Immuron Limited · ASX:IMC
Immuron — Shareholder Meeting (November 2011)
78 slides from Immuron's shareholder meeting presentation, Nov 30, 2011
Slide 1: AGM cover letter and proxy voting results
For personal use only 30 November 2011 The Manager The Company Announcement Office Australian Stock Exchange Sydney NSW 2000 Dear Sir Annual General Meeting- 30 November 2011 Attached are the following presentations made to the Annual General Meeting: Chairman’s address by Professor Colin Chapman.
Slide 2: Chairman's address
Chairman’s address a 2011 Annual Gene eral Meeting 30 N Novembeer 2011 For personal use only Good G morning ladies an nd gentlemen and welccome to Immuron’s 2011 Annual G General Me eeting. L me commence the meeting by introducing Let g you to the e Board Mem mbers and m members of o our managemen m
Slide 3: Chairman's address: Travelan, NASH and influenza progress
In the past six months or so there has been a very high level of activity in the global expansion of the Travelan, culminated in the announcement yesterday regarding the distribution and financing facility agreements with Paladin Labs Inc. of Canada. To bring these agreements to fruition has involve
Slide 4: Chairman's address: LPS-mediated disease
What does that mean to medicine and the company? LPS being mis-managed by the body has emerged particularly over the past 5 years as a common major driver of gut diseases as diverse as ulcerative colitis and chemotherapy induced mucositis. In the liver, LPS has emerged as a common ‘driver’ in liver
Slide 5: Annual General Meeting November 2011
For personal use only Annual General Meeting 30 November 2011 2011 CONFIDENTIAL – Immuron 1
Slide 6: Agenda
For personal use only AGENDA 1. INTRODUCTION BY CHAIRMAN AND CHAIRMAN’S ADDRESS 2. RESOLUTIONS TO SHAREHOLDERS 3. PRESENTATION BY CEO – JOE BAINI 4. PRESENTATION BY PROFESSOR YARON ILAN 2011 2
Slide 7: Resolution - Adoption of Remuneration Report
For personal use only RESOLUTION 1 ‐ ADOPTION OF REMUNERATION REPORT To receive and consider the remuneration report for the year ended 30 June 2011 and if thought fit, to pass the following resolution as an ordinary resolution: "To adopt the Remuneration Report for the year ended 30 June 2011 as se
Slide 8: Remuneration report resolution vote results
For personal use only Resolution 1 Open‐ Open‐ For Against Usable Unusable Abstain Excluded 18,115,172 5,602,376 - 2,018,586 74,000 5,855,932 4
Slide 9: Resolution - Re-election of Director
RESOLUTION 2 ‐ RE‐ELECTION OF DIRECTOR For personal use only To consider and, if thought fit, to pass, with or without amendment, the following resolution as an ordinary resolution: "That pursuant to article 83 of the Company's Constitution and ASX Listing Rule 14.4, the members of the Company appro
Slide 10: Director re-election vote results
For personal use only Resolution 2 Open‐ Open‐ For Against Usable Unusable Abstain Excluded 25,644,950 3,473,530 2,523,586 - 24,000 - 6
Slide 11: Resolution - Approval of prior issue of securities
RESOLUTION 7 – APPROVAL OF PRIOR ISSUE OF SECURITIES TO SOPHISTICATED OR PROFESSIONAL INVESTORS For personal use only To consider and, if thought fit, pass the following resolution as an ordinary resolution: “That, for the purposes of ASX Listing Rule 7.4 and for all other purposes, the members of t
Slide 12: Prior issue of securities vote results
For personal use only Resolution 7 Open‐ Open‐ For Against Usable Unusable Abstain Excluded 28,178,360 921,370 2,523,586 ‐ 42,750 ‐ 8
Slide 13: Oral immunotherapy using antibodies
For personal use only Oral immunotherapy using antibodies Joe Baini, CEO 30 November 2011 November 2011 Confidential ‐ Immuron 9
Slide 14: 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 15: For personal use only
For personal use only November 2011 CONFIDENTIAL – Immuron 11
Slide 16: Vision for Immuron's success
