o
|
|
REGISTRATION
STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE
ACT
OF 1934
|
x
|
|
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
For the fiscal year ended December 31, 2005 |
o
|
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
For
the transition period from
to
|
Title
of each class
|
Name
of each exchange on which registered
|
|
Common
Shares
|
The
American Stock Exchange and
The
Toronto Stock Exchange
|
PART
I
|
|
NOTE
REGARDING FORWARD LOOKING STATEMENTS
|
iii
|
Item
1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
|
1
|
Item
2. OFFER STATISTICS AND EXPECTED TIMETABLE
|
1
|
Item
3. KEY INFORMATION
|
1
|
Currency
and Exchange Rates
|
1
|
Selected
Financial Data
|
1
|
Capitalization
and Indebtedness
|
3
|
Reasons
for the Offer and Use of Proceeds
|
3
|
Risk
Factors
|
3
|
Item
4. INFORMATION ON THE CORPORATION
|
8
|
History
and Development of the Corporation
|
9
|
Business
Overview
|
9
|
Organizational
Structure
|
43
|
Property,
Plants and Equipment
|
43
|
Item
4A. UNRESOLVED STAFF COMMENTS
|
43
|
Item
5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS
|
43
|
Operating
Results
|
44
|
Liquidity
and Capital Resources
|
48
|
Research
and Development
|
48
|
Trend
Information
|
50
|
Off-Balance Sheet Arrangements
|
50
|
Tabular
Disclosure of Contractual Commitments
|
50
|
Item
6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
|
50
|
Directors
and Senior Management
|
50
|
Compensation
|
54
|
Board
Practices
|
56
|
Employees
|
58
|
Share
Ownership
|
58
|
Item
7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
|
60
|
Major
Shareholders
|
60
|
Related
Party Transactions
|
61
|
Interests
of Experts and Counsel
|
61
|
Item
8. FINANCIAL INFORMATION
|
61
|
Consolidated
Statements and Other Financial Information (Audited)
|
61
|
Significant
Changes
|
61
|
Item
9. THE OFFER AND LISTING
|
61
|
Offer
and Listing Details
|
61
|
Plan
of Distribution
|
63
|
Markets
|
63
|
Selling
Shareholders
|
64
|
Dilution
|
64
|
Expenses
of the Issue
|
64
|
Item
10. ADDITIONAL INFORMATION
|
64
|
Share
Capital
|
64
|
Memorandum
and Articles of Association
|
64
|
Material
Contracts
|
64
|
Exchange
Controls
|
64
|
Taxation
|
65
|
Dividends
and Paying Agents
|
69
|
Statement
by Experts
|
69
|
Documents
on Display
|
69
|
Subsidiary
Information
|
70
|
Item
11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
|
70
|
Quantitative
and Qualitative Information about Market Risk
|
70
|
Item
12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES
|
70
|
PART
II
|
|
Item
13. DEFAULTS, DIVIDEND, ARREARAGES AND DELINQUENCIES
|
70
|
Item
14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND
USE OF
PROCEEDS
|
70
|
Item
15. CONTROLS AND PROCEDURES
|
70
|
Item
16A. AUDIT COMMITTEE FINANCIAL EXPERT
|
70
|
Item
16B. CODE OF ETHICS
|
71
|
Item
16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES
|
71
|
Item
16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT
COMMITTEES
|
72
|
Item
16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED
PURCHASERS
|
72
|
PART
III
|
|
Item
17. FINANCIAL STATEMENTS
|
72
|
Item
18. FINANCIAL STATEMENTS
|
72
|
Item
19. EXHIBITS
|
73
|
A.
|
Directors
and Senior Management
|
B.
|
Advisers
|
C.
|
Auditors
|
2005
|
2004
|
2003
|
2002
|
2001
|
||||||||||||
Average
|
0.8254
|
0.7682
|
0.7136
|
0.6368
|
0.6457
|
Apr-06
|
|
Mar-06
|
|
Feb-06
|
|
Jan-06
|
|
Dec-05
|
|
Nov-05
|
|||||||||
Low
|
0.8534
|
0.8531
|
0.8638
|
0.8528
|
0.8521
|
0.8361
|
|||||||||||||
High
|
0.8926
|
0.8834
|
0.8788
|
0.8744
|
0.8690
|
0.8579
|
|||||||||||||
Average
|
0.8740
|
0.8641
|
0.8704
|
0.8642
|
0.8610
|
0.8464
|
Canadian
GAAP:
|
Fiscal
Year
Ended
December
31, 2005
|
Fiscal
Year
Ended
December
31, 2004
|
Fiscal
Year
Ended
December
31, 2003
|
Fiscal
Year
Ended
December
31, 2002
|
11-month
Period
Ended
December
31, 2001
|
|||||||||||
Operating
Results
|
||||||||||||||||
Product
sales
|
$
|
425,730
|
$
|
183,258
|
nil
|
nil
|
nil
|
|||||||||
License
revenue
|
1,153,308
|
302,080
|
$
|
16,900
|
nil
|
nil
|
||||||||||
Total
expenses
|
6,512,146
|
6,192,649
|
4,561,179
|
$
|
4,465,577
|
$
|
3,762,786
|
|||||||||
Investment
tax credits
|
198,923
|
205,000
|
223,146
|
189,908
|
131,000
|
|||||||||||
Interest
income
|
173,130
|
123,626
|
258,422
|
257,407
|
386,580
|
|||||||||||
Net
loss
|
$
|
4,989,705
|
$
|
5,568,899
|
$
|
4,062,711
|
$
|
4,018,262
|
$
|
3,245,206
|
||||||
Net
loss per share:
|
||||||||||||||||
-
basic and diluted loss
per share
|
$
|
0.23
|
$
|
0.26
|
$
|
0.19
|
$
|
0.20
|
$
|
0.17
|
||||||
Loss
from continuing operations
per share
|
$
|
0.23
|
$
|
0.26
|
$
|
0.19
|
$
|
0.20
|
$
|
0.17
|
(1)
|
|
In
2001, the Corporation changed its financial year end from January
31 to
December 31.
|
U.S.
GAAP:
|
Fiscal
Year ended
December 31, 2005
|
Fiscal
Year ended
December 31, 2004
|
Fiscal
Year ended
December
31, 2003
|
Fiscal
Year ended
December
31, 2002
|
11-Month
Period ended
December
31, 2001
|
|||||||||||
Operating
Results
|
||||||||||||||||
Net
loss
|
$
|
4,781,597
|
$
|
5,478,184
|
$
|
3,949,318
|
$
|
4,871,140
|
$
|
4,162,580
|
||||||
Net
loss per share:
|
||||||||||||||||
-
basic and diluted loss per share
|
$
|
0.22
|
$
|
0.26
|
$
|
0.19
|
$
|
0.24
|
$
|
0.22
|
As
at
|
As
at
|
As
at
|
As
at
|
As
at
|
||||||||||||
Canadian
GAAP:
|
December
31, 2005
|
December
31, 2004
|
December
31, 2003
|
December
31, 2002
|
December
31, 2001
|
|||||||||||
Financial
Position
|
||||||||||||||||
Total
assets
|
$
|
11,293,190
|
$
|
6,996,079
|
$
|
8,074,027
|
$
|
11,379,383
|
$
|
9,343,958
|
||||||
Long-term
debt
|
5,893,340
|
nil
|
nil
|
nil
|
nil
|
|||||||||||
Shareholders’
Equity
|
||||||||||||||||
Capital
stock
|
24,449,826
|
24,192,321
|
24,056,853
|
23,785,884
|
18,212,490
|
|||||||||||
Total
shareholders’ equity (net assets)
|
$
|
1,844,297
|
$
|
2,496,842
|
$
|
7,438,279
|
$
|
10,689,828
|
$
|
8,948,696
|
||||||
Weighted
average number of common shares outstanding
|
21,487,008
|
21,276,497
|
20,967,677
|
20,406,733
|
19,097,390
|
|||||||||||
Cash
dividends declared per share
|
nil
|
nil
|
nil
|
nil
|
nil
|
U.S.
