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Galt 5232013


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Galt 5232013

  1. 1. Annual Stockholder MeetingMay 23, 2013NASDAQ:
  2. 2. Forward Looking StatementsThis presentation contains, in addition to historical information, statements that look forward in time or that expressmanagement’s beliefs, expectations or hopes. Such statements are forward-looking statements within the meaning of thePrivate 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 andare subject to risks and uncertainties that could cause actual results to differ materially from those described in thestatements. These statements include our plans, expectations and goals regarding drugs in development, clinical trials andregulatory approval for any of our drugs or treatments, the anticipated timeline for clinical trials and results, related marketopportunities for our drugs, potential benefits of our drugs, efforts related to partnering opportunities with other companies,estimates regarding cash, liquidity and funding requirements for clinical trials, and estimates regarding those impacted byNASH, 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 factorsbeyond our control. Our clinical trials may not begin or produce positive results in a timely fashion, if at all, and anynecessary changes during the course of such trials could prove time consuming and costly. We may have difficulty inenrolling candidates for testing and we may not be able to achieve the desired results. Upon receipt of regulatory approvalfor any drug or treatment, we may face competition with other drugs and treatments that are currently approved or thosethat are currently in development, which could have an adverse impact on our ability to achieve revenues from theapproved indication. Plans regarding development, approval and marketing of any of our drugs are subject to change atany 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 inaccurateand, to the extent the estimates are correct, we may not be successful in achieving revenues from any such drugs, as thesuccessful marketing of any approved drugs will be subject to strong competition within the health care industry andpatient and physician acceptance of our drugs as safe, affordable and effective. Our ongoing discussions with othercompanies may not lead to partnering opportunities, and if we are unable to partner with other companies and/or raiseadditional capital, we will likely be unable to complete future stages of clinical trials and ultimately produce revenue fromour drugs in development. Funding from potential sources of capital, including the potential exercise of warrants, may notmaterialize. To date, we have incurred operating losses since our inception, and our ability to successfully develop andmarket drugs may be impacted by our ability to manage costs and finance our continuing operations. For a discussion ofadditional factors impacting our business, see our most recent Annual Report on Form 10-K and our subsequent filingswith the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events maycause our views to change, we disclaim any obligation to update forward-looking statements.2© 2013 Galectin TherapeuticsNASDAQ:GALT
  3. 3. Galectin Therapeutics: A clinical stagebiopharmaceutical company Targeting diseases with large unmet medical needs Focusing on diseases in which galectin proteins are importantin the development and promotion of those diseases© 2013 Galectin TherapeuticsNASDAQ:GALT3• Galectin proteins validated important inpre-clinical models of disease• Inflammation, acute and chronic• Organ fibrosis-liver, lung, kidney,heart• Cancer• Once targeting galectins in humans isachieved there will be many importantdisease indications.
