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Galectin Therapeutics | NASDAQ:GALT This presentation contains, in addition to historical information, forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statemen

Key Takeaway: Brendan Curti) Status Plan to initiate study July 2015 27 2015 Galectin Therapeutics | NASDAQ:GALT Phase 1b Clinical Trial In Patients With Advanced Melanoma Using GR MD 02 In Combination With KEYTRUDA Summary of Cancer Immunotherapy Program Collaboration with investigative group

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Brendan Curti) Status Plan to initiate study July 2015 27 2015 Galectin Therapeutics | NASDAQ:GALT Phase 1b Clinical Trial In Patients With Advanced Melanoma Using GR MD 02 In Combination With KEYTRUDA Summary of Cancer Immunotherapy Program Collaboration with investigative group at Providence Portland Medical Center (PPMC) who have significant expertise in basic tumor immunology and translational clinical trials Pre clinical studies demonstrate in multiple cancers that GR MD 02 augments the anti tumor effects of monoclonal antibody checkpoint inhibitors Initial target is advanced melanoma, but also applicable to other cancer types Two Phase 1b clinical trials with GR MD 02 in combination with Yervoy (ongoing) and KEYTRUDA (planned), funded by PPMC Advanced immune response markers being used to evaluate drug effect in addition to tumor response 28 2015 Galectin Therapeutics | NASDAQ: GALT MODERATE TO SEVERE PLAQUE PSORIASIS Other Potential Indications in Inflammatory Disease 29 2015 Galectin Therapeutics | NASDAQ:GALT 30 2015 Galectin Therapeutics | NASDAQ:GALT Exploratory Phase 2a Trial In Moderate to Severe Plaque Psoriasis Patient in Phase 1 trial had apparent remission of severe psoriasis while receiving GR MD 02 Galectin 3 is increased in skin lesions of patients with psoriasis https://clinicaltrials.gov/ct2/show/NCT02407041?term=GR MD 02 rank=4 Primary Endpoint: Evaluate the number of patients who have 75% improvement in Psoriasis Activity Severity Index (PASI 75) following 12 weeks of therapy with GR MD 02 Secondary Endpoints: PASI 50 and PASI 100 scores following 12 weeks of therapy with GR MD 02 Determine the durability of response to therapy in responders over a one year period following the end of therapy Determine whether there is any change in disease status of patients who also have psoriatic arthritis 2015 Galectin Therapeutics | NASDAQ:GALT 31 Q2 2015 Product and Program Pipeline Q2 2015 Q2 2015 7/2015 Clinical Focus Stage of Development Drug Indication Discovery Preclinical Phase 1 Phase 2 Phase 3 Fibrosis (monotherapy) GR MD 02 NASH cirrhosis NASH advanced fibrosis Lung, Kidney, Cardiovascular fibrosis Cancer Immunotherapy (combination therapy) GR MD 02 + Yervoy Melanoma GR MD 02 + Keytruda Melanoma Plaque Psoriasis GR MD 02 Moderate severe Galectin 3 Inhibitors Discovery program to identify subcutaneous and oral forms of carbohydrates and oral small molecules Study Indication Endpoints Start Data Reporting Phase 1b: Yervoy Advanced melanoma Safety ir RECIST Immune markers Underway Dose Group 1: complete Dose Group 2: initiated, two patients enrolled Phase 1b: KEYTRUDA Advanced melanoma Safety ir RECIST Immune markers July 2015 TBD 32 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); liver biopsy June 2015 End 2017 GT 028 NASH FX NASH with advanced fibrosis Multi parametric MRI Comparisons include MRE and FibroScan July 2015 2H 2016 Expected Development Program Milestones Study Indication Endpoints Start Data Reporting Phase 2a: GT 030 Moderate to severe plaque psoriasis Psoriasis Activity Severity Index (PASI) July 2015 July 2016 Psoriasis
Trial Site Providence Portland Medical Center (Dr. Brendan Curti) Status 26 2015 Galectin Therapeutics | NASDAQ:GALT http://clinicaltrials.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 Cohort 1 completed no dose limiting toxicity Cohort 2 underway (2 patients enrolled) 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 Primary Endpoint Determine a safe dose of GR MD 02 used in combination with the approved dose of Keytruda Secondary 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 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 Primary Endpoint Determine a safe dose of GR MD 02 used in combination with the approved dose of Yervoy Secondary 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 *Siegel, et al. CA Cancer J Clin 2012;62:10 Cancer Therapy Strategy Focus on Immunotherapy Advanced Melanoma as Initial Indication Critical Collaboration Established 2015 Galectin Therapeutics | NASDAQ:GALT 24 1 2 3 4 Years CTLA blockade (Yervoy ) PD 1 blockade (KEYTRUDA ) Immune checkpoint blockade Plus GR MD 02 GR MD 02 May Be A Complementary Therapy To Enhance Efficacy Of Immune Checkpoint Blockade Therapies Natural History Note: these are illustrative curves not representative of actual data; redrawn from figure of the American Association for Cancer Research, 2013 25 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.
