EANS-News: Epigenomics AG / Epigenomics AG Announces First Half 2012 Financial Results and Reports Operational Highlights

--------------------------------------------------------------------------------
Corporate news transmitted by euro adhoc. The issuer/originator is solely
responsible for the content of this announcement.
--------------------------------------------------------------------------------

quarterly report

Berlin (euro adhoc) - Berlin, Germany, and Seattle, WA, U.S.A.,
August 8, 2012 - Epigenomics AG (Frankfurt Prime Standard: ECX), the
German-American cancer molecular diagnostics company, today announced
its financial results for the first half and second quarter ending
June 30, 2012.

"During the second quarter of 2012 we maintained our focus on taking
the remaining steps necessary to gain U.S. regulatory approval for
Epi proColon®. The head-to-head comparative study against fecal
immunochemical testing is progressing according to plan and is
expected to be completed in the fourth quarter, thereby enabling us
to finalize our FDA Premarket Approval (PMA) application.", said
Geert Nygaard, Chief Executive Officer of Epigenomics AG. He
continued: "We are also seeing progress in terms of
commercialization. In June, we signed an additional LDT licensing
agreement with U.S. based Companion Dx Reference Lab. The
availability of a specific CPT-code for Septin9 testing is a further
essential prerequisite for obtaining reimbursement once the coding
reform for laboratory diagnostics in the U.S. will enter into force
at the beginning of 2013. In addition, the decision of Swiss Life in
France to reimburse up to 50% of the cost of the Septin9 blood based
test for early detection of colorectal cancer as part of a preventive
health program further validates our recently implemented
commercialization approach in Europe by which we collaborate closely
with key players in the healthcare system."

Q2 / H1 2012 Financial Results

- Revenue in Q2 2012 of EUR 156 thousand was significantly lower
than the comparable number for the previous year (Q2 2011: EUR 364
thousand), as no R&D income was recognized, as well as product sales
and licensing income lagged behind their comparables for the previous
year. - As expected, R&D costs increased notably in Q2 2012 from EUR
1.4 million in Q2 2011 to EUR 2.1 million. This is mainly due to the
start of the FIT comparison study and increased activities towards
the FDA approval process. In addition, capitalization of R&D expenses
as development costs of EUR 302 thousand in Q2 2011 have to be
considered in the comparison to last year's numbers since R&D expense
did not impact the profit and loss statement at that time. - SG&A
costs decreased year-over-year from EUR 1.8 million in Q2 2011 to EUR
1.5 million in Q2 2012, primarily due to restructuring measures
implemented in 2011 in the marketing and sales departments. -
EBIT for Q2 2012 amounted to EUR -3.4 million - a decrease of 15.7%
compared to Q2 2011 (EUR -3.0 million). EBIT for the first six months
of 2012 was on last year's level at EUR -5.7 million (H1 2011: EUR
-5.7 million). - Net loss for Q2 2012 amounted to EUR 3.4 million (Q2
2011: EUR 3.0 million) and for H1 2012 to EUR 5.7 million (H1 2011:
EUR 5.9 million). - Cash consumption in H1 2012 was EUR 5.0 million
(H1 2011: EUR 5.8 million), which included increasing payments in
connection with the activities towards the FDA approval process of
Epi proColon®. - Liquidity at the end of the period amounted
to EUR 9.1 million (December 31, 2011: EUR 14.0 million).

