Galectin Therapeutics Inc. · NASDAQ:GALT
Galectin Therapeutics — Investor Presentation (August 2016)
26 slides from Galectin Therapeutics's investor presentation, August 2016
Slide 1: Corporate Presentation
Corporate Presentation August 2016 NASDAQ: GALT www.galectintherapeutics.com © 2016 Galectin Therapeutics Inc.
Slide 2: Forward-Looking Statements
Forward-Looking Statements 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,”
Slide 3: Company Thesis: Fibrosis Therapy
Company Thesis: Fibrosis Therapy • Large unmet medical need: Fatty liver disease (NASH: non- alcoholic steatohepatitis) with cirrhosis (advanced scarring) • Galectin inhibition also a platform for other fibrotic/inflammatory diseases • Lead drug has strong pre-clinical data with a differentiated pro
Slide 4: Experienced Executive Leadership Team
Experienced Executive Leadership Team Marc Rubin, M.D. Chairman of the Board Years Relevant Experience: 30 Peter G. Traber, M.D. President, CEO, CMO Years Relevant Experience: 30 Harold H. Shlevin, Ph.D. COO; Corporate Secretary Years Relevant Experience: 35 Jack W. Callicutt CFO Years Relevant Expe
Slide 5: Financial Key Facts
Financial Key Facts Trading Symbol Nasdaq: GALT Corporate Headquarters Norcross, GA (suburb of Atlanta) Fiscal Year End December 31 Accounting Firm Cherry Bekaert Stock Price; 52 Week Range (August 5, 2016) $2.05 $1.08 - $3.33 Common Shares Outstanding 29 million Institutional 32% Common Share Owner
Slide 6: Fibrosis (Scarring) Affects Most Organs And Tissues
Fibrosis (Scarring) Affects Most Organs And Tissues And Is A Leading Cause Of Morbidity And Mortality • Asthma • Congestive • Diabetic • Steatohepatitis • Idiopathic heart failure nephropathy (NASH) Pulmonary • Atherosclerosis • Hypertension • Alcoholic liver Fibrosis • Endomyocardial • IgA nephropa
Slide 7: Fatty Liver Disease Is Most Common Cause Liver Disease In U.S.
Fatty Liver Disease Is Most Common Cause Liver Disease In U.S.* Fatty Liver Disease Non-Alcoholic Fatty Liver Disease (NAFLD) Non-Alcoholic Steatohepatitis (NASH) NASH with fibrosis NASH cirrhosis *Younossi, et al. Clin. Gasto. Hepatol. 2011;9:524-530 © 2016 Galectin Therapeutics | NASDAQ: GALT 7
Slide 8: NASH Is Gaining Mainstream Awareness
NASH Is Gaining Mainstream Awareness NASH Is the 21st Century’s Looming Public Health Threat --January 30, 2016 “NASH is a silent public health time bomb that may soon overload our health care system with hospital admissions.” “The need to develop effective drugs is paramount, says Dr. Wattacheril*…
Slide 9: NASH is a Global Epidemic with Very Large Potential Market
NASH is a Global Epidemic with Very Large Potential Market • One in four people in the world are affected by fatty liver disease1 • A life-time risk of ~20 million liver-related deaths among NAFLD patients currently alive1 • U.S. market could be $25 Billion by 20252 • Global market could be $35-40 B
Slide 10: Natural History of Fatty Liver Disease
Natural History of Fatty Liver Disease1 TARGET OF DRUG INTERVENTION FOR GR-MD-02 1 Rinella M, Charlton M. The globalization of nonalcoholic fatty liver disease: Prevalence and impact on world health. Hepatology 2016 Jul;64(1):19-22 © 2016 Galectin Therapeutics | NASDAQ:GALT 10
Slide 11: Scarring (Fibrosis) Of The Liver In NASH
Scarring (Fibrosis) Of The Liver In NASH Early Disease (low stage fibrosis) Late Disease (advanced fibrosis) Fibrosis Progression Stage 1 Stage 2 Stage 3 Stage 4 Liver biopsy (Blue = fibrosis) Cirrhosis No increased mortality* Increased mortality* *All cause mortality as compared to reference group
Slide 12: The Galectin-3 Protein Is Critical For The Development Of Fibrosis
The Galectin-3 Protein Made In Our Bodies Is Critical For The Development Of Fibrosis • Galectin-3 is validated to be important in pre-clinical models of disease • Elimination of galectin-3 prevents multiple types of fibrosis, including liver fibrosis • Our lead drug candidate, GR-MD-02, binds to an
Slide 13: GR-MD-02 Has Therapeutic Effect On NASH With Fibrosis In Mouse Model
GR-MD-02, A Galectin-3 Inhibitor, Has Therapeutic Effect On NASH With Fibrosis In Mouse Model Improvement is linked to decreased tissue Galectin-3 Normal NASH:Control NASH:GR-MD-02 GR-MD-02 Effects Normal Stain Disease Activity Score • Fat • Cell death • Inflammation Collagen Stain Collagen (Fibrosi
Slide 14: Robust Preclinical Data: GR-MD-02 Reversed Cirrhosis In Rat Model
