committed cancer detection...2005 reported on the methylation status of mgmt in tumor tissues from...
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CO M M I T T E D TO E A R LY C A N C E R D E T E CT I O N
A N D P E R S O N A L I Z E D PAT I E N T C A R E
BROCHURE 2006
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TABLE OF CONTENTS
An Innovator in Molecular Diagnostics 3
Key Achievements 2006 4
Letter to Our Shareholders 5
Core Activities 7
Detecting Cancer Early in its Development 8
Personalizing Treatment of Cancer Patients 9
Technology and Intellectual Property 11
Facilities 13
Personnel 14
Investor Relations 17
Key Financial Figures 18
�
OncoMethylome Sciences is focused on improving the diagnosis and care of cancer patients by providing treating physicians
with more accurate and informative diagnostic tests. Specifically, OncoMethylome’s innovative tests are designed to help
physicians accurately detect cancer in early stages of cancer development, predict a patient’s response to drug therapy,
and predict the likelihood of cancer recurrence. OncoMethylome’s goal is to empower physicians with the necessary tools to truly
“personalize” the treatment of each individual patient.
The company boasts a broad product development pipeline consisting of over nine products, spanning a number of prevalent cancers
such as colorectal, prostate and lung cancer. The products in development apply the innovative, patent-protected, DNA methylation
technology invented by Johns Hopkins University (USA).
OncoMethylome seeks to bring its products to the market by granting licenses to leading diagnostic companies with established sales
and marketing capabilities. In exchange, OncoMethylome typically receives milestone payments up-front and royalty payments on
future product sales. Two products, in the field of prostate cancer, have already been licensed in this manner to Veridex, a Johnson
& Johnson company. In addition, one of OncoMethylome’s tests for personalized cancer treatment is currently used in a number of
clinical trials, including a multi-center phase III trial together with Schering-Plough’s drug temozolomide.
OncoMethylome was founded in January 200� and is headquartered in Belgium. It has laboratories in Belgium and The Netherlands.
Its clinical and business development office is located in Durham (NC, USA).
A n i n n o v A t o r i n m o l e c u l A r d i A g n o s t i c s
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Expansion of Personalized Treatment Collaboration with Schering-Plough
• OncoMethylome test is used to stratify patients in large, multi-center, phase III, brain cancer clinical trial
• Clinical trial is validating correlation between MGMT gene methylation and brain tumor response to treatment with Schering-
Plough’s drug temozolomide
• Methylation testing for the trial is successfully done at OncoMethylome’s Amsterdam laboratory and at OncoMethylome’s subcontractor
BRT Laboratories in the USA
• The collaboration and clinical trials with Schering-Plough have been expanded into other cancers
License of Second Prostate Cancer Test to Veridex LLC, a Johnson & Johnson Company
• License covers urine-based test for prostate cancer screening
• Veridex takes over product commercialization responsibilities, including development of the test kit
• OncoMethylome received up-front milestone payment, and qualifies for royalty payments and additional sales-related milestone
payments in the future
Listing of OncoMethylome Shares on Eurolist by Euronext Brussels and Amsterdam
• Issued new shares, thereby increasing cash position by EUR 25.� million
• Secured necessary funds for advancing the company’s broad product pipeline
• Improved company visibility among potential investors and commercial partners
Increase in Product Development Capabilities
• R&D and business development teams significantly strengthened
• 70% increase in personnel
K e y A c h i e v e m e n t s 2 0 0 6
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Dear Shareholder,
2006 was a year of successful growth and transformation for OncoMethylome. We started the year as a private company, with limited
resources, and a relatively unknown, although very promising, product pipeline. Throughout 2006 we made monumental progress
on all these fronts, closing the year as a publicly-listed company, with increased human and financial resources, and two additional
commercial deals.
The significant progress we made on our product pipeline fueled our commercial news flow throughout the year. In the diagnostics
area, we most notably advanced our urine-based test for prostate cancer screening, completing the necessary clinical verification. In
December 2006 the test was licensed for commercialization to Veridex, a Johnson & Johnson company. In the area of personalized
treatment, we continued our efforts towards demonstrating, in a large clinical trial, that our MGMT methylation test is a predictor of
patient response to treatment with temozolomide, a Schering-Plough chemotherapy drug. Currently used in a multi-center phase III
clinical trial for brain cancer, this test has the potential to assist doctors in “personalizing” therapy of cancer patients. In October
2006 we announced the expansion of our collaboration with Schering-Plough into additional cancer indications.
