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Galt 5232013
1.
Annual Stockholder Meeting May
23, 2013 NASDAQ: GALT www.galectintherapeutics.com
2.
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, 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 © 2013 Galectin Therapeutics NASDAQ:GALT
3.
Galectin Therapeutics: A
clinical stage biopharmaceutical company Targeting diseases with large unmet medical needs Focusing on diseases in which galectin proteins are important in the development and promotion of those diseases © 2013 Galectin Therapeutics NASDAQ:GALT 3 • Galectin proteins validated important in pre-clinical models of disease • Inflammation, acute and chronic • Organ fibrosis-liver, lung, kidney, heart • Cancer • Once targeting galectins in humans is achieved there will be many important disease indications.
4.
Carbohydrate-based drugs for inhibition
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 Complex Carbohydrate Research at the University of Georgia) © 2013 Galectin Therapeutics NASDAQ:GALT 4
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 Therapeutics NASDAQ:GALT 5
6.
NASH with Fibrosis
Development Program: Accomplishments • New strategic focus: 2011 Annual Stockholder Meeting • NASH indication chosen based on pre-clinical experiments • Multiple studies in animal models confirmed robust effect on inhibition and regression of fibrosis, as well as reduction in inflammation 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 elucidating pharmacology, pharmacokinetics, and toxicology. • FDA review of IND for GR-MD-02 submitted Jan. 30, 2013 concluded that we may proceed with human clinical studies. © 2013 Galectin Therapeutics NASDAQ:GALT 6
7.
GR-MD-02 and GM-CT-01
both reverse cirrhosis 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 continued throughout drug treatment • Treatment with four weekly doses of GR or GM © 2013 Galectin Therapeutics NASDAQ:GALT 7 Vehicle Control GR-MD-02 GM-CT-01 N N = nodule Arrows indicate broken strands of fibrosis
8.
Development Program: Targeting Therapy
In The Progression of NASH 8 Development of Obesity Insulin Resistance/Diabetes Steatosis (fatty liver) NASH Fibrosis Cirrhosis Decades Because of effect on inflammation in NASH and ability to reduce existing fibrosis, our clinical program will target NASH patients with advanced fibrosis © 2013 Galectin Therapeutics NASDAQ:GALT
9.
9 M J J
A S O N D J F M A M J 2013 2014 Cohort-1 Phase 1 Clinical Trial © 2013 Galectin Therapeutics NASDAQ:GALT • Patient inclusion: Biopsy proven NASH with advanced fibrosis (stage 3) • Design: Dose escalation combining single and multiple dose in design. Single IV dose followed by three additional weekly doses in each cohort. At least three dose 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 effect including markers for inflammation, cell death, and fibrogenesis Cohort-2 Cohort-3 Guided by exposure from previous cohort
10.
Phase 1 Clinical
Trial Operations © 2013 Galectin Therapeutics NASDAQ:GALT 10 • Contract Research Organizations: CTI Clinical Trials & Consulting Services Inc. of Cincinnati Ohio, a full service clinical research organization with extensive experience in liver-related clinical 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 regulatory process, business contracts, and patient identification • Infusions begin within next few weeks
11.
11 Phase 2 Clinical
Trial Plans © 2013 Galectin Therapeutics NASDAQ: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 Phase 1 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.
Competition in NASH •
Most drugs in development focus on improving NASH activity score (fat, inflammation, and cell death) with minimal amounts of fibrosis. • Few companies are focused on fibrosis which is the key cause of liver failure in patients • Galectin: GR-MD-02 • Gilead: Lysyl oxidase-like-2 mAb (GS-6624): Monoclonal antibody that blocks the enzyme which cross links collagen fibers • Initiated Phase 2 trials in 2012 in patients with NASH and fibrosis • Top line data Q3 2015 © 2013 Galectin Therapeutics NASDAQ:GALT 12
13.
Fibrosis Strategy Summary •
NASH with Advanced Fibrosis: Evidence of efficacy of GR-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 mouse kidney • Lung fibrosis • Ongoing discussions with large pharmaceutical companies and other partnering opportunities • Discussions will provide foundation for partnering opportunities at the most opportune time © 2013 Galectin Therapeutics NASDAQ:GALT 13
14.
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 14 © 2013 Galectin Therapeutics NASDAQ:GALT
15.
