EANS-News: Epigenomics AG / Epigenomics AG Reports Results for the Financial Year Ended 31 December 2012

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Subtitle: * PMA application for Epi proColon® accepted and priority
review status granted by the FDA * Non-inferiority of Epi proColon®
to FIT for sensitivity shown in comparison study * Significant cost
savings implemented; EUR 5.0 million raised at the beginning of 2013

Financial Figures/Balance Sheet/Molecular Diagnostics

Berlin, Germany and U.S.A. (euro adhoc) - Epigenomics AG (Frankfurt
Prime Standard: ECX), the German-American cancer molecular
diagnostics company, today announced its results for the financial
year ended 31 December 2012 and provided an outlook for 2013.

Dr. Thomas Taapken, Chief Financial Officer and acting Chief
Executive Officer of Epigenomics commented: "By the close of 2012 we
had completed a very busy year in which we made significant progress
on our regulatory pathway for Epi proColon® in the U.S. and in the
development of our commercialization plans for this blood-based
colorectal cancer screening assay. By submitting our Premarket
Approval (PMA) application to the FDA, including encouraging data
from the recent comparison study, we achieved our primary objective
for the year. The next most significant milestone for us is to be
able to start commercialization of our product in the most relevant
market of the world - the United States of America - and to
ultimately transform Epigenomics into a commercially driven molecular
diagnostics company with growing revenue derived from product sales."

2012 Financial Results * 2012 revenue amounted to EUR 1.0 million
(2011: EUR 1.4 million) generated from product sales of EpiproColon®
kits, royalty payments, licensing income and partnering activities;
the decrease compared to 2011 is primarily due to one-off licensing
payments received in 2011 with no comparable effects in 2012. Product
sales prior to a potential approval of EpiproColon® in the US
continued on a low level, though moderately increasing, over the
year. * Other income increased to EUR 1.0 million (2011: EUR 0.5
million) primarily driven by the reversal of provisions related to
the restructuring of the Company in 2011. * Net loss improved by 22%
to EUR 12.2 million (2011: EUR 15.6 million). The decline in total
revenue and an increase of R&D costs due to the execution of the
comparison study were overcompensated by the absence of extraordinary
effects (i.e. restructuring and goodwill amortization) in 2012 (2011:
EUR 5.5 million). * Epigenomics implemented significant cost savings
in 2012. Consequently, cash consumption was reduced to EUR 10.9
million (2011: EUR 12.2 million) but contained high cash outflows
directly attributable to the study mentioned above (EUR 2.3 million)
and payments related to restructuring measures taken (in total EUR
1.4 million). * Cash and cash equivalents at year-end 2012 amounted
to EUR 2.7 million (2011: EUR 14.0 million). The Company raised gross
proceeds of EUR 5.0 million in an equity issue at the beginning of
2013.

Outlook for 2013 * Prior to securing approval of Epi proColon® as an
IVD product in the U.S. market, Epigenomics remains cautious and does
not expect revenues to significantly differ from 2012 levels. * EBIT
and net loss for 2013 are expected to be significantly lower than in
2012 due to the full effect of the 2011 restructuring and
significantly reduced R&D expenses. Net loss for 2013 expected in the
range of EUR 6.5 to 7.5 million. * In line with reduced net loss,
cash consumption 2013 is expected to be in the range of EUR 6.5 to
7.5 million. * Current financial resources expected to support the
Company's operations until the end of 2013. Epigenomics will continue
to diligently explore all strategic options, including the
possibility to raise capital.

Operational Highlights in 2012 and 2013 YTD

Non-inferiority of Epi proColon® against FIT demonstrated:
Epigenomics performed a head-to-head comparative study with the goal
to demonstrate non-inferiority of Epi proColon® to fecal
immunochemical testing (FIT) for the detection of CRC. This clinical
trial started in Q2 2012, after having agreed on the study protocol
with the FDA, and was successfully completed before year-end. In
summary, Epi proColon® met the critically important endpoint of
non-inferiority with respect to sensitivity compared to FIT. The
sensitivity - or cancer detection rate - amounted to 71%. The FIT
comparator used in the study showed a sensitivity of 67% and detected
less cancer cases than Epi proColon®. The difference in specificity -
or the rate of correctly assessed non-cancer cases -was determined at
81% for Epi proColon® and at 98% for FIT and is in line with previous
studies performed with Epi proColon® and published data for FIT. The
difference in specificity was anticipated and in our opinion is less
vital, since patients will undergo a colonoscopy - the currently
recommended screening procedure in the U.S. - as a result of a
positive test result.

PMA application for Epi proColon® completed: Epigenomics initiated
the process of gaining U.S. regulatory approval for its blood-based
CRC test early in the year. Four data modules of the PMA for Epi
proColon® were submitted to the FDA in the course of the year.
Through the submission of the fourth module by the end of 2012, the
Company formally completed its PMA application, which has been filed
with the FDA in early 2013 and will be subject to priority review by
the authorities.