GAAP:
|
As
at
December
31, 2005
|
As
at
December
31, 2004
|
As
at
December
31, 2003
|
As
at
December
31, 2002
|
As
at
December
31, 2001
|
|||||||||||
Financial
Position
|
||||||||||||||||
Total
assets
|
$
|
11,211,832
|
$
|
6,633,221
|
$
|
7,620,454
|
$
|
10,812,417
|
$
|
8,635,250
|
||||||
Long-term
debt
|
8,359,877
|
nil
|
nil
|
nil
|
nil
|
|||||||||||
Shareholders’
Equity
|
||||||||||||||||
Capital
stock
|
$
|
29,182,269
|
$
|
28,924,764
|
$
|
28,789,296
|
$
|
28,399,039
|
$
|
22,850,029
|
||||||
Total
shareholders’ equity (net assets)(deficiency)
|
$
|
(703,598
|
)
|
$
|
2,133,984
|
$
|
6,984,706
|
$
|
10,122,862
|
$
|
8,239,988
|
B.
|
Capitalization
and Indebtedness
|
•
|
Coronary
Artery Disease Risk Assessment Technology1
|
m
|
PREVU*
Point of Care (POC) Skin Sterol Test, which is cleared for sale in
Canada,
U.S. (CLIA-exempt) and CE-marked in
Europe
|
m
|
PREVU*
LT Skin Sterol Test (lab-processed format), currently in clinical
trials
|
m
|
PREVU*
PT Skin Sterol Test (home, or consumer, format), currently in
development
|
•
|
Cancer
Technologies
|
m
|
ColorectAlert™,
currently in clinical studies
|
m
|
LungAlert™,
currently in clinical studies
|
m
|
Breast
cancer test, currently in clinical
studies
|
•
|
greater
awareness of personal wellness and the increasing role by individuals
in
health maintenance;
|
•
|
a
health-conscious and aging population which is placing a growing
emphasis
on preventative care;
|
•
|
technological
advances that have improved both the ease-of-use and accuracy of
diagnostic products, thereby gaining greater support from medical
practitioners; and
|
•
|
availability
of over-the-counter (“OTC”) products and other therapies to treat serious
diseases.
|
•
|
gender
|
•
|
increasing
age
|
•
|
heredity
|
•
|
tobacco
smoking
|
•
|
high
blood pressure
|
•
|
physical
inactivity
|
•
|
diet
|
•
|
obesity
|
•
|
diabetes
mellitus
|
•
|
skin
cholesterol levels were found to be higher in individuals with abnormal
coronary angiograms than in those with normal coronary
angiograms;
|
•
|
skin
cholesterol levels were found to be elevated in individuals with
hyperlipoproteinemia compared to those with normal serum lipid levels;
and
|
•
|
skin
cholesterol levels were elevated in individuals having coronary bypass
surgery compared to age-matched healthy
controls.
|
DESCRIPTION
|
INVESTIGATOR
|
PRIMARY
STUDY
SITE
|
OBJECTIVES
|
OUTCOME
|
PUBLICATIONS/
PRESENTATIONS
|
PREVU*
Skin Sterol Test: Completed Studies
|
|
|
|
|
|
Skin
sterol and stress test
|
Dr.
Dennis Sprecher
|
The
Cleveland Clinic Foundation
|
Determine
relationship between skin sterol and serum lipid levels; measure
correlation of skin sterol to stress test outcome
|
Skin
sterol shown to correlate with presence of cardiovascular disease
(as
measured by stress test outcome) “independent[ly] of serum lipids”.
Researchers concluded that skin sterol may be a better predictor
of stress
test outcome than serum cholesterol.
|
Presented
at 31st Annual Oak Ridge Conference, 1999. Published in Journal
of Clinical Chemistry
in 2001
|
Skin
sterol and response to therapy
|
Dr.
Dennis Sprecher
|
The
Cleveland Clinic Foundation
|
Determine
ability of skin sterol to monitor patient response to lipid-lowering
medications
|
Skin
sterol may have utility in monitoring response to cholesterol-lowering
therapies
|
Presented
at American Association for Clinical Chemistry annual meeting in
1999
|
Measuring
skin sterol levels to assess CAD
|
Dr.
Dennis Sprecher
|
The
Cleveland Clinic Foundation; The Canadian Heart Research Centre;
The
Trillium Health Centre
|
Correlation
between skin sterol and angiography outcome
|
Skin
sterol shown to increase with extent of disease as measured by coronary
angiography, the gold standard for diagnosis of CAD, and to provide
new
information with respect to risk assessment for CAD. Skin sterol
and serum
levels of total cholesterol were not correlated.
Additionally,
patients with a history of myocardial infarction had a significantly
higher skin sterol level.
|
Presented
at American Heart Association (AHA) annual meeting, 2000; presented
at
Arteriosclerosis, Thrombosis and Vascular Biology annual meeting
in 2002;
published in journal Atherosclerosis
in 2003; presented at Arteriosclerosis, Thrombosis and Vascular Biology
annual meeting in 2005; published in Atherosclerosis
in
August 2005
|
Skin
sterol and other markers of CAD risk
|
Dr.
John Mancini
|
University
of British Columbia; St. Paul's Hospital
|
Determine
correlation of skin sterol to other measures of CAD risk, including
carotid sonography, flow-mediated brachial vasoactivity and serum
markers.
|
Skin
sterol correlates to Framingham Global Risk Score and inflammatory
markers, notably ICAM-1
|
Published
in American
Journal of Cardiology
in 2002
|
DESCRIPTION
|
INVESTIGATOR
|
PRIMARY
STUDY
SITE
|
OBJECTIVES
|
OUTCOME
|
PUBLICATIONS/
PRESENTATIONS
|
Pediatric
skin sterol study
|
Dr.
Katherine Morrison
|
St.
Joseph's Hospital
|
Examine
skin sterol levels in children with hypercholesterolemia
|
Skin
sterol can be reliably measured in children
|
Presented
at the 2003 Endocrine Society Annual Meeting
|
Skin
sterol and statins
|
Dr.
Marcus Reiter
|
University
of Vienna
|
Examine
skin sterol response to certain cholesterol-lowering
medications
|
Patients
treated with statins experienced decreases in skin sterol values
as well
as in blood cholesterol; initial data shows that skin sterol may
be a
useful monitoring tool for patients taking statins
|
Data
published in Journal
of Clinical Chemistry
in January 2005
|
Skin
sterol and carotid IMT
|
Dr.
James Stein
|
University
of Wisconsin
|
Measure
relationship between skin sterol and CAD using carotid IMT
(CIMT)
|
Skin
sterol has strong correlation to increased CIMT, an established risk
predictor of heart attack and stroke
|
Data
presented at American College of Cardiology annual meeting, March
2005;
published in American
Heart Journal,
December 2005
|
PRACTICE
|
Dr.
Milan Gupta
|
William
Osler Health Centre
|
Examine
skin sterol levels in South Asians
|
Interim
data confirmed that skin sterol provides new information about a
patient’s
risk of CAD. Skin sterol may have value in stratifying patients with
established CAD who have been treated with cholesterol-lowering
medications. Further data presented in 2005 showed that patients
who have
both high skin sterol and high levels of C-reactive protein have
an
increased risk of metabolic syndrome
|
Data
presented at Canadian Cardiovascular Congress in October 2004; further
data presented at Canadian Cardiovascular Congress in October 2005
and the
Arteriosclerosis, Thrombosis and Vascular Biology conference in April
2006
|
PREVU*
Skin Sterol Test: Ongoing Studies
|
|
|
|
|
|
PREPARE
|
Dr.
David Waters; Dr. Dennis Sprecher; Dr. John Mancini
|
Various,
in life insurance testing industry
|
Relationship
between skin sterol (PREVU* LT) and risk of CVD as estimated by Framingham
score
|
||
PASA
|
Dr.
James Stein
|
University
of Wisconsin and five other U.S. sites
|
Relationship
between skin sterol (PREVU* POC and PREVU* LT) and CAD using carotid
IMT
in a screening population
|
DESCRIPTION
|
INVESTIGATOR
|
PRIMARY
STUDY
SITE
|
OBJECTIVES
|
OUTCOME
|
PUBLICATIONS/
PRESENTATIONS
|
ARISE
(Aggressive Reduction in Inflammation Stops Events)
|
Dr.
Rob Scott
|
AtheroGenics,
Inc.; study conducted at multiple sites around world
|
Study
will examine skin sterol (PREVU* POC) changes in response to AtheroGenics’
AGI-1067 therapy. Trial will also provide data on relationship between
skin sterol and primary cardiovascular events
|
||
Correlation
study
|
Dr.
Jean-Claude Tardif
|
Montreal
Heart Institute
|
Trial
will evaluate the correlation between PREVU* POC and PREVU*
LT.
|
||
Skin
sterol and new CAD risk markers
|
Dr.
John Mancini;
Dr.
Sammy Chan;
Dr.
Jiri Frolich
|
University
of British Columbia
|
Study
will examine relationship between skin sterol (PREVU* POC and PREVU*
LT)
and a variety of new and established cardiovascular risk markers
in
high-risk patients. It will also examine how skin sterol responds
to
various therapies
|
||
MESA
(Multi-Ethnic Study of Atherosclerosis) sub-study
|
Dr.
