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Immuron Ltd — Investor Presentation 2011
Jun 26, 2011
35121_rns_2011-06-26_fd95c7cc-1754-427a-900d-4cf4f143f05c.pdf
Investor Presentation
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ABN: 80 063 114 045 Level 1, 39 Leveson Street North Melbourne, Vic 3051 Tel: +61 3 8637 1107 Fax: +61 3 9328 1675 www.immuron.com
27 June 2011
The Manager The Company Announcement Officer Australian Securities Exchange Sydney NSW 2000
Dear Sir
Bio International Convention - Washington
Immuron’s Chief Executive Officer, Joe Baini, and Vice President Business Development, Amos Meltzer, are attending the Bio International Convention which is being held in Washington USA during the period 27[th] to 30[th] June.
During the Convention they will be meeting with and presenting to a number of pharmaceutical organisations and other biotechnology companies who have shown interest in the Immuron pipeline and platform technology. Attached is a copy of the presentation that will be used during the meetings.
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Company Secretary Immuron Limited
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Oral Immunotherapy Using Antibodies
Joe Baini Chief Executive Officer
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.
About Immuron
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Melbourne based, ASX listed public company
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Market cap ~$24M
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Recent management changes with strong commercialization focus
• Commercial priorities
1. Expand Travelan® sales into US & other large markets
2. NASH (fatty liver disease) clinical trial. Currently NO treatment option, yet IMM‐124E showing early positive data in phase IIA. Pre‐IND meeting with US FDA pending.
3. Developing world’s first orally available preventative to fight influenza
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TRAVELAN®
Immuron's product in market
Antibodies directed against bacteria that cause travelers’ diarrhoea
TGA approved, sales in Australia
Unique natural preventative oral immune therapeutic
Seeking steep sales growth. Global market ~US$650m+ pa
Exclusively licensed to Nycomed in Aust/NZ since Apr 2010
Partnered with Meda Pharmaceuticals in the US
Additional global markets being aggressively pursued
US & other major territories aiming to launch 2011
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NASH – a silent killer the epidemic of the 21[st] century
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NASH – Non‐alcoholic Steatohepatitis
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Fatty liver: one of most common liver diseases in the industrialized world
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Chronic Inflammatory Disease, associated with Obesity, Type II Diabetes (insulin resistance), Hyperlipidemia
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1 in 5 NASH patients develop liver cirrhosis
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1 in 10 will die from NASH
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No specific treatment available
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Insufficiently served by “off‐label drugs”: US$1.8B $US3.2B in 2016
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NCID predicts >25m Americans will have NASH by 2025
Immuron’s – Solution to NASH
‐ IMM 124E
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Results to date very positive
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safe
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trending of all parameters in the desirable direction
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addresses inflammatory mechanism
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Pursuing commencement of Phase IIB clinical trials
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Intending to negotiate fast track development
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Oral administration
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Could be on the market < 4 years
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Influenza
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Direct medical costs in US – US$10.4B pa*
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3‐5m cases pa of severe illness
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>500,000 deaths worldwide pa
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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 8 burden and costs doi:10.1016/j.vaccine.2007.03.046
Immuron’s – Solution to Influenza
‐ Immuron Solution: IMM 255
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Antibodies designed to cope with the rapidly changing strains of flu as virus evolves
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Aiming for world’s first orally administered product for mucosal protection against influenza virus
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Natural‐base of product will particularly appeal to certain large markets
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Positive results to date in gold standard animal model
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Clinical Trials currently being planned
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Molinari et al. The annual impact of seasonal influenza in the US: Measuring disease 9 burden and costs doi:10.1016/j.vaccine.2007.03.046
Platform Technology ‐ overview
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All products based on Immuron’s bovine colostrum technology platform
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Natural product
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Strong safety profile – as confirmed byTravelan
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Accelerate to market
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Proprietary vaccine
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Orally administered; non‐invasive administration
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Supported by patents & other monopolies
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Platform Technology – CMI
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Immuron’s orally delivered antibodies can illicit an immune response.
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The immune response and metabolic regulation are highly integrated and the proper function of each is dependent on the other.
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Metabolic systems are integrated with pathogen‐sensing and immune responses, and these pathways are evolutionarily conserved
Macrophage Adipocyte Inflammatory response Metabolic response
- T cells can modulate macrophage and adipocyte functions within adipose tissue through cytokine secretion
Platform Technology – Passive Immunity
- Immuron’a antibodies also confer passive immunity
• The mechanism of action applicable to the prevention of pathogenic infections is passive immunity: aglutenation of the antibodies with the pathogens.
