Galectin Therapeutics Inc. · NASDAQ:GALT
Galectin Therapeutics — Investor Presentation (September 2013)
38 slides from Galectin Therapeutics's investor presentation, Sep 24, 2013
Slide 1: Corporate Presentation September 2013
Corporate Presentation September 2013 NASDAQ: GALT www.galectintherapeutics.com Exhibit 99.1
Slide 2: Forward Looking Statements
2 © 2013 Galectin Therapeutics NASDAQ:GALT 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
Slide 3: Agenda
© 2013 Galectin Therapeutics NASDAQ:GALT 3 Agenda The Company and Key Team Members Galectin Inhibitors Fibrosis Program – our key focus Tumor Immunotherapies Summary
Slide 4: What We Do
© 2013 Galectin Therapeutics NASDAQ:GALT 4 What We Do Clinical stage biopharmaceutical company targeting fibrotic diseases and cancer with novel compounds that inhibit galectin proteins Galectin proteins are important in the development and promotion of many fibrotic and neoplastic diseases Currentl
Slide 5: Key Facts - September 20, 2013
5 © 2013 Galectin Therapeutics NASDAQ:GALT Trading Symbol Nasdaq: GALT Key Facts - September 20, 2013 Corporate Headquarters Norcross, GA (suburb of Atlanta) Stock Price; 52 Week Range $9.34 $1.60 - $13.21 Shares Outstanding 17.6 million Daily Volume (50 day average) 197,930 shares Market Capitaliza
Slide 6: Experienced Leadership Team
6 © 2013 Galectin Therapeutics NASDAQ:GALT Experienced Leadership Team
Slide 7: Agenda
© 2013 Galectin Therapeutics NASDAQ:GALT 7 Agenda The Company and Key Team Members Galectin Inhibitors Fibrosis Program – our key focus Tumor Immunotherapies Summary
Slide 8: Galectins Inhibitors
© 2013 Galectin Therapeutics NASDAQ:GALT 8 Galectins Inhibitors Galectin family (15 members) are classified by structure and the number of carbohydrate binding domains (CRD). Galectins bind via their CRD to oligosaccharides containing terminal galactose residues on macromolecules such as glycoprotei
Slide 9: Intellectual Property
9 © 2013 Galectin Therapeutics NASDAQ:GALT Intellectual Property GM-CT Class (current NCE is GM-CT-01) US Composition of matter patent issued 2011 (expires 2023) Five US issued method of use patents in combination with cancer therapy for increased efficacy and reduced side effects International Pate
Slide 10: Agenda
© 2013 Galectin Therapeutics NASDAQ:GALT 10 Agenda The Company and Key Team Members Galectins and Disease Fibrosis Program – our key focus Tumor Immunotherapies Summary
Slide 11: Galectin-3 is critically important in the development of organ fibrosis
© 2013 Galectin Therapeutics NASDAQ:GALT 11 Galectin-3 is critically important in the development of organ fibrosis Galectin-3 null mice (no galectin-3) are resistant to fibrosis due to toxin-induced liver toxicity Galectin-3 null mice are also resistant to fibrosis in: Fatty liver disease Kidney fi
Slide 12: Galectin Inhibitors Reverse Cirrhosis in Rat
© 2013 Galectin Therapeutics NASDAQ:GALT 12 Galectin Inhibitors Reverse Cirrhosis in Rat GR-MD-02 Vehicle GM-CT-01 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 Broad bands
Slide 13: Galectin Inhibitor GR-MD-02 Improved Fat, Liver Cell Death, Inflammation, and Fibrosis
© 2013 Galectin Therapeutics NASDAQ:GALT 13 Galectin Inhibitor GR-MD-02 Improved Fat, Liver Cell Death, Inflammation, and Fibrosis in Mouse Model of Fatty Liver Disease with Fibrosis GR-MD-02 Control Control GR-MD-02 GR-MD-02 Fat Cell death Inflammation Fat Cell death Inflammation Red = Collagen Red
Slide 14: Potential Use in Lung Fibrosis: GR-MD-02
© 2013 Galectin Therapeutics NASDAQ:GALT 14 Potential Use in Lung Fibrosis: GR-MD-02 Reduces Fibrosis in Mouse Model Vehicle Normal GR-MD-02 Marked reduction in area and severity of fibrosis without aggregation into larger formations Large areas of confluent fibrosis. Lung fibrosis induced by trache
Slide 15: Potential Use in Kidney Fibrosis: GR-MD-02
© 2013 Galectin Therapeutics NASDAQ:GALT 15 Potential Use in Kidney Fibrosis: GR-MD- 02 Reduces Fibrosis in Diabetic Mouse Vehicle Normal GR-MD-02 Reduction in interstitial fibrosis Arrows show areas of interstitial fibrosis
Slide 16: Liver Fibrosis Development Program: NASH
© 2013 Galectin Therapeutics NASDAQ:GALT 16 Liver Fibrosis Development Program NASH (Non-Alcoholic SteatoHepatitis) 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
Slide 17: NASH with Fibrosis Development Program: Accomplishments
© 2013 Galectin Therapeutics NASDAQ:GALT 17 NASH with Fibrosis Development Program: Accomplishments 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 ce
Slide 18: Development Program: Targeting Therapy In The Progression of NASH
18 © 2013 Galectin Therapeutics NASDAQ:GALT Development Program: Targeting Therapy In The Progression of NASH 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,
Slide 19: Phase 1 Clinical Trial