Pamela Ouyang
|
National
Heart, Lung and Blood Institute; Johns Hopkins Bayview Medical
Center
|
Study
examining correlation of skin sterol (PREVU* POC) to early markers
of CAD
across different ethnic groups
|
Interim
data demonstrated that skin sterol levels correlated with the presence
and
extent of coronary calcification
|
Interim
data presented at American Heart Association in 2003; interim data
published in Atherosclerosis
in July 2005
|
All
Comers' study
|
Dr.
Dennis Sprecher
|
The
Cleveland Clinic Foundation
|
Study
examining relationship between skin sterol and Framingham Global
Risk
Score and other markers of CAD in patients suspected of having CAD.
Trial
includes PREVU* POC and PREVU* LT
|
•
|
Risk
assessment by physicians.
This market includes primary care physicians, hospitals and managed
care
organizations as well as various health care providers and programs,
such
as screening and preventive cardiology clinics where cardiovascular
risk
assessment is conducted.
|
•
|
Risk
assessment outside physicians’ offices.
This market includes retail pharmacies and in-store health clinics,
large
employers that offer health and wellness programs, wellness clinics
or
service providers, and natural health clinics or service providers.
|
•
|
Screening
for insurance risk assessment.
The
market for insurance testing represents a significant opportunity
for
PREVU* LT throughout North America. About 14 million new insurance
policies are granted every year, approximately 6.25 million of which
include screening performed using oral fluid testing and/or blood.
(American
Council of Life Insurers: Life Insurance Fact Book,
2004)
|
•
|
Home
testing market.
PREVU* PT could be purchased by individuals in a retail pharmacy
and
self-administered at home to test and monitor skin cholesterol levels.
The
U.S. cholesterol self-test market is projected to grow from about
US$30
million in 2003 to just under US$150 million in 2007, driven largely
by
the introduction of non-invasive measurement products. (Greystone
Associates, Cholesterol Monitoring: Self-Testing Markets and
Opportunities, 2003)
|
Stage
B:
|
tumor
has extended to the extracolonic or extrarectal tissue but there
is no
involvement of regional lymph nodes
|
•
|
yearly
fecal occult blood test (“FOBT”)*
|
•
|
flexible
sigmoidoscopy every five years
|
•
|
yearly
FOBT* plus flexible sigmoidoscopy every five years**
|
•
|
double
contrast barium enema (“DCBE”) every five
years
|
•
|
colonoscopy
every 10 years
|
DESCRIPTION
|
INVESTIGATOR
|
PRIMARY
STUDY
SITE
|
OBJECTIVES
|
OUTCOME
|
PUBLICATIONS/
PRESENTATIONS
|
ColorectAlert,
FOBT, CEA and Colonoscopy Study
|
Dr.
Norman Marcon
|
St.
Michael’s Hospital
|
Compare
ColorectAlert with FOBT and CEA in screening for cancerous and
pre-cancerous conditions, using colonoscopy to determine the actual
presence of disease in each patient
|
ColorectAlert
demonstrated the best overall level of accuracy of the three tests.
For
the entire study population, all three tests detected 81 per cent
of the
cancers (sensitivity), but ColorectAlert was much more specific,
which
means it produced significantly fewer false positive results than
either
FOBT or CEA.
|
Presented
at Digestive Diseases Week, May 2000 ; presented at the American
Association for Clinical Chemistry, July 2000.
|
Expanded
ColorectAlert Studies
|
Dr.
Norman Marcon
|
St.
Michael’s Hospital
|
Compare
ColoPath and ColorectAlert with FOBT and colonoscopy
|
ColorectAlert
demonstrated higher sensitivity for early-stage cancer than FOBT,
the
existing standard test. ColorectAlert was more sensitive than FOBT
and CEA
for early stage (A and B) cancers, and for cancers in asymptomatic
patients.
|
Presented
at the American Association for Cancer Research, July 2003; published
in
the Proceedings
of the American Association for Cancer Research
2003
|
U.S.
National Cancer Institute EDRN Study
|
Dr.
Dean Brenner
|
University
of Michigan; Dana Farber Cancer Institute; Dartmouth Medical School;
St.
Michael’s Hospital; M.D. Anderson Cancer Center
|
Prospective
cross-sectional cohort validation trial examining FOBT and other
markers
for colorectal cancer
|
Squamous
cell carcinoma:
|
Always
associated with smoking. Usually starts in bronchi.
|
Adenocarcinoma:
|
Begins
in mucus glands usually near the periphery of the lung.
|
Large-cell
undifferentiated
|
May
appear in any part of the lung. Tends to grow and spread
quickly.
|
Lung
cancer stages are:
|
|
T1:
|
Tumor
is smaller than 3 cm and has not spread to the main branches of
the
bronchus.
|
T2:
|
Tumor
is larger than 3 cm. Cancer has spread to the main bronchus. Cancer
partially clogs airway but does not cause pneumonia.
|
T3:
|
Tumor
has spread to the chest wall and/or the diaphragm. The cancer is
within 2
cm of the trachea. One or both lungs collapse.
|
T4:
|
Metastatic
spread. Two or more tumor modules are present in the same lobe
with
malignant pleural effusion.
|
1.
|
An
X-ray is a simple and safe procedure that is relatively ineffective.
Less
than 40% of all lung cancers can be detected by this screening method.
|
2.
|
Conventional
Sputum Cytology has been used for over 50 years; however it is the
least
sensitive and only able to identify 20% of lung cancer cases.
|
3.
|
Spiral
CT has been hailed as the technology that holds the greatest promise
for
cost effectively screening for lung cancer. Although it holds the
ability
to detect approximately 70% of lung cancers, it has a high cost which
translates into US$300-$1,000 per test.
|
4.
|
Positron
Emission Tomography is the most accurate screening test available
at over
90% sensitivity. Since it is extremely expensive at US$2,500 per
patient,
widespread use would be unfeasible.
|
5.
|
Bronchoscopy
is used as a final diagnostic option prior to surgery. It is highly
invasive and results in a 0.2% mortality rate with the majority of
patients unable to return to daily routines for several weeks or
months.
|
DESCRIPTION
|
INVESTIGATOR
|
PRIMARY
STUDY
SITE
|
OBJECTIVES
|
OUTCOME
|
PUBLICATIONS/
PRESENTATIONS
|
LungAlert
Pilot Study
|
Drs.
John Miller and Gerry Cox
|
St.
Joseph's Hospital
|
A
blinded study examining LungAlert in a population with healthy patients,
patients with benign lung disease and patients with
cancer.
|
LungAlert
detected 20 of 23 cancers.
|
Presented
at the American Thoracic Society, May 2001; published in the Journal
of Clinical Ligand Assay Society, 2002
|
LungAlert
Smokers’ Study
|
Drs.
John Miller and Gerry Cox
|
St.
Joseph’s Hospital
|
Determine
LungAlert’s effectiveness in detecting early-stage cancers, particularly
in smokers, and to establish the relationship between LungAlert values
and
the stage and size of tumors
|
Interim
data show that LungAlert’s reactivity in sputum samples may be useful as
an initial screening test to identify high-risk subjects who would
benefit
from other tests, such as spiral computed tomography. Patients with
cancer
had significantly higher values than those who did not.
|
American
Association for Cancer Research, July 2003; American Thoracic Society,
May
2004
|
I-ELCAP
(International Early Lung Cancer Action Program)
|
Dr.
Heidi Roberts
|
Princess
Margaret Hospital
|
Determine
the ability of LungAlert to detect cancers among a high-risk population
as
well as relationship between LungAlert values and the stage and location
of cancer. High-risk patients (1,000) undergo CT scans twice - once
at
baseline and once at one-year follow-up - and are tested with LungAlert.
|
•
|
Non-invasive
carcinoma
|
•
|
The
tumor is no more than about an inch across and cancer cells have
not
spread beyond the breast.
|
•
|
Tumor
in the breast is less than 1 inch across and the cancer has spread
to the
lymph nodes under the arm; or
|
•
|
Tumor is between 1 and 2 inches (with or without spread to the lymph nodes under the arm); or |
•
|
Metastatic
cancer
|
DESCRIPTION
|
INVESTIGATOR
|
PRIMARY
STUDY
SITE
|
OBJECTIVES
|
OUTCOME
|
PUBLICATIONS/
PRESENTATIONS
|
Pilot
Study
|
Dr.
Anees Chagpar
|
University
of Texas M.D. Anderson Center
|
Determine
ability of the breast cancer test to distinguish between cancerous
and
non-cancerous breast samples.
|
Data
showed that the test demonstrated a statistically significant difference
between early-stage breast cancer and non-cancerous samples, which
demonstrates the test's effectiveness in identifying early-stage
disease.
|
Presented
at American Association for Cancer Research, July 2003; published
in
Cancer,
July 2004
|
Pivotal
Study
|
Dr.
