OncoMethylome Announces Second Business Update for 2009 and Several
Business Changes
(Thomson Reuters ONE) - Liege (Belgium) - November 5, 2009, 8:00 AM CET - OncoMethylomeSciences announces today its third quarter financial results, thefocusing of the business, an update on the status of certain of itsproducts, 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 trialKey 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 onthree clinical areas: colorectal, prostate and bladder cancer.Moreover, the geographical emphasis for market entry with itsproducts will be on the USA, as it is and will be the main market formolecular diagnostics for the years to come. This implies that nodirect sales and marketing force will be built up in Europe byOncoMethylome for the foreseeable future. OncoMethylome willcontinue to work closely with large distribution partners and leadingnational testing laboratories. Although the focusing will likelyimpact the current organization, it will allow OncoMethylome toexpand clinical validation of the most advanced products in the keymedical markets and thereby should enhance the commercial potentialof the company's product pipeline.Colorectal cancer continues to be a leading cause of cancer-relateddeaths worldwide due in part to low patient compliance with existingscreening tests or to the inability of currently marketed tests todetect enough cancers at their earlier stages of development. Incolorectal cancer, OncoMethylome presented in Berlin in September2009 results of its blood-based DNA Methylation test from acase-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 patientblood-based colorectal cancer screening trial by Q1 2010 and thecompany continues to negotiate the distribution rights for the testwith several international companies.In prostate cancer, current tests fail to adequately address medicalneeds for patients with elevated PSA (prostate specific antigen).OncoMethylome has licensed to Veridex LLC two types of DNAMethylation tests to address these needs. The first is a DNAMethylation test on biopsy tissue with two markers (me-GSTP1 andme-APC) to assess the probability of a negative re-biopsy. Thistissue test is currently marketed by LabCorp in the USA under asub-license from Veridex. The second is a test on urine with threemarkers (me-GSTP1, me-APC and me-RAR2B), which is under developmentfor improved prostate cancer screening and monitoring of patientswith an initial negative biopsy. Veridex recently completed a500-patient Beta-clinical investigation where the results metperformance expectations.Veridex has informed OncoMethylome of its decision at this time notto 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 forpartners. This is expected to delay finalizing the kit developmentand regulatory process for the prostate products.In bladder cancer, OncoMethylome has done feasibility tests anddeveloped a prototype test for the application of early bladdercancer detection. The clinical data so far looks very promising andhas the potential to be significantly better than any other testscurrently on the market. Two main applications are being considered :(i) early detection of cancer among people at risk for bladder cancersuch as people with hematuria (blood in a person's urine is often thefirst and only sign of bladder cancer) and (ii) monitoring of cancerrecurrence among patients treated for bladder cancer in the previous5 years since 70% of bladder cancers recur within 5 years aftertreatment. In several published case-control studies,OncoMethylome's bladder test is showing both sensitivity andspecificity above 90% for the detection of bladder cancer amongpeople at risk. The company is also conducting prospective studiesfor the monitoring of bladder cancer recurrence.Herman Spolders (63) will retire as the CEO of OncoMethylomeeffective 1st of January 2010. Herman has founded the company and weare greatly indebted to him for building OncoMethylome from itsstart. Herman will continue as a non-executive board member. PhilipDevine will take over day to day management of the company and willbe combining his current role of CFO with that of interim CEO. Thecompany is conducting a search for a new CEO.Revenues for the full year 2009 are expected to be below those of2008. For 2010, revenues are expected to remain stable. The netloss for the full year 2009 is expected to increase compared to2008. For 2010, the net loss is expected to be reduced due to thefocusing of the business.About OncoMethylome SciencesOncoMethylome Sciences (Euronext Brussels: ONCOB; Euronext Amsterdam:ONCOA) is a molecular diagnostics company developing gene methylationtests to assist physicians in effectively detecting and treatingcancer. Specifically, the company's tests are designed to help thephysician (i) accurately detect cancer in early stages of cancerdevelopment, (ii) predict a patient's response to drug therapy, and(iii) predict the likelihood of cancer recurrence.OncoMethylome has products in development for major cancer areas(Colorectal, Bladder, and Prostate) and has several products alreadyon the market in the United States via LabCorp. The companycollaborates with leading international molecular oncology researchcenters, such as The Johns Hopkins University, and has a number ofcommercial and collaborative partnerships with Veridex LLC, a Johnson& Johnson company, LabCorp, Schering-Plough Corp., GlaxoSmithKlineBiologicals, Abbott, Merck KGaA, and Millipore Corporation'sBioScience Division. OncoMethylome's products are based onmethylation technology invented by Johns Hopkins University (USA).Established in January 2003, OncoMethylome has offices in Europe andthe United States.For more information please contact:Philip DevineTel. +32 4 364 2070ir(at)oncomethylome.comor visit: www.oncomethylome.comThis press release contains forward-looking statements and estimateswith respect to the anticipated future performance of OncoMethylomeand the market in which it operates. Such statements and estimatesare based on assumptions and assessments of known and unknown risks,uncertainties and other factors, which were deemed reasonable but maynot prove to be correct. Actual events are difficult to predict, maydepend upon factors that are beyond the Company's control, and mayturn out to be materially different.http://hugin.info/137314/R/1352655/327322.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 05.11.2009 - 08:07 Uhr
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