£
|
|
REGISTRATION
STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE
ACT
OF 1934
|
S
|
|
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
£
|
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
Title
of each class
|
Name
of each exchange on which registered
|
|
Common
Shares
|
The
American Stock Exchange and
The
Toronto Stock Exchange
|
NOTE
REGARDING FORWARD-LOOKING STATEMENTS
|
iii
|
PART
I
|
|
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
|
9
|
History
and Development of the Corporation
|
9
|
Business
Overview
|
10
|
Organizational
Structure
|
44
|
Property,
Plants and Equipment
|
44
|
Item
4A. UNRESOLVED STAFF COMMENTS
|
44
|
Item
5. OPERATING AND FINANCIAL REVIEW AND
PROSPECTS
|
45
|
Operating
Results
|
45
|
Liquidity
and Capital Resources
|
49
|
Research
and Development and Patents and Licenses
|
50
|
Trend
Information
|
52
|
Off-Balance
Sheet Arrangements
|
52
|
Tabular
Disclosure of Contractual Commitments
|
52
|
Item
6. DIRECTORS, SENIOR MANAGEMENT AND
EMPLOYEES
|
53
|
Directors
and Senior Management
|
53
|
Compensation
|
56
|
Board
Practices
|
58
|
Employees
|
60
|
Share
Ownership
|
60
|
Item
7. MAJOR SHAREHOLDERS AND RELATED PARTY
TRANSACTIONS
|
63
|
Major
Shareholders
|
63
|
Related
Party Transactions
|
63
|
Interests
of Experts and Counsel
|
63
|
Item
8. FINANCIAL INFORMATION
|
64
|
Consolidated
Statements and Other Financial Information (Audited)
|
64
|
Significant
Changes
|
64
|
Item
9. THE OFFER AND LISTING
|
64
|
Offer
and Listing Details
|
64
|
Plan
of Distribution
|
66
|
Markets
|
67
|
Selling
Shareholders
|
67
|
Dilution
|
67
|
Expenses
of the Issue
|
67
|
Item
10. ADDITIONAL INFORMATION
|
67
|
Share
Capital
|
67
|
Memorandum
and Articles of Association
|
67
|
Material
Contracts
|
67
|
Exchange
Controls
|
67
|
Taxation
|
68
|
Dividends
and Paying Agents
|
72
|
Statement
by Experts
|
72
|
Documents
on Display
|
72
|
Subsidiary
Information
|
73
|
Item
11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
|
73
|
Quantitative
and Qualitative Information about Market Risk
|
73
|
Item
12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY
SECURITIES
|
73
|
Item
13. DEFAULTS, DIVIDEND ARREARAGES AND
DELINQUENCIES
|
73
|
Item
14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY
HOLDERS AND USE OF PROCEEDS
|
73
|
Item
15. CONTROLS AND PROCEDURES
|
74
|
Item
16A. AUDIT COMMITTEE FINANCIAL EXPERT
|
74
|
Item
16B. CODE OF ETHICS/CODE OF BUSINESS CONDUCT
|
74
|
Item
16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES
|
75
|
Item
16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT
COMMITTEES
|
75
|
Item
16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED
PURCHASERS
|
75
|
PART III | |
Item
17. FINANCIAL STATEMENTS
|
75
|
Item
18. FINANCIAL STATEMENTS
|
76
|
Item
19. EXHIBITS
|
77
|
|
•anticipated
strategic alliances or arrangements with development or marketing
partners;
|
|
•anticipated
research and product development
results;
|
|
•projected
development and commercialization
timelines;
|
|
•descriptions
of plans or objectives of management for future operations, products
or
services;
|
|
•anticipated
financing activities;
|
|
•forecasts
of future economic performance; and
|
|
•descriptions
or assumptions underlying or relating to any of the above
items.
|
|
A.
|
Directors
and Senior Management
|
|
B.
|
Advisers
|
|
C.
|
Auditors
|
|
|
2006
|
2005
|
2004
|
|
2003
|
2002
|
|||||||||||||||||
Average
|
|
0.8818
|
0.8254
|
0.7682
|
0.7136
|
0.6368
|
||||||||||||||||||
|
May
07
|
|
Apr-07
|
Mar-07
|
Feb-07
|
Jan-07
|
Dec-06
|
|||||||||||||||||
Low
|
0.8980
|
0.8633
|
0.8467
|
0.8437
|
0.8457
|
0.8582
|
||||||||||||||||||
High
|
0.9345
|
0.9035
|
0.8673
|
0.8631
|
0.8586
|
0.8760
|
||||||||||||||||||
Average
|
0.9133
|
0.8812
|
0.8560
|
0.8540
|
0.8501
|
0.8672
|
Canadian
GAAP:
|
Fiscal
Year
Ended
December
31,
2006
|
Fiscal
Year
Ended
December
31,
2005
|
Fiscal
Year
Ended
December
31,
2004
|
Fiscal
Year
Ended
December
31,
2003
|
Fiscal
Year
Ended
December
31,
2002
|
|||||||||||||||
Operating Results | ||||||||||||||||||||
Product
sales
|
$ |
6,513
|
$ |
425,730
|
$ |
183,258
|
nil
|
nil
|
||||||||||||
License
revenue
|
3,328,827
|
1,153,308
|
302,080
|
$ |
16,900
|
nil
|
||||||||||||||
Total
expenses
|
9,712,856
|
6,512,146
|
6,192,649
|
4,561,179
|
$ |
4,465,577
|
||||||||||||||
Investment
tax credits
|
200,000
|
198,923
|
205,000
|
223,146
|
189,908
|
|||||||||||||||
Interest
income
|
265,369
|
173,130
|
123,626
|
258,422
|
257,407
|
|||||||||||||||
Net
loss
|
$ |
5,948,971
|
$ |
4,989,705
|
$ |
5,568,899
|
$ |
4,062,711
|
$ |
4,018,262
|
||||||||||
Net
loss per share:
|
||||||||||||||||||||
-
basic and diluted loss
per share
|
$ |
0.27
|
$ |
0.23
|
$ |
0.26
|
$ |
0.19
|
$ |
0.20
|
||||||||||
Loss
from continuing operations
per share
|
$ |
0.27
|
$ |
0.23
|
$ |
0.26
|
$ |
0.19
|
$ |
0.20
|
U.S.
GAAP:
|
Fiscal
Year
Ended
December
31,
2006
|
Fiscal
Year
Ended
December
31,
2005
(restated)
|
Fiscal
Year
Ended
December
31,
2004
|
Fiscal
Year
Ended
December
31,
2003
|
Fiscal
Year
Ended
December
31,
2002
|
|||||||||||||||
Net
loss
|
$ |
5,886,869
|
$ |
4,904,124
|
$ |
5,478,184
|
$ |
3,949,318
|
$ |
4,871,140
|
||||||||||
Net
loss per share:
|
||||||||||||||||||||
-
basic and diluted loss
per share
|
$ |
0.27
|
$ |
0.23
|
$ |
0.26
|
$ |
0.19
|
$ |
0.24
|
Canadian
GAAP:
|
As
at
December
31,
2006
|
As
at
December
31,
2005
|
As
at
December
31,
2004
|
As
at
December
31,
2003
|
As
at
December
31,
2002
|
|||||||||||||||
Financial
Position
|
||||||||||||||||||||
Total
assets
|
$ |
5,279,500
|
$ |
11,293,190
|
$ |
6,996,079
|
$ |
8,074,027
|
$ |
11,379,383
|
||||||||||
Long-term
debt
|
6,350,680
|
5,893,340
|
nil
|
nil
|
nil
|
|||||||||||||||
Shareholders’
Equity
|
||||||||||||||||||||
Capital
stock
|
25,263,480
|
24,449,826
|
24,192,321
|
24,056,853
|
23,785,884
|
|||||||||||||||
Total
shareholders’ equity (deficiency)
|
$ | (2,967,542 | ) | $ |
1,844,297
|
$ |
2,496,842
|
$ |
7,438,279
|
$ |
10,689,828
|
|||||||||
Weighted
average number of common shares
|
||||||||||||||||||||
Outstanding
|
21,663,698
|
21,487,008
|
21,276,497
|
20,967,677
|
20,406,733
|
|||||||||||||||
Cash
dividends declared per share
|
nil
|
nil
|
nil
|
nil
|
nil
|
U.S.
GAAP:
|
As
at
December
31,
2006
|
As
at
December
31,
2005
(restated)
|
As
at
December
31,
2004
|
As
at
December
31,
2003
|
As
at
December
31,
2002
|
|||||||||||||||
Financial
Position
|
||||||||||||||||||||
Total
assets
|
$ |
5,167,639
|
$ |
11,211,832
|
$ |
6,633,221
|
$ |
7,620,454
|
$ |
10,812,417
|
||||||||||
Derivative
liability
|
$ |
2,402,244
|
$ |
2,592,630
|
nil
|
nil
|
nil
|
|||||||||||||
Shareholders’
Equity
|
||||||||||||||||||||
Capital
stock
|
$ |
29,981,717
|
$ |
29,182,269
|
$ |
28,924,764
|
$ |
28,789,296
|
$ |
28,399,039
|
||||||||||
Total
shareholders’ equity (deficiency)
|
$ | (5,481,647 | ) | $ | (829,691 | ) | $ |
2,133,984
|
$ |
6,984,706
|
$ |
10,122,862
|
|
B.
|
Capitalization
and Indebtedness
|
|
•
|
Coronary
Artery Disease Risk Assessment Technology1
|
|
•
|
PREVU*
Point of Care (POC) Skin Cholesterol Test, which is cleared for sale
in
Canada, U.S. (CLIA-exempt) and CE-marked in
Europe
|
|
•
|
PREVU*
LT Skin Cholesterol Test (lab-processed format), which is cleared
for sale
in Canada, CE marked in Europe and will be under review by the FDA
in the
US.
|
|
•
|
PREVU*
PT Skin Cholesterol Test (home, or more user friendly format),
currently in development
|
|
•
|
Cancer
Technologies
|
|
•
|
ColorectAlert™,
currently in clinical studies
|
|
•
|
LungAlert™,
currently in clinical studies
|
|
•
|
Breast
cancer test, currently in
clinical studies
|
|
The
Home Testing Market
|
|
•
|
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 Cholesterol Test: Completed Studies
|
|
|
|
|
|
Skin
cholesterol and stress test
|
Dr.