Anees Chagpar
|
University
of Louisville
|
Confirm
and extend findings of pilot study.
|
Patent
Status
|
Title
|
Jurisdiction
|
Patent
Number
|
Grant
Date
|
Expiry
Date
|
Granted
|
Method
for producing affinity-enzymatic compounds for visual indication
of
cholesterol on skin surface
|
Canada
|
1,335,968
|
June
20, 1995
|
June
20, 2012
|
Granted
|
Method
of producing affinity-enzymatic compounds for the visual detection
of
cholesterol on the surface of the skin of a patient, based on a detecting
agent with an affinity for cholesterol and a visualization
agent
|
Europe
Austria
Great
Britain
France
Germany
Italy
Sweden
Switzerland
|
0
338 189
|
April
24, 1996
|
January
18, 2009
|
Granted
|
Multilayer
Analytical Element
|
Australia
South
Korea
United
States
Canada
China
Europe
Belgium
Germany
Spain
France
Great
Britain
Greece
Italy
Ireland
Netherlands
Portugal
Sweden
Mexico
Japan
|
702,663
235,211
6,605,440
2,207,555
95,197,367.3
0797774
227267
375507
|
June
3, 1999
September
21, 1999
August
12, 2003
February
24, 2004
June
23, 2004
November
10, 2004
April
15, 2005
January
6, 2006
|
December
14, 2015
December
14, 2015
December
14, 2015
December
14, 2015
December
14, 2015
December
14, 2015
December
14, 2015
December
14, 2015
|
Patent
Status
|
Title
|
Jurisdiction
|
Patent
Number
|
Grant
Date
|
Expiry
Date
|
Pending
|
Multilayer
Analytical Element
|
PCT
Brazil
|
CA95/00698
PI9510038-5
|
N/A
Notice
of Allowance Oct 4, 2005
|
N/A
|
Granted
|
Method
of Determining Skin Tissue Cholesterol
|
United
States
Japan
Canada
|
6,365,363
369,324
2281769
|
April
2, 2002
July
1, 2005
March
21, 2006
|
January
26, 2018
January
26, 2018
January
26, 2018
|
Pending
|
Method
of Determining Skin Tissue Cholesterol
|
PCT
Brazil
Europe
Hong
Kong
|
RU98/00010
PI9807594-2
98901608.4
00105898.2
|
N/A
|
N/A
|
Granted
|
Spectrophotometric
Measurement in Color-Based Biochemical and Immunological
Assays
As
it pertains to Skin Cholesterol Measurement
|
Australia
|
781034
|
August
18, 2005
|
August
4, 2020
|
Pending
|
Spectrophotometric
Measurement in Color-Based Biochemical and Immunological
Assays
As
it pertains to Skin Cholesterol Measurement
|
PCT
Brazil
China
Europe
Russia
Hong
Kong
India
Japan
|
PCT/CA00/00918
PI0013096.6
00813497.9
00954181.4
RU
2002103517
0310671.6
PCT/2002/00307
2001-51596.4
|
N/A/
Accepted
in Russia September 8, 2005
|
N/A
|
Patent
Status
|
Title
|
Jurisdiction
|
Patent
Number
|
Grant
Date
|
Expiry
Date
|
Pending
|
Spectrophotometric
Measurement in Color-Based Biochemical and Immunological
Assays
As
it Pertains to Skin Cholesterol Measurement
|
United
States
Continuation
in part
|
09/830,708
10/877,737
|
N/A
|
N/A
|
Pending
|
Direct
Assay of Cholesterol in Skin Samples Removed by Tape
Stripping
|
Canada
PCT
United
States
Continuation
in part
|
2,465,427
PCT/CA2005/00642
Pub
No. WO2005/106018
10/835,397
Pub
No. US2005 - 0244908-A1
11/116,412
Pub
No. US2005-0272212
|
N/A
|
N/A
|
Pending
|
Direct
Assay of Skin Protein in Skin Samples Removed by Tape
Stripping
|
United
States
|
60/682,837
|
N/A
|
N/A
|
Pending
|
Method
and Apparatus for Non-Invasive Measurement of Skin Tissue
Cholesterol
|
United
States
PCT
|
60/656,381
Number
not yet assigned
|
N/A
|
N/A
|
Abandoned
|
Method
for visual indication of cholesterol on skin surface agents used
therefore
and methods for producing such agents
|
United
States
|
5,489,510
|
February
6, 1996
|
February
6, 2013
Deemed
to be abandoned; request for reconsideration filed February
2006
|
Abandoned
|
Method
for producing affino-enzymatic compounds and visualizing agent and
application thereof
|
United
States
|
5,587,295
|
December
24, 1996
|
December
24, 2013
Deemed
to be abandoned; request for reconsideration filed February
2006
|
Patent
Status
|
Title
|
Jurisdiction
|
Patent
Number
|
Grant
Date
|
Expiry
Date
|
Granted
|
Rectal
Mucus Test and Kit for Detecting Cancerous and Precancerous
Conditions
|
USA
|
5,162,202
|
November
10, 1992
|
December
12, 2009
|
Granted
|
Screening
Test and Kit for Cancerous and Precancerous Conditions
|
USA
|
5,348,860
|
September
20, 1994
|
October
15, 2011
|
Granted
|
Rectal
Mucus Test and Kit for Detecting Cancerous and Precancerous
Conditions
|
Japan
|
2,990,528
|
October
15, 1999
|
April
27, 2010
|
Granted
|
Spectrophotometric
Measurement in Color-Based Biochemical and Immunological
Assays
As
it Pertains to
Cancer
Detection
|
Australia
|
781034
|
August
18, 2005
|
August
4, 2020
|
Pending
|
Spectrophotometric
Measurement in Color-Based Biochemical and Immunological
Assays
As
it Pertains to
Cancer
Detection
|
PCT
Brazil
China
Europe
Russia
Hong
Kong
India
Japan
|
PCT/CA00/00918
PI0013096.6
00813497.9
00954181.4
RU
2002103517
0310671.6
PCT/2002/00307
2001
515964
|
N/A
Accepted
in Russia September 8, 2005
|
N/A
|
Pending
|
Spectrophotometric
Measurement in Color-Based Biochemical and Immunological
Assays
As
it Pertains to
Cancer
Detection
|
USA
Continuation
in part
|
09/830,708
10/877,757
|
N/A
|
N/A
|
Pending
|
Liquid-Phase
Galactose Oxidase-Schiff’s Assay
|
USA
|
60/717,758
|
N/A
|
N/A
|
Patent
Status
|
Title
|
Jurisdiction
|
Patent
Number
|
Grant
Date
|
Expiry
Date
|
Granted
|
Screening
Test for the Early Detection of Colorectal Cancer
|
USA
|
6,187,591
|
February
13,2001
|
March
16, 2019
|
Granted
|
Screening
Test for the Early Detection of Colorectal Cancer
|
Australia
|
766,057
|
January
29, 2004
|
November
3, 2019
|
Granted
|
Screening
Test for the Early Detection of Colorectal Cancer
|
Israel
|
139545
|
April
25, 2005
|
November
3, 2019
|
Pending
|
Screening
Test for the Early Detection of Colorectal Cancer
|
Canada
|
2,352,184
|
N/A
|
N/A
|
Pending
|
Screening
Test for the Early Detection of Colorectal Cancer
|
Brazil
|
PI19915005
|
N/A
|
N/A
|
Pending
|
Screening
Test for the Early Detection of Colorectal Cancer
|
Mexico
|
012243
|
N/A
|
N/A
|
Pending
|
Screening
Test for the Early Detection of Colorectal Cancer
|
Korea
|
2001-7005707
|
N/A
|
N/A
|
Pending
|
Screening
Test for the Early Detection of Colorectal Cancer
|
India
|
INPCT/2001/00591
|
N/A
|
N/A
|
Granted
|
Screening
Test for the Early Detection of Colorectal Neoplasia
|
USA
|
5,416,025
|
May
16, 1995
|
November
29, 2013
|
Granted
|
Screening
Test for the Early Detection of Colorectal Neoplasia
|
Europe
|
0731914
|
November
23, 1994
|
November
23, 2014
|
Granted
|
Screening
Test for the Early Detection of Colorectal Neoplasia
|
France
|
0731914
|
April
18, 2001
|
November
23, 2014
|
Granted
|
Screening
Test for the Early Detection of Colorectal Neoplasia
|
Spain
|
ES
2155513
|
April
18, 2001
|
November
23, 2014
|
Granted
|
Screening
Test for the Early Detection of Colorectal Neoplasia
|
Germany
|
69427131.4
|
April
18, 2001
|
November
23, 2014
|
Granted
|
Screening
Test for the Early Detection of Colorectal Neoplasia
|
Great
Britain
|
0731914
|
April
18, 2001
|
November
23, 2014
|
Granted
|
Screening
Test for the Early Detection of Colorectal Neoplasia
|
Italy
|
0731914
|
April
18, 2001
|
November
23, 2014
|
Granted
|
Screening
Test for the Early Detection of Colorectal Neoplasia
|
Australia
|
687,939
|
March
5, 1998
|
November
23, 2014
|
Granted
|
Screening
Test for the Early Detection of Colorectal Neoplasia
|
South
Africa
|
94/9290
|
October
25, 1995
|
November
23, 2014
|
Pending
|
Screening
Test for the Early Detection of Colorectal Neoplasia
|
Canada
|
2,176,508
|
N/A
|
N/A
|
Patent
Status
|
Title
|
Jurisdiction
|
Patent
Number
|
Grant
Date
|
Expiry
Date
|
Granted
|
Screening
Test and Kit for Cancerous and Precancerous Conditions
|
USA
|
5,348,860
|
September
20,1994
|
October
