x |
REGISTRATION
STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE
ACT
OF 1934
|
For
the fiscal year ended December 31, 2004 and the nine month interim
period
ended September 30, 2005
|
|
OR
|
|
o |
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
OR
|
|
o |
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
Bruce
D. Hirsche, Q.C.
Parlee
McLaws LLP
1500,
Manulife Place
10801
- 108 Street
Edmonton,
Alberta, Canada T5J 4K1
(780)
423-8540
|
Joseph
P. Galda
Corsair
Advisors, Inc.
497
Delaware Avenue
Buffalo,
New York, USA
14202
(716)
882-2157
|
Title
of each class
|
Name
of each exchange on which registered
|
|
Common
Shares, No Par Value
|
Application
has been made to list the Common
Shares
on The American Stock Exchange
|
None
|
(Title
of Class)
|
None
|
(Title
of Class)
|
FORWARD
LOOKING INFORMATION
|
5
|
|
PART
I
|
6
|
|
Item
1.
|
Identity
of Directors, Senior Management and Advisors
|
6
|
Item
2.
|
Offer
Statistics and Expected Timetable
|
7
|
Item
3.
|
Key
Information
|
7
|
A.
|
Selected
financial data
|
7
|
B.
|
Capitalization
and indebtedness
|
9
|
C.
|
Reasons
for the offer and use of proceeds
|
11
|
D.
|
Risk
factors
|
12
|
Item
4.
|
Information
on ViRexx
|
26
|
A.
|
History
and Development of ViRexx
|
26
|
B.
|
Business
|
27
|
C.
|
Organizational
structure
|
49
|
D.
|
Property
and equipment
|
49
|
Item
5.
|
Operating
and Financial Review and Prospects
|
50
|
A.
|
Operating
results
|
51
|
B.
|
Liquidity
and capital resources
|
58
|
C.
|
Research
and development, patents and licenses, etc.
|
62
|
D.
|
Trend
information
|
63
|
E.
|
Off-Balance
Sheet Arrangements
|
63
|
F.
|
Tabular
Disclosure of Contractual Obligations
|
63
|
G.
|
Safe
Harbour
|
63
|
Item
6.
|
Directors,
Senior Management and Employees
|
64
|
A.
|
Directors
and senior management
|
64
|
B.
|
Compensation
|
72
|
C.
|
Board
practices
|
74
|
D.
|
Employees
|
77
|
E.
|
Share
ownership
|
77
|
Item
7.
|
Major
Shareholders and Related Party Transactions
|
80
|
A.
|
Major
shareholders
|
80
|
B.
|
Related
party transactions
|
80
|
C.
|
Interests
of experts and counsel
|
80
|
Item
8.
|
Financial
Information
|
81
|
A.
|
Consolidated
Statements and Other Financial Information
|
81
|
B.
|
Significant
Changes
|
81
|
Item
9.
|
The
Offer and Listing
|
81
|
A.
|
Offer
and listing details
|
81
|
B.
|
Stock
Option Pricing
|
85
|
C.
|
Pension
and Retirement Plans and Payments made upon Termination
of
Employment
|
85
|
D.
|
Plan
of Distribution
|
85
|
E.
|
Markets
|
85
|
F.
|
Selling
Shareholders
|
86
|
G.
|
Dilution
|
86
|
H.
|
Expenses
of the issue
|
86
|
Item
10.
|
Additional
Information
|
86
|
A.
|
Share
capital
|
86
|
B.
|
Memorandum
and articles of association
|
88
|
C.
|
Material
contracts
|
92
|
D.
|
Exchange
controls
|
98
|
E.
|
Taxation
|
99
|
F.
|
Dividends
and paying agents
|
103
|
G.
|
Statement
by experts
|
104
|
H.
|
Documents
on display
|
104
|
I.
|
Subsidiary
Information
|
104
|
Item
11.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
104
|
Item
12.
|
Description
of Securities Other than Equity Securities
|
104
|
PART
II
|
105
|
|
Item
13.
|
Defaults,
Dividend Arrearages and Delinquencies
|
105
|
Item
14.
|
Material
Modifications to the Rights of Security Holders and Use
of
Proceeds
|
105
|
Item
15.
|
[Reserved]
|
105
|
Item
16.
|
[Reserved]
|
105
|
Item
16A - Audit Committee Financial Expert
|
105
|
|
Item
16B - Code of Ethics
|
105
|
|
Item
16C - Principal Accountant Fees and Services
|
105
|
|
Item
16D - Exemption from the Listing Standards for Audit
Committees
|
105
|
|
Item
16E - Purchases of Equity Securities by the Issuer and
Affiliated
Purchasers
|
106
|
|
PART
III
|
107
|
|
Item
17.
|
Financial
Statements
|
107
|
Item
18.
|
Financial
Statements
|
107
|
Item
19.
|
Exhibits
|
107
|
Item
1.
|
Identity
of Directors, Senior Management and
Advisors
|
Names
|
Business
Address
|
Function
to the Corporation
|
Dr.
Antoine A. Noujaim
|
8223
Roper Road
Edmonton,
Alberta T6E 6S4
Canada
|
Director
|
Dr.
Lorne J. Tyrrell
|
8223
Roper Road
Edmonton,
Alberta T6E 6S4
Canada
|
Chief
Executive Officer,
Chief
Scientific Officer and
Director
|
Jacques
R. Lapointe
|
7774
Tenth Sideroad
Milton,
Ontario L9T 4Y9
Canada
|
Director
|
Bruce
D. Brydon
|
66
Suffolk Road
Salt
Spring Island
British
Columbia V8K 1L8
Canada
|
Director
|
Thomas
E. Brown
|
324
Osland Place
Edmonton,
Alberta T6R 1Z9
Canada
|
Director
|
Dr.
Jean Claude Gonneau
|
A
Farnell Mews
London
England SW5 9DL
|
Director
|
Douglas
Gilpin, CA
|
175
Wolf Willow Crescent
Edmonton,
Alberta T5T 1T3
Canada
|
Acting
Chairman and
Director
|
Macaraig
(Marc) Canton
|
8223
Roper Road
Edmonton,
Alberta T6E 6S4
Canada
|
President
and Chief
Operating
Officer and Acting
Chief
Financial Officer
|
Michael
W. Stewart
|
8223
Roper Road
Edmonton,
Alberta T6E 6S4
Canada
|
Vice
President, Operations,
Oncology
|
Dr.
Rajan George
|
8223
Roper Road
Edmonton,
Alberta T6E 6S4
Canada
|
Vice
President, Research &
Development,
Infectious
Diseases
|
Dr.
Andrew Stevens
|
8223
Roper Road
Edmonton,
Alberta T6E 6S4
Canada
|
Vice
President, Regulatory
Affairs
|
Dr.
Irwin Griffith
|
8223
Roper Road
Edmonton,
Alberta T6E 6S4
Canada
|
Vice
President, Drug
Development,
Infectious
Disease
|
Item
2.
|
Offer
Statistics and Expected
Timetable
|
Item
3.
|
Key
Information
|
(In thousands, except per share data) | ||||||||||||||||||||||
Nine
months ended September 30,
|
Years
ended December 31,
|
|||||||||||||||||||||
2005
(Unaudited)
|
2004
(Unaudited)
|
2004(1)
|
2003(1)
|
2002(1)
|
2001(1)
|
2000
(Unaudited)
|
||||||||||||||||
Revenues
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
Net
(loss)
|
(5,717
|
)
|
(2,306
|
)
|
(3,658
|
)
|
(1,384
|
)
|
(1,260
|
)
|
(1,012
|
)
|
(177
|
)
|
||||||||
Net
(loss) per share from continuing operations (basic and fully
diluted)
|
(0.10
|
)
|
(0.09
|
)
|
(0.14
|
)
|
(0.15
|
)
|
(0.14
|
)
|
(5.21
|
)
|
||||||||||
Weighted
average no. shares outstanding
|
54,877
|
26,420
|
25,268
|
9,129
|
8,763
|
34
|
||||||||||||||||
Working
capital
|
7,985
|
7,448
|
8,837
|
1,695
|
281
|
35
|
5
|
|||||||||||||||
Total
assets
|
41,956
|
8,759
|
45,722
|
3,742
|
1,093
|
757
|
126
|
|||||||||||||||
Long-term
liabilities
|
4,808
|
-
|
6,750
|
35
|
657
|
193
|
195
|
|||||||||||||||
Shareholders’
Equity
|
36,314
|
8,390
|
37,191
|
2,095
|
(56
|
)
|
102
|
(177
|
)
|
(In thousands, except per share data) | ||||||||||||||||||||||
Nine
months ended September 30,
|
Years
ended December 31,
|
|||||||||||||||||||||
2005
(Unaudited)
|
2004
(Unaudited)
|
2004(1)
|
2003(1)
|
2002(1)
|
2001(1)
|
2000
(Unaudited)
|
||||||||||||||||
Revenues
|
-
|
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
Net
(loss)
|
(5,663
|
)
|
(2,306
|
)
|
(31,217
|
)
|
(2,191
|
)
|
(1,390
|
)
|
(1,088
|
)
|
(177
|
)
|
||||||||
Net
(loss) per share (basic and fully diluted)
|
(0.10
|
)
|
(0.05
|
)
|
(1.24
|
)
|
(0.24
|
)
|
(0.16
|
)
|
|
(5.21
|
)
|
|||||||||
Weighted
average no. shares outstanding
|
54,877
|
26,420
|
25,268
|
9,129
|
8,763
|
34
|
||||||||||||||||
Working
capital
|
7,962
|
7,389
|
8,778
|
1,636
|
281
|
35
|
5
|
|||||||||||||||
Total
assets
|
9,381
|
8,516
|
11,152
|
3,480
|
904
|
660
|
16
|
|||||||||||||||
Long-term
liabilities
|
-
|
-
|
-
|
35
|
746
|
193
|
195
|
|||||||||||||||
Shareholders’
Equity (Deficiency)
|
8,524
|
7,845
|
9,311
|
1,774
|
(245
|
)
|
6
|
(187
|
)
|
|
US
Dollars Per One Canadian Dollar
Year
Ended December 31
|
|||||||||||||||
|
2004
|
2003
|
2002
|
2001
|
2000
|
|||||||||||
End
of period
|
0.8319
|
0.7713
|
0.6339
|
0.6275
|
0.6666
|
|||||||||||
Average
for the period
|
0.7685
|
0.7158
|
0.6369
|
0.6461
|
0.6740
|
US
Dollars per One Canadian Dollar
|
||||||||||||||||||||||
|
April
2005
|
May
2005
|
June
2005
|
July
2005
|
August
2005
|
September
2005
|
October
2005
|
|||||||||||||||
High
for the month
|
0.8232
|
0.8083
|
0.8159
|
0.8298
|
0.8411
|
0.8612
|
0.8755
|
|||||||||||||||
Low
for the month
|
0.7956
|
0.7872
|
0.7951
|
0.8044
|
0.8295
|
0.8412
|
0.8412
|
B.
|
Capitalization
and indebtedness
|
Common
shares
|
|||||||
#
|
$
|
||||||
Balance
- December 31, 2004
|
53,276,477
|
41,754,983
|
|||||
Issuance
of common shares for cash
|
4,134,675
|
3,018,651
|
|||||
Conversion
of Debentures
|
561,100
|
591,281
|
|||||
Exercise
of stock options
|
150,218
|
159,397
|
|||||
Exercise
of warrants
|
2,066,875
|
1,877,481
|
|||||
Share
issuance costs
|
-
|
(326,591
|
)
|
||||
Repurchased
|
(1,580,800
|
)
|
(1,259,560
|
)
|
|||
Balance
- September 30, 2005
|
58,608,545
|
45,815,642
|
Stock
Options
|
Weighted
exercise
price
|
||||||
#
|
$
|
||||||
Balance
- December 31, 2004
|
6,369,168
|
0.84
|
|||||
Granted
|
80,000
|
1.42
|
|||||
Expired
|
(178,750
|
)
|
3.90
|
||||
Exercised
|
(150,218
|
)
|
0.82
|
||||
Balance
- September 30, 2005
|
6,120,200
|
0.75
|
Warrants
|
Weighted
exercise
price
|
||||||
#
|
$
|
||||||
Balance
- December 31, 2004
|
12,543,095
|
1.06
|
|||||
Granted
|
2,459,299
|
1.20
|
|||||
Exercised
|
(2,066,875
|
)
|
0.85
|
||||
Balance
- September 30, 2005
|
12,935,519
|
1.10
|
September
30, 2005
|
December
31, 2004
|
||||||
$ |
$
|
||||||
United
States dollar convertible debentures
|
—
|
502,215
|
|||||
Canadian
dollar convertible debentures
|
175,000
|
450,000
|
|||||
Accrued
interest
|
82,120
|
144,009
|
|||||
Equity
component
|
(22,990
|
)
|
(59,118
|
)
|
|||
Balance
|
234,130
|
1,037,106
|
C.
|
Reasons
for the offer and use of
proceeds
|
D.
|
Risk
factors
|
(a)
|
we
may discover that our product candidates may cause, alone or
in
combination with another therapy, unacceptable side effects or
are not
effective at all;
|
(b)
|
we
may discover that our product candidates, alone or in combination
with
another therapy, does not exhibit the expected therapeutic results
in
humans;
|
(c)
|
results
from early trials may not be predictive of results that will
be obtained
from large-scale, advanced clinical trials as mentioned
above;
|
(d)
|
we
or the FDA or other regulatory agencies may suspend the clinical
trials of
one or more of our product
candidates;
|
(e)
|
patient
recruitment may be slower than expected;
|
(f)
|
patients
may drop out of our clinical trials;
and
|
(g)
|
there
may be cost overruns.
|
(a)
|
quarterly
variations in operating results;
|
(b)
|
market
conditions in the industry;
|
(c)
|
announcements
of results of testing, technological innovations
or
|
(d)
|
announcements
by our customers or competitors, developments affecting government
regulations, developments concerning proprietary rights, litigation,
and
public concerns as to the safety of our product
candidates;
|
(e)
|
announcements
of acquisitions;
|
(f)
|
general
fluctuations in the stock market;
and
|
(g)
|
revenues
and results of operations below the expectations of the public
market.
|
Item
4.
|
Information
on ViRexx
|
A.
|
History
and Development of
ViRexx
|
2004
|
2003
|
2002
|
||||||||
Lab
Equipment
|
$
|
290,422
|
$
|
87,994
|
$
|
87,500
|
||||
Leasehold
Improvements
|
36,303
|
-
|
-
|
|||||||
Office
Furniture & Equipment
|
32,269
|
1,892
|
9,722
|
|||||||
Computer
hardware
|
32,269
|
4,731
|
-
|
|||||||
Computer
software
|
12,101
|
-
|
-
|
|||||||
$
|
403,364
|
$
|
94,617
|
$
|
97,222
|
B.
