Immuron Limited · ASX:IMC
Immuron — Shareholder Meeting (November 2010)
51 slides from Immuron's shareholder meeting presentation, Nov 29, 2010
Slide 1: Annual General Meeting Presentations
For personal use only 29 November 2010 The Manager The Company Announcement Office Australian Stock Exchange Sydney NSW 2000 Dear Sir Annual General Meeting Presentations Attached are the following presentations made to the Annual General Meeting: Chairman’s address by Professor Colin Chapman. P
Slide 2: Chairman's address
Chairman’s address Professor Colin Chapman- Non Executive Chairman For personal use only 29 November 2010 Good morning ladies and gentlemen. It is my pleasure to welcome you to Immuron’s 2010 Annual General Meeting. The 2010 year has seen a significant change in the state of affairs of the Company,
Slide 3: Chairman's address (continued)
To use current terminology, the Company is entering into a “paradigm shift” in regard to the application of its technology platform. As a result of this “shift” the Board is of the opinion that the present market capitalisation of the Company does not truly reflect the value of its major asset, its
Slide 4: Oral Immunotherapy Using Antibodies - AGM 2010
For personal use only Oral Immunotherapy Using Antibodies AGM 2010 Dr Grant Rawlin Chief Executive Officer 1
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: 2010: Summary of the journey
2010: Summary of the journey For personal use only • Travelan® ‐ increasing sales • IMM 124E Phase 1/2a clinical trial in NASH complete • Flu trials in ferrets • New management structure • Hadassah relationship: a benefit growing on many levels • Strong commercial partnerships – more will follow • S
Slide 7: 2010 – A year of advancement
2010 – A year of advancement For personal use only • Significant advances in 2 key product areas: – Travelan® licensing with Nycomed – Completed NASH Phase1/2a clinical trial successfully • Hadassah partnership e.g. NASH project • Commercialisation focus via global partnerships • NASH: from concept
Slide 8: Focused Product Pipeline
Focused Product Pipeline For personal use only Indication Research Pre- Phase I Phase II Phase III Market Clinical Traveller’s Diarrhoea Metabolic Syndrome / NASH Influenza Clostridium difficile infection Influenza HIV Hepatic Carcinoma Others
Slide 9: Attacking rising incidence of Metabolic Syndrome / NASH
Attacking rising incidence of Metabolic Syndrome / NASH For personal use only 6
Slide 10: The "epidemic of the 21st Century"
The “epidemic of the 21st Century” For personal use only Metabolic Syndrome Adults & Children: numbers increasing annually worldwide Glucose Fats & Lipids: Fatty Liver Metabolism: Type High blood Disease/NASH 2 Diabetes pressure affects 1 A “hidden killer” no CDC estimates 1 in in 5 Americans approv
Slide 11: NASH – the value proposition
NASH – the value proposition For personal use only • NASH ‐ unmet medical need, no direct competition • Prospect of fast tracking clinical development • Oral therapy with high safety profile • Phase 1/2a data in humans • NASH is an area of high commercial interest. • Commercialisation with the right
Slide 12: Travelan for Travellers' Diarrhoea
TRAVELAN® For Travellers’ Diarrhoea For personal use only • Uniquely positioned as a preventative oral therapy • Global market estimated US$650 ‐US$1,175 million (2010) • In market since 2005 – high safety profile • Large scale production under GMP conditions • Licensed to Nycomed for Australia/New
Slide 13: Travelan Market Expansion
Travelan® Market Expansion For personal use only • Targeting further major international markets in 2011 • In discussions about the above • MEDA/Alaven expected t o release in 2011 • Production at TMI continues to meet increasing demand. 10
Slide 14: Influenza Product
Influenza Product For personal use only • Aiming to prevent infection • Additional possible use in treatment • Mouse trials: single dose provided protection for 7 days. Published in peer reviewed journal 2010 • Hadassah generating further results on cell mediated immunity • Ferret studies underway
Slide 15: Influenza product - Key Advantages
Influenza product‐ Key Advantages For personal use only Problem Immuron Solution Current antiviral medications Polyclonal antibodies designed to cope ‐ encountering resistance issues various strains of flu Circulating influenza strains change Specific antibodies produced quickly & quickly cost effec
Slide 16: Other R&D
Other R&D For personal use only • Seeking grant funding for early R&D • C. difficile: Preliminary data promising. Developing IP, R&D links and business case • HIV: Ongoing R&D ‐ Further government funding received for expanded preliminary work by University of Melbourne & Case Western Reserve Univer
Slide 17: Management Team
