OncoMethylome Announces Second Business Update for 2009 and Several
Business Changes
Business Changes
ONE
jueves, 5 noviembre 2009, 08:07
Liege (Belgium) - November 5, 2009, 8:00 AM CET - OncoMethylome
Sciences announces today its third quarter financial results, the
focusing of the business, an update on the status of certain of its
products, and a change in management.
Q3 2009 material events
* Published new clinical data on the blood-based colorectal cancer
screening test at Europe's largest cancer congress (ECCO-ESMO)
* Published further clinical data on the urine-based bladder cancer
detection test
* Remained on track for enrollment of new patients in the company's
largest clinical trials, such as the 7.000-patient colorectal
cancer screening trial
Key non-audited financials, as of September 30th, 2009:
Amounts as at and for the three months ended
+---------------------------------------------------------------+
Euro thousands Sept. 30, 2009 Sept 30, 2008
------------------------------+----------------+---------------
Revenues 577 758
------------------------------+----------------+---------------
EBITDA Income (Loss) (2,797) (2,079)
------------------------------+----------------+---------------
EBIT Operating Income (Loss) (3,036) (2,330)
------------------------------+----------------+---------------
Net Profit (Loss) (2,907) (2,065)
------------------------------+----------------+---------------
Cash and cash equivalents 21,065 23,999
+---------------------------------------------------------------+
Amounts as at and for the nine months ended
+---------------------------------------------------------------+
Euro thousands Sept. 30, 2009 Sept 30, 2008
------------------------------+----------------+---------------
Revenues 1,845 2,279
------------------------------+----------------+---------------
EBITDA Income (Loss) (8,862) (7,800)
------------------------------+----------------+---------------
EBIT Operating Income (Loss) (9,565) (8,548)
------------------------------+----------------+---------------
Net Profit (Loss) (9,247) (7,765)
------------------------------+----------------+---------------
Cash and cash equivalents 21,065 23,999
+---------------------------------------------------------------+
Business changes and outlook after Q3 2009:
OncoMethylome announces a focusing of its diagnostics business on
three clinical areas: colorectal, prostate and bladder cancer.
Moreover, the geographical emphasis for market entry with its
products will be on the USA, as it is and will be the main market for
molecular diagnostics for the years to come. This implies that no
direct sales and marketing force will be built up in Europe by
OncoMethylome for the foreseeable future. OncoMethylome will
continue to work closely with large distribution partners and leading
national testing laboratories. Although the focusing will likely
impact the current organization, it will allow OncoMethylome to
expand clinical validation of the most advanced products in the key
medical markets and thereby should enhance the commercial potential
of the company's product pipeline.
Colorectal cancer continues to be a leading cause of cancer-related
deaths worldwide due in part to low patient compliance with existing
screening tests or to the inability of currently marketed tests to
detect enough cancers at their earlier stages of development. In
colorectal cancer, OncoMethylome presented in Berlin in September
2009 results of its blood-based DNA Methylation test from a
case-control study (http://www.ecco-org.eu/Conferences-and-
Events/ECCO-15-ESMO-34/Press-Release/List-of-press-releases/New-blood-tests-promise-simple/page.aspx/1812).
The company expects to complete the enrollment in its 7.000 patient
blood-based colorectal cancer screening trial by Q1 2010 and the
company continues to negotiate the distribution rights for the test
with several international companies.
In prostate cancer, current tests fail to adequately address medical
needs for patients with elevated PSA (prostate specific antigen).
OncoMethylome has licensed to Veridex LLC two types of DNA
Methylation tests to address these needs. The first is a DNA
Methylation test on biopsy tissue with two markers (me-GSTP1 and
me-APC) to assess the probability of a negative re-biopsy. This
tissue test is currently marketed by LabCorp in the USA under a
sub-license from Veridex. The second is a test on urine with three
markers (me-GSTP1, me-APC and me-RAR2B), which is under development
for improved prostate cancer screening and monitoring of patients
with an initial negative biopsy. Veridex recently completed a
500-patient Beta-clinical investigation where the results met
performance expectations.
Veridex has informed OncoMethylome of its decision at this time not
to further develop nor to commercialize the prostate test itself,
based on a strategic choice to invest in other areas of its business.
Veridex, jointly with OncoMethylome, is reviewing alternatives for
partners. This is expected to delay finalizing the kit development
and regulatory process for the prostate products.