Secondary Endpoints: To determine the baseline adjusted change in magnetic resonance elastography (as measured in kPa) To determine the baseline adjusted change in FibroScan Score (as measured in kPa) https://clinicaltrials.gov/ct2/show/NCT02421094?term=GR MD 02 rank=3 Non Invasive Assessments of Liver Fibrosis in NASH FX trial 2015 Galectin Therapeutics | NASDAQ:GALT 19 Transient Elastography (FibroScan ) LiverMultiScan* Perspectum Diagnostics Whole liver assessment of fibrosis using multi parametric magnetic resonance imaging Regional assessment of liver for tissue stiffness (FDA approved) Echosense Normal MR Elastography Whole liver assessment of stiffness using magnetic resonance imaging with mechanical pulse Vibrator Probe Ribs Transducter Summary of NASH Advanced Fibrosis Program Galectin 3 a well validated target in pre clinical studies GR MD 02 binds gal 3 and is targeted to macrophages In pre clinical models GR MD 02 has multiple effects Reduces inflammation, fat and ballooning hepatocytes in NASH Reduces and reverses liver fibrosis and cirrhosis Reduces portal pressure, an endpoint of NASH CX trial In NASH patients with advanced fibrosis, GR MD 02 is safe, well tolerated and therapeutic doses have been defined GR MD 02 is well suited to target NASH with advanced fibrosis and cirrhosis, an area with less competition than early NASH Phase 2 clinical trial program address different patient populations NASH CX trial in cirrhosis with top line results end of 2017 NASH FX trial in stage 3 fibrosis with top line results 2H 2016 20 2015 Galectin Therapeutics | NASDAQ: GALT ADVANCED MELANOMA Lead Indication in Cancer Immunotherapy 21 2015 Galectin Therapeutics | NASDAQ:GALT CD8+ T Cells Cytokines (kill tumor cells) T Cells 22 Tumor Cells Potential Sites Of Action For Galectin Inhibition In Tumor Immunology Galectin 3 CD8+ T Cells Clonal Expansion 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 Immunotherapies Checkpoint Inhibitor Blockage: anti CTLA4 anti PD1 Tumor Vaccines 2015 Galectin Therapeutics | NASDAQ:GALT 23 2015 Galectin Therapeutics | NASDAQ:GALT In U.S. 76,000 new diagnoses and 9,100 deaths Even with newly approved drugs, a substantial unmet medical need remains 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 Robert W.
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). Phase 2 NASH Clinical Development Program Includes Trials In Two Separate Indications In NASH With Advanced Fibrosis 2015 Galectin Therapeutics | NASDAQ:GALT 15 1 Year of Therapy Indication NASH with Cirrhosis (Stage 4) Objective Expectation From Successful Study Reduction of portal pressure and fibrosis based on HVPG, liver biopsy, and non invasive tests Could be a pivotal trial in conjunction with another P3 trial Could be basis for FDA Breakthrough Designation NASH CX 4 Months of Therapy Reduction of liver fibrosis as assessed using three non invasive tests Could serve as basis for P2b or P3 trials Could be basis for FDA Breakthrough Designation NASH FX NASH with Advanced Fibrosis, but not Cirrhosis (Stage 3) 16 2015 Galectin Therapeutics | NASDAQ:GALT The NASH CX Trial (GT 026) Primary Endpoint: Reduction of hepatic venous pressure gradient (HVPG) as a measure of portal pressure compared to placebo at 1 year of treatment Secondary Endpoints: At least one stage change in histopathological fibrosis stage Liver collagen on liver biopsy (digital morphometric analysis) Liver stiffness as determined by FibroScan Score Metabolic capacity of the liver as determined by 13 C methacetin breath test Progression of cirrhosis as determined by complications Complications of Portal Hypertension in Cirrhosis Varices Ascites Shunting Encephalopathy Liver Cell Function Fibrosis Portal Pressure Complications Morbidity and Mortality 2015 Galectin Therapeutics | NASDAQ: GALT The Goal is to: 17 (Portal Hypertension = High Blood Pressure in Portal Vein) 18 2015 Galectin Therapeutics | NASDAQ:GALT The NASH FX Trial (GT 028) Primary Endpoint: Difference between placebo and GR MD 02 in the baseline adjusted mean change in liver fibrosis as measured by corrected T1 (cT1) mapping as determined from LiverMultiScan (LMS), a multi parametric MRI protocol.
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) 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 2015 Galectin Therapeutics | NASDAQ:GALT 14 80% 100% Placebo GR MD 02 (8 mg/kg) 3 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 *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.
