Immuron Ltd — AGM Information 2010

Nov 28, 2010

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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.

• Presentation by Dr Grant Rawlin, Chief Executive Officer of Immuron.

• Presentation by Professor Yaron Ilan, Medical Director of Immuron.

• Information paper on Metabolic Syndrome and NASH.

Yours Faithfully

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Graeme Stevens

Company Secretary

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Chairman’s address Professor Colin Chapman- Non Executive Chairman 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, with the acquisition of intellectual property from Hadasit, and the successful raising of capital from shareholders in excess of $4 million. On behalf of the Board I thank all shareholders that contributed to that capital raising.

In respect of your Board it was with great pleasure that Immuron welcomed Dr Elane Zelcer to the Company’s Board in November 2009. Since joining, Elane has been a regular and valuable contributor to all of Immuron’s activities, particularly those associated with the research conducted by Hadassah in Jerusalem. Elane also has considerable experience in the commercialisation of products in the biotechnology sector and her experience will be valuable in the coming period as we anticipate bringing new products to market.

There was also another change in the Board during the year with the resignation of Arie Nudel in March of this year. I would like to take this opportunity to thank Arie for his contribution as a Director where he was always on the lookout for opportunities to exploit Immuron’s technology platform, and to ensure shareholders were kept informed on the Company’s progress.

This year we reported an improvement of $722,534 in our financial performance over the previous financial year by reducing the loss from continuing operations to $1,902,425.

This improvement was primarily a result of a change in the Company’s strategic direction with the change in management from the United States back to Australia with significant cost savings. Additional comments on the operations for the 2010 financial year are contained in the annual report distributed to shareholders.

During the year we have seen the capitalisation of the company increase from $4.2 million in July 2009 to currently $24.5 million. Whilst this increase reflects the more than doubling in the number of shares on issue during that period, it also reflects the significant improvement that the market is attributing to the scientific results achieved during the year.

The successful scientific results achieved are largely due to the success of the relationship that we have developed with Hadasit and on your behalf I would like to the thank both Dr Grant Rawlin and Professor Yaron Ilan for the positive contributions that they have both made in the past year in developing the product portfolio and the future strategic direction of the Company.

The immediate strategy of Immuron will be focused on the progression of our work on NASH which has been described as the “epidemic of the 21[st] century”. We have distributed to all shareholders attending the meeting an information paper on NASH disease to provide an understanding and the extent of this disease, for which there is no known cure, and how Immuron is positioning itself to provide a product to assist in the cure of NASH. This paper will also be lodged with the ASX and will be available on the Company’s website.

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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 intellectual portfolio and know how. This position may present the Company as a potential takeover target and the Board is pleased that shareholders, through their proxy votes, have approved the resolution to reinsert in the Company’s constitution a clause that provides extra protection to shareholders in the event of the Company receiving a partial takeover offer.

We have commenced this financial year with some very positive results from our Phase 1/2 clinical trial for the treatment of liver disease, NASH and other aspects of Metabolic Syndrome, which we announced to the ASX on 23 August. The results of this trial were also presented by Professor Ilan at the Boston conference of the American Association for the Study of Liver Disease in November. Dr Rawlin also attended that conference.

Based on the results of that trial, which was a 10 person trial conducted in Israel, we are currently preparing the groundwork to conduct a 60 person multi-site clinical trial in the United States and Israel. This trial will be an FDA approved trial. We are in the process of preparing an application to the FDA which will be lodged with the FDA in the first quarter of 2011.

In addition to the proposed NASH FDA clinical trial, the main other research projects which will be ongoing and commence during the coming year are:

• Influenza with the continuation of the ferret trials and other work with the University of Melbourne.

• HIV with the University of Melbourne.

• C/Diff with Monash University.

Both Dr Rawlin and Professor Ilan will provide you with detailed reports on the scientific achievements later in the meeting, together with an outline of our ongoing research programs and product strategies for the current year and the year’s beyond.

On behalf of the Board I would like to express our gratitude to the management team for their positive contribution to the advancement of the Company’s projects during the past year. I again would sincerely thank the shareholders for their loyalty and strong support during the year.

