![]() Corporate Presentation February 10, 2014 NASDAQ: GALT www.galectintherapeutics.com © 2014 Galectin Therapeutics NASDAQ:GALT EXHIBIT 99.1 |
![]() Forward Looking Statements This presentation contains, in addition to historical information, statements that look forward in time or that express management’s beliefs, expectations or hopes. Such statements are 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 risks and uncertainties that could cause actual results to differ materially from those described in the statements. These statements include our plans, expectations and goals regarding drugs in development, clinical trials and regulatory approval for any of our drugs or treatments, the anticipated timeline for clinical trials and results, related market opportunities for our drugs, potential benefits of our drugs, efforts related to partnering opportunities with other companies, estimates regarding cash and spending, liquidity and funding requirements for clinical trials, and estimates regarding those impacted by NASH, liver fibrosis and cirrhosis. The risks and uncertainties impacting these statements include that our plans, expectations and goals regarding drugs in development, clinical trials and regulatory approval are subject to factors beyond our control. Our clinical trials may not begin or produce positive results in a timely fashion, if at all, and any necessary changes during the course of such trials could prove time consuming and costly. We may have difficulty in enrolling candidates for testing and we may not be able to achieve the desired results. Upon receipt of regulatory approval for any drug or treatment, we may face competition with other drugs and treatments that are currently approved or those that are currently in development, which could have an adverse impact on our ability to achieve revenues from the approved indication. Plans regarding development, approval and marketing of any of our drugs are subject to change at any time based on the changing needs of our company as determined by management and regulatory agencies. Estimates regarding the potential benefits of our drugs and the potential market for any of our drugs may be inaccurate and, to the extent the estimates are correct, we may not be successful in achieving revenues from any such drugs, as the successful marketing of any approved drugs will be subject to strong competition within the health care industry and patient and physician acceptance of our drugs as safe, affordable and effective. Our ongoing discussions with other companies may not lead to partnering opportunities, and if we are unable to partner with other companies and/or raise additional capital, we will likely be unable to complete future stages of clinical trials and ultimately produce revenue from our drugs in development. Funding from potential sources of capital, including the potential exercise of warrants, may not materialize. To date, we have incurred operating losses since our inception, and our ability to successfully develop and market drugs may be impacted by our ability to manage costs and finance our continuing operations. For a discussion of additional factors impacting our business, see our most recent Annual Report on Form 10-K and our subsequent filings with the SEC. 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 © 2014 Galectin Therapeutics NASDAQ:GALT |
![]() Agenda • The Company and Key Team Members • Galectin Inhibitors • Fibrosis Program – our primary focus • Cancer Immunotherapy • Summary © 2014 Galectin Therapeutics NASDAQ:GALT 3 |
