suppl
Filed
pursuant to General Instruction II.L. of
Form F-10;
File
No. 333-151513
Prospectus
Supplement
(To a Short Form Base Shelf Prospectus Dated June 16,
2008)
No securities regulatory authority has expressed an opinion
about these securities and it is an offence to claim
otherwise.
This prospectus supplement, together with the short form base
shelf prospectus dated June 16, 2008 to which it relates,
as amended or supplemented, and each document deemed to be
incorporated by reference into the short form base shelf
prospectus, constitutes a public offering of these securities
only in those jurisdictions where they may be lawfully offered
for sale and therein only by persons permitted to sell such
securities.
Information has been incorporated by reference in this
prospectus supplement and the accompanying short form base shelf
prospectus from documents filed with securities commissions or
similar authorities in Canada. Copies of the
documents incorporated by reference in this prospectus
supplement and the short form base shelf prospectus may be
obtained on request without charge from the Corporate Secretary
of Oncolytics Biotech Inc. at 210, 1167 Kensington Crescent
N.W., Calgary, Alberta T2N 1X7, telephone
(403) 670-7377,
and are also available electronically at www.sedar.com. See
Documents Incorporated by Reference.
3,450,000 Common
Shares
This prospectus supplement relates to the issuance of:
(i) up to 3,000,000 of our common shares (the
Common Shares), issuable from time to time,
on exercise of up to 3,000,000 common share purchase warrants
(expected to be issued by us on or about May 13, 2009
pursuant to the Unit Offering (as described below), (ii) up
to 450,000 Common Shares issuable from time to time, on exercise
of 450,000 common share purchase warrants that may be issued on
the exercise of the over-allotment option granted to the
underwriter pursuant to the Unit Offering; and (iii) such
indeterminate number of additional Common Shares that may be
issuable by reason of the anti-dilution provisions contained in
the Warrant Indenture (as defined herein). See Terms of
Warrants.
On May 6, 2009, we filed a prospectus supplement to a short
form base shelf prospectus dated June 16, 2008 with the
securities commissions in the provinces of British Columbia,
Alberta, Manitoba and Ontario and a registration statement on
Form F-10
(File
No. 333-151513),
principally filed on June 6, 2008, as amended June 17,
2008, with the United States Securities and Exchange Commission
(the SEC) relating to the offering (the
Unit Offering) by us in the provinces of
British Columbia, Alberta, Manitoba and Ontario of up to
3,450,000 units of the Corporation (the
Units), each Unit consisting of one Common
Share and one common share purchase warrant (the
Warrants). Each Warrant will entitle the
holder to purchase one Common Share upon payment of Cdn.$2.40,
subject to adjustment, at any time until 4:30 p.m. (Calgary
time) on the date that is 36 months from the date of the
closing of the Unit Offering. If on any date (the
Accelerated Exercise Date) the
10-day
volume weighted average trading price of the Common Shares on
the Toronto Stock Exchange (TSX) exceeds
$3.35 per share, then, at our sole discretion, and upon us
sending the holders of Warrants written notice of such
Accelerated Exercise Date and issuing a news release announcing
such Accelerated Exercise Date, the Warrants shall only be
exercisable for a period of 30 days following the later of
the date on which such written notice is sent to holders of
Warrants and the date on which such announcement is made by news
release. The exercise price of the Warrants was determined by
negotiation between us and the underwriter for the Unit
Offering. See Plan of Distribution.
Our outstanding Common Shares are listed for trading on the TSX
under the trading symbol ONC and on the NASDAQ
Capital Market (the NASDAQ) under the trading
symbol ONCY. The TSX has conditionally approved the
listing of the Common Shares issuable on the exercise of the
Warrants. Listing for the Common Shares issuable on the exercise
of the Warrants is subject to us fulfilling all of the
requirements of the TSX on or before August 4, 2009.
Pursuant to its procedure, the NASDAQ has confirmed that it will
not be objecting to the additional listing of the Common Shares
issuable upon exercise of the Warrants.
Investing in the Common Shares involves risks that are
described in the Risk Factors section beginning on
page S-20
of this prospectus supplement and page 4 of the
accompanying short form base shelf prospectus.
This prospectus supplement registers the offering of the
securities to which it relates under the United States
Securities Act of 1933, as amended (the
U.S. Securities Act), in accordance with
the multi-jurisdictional disclosure system adopted by the SEC.
This prospectus supplement does not qualify the distribution of
Common Shares in any province or territory of Canada.
NEITHER THE SEC NOR ANY STATE SECURITIES COMMISSION HAS
APPROVED OR DISAPPROVED THESE SECURITIES OR DETERMINED IF THIS
PROSPECTUS SUPPLEMENT OR THE ACCOMPANYING SHORT FORM BASE
SHELF PROSPECTUS IS TRUTHFUL OR COMPLETE. ANY REPRESENTATION TO
THE CONTRARY IS A CRIMINAL OFFENSE.
