EANS-News: Epigenomics AG Reports First Half 2009 Results

Key Figures

. Revenue: EUR 2.1 million in H1 2009, up by 37% (H1
2008: EUR 1.5 million)
. EBIT: EUR - 4.8 million in H1 2009,
improved by 19% (H1 2008: EUR -5.9 million)
. Net loss: EUR - 4.8
million in H1 2009, decreased by 15% (H1 2008: EUR -5.6 illion)
.
Liquid assets: EUR 12.1 million as of 30/06/2009 (31/12/2008: EUR
12.1 million)

Highlights of the First Half 2009

.
Significantly improved revenue, EBIT and net loss
. Progressed
PRESEPT colorectal cancer clinical study according to plan
. First
diagnostic mSEPT9 blood testing service for colorectal cancer
launched by Swiss Viollier AG
. Development of Abbott mSEPT9 IVD
product on track for European product launch in Q4/2009
. Awarded
grant by the German Federal Government for further research into
colorectal cancer biomarkers
. Presented mSEPT9 data and reported on
progress of PRESEPT Study at several international conferences
.
Received allowances for key patents in Europe
. Obtained ISO 13485
certification for development, manufacturing and distribution of IVD
products

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

companies/finances/Molecular diagnostics

Press release, Berlin, Germany, and Seattle, WA, U.S.A., August 11,
2009 (euro adhoc) - Epigenomics AG (Frankfurt Prime Standard: ECX), a
molecular diagnostics company focusing on the development and
commercialization of in vitro diagnostic products for cancer, today
reported financial results for the second quarter and first half of
2009, which ended June 30, 2009.

Commenting on the first six months, Geert Nygaard, the company's
Chief Executive Officer said: "In the first half of 2009 we have made
significant progress on moving towards becoming a commercial
molecular diagnostics company. The mSEPT9 colorectal cancer blood
test is now for the first time available to patients in Europe.
Further, we obtained ISO 13485 certification for the development,
manufacturing and distribution of IVD products. Both are important
milestones on our way to becoming a leading cancer molecular
diagnostics company."

"The significant progress in our partnerships, product development,
clinical PRESEPT Study and commercialization efforts are all
reflected in our first half financials. We are well on track for
meeting all our financial goals and guidance with an expected revenue
growth to more than EUR 3 million for fiscal 2009", added Oliver
Schacht, the company's Chief Financial Officer.

First Half 2009 - Financial Review

Epigenomics' revenue in the first half of 2009 amounted to EUR 2.1
million, an increase of more than 37% compared to EUR 1.5 million
during the same period in 2008. H1 revenue was generated from
continued and newly signed collaborations and licensing agreements in
the form of R&D payments, licensing fees, reimbursements as well as
product sales from Research-Use-Only (RUO) kits.

EBIT for H1 of 2009 of EUR -4.8 million was a 19% improvement
compared to EBIT for the corresponding period in 2008 of EUR -5.9
million.

R&D costs dropped from EUR 4.7 million in the first half of 2008 to
EUR 3.4 million in the reporting period primarily resulting from
increased resource allocation to Epigenomics' commercial
collaboration projects i.e. to cost of sales, as well as from
consolidating all laboratory operations at the Berlin site at the end
of the second quarter of 2008. Costs of sales increased to EUR 1.5
million compared to EUR 0.5 million in H1 2008, mainly as a result of
increased product development expenses within the collaboration
projects with Abbott Molecular (Abbott) and Philips.

Net loss for the reporting period amounted to EUR -4.8 million, a
substantial reduction compared to EUR -5.6 million in H1 2008. Basic
loss per share improved from EUR -0.22 in H1 2008 to EUR -0.17 in H1
2009.

In the first half of 2009, Epigenomics' cash flow and its financial
position were mainly affected by the continued net cash consumption
from operating activities and the successful PIPE financing
transaction in February 2009. As of June 30, 2009, liquid assets
amounted to EUR 12.1 million, virtually unchanged compared to
December 31, 2008.

Cash outflow from operating activities in H1 2009 totaled EUR 5.3
million. Cash inflow from investing activities amounted to EUR 0.4
million, primarily due to a redemption of marketable securities. Cash
flow from financing activities was positive at EUR 5.1 million, due
to the capital increase in February 2009. Overall, the net cash flow
in H1 2009 was positive at EUR 0.2 million.

