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IMMUTEP LIMITED Investor Presentation 2011

Jun 30, 2011

65122_rns_2011-06-30_11e40bb5-db0c-4d6a-8bd2-557401837288.pdf

Investor Presentation

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PRIMA BIOMED INVESTOR UPDATE

EDITION 4 JULY 2011

Message from the CEO

Welcome to the July issue of the Prima BioMed Investor Update.

As I refl ect on the Company’s progress since the last Investor Update, it gives me a great deal of satisfaction to report on what has been a period of signifi cant growth for Prima.

It also highlights what can be achieved when you have a committed team all pulling in the one direction – as we do at Prima.

But, this is no time to dwell on achievements to date. The second half of the year promises to be an extremely exciting time, as we prepare to commence our key Phase III Clinical Trial for our core program, the CVac[TM] immunotherapy ovarian Prima CEO Martin Rogers with cancer vaccine. Dr Amin Al Amiri, CEO Health Ministry UAE

In this issue of your Investor Update, we provide details of the preparation for our Pivotal Phase III Trial. The trial will be a major undertaking with 800 patients, across multiple sites in Europe, US and Australia.

In preparation for the Phase III trial, we recently achieved another signifi cant milestone, with the successful development of a Potency Assay for the CVac™ vaccine. The Potency Assay helps demonstrate a batch-to-batch consistency of the vaccine.

On the corporate front, the Company has completed a highly successful capital raising, with strong participation from investment funds and also our own loyal shareholders, and I would like to thank all our new and existing shareholders for their support.

Prima BioMed prepares for CVac[TM] Phase III Trial

The Company is excited to report on preparations for the CVac[TM] Phase III Clinical Trial.

The Phase III Trial is the fi nal trial in the development timeline for CVac[TM] . Subject to statistical endpoints being successfully reached, CVac™ will be well positioned to become the world’s fi rst ovarian cancer vaccine therapy treatment. This will open up a new paradigm for the treatment of ovarian cancer patients and oncologists globally.

Patient recruitment for the Phase III Trial for CVac[TM] is due to commence in August. The trial will be conducted on a 800 patient population in a double-blind, placebo-controlled study (randomized 1:1) of CVac™ vs Standard of Care.

The trial is a major undertaking, and will be conducted across multiple high quality medical sites in Europe, US and Australia.

These will include the world renowned Charite University Hospital in Berlin, Bonn University, both in Germany, Stanford Medical Centre in the United States and the Austin Hospital in Melbourne, Australia.

The Phase III Trial is designed to deliver statistically powered endpoints for progression free survival, and also for overall survival.

The objective of the trial is to further confi rm the ability of CVac™ to reduce the instance of relapse in ovarian cancer patients, control the metastases of the cancer and increase the life expectancy of patients. Patient quality of life and patient immunological markers will also be measured.

We eagerly await the commencement of patient recruitment into the trial and look forward to providing further details and updates on the progress of the trial over the coming months.

In this issue of your Investor Update, we include a message from our chairman Lucy Turnbull, AO and also hear from our chief medical offi cer Dr Neil Frazer.

In this Issue

  • Prima prepares for Phase III Trial

Also, we are delighted to report that CVac[TM] has been granted marketing and distribution approval by Dubai Healthcare City in Dubai. This is the fi rst commercial approval of CVac[TM] anywhere in the world, and allows us to commence treatment of ovarian cancer patients in a growing Middle Eastern healthcare market.

I trust you enjoy this issue of your Investor Update.

  • Prima Chairman Lucy Turnbull, AO on investment in medical innovation

  • Major capital raise completed

  • CVac™ granted approval in Dubai

  • Potency Assay developed for CVac™

  • Japanse patent granted for CVac™

  • Dr Neil Frazer at the American Society of Clinical Oncology conference ...and more.

Martin Rogers -

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Prima chairman Lucy Turnbull, AO – the importance of medical innovation

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Since October 2010 I have fulfi lled the role of Chairman of Prima Biomed. Being involved with a company like Prima which could develop the world’s fi rst therapy vaccine to treat ovarian cancer is very exciting. For decades, fi nding a good maintenance therapy for sufferers of ovarian cancer – one of the toughest cancers to diagnose and treat – has eluded medical researchers.

At Prima BioMed, we are working hard to develop a successful treatment for this horrible disease. I believe Prima has a very strong management team with the skills and capacity to drive Prima Biomed’s success.