  4. 4. Carbohydrate-based drugs forinhibition of galectin proteins• Complex carbohydrates derived from plant components• Terminal galactose residues bind to galectin proteins• Drugs in development• Galactomannan (GM) class: GM-CT-01• Galacto-rhamnogalaturonate (GR) class: GR-MD-02• Bind galectin-3 > galectin-1• Molecular weight of approximately 50KDa for intravenous use• Both drugs evaluated for each disease indication• Discovery pipeline• Derivatives of GM and GR for subcutaneous administration• Synthetic carbohydrates (in collaboration with Center for ComplexCarbohydrate Research at the University of Georgia)© 2013 Galectin TherapeuticsNASDAQ:GALT4
  5. 5. Liver Fibrosis Development Program• Multiple liver diseases lead to fibrosis• End stage fibrosis, or cirrhosis, leads to liver failure,medical complications, and death• Only current therapy is liver transplant• There is no approved medical therapy for liver fibrosis• Very large unmet medical need• 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• Over 20% will develop cirrhosis• NASH cirrhosis projected to be number 1 reason for liver transplant© 2013 Galectin TherapeuticsNASDAQ:GALT5
  6. 6. NASH with Fibrosis DevelopmentProgram: Accomplishments• New strategic focus: 2011 Annual Stockholder Meeting• NASH indication chosen based on pre-clinical experiments• Multiple studies in animal models confirmed robust effect oninhibition and regression of fibrosis, as well as reduction ininflammation and cell death in the liver.• GR-MD-02 more effective than GM-CT-01• GMP drug substance and product produced by CMO• Studies completed in multiple species elucidatingpharmacology, pharmacokinetics, and toxicology.• FDA review of IND for GR-MD-02 submitted Jan. 30, 2013concluded that we may proceed with human clinical studies.© 2013 Galectin TherapeuticsNASDAQ:GALT6
  7. 7. GR-MD-02 and GM-CT-01 both reversecirrhosis in rat model• Experiments in lab of Dr. Scott Friedman• Results presented at World Liver Congress• Animal model presented a very high hurdle for drug treatment:Cirrhosis induced with high dose toxin and continuedthroughout drug treatment• Treatment with four weekly doses of GR or GM© 2013 Galectin TherapeuticsNASDAQ:GALT7Vehicle Control GR-MD-02 GM-CT-01NN = nodule Arrows indicate broken strands of fibrosis
  8. 8. Development Program: TargetingTherapy In The Progression of NASH8Development of ObesityInsulin Resistance/DiabetesSteatosis (fatty liver)NASHFibrosis CirrhosisDecadesBecause of effect on inflammation in NASH and ability to reduce existingfibrosis, our clinical program will target NASH patients with advanced fibrosis© 2013 Galectin TherapeuticsNASDAQ:GALT
  9. 9. 9M J J A S O N D J F M A M J2013 2014Cohort-1Phase 1 Clinical Trial© 2013 Galectin TherapeuticsNASDAQ:GALT• Patient inclusion: Biopsy proven NASH with advanced fibrosis (stage 3)• Design: Dose escalation combining single and multiple dose in design. Single IVdose followed by three additional weekly doses in each cohort. At least threedose escalation cohorts guided by PK. Option to add additional cohorts.• Dose: Starting dose of 2 mg/ml which is within the presumptive therapeutic range• Primary endpoints:• Patient safety• Pharmacokinetics• Secondary endpoints:• Exploratory serum biomarkers to assess for potential treatment effectincluding markers for inflammation, cell death, and fibrogenesisCohort-2Cohort-3Guided by exposure from previous cohort
  10. 10. Phase 1 Clinical Trial Operations© 2013 Galectin TherapeuticsNASDAQ:GALT10• Contract Research Organizations: CTI Clinical Trials &Consulting Services Inc. of Cincinnati Ohio, a full service clinicalresearch organization with extensive experience in liver-relatedclinical trials. Labs performed by PPD Laboratories.• Principle Investigators: Leading US experts• Dr. Stephen Harrison; Brooke Army Medical Center, San Antonio TX• Dr. Naga Chalasani; Indiana University School of Medicine, Indianapolis IN• Dr. Brent Tetri; St. Louis University School of Medicine, St. Louis MO• Dr. Arun Sanyal; Virginia Commonwealth School of Medicine, Richmond VA• Dr. Ram Subramanian; Emory University School of Medicine, Atlanta GA• Dr. Thomas Schiano; Icahn School of Medicine at Mount Sinai, NYC• One site completed and others near completion of regulatoryprocess, business contracts, and patient identification• Infusions begin within next few weeks