Operational highlights

- FIT comparison study: In the second quarter of 2012,
Epigenomics started a head-to-head comparative study of Epi proColon®
to fecal immunochemical testing (FIT). This study will be an integral
part of the fourth and last module of the PMA submission to be filed
with the U.S. FDA. The goal of this study is to demonstrate
non-inferiority of Epi proColon® to FIT. In April 2012, the Company
announced the inclusion of the first study subject and the trail
progressed significantly since then. It is anticipated that this
study will be completed in the fourth quarter of 2012. - U.S.
regulatory process for Epi proColon®: In June 2012 the third module
of the PMA application, relating to analytical validation of the
test, was submitted to the FDA. The final module, containing all
clinical data, is scheduled for submission before the end of the
current year, which will then formally complete Epigenomics
regulatory submission documentation. - Licensing agreement for
Septin9 with Companion Dx: In June 2012, Epigenomics announced the
signature of an additional licensing agreement for its proprietary
DNA methylation biomarker Septin9 with Companion Dx Reference Lab,
Houston, TX, U.S.A. Under the terms of the agreement, Companion Dx
obtained rights to establish and commercialize a blood-based LDT for
the detection of colorectal cancer using methylated Septin9 as a
biomarker. Epigenomics is entitled to double-digit royalties on test
sales. With this licensing agreement, Epigenomics continues to
execute on its U.S. commercialization strategy of creating market
acceptance for Septin9 testing well ahead of the launch of a
proprietary diagnostic product approved by the FDA. The growing
uptake of the Septin9 assay through LDT licensees is encouraging. The
agreement with Companion Dx complements the already existing LDT
agreements with Quest Diagnostics, ARUP Laboratories and
Gamma-Dynacare Medical Laboratories (formerly: Warnex Medical
Laboratories) in North America. The availability of a specific
CPT-code for Septin9 testing is a further essential prerequisite for
obtaining reimbursement once the coding reform for laboratory
diagnostics in the U.S. will enter into force at the beginning of
2013. - Reimbursement of the Septin9 blood based colorectal cancer
test by Swiss Life in France (after the end of the reporting period):
In July 2012, Epigenomics announced that Swiss Life, France's third
largest private health insurance company, will recommend the Septin9
blood based test for the early detection of CRC to their
policyholders as part of their optional preventive health program. As
the first French insurance company, Swiss Life is now offering up to
50% reimbursement of the Septin9 test at a cost of EUR 95. French
Social Security does not currently cover the Septin9 test. Epi
proColon® 2.0 CE has recently become commercially available in France
so Epigenomics is now able to expand into the French market.

Outlook for 2012

- Throughout 2012, Epigenomics will continue to entertain an
active dialog with screening guideline inclusion groups,
reimbursement authorities, and has begun the process of speaking with
patient advocacy constituents, predominantly in the US.
Simultaneously, the Company is extending its network in the medical
expert community in order to gain support for its product by key
opinion leaders in the field. Epigenomics has also started
preparations for an FDA advisory panel meeting, which the Company
expects to become part of the review process by the FDA. - In line
with the previous guidance, own product sales from IVD diagnostic
products remained at a modest level during H1 2012. Epigenomics
continues to seek potential licensing partners in the United States
and distribution partners as well as key account customers in the
rest of world. However, own product-derived revenues are expected to
remain at modest levels prior to the U.S. approval of Epi proColon®
by the FDA. - EBIT and net loss are expected to narrow in 2012 in
comparison to 2011 due to the effect from the restructuring plan
implemented in 2011. However, a critically important strategic goal
for 2012 remains to secure the future of the business. The necessity
to invest into the regulatory related activities ahead of completion
of the FDA submission will force the Company to secure additional
resources to execute Epigenomics' plans. The Company is currently
evaluating all strategic options available, including the possibility
a capital markets transaction. - Overall, the Company remains
committed to completing the FDA submission later this year and on its
ultimate goal of introducing Epi proColon® as the first approved
blood-based test for the early detection of colorectal cancer into
the U.S. market.

Further Information

Conference call for press and analysts

The full 6-Months Financial Report 2012 can be obtained from
Epigenomics' website at: http://www.epigenomics.com/en/news-investors
/investors/financial-reports.html

Epigenomics' management will host a conference call and an audio
webcast at 3pm CET/9am ET today, Wednesday 8th August 2012. The
dial-in numbers for the conference call are:

Dial-in number (within Germany): + 49 69 247 501 899
Dial-in number (within the UK): +44 203 147 4862
Dial-in number (within the U.S.): +1 212 444 0296
Participants are kindly requested to dial in 10 minutes prior to the start of
the call.

The presentation accompanying the conference call and dial-in details for the
audio webcast will be available on Epigenomics' website:
http://www.epigenomics.com/en/news-investors.html

A webcast of the conference call will be provided on Epigenomics'
website subsequently:
http://www.epigenomics.com/en/news-investors.html

- Ends -

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 disclaimer 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 or Canada. The analytical and
clinical performance characteristics of any Epigenomics product based
on this technology which may be sold at some future time in the U.S.
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
--------------------------------------------------------------------------------

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