Galectin Therapeutics Inc. · NASDAQ:GALT
Galectin Therapeutics — Investor Presentation (January 2012)
33 slides from Galectin Therapeutics's investor presentation, Jan 9, 2012
Slide 1: Company Overview January 2012
Company Overview January 2012 OTC: GALT Exhibit 99.1
Slide 2: Forward Looking Statements
© 2012 Galectin Therapeutics OTC:GALT 2 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 pe
Slide 3: Galectin Therapeutics Highlights
3 © 2012 Galectin Therapeutics OTC:GALT Galectin Therapeutics Highlights • Leader in galectin science • Pipeline of carbohydrate-based drug compounds that inhibit galectins • Focus on proven galectin activity in fibrosis and cancer • Liver Fibrosis • Target validated in convincing pre-clinical data
Slide 4: Galectin Proteins Are Normal Cell Proteins
© 2012 Galectin Therapeutics OTC:GALT 4 Galectin Proteins Are Normal Cell Proteins That Promote Interactions Between Glycoproteins
Slide 5: Galectin Proteins Are Important In Disease Pathogenesis
© 2012 Galectin Therapeutics OTC:GALT 5 Galectin Proteins Are Important In Disease Pathogenesis Secreted Galectin Proteins PROMOTE PATHOLOGY Markedly Increased in: 1. Fibrosis 2. Cancer 3. Inflammation 1. Bind to cell surface and matrix glycoproteins 2. Modulate cell signaling 3. Promote cell-cell i
Slide 6: Our Galectin Inhibitors Are Novel Carbohydrate-Based Drug Compounds
© 2012 Galectin Therapeutics OTC:GALT 6 Galectin Proteins Galectin Inhibitor Our Galectin Inhibitors Are Novel Carbohydrate-Based Drug Compounds • Target secreted galectins and those associated with cell membrane • Strong binding to multiple galectin proteins and multiple galectins per drug molecule
Slide 7: Galectins Are Involved In The Pathogenesis Of Many Diseases
© 2012 Galectin Therapeutics OTC:GALT 7 Galectins Are Involved In The Pathogenesis Of Many Diseases • Fibrosis of organs • Nearly all cancers • Heart failure • Ischemic cardiovascular and cerebrovascular disease • Arthritis • Allergic disease • Eczema and skin inflammation • Inflammatory bowel disea
Slide 8: Disease Area Development Programs
© 2012 Galectin Therapeutics OTC:GALT 8 Disease Area Development Programs Cancer Fibrosis Liver Fibrosis Immunotherapy Chemotherapy GALECTINS
Slide 9: Disease Area Development Programs
© 2012 Galectin Therapeutics OTC:GALT 9 Disease Area Development Programs Cancer Fibrosis Liver Fibrosis Immunotherapy Chemotherapy GALECTINS
Slide 10: Multiple Diseases Lead To Liver Fibrosis And Cirrhosis
© 2012 Galectin Therapeutics OTC:GALT 10 Healthy Cirrhosis Hepatitis C (57%) Alcoholic liver disease (24%) Non-alcoholic fatty liver (9.1%) Hepatitis B (4.4%) Miscellaneous (5.5%) Source: Burden of liver disease in the United States: Summary of a workshop. American Association for the Study of Liver
Slide 11: Cirrhosis Is A Major Problem In The United States
© 2012 Galectin Therapeutics OTC:GALT 11 Liver Cirrhosis Is A Major Problem In The United States Transplants (6,291*) Wait List (17,000**) Death (44,677 # ) Cirrhosis (400,000 ## ) Millions of people with liver disease that may progress to cirrhosis * Performed in US in 2010 (UNOS) * * Prevalence in
Slide 12: Galectin-3 Is A Critical Target For Therapy of Liver Fibrosis
© 2012 Galectin Therapeutics OTC:GALT 12 Galectin-3 Is A Critical Target For Therapy of Liver Fibrosis 1. Galectin-3 is produced in large amounts by human fibrotic liver. 2. Galectin-3 is essential in mice for the development of liver fibrosis. Fibrosis due to toxin exposure or fatty liver does not
