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Immuron Ltd AGM Information 2012

Nov 25, 2012

35121_rns_2012-11-25_7bd71e5f-0982-4be8-869d-e203c6f5ae61.pdf

AGM Information

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ABN: 80 063 114 045 Level 1 18 Kavanagh Street Southbank, Vic 3006 Tel: +61 3 8648 4530 Fax: +61 3 9686 9460 www.immuron.com

26 November 2012

Chairman’s address to Annual General Meeting 26 November 2012.

Ladies and Gentlemen good morning and welcome to the Immuron AGM. My name is Roger Aston and I am the Chairman of Immuron. I joined the company in May this year and more recently was appointed as the Chairman in October.

Before we get started I would also like to introduce my colleagues and fellow directors on the Board, to my left we have:

Dr Elane Zelcer as Deputy Chairman

Mr Joe Baini the CEO

Mr. Daniel Pollock who recently joined the Board in October this year, Daniel is an internationally experienced lawyer and has significant commercial expertise in new market launches, including the USA. He also has experience in merger and acquisitions, distribution agreements and corporate start-ups. We are looking forward to benefit from his experience.

Dr. Stewart Washer: Joined us in February this year and brings significant biotech experience both by his years in the industry but also through his association with Investment Manager IB Managers.

Graeme Stevens, our Company secretary is also present as is our Auditor, Lisa Harker, a Partner from Price Waterhouse and to whom you may direct Audit related questions at the appropriate time.

We have clearly had substantial change to the Board during the past 12 months and I will talk more about this in a moment, however, I would like to extend my thanks to the directors who have served the company and retired during the course of the year; namely, Professor Colin Chapman, Professor Roy Robins-Brown, and Mr Simon Sallka.

The format of the meeting today will be a brief address by myself, followed by a presentation by the CEO, Joe Baini, and then we will deal with the various resolutions as outlined in the Notice of Meeting.

I refer to the first slide of the presentation which is a chart of the movements in the company’s share price during the past 10 years. Before I agreed to join the Immuron Board I considered this chart along with other information and I was torn between the following thoughts:

1

Firstly

  • What a great opportunity for a turn-around story – the company is clearly unloved by the market;

  • they have a product on the market and a product pipeline that could potentially make this a 50-100 million dollar company;

  • the products have a wonderfully simple manufacturing processes and a simple regulatory framework for approval; and more important

  • the company has enthusiastic interest from Global distributers for generating income.

And my second thought was - HOW COULD IT HAVE GONE SO WRONG!! OR HAVE I MISSED SOMETHING?

There is almost a direct inverse relationship between progress and share price. Because I couldn’t really come up with an answer for how it went so wrong at the time I decided to have a go at the turn-around story and joined the Board.

The key point of course is “can Immuron be turned around to give shareholders a chance to benefit from their investments?” – I think it can because the business is essentially based on good marketable products. We could spend considerable time pointing the finger at what may have gone wrong 3, 5 or 10 years ago but I have found over the years that most shareholders are satisfied with hearing a plan that could deliver value and they are less concerned with the history.

The new Board is committed to delivering the true value of this technology to shareholders and in order to achieve this we will:

  • Together with existing reductions in discretionary spending we will curtail spending through shelving projects that will not yield benefit within 12 months.

  • Sign up a US distributer for Travelan

  • Speed up approvals and launches with our partners

  • Raise additional capital

Out of these four items that I have mentioned, I consider signing a US distribution agreement as the most vital. Although I said earlier I don’t like to look back and point the finger, truth be said, a distribution agreement for Travelan for the US market was signed in 2008 – clearly neither distribution nor sales have been achieved here and the Company is now rectifying this!

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I think one thing that was probably not fully anticipated by Immuron historically were the timelines associated with approval, licensing and launch of new products by third parties; however, let’s not throw the baby out with the bathwater, we are nearly at the finish line, and we need to gather strength and resources to get over the line.

