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Galectin Therapeutics | NASDAQ:GALT Forward Looking Statements This presentation contains, in addition to historical information, forward looking statements within the meaning of the Private Securities Litigation Reform

Key Takeaway: Mean standard deviation 2. Placebo values were combined for all three cohorts because there were no differences (n=19 separate data points) 3. Not significant versus placebo, two sided t test (n=6) 4. Not significant versus placebo, two sided t test (n=7) 5. Significant for three

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Mean standard deviation 2. Placebo values were combined for all three cohorts because there were no differences (n=19 separate data points) 3. Not significant versus placebo, two sided t test (n=6) 4. Not significant versus placebo, two sided t test (n=7) 5. Significant for three groups versus placebo, ANOVA with Dunnett s test for multiple comparisons (n=7) Existing Patent Position Supporting Fibrosis Program Using GR MD 02 Patent Title Priority Issued International US 8,236,780 Galactose pronged polysaccharides in a formulation for anti fibrotic therapies 5/16/2006 8/7/2012 None US 8,658,787 Galacto rhamnogalacturonate compositions for the treatment of non alcoholic steatohepatitis and non alcoholic fatty liver disease 9/16/2011 2/25/2014 Pending US 8,722,645 Galactose pronged polysaccharides in a formulation for anti fibrotic therapies 5/16/2006 5/13/2014 None US 8,828,971 Galactose Pronged Carbohydrate Compounds for the Treatment of Diabetic Nephropathy and Associated Disorders 10/2011 9/9/2014 Pending US 8,871,925 Composition of Novel Carbohydrate Drug for Treatment of Human Diseases 12/28/2011 10/28/2014 Pending US 14/456,644 Composition of Novel Carbohydrate Drug for Treatment of Human Diseases 12/28/2011 10/15/2014 (NOA) Pending 37 2015 Galectin Therapeutics | NASDAQ:GALT Method of use patents for GR MD 02 are pending in cancer Immunotherapy, diseases related to inducible nitric oxide (iNOS) activity, and lung fibrosis Company also has multiple composition and method patents for GM CT 01, another inhibitor not currently in clinical trials 38 Trading Symbol Nasdaq: GALT Corporate Headquarters Norcross, GA (suburb of Atlanta) Fiscal Year End December 31 Accounting Firm McGladrey LLP Stock Price; 52 Week Range $3.47 $3.00 $19.11 Shares Outstanding 22.3 million Daily Volume (3 month average) 154,000 shares Market Capitalization $89 million Debt $0 Cash Equivalents $29.1 million Estimated Spending in 2015 $20 million Financial Key Facts As Of December 31, 2014 2015 Galectin Therapeutics | NASDAQ:GALT
All adverse events were mild (grade 1) and transient. An independent Data Safety Monitoring Board (DSMB) reviewed all data after first and second cohorts. 2015 Galectin Therapeutics | NASDAQ:GALT Phase 1 Trial: Safety Data 33 Proportional increase in drug coverage (AUC) for 2 mg/kg, 4 mg/kg, and first dose of 8 mg/kg Increase in AUC after four doses of 8 mg/kg indicates a saturable compartment model Cmax g/mL T1/2 H AUC g*h/mL 2 mg/kg x1 16.3 19.9 573 2 mg/kg x4 17.7 20.5 645 4 mg/kg x1 30 19.8 1039 4 mg/kg x4 31 19.5 1075 8 mg/kg x1 99.5 18.2 2449 8 mg/kg x4 169.9 18.4 4909 2015 Galectin Therapeutics | NASDAQ:GALT Mean GR MD 02 Plasma Concentration Time Profiles After First And Fourth Doses In All 3 Cohorts 34 Target Therapeutic Window The best therapeutic dose in mouse NASH was between 10 and 30 mg/kg Relationship between AUC and dose shows mouse and human equivalency 2015 Galectin Therapeutics | NASDAQ:GALT Pharmacokinetics Indicates 8 mg/kg Dose Is Within The Upper Range Of The Targeted Therapeutic Window AUC of Human 8 mg/kg dose AUC of Human 2 mg/kg dose 