Slide 1: Extraordinary General Meeting Presentations
31 May 2012 For personal use only The Manager The Company Announcement Office Australian Stock Exchange Sydney NSW 2000 Dear Sir Extraordinary General Meeting Presentations Attached are the following presentations to be made to the Extraordinary General Meeting on 31 May 2012: • Chairman's address b
Slide 2: Professor Colin Chapman's Address
For personal use only Professor Colin Chapman’s Address When we last convened on 30 November 2011, at our AGM, we confirmed that the company would be addressing 7 key points. Briefly these were: 1. Review the structure of the Board 2. Control spend 3. Continue the globalisation of Travelan 4. Discus
Slide 3: Board's view: a significant crossroads
Immuron is very fortunate to have an experienced CEO who has worked in pharmaceutical companies and has a track record in building and growing successful pharmaceutical products and businesses. There are only a few companies in our industry with such an executive at the helm. For personal use only I
Slide 4: Immuron's Progress Report, May 2012
For personal use only Immuron’s Progress Report, May 2012 31 May 2012 May 2012 Non‐Confidential ‐ 1 Immuron
Slide 5: Forward Looking Statement
FORWARD LOOKING STATEMENT For personal use only 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 6: Table of Content
Table of Content For personal use only May 2012 Non‐Confidential ‐ 3 Immuron
Slide 7: Section I: Company Overview
For personal use only Section I Company Overview May 2012 Non‐Confidential ‐ 4 Immuron
Slide 8: About Immuron
About Immuron For personal use only • Publically listed (ASX: IMC) Melbourne based biopharmaceutical company • Flexible platform supports multiple regulatory routes, including consumer products: quicker to market. • Focuses on Oral Immunotherapy using dairy‐derived antibodies • Superior safety profi
Slide 9: Section II: Board Objectives
For personal use only Section II Board Objectives May 2012 Non‐Confidential ‐ 6 Immuron
Slide 10: Company Objectives for 2012
Progress Report – May 2012 For personal use only Company Objectives – for 2012 1. Review of board structure 2. Control of expenditure 3. Continue globalisation of Travelan 4. Complete IND; commence discussions for NASH Phase 2b 5. Continued development of product pipeline – incl influenza 6. Continu
Slide 11: Board Restructure
Board Restructure For personal use only Internal Review • Commercialisation focus • Strong biotechnology investment focus • High profile, solid track record, well networked members sought • Experienced in development of medicines May 2012 Non‐Confidential ‐ 8 Immuron
Slide 12: Control of Expenditure
Control of Expenditure For personal use only Board and Management Control • Cash flow reviews • Reduced/cut expenditure in specific areas • Reduction of days worked by staff • Staff/board paid partly via options/shares May 2012 Non‐Confidential ‐ 9 Immuron
Slide 13: Travelan Globalisation
Travelan Globalisation For personal use only • Paladin Labs Inc • Distribution partner for Canada, Latin America, Africa • $2M + up to $115M in milestone payments • Filing commenced with Health Canada • IntegraMed Asia (Thailand) Co Ltd • Thailand, Vietnam, Cambodia, Laos, Hong Kong • 44M travellers
Slide 14: NASH Development
NASH Development For personal use only Discussions underway • IND cleared by FDA in January 2012 • Multi‐national pharmaceutical companies in discussion • Strategic investors showing strong interest • Clinical sites primed for recruitment May 2012 Non‐Confidential ‐ 11 Immuron
Slide 15: Product pipeline
Product pipeline For personal use only R&D rich with possibilities • Platform technology creates opportunities • Immuron seeks the best opportunities for return on investment • Influenza remains a priority to commence human trials • C. diff to be driven through Monash Uni as Immuron seeks an acceler
Slide 16: Product Supply Chain
Product Supply Chain For personal use only Supply being ramped • Countries placing orders ‐ planning & forecasting become critical • Cost of production & manufacturing remains a focus • Supply of finished goods provides opportunity to grow revenue through margins • Synlait Milk Ltd (NZ) to add great
Slide 17: Intellectual Property
Intellectual Property For personal use only Strengthen Core IP Monopoly • Patents cover aspects production & use of our products for prevention &/or treatment of diseases; including NASH & influenza • Patent monopolies are complemented by • regulatory hurdles that we have overcome; and • trade secre
