Galectin Therapeutics Inc. · NASDAQ:GALT
Galectin Therapeutics — Investor Presentation (February 2013)
33 slides from Galectin Therapeutics's investor presentation, Feb 5, 2013
Slide 1: Corporate Summary
Exhibit 99.1 Corporate Summary February 5, 2013 NASDAQ: GALT
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,”
Slide 3: Investment Highlights
Investment Highlights Proprietary • First in class, proprietary compounds that inhibit galectin proteins Compounds • Complex carbohydrate drugs with highly favorable safety profile • GM-CT-01: Enhanced ability of immune cells to kill of cancer cells • GR-MD-02: Potential to treat non-alcoholic steat
Slide 4: Experienced Management Team
Experienced Management Team Peter G. Traber, MD • Over 25 years experience in biomedicine and pharmaceutical industries in research President, CEO, CMO and development, clinical medicine, management and leadership, and business development. Medical expertise in liver disease • GlaxoSmithKline (CMO),
Slide 5: Science of Galectins, Immune Enhancement in Cancer Therapy, Liver Fibrosis
• Science of Galectins • Galectin Function • Galectin Inhibitors • Intellectual Property • Immune Enhancement in Cancer Therapy • Mechanism of Action • Regulatory and Clinical Plan • Competitive Positioning • Liver Fibrosis • Mechanism of Action • Regulatory and Clinical Plan • Competitive Positioni
Slide 6: Galectin Proteins Are Critical Participants In Pathogenesis of Many Fibrotic and Neoplastic Diseases
Galectin Proteins Are Critical Participants In Pathogenesis of Many Fibrotic and Neoplastic Diseases Bind to cell surface Markedly Increased in: and matrix 1. Inflammation glycoproteins 2. Fibrosis (galactose residues) 3. Cancer • Modulate cell signaling GALECTINS Secreted • Promote cell-cell PROMOT
Slide 7: Galectin Inhibitors: A New Class of Pathology Modulators
Galectin Inhibitors: A New Class of Pathology Modulators • Novel complex carbohydrate drugs that target secreted and membrane-associated galectins by virtue of high molecular weight • Strongest binding to galectin-3, most prominent galectin in disease processes • Binding to galectins disrupts functi
Slide 8: Intellectual Property
Intellectual Property • GM-CT Class (current NCE is GM-CT-01) • US Composition of matter patent Issued 2011 (expires 2023) • Five US issued method of use patents in combination with cancer therapy for increased efficacy and reduced side effects • International Patents: 14 granted and 5 pending • Met
Slide 9: Science of Galectins, Immune Enhancement in Cancer Therapy, Liver Fibrosis
• Science of Galectins • Galectin Function • Galectin Inhibitors • Intellectual Property • Immune Enhancement in Cancer Therapy • Mechanism of Action • Regulatory and Clinical Plan • Competitive Positioning • Liver Fibrosis • Mechanism of Action • Regulatory and Clinical Plan • Competitive Positioni
Slide 10: 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 & detachment • Metastasis: cell invasion and migration • Angiogenesis • Tumor immunity has recently been shown to be critically affecte
Slide 11: Tumors Evade the Immune System Using the Galectin Effect and GM-CT-01 Reverses This Effect
Tumors Evade the Immune System Using the “Galectin Effect” and GM-CT-01 Reverses This Effect Galectin-3 secreted by Treatment with GM-CT-01 tumor cells binds to surface blocks Galectin-3 and of T-cells and inhibits restores T-cell cytokine cytokine secretion secretion and tumor killing GM-CT-01 Gale
Slide 12: GM-CT-01 Has Demonstrated Safety in over 100 Human Subjects
