IMUGENE LIMITED - Investor Presentation 2012

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INVESTOR PRESENTATION

A New Direction with Linguet™� M aking good drugs better a commercial reality

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Imugene: Overview�
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Board & Management� Graham Dowland� Chairman� Dr Warwick Lamb� Managing Director� Roger Steinepreis� Non-Executive Director�

Key Statistics (08/05/12)	Key Statistics (08/05/12)
ASX Code	IMU
Current Share Prince	A$0.018
52 week high	A$0.044
52 week low	A$0.008
Shares on issue	143,637,220

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The Linguet™ Acquisition�
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Imugene will issue 100 million ordinary shares to Consegna Limited in consideration for the acquisition.�
Capital raising of $1 million through the issue of 100 million ordinary shares at 1 cent per share to clients of Forrest Capital and CPS Securities.�
Issue of 50 million adviser options, at an issue price of 0.01 cent. The options will be unlisted and exercisable at 2 cents on or before 31 December 2015.�

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Executive Summary�
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Subject to shareholder approval, Imugene will acquire Lingual Consegna Pty Ltd including its Intellectual Property and knowhow for Linguet™;�
Linguet™ is an oral buccal drug delivery technology that will be developed and commercialised with the support of the Linguet scientific team including Dr Nicholas Ede PhD, Steve Martin and Rod Tomlinson;�
Pig vaccine opportunities to be explored by Dr Warwick Lamb;�
IMU Board appointment of Fabio Pannuti, current Managing Director of Consegna.

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Linguet™: a platform technology with clear commercial opportunities �
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Linguet is targeted at those drugs that:�
Show poor oral bioavailability (e.g. progesterone, testosterone);�
Require rapid onset of action (e.g. analgesics, erectile dysfunction products);�
Cause gastro-intestinal irritation (e.g. NSAIDs, bisphosphonates & statins);�
Are degraded in the gastro-intestinal tract (GIT) and require dose compensation (e.g. hormone replacement formulations); and�

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Are adversely affected by high first-pass metabolism in the liver and thus rely on massive over dosing in order to deliver the correct therapeutic outcome (e.g. pain relief).�

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One of the opportunities for Linguet™�
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• Oral medicines market remains the largest proportion of the global pharmaceutical market but does not address the dysphagic market – patients with reduced ability to swallow medicines:�

35% of the general population have difficulty in swallowing medicines[1�]
30-40% of elderly institutionalised patients have difficulty in swallowing as well as 18-22% of patients in long-term care[1�]
Up to 50% of the population suffer from difficulty in the of swallowing tablets[2�]

• Ageing populations with increased reliance on “Care in the Community” provisions continues to drive the need for low-cost solutions to enhance patient compliance within the home setting.�

1. Sastry et al Pharm Sci & Tech Today 3: 138-145, 2000

2. Seager J Pharma Pharmacol 50: 375-382, 1998

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Linguet™: a technology that is ready to be exploited in a growing market�
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Linguet is the basis for a family of Intellectual Property patents and patent applications around the ability to:�
formulate; �
develop; and �
obtain regulatory approval for alternative drug delivery systems.

• The system has wide applicability:�

  - buccal;�

  - sub-lingual and vaginal delivery of drugs; and �

  - anywhere where there is a mucosal surface.

Linguet can be altered to meet targeted therapeutic requirements:�
- fast release;�
- sustained release;�
- taste masking; and�
- muco-adhesive.
Linguet uses standard pharmaceutical manufacturing equipment delivering low
COGS.�

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Linguet™: a targeted technology with wide applications�
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Linguet™ is able to be used in a wide range of therapeutic applications enabling a rich hunting ground to create world-class products that meet the commercial need. � Such breadth of choice allows for a de-risked business model.

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CNS Vaginal
Psychiatric conditions- Infections
conditions -
Parkinsonʼs Pain including Anti-
Pectoris�Angina Insomnia� Nausea� disorder, Bipolar Disease, palliative inflammatory Dysfunction�Sexual (Candiasis and Vaginitis�
Epilepsy, care, migraine� disease�
Anxiety, Alzheimerʼs Bacterial
Schizophrenia� Disease� Vaginosis)�
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Linguet™: a different business model to generate revenues�
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Linguet™: a targeted EU strategy�
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The identified Linguet™ projects will be developed based on the EU Regulatory environment:�

EU Regulatory environment is world class;�
Flexible regulatory environment to develop generic equivalents or generic plus products compared to other world markets;�
Diverse markets allow for increased opportunities;�
EU regulatory pathway significantly more cost effective than the US market;�
EU regulatory pathway is more predictable than US market in time to launch;�
Reduced risk for litigation in the EU than the US; and�
EU Approvals allow for strong Rest of the World markets including Middle East.�

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Linguet™: a clear pathway to commercialisation
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Linguet has a clear commercialisation strategy to deliver short term revenues & significant long term growth:�

Use of a nutrition product to validate manufacturing and production of Lingue t system to cGMP standards. Resultant Specific research product can be sold based upon or licensed� optimisation of IP portfolio. Target the use NSAIDS� Commencement of own product development plan� Development of Linguet™ PLUS including manufacturing and proof of concept�

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How will development occur?�
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The development program will use outsource partners to minimise internal overheads enabling maximum effort in generating products and revenues:�
Use of known development and manufacturing sites;�
Links with academic institutions to help advise on technology pathways;�
Use of established and proven medical and regulatory pathways with partners who have done it before; and�
Targeting simple and known molecules where the market is fully known.�
Use of proven rapid screening of formulations to reduce timescales and potential failure rates:�
Microcalorimetry stability screening for formulations, drug/excipient and drug/packaging interactions; and�
In-vitro porcine trans mucosal studies allowing for greater predictability for in-vitro pharmacokinetic and bioequivalence studies.�

• Use of proven manufacturing techniques:�

No requirement for investment in specialised equipment for manufacturing; and�
Use of Generally Regarded As Safe (GRAS) excipients.�

• Low cost development:�

Established molecules with lower requirements for toxicology and preclinical studies; and�
Relatively short time from lab to patient giving significant commercial advantage.�

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The experience and the knowhow comes with Linguet™�
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Imugene will be supported with a scientific team that have �� eep & successful formulation experience across multiple generics, super generics and nutritional product re-launchers.�

Dr Nick Ede (Melbourne based)�

Dr Ede has a record of successfully evolving research concepts to commercial products and processes. He has over 25 years experience in drug discovery and international business development gained at Chiron, EqiTX, Mimotopes and Adistem. He holds a PhD from Monash University and Grad. Cert. in Innovation from Melbourne Business School, and has published over 50 scientific papers and patents.�

Mr Steve Martin (UK based)�

Steve Martin is a commercial pharmacist in the UK with a track record in delivering established molecules from proof of concept through to regulatory approval. Working for both his own companies and also for differing international pharmaceutical companies, he has been involved in over 80 healthcare and pharmaceutical developments. These developments have led to successful regulatory approvals for clinical nutrition, medical devices and pharmaceutical products. He specializes in the rapid commercialization of products using a variety of different drug delivery systems, from sustained release, Buccal delivery and solid oral dose delivery dosage forms. He has also undertaken consultancy with many firms on different aspects of pharmaceutical strategy, including generic defense, lifecycle management and restructuring new product development pipelines.�

Rod Tomlinson (Melbourne based)�

Rod Tomlinson is a qualified industrial chemist who was Chief Chemist of Smith + Nephew Australia and post this was head of research for Ensign Laboratories. He then started his own business, Soltec Group that he sold in 1996 to FH Faulding & Co Limited for more than $20million. Rod continued to advise Faulding on drug delivery systems prior to retiring in 1998. He is currently the non-executive Chairman of Consegna Group Limited.�

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Linguet™: development plan – key milestones�
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Linguet™: summary�
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The Linguet™ business plan has positive advantages with a simple strategy to retain the knowhow and intellectual property to provide solutions to current market opportunities:�

Use of known molecules that have known and proven regulatory routes;�
Low cost development with rapid and identifiable commercialisation programs;�
Fully expandable product development pipeline;�
Opportunities within the Nutritional, Over the Counter and Prescription Medicine markets;�
Second-generation pipeline already identified;�
Ability to use multiple manufacturing sites to ensure rapid development program; and�
Varied commercialisation business models available.�

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AI assistant

IMUGENE LIMITED Investor Presentation 2012

65124_rns_2012-05-09_b32e4df0-19de-4b52-a8e7-69913ed1ea13.pdf

INVESTOR PRESENTATION

• The system has wide applicability:�

• Use of proven manufacturing techniques:�

• Low cost development:�

Dr Nick Ede (Melbourne based)�

Mr Steve Martin (UK based)�

Rod Tomlinson (Melbourne based)�

AI assistant

IMUGENE LIMITED — Investor Presentation 2012

65124_rns_2012-05-09_b32e4df0-19de-4b52-a8e7-69913ed1ea13.pdf

INVESTOR PRESENTATION

• The system has wide applicability:�

• Use of proven manufacturing techniques:�

• Low cost development:�

Dr Nick Ede (Melbourne based)�

Mr Steve Martin (UK based)�

Rod Tomlinson (Melbourne based)�

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IMUGENE LIMITED Investor Presentation 2012