I am also a passionate believer in the importance of investing in medical innovation which was incubated and developed in Australia: investing in medical innovation is one of the essential keys to a smart future for our nation.

We Australians have been blessed over the past decade with the economic benefi ts of a resources boom fed by China and the rest of Asia’s extraordinary growth. But the greatest asset we have in Australia is our people – and it is our people who undertake research that leads to innovation, and who will benefi t from innovation. We need to invest in them and we need to invest in innovation. As shareholders, you are assisting with this important national priority.

The Australian biotech sector continues to grow and demonstrate its ability to provide medical breakthroughs on a world scale. Companies such as Acrux and Mesoblast (not to mention Prima’s work in the area of cancer immunotherapies) should be congratulated for their foresight, and perseverance – and hopefully their success as well.

The Australian investment market should also be commended for its support of the biotech sector. Investment support, whether it be private or government funding, or from capital markets, is crucial to enabling the high quality of medical innovation we need.

Monash University in Melbourne developed the world’s fi rst IVF program. Without funding this program may not have become a reality. The IVF program has helped many couples have families and each time the program is utilised, a royalty goes back to Monash University which allows it to re-invest in medical advancements.

The head of Prima’s Scientifi c Advisory Board, Professor Ian Frazer, was the creator of the HPV vaccine against cervical cancer. This was the fi rst vaccine designed to prevent a cancer, and is now marketed globally by major pharmas, Merck & Co (as Gardasil) and GlaxoSmithKline (as Cervarix).

These are just two examples of medical innovation achieving breakthrough outcomes, and highlights the need to maintain a focus on medical funding.

Major capital raising completed

for Phase III Trial

The Company recently completed a major capital raising to help fund the Phase III Clinical Trial for CVac[TM] .

We raised a total of $41 million, through a combination of a placement to institutional and sophisticated investors and a share purchase plan to our loyal existing shareholders. The placement raised $21 million and the share purchase plan raised a total of $20 million.

The Company was delighted with the response to our capital raising, and we take it as a strong measure of confi dence in our program to develop CVac[TM] as the world’s fi rst commercially available therapy vaccine to treat ovarian cancer. The level of investor support is particularly pleasing, given the diffi cult conditions currently being experienced in the investment markets.

The placement component was actually expanded from $18 million to $21 million, as a result of the demand from Australian and international investors.

We thank all our new and existing shareholders for their support.

The funds raised will be specifi cally used in the ongoing development of the CVac[TM] vaccine, including the Phase III Clinical Trial which is due to commence patient enrollment in August. Funds will also provide working capital for the Company. The capital raise represents an important milestone for the company, as it provides suffi cient capital to fund the forecast costs of the Phase IIB and Phase III trials.

The issue price for both the placement and the share purchase plan was 28 cents. The placement was managed by Deutsche Bank AG, and Ord Minnett Limited

Best wishes

Lucy Turnbull AO Chairman

Advisory Board Chairman, Professor Ian Frazer

Approval to commercially market CVac[TM] in Dubai

In May the Company achieved a major milestone, with the approval for the marketing and distribution of CVac[TM] by Dubai Healthcare City (DHCC) in Dubai.

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one of major progress and development by the team at Prima, and one that I am most proud of. From the oversubscribed investor support, to the successful development of the Potency Assay for CVac[TM ] it has been a period of strong performance.“ Professor Ian Frazer, Prima BioMed Scientifi c Advisory Board Chairman

This represents the fi rst approval anywhere in the world to make CVac[TM] commercially available.

Subject to required regulatory steps being fi nalised, Prima expects the fi rst sales of CVac[TM] in DHCC to commence before the end of 2011. This will allow the Company to begin treatment of ovarian cancer patients and to generate revenues in a growing Middle Eastern healthcare market.

CVac[TM] will be available in DHCC through a partnership between Prima and The City Hospital in Dubai. The City Hospital is a state-of-the-art, multi-disciplinary modern hospital which provides world-class healthcare.

CVac[TM] - A ‘Focused Cancer Killer’

Prima and The City Hospital have signed a Memorandum of Understanding on the terms and conditions by which CVac[TM] will be available at The City Hospital. A further agreement between the parties will be signed in combination with full regulatory approval for CVac[TM] .

In this issue of your Investor Update we have again included the double-page centre-piece, titled ‘Focused Cancer Killer’, which provides an excellent graphical representation of how the CVac[TM] ovarian cancer vaccine actually works.

In the future, the parties also aim to pursue the potential to extend the application of CVac[TM] in Dubai to other mucin-1 positive tumours – and treat other types of cancer.

