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Epigenomics AG

EANS-News: EPIGENOMICS AG Releases 9-Months Financial Report

Berlin, Germany, November 9, 2010 (euro adhoc) -

  Corporate news transmitted by euro adhoc. The issuer/originator is solely
  responsible for the content of this announcement.
Company Information/9-month report/Molecular diagnostics
Epigenomics AG
(Frankfurt Prime Standard: ECX) reports today its third quarter and 
nine months financials for the period ended  September 30, 2010.
Key Financials
|               |         |Q3/10      |9M/10      | 9M/09     |% change   |
|               |         |(unaudited)|(unaudited)|(unaudited)|(9M)       |
|               |         |           |           |           |           |
|Revenue        |in mill. |0.36       |1.34       |3.2(1)     |-58%       |
|               |EUR        |           |           |           |           |
|EBIT           |in mill. |-3.01      |-8.44      |-7.1       |19%        |
|               |EUR        |           |           |           |           |
|Net Loss       |in mill. |-3.00      |-8.36      |-7.1       |18%        |
|               |EUR        |           |           |           |           |
|Liquid Assets  |in mill. |           |29.61(2)   |9.5        |           |
|               |EUR        |           |           |           |           |
1) Includes non-recurrent payments in R&D and licensing partnerships in
2009.
   2) Difference due to the raising of gross proceeds of approx. EUR 33.1
      million in a capital increase in early 2010
Operational Highlights in the Reporting Period
    • Dual track commercial strategy rolling out in Europe & US and key
      highlights during the 9 month period included:
         o Direct sales: Epi proColon kits available nationwide in Germany and
           Switzerland
         o Partners´ sales: colorectal cancer blood tests based on Septin9
           available in the US through Quest Diagnostics and ARUP Laboratories,
and Abbott (EU and Asia/Pacific)
         o New non-exclusive licensing agreement signed with Warnex for
           Canadian market, expected launch by the end of 2010
    • Tests now being shipped to customers internationally
    • Positive clinical data published at leading scientific conferences
      worldwide including results of the successfully completed prospective
      PRESEPT Study at the 2010 Digestive Disease Week
    • Launched new lung cancer diagnostic test, Epi proLung BL Reflex Assay, in
Europe after successful completion of pivotal performance evaluation study
Post Period End Events
• Exclusive distribution deals signed with Pronto Diagnostics, DATEKs and
      DPC for commercialization of Epi proColon in the entire Middle East region
    • Further positive clinical validation studies
         o ARUP presented data demonstrating that its Septin9 laboratory-
           developed test has 90% sensitivity for cancer at 89% specificity at
           ASCO-NI-EORTC meeting
         o Epigenomics presented new data generated by an independent
           laboratory with the PRESEPT Septin9 assay at the UEGW as well as
           AACR meetings showing sensitivity of 86% at specificity of 93%
    • Briefing booklet submitted to FDA on Epi proColon; Epigenomics expects
pre-IDE meeting to take place late 2010 / early 2011
    • Allocation of US$ 245,000 grant to Epigenomics as a partial  reimbursement
and co-funding of the clinical trial PRESEPT  for  the  fiscal  year  2009 under
the Qualifying Therapeutic Discovery Projects (QTDP)
program by  the US Internal Revenue Service.  The  QTDP  program  is 
funded through  the Patient Protection and Affordable Care Act.
Geert Nygaard, Chief Executive Officer of Epigenomics said: "We are 
proud of Epigenomics´ extensive operational achievements so far this 
year. Our dual track commercial strategy is developing well with new 
partners and distributors on board giving us access to new markets 
and countries with our test and technology. We are also seeing very 
positive clinical data which are reinforcing the independent view 
that blood-based colorectal cancer tests are going to become an 
essential method of screening for patients in the future."
He added: "Sales growth is taking longer than expected due to slower 
initial uptake of our test and this is likely going to continue at a 
gradual pace during 2011. However, we are taking proactive steps to 