35 p 0.05 5 p 0.01 5 ns 5 2 dose 4 dose + 14 da 4 dose + 3 da Cohort 3 4 dose + 14 da Cohort 1 4 dose + 3 da Cohort 2 ns ³ ns 4 Legend and Notes: A Significant Reduction In FibroTest Scores Were Seen At The 8 mg/kg Dose 2015 Galectin Therapeutics | NASDAQ:GALT FibroTest scores are calculated from age, gender, alpha 2 macroglobulin, haptoglobin, apolipoprotein A1, gamma glutamyl transpeptidase (GGT), and total bilirubin Mean Standard Deviation Placebo values (change from baseline) were combined for all three cohorts because there were no differences (n=19) Not significant versus placebo, two sided t test (n=6) Not significant versus placebo, two sided t test (n=7) Significant for three groups versus placebo, ANOVA with Dunnett s test for multiple comparisons (n=7) 5. 1. 2. 3. 4. th th th th nd 36 p 0.005 5 p 0.001 5 p 0.05 5 Cohort 3 8 mg/kg Cohort 1 2 mg/kg Cohort 2 4 mg/kg ns ³ ns 4 2015 Galectin Therapeutics | NASDAQ:GALT Highly Significant Reduction In Alpha 2 Macroglobulin Serum Levels Seen At The 8 mg/kg Dose A reduction in serum alpha 2 macroglobulin accounted for the reduction in FibroTest 4 th dose + 14 da 4 th dose + 3 da 2 nd dose 4 th dose + 14 da 4 th dose + 3 da Legend and Notes: 1.
After the last infusion, biomarkers assessed at 3 days and 14 days after infusion and FibroScan at 3 days and 28 days after infusion. Cohort 1 (2 mg/kg) Cohort 2 (4 mg/kg) Cohort 3 (8 mg/kg) Enrolled 8 10 13 Completed 8 9 13 Completed Patients Age Range (Mean) 40 64 (54) 34 69 (52) 31 69 (57) Sex (M/F) 2/6 6/4 6/7 BMI (Mean) 39 40 36 BMI 30 8 9 8 Diabetes 6 4 6 31 Phase 1 Trial: Patient Characteristics 2015 Galectin Therapeutics | NASDAQ:GALT 32 Cohort 1 (2 mg/kg) Cohort 2 (4 mg/kg) Cohort 3 (8 mg/kg) Active Placebo Active Placebo Active Placebo Completed protocol 6 2 7 2 7 6 Serious Adverse Events 0 0 0 0 0 0 TEAE s probably related 0 0 0 0 0 0 TEAE s possibly related 0 2 2 0 0 2 Therapy Emergent Adverse Events, possibly related to study drug were reported in 4 subjects who received placebo and 2 subjects who received GR MD 02.
Clinical trial sites Brooke Army Medical Center, Fort Sam Houston, TX Indiana University School of Medicine, Indianapolis, IN The Texas Liver Institute, San Antonio, TX University of Southern California, Los Angeles, CA VCU Medical Center, Richmond, VA Icahn School of Medicine at Mount Sinai, New York, NY St. Louis University, St. Louis, MO 29 2015 Galectin Therapeutics | NASDAQ:GALT Subjects: Biopsy proven NASH with Brunt Stage 3 fibrosis Design: Blinded, placebo controlled, sequential dose escalation Three cohorts: Four doses over 6 7 weeks of 2, 4, and 8 mg/kg lean body weight administered by IV infusion over one hour Primary Endpoints: Safety and Pharmacokinetics Exploratory Endpoints: Potential serum biomarkers 30 2015 Galectin Therapeutics | NASDAQ:GALT 3 Cohort Design Of Phase 1 Clinical Trial The red triangles indicate timing of blood draws for assessment of exploratory biomarkers and the blue triangles indicate timing of FibroScan assessment.
GT 027 NASH FX NASH with advanced fibrosis Liver stiffness (FibroScan ) Q2 2015 GT 028 NASH DX NASH with advanced fibrosis Liver stiffness (magnetic resonance elastography) Q2 2015 Development Program Milestones APPENDIX 28 2015 Galectin Therapeutics | NASDAQ:GALT A Multi Center, Partially Blinded, Maximum Tolerated Multiple Dose Escalation, Phase 1 Clinical Trial to Evaluate the Safety of GR MD 02 in Subjects with Non Alcoholic Steatohepatitis (NASH) with Advanced Hepatic Fibrosis Overall Objective: Evaluate safety and pharmacokinetics of GR MD 02 to provide information and support to design a Phase 2 clinical program to assess efficacy of GR MD 02 in patients with NASH with advanced fibrosis and cirrhosis.