|
Business
|
(a)
|
Duration
of the Agreement
|
(b)
|
Payment
Terms
|
(c)
|
Termination
Provisions
|
1
|
Italy,
Switzerland, Austria, Spain, Portugal, San Marino, Ukraine, Belarus,
Hungary, Poland, Czech Republic, Yugoslavia, Lithuania, Estonia,
Latvia,
Greece, Turkey, Cyprus, Croatia, Bosnia, Herzegovina, Macedonia,
Serbia,
Slovenia, Albania, Romania, Bulgaria, Israel, Egypt, Jordan, Saudi
Arabia,
Yemen, Oman, Iraq, Syria, Qatar, Bahrain, Kuwait, UAE, Iran, Palestine,
Lebanon
|
(d)
|
Other
Material Terms
|
(e)
|
Unither
represents and warrants that:
|
(i)
|
it
will use commercially reasonable efforts to develop, commercialize
and
market product candidates for one or more indications within the
field;
|
(ii)
|
it
will conduct all studies and clinical trials in accordance with
all
applicable laws, good clinical practices and medical ethical
rules;
|
(iii)
|
it
will adhere to all applicable laws and good manufacturing practices
in
manufacturing, storing, selling and exporting of product
candidates;
|
(iv)
|
it
will not use any individual to perform any services as contemplated
by the
agreement who has been disbarred pursuant to the United States
Food, Drug
and Cosmetic Act;
|
(v)
|
it
will adhere to all applicable laws regarding any of Unither’s obligations
under the agreement;
|
(vi)
|
it
will provide AltaRex with quarterly written progress
reports.
|
·
|
a
fully foreign monoclonal antibody (MAb) that targets CA125 in
circulation
|
·
|
induces
broad immune responses against CA125 and patients own ovarian
tumours
|
·
|
in
final stages of clinical development - Phase II and Phase III
ongoing
|
·
|
benign
safety profile and good quality of life during
treatment
|
·
|
has
been granted Orphan Drug status in U.S. and Europe and Fast Track
status
in U.S.
|
Globally
|
US
|
|||
People
Chronically Infected
|
370
million
|
1.25
million
|
||
New
Cases Per Year
|
Not
Available
|
78,000
|
Globally
|
US
|
|||
People
Chronically Infected
|
170
million
|
2.7
million
|
||
New
Cases Per Year
|
3-4
million
|
25,000
|
2
|
BRMs
or cytokines comprise a group of proteins made by the human body
that
alter the immune response to enhance, direct or restore the body's
ability
to fight disease. BRMs include colony stimulating factors,
erythropoietins, interferons, interleukins, and Tumour Necrosis
Factor
(“TNF”) inhibitors.
|
Globally
|
US
|
|||
Prevalence
|
30
- 40% of women 30-50 years of age
|
10.5
million
|
||
Target
Market
|
20%
of prevalence
|
2.1
million
|
Source:
Canadian Coordinating Office for Health
Technology Assessment; Statistics
Canada; Central Intelligence Agency Population Statistics; Society
of
Interventional Radiology.
|
Globally
|
US
|
|||
Prevalence
|
1,691,228
|
176,456
|
||
New
Cases per year
|
1,137,738
|
97,836
|
||
Source: GLOBOCAN 2002 |
-
|
all
of our employees must sign and are bound by confidentiality
agreements;
|
-
|
no
sensitive or confidential information is disclosed to any party
unless
appropriate confidential disclosure agreements are first signed;
and
|
-
|
all
confidential material that is provided to a party is marked as
confidential and is requested to be returned when the user no longer
has a
need to have the material, or when the term of any applicable confidential
disclosure agreement governing the use of the material
expires.
|
C.
|
Organizational
structure
|
D.
|
Property
and equipment
|
Annual
base rent:
|
$109,263.00
|
Term
expires:
|
May
31, 2011
|
Square
footage:
|
13,244
|
Laboratory
equipment
|
20%
|
|
Office,
furniture and equipment
|
20%
|
|
Computer
equipment
|
30%
|
|
Computer
software
|
100%
|
Item
5.
|
Operating
and Financial Review and
Prospects
|
A.
|
Operating
results
|
Increase
in number of staff members and general cost increases related to
staff
|
$
|
151,641
|
||
Preparation
of Occlusin™ 50 Injection preclinical activities
|
98,885
|
|||
Increase
in research and development tax credits
|
(65,061
|
)
|
||
Increase
in offsetting government assistance
|
(74,030
|
)
|
||
$
|
111,435
|
$
|
77,710
|
|||
Use
of third party consultants to accelerate HepaVaxx B preclinical
activities
(initial manufacturing); and
|
680,431
|
|||
Completion
of Occlusin™ 50 Injection preclinical activities (including manufacturing)
and initiation of the Phase I clinical trial (costs associated
with
contract research organization and regulatory filing).
|
575,947
|
|||
Other
|
79,519
|
|||
$
|
1,413,607
|
Manufacturing
of clinical material for the HepaVaxx B Phase I trial
|
$
|
530,640
|
||
Increase
in number of staff members and general cost increases related to
staff
|
442,561
|
|||
Use
of third party consultants to accelerate HepaVaxx B preclinical
activities
|
130,662
|
|||
Completion
of Occlusin™ 50 Injection preclinical activities (including manufacturing)
and ongoing Phase I clinical trial
|
184,711
|
|||
Decrease
in offsetting government assistance
|
499,430
|
|||
Expansion
of intellectual property portfolio
|
261,277
|
|||
Stock-based
compensation expense recorded for options granted
|
21,887
|
|||
Other
|
29,719
|
|||
$
|
2,100,887
|
Projected
Expenditures
|
|||||||||||||||||||||||||
YTD
2005
|
Quarter
4(1)
-
2005
|
2005
Total
|
Quarter
1(2)
2006
|
Quarter
2(3)
2006
|
Quarter
3(4)
2006
|
Quarter
4(5)
-
2006
|
2006
Total
|
||||||||||||||||||
Chimigen™
|
2,158,099
|
811,159
|
2,969,258
|
796,723
|
1,401,815
|
985,889
|
1,514,179
|
4,698,606
|
|||||||||||||||||
T-ACT™
|
810,021
|
847,930
|
1,657,951
|
819,274
|
924,639
|
1,162,176
|
1,183,680
|
4,089,769
|
|||||||||||||||||
AIT™
|
311,030
|
245,259
|
556,289
|
231,039
|
1,509,298
|
1,009,739
|
787,330
|
3,537,406
|
|||||||||||||||||
Total
Projected Research & Development Expenditures
|
3,279,150
|
1,904,348
|
5,183,498
|
1,847,036
|
3,835,752
|
3,157,804
|
3,485,189
|
12,325,780
|
(1)
|
Proposed
Milestones for 2005
|
(2)
|
Proposed
Milestones for 2006
|
(3)
|
Q2
2006
|
(4)
|
Q3
2006
|
(5)
|
Q4
2006
|
·
|
Products
may fail in clinical studies;
|
·
|
Hospitals,
physicians and patients may not be willing to participate in
clinical
studies;
|
·
|
Hospitals,
physicians and patients may not properly adhere to clinical study
procedures;
|
·
|
The
drugs may not be safe and effective or may not be perceived as
safe and
effective;
|
·
|
Other
approved or investigational therapies may be viewed as safer,
more
effective or more convenient;
|
·
|
Patients
may experience severe side effects during
treatment;
|
·
|
Patients
may die during the clinical study because their disease is too
advanced or
because they experience medical problems that are not related
to the drug
being studied;
|
·
|
Patients
may not enrol in the studies at the rate we
expect;
|
·
|
The
FDA, HPB and foreign regulatory authorities may delay or withhold
approvals to commence clinical trials or to manufacture
drugs;
|
·
|
The
FDA, HPB and foreign regulatory authorities may request that
additional
studies be performed;
|
·
|
Higher
than anticipated costs may be incurred due to the high cost of
contractors
for drug manufacture, research and clinical
trials;
|
·
|
Drug
supplies may not be sufficient to treat the patients in the studies;
and
|
·
|
The
results of preclinical testing may cause delays in clinical
trials.
|
For
twelve months ended December 31, 2004
|
For
twelve months ended December 31, 2003
|
For
twelve months ended December 31, 2002
|
||||||||
$ |
$
|
$
|
||||||||
IRAP
|
364,430
|
154,780
|
80,750
|
|||||||
AHFMR
|
500,000
|
-
|
-
|
|||||||
864,430
|
154,780
|
80,750
|
For
nine months
|
For
nine months
|
||||||
ended
Sept 30,
|
ended
Sept 30,
|
||||||
2005
|
2004
|
||||||
$ |
$
|
||||||
IRAP
|
45,000
|
364,430
|
|||||
AHFMR
|
-
|
180,000
|
|||||
45,000
|
544,430
|
Increase
in number of staff members and general cost increases related to
staff
|
$
|
52,115
|
||
Stock-based
compensation expense recorded for options granted
|
211,300
|
|||
Disposal
of property and equipment including decrease in related
expenses
|
(187,313
|
)
|
||
$
|
76,102
|
Consulting
and professional fees associated with investor relations and corporate
communication activities
|
$
|
130,000
|
||
Increase
in number of staff members and salary increases awarded to
staff
|
300,000
|
|||
Expenditure
of patent & trademarks
|
514,000
|
|||
Elevated
insurance premiums and expanded insurance coverage (director & officer
insurance)
|
45,000
|
|||
Other
|
6,675
|
|||
$
|
995,675
|
Consulting
and other costs associated with investor relations and corporate
communication activities
|
$
|
405,670
|
||
Increase
in number of staff members and general cost increases related to
staff
|
199,962
|
|||
Costs
related to the acquisition of AltaRex Medical Corp.
|
162,000
|
|||
Elevated
insurance premiums and expanded insurance coverage (director & officer
insurance)
|
45,000
|
|||
Stock-based
compensation expense recorded for options granted
|
305,659
|
|||
Other
|
72,476
|
|||
$
|
1,190,767
|
B.
|
Liquidity
and capital resources
|
|
First
9 Months Ended
September
30, 2005
|
Year
Ended
December
31, 2004
|
Year
Ended
December
31, 2003
|
||||||||||||||||||||||||||||
|
Q1
|
Q2
|
Q3
|
Q1
|
Q2
|
Q3
|
Q4
|
Q2
|
Q3
|
Q4
|
|||||||||||||||||||||
Government
assistance
|
-
|
45,000
|
-
|
261,525
|
193,936
|
88,969
|
320,000
|
79,934
|
15,066
|
67,277
|
|||||||||||||||||||||
Net
Earnings (Loss)
|
(1,702,833
|
)
|
(2,008,677
|
)
|
(2,005,191
|
)
|
(489,405
|
)
|
(853,798
|
)
|
(792,373
|
)
|
(1,522,184
|
)
|
(643,604
|
)
|
(271,165
|
)
|
(469,193
|
)
|
|||||||||||
Basic
and diluted earnings (loss) per share
|
(0.03
|
)
|
(0.04
|
)
|
(0.04
|
)
|
(0.03
|
)
|
(0.03
|
)
|
(0.03
|
)
|
(0.05
|
)
|
(0.07
|
)
|
(0.03
|
)
|
(0.05
|
)
|
C.
|
Research
and development, patents and licenses,
etc.
|
Issued
|
Pending
|
|||
Altered
Immunogenicity
|
2
|
7
|
||
Brevarex
|
4
|
24
|
||
Dendritic
Cells
|
1
|
13
|
||
Multi-Epitopic
|
30
|
11
|
||
Photoactivation
|
2
|
4
|
||
ProstaRex
|
2
|
6
|
||
Tactin
|
3
|
9
|
||
Occlusin
|
1
|
14
|
||
Chimigen
|
0
|
3
|
||
45
|
91
|
D.
|
Trend
information
|
E.
|
Off-Balance
Sheet Arrangements
|
F.
|
Tabular
Disclosure of Contractual
Obligations
|
Total
|
<
1 year(1)
|
1
- 3 years
|
>
3 years
|
||||||||||
Convertible
debentures
|
234,130
|
234,130
|
-
|
-
|
|||||||||
Long
term debt and obligations under capital leases
|
-
|
-
|
-
|
-
|
|||||||||
Operating
lease obligations
|
727,592
|
109,263
|
338,274
|
280,055(2
|
)
|
||||||||
Purchase
obligations
|
-
|
-
|
-
|
-
|
|||||||||
Milestone
payments
|
500,000(3
|
)
|
|||||||||||
Total
contractual obligations
|
961,722
|
343,393
|
338,274
|
780,055
|
(1)
|
Lease
on laboratory and offices of $109,263 per annum until May 31,
2007
|
(2)
|
Lease
on laboratory and offices of $115,885 per annum from June 1, 2007
to May
31, 2011
|
(3)
|
License
agreement milestone payments to third party upon commencement of
Phase III
clinical trials for each product
candidate
|
G.
|
Safe
Harbour
|
Item
6.
|
Directors,
Senior Management and
Employees
|
A.
|
Directors
and senior management
|
Name
|
Position
and Offices and Starting Date
|
Dr.
Antoine A. Noujaim
|
Former
Chairman, Former Chief Executive Officer and a Director since December
22,
2003 (on extended medical leave since October 24, 2005)
|
Dr.
Lorne J. Tyrrell
|
Chief
Executive Officer since November 1, 2005 and Chief Scientific
Officer
and a Director since December 22, 2003
|
Jacques
R. Lapointe
|
Director
since December 9, 2004
|
Bruce
D. Brydon
|
Director
since December 9, 2004
|
Thomas
E. Brown
|
Director
since December 22, 2003
|
Dr.
Jean Claude Gonneau
|
Director
since April 14, 2004
|
Douglas
Gilpin, CA
|
Director
since April 14, 2004; Acting Chairman of the Board since
October 24, 2005,
|
Macaraig
(Marc) Canton
|
President
and Chief Operating Officer since February 1, 2005, Acting
Chief Financial Officer since November 2, 2005
|
Michael
W. Stewart
|
Vice
President, Operations, Oncology since December 22, 2003
|
Dr.
Rajan George
|
Vice
President, Research & Development, Infectious Diseases since December
22, 2003
|
Dr.
Andrew Stevens
|
Vice
President, Clinical and Regulatory Affairs since December 22,
2003
|
Dr.
Irwin Griffith
|
Vice
President, Drug Development, Infectious Disease since April 5,
2004
|
Antoine
A. Noujaim, PH.D. D.Sc.
|
Dr.
Noujaim founded AltaRex in 1995, and served as Chairman of the
Board of
Directors, Chief Scientific Officer, and President and Chief Executive
Officer. In 1985, Dr. Noujaim co-founded Biomira Inc. (“Biomira”), a
biotechnology company listed on the Toronto Stock Exchange under
the
symbol “BRA” and from 1993 to 1995 he served as President of a subsidiary
unit, Biomira Research Inc. In addition, he acted as Senior Vice
President
of the Immunoconjugate Division of Biomira prior to 1994. Dr. Noujaim
is
Professor Emeritus of the University of Alberta and a director
of a number
of biotechnology companies. Dr. Noujaim co-founded ViRexx Research
Inc. in
September 2001, a predecessor corporation to ViRexx. Dr. Noujaim
has
served as an officer or chairman of various scientific organizations,
editorial boards and national scientific committees, has authored
more
than 200 publications, and is an inventor on more than 100 issued
patents
and patent applications. He is the recipient of a number of national
and
international awards for contributions in the field of antibody-mediated
therapeutics. Since October 24, 2005 Dr. Noujaim
has been on
extended medical leave but is still acting in a consulting
capacity.
|
Lorne
J. Tyrrell, Ph.D. M.D.
|
Dr.
