![]() Corporate Summary February 5, 2013 NASDAQ: GALT Exhibit 99.1 |
![]() 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,” “estimate,” “could,” “expect” and others. They are based on our current expectations and are subject to factors and uncertainties which could cause actual results to differ materially from those described in the statements. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others: incurrence of operating losses since our inception, uncertainty as to adequate financing of our operations, extensive and costly regulatory oversight that could restrict or prevent product commercialization, inability to achieve commercial product acceptance, inability to protect our intellectual property, dependence on strategic partnerships, product competition, and others stated in risk factors contained in our SEC filings. We cannot assure that we have identified all risks or that others may emerge which we do not anticipate. You should not place undue reliance on forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements. 2 © 2013 Galectin Therapeutics NASDAQ:GALT |
![]() Proprietary Compounds • First in class, proprietary compounds that inhibit galectin proteins • 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 steatohepatitis (NASH) and other causes of liver fibrosis Validated Science • Pre-clinical models show galectins are critical targets for intended diseases with mechanisms that would be novel in the market Large Market Opportunities • Enhancing the ability of immune system to kill cancer cells is synergistic with many current and experimental therapies • NASH and liver fibrosis indications would be first therapies for completely unmet medical needs, representing a multi-billion dollar market Intellectual Property • Sole ownership, no licenses granted • GM-CT-01: Matter and methods granted (expire 2023) • GR-MD-02: Use in liver fibrosis (expire 2026); Matter pending (priority of 2011) Experienced Management Team • Management team has collective experiencer in multiple biotech and Pharmaceutical companies and relevant scientific areas 3 Investment Highlights © 2013 Galectin Therapeutics NASDAQ:GALT |
![]() Experienced Management Team 4 Peter G. Traber, MD President, CEO, CMO • Over 25 years experience in biomedicine and pharmaceutical industries in research and development, clinical medicine, management and leadership, and business development. Medical expertise in liver disease • GlaxoSmithKline (CMO), Un of Pennsylvania (CEO), Baylor College of Medicine (CEO) Harold H. Shlevin, PhD COO • Over 25 years of senior management experience in the development and commercialization of pharmaceuticals, diagnostics and vaccines • Solvay Pharmaceuticals (CEO), CIBA Vision Ophthalmics (co-founder), Tikvah Therapeutics (Founder, CEO), Georgia Institute of Technology’s Advanced Technology Development Center, Altea Therapeutics Corporation Eliezer Zomer, PhD EVP, Product Development • Over 30 years experience in biotechnology engineering and regulatory in pharmaceuticals and diagnostics. • Koor Biotechnologies, Charm Sciences, Glycogenesis, HU Medical School (Jerusalem), Harvard University Thomas A. McGauley CFO (acting) • Over 10 years in accounting and finance with life science and technology companies • PricewaterhouseCoopers, Pro-Pharmaceuticals, deCode Genetics Anatole Klyosov, PhD Chief Scientist • Over 30 years’ experience in business and operations management for public and private scientific, and biotech corporations and startup companies • eHealthDirect, Signatron, ArsDigita and Thermo Fibergen J. Rex Horton Executive Director, Regulatory Affairs and Quality Assurance • Over 20 years of experience working in the biotech and life sciences industries, regulatory affairs and manufacturing. • Solvay Pharmaceuticals, Chelsea Therapeutics, Georgia Institute of Technology. © 2013 Galectin Therapeutics NASDAQ:GALT |
![]() • 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 5 © 2013 Galectin Therapeutics NASDAQ:GALT |
![]() Galectin Proteins Are Critical Participants In Pathogenesis of Many Fibrotic and Neoplastic Diseases 6 Bind to cell surface and matrix glycoproteins (galactose residues) • • • GALECTINS PROMOTE PATHOLOGY Markedly Increased in: 1. Inflammation 2. Fibrosis 3. Cancer *Secreted in small amounts normally by a number of cells, predominantly macrophages Galectin-3 is most prominent galectin secreted in disease © 2013 Galectin Therapeutics NASDAQ:GALT Promote cell- matrix interactions Promote cell-cell interactions Modulate cell signaling Secreted Galectin Proteins* |
