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C OMMITTED TO EARLY CANCER DETECTION AND PERSONALIZED PATIENT CARE BROCHURE 2006

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Page 1: COMMITTED CANCER DETECTION...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

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

Page 3: COMMITTED CANCER DETECTION...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

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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5

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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7

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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10

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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f A c i l i t i e s & p e r s o n n e l

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1�

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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AmsterdAm (the netherlAnds)

Leuven

(Belgium)

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(nc, usA)

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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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15

2006 2005 200�

56

��

21

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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16

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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17

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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14

07/06 08/06 09/06 10/06 11/06 12/06

*

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18

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

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INVESTOR CONTACTLucija Turcinov

[email protected]

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

Page 20: COMMITTED CANCER DETECTION...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

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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