Galectin Therapeutics Inc. · NASDAQ:GALT

Galectin Therapeutics — Shareholder Meeting (May 2014)

30 slides from Galectin Therapeutics's shareholder meeting presentation, May 14, 2014

  1. Slide 1: 2014 Annual Stockholder Meeting

    Exhibit 99.1 2014 Annual Stockholder Meeting May 14, 2014 NASDAQ: GALT www.galectintherapeutics.com © 2014 Galectin Therapeutics Inc

  2. Slide 2: Forward-Looking Statement Disclaimer

    Forward-Looking Statement Disclaimer 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

  3. Slide 3: Drugs are natural complex carbohydrates that bind to galectin-3

    Drugs are natural complex carbohydrates that bind to galectin-3 and block interactions with natural ligands • Galectin-3 is most important in pathological situations, is widely expressed, but highest in immune cells (macrophages) • In areas of acute or chronic inflammation and fibrogenesis, the gal-

  4. Slide 4: Our Pipeline Of Galectin-3 Inhibitors

    Our Pipeline Of Galectin-3 Inhibitors Clinical Focus Stage of Development Drug Indication Discovery Pre-clinical Phase 1 Phase 2 Phase 3 Fibrosis NASH (Fatty liver GR-MD-02 disease) with advanced fibrosis Lung fibrosis Kidney fibrosis Cardiovascular fibrosis Cancer Immunotherapy GR-MD-02 Melanoma Ga

  5. Slide 5: All Chronic Liver Diseases Lead To Fibrosis

    All Chronic Liver Diseases Lead To Fibrosis Example: Liver Fibrosis In Fatty Liver Disease (NASH) Stage 1 Stage 2 Stage 3 Stage 4 Liver biopsy Blue=fibrosis Pericellular/Central Portal/Central Bridging Fibrosis Cirrhosis (High Mag) Healthy Fatty Fibrosis Cirrhosis Only therapy for patients with Live

  6. Slide 6: GR-MD-02 Has Therapeutic Effect On NASH With Fibrosis In Mouse Model

    GR-MD-02, A Galectin-3 Inhibitor, Has Therapeutic Effect On NASH With Fibrosis In Mouse Model Improvement is linked to decreased tissue Galectin-3 Normal NASH:Control NASH:GR-MD-02 GR-MD-02 Effects Normal Stain Disease Activity Score • Fat • Cell death • Inflammation Collagen Stain Collagen (Fibrosi

  7. Slide 7: GR-MD-02 Reversed Cirrhosis in Rat Model

    GR-MD-02 Reversed Cirrhosis in Rat Model Vehicle • Animal model Broad bands of presented a very collagen with nodule high hurdle for drug formation (N) indicates advanced treatment fibrosis and cirrhosis • Cirrhosis induced with high dose toxin and continued throughout drug treatment GR-MD-02 • Trea

  8. Slide 8: GR-MD-02 Reduces Collagen Synthesis And Increases Collagen Degradation

    GR-MD-02 Is A Galectin-3 Inhibitor That Reduces Collagen Synthesis And Increases Collagen Degradation In Pre-Clinical Models Liver Fibrotic Tissue Homeostasis In the normal liver, collagen and matrix protein synthesis matches Normal degradation to provide appropriate amount of extracellular matrix.

  9. Slide 9: GR-MD-02 Being Developed For NASH With Advanced Fibrosis

    GR-MD-02 Is Being Developed For The Indication Of NASH With Advanced Fibrosis (Stage 3 and 4) Obesity/Insulin Resistance/Diabetes Steatosis (fatty liver) NASH (inflammation, cell death) Stage 1 2 3 Stage 4 Clinical Outcomes Fibrosis Cirrhosis Complications Transplant Death Early Disease Late Disease