First Half 2009 - Operational Review and Highlights

During the first half of 2009, Epigenomics' R&D activities continued
to focus on executing the PRESEPT Study. PRESEPT is a multicenter
study to characterize the clinical performance of Epigenomics' mSEPT9
biomarker and the potential health economic benefit of colorectal
cancer screening with mSEPT9 in a U.S. colorectal cancer
screening-guideline-eligible population. It enrolls individuals with
an average or increased disease risk according to U.S. screening
guidelines who undergo a screening colonoscopy. In line with
expectations, the 22 participating clinical sites in the U.S. and
Germany by the end of H1 2009 had enrolled a total of 4,906 subjects
that have yielded about two thirds of the target number of 50 cancer
cases. Overall, the study is expected to enroll 7,500 individuals.
First study results are expected to be available by the end of 2009.

In particular in the second quarter of 2009, Epigenomics further
advanced the commercialization of the mSEPT9 blood test for
colorectal cancer. On June 22, the company announced, that one of
Switzerland's largest diagnostics laboratory networks, Viollier AG,
launched mSEPT9 testing service on July 1, 2009. This makes the
mSEPT9 test the first blood test for colorectal cancer detection ever
offered in Europe to patients, general practitioners and
gastroenterologists. Epigenomics further expects several German
laboratories to start offering mSEPT9 testing by year-end and Quest
to launch a laboratory developed test (LDT) in the U.S. in due
course. For broad commercialization, Epigenomics' collaboration
partner Abbott is developing an IVD test kit for mSEPT9. With the
development progressing as expected, Epigenomics expects Abbott to
launch a CE- marked IVD product for mSEPT9 testing in Europe in Q4
2009.

In May 2009, Epigenomics received notice that the German Federal
Ministry of Education and Research (BMBF - Bundesministerium für
Bildung und Forschung) will fund a clinical research project to be
realized in an alliance with scientists from the 2nd Medical Clinic
of the University Hospital rechts der Isar of the Munich Technical
University and the Association of Statutory Health Insurance Doctors
in Bavaria (KVB - Kassenärztliche Vereinigung Bayerns). The project
aims at identifying further biomarkers that in combination with
mSEPT9 have a utility in early stage cancer and potentially polyp
detection. The total project budget is expected to be around EUR 1.3
million and has been successfully started in July.

To further support the adoption of colorectal cancer blood testing
with mSEPT9, Epigenomics during the second quarter of 2009 presented
mSEPT9 data and reported on the progress of the PRESEPT Study at
several scientific and medical conferences in the U.S. and Europe
including the Digestive Disease Week (DDW) in Chicago, IL, U.S.A.,
and the 11th World Congress on Gastrointestinal Cancer in Barcelona,
Spain.

Epigenomics IP position was further strengthened by two Rule 71 (3)
notifications stating that the European Patent Office intends to
grant patents protecting the company's PITX2 DNA methylation
biomarker (mPITX2), a biomarker with prognostic utility in prostate
and breast cancer. These notifications are equivalent to "Notices of
Allowance" by the United States Patent and Trademark Office.

Epigenomics obtained ISO 13485 certification for its quality
management system in June 2009. This certification was granted for
both the headquarters in Berlin, Germany, and the wholly owned
subsidiary Epigenomics, Inc. in Seattle, U.S.A., and is an important
prerequisite for the design, development, manufacture and
distribution of in vitro diagnostic (IVD) products in compliance with
regulatory requirements.

Outlook H2 2009

In the second half of 2009, Epigenomics' focus will continue to be
driving the mSEPT9 blood test through the final stages of clinical
validation and product development. Therefore, a significant part of
the operational activities will continue to be directed towards
executing the PRESEPT Study and delivering clinical results from that
trial. Also, the company will continue working with Abbott to support
them in completing the final phases of their product development with
the strategic goal of having Abbott launch a CE-marked IVD test kit
based on mSEPT9 in Europe in Q4 2009. Independently, the company will
work on broadening the number of laboratories in Europe and the
U.S.A. that offer mSEPT9 testing. The first launch of the mSEPT9 test
in July 2009 by Viollier AG is expected to considerably support the
sales and marketing activities in this area.