![]() Galectin Proteins Galectin Inhibitor Galectin Inhibitors: A New Class of Pathology Modulators 7 • 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 function and modulates multiple cellular pathways in pathology representing a potential new class of therapeutic agents • Low toxicity potential as a carbohydrate with no toxic metabolites • Two classes of compounds under development • GM-CT • GR-MD • Low manufacturing costs; abundant natural plant product starting materials © 2013 Galectin Therapeutics NASDAQ:GALT |
![]() 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 • Method of use in liver fibrosis issued 2012 (expires 2026) • Method of use in NASH patent pending (priority 2011) • GR-MD Class (current NCE is GR-MD-02) • Method of use in liver fibrosis patent issued (expires 2026) • Composition of matter patent pending (priority 2011) • Method of use in NASH patent pending (priority 2011) • All intellectual property generated in house with no encumbrances • No established generic pathway for such complex carbohydrate drugs 8 © 2013 Galectin Therapeutics NASDAQ:GALT |
![]() • 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 9 © 2013 Galectin Therapeutics NASDAQ:GALT |
![]() 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 affected by galectins 10 The “Galectin Effect” protects tumors from immune system © 2013 Galectin Therapeutics NASDAQ:GALT |
![]() 11 Cytokines Galectin-3 Cytokines Kill tumor cells GM-CT-01 Galectin-3 secreted by tumor cells binds to surface of T-cells and inhibits cytokine secretion Treatment with GM-CT-01 blocks Galectin-3 and restores T-cell cytokine secretion and tumor killing Experiments performed by Dr. Pierre van der Bruggen of the Ludwig Institute in Brussels, Belgium in collaboration with Galectin Therapeutics Tumors Evade the Immune System Using the “Galectin Effect” and GM-CT-01 Reverses This Effect © 2013 Galectin Therapeutics NASDAQ:GALT Tumor Cells T-Cells T-Cells Tumor Cells |
![]() 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 • Three Phase II trials were conducted, but only partially completed • One Phase II trial (DAVFU-001) of 5-FU plus GM-CT-01 in line 3/4 therapy of metastatic colorectal cancer showed 6.7 months median survival. In similar patients, Erbitux ®* had a 6.1 month survival compared to 4.6 months with no therapy • When the data from the three partially completed Phase II trials were pooled, the serious adverse events associated with 5-FU were reduced when compared to historical controls • Our preclinical efficacy and clinical safety data were strong enough to obtain an IMPD for Phase I/II trial in metastatic melanoma with a combination of a tumor vaccine and GM-CT-01 to test the efficacy of blocking the “Galectin Effect” [Study not being conducted under FDA IND, but there is open IND for GM-CT-01 12 *“Erbitux® is a registered trademark of ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company.“ © 2013 Galectin Therapeutics NASDAQ:GALT |
![]() 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” 13 Melanoma “Proof of Concept” Trial: Patients: Advanced metastatic melanoma Design: Two Stage (6 X 2 cohorts in stage 1 and 23 X 2 cohorts in stage 2) Regimen: Prime with melanoma specific peptide vaccine Treat with GM-CT-01 to block “Galectin Effect” Endpoint: Partial or complete response by imaging Group 2 patients have additional injection of GM-CT-01 in cutaneous tumors © 2013 Galectin Therapeutics NASDAQ:GALT |
![]() Tumor Immune Enhancement Development Program 14 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2012 2013 2014 GM-CT-01 Phase I/II Melanoma Trial* Pursue Partnering Discussions *Conducted in Belgium under an IMPD. Not conducted under FDA IND, but there is an open IND for GM-CT-01 At conclusion of Stage 1 of study: • • • • © 2013 Galectin Therapeutics NASDAQ:GALT Stage 2 TBD Top line results in Stage 1 Continue to Stage 2 with some efficacy Consider Phase IIb controlled trial with strong efficacy Seek partnership with company with marketed or late stage cancer immunotherapy Stop for lack of efficacy |
![]() 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 system • Two agents have been approved for use to date • Dendritic cell vaccine: Provenge® (Dendreon) • T-cell activator (CTLA4 receptor mAb): Yervoy® (Ipilimumab, BMS) • Many more vaccines and activators in development • Our drugs reverse the “Galectin Effect” by which tumors inhibit the immune system and may be synergistic with all tumor immunotherapies. • While tumor vaccines are patient and tumor specific, reversal of the “Galectin Effect” appears to be universal. Initial Phase I/II clinical trial in Belgium in combination with a vaccine to treat metastatic melanoma • The tumor vaccine market is forecast to be over $7 billion by 2015 15 © 2013 Galectin Therapeutics NASDAQ:GALT May be effective with unaltered immune system |
