Corporate Presentation

Transcription

1 Corporate Presentation August 2016 NASDAQ: GALT Galectin Therapeutics Inc.

2 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 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 factors and uncertainties which could cause actual results to differ materially from those described in the statements. These statements include those regarding potential therapeutic benefits of our drugs, expectations, plans and timelines related to our clinical trials, potential partnering opportunities and estimated spending for Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others, our trials may not lead to positive outcomes or regulatory approval. We may experience delays in our trials, which could include enrollment delays. Future phases or future clinical studies may not begin or produce positive results in a timely fashion, if at all, and could prove time consuming and costly. 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. Strategies and spending projections may change. We may be unsuccessful in developing partnerships with other companies or obtaining capital that would allow us to further develop and/or fund any studies or trials. We are currently the subject of litigation, which may impact our human and capital resources. To date, we have incurred operating losses since our inception, and our future success 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 Annual Report on Form 10-K for the year ended December 31, 2015, 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 Galectin Therapeutics NASDAQ:GALT 2

3 Company Thesis: Treatment of Inflammation and Fibrosis Large unmet medical need: Fatty liver disease (NASH: nonalcoholic steatohepatitis) with cirrhosis (advanced scarring) Galectin inhibition is a platform for multiple diseases Lead drug has strong pre-clinical data with a differentiated profile: reduces inflammation, prevents and reverses fibrosis Promising early clinical data Phase 1 studies in NASH with advanced fibrosis Phase 2a interim data in psoriasis Competitive positioning among NASH companies Phase 2 clinical data end of Q32016 and Q42017 Low valuation currently 2016 Galectin Therapeutics NASDAQ: GALT 3

4 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 Experience: Galectin Therapeutics NASDAQ:GALT 4

5 Financial Key Facts Trading Symbol Corporate Headquarters Nasdaq: GALT Norcross, GA (suburb of Atlanta) Fiscal Year End December 31 Accounting Firm Cherry Bekaert Stock Price; 52 Week Range (August 5, 2016) $2.05 $ $3.33 Common Shares Outstanding Common Share Ownership Daily Volume (3-month average) Market Capitalization 29 million Institutional 32% Individual 62% Board/Management 6% 113,000 shares $59 million Debt $0 Cash & Equivalents (as June 30, 2016) $18.0 million (expected to cover currently planned operations through June 2017) 2015 Galectin Therapeutics NASDAQ:GALT 5

6 Fibrosis (Scarring) Affects Most Organs And Tissues And Is A Leading Cause Of Morbidity And Mortality Asthma Idiopathic Pulmonary Fibrosis COPD Pulmonary arterial hypertension Congestive heart failure Atherosclerosis Endomyocardial fibrosis Myocardial infarction Arrhythmias Diabetic nephropathy Hypertension IgA nephropathy Transplant nephropathy Lupus nephritis It has been estimated that as many as 45% of all deaths in developed countries are related to organ fibrosis Steatohepatitis (NASH) Alcoholic liver disease HCV/HBV Primary sclerosing cholangitis Autoimmune hepatitis Primary biliary cirrhosis Wynn, TA. Nat Rev Immunol. 2004;4: doi: /nri Galectin Therapeutics NASDAQ:GALT 6

7 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: Galectin Therapeutics NASDAQ: GALT 7

8 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* *Dr. Julia Wattacheril is a Principle Investigator in GALT clinical trial and Assistant Professor of Medicine at the Center for Liver Disease and Transplantation at Columbia University 2016 Galectin Therapeutics NASDAQ: GALT 8

9 NASH is a Global Epidemic with Very Large Potential Market One in four people in the world are affected by fatty liver disease 1 A life-time risk of ~20 million liver-related deaths among patients currently alive 1 U.S. market could be $25 Billion by Global market could be $35-40 Billion by Rinella M, Charlton M. The globalization of nonalcoholic fatty liver disease: Prevalence and impact on world health. Hepatology 2016 Jul;64(1): Who will be the kings of NASH-ville? Key players and an overview. May 21, 2015, Alethia Young, Deutsche Bank Markets Research 2016 Galectin Therapeutics NASDAQ: GALT 9

10 Natural History of Fatty Liver Disease 1 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): Galectin Therapeutics NASDAQ:GALT 10

11 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 with prospective follow-up of up to 33 years (Ekstedt, et al. Hepatology 2015;61: ) 2016 Galectin Therapeutics NASDAQ:GALT 11

12 The Galectin-3 Protein Made In Our Bodies Is Critical For The Development Of Fibrosis Galectin-3 is validated to be important in preclinical models of disease Elimination of galectin-3 prevents fibrosis Our lead drug candidate, GR-MD-02, binds to and inhibits galectin Galectin Therapeutics NASDAQ:GALT 12

13 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 (Fibrosis) Gal-3 Stain Galectin-3 Protein Traber, et al. PLOS ONE 2013;8:e Galectin Therapeutics NASDAQ:GALT 13

14 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 pressure which correlates with primary endpoint in cirrhosis trial 2016 Galectin Therapeutics NASDAQ:GALT 14

15 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 Genfit Phase 2 Tobira Conatus Galmed Gilead Novo-Nordisk Octeta Others Phase 2 Galectin Gilead (Simtuzumab) Phase 2 Galectin Gilead (Simtuzumab) Conatus (start 2017) 2016 Galectin Therapeutics NASDAQ:GALT 15

16 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 Highest dose tested may have an effect on liver fibrosis Reduced FibroTest, a composite test of 5 serum markers Serum alpha-2 macroglobulin, a component of the FibroTest accounted for the reduction (appendix) Reduced liver stiffness assessed by FibroScan 2016 Galectin Therapeutics NASDAQ:GALT 16

