Author Disclosures Stephen A. Harrison Advisory Committees or Review Panels; Merck, Nimbus Discovery, NGM Bio, Fibrogen. Grant/Research Support: Merck, Genentech; Speaking and Teaching: Merck, Gilead, Janssen, AbbVie. Na

Includes following serum levels: alpha 2 macroglobulin, haptoglobin, apolipoprotein A1, gamma glutamyl transpeptidase, and total bilirubin 13 Results: FibroTest (FibroSure ) Scores 14 * Placebo values were combined after showing that there was no difference between different time points ** Statistical test: Three groups versus placebo, ANOVA with Dunnett s test for multiple comparisons *** Statistical test: Versus placebo, two sided t test p 0.05 p 0.01 ns ns ns Placebo GR 2 nd dose GR 4 th dose + 14 da GR 4 th dose + 3 da GR 4 th dose + 14 da GR 4 th dose + 3 da Cohort 3** Cohort 1*** Cohort 2*** Results: Alpha 2 Macroglobulin Serum Levels 15 p 0.005 p 0.001 p 0.05 Placebo GR 2 nd dose GR 4 th dose + 14 da GR 4 th dose + 3 da GR 4 th dose + 14 da GR 4 th dose + 3 da Cohort 3** Cohort 1*** Cohort 2*** * Placebo values were combined after showing that there was no difference between different time points ** Statistical test: Three groups versus placebo, ANOVA with Dunnett s test for multiple comparisons *** Statistical test: Versus placebo, two sided t test ns ns Summary Administration of 2, 4, and 8 mg/kg lean body weight of GR MD 02 intravenously for four doses over 6 weeks was safe and well tolerated in NASH patients with advanced fibrosis PK analysis demonstrated 8 mg/kg achieves targeted therapeutic dosing range derived from animal studies Analysis of most putative serum biomarkers showed high variability in both placebo and drug groups and are not felt to be useful in future studies Changes in the FibroTest were seen in the high dose cohort 3, attributable to a reduction in alpha 2 macroglobulin. 16 Phase 2 Clinical Trial Plans A Phase 2 clinical trial is planned based on: Pre clinical efficacy Phase 1 safety and tolerability Phase 1 PK and animal model/human dose equivalency Phase 1 evidence of pharmacodynamic effect at high dose The company has informed the study investigators that it has met with FDA to discuss Phase 2 trial design Preliminary Phase 2 clinical trial design Target patient population: Cirrhosis due to NASH Study endpoints will include those that are closely associated with outcomes in patients with cirrhosis Primary endpoint: Hepatic venous pressure gradient (HVPG) Secondary endpoint: Morphometric analysis of collagen on liver biopsies Other secondary endpoints will include non invasive tests to evaluate for correlation with HVPG and liver collagen Timeline: Study is planned to be initiated in second quarter of 2015 and an RFP has been responded to by 4 recognized CROs 17

All adverse events were mild (grade 1) and transient. An independent Data Safety Monitoring Board (DSMB) reviewed all data after first and second cohorts. Results: Mean GR MD 02 Plasma Concentration Time Profiles After First And Fourth Doses In All Three Cohorts 11 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 Pharmacokinetics Indicates 8 mg/kg dose Is Within The Upper Range Of The Targeted Therapeutic Window 12 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 AUC of Human 8 mg/kg dose AUC of Human 2 mg/kg dose Results: Exploratory Serum Biomarkers There are no validated serum biomarkers for evaluation of potential therapeutic changes over time in NASH or fibrosis A panel of serum tests were evaluated to explore potential biomarkers for use in future studies Most of the putative biomarkers showed high variability within the same individual in placebo and GR MD 02 patients, rendering them not useful as reliable biomarkers CK 18 (M30 and M65), TGF , Osteopontin, VEGF, IP 10, IL 6, IL 8, TNF , CD 40 ligand, metalloproteinases, INF , Endothelin 1 The ELF scores were not significantly changed relative to placebo Earlier results in this patient population that suggested changes in certain biomarkers were not evident with increased numbers of placebo patients for comparison FibroTest , a composite score that has been correlated with the extent of liver fibrosis, was significantly reduced by GR MD 02 treatment in cohort 3.

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 Study Sponsor: Galectin Therapeutics Inc 7 Methods: Three Cohort Design Of Phase 1 Clinical Trial Subjects: Biopsy proven NASH with Brunt Stage 3 fibrosis Design: Blinded, placebo controlled, sequential dose escalation Three cohorts: 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 8 1 st Infusion 2 nd Infusion 3 rd Infusion 4 th Infusion Week 6 7 Pharmacokinetics Pharmacokinetics Biomarkers Cohort 1 Cohort 2 Cohort 3 Cohort 1 (2 mg/kg) Cohort 2 (4 mg/kg) Cohort 3* (8 mg/kg) Enrolled 8 10 13 Completed 8 9 9 Pending Completion by end of December 4 Completed Patients Age Range (Mean) 40 64 (54) 34 69 (51.5) 44 69 (61) Sex (M/F) 2/6 6/4 5/4 BMI (Mean) 39 39.6 33.2 BMI 30 8/8 9/9 5/9 Diabetes 6 4 7 9 Results: Patient Characteristics * Enrollment of cohort 3 terminated at 13 patients since sufficient information obtained for phase 2 trial design Results: Safety Data On Completed Patients 10 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 6 3 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 1 Therapy Emergent Adverse Events, possibly related to study drug were reported in 3 subjects who received placebo and 2 subjects who received GR MD 02.