Slide 18: Milestones Achieved in Last Months
Milestones Achieved in Last 6 Months For personal use only 9 FDA cleared Phase 2b IND for IMM‐124E for NASH/Fatty Liver ‐ blockbuster potential 9 FDA provided further clarity/visibility on Phase III NASH endpoints 9 Completed license agreement and strategic investment with Paladin Labs for Travelan
Slide 19: 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 Non‐Confiden
Slide 20: 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 21: The Board of Directors
The Board of Directors For personal use only Professor Colin Chapman, Chairman and Non‐executive Director •Emeritus professor and Immediate Past Dean, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University; key role in establishment of Acrux Dr Elane Zelcer, Non‐executive Director •Exten
Slide 22: Section III: Platform Technology
For personal use only Section III Platform Technology May 2012 Non‐Confidential ‐ 19 Immuron
Slide 23: Mode of Action
Mode of Action For personal use only May 2012 Non‐Confidential ‐ 20 Immuron
Slide 24: Hyper-Immune Colostrum (HIC) - Advantages
Hyper‐Immune Colostrum (HIC) ‐ Advantages Immuron Product Typical small molecule product For personal use only 9 Completely natural product 8 Synthetic product 9 Not associated with immune 8 Can be associated with immune suppression suppression 9 No side effects or toxicity – low risk 8 Some side ef
Slide 25: Section IV: NASH - IND Cleared for Phase 2b
For personal use only Section IV NASH – IND Cleared for Phase 2b May 2012 Non‐Confidential ‐ 22 Immuron
Slide 26: Non-Alcoholic Steatohepatitis (NASH)
Non‐Alcoholic Steatohepatitis (NASH) NASH: the most severe form of liver For personal use only injury within 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 Diabetes (i
Slide 27: 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 28: 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 29: Immuron Value Proposition - IMM-124E
Immuron Value Proposition – IMM‐124E 9 IMM‐124E: Accelerated time For personal use only Typical to market commercial risk IMM‐124E value IMM‐124E risk 9Blockbuster indication 9Proven technology 9No competition 9Proven safety profile 9Large unmet need 9Clear development pathway 9Patient availability
Slide 30: Section V: Our Flagship - Travelan
For personal use only Section V Our Flagship – Travelan May 2012 Non‐Confidential ‐ 27 Immuron
Slide 31: 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 32: Travelan - Immuron's Product on the Market
Travelan – Immuron’s Product on the Market For personal use only • Unique oral preventative against bacteria that cause travellers’ diarrhoea • TGA approved, sales in Australia • Seeking steep sales growth. Global market ~US$650m+ pa • Exclusively licensed to Nycomed in Aust/NZ since Apr 2010 • Excl
Slide 33: www.travelan.com.au
www.travelan.com.au For personal use only May 2012 Non‐Confidential ‐ 30 Immuron
Slide 34: Section VI: Immuron's Pipeline - Influenza
For personal use only Section VI Immuron’s Pipeline ‐ Influenza May 2012 Non‐Confidential ‐ 31 Immuron
Slide 35: 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 36: 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 37: IMM-255 - Immuron's Solution to Influenza
IMM‐255 – Immuron’s Solution to Influenza Antibodies designed to cope with For personal use only 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 38: R&D Programs
R&D Programs For personal use only Monash University: Clostridium difficile infection Harvard Medical School: Radiation Therapy University of Melbourne: Influenza Hadassah Medical School:Hepatic Carcinoma; Hepatic Encephalitis; Mucositis; and a range of neurological disorders May 2012 Non‐Confidenti
Slide 39: Section VIII: Summary
For personal use only Section VIII Summary May 2012 Non‐Confidential ‐ 36 Immuron
Slide 40: 12-18 Months Outcomes
12‐18 Months Outcomes For personal use only $6 million investment: •Complete NASH Phase 2b clinical trial – ready to licence • Commence Global/Territorial license/distribution discussions with interested Pharma cos. • Pipeline products progressed • First human trial for Influenza • Clostridium diffi
Slide 41: Investment Summary
Investment Summary 9 Safe & proven technology platform For personal use only 9 Rich product pipeline 9 Travelan approved & 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) 9 2nd product
Slide 42: Summary
Summary • Oral Immunotherapy Using Antibodies For personal use only • 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