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Immuron Ltd — Investor Presentation 2011
Sep 4, 2011
35121_rns_2011-09-04_051dd57c-4f31-419b-b052-8e30d1394a37.pdf
Investor Presentation
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Oral immunotherapy using antibodies
Joe Baini, CEO
5 September 2011
2011
CONFIDENTIAL – Immuron
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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 based these forward‐looking statements on information currently available to us and on our current intentions, beliefs, expectations and projections about future events.
These statements are not guarantees of future performance which involves a range of risks, such as risks relating to the development of new products, any of which may cause Immuron’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward‐looking statements.
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CONFIDENTIAL – Immuron
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Table of Contents
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•Brief Company Overview Section I •Key Strategies and Targets Section II •The Roadmap Section III
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Section I
COMPANY OVERVIEW
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About Immuron
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Melbourne based, biopharmaceutical company (ASX: IMC)
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Market Cap~24M
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R&D at Hadassah Medical Center Israel, Uni. Melb. & Monash Uni.
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Focuses on Oral Immunotherapy using dairy‐derived antibodies
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Developed and patented a cost effective method to harvest polyclonal antibodies from hyper immune colostrum (HIC) of immunized cows
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Superior safety profile enables acceleration of product development
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• Strong pipeline
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First commercialized product – Travelan (travellers’ diarrhoea)
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Several clinical phase products & research and preclinical stage programs
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Addressing a broad range of indications in the infectious diseases, immune mediated diseases and oncology fields
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The Immuron Advantage
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Oral Immunotherapy Using Antibodies
Oral immunotherapy using dairy‐derived polyclonal antibodies for metabolic & infectious diseases, oncology, and additional indications
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Strong Intellectual Property
Immuron owns 7 patent families that protect its product portfolio Immuron has also acquired over 12 years of “trade secrets”
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Strong Collaboration with Key Research Partners
Collaborations with leading research centres at Hadassah Medical Center, University of Melbourne & Monash University
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Key Alliance with Global Pharmaceutical Company
Aggressive distribution in place with new partners (including Nycomed) expected to play a key role in global commercialization
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2010 2011 2012 2013
Travelan 1 [st] partner Consolidate/ 10+ Markets Significant
Expand Globally Revenue
INFLUENZA Mice/Ferrets End preclinical/ Consolidate trials/ Reg/Partners/
Commence Ph. 1 Commercial production Launch!
NASH Ph. 1/2a IND/Ph. 2b protocol Commence 2b/ License/
Seek partners Commence Ph. 3
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Section II
KEY STRATEGIES AND TARGETS
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CONFIDENTIAL – Immuron
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Adding Value/Decreasing Risk
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$/€
Commercial
Risk
Commercialisation
Development
Immuron Nycomed
Meda
New partners
Research
Hadassah
U Melbourne
Monash U
TIME
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COMMERCIAL VALUE
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Product Pipeline
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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
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Key Strategies
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I
- •Aggressively increase revenue through ramp-up of global partners/sales of Travelan
II
•Driving development of revolutionary influenza product ( IMM-255 ) towards a commercial-ready product in 2-3 years.
III
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IV
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NASH : accelerating development & license opportunities. Significant unmet medical need. FDA pre-IND mtg June. Blockbuster potential
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•Leverage Hadassah, Uni of Melbourne & Monash Uni partnerships to progress products into clinical trials from pipeline
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TRAVELAN ‐ MARKET EXPANSION
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Travellers’ Diarrhoea
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Travellers’ Diarrhoea (TD) is the most common health condition facing travellers
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Research shows that up to 50% of people who travel to developing countries will develop the problem
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Typically characterized by stomach cramps, diarrhoea , fever and nausea
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The most common cause of this condition is Enterotoxigenic E. Coli ( ETEC ) bacteria
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Up to 70% of all cases of TD are caused by ETEC
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Travelan – Immuron’s product in the market
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Antibodies directed against bacteria that cause travellers’ diarrhoea
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TGA approved , sales in Australia
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Unique preventative oral immune therapeutic
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Seeking steep sales growth. Global market ~US$650m+ pa
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Exclusively licensed to Nycomed in Aust/NZ since Apr 2010
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Partnered with Meda Consumer Healthcare in the US
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Additional global markets being aggressively pursued
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Major territories aiming to launch 2012‐13
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www.travelan.com.au
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INFLUENZA (IMM 255) – ACCELERATE:
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2013/14
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CONFIDENTIAL – Immuron
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Influenza
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Direct medical costs in US – $10.4B pa*
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3‐5m cases pa of severe illness
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Over 500,000 deaths worldwide pa
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Influenza is the 8[th] leading cause of American deaths
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*Molinari et al. The annual impact of seasonal influenza in the US: Measuring disease burden and costs doi:10.1016/j.vaccine.2007.03.046
