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Intercell AG

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

  Disclosure announcement transmitted by euro adhoc.
  The issuer is responsible for the content of this announcement.
08.05.2006
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
development met
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.
Intercell’s 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 Intercell’s 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.
Financial Highlights
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, Intercell’s priority has been its ongoing
global Phase III clinical trial program for Intercell’s 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 Commission’s designation of the "orphan drug
status" on Intercell’s 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 Company’s 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
2006.
Intellectual Property
The European Patent Office has granted an additional key patent
covering a component of Intercell’s 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.
end of announcement                               euro adhoc 08.05.2006 07:24:50

Further inquiry note:

Intercell AG
Mag. Katharina Wieser
Head of Corporate Communications
Tel. +43 1 20620-303
kwieser@intercell.com

Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Börsen: Wiener Börse AG / official market

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