GM-CT-01 Has Demonstrated Safety in over 100 Human Subjects in Phase I and Partially Completed Phase II Clinical Trials with Some Evidence of Efficacy • Phase I trial (DAVFU-001) in 40 subjects with end stage cancer showed GM- CT-01 was safe alone and in combination with the chemotherapy 5-FU • Thre
Slide 13: Melanoma Proof of Concept Trial Design
Preclinical efficacy and clinical safety data sufficient to obtain an IMPD for treatment of metastatic melanoma to test the efficacy of blocking the “Galectin Effect” Melanoma “Proof of Concept” Trial: Patients: Advanced metastatic melanoma Design: Two Stage (6 X 2 cohorts in stage 1 and 23 X 2 coho
Slide 14: Tumor Immune Enhancement Development Program
Tumor Immune Enhancement Development Program 2012 2013 2014 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Phase I/II Melanoma Trial* GM-CT-01 Top line results in Stage 2 TBD Stage 1 At conclusion of Stage 1 of study: • Continue to Stage 2 with some efficacy • Consider Phase IIb controlled trial with strong ef
Slide 15: Immune Enhancement by Blocking Galectin Effect is Synergistic With Many Emerging Cancer Immunotherapies
Immune Enhancement by Blocking “Galectin Effect” is Synergistic With Many Emerging Cancer Immunotherapies • Enhancing the ability of the immune system to recognize and kill tumor cells is a very active area in the personalized approach to cancer therapy. The “Galectin Effect” inhibits the immune sys
Slide 16: Best Positioned to Advance Tumor Immunotherapy with Galectin Inhibitor
Best Positioned to Advance Tumor Immunotherapy with Galectin Inhibitor • Market for tumor vaccines is expected to grow to $7B by 2015. If ipilimumab (Yervoy ®, BMS) is included, market is even larger • Blocking the “Galectin Effect” would be synergistic with all types of tumor vaccines or immune sti
Slide 17: Science of Galectins, Immune Enhancement in Cancer Therapy, Liver Fibrosis
• Science of Galectins • Galectin Function • Galectin Inhibitors • Intellectual Property • Immune Enhancement in Cancer Therapy • Mechanism of Action • Regulatory and Clinical Plan • Competitive Positioning • Liver Fibrosis • Mechanism of Action • Regulatory and Clinical Plan • Competitive Positioni
Slide 18: NASH and Liver Fibrosis are Multi-Billion Dollar Markets In US Alone
NASH and Liver Fibrosis are Multi- Billion Dollar Markets In US Alone • The ONLY current therapy for advanced fibrosis (cirrhosis) is liver transplantation • No approved medical therapy for fibrosis • While there are treatments for some underlying etiologies (Hepatitis C and B), there is no approved
Slide 19: Galectin-3 Is A Critical Protein Target For Therapy of Liver Fibrosis
Galectin-3 Is A Critical Protein Target For Therapy of Liver Fibrosis Key Evidence: Galectin-3 is produced in large amounts by fibrotic liver (animal and human) Galectin-3 is essential in mice for the development of liver fibrosis Fibrosis due to toxin exposure or fatty liver does not occur in mice
Slide 20: Galectin Inhibitor GR-MD-02 Effectively Treats Toxin-Induced Liver Fibrosis in Rats
Galectin Inhibitor GR-MD-02 Effectively Treats Toxin-Induced Liver Fibrosis in Rats Liver fibrosis induced in all rats by injection of chemical toxin (thioacetimide) for 8 weeks Treatment with vehicle alone for Treatment with GR-MD-02 for four four weeks (Control) shows weeks shows dramatic regressi
Slide 21: © 2013 Galectin Therapeutics NASDAQ:GALT
© 2013 Galectin Therapeutics NASDAQ:GALT 21
Slide 22: GR-MD-02 Markedly Improved NASH in a Mouse Model
GR-MD-02 Markedly Improved NASH (Non-Alcoholic Steatohepatitis) in a Mouse Model NASH was induced in mice by rendering them diabetic and feeding them a high fat diet Vehicle GR-MD-02 © 2013 Galectin Therapeutics NASDAQ:GALT
