EANS-News: Epigenomics AG: Full Year Results for the Year Ended 31 December 2011

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annual result/Company Information/molecular diagnostics

Subtitle: * Development of second generation product completed, PMA
filing process initiated in the US * Over 26,000 Septin9
laboratory-developed tests sold by North American partners in 2011 *
Tight fiscal control after implemented restructuring in 2011

Berlin, Germany, and Seattle, WA, U.S.A., March 23, 2012 (euro adhoc)
- Epigenomics AG (Frankfurt Prime Standard: ECX), the German-American
cancer molecular diagnostics company, today announced its full year
results for the year ended 31 December 2011 and provided an outlook
for 2012.

Geert Nygaard, Chief Executive Officer of Epigenomics commented:
"2011 has been a challenging year for Epigenomics, but also a year
where we have made significant progress in becoming a
commercially-oriented, product-driven growth company. We are pleased
to report the start of the regulatory process for our key product,
EpiproColon® in the US, with two of the four PMA modules submitted to
the FDA. The protocol for our Septin9 comparison study against FIT is
in place and we are eager to get it underway so that we can file our
final PMA module before year end. It remains the company's ultimate
goal to introduce our test to the largest commercial market for
molecular diagnostic products. We are encouraged to see that there is
a growing market for our test in the U.S. with more than 26,000
Septin9 tests being performed in 2011 by our license partners."

2011 Financial Results

* Revenue of EUR 1.4 million (2010: EUR 1.8 million) generated from
product sales of EpiproColon® kits, royalty payments, licensing
income and partnering activities; decrease in revenues compared to
2010 is mainly due to lower collaborative income; * EpiproColon®
European product sales were up by 38% compared to 2010; * Net loss
widened by 36% to EUR -15.6 million (2010: EUR -11.5 million), mainly
driven by one-time charges in connection with implemented
restructuring measures and goodwill amortization; * EUR -5.5 million
of the net loss was attributable to the restructuring measures and to
the amortization of the goodwill, EUR -4.6 million were non-cash
effective costs; * Cash consumption increased to EUR -12.2 million
compared to EUR -10.3 million in 2010, mostly by one-time effects
attributable to the restructuring; * Cash and cash equivalents at
year end 2011 were EUR 14.0 million (2010: EUR 24.6 million); Outlook
for 2012 * 2012 financial guidance: EBIT and net loss for 2012 to be
at significantly lower levels than in 2011, in the range of EUR -9.5
and -11.0 million; * Cash consumption in 2012 expected to be in the
range of EUR -9.5 to -11.0 million; * Epigenomics will diligently
explore all viable strategic options, including the option of
securing additional financial resources on the capital markets

Operational Highlights in 2011 and 2012 YTD

Development completion and roll out of Epi proColon® 2.0 test:
Epigenomics completed the development of its second generation
blood-based Epi proColon 2.0® test, the first world-wide
patient-friendly blood test for the early detection of colorectal
cancer.

The Company performed a clinical validation study of Epi proColon®
2.0 CE in Europe and presented positive results at the United
European Gastroenterology Week Meeting in Stockholm in October 2011.
The test accurately identified 81% of the cancer cases at 99%
specificity. Based on the very positive clinical results, Epigenomics
subsequently launched the product in Europe. Results from a separate
study in 184 study participants, which was conducted in collaboration
with Semmelweis University in Budapest, Hungary, highlighted that the
Septin9 biomarker detects colon cancer equally in both sides of the
colon, which is a competitive advantage to presently used screening
tests. Epi proColon® pivotal clinical validation study: Epigenomics
conducted a prospectively designed clinical validation study in the
U.S. The results announced in December confirmed the results in a
previously conducted academic study in a true screening population by
showing 68% sensitivity at 80% specificity. Following discussions
with the FDA, it has been confirmed that data from the U.S. clinical
validation study could be assessed as part of a Modular Premarket
Approval (PMA) review process. The first two PMA modules have already
been submitted to the FDA, with the third and fourth modules to be
submitted in the second quarter and second half of 2012 respectively.
The FDA has furthermore requested Epigenomics to perform a
head-to-head comparative study for colorectal cancer detection
through comparison with fecal immunochemical testing (FIT) for the
purpose of demonstrating non-inferiority of Epi proColon® to FIT.
This study will become an integral part of the PMA submission. After
consultation with the FDA, we have meanwhile agreed on the protocol
for the study. Site identification and recruitment is currently
ongoing with the aim of evaluating 100 cancer cases (post
colonoscopy) and 200 asymptomatic average risk individuals
(pre-colonoscopy). We will work diligently to complete this study and
file the clinical, and last, module of our PMA filing still in 2012.