Dennis Sprecher
|
The
Cleveland Clinic Foundation
|
Determine
relationship between skin cholesterol and serum lipid levels; measure
correlation of skin cholesterol to stress test outcome
|
Skin
cholesterol shown to correlate with presence of cardiovascular disease
(as
measured by stress test outcome) “independent[ly] of serum
lipids”. Researchers concluded that skin cholesterol 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
cholesterol and response to therapy
|
Dr.
Dennis Sprecher
|
The
Cleveland Clinic Foundation
|
Determine
ability of skin cholesterol to monitor patient response to lipid-lowering
medications
|
Skin
cholesterol may have utility in monitoring response to
cholesterol-lowering therapies
|
Presented
at American Association for Clinical Chemistry annual meeting in
1999
|
Measuring
skin cholesterol levels to assess CAD
|
Dr.
Dennis Sprecher
|
The
Cleveland Clinic Foundation; The Canadian Heart Research Centre;
The
Trillium Health Centre
|
Correlation
between skin cholesterol and angiography outcome
|
Skin
cholesterol 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 cholesterol and serum levels of total cholesterol
were not correlated.
Additionally,
patients with a history of myocardial infarction had a significantly
higher skin cholesterol 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
cholesterol and other markers of CAD risk
|
Dr.
John Mancini
|
University
of British Columbia; St. Paul's Hospital
|
Determine
correlation of skin cholesterol to other measures of CAD risk, including
carotid sonography, flow-mediated brachial vasoactivity and serum
markers.
|
Skin
cholesterol 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 cholesterol study
|
Dr.
Katherine Morrison
|
St.
Joseph's Hospital
|
Examine
skin cholesterol levels in children with
hypercholesterolemia
|
Skin
cholesterol can be reliably measured in children
|
Presented
at the 2003 Endocrine Society Annual Meeting
|
Skin
cholesterol and statins
|
Dr.
Marcus Reiter
|
University
of Vienna
|
Examine
skin cholesterol response to certain cholesterol-lowering
medications
|
Patients
treated with statins experienced decreases in skin cholesterol values
as
well as in blood cholesterol; initial data shows that skin cholesterol
may
be a useful monitoring tool for patients taking statins
|
Data
published in Journal of Clinical Chemistry in January
2005
|
Skin
cholesterol and carotid IMT
|
Dr.
James Stein
|
University
of Wisconsin
|
Measure
relationship between skin cholesterol and CAD using carotid IMT
(CIMT)
|
Skin
cholesterol 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 cholesterol levels in South Asians
|
Interim
data confirmed that skin cholesterol provides new information about
a
patient’s risk of CAD. Skin cholesterol 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 cholesterol 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 Cholesterol Test: Ongoing Studies
|
|
|
|
|
|
PREPARE
|
Dr.
David Waters;
Dr.
Dennis Sprecher;
Dr.
John Mancini
|
Various,
in life insurance testing industry
|
Relationship
between skin cholesterol (PREVU* LT) and risk of CVD as estimated
by
Framingham score
|
Data
has been used for regulatory submissions
|
Manuscript
being prepared
|
DESCRIPTION
|
INVESTIGATOR
|
PRIMARY
STUDY
SITE
|
OBJECTIVES
|
OUTCOME
|
PUBLICATIONS/
PRESENTATIONS
|
PASA
|
Dr.
James Stein
|
University
of Wisconsin and five other U.S. sites
|
Relationship
between skin cholesterol (PREVU* POC and PREVU* LT) and CAD using
carotid
IMT in a screening population
|
510
(K) submitted to U.S. FDA
|
Manuscript
being prepared
|
ARISE
(Aggressive Reduction in Inflammation Stops Events)
|
Dr.
Rob Scott
|
AtheroGenics,
Inc.;
study
conducted at multiple sites around world
|
Study
will examine skin cholesterol (PREVU* POC) changes in response to
AtheroGenics’ AGI-1067 therapy. Trial will also provide data on
relationship between skin cholesterol and primary cardiovascular
events
|
Anticipate
data in Q3 2007
|
|
Correlation
study
|
Dr.
Jean-Claude Tardif
|
Montreal
Heart Institute
|
Trial
will evaluate the correlation between PREVU* POC and PREVU*
LT.
|
Anticipate
data in Q3 2007
|
|
Skin
cholesterol and new CAD risk markers
|
Dr.
John Mancini;
Dr.
Sammy Chan;
Dr.
Jiri Frolich
|
University
of British Columbia
|
Study
will examine relationship between skin cholesterol (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 cholesterol
responds to various therapies
|
Anticipate
data in Q3 2007
|
|
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 cholesterol (PREVU* POC) to early markers
of
CAD across different ethnic groups
|
Interim
data demonstrated that skin cholesterol 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 cholesterol and Framingham Global
Risk
Score and other markers of CAD in patients suspected of having
CAD. Trial includes PREVU* POC and PREVU* LT
|
Study
completed
|
|
•
|
Risk
assessment by physicians. This market
includes primary care physicians, hospitals and managed care organizations
as well as various healthcare 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)
|
|
•
|
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
|
In
progress
|
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. Another 1,500 patients are tested at
baseline.
|
In
progress
|
|
•
|
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
|
|
•
|
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.
|
In
progress
|
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
|
Pending
|
Multilayer
Analytical Element
|
PCT
Brazil
|
CA95/00698
PI9510038-5
|
N/A
Notice
of Allowance Oct 4, 2005
|
N/A
|
Patent
Status
|
Title
|
Jurisdiction
|
Patent
Number
|
Grant
Date
|
Expiry
Date
|
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
|
Accepted
in Canada
June
8, 2005
|
N/A
|
Granted
|
Spectrophotometric
Measurement in Color-Based Biochemical and Immunological
Assays
As
it pertains to Skin Cholesterol Measurement
|
Australia
Russia
China
|
781034
|
August
18, 2005
March
10, 2006
Notice
of Grant
|
August
4, 2020
August
4, 2010
|
Pending
|
Spectrophotometric
Measurement in Color-Based Biochemical and Immunological
Assays
As
it pertains to Skin Cholesterol Measurement
|
PCT
Brazil
Europe
Hong
Kong
India
Japan
|
PCT/CA00/00918
PI0013096.6
00954181.4
0310671.6
PCT/2002/00307
2001-51596.4
|
N/A
|
N/A
|
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
Australia
Brazil
China
Europe
India
Japan
Hong
Kong
Mexico
Russia
United
States
US-
continuation
in part
|
2,465,427
PCT/CA2005/00642
Pub
No. WO2005/106018
2005238099
TBD
200580013893.2
5738502.3
3171/kolnp/2006
TBD
7101674.4
PA/a/2006/012326
2006137332
10/835,397
11/116,412
|
N/A
|
N/A
|
Pending
|
Direct
Assay of Skin Protein in Skin Samples Removed by Tape
Stripping
|
United
States
PCT
|
60/682,837
PCT/CA2006/00831
Pub
No.
WO/2006/122430
|
N/A
|
N/A
|
Pending
|
Method
and Apparatus for Non-Invasive Measurement of Skin Tissue
Cholesterol
|
United
States
PCT
|
60/656,381
PCT/CA2006/00293
|
N/A
|
N/A
|
Pending
|
Apparatus
for Non-Invasive skin sampling and testing
|
United
States
|
60/885,152
|
N/A
|
N/A
|
|
|
ColorectAlert™
|
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
Russia
|
781034
2271539
|
August
18, 2005
March
10, 2006
|
August
4, 2020
August
4, 2020
|
Pending
|
Spectrophotometric
Measurement in Color-Based Biochemical and Immunological
Assays
As
it Pertains to
Cancer
Detection
|
PCT
Brazil
China
Europe
Hong
Kong
India
Japan
|
PCT/CA00/00918
PI0013096.6
00813497.9
00954181.4
0310671.6
PCT/2002/00307
2001
515964
|
N/A
|
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
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
PCT
|
11,523/057
PCT/CA2006/001526
|
N/A
|
N/A
|
|
|
ColoPath™
|
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
|
Patent
Status
|
Title
|
Jurisdiction
|
Patent
Number
|
Grant
Date
|
Expiry
Date
|
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
|
|
LungAlert™
and Breast Cancer
Test
|
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 Cancer Detection
|
Australia
Russia
|
781034
2271539
|
August
18, 2005
March
10, 2006
|
August
4, 2020
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
|
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
PCT
|
11/523,057
PCT/CA2006/001526
|
N/A
|
N/A
|
|
Cost ($)
|
Accumulated
Depreciation ($)
|
Net
Book Value ($)
|
|||||||||
Manufacturing
equipment
|
20,585
|
10,056
|
10,529
|
|||||||||
Computer
equipment
|
299,947
|
218,529
|
81,418
|
|||||||||
Furniture
and equipment
|
65,609
|
48,373
|
17,236
|
|||||||||
Research
instrumentation
|
666,460
|
515,576
|
150,884
|
|||||||||
Laboratory
equipment
|
61,437
|
24,023
|
37,414
|
|||||||||
Leasehold
improvements
|
39,983
|
25,054
|
14,929
|
|||||||||
TOTAL
|
1,154,021
|
841,611
|
312,410
|
|
•
|
An
increase of $1,673,000 in spending on clinical trials for skin cholesterol
and cancer to $2,571,000 from $898,000 in 2005. This
increase is related to acceleration and completion of several large
trials
for skin cholesterol to lead to additional regulatory submissions
and
advancement of the lung cancer trial (the “I-ELCAP” study). The
Corporation currently has five clinical trials ongoing, compared
with 15
in 2005;
|
|
•
|
An
increase of $77,000 in product liability insurance due to the significant
increase in patients tested;
|
|
•
|
A
decrease of $173,000 in subcontract research as the development of
a
second-generation color reader for the skin cholesterol test was
completed;
|
|
•
|
A
decrease in compensation of $41,000, reflecting lower incentive payments
for the year for performance milestones and a personnel vacancy;
and
|
|
•
|
Minor
changes in other development costs during the
period.