We are permitted, under a multi-jurisdictional disclosure
system adopted by the United States, to prepare this prospectus
supplement and the accompanying short form base shelf prospectus
in accordance with Canadian disclosure requirements. You should
be aware that such requirements are different from those of the
United States. We have prepared our financial statements
included or incorporated herein by reference in accordance with
Canadian generally accepted accounting principles, and they are
subject to Canadian auditing and auditor independence standards.
Thus, they may not be comparable to the financial statements of
United States companies. Information regarding the impact upon
our financial statements of significant differences between
Canadian and United States generally accepted accounting
principles is contained in the notes to our audited financial
statements and in our Current Report on
Form 6-K
dated May 5, 2009, both of which are incorporated by
reference in this prospectus supplement and the accompanying
short form base shelf prospectus.
You should be aware that the purchase of Common Shares may
have tax consequences both in the United States and Canada. This
prospectus supplement and the accompanying short form base shelf
prospectus may not describe these tax consequences fully. You
should read the tax discussion in this prospectus supplement and
the accompanying short form base shelf prospectus. See
Canadian Federal Income Tax Considerations and
Certain United States Federal Income Tax
Considerations in this prospectus supplement and the
accompanying short form base shelf prospectus.
Your ability to enforce civil liabilities under United States
federal securities laws may be affected adversely by the fact
that we are incorporated under the laws of Canada, the majority
of our officers and directors and some of the experts named in
this prospectus supplement and the accompanying short form base
shelf prospectus are residents of Canada, and a substantial
portion of our assets and the assets of such persons are located
outside the United States.
Our head office and principal place of business is located at
210, 1167 Kensington Crescent N.W., Calgary, Alberta, T2N 1X7.
Our registered office is located at 4500 Bankers Hall East,
855 2nd Street S.W., Calgary, Alberta, T2P 4K7.
TABLE OF
CONTENTS
|
|
|
|
|
|
|
Page
|
|
|
|
|
S-1
|
|
|
|
|
S-1
|
|
|
|
|
S-2
|
|
|
|
|
S-2
|
|
|
|
|
S-4
|
|
|
|
|
S-4
|
|
|
|
|
S-4
|
|
|
|
|
S-6
|
|
|
|
|
S-6
|
|
|
|
|
S-6
|
|
|
|
|
S-6
|
|
|
|
|
S-7
|
|
|
|
|
S-7
|
|
|
|
|
S-8
|
|
|
|
|
S-9
|
|
|
|
|
S-12
|
|
|
|
|
S-20
|
|
|
|
|
S-20
|
|
IMPORTANT
NOTICE ABOUT THE INFORMATION
IN THIS PROSPECTUS SUPPLEMENT
This document is in two parts. The first part is this prospectus
supplement, which describes the specific terms of the Common
Shares being offered and also adds to and updates information
contained in the accompanying short form base shelf prospectus.
The second part, the accompanying short form base shelf
prospectus, gives more general information, some of which may
not apply to the Common Shares being offered under this
prospectus supplement.
You should rely only on the information contained in or
incorporated by reference in this prospectus supplement and the
accompanying short form base shelf prospectus. If the
description of the Common Shares varies between this prospectus
supplement and the accompanying short form base shelf
prospectus, you should rely on the information in this
prospectus supplement. We have not authorized anyone to provide
you with different or additional information. We are not making
an offer of the Common Shares in any jurisdiction where the
offer is not permitted by law. If anyone provides you with any
different or inconsistent information, you should not rely on
it. You should not assume that the information contained in or
incorporated by reference in this prospectus supplement or the
accompanying short form base shelf prospectus is accurate as of
any date other than the date on the front of this prospectus
supplement.
DEFINITIONS
AND OTHER MATTERS
In this prospectus supplement and in the accompanying short form
base shelf prospectus, unless otherwise indicated, references to
we, us, our,
Oncolytics or the Corporation are to
Oncolytics Biotech Inc.
and/or its
subsidiary corporations, as applicable. All references to
dollars, Cdn.$ or $ are to
Canadian dollars and all references to U.S.$ are to
United States dollars.
We prepare our financial statements in accordance with Canadian
generally accepted accounting principles (Canadian
GAAP), which differ from United States generally
accepted accounting principles
(U.S. GAAP).
S-1
Therefore, our consolidated financial statements incorporated by
reference in this prospectus supplement and in the accompanying
short form base shelf prospectus and in the documents
incorporated by reference in this prospectus supplement and in
the accompanying short form base shelf prospectus may not be
comparable to consolidated financial statements prepared in
accordance with U.S. GAAP. You should refer to Note 22
of our consolidated financial statements for the year ended
December 31, 2008 for a discussion of the principal
differences between our financial results determined under
Canadian GAAP and under U.S. GAAP. For our consolidated
financial statements as at and for the three months ended
March 31, 2009, you should refer to our reconciliation of
our consolidated financial statements as at and for the three
months ended March 31, 2009 to U.S. GAAP furnished to
the SEC on the Corporations Current Report on
Form 6-K
dated May 5, 2009 and incorporated into this prospectus
supplement by reference. See Documents Incorporated by
Reference.