2011 CONFIDENTIAL – Immuron
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IMM‐255 – Clinical Development Roadmap
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Initial trials were very effective in
identifying the protective action of
Immuron’s antibodies against infection by
the H1N1 human virus
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Following the above positive results
additional ferret trials were approved
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IMM‐255 to be developed for use in trials to
be developed as an oral formulation
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Revolutionizing the Treatment of Influenza
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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
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Passive immunity, inhibiting the influenza infection
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Binds and inhibits influenza
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infection
Boosts the immune system to fight influenza
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Decrease of suppressor cells
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Augment anti influenza cellular immunity
Not viral strain specific – product alteration not needed annually
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IMM‐255 – Immuron’s Solution to Influenza
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Aiming for world’s first
dual‐acting orally
administered product;
mucosal protection
against influenza virus
and boosting immunity
against influenza
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Antibodies designed to cope with the rapidly changing strains of flu as virus evolves (advantage of polyclonal antibodies)
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Convenience of an easily accessible OTC therapy – not requiring a doctor visit or prescription
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Market size : unlike vaccines, usually reserved for the elderly and immune compromised, IMM 255’s potential market is the entire population
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IMM 255 is safe
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IMM 255 is 100% natural
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IMM 255 is patent protected
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Commercial Strategy
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Q4 2011 Q4 2012 Q4 2013
Preparation of
Commercial
vaccine seed stock
production of anti‐
for commercial
influenza HIC
production
Carry out further
Carry out clinical
clinical trials (if Product Launch
trials
needed)
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NASH (IMM‐124E) ‐ FILE IND
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NASH – a major epidemic of the 21[st] Century
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NCID predicts: Over 25m Americans will have NASH by 2025
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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 (however ineffective) Positive & encouraging results for phase 1/2a Clinical Trials
Immuron’s solution for NASH could be on the market in less than 4 years
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IMM‐124E – Immuron’s Solution for NASH
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Could be on the market in less than 4 years
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Orally administrated treatment Results to date very positive : Safe Trending of all parameters in the desirable direction Addresses inflammatory mechanism Pursuing commencement of Phase 2b clinical trials Intending to negotiate fast track development
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IMM‐124E – Highlights and Next Steps
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Immuron is developing a therapy for NASH utilizing
HIC IP
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The therapy uses similar platform technology as
Travelan, incorporating the anti‐LPS antibodies
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The plan is now to proceed to a Phase 2b trial and a
Phase 3 trial in 2013
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Proposed that the Phase 2b trial will be conducted
over four sites in Israel, the US and Australia with
patients on treatment for three months
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Section III
THE ROAD MAP
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Key Strategies
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I
- •Aggressively increase revenue through ramp-up of global partners/sales of Travelan
II
•Driving development of revolutionary influenza product ( IMM-255 ) towards a commercial-ready product in 2-3 years.
III
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IV
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NASH : accelerating development & license opportunities. Serious unmet medical need. FDA pre-IND mtg June. Blockbuster potential
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•Leverage Hadassah, University of Melbourne & Monash Uni partnerships to progress products into clinical trials from pipeline
2011
CONFIDENTIAL – Immuron
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2010 2011 2012 2013
Travelan 1 [st] partner Consolidate/ 10+ Markets Significant
Expand Globally Revenue
INFLUENZA Mice/Ferrets End preclinical/ Consolidate trials/ Reg/Partners/
Commence Ph. 1 Commercial production Launch!
NASH Ph. 1/2a IND/Ph. 2b protocol Commence 2b/ License/
Seek partners Commence Ph. 3
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CONFIDENTIAL – Immuron
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Immuron’s Leadership: Management
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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
Mr Graeme Stevens , Chief Financial Officer & Company Secretary
- Qualified Chartered Accountant ; more than 30 years professional experience with large & small companies
Prof Yaron Ilan , Medical Director
- Directo r, Dept of Medicine, Hadassah Medical Center ‐ Hebrew University, Jerusalem. Scientist /clinician in internal medicine, immunology, liver diseases
Mr Amos Meltzer , VP Business Development
- Experienced life sciences technology commercialisation specialist , a scientist & lawyer , formerly with Compugen Ltd
Mr Brian Muller , Manager Regulatory Affairs
- Experienced scientist with commercial focus; more than 20 years R&D experience in Australian biotechnology companies
Dr. Nina Webster , Director Commercialisation & IP
- Successful biotech and pharmaceutical executive formerly with Acrux
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Immuron’s Leadership: Board
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Prof. Colin Chapman , Chairman
- 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 Pharmaceutical Sciences, Monash University
Prof. Roy Robins‐Browne , Non‐executive Director
- Professor & Head , Dept of Microbiology & Immunology, the University of Melbourne ; Joint Head , Infectious Diseases & Microbiology Research Group, Murdoch Children’s Research Institute , Royal Children’s Hospital, Melbourne
Dr Elane Zelcer , Non‐executive Director
- Executive Director, BioConsult Pty Ltd. Experienced start‐up CEO ; executive, board and advisory roles in private sector, universities, CRCs, State & Federal government committees
Mr Simon Sallka , Non‐executive Director
- Executive Director & Chief Investment Officer, Falcon Capital Pty Ltd; more than 25 years funds management experience as portfolio manager
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Summary
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Thank You
www.immuron.com
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www.travelan.com.au
2011
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