Now, I mentioned a moment ago the need for more capital: The new Board cannot wave a magic wand and put everything right. In this regard there will be a need to raise additional funds.

WHY –

Mainly due to unforseen delays in launching Travelan into the various territories in which we have distribution agreements. An example of this is our Canadian arrangements with Paladin where the initial product launch was anticipated to be in the current quarter which is now anticipated to be in the June 2013 quarter. Regulators, product claims and indications can take significant time to resolve and are out of our control.

We have not yet signed up a US distributer although we are in advanced discussions with 2 parties. The US market can enable Immuron to become largely self- sufficient but it won’t happen overnight; commercial product rollouts can take 12-18 months.

The Company’s strategy for ongoing product development and commercialisation will now be addressed by our CEO in his presentation.

The Annual General Meeting provides shareholders with the opportunity to pose questions to the Board on a number of matters and my experience with small biotech’s, still in the research stages, is that the main question posed is the rate of cash burn, and will you be seeking additional capital from shareholders in the coming months. Although I have addressed those two items previously I am happy to take questions on these and other matters after Joe’s presentation.

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Roger Aston Chairman

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Annual General Meeting 26 November 2012

AGM 2012

STRATEGY FOR TURNAROUND

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MANUFACTURE
TO GMP
NYCOMED
TRAVELAN FDA NASH
LAUNCH AUS IND GRANTED
HARVARD
PALADIN
MUCOSITIS
CANADA
HADASIT
PATENT
ACQUISITION
INFLUENZA
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AGM 2012

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Company Update

AGM 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.

ABOUT

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  • Melbourne based biopharmaceutical company

  • Publicly listed on the Australian Stock Exchange (ASX: IMC)

  • 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 travellers’ diarrhoea

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

  • Rich pipeline: infectious diseases, immune mediated diseases and oncology

AGM 2012

TECHNOLOGY AND PRODUCT HIGHLIGHTS

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Safe Technology – Hyper Immune Colostrum

Current in‐market product sold ~200,000 units with no adverse events reported

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Proven Platform Technology

Travelan launched successfully in Australia as an OTC medication for the treatment of travellers’ diarrhoea

Travelan validates Immuron’s platform

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Phase IIB Clinical Trials for Treating NASH

No currently approved treatment for NASH. IND cleared by FDA for Phase IIB clinical trials

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Developing World’s First Oral Dual‐Acting Preventive to Fight Influenza

Positive results to date in gold standard animal model

AGM 2012

HIGHLIGHTS 2012

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• Board changes: commercial focus, manufacturing • Capital raising

• Travelan • 9 expanded territories in Asia • Paladin Labs submitted to Health Canada for approval • Commenced US licencing discussions • NASH/Fatty Liver • IND accepted by FDA • ASH study to be funded by US NIH • Management: increased depth • R&D • Influenza in final ferrets trial • C.Diff commenced preclinical with Monash • Other programs on hold

AGM 2012

BOARD CHANGES

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The Board:

Dr Roger Aston (Chairman from Oct 2012) Dr Elane Zelcer (Sep 2010) Dr Stewart Washer (Feb 2012) Mr Daniel Pollock (Oct 2012) Mr Joe Baini (May 2012)

  • Extensive commercial experience

  • Strong manufacturing acumen

  • Biotechnology experience

  • Capital raising

  • Drug development

  • Licencing and business development track record

AGM 2012

MANAGEMENT ‐ INCREASED DEPTH

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Quality Manager:

  • contracted to correct and complete all necessary production processes in preparation for scale‐up

IP:

  • patent applications continue to progress

Project Manager:

  • co‐ordinates all elements across the operations of the company, including production, manufacturing and R&D

AGM 2012

MANAGEMENT TEAM

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Joe Baini, CEO & Managing Director

  • 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

Prof Yaron Ilan, Medical Director/Dr. Grant Rawlin Consultant CSO

  • Director, Department of Medicine, Hadassah Medical Center ‐ Hebrew University, Jerusalem. Scientist /clinician in internal medicine, immunology, liver diseases

