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IMMUTEP LIMITED Investor Presentation 2009

Apr 20, 2009

65122_rns_2009-04-20_cfa99ed5-c2a7-4d00-8eee-8058bd9c48e4.pdf

Investor Presentation

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PRIMA BIOMED LTD Australian Cancer Treatment Company

Moving Rapidly Towards Commercialisation Company Update Presentation - April 2009

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Cell Therapy – A new paradigm for the treatment of cancer

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Important Notice
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The purpose of the presentation is to provide an update of the business of Prima Biomed Ltd ACN 009 237 889 (ASX:PRR) (Prima). These slides have been prepared as a presentation aid only and the information they contain may require further explanation and/or clarification. Accordingly, these slides and the information they contain should be read in conjunction with past and future announcements made by Prima and should not be relied upon as an independent source of information. Please contact Prima and/or refer to the Company's website for further information.

The views expressed in this presentation contain information derived from publicly available sources that have not been independently verified. No representation or warranty is made as to the accuracy, completeness or reliability of the information. Any forward looking statements in this presentation have been prepared on the basis of a number of assumptions which may prove incorrect and the current intentions, plans, expectations and beliefs about future events are subject to risks, uncertainties and other factors, many of which are outside Prima Biomed Ltd’s control. Important factors that could cause actual results to differ materially from assumptions or expectations expressed or implied in this presentation include known and unknown risks. Because actual results could differ materially to assumptions made and Prima Biomed’s current intentions, plans, expectations and beliefs about the future, you are urged to view all forward looking statements contained in this presentation with caution. This presentation should not be relied on as a recommendation or forecast by Prima Biomed Limited. Nothing in this presentation should be construed as either an offer to sell or a solicitation of an offer to buy or sell shares in any jurisdiction.

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Cell Therapy – A new paradigm for the treatment of cancer

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About Prima Biomed
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Prima BioMed is an ASX listed Australian health care company, focused on cancer immunotherapy and immunology treatment. Its lead product is the CVac™ovarian cancer vaccine treatment . CVac[TM] is a maintenance therapy treatment administered postsurgery and post-chemotherapy to delay relapse and control metastases.

Ovarian cancer has a very high morbidity rate and there is a massive un-met global market for new treatments. Currently there are no ovarian cancer maintenance therapy products available. The US market for such therapies was valued at US$2.1b in 2007 and is expected to total US$3.6b by 2010. This is the market space that CVac™will occupy

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Cell Therapy – A new paradigm for the treatment of cancer

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Investment Highlights
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  • Progressing rapidly to commercialisation of world’s first ovarian cancer vaccine therapy treatment

  • Company has recently secured $12m equity funding facility, which funds commercialisation process

  • In final stages of US FDA IND process

  • Global ovarian cancer treatment market is massive; estimated to be worth US$3.6b in 2010

  • Ovarian cancer has very high morbidity rate and currently there are no maintenance treatment products commercially available

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Cell Therapy – A new paradigm for the treatment of cancer

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Investment Highlights
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  • World class scientific advisory team

  • Will commence Pivotal Clinical Trial with US FDA mid-2009 at world leading Fred Hutchinson Cancer Centre in Seattle, USA, which has 3 Nobel Laureates on staff, then

  • Seek US FDA approval to license the product commercially and begin generating revenue for the Company

  • Have already commenced selected treatment of patients in Australia

  • Pursuing fast-track of commercialisation in other jurisdictions outside US FDA

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Cell Therapy – A new paradigm for the treatment of cancer

Corporate Overview

Issued Capital and Price (20/4/09)

ASX Code: PRR (listed Jun 1988) Shares on issue: 344.7M Share Price: 3.2c 2009 high: 4.0c (@ 16/4/09) 2009 low: 0.05c

2009 low: 0.05c
Market Capitalisation (20/4/09) Share Register (as at 17/9/08)
Mkt. Cap (incl. cash) $11.7M Michael & Lynette Black: 2.46%
A Di Bella Pty Ltd: 1.93%
Top 20 shareholders hold: 22.85%
Total number of shareholders: 1,494
Board of Directors
Mr Ata Gokyildirim Chairman
Mr Martin Rogers Managing Director
Dr Richard Hammel Non-Executive Director

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Cell Therapy – A new paradigm for the treatment of cancer

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US FDA Approvals Process
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  • The US FDA provides the highest hurdle standard globally for the approval of new drug and therapy treatments

  • Approvals process is a detailed and lengthy process, involving clinical trials over 3 phases and other FDA mandated requirements

  • Onerous processed highlighted by the fact the FDA only approved a total of 18 drugs last year

  • US FDA approval process is a major catalyst for Value for Prima

Prima is in the final stages of its commercialisation timeline and will commence its Stage III Pivotal Clinical Trial with the US FDA midyear before seeking FDA approval to licence the product for commercial use

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Prima’s Scientific Team
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Prima has a team of eminent scientific advisers who are leaders in their fields and add major substance to the company’s business model

  • Prof. Ian Frazer

  • Wealth of experience in cancer/oncology and immunology, best known for his work on the development of the world’s first cervical cancer vaccine

  • The US FDA approved cervical cancer vaccine ( Gardasil™) in 2006 and it is now currently available worldwide, manufactured by Merck & Co and distributed in Australia by CSL Ltd

  • His work has transformed treatment of cancer to benefit patients and transform lives

  • – President of Cancer Council, was named Australian of the Year 2006 and recipient of Florey Medal (named in honour of Australian Nobel laureate Howard Florey)

• Dr Bruce Loveland

– Instrumental in Cvac™phase I and IIa trials in Australia

– Expert in human monocyte dendritic cells for cancer immunotherapy

  • Dr Cassian Yee & Dr Heidi Gray

  • Based in the Fred Hutchinson Cancer Centre Seattle, a leading institute with 3 Noble laureates

– Leading Prima with its US strategy and US relationships

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Prima Biomed – FDA Approval Timeline
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Achieved to date...