Slide 13: Galectin Inhibitors Effectively Treat Toxin-Induced Liver Fibrosis in Rats
© 2012 Galectin Therapeutics OTC:GALT 13 Galectin Inhibitors Effectively Treat Toxin-Induced Liver Fibrosis in Rats Liver Fibrosis, induced by injection of chemical toxin for 8 weeks Regression of Fibrosis after 4 weeks of treatment with GR-MD-02 Study performed under contract by Dr. Ji-yao Wang of
Slide 14: GR-MD-02 is Most Effective in Reducing Collagen Content in Fibrotic Rats
© 2012 Galectin Therapeutics OTC:GALT 14 N=8 N=8 N=8 GR-MD-02 is Most Effective in Reducing Collagen Content in Fibrotic Rats % Collagen Vehicle GR-MD-01 GR-MD-02 One way ANOVA Bondferroni P<0.001 P<0.05 P<0.05 P<0.05
Slide 15: Mouse NASH Model
© 2012 Galectin Therapeutics OTC:GALT 15 Early Rx Late Rx Early Rx Late Rx Mouse NASH Model (Non-Alcoholic Steatohepatitis, “Fatty Liver Disease”) GM-CT-01 (120 mg/kg 2X/week) GR-MD-02 (60 mg/kg 2X/week)
Slide 16: GR-MD-02 Markedly Improves NASH in a Mouse Model
© 2012 Galectin Therapeutics OTC:GALT 16 GR-MD-02 Markedly Improves NASH in a Mouse Model When it is Administered During Development of Disease and After Establishment of Disease Early Rx Vehicle GR-MD-02 Vehicle GR-MD-02 Late Rx
Slide 17: In a Mouse NASH Model GR-MD-02 Prevents and Completely Reverses Fibrosis
© 2012 Galectin Therapeutics OTC:GALT 17 In a Mouse NASH Model GR-MD-02 Prevents and Completely Reverses Fibrosis normal mouse 0.33 Early Rx Late Rx
Slide 18: Development Program & Markets
© 2012 Galectin Therapeutics OTC:GALT 18 Development Program & Markets • Pursue two indications for human proof of concept • NASH • Post-Transplant Hepatitis C Fibrosis • NASH • NIH estimates 5% of US population has NASH • Projected to become the number one reason for liver transplant • Multiple can
Slide 19: Fibrosis Development Program Timeline
© 2012 Galectin Therapeutics OTC:GALT 19 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2012 2013 2014 Phase II Post Tx Fibrosis Trial Phase I DE NASH GR-MD-02 Design Phase II Trial NASH NASH Fibrosis Development Program Preclinical Efficacy Studies GR-MD-02 First patient enrolled Pre-Clinical (Target SQ) Oral
Slide 20: Summary Of Development Program In Liver Fibrosis
© 2012 Galectin Therapeutics OTC:GALT 20 Summary Of Development Program In Liver Fibrosis • Liver fibrosis represents a very large unmet medical need • Galectin-3 protein is proven target • Drugs reverse liver fibrosis in animals and show efficacy in human cell culture models of fibrosis • Non toxic
Slide 21: Disease Area Development Programs
© 2012 Galectin Therapeutics OTC:GALT 21 Disease Area Development Programs Cancer Fibrosis Liver Fibrosis Immunotherapy GALECTINS Chemotherapy
Slide 22: Roles Of Secreted Galectins In Cancer
© 2012 Galectin Therapeutics OTC:GALT 22 Roles Of Secreted Galectins In Cancer The vast majority of cancers secrete large amounts of galectins • Tumor cell invasion: extracellular matrix adhesion & detachment • Stromal cell function • Metastasis: cell invasion and migration • Angiogenesis • Tumor im
Slide 23: Clinical Trial Performed In Metastatic Colorectal Cancer (DAVFU-003)
© 2012 Galectin Therapeutics OTC:GALT 23 Clinical Trial Performed In Metastatic Colorectal Cancer (DAVFU-003) Cancer Trial (DAVFU-003) Day 0 Day 28 GM-CT-01 Chemo (5-FU) • Phase 2 trial of 5-FU plus GM-CT-01 in line 3/4 therapy of metastatic colorectal cancer showed 6.7 months median survival. In si
