Slide 1: Company Presentation May 2016
For personal use only COMPANY PRESENTATION May 2016
Slide 2: Forward-Looking Statement
Forward-Looking Statement For personal use only Certain statements made in this presentation are forward-looking statements and are based on Immuron’s current expectations, estimates and projections. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “guida
Slide 3: Immuron Limited Introduction
Immuron Limited Introduction For personal use only • Clinical stage biopharmaceutical company focused on oral immunotherapies for the treatment of inflammatory and gut mediated diseases • Strong platform technology (dairy-derived antibodies); wide applicability/low cost - Validations: Product approv
Slide 4: Platform Overview: Oral Immunotherapy
Platform Overview Oral Immunotherapy - A Disruptive Technology For personal use only 1 2 3 Antibodies Are Vaccines Are Harvested from Broad Therapeutic Effect Developed Colostrum Induction - Reduces systemic of inflammation regulatory T-cells - Lowers organ injury + - Not associated with general imm
Slide 5: Pipeline: Clinical Assets Targeting Blockbuster Indications
Pipeline Clinical Assets Targeting Blockbuster Indications For personal use only Protectyn 5
Slide 6: Travelan/OTC Provide Unique Downside Protection
Immuron Limited Travelan/OTC Provide Unique Downside Protection For personal use only Travelan Forecast (AU$) $35,000,000 Other Launches (eg. Japan) $30.0M $30,000,000 EU Full Year Launch $25,000,000 USA, China Full Year $20,000,000 EU Launch $13.9M $15,000,000 USA Launch (Late 2016) $8.1M $10,000,0
Slide 7: Key Milestones
Key Milestones Near Term and Long Term Milestones For personal use only 7
Slide 8: Stellar KOL Support
Stellar KOL Support Principal Investigators & Scientific Advisory Board For personal use only Dr Arun Sanyal (MD) – University of Virginia. Professor of Medicine and Former Chairman of the Division of Gastroenterology, Hepatology and Nutrition, VCU Medical Center. Dr Sanyal is an internationally ren
Slide 9: Financial Position
Financials Financial Position For personal use only Financials Overview Share Price Performance (Mar 15- May 16) NASH C-Difficile Recruitment • Ticker: ASX (Australia): IMC 0.60 Update Results 0.55 • Share price (27/05/16): $0.33 CVS 0.50 Travelan • Shares outstanding: 75M 0.45 US Launch • Market Ca
Slide 10: Experienced Management Team
Experienced Management Team From Leading Organizations For personal use only Thomas Liquard Mr Liquard spent the majority of his career at Pfizer in New York in Chief Executive various commercial positions and was also COO, then CEO, of Officer Alchemia Limited, an oncology ASX biotech company Dan P
Slide 11: NASH
For personal use only NASH
Slide 12: Metabolic Syndrome
Metabolic Syndrome Growing Modern Diseases For personal use only Obesity / Unhealthy Living… … Drives Metabolic Diseases • Metabolic syndrome is associated with the risk of developing cardiovascular disease, diabetes and fatty liver • Some studies have shown the prevalence in the USA to be an estima
Slide 13: NASH (Non-Alcoholic Fatty Liver)
NASH (Non-Alcoholic Fatty Liver) Massive Unmet Need – No Treatment approved For personal use only NASH: The most severe form of liver injury in the spectrum of non- alcoholic fatty liver disease (NAFLD) Market Estimated to top $35B-$40B WW by 2030 driven by Size obesity epidemic (Deutche Bank – 2014
Slide 14: NASH Pathophysiology
NASH Pathophysiology Overview For personal use only NASH – Pathophysiology Key Takeaways • Blood derived antigens determines tolerance vs. inflammation • Kupffer cells play a key role in liver inflammation and fibrosis • Tregs hold a key role in tolerance (homeostasis) • Much like hepatic tolerance
Slide 15: Liver Homeostasis
Liver Homeostasis Overview For personal use only Immunological Mechanisms • Liver Homeostasis is maintained by both the Innate and adaptive systems • Circulating LPS and other antigens serve to create tolerance • All liver cells are exposed to the signals coming from the Gut • The adaptive system ca