Slide 23: GR-MD-02 Prevented and Completely Reversed Fibrosis in NASH Mouse Model
GR-MD-02 Prevented and Completely Reversed Fibrosis in NASH Mouse Model Early Treatment Late Treatment normal mouse 0.33 © 2013 Galectin Therapeutics 23 NASDAQ:GALT
Slide 24: Early and Late Therapy Compiled Data
Early and Late Therapy Compiled Data © 2013 Galectin Therapeutics 24 NASDAQ:GALT
Slide 25: Treatment with GR-MD-02 Markedly Reduces Galectin-3 in NASH Mice
Treatment with GR-MD-02 Markedly Reduces Galectin-3 in NASH Mice Immunohistochemistry for detection of Galectin-3 Vehicle GR-MD-02 © 2013 Galectin Therapeutics NASDAQ:GALT 25
Slide 26: Inhibition of Gal-3 May Have Multiple Sites of Action in Therapy of NASH
Inhibition of Gal-3 May Have Multiple Sites of Action in Therapy of NASH Metabolic Syndrome Cause of Liver Injury Glucose Fat Impaired Lipid Intolerance Accumulation Metabolism Mediators Hyperglycemia Adipocytokines Free Fatty Acids T-Cell Hepatocyte Bile Duct Cell Macrophage Galectin GR-MD-02 Gal-3
Slide 27: Targeting Anti-Galectin Therapy In The Progression of NASH
Targeting Anti-Galectin Therapy In The Progression of NASH Decades Development of Obesity Insulin Resistance/Diabetes Steatosis (fatty liver) NASH Fibrosis Cirrhosis Because of effect on inflammation in NASH and ability to reduce existing fibrosis, our clinical program will target NASH patients with
Slide 28: NASH Development Program: GR-MD-02
NASH Development Program: GR-MD-02 2012 2013 2014 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Phase 2 NASH Trial IND Phase 1 NASH trial NASH Pre-Clinical Completed Submitted Timelines on final design First patient Top line First patient enrolled results enrolled File Fast Track Designation to be filed; Brea
Slide 29: Examples of Therapeutic Approaches Under Investigation for Therapy of NASH
Examples of Therapeutic Approaches Under Investigation for Therapy of NASH General Mechanism Examples Comments Obesity • Lifestyle, dieting • Can be beneficial; not effective in advanced NASH Treat Diabetes and • Pioglitazone • Failed to achieve significant endpoints in phase 2 and Insulin Resistanc
Slide 30: Science of Galectins, Immune Enhancement in Cancer Therapy, Liver Fibrosis
Science of Galectins Galectin Function Galectin Inhibitors Intellectual Property Immune Enhancement in Cancer Therapy Mechanism of Action Regulatory and Clinical Plan Competitive Positioning Liver Fibrosis Mechanism of Action Regulatory and Clinical Plan Competitive Positioning Milestones © 2013 Gal
Slide 31: Key Company Milestones: 12 months
Key Company Milestones: 12 months • Cancer • Phase I/II (IIa) metastatic melanoma trial, first patient infused 5/12 • Five patients currently enrolled; stage 1 data likely available in first half of 2013. • NASH with Advanced Fibrosis (Fatty Liver Disease) • 1/30/13: IND Submitted to FDA • 3-4/13: I
Slide 32: Finances & Capitalization
Finances & Capitalization Cash on Hand: $11.1 million (at 9/30/12) Funded to Jan 2014 (based on current planned R&D) Common Stock Shares (9/30/12) Common Shares 15,966,437 Total Outstanding Preferred Series A 260,430 Management, (converted) Officers and Directors Preferred: Series B 2,000,000 10X Fu
Slide 33: Investment Highlights
Investment Highlights Proprietary • First in class, proprietary compounds that inhibit galectin proteins Compounds • Complex carbohydrate drugs with highly favorable safety profile • GM-CT-01: Enhanced ability of immune cells to kill of cancer cells • GR-MD-02: Potential to treat non-alcoholic steat
Galectin Therapeutics — Investor Presentation (February 2013) on 6ix