On June 27th, 2006 we successfully listed OncoMethylome shares on Eurolist by Euronext Brussels and Euronext Amsterdam. Raising
EUR 25.� million in the IPO, we obtained the necessary financial resources to sustain the growth of the company. During the year
we hired additional experienced personnel, closing the year with a 70% increase in headcount. In 2007 we expect to leverage our
increased human and financial resources to deliver further progress on our broad product pipeline, and to convert that progress into
additional commercial deals. With our prostate products partnered, we expect to spend much of 2007 focusing on developing and
commercially partnering our colorectal cancer and our personalized treatment products.
We would like to take this opportunity to extend a warm welcome to all of our new shareholders and thank them for putting their
trust in our company. We would also like to thank our external research collaborators and our valuable employees, whose hard work
and dedication have been central to the success of the company to date.
Finally, we were happy to see that since the IPO our share price responded positively to our commercial news. We consider ourselves
fortunate to be in a position to both create value for our shareholders, and at the same time work towards products that have the
potential to make a positive impact in the diagnosis and treatment of the people affected by cancer.
We look forward to continuing the positive momentum of the company in 2007!
Sincerely,
Dr. Robert Timmins Herman Spolders
Chairman of the Board Chief Executive Officer
l e t t e r t o o u r s h A r e h o l d e r s
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o u r c o r e A c t i v i t i e s
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o u r c o r e A c t i v i t i e s
Cancer is a very common illness. Approximately half of all men and
one third of all women develop cancer during their lifetime, which
amounts to more than �.� million new cancer cases diagnosed each
year in Europe and United States. Cancer develops when abnormal cells grow
and multiply uncontrollably, often gathering in tumors that eventually invade
healthy organs. Cancerous tumors interfere with normal organ function, and
unless stopped, often result in death. Cancer is most common in people over
the age of fifty, especially in those who have had prolonged exposure to
carcinogens such as tobacco smoke.
L i f e t i m e P r o b a b i l i t y o f D e v e l o p i n g C a n c e r
Prostate — 1 in 6
Lung and Bronchus — 1 in 12
Colon and Rectum — 1 in 17
291,270 273,560
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Breast — 1 in 8
Lung and Bronchus — 1 in 16
Colon and Rectum — 1 in 19
Source: American Cancer Society
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B e a t i n g C a n c e r t h r o u g h
E a r l y D e t e c t i o n
Without exception, one of the best ways to survive
cancer is to detect it early, when it is still confined
to its organ of origin, and is therefore most
effectively treatable. For example, the chances of surviving
colorectal cancer are excellent for patients whose cancer is
detected in the local stage. 90% of such patients survive
beyond five years; however, of those whose cancer is detected
in the distant phase when it has metastasized to other organs,
only 10% live beyond five years. Unfortunately, due to the
limitations of existing diagnostic tests, fewer than half of
colorectal cancers are detected when they are still local and
most effectively treatable. The situation is similar for most
other types of cancer; therefore, a strong and urgent need
remains for OncoMethylome to develop high-quality tests to
screen people for cancer and to detect cancers in their early
stage of development.
% o f c a n c e r p a t i e n t s l i v i n g 5 y e a r s o r l o n g e r
d e t e c t i n g c A n c e r e A r l y i n i t s d e v e l o p m e n t
0%
20%
40%
60%
80%
100% Breast
Colon
Lung
Bladder
Distant Regional Local
Cancer Stage at Time of Diagnosis
O n c o M e t h y l o m e ’ s D i a g n o s t i c T e s t s
OncoMethylome is committed to developing novel molecular
diagnostic tests for detecting cancer while it is still in early
stages of development. OncoMethylome is mainly developing
screening tests, as well as tests for early detection of cancer.
Screening refers to routinely testing seemingly healthy people
for cancer. These individuals may be tested because they are
at risk of developing a cancer due to exposure to carcinogens,
or simply due to their age. On the other hand, early detection
tests are tests that complement the existing diagnostic process
when existing tests are not able to accurately detect cancer.
