extraordinary general meeting presentations · share purchase plan – this is based on their...

31 May 2012

The Manager The Company Announcement Office Australian Stock Exchange Sydney NSW 2000 Dear Sir Extraordinary General Meeting Presentations Attached are the following presentations to be made to the Extraordinary General Meeting on 31 May 2012:

• Chairman's address by Professor Colin Chapman; and • presentation by Joe Baini, Chief Executive Officer of Immuron Limited.

Yours Faithfully

Graeme Stevens Company Secretary

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Professor Colin Chapman’s Address

When we last convened on 30 November 2011, at our AGM, we confirmed that the company would be addressing 7 key points. Briefly these were:

1. Review the structure of the Board 2. Control spend 3. Continue the globalisation of Travelan 4. Discussions underway with potential partners for NASH/fatty liver 5. Manage product supply chain 6. Continued development of product pipeline, including influenza 7. Continue to develop and strengthen the intellectual property strategy

This progress is reflected in recent announcements that relate to our NASH/fatty liver program, the commercialisation of Travelan, and to a revamped, more commercially focused board with expertise in our industry. The Executive Director will address each of these in more detail. It is significant that two well respected industry experts have joined the board, based on their belief in the company and the company’s management. It is also significant that one of Australia’s eminent brokers has underwritten our share purchase plan – this is based on their recognition of the company’s opportunities and its strong management. The $1M capital raising led by Patersons, was fully subscribed. The subsequent Share Purchase Plan is providing the opportunity for all shareholders to participate if they wish. Patersons is fully underwriting this SPP. Our progress has included and continues to include substantial work to build a robust regulatory infrastructure as we prepare for imminent registrations, and in the longer term, product registrations. In addition, we continue to improve the logistics of our production in preparation for anticipated greater volumes

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Immuron is very fortunate to have an experienced CEO who has worked in pharmaceutical companies and has a track record in building and growing successful pharmaceutical products and businesses. There are only a few companies in our industry with such an executive at the helm. In the Board’s view we have reached a significant crossroads

• We have strong and well credentialed management. • We have validated the technology beyond doubt, with Travelan now

licensed into many markets. • This gives the Company confidence with the NASH opportunity and our

pipeline. • This is further endorsed by the Company’s ability to attract directors of the

caliber of Stewart and Roger. • The Board recognizes that there has been some pressure on the share price

in recent months. We do not believe it is reflective of the progress Immuron has made to date. In fact the Directors are of the view that the current price represents good buying value.

• The Company has the support of Patersons Securities.

To conclude my address, I’d like to say that the SPP and Placement that are the subject of this meeting, place the Company in a strong financial position. We believe Immuron is entering into an exciting period of growth in Travelan and further development of our proprietary technology with a focus on the anticipated NASH trial.

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May 2012 Non‐Confidential ‐Immuron

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Immuron’s Progress Report, May 2012

31 May 2012

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FORWARD LOOKING STATEMENTThis 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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Table of ContentF

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Company Overview

Section I

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About Immuron

• Publically listed (ASX: IMC) Melbourne based biopharmaceutical company

• Flexible platform supports multiple regulatory routes, including consumer products: quicker to market.

• Focuses on Oral Immunotherapy using dairy‐derived antibodies

• Superior safety profile products makes it possible to accelerate product development

• First product on market: Travelan, for travelers’ diarrhea

• Cleared by the FDA: IND for Phase 2b double‐blind placebo controlled multi‐centre dose ranging study

• Rich pipeline over a broad range of indications: infectious diseases, immune mediated diseases and oncology F