15, 2011
|
Granted
|
Spectrophotometric
Measurement in Color-Based Biochemical and Immunological
Assays
As
it pertains to Skin Cholesterol Measurement
|
Australia
|
781034
|
August
18, 2005
|
August
4, 2020
|
Pending
|
Spectrophotometric
Measurement in Color-Based Biochemical and Immunological
Assays
As
it Pertains to Cancer
Detection
|
PCT
Brazil
China
Europe
Russia
Hong
Kong
India
Japan
|
PCT/CA00/00918
PI0013096.6
00813497.9
00954181.4
RU
2002103517
0310671.6
PCT/2002/00307
2001
515964
|
N/A
Accepted
in Russia September 8, 2005
|
N/A
|
Pending
|
Spectrophotometric
Measurement in Color-Based Biochemical and Immunological
Assays
As
it Pertains to Cancer
Detection
|
USA
Continuation
in part
|
09/830,708
10/877,737
|
N/A
|
N/A
|
Pending
|
Liquid-Phase
Galactose Oxidase-Schiff’s Assay
|
USA
|
60/717,758
|
|
Cost ($)
|
Accumulated
Depreciation ($)
|
Net
Book Value ($)
|
|||||||
Manufacturing
equipment
|
20,585
|
10,056
|
10,529
|
|||||||
Computer
equipment
|
293,388
|
185,361
|
108,027
|
|||||||
Furniture
and equipment
|
65,609
|
44,064
|
21,545
|
|||||||
Research
instrumentation
|
669,183
|
452,701
|
216,482
|
|||||||
Laboratory
equipment
|
60,496
|
14,787
|
45,709
|
|||||||
Leasehold
improvements
|
23,159
|
14,815
|
8,344
|
|||||||
TOTAL
|
1,132,420
|
721,784
|
410,636
|
•
|
A
$410,000 increase in spending on clinical trials for skin cholesterol
and
cancer to $898,000 from $488,000 in 2004. This increase is related
to
additional trials for skin cholesterol to lead to additional regulatory
approvals, a new trial for breast cancer and continuation of the
lung
cancer trial (the “I-ELCAP” study). The Corporation currently has 15
clinical trials ongoing;
|
•
|
Increased
legal fees on intellectual property, which amounted to $331,000 compared
with $292,000 in fiscal 2004. These costs include $189,000 in 2005
($96,000 in 2004) related to the petition for reinstatement of two
U.S.
patents for skin cholesterol that had been deemed
abandoned;
|
•
|
An
increase of $135,000 in subcontract research to $451,000 in support
of the
development of a second-generation color reader for the skin cholesterol
test. This was partially offset by a decrease in product development
expenditures for supplies of
$55,000;
|
•
|
An
increase in stock-based compensation expense of $23,000 resulted
in
non-cash expenses for research personnel of $147,000 in 2005 compared
with
$124,000 for 2004. This reflects the amortization of the 2003 and
2004
grants as well as the 2005 grants;
and
|
•
|
A
decrease in compensation of $53,000, reflecting lower incentive payments
for the year for performance
milestones.
|
•
|
A
reduction of $434,000 in professional expenses resulting from the
non-recurring expenditure of $478,000 incurred in 2004 for the unsolicited
offer to acquire the shares of IBEX Technologies Inc.
(“IBEX”);
|
•
|
A
reduction of $54,000 in stock-based compensation for options for
administrative personnel and consultants. This resulted in a non-cash
expense of $422,000 compared with $476,000 in 2004. The 2004 amount
included $95,000 as the fair value of the cashless exercise of options
by
an officer of the Corporation;
|
•
|
A
reduction in investor relations expenses by $61,000 following the
completion of some consulting contracts during
2005;
|
•
|
A
reduction in compensation of $38,000, reflecting lower incentive
payments
for 2005 for performance milestones;
and
|
•
|
A
reduction of $45,000 in travel expenses as a result of fewer international
business development meetings.
|
•
|
A
$253,000 increase in spending on clinical trials for skin cholesterol
and
cancer to $488,000 from $235,000 in 2003. This increase is related
to a
lung cancer trial (the “I-ELCAP” study) and the large skin cholesterol
study being conducted with AtheroGenics, Inc. that commenced in the
latter
part of 2003;
|
•
|
Increased
filing fees on intellectual property, which amounted to $196,000
compared
with $92,000 in fiscal 2003. During the year, the Corporation filed
new
patents on skin cholesterol in numerous European countries. In addition,
the Corporation incurred costs of $96,000 related to filing a petition
for
reinstatement of two U.S. patents for skin cholesterol that had been
deemed abandoned;
|
•
|
Increases
in total compensation and benefits for research personnel of $221,000,
reflecting annual increases plus accruals for incentive compensation
based
on performance;
|
•
|
Increases
in subcontract research expenditures of $114,000, as the Corporation
continued further development of new prototypes of laboratory and
consumer
(over-the-counter) formats of the skin cholesterol technology;
and
|
•
|
A
reduction in stock-based compensation, which was prospectively adopted
in
2003, resulted in non-cash expenses for research personnel of $124,000
in
2004 compared with $189,000 for 2003, reflecting fewer options being
granted in 2004.
|
•
|
A
one-time cost of $478,000 in 2004 related to the Corporation’s unsolicited
offer to acquire the shares of IBEX Technologies Inc. (“IBEX”). The
Corporation allowed the offer to expire in December 2004 and did
not
complete the purchase;
|
•
|
A
$221,000 increase in stock-based compensation for options for
administrative personnel that resulted in a non-cash expense of $476,000
for the year compared with $255,000 for 2003. This increase was primarily
for options granted in 2004 pursuant to a U.S. consulting contract
that
vested over nine months and for the cashless exercise of options
by an
officer of the Corporation;
|
•
|
An
$80,000 increase in professional fees, primarily due to legal fees
related
to finalizing the global licensing agreement with
McNeil;
|
•
|
A
$64,000 increase in insurance premiums over 2003 as a result of listing
on
the American Stock Exchange
(“Amex”);
|
•
|
A
reduction to nil in 2004 ($179,000 in 2003) for costs related to
the
Corporation’s U.S. listing on Amex, which was completed in September
2003;
|
•
|
A
reduction in travel expenses by $76,000 following completion of the
McNeil
agreement as a result of less foreign travel;
and
|
•
|
An
increase of $160,000 in total compensation and benefits for administration
personnel reflecting annual increases plus accrued incentive compensation
based on performance.
|
Product
|
|
Description
/
Indication
|
|
Phase
of
Development
|
|
Approx.
% Completed
|
|
Collaborator
|
|
Estimate
of
Completion
of
Phase
|
Coronary
Artery Disease (CAD) Risk Assessment Technology:
|
||||||||||
PREVU*
POC Skin Sterol Test
(previously
Cholesterol 1,2,3™)
|
|
Point
of care skin cholesterol test that provides information about an
individual’s risk of coronary artery disease
|
|
Regulatory
clearance in Canada, U.S. and Europe; start of commercial
sales
Expand
regulatory claims
|
|
100%
60%
|
|
McNeil
Various
clinical trial sites
|
|
2005
2006
|
PREVU*
LT Skin Sterol Test
|
|
Lab-processed
skin cholesterol test
|
|
Clinical
trials in progress
|
|
75%
|
|
McNeil
|
|
2006
|
Commercial
launch in select markets
|
nil
|
McNeil
|
2006
|
|||||||
PREVU*
PT Skin Sterol Test
|
Semi-quantitative
consumer test
|
Prototype
development
|
50%
|
McNeil
|
2006
|
|||||
Cancer
Technologies:
|
||||||||||
ColorectAlert™&
Colopath™
|
|
Mucus
tests for early detection of colorectal cancer
|
|
2,000
patients tested in clinical trials
|
|
100%
|
|
St.
Michael’s Hospital
|
|
2004
|
Additional
clinical studies to support commercialization
|
10%
|
N/A
|
2006/07
|
|||||||
LungAlert™
|
|
Sputum
test for early detection of lung cancer
|
|
Automation
of procedures
1,000
patients tested in clinical trials
|
|
60%
80%
|
|
St.