Director Regulatory Affairs at Solvay Pharmaceuticals and Chelsea Therapeutics, Georgia Institute of Technology. Study Indication Endpoints Start Data Reporting Phase 1b: Yervoy Advanced melanoma Safety ir RECIST Immune markers Underway Cohort 1: 1H 2015 Phase 1b: Keytruda Advanced melanoma Safety ir RECIST Immune markers Q2 2015 TBD 27 2015 Galectin Therapeutics | NASDAQ:GALT Advanced Liver Fibrosis/Cirrhosis Advanced Melanoma Study Indication Endpoints Start Data Reporting GT 026 NASH CX NASH with cirrhosis Portal pressure (HVPG) Q2 2015 The full trial design and the expected timings for top line results will be outlined in detail in February 2015.
CFO Reach Health, CFO of Vystar Corporation, CFO Corautus Genetics, Deloitte Over 30 years experience in biotechnology engineering and regulatory in pharmaceuticals and diagnostics. Koor Biotechnologies, Charm Sciences, Glycogenesis, HU Medical School (Jerusalem), Harvard University Over 24 years of experience working in the biotech and life sciences industries, regulatory affairs and manufacturing.
GlaxoSmithKline (CMO), Un of Pennsylvania (CEO, Chief of GI, Chairman of Medicine), Baylor College of Medicine (CEO) Over 32 years of senior experience in the development and commercialization of pharmaceuticals and business development including mergers and acquisitions. Solvay Pharmaceuticals (CEO), CIBA Vision Ophthalmics (n/k/a Novartis Vision) (SVP co founder), Tikvah Therapeutics (Founder, CEO) Over 24 years in accounting and finance with life science and technology companies with significant experience in negotiating and closing financing transactions.
Shlevin, Ph.D. COO Corporate Secretary Jack W. Callicutt CFO Eliezer Zomer, Ph.D. Pharmaceutical Development J. Rex Horton Executive Director, Regulatory Affairs and Quality Assurance Manager and general partner of 10X Fund, L.P., Co Founder, Pro Pharmaceuticals, CEO, Minerva Biotechnologies Corporation Over 28 years experience in biomedicine and pharmaceutical industries in research and development, clinical medicine and business development.
Brendan Curti) Status Plan to initiate study Q2 2015 25 2015 Galectin Therapeutics | NASDAQ:GALT Phase 1b Clinical Trial In Patients With Advanced Melanoma Using GR MD 02 In Combination With Keytruda 26 Experienced Leadership Team 2015 Galectin Therapeutics | NASDAQ:GALT James Czirr, Executive Chairman Peter G. Traber, M.D. President, CEO, CMO Harold H.
Trial Site Providence Portland Medical Center (Dr. Brendan Curti) Status Actively recruiting: Three patients enrolled in cohort 1, one drop out 24 2015 Galectin Therapeutics | NASDAQ:GALT http://clinicaltrial.gov/ct2/show/NCT02117362?term=GR MD 02 rank=1 Phase 1b Clinical Trial In Patients With Advanced Melanoma Using GR MD 02 In Combination With Yervoy Patients Patients who have had melanoma progression after Yervoy and/or BRAF targeted therapy in melanomas with a BRAF mutation Patients who have had melanoma progression after Keytruda monotherapy Design Three patients per cohort (+3 if adverse events) with 10 patients treated with maximum dose achieved Dose GR MD 02 IV starting at dose of 1 mg/kg and escalating following each cohort to 8 mg/kg followed by standard dose of Keytruda 1 endpoint Determine a safe dose of GR MD 02 used in combination with the approved dose of Keytruda 2 endpoints Measure the response rate as assessed by ir RECIST criteria Assess the biological activity by measuring: CD4+ T cells with a memory phenotype CD8+ T cells with an effector phenotype Melanoma specific T cells using autologous and/or HLA matched tumor Examine composition of the tumor immune infiltrate from tumor biopsies Assess quality of life during therapy using the FACT M questionnaire Trial Site Providence Portland Medical Center (Dr.