OncoMethylome’s broad diagnostic product pipeline is made
up of tests for six different cancer types. Two products, a
tissue test for prostate cancer detection, plus a urine test for
prostate cancer screening, are licensed for commercialization
to Veridex, a Johnson & Johnson company. In addition, five
other products, targeting high-need cancers are well positioned
to fuel the future growth of OncoMethylome. Among these,
the most advanced are a stool-based test for colorectal cancer
screening as well as a urine-based bladder cancer test aimed
at early detection of bladder cancer as well as at monitoring
for bladder cancer recurrence, which occurs in up to 70% of
bladder cancer patients.
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O n c o M e t h y l o m e D i a g n o s t i c P r o d u c t D e v e l o p m e n t P i p e l i n e
Partnered for
Commercialization
Breast Cancer
Early Detection Test
Lung Cancer
Screening Test
Colorectal Cancer
Screening Test
Prostate Cancer
Early Detection Test
Cervical Cancer
Early Detection Test
Bladder Cancer
Early Detection and
Monitoring Test
Prostate Cancer
Screening Test
p e r s o n A l i z i n g t r e A t m e n t o f c A n c e r p A t i e n t s
OncoMethylome’s personalized treatment solutions are
designed to help doctors most effectively treat cancer.
Today, when a patient is diagnosed with cancer, the
treating physician generally follows a standard treatment
protocol, assigning the treatment that gives a favorable
response in the largest proportion of patients. The physician
will typically switch to an alternative treatment only once
he or she observes that the patient is not responding to the
standard treatment. OncoMethylome’s personalized treatment
products analyze the molecular make-up of a patient’s tumor,
and are designed to provide treating physicians with additional
and valuable information about a patient’s cancer at the time
of diagnosis. In other words, these tests provide the physician
with useful information to help the physician “personalize” the
treatment of each individual patient.
Pharmacogenomics Tests predict whether a drug treatment is
likely to be effective for a specific patient
Recurrence Prediction Tests assess whether cancer is likely to
recur after initial surgery
OncoMethylome’s most advanced personalized treatment product
is a test for predicting patient response to temozolomide,
a Schering-Plough chemotherapy drug. The test assesses
the methylation status of the MGMT gene. A landmark study
published in The New England Journal of Medicine in March
2005 reported on the methylation status of MGMT in tumor
tissues from patients with brain tumors. In this study, and
others, the MGMT methylation status demonstrated a correlation
with response to temozolomide therapy. OncoMethylome is in
the process of confirming these studies in a multi-center brain
cancer clinical trial. Furthermore, through its collaboration
with Schering-Plough, OncoMethylome is also exploring the
impact of MGMT methylation on cancer treatment in a number
of other cancer indications beyond brain cancer.
In addition to the above mentioned MGMT pharmacogenomic
test, OncoMethylome’s development pipeline also includes a
second pharmacogenomics test, as well as a test for predicting
the likelihood of lung cancer recurrence.
Marker and Test DevelopmentMarker Identification Clinical Verification
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t e c h n o l o g y A n d i n t e l l e c t u A l p r o p e r t y
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t e c h n o l o g y A n d i n t e l l e c t u A l p r o p e r t y
OncoMethylome develops novel molecular tests for
detecting cancer and for personalizing the treatment
of cancer. Molecular tests are a new generation of
tests performed on DNA isolated from any bodily tissue or fluid
such as blood or urine.
DNA is found at the core of each cell in the human body.
It consists of genes that carry genetic instructions and are
necessary for the proper functioning of human cells. Some
genes carry instructions for producing compounds that protect
cells from cancers. Genes that code for tumor suppressor
enzymes and DNA repair enzymes are examples of such genes.
In a healthy cell, specific genes are turned on or off, as
required by the cell. One of the mechanisms that the body
uses to regulate gene expression is methylation. In cancerous
cells, excessive and abnormal methylation turns off genes that
protect cells from cancer. In this manner cancerous growth
becomes unchecked and cancer progresses.
Because abnormal methylation appears to be present in all
cancers, and because it occurs at the earliest stages of cancer
development, it is a very reliable indicator of cancer presence.