Joseph’s Hospital;
I-ELCAP
|
|
2006
|
Expand
clinical trials; publish scientific papers
|
50%
|
2006/07
|
||||||||
Breast
Cancer Test
|
Aspirate
test for early detection of breast cancer
|
Completed
pilot study; pivotal study underway
|
25%
|
University
of Louisville
|
2006
|
|||||
All Cancer Tests | Improvement of assay method |
Alternative
format development
|
80% | N/A | 2006 |
Product
|
Fiscal
Year
Ended
December
31, 2005
|
Fiscal
Year
Ended
December
31, 2004
|
Fiscal
Year
Ended
December 31, 02003
|
Fiscal
Year
Ended
December
31,2002
|
Historical
Cumulative
total
since
February
1, 1997
|
|||||||||||
CAD
Risk Assessment Technologies
|
$
|
2,025,000
|
$
|
1,476,000
|
$
|
860,000
|
$
|
1,188,000
|
$
|
8,567,000
|
||||||
ColorectAlert™
and ColoPath™
|
$
|
309,000
|
$
|
304,000
|
$
|
327,000
|
$
|
495,000
|
$
|
2,990,000
|
||||||
LungAlert™
|
$
|
309,000
|
$
|
255,000
|
$
|
228,000
|
$
|
178,000
|
$
|
1,138,000
|
||||||
Breast
Cancer
|
$
|
66,000
|
$
|
42,000
|
$
|
45,000
|
nil
|
$
|
153,000
|
E.
|
Off-Balance
Sheet Arrangements
|
Total
|
Less
than
1
Year
|
1
- 2 Years
|
2−5
Years
|
||||||||||
Clinical
Trials
|
$
|
2,478,000
|
$
|
1,698,000
|
$
|
780,000
|
$
|
nil
|
|||||
Research
Agreements
|
72,000
|
72,000
|
nil
|
nil
|
|||||||||
Other
|
431,000
|
137,000
|
139,000
|
155,000
|
|||||||||
Total
|
$
|
2,981,000
|
$
|
1,907,000
|
$
|
919,000
|
$
|
155,000
|
Name
and Position
|
Financial
Year Ended
|
Annual
Compensation
|
Long-term
Compensation
|
All
other
Compensation
($)
|
||
Salary
($)
|
Bonus
($)
|
Other
Annual Compen-
sation(1)
($)
|
Securities
Under
Option
Granted
(#)
|
|||
Dr.
Brent Norton
President
and Chief Executive Officer
|
Dec.
31, 2005
Dec.
31, 2004
Dec.
31, 2003
|
$331,250
$285,000
$285,000
|
$28,500
$142,500
-
|
-
-
-
|
100,000
-
70,000
|
$22,101
-
|
Ronald
Hosking
Vice
President, Finance and Chief Financial Officer
|
Dec.
31, 2005
Dec.
31, 2004
Dec.
31, 2003
|
$191,461
$167,500
$150,000
|
$30,000
$30,000
$24,000
|
-
-
-
|
52,000
-
85,000
|
$13,691
-
-
|
Michael
Evelegh
Ph.D.,
Executive Vice President, Clinical and Regulatory Affairs
|
Dec.
31, 2005
Dec.
31, 2004
Dec.
31, 2003
|
$244,125
$225,000
$225,000
|
$22,500
$56,250
-
|
-
-
-
|
65,000
-
50,000
|
-
-
-
|
Tim
Currie
Vice
President, Corporate Development
|
Dec.
31, 2005
Dec.
31, 2004
|
$200,400
$150,000
|
$29,100
$45,000
|
-
-
|
52,000
35,000
|
$6,230
-
|
(1)
|
Unless
otherwise disclosed, the aggregate amount of perquisites and other
personal benefits do not exceed the lesser of $50,000 and 10% of
the
salary and the bonus of each Named Executive Officer for the years
ended
December 31, 2005, 2004 and 2003.
|
2.
|
Long-term
Incentive Plan Awards during the Year Ended December 31,
2005
|
During
the year ended December 31, 2005, the following incentive stock
options
were granted to the Named Executive
Officers:
|
Name
and Position
|
Securities
Under
Options
Granted
(#)
(1)
|
%
of Total Options
Granted
to Employees
in
Financial Year
|
Exercise
or
Base
Price
($/Security)
|
Market
Value
of
Securities Underlying
Options
on the
Date
of Grant
($/Security)
|
Expiration
Date
|
Dr.
Brent Norton
President
and Chief Executive Officer
|
100,000
|
19.2%
|
$2.95
|
$2.95
|
February
6, 2010
|
Ronald
Hosking
Vice
President, Finance and Chief Financial Officer
|
52,000
|
10.0%
|
$2.95
|
$2.95
|
February
6, 2010
|
Michael
Evelegh
Ph.D.,
Executive Vice President, Clinical and Regulatory Affairs
|
65,000
|
12.5%
|
$2.95
|
$2.95
|
February
6, 2010
|
Tim
Currie
Vice
President, Corporate Development
|
52,000
|
10.0%
|
$2.95
|
$2.95
|
February
6, 2010
|
(1)
|
These
options will vest annually over a period of five years.
|
4.
|
Aggregated
Option Exercises during the Year Ended December 31, 2005 and Financial
Year-end Option Values
|
Name
and Position
|
Securities
Acquired
on
Exercise
(#)
|
Aggregate
Value
Realized
($)
|
Unexercised
Options
at
FY-End (#)
Exercisable/
Unexercisable
|
Value
of Unexercised
in-the-money
Options
at
FY-End
($)
Exercisable/
Unexercisable
(3)
|
Dr.
Brent Norton, President and
Chief
Executive Officer
|
-
|
-
|
650,000
(1)
532,500/117,500(2)
|
nil/nil
|
Ronald
Hosking,
Vice
President, Finance and Chief Financial Officer
|
-
|
-
|
173,000
(1)
62,800/110,200(2)
|
nil/nil
|
Michael
Evelegh, Ph.D., Executive Vice President, Clinical and Regulatory
Affairs
|
-
|
-
|
285,000
(1)
207,500/77,500(2)
|
nil/nil
|
Tim
Currie
Vice
President, Corporate Development
|
-
|
-
|
273,000
(1)
125,000/148,000(2)
|
nil/nil
|
(1)
|
These
options will vest (i) upon the occurrence of certain performance-related
milestones of the Corporation relating to the Corporation’s core
technologies (e.g. launch of clinical trials, FDA clearance of
initial
claims); (ii) based upon the Corporation’s financial performance (e.g.
earnings per share targets); and/or (iii) annually over a pre-determined
number of years.
|
(2)
|
These
options were not yet exercisable as the milestones or time periods
referred to in note (1) above had not yet been
attained.
|
(3) | Based upon a closing price of $1.46 for the Common Shares on the Toronto Stock Exchange on December 31, 2005. |
Name
|
|
Position
|
|
Term
|
Dr.
H.B. Brent Norton
|
|
President,
Chief Executive Officer
and
Director
|
|
President,
CEO: 1992-present
Director:
March 17, 1993-present
|
Stephen
A. Wilgar
|
|
Director
and Chairman
|
|
March
17, 1993-present
|
Anthony
F. Griffiths
|
|
Director
|
|
July
13, 1995-present
|
Ronald D. Henriksen |
Director
|
June
16, 2004-present
|
||
David
A. Rosenkrantz
|
|
Director
|
|
June
11, 1998-present
|
Name
|
Common
Shares
held
directly
and beneficially
|
%
of Outstanding
Common
Shares as of April 15, 2006
|
Options
outstanding
|
Exercise
price
|
Expiration
date
|
|||||||||||
Dr.
H.B. Brent Norton
|
2,437,748
|
11.3
|
%
|
120,000
|
$
|
4.00
|
Feb.
16, 2007
|
|||||||||
|
240,000
|
$
|
2.86
|
Nov.
16, 2007
|
||||||||||||
|
70,000
|
$
|
4.00
|
Dec.
5, 2008
|
||||||||||||
100,000
|
$
|
2.95
|
Feb.
6, 2010
|
|||||||||||||
200,000
|
$
|
1.25
|
Feb.
16, 2011
|
|||||||||||||
Michael
Evelegh, Ph.D
|
379,261
|
1.8
|
%
|
60,000
|
$
|
4.00
|
Feb.
16, 2007
|
|||||||||
|
50,000
|
$
|
2.86
|
Nov.
16, 2007
|
||||||||||||
|
50,000
|
$
|
4.00
|
Dec.
5, 2008
|
||||||||||||
65,000
|
$
|
2.95
|
Feb.