Linch, Melissa J. Kasiewicz, Peter G. Traber, and William L. Redmond, Galectin Therapeutics and Earle A. Chiles Research Institute (EACRI), Portland Oregon *p 0.05 These data are on TC 1 prostate cancer cells (also effective in breast cancer, melanoma, and sarcoma) Checkpoint Inhibitors Plus GR MD 02 Boosts Anti Tumor Immunity, Reduces Tumor Size And Increases Survival In Mouse Cancer Models 2015 Galectin Therapeutics | NASDAQ:GALT 2015 Galectin Therapeutics | NASDAQ:GALT 23 CTLA blockade (Yervoy ) PD 1 blockade (Keytruda ) Hypothetical: Immune checkpoint blockade Plus GR MD 02 Hypothesis: GR MD 02 May Be A Complementary Therapy To Enhance Efficacy Of Immune Checkpoint Blockade Therapies 1 2 3 4 Years Patients Advanced melanoma with indication for Yervoy treatment Design Three patients per cohort (+3 if serious adverse events) with 10 patients treated with maximum dose achieved Dose GR MD 02 starting at dose of 1 mg/kg and escalating following each cohort to 8 mg/kg followed by standard dose of Yervoy 1 endpoint Determine a safe dose of GR MD 02 used in combination with the approved dose of Yervoy 2 endpoints Measure the response rate as assessed by ir RECIST criteria Assess the biological activity by measuring: CD4+ T cells with a memory phenotype CD8+ T cells with effector phenotype Melanoma specific T cells using autologous and/or HLA matched tumor Examine composition of the tumor immune infiltrate from tumor biopsies Assess quality of life during therapy using the FACT M questionnaire.
Franz Cancer Research Center, Earle A. Chiles Research Institute (EACRI) Providence Portland Medical Center, Portland Oregon Demonstrated clinical trial expertise in melanoma and tumor immunology basic science research Ability to conduct clinical trials and assist in funding Cancer Therapy Strategy *Siegel, et al. CA Cancer J Clin 2012;62:10 22 aCTLA 4 = anti CTLA 4 mAb [ipilimumab in humans (Yervoy , BMS)] aPD 1 = anti PD 1 mAb [pembrolizumab in humans (Keytruda ) Merck] Unpublished data 2013: Stefanie N.
Five patients in cohort 3 were not available for FibroScan analysis (3 placebo and 2 active) because of unavailability of the instrument at the site (1 placebo and 1 active), unavailability of the appropriate instrument probe (1 active), a technically inadequate baseline scan (1 placebo), and the Day 63 scan not being performed (1 placebo). GR MD 02 at doses up to 8 mg/kg IV is safe and well tolerated in NASH patients with advanced fibrosis A dose of 8 mg/kg IV is in the upper range of the targeted therapeutic window for drug administration The combined results of a reduction in serum alpha 2 macroglobulin and a reduction in liver stiffness as assessed by FibroScan suggests that GR MD 02 at the highest dose tested may have an effect on liver fibrosis In conclusion, these results provide a firm foundation for entry into a Phase 2 development program 17 2015 Galectin Therapeutics | NASDAQ:GALT Conclusions From Results Of Phase 1 Trial In NASH Patients With Advanced Fibrosis Multiple, concurrent Phase 2 clinical trials will be conducted Two indications in patients with NASH will be evaluated Cirrhosis with portal hypertension Advanced fibrosis as indicated by liver stiffness Multiple modalities for the assessment of liver fibrosis will be used in the trials, depending on the design Hepatic venous wedge pressure (measure portal pressure) Liver biopsy (assess degree of liver fibrosis) FibroScan (assess liver stiffness) Magnetic resonance elastography (assess liver stiffness) Multi parametric magnetic resonance imaging (LiverMultiScan) (assess liver inflammation and fibrosis) C methacetin breath test (assess liver metabolism) Trial design and timetables will be presented in February 2015 and trials will commence in the second quarter of 2015 18 2015 Galectin Therapeutics | NASDAQ:GALT Goals of the Phase 2 Development Program 13 ADVANCED MELANOMA Lead Indication in Cancer Immunotherapy 19 2015 Galectin Therapeutics | NASDAQ:GALT Tumor cell invasion: extracellular matrix adhesion and detachment Metastasis: cell invasion and migration Angiogenesis Tumor immunity has recently been shown to be critically affected by galectins 20 The Vast Majority of Cancers Secrete Large Amounts of Galectins, Which Have Multiple Roles In Tumor Pathogenesis 2015 Galectin Therapeutics | NASDAQ:GALT 21 2015 Galectin Therapeutics | NASDAQ:GALT Advanced Melanoma as Initial Indication In U.S. 76,000 new diagnoses and 9,100 deaths* Even with newly approved drugs, a substantial unmet medical need remains Focus on Immunotherapy Immunotherapy is a major breakthrough in cancer therapeutics Galectin 3 has an important role in reducing the ability of immune system to fight cancer GR MD 02 is efficacious on tumors in combination with other immunotherapies in animal models Critical Collaboration Established Robert W.
