Immuron Ltd — AGM Information 2011

Nov 29, 2011

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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.

• Presentation by Joe Baini, Chief Executive Officer of Immuron.

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

In respect of the resolutions put to the meeting, resolutions 3 to 6 inclusive were withdrawn. These resolutions related to the issue of options to Directors. The remaining resolutions put to the meeting were all passed with the proxy voting details being as follows.

Resolution For Against Open Usable 1. Remuneration report 18,115,172 5,602,376 - 2. Re-election of Director – Roy Robins-Browne 25,644,950 3,473,530 2,523,586 7. Approval of prior issue of securities 28,178,360 921,370 2,523,586	Abstain 74,000 24,000 42,750	Excluded 5,855,932 - -

Yours Faithfully

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Graeme Stevens Company Secretary

1

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Chairman’s address 2011 Annual General Meeting 30 November 2011

G ood morning ladies a n d gentlemen and wel c ome to Immuron’s 2011 Annual G eneral M e eting.

L et me commence the meeting by introducin g you to th e Board Me m bers and m embers o f our m anageme n t team.

• Joi n ing me at the front ar e the other non-execu t ive directo r s, Profess o r Roy Rob i ns-Browne, Si m on Sallka a nd Elane Z elcer.

• Members of o u r manage m ent team a t the front table are o u r CEO, Jo e Baini, an d our CFO an d Company Secretary G raeme St e vens.

• I also acknowledge that i n the audie n ce are A m os Meltzer, our Vice p resident B u siness De v elopment, Grant Ra w lin our Chi e f Scientific Officer an d Dr Nina W ebster, Director of Co m mercialis a tion and I n tellectual P roperty.

• I also acknowledge our v i sitors from Israel, Pro f essor Yaron Ilan, the C ompany’s Medical Dir e ctor, and D r Einat Zi s man, the C EO of Had a sit Resea r ch Service s & Develo p ment Li m ited, the C o mpany’s l a rgest shar e holder.

• I also welcom e Mrs Lisa H arker, the Company’ s auditor a n d other re p resentativ e s from PW C .

The forma t for today’ s meeting i s as follows:

• Ch a irman’s report. I would prefer an y question s arising fro m my repo r t be raised at the co n clusion of t he formal p art of the m eeting.

• Th e formal part of the m e eting as s e t out in the notice of m eeting for w arded to all sh a reholders.

• De t ailed pres e ntations b y the Comp a ny’s CEO, Joe Baini a nd Profes s or Yaron Ilan on the op e rational a n d scientific activities t h at have ta k en place s i nce the la s t AGM and what we a r e planning for in the imme d iate future.

Chairman’s report

In my message to sh a reholders c ontained i n the share h older upd a te which w as forward e d to all sharehold e rs in June of this yea r , I indicate d that it wa s with great pleasure t h at Immuro n welcome d the appointment of J o e Baini as t he Compa n y’s new C h ief Executive Officer i n January o f this year . Joe came w ith considerable exp e rience in t h e pharma c eutical ind u stry, inclu d ing consid e rable experienc e in produc t commerci a lisation th r ough partn e ring and li c ensing arr a ngements.

• Prior to Jo e joining th e Compan y he was in v olved in a s sisting the Board in s e tting its str a tegic direction f o r the comi n g 12 to 24 months. T h e major c o mponents o f the forw a rd strateg y were:  Global expa n sion of the markets for Travelan.  Licence the d evelopme n t and com m ercialisati o n of the C o mpany’s N ASH prod u ct to a major p h armaceuti c al company.

• C o mmence h uman trial s for the pr e vention of infection fr o m the influ e nza virus.

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 involved very long discussions at all hours of the day and night. At various stages there were three competing international pharmaceutical companies seeking the right to distribute Travelan in Canada. However, in the view of the Directors, the final agreement reached with Paladin Labs is the appropriate deal for Immuron at this point of time. Whilst the other two competing companies are disappointed with the final decision they have clearly indicated that they wish to continue discussions in respect of other territories.

I will leave it to Joe in his presentation to provide you with the full details of the Paladin transaction as Joe and his team have lived and breathed this transaction for the past two plus months.

On your behalf, and especially on behalf of the Board, I would like to express the appreciation of us all for the long and unusual hours spent by Joe and Amos Meltzer in finalising the transaction with Paladin Labs Inc.