This prospectus supplement is deemed to be incorporated by
reference into the accompanying short form base shelf prospectus
solely for the purposes of the offering of the Common Shares.
Other documents are also incorporated or deemed to be
incorporated by reference into this prospectus supplement and
into the accompanying short form base shelf prospectus. See
Documents Incorporated by Reference in this
prospectus supplement.
SPECIAL
NOTICE REGARDING FORWARD-LOOKING STATEMENTS
Some of the statements that we make contain forward-looking
statements reflecting our current beliefs, plans, estimates and
expectations. Readers are cautioned that these forward-looking
statements involve risks and uncertainties, including, without
limitation, clinical trial study delays, product development
delays, our ability to attract and retain business partners,
future levels of government funding, competition from other
biotechnology companies and our ability to obtain the capital
required for research, product development, operations and
marketing. These factors should be carefully considered and
readers should not place undue reliance on our forward-looking
statements. Actual events may differ materially from our current
expectations due to risks and uncertainties.
Our statements of belief, estimates,
expectations and other similar statements are based
primarily upon our results derived to date from our research and
development program with animals and early stage human results
and upon which we believe we have a reasonable scientific basis
to expect the particular results to occur. It is not possible to
predict, based upon studies in animals or early stage human
results, whether a new therapeutic will be proved to be safe and
effective in humans. There can be no assurance that the
particular result expected by us will occur. Except as required
by applicable securities laws, we undertake no obligation to
update publicly any forward-looking statements for any reason
after the date of this prospectus supplement or to conform these
statements to actual results or to changes in our expectations.
DOCUMENTS
INCORPORATED BY REFERENCE
This prospectus supplement is deemed to be incorporated by
reference into the accompanying short form base shelf prospectus
solely for the purposes of the offering of the Common Shares.
Other information has also been incorporated by reference in
the accompanying base shelf prospectus from documents filed with
securities commissions or similar authorities in certain of the
provinces of Canada. Copies of the documents incorporated
herein by reference may be obtained on request without charge
from our Corporate Secretary at 210, 1167 Kensington Crescent
N.W., Calgary, Alberta, T2N 1X7 telephone
(403) 670-7377,
and are available electronically at www.sedar.com.
We have filed the following documents with the securities
commissions or similar regulatory authorities in certain of the
provinces of Canada and such documents are specifically
incorporated by reference in and form an integral part of the
accompanying base shelf prospectus and this prospectus
supplement:
|
|
|
|
|
our Annual Information Form, which is comprised of our Annual
Report on
Form 20-F
dated March 6, 2009, for the year ended December 31,
2008 (the AIF);
|
|
|
|
our Management Proxy Circular dated March 20, 2008 relating
to the annual and special meeting of shareholders held on
May 7, 2008;
|
S-2
|
|
|
|
|
our Management Proxy Circular dated March 18, 2009 relating
to the annual and special meeting of shareholders held on
May 5, 2009;
|
|
|
|
our audited consolidated financial statements, together with the
notes thereto, as at December 31, 2008 and 2007 and for
each of the years in the three year period ended
December 31, 2008 and for the cumulative period from
inception on April 2, 1998 and the auditors report
thereon addressed to our shareholders;
|
|
|
|
our managements discussion and analysis of financial
condition and results of operations dated March 4, 2009,
for the year ended December 31, 2008;
|
|
|
|
our unaudited interim consolidated financial statements,
together with the notes thereto, as at and for the three months
ended March 31, 2009;
|
|
|
|
our managements discussion and analysis of financial
condition and results of operations dated May 5, 2009, for
the three months ended March 31, 2009;
|
|
|
|
the reconciliation of our unaudited interim consolidated
financial statements as at and for the three months ended
March 31, 2009 to U.S. GAAP, filed on May 5, 2009
under the heading Other; and
|
|
|
|
our material change report dated March 5, 2009 relating to
the acquisition of all the issued and outstanding shares of a
private company.
|
Any documents of the type required by Section 11.1 of
Form 44-101F1
Short Form Prospectus promulgated under National
Instrument
44-101
Short Form Prospectus Distributions of the Canadian
Securities Administrators to be incorporated by reference in a
short form prospectus, including, without limitation, any annual
information form, comparative annual financial statements and
the auditors report thereon, comparative interim financial
statements, managements discussion and analysis of
financial condition and results of operations, material change
report (except a confidential material change report), business
acquisition report and information circular, if filed by us with
the securities commissions or similar authorities in the
provinces of British Columbia, Alberta, Manitoba and Ontario
after the date of this prospectus supplement and prior to the
termination of the distribution of the Common Shares under this
prospectus supplement shall be deemed to be incorporated by
reference in the accompanying base shelf prospectus for the
purposes of the offering of the Common Shares issuable from time
to time on the exercise of the Warrants.