Slide 24: Development Approach In Colorectal Cancer
© 2012 Galectin Therapeutics OTC:GALT 24 Development Approach In Colorectal Cancer • Studies demonstrate potential utility of galectin inhibitors in combination with chemotherapy in cancer • FDA has confirmed that preclinical and clinical data are adequate to proceed with large clinical trials • We
Slide 25: Blocking Galectins Enhances Tumor Killing By Immune System
© 2012 Galectin Therapeutics OTC:GALT 25 Cytotoxicity Tumor-Specific Cytotoxic T-Cell Lymphocytes Blocking Galectins Enhances Tumor Killing By Immune System Tumor Cells There are tumor specific cytotoxic T-cells in patients with cancer that are capable of killing tumor cells Experiments performed by
Slide 26: Blocking Galectins Enhances Tumor Killing By Immune System
© 2012 Galectin Therapeutics OTC:GALT 26 Tumor-Specific Cytotoxic T-Cell Lymphocytes Blocking Galectins Enhances Tumor Killing By Immune System Tumor Cells However, these T-cells lose the ability to kill tumor cells. A key reason is that Galectin-3 secreted by tumors bind to T-cells and turn off the
Slide 27: Blocking Galectins Enhances Tumor Killing By Immune System
© 2012 Galectin Therapeutics OTC:GALT 27 Cytotoxicity Tumor-Specific Cytotoxic T-Cell Lymphocytes Blocking Galectins Enhances Tumor Killing By Immune System Tumor Cells Addition of our drugs, which inhibit galectins, Experiments performed by Dr. Pierre van der Bruggen of the Ludwig Institute in Brus
Slide 28: GM-CT-01 Restores Ability of Immune Cells to Kill Tumor Cells
© 2012 Galectin Therapeutics OTC:GALT 28 GM-CT-01 Restores Ability of Immune Cells to Kill Tumor Cells
Slide 29: Melanoma Clinical Trial Design (I)
© 2012 Galectin Therapeutics OTC:GALT 29 Melanoma Clinical Trial Design (I) Phase I/II study of peptide vaccination associated with GM-CT-01, a galactomannan oligomer that inhibits galectin-3, in patients with advanced metastatic melanoma IMPD approved by EMA
Slide 30: Tumor Immune Enhancement Development Program
© 2012 Galectin Therapeutics OTC:GALT 30 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Tumor Immune Enhancement Development Program 2012 2013 2014 Preclinical Efficacy Studies GM-CT-01 & GR-MD-02 GM-CT-01 Phase I/II Melanoma Trial Top line results in Stage 1 First patient enrolled Top line results in Stage 2
Slide 31: Development Program In Cancer
© 2012 Galectin Therapeutics OTC:GALT 31 Development Program In Cancer Immunotherapy • Galectin proteins secreted by tumor cells are directly responsible for inhibiting the ability of immune cells to kill tumors • GM-CT-01 restores the ability of immune cells to kill tumor cells • Initial clinical t
Slide 32: Pipeline
© 2012 Galectin Therapeutics OTC:GALT 32 Pre-Clinical Registration Submitted Phase 1 Phase 3 Phase 2 Pipeline Chemotherapy Colorectal Cancer: GM-CT-01 • International (Colombia) • United States Immune Enhancer Melanoma: GM-CT-01 Liver Fibrosis Post Tx: GR-MD-02 NASH: GR-MD-02
Slide 33: Galectin Therapeutics Highlights
33 © 2012 Galectin Therapeutics OTC:GALT Galectin Therapeutics Highlights • Leader in galectin science • Pipeline of carbohydrate-based drug compounds that inhibit galectins • Focus on proven galectin activity in fibrosis and cancer • Liver Fibrosis • Target validated in convincing pre-clinical data
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