Tyrrell, a virologist of international repute, the former Dean
of the
Faculty of Medicine and Dentistry at the University of Alberta
and the
Director of the Glaxo Heritage Research Institute. His exceptional
contributions to medical research have been recognized by his peers
through awards such as the ASTech Award for Innovation and Science
in
Alberta, the Rutherford Award as “Outstanding Teacher for Undergraduate
Students”, the Kaplin Award for Excellence in Research, and the Prix
Galien Canada Medal for Research for his groundbreaking work on
antiviral
drugs for hepatitis B. In 2000, Dr. Tyrrell was awarded the gold
medal by
the Canadian Liver Foundation and the Canadian Association for
the Study
of Liver, and the Alberta Order of Excellence from the Province
of
Alberta. In September 2001, Dr. Tyrrell co-founded ViRexx Research
Inc.
along with Dr. Noujaim. In 2002, he was appointed an officer of
the Order
of Canada by the Government of Canada. In addition to authoring
over 200
publications, he played a pivotal role in the development of the
antiviral
agent Lamivudine presently marketed by Glaxo as Epivir® for the treatment
of HBV and HIV. Dr. Tyrrell became Chief Executive Officer
of ViRexx
on November 1, 2005.
|
Jacques
R. Lapointe
|
Mr.
Lapointe has been a Director of ViRexx since December 9, 2004.
He is
President and Chairman of the Board of ConjuChem Inc. and recent
President
and Chief Operating Officer of BioChem Pharma, Inc. (Montreal,
Quebec).
Mr. Lapointe has more than 30 years of leadership and operational
experience with global biotechnology and pharmaceutical organizations.
Prior to BioChem Pharma, Mr. Lapointe was with Glaxo Wellcome plc
for 12
years and held the positions of President and CEO of Glaxo Canada
as well
as Glaxo Wellcome U.K. His earlier experience included operations,
marketing and sales, in positions at Johnson & Johnson Canada. Mr.
Lapointe is a former Chairman of the Pharmaceutical Manufacturers
Association of Canada (PMCA), now known as Canada’s Research-based
Pharmaceutical Companies (Rx&D). In 2003, Mr. Lapointe became
President and CEO of ConjuChem Inc.
|
Bruce
D. Brydon
|
Mr.
Brydon has been a Director of ViRexx since December 9, 2004. Mr.
Brydon is
the former President and Chief Executive Officer of Biovail Corporation.
He has more than 27 years of pertinent operational experience in
biotechnology and pharmaceuticals, particularly in key industry
areas such
as registration and approval processes in the U.S., Canada and
Europe,
product licensing, and capital raising in the U.S. and Canadian
debt/equity markets. Prior to Biovail, Mr. Brydon served as President
and
Chairman of Boerhinger Mannheim’s Canadian operations and as President of
Beirsdorf AG’s Canadian health care and industrial business
entities.
|
Thomas
E. Brown
|
Mr.
Brown has been a director of ViRexx since December 22, 2004. Mr.
Brown is
the Founder, Director and former President of Somagen Diagnostics
Inc.,
(“Somagen”) an Edmonton-based, privately held sales and marketing company
in the clinical laboratory diagnostic testing industry. Somagen’s clinical
diagnostic product lines are provided by some of the world’s leading
manufacturers in the areas of general chemistry, special chemistry,
point
of care, immunology, microbiology and cellular pathology. Somagen
is
currently the largest private clinical diagnostics company in Canada
with
sales, service and technical support in all regions of the
country.
|
Dr.
Jean Claude Gonneau
|
Dr.
Gonneau has been a director of ViRexx since April 14, 2004. Dr.
Gonneau is
currently the General Manager of SG Cowen, Europe SAS, an investment
banking institution. He has more than 25 years experience working
in the
financial markets in Europe and North America and maintains responsibility
for the European operations of SG Cowen. Prior to his appointment
as
General Manager, he was Managing Director of SG Cowen. Dr. Gonneau
is a
director of numerous publicly traded companies and lives in London,
England.
|
Douglas
Gilpin, CA
|
Mr.
Douglas Gilpin has been a director of ViRexx since April 14, 2004.
Mr.
Gilpin is a Chartered Accountant with more than 30 years of business
advisory and consultancy experience. He was a partner with KPMG
LLP from
1981 until his retirement from the firm in 1999. His practice focused
on
business advisory and assurance and involved work with numerous
companies
in the biotechnology field. Since October 24, 2005, Mr. Gilpin
has been
Acting Chairman of ViRexx
|
Macaraig
(Marc) Canton, B.Sc., MBA
|
Mr.
Canton has over 23 years of pharmaceutical and research experience.
He
joined ViRexx from Biovail Corporation where for 9 years he held
key
positions in multiple areas of the business in Canada and the United
States, including marketing & sales, contract research and business
development where he was responsible for all deal-related activities,
including in-licensing and out-licensing products and technologies,
partnering, and securing clinical trial contracts. Since November
2, 2005,
Mr. Canton has been Acting Chief Financial Officer of ViRexx pending
identification of a new Chief Financial Officer.
|
Michael
W. Stewart, M.Sc.
|
Mr.
Stewart has a 20-year history in the area of platelet biology and
hematology. Mr. Stewart obtained his Master of Science degree in
Experimental Medicine from the University of Alberta in 1982. In
his
capacity as Laboratory Scientist for the Department of Laboratory
Medicine
at Edmonton’s Capital Health Authority (1982 - 1997), Mr. Stewart authored
more than 35 publications in peer reviewed medical journals. In
addition,
Mr. Stewart is named as inventor of 15 issued patents and 22 patents
pending. Prior to joining ViRexx, Mr. Stewart served as Vice President
Research and Development for Novolytic Inc. from 1999 to 2002 and
prior to
that as Director of Research and Development for Thrombotics, Inc.,
a
biotechnology company (1997 to 1999).
|
Rajan
George, Ph.D.
|
Dr.
George has 25 years of research experience within a broad spectrum
of the
biomedical sciences including biochemistry, molecular biology,
virology
and immunology. Prior to joining ViRexx, Dr. George was a research
scientist at the Glaxo Heritage Research Institute, University
of Alberta
carrying out research on various biochemical aspects of replication
of
hepatitis B viruses. This involved the cloning and expression of
the viral
proteins as well as the generation of synthetic peptides for use
as
antigens to generate antibodies for therapeutic vaccine development.
Dr.
George has more than 35 publications in peer reviewed medical journals
to
his credit.
|
Andrew
Stevens, Ph.D.
|
Prior
to joining ViRexx, Dr. Stevens was the Vice President of Product
Development at Cytovax Inc., a biotechnology company, Dr. Stevens’
extensive experience includes responsibilities as Director of Clinical
Research with ViRexx and serving as Director of Clinical and Regulatory
Affairs and Director of Clinical and Professional Affairs at Biomira
Inc.,
a biotechnology company. Dr. Stevens has over 30 years of clinical
research, regulatory affairs, and product development experience
gathered
in the commercial development of various pharmaceuticals and
radiopharmaceuticals in Canada and the US. He holds a Bachelor
of Science
degree in Pharmacy and a Ph.D. in Bionucleonics.
|
Irwin
Griffith, Ph.D.
|
Dr.
Irwin Griffith has more than 15 years of expertise in the development
and
commercialization of immunotherapies for cancer, inflammatory and
autoimmune diseases. He previously served as Senior Director for
Business
Development with Biomira Inc. prior to founding Rational BioDevelopment
Inc. in 2003.
|
1.
|
Dr.
Lorne Tyrrell (Effective
November 1, 2005)
|
2.
|
Macaraig
(Marc) Canton
(effective February 1, 2005)
|
(a)
|
ViRexx
may terminate employment without cause
upon:
|
(b)
|
Mr.
Canton may resign from his employment on the following
terms:
|
3.
|
Michael
Stewart (Effective January 1, 2004)
|
4.
|
Dr.
Irwin Griffith (Effective April 6,
2004)
|
5.
|
Dr.
Rajan George (Effective January 1,
2004)
|
6.
|
Dr.
Andrew Stevens (effective January 1,
2004)
|
B.
|
Compensation
|
Annual
Compensation
|
Long-Term
Compensation
|
|||||||
Awards
|
Payouts
|
|||||||
Name
and Principal Position
|
Year
|
Gross
Salary
($)
|
Bonus
($)
|
Other
Annual Compensation
($)
|
Securities
Under Options/
SARs(11)
Granted
(#)
|
Restricted
Shares
or
Restricted
Share Units
($)
|
LTIP(1)
Payouts(2)
($)
|
All
Other Compensation
($)
|
Dr.
Antoine A. Noujaim, (3) Chairman,
President, Chief Executive Officer & Director
|
2004
|
168,000
|
33,600
|
Nil
|
1,675,000(4)
|
Nil
|
Nil
|
Nil
|
Rob
Salmon, (5) [Former
Chief
Financial Officer & Secretary]
|
2004
|
144,000
|
28,800
|
Nil
|
1,000,000(6)(7)
|
Nil
|
Nil
|
Nil
|
Dr.
Lorne J. Tyrrell, Chief Scientific Officer
|
320,000
|
Nil
|
Nil
|
Nil
|
||||
Jacques
R. Lapointe, Director
|
405,000(8)
|
Nil
|
Nil
|
Nil
|
||||
Bruce
D. Brydon, Director
|
230,000(9)
|
Nil
|
Nil
|
Nil
|
||||
Thomas
E. Brown, Director
|
170,000
|
Nil
|
Nil
|
Nil
|
||||
Dr.
Jean Claude Gonneau, Director
|
145,000
|
Nil
|
Nil
|
Nil
|
||||
Douglas
Gilpin, CA, Director
|
145,000
|
Nil
|
Nil
|
Nil
|
||||
Macaraig
(Marc) Canton(10)
, President
and COO
|
||||||||
Michael
W. Stewart, Vice President of Operations, Oncology
|
2004
|
120,000
|
165,000
|
Nil
|
Nil
|
Nil
|
||
Dr.
Rajan George, Vice President, Research and Development, Infectious
Diseases
|
2004
|
120,000
|
165,000
|
Nil
|
Nil
|
Nil
|
||
Dr.
Andrew Stevens, Vice President, Clinical and Regulatory
|
2004
|
92,500
|
115,000
|
Nil
|
Nil
|
Nil
|
||
Dr.
Irwin Griffith, Vice President, Drug Development and Infectious
Diseases
|
2004
|
102,868
|
115,000
|
Nil
|
Nil
|
Nil
|
(1)
|
Long
Term Incentive Plan (“LTIP”) is a plan of compensation based on the
performance of ViRexx over several financial
years.
|
(2)
|
ViRexx
does not have any plans, which provide compensation intended to
serve as
incentive to executive officers for performance to occur over a
period
longer than one year.
|
(3)
|
Dr.
Antoine Noujaim was appointed Chairman, President, Chief Executive
Officer
and Director on the date of the ViRexx Amalgamation, December 22,
2003.
Subsequent to December 31, 2004, Dr. Noujaim resigned his position
as
President of ViRexx effective February 1, 2005 and his position
as Chief
Executive Officer effective November 1,
2005.
|
(4)
|
Of
these, 1,125,000 Options were issued as replacement Options pursuant
to
the Arrangement.
|
(5)
|
Rob
Salmon was appointed Chief Financial Officer on the date of the
ViRexx
Amalgamation, December 23, 2003.
|
(6)
|
Of
these, 625,000 Options were issued as replacement Options pursuant
to the
Arrangement.
|
(7)
|
500,000
Options were granted to Rob Salmon in fiscal 2003 by ViRexx Research
Inc.,
a corporation amalgamated under the ABCA (“Former ViRexx”). 300,000 of
such Options were exercised prior to the ViRexx Amalgamation on
March 7,
2003. The remaining 200,000 Options were cancelled pursuant to
the ViRexx
Amalgamation Agreement and 200,000 replacement Options were issued
by
ViRexx on December 23, 2003.
|
(8)
|
Of
these, 280,000 Options were issued as replacement Options pursuant
to the
Arrangement.
|
(9)
|
Of
these, 105,000 Options were issued as replacement Options pursuant
to the
Arrangement.
|
(10)
|
Was
hired in January of 2005.
|
(11)
|
Stock
Appreciation Right (“SAR”) is a right granted by ViRexx as compensation
for services rendered or otherwise in connection with office or
employment
to receive payment of cash or an issue or transfer of securities
based
wholly or in part on changes in the trading price of publicly traded
securities.
|
C.
|
Board
practices
|
D.
|
Employees
|
E.
|
Share
ownership
|
Name
|
Title/Office
|
As
a % of Outstanding Shares
|
||
Dr.
Antoine A. Noujaim
|
Director
and Former Chief Executive Office
|
5,794,019
10.6%(1)
|
||
Dr.
Lorne J. Tyrrell
|
Chief
Executive Officer, Chief Scientific Officer and Director
|
1,566,792
2.9%(2)
|
||
Jacques
R. Lapointe
|
Director
|
37,500
0.07%(3)
|
||
Bruce
D. Brydon
|
Director
|
Nil(4)
|
||
Thomas
E. Brown
|
Director
|
709,214
1.3%(5)
|
||
Dr.
Jean Claude Gonneau
|
Director
|
Nil(6)
|
||
Douglas
Gilpin, CA
|
Acting
Chairman and Director
|
Nil(7)
|
||
Macaraig
(Marc) Canton
|
President
and Chief Operating Officer
and
Acting Chief Financial Officer
|
Nil(8)
|
||
Michael
W. Stewart
|
Vice
President, Operations, Oncology
|
266,039
0.49%(9)
|
||
Dr.
Rajan George
|
Vice
President, Research &
Development,
Infectious Diseases
|
72,763
0.13%(10)
|
||
Dr.
Andrew Stevens
|
Vice
President Regulatory Affairs
|
Nil(11)
|
||
Dr.
Irwin Griffith
|
Vice
President, Drug Development, Infectious Disease
|
Nil(12)
|
(1)
|
Dr.
Noujaim’s wife, Jean Noujaim also holds 26,430 Shares or 0.048% of the
issued and outstanding Shares of ViRexx. Dr. Noujaim also holds
options
for an additional 1,675,000 ViRexx Shares and warrants for an additional
625,000 ViRexx Shares which, if exercised, would raise the total
number of
Shares beneficially owned, directly or indirectly by Dr. Noujaim
to
8,094,019 ViRexx Shares. Assuming no other changes in share capital
but
the exercise of the options and warrants held by Dr. Noujaim, upon
such
exercise Dr. Noujaim would beneficially own, directly or indirectly
14.23%
of the issued ViRexx Shares.
|
(2)
|
Dr.
Tyrrell also holds options for an additional 320,000 ViRexx Shares,
which,
if exercised, would raise the total number of Shares beneficially
owned,
directly or indirectly by Dr. Tyrrell to 1,886,792 Shares. Assuming
no
other changes in share capital but the exercise of the Options
held by Dr.