Any report filed by us with the SEC pursuant to
section 13(a), 13(c), 14 or 15(d) of the United States
Securities Exchange Act of 1934, as amended, after the date of
this prospectus supplement shall be deemed to be incorporated by
reference into the registration statement of which this
prospectus supplement forms a part, if and to the extent
expressly provided in such report.
Any statement contained in the accompanying base shelf
prospectus, in this prospectus supplement or in a document
incorporated or deemed to be incorporated by reference in the
accompanying base shelf prospectus will be deemed to be modified
or superseded for purposes of this prospectus supplement to the
extent that a statement contained in this prospectus supplement
or in any other subsequently filed document which also is, or is
deemed to be, incorporated by reference into the accompanying
base shelf prospectus modifies or supersedes that statement. The
modifying or superseding statement need not state that it has
modified or superseded a prior statement or include any other
information set forth in the document that it modifies or
supersedes. The making of a modifying or superseding statement
shall not be deemed an admission for any purposes that the
modified or superseded statement when made, constituted a
misrepresentation, an untrue statement of a material fact or an
omission to state a material fact that is required to be stated
or that is necessary to make a statement not misleading in light
of the circumstances in which it was made. Any statement so
modified or superseded shall not be deemed, except as so
modified or superseded, to constitute part of this prospectus
supplement or the accompanying base shelf prospectus.
Upon a new annual information form and related audited annual
financial statements and managements discussion and
analysis being filed by us with, and where required, accepted
by, the securities commission or similar regulatory authority in
each of the provinces of British Columbia, Alberta, Manitoba and
Ontario during the term of this prospectus supplement, the
previous annual information form, the previous audited annual
consolidated financial statements and related managements
discussion and analysis, all unaudited interim consolidated
financial
S-3
statements and related managements discussion and
analysis, material change reports and business acquisition
reports filed prior to the commencement of our financial year in
which the new annual information form and related audited annual
consolidated financial statements and managements
discussion and analysis are filed shall be deemed no longer to
be incorporated into the accompanying base shelf prospectus for
purposes of future offers and sales of Common Shares under this
prospectus supplement. Upon new interim consolidated financial
statements and related managements discussion and analysis
being filed by us with the securities commission or similar
regulatory authority in each of the provinces of British
Columbia, Alberta, Manitoba and Ontario during the term of this
prospectus supplement, all interim consolidated financial
statements and related managements discussion and analysis
filed prior to the new interim consolidated financial statements
and related managements discussion and analysis shall be
deemed no longer to be incorporated into the accompanying base
shelf prospectus for purposes of future offers and sales of
Common Shares under this prospectus supplement. Upon a new
information circular relating to an annual meeting of holders of
Common Shares being filed by us with the securities commission
or similar regulatory authority in each of the provinces of
British Columbia, Alberta, Manitoba and Ontario during the term
of this prospectus supplement, the information circular for the
preceding annual meeting of holders of Common Shares shall be
deemed no longer to be incorporated into the accompanying base
shelf prospectus for purposes of future offers and sales of
Common Shares under this prospectus supplement.
DOCUMENTS
FILED AS PART OF THE REGISTRATION STATEMENT
The following documents have been filed with the SEC as part of
the registration statement on
Form F-10
(File
No. 333-151513)
of which this prospectus supplement forms a part: the documents
referred to under Documents Incorporated by
Reference, consent of Ernst & Young LLP, consent
of Bennett Jones LLP, and powers of attorney from our directors
and officers.
The Warrant Indenture for the Warrants has been or will be filed
with the SEC as part of the registration statement on
Form F-10
(File
No. 333-151513).
ONCOLYTICS
BIOTECH INC.
Oncolytics Biotech Inc. was incorporated pursuant to the
provisions of the Business Corporations Act (Alberta) on
April 2, 1998 as 779738 Alberta Ltd. On April 8, 1998,
we amended our articles and changed our name to Oncolytics
Biotech Inc. On July 29, 1999, we further amended our
articles by removing the private company restrictions and
subdividing our 2,222,222 Common Shares issued and outstanding
into 6,750,000 Common Shares. On February 9, 2007, we
further amended our articles to permit for our shareholder
meetings to be held at any place in Alberta or at any other
location as determined by our directors.
Our head office and principal place of business is located at
210, 1167 Kensington Crescent N.W., Calgary, Alberta T2N 1X7.
Our registered office is located at 4500 Bankers Hall East, 855
- 2nd Street S.W., Calgary, Alberta T2P 4K7.
