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Immuron Ltd — Investor Presentation 2012
May 9, 2012
35121_rns_2012-05-09_61795b0d-72ac-4b2a-8374-8dc910852b0f.pdf
Investor Presentation
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Oral immunotherapy using antibodies
May 2012
Confidential ‐ Immuron
May 2012
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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.
Confidential ‐ Immuron
May 2012
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Table of Content
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Section I • Company Overview Section II • Platform Technology • NASH Section III • Travelan Section IV • Influenza Section V • R&D Section VI May 2012
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Section I
Company Overview
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About Immuron
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Melbourne based biopharmaceutical company
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Publicly listed on the Australian Stock Exchange (ASX: IMC)
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Focuses on Oral Immunotherapy using dairy‐derived antibodies
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Superior safety profile products makes it possible to accelerate product development
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First product on market : Travelan, for travelers’ diarrhea
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Cleared by the FDA: IND for phase IIB double‐blind placebo controlled multi‐centre dose ranging study
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Rich pipeline over a broad range of indications: infectious diseases, immune mediated diseases and oncology
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Investment Highlights
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Safe and proven technology platform
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Rich product pipeline
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Travelan approved and already in market generating sales
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Paladin Labs Inc recently signed up as distribution partner for Canada, Latin America, Africa ($2m + up to $115m in royalties)
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2[nd] product: IMM124E targeting NASH ‐ an expected off‐label use $3.2B market by 2016 in the US alone with no current treatment
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Very positive Phase I/IIa results
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FDA granted IND for Phase IIB trials for NASH
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Multiple revenue streams forIMM124E by also accessing medical food & dietary supplements for NASH/fatty liver disease
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3[rd] product: developing world’s first oral dual‐acting preventative to fight influenza.
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Bonus issue of options (ex 4.0 cents; exp 30 April 2015; will be listed) to all shareholders on the register as at 23 July 2012
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Milestones Achieved in Last 6 Months
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FDA cleared Phase IIB IND for IMM‐124E for NASH/Fatty Liver, a product
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with block buster potential
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FDA provided further visibility on Phase III NASH endpoints
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Completed license agreement and strategic investment with Paladin
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Labs for Travelan (Canada, Latin America, Africa)
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Up to $115 million in milestones over agreement period
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Board of Directors restructured ‐ aligned with bio‐pharmaceutical focus
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Completed licence for Travelan with IntegraMed (5 Asian countries)
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Immuron’s Competitive 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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Monopoly Powers
>12 patent families that protect the use of Immuron’s products Regulatory hurdles
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May 2012
Strong Collaborations with Research Partners
Hadassah Medical Center – for pre‐clinical and clinical development University of Melbourne – for early stage R&D Monash University – for early stage R&D Harvard Medical School – for early stage R&D Alliance with Global Pharmaceutical Companies
Aggressive distribution in place with new partners expected to play a key role in global commercialization
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Technology and Product Highlights
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Safe Technology – Hyper Immune Colostrum
Immuron is able to increase IgG immunoglobulins of choice in bovine colostrum
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Proven Platform Technology
Travelan launched successfully in Australia as an OTC medication for the treatment of traveller’s diarrhea
Travelan is validation that Immuron’s platform works
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Phase IIB Clinical Trials for Treating NASH
No currently approved treatment for NASH. Immuron filed an IND for Phase IIB clinical trials for this $3.5 Billion market
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May 2012
Developing World’s First Oral Preventive to Fight Influenza Positive results to date in gold standard animal model, clinical trials imminent
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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)
Clostridium difficile
infection
HIV IMM‐243
Hepatic Carcinoma
Cancer/radiation
therapies
Other
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Management Team
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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 Grant Rawlin, Chief Scientific Officer
- Registered veterinary surgeon; extensive experience in regulatory affairs and R&D
Prof Yaron Ilan, Medical Director
- Director, Deptartment 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
Dr. Nina Webster, Director Commercialisation & IP
- Successful biotech and pharmaceutical executive formerly with Acrux
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Section II
Platform Technology
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Mode of Action
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Oral Immunotherapy Using Antibodies
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Oral Immunotherapy
An approach to treat autoimmune, infectious and inflammatory disease through the oral delivery of antibodies
An active process that uses the inherent ability of the GI tract's immune system to elicit cell mediated immune responses, by inducing T cells in an antigen‐specific manner
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Disease Specific Antibodies