VISION for Immuron’s success For personal use only Immuron is a biopharmaceutical development company with a unique technology platform and strong Intellectual Property. With its first product already in the market, and an enviable pipeline, the company has a clear and realistic vision to become pro
Slide 17: 2011 Highlights
2011 Highlights For personal use only • Consolidated Nycomed Australia arrangement to grow sales $ • Progress IMM‐124E to IND submission with phase 2B NASH/Fatty Liver study protocol • Develop company R&D plan • Earned grant for C.Difficle development through Monash University • Progress Influenza P
Slide 18: 2011 Highlights
2011 Highlights For personal use only • Successfully completed a licence deal for Travelan® with Paladin Labs – Significant up front fee – Milestone payments that support a prosperous OTC brand – Sales of finished goods – Validates our platform – Option on IMM‐255 for future influenza product • Othe
Slide 19: Table of Contents
Table of Contents For personal use only Section I •Brief Company Overview Section II •Key Strategies and Targets Section III •The Roadmap November 2011 Confidential ‐ Immuron 15
Slide 20: Section I: Company Overview
For personal use only SECTION I COMPANY OVERVIEW November 2011 Confidential ‐ Immuron 16
Slide 21: The Immuron Advantage
The Immuron Advantage For personal use only Oral Immunotherapy Using Antibodies Oral immunotherapy using dairy‐derived polyclonal antibodies for metabolic & infectious diseases, oncology, and additional indications Strong Intellectual Property Immuron owns 7 patent families that protect its product
Slide 22: Summary of cash outlays for past months
For personal use only Summary of cash outlays for past 18 months 1400 1200 1000 800 Jan to Jun‐10 July to Dec‐10 600 Jan to Jun‐11 400 200 0 Inventories and Corporate & Research & Total Payments travelan business development production development November 2011 Confidential ‐ Immuron 18
Slide 23: For personal use only
For personal use only 2010 2011 2012/13 2013/14 Travelan 1st partner Consolidate/ 10+ Markets Significant Expand Globally Revenue INFLUENZA Mice/Ferrets End preclinical Commence ph. 1 trials/ Reg/Partners/ Commercial production Launch! NASH Ph. 1/2a IND/Ph. 2b protocol Commence 2b/ License/ Seek par
Slide 24: Section II: Key Strategies and Targets
For personal use only SECTION II KEY STRATEGIES AND TARGETS November 2011 Confidential ‐ Immuron 20
Slide 25: Adding Value/Decreasing Risk
Adding Value/Decreasing Risk $/€ For personal use only Commercial COMMERCIAL VALUE Risk Development Commercialisation Immuron Nycomed Meda Paladin Labs Others to follow Research Hadassah U Melbourne Monash U TIME November 2011 Confidential ‐ Immuron 21
Slide 26: 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) 2013/14 Clostridium difficile infection HIV (IMM‐243 & IMM‐252) Hepatic Carcinoma Others November 2011 Confidential
Slide 27: Key Strategies
Key Strategies For personal use only •Aggressively increase revenue through continuing ramp-up of global partners/sales of Travelan and reduce COGs I •Driving development of our revolutionary influenza product (IMM-255) II towards a commercial-ready product in 2-3 years. •NASH: accelerating developm
Slide 28: Travelan Market Expansion
For personal use only TRAVELAN MARKET EXPANSION November 2011 Confidential ‐ Immuron 24
Slide 29: Travellers' Diarrhoea
Travellers’ Diarrhoea For personal use only • Travellers’ Diarrhoea (TD) ‐ most common health condition facing travellers • Research shows that up to 50% of people who travel to developing countries will develop the problem • Typically characterized by stomach cramps, diarrhoea, fever and nausea • M
Slide 30: Travelan - Immuron's product in the market