We have three direct wholly-owned subsidiaries: Oncolytics
Biotech (Barbados) Inc. (Oncolytics
Barbados), which is incorporated pursuant to the laws
of Barbados; Valens Pharma Ltd., which is incorporated pursuant
to the laws of the Province of Alberta; 145302 Alberta Ltd.,
which is incorporated pursuant to the laws of the Province of
Alberta; and one indirect wholly-owned subsidiary, Oncolytics
Biotech (U.S.), Inc., which is incorporated pursuant to the laws
of Delaware.
OUR
BUSINESS
We focus on the discovery and development of oncolytic viruses
for the treatment of cancers that have not been successfully
treated with conventional therapeutics. Recent scientific
advances in oncology, virology, and molecular biology have
created opportunities for new approaches to the treatment of
cancer. The product we are presently developing may represent a
novel treatment for Ras-mediated cancers which can be used as an
alternative to existing cytotoxic or cytostatic therapies or as
an adjuvant therapy to conventional chemotherapy, radiation
therapy,
S-4
or surgical resections. It could also potentially be used to
treat certain cellular proliferative disorders for which no
current therapy exists.
Our technologies are based primarily on discoveries in the
Department of Microbiology and Infectious Diseases at the
University of Calgary in the 1990s. Oncolytics was formed in
1998 to explore the natural oncolytic capability of the
reovirus, a virus that preferentially replicates in cells with
an activated Ras pathway.
The lead product being developed by us may represent a novel
treatment for certain tumour types and some cellular
proliferative disorders. Our lead product is a virus that is
able to replicate specifically in, and hence kill, certain
tumour cells both in tissue culture as well as in a number of
animal models without damaging normal cells.
Our potential product for human use,
REOLYSIN®,
is developed from the reovirus. This virus has been demonstrated
to replicate specifically in tumour cells bearing an activated
Ras pathway. Activating mutations of Ras occur in approximately
thirty per cent of all human tumours directly, but considering
its central role in signal transduction, activation of the Ras
pathway has been shown to play a role in approximately
two-thirds of all tumours.
The functionality of
REOLYSIN®
is based upon the finding that tumours bearing an activated Ras
pathway are deficient in their ability to activate the
anti-viral response mediated by the host cellular protein,
Protein Kinase R (PKR). Since PKR is
responsible for preventing reovirus replication, tumour cells
lacking the activity of PKR are susceptible to reovirus
infections. As normal cells do not possess Ras activations,
these cells are able to thwart reovirus infections by the
activity of PKR. In a tumour cell with an activated Ras pathway,
reovirus is able to freely replicate and hence kill the host
tumour cell. The result of this replication is progeny viruses
that are then free to infect surrounding cancer cells. This
cycle of infection, replication and cell death is believed to be
repeated until there are no longer any tumour cells carrying an
activated Ras pathway available.
The following schematic illustrates the molecular basis of how
the reovirus kills cancer cells.
For both non-cancer cells and cancer cells with an activated Ras
pathway, virus binding, entry, and production of viral genes all
proceed normally. In the case of normal cells however, the viral
genes cause the activation of the anti-viral response that is
mediated by the host cells PKR, thus blocking the
replication of the reovirus. In cells with an activated Ras
pathway, the activation of PKR is prevented or reversed by an
element of the Ras signal transduction pathway, thereby allowing
the replication of the reovirus in these cancer cells. The end
result of this replication is the death of the cancer cell. The
action of the Ras pathway in allowing reovirus replication to
ensue can be mimicked in non-cancerous cells by treating these
cells with the chemical
2-aminopurine
(2-AP) which
prevents the activation of PKR.
S-5
RECENT
DEVELOPMENTS
On May 6, 2009, we filed a prospectus supplement to the
short form base shelf prospectus dated June 16, 2008 in
respect of the Unit Offering.
CAPITALIZATION
On March 31, 2009 we had 43,855,748 Common Shares issued
and outstanding. On May 12, 2009, we had 45,750,869 Common
Shares issued and outstanding. If all of our stock options and
warrants outstanding as of May 12, 2009 were exercised, we
would have 55,126,862 Common Shares issued and outstanding.
Following the Unit Offering, we will have up to 48,750,869
Common Shares issued and outstanding (up to 61,426,862 Common
Shares on a fully-diluted basis). Following the Unit Offering,
and assuming the over-allotment option granted to the
underwriter pursuant to the Unit Offering is exercised in full,
we will have 49,200,869 Common Shares issued and outstanding
(62,371,862 Common Shares on a fully-diluted basis).