OncoMethylome’s technology portfolio detects methylation
at specific methylation markers. Methylation markers are
genes whose methylation is indicative of cancer presence
or response to therapy. OncoMethylome has filed patents on
over �00 methylation markers, with patents already granted
on some of the key markers. OncoMethylome’s process for
detecting methylation in DNA, called Methylation-Specific
PCR, was invented at Johns Hopkins University and patents
on the technology have been granted in key markets such as
Europe, United States, and Japan. OncoMethylome’s detection
technology is extremely sensitive, which is a necessity when
looking for early-stage cancer, as only one to ten tumor cells
may be present in a sample containing thousands of healthy
cells.
Gene expression active
Gene expression blocked
Me Me Me
MeMe
Transcription factor binds to unmethylated promotor region
Transcription factor cannot bind to methylated promotor
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OncoMethylome is headquartered in Liege, Belgium. In addition,
the company has locations in Leuven (Belgium), Amsterdam (The
Netherlands), and Durham (NC, USA).
The Liege location hosts the company’s main development laboratory. The
Leuven laboratory is responsible for personalized treatment and marker
discovery services. Testing services for third party clinical trials are carried
out in OncoMethylome’s certified laboratory in Amsterdam, which also
contributes to the company’s colorectal cancer program. OncoMethylome’s
clinical development and business development teams are located in the
company’s offices near Research Triangle Park in Durham (NC, USA), from
where OncoMethylome maintains close contact with its numerous US-based
commercial and research partners.
OncoMethylome currently operates approximately 2,000 square meters of
facilities.
f A c i l i t i e s & p e r s o n n e l
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Leuven
(Belgium)
Liège
(Belgium)durhAm
(nc, usA)
1�
p e r s o n n e l
2006 was a period of strong growth in
human resources, as reflected
in the increase in company
personnel. OncoMethylome added 2� employees, which was
equivalent to a 70% increase in headcount. Most of the growth
came about in the second half of the year, after the IPO, when
OncoMethylome reinforced its R&D and business development
teams. R&D personnel account for 80% of OncoMethylome’s
employees, and over one third of the R&D personnel hold PhD
degrees. Despite its rapid growth, OncoMethylome maintained
its innovative and fast-moving spirit that typifies its team
culture.
In addition to its internal personnel, OncoMethylome also
works with a large number of academic and medical centers,
typically funding research conducted by one or more designated
scientists within the laboratory of the partner institute.
Examples of organizations with whom OncoMethylome
collaborates on a regular basis include Johns Hopkins University
Medical Institutions (USA), Lovelace Respiratory Research
Institute (USA), the GROW Institute at the University Hospital
of Maastricht (The Netherlands), Free University Medical
Center (The Netherlands), Fox Chase Cancer Center (USA), The
University Hospital of Groningen (The Netherlands), and the
University of Ghent (Belgium).
• Harry Schrickx, VP Business Development and Marketing,
Durham (NC, USA):
• In 2006, awareness of OncoMethylome, and familiarity
with our methylation technology, have both increased
dramatically within the diagnostics and pharmaceutical
industries. It is exciting to experience this positive
momentum and the doors it has opened with potential
partners.
• Inge Wijdenes, Laboratory Technician, Amsterdam (The
Netherlands)
• One of my responsibilities is processing clinical
samples from the current multi-center brain cancer
clinical trial. I will be very proud when the personalized
treatment test that I work with is available to doctors
for patient management.
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2006 2005 200�
56
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E v o l u t i o n o f t h e n u m b e r o f e m p l o y e e s
30%
29%
41%
E d u c a t i o n
• Dr. Wim Van Criekinge, VP Biomarker and
Pharmacogenomics Research, Leuven (Belgium)
• In our laboratory our team works with cutting-edge
computing and laboratory technology in order to
find new biomarkers that continuously enhance the
performance of our molecular tests.
• Isabelle Renard, Sr. Project Leader, Liège (Belgium)
• I work closely with our laboratory technicians, as well
with our external clinical collaborators, on developing
our urine test for detecting bladder cancer. Most
of the work at OncoMethylome is done in teams,
with individuals coming together to make valuable
contributions.