BMC Gastro, 2006; Poynard, et al. BMC Gastro, 2007; Poynard, et al. J. Hepatology, 2012; Poynard, et al. J. Hepatology, 2013 2015 Galectin Therapeutics | NASDAQ:GALT 15 FibroScan uses an electromechanical vibrator and pulse echo ultrasound to evaluate the elastic shear wave in liver tissue The volume of liver tissue assessed is ~100 times greater than volume assessed by liver biopsy The stiffness of the liver is recorded as the pressure measurement of kiloPascals The stiffness of the liver correlates with the degree of liver fibrosis as assessed by liver biopsy FibroScan represents a promising non invasive, out patient method for measuring changes in liver fibrosis over time FibroScan Is A Non Invasive, Ultrasound Based Method For Assessing Liver Stiffness, Which Correlates With Liver Fibrosis 2015 Galectin Therapeutics | NASDAQ:GALT 16 Placebo GR MD 02 (8 mg/kg) of 5 patients treated with GR MD 02 had reduction in liver stiffness to below 80% of baseline values (red squares)* Evidence Of Reduced FibroScan Scores In Cohort 3 Patients Treated With GR MD 02 80% 100% 150 100 50 0 150 100 50 0 Day 1 Day 38 Day 63 Day 1 Day 38 Day 63 3 *In cohort 3 there were technically adequate scans at baseline, Day 38 and Day 63 in 5 patients administered GR MD 02 and 3 patients administered placebo.
Mean standard deviation 2. Placebo values were combined for all three cohorts because there were no differences (n=19 separate data points) 3. Not significant versus placebo, two sided t test (n=6) 4. Not significant versus placebo, two sided t test (n=7) 5. Significant for three groups versus placebo, ANOVA with Dunnett s test for multiple comparisons (n=7) FibroTest is a composite fibrosis score that is calculated from serum A2M levels and four other tests, including GGTP, total bilirubin, haptoglobin and apolipoprotein A1 FibroTest has been shown to correlate with stage of fibrosis, changes with fibrosis regression and progression, and may predict liver related mortality* A reduction in FibroTest would suggest an improvement in liver fibrosis In this acute setting, following four doses of 8 mg/kg GR MD 02, the reduction in FibroTest is due entirely to reduced serum levels of A2M A2M is a relevant marker for liver fibrosis because it is known to: Inhibit proteases such as collagenase, which may promote fibrosis Is increased in fibrogenic stellate cells in liver fibrosis Serum levels have been shown to correlate with liver fibrosis The reduction seen in A2M does not necessarily mean fibrosis got better in this short study, but does suggest changes in the fibrogenic process that might lead to an improvement in fibrosis with longer term therapy 14 2015 Galectin Therapeutics | NASDAQ:GALT Reduction In A2M Is Encouraging For GR MD 02 Effect On Liver Fibrosis *Ratziu, et al.