The key strategic focus in Epigenomics' marketing and business
development activities in 2009 and 2010 will be on closing additional
non-exclusive licensing deals for mSEPT9 similar to the partnership
with Sysmex Corporation initiated in the first quarter of 2009.
However, to maximize value in any future arrangement, the company
will carefully coordinate the timing of mSEPT9 licensing agreements
with expected results from the PRESEPT Study as well as the expected
Abbott product launch in Europe.

The company's further research and development activities will be
focused on progressing pipeline programs in colorectal, lung and
prostate cancer.

Management expects solid growth in revenue to more than EUR 3 million
for fiscal year 2009 to come from current partnering activities in
diagnostics as milestones are expected to be reached including the
launch of a CE-marked mSEPT9 test kit by Abbott in Europe and the
launch of an LDT by Quest Diagnostics in the U.S., as RUO kit sales
for our mSEPT9, mPITX2 and mGSTP1 kits gain some traction, and as
revenue from new partnerships is introduced. As the bulk of the
PRESEPT expenses will influence 2009 operating expenses, Epigenomics
expects EBIT and net loss for 2009 to correspond to 2008 actuals
despite the increased revenue. Cash burn for fiscal 2009 should be at
a very similar level compared to 2008, i.e. around EUR 10 million.

Further Information

The full 6-Months Report 2009 can be obtained from Epigenomics'
website at:

http://www.epigenomics.com/en/investor_relations/Financial_Informatio
n/

Epigenomics' management will host a conference call on the second
quarter and half year 2009 results at 3pm CET today, Tuesday 11th
August.

The dial-in numbers for the conference call are:

Dial-in number (within Germany): +49 (0)69 247 501 899
Dial-in number (within the US): +1 212 444 0297

Participants are kindly requested to dial in 10 minutes prior to the
start of the call.

The presentation accompanying the conference call will be available
for download on the Epigenomics website:

http://www.epigenomics.com/en/down_loads/corporate_material/

A recording of the conference call will be provided on Epigenomics'
website subsequently:

http://www.epigenomics.com/en/down_loads/corporate_material/

About Epigenomics

Epigenomics is a molecular diagnostics company with a focus on the
development of novel products for cancer. Using DNA methylation
biomarkers, Epigenomics' tests in development aim at diagnosing
cancer at an early stage before symptoms occur and thereby may reduce
mortality from this dreaded disease.

Epigenomics' product pipeline contains a validated biomarker for the
early detection of colorectal cancer in blood plasma, and further
proprietary DNA methylation biomarkers at various stages of
development for prostate and lung cancer detection in urine, blood
and bronchial lavage specimens. Epigenomics' biomarker mSEPT9 for the
early detection of colorectal cancer in a simple blood sample has
demonstrated continuously highest performance in multiple clinical
studies with in total more than 3,000 individuals tested. A large
prospective clinical study - PRESEPT - for evaluation of mSEPT9 in a
screening population is currently under way (www.presept.net).

For development and global commercialization of in vitro diagnostic
test products, Epigenomics pursues a non-exclusive partnering
strategy. Strategic diagnostics industry partners include Abbott
Molecular, Philips, Sysmex Corporation and Quest Diagnostics
Incorporated, for diagnostics test products and services, and QIAGEN
N.V. for sample preparation solutions and research products.

Partners in the health care industry and the biomedical research
community can access Epigenomics' portfolio of proprietary DNA
methylation technologies and biomarkers protected by more than 150
patent families through research products, Biomarker Services, IVD
Development Collaborations, and Licensing. The company is
headquartered in Berlin, Germany, and has a wholly owned subsidiary
in Seattle, WA, U.S.A. For more information, please visit
Epigenomics' website at www.epigenomics.com.

Epigenomics' 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.

end of announcement euro adhoc
--------------------------------------------------------------------------------

ots Originaltext: Epigenomics AG
Im Internet recherchierbar: http://www.presseportal.de

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, Technologie All Share
Börsen: Frankfurt / regulated dealing/prime standard
Berlin / free trade
Hamburg / free trade
Stuttgart / free trade
Düsseldorf / free trade
München / free trade