+
Colostrum Adjuvants
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Presented in the Intestine
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Oral Immunotherapy
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Target organs
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No side effects or toxicity
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Pancreas
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• Adipose Tissue
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Not associated with general immune suppression
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Liver
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• Brain • No risks of severe infection or
malignancy
• Easily tolerated by patients
Elicit T cells • Platform for a wide range of
diseases
response
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- No risks of severe infection or malignancy
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Hyper‐Immune Colostrum (HIC) ‐ Advantages
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| Immuron Product | Typical small molecule product |
|---|---|
| Completely natural product | Synthetic product |
| Not associated with immune suppression |
Can be associated with immune suppression |
| No side effects or toxicity – low risk profile |
Some side effects or toxicity |
| Easily tolerated by patients | Not easily tolerated by patients |
| Polyclonal antibodies advantageous in combating infectious diseases |
Monoclonal antibodies strain specific |
| Oral administration | Oral administration |
| Rapid Development Cycle | Longer development time |
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Section III
NASH – IND Cleared for Phase IIb
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Non‐Alcoholic Steatohepatitis (NASH)
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NASH: the most severe form of liver injury in the spectrum of non‐alcoholic fatty liver disease (NAFLD)
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Fatty liver: one of most common liver diseases in the industrialized world
Chronic Inflammatory Disease, associated with Obesity, Type II Diabetes (insulin resistance), Hyperlipidemia Insufficiently served by “off‐label drugs” No Indicated treatment available
1 in 5 NASH patients develop liver CIRROSIS
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NASH – A Major Epidemic of the 21[st] Century
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NCID : >25m Americans will have NASH by 2025
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No approved treatment for NASH or Fatty Liver Disease globally
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May 2012
Demand for off‐label use expected to be US$3.2bn at 2016
Very Positive Results for phase 1/2a Clinical Trials
Immuron’s solution for NASH could be on the market in 3‐4 years
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Background and Pathogenesis of NASH
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NAFL & NASH are a result of reinforcing cycle between Insulin resistance, Obesity, and Metabolic derangements causing chronic inflammation, resulting in organ damage
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Insulin resistance
Metabolic derangements
Obesity
Chronic inflammation Immune system
Target organ damage
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Hotamisligil, Nature, 2006
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IMM‐124E – Immuron’s Rx Solution to NASH
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Orally administrated treatment
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Results to date very positive : Safe
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Phase I/IIa trials for IMM‐124E showed trending of all parameters in the right direction and only after 30 days of treatment.
Trending of all parameters in the desirable direction Addresses inflammatory mechanism
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IND for Phase IIB clinical cleared
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See appendix for results
Intending to negotiate fast track development
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Immuron Value Proposition – IMM‐124E
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IMM‐124E: Accelerated time
Typical to market
commercial risk
IMM‐124E value
IMM‐124E risk Blockbuster indication
Proven technology No competition
Proven safety profile Large unmet need
Clear development pathway
Patient availability
Typical commercial
value of the average
therapeutic
Pre‐clinical Ph I Ph II Ph III NDA Market
TIME
IMM‐124E
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RISK
COMMERCIAL VALUE $$$
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IMM‐124E US Revenue Stream Sales Potential
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Assuming no competitor enters market in this time frame
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Section IV
Product on Market – Travelan
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Traveller's Diarrhoea
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Travelers’ Diarrhea: the most common health condition facing travellers
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Up to 50% of people who travel to developing countries will contract the disease
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Typically characterized by stomach cramps, diarrhea, fever and nausea
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The most common bacteria that causes this condition is Enterotoxigenic E. Coli (ETEC)
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Travelan ‐ Immuron’s Solution to TD
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Double blinded, placebo controlled clinical trials completed vs. high dose challenge of 10 to the power of 9 ETEC show a greater than 90% protection rate[(1)]
Travelan is the most effective and the only naturally occurring preventative for travelers’ diarrhea
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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 diarrhea in those that were still affected by ETEC
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(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 May 2012 Confidential ‐ Immuron
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US Independent Market Research
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Americans travelling abroad:
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80% prefer a preventative
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13% prefer a cure
The only other clinically tested preventative known as Dukoral (a prescription medicine) is not available in the US
79% indicated that if a preventative dietary supplement (~$25) was available, they are "likely to" or "would definitely" purchase such a product
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US Independent Market Research
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Respondents were informed the label would not state "preventative“ • in market research terms, this is a resounding support to launch.