Tyrrell, upon such exercise Dr. Tyrrell would beneficially own,
directly
or indirectly 3.4% of the issued ViRexx
Shares.
|
(3)
|
Mr.
Lapointe also holds options for 405,000 ViRexx Shares, which, if
exercised, assuming no other changes, would result in Mr. Lapointe
holding
442,500 or 0.8% of the ViRexx
Shares.
|
(4)
|
Mr.
Brydon holds options for 230,000 ViRexx Shares, which, if exercised,
assuming no other changes, would result in Mr. Brydon holding 230,000
or
0.4% of the ViRexx Shares.
|
(5)
|
Thomas
Brown also holds options for an additional 170,000 ViRexx Shares,
which,
if exercised, would raise the total number of ViRexx Shares beneficially
owned, directly or indirectly by Mr. Brown to 879,214 Shares. Assuming
no
other changes in share capital but the exercise of the options
held by Mr.
Brown, upon such exercise Mr. Brown would beneficially own, directly
or
indirectly 1.6% of the issued ViRexx
Shares.
|
(6)
|
Dr.
Gonneau also holds options for 145,000 ViRexx Shares. Assuming
no other
changes in share capital but the exercise of the options held by
Dr.
Gonneau, upon such exercise Dr. Gonneau would beneficially own,
directly
or indirectly 0.26% of the issued ViRexx
Shares.
|
(7)
|
Mr.
Gilpin holds options for 145,000 ViRexx Shares. Assuming no other
changes
in share capital but the exercise of the options held by Mr. Gilpin,
upon
such exercise Mr. Gilpin would beneficially own, directly or indirectly
0.26% of the issued ViRexx Shares.
|
(8)
|
Mr.
Canton holds options for 300,000 ViRexx Shares. Assuming no other
changes
in share capital but the exercise of the options held by Mr. Canton,
upon
such exercise Mr. Canton would beneficially own, directly or indirectly
0.6% of the issued ViRexx Shares.
|
(9)
|
Mr.
Stewart also holds options for an additional 165,000 ViRexx Shares,
which,
if exercised, would raise the total number of ViRexx Shares beneficially
owned, directly or indirectly by Mr. Stewart to 431,039 Shares.
Assuming
no other changes in share capital but the exercise of the options
held by
Mr. Stewart, upon such exercise Mr. Stewart would beneficially
own,
directly or indirectly 0.8% of the issued ViRexx
Shares.
|
(10)
|
Dr.
George’s wife, Daisy George also holds 6,904 Shares in an RRSP account
or
0.013% of the issued and outstanding Shares of ViRexx. Dr. George
also
holds options for an additional 165,000 ViRexx Shares, which, if
exercised, would raise the total number of ViRexx Shares beneficially
owned, directly or indirectly by Dr. George to 237,763 Shares.
Assuming no
other changes in share capital but the exercise of the options
held by Dr.
George, upon such exercise Dr. George would beneficially own, directly
or
indirectly 0.4% of the issued ViRexx
Shares.
|
(11)
|
Dr.
Stevens holds options for 115,000 ViRexx Shares. Assuming no other
changes
in share capital but the exercise of the options held by Dr. Stevens,
upon
such exercise Dr. Stevens would beneficially own, directly or indirectly
0.2% of the issued ViRexx Shares.
|
(12)
|
Dr.
Griffith holds options for 115,000 ViRexx Shares. Assuming no other
changes in share capital but the exercise of the options held by
Dr.
Griffith, upon such exercise Dr. Griffith would beneficially own,
directly
or indirectly 0.2% of the issued ViRexx
Shares.
|
Name
|
Title/Office
|
Number
of
Shares
|
Exercise
Price
|
Expiry
Date
|
||||
Dr.
Antoine A. Noujaim,
|
Director(1)
,
Former President
&
Chief Executive Officer
|
350,000(2)
1,125,000(2)(5)
200,000(2)
|
$0.80
$0.48
$0.90
|
Dec.
23, 2008
May
15, 2013
Dec.
16, 2014
|
||||
Dr.
Lorne J. Tyrrell
|
Chief
Executive Officer,
Chief
Scientific Officer &
Director
|
300,000
20,000
|
$0.80
$0.90
|
Dec.
23, 2008
Dec.
16, 2014
|
||||
Dr.
Jean Claude Gonneau
|
Director
|
125,000
20,000
|
$0.80
$0.90
|
April
14, 2009
Dec.
16, 2014
|
||||
Douglas
Gilpin
|
Director
|
125,000
20,000
|
$0.80
$0.90
|
April
14, 2009
Dec.
16, 2014
|
Name
|
Title/Office
|
Number
of
Shares
|
Exercise
Price
|
Expiry
Date
|
Jacques
R Lapointe
|
Director
|
10,000
20,000
50,000
200,000
125,000
|
$6.26
$0.94
$0.76
$0.86
$0.90
|
May
24, 2011
June
19, 2012
July
18, 2012
June
9, 2013
Dec.
16, 2014
|
||||
Bruce
D. Brydon
|
Director
|
10,000
20,000
75,000
125,000
|
$3.90
$0.94
$0.86
$0.90
|
April
10, 2011
June
19, 2012
June
9, 2013
Dec.
16, 2014
|
||||
Thomas
E. Brown
|
Director
|
150,000
20,000
|
$0.80
$0.90
|
Dec.
23, 2008
Dec.
16, 2014
|
||||
3,090,000
|
(1)
|
Dr.
Antoine Noujaim was appointed Chairman, President, Chief Executive
Officer
and Director on the date of the ViRexx Amalgamation, December 23,
2003.
Subsequent to December 31, 2004, Dr. Noujaim resigned his position
as
President of ViRexx
effective February 1, 2005 and his position as Chief Executive
Officer
effective November 1, 2005.
|
(2)
|
Options
are exercisable into Shares of
ViRexx.
|
(3)
|
These
Options vested on December 22,
2004.
|
(4)
|
All
previously issued stock options were cancelled pursuant to the
Arrangement
and replacement Options were issued by ViRexx on December 10, 2004,
at
which time ViRexx’s Shares were trading on the
TSXV.
|
Item
7.
|
Major
Shareholders and Related Party3
Transactions
|
A.
|
Major
shareholders
|
Name
|
Class
|
Amount
Owned(1)
|
%
of Class
|
Dr.
Antoine A. Noujaim
|
Common
|
5,794,019
|
9.85%
|
Canmarc
Trading Co.(2)
|
Common
|
4,010,010
|
6.81%
|
(1)
|
Includes
the Common Shares directly controlled by Dr.
Noujaim.
|
(2)
|
Michael
Marcus of Houston, Texas, holds 100% voting and dispositive power
over
Canmarc Trading Co.
|
B.
|
Related
party transactions
|
C.
|
Interests
of experts and
counsel
|
3
|
“Related
Party” means, in relation to a corporation, a promoter, officer, Director,
other insider or Control Person of that corporation (including
an issuer)
and any associates and affiliates of any of such persons. In relation
to
an individual, related party means any associates of the individual
or any
corporation of which the individual is a promoter, officer, Director
or
Control Person.
|
Item
8.
|
Financial
Information
|
A.
|
Consolidated
Statements and Other Financial
Information
|
B.
|
Significant
Changes
|
Item
9.
|
The
Offer and Listing
|
A.
|
Offer
and listing details
|
High
|
Low
|
||
TSX
- Toronto Stock Exchange
|
|||
December
16, 2004 - December 31, 2004(1)
|
1.22
|
0.85
|
|
TSX
Venture Exchange
|
|||
December
15, 2004(1)
|
1.60
|
0.90
|
|
December
31, 2003(2)
|
0.14
|
0.10
|
|
December
31, 2002(3)
|
0.23
|
0.15
|
|
December
31, 2001(3)
|
0.55
|
0.30
|
|
December
31, 2000(3)
|
0.55
|
0.16
|
(1)
|
ViRexx’s
Shares were delisted from the TSXV on December 15, 2004 and commenced
trading on the TSX on December 16, 2004 as a result of the AltaRex
Arrangement effective December 10,
2004.
|
(2)
|
Prior
to the ViRexx Amalgamation, Norac, one of the predecessors to ViRexx,
was
a publicly listed company on the TSXV. On June 23, 2003, trading
of
Norac’s common shares was halted upon the announcement of the ViRexx
Amalgamation. On August 18, 2003, Norac’s listing was moved to the NEX
board of the TSXV as a result of its inactive status. Pursuant
to the
ViRexx Amalgamation, the common shares of Norac were delisted from
the
TSXV on January 2, 2004 and ViRexx’s Shares were listed on the TSXV that
same date but remained halted. ViRexx’s Shares resumed trading on the TSXV
on April 16, 2004.
|
(3)
|
The
trading price of common shares of
Norac.
|
TSX
- Toronto Stock Exchange
|
High
|
Low
(1)
|
|
January
1 - June 30, 2005
|
2.13
|
0.96
|
|
December
16, 2004 - December 31, 2004
|
1.22
|
0.85
|
|
TSX
Venture Exchange
|
|||
December
15, 2004
|
1.20
|
0.94
|
|
September
30, 2004
|
1.18
|
0.90
|
|
June
30, 2004
|
1.60
|
1.02
|
|
March
31, 2004
|
-
|
-
|
|
December
31, 2003
|
-
|
-
|
|
September
30, 2003
|
-
|
-
|
|
June
30, 2003
|
0.14
|
0.10
|
|
March
31, 2003
|
-
|
-
|
(1)
|
Prior
to the ViRexx Amalgamation, Norac, one of the predecessors to ViRexx,
was
a publicly listed company on the TSXV. On June 23, 2003, trading
of
Norac’s common shares was halted upon the announcement of the ViRexx
Amalgamation. On August 18, 2003, Norac’s listing was moved to the NEX
board of the TSXV as a result of its inactive status. Pursuant
to the
ViRexx Amalgamation, the common shares of Norac were delisted from
the
TSXV on January 2, 2004 and ViRexx’s Shares were listed on the TSXV that
same date but remained halted. ViRexx’s Shares resumed trading on the TSXV
on April 16, 2004.
|
High
|
Low
|
||
TSX
- Toronto Stock Exchange
|
|||
October
31, 2005
|
1.04
|
0.94
|
|
September
30, 2005
|
1.14
|
0.94
|
|
August
31, 2005
|
1.15
|
0.90
|
|
July
31, 2005
|
1.04
|
0.96
|
|
June
30, 2005
|
1.12
|
0.96
|
|
May
31, 2005
|
1.43
|
1.03
|
|
April
30, 2005
|
1.59
|
1.30
|
|
March
31, 2005
|
2.13
|
1.45
|
|
February
28, 2005
|
2.00
|
1.10
|
|
TSX
Venture Exchange
|
|||
December
1, 2004 - December 15, 2004
|
1.09
|
0.94
|
|
November
30, 2004
|
1.10
|
0.95
|
|
October
31, 2004
|
1.20
|
1.01
|
Granted
Options pursuant to licensing agreements:
|
||||||||
License
Agreement: Tyrrell Hepatitis monoclonal technology
|
||||||||
Time
of Grant: Concurrent with close of each financing round and/or
financing
tranche
|
||||||||
Vesting:
Concurrent with grant of option
|
||||||||
Term:
Five years from grant of option
|
Vesting
|
Date
of
|
Expiry
|
Exercise
|
Options
|
Outstanding
|
Vested
|
Expiration
|
|
Name
|
Schedule
|
Grant
|
Date
|
Price
|
Granted
|
9/30/2005
|
9/30/2005
|
Year
|
University
of Alberta
|
Immediate
|
23-Dec-2003
|
23-Dec-2008
|
$0.80
|
50,000
|
50,000
|
50,000
|
2008
|
University
of Alberta
|
Immediate
|
14-Apr-2004
|
14-Apr-2009
|
$0.80
|
85,000
|
85,000
|
85,000
|
2009
|
135,000
|
135,000
|
135,000
|
30-Sept-05
|
|||||||||||||||||||
|
|
|
|
(Unaudited)
|
|||||||||||||||
Exercise
|
Opening
|
Granted
|
Exercised
|
Cancelled
|
Closing
|
||||||||||||||
price
|
#
|
#
|
#
|
#
|
#
|
||||||||||||||
Expiry
date
|
$
|
||||||||||||||||||
14-Apr-05
|
0.8
|
1,100,000
|
-
|
(1,100,000
|
)
|
-
|
-
|
||||||||||||
23-Jun-05
|
0.8
|
500,000
|
-
|
(500,000
|
)
|
-
|
-
|
||||||||||||
14-Oct-05
|
1
|
5,086,595
|
-
|
(189,000
|
)
|
-
|
4,897,595
|
||||||||||||
14-Oct-05
|
1
|
5,496,500
|
-
|
(277,875
|
)
|
-
|
5,218,625
|
||||||||||||
26-Nov-06
|
4
|
360,000
|
-
|
-
|
-
|
360,000
|
|||||||||||||
31-Jan-07
|
1.2
|
37,900
|
37,900
|
||||||||||||||||
9-Sep-07
|
1.2
|
2,421,399
|
2,421,399
|
||||||||||||||||
12,543,095
|
2,459,299
|
(2,066,875
|
)
|
0
|
12,935,519
|
31-Dec-04
|
|||||||||||||||||||
(Audited)
|
|||||||||||||||||||
Exercise
|
Opening
|
Granted
|
Exercised
|
Cancelled
|
Closing
|
||||||||||||||
price
|
#
|
#
|
#
|
#
|
#
|
||||||||||||||
Expiry
date
|
$
|
||||||||||||||||||
14-Apr-05
|
0.8
|
-
|
1,100,000
|
-
|
-
|
1,100,000
|
|||||||||||||
23-Jun-05
|
0.8
|
500,000
|
-
|
-
|
-
|
500,000
|
|||||||||||||
7-Jul-05
|
1
|
5,000,000
|
318,595
|
2,000
|
230,000
|
5,086,595
|
|||||||||||||
14-Oct-05
|
1
|
-
|
5,500,000
|
3,500
|
-
|
5,496,500
|
|||||||||||||
26-Nov-06
|
4
|
-
|
360,000
|
-
|
-
|
360,000
|
|||||||||||||
5,500,000
|
7,278,595
|
5,500
|
230,000
|
12,543,095
|
31-Dec-03
|
|||||||||||||||||||
(Audited)
|
|||||||||||||||||||
Exercise
|
Opening
|
Granted
|
Exercised
|
Cancelled
|
Closing
|
||||||||||||||
price
|
#
|
#
|
#
|
#
|
#
|
||||||||||||||
Expiry
date
|
$
|
||||||||||||||||||
23-Jun-05
|
0.8
|
-
|
500,000
|
-
|
-
|
500,000
|
|||||||||||||
7-Jul-05
|
1
|
-
|
5,000,000
|
-
|
-
|
5,000,000
|
|||||||||||||
|
-
|
5,500,000
|
-
|
-
|
5,500,000
|
30-Sep-05
|
30-Jun-05
|
31-Dec-04
|
31-Dec-03
|
||||||||||||||||||||||
(Unaudited)
|
(Unaudited)
|
(Audited)
|
(Audited)
|
||||||||||||||||||||||
Stock
|
Weighted
|
Stock
|
Weighted
|
Stock
|
Weighted
|
Stock
|
Weighted
|
||||||||||||||||||
options
|
average
|
options
|
average
|
options
|
average
|
options
|
average
|
||||||||||||||||||
#
|
Exercise
|
#
|
Exercise
|
#
|
Exercise
|
#
|
Exercise
|
||||||||||||||||||
price
|
price
|
price
|
price
|
||||||||||||||||||||||
$ |
$
|
$ |
$
|
||||||||||||||||||||||
Outstanding
- Beginning of period
|
6,369,168
|
0.84
|
6,369,168
|
0.84
|
2,103,218
|
0.8
|
685,000
|
0.5
|
|||||||||||||||||
Granted
|
80,000
|
1.42
|
80,000
|
1.42
|
4,564,168
|
0.85
|
2,403,218
|
0.7
|
|||||||||||||||||
Exercised
|
(150,218
|
)
|
0.84
|
(100,218
|
)
|
0.83
|
(13,218
|
)
|
0.8
|
(300,000
|
)
|
0.001
|
|||||||||||||
Expired
|
(178,750
|
)
|
3.9
|
(75,000
|
)
|
0.86
|
(285,000
|
)
|
0.8
|
(685,000
|
)
|
0.5
|
|||||||||||||
Outstanding
- End of period
|
6,120,200
|
0.75
|
6,273,950
|
0.84
|
6,369,168
|
0.84
|
2,103,218
|
0.8
|
|||||||||||||||||
Exercisable
- End of period
|
5,310,500
|
0.75
|
5,148,417
|
0.83
|
5,121,968
|
0.83
|
2,103,218
|
0.8
|
B.