![]() 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 stimulatory approaches • In this regard, competition will come from other galectin-inhibitors • Galecto Biotech AG (Sweden): Discovery phase focusing on small molecule inhibitors. Development program focused on lung fibrosis. • LaJolla Pharmaceuticals (CA): In Jan. 2012, they purchased GCS-100 from Solana Therapeutics (formally Prospect Therapeutics, formally Glycogenesis). GCS-100 is a natural product compound with claims for binding galectins; focused on blood cancers; significant side effects reported. Progressing in development for cancer and kidney fibrosis. • Mandel Med (Oakland, CA): Truncated galectin-3 protein. Not progressed into human trials and no active program currently. • Galectin Therapeutics is best positioned with a human trial in cancer immunotherapy; GM-CT-01 has proved safe in Phase I and three partially completed Phase II trials. 16 © 2013 Galectin Therapeutics NASDAQ:GALT |
![]() • 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 17 © 2013 Galectin Therapeutics NASDAQ:GALT |
![]() NASH and Liver Fibrosis are Multi- Billion Dollar Markets In US Alone Transplants (6,291*) Wait List (17,000**) Death From Cirrhosis (44,677 # ) Cirrhosis (400,000 ## ) NASH: 9-15 Million & * Performed in US in 2010 (UNOS) * * Prevalence in US 2010 (UNOS) 18 # Deaths in 1998 (AASLD Workshop, 2001) ## Prevalence in US 1976-1980 (NIDDK) Hepatitis C, Hepatitis B, Alcohol & Prevalence in US 2011 (NIH) • 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 therapy for NASH © 2013 Galectin Therapeutics NASDAQ:GALT |
![]() Galectin-3 Is A Critical Protein Target For Therapy of Liver Fibrosis 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 that lack the galectin-3 gene Galectin inhibitors reverse experimental fibrosis in rats induced by both fibrosis and fatty liver 19 Key Evidence: Key Evidence: © 2013 Galectin Therapeutics NASDAQ:GALT |
![]() Galectin Inhibitor GR-MD-02 Effectively Treats Toxin-Induced Liver Fibrosis in Rats Treatment with vehicle alone for four weeks (Control) shows robust fibrosis Treatment with GR-MD-02 for four weeks shows dramatic regression of fibrosis 20 Galectin Therapeutics Data Liver fibrosis induced in all rats by injection of chemical toxin (thioacetimide) for 8 weeks © 2013 Galectin Therapeutics NASDAQ:GALT |
![]() 21 © 2013 Galectin Therapeutics NASDAQ:GALT |
![]() GR-MD-02 Markedly Improved NASH (Non-Alcoholic Steatohepatitis) in a Mouse Model Vehicle GR-MD-02 NASH was induced in mice by rendering them diabetic and feeding them a high fat diet © 2013 Galectin Therapeutics NASDAQ:GALT |
![]() GR-MD-02 Prevented and Completely Reversed Fibrosis in NASH Mouse Model 23 Early Treatment Late Treatment normal mouse 0.33 © 2013 Galectin Therapeutics NASDAQ:GALT |
![]() Early and Late Therapy Compiled Data © 2013 Galectin Therapeutics NASDAQ:GALT 24 |
![]() Treatment with GR-MD-02 Markedly Reduces Galectin-3 in NASH Mice 25 Vehicle GR-MD-02 Immunohistochemistry for detection of Galectin-3 © 2013 Galectin Therapeutics NASDAQ:GALT |
![]() Inhibition of Gal-3 May Have Multiple Sites of Action in Therapy of NASH 26 Extracellular Matrix Cytokines ECM Dissolution MMPs Inflammation ceases Stellate Cells Macrophages Gal-3 Gal-3 Gal-3 Gal-3 Stellate Cell Release of multiple inflammatory cytokines, including TGF- 1, a critical mediator of fibrosis Quiescent Activated Hepatocyte Macrophage T-Cell Bile Duct Cell Lipo-peroxidation Products Scavenger receptor increases cellular uptake of toxic products Inhibit scavenger mechanism and reduce cellular toxicity Galectin GR-MD-02 Increases TGF- receptor signaling Reduce cell membrane TGF- receptor activity Promotes activation of stellate cells to myofibroblasts Reduces activation of stellate cells ? Effect on ECM dissolution; Macrophages © 2013 Galectin Therapeutics NASDAQ:GALT Gal-3 expression and activation of macrophages Reduces Gal-3 and activation of macrophages; changes in macrophage subtypes? Hyperglycemia Adipocytokines Free Fatty Acids Metabolic Syndrome Glucose Intolerance Fat Accumulation Impaired Lipid Metabolism Cause of Liver Injury Mediators Inflammation Fibrosis Resolution 1 |
![]() Targeting Anti-Galectin Therapy In The Progression of NASH 27 Decades Because of effect on inflammation in NASH and ability to reduce existing fibrosis, our clinical program will target NASH patients with advanced fibrosis © 2013 Galectin Therapeutics NASDAQ:GALT Development of Obesity Insulin Resistance/Diabetes Steatosis (fatty liver) NASH Fibrosis Cirrhosis |
