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euro adhoc: Intercell AG
quarterly or semiannual financial statement /
Intercell announces Q1 results:
New strategic partnership with Kirin - All development projects on track -
Strong cash position
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Product development progress: » Japanese Encephalitis: Recruitment
for pivotal Phase III study completed - Orphan Drug Status granted
by the European Commission - Positive initial safety data in Phase
III trials » Hepatitis C Vaccine: Route and frequency of
administration optimized - success criteria for further
Commercialization of technologies: Strategic alliance with Kirin
Brewery Co., Ltd. (Tokyo, Japan) to develop human monoclonal
antibodies for the treatment of severe pneumococcal infections: »
Monoclonal antibodies - a novel use for Intercell's technologies with
significant potential in anti-infection applications » Streptococcus
pneumoniae infections - a field of rapidly growing medical
importance » Intercell is entitled to milestone payments totaling
approximately EUR 40 million - including a EUR 4 million upfront
payment and royalties on future net sales of the product
Financials: » Net loss of EUR 8.8 million driven by Phase III costs
related to the Japanese Encephalitis vaccine candidate » Strong
cash position with EUR 38.8 million in liquid funds at end of Q1 2006
Vienna (Austria), May 8, 2006 - Vaccine company Intercell AG (VSE: ICLL) today announced its financial results for the first quarter of 2006.
Intercells net loss in the first quarter 2006 was EUR 8.8 million compared to EUR 5.0 million in the first quarter of 2005. This increase was primarily due to higher research and development expenses.
Research and development expenses increased from EUR 4.0 million in the first three months of 2005 to EUR 6.8 million in the same period of 2006, or by 70.0 percent. This increase resulted primarily from the costs associated with the international Phase III pivotal clinical trials of Intercells JEV vaccine and license payments triggered by the achievement of milestones in the development of this vaccine. General, selling and administrative expenses were EUR 2.0 million for the three months ended March 31, 2006 compared to EUR 1.6 million for the three months ended March 31, 2005. This increase of 25.0 percent was primarily due to higher personnel expenses, which in turn were due to an increase in performance-based employee compensation costs.
As of March 31, 2006 Intercell had liquid funds of EUR 38.8 million of which EUR 5.7 million was cash and cash equivalents and EUR 33.1 million was available-for-sale financial assets.
EUR in thousands 3 months ended Year ended
March 31, March 31, Dec 31,
2006 2005 2005
Revenues 327 353 8,469
Net loss -8,814 -5,043 -25,06
Net operating cash flow -8,482 -6,98 -24,023
Cash and marketable
securities, end of period 38,817 70,853 50,178
Operational and Business Strategy Review Q1 2006
Japanese Encephalitis (JEV)
Over the last few months, Intercells priority has been its ongoing global Phase III clinical trial program for Intercells Japanese Encephalitis vaccine. With recruitment of the pivotal Phase III immunogenicity clinical trial completed, the global Phase III program is progressing faster than initially planned. In addition, an independent data and safety monitoring board (DSMB) concluded that it observed no safety concerns in its evaluation of the safety data from the first proportion of subjects vaccinated in the Phase III clinical trial. The European Commissions designation of the "orphan drug status" on Intercells JEV product candidate will result in ten years of exclusive market rights within the European Union, Norway and Iceland upon licensure of the vaccine, and considerable fee reductions during the pre- and post-approval phases. The fast progress made during the entire Phase III program, lend supports to the Companys planned development strategy of its leading product candidate, which is fully on track towards its expected market introduction in 2007. Initiation of US regulatory filing is expected at the end of 2006; product Registration in the United States is expected in 2007.
Hepatitis C (IC41)
In previous months, Intercell has made significant progress in its clinical trial program for its therapeutic vaccine against Hepatitis C. A follow-up clinical trial has been designed to further increase the T-cell response essential to fighting the infection by optimizing the route and frequency of vaccinations. Results of this clinical trial, which was completed in Q1 2006, indicate that IC41, when given in optimized route and schedule, is considerably more immunogenic than has been previously shown. 50 healthy adults were vaccinated with IC41 in alternative regimes. The optimization clinical trial showed that the T-cell responses were stronger and significantly more frequent than had been seen up to then. Compared to the previous regime, the improvements were positive and met the criteria for further development. Based on these results, Intercell is now planning to test IC41 with this optimized schedule in a further Phase II clinical trial in patients with chronic Hepatitis C. This study aims to show sustained reductions of HCV-RNA through IC41 stand-alone therapy in a substantial subset of patients. Intercell plans to start the clinical trial in Q3 2006, with initial results expected in mid-2007. In addition, results from an ongoing Phase II clinical trial in combination with the Interferon/Ribavirin standard therapy are expected in mid-2006.
Strategic Alliances & Licensing
All existing strategic partnerships and collaborations are moving
forward according to schedule. In Q1 2006, Intercell entered a new
strategic alliance with Kirin Brewery Co. Ltd. to develop antibodies
for the treatment of severe pneumococcal infections: » Monoclonal
antibodies against bacterial infections - a novel use for
Intercell's technologies with significant potential in anti-infection
applications, in addition to their current use in the field of
vaccines. » Streptococcus pneumoniae infections - a field of rapidly
growing medical importance with 1 in every 1000 elderly
individuals infected in Europe and the United States each year. »
Kirin Brewery Co. Ltd. obtained global rights to develop and
commercialize antibodies directed against antigens that have been
detected by Intercell's proprietary Antigen Identification Program
(AIP®). » Intercell is entitled to milestone payments totaling
approximately EUR 40 million - including a EUR 4 million upfront
payment and royalties on future net sales of the product. Up-front
payment is to be deferred and recognized as revenue over future
accounting periods. Intercell currently expects to enter into
additional product collaborations resulting from its technologies and
to achieve further milestones under its existing partnerships in
The European Patent Office has granted an additional key patent covering a component of Intercells novel proprietary synthetic adjuvant, IC31TM. The newly issued patent (EP 1 326 634 B) specifically covers the peptide (KLK) component of IC31TM. A separate patent (EP 1 296 713 B), which was issued in 2003, covers the second component of the adjuvant, an oligonucleotide (I-ODN). Both patents together provide broad patent protection for the use of IC31TM as a B- and T-cell adjuvant in vaccines.
The full quarterly report including un-audited financial statements can be downloaded at www.intercell.com.
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ots Originaltext: Intercell AG
Im Internet recherchierbar: http://www.presseportal.de
Further inquiry note:
Mag. Katharina Wieser
Head of Corporate Communications
Tel. +43 1 20620-303
Börsen: Wiener Börse AG / official market