|
Stock
Option Pricing
|
C.
|
Pension
and Retirement Plans and Payments made upon Termination of
Employment
|
D.
|
Plan
of Distribution
|
E.
|
Markets
|
F.
|
Selling
Shareholders
|
G.
|
Dilution
|
H.
|
Expenses
of the issue
|
Item
10.
|
Additional
Information
|
A.
|
Share
capital
|
Date
of Issue
|
Number
of
Shares
Issued
|
Price
per Share
|
Gross
Proceeds
|
Manner
of Issuance
|
March
27, 2003
|
48,000
|
$0.65
|
$31,200
|
Share
Subscription
|
April
8, 2003
|
300,000
|
$0.001
|
$300
|
Employee
Options
|
August
6, 2003(1)
|
521,233
|
$0.369/$0.422
|
$192,333
|
Debenture
Conversion
|
December
22, 2003(2)
|
163,415
|
$0.422
|
$68,944
|
Debenture
Conversion
|
(1)
|
On
August 6, 2003, Dr. Antoine Noujaim converted his $175,000 principal
amount of indebtedness plus accrued interest of $17,333 (for
an aggregate
of $192,333) into 521,233 ViRexx Shares on the following conversion
basis.
The principal amount of $175,000 was converted at $0.369 per
ViRexx Share
for a total of 480,160 ViRexx Shares and accrued interest of
$17,333 was
converted at $0.422 per ViRexx Share for a total of 41,073 ViRexx
Shares.
|
(2)
|
(See
“Consolidated Loan and Share
Capital”).
|
Date
of Issue
|
Number
of
Shares
Issued (1)
|
Price
per Share
|
Manner
of Issuance
|
December
29, 2003
|
10,400,000
|
Deemed
$0.80
|
From
treasury
|
December
31, 2003
|
200,000
|
Deemed
$0.80
|
From
treasury as corporate
finance fee
to
the Agent
|
(1)
|
5,000,000
ViRexx Private
Placement
Special
Warrants were issued pursuant to the ViRexx Private Placement issuable
as
ViRexx Private Placement Units of one ViRexx Share and one ViRexx
Private
Placement
Warrant.
|
Date
of Issue
|
Number
of
Shares
Issued (1)
|
Price
per Share
|
Manner
of Issuance
|
April
14, 2004
|
11,000,000
|
$0.80
|
From
treasury
|
April
14, 2004
|
400,000
|
$0.80
|
From
treasury as corporate finance fee to the
Agent
|
(1)
|
10,000,000
Units were also issued pursuant to the ViRexx Public Offering,
10,000,000
of such units consisting of one ViRexx Share and one half
ViRexx Public Offering Warrant, 1,000,000 of such units (the Agent’s
over-allotment option) consisting of one ViRexx Share and one half
ViRexx
Public Offering Warrant.
|
·
|
is
an arrangement by way of security for money lent to or obligations
undertaken by the director for the benefit of ViRexx or an
affiliate;
|
·
|
relates
primarily to his or her remuneration as a director, officer, employee
or
agent of ViRexx or an affiliate;
|
·
|
is
for indemnity or insurance; or
|
·
|
is
with an affiliate.
|
·
|
borrow
money upon the credit of ViRexx;
|
·
|
issue,
reissue, sell or pledge debt obligations of
ViRexx;
|
·
|
subject
to certain disclosure requirements of the ABCA,
give
a guarantee on behalf of ViRexx to secure performance of an obligation
of
any person;
|
·
|
mortgage,
hypothecate, pledge or otherwise create a security interest in
all or any
property of ViRexx owned or subsequently acquired to secure any
obligation
of the ViRexx; and
|
·
|
the
directors by resolution may delegate to a director, a committee
of
directors or an officer any of these
powers.
|
1.
|
An
investment to establish a new Canadian business;
and
|
2.
|
An
investment to acquire control of a Canadian business that is not
reviewable pursuant to the Act.
|
1.
|
An
investment is reviewable if there is an acquisition of a Canadian
business
and the asset value of the Canadian business being acquired equals
or
exceeds the following thresholds:
|
(a)
|
For
non-World Trade Organization (“WTO”) investors, the threshold is $5
million for a direct acquisition and $50 million for an indirect
acquisition; the $5 million threshold will apply however for
an indirect
acquisition if the asset value of the Canadian business being
acquired
exceeds 50% of the asset value of the global
transaction;
|
(b)
|
Except
as specified in paragraph (c) below, a threshold is calculated
annually
for reviewable direct acquisitions by or from WTO investors. The
threshold
for 2003 was $223 million. Pursuant to Canada’s international commitments,
indirect acquisitions by or from WTO investors are not
reviewable;
|
(c)
|
The
limits set out in paragraph (a) apply to all investors for acquisitions
of
a Canadian business that:
|
(i)
|
engages
in the production of uranium and owns an interest in a producing
uranium
property in Canada;
|
(ii)
|
provides
any financial service;
|
(iii)
|
provides
any transportation services; or
|
(iv)
|
is
a cultural business.
|
2.
|
Notwithstanding
the above, any investment which is usually only notifiable, including
the
establishment of a new Canadian business, and which falls within
a
specific business activity, including the publication and distribution
of
books, magazines, newspapers, film or video recordings, audio or
video
music recordings, or music in print or machine-readable form may
be
reviewed if an Order-in-Council directing a review is made and
a notice is
sent to the Investor within 21 days following the receipt of a
certified
complete notification.
|
C.
|
Material
contracts
|
·
|
the
transfer of AltaRex’s biotechnology assets, together with all associated
contractual obligations and liabilities, to Medical, with Medical
continuing to pursue the same commercialization strategy that
AltaRex
previously had for OvaRex and all other products currently in
development;
|
·
|
Nova
Bancorp subscribed for $4,770,985 (CDN) principal amount of 10%
convertible demand notes of Twin Butte (formerly AltaRex), convertible
into non-voting shares of Twin Butte at a ratio of 2,583 non-voting
shares
per $1,000 (CDN) of principal;
|
·
|
Twin
Butte (formerly AltaRex) subscribed for 12,746,935 common shares
in
Medical for $5.045 million (CDN) in cash less a holdback of $50,000
(CDN);
|
·
|
the
outstanding stock options and warrants of Twin Butte (formerly
AltaRex)
were cancelled and terminated and cease to represent any right
or claim
whatsoever, and new Medical options and warrants were issued
in their
place on identical terms;
|
·
|
immediately
following the completion of the Nova Bancorp Arrangement, a private
placement by Nova Bancorp of $1,379,015 (CDN) in consideration
for
3,500,000 Twin Butte new common shares was completed representing
40% of
the voting shares of Twin Butte; and
|
·
|
each
10 common shares of Twin Butte (formerly AltaRex ) outstanding
at the
close of business on February 2, 2004 were deemed to be exchanged
for one
“new” voting common share of Twin Butte and 10 voting common shares
of
Medical with the following two
exceptions:
|
1.
|
AltaRex
shareholders who held 151 to 1,000 common shares received an
aggregate
payment equal to $0.05 (CDN) per common share held and also
received one
Medical share for each common share held;
and
|
2.
|
AltaRex
shareholders who held 150 common shares or less, received an
aggregate
cash payment equal to $0.55 (CDN) per share.
|
·
|
Each
of the issued and outstanding common shares of AltaRex were deemed
to be,
transferred to ViRexx (free of any claims) and the holder of
AltaRex
common shares received from ViRexx in exchange for each AltaRex
common
share one-half of one ViRexx common
share;
|
·
|
40%
of the ViRexx common shares received by each former holder of
AltaRex
common shares issued pursuant to the AltaRex Arrangement were
non-transferable and subject to a hold period for a period of
six months
following the effective date of the AltaRex Arrangement;
and
|
·
|
the
outstanding stock options and warrants of AltaRex were deemed
to be
transferred to ViRexx (free of any claims) and in consideration
for such
transfer, the holder of such AltaRex stock options and warrants
received
an stock options and warrants to purchase the number of ViRexx
common
shares determined by multiplying the number of AltaRex common
shares
subject to the particular AltaRex stock options and warrants
by one-half,
at an exercise price per ViRexx common share equal to the exercise
price
per share of the particular AltaRex stock option or warrant multiplied
by
two. The other terms of all stock options and warrants issued
by ViRexx in
exchange for AltaRex stock options and warrants were identical
in all
material respects to the terms of the AltaRex stock options and
warrants
in respect of which they were
issued.
|
G.
|
Statement
by experts
|
Item
11.
|
Quantitative
and Qualitative Disclosures About Market
Risk
|
Item
12.
|
Description
of Securities Other than Equity
Securities
|
Item
13.
|
Defaults,
Dividend Arrearages and
Delinquencies
|
Item
14.
|
Material
Modifications to the Rights of Security Holders and Use of
Proceeds
|
Item
15.
|
[Reserved]
|
Item
16.
|
[Reserved]
|
Period
December
14, 2004
to
May 31, 2005
|
(a)
Total Number of
Shares
(or Units)
Purchased
|
(b)
Average Price
Paid
per Share (or
Units)
|
(c)
Total Number of
Shares
(or Units)
Purchased
as Part of
Publicly
Announced
Plans
or Programs
|
(d)
Maximum
Number
(or
Approximate
Dollar
Value)
of Shares (or
Units)
that May Yet
Be
Purchased Under
the
Plans or
Programs
|
Month
#1
December
23, 2004
to
December 22,
2005
|
___
|
___
|
___
|
2,663,823
|
Month
#2
January
1, 2005 to
January
31, 2005
|
40,800
|
$1.10
|
___
|
2,623,023
|
Month
#3
February
1, 2005 to
February
28, 2005
|
200
|
$1.10
|
___
|
2,622,823
|
Month
#4
March
1, 2005 to
March
31, 2005
|
90,000
|
$1.48
|
___
|
2,532,823
|
Month
#5
April
1, 2005 to
April
30, 2005
|
6,000
|
$1.44
|
___
|
2,526,823
|
Month
#6
May
1, 2005 to
May
31, 2005
|
___
|
___
|
___
|
2,526,823
|
Month
#7
June
1, 2005 to
June
30, 2005
|
108,800
|
$1.01
|
___
|
2,418,023
|
Month
#8
July
1, 2005 to
July
31, 2005
|
331,200
|
$1.00
|
2,086,823
|
|
Month
#9
August
1, 2005 to
August
31, 2005
|
1,003,800
|
$1.04
|
1,083,023
|
|
Month
#10
September
1,
2005
to
September
30,
2005
|
____
|
____
|
____
|
1,083,023
|
(1)
|
A
Normal Course Issuer Bid was approved by the TSX on December 21,
2004 and
the intention of ViRexx to engage in this program was announced
on
December 22, 2004 and will terminate on December 23, 2005. Trading
under
the program commenced on December 22, 2004 and will terminate on
December
22, 2005 at the close of trading. The trading will take place through
the
TSX and there is no restriction on the price paid per share. This
Normal
Course Issuer Bid is the first program of this nature ever implemented
by
ViRexx.
|
Item
17.
|
Financial
Statements
|
Item
18.
|
Financial
Statements
|
Item
19.
|
Exhibits
|
VIREXX MEDICAL CORP. | ||
|
|
|
By: | /s/ Dr. Lorne Tyrrell | |
Name: Dr. Lorne Tyrrell |
||
Title: Chief Executive Officer | ||
Date:
December 15, 2005
|
By: | /s/ Macaraig Canton | |
Name: Macaraig Canton |
||
Title: Acting Chief Financial Officer | ||
Date:
December 15, 2005
|
Exhibit
No.
|
Description
of Document
|
Page
No.
|
1.1
|
Notice
of Annual and Special Meeting of the Shareholders of ViRexx
Medical Corp.
and Management Information Circular and Proxy for a meeting
to be held on
June 16, 2005 and dated April 30, 2005
|
E-1
|
1.2
|
Articles
of Amalgamation of ViRexx Medical Corp.
|
E-39
|
1.3
|
Bylaw
No. 1 of ViRexx Medical Corp.
|
E-42
|
1.4
|
Employment
Agreement dated May 15, 2003 between ViRexx Research Inc. and
Dr.Antoine
Noujaim
|
E-53
|
1.5
|
Confidentiality
Agreement dated May 15, 2003 between ViRexx Research Inc. and
Dr. Antoine
Noujaim
|
E-67
|
1.6
|
Employment
Agreement dated February 1, 2005 between ViRexx Medical Corp.
and Macaraig
Canton
|
E-77
|
1.7
|
Confidentiality
Agreement dated February 1, 2005 between ViRexx Medical Corp.
and Macaraig
Canton
|
E-92
|
1.8
|
Employment
Agreement dated November 1, 2005 between ViRexx Medical Corp.
and Dr.
Lorne Tyrrell
|
E-98
|
1.9
|
Confidentiality
Agreement dated November 1, 2005 between ViRexx Medical Corp.
and Dr.
Lorne Tyrrell
|
E-121
|
1.10
|
Employment
Agreement dated January 1, 2004 between ViRexx Medical Corp.
and Michael
W. Stewart
|
E-131
|
1.11
|
Confidentiality
Agreement dated January 1, 2004 between ViRexx Medical Corp.
and Michael
W. Stewart
|
E-153
|
1.12
|
Employment
Agreement dated January 1, 2004 between ViRexx Medical Corp.
and Dr.
Andrew Stevens
|
E-162
|
1.13
|
Confidentiality
Agreement dated January 1, 2004 between ViRexx Medical Corp.
and Dr.
