can be considered a surrogate marker for clinical outcome • FDA has agreed to review protocol under Special Protocol Assessment • Trial cou

  25. Slide 25: The NASH-FX Trial (GT-028)

    The NASH-FX Trial (GT-028) Patients NASH with advanced fibrosis (>Brunt stage 3 fibrosis) Design • Randomized, controlled, blinded, single center trial • Two groups for a total of 30 subjects Dose & • Placebo and 8 mg/kg GR-MD-02 Duration • Randomized 1:2 • 16 week treatment period with drug adminis

  26. Slide 26: Non-Invasive Assessments of Liver Fibrosis in NASH-FX trial

    Non-Invasive Assessments of Liver Fibrosis in NASH-FX trial MR-Elastography LiverMultiScan* Transient Elastography (FibroScan™) Whole liver assessment of Whole liver assessment of Regional assessment of stiffness using magnetic fibrosis using multi- liver for tissue stiffness resonance imaging with

  27. Slide 27: Key Points of NASH-FX Clinical Trial

    Key Points of NASH-FX Clinical Trial • Different population of patients than NASH-CX trial with advanced fibrosis, but not necessarily cirrhosis • Shorter term treatment than NASH-CX trial • Evaluation of three promising non-invasive tests for assessment of liver fibrosis • A positive study might be

  28. Slide 28: Lead Indication in Cancer Immunotherapy: Advanced Melanoma

    Lead Indication in Cancer Immunotherapy ADVANCED MELANOMA © 2015 Galectin Therapeutics | NASDAQ:GALT 28

  29. Slide 29: The Vast Majority of Cancers Secrete Large Amounts of Galectins

    The Vast Majority of Cancers Secrete Large Amounts of Galectins, Which Have Multiple Roles In Tumor Pathogenesis • Tumor cell invasion: extracellular matrix adhesion and detachment • Metastasis: cell invasion and migration • Angiogenesis • Tumor immunity has recently been shown to be critically affe

  30. Slide 30: Potential sites of action for galectin inhibition in tumor immunology

    Potential sites of action for galectin inhibition in tumor immunology Potential for galectin Potential for galectin inhibitors inhibitors to enhance to enhance anti-tumor activity anti-tumor immune of T-cells by blocking response “Galectin Effect” © 2015 Galectin Therapeutics | NASDAQ:GALT 30

  31. Slide 31: Cancer Therapy Strategy

    Cancer Therapy Strategy • Immunotherapy is a major breakthrough in cancer therapeutics • Galectin-3 has an important role in reducing the ability of immune system to fight cancer • GR-MD-02 is efficacious on tumors in combination with other immunotherapies in animal models • In U.S. 76,000 new diagn

  32. Slide 32: 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) aCTLA-4 = anti-CTLA-4 mAb [ipilimumab in humans (Yervoy®, BMS)] aPD-

  33. Slide 33: Hypothesis: GR-MD-02 May Be A Complementary Therapy To Checkpoint Blockade

    Hypothesis: GR-MD-02 May Be A Complementary Therapy To Enhance Efficacy Of Immune Checkpoint Blockade Therapies Note: these are illustrative curves not representative of actual data; redrawn from figure of the American Association for Cancer Research, 2013 © 2015 Galectin Therapeutics | NASDAQ:GALT

  34. Slide 34: Phase 1b Clinical Trial In Advanced Melanoma 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 st

  35. Slide 35: Phase 1b Clinical Trial In Advanced Melanoma 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® mo

  36. Slide 36: Expected Development Program Milestones

    Expected Development Program Milestones Advanced Liver Fibrosis/Cirrhosis Study Indication Endpoints Start Data Reporting GT-026 NASH with Portal pressure Q2 2015 Q4 2017 “NASH-CX” cirrhosis (HVPG) GT-028 NASH with Liver stiffness Q2 2015 Q2 2016 “NASH-FX” advanced fibrosis (magnetic resonance elast

  37. Slide 37: Experienced Leadership Team

    Experienced Leadership Team © 2015 Galectin Therapeutics | NASDAQ:GALT 37

  38. Slide 38: Financial Key Facts – As Of December 31, 2014

    Financial Key Facts – As Of December 31, 2014 Trading Symbol Nasdaq: GALT Corporate Headquarters Norcross, GA (suburb of Atlanta) Fiscal Year End December 31 Accounting Firm McGladrey LLP Stock Price; 52 Week Range $3.47 $3.00 - $19.11 Shares Outstanding 22.3 million Daily Volume (3-month average) 1

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