20%
80%
G r o u p
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A s t r o n g g r o w t h i n h u m a n r e s o u r c e s
R&D
G&A
PhD
University
degreeHigher
education
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C H A L L E N G ENum. Te nonsupplii poterobuli, nostam potanume
i n v e s t o r r e l A t i o n s
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CORPORATE REPORTING CALENDAR
2007:
Annual General Shareholders’ Meeting: Friday, May 25, 2007
Half Year Results 2007: Thursday, September 20, 2007
2008:
Full Year Results 2007: Thursday, March 1�, 2008
Annual Shareholders’ Meeting: Friday, May �0, 2008
SHARE INFORMATION
Stock Exchange Ticker Symbol
Euronext Brussels ONCOB
Euronext Amsterdam ONCOA
Number of Shares
31.12.06 31.12.05
Issued Shares 10,�50,95� 6,109,880
Vested & Granted Warrants 227,188 88,125
Unvested Granted Warrants �75,062 1�5,625
* Taking into account the 5 to 1 stock split executed on May 23, 2006
2006 SHARE PRICE CHARTO
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8
10
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07/06 08/06 09/06 10/06 11/06 12/06
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K e y f i n A n c i A l f i g u r e s
Years ended December 31
in ‘000 EUR
Consolidated Income Statement Data 2006 2005 2004
Revenues 2 771 � 081 �88
Gross profit 2 716 2 967 �79
Research and development expenses -8 6�8 -5 78� -� 596
Selling, general and administrative expenses -1 896 -1 519 -1 0�2
Other operating income/expenses -1� -2 -�
Operating Profit (EBIT) -7 8�2 -� ��8 -5 252
Financial result �7� 56 58
Income taxes 0 0 0
Net profit / (Loss) -7 �68 -� 282 -5 19�
Consolidated Balance Sheet Data 2006 2005 2004
ASSETS
Total non-current assets 2 102 2 012 9�5
Total current assets �� 67� 12 180 5 520
Of which cash, cash equivalents and current
investments available for sale �2 809 9 �21 � 629
Total assets �6 776 1� 192 6 �65
LIABILITIES AND SHAREHOLDERS’ EQUITY
Total equity �1 980 10 089 5 196
Non-current liabilities 65� 1 �96 119
Current liabilities � 1�2 2 607 1 150
Total liabilities and shareholders’ equity �6 776 1� 192 6 �65
Consolidated Cash Flow Statement 2006 2005 2004
Operating cash flow -5 181 -� 095 -� 527
Investing cash flow -55� � �1� -828
Financing cash flow 29 12� 8 991 � 688
Net change in cash and cash equivalents 2� �90 9 209 -667
Cash and cash equivalents at end of period �2 809 9 �21 229
INVESTOR CONTACTLucija Turcinov
T: +32 (0)4 364 20 70
F: +32 (0)4 364 20 71
CORPORATE REPORTING CALENDAR
2007:
Annual General Shareholders’ Meeting: Friday, May 25, 2007
Half Year Results 2007: Thursday, September 20, 2007
2008:
Full Year Results 2007: Thursday, March 13, 2008
Annual Shareholders’ Meeting: Friday, May 30, 2008
OncoMethylome Sciences SA
Tour 5 GIGA niveau +3Avenue de l’Hôpital 114000 Liège - BelgiumT: +32 (0) 4 364 20 70 F: +32 (0) 4 364 20 71E-mail : [email protected] Site : www.oncomethylome.com
VAT : BE 0479.292.440 RPM Liège
Until June 1, 2007
OncoMethylome Sciences NV
Kapucijnenvoer 33 - blok “n” (3rd Floor)
3000 Leuven - Belgium
T: +32 (0) 16 33 63 87
F: +32 (0) 16 33 63 88
After June 1, 2007
Gaston Geenslaan 1
3001 Leuven - Belgium
T: +32 (0) 16 75 13 80
F: +32 (0) 16 75 13 81
OncoMethylome Sciences Inc
2505 Meridian Parkway
Suite 310
Durham - NC 27713
USA
T: +1 919 281 0980
F: +1 919 281 0981
OncoMethylome Sciences BV
Meibergdreef 59
1105 BA Amsterdam
The Netherlands
T: +31 (0) 20 566 21 45
F: +31 (0) 20 566 90 81
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