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Conference Call regarding the report Q1 2005
Monday, May 9, 2005
- Strong financial position with more than EUR 70 million in cash
reserves after completion of IPO and exercise of greenshoe
- Net loss of EUR 5.0 million - up 7,5 % compared to first quarter of
2004 - driven by advancement of late stage product pipeline
- Latest achievement: Collaboration for development of new Malaria
vaccine with Naval Medical Research Center (US Navy)
- Preparations for Phase III trials in Japanese Encephalitis on
track for start in 2005
Vienna (Austria), May 9, 2005 - Vaccine company Intercell AG (Vienna
Stock Exchange, VSE: ICLL) today announced its financial results for
the first quarter of 2005. Intercells net loss for the first quarter
of 2005 was EUR 5.0 million compared to EUR 4.7 million in the first
quarter of 2004. The increase is a result of advanced spending in the
Companys late stage vaccine development programs. Revenues, which in
the past have been fluctuating over the quarters of a year, were EUR
0.4 million for the first three months of 2005 compared to EUR 0.3
million in the same period of 2004. Operating expenses for the first
quarter increased from EUR 5.1 million in 2004 to EUR 5.6 million in
2005 due to an increase in research and development costs, which was
partly offset by a decrease in sales, general and administration
costs and other operating expenses.
The Companys liquid reserves at the end of the first quarter 2005
were EUR 70.9 million. The successful IPO in February 2005, including
the exercise of the greenshoe, resulted in net proceeds of EUR 46.0
"The strong cash position will allow us to drive our Japanese
Encephalitis vaccine through Phase III development and market
registration and to advance our Hepatitis C therapeutic vaccine as
well as our early stage product pipeline," states Werner Lanthaler,
CFO of Intercell. "Spending for programs is in line with expectations
and we expect stronger revenue generation from collaborations and
licensing during the year."
A Cooperative Research and Development Agreement was signed with the
US Naval Medical Research Center (NMRC) for the use of Intercell´s
IC31TM Immunizer technology as adjuvant in the NMRCs Malaria vaccine
program. Under the Agreement, Intercells adjuvant IC31TM is combined
with NMRCs Malaria vaccine antigens and tested in Malaria protection
models at the NMRC. "The new agreement underlines our good
relationship with the US public bodies and the increasing awareness
for our Immunizer IC31TM in private companies and public institutions
on a worldwide basis. We are very satisfied that the US Navy uses our
technology for this important program against Malaria," states Gerd
Zettlmeissl, COO of Intercell.
IC31TM is also partnered with Statens Serum Institut and SciGen Ltd.
to develop a Tuberculosis vaccine and a therapeutic Hepatitis B
EUR million Three months ended Year ended
March 31, 2005 March 31, 2004 Dec. 31, 2004
Revenues 0.4 0.3 4.6
Net loss (5.0) (4.7) (20.3)
cash flow (6.8) (4.6) (11.9)
Cash and marketable
securities, end of
period 70.9 26.6 31.3
Operational and Business Strategy Review First Quarter 2005
Japanese Encephalitis (JEV)
The highest priority is given to the preparations for the start of
Phase III trials in 2005, which include the manufacturing of clinical
materials. The study centers for the global trial are set up. A major
part of the study will be conducted in the US. After the US FDAs
agreement on Intercell´s development strategy last fall, we expect
final guidance for our Phase III development program from the
Scientific Advice Group of the European Medicines Agency (EMEA)
within the next months. We expect BLA filing in 2006 and product
registration in the US in 2007.
Regarding the development, manufacturing and marketing of the vaccine
in Asia our strategic alliance with Biological E Ltd. represents a
pivotal milestone. We expect marketing agreements for Australia
After completion of our first Phase II clinical study with our IC 41
therapeutic vaccine against Hepatitis C at the end 2004 the clinical
development program has been further extended. A follow-up study has
been designed to increase further the T-cell response that is pivotal
to fight the infection by optimizing the route and the frequency of
vaccinations. The new study, for which recruitment has been recently
completed, is being performed at the General Hospital of Vienna,
where Intercell´s IC41 Hepatitis C vaccine, is applied to over 50
healthy volunteers by administering up to 16 vaccinations at weekly
intervals. Should results warrant, the study will be extended to
chronic HCV patients in 2006. The start of Phase III registration
trials is planned for 2008.
IC41 is also being tested in combination with Interferon/Ribavirin
standard therapy in another Phase II trial. This trial is expected to
be completed in 2006.
Significant progress has been made in our pre-clinical programs. We
currently give highest priority to our programs against Streptococcus
pneumoniae and Group A Streptococcus infections to define vaccine
candidates in 2005 for future clinical development.
Antigen programs for e.g. against Travelers Diarrhea, Group B
Streptococcus and germs involved in nosocomial infections are being
also diligently pursued to further strengthen our intellectual
property positions for own future development and possible strategic
For the development of our novel antibody therapies we intend to
partner at least one program in 2005.
Strategic Alliances & Licensing
All existing strategic alliances which have resulted from our highly
successful antigen identification and IC31TM adjuvant technologies
are moving forward according to the intended timelines. In some of
these partnerships we expect first clinical trials within this year.
Our major strategic partners are: Merck&Co., Inc. (USA), Sanofi
Aventis (France), Statens Serum Institut (Denmark) and SciGen Ltd.
We expect further technology alliances within the next months.
The full quarterly report including un-audited financial statements
can be downloaded at www.intercell.com.
end of announcement euro adhoc 09.05.2005 08:01:03
Further inquiry note:
Mag. Katharina Wieser
Head of Corporate Communications
Tel. +43 1 20620-303
Börsen: Wiener Börse AG / official market