OncoMethylome Sciences Reports 2010 Half-Year Results and Announces New Strategy

Donnerstag, 26.08.2010 08:05 von Hugin - Aufrufe: 139

DURHAM, NC, and LIEGE, BELGIUM - August 26, 2010 - OncoMethylome Sciences
(Euronext Brussels: ONCOB, Euronext Amsterdam: ONCOA), a leading molecular
diagnostics company, announced today its 2010 half-year results and its new
strategy.
 
Highlights
 
-    Strategic/Commercial
         o   Cervical cancer triage test partnered with Self-Screen BV
         o   Initiated Roche (Avastin) trial to use MGMT testing services for
brain cancer
         o   Stool-based colorectal cancer biomarkers partnered with Exact
Sciences (July)
-    Financial
         o   Net cash flows improved by 48% from H1 2009
         o   Net result and EPS improved by 21% from H1 2009
         o   Commercial revenues improved by 55% from H1 2009
-    Corporate
         o   New CEO
         o   Strengthened Board of Directors
-    Operational
         o   Consolidated lab operations
         o   Obtained ISO certification for the company's commercial lab
 
"Our commercial, financial and operational results for the first half of 2010
are much improved compared to the same period in 2009, and we expect results for
the second half of 2010 to follow the same path," said Dr. Jan Groen, CEO of
OncoMethylome Sciences.
 
"Furthermore," continued Dr. Groen, "since I joined OncoMethylome, management
has worked very closely with the Board of Directors to define a sustainable path
of accelerated growth and, capitalizing on our unique DNA methylation platform,
positioning OncoMethylome as a leader in the rapidly growing market of molecular
diagnostics. The cornerstone of our new strategy will be the development and
commercialization of high-value predictive and prognostic laboratory developed
tests - a step that will move OncoMethylome away from its historical, long-term
focus on basic research for cancer screening applications and out-licensing of
biomarkers to third parties for eventual product development and
commercialization. The aim of this new strategy is to forge a company that can
determine its own fate, is less dependent on priorities and timelines of
licensing partners, and operates in a space with high-end products in terms of
pricing and reimbursement. First and foremost, it is our goal to reap the full
benefits of our proprietary DNA methylation platform by developing stand-alone
 molecular diagnostic products for rapid commercialization.
 
Management and the Board of Directors believe that the new business model will
improve cash flows, while allowing the company to out-license the validated
biomarkers related to screening programs. Management and Board of Directors are
confident that the new course they are plotting for OncoMethylome should create
improved shareholder value in the short, medium and long-term."
 
Strategic/Commercial Deals
 
* Cervical cancer
 
      OncoMethylome and its new partner, SelfScreen BV are developing a test to
identify/triage those HPV-positive women that really have cancer and thus need a
follow-up examination with a gynaecologist.  Many women screened for cervical
cancer are found to have the HPV virus, but few of them actually have cervical
cancer.  The partners are seeking a worldwide licensing partner to commercialize
the test.
 
* F. Hoffmann-La Roche Ltd.,  --  Avastin in brain cancer
 
      OncoMethylome has entered into an agreement with Roche for MGMT gene
promoter methylation testing in a Phase III clinical trial for the use of
Avastin in newly diagnosed glioblastoma (GBM) brain tumors. OncoMethylome's MGMT
assay helps to predict those brain cancer patients that will respond to therapy
and so is useful in patient stratification in the clinical trial. Following
treatment, GBM patients whose tumors are positive for MGMT gene promoter
methylation have demonstrated improved overall survival compared to patients
with unmethylated or normally functioning MGMT.  This new trial expands on the
numerous other trials of other pharmaceutical companies that already use
OncoMethylome's proprietary MGMT methylation test.
 
* Stool-based Colorectal cancer screening biomarkers
 
      OncoMethylome has partnered its stool-based colorectal cancer biomarkers
with Exact Sciences Corporation.  Exact Sciences is developing a colorectal
cancer test and has announced an intention to seek FDA approval for the test in
2012 and to commercialize it as an IVD kit.
 