The coming year will be an exciting year in the evolution of Immuron. We have a very clear product development plan to implement and I would encourage shareholders to take an active interest if the future announcements we will be making to the ASX and the information updated on our website.

On behalf of the Board I thank you for your continuing interest in Immuron as indicated by your attendance at today’s meeting.

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Colin Chapman Chairman

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Oral Immunotherapy Using Antibodies

AGM 2010 Dr Grant Rawlin Chief Executive Officer

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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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2010: Summary of the journey

• 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

• Strong focus on growing shareholder value. Increased market cap

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2010 – A year of advancement

• 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 to clinical trial in 2 years

• Increased shareholder value: Market cap increased from $4.2 million in July 2009 to about $25 million

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Focused Product Pipeline

Indication	Research	Pre- Clinical	Phase I	Phase II	Phase III	Market
Traveller’s Diarrhoea
Metabolic Syndrome / NASH Influenza
Clostridium difficile infection
Influenza
HIV
Hepatic Carcinoma
Others

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Attacking rising incidence of Metabolic Syndrome / NASH

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The “epidemic of the 21[st] Century”

Metabolic Syndrome Adults & Children: numbers increasing annually worldwide

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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 approved treatment.
3 adults by 2050
25% of Americans 1 in 5 will develop
Childhood have liver cirrhosis; 10%
incidence on the atherosclerosis will die from liver
rise failure
3% will die of
atherosclerosis CDC predicts >25m
Americans will have
NASH by 2025
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NASH – the value proposition

• 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 partner will be a major focus of 2011

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TRAVELAN®

For Travellers’ Diarrhoea

• 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 Zealand since April 2010. Increased sales seen

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Travelan® Market Expansion

• 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.

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Influenza Product

• 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

• Testing formulations at CSIRO.

• Preliminary results expected in early Q1 2011

• Objective for 2011: define final product pathway, partner to co‐develop the product

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Influenza product‐ Key Advantages

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 effectively Vaccinations do not adequately protect all Suitable for children too young to receive groups conventional vaccinations and elderly population who do not respond well to vaccinations

Immuron’s product may provide a significant tool for individual and large‐ scale public health management of influenza

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Other R&D

• 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 University, USA

• Mucositis: Tel Aviv trial terminated

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Management Team

Dr Grant Rawlin Registered veterinary surgeon, significant experience in regulatory affairs and R&D. Pivotal to company development to date.	Chief Executive 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 Technology commercialisation specialist , scientific and legal qualifications, 20 years experience with technology companies, 12 years in life sciences.	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 Milestone Aims

Preliminary results of ferret trials in influenza Publication of HIV Microbicide results	Q1 2011 Q1/2 2011
FDA Pre‐IND meeting for Phase 2b NASH clinical trial Completed deal to expand Travelan territories Commence multi‐site Phase 2b NASH clinical trial Commence Phase 1 clinical trial in influenza (subject to success in ferret trials)	Q1/2 2011 Q2/3 2011 Q3/4 2011 Q4 2011

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Beyond 2011: medium term goals

• Increased revenue through Travelan® sales

• Licensing & partnering deals around NASH and Influenza

• More products in clinical trials from current early pipeline

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Thank you for your support over the year.

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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

Disclosure Statement

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 given.

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Oral Immunotherapy

Passive Immunity (Topical) using bovine antibodies Active Immunity (Cellular) using bovine antibodies

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Active, naturally
Addresses
derived, safe oral
major
immunotherapy
medical
needs
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• An attractive approach to treat autoimmune, infectious, malignant and inflammatory diseases.

• A process using the inherent ability of the gastrointestinal tract's immune system to control unwanted systemic immune responses, by inducing regulation of immune response in a specific manner.