17 Association of NASH with Psoriasis Patients with psoriasis have over two fold higher incidence of NASH with greater fibrosis 1 Galectin-3 plays important role in skin and there is increase in skin vessels of patients with psoriasis 2,3 One patient in Phase 1 trial had long-term remission of psoriasis when treated with GR-MD-02 (4 mg/kg). Conducting Phase 2a open label trial in patients with moderate to severe plaque psoriasis 1 Roberts KK, et al. Alimentary Pharmacology and Therapeutics. 2015;41: Larsen L, et al. J. Derm Sci. 2011;64: Lacina L, et al. Folia Biologica. 2006;52: Galectin Therapeutics NASDAQ: GALT 17

18 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 Week 12 Patient 4 Baseline Week 12 Baseline Patient 1 Baseline Week 12 Week Galectin Therapeutics NASDAQ:GALT 18

19 NASH-CX Phase 2 Clinical Trial Intended lead market indication: NASH Cirrhosis Potential registration endpoints Indication Objective Expectation NASH-CX NASH Cirrhosis 1 Year of Therapy Reduce portal pressure and liver fibrosis Proof-of-concept in NASH cirrhosis Evaluation of registration endpoints 156 patients, 47 U.S. sites, three arms (placebo, 2 drug) Study Endpoints Primary: Portal pressure (HVPG hepatic venous pressure gradient) Secondary: Liver biopsy, FibroScan, methacetin breath test Patient recruitment completed On track to report top line data end of 2017 For more information see clinicaltrials.gov 2016 Galectin Therapeutics NASDAQ:GALT 19

20 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-FX NASH with advanced fibrosis (not cirrhosis) 4 Months of Therapy Evaluate liver fibrosis by noninvasive endpoints Assess noninvasive tests Effect of drug on tests/biomarkers Single site, double-blinded, placebo-controlled, 2-arm study in 30 patients (15 placebo, 15 GR-MD-02 (8mg/kg)) Non-invasive endpoints: MRI imaging (LiverMultiScan) and 2 measures of liver stiffness (FibroScan and MRE) Top line data Sept For more information see clinicaltrials.gov 2016 Galectin Therapeutics NASDAQ:GALT 20

21 NASH Advanced Fibrosis Program with GR-MD-02: Summary Unmet medical need with a very large potential market Competitively well positioned in NASH with cirrhosis Reversal of fibrosis/cirrhosis in preclinical models Extensive safety data in rodent and monkey supporting chronic administration In human Phase 1, GR-MD-02 is safe and well tolerated with evidence of potential effect on fibrosis Phase 2 clinical trials with near- and mid-term timing of results 2016 Galectin Therapeutics NASDAQ: GALT 21

22 Cancer Immunotherapy Opportunity Focus on Immunotherapy Galectin-3 plays an important role in reducing the ability of immune system to fight cancer Advanced Melanoma as Initial Indication Even with newly approved drugs, a substantial unmet medical need remains Providence Cancer Center, Portland Oregon Critical Collaboration Established Performed preclinical studies showing efficacy of GR-MD-02 with checkpoint inhibitors Conducting and funding clinical trials *Siegel, et al. CA Cancer J Clin 2012;62: Galectin Therapeutics NASDAQ:GALT 22

23 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 complete showing no dose-limiting toxicity Patients With Advanced Melanoma Using GR-MD-02 In Combination With KEYTRUDA Melanoma progression after Yervoy and/or BRAF targeted therapy Melanoma progression after KEYTRUDA monotherapy Remainder of design mirrors first study Trial initiated in Q4 2015, enrollment ongoing Study details on clinicaltrials.gov 2016 Galectin Therapeutics NASDAQ:GALT 23

24 Potential As A Platform Technology For Other Diseases Lung fibrosis Kidney fibrosis Heart and vascular fibrosis Positive preclinical results, but not moving into development at this time Skin inflammatory disease: psoriasis Cancer Unlikely to move these further into development without a strategic partner 2016 Galectin Therapeutics NASDAQ: GALT 24

25 Expected Development Program Milestones Advanced Liver Fibrosis/Cirrhosis Study Indication Endpoints Start Data Reporting GT-026 NASH-CX GT-028 NASH-FX Advanced Melanoma Study Indication Endpoints Start Data Reporting Phase 1b: Yervoy Phase 1b: KEYTRUDA Psoriasis NASH cirrhosis NASH with advanced fibrosis Advanced melanoma Advanced melanoma Portal pressure (HVPG); liver biopsy Multi-parametric MRI MRE and FibroScan Safety ir-recist Immune markers Safety ir-recist Immune markers Recruitment Complete Enrollment Complete Rx Phase Underway: under direction of Providence Underway: (Providence) End 2017 September 2016 Dose Group 1: complete Dose Group 2: complete Dose Group 3: enrolling Dose Group 1: enrolled Dose Group 2: enrolling Study Indication Endpoints Start Data Reporting Phase 2a: GT-030 Moderate-to-severe plaque psoriasis Psoriasis Activity Severity Index (PASI 75) Underway Interim data reported Next report: Sept Galectin Therapeutics NASDAQ:GALT 25

26 Information for Prospective Investors Easily accessible, in depth information on programs: Newsweek feature article Analyst Coverage FBR Capital Markets & Co. H.C. Wainwright & Co. Roth Capital Partners 2016 Galectin Therapeutics NASDAQ: GALT 26