Financial Highlights
 
Key Figures (EUR thousands, except number of shares and per share data):
 
+-------------------------------------------+---------------+---------------+
|   | June 30, 2010 | June 30, 2009 |
+-------------------------------------------+---------------+---------------+
| Revenues | 1,258 | 1,268 |
+-------------------------------------------+---------------+---------------+
| Operating loss (EBIT) | -5,152 | -6,529 |
+-------------------------------------------+---------------+---------------+
| Net loss | -4,996 | -6,340 |
+-------------------------------------------+---------------+---------------+
| Earnings per share, basic and diluted (¤) | -0.38 | -0.48 |
+-------------------------------------------+---------------+---------------+
| Number of outstanding shares | 13,185,614 | 13,185,614 |
+-------------------------------------------+---------------+---------------+
| Cash and cash equivalents | 14,437 | 23,745 |
+-------------------------------------------+---------------+---------------+
 
Revenues
Total revenues remained stable at EUR 1.3 million.  The commercial revenues, as
a component of total revenues, increased by 55% due to higher testing volume.
Grant revenues decreased by 31% due to the company's focus on development and
commercialization efforts rather than on subsidized basic research projects.
 
Costs and Profitability
Total research and development expenses for the first half of 2010 were EUR 4.4
million compared with EUR 5.6 million for the first half of 2009. This 22%
decrease resulted from a reduction in both internal and external R&D expenses.
As part of the optimization efforts commenced at the end of 2009, the company
spent less in 2010 on basic research projects with external parties and
internally the company consolidated its R&D facilities.
 
Selling, general and administrative expenses decreased by 7% to EUR 2 million in
the first half of 2010 from EUR 2.1 million in H1 2009.
 
The decrease in R&D and SG&A expenses achieved in H1 2010 allowed the total
operating costs to decrease by 19% compared to the same period in 2009.
Excluding one-time restructuring charges, the adjusted total operating charges
therefore reflect a decrease of 24% compared to H1 2009.
 
Cash Position
OncoMethylome's cash and cash equivalents amounted to EUR 14.4 million at June
30, 2010. Total net cash consumed in the first 6 months of 2010 decreased to EUR
3.6 million compared to a total net cash consumption of EUR 6.9 million in the
same period of 2009.  This 48% improvement in cash flow was the result of
efforts launched at the end of 2009 to reduce the cash burn, to accelerate
collection of receivables, and from the sale of some financial assets.
 
Management and Board Highlights
 
* In April, the Board of Directors appointed Dr. Jan Groen as CEO. Dr. Groen
has more than 25 years of experience in the clinical diagnostic industry,
with a focus on emerging technologies, product development and
commercialization. He was previously the president of Agendia Inc. and COO
of Agendia B.V., and was responsible for their U.S. and European diagnostic
operations.  Prior to this he was vice president of research and development
at Focus Diagnostics Inc., a subsidiary of Quest Diagnostics, in California.
He has held numerous management and scientific positions at ViroClinics
B.V., the Erasmus Medical Center, and Akzo-Nobel. Dr. Groen is a supervisory
board member of IBL International B.V.
 
* On May 28, 2010, Ms. Hilde Windels, Mr. Edward L. Erickson, and Mr. Mark
Myslinski were elected to the Board of Directors, adding three seasoned
industry professionals to the Board.
 
* Recently OncoMethylome's Board of Directors elected Mr. Edward L. Erickson
as Chairman of the company.  He has served as President, CEO and Director of
a number of US life sciences companies.
 
* Effective August 25, 2010, Mr. Alain Parthoens has stepped down from the
board to focus on his venture capital activities. The company thanks Mr.
Parthoens for his valuable contribution to the company and to the Board.
 
Operational Highlights
 
* OncoMethylome is in the process of consolidating all European activities in
Belgium and thus will close its Netherlands facility by the end of 2010.
 
* OncoMethylome obtained ISO certification for its Liege based laboratory.
This facility is the main research and development facility and commercial
testing lab of the company and also provides clinical testing services for
its pharmaceutical partners.
 