  10. Slide 10: Phase 1 Clinical Trial Of GR-MD-02 In NASH: Fast Track FDA Designation

    Phase 1 Clinical Trial Of GR-MD-02 In NASH With Advanced Fibrosis: Fast Track FDA Designation Patient inclusion: Biopsy proven NASH with advanced fibrosis (stage 3) Design: Cohort has 8 patients (6 active, 2 placebo, blinded) Dose: Starting dose of 2 mg/kg lean body weight (equivalent to 80 mg/m 2);

  11. Slide 11: Patient Characteristics, Safety and Pharmacokinetics: Cohort 1

    Patient Characteristics, Safety and Pharmacokinetics: Cohort 1 Patient Characteristics Pharmacokinetics • 6 women and 2 men • GR-MD-02 blood levels were consistent • Ages 40-64 (mean=54) between individuals with a t1/2 of 20 hours • Mean body mass index (BMI)=39 • Blood levels not significantly diff

  12. Slide 12: Major Pathological Processes in NASH

    Major Pathological Processes in NASH Steato-Hepatitis (NASH Activity) Fibrosis/Cirrhosis • Ballooning of liver cells (cell • Increase in collagen/matrix death/apoptosis) key hallmark • Disruption of architecture • Fat in liver cells (steatosis) • Liver cell nodules • Immune cell infiltration (inflam

  13. Slide 13: Serum Biomarkers Of Fibrosis In NASH

    Serum Biomarkers Of Fibrosis In NASH Composite Scores Individual Markers FibroTest™ (FibroSURE™) • Indirect biomarker of fibrosis Hyaluronic Acid • Age and gender, Alpha-2- • Matrix polysaccharide macroglobulin, Haptoglobin, • Direct marker Apolipoprotein A1, GGTP, Total • Correlates to fibrosis bil

  14. Slide 14: FibroTest Scores Significantly Decreased In GR-MD-02 Treated Patients

    FibroTest ™ (FibroSURE™) Scores Significantly Decreased In GR-MD-02 Treated Patients FibroTest ™ has been shown to: 1) Correlate with stage of fibrosis; 2) Assess fibrosis regression; 3) Assess fibrosis progression; 4) Predict liver-related mortality One patient on GR-MD-02 had scores < 0.08 which w

  15. Slide 15: Serum Biomarkers of NASH Inflammation and Injury

    Serum Biomarkers of NASH Inflammation and Injury Inflammatory Cytokines Cellular Injury Key cytokines* Serum Transaminases • IL-6 • ALT and AST • Enzymes released from liver cells • IL-8 • 2/3 of NASH patients have normal • TNF- levels at any given time Exploratory** • Entire spectrum of disease can

  16. Slide 16: Interleukin-6 Levels Were Significantly Reduced In Treated Patients

    Interleukin-6 Levels Were Significantly Reduced In GR-MD-02 Treated Patients • Pro-Inflammatory cytokine secreted by T cells and macrophages. • GR-MD-02 treated patients had significant reduction when compared to placebo See presentation for full results: http://bit.ly/QAcJbz © 2014 Galectin Therape

  17. Slide 17: GR-MD-02 Treatment Appears To Improve Both Major Pathological Processes In NASH

    GR-MD-02 Treatment Appears To Improve Both Major Pathological Processes In NASH Steato-Hepatitis (NASH Activity) Fibrosis/Cirrhosis • Ballooning of liver cells (cell • Increase in collagen/matrix death/apoptosis) key hallmark • Disruption of architecture • Fat in liver cells (steatosis) • Liver cell

  18. Slide 18: Summary of Findings From Cohort 1

    Summary of Findings From Cohort 1 • GR-MD-02 was safe and well tolerated at 2 mg/kg (80 mg/m 2) with no drug- related adverse events • Pharmacokinetics was consistent between individuals and after single and multiple doses; exposure was 40% of lowest dose used in NASH animal model; this was a therap