In bladder cancer, OncoMethylome has done feasibility tests and
developed a prototype test for the application of early bladder
cancer detection. The clinical data so far looks very promising and
has the potential to be significantly better than any other tests
currently on the market. Two main applications are being considered :
(i) early detection of cancer among people at risk for bladder cancer
such as people with hematuria (blood in a person's urine is often the
first and only sign of bladder cancer) and (ii) monitoring of cancer
recurrence among patients treated for bladder cancer in the previous
5 years since 70% of bladder cancers recur within 5 years after
treatment. In several published case-control studies,
OncoMethylome's bladder test is showing both sensitivity and
specificity above 90% for the detection of bladder cancer among
people at risk. The company is also conducting prospective studies
for the monitoring of bladder cancer recurrence.
Herman Spolders (63) will retire as the CEO of OncoMethylome
effective 1st of January 2010. Herman has founded the company and we
are greatly indebted to him for building OncoMethylome from its
start. Herman will continue as a non-executive board member. Philip
Devine will take over day to day management of the company and will
be combining his current role of CFO with that of interim CEO. The
company is conducting a search for a new CEO.
Revenues for the full year 2009 are expected to be below those of
2008. For 2010, revenues are expected to remain stable. The net
loss for the full year 2009 is expected to increase compared to
2008. For 2010, the net loss is expected to be reduced due to the
focusing of the business.
About OncoMethylome Sciences
OncoMethylome Sciences (Euronext Brussels: ONCOB; Euronext Amsterdam:
ONCOA) is a molecular diagnostics company developing gene methylation
tests to assist physicians in effectively detecting and treating
cancer. Specifically, the company's tests are designed to help the
physician (i) accurately detect cancer in early stages of cancer
development, (ii) predict a patient's response to drug therapy, and
(iii) predict the likelihood of cancer recurrence.
OncoMethylome has products in development for major cancer areas
(Colorectal, Bladder, and Prostate) and has several products already
on the market in the United States via LabCorp. The company
collaborates with leading international molecular oncology research
centers, such as The Johns Hopkins University, and has a number of
commercial and collaborative partnerships with Veridex LLC, a Johnson
& Johnson company, LabCorp, Schering-Plough Corp., GlaxoSmithKline
Biologicals, Abbott, Merck KGaA, and Millipore Corporation's
BioScience Division. OncoMethylome's products are based on
methylation technology invented by Johns Hopkins University (USA).
Established in January 2003, OncoMethylome has offices in Europe and
the United States.
For more information please contact:
Philip Devine
Tel. +32 4 364 2070
ir@oncomethylome.com
or visit: www.oncomethylome.com
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.
This announcement was originally distributed by Hugin. The issuer is
solely responsible for the content of this announcement.
Sciences announces today its third quarter financial results, the
focusing of the business, an update on the status of certain of its
products, and a change in management.
Q3 2009 material events
* Published new clinical data on the blood-based colorectal cancer
screening test at Europe's largest cancer congress (ECCO-ESMO)
* Published further clinical data on the urine-based bladder cancer
detection test
* Remained on track for enrollment of new patients in the company's
largest clinical trials, such as the 7.000-patient colorectal
cancer screening trial
Key non-audited financials, as of September 30th, 2009:
Amounts as at and for the three months ended
+---------------------------------------------------------------+
Euro thousands Sept. 30, 2009 Sept 30, 2008
------------------------------+----------------+---------------
Revenues 577 758
------------------------------+----------------+---------------
EBITDA Income (Loss) (2,797) (2,079)
------------------------------+----------------+---------------
EBIT Operating Income (Loss) (3,036) (2,330)
------------------------------+----------------+---------------
Net Profit (Loss) (2,907) (2,065)
------------------------------+----------------+---------------
Cash and cash equivalents 21,065 23,999
+---------------------------------------------------------------+
Amounts as at and for the nine months ended
+---------------------------------------------------------------+
Euro thousands Sept. 30, 2009 Sept 30, 2008
------------------------------+----------------+---------------
Revenues 1,845 2,279
------------------------------+----------------+---------------
EBITDA Income (Loss) (8,862) (7,800)
------------------------------+----------------+---------------
EBIT Operating Income (Loss) (9,565) (8,548)
------------------------------+----------------+---------------
Net Profit (Loss) (9,247) (7,765)
------------------------------+----------------+---------------
Cash and cash equivalents 21,065 23,999
+---------------------------------------------------------------+
Business changes and outlook after Q3 2009:
OncoMethylome announces a focusing of its diagnostics business on
three clinical areas: colorectal, prostate and bladder cancer.
Moreover, the geographical emphasis for market entry with its
products will be on the USA, as it is and will be the main market for
molecular diagnostics for the years to come. This implies that no
direct sales and marketing force will be built up in Europe by
OncoMethylome for the foreseeable future. OncoMethylome will
continue to work closely with large distribution partners and leading
national testing laboratories. Although the focusing will likely
impact the current organization, it will allow OncoMethylome to
expand clinical validation of the most advanced products in the key
medical markets and thereby should enhance the commercial potential
of the company's product pipeline.