![]() What We Do • Clinical stage biopharmaceutical company targeting fibrotic diseases and cancer with novel compounds that inhibit galectin proteins (galectin-3) • Galectin proteins are important in the development and promotion of many inflammatory, fibrotic and neoplastic diseases • Currently in clinical trials in liver fibrosis and cancer • Liver fibrosis indication: NASH (Fatty Liver Disease) with advanced liver fibrosis • Cancer immunotherapy indication: Metastatic melanoma 4 © 2014 Galectin Therapeutics NASDAQ:GALT |
![]() Key Facts – As of February 7, 2014 5 Trading Symbol Nasdaq: GALT Corporate Headquarters Norcross, GA (suburb of Atlanta) Stock Price; 52 Week Range $13.91 $2.61 - $17.88 Shares Outstanding 21.5 million Daily Volume (50 day average) 555,231 shares Market Capitalization $299 million Debt $0 Cash & Equivalents $35 million Estimated Spending in 2014 $14.5 million Fiscal Year Ends December 31 Accounting Firm McGladrey LLP © 2014 Galectin Therapeutics NASDAQ:GALT |
![]() Experienced Leadership Team 6 © 2014 Galectin Therapeutics NASDAQ:GALT |
![]() Agenda • The Company and Key Team Members • Galectin Inhibitors • Fibrosis Program – our key focus • Cancer Immunotherapy • Summary 7 © 2014 Galectin Therapeutics NASDAQ:GALT |
![]() Galectin Proteins: Bind galactose residues on glycoproteins 8 • Galectin-3 is most important in pathological situations, is widely expressed, but highest in immune cells (macrophages) • Under normal physiological situations, galectin-3 is expressed at low levels • In areas of acute or chronic inflammation and fibrogenesis, the gal-3 expression is markedly increased. The majority of cancers express high levels of galectin-3 © 2014 Galectin Therapeutics NASDAQ:GALT |
![]() Our drugs are natural complex carbohydrates that bind to galectin-3 and block interactions with natural ligands © 2014 Galectin Therapeutics NASDAQ:GALT 9 Galacturonic Acid Rhamnose Galactose Mannose GR-MD-02 (simplified schematic) • Produced from apple pectin • Method of use patents in liver fibrosis, fatty liver disease, and diabetic kidney disease (others pending) • Composition of matter pending GM-CT-01 (simplified schematic) • Produced from guar gum • Method of use patents in liver fibrosis and cancer (others pending) • Composition of matter patent |
![]() Agenda • The Company and Key Team Members • Galectins and Disease • Fibrosis Program – our key focus • Cancer Immunotherapy • Summary 10 © 2014 Galectin Therapeutics NASDAQ:GALT |
![]() Fundamental Science on Target is Strong: Galectin-3 is critically important in the development of organ fibrosis • Galectin-3 null mice (no galectin-3) are resistant to fibrosis due to toxin-induced liver toxicity • Galectin-3 null mice are also resistant to fibrosis in: • Fatty liver disease • Lung fibrotic disease • Kidney fibrotic disease 11 Normal mouse No gal-3 mouse Red stain is collagen, the principal component of fibrotic tissue Henderson, et al 2006 Mice treated with liver toxin to induce fibrosis Normal mice develop fibrosis whereas those without gal-3 do not © 2014 Galectin Therapeutics NASDAQ:GALT |
![]() Company’s Galectin Inhibitors Reverse Cirrhosis in Rat Model 12 GR-MD-02 Vehicle GM-CT-01 • Animal model presented a very high hurdle for drug treatment: Cirrhosis induced with high dose toxin and continued throughout drug treatment • Treatment with four weekly doses Broad bands of collagen with nodule formation (N) indicates advanced fibrosis and cirrhosis Reduction in collagen with thin and broken bands (arrow) indicates resolving fibrosis and cirrhosis © 2014 Galectin Therapeutics NASDAQ:GALT |
![]() Galectin Inhibitor GR-MD-02 Improved Fat, Liver Cell Death, Inflammation, and Fibrosis in Mouse Model of Fatty Liver Disease (NASH) with Fibrosis 13 Fat Cell death Inflammation Fat Cell death Inflammation Red = Collagen Red = Collagen © 2014 Galectin Therapeutics NASDAQ:GALT Control GR-MD-02 GR-MD-02 Control |