Travelan – Immuron’s product in the market For personal use only • Antibodies directed against bacteria that cause travellers’ diarrhoea • TGA approved, sales in Australia • Unique preventative oral immune therapeutic • Seeking steep sales growth. Global market ~US$650m+ pa • Exclusively licensed to
Slide 31: www.travelan.com.au
www.travelan.com.au For personal use only November 2011 Confidential ‐ Immuron 27
Slide 32: Influenza (IMM 255) - Accelerate
For personal use only INFLUENZA (IMM 255) ‐ ACCELERATE 2013/14 November 2011 Confidential ‐ Immuron 28
Slide 33: 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 34: IMM-255 - Clinical Development Roadmap
IMM‐255 – Clinical Development Roadmap For personal use only Initial trials were very effective in identifying protective action of Immuron’s antibodies against infection by the H1N1 human virus Following the above positive results additional ferret trials were approved – now in final stages IMM‐255
Slide 35: Revolutionizing the Treatment of Influenza
Revolutionizing the Treatment of Influenza For personal use only IMM 255 is being designed as the world’s first dual‐acting and all‐natural oral therapy that can both: Oral Antibody IMM 255 + Colostrum Derived Adjuvants Passive immunity, inhibiting the Boosts the immune system to fight influenza inf
Slide 36: 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 accessible ORAL therapy – Aiming for world’s first OTC potentially not requiring a dual‐
Slide 37: Commercial Strategy
Commercial Strategy For personal use only Q1/2 2012 Q1 2013 Q1 2014 Preparation of Commercial vaccine seed stock production of anti‐ for commercial production influenza HIC Carry out further Commence 1st clinical clinical trials (if Product Launch trial needed) November 2011 Confidential ‐ Immuron 3
Slide 38: NASH (IMM 124E) - File IND
For personal use only NASH (IMM 124E) – FILE IND November 2011 Confidential ‐ Immuron 34
Slide 39: The NASH/Fatty Liver Dilemma
The NASH/Fatty Liver Dilemma For personal use only “The research pipeline for this disease is thin, so there is an enormous opportunity for a successful first mover. Immuron’s novel approach and the high safety profile of its underlying technology puts it in a strong position to get a treatment to m
Slide 40: NASH - a major epidemic of the 21st Century
NASH – a major epidemic of the 21st Century National Center for Infectious Diseases predicts: For personal use only Over 25m Americans will have NASH by 2025 NO approved treatment for NASH by either the FDA or the European Medicines Agency Demand for off‐label use, expected to be US$3.2bn at 2016 (h
Slide 41: IMM-124E - Immuron's Solution for NASH
IMM‐124E – Immuron’s Solution for NASH For personal use only Orally administrated treatment Results to date very positive: Safe Trending of all parameters in the desirable direction Could be on the Addresses inflammatory market in mechanism less than 4 years Pursuing commencement of Phase 2b clinica
Slide 42: IMM-124E - Highlights and Next Steps
IMM‐124E – Highlights and Next Steps For personal use only Immuron is developing a therapy for NASH/Fatty Liver disease utilizing HIC The therapy uses similar platform technology as Travelan, incorporating the anti‐LPS antibodies The plan is now to proceed to a Phase 2b trial and a Phase 3 trial in
Slide 43: Section III: The Road Map
For personal use only SECTION III THE ROAD MAP November 2011 Confidential ‐ Immuron 39
Slide 44: Key Strategies
Key Strategies For personal use only •Aggressively increase revenue through continuing ramp-up of global partners/sales of Travelan and reduce COGs I •Driving development of our revolutionary influenza product (IMM-255) II towards a commercial-ready product in 2-3 years. •NASH: accelerating developm
Slide 45: For personal use only
For personal use only 2010 2011 2012/13 2013/14 Travelan 1st partner Consolidate/ 10+ Markets Significant Expand Globally Revenue INFLUENZA Mice/Ferrets End preclinical Commence ph. 1 trials/ Reg/Partners/ Commercial production Launch! NASH Ph. 1/2a IND/Ph. 2b protocol Commence 2b/ License/ Seek par