![]() 28 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2012 2013 2014 Phase 1 NASH trial NASH NASH Development Program: GR-MD-02 Phase 2 NASH Trial File Fast Track Designation to be filed; Breakthrough Designation following Phase 1 IND Submitted Phase 1 Trial: Patient Inclusion: Phase 2 Trial: Patient Inclusion: Biopsy proven NASH with advanced fibrosis © 2013 Galectin Therapeutics NASDAQ:GALT Timelines on final design First patient enrolled Top line results First patient enrolled Pre-Clinical Completed Serum biomarkers to assess for pharmacodynamic effect Patient safety Four weekly IV doses per cohort with escalation to target dose Biopsy proven NASH with advanced fibrosis Design Primary Endpoint Secondary Endpoints Secondary Endpoints Safety; Serum biomarkers, MR-fat and elastography Primary Endpoint Liver biopsy evaluated for percent area collagen Design Randomized, controlled, double blinded study with at least six months of therapy : : : : : : |
![]() 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 Insulin Resistance • Pioglitazone • Failed to achieve significant endpoints in phase 2 and phase 3 clinical trials, but some evidence of effect Lipid Metabolism • Aramchol & others • Cholesterol inhibition, no clinical results Modulate the Immune System • EGS21 (Enzo) • Pentoxifylline • Abandoned after phase 2 trial • Non significant phase 3 results Protease Inhibition • GS-9450 (Gilead) • Liver toxicity in phase 2: abandoned Bile salt metabolism • Colesevelam • Obeticolic acid • Intestinal bile salt binder, Phase 2 trial failed • FXR agonist; Phase 2 coming to conclusion Anti-Oxidant / toxin metabolism • Vitamin E • MND-21 (Mochida) • Cysteamine • Effective in NASH score in phase 3, but not fibrosis • Omega-3 fatty acid (phase 2 trial) • Phase 2 trial in adolescents underway Anti-collagen cross- linking • Lysyl oxidase-like-2 mAb (GS-6624, Gilead) • Initiated Phase 2 trials in 2012 in patients with NASH and fibrosis, top line data Q3 2015. 29 • GR-MD-02 is well positioned with respect to competition • Most attractive mechanism: multiple sites of action in disease • Independent of hyperglycemia or hyperlipidemia • May reverse established fibrosis • Low toxicity potential as a carbohydrate with no toxic metabolites © 2013 Galectin Therapeutics NASDAQ:GALT |
![]() 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 30 © 2013 Galectin Therapeutics NASDAQ:GALT |
![]() 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: Initiate Phase 1 NASH trial • 1/14: Phase 1 NASH trial results • Q1 2014: Initiate Phase 2 NASH trial • Top line data from Phase 2 trial TBD based on design 31 © 2013 Galectin Therapeutics NASDAQ:GALT |
![]() Finances & Capitalization Common Stock Shares (9/30/12) Common Shares 15,966,437 Preferred Series A (converted) 260,430 Preferred: Series B (converted) 2,000,000 Preferred: Series C (converted) 366,680 Warrants: Series B* 5,000,000 Other Warrants** 2,424,241 Options Outstanding*** 3,541,630 Total Outstanding 29,559,418 32 * Exercise Price: $3.00 (all controlled by 10X Fund) ** Weighted Average Exercise Price: $4.97 Cash on Hand: $11.1 million (at 9/30/12) Funded to Jan 2014 (based on current planned R&D) *** Weighted Average Exercise Price: $5.88 © 2013 Galectin Therapeutics NASDAQ:GALT Total Outstanding Management, Officers and Directors 10X Fund (includes Series B Shares) Series A Shares Series C Shares Other Warrants and Options Publicly Traded Warrants Public Float |
![]() Proprietary Compounds • First in class, proprietary compounds that inhibit galectin proteins • 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 steatohepatitis (NASH) and other causes of liver fibrosis Validated Science • Pre-clinical models show galectins are critical targets for intended diseases with mechanisms that would be novel in the market Large Market Opportunities • Enhancing the ability of immune system to kill cancer cells is synergistic with many current and experimental therapies • NASH and liver fibrosis indications would be first therapies for completely unmet medical needs, representing a multi-billion dollar market Intellectual Property • Sole ownership, no licenses granted • GM-CT-01: Matter and methods granted (expire 2023) • GR-MD-02: Use in liver fibrosis (expire 2026); Matter pending (priority of 2011) Experienced Management Team • Management team has collective experiencer in multiple biotech and Pharmaceutical companies and relevant scientific areas 33 Investment Highlights © 2013 Galectin Therapeutics NASDAQ:GALT |