Management Team For personal use only Dr Grant Rawlin Chief Executive Officer Registered veterinary surgeon, significant experience in regulatory affairs and R&D. Pivotal to company development to date. Mr Graeme Stevens Chief Financial Officer Qualified Chartered Accountant; more than 30 years prof
Slide 18: 2011 Milestone Aims
2011 Milestone Aims For personal use only Preliminary results of ferret trials in influenza Q1 2011 Publication of HIV Microbicide results Q1/2 2011 FDA Pre‐IND meeting for Phase 2b NASH clinical trial Q1/2 2011 Completed deal to expand Travelan territories Q2/3 2011 Commence multi‐site Phase 2b NAS
Slide 19: Beyond 2011: medium term goals
Beyond 2011: medium term goals For personal use only • Increased revenue through Travelan® sales • Licensing & partnering deals around NASH and Influenza • More products in clinical trials from current early pipeline 16
Slide 20: Thank you for your support over the year
For personal use only Thank you for your support over the year. 17
Slide 21: Oral Immunotherapy: Treatment for the 21st century epidemic
For personal use only Oral Immunotherapy Treatment for the 21st century epidemic Yaron Ilan, M.D. Department of Medicine Hebrew University‐Hadassah Medical Center Jerusalem, Israel November 2010 1
Slide 22: Disclosure Statement
Disclosure Statement For personal use only I am not in a position to discuss any commercial issues or chances of success. I will discuss data related to the scientific studies performed at Hadassah. As with any new product there is uncertainty as to the potential of success and no guarantee can be g
Slide 23: Oral Immunotherapy
Oral Immunotherapy For personal use only Passive Immunity (Topical) using bovine antibodies Active, naturally Addresses derived, safe oral major immunotherapy medical Active Immunity needs (Cellular) using bovine antibodies • An attractive approach to treat autoimmune, infectious, malignant and infl
Slide 24: How it works
For personal use only 4 How it works
Slide 25: Oral Immunotherapy - Strengths
Oral Immunotherapy ‐ Strengths For personal use only • Naturally occurring proteins derived from bovine colostrum (disease specific antigens produced) • Antibodies with adjuvants induce regulatory T cells and passive and active immunity • Not associated with immune suppression • No side effects or t
Slide 26: Metabolic Syndrome
Metabolic Syndrome For personal use only THE EPIDEMIC OF THE 21st CENTURY Metabolic Syndrome is a combination of medical disorders – Fatty liver disease, Type 2 diabetes, Obesity, Hyperlipidemia and Atherosclerosis.
Slide 27: Obesity – The Rising Epidemic
Obesity – The Rising Epidemic For personal use only 7
Slide 28: Obesity – The Rising Epidemic
Obesity – The Rising Epidemic For personal use only 8
Slide 29: Preclinical Studies in Leptin deficient Ob/Ob Mice
Preclinical Studies in Leptin deficient Ob/Ob Mice For personal use only • Controls diabetes in mice following 4 weeks of therapy 180 160 140 Glucose (mg%) 120 100 80 60 40 20 0 Control diabetes Anti-insulin Colostrum enriched antibodies anti-insulin antibodies
Slide 30: Preclinical Studies in Leptin deficient Ob/Ob Mice
Preclinical Studies in Leptin deficient Ob/Ob Mice For personal use only • Reduces liver damage in mice with NASH following 4 weeks of therapy 800 700 600 500 ALT (IU) 400 300 200 100 0 Control diabetes Anti-insulin antibodies Colostrum enriched anti-insulin antibodies
Slide 31: Preclinical Studies in Leptin deficient Ob/Ob Mice
Preclinical Studies in Leptin deficient Ob/Ob Mice For personal use only • Decreases serum lipid levels in mice with hyperlipidemia following 4 weeks of therapy 160 150 Triglycerides levels 140 130 120 110 100 Control diabetes Anti-insulin antibodies Colostrum enriched anti-insulin antibodies
Slide 32: Preclinical Studies in Leptin deficient Ob/Ob Mice
Preclinical Studies in Leptin deficient Ob/Ob Mice For personal use only • Decreases fat in the liver of mice following 4 weeks of therapy 100 Decrease hepatic fat (ratio) 80 60 40 20 0 Control diabetes Anti-insulin Colostrum enriched antibodies anti-insulin antibodies
Slide 33: Non-Alcoholic Steatohepatitis (NASH)
Non‐Alcoholic Steatohepatitis (NASH) For personal use only • The most common liver disease in the western world • A more severe form of Non‐alcoholic fatty liver disease (NAFL) associated with Obesity, Type 2 diabetes, Hyperlipidemia • Affects 5% of the lean population, 20% of the obese population,
Slide 34: Non-alcoholic Fatty Liver (NAFL) Prevalence - USA
Non‐alcoholic Fatty Liver (NAFL) Prevalence ‐ USA For personal use only • 1/3 of adults in the USA have fatty livers 14 A. Mae Diehl, EASL NASH, 2009
Slide 35: NAFL Prevalence - EU
NAFL Prevalence ‐ EU For personal use only General population (subjects with normal weight): • 15‐20% in children • 20‐24% in adults – average 22% ‐ Increases with age ‐ Higher in males vs. females ‐ Higher in Caucasian and Hispanic population ‐ Not significantly higher in subjects with alteration o