|
|
•
|
An
increase of $435,000 in professional expenses which included approximately
$330,000 in legal fees relating to litigation regarding the ColorectAlert™
License Agreements. The litigation was settled on January 5,
2007;
|
|
•
|
A
payment of $175,000 upon completion of an amendment to the ColorectAlert
License Agreements on January 5, 2007 (see note 8[b][i] to the
consolidated financial statements);
|
|
•
|
An
increase in market research expenses of $46,000 and in travel of
$58,000
relating to business development
opportunities;
|
|
•
|
A
reduction of $44,000 in expenses (from $44,000 to nil) relating to
a prior
year’s unsolicited offer to acquire the shares of another
company;
|
|
•
|
A
reduction in compensation of $105,000 reflecting lower incentive
payments
for 2006 for performance milestones and a personnel
vacancy;
|
|
•
|
A
reduction in investor relations expenses and annual report costs
of
$99,000 and $40,000, respectively;
and
|
|
•
|
A
reduction of $38,000 in stock-based compensation for options for
administrative personnel and consultants resulting in a non-cash
expense
of $384,000 compared with $422,000 in
2005.
|
|
•
|
A
$410,000 increase in spending on clinical trials for skin cholesterol
and
cancer to $898,000 from $488,000 in 2004. This increase was
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);
|
|
•
|
Increased
legal fees on intellectual property, which amounted to $331,000 compared
with $292,000 in fiscal 2004. These costs included $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 resulting
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;
and
|
|
•
|
Minor
changes in other development costs during the
period.
|
|
•
|
A
reduction of $434,000 in professional expenses resulting from the
non-recurring expenditure of $478,000 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 which 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.
|
Product
|
|
Description
/
Indication
|
|
Phase
of
Development
|
|
Approx.
%
Completed
|
|
Collaborator
|
|
Estimate
of
Completion
of Phase
|
Coronary
Artery Disease (CAD) Risk Assessment
Technology:
|
||||||||||
PREVU*
POC Skin Cholesterol 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%
80%
|
|
McNeil
(until December 2006)
Clinical
trial data being analyzed
|
|
2006
2007
|
PREVU*
LT Skin Cholesterol Test
|
|
Lab-processed
skin cholesterol test
|
|
Regulatory
clearance in Canada, CE-marked in Europe;
510(k)
filed in US for screening life insurance applicants
|
|
85%
|
|
Insurance
companies
|
|
2007
|
Commercial
launch in select markets
|
nil
|
N/A
|
2007
|
|||||||
PREVU*
PT Skin Cholesterol Test
|
Semi-quantitative
consumer-oriented test
|
Prototype
development
|
50%
|
N/A
|
2008
|
Product
|
|
Description
/
Indication
|
|
Phase
of
Development
|
|
Approx.
%
Completed
|
|
Collaborator
|
|
Estimate
of
Completion
of Phase
|
Cancer
Technologies:
|
||||||||||
ColorectAlert™&
Colopath™
|
|
Mucus
tests for early detection of colorectal cancer
|
|
2,500
patients tested in clinical trials
|
|
100%
|
|
St.
Michael’s Hospital
|
|
2004
|
Additional
clinical studies to support commercialization
|
10%
|
EDRN
|
2007/08
|
|||||||
LungAlert™
™
|
|
Sputum
test for early detection of lung cancer
|
|
Automation
of procedures
2,500
patients tested in clinical trials
|
|
80%
80%
|
|
St.
Joseph’s Hospital;
I-ELCAP
|
|
2007
2007
|
Breast
Cancer Test
All
Cancer Tests
|
Aspirate
test for early detection of breast cancer
Improvement
of assay method
|
Completed
pilot study; pivotal study underway
Alternative
format development
|
50%
80%
|
University
of Louisville
N/A
|
2007
2007
|
Product
|
Fiscal
Year
Ended
December
31,
2006
|
Fiscal
Year
Ended
December
31,
2005
|
Fiscal
Year
Ended
December
31,
2004
|
Fiscal
Year
Ended
December
31,
2003
|
Historical
Cumulative
total
since
February
1,
1997
|
|||||||||||||||
CAD
Risk Assessment Technologies
|
$ |
3,103,000
|
$ |
2,025,000
|
$ |
1,476,000
|
$ |
860,000
|
$ |
11,670,000
|
||||||||||
ColorectAlert™
and ColoPath™
|
$ |
275,000
|
$ |
309,000
|
$ |
304,000
|
$ |
327,000
|
$ |
3,265,000
|
||||||||||
LungAlert™
™
|
$ |
659,000
|
$ |
309,000
|
$ |
255,000
|
$ |
228,000
|
$ |
1,797,000
|
||||||||||
Breast
Cancer Test
|
$ |
79,000
|
$ |
66,000
|
$ |
42,000
|
$ |
45,000
|
$ |
232,000
|
||||||||||
|
E.
|
Off-Balance
Sheet Arrangements
|
Total
|
Less
than
1
Year
|
1
- 2 Years
|
2−5
Years
|
||||||||||
Clinical
Trials
|
$ |
305,000
|
$ |
305,000
|
nil
|
nil
|
|||||||
Other
|
261,000
|
140,000
|
121,000
|
nil
|
|||||||||
Total
|
$ |
566,000
|
$ |
121,000
|
$ |
121,000
|
nil
|
|
Michael
Evelegh, Ph.D., 54, Executive Vice President, Clinical and Regulatory
Affairs
|
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, 2006
Dec.
31, 2005
Dec.
31, 2004
|
325,000
331,250
285,000
|
32,500
28,500
142,500
|
-
-
|
230,000
100,000
-
|
7,713
22,101
-
|
Ronald
Hosking
Vice
President, Finance and Chief Financial Officer
|
Dec.
31, 2006
Dec.
31, 2005
Dec.
31, 2004
|
185,400
191,461
167,500
|
-
30,000
30,000
|
-
-
-
|
78,000
52,000
-
|
-
13,691
-
|
Michael
Evelegh
Ph.D.,
Executive Vice President, Clinical and Regulatory Affairs
|
Dec.
31, 2006
Dec.
31, 2005
Dec.
31, 2004
|
231,750
244,125
225,000
|
23,175
22,500
56,250
|
-
-
-
|
150,000
65,000
-
|
-
-
-
|
Tim
Currie
Vice
President, Corporate Development
|
Dec.
31, 2006
Dec.
31, 2005
Dec.
31, 2004
|
185,400
200,400
150,000
|
18,450
29,100
45,000
|
-
-
-
|
150,000
52,000
35,000
|
21,320
6,230
-
|
|
During
the year ended December 31, 2006, 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
|
200,000(1)
30,000(3)
|
20.2%
3.0%
|
$1.25
$2.35
|
$1.25
$2.35
|
February
16, 2011
October
28, 2011
|
Ronald
Hosking
Vice
President, Finance and Chief Financial Officer
|
48,000(2)
30,000(3)
|
4.8%
3.0%
|
$1.40
$2.35
|
$1.40
$2.35
|
February
28, 2011
October
28, 2011
|
Michael
Evelegh
Ph.D.,
Executive Vice President, Clinical and Regulatory Affairs
|
120,000(1)
30,000(3)
|
12.1%
3.0%
|
$1.25
$2.35
|
$1.25
$2.35
|
February
16, 2011
October
28, 2011
|
Tim
Currie
Vice
President, Corporate Development
|
120,000(1)
30,000(3)
|
12.1%
3.0%
|
$1.25
$2.35
|
$1.25
$2.35
|
February
16, 2011
October
28, 2011
|
(1)
|
These
options will vest annually over a period of five
years.
|
(2)
|
These
options will vest annually over a period of two
years.
|
(3)
|
These
options will vest upon completion of specific measurable
milestones.
|
Name
and Position
|
Securities
Acquired
on
Exercise
(#)
|
Aggregate
Value
Realized
($)
|
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
|
-
|
-
|
760,000
(1)
450,000/310,000(2)
|
nil/250,000
|
Ronald
Hosking,
Vice
President, Finance and Chief Financial Officer
|
-
|
-
|
251,000
(1)
93,800/157,200(2)
|
nil/67,200
|
Michael
Evelegh, Ph.D., Executive Vice President, Clinical and Regulatory
Affairs
|
-
|
-
|
375,000
(1)
173,500/202,000(2)
|
nil/150,000
|
Tim
Currie
Vice
President, Corporate Development
|
-
|
-
|
323,000
(1)
76,000/247,000(2)
|
nil/150,000
|
(1)
|
These
options will vest (i) annually over a pre-determined number of years;
and/or (ii) upon the occurrence of certain performance-related milestones
of the Corporation relating to the Corporation’s core technologies (e.g.,
FDA clearance of initial claims, strategic relationships, new
technologies)
|
(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 $1.95 for the Common Shares on the Toronto
Stock
Exchange on December 31, 2006.
|
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 May
31, 2007
|
|
|
Options
outstanding
|
|
Exercise
price
|
|
Expiration
date
|
|
Dr.