It shows a roadmap of the vaccine in action;

from the body’s own key cells being engaged, >> to the cells being selectively harvested from the patient’s blood to make the vaccine, and fi nally >> to the vaccine being administered to the patient and the activated cells targeting the tumour cells

The market for CVac[TM] in the Middle East region is a growing one, with increasing numbers of people gaining access to modern medical treatment options. Access Economics conducted an analysis of IMS Health market data for Prima, and according to its fi ndings the annual global market for oncology chemotherapy is estimated at US$43 billion - of which at least US$517 million is attributable to the Middle East region.

It also provides answers to a number of frequently asked questions on CVac[TM] , and provides some key statistics on ovarian cancer, which help highlight the need for new, alternative treatment options.

In addition to the opportunity to provide CVac[TM] on a commercial scale for the fi rst time, the Company views the approval to market and distribute CVac[TM] in this region as an ideal complement to its core focus of its upcoming Phase III Trial.

Links to additional information on Prima and CVac[TM]

The Prima BioMed company website is set up with a range of different information on the CVac[TM] ovarian cancer therapy vaccine. Below are links to two different items that may be of interest for anyone wanting to know more about how CVac[TM] works and the demand for ovarian cancer treatment options.

Webcast of a recent Experts Conference Call; http://www.investorcalendar.com/IC/CEPage.asp?ID=163542

A short video which provides an overview of how the CVac™ vaccine works in practice; www.primabiomed.com.au/movies/movie_3.php.

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Ovarian cancer Ever since the days of William Coley in represents New York, who pioneered in the year the 1893 the use bacterial injections in an attempt to stimulate the immune system 6th to fi ght cancer, physicians have attempmost ted to harness the awesome power of the commonly human immune system to fi ght tumours. diagnosed Dr. Coley’s patient lived for an additional cancer twenty six years, and his tumour vanished. Such a success should have led to more among and more sophisticated cancer immune women therapies, but physicians chose the route worldwide. of toxic chemotherapy, and harmful radiation to destroy rampaging tumours. Killing fast dividing cells by damaging their DNA seemed swifter than waiting for the body It causes to mount a massive immune system attack more deaths per year than any other cancer of the female reproductive Mucin-1 system Dendritic Cell It is the 5th leading cause of cancer death among women globally Only 3 THE KEY CELLS out of The immune system is primed to fi nd “foreign” proteins and to send killer cells 10 to destroy them. The cells that fi nd the women with foreign protein are antigen presenting ovarian cells, and dendritic cells are a key antigen cancer live presenting cell. The antigen presenting more than cell then picks up some of the bad profi ve years tein, and shows it to T cells. The T cells

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STATISTICS FOCUSED CANCER KILLER

Dying Cancer Cell

on the tumour. In April of 2010, Dendreon Corporation became the fi rst company in history to get Food and Drug Administration approval in the United States for Provenge, a product consisting of patients own cells, primed to target PAP a protein found in high quantities in prostate tumour cells. Giving patients their own cells to boost the immune system proved an effective therapy, and patients lived on average 4.1 months longer than those given a sham treatment. Many new therapies are in development to target tumours, and an Australian company Prima Biomed Ltd is in the lead to develop a therapy for ovarian cancer that uses the patient’s own cells to tackle their tumours.

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Fighting Cancer with a Vaccine Cancer Cell Illustration by

Mucin-1 Customised Dendritic cells targeted to Mucin-1 Dendritic Cell Activated T-Cells Inactive T-Cells

TARGETING THE TUMOUR

VACCINE THERAPY

“foreign” proteins and to send killer cells to destroy them. The cells that fi nd the foreign protein are antigen presenting cells, and dendritic cells are a key antigen presenting cell. The antigen presenting cell then picks up some of the bad protein, and shows it to T cells. The T cells then know what protein to fi nd, and they kill any cell carrying that protein.

Therapy involves selectively harvesting cells from the patient‘s blood that can be matured into dendritic cells. These dendritic cells are then customised to the foreign protein or cancer antigen called mucin-1. The mucin-1 targeted dendritic cells are the treatment or in the case of PrimaBioMed, CVac™.

When the cells are injected back into the patient’s skin, they fi nd T cells and show them the antigen. Activated T cells then hunt down tumour cells displaying Mucin-1 and destroy them.

FREQUENTLY ASKED QUESTIONS

HOW IS CVAC ™ DIFFERENT FROM OTHER IMMUNE THERAPIES FOR CANCER?

