Liege (Belgium) - November 5, 2009, 8:00 AM CET - OncoMethylome Sciences announces today its third quarter financial results, the focusing of the business, an update on the status of certain of its products, and a change in management.

Q3 2009 material events
Published new clinical data on the blood-based colorectal cancer screening test at Europe's largest cancer congress (ECCO-ESMO)
Published further clinical data on the urine-based bladder cancer detection test
Remained on track for enrollment of new patients in the company's largest clinical trials, such as the 7.000-patient colorectal cancer screening trial

Key non-audited financials, as of September 30th, 2009:

Amounts as at and for the three months ended
Euro thousands Sept. 30, 2009 Sept 30, 2008
Revenues 577 758
EBITDA Income (Loss) (2,797) (2,079)
EBIT Operating Income (Loss) (3,036) (2,330)
Net Profit (Loss) (2,907) (2,065)
Cash and cash equivalents 21,065 23,999

Amounts as at and for the nine months ended
Euro thousands Sept. 30, 2009 Sept 30, 2008
Revenues 1,845 2,279
EBITDA Income (Loss) (8,862) (7,800)
EBIT Operating Income (Loss) (9,565) (8,548)
Net Profit (Loss) (9,247) (7,765)
Cash and cash equivalents 21,065 23,999


Business changes and outlook after Q3 2009:

OncoMethylome announces a focusing of its diagnostics business on three clinical areas: colorectal, prostate and bladder cancer. Moreover, the geographical emphasis for market entry with its products will be on the USA, as it is and will be the main market for molecular diagnostics for the years to come. This implies that no direct sales and marketing force will be built up in Europe by OncoMethylome for the foreseeable future. OncoMethylome will continue to work closely with large distribution partners and leading national testing laboratories. Although the focusing will likely impact the current organization, it will allow OncoMethylome to expand clinical validation of the most advanced products in the key medical markets and thereby should enhance the commercial potential of the company's product pipeline.

Colorectal cancer continues to be a leading cause of cancer-related deaths worldwide due in part to low patient compliance with existing screening tests or to the inability of currently marketed tests to detect enough cancers at their earlier stages of development. In colorectal cancer, OncoMethylome presented in Berlin in September 2009 results of its blood-based DNA Methylation test from a case-control study (http://www.ecco-org.eu/Conferences-and- Events/ECCO-15-ESMO-34/Press-Release/List-of-press-releases/New-blood-tests-promise-simple/page.aspx/1812). The company expects to complete the enrollment in its 7.000 patient blood-based colorectal cancer screening trial by Q1 2010 and the company continues to negotiate the distribution rights for the test with several international companies.

In prostate cancer, current tests fail to adequately address medical needs for patients with elevated PSA (prostate specific antigen). OncoMethylome has licensed to Veridex LLC two types of DNA Methylation tests to address these needs. The first is a DNA Methylation test on biopsy tissue with two markers (me-GSTP1 and me-APC) to assess the probability of a negative re-biopsy. This tissue test is currently marketed by LabCorp in the USA under a sub-license from Veridex. The second is a test on urine with three markers (me-GSTP1, me-APC and me-RAR2B), which is under development for improved prostate cancer screening and monitoring of patients with an initial negative biopsy. Veridex recently completed a 500-patient Beta-clinical investigation where the results met performance expectations.
Veridex has informed OncoMethylome of its decision at this time not to further develop nor to commercialize the prostate test itself, based on a strategic choice to invest in other areas of its business. Veridex, jointly with OncoMethylome, is reviewing alternatives for partners. This is expected to delay finalizing the kit development and regulatory process for the prostate products.

In bladder cancer, OncoMethylome has done feasibility tests and developed a prototype test for the application of early bladder cancer detection. The clinical data so far looks very promising and has the potential to be significantly better than any other tests currently on the market. Two main applications are being considered : (i) early detection of cancer among people at risk for bladder cancer such as people with hematuria (blood in a person's urine is often the first and only sign of bladder cancer) and (ii) monitoring of cancer recurrence among patients treated for bladder cancer in the previous 5 years since 70% of bladder cancers recur within 5 years after treatment. In several published case-control studies, OncoMethylome's bladder test is showing both sensitivity and specificity above 90% for the detection of bladder cancer among people at risk. The company is also conducting prospective studies for the monitoring of bladder cancer recurrence.

Herman Spolders (63) will retire as the CEO of OncoMethylome effective 1st of January 2010. Herman has founded the company and we are greatly indebted to him for building OncoMethylome from its start. Herman will continue as a non-executive board member. Philip Devine will take over day to day management of the company and will be combining his current role of CFO with that of interim CEO. The company is conducting a search for a new CEO.

Revenues for the full year 2009 are expected to be below those of 2008. For 2010, revenues are expected to remain stable. The net loss for the full year 2009 is expected to increase compared to 2008. For 2010, the net loss is expected to be reduced due to the focusing of the business.