Slide 46: Immuron's Leadership: Management
Immuron’s Leadership: Management For personal use only Joe Baini, CEO • Experienced biotechnology executive; former GM for Gilead Sciences & non‐exec chairman for Avexa Ltd Dr Grant Rawlin, Chief Scientific Officer • Registered veterinary surgeon; extensive experience in regulatory affairs and R&D G
Slide 47: Immuron's Leadership: Board
Immuron’s Leadership: Board For personal use only Prof. Colin Chapman, Chairman & Non‐executive Director •Professional Fellow at the Australian Health Workforce Institute, University of Melbourne. Key role in establishment of Acrux. Emeritus professor and Immediate past Dean, Faculty of Pharmacy and
Slide 48: Immuron 2011 and beyond
IMMURON 2011 and beyond For personal use only FLU NASH PIPELINE November 2011 Confidential ‐ Immuron 44
Slide 49: Summary - Thank You
Summary For personal use only Thank You www.immuron.com www.travelan.com.au November 2011 Confidential ‐ Immuron 45
Slide 50: Presentation by Prof. Yaron Ilan
For personal use only PRESENTATION BY Prof. YARON ILAN June 2011 CONFIDENTIAL – Immuron 46
Slide 51: Treating the Metabolic Syndrome
For personal use only Making People Healthy & Making “Healthy” People Healthier Treating the Metabolic Syndrome Yaron Ilan M.D. Gastroenterology and Liver Units Department of Medicine Hebrew University – Hadassah Medical Center Jerusalem, Israel 47 December 2011
Slide 52: 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 53: For personal use only
For personal use only Passive Immunity (Local) using bovine antibodies Active naturally-derived Addresses and safe oral immunotherapy major medical Active immunity targets (Cellular) triggered by oral bioactives 49
Slide 54: Metabolic Syndrome: The Epidemic of the 21st Century
Metabolic Syndrome: The Epidemic of the 21st Century For personal use only Metabolic Syndrome is a combination of: •Type 2 diabetes: above 9% of the population •Fatty liver disease: 30% of the population •Hyperlipidemia •Atherosclerosis 50
Slide 55: The Global Rise in Obesity
The Global Rise in Obesity For personal use only 51
Slide 56: Non-alcoholic Fatty Liver Disease (NAFLD) Prevalence - USA
Non‐alcoholic Fatty Liver Disease (NAFLD) Prevalence ‐ USA For personal use only • 1/3 of adults in the USA have fatty livers • The National Center of Infectious Diseases predicts that by 2025 more than 25 million Americans may be affected by NASH A. Mae Diehl, EASL NASH,522009
Slide 57: Non-alcoholic Steatohepatitis
Non‐alcoholic Steatohepatitis For personal use only The most common liver disease in the western world Liver cancer A. Mae Diehl, EASL NASH,532009
Slide 58: Non-alcoholic Steatohepatitis (NASH)
Non‐alcoholic Steatohepatitis (NASH) For personal use only • No approved treatment available • The demand for off label pharmaceuticals is expected to grow to US$3.1 billion by 2016 • The approval of a drug for NASH is expected to raise this estimate considerably Global Data Forecast, 2011 54
Slide 59: Obesity = chronic inflammation
Obesity = chronic inflammation For personal use only • Obesity is characterized by chronic activation of inflammatory pathways in peripheral tissues. 55 Hotamisligil GS et al. Nutrient sensing and inflammation in metabolic diseases. Nature Reviews Immunology 8, 923‐934 | doi:10.1038/nri2449
Slide 60: The Product
The Product For personal use only Oral Immunotherapy Oral administration of naturally derived IMM‐124‐E from colostrum as a means for treating the metabolic syndrome 56
Slide 61: Oral Immunotherapy
Oral Immunotherapy For personal use only An active process that uses the inherent ability of the GI tract's immune system to control unwanted systemic immune responses by: • Preventing bacterial translocation • Inducing regulatory T cells 57
Slide 62: How Does It Work?