In the case of Provenge ®, the vaccine targets prostate cancer only. The cells are injected into a vein, whereas CVac ™ is injected under the skin where it fi nds T cells in large numbers. Other immune therapies may take a sample of the patients tumour, killing it and returning it the patient in the hopes that the body will start treating the tumour as an invader, and attack it. Yet other therapies simply boost the whole immune system, running the risk that other tissues will be damaged by attack by T cells.

WHAT OTHER TUMOURS ARE BEING TARGETED BY VACCINE THERAPY? There are many immune therapies in development for cancers, and many have shown promise during early development. Another company, Merck KgA, is developing a vaccine against Mucin-1, but in their case, they target lung and breast cancer. The vaccine is called Stimuvax ™ and in early studies, patients lived 17 months longer on average than patients receiving a placebo.

WHY DOES THE BODY NOT RECOGNIZE TUMOUR CELLS AS ABNORMAL BEFORE IT GETS THE VACCINE? Tumour cells have escaped the normal patrolling T cells and hide in the background. It is only when the vaccine is given, and many new T cells are recruited to hunt down the tumour, then it can no longer remain undetected with such a focused attack.

DO VACCINES WORK TO PREVENT CANCER?

They may do in the future. However, each vaccine tends to be targeted at one tumour type, and we would all have to receive thousands of vaccines to try to prevent any type of tumour from developing.

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Potency Assay successfully developed

Last month, the Company reported a signifi cant milestone in the development path of CVac™ with the announcement that a Potency Assay for CVac™ had been successfully developed.

The purpose of a Potency Assay is to ensure that a given batch of the vaccine has a pre-defi ned minimum level of potential biological activity that will deliver an expected result. It also helps demonstrate a batch-to-batch consistency of the vaccine.

The Potency Assay provides Prima the opportunity to compare manufacturing of the CVac™ vaccine across its different world-wide facilities, and will lead to a validation tool for regulatory purposes once patient data from the upcoming Phase III Trial are available.

Having this analytical bio-assay to support the determination of CVac™ consistency for the Phase III Trial is a key achievement in the development of CVac™. It is also a key component in the process to establish CVac™ as a pharmaceutical grade product, and will become an integral part of any future registration regulatory package for CVac™.

The successful qualifi cation of the Potency Assay was based on more than 18 months of Research.

Japanese patent awarded for CVac™

In addition to Prima’s focus on its late stage clinical trials for CVac™ in the USA, Europe and Australia, the Company has also been granted a Japanese patent for the CVac™ vaccine.

The patent has been granted by the Japanese Patent Offi ce

to Prima’s subsidiary company, Cancer Vac Pty Ltd. The details of the patent are as follows; The claims secured in patent number 4669930 entitled “Composition including mannose receptor bearing cell and antigen and immunoregulatory mannose receptor-bearing cell population” provide for the manufacture of mannan fusion protein (MFP) conjugated vaccine to a patient’s own dendritic cells.

Prima’s current focus is the development of Cvac[TM] to target the tumour specifi c antigen Mucin-1, an antigen highly expressed on the surface of ovarian cancer cells. The granted patent will allow the conjugation of Mucin-1 as well as other cancer antigens to MFP.

In Japan Orphan Drug Designation provides a period of exclusivity of 10 years, commencing from the marketing approval date. Prima intends to fi le for Orphan Drug Designation in Japan. It has already received Orphan Drug Designation from the US Food and Drug Administration (in September 2010) and European Medicines Evaluation Agency (in June 2010).

Dr Neil Frazer at the American Society of Clinical Oncology conference

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The Company’s Chief Medical Offi cer Dr Neil Frazer recently attended the American Society of Clinical Oncology conference in Chicago in the USA. This is a major event for those in the oncology fi eld of medicine, and is attended by tens of thousands of medical professionals, making it a key platform for Prima to provide an update on the progress of its clinical trials for CVac™.

Dr Frazer made a presentation to the Cooperative Ovarian cancer Group for Immunotherapy (COGI) meeting at the conference, on the current status of CVac™’s clinical trials process.

The COGI meeting was attended by key opinion leaders(KOL) and other important people in the gynecology oncology space, and Dr Frazer’s CVac™ presentation was most timely, given the late stage nature of CVac™’s trial process and the audience in attendance.

The presentation was extremely well received and served to underline Prima’s intention to develop CVac™ as a viable treatment option in the multi billion dollar pharmacy oncology market.