Slide 36: Mechanisms regulating NASH outcomes poorly understood
Mechanisms regulating NASH For personal use only outcomes poorly understood Liver cancer A. Mae Diehl, EASL NASH, 2009
Slide 37: Results of Phase 1/2 Clinical Trial in NASH and Metabolic Syndrome
Results of Phase 1/2 Clinical Trial in For personal use only NASH and Metabolic Syndrome • Presented at the American Liver Association Meeting, Boston, 2010 • Oral administration of IMM124‐E is ‐ safe ‐ improves liver enzyme levels ‐ improves markers for Type 2 diabetes ‐ improves hyperlipidemia ‐ p
Slide 38: IMM 124-E improved liver enzyme levels
Administration of IMM 124‐E improved liver enzyme levels For personal use only 100.0 100.0 90.0 80.0 GGT levels (u/L) 80.0 AP levels (u/L) 70.0 60.0 60.0 50.0 40.0 40.0 Day 1 Day 30 Day 1 Day 30 80.0 60.0 70.0 ALT levels (u/L) 55.0 AST levels (u/L) 60.0 50.0 50.0 45.0 40.0 40.0 Day 1 Day 30 Day 1 Da
Slide 39: IMM124-E improved insulin resistance and Type 2 diabetes
Administration of Imm124‐E improved insulin resistance and Type 2 diabetes For personal use only 8.0 8.0 7.0 7.0 HbA1C FPG (mmol/L) 6.0 6.0 5.0 5.0 4.0 Day 1 Day 30 Day 1 Day 30 30 m in (p g /m l) In su lin levels 1000 after 500 0 Day 1 Day 30 19 (9/10 Pt. p<0.001)
Slide 40: IMM124-E improved hyperlipidemia
Administration of Imm124-E improved hyperlipidemia For personal use only 6.0 Serum LDL ( M/dL) 4.0 2.0 Day 1 Day 30 6.0 Cholesterol levels ( M/dL) 4.0 2.0 Day 1 Day 30 20 (9/10 Pt. p<0.005)
Slide 41: Regulatory Pathways
Regulatory Pathways For personal use only IMM 124‐E can be developed as a drug and/or as a prescribed medical food providing Immuron with “two hits at the goal” Advantages of development as a drug ‐ shorter development path than standard as a “Botanical Drug” ‐ exclusive FDA/EMEA approval ‐ larg
Slide 42: Next Steps – IMM 124-E
Next Steps – IMM 124‐E For personal use only Milestone Timing Protocol planning for Phase II trial Complete Appoint Principle Investigator Q4 2010 Pre‐IND meeting with FDA Q1/2 2011 Prepare trial sites (US/Australia/Israel) Q2/3 2011 Commence multi‐centre double blind placebo Q3/4 2011 controlled tr
Slide 43: IMM 124-E Development Program
IMM 124‐E Development Program Potential For personal use only 2011 2012 2013 2015 2016 IMM124-E New Clinical Program applications US FDA Launch Proof- US FDA Phase III IMM 124 E IMM 124-E of-Concept Post P-II Pivotal + NDA Pre-IND Anti NASH (Phase II) Meeting Toxicology Meeting Drug Launch Revenues,
Slide 44: Future Applications
Future Applications For personal use only Area Disease Infections Influenza Cancer Hepatocellular carcinoma • Immuron has conducted pre‐clinical studies in these areas • Preliminary results for the use of colostrum enriched with anti influenza antibodies • Preliminary results for the use of colostru
Slide 45: Influenza
Influenza • Oral administration of colostrum derived anti‐influenza For personal use only antibodies with adjuvants improve the anti‐influenza immune response Oral antibody + colostrum derived adjuvants Passive immunity Active immunity Decrease of suppressor cells Augment of anti‐influenza cellular
Slide 46: Colostrum enriched with anti influenza antibodies increases cellular immunity
Colostrum enriched with anti influenza antibodies increases anti‐influenza cellular immunity For personal use only
Slide 47: Anti hepatitis antibodies suppress growth of liver cancer in mice
Colostrum enriched with anti hepatitis antibodies suppresses the growth of liver cancer in mice For personal use only 0.9 A Control 0.8 B Treated 10 g C Treated 1 g 0.7 Tumor size (mm X 3) 0.6 0.5 0.4 0.3 0.2 0.1 0 30.3.09 7.04.09 16.4.09 23.04.09 30.04.09 7.05.09
Slide 48: Summary
Summary For personal use only • Orally‐delivered disease specific natural polyclonal antibodies derived from colostrum • Established clinical record and safety profile • Easily tolerated by patients • Ability to fast track preclinical & clinical development • Robust pipeline with broad market opport
Slide 49: Thank you
For personal use only Thank you
Slide 50: Metabolic Syndrome and NASH
Metabolic Syndrome and NASH What is Metabolic Syndrome? Metabolic Syndrome is a combination of medical For personal use only disorders: type II diabetes, fatty liver disease, atherosclerosis, hyperlipidaemia. Metabolic Syndrome increases the risk of cardiovascular disease, type 2 diabetes and non-al
Slide 51: For personal use only
Since 2001 revenues from pharmaceuticals used to treat NASH have risen from US$755 million to US$1.8 billion in 2009. The market for off-label prescriptions is expected to grow to US$3.1 billion by 2016. The approval of a product that specifically treats NASH is expected to raise this market estimat