H.B. Brent Norton
|
|
2,360,948
|
|
9.4
|
%
|
|
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
|
|||||||
30,000
|
$
|
2.35
|
Oct.
28, 2011
|
|||||||||
200,000
|
$
|
1.70
|
Mar.
19, 2012
|
|||||||||
Michael
Evelegh, Ph.D
|
|
379,261
|
|
1.5
|
%
|
|
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
|
||||||
30,000
|
$
|
2.35
|
Oct.
28, 2011
|
|||||||||
140,000
|
$
|
1.70
|
Mar.
19, 2012
|
Name
|
|
Common
Shares
held
directly and beneficially
|
|
%
of
Outstanding
Common
Shares
as of April 15, 2007
|
|
|
Options
outstanding
|
|
Exercise
price
|
Expiration
date
|
||
Ronald
G. Hosking
|
|
293,778
|
|
1.2
|
%
|
|
50,000
|
$
|
2.85
|
Jun
27, 2008
|
||
35,000
|
$
|
4.00
|
Dec.
5, 2008
|
|||||||||
52,000
|
$
|
2.95
|
Feb.
6, 2010
|
|||||||||
48,000
|
$
|
1.40
|
Feb.
28, 2011
|
|||||||||
30,000
|
$
|
2.35
|
Oct.
28, 2011
|
|||||||||
120,000
|
$
|
1.70
|
Mar.
19, 2012
|
|||||||||
Tim
Currie
|
27,560
|
0.1
|
%
|
|
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
|
|||||||||
30,000
|
$
|
2.35
|
Oct.
28, 2011
|
|||||||||
120,000
|
$
|
1.70
|
Mar.
19, 2012
|
|||||||||
Stephen
A. Wilgar
|
|
290,827
|
|
1.2
|
%
|
|
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
|
|||||||||
30,000
|
$
|
2.95
|
June
24, 2011
|
|||||||||
30,000
|
$
|
1.10
|
June
24, 2012
|
|||||||||
Anthony
F. Griffiths
|
|
510,500
|
|
2.0
|
%
|
|
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
|
|||
15,000
|
$
|
2.95
|
June
24, 2011
|
|||||||||
15,000
|
$
|
1.10
|
June
24, 2012
|
|||||||||
David
A. Rosenkrantz
|
|
278,033
|
|
1.1
|
%
|
|
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
|
||
15,000
|
$
|
2.95
|
June
24, 2011
|
|||||||||
15,000
|
$
|
1.10
|
June
24, 2012
|
|||||||||
Ronald
Henriksen
|
45,000
|
0.2
|
%
|
15,000
|
$
|
3.50
|
Apr.
12, 2009
|
|||||
15,000
|
$
|
3.41
|
June
25, 2010
|
|||||||||
15,000
|
$
|
2.95
|
June
24, 2011
|
|||||||||
15,000
|
$
|
1.10
|
June
24, 2012
|
|
Number
of Voting
Securities
Owned
|
|||||||
Name
|
Common
Shares
|
Percentage
of
Class
|
||||||
Dr.
H.B. Brent Norton
|
2,360,948
|
9.4 | % | |||||
Midsummer
Investment Ltd
|
1,945,865
|
7.8 | % |
|
•
|
|
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
($US)
|
Low
($US)
|
|||||
Dec-06
|
3.36
|
1.19
|
3.00
|
1.02
|
||||
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
|
-
|
-
|
||||
|
(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
($US)
|
Low
($US)
|
|||||
Q1/07
Jan
- Mar
|
2.10
|
1.06
|
1.79
|
1.22
|
||||
Q4/06
Oct-Dec
|
2.62
|
1.34
|
2.39
|
1.25
|
||||
Q3/06
July-Sept
|
3.36
|
1.68
|
3.00
|
1.50
|
||||
Q2/06
Apr-Jun
|
3.02
|
1.85
|
1.92
|
1.61
|
||||
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
|
|
(c)
|
|
for
the most recent six months: the high and low market prices for each
month:
|
TSX
|
AMEX
|
|||||||
High
($)
|
Low
($)
|
High
($US)
|
Low
($US)
|
|||||
May
07
|
1.42
|
0.89
|
1.30
|
0.94
|
||||
Apr
07
|
1.40
|
1.08
|
1.23
|
1.00
|
||||
Mar
07
|
1.55
|
1.06
|
1.36
|
0.95
|
||||
Feb-07
|
1.85
|
1.51
|
1.70
|
1.30
|
||||
Jan-07
|
2.10
|
1.57
|
1.79
|
1.40
|
||||
Dec-06
|
1.99
|
1.34
|
1.74
|
1.25
|
||||
|
(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
|
2005
|
2006
|
||||||
Amount
|
%
|
Amount
|
%
|
||||
Audit
Fees
|
$
125,000
|
91.9
|
$137,000
|
91.3
|
|||
Audit-Related Fees
|
Nil
|
2,000
|
1.3
|
||||
Tax
Fees(1)
|
11,000
|
8.1
|
11,000
|
7.4
|
|||
Total
|
$
136,000
|
100.0
|
$150,000
|
100.0
|
|||
The
following financial statements, together with the report of
Ernst & Young LLP thereon, are filed as part of this Annual
Report on Form 20-F:
|
|
|
Report of Independent Registered Public Accounting Firm
|
|
F-2
|
Consolidated Balance Sheets
|
|
F-3
|
Consolidated Statements of Loss and Deficit
|
|
F-4
|
Consolidated Statements of Cash Flows
|
|
F-5
|
Notes to Consolidated Financial Statements
|
|
F-6
|
1.1
|
|
Articles
of Amalgamation of the Corporation. Previously filed as Exhibit 1.1
to the
Corporation’s Registration Statement on Form 20-F filed on June 18, 2002
(File No. 001-31360).
|
|
1.2
|
By-laws
of the Corporation. Previously filed as Exhibit 1.2 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. Previously filed as Exhibit 1.3 to the Corporation’s
Annual Report on Form 20-F filed on May 12, 2006 (File No.
001-31360).
|
|
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. Previously filed as Exhibit 1.4 to the Corporation’s Annual
Report on Form 20-F filed on May 12, 2006 (File No.
001-31360).
|
||
2.1
|
Certificate
of 7% Convertible Debenture due August 30, 2009 and issued August
30,
2005. Previously filed as Exhibit 2.1 to the Corporation’s Annual Report
on Form 20-F filed on May 12, 2006 (File No.
001-31360).
|
||
2.2
|
Certificate
of Common Stock Purchase Warrant dated August 30, 2005. Previously
filed
as Exhibit 2.2 to the Corporation’s Annual Report on Form 20-F filed on
May 12, 2006 (File No. 001-31360).
|
||
2.3 |
Securities
Purchase Agreement by and between the Registrant and each purchaser
identified on the signature pages thereto dated March 20,
2007. Previously filed as Exhibit 99.2 to the Form 6-K on March
22, 2007 (File No. 001-31360).
|
||
2.4 | Common Stock Purchase Warrant. Previously filed as Exhibit 99.3 to the Form 6-K on March 22, 2007 (File No. 001-31360). | ||
2.5
|
Registration
Rights Agreement by and between the Registrant and each of the several
purchasers signatory thereto dated March 20, 2007. Previously filed
as
Exhibit 99.4 to the Form 6-K on March 22, 2007 (File No.
001-31360).
|
||
4.1*
|
|
Supply
Agreement by and between the Registrant and Diagnostic Chemicals
Limited
dated June 19, 2001. Previously filed as Exhibit 4.1 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 Exhibit 4.2 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. Previously filed as Exhibit 4.3 to the Corporation’s
Annual Report on Form 20-F filed on May 12, 2006 (File No.
001-31360).
|
|
4.4
|
Employment
Agreement by and between the Registrant and Tim Currie dated January
10,
2006. Previously filed as Exhibit 4.4 to the Corporation’s Annual Report
on Form 20-F filed on May 12, 2006 (File No.
001-31360).
|
||
4.5
|
|
Employment
Agreement by and between the Registrant and Dr. H.B. Brent Norton
dated
Jan. 1, 2001. Previously filed as Exhibit 4.4 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 Exhibit 4.5 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 between the Registrant, and 448048 Ontario Inc.
dated
November 19, 2004. Previously filed as Exhibit 4.6 to the
Corporation’s Annual Report 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. Previously filed as
Exhibit 4.8 to the Corporation’s Annual Report on Form 20-F filed on May
12, 2006 (File No. 001-31360).
|
|
4.9*
|
|
License,
Development and Supply Agreement between McNeil PDI Inc. and the
Registrant dated May 9, 2002. Previously filed as Exhibit 4.8
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 Exhibit 4.9 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 Exhibit 99.1 to the
Form 6-K 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 9, 2002
as
amended December 20, 2002. Previously filed as Exhibit 4.12 to
the Corporation’s Annual Report on Form 20-F filed on May 12, 2006 (File
No. 001-31360).
|
||
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. Previously filed as Exhibit 4.13 to the
Corporation’s Annual Report on Form 20-F filed on May 12, 2006 (File No.