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How it works

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Oral Immunotherapy ‐ Strengths

• 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 toxicity – low risk profile

• Easily tolerated by patients

• Platform for a wide range of diseases

• Oral administration, painless

• Low cost

• Rapid development cycle

Metabolic Syndrome

THE EPIDEMIC OF THE 21[st] CENTURY Metabolic Syndrome is a combination of medical disorders – Fatty liver disease, Type 2 diabetes, Obesity, Hyperlipidemia and Atherosclerosis.

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Obesity – The Rising Epidemic

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Obesity – The Rising Epidemic

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Preclinical Studies in Leptin deficient Ob/Ob Mice

• Controls diabetes in mice following 4 weeks of therapy

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180
160
140
120
100
80
60
40
20
0
Control diabetes Anti-insulin Colostrum enriched
antibodies anti-insulin
antibodies
Glucose (mg%)
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Preclinical Studies in Leptin deficient Ob/Ob Mice

• Reduces liver damage in mice with NASH following 4 weeks of therapy

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800
700
600
500
400
300
200
100
0
Control diabetes Anti-insulin antibodies Colostrum enriched
anti-insulin antibodies
ALT (IU)
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Preclinical Studies in Leptin deficient Ob/Ob Mice

• Decreases serum lipid levels in mice with hyperlipidemia following 4 weeks of therapy

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160
150
140
130
120
110
100
Control diabetes Anti-insulin antibodies Colostrum enriched
anti-insulin antibodies
Triglycerides levels
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Preclinical Studies in Leptin deficient Ob/Ob Mice

• Decreases fat in the liver of mice following 4 weeks of therapy

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100
80
60
40
20
0
Control diabetes Anti-insulin Colostrum enriched
antibodies anti-insulin
antibodies
Decrease hepatic fat (ratio)
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Non‐Alcoholic Steatohepatitis (NASH)

• 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, and 50% of morbidly obese people

• • No approved treatment available

• The United States CDC predicts that more than 25 million Americans may be affected by NASH by 2025

• The demand for off label pharmaceuticals is expected to grow to US$3.1 billion by 2016 – GlobalData Forecast

• The approval of a drug that specifically treats NASH is expected to raise this market estimate considerably

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Non‐alcoholic Fatty Liver (NAFL) Prevalence ‐ USA

• 1/3 of adults in the USA have fatty livers

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A. Mae Diehl, EASL NASH, 2009

NAFL Prevalence ‐ EU

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 of ALT vs. normal

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Bellentani, EASL NASH, 2009

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Mechanisms regulating NASH outcomes poorly understood

Liver cancer

A. Mae Diehl, EASL NASH, 2009

Results of Phase 1/2 Clinical Trial in 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

• promotes regulatory cells and corrects some abnormalities associated with metabolic syndrome

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Administration of IMM 124‐E improved liver enzyme levels

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100.0
100.0
90.0
80.0
80.0
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
55.0
60.0
50.0
50.0
45.0
40.0
40.0
Day 1 Day 30 Day 1 Day 30
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AP levels (u/L) GGT levels (u/L)
ALT levels (u/L)
AST levels (u/L)
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(7/10 Pt. p<0.002)
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Administration of Imm124‐E improved insulin resistance and Type 2 diabetes

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8.0 8.0
7.0
7.0
6.0
6.0
5.0
5.0 4.0
Day 1 Day 30 Day 1 Day 30
1000
500
0
Day 1 Day 30
(9/10 Pt. p<0.001)
HbA1C
FPG (mmol/L)
after
In su lin levels 30 min (p g /ml)
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Administration of Imm124-E improved hyperlipidemia

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6.0
4.0
2.0
Day 1 Day 30
6.0
4.0
2.0
Day 1 Day 30
M/dL)

(
Serum LDL
M/dL)

Cholesterol levels (
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(9/10 Pt. p<0.005)

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Regulatory Pathways

• 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

• larger profit margin

• Advantages of development as a prescribed medical food include: ‐ a reduced time to market

• proper differentiation from other complimentary/alternative medicine products due to therapeutic claims

• a lucrative price can be sought

• establishment of foundations for its introduction as a drug (prior market education

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Next Steps – IMM 124‐E

Milestone Timin g Protocol lannin for Phase II trial Com lete p g p 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 trial (including US centres) Conclude clinical trial Q1/2 2012 Publish clinical trial results Q2/3 2012

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IMM 124‐E Development Program Potential

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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,
IMM 124-E
Market Experience,
Medical
Pharmacovigilence
Food
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Future Applications

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 colostrum enriched with anti hepatitis B virus antibodies

Influenza

• Oral administration of colostrum derived anti‐influenza 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 immunity

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Advantages: Not viral strain specific One treatment for all influenza strains (?)