![]() Potential Use in Lung Fibrosis: GR-MD-02 Reduces Fibrosis in Mouse Model 14 Vehicle Normal GR-MD-02 Marked reduction in area and severity of fibrosis without aggregation into larger formations Large areas of confluent fibrosis. Lung fibrosis induced by tracheal instillation of bleomycin followed by four infusions of either vehicle or GR-MD-02 © 2014 Galectin Therapeutics NASDAQ:GALT |
![]() Potential Use in Kidney Fibrosis: GR-MD-02 Reduces Fibrosis in Diabetic Mouse 15 Vehicle Normal GR-MD-02 Reduction in interstitial fibrosis Arrows show areas of interstitial fibrosis © 2014 Galectin Therapeutics NASDAQ:GALT |
![]() Liver Fibrosis Development Program NASH (Non-Alcoholic SteatoHepatitis): Very Large Unmet Medical Need • Multiple liver diseases lead to fibrosis which leads to liver failure, medical complications, and death • There is no approved medical therapy for liver fibrosis • Only current therapy is liver transplantation • First indication is fatty liver disease with fibrosis (non-alcoholic steatohepatitis, or NASH). • Prevalence of NASH in U.S. is between 9-15 million people • Approximately 30% will develop cirrhosis; estimated prevalence of patients with advanced fibrosis is approximately 6 million. • NASH cirrhosis projected to be primary reason for liver transplant • IND for GR-MD-02 with advanced fibrosis: Jan. 30, 2013 • Fast Tract Designation received in August 2013 • Phase 1 trial: First cohort enrollment completed. Data to be reported around end of first quarter 2014. 16 © 2014 Galectin Therapeutics NASDAQ:GALT |
![]() Development Program: Targeting Therapy In The Progression of NASH 17 Obesity/Insulin Resistance/Diabetes Steatosis (fatty liver) NASH (inflammation, cell death) Stage 1 2 3 Fibrosis Stage 4 Cirrhosis Decades • No certainty of progression from early to late disease in an individual • Late disease much closer to clinical outcomes • Because of effect on inflammation in NASH and ability to reduce existing fibrosis, our clinical program targets NASH patients with late disease Early Disease Late Disease Clinical Outcomes Complications Transplant Death © 2014 Galectin Therapeutics NASDAQ:GALT |
![]() Phase 1 Clinical Trial of GR-MD-02 in NASH (Fatty Liver Disease) with Advanced Fibrosis 18 0 28 35 42 56 70 Day Infusion -1 Biomarkers Biomarkers Patient inclusion: Biopsy proven NASH with advanced fibrosis (stage 3) Design: Each cohort has 8 patients (6 active, 2 placebo, blinded) Dose: Starting dose of 2 mg/kg which is within the presumptive therapeutic range; next two cohort doses 4 mg/kg and 8 mg/kg. Primary endpoints: Safety; Pharmacokinetics Secondary endpoints: Serum biomarkers to assess for potential treatment Timing of expected data from each cohort Cohort 1: Mar-Apr 2014 Cohort 2: Jul-Aug 2014 Cohort 3: Oct–Nov 2014 © 2014 Galectin Therapeutics NASDAQ:GALT |
![]() Key Biomarkers for Assessing Potential Efficacy in Phase 1 Clinical Trial • Most important biomarkers are clinically validated composite scores that have been shown to correlate with fibrosis • ELF (Enhanced Liver Fibrosis) Score: Includes measurement of hyaluronic acid, tissue inhibitor of metalloproteinase-1, and PIIINP (amino terminal propeptide of type III pro-collagen) • Fibrotest: age and gender, alpha-2-macroglobulin, haptoglobin, apolipoprotein A1, GGTP, total bilirubin • Other fibrosis markers: TGF-ß, lumican, Matrix metalloproteinase-1, -3, and -9 • Biomarkers associated with NASH—ballooning degeneration of hepatocytes • Cytokeratin-18 (M30 and M65 antibody tests) • A variety of inflammatory biomarkers are also being explored 19 © 2014 Galectin Therapeutics NASDAQ:GALT |