  19. Slide 19: Phase 1 Trial: Second and third cohort

    Phase 1 Clinical Trial Of GR-MD-02 In NASH With Advanced Fibrosis: Second and third cohort Infusion Patients Cohort (A/P) 1 Day -1 0 28 35 42 56 70 6/2 (2 mg/kg) BM BM 2 -1 0 21 28 35 38 49 63 10* (4 mg/kg) BM/FS BM/FS -1 0 21 28 35 38 49 63 20** 3 (8 mg/kg) BM BM BM/FS BM BM=Biomarkers Timing of re

  20. Slide 20: Competition in NASH: Different Indications and Clinical Trial Endpoints

    Competition in NASH: Different Indications and Clinical Trial Endpoints NASH (inflammation, cell death) Clinical Outcomes Stage 1 2 3 Stage 4 Complications Fibrosis Cirrhosis Transplant Death Early Disease Late Disease • Focus is on improving • Focus is on stopping NAFLD Activity Score (8 progressio

  21. Slide 21: Fibrosis Program Summary

    Fibrosis Program Summary • First liver fibrosis indication: NASH with advanced fibrosis and/or cirrhosis • Phase 1 trial indicates positive effects on fibrosis and NASH activity (inflammation and cell death) • Controlled phase 2 clinical trial program to follow completion of phase 1 trial. • The res

  22. Slide 22: Our Pipeline Of Galectin-3 Inhibitors

    Our Pipeline Of Galectin-3 Inhibitors Clinical Focus Stage of Development Drug Indication Discovery Pre-clinical Phase 1 Phase 2 Phase 3 Fibrosis NASH (Fatty liver GR-MD-02 disease) with advanced fibrosis Lung fibrosis Kidney fibrosis Cardiovascular fibrosis Cancer Immunotherapy GR-MD-02 Melanoma Ga

  23. Slide 23: Cancers Secrete Large Amounts of Galectins With Multiple Roles in Tumor Pathogenesis

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

  24. Slide 24: Cancer Therapy Strategy

    Cancer Therapy Strategy • Focus on cancer immunotherapy based on the hypothesis that galectin inhibitors will enhance efficacy of immunotherapies • Metastatic melanoma is initial cancer indication • In US 76,000 new diagnoses and 9,100 deaths annually • 5% five year survival for metastatic disease •

  25. Slide 25: Checkpoint inhibitors plus GR-MD-02 boosts anti-tumor immunity in mouse models

    Checkpoint inhibitors plus GR-MD-02 boosts anti- tumor immunity, reduce tumor size and increase survival in mouse cancer models Also effective in breast cancer, melanoma, and sarcoma TC-1 (prostate) TC-1 (prostate) *p<0.05 *p<0.05 aCTLA-4 = anti-CTLA-4 mAb [ipilimumab in humans (Yervoy, BMS)] aPD-1

  26. 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® (ipilimumab): Actively Enrolling Patient inclusion: Advanced melanoma with indication for Yervoy® treatment Design: 3+3 dose escalation (3 patients if no adverse events); 10 patients treated with ma

  27. Slide 27: Cancer Therapy Summary

    Cancer Therapy Summary • Two immunotherapy agents have been approved for use to date, with many more vaccines and activators in development • Our strategy is to leverage world class expertise in basic tumor immunology and in the conduct of melanoma clinical trials. • Providence Portland Medical Cent

  28. Slide 28: Financial Key Facts – As of May 9, 2014

    Financial Key Facts – As of May 9, 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 $10.23 $3.90 - $19.11 Shares Outstanding 21.9 million Daily Volume (50 day average) 527,000

  29. Slide 29: Summary

    Summary • Liver fibrosis program has advanced from a concept presented three years ago at Annual Meeting to Phase 1 human results showing safety and evidence of disease effect • Melanoma immunotherapy program has strong pre-clinical results with an active Phase 1B clinical trial underway • Pipeline

  30. Slide 30: THANK YOU!

    THANK YOU! © 2014 Galectin Therapeutics | NASDAQ:GALT 30

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