Cancer Therapy Strategy •
Focus on tumor immunotherapy • Hypothesis: galectin inhibitors will enhance efficacy of immunotherapies • 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 Research Institute (EACRI) Providence-Portland Medical Center, Portland Oregon © 2013 Galectin Therapeutics NASDAQ:GALT 15
16.
CD8+ T-Cells Cytokines (kill tumor
cells) T-Cells 16 Tumor Cells Potential sites for galectin inhibition in tumor immunology © 2013 Galectin Therapeutics NASDAQ:GALT Galectin-3 CD8+ T-Cells Clonal Expansion Immunotherapies Checkpoint Inhibitor Blockade: anti-CTLA4 anti-PD1 Tumor Vaccines 1. Potential for galectin inhibitors to enhance anti-tumor immune response 2. Potential for galectin inhibitors to enhance anti- tumor activity of T-cells by blocking “Galectin Effect” Galectin-3
17.
Ludwig Institute Clinical
Trial to Evaluate combination of melanoma vaccine with GM-CT-01 17 Melanoma “Proof of Concept” Trial: Patients: Metastatic melanoma Design: 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 melanoma patients express one or the other antigens) then treat with GM-CT-01 Endpoint: Partial or complete response by imaging Study sites: Ludwig Institute, Brussels Belgium; second site Antwerp Study funding: Ludwig Institute (stage 1; 12 patients) Group 2 patients have additional injection of GM-CT-01 in cutaneous tumors © 2013 Galectin Therapeutics NASDAQ:GALT
18.
Clinical Trial LUC10-001:
Accrual © 2013 Galectin Therapeutics NASDAQ:GALT 18 2 patients: 1 MxR-PD 1 PD 1 patient: 1 MxR-PD Evaluable for: Tumor response GM-CT-01 Toxicity Group 1 GM infusion 4 Patients Group 2 GM infusion + peritumor 2 patients 2 patients stopped at V3 1 patient stopped at V3 8 patients Screened 6 patients Included 2 patients failed screening • No grade 3/4 adverse events or serious adverse events • Two out of three mixed responses encouraging, but no responses by RECIST • Patient accrual continuing Note: one center at initiation and first patient completed protocol before more enrolled; once safety confirmed additional patients enrolled and second center initiated
19.
19 Potential sites for
galectin inhibition in tumor immunotherapy © 2013 Galectin Therapeutics NASDAQ:GALT CD8+ T-Cells Cytokines (kill tumor cells) T-Cells Tumor Cells Galectin-3 CD8+ T-Cells Clonal Expansion Immunotherapies Checkpoint Inhibitor Blockade: anti-CTLA4 anti-PD1 Tumor Vaccines Galectin-3 Collaboration established in 2012 with Earle A. Chiles Research Institute (EACRI) to evaluate the effect of galectin inhibitors on the induction of T-cell activity alone and in combination with checkpoint inhibitor blockade.
20.
© 2013 Galectin
Therapeutics NASDAQ:GALT 20 Checkpoint 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.
Checkpoint inhibitor blockage
plus GR-MD-02 boosts anti-tumor immunity in syngeneic mouse models of prostate and breast cancer © 2013 Galectin Therapeutics NASDAQ:GALT 21 *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
22.
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. • Ludwig Cancer Institute: Complete ongoing clinical trial with interim results reported at appropriate intervals • Earle A. Chiles Research Institute (EACRI): Ongoing pre-clinical studies; phase 1 clinical trial in melanoma with combination of Yervoy and GR-MD-02 in design phase • 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 22 © 2013 Galectin Therapeutics NASDAQ:GALT
23.
Finances • March 31,
2013 cash balance: $7.0 million • Funded through Q1 2014 and completion of Phase I clinical trial for GR-MD-02 • Additional funding required for operations through 2015 and 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 fundamental investors; growing interest in funding Phase 2 • Fundamental investors are value investors with 3-5 year time horizon who are interested in investing at market © 2013 Galectin Therapeutics NASDAQ:GALT 23
24.
Considerations for Stockholders •
Refer interested potential investors • Educate your broker about Galectin and refer to us for more information • Follow us on twitter: @GalectinGALT • Share our web site on social media sites © 2013 Galectin Therapeutics NASDAQ:GALT 24
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 broad application of drugs in organ fibrosis • 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 © 2013 Galectin Therapeutics NASDAQ:GALT 25
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