euro adhoc: Intercell AG
Quarterly or Semiannual Financial
Intercell announces first quarter 2005 results - strong
financial position - new strategic alliance for IC31TM technology
with US Navy research center
Disclosure announcement transmitted by euro adhoc. The issuer is responsible for the content of this announcement.
Conference Call regarding the report Q1 2005 Monday, May 9, 2005 14.30 CET Tel: +43.1.23032 PIN: 122448
- 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 million. "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."
Latest Achievement 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 vaccine, respectively.
~ 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) Net operating 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 within 2005.
Hepatitis C 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.
Pre-clinical Products: 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 partnerships. 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. (Australia/Singapore). 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
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