reach out to the medical profession about the benefits of the test to
patients. In addition, with the recent funding of EUR33.1m gross 
proceeds, the Company is in a solid financial position to support the
commercial strategy at this early stage and in bringing new partners 
on board."
The full 9-Months Financial Report 2010 is available for download at
www.epigenomics.com/en/investor_relations/Financial_Information/
The Company´s management will be available for analyst and investor 
meetings at the upcoming Lazard Capital Markets 7th Annual Healthcare
Conference in New York, USA, on November 16-17, 2010 and the German 
Equity Forum 2010 in Frankfurt am Main, Germany, on November 22-23, 
2010.
-Ends-
Notes to the Editor
|Contact Epigenomics AG                                                      |
|Dr. Achim Plum                                                              |
|Sen. VP Corporate Development                                               |
|Epigenomics AG                                                              |
|Tel +49 (0) 30 24345 368                                                    |
|pr@epigenomics.com                                                          |
|www.epigenomics.com                                                      |
Conference Details
Lazard Capital Markets 7th Annual Healthcare Conference
Epigenomics´ presentation on November 16, 2010 at 10:25 am EST 
The St. Regis Hotel, 22 East 55th Street, New York, USA
German Equity Forum 2010 Epigenomics´ presentation on November 23, 
2010 at 12:00 noon CET, Room Madrid, Congress Center, Messe 
Frankfurt, Ludwig-Erhard-Anlage 1, Frankfurt am Main, Germany
About Epigenomics
Epigenomics AG is a molecular diagnostics company with a focus on the
development of novel products for cancer. Using DNA methylation 
biomarkers, Epigenomics´ tests on the market and in development for 
colorectal, lung, and prostate cancer aim at aiding in an earlier and
more accurate diagnosis of these diseases thereby potentially 
increasing the patient´s chances of survival.
For development and global commercialization of IVD test products, 
Epigenomics pursues a dual business strategy in which direct 
commercialization of proprietary diagnostic test products is combined
with non-exclusive licensing to diagnostic industry players with 
broad customer access. Strategic diagnostics industry partners 
include Abbott Molecular, Sysmex Corporation, Quest Diagnostics 
Incorporated, ARUP Laboratories, Inc., and Warnex Laboratories, Inc. 
for diagnostics test products and services, and QIAGEN N.V. for 
sample preparation solutions and research products. The company is 
headquartered in Berlin, Germany, and has a wholly owned subsidiary, 
Epigenomics Inc., in Seattle, WA, USA. For more information, please 
visit Epigenomics´ website at www.epigenomics.com.
Epigenomics´ legal disclaimers. This communication expressly or 
implicitly contains certain forward-looking statements concerning 
Epigenomics AG and its business. Such statements involve certain 
known and unknown risks, uncertainties and other factors which could 
cause the actual results, financial condition, performance or 
achievements of Epigenomics AG to be materially different from any 
future results, performance or achievements expressed or implied by 
such forward-looking statements. Epigenomics AG is providing this 
communication as of this date and does not undertake to update any 
forward-looking statements contained herein as a result of new 
information, future events or otherwise.
The information contained in this communication does not constitute 
nor imply an offer to sell or transfer any product, and no product 
based on this technology is currently available for sale by 
Epigenomics in the United States of America. The analytical and 
clinical performance characteristics of any product based on this 
technology which may be sold at some future time in the USA have not 
been established.
end of announcement                               euro adhoc

Further inquiry note:

Epigenomics AG
Dr. Achim Plum
Sen. VP Corporate Development
Tel: +49 30 24345 368
achim.plum@epigenomics.com

Branche: Biotechnology
ISIN: DE000A0BVT96
WKN: A0BVT9
Index: Prime All Share, Technology All Share
Börsen: Frankfurt / regulated dealing/prime standard
Berlin / free trade
Hamburg / free trade
Stuttgart / free trade
Düsseldorf / free trade
München / free trade

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