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WILEX Q3 report 2007: progress with development projects – 2007 financial outlook confirmed


Munich, 11 October 2007. The Munich-based biopharmaceutical company WILEX AG (ISIN DE0006614720/Frankfurt Stock Exchange/Prime Standard) today published its results and report for Q1 – Q3 / 2007 (1 December 2006 – 31 August 2007).

WILEX AG continued to be successful with the development of its drug and medical product candidates and the financial result is in line with expectations. Below is a summary of the highlights:

Phase III ARISER trial with RENCAREX®

  The Independent Data Monitoring Committee (IDMC) convened on 1 October 2007. The Committee reviews the safety of the ongoing ARISER trial at regular intervals. The IDMC members were unanimous in their recommendations for continuation of the trial according to protocol.

  The number of relapses in the trial reached 100 in October, triggering the preparations for the interim analysis for futility. The results of the comprehensive analysis are expected as planned within this year. In addition, patient recruitment has again advanced significantly. To date WILEX has enrolled over 670 of the total number of 856 patients required.

Patient recruitment has started in the Phase II combination trial with WX-671 in pancreatic cancer.

A Phase Ib trial with WX-671 was successfully completed in patients with head & neck cancer and demonstrated a good safety and tolerance profile. Another important result is that the active principle is found in the tumour tissue.

WILEX has also made considerable progress with the preparation of the registration trial for CA9-SCAN.

Income and expenses are within the guidance, thus confirming the positively revised targets for 2007 published with the Q2 interim report.

 

The financial result breaks down as follows:

Operating expenses in the first nine months of 2007 totalled EUR 19.49 million (Q1 – Q3 / 2006: EUR 13.15 million; an increase of 48.2%). This increase was again mainly attributable to an increase in research and development costs, which was in line with expectations. These costs were up from EUR 10.53 million in the previous year to EUR 16.61 million in the first nine months of 2007 (an increase of 57.8%), representing 85% of total expenses (9M 2006: 80%). Approximately 64% of research and development costs were invested in the clinical development of monoclonal antibodies (RENCAREX® and CA9-SCAN). The optimisation of cost structures, mainly in the production of RENCAREX®, has already made an impact in the third quarter. Costs for research and development were reduced by 2% compared to the second quarter of 2007.

Other operating income rose in the third quarter of 2007 to EUR 0.94 million (Q2 2007: EUR 0.71 million). The increase is attributable to the realisation of milestone payments. In the first nine months of financial year 2007, WILEX achieved other operating income totalling EUR 2.16 million, which is more than double the amount generated in the same period in 2006 (EUR 0.97 million).

As in the first two quarters of the current year, the net financial result reported by WILEX was also clearly positive in the third quarter. This is mainly accounted for by the investment of liquid funds not yet drawn on for clinical development. For the first nine months of 2007, the Company reported a net financial result of EUR 1.32 million in total (previous year: EUR -1.36 million).

According to plan, WILEX reported a result before tax of EUR -16.01 million for the first nine months of the 2007 financial year (previous year: EUR -13.54 million; an increase of 18.2%). Of this, EUR -5.30 million was attributable to Q3 2007 (Q2 2007: EUR -5.78 million).

"We have made significant progress with our projects and can confirm our financial guidance," commented Peter Llewellyn-Davies, CFO of WILEX AG. Llewellyn-Davies continued: "Together with our new colleague Dr. Thomas Borcholte, who was appointed as Chief Business Officer at the beginning of this month, we will focus our attention on the commercialisation of our products."

The 9M report was published on the Company's website: www.wilex.com.

About WILEX AG
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 is focused on the development of new cancer therapies based on antibodies and small molecules. The therapeutic approach of WILEX targets the prevention of growth, spread and the metastasis of malignant tumours and the destruction of malignant tumours in the body. The late stage multi-product portfolio includes both drug and medical product candidates ranging from research to late stage clinical development. Currently the following compounds are in clinical development: WX-G250 (development name: RENCAREX®), WX-671, WX-UK1 and CA9-SCAN. The Company’s strategy is to develop WILEX into a commercially successful biopharmaceutical Company with a broad portfolio of new drugs and medical products for the treatment of cancer. WILEX AG is listed on the Frankfurt Stock Exchange in the Official Market Segment (Amtlicher Markt) / 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: investors@wilex.com
Website: http://www.wilex.com

Overview of earnings key figures:

P&L earnings key figures in EUR '000
Q1-Q3 2007
Q1-Q3 2006
Change in %
Other operating income
2.158 966 123,4
Operating expenses
(19.486) (13.149) 48,2
of which research and development
(16.606) (10.527) 57,8
Operating result
(17.328) (12.183) 42,2
Result before tax
(16.005) (13.543) 18,2
Net loss for the period
(16.024) (13.551) 18,2
Earnings per share in EUR
(1,34) (1,74)  
Liquid funds
40.108 14.826  
Equity ratio
72,7% 0,3%  

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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