MARKET
FOR SECURITIES
Our outstanding Common Shares are listed and posted for trading
on the TSX under the trading symbol ONC and on
NASDAQ under the trading symbol ONCY. The following
table sets forth the market price ranges and the aggregate
volume of trading of the Common Shares on the TSX and NASDAQ for
the periods indicated:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TSX
|
|
|
NASDAQ
|
|
|
|
High
|
|
|
Low
|
|
|
Close
|
|
|
|
|
|
High
|
|
|
Low
|
|
|
Close
|
|
|
Volume
|
|
|
|
($)
|
|
|
($)
|
|
|
($)
|
|
|
Volume (Shares)
|
|
|
(U.S.$)
|
|
|
(U.S.$)
|
|
|
(U.S.$)
|
|
|
(Shares)
|
|
|
Period
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May
|
|
|
2.18
|
|
|
|
1.60
|
|
|
|
2.15
|
|
|
|
6,682,910
|
|
|
|
2.21
|
|
|
|
1.62
|
|
|
|
2.15
|
|
|
|
897,410
|
|
June
|
|
|
2.40
|
|
|
|
1.85
|
|
|
|
1.98
|
|
|
|
786,060
|
|
|
|
2.39
|
|
|
|
1.84
|
|
|
|
1.95
|
|
|
|
934,260
|
|
July
|
|
|
2.10
|
|
|
|
1.80
|
|
|
|
1.91
|
|
|
|
508,040
|
|
|
|
2.00
|
|
|
|
1.79
|
|
|
|
1.85
|
|
|
|
467,500
|
|
August
|
|
|
2.01
|
|
|
|
1.82
|
|
|
|
1.87
|
|
|
|
333,770
|
|
|
|
1.90
|
|
|
|
1.75
|
|
|
|
1.77
|
|
|
|
297,960
|
|
September
|
|
|
1.94
|
|
|
|
1.40
|
|
|
|
1.57
|
|
|
|
484,830
|
|
|
|
1.80
|
|
|
|
1.32
|
|
|
|
1.50
|
|
|
|
634,990
|
|
October
|
|
|
1.92
|
|
|
|
1.23
|
|
|
|
1.64
|
|
|
|
1,147,860
|
|
|
|
1.54
|
|
|
|
1.00
|
|
|
|
1.39
|
|
|
|
2,045,040
|
|
November
|
|
|
1.90
|
|
|
|
1.35
|
|
|
|
1.44
|
|
|
|
694,411
|
|
|
|
1.64
|
|
|
|
1.12
|
|
|
|
1.17
|
|
|
|
1,106,707
|
|
December
|
|
|
1.79
|
|
|
|
1.26
|
|
|
|
1.49
|
|
|
|
1,086,919
|
|
|
|
1.38
|
|
|
|
1.03
|
|
|
|
1.21
|
|
|
|
1,002,720
|
|
2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
January
|
|
|
1.69
|
|
|
|
1.44
|
|
|
|
1.56
|
|
|
|
475,217
|
|
|
|
1.41
|
|
|
|
1.15
|
|
|
|
1.26
|
|
|
|
605,857
|
|
February
|
|
|
1.95
|
|
|
|
1.46
|
|
|
|
1.67
|
|
|
|
667,374
|
|
|
|
1.60
|
|
|
|
1.18
|
|
|
|
1.30
|
|
|
|
807,838
|
|
March
|
|
|
1.75
|
|
|
|
1.41
|
|
|
|
1.57
|
|
|
|
332,754
|
|
|
|
1.40
|
|
|
|
1.14
|
|
|
|
1.26
|
|
|
|
679,705
|
|
April
|
|
|
2.33
|
|
|
|
1.50
|
|
|
|
2.09
|
|
|
|
1,367,754
|
|
|
|
1.95
|
|
|
|
1.21
|
|
|
|
1.74
|
|
|
|
1,301,319
|
|
May 1-11
|
|
|
2.05
|
|
|
|
1.90
|
|
|
|
2.00
|
|
|
|
408,561
|
|
|
|
1.75
|
|
|
|
1.60
|
|
|
|
1.71
|
|
|
|
301,227
|
|
USE OF
PROCEEDS
From time to time, when the Warrants are exercised, we will
receive proceeds equal to the aggregate exercise price of such
Warrants. Assuming that all of the Warrants are exercised prior
to their expiry time and that no adjustment based on the
anti-dilution provisions contained in the Warrant Indenture has
taken place, the gross proceeds to us from the exercise of the
Warrants will be approximately $8,280,000.
The net proceeds for the exercise of the Warrants will be used
by us for our research and development program, our
manufacturing activities in support of the program and general
corporate purposes.
The principal purposes in the research and development area will
be the advancement of our clinical trial program and the
continued development of our manufacturing process. Our clinical
trial program has been designed
S-6
and directed to test the safety and activity of
REOLYSIN®
either as a mono-therapy or in combination with other approved
chemotherapies.
The net proceeds of exercise of the Warrants will further these
objectives and will assist us in completing our ongoing
Phase II clinical trial program. Specifically, the net
proceeds will further our mono and co-therapy trials in the
U.S. and our co-therapy trials in the U.K. Manufacturing is
a key element in the progress towards regulatory approval and
the net proceeds will assist in funding the lyophilization and
process development activities in this area. These two areas in
the development process are expected to cost approximately
$6 million in 2009.