![]() 20 Phase 2 Clinical Trial Plans • Patient inclusion: Biopsy proven NASH with advanced fibrosis (stage 3 and stage 4 with no complications of cirrhosis) • Design: Randomized, placebo controlled, and double blind. • Dose: Likely two dosage groups • Treatment Duration: TBD • Primary endpoint: Liver biopsy: Collagen proportional area • Galectin human NASH biopsy study done to guide design • Timeline: Start around end of 2014; Top line data dependent on trial design: expectation is 1H 2016. • Secondary endpoints: • Liver Biopsy: NASH Activity Score and Fibrosis Stage • Liver function testing: HepQuant (bile acid clearance test) • Imaging methods—Fibroscan and/or MR-elastography • Serum biomarkers based on analysis of Phase 1 data: Fibrotest and ELF Score key biomarkers © 2014 Galectin Therapeutics NASDAQ:GALT |
![]() Comparison of Galectin-3 Inhibitors 21 Galectin Thera. La Jolla Pharm. Galecto Biotech Drug GR-MD-02 GCS-100 TD 139 Drug Characteristics Mod. apple pectin: MW: 20-70K; aqueous solution* Mod. citrus pectin; MWt >100K colloidal solution** Modified lactose, a disaccharide Cell culture effects No cytotoxicity or apoptosis; inhibits cytokine production * Kills cells through apoptosis**; no effect on cytokines* Shown to reduce TGF- signaling Human side effects TBD; in phase 1 DLT was Grade 3 maculopapular rash (vasculitis). Animal studies.*** Unknown, pre- clinical Clinical Development NASH with advanced fibrosis Kidney insufficiency Pre-clinical; Lung fibrosis; inhalation Dosing in clinical program Phase 1 starting dose= 2 mg/kg Highest dose= 0.75 mg/kg # TBD *GALT patents **LJPC patents ***GCS-100 published abstract # LJPC press release © 2014 Galectin Therapeutics NASDAQ:GALT |
![]() Competition in NASH 22 NASH (inflammation, cell death) Stage 1 2 3 Fibrosis Stage 4 Cirrhosis Early Disease Late Disease Clinical Outcomes Complications Transplant Death © 2014 Galectin Therapeutics NASDAQ:GALT • Focus is on improving NAFLD Activity Score (8 points total): • Fat (3 pts.), Ballooning (2 pts.), Inflammation (3 pts.) • PIVENS (pioglitazone and vitamin E • FLINT (NIDDK and Intercept) • Genfit trial • Focus is on stopping progression or reversing fibrosis • Galectin Therapeutics Trials • Gilead Trials • LOL-2 (Lysyl oxidase-like-2) mAb (GS-6624): Monoclonal antibody that blocks the enzyme which cross links collagen fibers |
![]() Fibrosis Strategy Summary • NASH with Advanced Fibrosis: Evidence of efficacy of GR-MD-02 from well controlled phase 2 clinical trial • Other Organ Fibrosis: Potential for partnering opportunities • Lung fibrosis – pre-clinical results suggest possible use in Idiopathic Pulmonary Fibrosis • Kidney fibrosis • Ongoing discussions with large pharmaceutical companies • Discussions will provide foundation for partnering opportunities at the most opportune time 23 © 2014 Galectin Therapeutics NASDAQ:GALT |
![]() Agenda • The Company and Key Team Members • Galectin Inhibitors • Fibrosis Program – our key focus • Cancer Immunotherapy • Summary 24 © 2014 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 25 © 2014 Galectin Therapeutics NASDAQ:GALT |
![]() 26 Checkpoint Inhibitor Blockade • CTLA4 receptor mAb: Yervoy® (Ipilimumab, BMS) • Anti-PD-1 (nivolumab BMS; lambrolizumab Merck) • Anti PD-L1 (MPDL3280A , Roche) May 22, 2013 © 2014 Galectin Therapeutics NASDAQ:GALT • In Development: • Marketed: Cancer Immunotherapy Named Top Scientific Breakthrough of 2013 by Science Magazine |