001-31360)
|
||
4.14
|
|
|
Code
of Ethics/Code of Business Conduct previously filed as Exhibit 4.11
to the
Corporation’s Annual Report on Form 20-F filed on June 23, 2004 (File No.
001-31360)
|
4.15
|
Underwriting
Agreement between Orion Securities Inc., Loewen, Ondaatje, McCutcheon
Limited and the Registrant dated August 30, 2005. Previously
filed as Exhibit 4.16 to the Corporation’s Annual Report on Form 20-F
filed on May 12, 2006 (File No. 001-31360)
|
||
4.16
|
Manufacturing
services agreement with Jabil Circuit, Inc., dated March 30,
2007, filed herewith.
|
||
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.
|
||
|
|
/s/ RONALD
HOSKING
|
By:
|
|
Ronald
Hosking
|
Its:
|
|
Vice
President, Finance and Chief Financial
Officer
|
The
following financial statements, together with the report of
Ernst & Young LLP thereon, are filed as part of this Annual
Report on Form 20-F:
|
|
|
Report of Independent Registered Public Accounting Firm
|
|
F-2
|
Consolidated Balance Sheets
|
|
F-3
|
Consolidated Statements of Loss and Deficit
|
|
F-4
|
Consolidated Statements of Cash Flows
|
|
F-5
|
Notes to Consolidated Financial Statements
|
|
F-6
|
|
|
2006
|
|
2005
|
|
||
As
at December 31
|
|
$
|
|
$
|
|
||
|
|
|
|
|
|
||
ASSETS
|
|
|
|
|
|
|
|
Current
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
|
112,577
|
|
|
773,199
|
|
Short-term
investments
|
|
|
3,163,482
|
|
|
7,905,883
|
|
Accounts
receivable [note 3]
|
|
|
11,221
|
|
|
881,891
|
|
Inventory
|
|
|
179,219
|
|
|
36,306
|
|
Prepaid
expenses and other receivables
|
|
|
570,773
|
|
|
317,264
|
|
Investment
tax credits receivable
|
|
|
200,000
|
|
|
200,000
|
|
Total
current assets
|
|
|
4,237,272
|
|
|
10,114,543
|
|
Deferred
financing fees, net of accumulated amortization of $174,863 [2005
-
$43,059] [note 5]
|
|
|
347,589
|
|
|
477,725
|
|
Capital
assets, net [note 4[a]]
|
|
|
312,410
|
|
|
410,636
|
|
Intangible
assets, net of accumulated amortization of $915,027 [2005 - $856,970]
[note 4[b] and 8[a]]
|
|
|
382,229
|
|
|
290,286
|
|
|
|
|
5,279,500
|
|
|
11,293,190
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND SHAREHOLDERS’ EQUITY (DEFICIENCY)
|
|
|
|
|
|
|
|
Current
|
|
|
|
|
|
|
|
Accounts
payable
|
|
|
963,990
|
|
|
291,125
|
|
Accrued
liabilities
|
|
|
932,372
|
|
|
655,113
|
|
Current
portion of deferred revenue [note 8[a]]
|
|
|
-
|
|
|
311,915
|
|
Total
current liabilities
|
|
|
1,896,362
|
|
|
1,258,153
|
|
Convertible
debentures [note 6]
|
|
|
6,350,680
|
|
|
5,893,340
|
|
Deferred
revenue [note 8[a]]
|
|
|
-
|
|
|
2,297,400
|
|
Total
liabilities
|
|
|
8,247,042
|
|
|
9,448,893
|
|
Commitments
[note 8]
|
|
|
|
|
|
|
|
Shareholders’
equity (deficiency)
|
|
|
|
|
|
|
|
Capital
stock [note 6]
|
|
|
25,263,480
|
|
|
24,449,826
|
|
Contributed
surplus [note 6]
|
|
|
2,521,915
|
|
|
1,840,979
|
|
Equity
component of convertible debentures [note 5]
|
|
|
2,239,385
|
|
|
2,393,145
|
|
Warrants
[notes 5, 6[c] and 8[b][ii]]
|
|
|
1,170,020
|
|
|
1,373,718
|
|
Deficit
|
|
|
(34,162,342
|
)
|
|
(28,213,371
|
)
|
Total
shareholders’ equity (deficiency)
|
|
|
(2,967,542
|
)
|
|
1,844,297
|
|
|
|
|
5,279,500
|
|
|
11,293,190
|
|
|
|
2006
|
|
2005
|
|
2004
|
|
|||
Years
ended December 31
|
|
$
|
|
$
|
|
$
|
|
|||
|
|
|
|
|
|
|
|
|||
REVENUE
|
|
|
|
|
|
|
|
|
|
|
Product
sales [note 3]
|
|
|
6,513
|
|
|
425,730
|
|
|
183,258
|
|
License
revenue [note 3]
|
|
|
3,328,827
|
|
|
1,153,308
|
|
|
302,080
|
|
|
|
|
3,335,340
|
|
|
1,579,038
|
|
|
485,338
|
|
Cost
of product sales, including amortization of nil [2005 - $3,456; 2004
-
$6,600]
|
|
|
36,824
|
|
|
428,650
|
|
|
190,214
|
|
Gross
profit
|
|
|
3,298,516
|
|
|
1,150,388
|
|
|
295,124
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EXPENSES
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
4,773,762
|
|
|
3,120,276
|
|
|
2,612,770
|
|
General
and administration
|
|
|
3,024,811
|
|
|
2,690,790
|
|
|
3,346,720
|
|
Interest
on convertible debentures [notes 5 and 6]
|
|
|
677,723
|
|
|
228,481
|
|
|
-
|
|
Imputed
interest on convertible debentures [note 5]
|
|
|
819,609
|
|
|
255,529
|
|
|
-
|
|
Amortization
[notes 4[a], [b] and 5]
|
|
|
319,205
|
|
|
252,804
|
|
|
224,428
|
|
Loss
(gain) on foreign exchange
|
|
|
97,746
|
|
|
(35,734
|
)
|
|
8,731
|
|
|
|
|
9,712,856
|
|
|
6,512,146
|
|
|
6,192,649
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RECOVERIES
AND OTHER INCOME
|
|
|
|
|
|
|
|
|
|
|
Investment
tax credits
|
|
|
200,000
|
|
|
198,923
|
|
|
205,000
|
|
Interest
|
|
|
265,369
|
|
|
173,130
|
|
|
123,626
|
|
|
|
|
465,369
|
|
|
372,053
|
|
|
328,626
|
|
Net
loss for the year
|
|
|
(5,948,971
|
)
|
|
(4,989,705
|
)
|
|
(5,568,899
|
)
|
Deficit,
beginning of year
|
|
|
(28,213,371
|
)
|
|
(23,223,666
|
)
|
|
(17,654,767
|
)
|
Deficit,
end of year
|
|
|
(34,162,342
|
)
|
|
(28,213,371
|
)
|
|
(23,223,666
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted loss per share
|
|
$
|
(0.27
|
)
|
$
|
(0.23
|
)
|
$
|
(0.26
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average number of common shares outstanding
|
|
|
21,663,698
|
|
|
21,487,008
|
|
|
21,276,497
|
|
|
|
2006
|
|
2005
|
|
2004
|
|
|||
Years
ended December 31
|
|
$
|
|
$
|
|
$
|
|
|||
|
|
|
|
|
|
|
|
|||
OPERATING
ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
Net
loss for the year
|
|
|
(5,948,971
|
)
|
|
(4,989,705
|
)
|
|
(5,568,899
|
)
|
Add
(deduct) items not involving cash
|
|
|
|
|
|
|
|
|
|
|
Amortization
|
|
|
319,205
|
|
|
256,260
|
|
|
231,028
|
|
Stock-based
compensation costs included in
|
|
|
|
|
|
|
|
|
|
|
Research
and development expense
|
|
|
156,920
|
|
|
147,085
|
|
|
123,925
|
|
General
and administration expense
|
|
|
383,767
|
|
|
421,812
|
|
|
476,164
|
|
Loss
(gain) on sale of capital asset
|
|
|
(1,743
|
)
|
|
-
|
|
|
6,098
|
|
Imputed
interest on convertible debenture
|
|
|
819,609
|
|
|
255,529
|
|
|
-
|
|
Interest
on convertible debenture paid in common shares
|
|
|
281,462
|
|
|
-
|
|
|
-
|
|
Loss
(gain) on foreign exchange
|
|
|
97,748
|
|
|
(35,734
|
)
|
|
8,731
|
|
Net
change in non-cash working capital balances related to operations
[note 9]
|
|
|
1,422,730
|
|
|
(1,061,397
|
)
|
|
535,284
|
|
Increase
(decrease) in deferred revenue
|
|
|
(2,609,315
|
)
|
|
(301,885
|
)
|
|
2,818,100
|
|
Cash
used in operating activities
|
|
|
(5,078,588
|
)
|
|
(5,308,035
|
)
|
|
(1,369,569
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INVESTING
ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
Short-term
investments
|
|
|
4,589,356
|
|
|
(3,065,568
|
)
|
|
1,678,190
|
|
Purchase
of trademark
|
|
|
(150,000
|
)
|
|
-
|
|
|
-
|
|
Purchase
of capital assets
|
|
|
(24,965
|
)
|
|
(130,310
|
)
|
|
(164,789
|
)
|
Sale
of capital assets
|
|
|
3,000
|
|
|
-
|
|
|
628
|
|
Cash
provided by (used in) investing activities
|
|
|
4,417,391
|
|
|
(3,195,878
|
)
|
|
1,514,029
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FINANCING
ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
Issuance
of convertible debentures [note 5]
|
|
|
-
|
|
|
9,827,616
|
|
|
-
|
|
Financing
fees [note 5]
|
|
|
(51,399
|
)
|
|
(861,328
|
)
|
|
-
|
|
Issuance
of capital stock, net of issue costs
|
|
|
-
|
|
|
198,400
|
|
|
33,373
|
|
Cash
provided by (used in) financing activities
|
|
|
(51,399
|
)
|
|
9,164,688
|
|
|
33,373
|
|
Effect
of exchange rate changes on cash and cash
equivalents
|
|
|
51,974
|
|
|
(127,034
|
)
|
|
-
|
|
Net
increase (decrease) in cash and cash equivalents during the
year
|
|
|
(660,622
|
)
|
|
533,741
|
|
|
177,833
|
|
Cash
and cash equivalents, beginning of year
|
|
|
773,199
|
|
|
239,458
|
|
|
61,625
|
|
Cash
and cash equivalents, end of year
|
|
|
112,577
|
|
|
773,199
|
|
|
239,458
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Represented
by
|
|
|
|
|
|
|
|
|
|
|
Cash
|
|
|
112,577
|
|
|
773,199
|
|
|
173,302
|
|
Cash
equivalents
|
|
|
-
|
|
|
-
|
|
|
66,156
|
|
|
|
|
112,577
|
|
|
773,199
|
|
|
239,458
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental
cash flow information
|
|
|
|
|
|
|
|
|
|
|
Cash
paid during the year for interest
|
|
|
396,261
|
|
|
228,481
|
|
|
-
|
|
|
•
|
All
financial assets be measured at fair value, with some exceptions,
such as
loans and receivables and investments that are classified as
held-to-maturity;
|
|
•
|
All
financial liabilities be measured at fair value if they are derivatives
or
classified as held-for-trading purposes. Other financial liabilities
are
measured at their carrying value;
and
|
|
•
|
All
derivative financial instruments be measured at fair value, even
when they
are part of a hedging relationship.