  11. 11. 11Phase 2 Clinical Trial Plans© 2013 Galectin TherapeuticsNASDAQ:GALT• Patient inclusion: Biopsy proven NASH with advanced fibrosis(stage 3 and potentially stage 4 with well compensated cirrhosis)• Design: Randomized, placebo controlled, and double blind.• Dose: One or two dosage groups chosen based on data from Phase1 trial• Treatment Duration: 6-12 months TBD• Primary endpoint: Liver biopsy: Collagen proportional area• FDA-AASLD liver fibrosis endpoints workshop planned this year• Galectin human NASH biopsy study ongoing• Timeline: Start Q3 2014; Top line data: Q4 2015 to 1H 2016.• Secondary endpoints:• Liver Biopsy: NASH Activity Score and Fibrosis Stage• Imaging methods• Serum biomarkers based on analysis of Phase 1 data
  12. 12. Competition in NASH• Most drugs in development focus on improving NASHactivity score (fat, inflammation, and cell death) withminimal amounts of fibrosis.• Few companies are focused on fibrosis which is the keycause of liver failure in patients• Galectin: GR-MD-02• Gilead: Lysyl oxidase-like-2 mAb (GS-6624): Monoclonal antibodythat blocks the enzyme which cross links collagen fibers• Initiated Phase 2 trials in 2012 in patients with NASH andfibrosis• Top line data Q3 2015© 2013 Galectin TherapeuticsNASDAQ:GALT12
  13. 13. Fibrosis Strategy Summary• NASH with Advanced Fibrosis: Evidence of efficacy ofGR-MD-02 from well controlled phase 2 clinical trial• Other Organ Fibrosis: Analysis of pre-clinical models• Studies to demonstrate broad application of drugs in organ fibrosis• Kidney fibrosis: Reported reversal of fibrosis in diabetic mousekidney• Lung fibrosis• Ongoing discussions with large pharmaceuticalcompanies and other partnering opportunities• Discussions will provide foundation for partnering opportunities atthe most opportune time© 2013 Galectin TherapeuticsNASDAQ:GALT13
  14. 14. The Vast Majority of Cancers Secrete Large Amountsof Galectins Which Have Multiple Roles in TumorPathogenesis• Tumor cell invasion:extracellular matrixadhesion & detachment• Metastasis:cell invasion and migration• Angiogenesis• Tumor immunity hasrecently been shown to becritically affected bygalectins14© 2013 Galectin TherapeuticsNASDAQ:GALT
  15. 15. Cancer Therapy Strategy• Focus on tumor immunotherapy• Hypothesis: galectin inhibitors will enhance efficacy ofimmunotherapies• Metastatic melanoma is initial cancer indication• 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 ResearchInstitute (EACRI) Providence-Portland Medical Center, PortlandOregon© 2013 Galectin TherapeuticsNASDAQ:GALT15
  16. 16. CD8+T-CellsCytokines (kill tumor cells)T-Cells16TumorCellsPotential sites for galectin inhibition intumor immunology© 2013 Galectin TherapeuticsNASDAQ:GALTGalectin-3CD8+T-CellsClonalExpansionImmunotherapiesCheckpoint InhibitorBlockade:anti-CTLA4anti-PD1Tumor Vaccines1. Potential forgalectin inhibitors toenhance anti-tumorimmune response2. Potential for galectininhibitors to enhance anti-tumor activity of T-cells byblocking “Galectin Effect”Galectin-3
  17. 17. Ludwig Institute Clinical Trial to Evaluate combinationof melanoma vaccine with GM-CT-0117Melanoma “Proof of Concept” Trial:Patients: Metastatic melanomaDesign: Two stage Phase 2a (6x2 cohorts in stage 1 and 23x2 cohorts in stage 2)Regimen: Prime with melanoma specific peptide vaccine (overall 60% of melanomapatients express one or the other antigens) then treat with GM-CT-01Endpoint: Partial or complete response by imagingStudy sites: Ludwig Institute, Brussels Belgium; second site AntwerpStudy funding: Ludwig Institute (stage 1; 12 patients)Group 2 patients have additional injection of GM-CT-01 in cutaneous tumors© 2013 Galectin TherapeuticsNASDAQ:GALT
  18. 18. Clinical Trial LUC10-001: Accrual© 2013 Galectin TherapeuticsNASDAQ:GALT182 patients:1 MxR-PD1 PD1 patient:1 MxR-PDEvaluable for:Tumor responseGM-CT-01 ToxicityGroup 1GM infusion4 PatientsGroup 2GM infusion + peritumor2 patients2 patientsstopped at V31 patient stoppedat V38 patientsScreened6 patientsIncluded2 patients failedscreening• No grade 3/4 adverse events or serious adverse events• Two out of three mixed responses encouraging, but no responses by RECIST• Patient accrual continuingNote: one center at initiationand first patient completedprotocol before more enrolled;once safety confirmedadditional patients enrolledand second center initiated
  19. 19. 19Potential sites for galectin inhibition intumor immunotherapy© 2013 Galectin TherapeuticsNASDAQ:GALTCD8+T-CellsCytokines (kill tumor cells)T-CellsTumorCells Galectin-3CD8+T-CellsClonalExpansionImmunotherapiesCheckpoint InhibitorBlockade:anti-CTLA4anti-PD1Tumor VaccinesGalectin-3Collaboration established in 2012 with Earle A. Chiles Research Institute(EACRI) to evaluate the effect of galectin inhibitors on the induction of T-cellactivity alone and in combination with checkpoint inhibitor blockade.
