Corporate | 10 April 2008 09:12
WILEX AG / Quarter Results
Release of a Corporate News, transmitted by DGAP - a company of EquityStory
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PRESS INFORMATION
WILEX reports successful first quarter 2008
Phase III ARISER trial with RENCAREX®:
Positive result of the interim analysis for futility
Recruitment in Europe completed
SPA for Phase III registration trial with CA9-SCAN received
IND for second Phase II trial with WX-671 granted
Munich, 10 April 2008. The Munich-based biopharmaceutical company WILEX AG
(ISIN DE0006614720/Frankfurt Stock Exchange/Prime Standard) today published
its results and report for the first quarter of 2008 (1 December 2007 – 29
February 2008).
WILEX achieved important milestones in all clinical projects in Q1 2008:
RENCAREX®: In December 2007 WILEX announced a positive result of the
interim analysis for futility for the Phase III ARISER trial with
RENCAREX®. The analysis of the Independent Data Monitoring Committee showed
that the trial will probably deliver a significant result. Recruitment in
Europe was completed in January 2008. Recruitment in the Americas will
continue for a few months. At present more than 95 % of the target of 856
patients have been included in the trial. We still expect to reach the
total of the 343 relapses required for an interim analysis for efficacy in
early 2009.
CA9-SCAN: At the beginning of February 2008 the US-Food and Drug
Administration (FDA) issued a special protocol assessment (SPA) for a Phase
III registration trial with CA9-SCAN. With this SPA the FDA confirms that
the design and planned analysis of the clinical trial adequately address
the requirements for a regulatory submission.
WX-671: In January 2008 the FDA approved an Investigational New Drug
application (IND) from WILEX for a clinical Phase II trial with its drug
candidate WX-671 in patients with metastatic breast cancer.
The results in the first quarter of the current financial year saw an
improvement compared with the same quarter in 2007.
Other operating income totalled EUR 0.56 million in Q1 2008, up from EUR
0.51 million in the same period of the previous year (increase of 10.6%).
Operating expenses in the first quarter of 2008 totalled EUR 5.75 million
(Q1 2007: EUR 5.88 million; reduction of 2.2%). These expenses include the
research and development costs, which reduced from EUR 5.02 million from
the first quarter 2007 to EUR 4.73 million in Q1 2008 (reduction of 5.7%).
Research and development costs as a percentage of total expenditure
declined from 85.4 % in Q1 2007 to 82.3 % in Q1 2008.
WILEX closed Q1 2008 with earnings before tax of EUR -4.88 million
(previous year: EUR -4.93 million; reduction of 0.8%), in line with
expectations.
Earnings per share amounted to EUR -0.41 as in the corresponding quarter
last year.
'Our results in the first quarter of the financial year are better than Q1
last year despite the further development of all projects,' commented Peter
Llewellyn-Davies, CFO of WILEX AG. 'The costs are in line with our
expectations. However they could increase as planned in the coming months
as further clinical trials are initiated. We reached important milestones
in the development of all clinical projects. With two Phase III candidates
and one Phase II candidate our portfolio has matured further. We will
continue to diligently pursue our published project- and commercialisation
strategies.' Llewellyn-Davies continued.
The quarterly report is available on the Company's website: www.wilex.com.
About WILEX
WILEX is a biopharmaceutical Company based in Munich founded in 1997 by a
team of physicians and oncologists from the Technical University of Munich.
WILEX’s mission is to develop drugs and diagnostic agents with a low side
effect profile and targeted treatment of different types of cancer as well
as for early detection of tumours. WILEX’s product candidates are based on
antibodies and small molecules. WILEX possesses an attractive pipeline
which includes both drug and diagnostic product candidates: The substances
RENCAREX® and CA9-SCAN are currently undergoing a Phase III registration
trial. The substance WX-671 is currently in a Phase II programme. Based on
this pipeline, WILEX’s aim is to achieve profitability within a few years
through the commercialisation of its products and in the long term to
finance its research and development programmes from its operating
business. WILEX AG is listed at the Frankfurt Stock Exchange at the
Regulated Market / Prime Standard (ISIN DE0006614720 / WKN 661472 / Symbol
WL6).
This communication contains certain forward-looking statements, relating to
the Company’s business, which can be identified by the use of
forward-looking terminology such as 'estimates', 'believes', 'expects',
'may', 'will' 'should' 'future', 'potential' or similar expressions or by
general discussion of strategy, plans or intentions of the Company. Such
forward-looking statements involve known and unknown risks, uncertainties
and other factors, which may cause our actual results of operations,
financial condition, performance, or achievements, or industry results, to
be materially different from any future results, performance or
achievements expressed or implied by such forward-looking statements. Given
these uncertainties, prospective investors and partners are cautioned not
to place undue reliance on such forward-looking statements. We disclaim any
obligation to update any such forward-looking statements to reflect future
events or developments.
Given these uncertainties, prospective investors and partners are cautioned
not to place undue reliance on such forward-looking statements. We disclaim
any obligation to update any such forward-looking statements to reflect
future events or developments.
10.04.2008 Financial News transmitted by DGAP
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Language: English
Issuer: WILEX AG
Grillparzerstr. 10
81675 München
Deutschland
Phone: +49 (0)89 41 31 38 - 0
Fax: +49 (0)89 41 31 38 - 99
E-mail: info@wilex.com
Internet: www.wilex.com
ISIN: DE0006614720
WKN: 661472
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