Galectin Therapeutics Inc. · NASDAQ:GALT
Galectin Therapeutics — Investor Presentation (September 2014)
27 slides from Galectin Therapeutics's investor presentation, Sep 12, 2014
Slide 1: Corporate Presentation
Exhibit 99.1 Corporate Presentation September 12, 2014 NASDAQ: GALT www.galectintherapeutics.com © 2014 Galectin Therapeutics Inc
Slide 2: Forward-Looking Statement Disclaimer
Forward-Looking Statement Disclaimer 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
Slide 3: Biopharmaceutical Company Focused On Major Unmet Medical Needs
Biopharmaceutical Company Focused On Major Unmet Medical Needs • Novel complex carbohydrate drugs that block galectin-3 Drugs Target protein, which is involved in multiple disease processes Galectin Proteins • Robust efficacy in pre-clinical animal models of disease • Lead candidate (GR-MD-02) paten
Slide 4: Pipeline
Pipeline Clinical Focus Stage of Development Drug Indication Discovery Pre-clinical Phase 1 Phase 2 Phase 3 Fibrosis GR-MD-02 NASH cirrhosis H1 2015 Lung fibrosis Kidney fibrosis Cardiovascular fibrosis Cancer Immunotherapy GR-MD-02 Melanoma Galectin-3 Inhibitors GR-MD-03 Subcutaneous GR-MD-04 Oral
Slide 5: Function of Galectin Proteins And Drug Inhibition
Function of Galectin Proteins And Drug Inhibition Molecular • Proteins bind to galactose residues in glycoproteins • Promote interactions between glycoproteins Interactions • 15 protein family; Gal-3 critical target for therapy • Gal-3 widely expressed; highest in macrophages Expression & • Modulate
Slide 6: Lead Indication in Organ Fibrosis: Cirrhosis Due to NASH
Lead Indication in Organ Fibrosis CIRRHOSIS DUE TO NASH (NON-ALCOHOLIC STEATOHEPATITIS) © 2014 Galectin Therapeutics | NASDAQ:GALT 6
Slide 7: NASH Is Epidemic And There Are No Approved Therapies
NASH Is Epidemic And There Are No Approved Therapies Estimated prevalence of NASH in US adults 1, 2: > 28 million US prevalence in asymptomatic, middle-aged 2 adults US (% of population) Obesity 45% Diabetes 16.5% Fatty Liver 46% NASH 12.2% 1 Based on July 2013 US census data for people >20 years ol
Slide 8: The End Stage of Fibrosis (Cirrhosis) Is When Patients Experience Symptoms
The End Stage of Fibrosis (Cirrhosis) Is When Patients With NASH Experience Symptoms And Complications Estimated prevalence of advanced fibrosis1, 2: ~ 6 million 1 Estimated prevalence of cirrhosis : ~ 2 million NASH Fibrosis Progression Stage 1 Stage 2 Stage 3 Stage 4 Liver biopsy (Blue = fibrosis)
Slide 9: GR-MD-02 Has Robust Therapeutic Effect On NASH In Rodent Models
GR-MD-02 Has Robust Therapeutic Effect On NASH With Fibrosis And Cirrhosis In Rodent Models 1 Mouse NASH Model Normal Stain Collagen Stain Gal-3 Stain • GR-MD-02 decreases: • NASH Activity Fat Inflammation Ballooning • Collagen (fibrosis) • Galectin-3 protein 1Traber, et al. PLOS ONE 2013;8:e83481 2
Slide 10: GR-MD-02 Is Being Developed For The Indication Of Cirrhosis Due To NASH
GR-MD-02 Is Being Developed For The Indication Of Cirrhosis Due To NASH • Cirrhosis is late disease that is closer to adverse clinical outcomes; cannot predict which patients with early disease will progress to cirrhosis • Goal of therapy is to reverse fibrosis and cirrhosis, thereby reducing likeli
Slide 11: Phase 1 Clinical Trial Of GR-MD-02 In NASH With Advanced Fibrosis
Phase 1 Clinical Trial Of GR-MD-02 In NASH With Advanced Fibrosis: Fast Track FDA Designation Patient: Biopsy proven NASH with advanced fibrosis (at least stage 3) Design : Ascending dose cohort; single and multiple dose First 2 cohorts enrolled, have at least 8 patients (6 active, 2 placebo); Third
Slide 12: Primary Endpoints Were Met In Cohort 1 and 2
Primary Endpoints Were Met In Cohort 1 and 2 • GR-MD-02 was safe and well tolerated at doses of 2 mg/kg and 4 mg/kg • The independent Data Safety Monitoring Board (DSMB) approved moving forward with Cohort 3. • Pharmacokinetics revealed a proportional increase in total drug exposure with doubling of
Slide 13: Exploratory Secondary Endpoints
Exploratory Secondary Endpoints • While the current gold standard for the evaluation of NASH with advanced fibrosis is liver biopsy, it is not appropriate to subject individuals to serial liver biopsies over a short Phase 1 clinical trial. Biopsy assessment of liver fibrosis will be the primary endp