- The polyclonal nature of the antibodies is particularly advantageous for this type of Immunity
Platform Technology ‐ Production
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Proprietary methods to significantly increase levels of antibodies of choice.
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Process consists of immunising cows with certain antigens – results in ‘hyperimmune’ colostrum (HIC).
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As a result, colostrum from hyperimmunised cows contains antibodies to all the pathogens and antigens to which the cows have been exposed, and this includes the specific antibodies against the antigens present in Immuron’s vaccine used to immunise the cows.
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Collected colostrum is then refined according to proprietary protocols
Platform Technology ‐ Antibodies
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A majority of global antibody research is in the area of monoclonal antibodies derived from tumour cells grown in mice or cell cultures, which all bind to one specific part of their target.
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Polyclonal antibodies however, are formed normally by the immune system in humans and animals in response to a target. They are a group of different antibodies that bind to many parts of the same target.
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As a result of the variety exhibited by polyclonal antibodies, such antibodies have an advantage over monoclonal antibodies in combating infectious diseases, such as travelers’ diarrhea
Platform Technology ‐ Manufacturing
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Immuron’s Bovine Colostrum Powder(BCP) is manufactured, stored, transported and treated under dairy food standards until it is a freeze dried powder (A TGA Listed Substance).
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Once approved for safety and efficacy as a raw material, Immuron supplies the BCP raw material to a TGA approved GMP manufacturer who then processes the BCP into the finished caplets known as “Travelan”.
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BCP is a Listed Substance.
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The all‐natural dairy‐derived platform, has a US regulatory classification as GRAS (Generally Regarded as Safe) when administered orally.
Travelan ‐ Clinical Trials
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Double blinded, placebo controlled clinical trials completed in Baltimore and Poland vs high dose challenge of 10 to the power of 9 ETEC show a greater than 90% protection rate.(1)
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The challenge dose is 1000 times stronger than what you will see in field conditions
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Also found that it reduced discomfort and diarrhoea in those that were still affected by ETEC
Excellent reports from the toughest in‐field test: the travelling public
- (1) Otto et al, 2011. Scandanavian Journal of Gastroenterology (in press) Randomised control trials using a tablet formulation of hyperimmune bovine colostrum to prevent diarrhoea caused by enterotoxigenic Escherichia coli in volunteers
Product Pipeline
| Indication | Research | Pre‐Clinical | Phase I | Phase II | Phase III | Market |
|---|---|---|---|---|---|---|
| Traveller’s Diarrhoea | ||||||
| Metab Syndrome/NASH (IMM‐124E) |
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| Influenza (IMM‐255) | ||||||
| Clostridium difficile infection |
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| HIV (IMM‐243 & IMM‐252) |
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| Hepatic Carcinoma | ||||||
| Others |
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Commercial strategy
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Travelan – build sales over 2011/2012 for cash flow
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NASH – license based on added value from successful
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trials, seek fast‐track approvals
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Other pipeline – further development & active
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licensing
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Key Partners
Hadassah Medical Center
Largest hospital/medical research centre in Middle East Globally recognized medical research FDA compliant clinical trials unit Joint programs in NASH & Influenza Major shareholder in Immuron
University of Melbourne, Dept Microbiology & Immunology
Long standing research collaboration Melbourne University team conceived Travelan®
Current research in treatment & prevention of Influenza and HIV
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Mana ement g
| Joe Baini Experienced biotechnology executive; former GM of Gilead Sciences & non‐exec chairman of Avexa Ltd |
Chief Executive Officer |
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| Dr Grant Rawlin Registered veterinary surgeon, extensive experience in regulatory affairs and R&D |
Chief Scientific Officer |
| Mr Graeme Stevens Qualified Chartered Accountant; more than 30 years professional experience with large & small companies |
Chief Financial Officer & Company Secretary |
| Prof Yaron Ilan Director, Dept of Medicine, Hadassah Medical Center ‐ Hebrew University, Jerusalem. Scientist /clinician in internal medicine, immunology, liver diseases |
Medical Director |
| Mr Amos Meltzer Experienced life sciences technology commercialisation specialist, a scientist & lawyer, formerly with Compugen Ltd |
VP Business Development |
| Mr Brian Muller Experienced scientist with commercial focus; more than 20 years R&D experience in Australian biotechnology companies |
Manager Regulatory Affairs |
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2011/2012
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Aggressively increase revenue through ramp‐up of global partners/sales of Travelan
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NASH, accelerating development & license collaboration sought. Serious unmet medical need. FDA pre‐IND mtg June. Blockbuster potential
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Driving development of revolutionary flu lozenge
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Leverage Hadassah & Univ. Melbourne partnerships to progress products into clinical trials from pipeline
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