Key Figures (in EUR thousand)
* Revenues: 1,511 in H1 2008; increased by 13% (H1
2007: 1,343)
* EBIT: -5,888 in H1 2008; improved by 15%
(H1 2007: -6,949)
* Net loss: -5,632 in H1 2008; reduced by 16% (H1
2007: -6,699)
* Liquid assets: 17,753 at end of H1 2008 (Year end
2007: 10,016)
Highlights of the Successful First Half of 2008 and Year to Date
* Solid revenue growth, improved EBIT and reduced net loss
* Secured future funding via capital increase, "Epi 2010"
initiative to evolve the commercial organization
* Signed Septin 9 licensing deal with Quest Diagnostics
* Confirmed new Septin 9 assay for colorectal cancer blood
test in clinical studies
* Received notice of allowance for key Septin 9 patent in
Europe
* Initiated PRESEPT study in colorectal cancer program
* Successfully completed two clinical studies in lung
cancer program
* Generated additional data on tissue and urine samples in
prostate cancer program
* Signed technology licensing deals with OncoMethylome
Sciences and DxS
* Management evolution continues with hire of new Sr. VP
Product Development
BERLIN and SEATTLE, Aug. 5, 2008 (PRIME NEWSWIRE) -- Epigenomics AG (Frankfurt:ECX), a cancer molecular diagnostics company developing tests based on DNA methylation, today reported financial results for the second quarter and first half of 2008, ended June 30, 2008, and provided a corporate update.
Commenting on the first six months, Geert Nygaard, the company's Chief Executive Officer, said: "After the successful financing in the first quarter, we have dedicated ourselves to our product development operations in the second quarter and have made significant progress across the portfolio. In particular I would like to highlight the successes in the clinical evaluation of our improved assay procedure for colorectal cancer blood testing, the timely initiation of the PRESEPT study, and significant progress in our lung cancer program. At the same time we were able to execute on our "Epi 2010" initiative to continuously optimize our organization while reducing net cash consumption and ensure adequate funding for our key value drivers."
First Half of 2008 -- Operational Review and Highlights
During the first half and especially in the second quarter of 2008, all of Epigenomics' product development programs have made significant progress. The company continued to concentrate on its key value drivers, especially the colorectal cancer screening program. To this end, Epigenomics successfully completed two studies on clinical blood specimens that validated the Septin 9 marker's ability to detect colorectal cancer across all stages. In two studies testing more than 500 blood plasma samples for evidence of Septin 9 methylation, the marker demonstrated sensitivities of 74% and 69% at specificities of 92% and 89%, respectively. These studies confirmed the analytical and clinical performance of the Septin 9 marker observed in previous studies from 2006. The new 2008 clinical studies were performed using Epigenomics' improved assay procedure that is compatible with requirements of routine clinical laboratory processes. In total, the Septin 9 biomarker has now been evaluated in numerous case control studies with a total of about 3,500 blood samples.
Quest Diagnostics Inc. and Abbott Molecular Inc., the company's initial Septin 9 licensees, are progressing towards commercialization. In July 2008, Quest Diagnostics reported its portfolio approach to expand their leadership in colorectal cancer screening to include the development of the first blood based test to detect colorectal cancer using the Septin 9 methylated biomarker from Epigenomics. Partner Abbott Molecular expects to launch a CE-marked in vitro diagnostic assay on its m2000 instrument in Europe in 2009. Through these partnerships, Epigenomics will make available to patients and doctors early commercial access to its cancer detection biomarkers in both the United States and Europe.
To further accelerate the development of its colorectal cancer screening test, Epigenomics has initiated the PRESEPT study. PRESEPT is a multi-center study to characterize clinical performance of Septin 9 in a U.S. CRC screening guideline-eligible population. It will enroll individuals who have an average and increased risk according to U.S. guidelines and who undergo a screening colonoscopy. In addition to demonstrating the clinical utility of Septin 9 for colorectal cancer screening, the performance characteristics established in PRESEPT will be used to determine the potential health economic benefit of blood-based colorectal cancer screening using a validated health economic model. Furthermore, Epigenomics will be in a position to provide its industry partners developing Septin 9 IVD tests access to the PRESEPT samples and data to perform their respective pivotal clinical trials necessary to obtain regulatory approvals.
A Clinical Study Steering Committee for PRESEPT has been established and first subjects have already been enrolled. As of today there are three clinical sites that have initiated sample collection with a total of 19 German and U.S. sites having been successfully qualified or are in the process of qualification. Overall, Epigenomics expects that approximately 7,500 individual subjects will be required to yield the 50 colorectal cancer cases called for in the PRESEPT study design. Study results are expected to become available in 2009.
In Q2 2008, Epigenomics successfully completed two clinical studies in its lung cancer program. Both studies were run in close collaboration with the Charite -- Universitatsmedizin Berlin, Germany. The first clinical study demonstrated that a panel of two proprietary biomarkers detected 79% of lung cancer patients using bronchial lavage specimens at a specificity of 95%. The second study that was performed with blood plasma samples showed that a panel of two biomarkers correctly identified two-thirds of all lung cancers (66% sensitivity) at a false positive rate of only 12% (88% specificity).