PLOS ONE 2013;8:e75361. GR MD 02 Reversed Cirrhosis In Rat Model* Toxin induced cirrhosis in rats; toxin continued during GR MD 02 treatment 2015 Galectin Therapeutics | NASDAQ:GALT Reduces portal pressure which correlates with primary endpoint in planned cirrhosis trial Multiple dose escalation, double blind, placebo controlled trial in NASH patients with advanced fibrosis GR MD 02 up to 8 mg/kg IV was safe and well tolerated 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 Results provide strong foundation for entering Phase 2 12 2015 Galectin Therapeutics | NASDAQ:GALT Phase 1 Trial Completed December 2014 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: 1.
Therapy of Regression of fibrosis and reversal of cirrhosis in rats by galectin inhibitors in thioacetamide induced liver disease. PLOS ONE 2013;8:e75361. 10 2015 Galectin Therapeutics | NASDAQ: GALT 11 Vehicle Treated GR MD 02 Treated (4 weekly doses) *Traber PG, Chou H, Zomer E, Hong F, Klyosov A Fiel M I, Friedman, SL. Therapy of Regression of fibrosis and reversal of cirrhosis in rats by galectin inhibitors in thioacetamide induced liver disease.
Therapy of Experimental NASH and Fibrosis with Galectin Inhibitors. PLOS ONE 2013;8:e83481 Rat model of liver fibrosis/cirrhosis Reduces inflammation and cell death Reverses fibrosis and cirrhosis Reduces portal hypertension associated with cirrhosis Targets macrophages and reduces galectin 3 Peer reviewed publication: 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 Early Disease (low stage fibrosis) Late Disease (advanced fibrosis) NASH Stage 2 Competitive Landscape* 9 Simtuzumab (Gilead) Emricasan (Conatus) GR MD 02 (Galectin) Obeticholic Acid (Intercept) GFT505 (GenFit) Liraglutide (Novo Nordisk) Aramchol (Galmed) Cysteamine (Raptor) Cenicriviroc (Tobira) Emricasan (Conatus) 2015 Galectin Therapeutics NASDAQ:GALT Regulatory endpoints for late stage disease better defined and closer to clinical outcomes including complications of cirrhosis, liver transplant, and death Ultimately, combination therapies may be employed with agents that are tailored to different disease stages * Multiple other companies in discovery and Phase 1 Stage 1 Stage 2 Stage 3 Stage 4 Early Disease (low stage fibrosis) Late Disease (advanced fibrosis) Published Preclinical Data Shows That GR MD 02 Can Reverse NASH, Fibrosis, and Cirrhosis Mouse model of NASH Reduces inflammation, fat, and cell death Prevents as well as reverses fibrosis Targets macrophages and reduces galectin 3 Peer reviewed publication: Traber PG and Zomer E.
Prevalence in Asymptomatic Adults (% of population studied) 2 45% 17% 46% 12% 2 Prospective evaluation of NAFLD and NASH prevalence (Williams, et al. Gastro. 2011;140:124 131) Note: population recruited for this study were between ages 18 and 70 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 Obesity Obesity Diabetes Diabetes Fatty Liver Fatty Liver NASH NASH NASH: An Epidemic With No Approved Therapies 8 2015 Galectin Therapeutics | NASDAQ:GALT 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 Estimated US prevalence of advanced fibrosis 1,2 : ~ 6 million Estimated US prevalence of cirrhosis 1 : ~ 1 2 million Approximately one third will advance to Stage 3/4 fibrosis 3 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 3 Registered trademark, Bristol Myers Squib 4 Registered trademark, Merck Sharp Dome 4 Experienced Leadership Team 2015 Galectin Therapeutics | NASDAQ:GALT 5 2015 Galectin Therapeutics | NASDAQ:GALT Role in Disease Gal 3 is increased in inflammation and fibrogenesis Genetic modification in mice that eliminates gal 3 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 between these proteins 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 affecting 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 ADVANCED FIBROSIS AND CIRRHOSIS DUE TO NASH (NON ALCOHOLIC STEATOHEPATITIS) Lead Indication in Organ Fibrosis 6 2015 Galectin Therapeutics | NASDAQ:GALT 7 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. Forward Looking Statements 3 2015 Galectin Therapeutics | NASDAQ:GALT Organ Fibrosis 45% of U.S. deaths estimated to be associated with fibrotic disease 1 Lead indication is liver fibrosis/cirrhosis due to fatty liver disease (75% of all liver disease in U.S. 2 ) Potentially applicable to other fibrotic diseases based on pre clinical studies Phase 1 clinical trial completed Phase 2 trials in two NASH indications to start Q2 2015 Cancer Immunotherapy Focus on combination immunotherapy, one of the most prominent approaches to cancer therapy Lead indication is advanced melanoma, but technology applicable to other cancers Phase 1b trial in combination with Yervoy 3 in progress Phase 1b trial in combination with KEYTRUDA 4 expected to start Q3 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, 2014, 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.
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 May 11, 2015 NASDAQ: GALT www.galectintherapeutics.com 2015 Galectin Therapeutics Inc. Exhibit 99.1 2 2015 Galectin Therapeutics | NASDAQ:GALT 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.
Last updated: May 11, 2015