Slide 16: IMM-124E: NASH Mechanism of Action
IMM-124E NASH – Mechanism of Action Addresses Unmet Need For personal use only LIVER: IMM-124E • Activated Kupffer Cells ↓ (F4/80 macrophages) • Fibrosis and Inflammation ↓ GUT: • Intestinal LPS ↓ • Intestinal Permeability ↓ SERUM: • Microbiome antigen • Insulin resistance ↓ change • Circulating LPS
Slide 17: IMM-124E in Ob/Ob Model
IMM-124E in Ob/Ob Model Synergistic Potency For personal use only Anti-LPS and Adjuvants in IMM-124E Results A Synergistic Effect in Animal Models of NASH Decreased Liver Decreased Serum • Both Ig and Enzymes Triglycerides Adjuvants 900 demonstrated 800 potential in lowering 700 * 600 500 Triglyceri
Slide 18: IMM-124E Animal Models: Prevents Fibrosis
IMM-124E Animal Models: Macroscopy – Prevents Fibrosis For personal use only Fibrotic Liver IMM-124E Liver CCl4 (carbon tetrachloride) CCl4 (carbon tetrachloride) IMM- 124E Treatment with IMM-124E prevents Fibrosis and Inflammation Mizrahi M. 2013, AASLD; Hepatology 751A 18
Slide 19: IMM-124E Improves Inflammation and Fibrosis Markers
IMM-124E Animal Models: Improves Inflammation and Fibrosis Markers For personal use only Group A: Group B: Naïve Group A: Group B: Control anti LPS Naïve anti LPS Control Group C: Group D: Group C: Group D: Treated Treated Treated Treated Decrease Portal Inflammation Improved Metavir Fibrosis Score
Slide 20: IMM-124E Suppression of F4/80High Macrophages
IMM-124E Suppression of F4/80High Macrophages For personal use only 20
Slide 21: Phase I/IIa: Improves Liver Function and Insulin Resistance
IMM-124E Phase I/IIa: Improves Liver Function and Insulin Resistance For personal use only Results of a Phase I/IIA clinical trial; N=10 30 Days Treatment Endpoint Met; NO SAFETY ISSUES REPORTED Improved Liver Enzymes Improved HBA1C, OGTT and HOMA Mizrahi M, J Inflamm Res. 2012;5:141-50 21
Slide 22: Phase I/IIa: Improves Inflammatory Biomarkers
IMM-124E Phase I/IIa: Improves Inflammatory Biomarkers For personal use only Increased CD4+CD25+FOXP3+ TREGS Day 1 Increased GLP1 and Adiponectin Day 30 Mizrahi M. J Inflamm Res. 2012 22
Slide 23: NASH Phase II Design
NASH Phase II Design For personal use only Lead Principal Investigator: Arun Sanyal; Former President of the AASLD (American Association for the Study of Liver Diseases) and current Chair of the Liver Study Section at the NIH (National Institute of Health) Scope: Multi-Center, Developed Countries, D
Slide 24: NASH Competitive Landscape: Strongly Differentiated
NASH – Competitive Landscape IMM-124E Is Strongly Differentiated For personal use only IMM-124E Competition Strong Differentiation Bile Acid • Represents a mufti-factorial Shire - LUM-002 approach to NASH, not just one Intercept - Obeticholic acid, modified bile acid pathway Galmed - Aramchol, Conju
Slide 25: NASH Competitive Landscape: Unique Profile
NASH – Competitive Landscape IMM-124E MOA Confers Unique Competitive Profile For personal use only IMM- • Safety profile potentially opens all segments (Fibrosis – F0-F4 and NAFLD) 124E • Can potentially be used in combination with other agents, not only as monotherapy Liver Cancer 39K US incidence
Slide 26: C-Difficile
For personal use only C-DIFFICILE
Slide 27: C-Difficile: A Growing Public Health Issue
C-DIFFICILE A Growing Public Health Issue For personal use only • Therapeutic market is expected to grow from US$356.3 million in 2014 to over $1.5 billion by 2024 – CAGR 15% Market Opportunity • Nearly 30,000 patients die each year from c. difficile infections (US) • Orphan disease (7 years market
Slide 28: IMM-529 Unique MOA in CDI
IMM-529 Unique MOA in CDI For personal use only Spores – Infectious Particles IMM-529 antibodies bind to Heat, ethanol & UV surface antigens on spores resistant. Survive gastric & prevent adheres to host acid, adhere to cells in the cells & limit germination. colon & germinate Vegetative Cells Fimbr
Slide 29: IMM-529 Results of Pre-Clinical Study