Although the major thrust of our commercialisation program has been on obtaining global markets for Travelan, the company has also made considerable progress on R&D activities involving influenza and NASH.

• The results of a successful phase 1(a) clinical trial with the company’s NASH product resulted in an application to the USA’s Federal Drug Administration (FDA) for a pre-IND meeting in July, which was followed up with an IND application lodged with the FDA in November. The company is awaiting the FDA’s comments on the application, which we should receive in the coming 10 days.

• There is ongoing R&D into the company’s possible product for influenza, with recent trials involving the ferret ‘model’ which continues to show promise.

Further details in respect of the above two activities will be provided in both Joe’s and Yaron’s presentations.

In the company’s various Press Releases over the past 12 months or so, you will have seen reference to the company’s platform technology.

Most of you will know that out technology centers on immunising dairy cattle and using the polyclonal antibodies produced for the treatment of an increasing number of diseases.

Our technology may appear to be deceptively simple but it has come up with two pleasant surprises along the way:

• The company appears to have developed (and has patented) a way of influencing chronic inflammation in the body

• Work from a collaboration between Immuron and Melbourne University has revealed that the cattle have a different antibody reaction to an important part of Human Immunodeficiency virus than we expected.

What do these surprises/discoveries mean?

• The first relates to an antibody ‘set’ we have created that reacts very strongly with Endotoxin or Lipopolysaccharide (LPS). LPS is a diverse group of molecules that are part of the building blocks of the cell wall of gram negative bacteria, with different bacteria making different LPS molecules. These various LPS molecules can trigger key immune cells and cause all sorts of trouble, and the exciting development is that the antibodies made by immunising dairy cattle with just one type of LPS are able to react with every one of the different LPS molecules we have pitted against these antibodies. That was a surprise, and it means we have a broad tool against LPS as a group rather than just one particular LPS.

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 diseases such as diverse as Hepatitis B and Hepatitis C, Hepatic encephalopathy (a liver related brain disease) and of course, NASH. There are many other diseases, and an anti-LPS function may be an important way in which our antibody set works. The range of targets is frankly bewildering and is growing as more researchers look at LPS and its role in diseases that are of interest to them.

As a company, Immuron is trying to ‘own’ as much of this LPS-mediated disease territory as it can: the market for fatty liver disease is large at $4.4 billion but that is the very tip of what we appear to have uncovered: a controlling mechanism of many chronic and common inflammatory diseases

• The second surprise/discovery relates to the collaborative research I mentioned a short while ago; that the cattle have a different antibody reaction to an important part of Human Immunodeficiency virus than was expected. This means that the immune system of dairy cattle seems to respond differently to what is expected: that there is a much broader response than expected, which means that the antibodies generated have a much broader range of targets than expected. This has very important implications for the hyper-immune colostrum antibodies being developed by Immuron; it certainly broadens the company’s platform technology.

Before we proceed to the formal part of the meeting I wish to comment on the recent capital raising conducted through the non-renounceable rights issue. Given the state of the overall share market and the pricing of the offer in difficult market conditions, the Board is very appreciative of all shareholders, whether they are existing or new shareholders, in contributing to the issue that closed on 28 October. As announced at the closure of the issue there was a considerable shortfall in the take up under the offer and as indicated in the offer document the Directors have a three month time frame in which to place the shortfall together with the attaching options.

I would also like to indicate that during the past six months both management and the Board have been very conscious of the cash burn rate and have ensured that only expenditures vital to the expansion of the market for our Travelan product and essential research activities are being undertaken. A number of our early research projects, such as C/Diff and HIV work are being conducted under various agreements with the universities that are in receipt of grant monies. Joe will comment on each of these points during his presentation.

Again before proceeding to the formal part of the meeting I would like to repeat myself and on behalf of the Board express our thanks to the total management team and all R&D collaborators for their ongoing positive contributions over the past year.

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Colin Chapman Chairman

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Annual General Meeting

30 November 2011

2011

CONFIDENTIAL – Immuron

1

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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

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 set out on pages 6 to 13 in the Annual Report”.

Please note that section 250R (3) of the Corporations Act 2011 (Cth) provides that the vote on the resolution is advisory only and does not bind the Directors or the Company.