We contract out the majority of our activities, conducting our
clinical trial program at selected clinical trial sites
coordinated and managed through Contract Research Organizations.
The manufacturing program is contracted out to a major
manufacturer and directed by us.
In order to reach commercial production we will need to receive
regulatory approval allowing us to sell
REOLYSIN®.
To receive regulatory approval, we will be required to run a
successful pivotal clinical trial program and validate our cGMP
manufacturing process. We expect to commence these activities in
the later part of 2009. As we have yet to determine the size of
our pivotal trial program, the jurisdictions where we plan to
file our program, and who the principal investigators will be,
the timing and the ultimate costs of such activities are
currently indeterminable.
PRIOR
SALES
Other than as set forth below, no Common Shares or securities
exchangeable or convertible into Common Shares have been issued
during the twelve month period preceding the date of this
prospectus supplement.
On December 5, 2008, we issued 2,650,000 units, each
unit consisting of one Common Share and one Common Share
purchase warrant, at a price of $1.50 per unit. Each whole
Common Share purchase warrant entitles the holder to acquire one
additional Common Share of Oncolytics upon payment of $1.80 on
or before December 5, 2012, subject to an acceleration of
the expiry date in certain circumstances.
On December 11, 2008, we granted options to acquire an
aggregate of 15,500 Common Shares at an exercise price of $1.45
per Common Share.
On January 20, 2009, we issued 25,000 Common Shares on the
exercise of 25,000 options at an exercise price of $0.85 per
Common Share.
On April 9, 2009, we issued 1,875,121 Common Shares in
connection with the acquisition of all the issued and
outstanding securities of an inactive private company at an
ascribed value of $1.69 (being the 20 day volume weighted
average trading price of our Common Shares on the TSX up to and
including March 2, 2009).
On May 6, 2009, we issued 20,000 Common Shares on the
exercise of 20,000 warrants at an exercise price of $1.80 per
warrant.
TERMS OF
WARRANTS
The Warrants will be governed by an indenture (the
Warrant Indenture) to be entered into between
us and Computershare Trust Company of Canada, as agent for
the holders of the Warrants. The following is a summary of the
material attributes and characteristics of the Warrants. The
following description of the terms of the Warrant Indenture is
subject to the detailed provisions of the Warrant Indenture.
Under the Unit Offering, up to 3,450,000 Warrants may be issued.
Each Warrant will entitle the holder to purchase one Common
Share upon payment of $2.40, subject to adjustment, at any time
until 4:30 p.m. (Calgary time) on the date that is
36 months following the closing of the Unit Offering. If on
any Accelerated Exercise Date the 10 day volume weighted
average trading price of our Common Shares on the TSX exceeds
$3.35 per share, then, at our sole discretion and upon us
sending the holders of the Warrants written notice of such
Accelerated Exercise Date (the Notice) and
issuing a news release announcing such Accelerated Exercise
Date, the Warrants shall only be exercisable for a period of
30 days following the later of the date on which such
Notice is sent to holders of
S-7
Warrants and the date on which such announcement is made by news
release. The Notice will be deemed to be sent by us on the date
the Notice is deposited in first class mail to the registered
address of the holder of the Warrants as reflected on the
Warrant register maintained under the Warrant Indenture.
No U.S. Person (as that term is defined by
Regulation S under the U.S. Securities Act), person
within the United States or person holding Warrants for the
account or benefit of a U.S. Person or person within the
United States is permitted to exercise Warrants during any
period of time prior to the expiration date of the Warrants
during which a registration statement under the
U.S. Securities Act, relating to the Common Shares
underlying the Warrants, is not effective. As a condition to
closing the Unit Offering, we have agreed to use reasonable
efforts to maintain the registration statement on
Form F-10
(File
No. 333-151513)
relating to the short form base shelf prospectus accompanying
the prospectus supplement, or another registration statement
relating to the Common Shares underlying the Warrants, effective
until the earlier of the expiration date of the Warrants and the
date on which no Warrants remain outstanding. If a registration
statement under the U.S. Securities Act is not effective
during such period of time, we will notify the holders of the
Warrants in the United States, in accordance with the Warrant
Indenture.
Holders of Warrants will not have any voting rights or any other
rights which a holder of Common Shares would have (including,
without limitation, the right to receive notice of or to attend
meetings of shareholders or any right to receive dividends or
other distributions). Holders of Warrants will have no
pre-emptive rights to acquire our securities. If all of the
Warrants were exercised, we would be required to issue 3,450,000
Common Shares (subject to adjustment in certain
circumstances), assuming exercise in full of the
over-allotment option granted to the underwriter in connection
with the Unit Offering.
