Slide 1: Oral immunotherapy using antibodies
For personal use only Oral immunotherapy using antibodies May 2012 May 2012 Confidential ‐ Immuron 1
Slide 2: Forward Looking Statement
For personal use only FORWARD LOOKING STATEMENT This presentation and Immuron’s accompanying comments and explanations may include forward‐looking statements including statements containing words such as “may”, “expect”, “believe”, and “intend”, and may describe opinions about future events. We have
Slide 3: Table of Content
Table of Content For personal use only Section I • Company Overview Section II • Platform Technology Section III • NASH Section IV • Travelan Section V • Influenza Section VI • R&D May 2012 Confidential ‐ Immuron 3
Slide 4: Section I: Company Overview
For personal use only Section I Company Overview May 2012 Confidential ‐ Immuron 4
Slide 5: About Immuron
About Immuron For personal use only • Melbourne based biopharmaceutical company • Publicly listed on the Australian Stock Exchange (ASX: IMC) • Focuses on Oral Immunotherapy using dairy‐derived antibodies • Superior safety profile products makes it possible to accelerate product development • First
Slide 6: Investment Highlights
Investment Highlights For personal use only Safe and proven technology platform Rich product pipeline Travelan approved and already in market generating sales • Paladin Labs Inc recently signed up as distribution partner for Canada, Latin America, Africa ($2m + up to $115m in royalties) 2nd
Slide 7: Milestones Achieved in Last Months
Milestones Achieved in Last 6 Months For personal use only FDA cleared Phase IIB IND for IMM‐124E for NASH/Fatty Liver, a product with block buster potential FDA provided further visibility on Phase III NASH endpoints Completed license agreement and strategic investment with Paladin Labs for T
Slide 8: Immuron's Competitive Advantage
Immuron’s Competitive Advantage For personal use only Oral Immunotherapy Using Antibodies Oral immunotherapy using dairy‐derived polyclonal antibodies for metabolic & infectious diseases, oncology, and additional indications Monopoly Powers >12 patent families that protect the use of Immuron’s produ
Slide 9: Technology and Product Highlights
Technology and Product Highlights For personal use only Safe Technology – Hyper Immune Colostrum Immuron is able to increase IgG immunoglobulins of choice in bovine colostrum Proven Platform Technology Travelan launched successfully in Australia as an OTC medication for the treatment of traveller’s
Slide 10: Product Pipeline
Product Pipeline For personal use only Indication Research Pre‐Clinical Phase I Phase II Phase III Market Traveller’s Diarrhea Metabolic Syndrome / NASH (IMM‐124E) Influenza (IMM‐255) Clostridium difficile infection HIV IMM‐243 Hepatic Carcinoma Cancer/radiation therapies Other May 2012 Confidential
Slide 11: Management Team
Management Team For personal use only Joe Baini, CEO • Experienced pharmaceutical executive; former GM for Gilead Sciences & non‐exec chairman for Avexa Ltd Mr Graeme Stevens, Chief Financial Officer & Company Secretary • Qualified Chartered Accountant; more than 30 years professional experience Dr
Slide 12: Section II: Platform Technology
For personal use only Section II Platform Technology May 2012 Confidential ‐ Immuron 12
Slide 13: Mode of Action
Mode of Action For personal use only May 2012 Confidential ‐ Immuron 13
Slide 14: Oral Immunotherapy Using Antibodies
Oral Immunotherapy Using Antibodies For personal use only Oral Immunotherapy An approach to treat autoimmune, infectious and inflammatory disease through the oral delivery of antibodies An active process that uses the inherent ability of the GI tract's immune system to elicit cell mediated immune re
Slide 15: Hyper-Immune Colostrum (HIC) - Advantages
Hyper‐Immune Colostrum (HIC) ‐ Advantages For personal use only Immuron Product Typical small molecule product Completely natural product Synthetic product Not associated with immune Can be associated with immune suppression suppression No side effects or toxicity – low risk Some side ef
Slide 16: Section III: NASH - IND Cleared for Phase IIb
For personal use only Section III NASH – IND Cleared for Phase IIb May 2012 Confidential ‐ Immuron 16
Slide 17: Non-Alcoholic Steatohepatitis (NASH)
Non‐Alcoholic Steatohepatitis (NASH) For personal use only NASH: the most severe form of liver injury in the spectrum of non‐alcoholic fatty liver disease (NAFLD) Fatty liver: one of most common liver diseases in the industrialized world Chronic Inflammatory Disease, associated with Obesity, Type II
Slide 18: NASH - A Major Epidemic of the 21st Century
NASH – A Major Epidemic of the 21st Century For personal use only NCID : >25m Americans will have NASH by 2025 No approved treatment for NASH or Fatty Liver Disease globally Demand for off‐label use expected to be US$3.2bn at 2016 Very Positive Results for phase 1/2a Clinical Trials Immuron’s soluti
Slide 19: Background and Pathogenesis of NASH
Background and Pathogenesis of NASH For personal use only NAFL & NASH are a result of reinforcing cycle between Insulin resistance, Obesity, and Metabolic derangements causing chronic inflammation, resulting in organ damage Insulin resistance Metabolic derangements Obesity Chronic inflammation Immun
Slide 20: IMM-124E - Immuron's Rx Solution to NASH
IMM‐124E – Immuron’s Rx Solution to NASH For personal use only Orally administrated treatment Results to date very positive: Phase I/IIa trials for Safe IMM‐124E showed Trending of all parameters in the trending of all desirable direction Addresses inflammatory parameters in the right mechanism dire