  20. 20. © 2013 Galectin TherapeuticsNASDAQ:GALT20Checkpoint Inhibitor Blockade• Marketed:• CTLA4 receptor mAb: Yervoy® (Ipilimumab, BMS)• In Development:• Anti-PD-1 (nivolumab BMS; lambrolizumab Merck)• Anti PD-L1 (MPDL3280A , Roche)May 22, 2010
  21. 21. Checkpoint inhibitor blockage plus GR-MD-02 boostsanti-tumor immunity in syngeneic mouse models ofprostate and breast cancer© 2013 Galectin TherapeuticsNASDAQ:GALT21*p<0.05aCTLA-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
  22. 22. Cancer Therapy Strategy: Summary• Two immunotherapy agents have been approved for useto date, with many more vaccines and activators indevelopment• Our strategy is to leverage world class expertise in basictumor immunology and in the conduct of melanomaclinical trials.• Ludwig Cancer Institute: Complete ongoing clinical trial withinterim results reported at appropriate intervals• Earle A. Chiles Research Institute (EACRI): Ongoing pre-clinicalstudies; phase 1 clinical trial in melanoma with combination ofYervoy and GR-MD-02 in design phase• Ongoing discussions with large pharmaceuticalcompanies in the immunotherapy space to seek apartnering opportunity to take beyond proof of conceptfrom initial clinical trials22© 2013 Galectin TherapeuticsNASDAQ:GALT
  23. 23. Finances• March 31, 2013 cash balance: $7.0 million• Funded through Q1 2014 and completion of Phase I clinical trialfor GR-MD-02• Additional funding required for operations through 2015and completion of a Phase 2 clinical trial for GR-MD-02• Potential warrant exercises ($3 million)• Ongoing discussions with potential partners• Continue calling on new and interested fundamentalinvestors; growing interest in funding Phase 2• Fundamental investors are value investors with 3-5 yeartime horizon who are interested in investing at market© 2013 Galectin TherapeuticsNASDAQ:GALT23
  24. 24. Considerations for Stockholders• Refer interested potential investors• Educate your broker about Galectin and refer to us formore information• Follow us on twitter: @GalectinGALT• Share our web site on social media sites© 2013 Galectin TherapeuticsNASDAQ:GALT24
  25. 25. Summary• Liver Fibrosis• First indication: GR-MD-02 in NASH with advanced fibrosis• Phase 1 clinical trial underway• Other Organ Fibrosis: Studies to demonstrate broadapplication of drugs in organ fibrosis• Cancer Therapy: Combination immunotherapy to enhancethe ability of the immune system to recognize and killtumor cells in metastatic melanoma• Leverage world class expertise in basic tumor immunology and inthe conduct of melanoma clinical trials.• Ongoing discussions with large pharmaceuticalcompanies to provide foundation for partneringopportunities at the most opportune time© 2013 Galectin TherapeuticsNASDAQ:GALT25