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Board Objectives

Section II

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Progress Report – May 2012

Company Objectives – for 2012

1. Review of board structure

2. Control of expenditure

3. Continue globalisation of Travelan

4. Complete IND; commence discussions for NASH Phase 2b

5. Continued development of product pipeline – incl influenza

6. Continuity of product supply chain

7. Continue to develop & strengthen IP strategyFor

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Board Restructure

Internal Review

• Commercialisation focus

• Strong biotechnology investment focus

• High profile, solid track record, well networked members sought

• Experienced in development of medicines

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Control of Expenditure

Board and Management Control

• Cash flow reviews

• Reduced/cut expenditure in specific areas

• Reduction of days worked by staff

• Staff/board paid partly via options/shares

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Travelan Globalisation

• Paladin Labs Inc• Distribution partner for Canada, Latin America, Africa • $2M + up to $115M in milestone payments• Filing commenced with Health Canada

• IntegraMed Asia (Thailand) Co Ltd• Thailand, Vietnam, Cambodia, Laos, Hong Kong• 44M travellers + 190M residents• Regulatory process commenced

• Ziwell Medical (S) Pte Ltd• Singapore, Malaysia, Brunei• 34M travellers + 33M residents• Regulatory process commenced

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NASH Development

Discussions underway

• IND cleared by FDA in January 2012• Multi‐national pharmaceutical companies in discussion• Strategic investors showing strong interest• Clinical sites primed for recruitment

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Product pipeline

R&D rich with possibilities

• Platform technology creates opportunities• Immuron seeks the best opportunities for return on

investment• Influenza remains a priority to commence human trials• C. diff to be driven through Monash Uni as Immuron

seeks an accelerated program• Others including hepatic carcinoma & hepatic

encephalopathy are being reviewed

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Product Supply Chain

Supply being ramped

• Countries placing orders ‐ planning & forecasting become critical

• Cost of production & manufacturing remains a focus• Supply of finished goods provides opportunity to grow

revenue through margins• Synlait Milk Ltd (NZ) to add great value, increase output

and reduce costs

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Intellectual Property

Strengthen Core IP Monopoly

• Patents cover aspects production & use of our products for prevention &/or treatment of diseases; including NASH & influenza

• Patent monopolies are complemented by • regulatory hurdles that we have overcome; and • trade secret advantages

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Milestones Achieved in Last 6 Months

FDA cleared Phase 2b IND for IMM‐124E for NASH/Fatty Liver ‐blockbuster potential

FDA provided further clarity/visibility on Phase III NASH endpoints

Completed license agreement and strategic investment with Paladin Labs for Travelan (Canada, Latin America, Africa)

Board of Directors restructured ‐ aligned with bio‐pharmaceutical & commercial focus

Recent licence for Travelan with IntegraMed & Ziwell (7 Asian countries)

Agreement with Synlait announced – reflects substantially improved COGs & gross marginsF

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Product Pipeline

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

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, Department 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 commercialisation specialist, scientist & lawyer, formerly Compugen

Ltd

Dr. Nina Webster, Director Commercialisation & IP • Successful biotech and pharmaceutical executive formerly with Acrux

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The Board of Directors

Professor Colin Chapman, Chairman and Non‐executive Director•Emeritus professor and Immediate Past Dean, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University; key role in establishment of Acrux

Dr Elane Zelcer, Non‐executive Director•Extensive senior executive, board and commercialisation experience in biotechnology & multinational companies, universities & government‐related roles

Dr Stewart Washer, Non‐executive Director•Significant CEO and board experience in medical and agricultural innovation companies

Dr. Roger Aston, Non‐executive Director•Extensive board & CEO experience in manufacturing, clinical development and commercialisation in pharmaceutical, banking and stockbroking sectors

Joe Baini, Executive Director and CEO•Experienced pharmaceutical executive; former GM for Gilead Sciences & non‐exec chairman for Avexa Ltd

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Platform Technology

Section III

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Mode of ActionF

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Hyper‐Immune Colostrum (HIC) ‐ Advantages

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 & toxicity cause issues for patients

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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NASH – IND Cleared for Phase 2b

Section IV

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Non‐Alcoholic Steatohepatitis (NASH)

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

NASH: the most severe form of liver injury within non‐alcoholic fatty liver disease (NAFLD)

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NASH – A Major Epidemic of the 21st Century

NCID : >25m Americans will have NASH by 2025

No approved treatment for NASH or Fatty Liver Disease globally

Demand for off‐label use expected to be US$3.2bn at 2016

Immuron’s solution for NASH could be on the market in 3‐4 years

Very Positive Results for phase 1/2a Clinical Trials

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IMM‐124E – Immuron’s Rx Solution to NASH

Phase I/IIa trials for IMM‐124E showed trending of all

parameters in the right direction and only after 30 days of treatment.