Pre-marketing activities in the U.S.: Although reimbursement levels
are still to be determined, Septin9 was included in the new AMA
coding document (CPT code 81401), which will be introduced in 2013.
Epigenomics is also undertaking steps to increase awareness of the
test among KOLs and the patient population. During the period
Epigenomics and its partners announced the results of several surveys
in the U.S. and Europe showing that the vast majority of patients
would prefer blood tests over conventional methods for colorectal
cancer screening.

Partnering activities: Overall in 2011, Epigenomics' LDT partners
sold over 26,000 tests in North America. Quest, ARUP laboratories and
Warnex in Canada (now part of Labcorp), continue to make their
laboratory-developed Septin9 tests (LDT) available in North America.
In 2011, Quest received approval of their test version,
ColoVantageTM, by the New York State's Department of Health and
demonstrated encouraging sales volume growth since it started
actively promoting the test across the U.S. ARUP presented the
results of their clinical validation study at the Association of
Molecular Pathology Meeting in November 2011. ARUP's Septin9 LDT
assay detected 90% of the colorectal cancer cases at 88% specificity.
In February 2011, QIAGEN signed a two-year option agreement to
develop and commercialize a colorectal cancer blood test based on the
Septin9 biomarker and certain DNA methylation analysis technologies.
Abbott is also continuing their development efforts towards US
regulatory submission of its own IVD Septin9 product based on a
license from Epigenomics.

European marketing activities: The company's revised European
marketing activities of targeting key European accounts is on-going.
The test is now available through selected laboratories in Germany at
a price of EUR 99 to the customer.

Epi proLung® developments: The company's second test, Epi proLung®,
has recently shown very encouraging results in a clinical study in
patients suspected of having lung carcinoma. Based on these results,
Charité University Hospital in Berlin, Germany, has announced that
the assay will be introduced into its clinical practice as a routine
aid in the diagnosis of lung cancer.

Corporate restructuring: In the summer of 2011, Epigenomics
implemented restructuring measures to effectively control expenses in
2012 and beyond. The number of employees has decreased from 85 in
mid-2011 to currently 45. R&D efforts are being focused on existing
and near-term product opportunities, with longer term projects being
put on hold for the time being.

Management changes: In 2011 Epigenomics added two experienced
industry players to its management team. Dr. Thomas Taapken was
appointed as Epigenomics' new CFO. He joined from publicly listed
Biotie Therapies, Turku, Finland. Mr. Noel Doheny was appointed as
Chief Executive Officer of Epigenomics' U.S. subsidiary. He has 30+
years of experience in the field of diagnostics, with over 20 years
in senior management of companies including Affymetrix and QIAGEN.
-Ends-

Conference calls for press and analysts

The Annual Report 2011, 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 11 am CET today. The company will also
be hosting a conference call and audio webcast on the same day for
analysts at 3pm CET today. 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
Tel +49 (0) 30 24345 386
ir@epigenomics.com
www.epigenomics.com

About Epigenomics

Epigenomics (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 multiple
partnerships with leading global diagnostic companies including
Abbott, QIAGEN, Sysmex, and Quest Diagnostics. 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
antje.zeise@epigenomics.com

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