cerbera as my heading stated i was posting the buy rec from...

cerbera as my heading stated i was posting the buy rec from kinetic securities so thats what i posted and didnt forget anything.i provided a link to read the whole thing but if you need it heres the whole lot just for you.your sounding a bit like someone sour that they have missed out on something.


Prima BioMed Ltd
Overview
Recommendation: Long Term Speculative Buy
Investment: Prima Biomed Ltd
ASX Code: PRR
Market Cap: $24.6m
12 Month Performance: +1300%
Technical Note: The stock price has been finding support at the 50%
retracement level of the recent trading range. On Friday the share
price pushed off from this level, the stock is very favourably
positioned to move higher in the future.
About the investment
Prima Biomed’s lead product CVac™ ovarian cancer vaccine treatment, if successful will
become a second-line and maintenance based therapy to existing ovarian cancer treatments.
Currently, there is only one proven treatment for Ovarian cancer—Taxol, should patients
relapse (which often occurs within a short time frame) this leaves medical oncologists with no
choice but to treat patients with another round of Taxol. This is poor medical practice, but
there is no alternative and this is where CVac™ is used as a second-line and maintenance
based therapy.
The need
Each year 318,000 women are diagnosed with ovarian cancer and 75,000 women are
diagnosed in developed markets (within countries where patients can afford medical
treatment) with ovarian cancer in the US, Europe, Australia and Japan alone. Of these 75,000
women, only 10% - 20% survive beyond 5yrs.
The potential
By 2010 the global chemotherapeutic ovarian cancer treatment market is estimated to be
worth US$3.6b. Prima Biomed aims to capture conservatively 10% of this market or
US$360m. This doesn’t include ongoing maintenance use of the vaccine or a predicted
preference of the non toxic benefits of CVac™ versus the side effects of chemotherapy
(nausea, hair loss etc).
Contact Details
Web:
www.kineticsecurities.com
Email:
[email protected]
Head Office:
Kinetic Securities Pty Ltd
Lvl 9, 23-25 O’Connell St
Sydney, NSW, Australia
©Kinetic Securities 9/05/2009 2 of 9
Currently the market cap of Prima Biomed is only $24.6m (the cancer vaccine peer for
prostate cancer Dendreon (DNDN.NSD) is US$2b plus), should the company be successful
with CVac™ then there is significant upside potential for this investment.
Insight - US FDA approval of drugs has declined from 53 in 1996 to 18 in 2007 leaving a
glut of blockbuster drugs coming off patents in the following years. Major pharmaceutical
companies are in desperate need of new multi-billion dollar block buster drugs. This means,
Prima Biomed could become a takeover target.
Of recent the Obama administration has established a new FDA commissioner, Margaret
Hamburg and a new associate commissioner Joshua Sharfstein along with an increased
budget for the FDA. This change of board is positive for Prima as it allows a faster and more
proactive drug approval process.
Investment Vehicles
• Direct investment through the ASX (Code: PRR)
• Company listed options expiring 31st Dec 2011 with a strike of $0.02 (Code: PRRO)
How To Invest
Contact Kinetic Securities on 1300 306 114 (Sydney office) or 1300 664 045 (Gold Coast
office)
Investment Information
About CVac™
CVac™ is intended to be a second line maintenance based therapy vaccine to ovarian cancer.
The promising factor about CVac™ is the approach taken to attack tumour cells—the current
approach for treating ovarian cancer includes surgery, chemotherapy and radiation whereas
CVac™ uses the patient’s own immune system to fight tumour cancers. This new approach
excites the scientific and medical community. For this reason Prima has established a worldclass
following of medical professionals that are taking an active interest and role in helping
with the development and commercialisation of this drug.
The CVac™ treatment is a 6 day process which starts by collecting the patient’s blood,
separating dendritic cells, multiply these cells in a cell therapy laboratory and are then
activated. Once this process is complete, these cells are then injected back into the patient to
assist the immune system in the production of mucin-1 cells which attack the tumours.
Recently there has been positive results in phase I trials where all 14 patients generated an
immune response halting tumour growth for more than 3 years. Phase II trials are said to
have exceeded internal hurdles and have excited the scientific community.
©Kinetic Securities 9/05/2009 3 of 9
Meet Rosalie Martin
More than 2 years after successful treatment of CVac™,
Rosalie is living a healthy life completely free of cancer
today.
Remember that currently only 10% - 20% of women
survive beyond five years - currently. Ovarian cancer is an
insidious and painful disease with no current treatment
available. The topic of ovarian cancer is close to most
people that either know someone or are related to someone
that suffers from this debilitating and terminal illness.
The vaccine creates hope and considerably improves the
quality of life for CVac™ patients by boosting their immune
system.
How does Cvac™ work
Dendritic cell therapy is currently being utilised in Prima’s CVac™ program, a completed
Phase II clinical trial in ovarian cancer.