3

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Resolution 1

For	Against	Open‐ Usable	Open‐ Unusable	Abstain	Excluded
18,115,172	5,602,376	-	2,018,586	74,000	5,855,932

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RESOLUTION 2 ‐ RE‐ELECTION OF DIRECTOR

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 approve the re‐ election of Professor Roy Robins‐Browne as a Director of the Company, who is retiring by rotation, and being eligible, offers himself for re‐election.“

5

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Resolution 2

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Open‐ Open‐
For Against Usable Unusable Abstain Excluded
- -
25,644,950 3,473,530 2,523,586 24,000
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RESOLUTION 7 – APPROVAL OF PRIOR ISSUE OF SECURITIES TO SOPHISTICATED OR PROFESSIONAL INVESTORS

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 the Company approve and ratify the prior issue of 7,380,000 fully paid shares and 2,460,460 options in the Company to professional or sophisticated investors on the terms and conditions set out in the Explanatory Statement accompanying this Notice of Meeting.”

7

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Resolution 7

For	Against	Open‐ Usable	Open‐ Unusable	Abstain	Excluded
28,178,360	921,370	2,523,586	‐	42,750	‐

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Oral immunotherapy using antibodies

Joe Baini, CEO

30 November 2011

Confidential ‐ Immuron

November 2011

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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

November 2011

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November 2011 CONFIDENTIAL – Immuron 11

VISION for Immuron’s success

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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 profitable by end of 2014 using the following key strategies:

1. Expand and leverage the commercial availability in Australia of Travelan® globally, especially into large and significant markets

2. License its development program for the critical unmet medical need, NASH (Non Alcoholic Steatohepatitis) to a major pharmaceutical company

3. Commence early human trials for the globally prevalent diseases Influenza and HIV, as well as for specialty and high value therapeutic markets that currently .

have little or no treatment options such as Clostridium Difficile

Confidential ‐ Immuron

November 2011

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2011 Highlights

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• 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 Program IM‐255 toward first human trial

• Granted key patent for Influenza product

• Progress HIV prevention program

• Appointed Dr. Arun Sanyal to lead Phase 2 trial for NASH/Fatty Liver

• Travelan confirmed to affect O104 E.Coli which had killed over 90 people in an European outbreak

Confidential ‐ Immuron

November 2011

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2011 Highlights

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• 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

• Others to follow....

• NASH/Fatty Liver product CDAs in place with multinational pharmaceutical companies

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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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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November 2011

Key Alliance with Global Pharmaceutical Company

Aggressive distribution in place with new partners (including Nycomed) expected to play a key role in global commercialization Confidential ‐ Immuron

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Summary of cash outlays for past 18 months

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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
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2010 2011 2012/13 2013/14
Travelan 1 [st] 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 partners Commence Ph. 3
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November 2011 Confidential ‐ Immuron 19

SECTION II

KEY STRATEGIES AND TARGETS

Confidential ‐ Immuron

November 2011

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Adding Value/Decreasing Risk

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$/€
Commercial
Risk
Commercialisation
Development
Immuron Nycomed
Meda
Paladin Labs
Others to follow
Research
Hadassah
U Melbourne
Monash U
TIME
November 2011 Confidential ‐ Immuron 21
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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November 2011 Confidential ‐ Immuron 22

Key Strategies

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I

• •Aggressively increase revenue through continuing ramp-up of global partners/sales of Travelan and reduce COGs

II

III

• •Driving development of our revolutionary influenza product ( IMM-255 ) towards a commercial-ready product in 2-3 years.

• NASH : accelerating development & license opportunities. Significant unmet medical need. FDA IND submission completed. Blockbuster potential

IV

• •Leverage Hadassah, Uni of Melbourne & Monash Uni partnerships to progress products into clinical trials from pipeline

Confidential ‐ Immuron

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TRAVELAN MARKET EXPANSION

Confidential ‐ Immuron

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Travellers’ Diarrhoea

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• 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 ost commonly caused by Enterotoxigenic E. Coli ( ETEC ) bacteria

• Up to 70% of all cases of TD are caused by ETEC

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November 2011

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Travelan – Immuron’s product in the market

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• 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 Nycomed in Aust/NZ since Apr 2010