Orally administrated treatment

Results to date very positive:SafeTrending of all parameters in the desirable directionAddresses inflammatory mechanism

IND for Phase IIB clinical cleared

Intending to negotiate fast track development

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26IMM‐124E

Immuron Value Proposition – IMM‐124E

TIME

Typical commercial risk

IMM‐124E riskProven technologyProven safety profileClear development pathwayPatient availability

Typical commercial value of the average therapeutic

IMM‐124E valueBlockbuster indicationNo competitionLarge unmet need

Pre‐clinical Ph I Ph II Ph III NDA Market

IMM‐124E: Accelerated time to market

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Our Flagship – Travelan

Section V

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Traveller's Diarrhoea

• Travelers’ Diarrhea: the most common health condition facing travellers

• Up to 50% of people who travel to developing countries will contract the disease

• Typically characterized by stomach cramps, diarrhea, fever and nausea

• The most common bacteria that causes this condition is Enterotoxigenic E. Coli (ETEC)

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Travelan – Immuron’s Product on the Market

• Unique oral preventative against bacteria that cause travellers’diarrhoea

• TGA approved, sales in Australia

• Seeking steep sales growth. Global market ~US$650m+ pa

• Exclusively licensed to Nycomed in Aust/NZ since Apr 2010

• Exclusively licensed to Paladin for Canada, LatAm and Sub‐Saharan Africa

• With Meda’s consent, seeking stronger consumer partner for USA

• Additional global markets being aggressively pursuedInfection

Infection prevented through passive immunityF

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www.travelan.com.auF

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Immuron’s Pipeline ‐ Influenza

Section VI

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Influenza

• Direct medical costs in US – $10.4B pa*• 3‐5m cases pa of severe illness • Over 500,000 deaths worldwide pa• Influenza is the 8th leading cause of American deaths

*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

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

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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IMM‐255 – Immuron’s Solution to Influenza

Aiming for world’s first dual‐acting orally

administered product; mucosal protection

against influenza virus and boosting immunity

against influenza

Antibodies designed to cope with the rapidly changing strains of flu as virus evolves (advantage of polyclonal antibodies)

IMM 255 is safe

IMM 255 is 100% natural

Convenience of an easily accessible OTC therapy – not requiring a doctor visit or prescription

Market size: unlike vaccines, usually reserved for the elderly and immune compromised, IMM 255’s potential market is the entire population

IMM 255 is patent protected

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R&D Programs

Monash University: Clostridium difficile infection

Harvard Medical School: Radiation Therapy

University of Melbourne: Influenza

Hadassah Medical School:Hepatic Carcinoma; Hepatic Encephalitis; Mucositis; and a range of neurological disorders

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Summary

Section VIII

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12‐18 Months Outcomes

$6 million investment:

•Complete NASH Phase 2b clinical trial – ready to licence

• Commence Global/Territorial license/distribution discussions with interested Pharma cos.

• Pipeline products progressed• First human trial for Influenza• Clostridium difficile prevention and treatment• Hepatic carcinoma treatment• Cancer & radiation treatments• OthersF

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Investment Summary

Safe & proven technology platformRich product pipelineTravelan approved & 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)

2nd 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

3rd 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

• Oral Immunotherapy Using Antibodies

• Strong Intellectual Property

• Tight Collaboration with Key Research Partners

• Key Alliance with Global Pharmaceutical Company

• Proven, Novel Technology – Hyper Immune Colostrum (HIC)

• Innovation Commercialized Product: Travelan

• Phase IIB Clinical Trials for a Treatment for NASH

• Developing World’s First Oral Preventive to Fight Influenza

Thank You

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