Galectin Therapeutics Inc. · NASDAQ:GALT

Galectin Therapeutics — Investor Presentation (January 2015)

38 slides from Galectin Therapeutics's investor presentation, Jan 7, 2015

  1. Slide 1: Corporate Presentation

    Exhibit 99.1 Corporate Presentation January 7, 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 1 • 45% of U.S. deaths are associated with 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 • 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 NASH with • Initial focus on the treatment of NASH

  5. Slide 5: Lead Drug Candidate Targets Galectin-3 Protein

    Lead Drug Candidate Targets Galectin-3 Protein • Binds to galactose residues in glycoproteins and Galectin-3 Protein promotes 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 Clinical Focus Stage of Development Drug Indication Discovery Preclinical Phase 1 Phase 2 Phase 3 Fibrosis (monotherapy) GR-MD-02 NASH cirrhosis Q2 2015 Lung fibrosis Kidney fibrosis Cardiovascular fibrosis Cancer Immunotherapy (combination therapy) GR-MD-02 Melanoma Galectin-3

  7. Slide 7: 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 cirrhosis1: ~ 1-2 million NASH Fibrosis Progression Stage 1 Stage 2 Stage 3 Stage 4 Liver biopsy (Blue = fibrosis) Asympto

  10. Slide 10: Robust Preclinical Data: GR-MD-02 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 Normal NASH: Control NASH: GR-MD-02 GR-MD-02 Effects Galectin-3 Stain Galectin-3 Protein Cellular Stain NAFLD Activity

  11. Slide 11: Robust Preclinical Data: GR-MD-02 Reversed Cirrhosis In Rat Model

    Robust Preclinical Data: GR-MD-02 Reversed Cirrhosis And Improved Portal Hypertension In Rat Model* Vehicle-Treated Collagen Portal Pressure GR-MD-02-Treated (90 mg/kg, 1/W x 4) N=10 N=10 N=10 N=10 N=10 *Traber PG, Chou H, Zomer E, Hong F, Klyosov A Fiel M-I, Friedman, SL. Therapy of Regression of f

  12. Slide 12: Successful Phase 1 Clinical Trial In NASH Patients Met Key Endpoints

    Successful Phase 1 Clinical Trial In NASH Patients With Advanced Fibrosis Met Key Endpoints • Safety • GR-MD-02 was safe and well tolerated after IV administration of four doses of 2 mg/kg, 4 mg/kg and 8mg/kg lean body weight • Drug Levels • Pharmacokinetics revealed drug exposure in humans at the 8

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

    Highly Significant Reduction In Alpha-2 Macroglobulin (A2M) Serum Levels Seen At The 8 mg/kg Dose ns4 Legend and Notes: ns³ 1. Mean ± standard deviation 2. Placebo values were combined p < 0.055 for all three cohorts because there were no differences (n=19 p < 0.0055 separate data points) p < 0.0015

  14. Slide 14: Reduction In A2M Is Encouraging For GR-MD-02 Effect On Liver Fibrosis

    Reduction In A2M Is Encouraging For GR-MD-02 Effect On Liver Fibrosis • FibroTest ® is a composite fibrosis score that is calculated from serum A2M levels and four other tests, including GGTP, total bilirubin, haptoglobin and apolipoprotein A1 • FibroTest ® has been shown to correlate with stage of

  15. Slide 15: 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

  16. Slide 16: 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) 150 150 100 100 100% 80% 50 50 0 0 Day -1 Day 38 Day 63 Day -1 Day 38 Day 6

  17. Slide 17: Conclusions From Results Of Phase 1 Trial In NASH Patients

    Conclusions From Results Of Phase 1 Trial In NASH Patients With Advanced Fibrosis 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 administration The combined r

  18. Slide 18: Goals of the Phase 2 Development Program

    Goals of the Phase 2 Development Program • Multiple, concurrent Phase 2 clinical trials will be conducted • Two indications in patients with NASH will be evaluated • Cirrhosis with portal hypertension • Advanced fibrosis as indicated by liver stiffness • Multiple modalities for the assessment of liv

  19. Slide 19: Advanced Melanoma

    Lead Indication in Cancer Immunotherapy ADVANCED MELANOMA © 2015 Galectin Therapeutics | NASDAQ:GALT 19