• Partnered with Meda Consumer Healthcare in the US

• Now partnered with Paladin Labs

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• Additional global markets being aggressively pursued

• Major territories aiming to launch 2012‐13

Confidential ‐ Immuron

November 2011

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November 2011

www.travelan.com.au

Confidential ‐ Immuron

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INFLUENZA (IMM 255) ‐ ACCELERATE

2013/14

Confidential ‐ Immuron

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Influenza

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• Direct medical costs in US – $10.4B pa*

• 3‐5M cases pa of severe illness

• Over 500,000 deaths worldwide pa

• • 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

November 2011 Confidential ‐ Immuron

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IMM‐255 – Clinical Development Roadmap

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Initial trials were very effective in identifying
protective action of Immuron’s antibodies
against infection by the H1N1 human virus
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Following the above positive results
now
additional ferret trials were approved –
in final stages
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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

• Binds and inhibits influenza

• infection

Boosts the immune system to fight influenza

• Decrease of suppressor cells

• Augment anti influenza cellular immunity

Not viral strain specific – product alteration not needed annually

Confidential ‐ Immuron

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IMM‐255 – Immuron’s Solution to Influenza

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Aiming for world’s first OTC
dual‐acting orally
administered product;
1) mucosal protection
against influenza virus &
2) 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 ORAL therapy – potentially 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

Confidential ‐ Immuron

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Commercial Strategy

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Q1/2 2012 Q1 2013 Q1 2014
Preparation of
Commercial
vaccine seed stock
production of anti‐
for commercial
influenza HIC
production
Carry out further
Commence 1st clinical
clinical trials (if Product Launch
trial
needed)
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NASH (IMM 124E) – FILE IND

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The NASH/Fatty Liver Dilemma

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“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 market relatively quickly and at low cost compared with alternative strategies.” Gordon Capital Research Report March 2011

“Global Data expects the NASH market to grow at 8.4% from US$1.8 billion in 2009 to $3.2 billion by 2016.” Alpha Securities Research Report September 2011

• “...unmet medical need; the disease of the 21[st] Century. An epidemic in the making.”

Professor Arun Sanyal, recent President of “American Association for the Study Liver Diseases”

Confidential ‐ Immuron

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NASH – a major epidemic of the 21[st] Century

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National Center for Infectious Diseases 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

November 2011

Confidential ‐ Immuron

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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

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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

Confidential ‐ Immuron

November 2011

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IMM‐124E – Highlights and Next Steps

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Immuron is developing a therapy for NASH/Fatty
Liver disease utilizing HIC
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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 Phase 2b trial will be conducted
over six sites in Israel, the US and Australia
with patients on treatment for six months
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Confidential ‐ Immuron

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SECTION III

THE ROAD MAP

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November 2011

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Key Strategies

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I

•Aggressively increase revenue through continuing ramp-up of global partners/sales of Travelan and reduce COGs

II

• •Driving development of our 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 IND submitted and on hold. Blockbuster potential

• •Leverage Hadassah, University of Melbourne & Monash Uni partnerships to progress products into clinical trials from pipeline

Confidential ‐ Immuron

November 2011

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2010 2011 2012/13 2013/14
Travelan 1 [st] 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 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

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

Amos Meltzer , VP Business Development

• Experienced life sciences technology commercialisation specialist , a scientist & lawyer , formerly with Compugen Ltd

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 Ltd, with science, law and business qualifications, including an MBA

November 2011

Confidential ‐ Immuron

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Immuron’s Leadership: Board

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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 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

Confidential ‐ Immuron

November 2011

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IMMURON 2011 and beyond

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FLU NASH PIPELINE

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Confidential ‐ Immuron

November 2011

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Summary

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Thank You

www.immuron.com

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www.travelan.com.au

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November 2011

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PRESENTATION BY Prof. YARON ILAN

CONFIDENTIAL – Immuron

June 2011

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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

December 2011

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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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Passive Immunity (Local) using bovine antibodies

Addresses major medical Active immunity targets (Cellular) triggered by oral bioactives

Active naturally-derived and safe oral immunotherapy

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Metabolic Syndrome: The Epidemic of the 21[st] Century

Metabolic Syndrome is a combination of:

• Type 2 diabetes: above 9% of the population

• Fatty liver disease: 30% of the population

• Hyperlipidemia

• Atherosclerosis

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The Global Rise in Obesity

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Non‐alcoholic Fatty Liver Disease (NAFLD) Prevalence ‐ USA

• 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

52 A. Mae Diehl, EASL NASH, 2009

Non‐alcoholic Steatohepatitis

The most common liver disease in the western world

Liver cancer

53 A. Mae Diehl, EASL NASH, 2009

Non‐alcoholic Steatohepatitis (NASH)

• 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

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Obesity = chronic inflammation

• Obesity is characterized by chronic activation of inflammatory pathways in peripheral tissues.