Andrew Stevens
|
E-184
|
1.14
|
Employment
Agreement dated April 5, 2004 between ViRexx Medical Corp.
and Dr. Irwin
Griffith
|
E-193
|
1.15
|
Confidentiality
Agreement dated April 6, 2004 between ViRexx Medical Corp.
and Dr. Irwin
Griffith
|
E-214
|
1.16
|
Employment
Agreement dated January 1, 2004 between ViRexx Medical Corp.
and Dr. Rajan
George
|
E-222
|
1.17
|
Confidentiality
Agreement dated January 1, 2004 between ViRexx Medical Corp.
and Dr. Rajan
George
|
E-244
|
1.18
|
Agency
Agreement between ViRexx Medical Corp. and Canaccord Capital
Corporation
dated March 26, 2005
|
E-253
|
12
|
Certification |
E-294
|
C.1
|
Exclusive
License Agreement between Unither Pharmaceuticals, Inc. and
AltaRex Corp.
dated April 17, 2002
|
E-295
|
C.2
|
First
Amendment to the License Agreement beween Unither Pharmaceuticals,
Inc.
and AltaRex Corp. dated August 6, 2003
|
E-353
|
C.3
|
Subscription
and Debenture Purchase Agreement between United Therapeutics
Corporation
and AltaRex Corp. dated April 17, 2002
|
E-357
|
C.4
|
Registration
Rights Agreement between United Therapeutics Corporation and
AltaRex Corp.
dated April 17, 2002
|
E-420
|
C.4
|
Security
Agreement between United Therapeutics Corporation and AltaRex
Corp. dated
April 17, 2002
|
E-448
|
C.5
|
Arrangement
Agreement among Nova Bancorp Investments Ltd., AltaRex Corp.
and AltaRex
Medical Corp. dated December 23, 2003
|
E-461
|
C.6
|
Asset
Purchase Agreement between AltaRex Corp. and AltaRex Medical
Corp. dated
December 31, 2003
|
E-534
|
C.7
|
Indemnity
Agreement between AltaRex Corp. and AltaRex Medical Corp. dated
effective
February 3, 2004
|
E-554
|
C.8
|
Convertible
Note Payable with a prescribed interest rate of 6% granted
in favour of
United Therapeutics Corporation by AltaRex Medical Corp. dated
February 3,
2004
|
E-569
|
C.9
|
Distribution
Agreement between AltaRex Medical Corp. and Dompé International S.A. dated
June 8, 2004
|
E-572
|
C.10
|
Arrangement
Agreement between AltaRex Medical Corp. and ViRexx Medical
Corp. dated
October 15, 2004
|
E-607
|
C.12
|
Collaborative
Development Agreement between Protein Sciences Corporation
and ViRexx
Medical Corp. effective April 20, 2005
|
E-671
|
C.13
|
License
Agreement between The Governors of the University of Alberta
and ViRexx
Research Inc. dated the 13 day of December, 2001
|
E-695
|
C.14
|
Contract
Research Agreement between the Board of Governors of the University
of
Alberta on behalf of the Noujaim Institute for Pharmaceutical
Oncology
Research, Faculty of Pharmacy and Pharmaceutical Sciences,
University of
Alberta and Noustar Technologies Inc. and Somagen Diagnostics
Inc.
effective the 15th
day of November, 1998
|
E-719
|
C.15
|
License
Agreement between The Governors of the University of Alberta
and Virexx
Research Inc. made the 1st
day of May, 2002
|
E-726
|
C.16
|
Royalty
Assignment Agreement between Thrombotics Inc., Novolytic Inc.
an AltaRex
Corp. dated the 1st
day of November, 1999
|
E-764
|
September
30,
2005
$
(Unaudited)
|
December
31,
2004
$
(Restated
-
Note
3)
|
December
31,
2003
$
(Restated
-
Note
3)
|
||||||||
Assets
|
||||||||||
|
||||||||||
Current
assets
|
||||||||||
Cash
and cash equivalents
|
8,319,266
|
9,462,988
|
2,708,599
|
|||||||
Restricted
cash (note 8)
|
257,120
|
659,000
|
-
|
|||||||
Goods
and services tax recoverable
|
44,986
|
94,903
|
56,231
|
|||||||
Prepaid
expenses and deposits
|
197,349
|
383,143
|
4,958
|
|||||||
Investment
tax credits recoverable
|
-
|
-
|
447,013
|
|||||||
Share
subscriptions receivable
|
-
|
-
|
37,500
|
|||||||
Other
current assets
|
-
|
18,527
|
52,082
|
|||||||
|
||||||||||
|
8,818,721
|
10,618,561
|
3,306,383
|
|||||||
Property
and equipment
(note 5)
|
561,869
|
533,202
|
173,800
|
|||||||
Patents
and trademarks
|
-
|
-
|
242,626
|
|||||||
Acquired
intellectual property (note
6)
|
32,575,639
|
34,570,682
|
19,100
|
|||||||
|
||||||||||
41,956,229
|
45,722,445
|
3,741,909
|
||||||||
Liabilities
|
||||||||||
|
||||||||||
Current
liabilities
|
||||||||||
Accounts
payable and accrued liabilities
|
599,818
|
744,805
|
1,131,154
|
|||||||
Convertible
debentures (note 8)
|
234,130
|
1,037,106
|
480,365
|
|||||||
|
||||||||||
|
833,948
|
1,781,911
|
1,611,519
|
|||||||
Future
income taxes
(note 4)
|
4,808,257
|
6,749,947
|
-
|
|||||||
Amount
due to related party
(note 7)
|
-
|
-
|
35,341
|
|||||||
|
||||||||||
|
5,642,205
|
8,531,858
|
1,646,860
|
|||||||
|
||||||||||
Commitments
and contingencies
(note 9)
|
||||||||||
|
||||||||||
Shareholders’
Equity
|
||||||||||
|
||||||||||
Common
shares - no
par value; unlimited shares authorized; 58,608,545 shares, 53,276,477
shares and 15,600,000 shares issued and outstanding,
respectively
(note 12)
|
45,815,642
|
41,754,983
|
5,603,667
|
|||||||
Contributed
surplus (note
12)
|
4,901,174
|
3,626,905
|
1,024,923
|
|||||||
Equity
component of convertible debenture (note 8)
|
22,990
|
59,118
|
59,118
|
|||||||
Deficit
accumulated during development stage
|
(14,425,782
|
)
|
(8,250,419
|
)
|
(4,592,659
|
)
|
||||
|
||||||||||
36,314,024
|
37,190,587
|
2,095,049
|
||||||||
41,956,229
|
45,722,445
|
3,741,909
|
Approved
by the Board of Directors
|
|
______________________________________________
Director
|
______________________________________________
Director
|
Common
stock
|
|||||||||||||||||||
Number
#
|
Amount
$
|
Equity
component
of
debenture
$
|
Contributed
surplus
$
|
Deficit
Accumulated
during
development
stage
$
|
Total
shareholders’
equity
$
|
||||||||||||||
Balance
- December 31, 1999
|
-
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||
Shares
issued on incorporation
|
200
|
259
|
-
|
-
|
-
|
259
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(177,397
|
)
|
(177,397
|
)
|
|||||||||||
|
|||||||||||||||||||
Balance
- December 31, 2000
|
200
|
259
|
-
|
-
|
(177,397
|
)
|
(177,138
|
)
|
|||||||||||
|
|||||||||||||||||||
Issuance
of common shares
|
16,617,283
|
1,153,081
|
-
|
-
|
-
|
1,153,081
|
|||||||||||||
Exercise
of warrants
|
260,039
|
207,094
|
-
|
-
|
-
|
207,094
|
|||||||||||||
Share
issue costs
|
-
|
(69,067
|
)
|
-
|
-
|
-
|
(69,067
|
)
|
|||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(1,011,957
|
)
|
(1,011,957
|
)
|
|||||||||||
|
|||||||||||||||||||
Balance
- December 31, 2001
|
16,877,522
|
1,291,367
|
-
|
-
|
(1,189,354
|
)
|
102,013
|
||||||||||||
|
|||||||||||||||||||
Shares
issued on settlement of debt
|
682,686
|
218,460
|
-
|
-
|
-
|
218,460
|
|||||||||||||
Issuance
of common shares
|
184,000
|
800,024
|
-
|
-
|
-
|
800,024
|
|||||||||||||
Exercise
of warrants
|
1,869
|
1,428
|
-
|
-
|
-
|
1,428
|
|||||||||||||
Share
issue costs
|
-
|
(7,749
|
)
|
-
|
-
|
-
|
(7,749
|
)
|
|||||||||||
Issuance
of convertible debenture
|
-
|
-
|
90,000
|
-
|
-
|
90,000
|
|||||||||||||
Amalgamation
|
(1,000,000
|
)
|
-
|
-
|
-
|
-
|
-
|
||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(1,260,472
|
)
|
(1,260,472
|
)
|
|||||||||||
|
|||||||||||||||||||
Balance
- December 31, 2002
|
16,746,077
|
2,303,530
|
90,000
|
-
|
(2,449,826
|
)
|
(56,296
|
)
|
|||||||||||
|
|||||||||||||||||||
Issued
under private placement
|
48,000
|
31,200
|
-
|
-
|
-
|
31,200
|
|||||||||||||
Exercise
of stock options
|
300,000
|
126,600
|
-
|
-
|
-
|
126,600
|
|||||||||||||
Conversion
of debentures
|
684,648
|
261,277
|
(30,882
|
)
|
-
|
-
|
230,395
|
||||||||||||
Amalgamation
|
(7,378,725
|
)
|
-
|
-
|
-
|
(24,498
|
)
|
(24,498
|
)
|
||||||||||
Issue
of special warrants
|
5,200,000
|
2,881,060
|
-
|
205,150
|
-
|
3,086,210
|
|||||||||||||
Stock
options issued to non-employees
|
-
|
-
|
-
|
85,000
|
-
|
85,000
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(1,383,562
|
)
|
(1,383,562
|
)
|
|||||||||||
|
|||||||||||||||||||
Balance
- December 31, 2003
|
15,600,000
|
5,603,667
|
59,118
|
290,150
|
(3,857,886
|
)
|
2,095,049
|
||||||||||||
|
|||||||||||||||||||
Retroactive
adjustment for stock-based compensation
|
-
|
-
|
-
|
734,773
|
(734,773
|
)
|
-
|
||||||||||||
|
Common
stock
|
|||||||||||||||||||
Number
#
|
Amount
$
|
Equity
component
of
debenture
$
|
Contributed
surplus
$
|
Deficit
Accumulated
during
development
stage
$
|
Total
shareholders’
equity
$
|
Balance
- December 31, 2003 (Restated)
|
15,600,000
|
5,603,667
|
59,118
|
1,024,923
|
(4,592,659
|
)
|
2,095,049
|
||||||||||||
|
|||||||||||||||||||
Issued
through public offering
|
11,000,000
|
8,388,820
|
-
|
411,180
|
-
|
8,800,000
|
|||||||||||||
Issued
as corporate finance fee
|
400,000
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||
Exercise
of warrants
|
5,500
|
5,500
|
-
|
-
|
-
|
5,500
|
|||||||||||||
Acquisition
of AltaRex Medical Corp.