![]() 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 • Even with newly approved drugs, still a substantial unmet medical need • We have sought collaborations with institutions that have: • Demonstrated clinical trial expertise in melanoma • Tumor immunology basic science research • Ability to conduct clinical trials and assist in funding • Two collaborations have been established • Ludwig Cancer Institute, Brussels Belgium • Robert W. Franz Cancer Research Center, Earle A. Chiles Research Institute (EACRI) Providence-Portland Medical Center, Portland Oregon 27 © 2014 Galectin Therapeutics NASDAQ:GALT |
![]() CD8+ T-Cells Cytokines (kill tumor cells) T-Cells 28 Tumor Cells Potential sites of action for galectin inhibition in tumor immunology Galectin-3 CD8+ T-Cells Clonal Expansion Immunotherapies Checkpoint Inhibitor Blockage: anti-CTLA4 anti-PD1 Tumor Vaccines Potential for galectin inhibitors to enhance anti-tumor immune response Potential for galectin inhibitors to enhance anti-tumor activity of T-cells by blocking “Galectin Effect” Galectin-3 © 2014 Galectin Therapeutics NASDAQ:GALT |
![]() Checkpoint inhibitors plus GR-MD-02 boosts anti- tumor immunity, reduce tumor size and increase survival in mouse model of prostate cancer (similar results in breast cancer, melanoma and sarcoma) 29 *p<0.05 aCTLA-4 = anti-CTLA-4 mAb [ipilimumab in humans (Yervoy, BMS)] aPD-1 = anti-PD-1 mAb [positive results in clinical trials, BMS, Merck] Unpublished data 2013: Stefanie N. Linch, Melissa J. Kasiewicz, Peter G. Traber, and William L. Redmond, Galectin Therapeutics and Earle A. Chiles Research Institute (EACRI), Portland Oregon © 2014 Galectin Therapeutics NASDAQ:GALT |
![]() Phase 1B Clinical Trial in patients with advanced melanoma using GR-MD-02 in combination with Yervoy® (ipilimumab): March 2014 Start 30 1 23 64 85 Day Infusion: GR-MD-02 followed by Yervoy at standard doses Patient inclusion: Advanced melanoma with indication for Yervoy Rx Design: 3+3 dose escalation; 10 patients treated with MTD Dose: Starting dose of 1 mg/kg Endpoints: Followed every 12 weeks for survival Bx Bx © 2014 Galectin Therapeutics NASDAQ:GALT 43 • Safety; Pharmacokinetics • Tumor response: immune response RECIST criteria • Biological responses including memory CD4+ T-cells, memory CD8+ T-cells, melanoma specific T-cells, and composition of tumor immune infiltrate from tumor biopsies when available. |
![]() Cancer Therapy Strategy: 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 Center and Earle A. Chiles accepted for phase 1B clinical trial in patients with advanced melanoma treated with a combination of Yervoy and GR-MD-02 • Initial funding of clinical trial by PPMC/EACRI. Galectin is providing GR-MD-02 study drug, reference to its IND, and PK analysis • Ongoing discussions with large pharmaceutical companies in the immunotherapy space to seek a partnering opportunity to take beyond proof of concept from initial clinical trials 31 © 2014 Galectin Therapeutics NASDAQ:GALT : Ongoing pre-clinical studies; IND Research Institute (EACRI) |
![]() Agenda • The Company and Key Team Members • Galectins and Disease • Fibrosis Program – our key focus • Cancer Immunotherapy • Summary 32 © 2014 Galectin Therapeutics NASDAQ:GALT |
![]() Summary of Development Program • Liver Fibrosis • First indication: GR-MD-02 in NASH with advanced fibrosis • Phase 1 clinical trial underway; interim data expected March-April 2014 • Other Organ Fibrosis: Studies to demonstrate broad application of drugs in organ fibrosis; seek partner • Cancer Therapy: Combination immunotherapy to enhance the ability of the immune system to recognize and kill tumor cells in metastatic melanoma • Leverage world class expertise in basic tumor immunology and in the conduct of melanoma clinical trials. • Ongoing discussions with large pharmaceutical companies to provide foundation for partnering opportunities at the most opportune time 33 © 2014 Galectin Therapeutics NASDAQ:GALT |