  20. Slide 20: 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

  21. Slide 21: 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

  22. Slide 22: 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

  23. Slide 23: 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 Hypothetical: Immune checkpoint blockade Plus GR-MD-02 PD-1-blockade (Keytruda ®) CTLA-blockade (Yervoy ®) 1 2 3 4 Years © 2015 Galectin Therapeutics | NASDAQ:GALT 23

  24. Slide 24: Phase 1b 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 s

  25. Slide 25: Phase 1b 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 ® m

  26. Slide 26: Experienced Leadership Team

    Experienced Leadership Team James Czirr, Executive Manager and general partner of 10X Fund, L.P., Co-Founder, Pro-Pharmaceuticals, Chairman CEO, Minerva Biotechnologies Corporation Peter G. Traber, M.D. Over 28 years experience in biomedicine and pharmaceutical industries in research President, CEO,

  27. Slide 27: Development Program Milestones

    Development Program Milestones Advanced Liver Fibrosis/Cirrhosis Study Indication Endpoints Start Data Reporting GT-026 NASH with Portal pressure Q2 2015 “NASH-CX” cirrhosis (HVPG) The full trial design GT-027 NASH with Liver stiffness Q2 2015 and the expected timings for top-line “NASH-FX” advanced

  28. Slide 28: Appendix

    APPENDIX © 2015 Galectin Therapeutics | NASDAQ:GALT 28

  29. Slide 29: Multi-Center Phase 1 Dose Escalation Trial of GR-MD-02 In NASH

    A Multi-Center, Partially Blinded, Maximum Tolerated Multiple Dose Escalation, Phase 1 Clinical Trial to Evaluate the Safety of GR-MD-02 in Subjects with Non-Alcoholic Steatohepatitis (NASH) with Advanced Hepatic Fibrosis • Overall Objective: • Evaluate safety and pharmacokinetics of GR-MD-02 to pro

  30. Slide 30: 3-Cohort Design Of Phase 1 Clinical Trial

    3-Cohort Design Of Phase 1 Clinical Trial • 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 one hour • Primar

  31. Slide 31: Phase 1 Trial: Patient Characteristics

    Phase 1 Trial: Patient Characteristics Cohort 1 Cohort 2 Cohort 3 (2 mg/kg) (4 mg/kg) (8 mg/kg) Enrolled 8 10 13 Completed 8 9 13 Completed Patients Age Range (Mean) 40-64 (54) 34-69 (52) 31-69 (57) Sex (M/F) 2/6 6/4 6/7 BMI (Mean) 39 40 36 BMI 30 8 9 8 Diabetes 6 4 6 © 2015 Galectin Therapeutics |

  32. Slide 32: Phase 1 Trial: Safety Data

    Phase 1 Trial: Safety Data 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 Serious Adverse Events 0 0 0 0 0 0 TEAE’s probably related 0 0 0 0 0 0 TEAE’s possibly related 0 2 2 0 0 2 • Therapy Emergent Adverse Events

  33. Slide 33: Mean GR-MD-02 Plasma Concentration-Time Profiles

    Mean GR-MD-02 Plasma Concentration-Time Profiles After First And Fourth Doses In All 3 Cohorts • Proportional increase in drug coverage (AUC) for 2 mg/kg, 4 mg/kg, and first dose of 8 mg/kg • Increase in AUC after four doses of 8 mg/kg indicates a saturable compartment model Cmax T1/2 AUC µg/mL H µg

  34. Slide 34: 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 Target Therapeutic Window AUC of Human 8 mg/kg dose AUC of

  35. Slide 35: A 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 ns4 Legend and Notes: ns³ 1. Mean ± Standard Deviation p < 0

  36. Slide 36: Highly Significant Reduction In Alpha-2 Macroglobulin Serum Levels At 8 mg/kg

    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: ns³ 1. Mean ± standard deviation 2. Placebo values were combined p < 0.055 for all three cohorts bec

  37. Slide 37: Existing Patent Position Supporting Fibrosis Program Using GR-MD-02

    Existing Patent Position Supporting Fibrosis Program Using GR-MD-02 Patent Title Priority Issued International US 8,236,780 Galactose-pronged polysaccharides in a 5/16/2006 8/7/2012 None formulation for anti-fibrotic therapies US 8,658,787 Galacto-rhamnogalacturonate compositions for the 9/16/2011 2

  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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