Colostrum enriched with anti influenza antibodies increases anti‐influenza cellular immunity

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Colostrum enriched with anti hepatitis antibodies suppresses the growth of liver cancer in mice

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0.9
A Control
B Treated 10
0.8  g
C Treated 1  g
0.7
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
Tumor size (mm X 3)
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Summary

• 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 opportunities: Unmet medical needs

• Low manufacturing costs

• Natural product regulated as medical food and/or botanical drug

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Thank you

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Metabolic Syndrome and NASH

What is Metabolic Syndrome?

Metabolic Syndrome is a combination of medical disorders: type II diabetes, fatty liver disease, atherosclerosis, hyperlipidaemia. Metabolic Syndrome increases the risk of cardiovascular disease, type 2 diabetes and non-alcoholic fatty liver disease.

What is Non-alcoholic Steatohepatitis (NASH)?

The current understanding of NASH is that that for the majority of patients it is part of Metabolic Syndrome and is a chronic inflammatory condition. NASH is a more severe form of non-alcoholic fatty liver disease (NAFLD) which resembles alcoholic liver disease, but occurs in people who drink little or no alcohol.

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NASH is one of the most common liver diseases in the western world and is associated with obesity, diabetes and hyperlipidaemia. It is also associated with excess cardiovascular mortality. The major feature in NASH is fat in the liver and associated inflammation and liver damage. NASH is also linked to the development of liver cancer.

NASH is a “hidden killer” as it is frequently asymptomatic in the early stages. Symptoms include fatigue, weight loss, weakness and frequent infections. NASH can be severe and lead to cirrhosis, in which the liver is permanently damaged and scarred and no longer able to function properly. Early stage cirrhosis has similar symptoms to NASH as well as itching, fluid retention in the legs and abdominal pain. Many sufferers of these liver conditions lose functionality in their daily lives and are forced to take considerable time off work before a diagnosis is reached.

Why are Metabolic Syndrome and NASH growing health concerns worldwide?

The incidence of Metabolic Syndrome is steadily rising across the western world. 34% of adults in 2006 had Metabolic Syndrome in the USA, an increase from 29% in1994. According to a new analysis from the Centers for Disease Control and Prevention as many as 1 in 3 adults in the USA could have type 2 diabetes by 2050 if current trends continue. Some studies estimate the prevalence in the USA and Australia to be up to 25% of the population. The prevalence of the syndrome is also increasing in children.

The economic burden of metabolic syndrome is rising rapidly with estimated costs in the USA for type 2 diabetes alone reaching $3.35 trillion by 2020[1] .

Over the past 10 years the incidence of NASH has been steadily rising. Approximately 3-5% of the general population has NASH and it is more prevalent in the obese population with 20% suffering from NASH. Fifteen percent of patients with NASH develop cirrhosis. Ten percent of patients with NASH die from liver failure. The United States National Centers for Disease Control and Prevention predicts that by 2025 more than 25 million Americans may be affected by NASH. The incidence of NASH in Australia is believed to be on par with that in the USA.

Currently, there is no approved pharmaceutical treatment for NASH which represents a major area of unmet medical need. The market for this condition is characterised by “off-label” prescriptions which are scripts for drugs that are approved for other diseases and believed to assist in the treatment of NASH. They have limited effectiveness.

1 The United States of Diabetes: Challenges and Opportunities in the Decade Ahead. United Health Group Inc 2010.

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 estimate considerably.

Immuron’s IMM 124-E shows particular promise as a candidate for treating this unmet medical need.

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Source: Global Data – NASH forecasts