6, 2010
|
|||||||||||||
120,000
|
$
|
1.25
|
Feb.
11, 2011
|
|||||||||||||
Ronald
G. Hosking
|
293,778
|
1.4
|
%
|
36,000
|
$
|
4.00
|
Feb.
16, 2007
|
|||||||||
50,000
|
$
|
2.85
|
Jun
27, 2008
|
|||||||||||||
35,000
|
$
|
4.00
|
Dec.
5, 2008
|
|||||||||||||
65,000
|
$
|
2.95
|
Feb.
6, 2010
|
|||||||||||||
52,000
|
$
|
2.95
|
Feb.
6, 2010
|
|||||||||||||
48,000
|
$
|
1.40
|
Feb.
28, 2011
|
|||||||||||||
Tim
Currie
|
12,000
|
0.1
|
%
|
20,000
|
$
|
3.45
|
Mar.
1, 2006
|
|||||||||
10,000
|
$
|
3.60
|
Mar.
20, 2006
|
|||||||||||||
36,000
|
$
|
4.00
|
Feb.
16, 2007
|
|||||||||||||
50,000
|
$
|
2.85
|
Mar.
3, 2008
|
|||||||||||||
35,000
|
$
|
4.00
|
Feb.
23, 2009
|
|||||||||||||
52,000
|
$
|
2.95
|
Feb.
6, 2010
|
|||||||||||||
120,000
|
$
|
1.25
|
Feb.
16, 2011
|
Name
|
Common
Shares
held
directly
and beneficially
|
%
of Outstanding
Common
Shares as of April 15, 2006
|
Options
outstanding
|
Exercise
price
|
Expiration
date
|
|||||||||||
Stephen
A. Wilgar
|
275,038
|
1.3
|
%
|
10,000
|
$
|
2.86
|
Nov.
16, 2007
|
|||||||||
|
30,000
|
$
|
4.00
|
Dec.
5, 2008
|
||||||||||||
|
30,000
|
$
|
4.09
|
Aug.
7, 2009
|
||||||||||||
30,000
|
$
|
3.41
|
June
25, 2010
|
|||||||||||||
Anthony
F. Griffiths
|
510,500
|
2.4
|
%
|
5,000
|
$
|
2.86
|
Nov.
16, 2007
|
|||||||||
|
15,000
|
$
|
4.00
|
Dec.
5, 2008
|
||||||||||||
|
15,000
|
$
|
4.09
|
Aug.
7, 2009
|
||||||||||||
|
15,000
|
$
|
3.41
|
June
25, 2010
|
||||||||||||
David
A. Rosenkrantz
|
354,133
|
1.6
|
%
|
5,000
|
$
|
2.86
|
Nov.
16, 2007
|
|||||||||
|
15,000
|
$
|
4.00
|
Dec.
5, 2008
|
||||||||||||
|
15,000
|
$
|
4.09
|
Aug.
7, 2009
|
||||||||||||
|
15,000
|
$
|
3.41
|
June
25, 2010
|
||||||||||||
Ronald
Henriksen
|
0
|
0.0
|
%
|
15,000
|
$
|
3.50
|
Apr.
12, 2009
|
|||||||||
15,000
|
$
|
3.41
|
June
25, 2010
|
|
Number
of Voting
Securities
Owned
|
||||||
Name
|
Common
Shares
|
Percentage
of Class
|
|||||
Dr.
H.B. Brent Norton
|
2,437,748
|
11.3
|
%
|
|
•
|
|
Consolidated
Balance Sheets
|
|
•
|
|
Consolidated
Statements of Loss and Deficit
|
|
•
|
|
Consolidated
Statements of Cash Flows
|
|
•
|
|
Notes
to Consolidated Financial Statements
|
|
1.
|
|
Indicate
the expected price at which the securities will be offered or the
method
of determining the price, and the amount of any expenses specifically
charged to the subscriber or purchaser.
|
|
2.
|
|
If
there is not an established market for the securities, the document
shall
contain information regarding the manner of determination of the
offering
price as well as of the exercise price of warrants and the conversion
price of convertible securities, including who established the
price or
who is formally responsible for the determination of the price,
the
various factors considered in such determination and the parameters
or
elements used as a basis for establishing the price.
|
|
3.
|
|
If
the corporation’s shareholders have pre-emptive purchase rights and where
the exercise of the right of pre-emption of shareholders is restricted
or
withdrawn, the corporation shall indicate the basis for the issue
price if
the issue is for cash, together with the reasons for such restriction
or
withdrawal and the beneficiaries of such restriction or withdrawal
if
intended to benefit specific persons.
|
|
4.
|
|
The
following table sets forth information regarding the price history
of the
Common Shares on the Toronto Stock Exchange and the American Stock
Exchange for the periods indicated.
|
|
(a)
|
|
for
the five most recent full financial years: the annual high and
low market
prices:
|
TSX
|
Amex
|
||||||||||||
|
High
($)
|
Low
($)
|
High
($)
|
Low
($)
|
|||||||||
Dec-05
|
4.14
|
1.32
|
3.50
|
1.05
|
|||||||||
Dec-04
|
4.70
|
2.60
|
3.40
|
1.88
|
|||||||||
Dec-03
|
4.89
|
2.41
|
3.65
|
2.84
|
|||||||||
Dec-02
|
7.15
|
2.20
|
-
|
-
|
|||||||||
Dec-01
|
6.00
|
3.09
|
-
|
-
|
|
(b)
|
|
for
the most recent full financial years and any subsequent period:
the high
and low market prices for each full financial quarter:
|
TSX
|
Amex
|
||||||||||||
|
High
($)
|
Low
($)
|
High
($)
|
Low
($)
|
|||||||||
Q1/06
Jan
- Mar
|
2.47
|
1.16
|
2.15
|
1.02
|
|||||||||
Q4/05
Oct-Dec
|
2.50
|
1.32
|
2.09
|
1.05
|
|||||||||
Q3/05
July-Sept
|
3.45
|
2.06
|
2.80
|
1.72
|
|||||||||
Q2/05
Apr-Jun
|
3.94
|
2.12
|
3.27
|
1.74
|
|||||||||
Q1/05
Jan-Mar
|
4.14
|
2.91
|
3.50
|
2.35
|
|||||||||
Q4/04
Oct-Dec
|
3.50
|
2.77
|
2.83
|
2.33
|
|||||||||
Q3/04
July-Sept
|
4.17
|
3.00
|
3.20
|
2.31
|
|||||||||
Q2/04
Apr-Jun
|
4.70
|
2.60
|
3.40
|
1.88
|
|||||||||
Q1/04
Jan-Mar
|
4.25
|
3.60
|
3.30
|
2.70
|
|
(c)
|
|
for
the most recent six months: the high and low market prices for
each month:
|
TSX
|
AMEX
|
||||||||||||
|
High
($)
|
Low
($)
|
High
($)
|
Low
($)
|
|||||||||
Apr-06
|
2.50
|
1.85
|
2.22
|
1.61
|
|||||||||
Mar-06
|
2.47
|
1.16
|
2.15
|
1.02
|
|||||||||
Feb-06
|
1.49
|
1.31
|
1.28
|
1.12
|
|||||||||
Jan-06
|
1.58
|
1.19
|
1.50
|
1.03
|
|||||||||
Dec-05
|
1.64
|
1.32
|
1.30
|
1.24
|
|||||||||
Nov-05
|
2.30
|
1.47
|
2.00
|
1.30
|
|||||||||
Oct-05
|
2.50
|
1.92
|
2.09
|
1.70
|
|
(d)
|
|
for
pre-emptive issues, the market prices for the first trading day
in the
most recent six months, for the last trading day before the announcement
of the offering and (if different) for the latest practicable date
prior
to publication of the document.
|
|
5.
|
|
State
the type and class of securities being offered or listed and furnish
the
following information:
|
|
(a)
|
|
Indicate
whether the shares are registered shares or bearer shares and provide
the
number of shares to be issued and to be made available to the market
for
each kind of share. The nominal par or equivalent value should
be given on
a per share basis and, where applicable, a statement of the minimum
offer
price. Describe the coupons attached, if applicable.
|
|
(b)
|
|
Describe
arrangements for transfer and any restrictions on the free transferability
of the shares.
|
|
6.
|
|
If
the rights evidenced by the securities being offered or listed
are or may
be materially limited or qualified by the rights evidenced by any
other
class of securities or by the provisions of any contract or other
documents, include information regarding such limitation or qualification
and its effect on the rights evidenced by the securities to be
listed or
offered.
|
|
7.
|
|
With
respect to securities other than common or ordinary shares to be
listed or
offered, outline briefly the rights evidenced thereby.
|
A.
