OncoMethylome Achieves Excellent Clinical Results and 2007 Financial Results Match Expectations

 

 

• Entered into new collaborations with GlaxoSmithKline Biologicals, Abbott, and other pharmaceutical companies in the area of companion diagnostics
• Initial clinical studies demonstrated excellent clinical performance of OncoMethylome's stool-based colorectal cancer screening test: 86% sensitivity, 96% specificity
• Initial clinical studies demonstrated excellent clinical performance of OncoMethylome's blood-based colorectal cancer screening test: 74% sensitivity, 92% specificity
• Initial clinical studies demonstrated excellent clinical performance of OncoMethylome's urine-based bladder cancer screening test: 88% sensitivity, 93% specificity
• Laboratory Corporation of America® (LabCorp), one of the largest service laboratories in the USA, licensed OncoMethylome's tissue test for prostate cancer from Veridex, LLC
• OncoMethylome ended 2007 with a higher cash balance, amounting to €33.1 million
• Over €2.5 million in new R&D grants were awarded to OncoMethylome
• OncoMethylome's laboratory facilities were expanded

 

Key Figures (EUR thousands, except number of shares and per share data):

 

Revenues

Consistent with the revenue guidance provided during the publication of the half-year results, revenues in 2007 of EUR 2.641 million remained comparable to the EUR 2.771 million of 2006.  Consistent with 2006, in 2007 the majority of revenues consisted of R&D grants and revenues from Schering-Plough and Veridex LLC.

 

Costs and Profitability

The broadening of the Company's product development pipeline required an expansion of the R&D activities which was initiated in the second half of 2006 and completed in 2007.  In addition, the number and breadth of the clinical trials on various products was increased.  As a consequence, the R&D costs increased by 24% to EUR 10.7 million, and continue to represent 81-82% of all operating costs. 

 

Cash Position

OncoMethylome's cash and cash equivalents amounted to EUR 33.1 million at December 31, 2007, which is comparable to the balance of EUR 32.8 million at December 31, 2006. The cash used in Operations was offset in 2007 by a private placement to institutional and qualified investors which generated EUR 10.1 million in net proceeds. 

 

 

• Additional deals are expected in 2008, mainly commercial deals with US service laboratories and companion diagnostics collaborations with pharmaceutical companies.
• The American Cancer Society's recent inclusion of stool-based DNA testing in the medical guidelines for colorectal cancer screening should continue to increase awareness for stool-based DNA colorectal cancer screening. OncoMethylome plans to build on this momentum and close a deal with a US service laboratory for distribution in the US and will develop a plan for launching stool-based colorectal cancer screening services in Europe.
• OncoMethylome expects its tissue test for prostate cancer and the MGMT alkylating agent companion diagnostic to be launched in the US in 2008.
• In Europe, at least two CE-marked test kits will be developed.
• Total revenues should increase faster than costs in 2008, but the amounts and timing of revenues will remain irregular as they will still be dominated by one-time fees and milestone fees.

 "In 2007, OncoMethylome achieved all of its clinical development goals, especially for colon cancer screening tests and bladder cancer screening tests, and is now in discussions with potential commercial partners for the commercialization of those products. In the area of personalized treatment, our existing relationship with Schering-Plough was expanded with additional clinical trials, and we brought onboard many new pharmaceutical industry partners such as GlaxoSmithKline Biologicals and Abbott. In 2008, we look forward to the commercial launch of several of our products" commented Herman Spolders, CEO of OncoMethylome Sciences.

 

The financial information included in this press release is derived from the audited consolidated financial statements under IFRS. OncoMethylome's auditors, BDO Atrio Réviseurs d'Entreprises, will issue an unqualified audit opinion. 

 

To download the complete audited financial statements of 2007, click here:  ONCO 2007 Financial Statement PDF.

 

The 2007 Annual Report will be available for downloading in the investors section of www.oncomethylome.com website at the end of April 2008. Requests for printed copies can be emailed to ir@oncomethylome.com.

 

OncoMethylome Sciences will host a conference call today at 9.30 CET, which will also be simultaneously broadcast via the internet. The event is open to the public and is accessible via internet broadcast at www.oncomethylome.com and via telephone at +32 2 290 1401. In order to ask questions during the Q&A session, please join the event via telephone. A recording of the event will also be made available at www.oncomethylome.com after the call.

 

May 8, 2008 - Q1 business update 

May 30, 2008 - General shareholders' meeting 

August 28, 2008 - Half year 2008 results 

November 6, 2008 - Q3 business update 

March 12, 2009 - Full year 2008 results 

 

 

To download this press release as a PDF, click here:  Press Release PDF 

 

 

 

OncoMethylome boasts a broad product development pipeline consisting of ten products and a solid partnering record. The company collaborates with leading international molecular oncology research centers, such as The Johns Hopkins University, and has a number of commercial and collaborative partnerships with Veridex LLC, a Johnson & Johnson company, Schering-Plough Corp., GlaxoSmithKline Biologicals, Abbott, Millipore Corporation's BioScience Division, and EXACT Sciences Corp. OncoMethylome's products are based on methylation technology invented by Johns Hopkins University (USA).  

 

Established in January 2003, OncoMethylome has offices in Liege and Leuven (Belgium), in Durham, NC (USA), and in Amsterdam (the Netherlands).

 

Lucija Turcinov

Tel. +32-479-801-902

Lucija.Turcinov@oncomethylome.com 

or visit www.oncomethylome.com