To learn more about how this process works, view this short movie from Prima;
http://www.primabiomed.com.au/images/PrimaBioMed_web.mov
The future of Prima Biomed Ltd
The company has recently secured $12m to advance the commercialisation of CVac™.
Currently Prima Biomed is in the final stages of its commercialisation timeline and will
commence its stage IIb/III pivotal clinical trial with the US FDA mid year before seeking FDA
approval to licence the product for commercial use.
Once licensed for commercial use Prima Biomed can begin tapping the potential US$3.6b
market for ovarian cancer.
When you consider that this treatment may also be applied to other solid tumour cancers
with high levels of mucin-1 target, the market size potential of CVac™ rises 5 or 10 times this
US$360m figure. Pancreatic, breast, lung and kidney solid tumour cancers are
characerstically high in the target mucin-1 protein.
This scalability and safety profile of CVac™ is a key feature of the treatment which in our
view makes it an attractive target for a large pharmaceutical company.
Other Prima Biomed investments
Prima Biomed has three other non-core assets:
• Oncomab Pty Ltd (monoclonal antibody for the anti-cancer Cripto-1), 100% ownership
• Anthron (Trillium Therapeutics Inc), 7% stake worth approx AUD$3m
• Panvax Pty Ltd, 100% ownership
©Kinetic Securities 9/05/2009 4 of 9
The company is currently in negotiations with interested parties to divest these assets which
could contribute significantly to the company’s balance sheet.
Investing in Prima Biomed
There are two avenues to invest in Prima BioMed.
1. Purchase shares in the company on the Australian Stock Exchange (Code: PRR). The stock
last traded at $0.07 (8th of May 2009)
2. Purchase company listed options which expire on the 31st of December 2011 with a strike
price of $0.02
Considering the potential long term nature of this investment, it is recommended investors
opt for direct share investment.
The Prima Story So Far
There are two components to the recent share price movements in Prima Biomed share price.
Firstly, the company announced on March 11 that it had secured a $12 million equity draw
down facility from Fortrend to support registration trials of CVac™. The net effect of this
arrangement is that it has enabled Prima to approach other potential investors on a more
confident basis, demonstrating that a key risk with the company (funding) is essentially
underwritten.
Secondly, and perhaps much more significant for Prima, has been the massive increase in
Dendreon's share price, which increased by 702% in the same period. Like Prima, Dendreon
has been developing a cancer immune-therapy, named Provenge, but targeted at prostate
cancer. Dendreon said that its treatment increased overall survival times in a just completed
512 patient Phase III study, at the urology conference in New York.
Dendreon was confident enough to say that Provenge "significantly prolongs survival".
It would appear that the result is the validation sought for many years by immunotherapy
developers that cancer vaccines not only stabilize disease but increase survival. This is very
bullish for Prima. Prima has to its advantage Orphan Drug Designation for ovarian cancer
which means it will be fast tracked through the FDA and have a 7 year patent extension in US
and 10 year patent extension in Europe.
Until recent board and management changes at Prima with the appointment of Martin Rogers
and Ata Gokyildirim, Prima Biomed was a company in a parlous condition lacking direction
and cash. Now it is focused and financed to take advantage of the multibillion dollar oncology
drug market.
©Kinetic Securities 9/05/2009 5 of 9
Phase IIb/III Clinical Trial Plan for Cvac™
Prima Biomed has made significant progress towards filing an Investigational New Drug
application for CVac™ with the FDA. The company has been guided by Professor Ian
Frazer from the University of Queensland, who is noted for his co-invention with Jian
Zhou of the cervical cancer vaccine Gardasil (Merck/CSL). Frazer has provided, along with
several other interested parties, in-kind support for the next stages of clinical development
of CVac™. Other members of the Prima scientific team include Dr Bruce Loveland, who
was involved with the Phase I and Phase II trials of CVac™ and Dr Cassian Yee and Dr Heidi
Gray from the Fred Hutchinson Cancer Research Center in Seattle.
Interestingly Prima Biomed now looks set to follow positively in the path of Dendreon and
benefit from the questions posed to Dendreon by the FDA regarding manufacturing of
autologous immunotherapy’s, with a clearer pathway mapped out. Prima will also be using
the same manufacturer that Dendreon has used.
Management
Mr Martin Rogers (CEO)
Director since 16 November 2007
Mr Rogers, has a science and corporate consultancy background with a focus on the
incubation of business ideas and the establishment of both internal ventures and external
partnerships, including finance concept origination for the likes of Macquarie Bank. Mr Roger’s
role with Prima Biomed will be to strengthen business development, its investor relations and
to assist the Company with seeking corporate opportunities. Mr. Rogers holds a bachelor of
Chemical Engineering and a bachelor of Computer Science from the University of NSW.
Mr Ata Gokyildirim (Non-Executive Chairman of the Board)
Director since 20 December 2007
Mr Gokyildirim has extensive merchant banking experience and recently Mr Gokyildirim
founded a marketing and distribution business for the pharmaceutical industry in Turkey and
the Middle East. He has vast experience in helping restructure companies in need and deliver
substantial shareholder returns from these reforms.