|
Share
Capital
|
|
•
|
|
for
purposes of the U.S. Internal Revenue Code of 1986, as amended,
through
the date hereof (the “Code”), are U.S. persons and, for purposes of the
Income Tax Act (Canada) (the “Income Tax Act”) and the Canada-United
States Income Tax Convention (1980), are non-residents of Canada
and
residents of the U.S. respectively, at all relevant times;
|
|
•
|
|
hold
Common Shares as capital assets for purposes of the Code and capital
property for the purposes of the Income Tax Act;
|
|
•
|
|
deal
at arm’s length with, and are not affiliated with, the Corporation for
purposes of the Income Tax Act; and
|
|
•
|
|
do
not and will not use or hold the Common Shares in carrying on a
business
in Canada.
|
|
•
|
|
the
Income Tax Act and regulations under the Income Tax Act;
|
|
•
|
|
the
Code and Treasury regulations under the Code;
|
|
•
|
|
the
Canada-United States Income Tax Convention (1980);
|
|
•
|
|
the
administrative policies and practices published by the Canada Revenue
Agency;
|
|
•
|
|
all
specific proposals to amend the Income Tax Act and the regulations
under
the Income Tax Act that have been publicly announced by or on behalf
of
the Minister of Finance (Canada) prior to the date of this report;
|
|
•
|
|
the
administrative policies published by the U.S. Internal Revenue
Service;
and
|
|
•
|
|
judicial
decisions.
|
|
•
|
|
75%
or more of the Corporation’s gross income is “passive income,” which
includes interest, dividends and certain rents and royalties; or
|
|
•
|
|
the
average quarterly percentage, by fair market value of the Corporation’s
assets that produce or are held for the production of “passive income,” is
50% or more of the fair market value of all the Corporation’s assets.
|
A.
|
Disclosure
Controls and
Procedures
|
1.
|
Over
10 years of experience in investing as a principal in private companies
as
Chairman of Patica Corporation, a merchant banking
company
|
2.
|
Over
7 years of experience in investing in and bringing to the public
markets
junior, high-growth companies
|
3.
|
Controlling
shareholder of several private
corporations
|
4.
|
Chief
Compliance Officer of Patica Securities Limited, a Limited Market
Dealer
in Ontario, as defined and regulated by the Ontario Securities
Commission
|
5.
|
Former
Chief Compliance Officer for Patica Securities Inc. (now, Kingsdale
Capital Markets Inc.), regulated by the Investment Dealers Association
and
the Ontario Securities Commission,
and
|
6.
|
Over
10 years of serving as a director on various public company boards,
including work chairing and participating on several audit committees
|
2004
|
2005
|
||||||||||||
|
Amount
|
% |
Amount
|
% | |||||||||
Audit
Fees
|
$
|
118,730
|
45.1
|
$
|
138,655
|
92.7
|
|||||||
Audit-Related
Fees
|
127,110
|
48.3
|
-
|
-
|
|||||||||
Tax
Fees(1)
|
17,205 | 6.5 | 11,000 | 7.3 | |||||||||
Total
|
$
|
263,045
|
100.0
|
$
|
149,655
|
100.0
|
1.1
|
|
Articles
of Amalgamation of the Corporation. Previously filed as an exhibit
to the
Corporation’s Registration
Statement on Form 20-F filed on June 18, 2002 (File No.
001-31360).
|
|
1.2
|
B
By-laws of the Corporation. Previously filed as an exhibit to the
Corporation’s Registration Statement on Form 20-F filed on June 18, 2002
(File No. 001-31360).
|
||
1.3
|
|
Articles
of Amendment of the Corporation to change the name of the Corporation
from
IMI International Medical Innovations Inc. to PreMD Inc. dated
September
26, 2005.
|
|
1.4
|
Certificate
of Amendment of the Corporation to change the name of the Corporation
from
IMI International Medical Innovations Inc. to PreMD Inc. dated
September
26, 2005.
|
||
2.1
|
Certificate
of 7% Convertible Debenture due August 30, 2009 and issued August
30,
2005.
|
||
2.2
|
Certificate
of Common Stock Purchase Warrant dated August 30, 2005.
|
||
4.1*
|
|
Supply
Agreement by and between the Registrant and Diagnostic Chemicals
Limited
dated June 19, 2001. Previously filed as an exhibit to the Corporation’s
Registration Statement on Form 20-F filed on June 18, 2002 (File
No.
001-31360).
|
|
4.2*
|
|
Cholesterol
1,2,3 - Skin Cholesterol Measurement System - Product Development,
Manufacturing and Marketing and Sales Agreement by and between
the
Registrant and X-Rite, Inc. dated May 14, 1999. Previously filed
as an
exhibit to the Corporation’s Registration Statement on Amendment No. 1 to
the Form 20-F filed on October 28, 2002 (File No.
001-31360).
|
|
4.3
|
|
Employment
Agreement by and between the Registrant and Ronald Hosking dated
February
2, 2006.
|
|
4.4
|
Employment
Agreement by and between the Registrant and Tim Currie dated January
10,
2006.
|
||
4.5
|
|
Employment
Agreement by and between the Registrant and Dr. H.B. Brent Norton
dated
Jan. 1, 2001. Previously filed as an exhibit to the Corporation’s
Registration Statement on Form 20-F filed on June 18, 2002 (File
No.
001-31360).
|
|
4.6
|
|
Employment
Agreement by and between the Registrant and Michael Evelegh dated
Jan 1,
2001. Previously filed as an exhibit to the Corporation’s Registration
Statement on Amendment No.1 to the Form 20-F filed on October 28,
2002
(File No. 001-31360).
|
|
4.7
|
|
Lease
Agreement by and among the Registrant, and 448048 Ontario Inc.
dated
November 19, 2004. Previously
filed as an exhibit to the Corporation’s Annual and Transition Report of
Foreign Private Issuers on Form 20-F filed on June 30, 2005 (File
No.
001-31360).
|
|
4.8
|
|
McMaster
Bioscience Incubation Centre Host Agreement between McMaster University
and the Registrant dated November 17, 2005.
|
|
4.9*
|
|
License,
Development and Supply Agreement between McNeil PDI Inc. and the
Registrant dated May 9, 2002. Previously filed as an exhibit to
the
Corporation’s Registration Statement on Amendment No. 4 to the Form 20-F
filed on March 7, 2003 (File No. 001-31360).
|
|
4.10*
|
|
Amendment
to License, Development and Supply Agreement by and between McNeil
PDI
Inc. and the Registrant dated December 20, 2002. Previously filed
as an
exhibit to the Corporation’s Registration Statement on Amendment No. 4 to
the Form 20-F filed on March 7, 2003 (File No.
001-31360).
|
4.11*
|
License,
Development and Supply Agreement by and between McNeil PDI Inc.,
McNeil
Consumer & Specialty Pharmaceuticals Division of McNeil-PPC, Inc., IMI
International Medical Innovations Inc. (Switzerland) and the Registrant,
dated May 28, 2004. Previously filed as an exhibit to a 6K filed
on June
9, 2004 (File No. 001-31360)
|
||
4.12*
|
Amendment
dated December 9, 2005 to the License, Development and Supply Agreement
by
and between McNeil PDI Inc. and the Registrant dated May 10, 2002
as
amended December 20, 2002.
|
||
4.13*
|
Amendment
dated December 9, 2005 to the License, Development and Supply Agreement
by
and between McNeil PDI Inc., McNeil Consumer & Specialty
Pharmaceuticals Division of McNeil-PPC, Inc., IMI International
Medical
Innovations Inc. (Switzerland) and the Registrant, dated May 28,
2004.
|
||
4.14
|
|
|
Code
of Ethics/Code of Business Conduct previously filed as an Exhibit
to the
Corporation’s Registration Statement on Form 20-F filed on June 4, 2003
(File No. 001-31360)
|
4.15
|
Fiscal
2005 consolidated financial statements and notes to the consolidated
financial statements previously filed under Form 6-K on March 30,
2006
(File No. 001-31360) and Form 6-K/A on April 5, 2006 (File No.
001-31360)
|
||
4.16
|
Underwriting
Agreement between Orion Securities Inc., Loewen, Ondaatje, McCutcheon
Limited and the Registrant dated August 30, 2005.
|
||
12.1
|
|
|
Certification
of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley
Act.
|
12.2
|
|
|
Certification
of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley
Act.
|
13.1
|
|
|
Certification
of Chief Executive Officer and Chief Financial Officer Pursuant
to Section
906 of the Sarbanes-Oxley Act.
|
*
|
|
|
Certain
confidential information contained in this exhibit, marked by brackets
with asterisks, has been omitted and filed separately with the
Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange
Act of 1934, as amended.
|
PreMD
INC.
|
|||
By:
|
|
/s/ RONALD
HOSKING
|
|
|
|
Ronald
Hosking
|
|
Its:
|
|
Vice
President, Finance and Chief Financial
Officer
|