  • Research expertise with Immuron’s platform technology

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

Dr. Gerhard Rank, Production Project Manager

  • Projects background, contracted for production & manufacturing purposes

AGM 2012

CAPITAL RAISING

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  • Engaged Patersons Securities, one of Australia’s leading brokerage firm

  • Led a $1m capital raising

  • fully subscribed

  • Share purchase plan

  • opportunity for existing shareholders to participate

  • raised additional $442,050

  • Bonus options included, with an expiry date of April 2015

  • Patersons provided Research Report, 13 November 2012

AGM 2012

TRAVELAN – EXPANDING TERRITORIES

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Expanded Asian territories:

20% global travel destination in 2011

  • Cambodia

  • China

  • Hong Kong

  • Laos

  • Malaysia

  • Singapore

  • Taiwan

  • Thailand

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  • Vietnam

  • Canada/Paladin: submission to Health Canada early this year; approval expected shortly with formal launch H1 2013

  • Latin America/Paladin: territories being examined

  • US: licensing discussions underway

AGM 2012

Travelan – Product on the Market

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  • Antibodies directed against bacteria that cause travellers’ diarrhoea

  • TGA approved, sales in Australia (volume growth of 112% over previous financial year)

  • Unique preventative oral immune therapeutic (with lower claims due to listing as dietary supplement)

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

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

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

  • Additional global markets being aggressively pursued

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Infection
AGM 2012
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Passive immunity prevents infection

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www.travelan.com.au

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AGM 2012

NASH PROGRESS

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FDA:

  • IND approval January 2012

  • Supportive and helpful feedback

  • Further “visibility” on Phase III NASH endpoints

Large pharmaceutical companies:

  • Met and presented to several

  • Positive responses from all

  • General consensus for validation study

Pursuing dual strategy

  1. Public funding incl US National Institutes of Health and other government funds

  2. Seeking to secure validation data once funding available via US Travelan licence

AGM 2012

NASH – PATHWAY WITH REDUCED RISK

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Immuron’s De-Risked
Traditional NCE
Platform
Pre‐clinical Pre‐clinical
Phase I clinical
Phase I clinical
OR
OTC
Consumer
Phase II clinical
Phase II clinical
OR
OTC
Consumer
Phase III clinical Phase III clinical
OR
Medical
Prescribed Prescribed food
drug on drug on
market market
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AGM 2012

ALCOHOLIC STEATOHEPATITIS ‐ ASH

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  • Cause & progression may differ from NASH but:

  • Histologically identical

  • Both characterized by fatty deposits on the liver, inflammation and liver deterioration

  • Treatment: Same for both conditions

  • Funding: Principal investigator for Immuron NASH Phase IIb clinical trial awarded a National Institutes of Health (NIH) grant to conduct human clinical trial for ASH

  • Outcomes: expected to support NASH product development

  • ASH treatment: part of Immuron’s patent portfolio

AGM 2012

R&D PROGRAM

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Influenza in final ferrets trial

  • Using latest California 7 strain

  • Study commenced November 5

  • Supported by Federal Government Grants

C. Difficile

  • Preclinical study with Monash University

  • Supported by Federal Government Grant

Harvard Medical School

  • Radiation Therapy

  • Product supply only for investigator driven study

Hadassah Medical Center

  • Hepatic Carcinoma, Hepatic Encephalitis, Mucositis, Neurological disorders

  • On hold until funds available

AGM 2012

PRODUCT PIPELINE

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AGM 2012

2013 IMPERATIVES

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US License
Agreement
Capital Raising
Immediate revenue
stream
NASH validation
Further validation of
study/trials commence
Immuron’s technology &
Hadassah’s collaboration
value
= future pipeline
Operations
Opens doors to other
significant territories
AGM 2012
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Summary

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  • 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

www.immuron.com www.travelan.com.au

AGM 2012