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 2008
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 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.
For a direct download click here.
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).
Contact
Juliane Giese
Manager Public Relations
WILEX AG
Grillparzerstr. 10
81675 Munich
Germany
Tel.: +49 (0)89-41 31 38-29
Fax: +49 (0)89-41 31 38-99
email: press@wilex.com
Website: http://www.wilex.com
* temporary name while under development
Overview of earnings key figures:
Earnings in EUR `000
|
Q1 2008
|
Q1 2007
|
Change in %
|
Other
operating income
|
560 |
506 |
10,6 |
Operating
expenses
|
(5,751) |
(5,878) |
(2.2) |
of which research
and development
|
(4,732) |
(5.017) |
(5.7) |
|
|
(5,191) |
(5,371) |
(3.4) |
Earnings
before tax
|
(4,884) |
(4,925) |
(0.8) |
Net
loss of the period
|
(4,891) |
(4,925) |
(0.7) |
Earnings per share
in EUR
|
(0.41) |
(0.41) |
(0.7) |
| |
|
|
|
Balance sheet as at 29.02. in EUR
`000
|
|
|
|
| Total assets |
31,577 |
56,065 |
(43.7) |
| Cash and cash equivalents 1) |
28,039 |
52,649 |
(46.7) |
| Shareholders equity |
21,168 |
42,929 |
(50.7) |
Equity ratio 2) in %
|
67.0 |
76.6 |
(12.4) |
|
|
|
|
| Cash flow in EUR `000 |
|
|
|
| from operating activities |
(6,393) |
(4,070) |
57.1 |
| from investing activities 3) |
(25) |
(22) |
14.3 |
| from financing activities |
(22) |
(425) |
(94.9) |
| |
|
|
|
| Employees |
|
|
|
| Employees as at 29.02. |
60 |
49 |
22.4 |
| Employees – annual
average |
59 |
48 |
22.9 |
1) Including financial assets
2) Shareholders’ equity / total assets
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.
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