Pre-marketing activities in the U.S.: Although reimbursement levels
are still to be determined, a major accomplishment in 2012 has been
the inclusion of Septin9 testing with its own defined code into the
Current Procedural Terminology (CPT) coding document issued by the
American Medical Association, which is the basis for reimbursement of
laboratory tests by payers in the United States and will be first
applied in 2013. Epigenomics is also undertaking steps to increase
awareness of the test among KOLs and medical experts setting
screening guidelines.

U.S. partnering activities expanded: In June 2012, the Company signed
another LDT agreement with Companion Dx Reference Lab, a strong
partner serving the Texan cancer-testing market. Encouragingly,
Epigenomics is seeing a growing market acceptance for its test in
North America with more than 45,000 Septin9 tests performed in 2012
by its license partners compared to 26,000 tests in 2011.

Increasing acceptance from European healthcare bodies: After a
far-reaching restructuring of commercialization activities in Europe,
Epigenomics is starting to see increasing acceptance from players in
the healthcare systems to adopt the patient-friendly blood test for
the early detection of CRC. As a measure of initial success Swiss
Life, one of France's largest private health insurance companies, has
decided to recommend and reimburse up to 50% of the costs of the
Septin9 test. This decision clearly confirms Epigenomics' approach in
Europe and the Company will continue on this path.

Organizational changes reducing cost base: At the Company's Annual
General Meeting (AGM) in May 2012, the shareholders voted with vast
majority in favor of a reduction of the Supervisory Board from six to
three members. They elected Heino von Prondzynski as new member and
confirmed the former members Ann Clare Kessler, Ph. D., and Prof. Dr.
Günther Reiter for a further term until the AGM in 2015. In the
initial meeting the newly elected Supervisory Board subsequently
elected Heino von Prondzynski as its new Chairman and Ann Clare
Kessler as Vice-Chairwoman. Epigenomics' former CEO Geert Nygaard
agreed with the Supervisory Board of the Company to retire from the
Executive Board and to leave the Company effective September 30,
2012. Simultaneously, the Supervisory Board appointed the Company's
CFO, Dr. Thomas Taapken, to serve as acting CEO in addition to his
responsibilities as CFO, effective October 1, 2012. Epigenomics'
Executive Board was therefore reduced to one person, marking a
significant step in reducing the Company's cost basis.

Successful capital increase: On January 25, 2013, after the reporting
period, Epigenomics announced a capital increase from authorized
capital for 3,149,430 new ordinary bearer shares, generating gross
proceeds of EUR 5.0 million. 2,811,707 of these shares were taken up
by existing shareholders at a subscription price of EUR 1.58 per
share and the remaining 337,723 shares were sold at the same price in
a private placement to institutional investors, which was
significantly oversubscribed.

-Ends-

Conference call for press and analysts

The Annual Report 2012, which was released today, can be obtained
from Epigenomics' website at: http://www.epigenomics.com/en/news-inve
stors/investors/financial-reports.html.

Epigenomics will host an annual press conference in Frankfurt Main,
Germany in German language at 9.30 am CET today. The Company will
also be hosting a conference call on the same day at 3.00 pm CET
today. The presentation can be followed as a slide show on the
website. Details of both events will be available on Epigenomics'
website at http://www.epigenomics.com/en/news-investors.html.

Contact Epigenomics AG

Antje Zeise
Manager IR | PR
Epigenomics AG
Kleine Praesidentenstrasse 1
10178 Berlin
Tel +49 (0) 30 24345 386
{ir@epigenomics.com}[HYPERLINK: mailto:ir@epigenomics.com]
{www.epigenomics.com}[HYPERLINK: http://www.epigenomics.com/]

For US press inquiries:

Epigenomics, Inc.
9700 Great Seneca Highway
Rockville, Maryland 20850
{pr@epigenomics.com}[HYPERLINK: mailto:pr@epigenomics.com]

About Epigenomics Epigenomics ({www.epigenomics.com}[HYPERLINK:
http://www.epigenomics.com]) is a molecular diagnostics company
developing and commercializing a pipeline of proprietary products for
cancer. The Company's products enable doctors to diagnose cancer
earlier and more accurately, leading to improved outcomes for
patients. Epigenomics' lead product, Epi proColon®, is a blood-based
test for the early detection of colorectal cancer, which is currently
marketed in Europe and is in development for the U.S.A. The Company's
technology and products have been validated through partnerships with
leading diagnostic companies and testing laboratories. Epigenomics is
an international company with operations in Europe and the U.S.A.

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 U.S.A. have
not been established.

Further inquiry note:
Antje Zeise | CIRO
Manager IR/PR
Epigenomics AG
Tel: +49 30 24345 386

end of announcement euro adhoc
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company: Epigenomics AG
Kleine Präsidentenstraße 1
D-10178 Berlin
phone: +49 30 24345-0
FAX: +49 30 24345-555
mail: ir@epigenomics.com
WWW: http://www.epigenomics.com
sector: Biotechnology
ISIN: DE000A1K0516
indexes: Prime All Share, Technology All Share
stockmarkets: free trade: Berlin, München, Hamburg, Düsseldorf, Stuttgart,
regulated dealing/prime standard: Frankfurt
language: English