Colorectal cancer continues to be a leading cause of cancer-related
deaths worldwide due in part to low patient compliance with existing
screening tests or to the inability of currently marketed tests to
detect enough cancers at their earlier stages of development. In
colorectal cancer, OncoMethylome presented in Berlin in September
2009 results of its blood-based DNA Methylation test from a
case-control study (http://www.ecco-org.eu/Conferences-and-
Events/ECCO-15-ESMO-34/Press-Release/List-of-press-releases/New-blood-tests-promise-simple/page.aspx/1812).
The company expects to complete the enrollment in its 7.000 patient
blood-based colorectal cancer screening trial by Q1 2010 and the
company continues to negotiate the distribution rights for the test
with several international companies.
In prostate cancer, current tests fail to adequately address medical
needs for patients with elevated PSA (prostate specific antigen).
OncoMethylome has licensed to Veridex LLC two types of DNA
Methylation tests to address these needs. The first is a DNA
Methylation test on biopsy tissue with two markers (me-GSTP1 and
me-APC) to assess the probability of a negative re-biopsy. This
tissue test is currently marketed by LabCorp in the USA under a
sub-license from Veridex. The second is a test on urine with three
markers (me-GSTP1, me-APC and me-RAR2B), which is under development
for improved prostate cancer screening and monitoring of patients
with an initial negative biopsy. Veridex recently completed a
500-patient Beta-clinical investigation where the results met
performance expectations.
Veridex has informed OncoMethylome of its decision at this time not
to further develop nor to commercialize the prostate test itself,
based on a strategic choice to invest in other areas of its business.
Veridex, jointly with OncoMethylome, is reviewing alternatives for
partners. This is expected to delay finalizing the kit development
and regulatory process for the prostate products.
In bladder cancer, OncoMethylome has done feasibility tests and
developed a prototype test for the application of early bladder
cancer detection. The clinical data so far looks very promising and
has the potential to be significantly better than any other tests
currently on the market. Two main applications are being considered :
(i) early detection of cancer among people at risk for bladder cancer
such as people with hematuria (blood in a person's urine is often the
first and only sign of bladder cancer) and (ii) monitoring of cancer
recurrence among patients treated for bladder cancer in the previous
5 years since 70% of bladder cancers recur within 5 years after
treatment. In several published case-control studies,
OncoMethylome's bladder test is showing both sensitivity and
specificity above 90% for the detection of bladder cancer among
people at risk. The company is also conducting prospective studies
for the monitoring of bladder cancer recurrence.
Herman Spolders (63) will retire as the CEO of OncoMethylome
effective 1st of January 2010. Herman has founded the company and we
are greatly indebted to him for building OncoMethylome from its
start. Herman will continue as a non-executive board member. Philip
Devine will take over day to day management of the company and will
be combining his current role of CFO with that of interim CEO. The
company is conducting a search for a new CEO.
Revenues for the full year 2009 are expected to be below those of
2008. For 2010, revenues are expected to remain stable. The net
loss for the full year 2009 is expected to increase compared to
2008. For 2010, the net loss is expected to be reduced due to the
focusing of the business.
About OncoMethylome Sciences
OncoMethylome Sciences (Euronext Brussels: ONCOB; Euronext Amsterdam:
ONCOA) is a molecular diagnostics company developing gene methylation
tests to assist physicians in effectively detecting and treating
cancer. Specifically, the company's tests are designed to help the
physician (i) accurately detect cancer in early stages of cancer
development, (ii) predict a patient's response to drug therapy, and
(iii) predict the likelihood of cancer recurrence.
OncoMethylome has products in development for major cancer areas
(Colorectal, Bladder, and Prostate) and has several products already
on the market in the United States via LabCorp. The company
collaborates with leading international molecular oncology research
centers, such as The Johns Hopkins University, and has a number of
commercial and collaborative partnerships with Veridex LLC, a Johnson
& Johnson company, LabCorp, Schering-Plough Corp., GlaxoSmithKline
Biologicals, Abbott, Merck KGaA, and Millipore Corporation's
BioScience Division. OncoMethylome's products are based on
methylation technology invented by Johns Hopkins University (USA).
Established in January 2003, OncoMethylome has offices in Europe and
the United States.
For more information please contact:
Philip Devine
Tel. +32 4 364 2070
ir@oncomethylome.com
or visit: www.oncomethylome.com
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.
This announcement was originally distributed by Hugin. The issuer is
solely responsible for the content of this announcement.
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