* An assessment of the ongoing validation studies of the company's colorectal
cancer (CRC) blood-based screening program has demonstrated comparable
performance to a competing test already on the market. While CRC will
constitute one of the important areas of OncoMethylome's new strategy, this
blood-based screening test and its associated biomarkers are no longer a
strategic fit. Therefore the company will out-license these biomarkers as
soon as practical.
 
Outlook for H2 2010
 
For the full year 2010 OncoMethylome expects:
    ·     Revenues to remain stable compared to 2009, with an increase in
commercial revenues off-setting the decrease in grant revenues.
    ·     Total operating costs are expected to decrease by 20%, although these
may be impacted by one-time charges in connection with the consolidation of our
facilities and related operations.
    ·     The net result is expected to improve by more than 20%.
 
The company intends to announce its new strategy in more detail in 4-6 weeks.
Furthermore, in line with the company's transition from a basic research company
to a commercial clinical diagnostic entity, the company intends to propose a new
corporate name to its shareholders that better captures its commercial
ambitions. As a consequence, the company plans to convene an extraordinary
shareholders' meeting.
 
Statutory Auditor's Limited Review Report
 
"We have reviewed the accompanying consolidated statement of financial position
of OncoMethylome Sciences S.A. and its subsidiaries, as of 30 June 2010 and the
related consolidated income statement, statement of comprehensive income,
changes in equity and cash flows for the six month period then ended, as well as
the condensed explanatory notes. The board of directors is responsible for the
preparation and presentation of this condensed consolidated interim financial
information in accordance with IAS 34 as adopted by the European Union. Our
responsibility is to express a conclusion on this condensed consolidated interim
financial information based on our review.
 
We conducted our review in accordance with the recommendation of the Belgian
Institute of Company Auditors related to the performance of reviews.
Accordingly, it involved principally analysis, comparison and discussion of the
condensed consolidated interim financial information and, accordingly, was less
extensive in scope than an audit of that information.
 
Our review did not reveal any matters requiring correction of the condensed
consolidated interim financial information for it to have been prepared, in all
material respects, in accordance with IAS 34 as adopted by the European Union."
 
Zaventem - August 25, 2010
The Statutory Auditor
BDO Atrio Réviseurs d'Entreprises Soc. Civ. SCRL
Represented by Bert Kegels
 
Complete Financial Statements:
 
To download the 2010 interim report, go to
http://www.oncomethylome.com/investors/documents
 
About OncoMethylome Sciences
OncoMethylome Sciences is a leading molecular diagnostics company that
commercializes and develops cancer tests to assist physicians in personalizing
cancer treatment. The company's tests are based on proprietary DNA methylation
technology invented at Johns Hopkins University and are designed to help the
physician accurately identify cancer and its aggressiveness, predict a patient's
response to drug therapy, and predict the likelihood of cancer recurrence.
OncoMethylome Sciences collaborates with leading cancer research centers, such
as Johns Hopkins, in Baltimore, MD, and has a number of commercial and
collaborative partnerships with LabCorp, Schering-Plough, GlaxoSmithKline
Biologicals,  F. Hoffmann-La Roche, Merck Serono and Qiagen.
 
For more information:
Dr. Jan Groen
CEO
Telephone (+32) 4.364.20.70
 
This press release contains forward-looking statements and estimates with
respect to the anticipated future performance of OncoMethylome and the market in
which it operates. Such statements and estimates are based on assumptions and
assessments of known and unknown risks, uncertainties and other factors, which
were deemed reasonable but may not prove to be correct. Actual events are
difficult to predict, may depend upon factors that are beyond the Company's
control, and may turn out to be materially different.  OncoMethylome expressly
disclaims any obligation to update any such forward-looking statements in this
release to reflect any change in its expectations with regard thereto or any
change in events, conditions or circumstances on which any such statement is
based unless required by law or regulation.
 
[HUG#1440347]
 
2010-8-26 Half year results:
http://hugin.info/137314/R/1440347/384731.pdf
 
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
All reproduction for further distribution is prohibited.

Source: OncoMethylome Sciences via Thomson Reuters ONE
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