|
26,257,759
|
28,620,957
|
-
|
-
|
-
|
28,620,957
|
|||||||||||||
Exercise
of stock options
|
13,218
|
15,727
|
-
|
(5,153
|
)
|
-
|
10,574
|
||||||||||||
Share
issue costs
|
-
|
(879,688
|
)
|
-
|
-
|
-
|
(879,688
|
)
|
|||||||||||
Fair
value of stock options issued on the acquisition of
AltaRex
|
-
|
-
|
-
|
1,815,378
|
-
|
1,815,378
|
|||||||||||||
Stock
options issued
|
-
|
-
|
-
|
380,577
|
-
|
380,577
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(3,657,760
|
)
|
(3,657,760
|
)
|
|||||||||||
|
|||||||||||||||||||
Balance
- December 31, 2004
|
53,276,477
|
41,754,983
|
59,118
|
3,626,905
|
(8,250,419
|
)
|
37,190,587
|
||||||||||||
|
|||||||||||||||||||
Repurchase
of shares
|
(1,580,800
|
)
|
(1,259,560
|
)
|
-
|
-
|
(458,662
|
)
|
(1,718,222
|
)
|
|||||||||
Exercise
of stock options
|
150,218
|
159,397
|
-
|
(36,183
|
)
|
-
|
123,214
|
||||||||||||
Private
placement
|
4,035,665
|
2,918,651
|
-
|
1,117,014
|
-
|
4,035,665
|
|||||||||||||
Exercise
of warrants
|
2,066,875
|
1,877,481
|
-
|
(130,606
|
)
|
-
|
1,746,875
|
||||||||||||
Conversion
of debentures
|
561,100
|
591,281
|
-
|
-
|
-
|
591,281
|
|||||||||||||
Redemption
of debenture
|
-
|
-
|
(36,128
|
)
|
-
|
-
|
(36,128
|
)
|
|||||||||||
Share
issue costs
|
99,010
|
(226,591
|
)
|
-
|
-
|
-
|
(226,591
|
)
|
|||||||||||
Stock
options issued
|
-
|
-
|
-
|
324,044
|
-
|
324,044
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(5,716,701
|
)
|
(5,716,701
|
)
|
|||||||||||
|
|||||||||||||||||||
Balance
- September 30, 2005 (unaudited)
|
58,608,545
|
45,815,642
|
22,990
|
4,901,174
|
(14,425,782
|
)
|
36,314,024
|
Nine-month
periods ended
September
30,
|
Years
ended December 31,
|
||||||||||||||||||
2005
$
(Unaudited)
|
2004
$
(Unaudited)
(Restated -
Note
3)
|
|
2004
$
(Restated
-
Note
3)
|
|
2003
$
(Restated
-
Note
3)
|
|
2002
$
|
|
Cumulative
from
October 30, 2000 to
September 30,
2005
$
(Unaudited)
|
||||||||||
Revenue
|
-
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||
|
|||||||||||||||||||
Expenses
|
|||||||||||||||||||
Research
and development (note 11)
|
3,279,150
|
1,178,263
|
1,796,680
|
383,073
|
271,638
|
6,483,892
|
|||||||||||||
Corporate
administration
|
2,325,743
|
1,134,976
|
1,887,711
|
892,036
|
815,934
|
6,284,925
|
|||||||||||||
Depreciation
and amortization
|
2,088,113
|
34,296
|
71,348
|
31,596
|
37,501
|
2,250,282
|
|||||||||||||
Debenture
interest
|
95,201
|
47,359
|
61,999
|
76,052
|
39,708
|
272,960
|
|||||||||||||
Interest
income
|
(169,729
|
)
|
(76,382
|
)
|
(127,728
|
)
|
(7,497
|
)
|
-
|
(304,954
|
)
|
||||||||
Loss
(gain) on foreign exchange
|
43,644
|
(1,870
|
)
|
(14,971
|
)
|
(4,401
|
)
|
1,361
|
75,769
|
||||||||||
Other
income
|
(3,731
|
)
|
(10,452
|
)
|
(15,324
|
)
|
-
|
-
|
(19,055
|
)
|
|||||||||
(Gain)
loss on disposal of property and equipment
|
-
|
-
|
(1,955
|
)
|
12,703
|
94,972
|
105,720
|
||||||||||||
|
|||||||||||||||||||
|
7,658,391
|
2,306,190
|
3,657,760
|
1,383,562
|
1,261,114
|
15,149,539
|
|||||||||||||
|
|||||||||||||||||||
Loss
before income taxes
|
(7,658,391
|
)
|
(2,306,190
|
)
|
(3,657,760
|
)
|
(1,383,562
|
)
|
(1,261,114
|
)
|
(15,149,539
|
)
|
|||||||
|
|||||||||||||||||||
Income
taxes (recovery)
|
(1,941,690
|
)
|
-
|
-
|
-
|
(642
|
)
|
(1,941,690
|
)
|
||||||||||
|
|||||||||||||||||||
Net
loss
|
(5,716,701
|
)
|
(2,306,190
|
)
|
(3,657,760
|
)
|
(1,383,562
|
)
|
(1,260,472
|
)
|
(13,207,849
|
)
|
|||||||
|
|||||||||||||||||||
Basic
and diluted loss per common share (note 13)
|
(0.10
|
)
|
(0.09
|
)
|
(0.14
|
)
|
(0.15
|
)
|
(0.14
|
)
|
Nine-month
periods ended
September
30,
|
Years
ended December 31,
|
||||||||||||||||||
2005
$
(Unaudited)
|
2004
$
(Unaudited)
(Restated
-
Note
3)
|
|
2004
$
(Restated
-
Note
3)
|
|
2003
$
(Restated
-
Note
3)
|
|
2002
$
|
|
Cumulative
from
October
30,
2000
to
September
30,
2005
$
(Unaudited)
|
|
|||||||||
Cash
provided by (used in)
|
|||||||||||||||||||
|
|||||||||||||||||||
Operating
activities
|
|||||||||||||||||||
Net
loss for the period
|
(5,716,701
|
)
|
(2,306,190
|
)
|
(3,657,760
|
)
|
(1,383,562
|
)
|
(1,260,472
|
)
|
(13,207,849
|
)
|
|||||||
Items
not affecting cash
|
|||||||||||||||||||
Debenture
interest
|
95,201
|
47,359
|
54,526
|
76,052
|
39,708
|
265,487
|
|||||||||||||
Depreciation
and amortization
|
2,088,113
|
34,296
|
71,348
|
31,596
|
37,501
|
2,250,282
|
|||||||||||||
Future
income taxes
|
(1,941,690
|
)
|
-
|
-
|
-
|
-
|
(1,941,690
|
)
|
|||||||||||
Stock-based
compensation
|
324,044
|
200,099
|
380,577
|
211,300
|
-
|
915,921
|
|||||||||||||
Write
off of patent costs
|
-
|
-
|
242,626
|
-
|
-
|
242,626
|
|||||||||||||
(Gain)
loss on disposal of property and equipment
|
-
|
-
|
(1,955
|
)
|
12,703
|
94,972
|
105,364
|
||||||||||||
Unrealized
foreign exchange gain (loss)
|
(356
|
)
|
-
|
(9,471
|
)
|
-
|
-
|
(9,471
|
)
|
||||||||||
Net
change in non-cash working capital items (note 14)
|
109,251
|
(1,099,093
|
)
|
(346,104
|
)
|
476,659
|
2,945
|
284,842
|
|||||||||||
|
|||||||||||||||||||
|
(5,042,138
|
)
|
(3,123,529
|
)
|
(3,266,213
|
)
|
(575,252
|
)
|
(1,085,346
|
)
|
(11,094,488
|
)
|
|||||||
Financing
activities
|
|||||||||||||||||||
Issuance
of share capital
|
5,660,764
|
8,805,500
|
7,405,027
|
3,280,210
|
815,000
|
18,452,527
|
|||||||||||||
Amounts
due to related parties
|
-
|
(35,341
|
)
|
(35,341
|
)
|
13,368
|
21,973
|
-
|
|||||||||||
Advances
from shareholder
|
-
|
-
|
-
|
575,000
|
-
|
769,900
|
|||||||||||||
Repayment
of advances from shareholder
|
-
|
-
|
-
|
(575,000
|
)
|
(193,307
|
)
|
(769,900
|
)
|
||||||||||
Convertible
debentures
|
(324,625
|
)
|
(3,667
|
)
|
-
|
-
|
685,000
|
360,375
|
|||||||||||
Restricted
cash
|
401,880
|
-
|
(659,000
|
)
|
-
|
-
|
(257,120
|
)
|
|||||||||||
Repayment
of note payable
|
-
|
-
|
-
|
-
|
(25,000
|
)
|
-
|
||||||||||||
Redemption
of shares
|
(1,718,222
|
)
|
(890,291
|
)
|
-
|
-
|
-
|
(1,718,222
|
)
|
||||||||||
|
|||||||||||||||||||
|
4,019,797
|
7,876,201
|
6,710,686
|
3,293,578
|
1,303,666
|
16,837,560
|
|||||||||||||
Investing
activities
|
|||||||||||||||||||
Acquisition
of property and equipment
|
(131,458
|
)
|
(55,119
|
)
|
(403,364
|
)
|
(94,617
|
)
|
(97,222
|
)
|
(907,889
|
)
|
|||||||
Cash
acquired on acquisition
|
-
|
-
|
3,710,419
|
19,142
|
-
|
3,729,561
|
|||||||||||||
Proceeds
on sale of property and equipment
|
10,077
|
-
|
2,861
|
9,210
|
-
|
22,148
|
|||||||||||||
Expenditures
on patents and trademarks
|
-
|
-
|
-
|
(74,824
|
)
|
(94,633
|
)
|
(267,626
|
)
|
||||||||||
|
|||||||||||||||||||
|
(121,381
|
)
|
(55,119
|
)
|
3,309,916
|
(141,089
|
)
|
(191,855
|
)
|
2,576,194
|
|||||||||
|
|||||||||||||||||||
(Decrease)
increase in cash and cash equivalents
|
(1,143,722
|
)
|
4,697,553
|
6,754,389
|
2,577,237
|
26,465
|
8,319,266
|
||||||||||||
|
|||||||||||||||||||
Cash
and cash equivalents -
Beginning of period |
9,462,988
|
2,708,599
|
2,708,599
|
131,362
|
104,897
|
-
|
|||||||||||||
|
|||||||||||||||||||
Cash
and cash equivalents -
End of period |
8,319,266
|
7,406,152
|
9,462,988
|
2,708,599
|
131,362
|
8,319,266
|
|||||||||||||
|
|||||||||||||||||||
Supplementary
information
(note 14) |
1
|
Nature
of operations
|
2
|
Summary
of significant accounting
policies
|
a)
|
Basis
of consolidation
|
b)
|
Cash
and cash equivalents
|
c)
|
Revenue
|
d)
|
Property
and equipment
|
Laboratory
equipment
|
20%
|
|||
Office,
furniture and equipment
|
20%
|
|||
Computer
equipment
|
30%
|
|||
Computer
software
|
100%
|
e)
|
License
|
f)
|
Unither
agreement
|
g)
|
Government
grants and investment tax credits
|
h)
|
Research
and development costs
|
i)
|
Foreign
currency translation
|
j)
|
Income
taxes
|
k)
|
Stock-based
compensation
|
l)
|
Impairment
of long-lived assets
|
m)
|
Loss
per share
|
3
|
Accounting
changes
|
4
|
Income
taxes
|
September
30,
2005
$
(Unaudited)
|
September
30,
2004
$
(Unaudited)
|
December
31,
2004
$
(Restated)
|
December
31,
2003
$
(Restated)
|
December
31,
2002
$
|
||||||||||||
Canadian
statutory rates
|
33.62
|
%
|
35.47
|
%
|
33.87
|
%
|
36.74
|
%
|
17.77
|
%
|
||||||
Expected
recovery at the statutory rate
|
(2,575,000
|
)
|
(818,000
|
)
|
(1,239,000
|
)
|
(508,000
|
)
|
(224,000
|
)
|
||||||
Unrecognized
deductible temporary differences and tax losses
|
524,310
|
747,000
|
1,109,000
|
429,000
|
222,358
|
|||||||||||
Stock-based
compensation and other non-deductible expenses
|
109,000
|
71,000
|
130,000
|
79,000
|
1,000
|
|||||||||||
Total
income taxes
|
(1,941,690
|
)
|
-
|
-
|
-
|
(
642
|
)
|
September
30,
2005
$
(Unaudited)
|
December
31,
2004
$
(Restated)
|
December
31,
2003
$
(Restated)
|
||||||||
Future
tax assets
|
||||||||||
Non-capital
loss carry forwards
|
2,280,796
|
1,577,315
|
536,251
|
|||||||
Research
and development deductions and
investment
tax credits
|
1,978,376
|
1,244,976
|
257,046
|
|||||||
Other
assets
|
247,625
|
420,599
|
283,572
|
|||||||
4,506,797
|
3,242,890
|
1,076,869
|
||||||||
Future
tax liabilities
|
||||||||||
Acquired
intellectual property
|
(9,315,054
|
)
|
(9,992,837
|
)
|
-
|
|||||
Valuation
allowance
|
-
|
-
|
(1,076,869
|
)
|
||||||
Net
future tax liability
|
(4,808,257
|
)
|
(6,749,947
|
)
|
-
|
Non-capital
loss
carry
forwards
$
|
Investment
tax
credits
$
|
||||||
2007
|
138,101
|
-
|
|||||
2008
|
234,160
|
-
|
|||||
2009
|
399,890
|
9,767
|
|||||
2010
|
820,624
|
767
|
|||||
2012
|
-
|
2,315
|
|||||
2013
|
-
|
28,127
|
|||||
2014
|
3,098,822
|
560,137
|
|||||
4,691,597
|
601,113
|
5
|
Property
and equipment
|
September
30, 2005
(Unaudited)
|
||||||||||
Cost
$
|
Accumulated
depreciation
$
|
Net
$
|
||||||||
Laboratory
equipment
|
465,872
|
124,218
|
341,654
|
|||||||
Office
furniture and equipment
|
107,459
|
25,826
|
81,633
|
|||||||
Computer
equipment and software
|
171,905
|
64,786
|
107,119
|
|||||||
Leasehold
improvements
|
36,469
|
5,006
|
31,463
|
|||||||
781,705
|
219,836
|
561,869
|
December
31, 2004
|
||||||||||
Cost
$
|
Accumulated
depreciation
$
|
Net
$
|
||||||||
Laboratory
equipment
|
465,394
|
76,090
|
389,304
|
|||||||
Office
furniture and equipment
|
64,124
|
13,210
|
50,914
|
|||||||
Computer
equipment and software
|
98,297
|
38,787
|
59,510
|
|||||||
Leasehold
improvements
|
34,343
|
869
|
33,474
|
|||||||
662,158
|
128,956
|
533,202
|
December
31, 2003
|
||||||||||
Cost
$
|
Accumulated
depreciation
$
|
Net
$
|
||||||||
Laboratory
equipment
|
175,238
|
29,545
|
145,693
|
|||||||
Office
furniture and equipment
|
15,285
|
4,765
|
10,520
|
|||||||
Computer
equipment
|
30,366
|
12,779
|
17,587
|
|||||||
220,889
|
47,089
|
173,800
|
6
|
Acquired
intellectual property
|
September
30,
2005
$
(Unaudited)
|
December
31,
2004
$
|
December
31,
2003
$
|
||||||||
Unither
development agreement - net of accumulated amortization $1,993,481
(2004 -
$nil)
|
32,560,185
|
34,553,666
|
-
|
|||||||
Other
licenses - net of accumulated amortization of $9,546 (2004 - $7,984;
2003
- $5,900)
|
15,454
|
17,016
|
19,100
|
|||||||
32,575,639
|
34,570,682
|
19,100
|
·
|
On
May 1, 2002, the Company entered into an agreement with the Governors
of
the University of Alberta, under which the Company acquired an exclusive
world-wide license encompassed by a patent issued January 2, 2001
and
patent applications filed June 7, 1995 and September 22, 2000, related
to
“Methods of Eliciting a Th1 Specific Immune Response”. Under this
agreement the following milestone payments are due to the University
of
Alberta:
|
(a)
|
CDN
$100,000 is due after enrollment of the first patient for a Phase
II
clinical trial of a licensed product
candidate;
|
(b)
|
CDN$
150,000 is due after enrollment of the first patient for a Phase
III
clinical trial of a licensed product
candidate;
|
(c)
|
CDN$250,000
is due after the first marketing approval for a licensed product
by the US
Food and Drug Administration.
|
(a)
|
1.0%
of net sales of licensed products sold in the US by the Company or
Sublicensees or by both;
|
(b)
|
0.5%
of net sales of licensed products sold in countries other than the
US by
Company or Sublicensees or by both.
|
(a)
|
5%
of all sublicense revenues if such sublicense is granted in conjunction
with the Company’s proprietary
components;
|
(b)
|
50%
of all sublicense revenues if such sublicense is granted less than
1 year
after the effective date of the agreement and such license transaction
does not include the Company’s proprietary
components;
|
(c)
|
30%
of all sublicense revenues if such sublicense transaction does not
include
the Company’s proprietary components and the Company spends at least 1
year but less than 2 years after the effective date of the agreement
developing the licensed technology;
|
(d)
|
15%
of all sublicense revenues if such sublicense transaction does not
include
the Company’s proprietary components and the Company spends at least 2
years or longer after the effective date of the agreement developing
the
licensed technology;
|
·
|
On
November 1, 2001, the Company entered into an agreement with The
Governors
of the University of Alberta, under which the Company acquired worldwide
rights to certain cloned and purified antigens, certain antibody
clones
and an animal model for Duck Hepatitis B. The Company shall pay to
the
University one milestone payment of $250,000 CAD upon commencement
of
Phase III clinical trials for each product candidate that usies the
cloned
and purified antigens or antibody clones. The University of Alberta
will
receive a 1% royalty on worldwide net sales from products derived
from
these antigens or antibodies. Under this agreement, the University
of
Alberta is entitled to stock options when the Company completes a
round of
financing during the first three years of the agreement term. These
options shall provide to the University the right to acquire a number
of
common shares of the Company equal to 5% of available
options.
|
7
|
Related
party transactions and
balances
|
8
|
Convertible
debentures
|
September
30,
2005
$
(Unaudited)
|
December
31,
2004
$
|
December
31,
2003
$
|
||||||||
U.S.
dollar convertible debenture
|
-
|
502,215
|
-
|
|||||||
Canadian
dollar convertible debentures
|
175,000
|
450,000
|
450,000
|
|||||||
Equity
component of convertible debentures
|
(22,990
|
)
|
(59,118
|
)
|
(59,118
|
)
|
||||
Unpaid
interest
|
82,120
|
144,009
|
89,483
|
|||||||
234,130
|
1,037,106
|
480,365
|
9
|
Commitments
and contingencies
|
$ | |||||||
2005
|
109,263
|
||||||
2006
|
109,263
|
||||||
2007
|
113,126
|
||||||
2008
|
115,885
|
||||||
2009
|
115,885
|
||||||
Thereafter
|
164,170
|
||||||
727,592
|
10
|
Government
assistance and research and development
projects
|
11
|
Research
and development projects
|
·
|
OvaRex®
MAb is a murine monoclonal antibody that has a high degree of specificity
to a tumour associated antigen that is over-expressed by the majority
of
late stage ovarian cancer patients. The Company believes that the
product
acts as a immunotherapeutic agent by inducing and/or amplifying the
human
body’s immune response against ovarian cancer. All development costs for
OvaRex®
MAb are borne by United Therapeutics pursuant to the license agreement
described in note 6.
