Galectin Therapeutics Inc. · NASDAQ:GALT
Galectin Therapeutics — Investor Presentation (September 2011)
38 slides from Galectin Therapeutics's investor presentation, Sep 29, 2011
Slide 1: Company Update September 27, 2011
Company Update September 27, 2011 OTC: GALT Exhibit 99.1
Slide 2: Forward Looking Statements
© 2011 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: Recent Highlights
© 2011 Galectin Therapeutics OTC:GALT 3 Recent Highlights • March 2011: New CEO • May 2011: Announced new strategic priorities, new web site • May 2011: Name changed to Galectin Therapeutics (Formally Pro-Pharmaceuticals) • July 2011: Analyst coverage initiated by Shiv Kapoor of Morgan Joseph TriArt
Slide 4: Galectin Therapeutics Highlights
4 © 2011 Galectin Therapeutics OTC:GALT Galectin Therapeutics Highlights • Leader in galectin science • Pipeline of carbohydrate-based drug compounds that inhibit galectins • Liver fibrosis program goal to be first therapy for this indication • Target validated in convincing pre-clinical data • Clin
Slide 5: Galectin Proteins Are Important In Disease Pathogenesis
© 2011 Galectin Therapeutics OTC:GALT 5 Galectin Proteins Are Important In Disease Pathogenesis Secreted Galectin Proteins 1. Bind to cell surface and matrix glycoproteins ( galactose residues) 2. Modulate cell signaling 3. Promote cell-cell interactions 4. Promote cell- matrix interactions PROMOTE
Slide 6: Our Galectin Inhibitors Are Novel Carbohydrate-Based Drug Compounds
© 2011 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: We Are The Leaders In Galectin Inhibitor Drug Development
7 © 2011 Galectin Therapeutics OTC:GALT We Are The Leaders In Galectin Inhibitor Drug Development • Only company with galectin inhibitors in clinical development • Published authoritative books in the field
Slide 8: Galectins Are Involved In The Pathogenesis Of Many Diseases
8 © 2011 Galectin Therapeutics OTC:GALT 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 9: How Do We Choose Diseases For Drug Development?
9 © 2011 Galectin Therapeutics OTC:GALT So, How Do We Choose Diseases For Drug Development? • Galectins are proven important in the mechanism of disease • There are serious, life threatening consequences to patients • There are no, few, or ineffective therapies • Rapid development pathways are possi
Slide 10: Disease Area Development Programs
10 © 2011 Galectin Therapeutics OTC:GALT Disease Area Development Programs Cancer Fibrosis Liver Fibrosis Chemotherapy Immunotherapy GALECTINS
Slide 11: Disease Area Development Programs
11 © 2011 Galectin Therapeutics OTC:GALT Disease Area Development Programs Cancer Fibrosis Liver Fibrosis Chemotherapy Immunotherapy GALECTINS
Slide 12: Galectin Therapeutics
Galectingy Therapeutics Maal
Slide 13: Cirrhosis Is A Major Problem In The United States
13 © 2011 Galectin Therapeutics OTC:GALT 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 14: Galectin-3 Is A Critical Target For Therapy of Liver Fibrosis
© 2011 Galectin Therapeutics OTC:GALT 14 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 3. Galectin inhibitors block production of fibrogenic mar
Slide 15: Galectin Inhibitors Effectively Treat Liver Fibrosis in Rats
15 © Galectin Therapeutics OTC : GALT Galectin Inhibitors Effectively Treat 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-01
Slide 16: Summary Of Development Program
© Galectin Therapeutics OTC : GALT 16 Summary Of Development Program Rationale 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 • No
Slide 17: Development Program & Markets
© 2011 Galectin Therapeutics OTC:GALT 17 Development Program & Markets • Initial Indication: Post transplant recurrent Hepatitis C with fibrosis • Focus of first phase II clinical trial • Orphan disease designation possible • Additional peri-transplant indications: • Established cirrhosis of various
Slide 18: Fibrosis Pipeline: Drug Advancement
Pre-Clinical Phase 1 Phase Phase Registration Submitted © 2011 Galectin Therapeutics OTC:GALT 18 2 3 Fibrosis Pipeline: Drug Advancement December 2011 Liver Fibrosis GM-CT-01 GM-CT-02 GR-MD-01 GR-MD-02 More advanced than typical pre-clinical development program: Efficacy shown in human cells as well
Slide 19: Fibrosis Clinical Program (First Indication Clinical Trials)
© 2011 Galectin Therapeutics OTC:GALT 19 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Fibrosis Clinical Program (First Indication Clinical Trials) 2011 2012 2013 Pre-IND Meeting Initiate P-II Initiate P-I Submit IND GM-CT-01 Others
Slide 20: Disease Area Development Programs
© 2011 Galectin Therapeutics OTC:GALT 20 Disease Area Development Programs Cancer Fibrosis Liver Fibrosis Immunotherapy Chemotherapy GALECTINS