Therapy of Regression of fibrosis and reversal of cirrhosis in rats by galectin inhibitors in thioacetamide induced liver disease. PLOS ONE 2013;8:e75361. N=10 N=10 N=10 Robust Preclinical Data: GR MD 02 Reversed Cirrhosis And Improved Portal Hypertension In Rat Model* N=10 N=10 Portal Pressure Collagen Safety GR MD 02 was safe and well tolerated after IV administration of four doses of 2 mg/kg, 4 mg/kg and 8mg/kg lean body weight Drug Levels Pharmacokinetics revealed drug exposure in humans at the 8 mg/kg dose that was equivalent to the upper range of the targeted therapeutic dose determined from effective doses in NASH animal models Disease Serum Marker Effect There was a statistically significant, dose dependent reduction in FibroTest scores due to a statistically significant reduction in alpha 2 macroglobulin serum levels Liver Stiffness Effect There was a signal of reduced liver stiffness in patients receiving GR MD 02 as measured by FibroScan 12 2015 Galectin Therapeutics | NASDAQ:GALT See Appendix for additional detailed Phase 1 results Successful Phase 1 Clinical Trial In NASH Patients With Advanced Fibrosis Met Key Endpoints 13 p 0.005 5 p 0.001 5 p 0.05 5 2 nd dose 4 th dose + 14 da 4 th dose + 3 da Cohort 3 8 mg/kg 4 th dose + 14 da Cohort 1 2 mg/kg 4 th dose + 3 da Cohort 2 4 mg/kg ns ³ ns 4 Legend and Notes: 2015 Galectin Therapeutics | NASDAQ:GALT Highly Significant Reduction In Alpha 2 Macroglobulin (A2M) Serum Levels Seen At The 8 mg/kg Dose 1.
Therapy of Experimental NASH and Fibrosis with Galectin Inhibitors. PLOS ONE 2013;8:e83481 Galectin 3 Protein Galectin 3 Stain GR MD 02 reduces Gal 3, which results in reduction in liver inflammation and fibrosis Robust Preclinical Data: GR MD 02 Has Therapeutic Effect On NASH With Fibrosis In Mouse Model* 11 Vehicle Treated GR MD 02 Treated (90 mg/kg, 1/W x 4) *Traber PG, Chou H, Zomer E, Hong F, Klyosov A Fiel M I, Friedman, SL.
Gastro. 2011;140:124 131 1 Kleiner, et al. Hepatology 2005;41:1313 1320 3 Caldwell, et al. Dig Dis 2010;28:162 168 End Stage Fibrosis (Cirrhosis) Is When Patients With NASH Experience Symptoms And Complications 1 3 10 Normal NASH: Control NASH: GR MD 02 GR MD 02 Effects NAFLD Activity Score Fat Cell death Inflammation Collagen (Fibrosis) Collagen Stain Cellular Stain *Traber PG and Zomer E.
Prevalence in Asymptomatic, Middle Aged Adults (% of population) 45% 16.5% 46% 12.2% 2 Prospective evaluation of NAFLD and NASH prevalence (Williams, et al. Gastro. 2011;140:124 131) Estimated prevalence of NASH in U.S. adults 1, 2 28 million 1 Based on July 2013 US census data for people 20 years old (233,880,752) Obesity Diabetes Fatty Liver NASH NASH: An Epidemic With No Approved Therapies 2 9 2015 Galectin Therapeutics | NASDAQ:GALT NASH Complications (variceal bleeding, ascites, encephalopathy) Liver Transplantation (projected to be leading reason) Liver Related Death Fibrosis Progression Stage 1 Stage 2 Stage 3 Stage 4 Liver biopsy (Blue = fibrosis) Cirrhosis Asymptomatic Estimated prevalence of advanced fibrosis 1,2 : ~ 6 million Estimated prevalence of cirrhosis : ~ 1 2 million Approximately one third will advance to Stage 3/4 fibrosis 2 Williams, et al.