|
|
•
|
Changes
in the fair value of a hedged item and a hedging item;
and
|
|
•
|
Changes
resulting from risk exposure relating to a hedged item and a hedging
item.
|
Manufacturing
equipment
|
useful
life on basis of units produced
|
Computer
equipment
|
30%
|
Furniture
and equipment
|
20%
|
Research
instrumentation
|
30%
|
Laboratory
equipment
|
20%
|
Leasehold
improvements
|
straight-line
over the term of the lease
|
|
•
|
For
capital assets - as a reduction of the cost of the related asset;
and
|
|
•
|
For
operating expenses - as a recovery within the consolidated statements
of
loss and deficit.
|
|
|
2006
|
|
|||||||
|
|
|
|
Accumulated
|
|
Net
book
|
|
|||
|
|
Cost
|
|
amortization
|
|
value
|
|
|||
|
|
$
|
|
$
|
|
$
|
|
|||
|
|
|
|
|
|
|
|
|||
Manufacturing
equipment
|
|
|
20,585
|
|
|
10,056
|
|
|
10,529
|
|
Computer
equipment
|
|
|
299,947
|
|
|
218,529
|
|
|
81,418
|
|
Furniture
and equipment
|
|
|
65,609
|
|
|
48,373
|
|
|
17,236
|
|
Research
instrumentation
|
|
|
666,460
|
|
|
515,576
|
|
|
150,884
|
|
Laboratory
equipment
|
|
|
61,437
|
|
|
24,023
|
|
|
37,414
|
|
Leasehold
improvements
|
|
|
39,983
|
|
|
25,054
|
|
|
14,929
|
|
|
|
|
1,154,021
|
|
|
841,611
|
|
|
312,410
|
|
|
|
2005
|
|
|||||||
|
|
|
|
Accumulated
|
|
Net
book
|
|
|||
|
|
Cost
|
|
amortization
|
|
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
|
|
|
|
|
1,132,420
|
|
|
721,784
|
|
|
410,636
|
|
|
|
2006
|
|
|||||||
|
|
|
|
Accumulated
|
|
Net
book
|
|
|||
|
|
Cost
|
|
amortization
|
|
value
|
|
|||
|
|
$
|
|
$
|
|
$
|
|
|||
|
|
|
|
|
|
|
|
|||
Patents
and patent rights
|
|
|
1,147,256
|
|
|
915,027
|
|
|
232,229
|
|
Trademarks
|
|
|
150,000
|
|
|
-
|
|
|
150,000
|
|
|
|
|
1,297,256
|
|
|
915,027
|
|
|
382,229
|
|
|
|
2005
|
|
|||||||
|
|
|
|
Accumulated
|
|
Net
book
|
|
|||
|
|
Cost
|
|
amortization
|
|
value
|
|
|||
|
|
$
|
|
$
|
|
$
|
|
|||
|
|
|
|
|
|
|
|
|||
Patents
and patent rights
|
|
|
1,147,256
|
|
|
856,970
|
|
|
290,286
|
|
|
|
|
1,147,256
|
|
|
856,970
|
|
|
290,286
|
|
|
|
Equity
|
|
|
|
||
|
|
component
|
|
Warrants
|
|
||
|
|
|
|
|
|
||
Expected
volatility
|
|
|
42.7
|
%
|
|
41.7
|
%
|
Risk-free
interest rate
|
|
|
3.35
|
%
|
|
3.35
|
%
|
Expected
option life
|
|
|
4
years
|
|
|
5
years
|
|
Dividend
yield
|
|
|
nil
|
|
|
nil
|
|
|
|
|
|
Deferred
|
|
|
|
|||
|
|
|
|
financing
|
|
|
|
|||
|
|
Proceeds
|
|
fees
|
|
Net
|
|
|||
|
|
$
|
|
$
|
|
$
|
|
|||
|
|
|
|
|
|
|
|
|||
Issuance
of convertible debenture
|
|
|
9,827,616
|
|
|
861,328
|
|
|
8,966,288
|
|
Equity
component of convertible debentures
|
|
|
(2,621,437
|
)
|
|
(228,292
|
)
|
|
(2,393,145
|
)
|
Warrants
|
|
|
(1,288,970
|
)
|
|
(112,252
|
)
|
|
(1,176,718
|
)
|
Liability
component of convertible debenture
|
|
|
5,917,209
|
|
|
520,784
|
|
|
5,396,425
|
|
|
|
$
|
|
|
|
|
|
|
|
Issuance
of convertible debentures, August 30, 2005
|
|
|
5,917,209
|
|
Changes
in foreign exchange rates
|
|
|
(279,398
|
)
|
Imputed
interest
|
|
|
255,529
|
|
Balance,
December 31, 2005
|
|
|
5,893,340
|
|
Conversion
to common shares
|
|
|
(357,304
|
)
|
Changes
in foreign exchange rates
|
|
|
(4,965
|
)
|
Imputed
interest
|
|
|
819,609
|
|
Balance,
December 31, 2006
|
|
|
6,350,680
|
|
|
|
|
|
Stated
|
|
Contributed
|
|
|
|
||||
|
|
Number
|
|
value
|
|
surplus
|
|
Total
|
|
||||
Common
shares
|
|
$
|
|
$
|
|
$
|
|
$
|
|
||||
|
|
|
|
|
|
|
|
|
|
||||
Balance,
December 31, 2003
|
|
|
21,260,902
|
|
|
24,056,853
|
|
|
723,993
|
|
|
24,780,846
|
|
Expiry
of warrants [notes 6[c] and 8[b][ii]]
|
|
|
-
|
|
|
-
|
|
|
115,200
|
|
|
115,200
|
|
Stock-based
compensation expense [note 6[d]]
|
|
|
-
|
|
|
-
|
|
|
488,994
|
|
|
488,994
|
|
Issued
under share purchase plan [note 6[e]]
|
|
|
1,830
|
|
|
7,595
|
|
|
-
|
|
|
7,595
|
|
Issued
on exercise of options [note 6[d]]
|
|
|
8,150
|
|
|
23,368
|
|
|
-
|
|
|
23,368
|
|
Issued
on cashless exercise of options
|
|
|
27,713
|
|
|
94,500
|
|
|
-
|
|
|
94,500
|
|
Repayment
of share purchase loans
|
|
|
15,000
|
|
|
10,005
|
|
|
-
|
|
|
10,005
|
|
Balance,
December 31, 2004
|
|
|
21,313,595
|
|
|
24,192,321
|
|
|
1,328,187
|
|
|
25,520,508
|
|
Expiry
of warrants [note 6[c]]
|
|
|
-
|
|
|
-
|
|
|
3,000
|
|
|
3,000
|
|
Stock-based
compensation expense [note 6[d]]
|
|
|
-
|
|
|
-
|
|
|
509,792
|
|
|
509,792
|
|
Issued
under share purchase plan [note 6[e]]
|
|
|
23,167
|
|
|
59,105
|
|
|
-
|
|
|
59,105
|
|
Issued
on exercise of options [note 6[d]]
|
|
|
31,000
|
|
|
78,400
|
|
|
-
|
|
|
78,400
|
|
Repayment
of share purchase loans
|
|
|
180,000
|
|
|
120,000
|
|
|
-
|
|
|
120,000
|
|
Balance,
December 31, 2005
|
|
|
21,547,762
|
|
|
24,449,826
|
|
|
1,840,979
|
|
|
26,290,805
|
|
Expiry
of warrants [note 8[b][i]]
|
|
|
-
|
|
|
-
|
|
|
197,000
|
|
|
197,000
|
|
Stock-based
compensation expense [note 6[d]]
|
|
|
-
|
|
|
-
|
|
|
483,936
|
|
|
483,936
|
|
Issued
under share purchase plan [note 6[e]]
|
|
|
25,910
|
|
|
56,751
|
|
|
-
|
|
|
56,751
|
|
Issued
as payment for interest [note 5]
|
|
|
133,674
|
|
|
281,462
|
|
|
-
|
|
|
281,462
|
|
Issued
on conversion of debenture [note 5]
|
|
|
150,877
|
|
|
475,441
|
|
|
-
|
|
|
475,441
|
|
Balance,
December 31, 2006
|
|
|
21,858,223
|
|
|
25,263,480
|
|
|
2,521,915
|
|
|
27,785,395
|
|
|
|
2006
|
|
2005
|
|
2004
|
|
||||||||||||
|
|
|
|
Weighted
|
|
|
|
Weighted
|
|
|
|
Weighted
|
|
||||||
|
|
|
|
average
|
|
|
|
average
|
|
|
|
average
|
|
