IMUGENE LIMITED — Investor Presentation 2012

Nov 19, 2012

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Melbourne, 20 November 2012 : Imugene (ASX.IMU) has today released an updated investor presentation containing details of its commercialisation strategy for its Linguet drug delivery technology.

This presentation can also be viewed at Imugene’s website which has been updated to reflect the company’s new direction please visit www.imugene.com.

Ends

Enquiries: Kyahn Williamson Buchan Consulting +61 3 9866 4722 kwilliamson@buchanwe.com.au

About Imugene

Imugene Limited (ASX:IMU) is commercialising drug delivery applications based on its novel buccal (drugs administered via the cheek) Linguet™ technology. Linguet™ is a patient friendly and cost effective system used to deliver established pharmaceutical and nutraceutical products.

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

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Imugene: Financial Highlights�

Board & Management� Fabio Pannuti� Executive Chairman� Paul Hopper� Non-Executive Director� Steve Harris� Non-Executive Director� Steve Martin� Head of Development�

Key Statistics (01/11/12)	Key Statistics (01/11/12)
ASX Code	IMU
Current Share Prince	A$0.013
52 week high	A$0.033
52 week low	A$0.007
Shares on issue	343,637,220
Market Capitalisation	A$4,470,000
Cash at 30 Sep 2012	A$1,645,000
Monthly cash burn	A$100,000

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Executive Summary�

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• In July 2012, IMU acquired Lingual Consegna Pty Ltd and it’s 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 and poultry vaccine platform terminated due to lack of commercial interest; and�

• IMU Board appointments of Fabio Pannuti, Steve Harris and Paul Hopper.�

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Linguet™: the opportunity�

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1. Sastry et al Pharm Sci & Tech Today 3: 138-145, 2000 2. Seager J Pharma Pharmacol 50: 375-382, 1998

• Oral medicines market remains the largest proportion of the global pharmaceutical market but does not address the dysphagic market – the 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�

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Linguet™: a platform technology with clear commercial opportunities �

• 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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Linguet™: a technology that is ready to be exploited in a growing market�

• 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�

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 -
Parkinson’s Pain including Anti-
Pectoris�Angina Insomnia� Nausea� disorder, Bipolar Disease, palliative inflammatory Dysfunction�Sexual (Candiasis and Vaginitis�
Epilepsy, care, migraine� disease�
Anxiety, Alzheimer’s 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�

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;�

• EU Approvals allow for strong Rest of the World markets including Middle East.�

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Linguet : Commercialisation Strategy�

• The Linguet product development program should focus upon simple selection criteria as below�

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Linguet™: a clear pathway to commercialisation

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

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Use of a nutrition
(analogue of Vitamin
D) product to
validate
manufacturing and
production of Linguet Specific research
system to cGMP based upon
standards. Resultant optimisation of IP
product can be sold portfolio. Target the
or licensed� use NSAIDS and
Commencement of
Erectile Dysfunction�
own product
development plan�
Development of Linguet™ PLUS
including manufacturing and proof
of concept�
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How will development occur?�

• 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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Linguet™: development plan – key milestones�

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Linguet™: summary�

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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