PLOS ONE 2013;8:e75361. Collagen N=10 N=10 Portal Pressure N=10 N=10 N=10 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.

Therapy of Experimental NASH and Fibrosis with Galectin Inhibitors. PLOS ONE 2013;8:e83481 Pre Clinical: GR MD 02 Reversed Cirrhosis And Improved Portal Hypertension In Thioacetamide Treated Rat Model* 6 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. Therapy of Regression of fibrosis and reversal of cirrhosis in rats by galectin inhibitors in thioacetamide induced liver disease.

Army Office of the Surgeon General, the Department of the Army, Department of Defense or the U.S. Government. 3 Background Advanced liver fibrosis and cirrhosis are unmet medical needs NASH is the most common liver disease in the US and a growing cause of cirrhosis requiring liver transplantation Galectin 3 is a protein that binds to terminal galactose residues on glycoproteins and is highly expressed in macrophages Knockout mouse experiments have shown that galectin 3 is a critical protein in fibrogenesis in multiple organs, including liver fibrosis due to toxins and NASH GR MD 02 is a complex carbohydrate drug containing terminal galactose residues that binds to galectin 3 and inhibits its function 4 Pre Clinical: GR MD 02 Has Therapeutic Effect On NASH With Fibrosis In Mouse Model* 5 Normal NASH:Control NASH:GR MD 02 GR MD 02 Effects NAFLD Activity Score Fat Cell death Inflammation Collagen (Fibrosis) Pico Sirius Red Galectin 3 Protein Galectin 3 H E *Traber PG and Zomer E.

Traber Management Position: Galectin Therapeutics The following people have nothing to disclose: Smitha Marri, Mazen Noureddin, Thomas D. Schiano, Mohammad S. Siddiqui 2 Presenter Disclosure Slide The view(s) expressed herein are those of the author(s) and do not reflect the official policy or position of Brooke Army Medical Center, the U.S. Army Medical Department, the U.S.

Sanyal Advisory Committees or Review Panels: Bristol Myers, Gilead, Abbott, Ikaria; Consulting: Salix, Immuron, Exhalenz, Nimbus, Genentech, Echosens, Takeda; Grant /Research Support: Salix, Genentech, Genfit, Intercept, Ikaria, Takeda, GalMed, Novartis, Gilead; Independent Contractor; UpToDate, Elsevier Brent A. Neuschwander Tetri Advisory Committees or Review Panels: Boehringer Ingerheim Peter G.

Naga P. Chalasani Consulting: Salix, AbbVie, Lilly, Boerhinger Ingelham, Aegerion; Grant/Research Support: Intercept, Lily, Gilead, Cumberland, Galectin Eric Lawitz Advisory Committees or Review Panels: AbbVie, Achillion Pharmaceuticals, BioCryst, Biotica, Enanta, Idenix Pharmaceuticals, Janssen, Merck Co, Novartis, Santaris Pharmaceuticals, Theravance, Vertex Pharmaceuticals; Grant/Research Support: AbbVie, Achillion Pharmaceuticals, Boehringer Ingelheim, Bristol Myers Squibb, Gilead Sciences, GlaxoSmithKline, Idenix Pharmaceuticals, Intercept Pharmaceuticals, Janssen, Merck Co, Novartis, Presidio, Roche, Santaris Pharmaceuticals, Vertex Pharmaceuticals; Speaking and Teaching: Gilead, Kadmon, Merck, Vertex Arun J.

Louis University, St. Louis, MO; 8 Galectin Therapeutics, Norcross, GA; 9 Emory University School of Medicine, Atlanta, GA AASLD Abstract No. 57 Exhibit 99.1 Author Disclosures Stephen A. Harrison Advisory Committees or Review Panels; Merck, Nimbus Discovery, NGM Bio, Fibrogen. Grant/Research Support: Merck, Genentech; Speaking and Teaching: Merck, Gilead, Janssen, AbbVie.

Traber 8,9 1 Brooke Army Medical Center, Fort Sam Houston, TX; 2 Indiana University School of Medicine, Indianapolis, IN; 3 The Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX; 4 University of Southern California, Los Angeles, CA; 5 VCU Medical Center, Richmond, VA; 6 Icahn School of Medicine at Mount Sinai, New York, NY; 7 St.

Phase 1 Clinical Trial Results Of GR MD 02, A Galectin 3 Inhibitor, In Patients Having Non Alcoholic Steatohepatitis (NASH) With Advanced Fibrosis Stephen A. Harrison 1 , Naga P. Chalasani 2 , Eric Lawitz 3 , Smitha Marri 2 , Mazen Noureddin 4 , Arun J. Sanyal 5 , Thomas D. Schiano 6 , Mohammad S. Siddiqui 5 , Brent A. Neuschwander Tetri 7 , Peter G.