  • CVac™commenced research in 1996.

  • Phase I trials commenced in 2001. Trails conducted on 14

  • patients with a variety of malignant tumours

  • Phase II trials completed in 2007. Trials conducted on 21 patients with elevated CA125 levels (a key biomarker for disease activity)

  • FDA pre-Investigational New Drug Application (preIND) meeting request complete August 2008. A PreIND meeting is a key milestone in FDA approval process

  • FDA pre-Investigational New Drug Application (preIND) meeting, successfully completed - October 2008

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Prima Biomed – FDA Approval Timeline
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Upcoming...

  • Commence US FDA IND application for CVac™- May 2009

  • US FDA grant of Investigational New Drug Application (IND) for CVac™ovarian cancer treatment - mid-2009. Confirms data, manufacturing and statistics all to FDA standards

  • Pivotal Clinical Trial to commence – mid-2009. Trial to be conducted on total of 340 patients(approx) in 3 tranches

  • FDA grant of Biological Licence Authority (BLA). BLA allows company to commence charging for use of Cvac™

  • Full commercialisation of Cvac™. Licensing or sale to pharmaceutical/drug major

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Demand for CVac™
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  • The global market size of ovarian cancer in 2007 was valued at US$2.1b

  • This is estimated to grow to US$3.6b by 2010

  • Each year 73,000 women are diagnosed with ovarian cancer in the US, Europe, Australia and Japan

  • Of this number only 10-20% survive beyond 5 years

  • A maintenance style treatment like CVac™would be the first of its type in the market and would initially aim to take 10% of this ovarian cancer market

  • A 10% market share equates to approximately US$360m

  • Cvac™has indications across a multitude of cancers

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A Comparison – The Dendreon story
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  • Dendreon is a NASDAQ-listed health care company in the US(NASDAQ:DNDN)

  • The company is developing similar technology to Prima with its core product Provenge, a therapy treatment for prostate cancer

  • Dendreon has just released results of its Phase III trial of Provenge, with extremely positive results

  • Dendreon’s share price has risen from a 52 week low of US$2.55 to US$19.24 (@17/4/09) on the back of the results

  • Company now has a market capitalisation of around US$1.74B

  • The treatment has a similar therapeutic approach to Prima’s CVac™ and paves the way for CVac™’s technology in the ovarian cancer market

The success of Dendreon highlight the major opportunity that Prima Biomed represents for investors

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CVac™- Results to date
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  • In Phase I trials, the treatment generated an impressive immune response in all patients

  • Included two outstanding survival accounts where tumour growth was halted for more than 3 years

  • Results provided a strong lead into phase II trials

  • In Phase II trials, patients already had advanced stage growing ovarian cancers. Treatment consisted of 3 CVac™ injections in a 10 week period, followed by injections every 10 weeks after this to a total of 7 injections

  • Phase II trial results exceeded internal hurdles and have

  • excited the scientific community

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CVac™- Results to date
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Phase II trial Results

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  • Based on an incurable recurrent disease (diagnosed by elevated CA125 marker)

  • CVac[TM] treatment

  • demonstrated stabilisation of CA125;

    • initially for 4mths, then

    • for a further 18mths post further injections of CVac[TM]

Stable disease

4mths

18mths

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CVac™- Results to date
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A success story

More than 2 years after successful treatment of CVac™Rosalie Martin AM (pictured) is living a healthy life today.

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How Cvac™Works
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How Cvac™Works
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How Cvac™Works
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How Cvac™Works
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How Cvac™Works
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Pharmaceutical Sector Market
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  • In 2007, US FDA approved only 18 drugs, down substantially from 53 approved in 1996

  • This lack of new drug approvals plus a glut of blockbuster drugs coming off patents means major pharmaceutical companies are in desperate need of new multi-billion dollar block buster drugs

Sales of recent cancer drugs in 2007

  • CSL / Merck

  • Gardasil US $1.9Bn – Cervical Cancer Vaccine

  • Genentech

  • Herceptin US $1.4Bn – Breast Cancer

  • Avastin US $2.1Bn – Colon Cancer

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Prima’s Other Assets
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  • Prima Biomed has 3 non-core assets that represent significant divestment opportunities

  • Oncomab Pty Ltd (monoclonal antibody for the anti-cancer Cripto-1)

  • Anthron(Trillium Therapeutics Inc.)

  • Panvax Pty Ltd

  • The divestment of each of these assets would contribute significantly to the company’s balance sheet

  • Negotiations in respect of these assets with a number of interested parties are ongoing

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Cell Therapy – A new paradigm for the treatment of cancer