|
·
|
The
Company’s T-ACT™ technology platform is a novel and proprietary targeted
tumor starvation technology platform which has the potential to produce
a
wide range of products that stop the flow of blood to solid tumors,
both
malignant (cancer) and non-malignant
(benign).
|
·
|
The
Chimigen™ technology platform encompasses a molecular design recognizable
by the body’s immune system to break tolerance by mounting a humoral
(antibody) as well as a highly desirable cellular response to clear
the
virus that is responsible for the chronic
infection.
|
Nine-month
periods ended
September
30,
|
Years
ended December 31,
|
|||||||||||||||
2005
$
(Unaudited)
|
2004
$
(Unaudited)
|
2004
$
|
2003
$
|
2002
$
|
||||||||||||
T-ACT™
|
810,021
|
596,226
|
410,018
|
426,024
|
367,534
|
|||||||||||
Chimigen™
|
2,203,099
|
1,126,467
|
2,251,092
|
563,304
|
371,268
|
|||||||||||
OvaRex®
MAb
|
311,030
|
-
|
-
|
-
|
-
|
|||||||||||
Gross
research and development
|
3,324,150
|
1,722,693
|
2,661,110
|
989,328
|
738,802
|
|||||||||||
Government
grants
|
(45,000
|
)
|
(544,430
|
)
|
(864,430
|
)
|
(154,780
|
)
|
(80,750
|
)
|
||||||
Tax
credits
|
-
|
-
|
-
|
(451,475
|
)
|
(386,414
|
)
|
|||||||||
Net
research and development
|
3,279,150
|
1,178,263
|
1,796,680
|
383,073
|
271,638
|
12
|
Share
capital
|
September
30, 2005
(Unaudited)
|
December
31, 2004
|
December
31, 2003
|
|||||||||||||||||
Stock
options
#
|
Weighted
average
Exercise
price
$
|
Stock
options
#
|
Weighted
average
Exercise
price
$
|
Stock
options
#
|
Weighted
average
Exercise
price
$
|
||||||||||||||
|
|||||||||||||||||||
Outstanding
-
Beginning of period |
6,369,168
|
0.84
|
2,103,218
|
0.80
|
685,000
|
0.50
|
|||||||||||||
Granted
|
80,000
|
1.42
|
4,564,168
|
0.85
|
2,403,218
|
0.70
|
|||||||||||||
Exercised
|
(150,218
|
)
|
0.82
|
(13,218
|
)
|
0.80
|
(300,000
|
)
|
0.001
|
||||||||||
Expired
|
(178,750
|
)
|
3.90
|
(285,000
|
)
|
0.80
|
(685,000
|
)
|
0.50
|
||||||||||
Outstanding
-
End of period |
6,120,200
|
0.75
|
6,369,168
|
0.84
|
2,103,218
|
0.80
|
|||||||||||||
Exercisable
-
End of period |
5,310,500
|
0.64
|
5,121,968
|
0.83
|
2,103,218
|
0.80
|
September
30, 2005
(Unaudited)
|
|||||||||||||
Outstanding
|
|
Exercisable
|
|||||||||||
Exercise
price
$
|
Number
of
shares
#
|
Average
expiration
life
(years)
|
|
Number
of
shares
#
|
|||||||||
|
|||||||||||||
0.48
|
1,675,000
|
7.63
|
1,675,000
|
||||||||||
0.76
|
50,000
|
7.75
|
50,000
|
||||||||||
0.80
|
2,933,000
|
2.96
|
2,673,000
|
||||||||||
0.86
|
425,000
|
5.35
|
425,000
|
||||||||||
0.90
|
697,200
|
9.21
|
205,000
|
||||||||||
0.94
|
240,000
|
4.47
|
202,500
|
||||||||||
1.39
|
50,000
|
1.33
|
50,000
|
||||||||||
1.46
|
30,000
|
-
|
10,000
|
||||||||||
3.90
|
10,000
|
5.53
|
10,000
|
||||||||||
6.26
|
10,000
|
5.65
|
10,000
|
||||||||||
6,120,200
|
5,310,500
|
December
31, 2004
|
|||||||||||||
Outstanding
|
Exercisable
|
||||||||||||
Exercise
price
$
|
Number
of
shares
#
|
Average
expiration
life
(years)
|
Number
of
shares
#
|
||||||||||
0.48
|
1,675,000
|
8.38
|
1,675,000
|
||||||||||
0.76
|
50,000
|
7.55
|
50,000
|
||||||||||
0.80
|
3,070,000
|
3.71
|
2,465,000
|
||||||||||
0.86
|
575,000
|
6.16
|
575,000
|
||||||||||
0.90
|
697,200
|
9.96
|
205,000
|
||||||||||
0.94
|
240,000
|
5.22
|
90,000
|
||||||||||
1.03
|
13,218
|
0.33
|
13,218
|
||||||||||
3.90
|
10,000
|
6.28
|
10,000
|
||||||||||
6.26
|
10,000
|
6.40
|
10,000
|
||||||||||
11.20
|
3,125
|
3.55
|
3,125
|
||||||||||
11.92
|
12,500
|
5.13
|
12,500
|
||||||||||
26.40
|
625
|
2.85
|
625
|
||||||||||
29.44
|
12,500
|
2.52
|
12,500
|
||||||||||
6,369,168
|
5,121,968
|
December
31, 2003
|
|||||||||||||
Outstanding
|
|
Exercisable
|
|||||||||||
Exercise
price
$
|
Number
of
shares
#
|
Average
expiration
life
(years)
|
Number
of
shares
#
|
||||||||||
0.80
|
2,103,218
|
4.71
|
2,103,218
|
September
30,
2005
(Unaudited)
|
December
31,
2004
|
December
31,
2003
|
||||
Expected
life
|
4
years
|
5
years
|
5
years
|
|||
Risk-free
rate
|
3.55%
|
|
4.0%
|
3.9%
|
||
Expected
volatility
|
84.2%
|
77.2%
|
51.0%
|
|||
Expected
dividend yield
|
0.0%
|
0.0%
|
0.0%
|
|||
$
|
$
|
$
|
||||
Weighted
average fair value of options granted
|
0.80
|
0.54
|
0.39
|
September
30, 2005
(Unaudited)
|
|||||||||||||||||||
Expiry
date
|
Exercise
price
$
|
Opening
#
|
Granted
#
|
Exercised
#
|
Cancelled
#
|
Closing
#
|
|||||||||||||
April
14, 2005
|
0.80
|
1,100,000
|
-
|
(1,100,000
|
)
|
-
|
-
|
||||||||||||
June
23, 2005
|
0.80
|
500,000
|
-
|
(500,000
|
)
|
-
|
-
|
||||||||||||
October
14, 2005
|
1.00
|
5,086,595
|
-
|
(189,000
|
)
|
-
|
4,897,595
|
||||||||||||
October
14, 2005
|
1.00
|
5,496,500
|
-
|
(277,875
|
)
|
-
|
5,218,625
|
||||||||||||
November
26, 2006
|
4.00
|
360,000
|
-
|
-
|
-
|
360,000
|
|||||||||||||
September
9, 2007
|
1.20
|
-
|
2,459,299
|
-
|
-
|
2,459,299
|
|||||||||||||
12,543,095
|
2,459,299
|
(2,066,875
|
)
|
-
|
12,935,519
|
December
31, 2004
|
|||||||||||||||||||
Expiry
date
|
Exercise
price
$
|
Opening
#
|
Granted
#
|
Exercised
#
|
Cancelled
#
|
Closing
#
|
|||||||||||||
April
14, 2005
|
0.80
|
-
|
1,100,000
|
-
|
-
|
1,100,000
|
|||||||||||||
June
23, 2005
|
0.80
|
500,000
|
-
|
-
|
-
|
500,000
|
|||||||||||||
July
7, 2005
|
1.00
|
5,000,000
|
318,595
|
(2,000
|
)
|
(230,000
|
)
|
5,086,595
|
|||||||||||
October
14, 2005
|
1.00
|
-
|
5,500,000
|
(3,500
|
)
|
-
|
5,496,500
|
||||||||||||
November
26, 2006
|
4.00
|
-
|
360,000
|
-
|
-
|
360,000
|
|||||||||||||
5,500,000
|
7,278,595
|
(5,500
|
)
|
(230,000
|
)
|
12,543,095
|
December
31, 2003
|
|||||||||||||||||||
Exercise
price
$
|
Opening
#
|
Granted
#
|
Exercised
#
|
Cancelled
#
|
Closing
#
|
||||||||||||||
June
23, 2005
|
0.80
|
-
|
500,000
|
-
|
-
|
500,000
|
|||||||||||||
July
7, 2005
|
1.00
|
-
|
5,000,000
|
-
|
-
|
5,000,000
|
|||||||||||||
|
|
-
|
5,500,000
|
-
|
-
|
5,500,000
|
Nine-month
periods ended
September
30,
|
Years
ended December 31,
|
|||||||||||||||
2005
$
(Unaudited)
|
2004
$
(Unaudited)
|
2004
$
|
2003
$
|
|
2002
$
|
|||||||||||
|
||||||||||||||||
Loss
attributable to common shareholders
|
(5,716,701
|
)
|
(2,306,190
|
)
|
(3,657,760
|
)
|
(1,383,562
|
)
|
(1,260,472
|
)
|
||||||
|
#
|
#
|
#
|
#
|
#
|
|||||||||||
Weighted
average number of common shares outstanding
|
54,877,238
|
26,420,165
|
25,268,388
|
9,128,866
|
8,762,781
|
|||||||||||
$
|
|
$
|
$
|
|
$
|
|
$
|
|||||||||
Basic
and diluted loss per share
|
(0.10
|
)
|
(0.09
|
)
|
(0.14
|
)
|
(0.15
|
)
|
(0.14
|
)
|
14
|
Supplementary
cash flow information
|
Nine-month
periods ended
September
30,
|
Years
ended December 31,
|
|||||||||||||||
2005
$
(Unaudited)
|
2004
$
(Unaudited)
|
2004
$
|
2003
$
|
2002
$
|
||||||||||||
Net
change in non-cash working capital items
|
||||||||||||||||
Other
current assets
|
18,527
|
(36,090
|
)
|
42,471
|
(13,460
|
)
|
(37,437
|
)
|
||||||||
Goods
and services tax recoverable
|
49,917
|
34,784
|
(17,422
|
)
|
(27,784
|
)
|
16,685
|
|||||||||
Investment
tax credits recoverable
|
-
|
-
|
447,013
|
(79,659
|
)
|
(17,744
|
)
|
|||||||||
Prepaid
expenses and deposits
|
185,794
|
(54,144
|
)
|
(337,114
|
)
|
1,756
|
(6,383
|
)
|
||||||||
Income
taxes recoverable
|
-
|
-
|
-
|
8,436
|
(8,436
|
)
|
||||||||||
Accounts
payable and accrued liabilities
|
(144,987
|
)
|
(1,043,643
|
)
|
(481,052
|
)
|
587,370
|
56,902
|
||||||||
Income
taxes payable
|
-
|
-
|
-
|
-
|
(642
|
)
|
||||||||||
90,724
|
(1,063,003
|
)
|
(388,575
|
)
|
490,119
|
40,382
|
Nine-month
periods ended
September
30,
|
|
Years
ended December 31,
|
||||||||||||||
2005
$
(Unaudited)
|
2004
$
(Unaudited)
|
2004
$
|
2003
$
|
2002
$
|
||||||||||||
Income
taxes paid
|
-
|
-
|
-
|
-
|
-
|
|||||||||||
Interest
paid
|
47,359
|
3,667
|
3,667
|
-
|
-
|
|||||||||||
Interest
received
|
169,729
|
76,382
|
127,728
|
7,497
|
-
|
15
|
Financial
instruments
|
16
|
United
States Accounting
principles
|
September
30,
2005
$
(Unaudited)
|
December
31,
2004
$
|
December
31,
2003
$
|
||||||||
Assets
|
||||||||||
Current
assets
|
8,818,721
|
10,618,561
|
3,306,383
|
|||||||
Property
and equipment
|
561,869
|
533,202
|
173,800
|
|||||||
Total
assets
|
9,380,590
|
11,151,763
|
3,480,183
|
$ |
$
|
$
|
||||||||
Liabilities
|
||||||||||
Current
liabilities
|
599,818
|
744,805
|
1,131,154
|
|||||||
Other
long-term liabilities
|
-
|
-
|
35,341
|
|||||||
Convertible
debentures
|
257,120
|
1,096,224
|
539,483
|
|||||||
Total
liabilities
|
856,938
|
1,841,029
|
1,705,978
|
|||||||
Shareholders’
equity
|
||||||||||
Common
stock
|
45,815,642
|
41,754,983
|
5,603,667
|
|||||||
Contributed
surplus
|
4,937,684
|
3,663,415
|
1,061,433
|
|||||||
Deficit
accumulated during development stage
|
(42,229,674
|
)
|
(36,107,664
|
)
|
(4,890,895
|
)
|
||||
Total
shareholders’ equity
|
8,523,652
|
9,310,734
|
1,774,205
|
|||||||
Total
liabilities and shareholders’ equity
|
9,380,590
|
11,151,763
|
3,480,183
|
Nine-month
period
ended
September
30,
|
|
Years
ended December 31,
|
|||||||||||
2005
$
|
2004
$
|
2003
$
|
2002
$
|
||||||||||
Net
loss in accordance with Canadian GAAP
|
(5,716,701
|
)
|
(3,657,760
|
)
|
(1,383,562
|
)
|
(1,260,472
|
)
|
|||||
Adjustments
to reconcile to U.S. GAAP
|
|||||||||||||
Acquired
intellectual property rights
|
-
|
(34,311,040
|
)
|
(74,824
|
)
|
(94,633
|
)
|
||||||
Acquired
intellectual rights amortization
|
1,995,043
|
2,084
|
2,083
|
2,081
|
|||||||||
Future
income taxes
|
(1,941,690
|
)
|
6,749,947
|
-
|
-
|
||||||||
Stock-based
compensation
|
-
|
-
|
(734,773
|
)
|
(36,510
|
)
|
|||||||
Net
loss and comprehensive loss in accordance with U.S. GAAP
|
(5,663,348
|
)
|
(31,216,769
|
)
|
(2,191,076
|
)
|
(1,389,534
|
)
|
|||||
$
|
|
$
|
$
|
|
$
|
||||||||
Net
loss per share of common stock - basic and diluted
|
(0.10
|
)
|
(1.24
|
)
|
(0.24
|
)
|
(0.16
|
)
|
|||||
|
#
|
#
|
#
|
#
|
|||||||||
Weighted-average
number of shares of common stock outstanding - basic and
diluted
|
54,877,238
|
25,268,388
|
9,128,866
|
8,762,781
|