IMM-529 Results of Pre-Clinical Study For personal use only S u r v iv a l 100 All studies Prevention U n in f e c t e d , N o t r e a t m e n t 80 In f e c t e d , N o t r e a t m e n t Demonstrated 80% P e r c e n t s u r v iv a l Studies statistically In fe c t e d , N o n - im m u n e Ig G t r e
Slide 30: IMM-529 Phase 1/2 Adaptive Trial Design Overview
IMM-529 Phase 1/2 – Adaptive Trial Design Overview For personal use only A Phase I/II dose escalation & safety assessment in combination with SOC in C. difficile patients (18 patients x 3 doses; 6 patients per dose) - Three escalating dose levels in combination with SOC - 8 week assessment per patie
Slide 31: OTC Business
For personal use only OTC BUSINESS
Slide 32: Travelan: A Unique Preventative Product
Travelan® A Unique Preventative Product For personal use only • Marketed in the US, The only therapy that Australia by Immuron prevents Travelers’ and by Paladin/Endo in Diarrhea by up to Canada 90% • Global market estimate: US$ 600M - 1.2B • All-natural product; Without Travelan®: With Travelan®: B
Slide 33: Travelan: Powerful Anti-Infective
Travelan – Powerful Anti-Infective Clinical Evidence For personal use only • Significantly reduces adherence of CFA/I producing ETEC strains to a cell-line that mimics the human small intestinal epithelium Pre- • Significantly reduces the motility of ETEC strains through soft agar Clinical Studies •
Slide 34: Travelan Offers Wide Protection
Travelan Offers Wide Protection Not Just E-Coli; Travelan Binds to Other Gram-Negative Bacteria For personal use only Formulated with 13 Strains of Proven to Be Cross-Reactive (binds) to Other E-Coli E-Coli Strains and Gram-Negative Bacteria Serotype Strains # • ETEC strain M452C1 [serotype O20:H-]
Slide 35: Travelan/OTC Provide Unique Downside Protection
Immuron Limited Travelan/OTC Provide Unique Downside Protection For personal use only Travelan Forecast (AU$) $35,000,000 Other Launches (eg. Japan) $30.0M $30,000,000 EU Full Year Launch $25,000,000 USA, China Full Year $20,000,000 EU Launch $13.9M $15,000,000 USA Launch (Late 2016) $8.1M $10,000,0
Slide 36: Travelan / OTC Business: Multiple Paths for Growth
Travelan / OTC Business Multiple Paths for Growth For personal use only • Travelan/OTC: Unique value proposition that is valued by consumers and customers - High Efficacy - High safety profile - Only preventative product for Travellers' Diarrhoea • Multiple ways to keep growing OTC business: - Conti
Slide 37: Outlook & Value
For personal use only OUTLOOK & VALUE
Slide 38: Attractive NASH Deal Landscape
Attractive NASH Deal Landscape Big Pharma Deals Driving Valuations For personal use only • (2016) Acquired Nimbus Phase I ACC inhibitor for $400m upfront + potential for future payments (total deal up to $800M) • (2010) Acquired Arresto for $225m + potential for future payments: Phase I asset (LoxL2
Slide 39: Comparables
Comparables NASH and C-Diff Market Cap ($US Millions as 03/06/16) For personal use only Leader in NASH; In PIII; Positive Phase II funded by - Average valuation for PII NASH NIH; Significant safety issues companies: $54M US (2.5X current (e.g., LDL); $6B+ valuation increase with positive PII valuati
Slide 40: Investment Highlights
Immuron Limited Investment Highlights For personal use only • Strong Platform – Product already launched; NIH sponsored trials; Support from leading KOLs • Strong Pipeline with Significant Upside – Two Phase II clinical trials with differentiated profiles in multi-billion market (Fatty liver disease
Slide 41: Appendices
For personal use only APPENDICES
Slide 42: Extended Market Protection
Extended Market Protection Strong Patent Portfolio, Biologics Exclusivity and Gx Protection For personal use only • 7 Major patent families offering both matter of composition and formulation patents Strong Patent • Approved / pending in major geographies including US, Portfolio Europe, Japan, China
Slide 43: Thank You
For personal use only THANK YOU