How Does It Work? For personal use only Target organs • Pancreas • Adipose tissue • Liver Oral administration • Brain 0 Presented to the immune system in the bowel • Improvement of the immune imbalance • Altered regulatory cells and prevention of bacterial overgrowth 58
Slide 63: Non-alcoholic steatohepatitis (NASH) - IMM 124-E
For personal use only Non‐alcoholic steatohepatitis (NASH) – IMM 124‐E 59
Slide 64: Oral Administration of IMM124-E in Patients with Metabolic Syndrome
Oral Administration of IMM124‐E in Patients with Metabolic Syndrome: For personal use only • A safe product • Improves liver enzymes • Improves diabetes • Improves hyperlipidemia • Promotes regulatory cells and corrects some of the abnormalities associated with the disease 60
Slide 65: IMM 124-E improved liver enzymes levels
Administration of IMM 124‐E improved liver enzymes levels For personal use only (7/10 Pt. p<0.002) 61
Slide 66: IMM 124-E improved insulin resistance & diabetes
Administration of IMM 124‐E improved insulin resistance & diabetes For personal use only Insulin levels after 1000 30 min (pg/ml) 800 600 400 200 0 Day 1 Day 30 62 (9/10 Pt. p<0.001)
Slide 67: IMM 124-E improved hyperlipidemia
Administration of IMM 124‐E improved hyperlipidemia For personal use only 63 (9/10 Pt. p<0.005)
Slide 68: American Liver Association Immuron Investigator Meeting
American Liver Association Immuron Investigator Meeting – held For personal use only in November 2011 • Dr. Arun Sanyal (AS) Virginia Commonwealth University • Assoc. Professor Stuart Roberts (SR) The Alfred Hospital Melbourne • Dr Mary Rinella (MR) Northwestern University • Dr. John Vierling (JV) B
Slide 69: Influenza - IMM
For personal use only Influenza – IMM 255 65
Slide 70: Oral anti-influenza antibodies with adjuvants improve immune response
Oral administration of colostrum derived anti‐ influenza antibodies with adjuvants improves the For personal use only anti‐influenza immune response Colostrum Oral derived antibodies adjuvants Passive immunity Active immunity Decrease of suppressor cells Augmentation of anti‐influenza cellular immun
Slide 71: Colostrum with anti-hepatitis antibodies suppresses liver cancer in mice
Colostrum enriched with anti‐hepatitis antibodies suppresses the growth of liver cancer in mice For personal use only Control Treated 10 g Treated 1 g
Slide 72: The Opportunity for Immuron
The Opportunity for Immuron For personal use only • Low Technology Risk: A safe compound that can be turned into effective pharmacological agents. • Fast Time To Market • Blockbuster Markets: A need for drugs that can effectively alter the immune system and suppress inflammation in target organs. 68
Slide 73: Regulatory Pathways
REGULATORY PATHWAYS MOVING FORWARD IN PARALLEL For personal use only Food Medical Food Botanical Supplement Drug
Slide 74: Advantages of Developing Food Supplement, Medical Food and Drug in Parallel
THE ADVANTAGES FOR DEVELOPING FOOD SUPPLEMENT, MEDICAL FOOD, AND A DRUG IN For personal use only PARALLEL 1.A prospective safety data 2.A proof of efficacy that support the development of a drug 3.Ongoing income
Slide 75: Two Different Indications
TWO DIFFERENT INDICATIONS For personal use only Phase I 2010 Phase IIA 2012 Phase IIB 2013 Medical Food 2014 Phase III / Pivotal No. 1 2017 Phase III / Pivotal No. 2 Fatty Liver 2018 Botanical Drug NASH
Slide 76: Clinical Development Plan
CLINICAL DEVELOPMENT PLAN – following Immuron’s full R&D Plan For personal use only I II III IV • NASH Phase II • Influenza • Alzheimer’s • HCV • Hepatic • ADHA Encephalopathy • C. Diff • HIV
Slide 77: Summary
Summary For personal use only • Orally delivered natural antibodies with adjuvants derived from hyper‐immune colostrum • Established clinical record and safety profile • Broad market opportunities: Unmet need • Low manufacturing costs • Not associated with immune suppression • No side effects or tox
Slide 78: Thank you
For personal use only Thank you 74