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WILEX reports successful first quarter 2008
Phase III ARISER trial with RENCAREX®:
o Positive result of the interim analysis for futility
o 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.
If you have any further questions, please do not hesitate to contact us.
Kind regards
Juliane Giese
Manager Public Relations
WILEX AG
Grillparzerstr. 10
81675 Muenchen
Germany
Tel.: +49 (0)89-41 31 38-29
Fax: +49 (0)89-41 31 38-99
Email: juliane.giese@wilex.com
Website: http://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).
Overview of earnings key figures:
Q1 2008 Q1 2007 Change
Earnings in EUR ’000 in %
Other operating income 560 506 10,6
Operating expensed (5,751) (5,878) (2.2)
Of which research and development costs (4,732) (5.017) (5.7)
Operating result (5,191) (5,371) (3.4)
Earnings before tax (4,884) (4,925) (0.8)
Net los 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 equivalents1) 28,039 52,649 (46.7)
Shareholders’ equity 21,168 42,929 (50.7)
Equity ratio2) in % 67.0 76.6 (12.4)
Cash flow in Euro ‘000
From operating activities (6,393) (4,070) 57.1
From investing activities (25) (22) 14.3
From financing activities (22) (425) (94.9)
Employees
Employees as at 29 February 60 49 22.4
Employees – quarterly 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.
WILEX AG | Grillparzerstraße 10, 81675 München, Deutschland, Tel. +49 (0) 89 413138-0, Fax +49 (0) 89 413138-99, info@wilex.com, www.wilex.com | Vorstand: Prof. Dr. Olaf G. Wilhelm (Vorsitzender), Dr. Paul Bevan, Dr. Thomas Borcholte, Peter Llewellyn-Davies | Vorsitzender des Aufsichtsrates: Dr. David R. Ebsworth | Sitz der Aktiengesellschaft: München, Amtsgericht München, HRB 136670 | HypoVereinsbank München, BLZ 700 202 70, Kto. 5800225304 | Deutsche Bank München, BLZ 700 700 10, Kto. 1616150
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