Robust Preclinical Data: GR-MD-02 Reversed Cirrhosis In Rat Model Differentiated Profile: reduce inflammation and prevent and reverse fibrosis Vehicle-Treated (control) GR-MD-02-Treated (4 weekly doses) Toxin induced cirrhosis in rats Toxin continued during GR-MD-02 treatment Reduces portal pres
Slide 15: Targeting Late-Stage NASH, Including NASH Cirrhosis
Galectin Therapeutics Is Targeting Late-Stage NASH, Including NASH Cirrhosis Early Disease (low stage fibrosis) Late Disease (advanced fibrosis) Stage 1 Stage 2 Stage 3 Stage 4 (Cirrhosis) • Phase 3 • Intercept • Phase 2 • Genfit • Galectin • Phase 2 • Gilead (Simtuzumab) • Tobira • Conatus • Galmed
Slide 16: Successful Phase 1 Trial In NASH Patients With Advanced Fibrosis
Successful Phase 1 Trial In NASH Patients With Advanced Fibrosis • Fast Track designation from FDA • Four dose, double-blind, placebo-controlled, dose escalation trial in NASH patients with advanced fibrosis • GR-MD-02 was safe and well tolerated • Reached targeted doses without adverse effects • Hi
Slide 17: Association of NASH with Psoriasis
Association of NASH with Psoriasis • One patient in Phase 1 trial had long-term remission of psoriasis when treated with GR-MD-02 • Patients with psoriasis have over two fold higher incidence of NASH with greater fibrosis1 • Galectin-3 plays important role in skin and there is increase in skin vesse
Slide 18: Clinical Improvement in Psoriasis After 12 Weeks of Treatment
Clinical Improvement in Psoriasis After 12 Weeks of Treatment with GR-MD-02 Patient 2 Baseline GR-MD-02 HAS ACTIVITY IN A HUMAN DISEASE Patient 4 Week 12 Baseline Week 12 Baseline Patient 1 Week 12 Baseline Week 12 © 2016 Galectin Therapeutics | NASDAQ:GALT 18
Slide 19: NASH-CX Phase 2 Clinical Trial
NASH-CX Phase 2 Clinical Trial • Intended lead market indication: NASH Cirrhosis • Potential registration endpoints Indication Objective Expectation • Proof-of-concept NASH Reduce portal in NASH cirrhosis 1 Year of NASH-CX Cirrhosis pressure and • Evaluation of Therapy liver fibrosis registration en
Slide 20: NASH-FX Phase 2 Clinical Trial
NASH-FX Phase 2 Clinical Trial • Evaluation of non-invasive liver fibrosis tests for future studies • Designed to extend/confirm Phase 1 efficacy observations • Not intended to be a registration trial Indication Objective Expectation NASH with • Assess non- Evaluate liver advanced 4 Months fibrosis
Slide 21: NASH Advanced Fibrosis Program with GR-MD-02: Summary
NASH Advanced Fibrosis Program with GR-MD-02: Summary • Unmet medical need with a very large potential market • Competitively well positioned in NASH cirrhosis • Reversal of fibrosis/cirrhosis in preclinical models • Extensive safety data in rodent and monkey supporting chronic administration • In h
Slide 22: Cancer Immunotherapy Opportunity
Cancer Immunotherapy Opportunity • Many tumors produce high levels of Galectin-3 Focus on Immunotherapy • Galectin-3 plays an important role in reducing the ability of immune system to fight cancer Advanced • Even with newly approved drugs, a substantial Melanoma as unmet medical need remains Initia
Slide 23: Investigator Initiated Trials: Melanoma
Investigator Initiated Trials: Melanoma • Patients With Advanced Melanoma Using GR-MD-02 In Combination With Yervoy® • Advanced melanoma with indication for Yervoy® treatment • Dose escalation with GR-MD-02 plus standard Yervoy ® • Measure tumor and immune system response • Two dosing groups complet
Slide 24: Potential As A Platform Technology For Other Diseases
Potential As A Platform Technology For Other Diseases • Lung fibrosis Positive pre- clinical results, • Kidney fibrosis but not moving into development • Heart and vascular fibrosis at this time • Skin inflammatory disease: psoriasis • Cancer • Unlikely to move these further into development without
Slide 25: Expected Development Program Milestones
Expected Development Program Milestones Advanced Liver Fibrosis/Cirrhosis Study Indication Endpoints Start Data Reporting GT-026 NASH cirrhosis Portal pressure (HVPG); Recruitment End 2017 “NASH-CX” liver biopsy Complete GT-028 NASH with Multi-parametric MRI Enrollment September 2016 “NASH-FX” advan
Slide 26: Information for Prospective Investors
Information for Prospective Investors • Easily accessible, in depth information on programs: http://perspectives.galectintherapeutics.com/ • Newsweek feature article • Analyst Coverage • FBR Capital Markets & Co. • H.C. Wainwright & Co. • Roth Capital Partners © 2016 Galectin Therapeutics | NASDAQ:
Galectin Therapeutics — Investor Presentation (August 2016) on 6ix