Slide 21: Immuron Value Proposition - IMM-124E
Immuron Value Proposition – IMM‐124E For personal use only IMM‐124E: Accelerated time Typical to market commercial risk IMM‐124E value COMMERCIAL VALUE $$ IMM‐124E risk Blockbuster indication Proven technology No competition Proven safety profile Large unmet need Clear development pat
Slide 22: IMM-124E US Revenue Stream Sales Potential
IMM‐124E US Revenue Stream Sales Potential For personal use only Assuming no competitor enters market in this time frame May 2012 Confidential ‐ Immuron 22
Slide 23: Section IV: Product on Market - Travelan
For personal use only Section IV Product on Market – Travelan May 2012 Confidential ‐ Immuron 23
Slide 24: Traveller's Diarrhoea
Traveller's Diarrhoea For personal use only • Travelers’ Diarrhea: the most common health condition facing travellers • Up to 50% of people who travel to developing countries will contract the disease • Typically characterized by stomach cramps, diarrhea, fever and nausea • The most common bacteria
Slide 25: Travelan - Immuron's Solution to TD
Travelan ‐ Immuron’s Solution to TD For personal use only Double blinded, placebo controlled clinical trials completed vs. high dose challenge of 10 to the power of 9 ETEC show a greater than 90% protection rate(1) Travelan is the most effective and the only The challenge dose is 1000 naturally occu
Slide 26: US Independent Market Research
US Independent Market Research For personal use only Americans travelling abroad: • 80% prefer a preventative • 13% prefer a cure The only other clinically tested preventative known as Dukoral (a prescription medicine) is not available in the US 79% indicated that if a preventative dietary supplemen
Slide 27: US Independent Market Research
US Independent Market Research For personal use only Respondents were informed the label would not state "preventative“ • in market research terms, this is a resounding support to launch. The major destinations where such a product would be used are: • Mexico • Caribbean • Asia 93% of respondents st
Slide 28: Travelan - Immuron's Product on the Market
Travelan – Immuron’s Product on the Market For personal use only • Antibodies directed against bacteria that cause travelers’ diarrhea • TGA approved, sales in Australia • Unique preventative oral immune therapeutic • Seeking steep sales growth. Global market ~US$650m+ pa • Exclusively licensed to N
Slide 29: www.travelan.com.au
www.travelan.com.au For personal use only May 2012 Confidential ‐ Immuron 29
Slide 30: Section V: Immuron's Pipeline - Influenza
For personal use only Section V Immuron’s Pipeline ‐ Influenza May 2012 Confidential ‐ Immuron 30
Slide 31: Influenza
Influenza For personal use only • Direct medical costs in US – $10.4B pa* • 3‐5m cases pa of severe illness • Over 500,000 deaths worldwide pa • Influenza is the 8th leading cause of American deaths *Molinari et al. The annual impact of seasonal influenza in the US: Measuring disease burden and cost
Slide 32: Revolutionising the Influenza Therapy
Revolutionising the Influenza Therapy For personal use only IMM 255 is being designed as the world’s first dual‐acting and all‐natural OTC therapy that can both: Oral Antibody IMM 255 + Colostrum Derived Adjuvants Passive immunity, inhibiting the Boosts the immune system to fight influenza infection
Slide 33: IMM-255 - Immuron's Solution to Influenza
IMM‐255 – Immuron’s Solution to Influenza For personal use only Antibodies designed to cope with the rapidly changing strains of flu as virus evolves (advantage of polyclonal antibodies) Convenience of an easily Aiming for world’s first accessible OTC therapy – not dual‐acting orally requiring a doc
Slide 34: Section VI: R&D
For personal use only Section VI R&D May 2012 Confidential ‐ Immuron 34
Slide 35: R&D Programs
R&D Programs For personal use only Monash University: Clostridium difficile infection Harvard Medical School: Radiation Therapy University of Melbourne: HIV Treatment Hadassah Medical School:Hepatic Carcinoma; Hepatic Encephalitis; Mucositis; and a range of neurological disorders May 2012 Confidenti
Slide 36: Section VIII: Summary
For personal use only Section VIII Summary May 2012 Confidential ‐ Immuron 36
Slide 37: 12-18 Months Outcomes
12‐18 Months Outcomes For personal use only $6 million investment: • Complete NASH Phase IIb clinical trial – ready to licence • Commence Global/Territorial license/distribution discussions with interested Pharma cos. • Pipeline products progressed • First human trial for Influenza • Clostridium dif
Slide 38: Investment Summary
Investment Summary For personal use only Safe and proven technology platform Rich product pipeline Travelan approved and already in market generating sales • Paladin Labs Inc recently signed up as distribution partner for Canada, Latin America, Africa ($2m + up to $115m in royalties) 2nd pro
Slide 39: Summary
Summary For personal use only • Oral Immunotherapy Using Antibodies • Strong Intellectual Property • Tight Collaboration with Key Research Partners • Key Alliance with Global Pharmaceutical Company • Proven, Novel Technology – Hyper Immune Colostrum (HIC) • Innovation Commercialized Product: Travela
Slide 40: Planned Phase IIb Clinical Trial
Planned Phase IIb Clinical Trial For personal use only FDA cleared IND application • Immuron plans to commence a Phase IIb clinical trial of IMM‐124E • Indicated for both NASH &Fatty Liver Clinical trial summary: • double‐blind • placebo‐controlled • dose ranging • multi‐centre (sites in the United