19 M J J A S O N D J F M A M J © 2013 Galectin Therapeutics NASDAQ:GALT 2013 2014 Cohort-1 Phase 1 Clinical Trial Sites: Top academic investigators in NASH; all US sites Patient inclusion: Biopsy proven NASH with advanced fibrosis (stage 3) Design: Dose escalation combining single and multiple dose
Slide 20: Phase 2 Clinical Trial Plans
20 © 2013 Galectin Therapeutics NASDAQ:GALT Phase 2 Clinical Trial Plans 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 ba
Slide 21: Competition in NASH
© 2013 Galectin Therapeutics NASDAQ:GALT 21 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: G
Slide 22: Fibrosis Strategy Summary
© 2013 Galectin Therapeutics NASDAQ:GALT 22 Fibrosis Strategy Summary NASH with Advanced Fibrosis: Evidence of efficacy of GR-MD-02 from well controlled phase 2 clinical trial Other Organ Fibrosis: Potential for partnering opportunities Lung fibrosis – pre-clinical results suggest possible use in Id
Slide 23: Agenda
© 2013 Galectin Therapeutics NASDAQ:GALT 23 Agenda The Company and Key Team Members Galectin Inhibitors Fibrosis Program – our key focus Tumor Immunotherapies Summary
Slide 24: Checkpoint Inhibitor Blockade
© 2013 Galectin Therapeutics NASDAQ:GALT 24 Marketed: CTLA4 receptor mAb: Yervoy® (Ipilimumab, BMS) In Development: Anti-PD-1 (nivolumab BMS; lambrolizumab Merck) Anti PD-L1 (MPDL3280A , Roche) May 22, 2010 Checkpoint Inhibitor Blockade
Slide 25: Cancers Secrete Large Amounts of Galectins
25 © 2013 Galectin Therapeutics NASDAQ:GALT 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
Slide 26: Cancer Therapy Strategy
© 2013 Galectin Therapeutics NASDAQ:GALT 26 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
Slide 27: Potential sites for galectin inhibition in tumor immunology
27 © 2013 Galectin Therapeutics NASDAQ:GALT Potential sites for galectin inhibition in tumor immunology 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
Slide 28: Ludwig Institute Clinical Trial: Melanoma Vaccine with GM-CT-01
28 © 2013 Galectin Therapeutics NASDAQ:GALT Ludwig Institute Clinical Trial to Evaluate combination of melanoma vaccine with GM-CT-01 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 m
Slide 29: Clinical Trial LUC10-001: Accrual
© 2013 Galectin Therapeutics NASDAQ:GALT 29 • 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 Clinical Trial LUC10-001: Accrual Note: one center at initiation and first patient completed pro
Slide 30: Potential sites for galectin inhibition in tumor immunotherapy
30 © 2013 Galectin Therapeutics NASDAQ:GALT Potential sites for galectin inhibition in tumor immunotherapy 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
Slide 31: Checkpoint inhibitor blockage plus GR-MD-02 boosts anti-tumor immunity
© 2013 Galectin Therapeutics NASDAQ:GALT 31 Checkpoint inhibitor blockage plus GR-MD-02 boosts anti-tumor immunity in syngeneic mouse models of prostate and breast cancer *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
Slide 32: Cancer Therapy Strategy: Summary
32 © 2013 Galectin Therapeutics NASDAQ:GALT 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 c
Slide 33: Agenda
© 2013 Galectin Therapeutics NASDAQ:GALT 33 Agenda The Company and Key Team Members Galectins and Disease Fibrosis Program – our key focus Tumor Immunotherapies Summary
Slide 34: Finances
© 2013 Galectin Therapeutics NASDAQ:GALT 34 Finances September 20, 2013 cash balance: $9.8 million Raised $6 million from private placement and warrant exercises in July/August 2013 Funded through Q2 2014 and completion of Phase I clinical trial for GR-MD-02 Additional funding required for a Phase 2
Slide 35: Development Program
© 2013 Galectin Therapeutics NASDAQ:GALT 35 Development Program Liver Fibrosis First indication: GR-MD-02 in NASH with advanced fibrosis Phase 1 clinical trial underway; interim data Jan. 2014 Other Organ Fibrosis: Studies to demonstrate broad application of drugs in organ fibrosis; seek partner Can
Slide 36: Summary: Proprietary Compounds, Validated Science, Large Market Opportunities
Proprietary Compounds Validated Science Large Market Opportunities Intellectual Property Experienced Management Team 36 © 2013 Galectin Therapeutics NASDAQ:GALT First in class, proprietary compounds that inhibit galectin proteins Complex carbohydrate drugs with favorable safety profile GR-MD-02: Pot
Slide 37: Appendix
© 2013 Galectin Therapeutics NASDAQ:GALT 37 APPENDIX
Slide 38: Inhibition of Gal-3 May Have Multiple Sites of Action in Therapy of NASH
© 2013 Galectin Therapeutics NASDAQ:GALT 38 Inhibition of Gal-3 May Have Multiple Sites of Action in Therapy of NASH Stellate Cells Macrophages Inhibit scavenger receptor mechanism and reduce cellular toxicity Potential sites of anti-galectin activity Reduces activation of stellate cells. TGF- recep
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