Richard Hammel, Ph.D (Non-Executive Director)
Director since 24 January 2005
Dr. Hammel is the founding partner with ProPharma International Partners in San Francisco,
USA. ProPharma is a pharmaceutical/biotechnology consulting firm providing a range of
business, financial and product development services. He previously held senior management
positions with Connetics Corporation (Vice President for Commercial Development), Matrix
Pharmaceuticals Inc. (Vice President Business Development, Sales and Marketing) and held
several positions at Glaxo Inc (Director, Professional Affairs; Director, New Business
Development; and Director, Marketing Services). Dr Hammel is widely recognised in the US,
Europe and Japan for his extensive 26 years expertise in the commercialisation and licensing
in emerging and developing biotechnology companies.
©Kinetic Securities 9/05/2009 6 of 9
Prof. Ian Frazer (Scientific Adviser)
Adviser since 19 March 2008
Professor Ian Frazer is a leading cancer/oncology and immunology expert. His wealth of
experience includes his well known work on the development of the world’s first cervical
cancer vaccine Gardasil™ in 2006 which is now available worldwide, manufactured by Merck
& Co and distributed in Australia by CSL Ltd. Professor Ian Frazer is the president of the
Cancer Council, was named Australian of the Year 2006, and is a recipient of the Florey Medal
named in honour of Australian Nobel laureate Howard Florey.
Financials
Income Statement 2008 2007 2006 2005
Revenue $57,940 $156,122 $3,876,910 $1,068,386
Research & Development ‐$70,146 ‐$974,404 ‐$2,759,775 ‐$3,654,903
Corporate Administration ‐$1,362,404 ‐$1,503,626 ‐$2,373,210 ‐$1,921,888
Net Loss ‐$1,887,378 ‐$3,139,034 ‐$4,357,874 ‐$7,145,520
Balance Sheet 2008 2007 2006 2005
Total Current Assets $1,181,255 $704,281 $3,391,930 $7,817,981
Total Non‐Current Assets $1,639,995 $3,653,996 $3,967,994 $1,313,231
Total Assets $2,821,250 $4,358,277 $7,359,924 $9,131,212
Total Current Liabilities $187,817 $261,091 $1,026,317 $774,543
Total Non‐Current Liabilities ‐ $17,116 $17,009 $13,568
Total Liabilities $187,817 $278,207 $1,043,326 $788,111
Net Assets $2,633,433 $4,080,070 $6,316,598 $8,343,101
Cash Flow Statement 2008 2007 2006 2005
Net Operating Cash Flows ‐$1,554,336 ‐$3,329,338 ‐$5,051,642 ‐$4,734,789
Net Investing Cash Flows ‐$4,571 ‐$9,417 $749,914 ‐$8,687
Net Financing Cash Flows $1,985,386 $799,186 $19,925 ‐$546,294
Net Increase / (Decrease) in Cash $426,479 ‐$2,539,569 ‐$4,321,653 $4,748,230
Cash and Cash Equivalents Year End $1,098,259 $671,780 $3,211,349 $7,533,002
©Kinetic Securities 9/05/2009 7 of 9
Dendreon Corp
The Dendreon Story
Dendreon (DNDN)—a NASDAQ listed health care company is developing a similar technology
to Prima but with a focus on prostate cancer. Dendreon has paved the way for this
technology through the US Food and Drug Administration which will assist with slipstreaming
the process of CVac™ through US FDA trials.
More importantly Dendreon recently released results of its phase III trial of Provenge with
extremely positive results which resulted in the share price rallying 966% from low to high,
DNDN is currently trading at USD$19.24 a share!
Prima BioMed - holding 50% retrace level
After rallying 1300% in the last 12 months, the price of PRR is resting around the 50% level
of this trading range. Often stocks will form major lows on this 50% level. If PRR can
continue to consolidate and hold above $0.06 in the near future, then the stock could be
positioned to move significantly higher in the future. PRR is approximately 2 – 3 years
behind DNDN, with some positive trials and a FDA approval, PRR has huge potential upside.
©Kinetic Securities 9/05/2009 8 of 9
Locations
Sydney Office:
Level 9
Permanent Trustee House
23-25 O’Connell Street
Sydney NSW 2000 Australia
Tel: +61 2 9295 9800
Fax: +61 2 9295 9890
Aust Toll Free: 1300 306 114
NZ Toll Free: 0800 507 015
Gold Coast Office:
Level 19
50 Cavill Avenue
Surfers Paradise QLD 4217 Australia
Tel: +61 7 5562 9413
Fax: +61 7 5562 9490
Aust Toll Free: 1300 664 045
NZ Toll Free: 0800 023 567
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DISCLOSURE: Kinetic Securities Pty Ltd and/or its directors, associates, employees or representatives may not effect a
transaction upon its or their own account in the investments referred to in this report or any related investment until the expiry
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©Kinetic Securities 9/05/20