Slide 21: Roles Of Secreted Galectins In Cancer
21 © 2011 Galectin Therapeutics OTC:GALT Roles Of Secreted Galectins In Cancer The vast majority of cancers secrete large amounts of galectins • Galectins impact cancer growth at many points • Interfering with galectin function has been shown to have beneficial effects • Galectin Therapeutics has pr
Slide 22: Phase 2 Clinical Trial Performed in Metastatic Colorectal Cancer (DAVFU-003)
Phase 2 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 Twenty (20) patients enrolled who all had 3 to 4 previous courses of chemot
Slide 23: GM-CT-01 Reduces 5-FU Chemotherapy Related Side Effects
© 2011 Galectin Therapeutics OTC:GALT 23 GM-CT-01 Reduces 5-FU Chemotherapy Related Side Effects Simultaneous improved efficacy with reduction in side effects of standard chemotherapy would be desirable in cancer therapeutics Data on 5-FU+GM-CT-01 compiled from patients receiving full dose therapy i
Slide 24: Development Approach In Colorectal Cancer
© 2011 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 • Our
Slide 25: Registration And Marketing GM-CT-01 In Colombia And Latin America
© 2011 Galectin Therapeutics OTC:GALT 25 Registration And Marketing GM-CT-01 In Colombia And Latin America • The government of Colombia, and oncology key opinion leaders in that country, expressed an interest in making GM-CT-01 available for use in Colombia for patients with metastatic colorectal ca
Slide 26: Disease Area Development Programs
© 2011 Galectin Therapeutics OTC:GALT 26 Disease Area Development Programs Cancer Fibrosis Liver Fibrosis Immunotherapy GALECTINS Chemotherapy
Slide 27: Enhancing Anti-Tumor Immunity Is A Promising Effect Of Blocking Galectins
© 2011 Galectin Therapeutics OTC:GALT 27 Enhancing Anti-Tumor Immunity Is A Promising Effect Of Blocking Galectins • Tumor cell invasion: extracellular matrix adhesion & detachment • Stromal cell function • Metastasis: cell invasion and migration • Angiogenesis • Tumor immunity
Slide 28: Blocking Galectins Enhances Tumor Killing By Immune System
© 2011 Galectin Therapeutics OTC:GALT 28 Cytotoxicity Tumor-Specific Cytotoxic T-Cell Lymphocytes Blocking Galectins Enhances Tumor Killing By Immune System Studies done in collaboration with Ludwig Institute, Brussels, Belgium Tumor Cells
Slide 29: GM-CT-01 Restores Ability of Immune Cells to Kill Tumor Cells
© 2011 Galectin Therapeutics OTC:GALT 29 GM-CT-01 Restores Ability of Immune Cells to Kill Tumor Cells
Slide 30: GM-CT-01 In Tumor Immunotherapy
© 2011 Galectin Therapeutics OTC:GALT 30 GM-CT-01 In Tumor Immunotherapy • A Phase 1/2 study is scheduled to begin in Q4 2011 • IMPD (Investigational Medicinal Product Dossier) was submitted to the EMA (European Medicines Agency) on September 20, 2011 • Patients with advanced metastatic melanoma • T
Slide 31: Melanoma Clinical Trial Design (I)
© 2011 Galectin Therapeutics OTC:GALT 31 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
Slide 32: Melanoma Clinical Trial Design (II)
© 2011 Galectin Therapeutics OTC:GALT 32 Melanoma Clinical Trial Design (II) 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
Slide 33: Regimen of GM-CT-01 in Melanoma Trial Versus Colorectal Cancer Trial
© 2011 Galectin Therapeutics OTC:GALT 33 Regimen of GM-CT-01 in Melanoma Trial Versus Colorectal Cancer Trial GM-CT-01 Melanoma Trial Day 0 Day 21 Vaccine Cancer Trial (DAVFU-003) Day 0 Day 28 GM-CT-01 Chemo (5-FU)
Slide 34: Development Program In Cancer Immunotherapy
© 2011 Galectin Therapeutics OTC:GALT 34 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 35: Pipeline
Pre-Clinical Phase 1 Phase 2 Phase 3 Registration Submitted 35 © 2011 Galectin Therapeutics OTC:GALT Colorectal Cancer GM-CT-01 • International (Colombia) • United States Tumor Vaccine GM-CT-01 Liver Fibrosis GM-CT-01 GM-CT-02 GR-MD-01 GR-MD-02 Pipeline
Slide 36: Catalyst Milestones
© 2011 Galectin Therapeutics OTC:GALT 36 Catalyst Milestones • Fibrosis Program • Complete pre-clinical assessment and announce drug or drugs to take into clinical development: December 2011 • Commence phase 2 trial Q2 2012 with top line results Q2/Q3 2013 (GM-CT-01) • Commence phase 1 trial Q3 2012
Slide 37: Galectin Therapeutics Highlights
37 © 2011 Galectin Therapeutics OTC:GALT Galectin Therapeutics Highlights • Leader in galectin science • Pipeline of carbohydrate-based drug compounds that inhibit galectins • Liver fibrosis program goal to be first therapy for this indication • Target validated in convincing pre-clinical data • Cli
Slide 38: Galectin Therapeutics
Galectin gy Therapeutics
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