Nat Rev Immunol. 2004;4:583 594. doi:10.1038/nri1412 2 Younossi, et al. Clin. Gasto. Hepatol. 2011;9:524 530 Developing Products For Major Unmet Medical Needs 2 1 4 2015 Galectin Therapeutics | NASDAQ:GALT Strong Intellectual Property Multiple composition of matter patents and method patents Knowledge Expertise with complex carbohydrate drugs that promote galectin 3 inhibition, with applicability to large patient populations Initial focus on the treatment of NASH with advanced fibrosis, with encouraging data in early human trials and preclinical data showing potential for reversal of disease Investment Highlights NASH with Advanced Fibrosis Lead compound, GR MD 02, directed to a potential cirrhosis and advanced fibrosis market, currently approximately 6 million people in the U.S. and growing Large Market Unmet Need Melanoma Experienced Team Defined Regulatory Pathway GR MD 02 is also being studied in advanced melanoma in combination with two different cancer immunotherapeutic agents Potential Partnering Multiple near term clinical and regulatory milestones and potential for Phase 2 program under an SPA, which may include a registration trial A product pipeline that may be attractive to licensing agreements with large pharmaceutical companies An accomplished management team with significant large pharma and entrepreneurial experience 5 2015 Galectin Therapeutics | NASDAQ:GALT Role in Disease Gal 3 is increased in inflammation and fibrogenesis Elimination of gal 3 in mice prevents fibrosis in liver, lung, kidney and heart The majority of cancers express high levels of gal 3, which promotes tumor and inhibits immune response Galectin 3 Protein Function Binds to galactose residues in glycoproteins and promotes interactions High expression in immune cells (macrophages) Modulates cell signaling and immune cell function Lead Drug Candidate GR MD 02 A complex carbohydrate with terminal galactose residues that binds to gal 3 and disrupts function, particularly immune/repair function in macrophages Efficacy in preclinical models of fibrotic disease and cancer immunotherapy with encouraging early human results Existing patent coverage through 2031 with 2 composition and 4 method patents issued Lead Drug Candidate Targets Galectin 3 Protein 2015 Galectin Therapeutics | NASDAQ:GALT 6 Galectin Sciences, LLC Deep Product Pipeline Q2 2015 Clinical Focus Stage of Development Drug Indication Discovery Preclinical Phase 1 Phase 2 Phase 3 Fibrosis (monotherapy) GR MD 02 NASH cirrhosis Lung fibrosis Kidney fibrosis Cardiovascular fibrosis Cancer Immunotherapy (combination therapy) GR MD 02 Melanoma Galectin 3 Inhibitors GR MD 03 Subcutaneous GR MD 04 GM CT 04 Oral G XXX Oral ADVANCED FIBROSIS AND CIRRHOSIS DUE TO NASH (NON ALCOHOLIC STEATOHEPATITIS) Lead Indication in Organ Fibrosis 7 2015 Galectin Therapeutics | NASDAQ:GALT 8 2015 Galectin Therapeutics | NASDAQ:GALT U.S.
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. 3 2015 Galectin Therapeutics | NASDAQ:GALT Organ Fibrosis 45% of U.S. deaths are associated with fibrotic disease Lead indication is liver fibrosis/cirrhosis due to fatty liver disease (75% of all liver disease in U.S.) Potentially applicable to other fibrotic diseases Phase 1 clinical trial completed Phase 2 clinical trials to start Q2 2015 Cancer Immunotherapy Focus on combination immunotherapy, one of the most prominent approaches to cancer therapy Lead indication is advanced melanoma Technology applicable to other cancers Phase 1b clinical trial in progress Second trial to start Q2 2015 1 Wynn, TA.
We are currently the subject of litigation, which may impact our human and capital resources. To date, we have incurred operating losses since our inception, and our future success 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 Annual Report on Form 10 K for the year ended December 31, 2013, and our subsequent filings with the SEC.
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. Strategies and spending projections may change. We may be unsuccessful in developing partnerships with other companies or obtaining capital that would allow us to further develop and/or fund any studies or trials.
Factors that could cause our actual performance to differ materially from those discussed in the forward looking statements include, among others, our trials may not lead to positive outcomes or regulatory approval. We may experience delays in our trials, which could include enrollment delays. Future phases or future clinical studies may not begin or produce positive results in a timely fashion, if at all, and could prove time consuming and costly.
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. These statements include those regarding potential therapeutic benefits of our drugs, expectations, plans and timelines related to our clinical trials, potential partnering opportunities and estimated spending for 2015 .
Corporate Presentation January 7, 2015 NASDAQ: GALT www.galectintherapeutics.com 2015 Galectin Therapeutics Inc. Exhibit 99.1 2 2015 Galectin Therapeutics | NASDAQ:GALT 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.
Last updated: Jan 7, 2015