||||||
|
|
Number
of
|
|
exercise
|
|
Number
of
|
|
exercise
|
|
Number
of
|
|
exercise
|
|
||||||
|
|
warrants
|
|
price
|
|
warrants
|
|
price
|
|
warrants
|
|
price
|
|
||||||
|
|
#
|
|
$
|
|
#
|
|
$
|
|
#
|
|
$
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Outstanding,
beginning of year
|
|
|
1,388,970
|
|
|
3.60
|
|
|
110,000
|
|
|
4.05
|
|
|
185,000
|
|
|
4.23
|
|
Granted
|
|
|
-
|
|
|
-
|
|
|
1,288,970
|
|
|
3.57
|
|
|
10,000
|
|
|
4.50
|
|
Expired
or forfeited
|
|
|
(100,000
|
)
|
|
4.00
|
|
|
(10,000
|
)
|
|
4.50
|
|
|
(85,000
|
)
|
|
4.50
|
|
Outstanding,
end of year
|
|
|
1,288,970
|
|
|
3.57
|
|
|
1,388,970
|
|
|
3.60
|
|
|
110,000
|
|
|
4.05
|
|
|
|
2006
|
|
2005
|
|
2004
|
|
||||||||||||
|
|
|
|
Weighted
|
|
|
|
Weighted
|
|
|
|
Weighted
|
|
||||||
|
|
|
|
average
|
|
|
|
average
|
|
|
|
average
|
|
||||||
|
|
Number
|
|
exercise
|
|
Number
|
|
exercise
|
|
Number
|
|
exercise
|
|
||||||
|
|
of
shares
|
|
price
|
|
of
shares
|
|
price
|
|
of
shares
|
|
price
|
|
||||||
|
|
#
|
|
$
|
|
#
|
|
$
|
|
#
|
|
$
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Outstanding,
beginning of year
|
|
|
2,297,785
|
|
|
3.41
|
|
|
1,954,285
|
|
|
3.54
|
|
|
1,757,035
|
|
|
3.45
|
|
Granted
|
|
|
896,500
|
|
|
1.48
|
|
|
549,500
|
|
|
3.02
|
|
|
406,000
|
|
|
3.79
|
|
Exercised
|
|
|
-
|
|
|
-
|
|
|
(31,000
|
)
|
|
2.53
|
|
|
(33,613
|
)
|
|
2.24
|
|
Expired
or forfeited
|
|
|
(454,981
|
)
|
|
3.08
|
|
|
(175,000
|
)
|
|
3.79
|
|
|
(175,137
|
)
|
|
3.50
|
|
Outstanding,
end of year
|
|
|
2,739,304
|
|
|
2.83
|
|
|
2,297,785
|
|
|
3.41
|
|
|
1,954,285
|
|
|
3.54
|
|
Options
exercisable end of year
|
|
|
1,461,783
|
|
|
3.47
|
|
|
1,458,114
|
|
|
3.49
|
|
|
1,258,957
|
|
|
3.52
|
|
|
|
|
|
Weighted
|
|
Weighted
|
|
|
|
Weighted
|
|
|||||
|
|
|
|
average
|
|
average
|
|
|
|
average
|
|
|||||
|
|
Number
|
|
remaining
|
|
exercise
|
|
Number
|
|
exercise
|
|
|||||
Range
of exercise prices
|
|
outstanding
|
|
life
|
|
price
|
|
exercisable
|
|
price
|
|
|||||
$
|
|
#
|
|
[in
years]
|
|
$
|
|
#
|
|
$
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||
1.25
- 1.40
|
|
|
735,500
|
|
|
4.14
|
|
|
1.31
|
|
|
-
|
|
|
-
|
|
2.20
- 2.95
|
|
|
1,056,304
|
|
|
2.20
|
|
|
2.88
|
|
|
633,783
|
|
|
2.86
|
|
3.20
- 3.97
|
|
|
218,000
|
|
|
2.77
|
|
|
3.58
|
|
|
168,200
|
|
|
3.48
|
|
4.00
- 4.09
|
|
|
709,500
|
|
|
1.24
|
|
|
4.01
|
|
|
643,800
|
|
|
4.01
|
|
6.05
|
|
|
20,000
|
|
|
0.43
|
|
|
6.05
|
|
|
16,000
|
|
|
6.05
|
|
|
|
|
2,739,304
|
|
|
2.51
|
|
|
2.83
|
|
|
1,461,783
|
|
|
3.47
|
|
|
|
2006
|
|
2005
|
|
2004
|
|
|||
|
|
|
|
|
|
|
|
|||
Expected
volatility
|
|
|
43.9
|
%
|
|
42.2
|
%
|
|
50.1
|
%
|
Risk-free
interest rate
|
|
|
3.97
|
%
|
|
3.66
|
%
|
|
3.79
|
%
|
Expected
life
|
|
|
5
years
|
|
|
5
years
|
|
|
5
years
|
|
|
|
December
31, 2006
|
|
December
31, 2005
|
|
December
31, 2004
|
|
||||||||||||
|
|
|
|
Weighted
|
|
|
|
Weighted
|
|
|
|
Weighted
|
|
||||||
|
|
|
|
average
|
|
|
|
average
|
|
|
|
average
|
|
||||||
|
|
Number
|
|
exercise
|
|
Number
|
|
exercise
|
|
Number
|
|
exercise
|
|
||||||
|
|
of
shares
|
|
price
|
|
of
shares
|
|
price
|
|
of
shares
|
|
price
|
|
||||||
|
|
#
|
|
$
|
|
#
|
|
$
|
|
#
|
|
$
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Outstanding,
beginning of year
|
|
|
176,000
|
|
|
3.46
|
|
|
176,000
|
|
|
3.46
|
|
|
214,750
|
|
|
3.54
|
|
Granted
|
|
|
120,000
|
|
|
2.35
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
Exercised
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
(2,250
|
)
|
|
3.45
|
|
Expired
or forfeited
|
|
|
(115,000
|
)
|
|
3.17
|
|
|
-
|
|
|
-
|
|
|
(36,500
|
)
|
|
3.93
|
|
Outstanding,
end of year
|
|
|
181,000
|
|
|
2.91
|
|
|
176,000
|
|
|
3.46
|
|
|
176,000
|
|
|
3.46
|
|
Options
exercisable end of year
|
|
|
34,700
|
|
|
4.00
|
|
|
85,825
|
|
|
3.29
|
|
|
85,825
|
|
|
3.29
|
|
|
|
|
|
Weighted
|
|
Weighted
|
|
|
|
Weighted
|
|
|||||
|
|
|
|
average
|
|
average
|
|
|
|
average
|
|
|||||
|
|
Number
|
|
remaining
|
|
exercise
|
|
Number
|
|
exercise
|
|
|||||
Range
of exercise prices
|
|
outstanding
|
|
life
|
|
price
|
|
exercisable
|
|
price
|
|
|||||
$
|
|
#
|
|
[in
years]
|
|
$
|
|
#
|
|
$
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||
2.35
|
|
|
120,000
|
|
|
4.83
|
|
|
2.35
|
|
|
-
|
|
|
-
|
|
4.00
|
|
|
61,000
|
|
|
0.13
|
|
|
4.00
|
|
|
34,700
|
|
|
4.00
|
|
|
|
|
181,000
|
|
|
3.24
|
|
|
2.91
|
|
|
34,700
|
|
|
4.00
|
|
|
|
2006
|
|
2005
|
|
2004
|
|
|||
|
|
$
|
|
$
|
|
$
|
|
|||
|
|
|
|
|
|
|
|
|||
Net
loss as reported
|
|
|
(5,948,971
|
)
|
|
(4,989,705
|
)
|
|
(5,568,899
|
)
|
Estimated
stock-based compensation expenses
|
|
|
(50,610
|
)
|
|
(116,286
|
)
|
|
(223,830
|
)
|
Pro
forma net loss
|
|
|
(5,999,581
|
)
|
|
(5,105,991
|
)
|
|
(5,792,729
|
)
|
Pro
forma basic and diluted loss per common share
|
|
$
|
(0.28
|
)
|
$
|
(0.24
|
)
|
$
|
(0.27
|
)
|
|
|
2006
|
|
2005
|
|
||
|
|
$
|
|
$
|
|
||
|
|
|
|
|
|
||
Future
tax assets
|
|
|
|
|
|
|
|
Federal
tax loss carryforwards
|
|
|
3,045,000
|
|
|
2,450,000
|
|
Ontario
tax loss carryforwards
|
|
|
2,170,000
|
|
|
1,612,000
|
|
Investment
tax credits
|
|
|
2,061,000
|
|
|
1,700,000
|
|
Financing
and share issue costs
|
|
|
194,000
|
|
|
263,000
|
|
SR&ED
expenditures
|
|
|
3,684,000
|
|
|
3,380,000
|
|
Capital
assets
|
|
|
95,000
|
|
|
99,000
|
|
Deferred
revenue
|
|
|
-
|
|
|
684,000
|
|
Future