Key opinion leaders in attendance at the COGI meeting included; Dr Jonathan Berek from Stanford University, Dr Paul Sabbatini from Sloan Kettering Memoral Hospital in the US and Dr Michael Quinn from the Royal Women’s Hospital in Melbourne.

Other news in ovarian cancer treatment

In addition to the clinical trials being conducted by Prima BioMed with CVac™, as a treatment option for ovarian cancer patients, other companies are also in trials on different products to form part of a treatment regime for ovarian cancer patients.

Of interest is that Roche has just concluded a successful Phase III Trial for a product called Bevacizumab (or Avastin as it is known commercially). The trial showed that it prolonged progression free survival for women with platinum-sensitive ovarian cancer.

It works by inhibiting the blood supply to the tumor (known as angiogenesis). Prima views the treatment as noncompetitive to CVac™, and potentially complementary to CVac™. The trial results are a major positive for ovarian cancer patients as it provides another option in the treatment regime.

Planned upcoming activity

The Company is entering an extremely active phase in its development plans for CVac™, and also its other clinical programs. Following is an overview of some of the key pieces of upcoming Company activity to look out for.

Event Indicative timeline*
German/European CVac™ manufacturing licence Q3, 2011
Phase IIb Clinical Trial completing enrollment Q3, 2011
Phase III Clinical Trial commence patient recruitment Q3, 2011
Update on Oral HPV vaccine Q4, 2011
Update on Cripto 1 program Q4, 2011
  • The timelines listed above are indicative only, and are designed to provide a guide on timing of key upcoming events. The actual times of delivery of these events is subject to change and may vary depending on a number of internal and external factors.

The above represents some of the major upcoming events scheduled for 2011. For details of all material information releases from Prima, please refer to the Company’s ASX announcements during the course of the year.

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New addition to the Prima team

Prima BioMed – Fast Facts

Listings

With the granting of approval to market CVac[TM] in Dubai, the Company is pleased to welcome Dr Hind Al Saadi to its team, as General Manager of Prima BioMed’s Middle East operations.

Dr Al Saadi will lead the Company’s commercialisation effort for CVac[TM] in Dubai and the Middle East region. Dr Al Saadi is a pharmacist by training, and has nearly 20 years of international industry experience in marketing, sales, distribution, and regulatory affairs. She has previously worked for Baxter Healthcare in New Zealand, as well as Globalpharma and The Center for Healthcare Planning and Quality in Dubai. Commenting on her appointment Dr Al Saadi said:

“I am very pleased to be a part of the Prima BioMed team and bring CVac[TM] to its fi rst commercial market. We look forward to working with our partners at The City Hospital to fi nalize our regulatory steps and commence treatment of cancer patients in the very near future. We see this as a signifi cant advancement for cancer treatment in the Middle East region.”

Australian Securities Exchange (ASX)

ASX Code: PRR

Issued Capital - Ordinary shares 973.8M

(Listed) Options

88.1M (exercise price $0.02 on or before 31 Dec 2011)

Market Capitalisation(fully diluted) A$318.4M (@ 25/06/11)

Cash Position A$56.4M (@ 25/6/11)

Board

Ms Lucy Turnbull, AO Non-executive Chairman

Mr Albert Wong

Non-executive Deputy Chairman

Managing Director and Chief Executive Offi cer

Mr Martin Rogers

For further information please contact:

Mr Martin Rogers

Chief Executive Offi cer Prima BioMed

Dr Neil Frazer Executive Director and Chief Medical Offi cer

Dr Richard Hammel Non-executive Director

Ph: +61 (02) 9276 1242 E: [email protected] W: www.primabiomed.com.au

Forward looking statement

Any forward looking statements in this newsletter 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 any assumptions or expectations expressed or implied in this newsletter include known and unknown risks. As actual results may differ materially to any assumptions made in this newsletter, you are urged to view any forward looking statements contained in this newsletter with caution.This newsletter should not be relied on as a recommendation or forecast by Prima BioMed Limited, and should not be construed as either an offer to sell or a solicitation of an offer to buy or sell shares in any jurisdiction

Senior Management

Ian Bangs

Matthew Lehman Chief Operating Offi cer

Dr Sharron Gargosky Senior Vice President, CVac™ Program

Vanessa Waddell

Business Development and Intellectual Property Manager

Larisa Chisholm Dr Hind Al Saadi

Intellectual Property Manager General Manager, Middle East

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