Slide 14: Next Steps: Completion of Phase 1 Trial
Next Steps: Completion of Phase 1 Trial 2 • The dose of GR-MD-02 was increased to 8 mg/kg (320 mg/m ) in the third and final cohort, a dose projected to be well within the therapeutic range as predicted in pre-clinical studies. • The number of patients in the third cohort will be expanded up to 20 t
Slide 15: Next Steps: Phase 2 Clinical Trial
Next Steps: Phase 2 Clinical Trial • Planning for phase 2 clinical trials is ongoing • Phase 2 trial will be initiated in H1 2015; details of the trial(s) will be announced when planning is complete • The results of the first and second cohort suggest that 2 mg/kg and 4 mg/kg are safe and well-toler
Slide 16: Fibrosis Program Summary
Fibrosis Program Summary • First liver fibrosis indication: NASH with cirrhosis, a major unmet medical need • Current Phase 1 trial results shows safety of four doses of 2 mg/kg and 4 mg/kg. • Controlled phase 2 clinical trial program to follow completion of phase 1 trial. • The current results of t
Slide 17: Lead Indication in Cancer Immunotherapy: Advanced Melanoma
Lead Indication in Cancer Immunotherapy ADVANCED MELANOMA © 2014 Galectin Therapeutics | NASDAQ:GALT 17
Slide 18: Cancers Secrete Large Amounts of Galectins With Multiple Roles In Tumor Pathogenesis
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 affecte
Slide 19: Cancer Therapy Strategy
Cancer Therapy Strategy • Focus on cancer immunotherapy based on the hypothesis that galectin inhibitors will enhance efficacy of immunotherapies • Many cancers secrete large amounts of galectins & have multiple roles in tumor pathogenesis – importantly on tumor immunity • Metastatic melanoma is ini
Slide 20: Checkpoint Inhibitors Plus GR-MD-02 Boosts Anti-Tumor Immunity In Mouse Models
Checkpoint Inhibitors Plus GR-MD-02 Boosts Anti- Tumor Immunity, Reduces Tumor Size And Increases Survival In Mouse Cancer Models These studies on TC-1 prostate cancer cells (also effective in breast cancer, melanoma, and sarcoma) *p<0.05 aCTLA-4 = anti-CTLA-4 mAb [ipilimumab in humans (Yervoy, BMS)
Slide 21: Hypothesis: GR-MD-02 May Be A Complimentary Therapy To Immune Checkpoint Blockade
Hypothesis: GR-MD-02 May Be A Complimentary Therapy To Enhance Efficacy Of Immune Checkpoint Blockade Therapies ICB = Immune Checkpoint Blockade © 2014 Galectin Therapeutics | NASDAQ:GALT 21
Slide 22: Phase 1B Clinical Trial in Advanced Melanoma With Yervoy
Phase 1B Clinical Trial in patients with advanced melanoma using GR-MD-02 in combination with Yervoy® (ipilimumab): Actively Enrolling Patient inclusion: Advanced melanoma with indication for Yervoy® treatment Design: 3+3 dose escalation (3 patients if no adverse events); 10 patients treated with ma
Slide 23: Cancer Therapy Summary
Cancer Therapy 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. • Providence Portland Medical Cent
Slide 24: Milestones
Milestones Compound Program Milestone Timing GR-MD-02 NASH Cirrhosis Complete Phase 1 Trial End 2014 Start Phase 2 Trial H1 2015 Phase 2 Results TBD GR-MD-02 Melanoma Complete Phase 1B Trial End 2015 © 2014 Galectin Therapeutics | NASDAQ:GALT 24
Slide 25: Key Executive Officers
Key Executive Officers • Peter G. Traber, MD – CEO & CMO • President & CEO of Baylor College of Medicine • Sr. VP Clinical Development and CMO – GlaxoSmithKline plc • Chairman & CEO of TerraSep, LLC • President & CEO of University of Pennsylvania Health System, • Chair of Internal Medicine and Chief
Slide 26: Key Employees/Consultants
Key Employees/Consultants • J. Rex Horton – Executive Director of Regulatory Affairs and Quality Assurance • Director of Regulatory Affairs – Chelsea Therapeutics • Director of Regulatory Affairs – Solvay Pharmaceuticals, Inc. • Eliezer Zomer, PhD – Manufacturing and Product Development Head • Execu
Slide 27: Financial Key Facts – As of September 8, 2014
Financial Key Facts – As of September 8, 2014 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 $5.81 $4.28 - $19.11 Shares Outstanding 22 million Daily Volume (3-month average) 733
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