tax assets before valuation allowance
|
|
|
11,249,000
|
|
|
10,188,000
|
|
Valuation
allowance
|
|
|
11,249,000
|
|
|
10,188,000
|
|
Net
future tax assets
|
|
|
-
|
|
|
-
|
|
|
|
|
|
|
|
Investment
|
|
|||
|
|
Federal
|
|
Ontario
|
|
tax
credits
|
|
|||
|
|
$
|
|
$
|
|
$
|
|
|||
|
|
|
|
|
|
|
|
|||
2007
|
|
|
1,062,000
|
|
|
1,340,000
|
|
|
-
|
|
2008
|
|
|
1,562,000
|
|
|
1,562,000
|
|
|
-
|
|
2009
|
|
|
2,887,000
|
|
|
2,887,000
|
|
|
18,000
|
|
2010
|
|
|
2,018,000
|
|
|
2,018,000
|
|
|
247,000
|
|
2011
|
|
|
-
|
|
|
-
|
|
|
337,000
|
|
2012
|
|
|
-
|
|
|
-
|
|
|
297,000
|
|
2013
|
|
|
-
|
|
|
-
|
|
|
397,000
|
|
2014
|
|
|
494,000
|
|
|
494,000
|
|
|
423,000
|
|
2015
|
|
|
2,178,000
|
|
|
2,178,000
|
|
|
464,000
|
|
2016
|
|
|
5,024,000
|
|
|
5,024,000
|
|
|
458,000
|
|
|
|
|
15,225,000
|
|
|
15,503,000
|
|
|
2,641,000
|
|
|
|
2006
|
|
2005
|
|
2004
|
|
||||||||||||
|
|
$
|
|
%
|
|
$
|
|
%
|
|
$
|
|
%
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Loss
before income taxes
|
|
|
(5,948,971
|
)
|
|
|
|
|
(4,989,705
|
)
|
|
|
|
|
(5,568,899
|
)
|
|
|
|
Expected
recovery of income taxes
|
|
|
(2,148,768
|
)
|
|
(36.1
|
)
|
|
(1,802,281
|
)
|
|
(36.1
|
)
|
|
(2,011,486
|
)
|
|
(36.1
|
)
|
Permanent
differences
|
|
|
526,482
|
|
|
8.8
|
|
|
299,044
|
|
|
6.0
|
|
|
268,428
|
|
|
4.8
|
|
Change
in valuation allowance
|
|
|
1,622,286
|
|
|
27.3
|
|
|
1,503,237
|
|
|
30.1
|
|
|
1,743,058
|
|
|
31.3
|
|
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
|
$
|
|
|
|
|
|
|
|
2007
|
|
|
226,000
|
|
2008
|
|
|
135,000
|
|
2009
|
|
|
19,000
|
|
2010
and thereafter
|
|
|
-
|
|
|
|
|
380,000
|
|
|
|
2006
|
|
2005
|
|
2004
|
|
|||
|
|
$
|
|
$
|
|
$
|
|
|||
|
|
|
|
|
|
|
|
|||
Accounts
receivable
|
|
|
870,670
|
|
|
(659,543
|
)
|
|
(211,648
|
)
|
Inventory
|
|
|
(142,913
|
)
|
|
231,194
|
|
|
(267,500
|
)
|
Prepaid
expenses and other receivables
|
|
|
(253,509
|
)
|
|
(180,249
|
)
|
|
186,774
|
|
Investment
tax credits receivable
|
|
|
-
|
|
|
189,000
|
|
|
(209,000
|
)
|
Accounts
payable and accrued liabilities
|
|
|
948,482
|
|
|
(641,799
|
)
|
|
1,036,658
|
)
|
|
|
|
1,422,730
|
|
|
(1,061,397
|
)
|
|
535,284
|
|
|
|
2006
|
|
2005
|
|
2004
|
|
|||
|
|
$
|
|
$
|
|
$
|
|
|||
|
|
|
|
|
|
|
|
|||
|
|
|
|
[note
b]
|
|
|
|
|||
Net
loss for the year [Canadian GAAP]
|
|
|
(5,948,971
|
)
|
|
(4,989,705
|
)
|
|
(5,568,899
|
)
|
Adjustments
|
|
|
|
|
|
|
|
|
|
|
Amortization
of acquired technology [a]
|
|
|
58,057
|
|
|
72,572
|
|
|
90,715
|
|
Mark-to-market
adjustment on derivative [b]
|
|
|
54,088
|
|
|
28,807
|
|
|
-
|
|
Amortization
of deferred financing fees [c]
|
|
|
(50,043
|
)
|
|
(15,798
|
)
|
|
-
|
|
Net
loss and comprehensive loss for the year
|
|
|
|
|
|
|
|
|
|
|
[U.S.
GAAP] [e]
|
|
|
(5,886,869
|
)
|
|
(4,904,124
|
)
|
|
(5,478,184
|
)
|
Basic
and diluted loss per share
|
|
|
|
|
|
|
|
|
|
|
[U.S.
GAAP]
|
|
$
|
(0.27
|
)
|
$
|
(0.23
|
)
|
$
|
(0.26
|
)
|
Weighted
average number of common shares outstanding
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted
|
|
|
21,663,698
|
|
|
21,487,008
|
|
|
21,276,497
|
|
|
|
2006
|
|
2005
|
|
2004
|
|
|||
|
|
$
|
|
$
|
|
$
|
|
|||
|
|
|
|
|
|
|
|
|||
ASSETS
|
|
|
|
|
|
|
|
|
|
|
Intangible
assets, net [a]
|
|
|
150,000
|
|
|
-
|
|
|
-
|
|
Deferred
financing fees [c]
|
|
|
475,851
|
|
|
686,653
|
|
|
-
|
|
|
|
|
5,167,639
|
|
|
11,211,832
|
|
|
6,633,221
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND SHAREHOLDERS’ EQUITY
|
|
|
|
|
|
|
|
|
|
|
Derivative
liability [b]
|
|
|
2,402,244
|
|
|
2,592,630
|
|
|
-
|
|
|
|
|
10,649,286
|
|
|
12,041,523
|
|
|
4,499,237
|
|
Shareholders’
equity
|
|
|
|
|
|
|
|
|
|
|
Capital
stock
|
|
|
29,981,717
|
|
|
29,182,269
|
|
|
28,924,764
|
|
Additional
paid-in capital [d]
|
|
|
5,167,851
|
|
|
4,735,952
|
|
|
3,049,442
|
|
Deficit
[a] [b] [c]
|
|
|
(40,631,215
|
)
|
|
(34,747,912
|
)
|
|
(29,840,222
|
)
|
|
|
|
(5,481,647
|
)
|
|
(829,691
|
)
|
|
2,133,984
|
|
|
|
|
5,167,639
|
|
|
11,211,832
|
|
|
6,633,221
|
|
|
•
|
The
fair value of the conversion feature of $2,621,437, as at August
30, 2005,
being the same value as the equity component under Canadian GAAP,
was
reclassified from convertible debentures to derivative
liability;
|
|
•
|
The
derivative liability was revalued to $2,592,630 as at December 31,
2005
which represents a mark-to-market gain of
$28,807.
|
|
|
2006
|
|
2005
|
|
2004
|
|
|||
|
|
$
|
|
$
|
|
$
|
|
|||
|
|
|
|
|
|
|
|
|||
|
|
|
|
[note
b]
|
|
|
|
|||
Net
loss for the year
|
|
|
|
|
|
|
|
|
|
|
U.S.
GAAP - as reported
|
|
|
(5,886,869
|
)
|
|
(4,904,124
|
)
|
|
(5,478,184
|
)
|
Pro
forma stock-based compensation expense [d]
|
|
|
(45,888
|
)
|
|
(225,923
|
)
|
|
(376,879
|
)
|
Net
loss under U.S. GAAP - pro forma
|
|
|
(5,932,757
|
)
|
|
(5,130,047
|
)
|
|
(5,855,063
|
)
|
Basic
and diluted loss per share [U.S. GAAP]
|
|
|
|
|
|
|
|
|
|
|
As
reported
|
|
$
|
(0.27
|
)
|
$
|
(0.24
|
)
|
$
|
(0.26
|
)
|
Pro
forma
|
|
$
|
(0.27
|
)
|
$
|
(0.24
|
)
|
$
|
(0.28
|
)
|
Weighted
average number of common shares outstanding
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted
|
|
|
21,663,698
|
|
|
21,487,008
|
|
|
21,276,497
|
|
|
|
High
|
|
Low
|
|
||
|
|
|
|
|
|
||
Expected
volatility
|
|
|
62.3
|
%
|
|
55.5
|
%
|
Risk-free
interest rate
|
|
|
6.19
|
%
|
|
4.56
|
%
|
Expected
option life
|
|
|
5
years
|
|
|
5
years
|
|
Dividend
yield
|
|
|
Nil
|
|
|
Nil
|
|