Hotamisligil GS et al. Nutrient sensing and inflammation in metabolic diseases. Nature Reviews Immunology 8, 923‐934 | doi:10.1038/nri2449

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The Product

Oral Immunotherapy Oral administration of naturally derived IMM‐124‐E from colostrum as a means for treating the metabolic syndrome

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Oral Immunotherapy

An active that uses the inherent process ability of the GI tract's immune to control system unwanted systemic immune responses by: • Preventing bacterial translocation

• Inducing regulatory T cells

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How Does It Work?

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Target organs
• Pancreas
• Adipose tissue
• Liver
Oral administration • Brain
Presented to the immune
system in the bowel •
Improvement of the
immune imbalance
•
Altered regulatory cells
and prevention
of bacterial overgrowth
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0
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Non‐alcoholic steatohepatitis (NASH) – IMM 124‐E

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Oral Administration of IMM124‐E in Patients with Metabolic Syndrome:

• A safe product

• Improves liver enzymes

• Improves diabetes

• Improves hyperlipidemia

• Promotes regulatory cells and corrects some of the abnormalities associated with the disease

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Administration of IMM 124‐E improved liver enzymes levels

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(7/10 Pt. p<0.002) 61
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Administration of IMM 124‐E improved insulin resistance & diabetes

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1000
800
600
400
200
0
Day 1 Day 30
(9/10 Pt. p<0.001) 62
30 min (pg/ml)
Insulin levels after
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Administration of IMM 124‐E improved hyperlipidemia

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(9/10 Pt. p<0.005)
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American Liver Association Immuron Investigator Meeting – held in November 2011

• Dr. Arun Sanyal (AS)

Virginia Commonwealth University The Alfred Hospital Melbourne Northwestern University Baylor College of Medicine Cleveland Clinic Foundation

• Assoc. Professor Stuart Roberts (SR)

• Dr Mary Rinella (MR)

• Dr. John Vierling (JV)

• Dr. Arthur McCullough (AMc)

Influenza – IMM 255

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Oral administration of colostrum derived anti‐ influenza antibodies with adjuvants improves the anti‐influenza immune response

Oral antibodies

Colostrum derived adjuvants

Passive immunity

Active immunity Decrease of suppressor cells Augmentation of anti‐influenza cellular immunity

ADVANTAGES:

• Not viral strain specific

• One treatment for all influenza strains (?)

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

Control Treated 10  g Treated 1  g

The Opportunity for Immuron

• 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.

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REGULATORY PATHWAYS MOVING FORWARD IN PARALLEL

Food Medical Food Botanical Supplement Drug

THE ADVANTAGES FOR DEVELOPING FOOD SUPPLEMENT, MEDICAL FOOD, AND A DRUG IN PARALLEL

1.A prospective safety data 2.A proof of efficacy that support the development of a drug

3.Ongoing income

TWO DIFFERENT INDICATIONS

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Phase I
2010 Phase IIA
2012
Phase IIB
2013 Medical Food
2014
Phase III / Pivotal No. 1
2017
Fatty Liver
Phase III / Pivotal No. 2
2018
Botanical Drug
NASH
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CLINICAL DEVELOPMENT PLAN – following Immuron’s full R&D Plan

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I II III IV
• • • •
NASH Phase II Influenza Alzheimer’s HCV
• •
Hepatic ADHA
Encephalopathy
•
C. Diff
•
HIV
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I II III IV
• • • •
NASH Phase II Influenza Alzheimer’s HCV
• •
Hepatic ADHA
Encephalopathy
•
C. Diff
•
HIV
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Summary

• 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 toxicity

• Easily tolerated by patients

• Rapid development cycle

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

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Thank you

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