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The major destinations where such a product would be used are: • Mexico
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Caribbean
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Asia
93% of respondents stated they had experienced traveler’s diarrhea when visiting such places in the past 2 years
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Travelan – Immuron’s Product on the Market
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Antibodies directed against bacteria that cause travelers’ diarrhea
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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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Exclusively licensed to Paladin for Canada, LatAm and Sub‐saharan Africa
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Additional global markets being aggressively pursued
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Infection
May 2012
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Infection prevented through passive immunity
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www.travelan.com.au
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Section V
Immuron’s Pipeline ‐ Influenza
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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
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Revolutionising the Influenza Therapy
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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
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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
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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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Section VI
R&D
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R&D Programs
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Monash University: Clostridium difficile infection
Harvard Medical School: Radiation Therapy
University of Melbourne: HIV Treatment
Hadassah Medical School:Hepatic Carcinoma; Hepatic Encephalitis; Mucositis; and a range of neurological disorders
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Section VIII
Summary
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12‐18 Months Outcomes
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$6 million investment:
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Complete NASH Phase IIb clinical trial – ready to licence
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Commence Global/Territorial license/distribution discussions with interested Pharma cos.
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Pipeline products progressed
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First human trial for Influenza
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Clostridium difficile prevention and treatment
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HIV treatment
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Hepatic carcinoma treatment
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Cancer & radiation treatments
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Others
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Investment Summary
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Safe and proven technology platform
-
Rich product pipeline
-
Travelan approved and 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)
-
2[nd] product: IMM124E targeting NASH ‐ an expected off‐label use $3.2B market by 2016 in the US alone with no current treatment
-
Very positive Phase I/IIa results
-
FDA granted IND for Phase IIB trials for NASH
-
Multiple revenue streams forIMM124E by also accessing medical food & dietary supplements for NASH/fatty liver disease
-
3[rd] product: developing world’s first oral dual‐acting preventative to fight influenza.
-
Bonus issue of options (ex 4.0 cents; exp 30 April 2015; will be listed) to all shareholders on the register as at 23 July 2012
-
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Summary
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Oral Immunotherapy Using Antibodies
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Strong Intellectual Property
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Tight Collaboration with Key Research Partners
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Key Alliance with Global Pharmaceutical Company
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Proven, Novel Technology – Hyper Immune Colostrum (HIC)
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Innovation Commercialized Product: Travelan
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Phase IIB Clinical Trials for a Treatment for NASH
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Developing World’s First Oral Preventive to Fight Influenza
Thank You !!!
www.immuron.com
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May 2012
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Planned Phase IIb Clinical Trial
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FDA cleared IND application
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Immuron plans to commence a Phase IIb clinical trial of IMM‐124E
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Indicated for both NASH &Fatty Liver
Clinical trial summary:
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double‐blind
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placebo‐controlled
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dose ranging
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multi‐centre (sites in the United States, Australia &Israel)
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120 patients
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Both safety and efficacy endpoints
Dr Arun J Sanyal, Professor of Medicine at Virginia Commonwealth University, has been appointed as global principal investigator
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