PLAN OF
DISTRIBUTION
This prospectus supplement relates to the issuance of:
(i) up to 3,000,000 Common Shares, issuable from time to
time, on exercise of 3,000,000 common share purchase warrants
(expected to be issued by us on or about May 13, 2009
pursuant to the Unit Offering (as described below), (ii) up
to 450,000 Common Shares issuable from time to time, on exercise
of 450,000 common share purchase warrants that may be issued on
the exercise of the over-allotment option granted to the
underwriter pursuant to the Unit Offering; and (iii) such
indeterminate number of additional Common Shares that may be
issuable by reason of the anti-dilution provisions contained in
the Warrant Indenture governing the Warrants. See Terms of
Warrants.
This prospectus supplement registers the offering of the
securities to which it relates under the U.S. Securities
Act, in accordance with the multi-jurisdictional disclosure
system adopted by the SEC and the securities commission or
similar regulatory authority in each of the provinces of Canada.
This prospectus supplement does not qualify the distribution of
the Common Shares in any province or territory of Canada.
Holders of Warrants resident in the United States who acquire
Common Shares pursuant to the exercise of Warrants in accordance
with their terms and under the accompanying short form base
shelf prospectus and this prospectus supplement may have a right
of action against us for any misrepresentation in the
accompanying base shelf prospectus and this prospectus
supplement. However, the existence and enforceability of such a
right of action is not without doubt. By contrast, holders of
Warrants resident in Canada who may acquire Common Shares
pursuant to the exercise of Warrants in accordance with their
respective terms and who will be deemed to acquire such Common
Shares under applicable Canadian prospectus exemptions, will not
have any such right of action with respect to such acquisition
of Common Shares.
The Common Shares to which this prospectus supplement relates
will be sold directly by us to holders of Warrants on the
exercise of such Warrants. No underwriters, dealers or agents
will be involved in these sales.
On June 16, 2008, we filed a short form base shelf
prospectus with the Alberta Securities Commission, as principal
regulator, and on June 6, 2008, as amended June 17,
2008, a registration statement on
Form F-10
(File
No. 333-151513)
with the SEC relating to the offering by the Corporation from
time to time during the 25 months that the short form base
shelf prospectus, including amendments thereto, remained valid
of up to Cdn.$150,000,000 of Common Shares, subscription
receipts, warrants, debt securities and units. The shelf
registration statement became effective with the SEC pursuant to
Rule 467(a) of the U.S. Securities Act on
June 17, 2008.
S-8
On May 6, 2009, we filed a prospectus supplement to the
short form base shelf prospectus dated June 16, 2008 with
the securities commissions in the provinces of British Columbia,
Alberta, Manitoba and Ontario and a registration statement on
Form F-10
(File
No. 333-151513)
with the SEC relating to the offering by us in British Columbia,
Alberta, Manitoba and Ontario of (i) up to 3,450,000 Units,
each Unit consisting of one Common Share and one common share
purchase warrant and (ii) up to 345,000 broker warrants.
Each Warrant will entitle the holder to purchase one Common
Share upon payment of Cdn.$2.40, subject to adjustment, at any
time until 4:30 p.m. (Calgary time) on the date that is
36 months from the date of the closing of the Unit
Offering. If on the Accelerated Exercise Date the
10-day
volume weighted average trading price of the Common Shares on
the TSX exceeds $3.35 per share, then, at our sole discretion,
and upon us sending the holders of Warrants written notice of
such Accelerated Exercise Date and issuing a news release
announcing such Accelerated Exercise Date, the Warrants shall
only be exercisable for a period of 30 days following the
later of the date on which such written notice is sent to
holders of Warrants and the date on which such announcement is
made by news release. The exercise price of the Warrants was
determined by negotiation between us and the underwriter for the
Unit Offering. Each broker warrant is exercisable, in whole or
in part, within 3 years of the initial closing date of the
Unit Offering (subject to acceleration), into one Common Share
at an exercise price of $2.40. The Unit Offering is expected to
be completed on or about May 13, 2009.
It is a condition of closing of the Unit Offering that the shelf
registration statement remain effective with the SEC and that we
file with the SEC this prospectus supplement registering the
offering of the Common Shares issuable from time to time on the
exercise of the Warrants.
No U.S. Person, person within the United States or person
holding Warrants for the account or benefit of a
U.S. Person or person within the United States may exercise
the Warrants during any period of time when a registration
statement covering such Common Shares is not effective. See
Terms of Warrants.
CANADIAN
FEDERAL INCOME TAX CONSIDERATIONS
In the opinion of Bennett Jones LLP
(Counsel), the following is a general summary
of the principal Canadian federal income tax considerations
generally applicable to an investor who acquires Common Shares
upon the exercise of Warrants issued under the Unit Offering.
This summary is applicable only to investors who, for the
purposes of the Tax Act and at all relevant times, will hold the
Common Shares and hold the Warrants as capital property, and
deal at arms length, and are not affiliated with us.
Common Shares and Warrants will generally constitute capital
property to an investor provided that the investor does not hold
such securities in the course of carrying on a business and has
not acquired such securities in a transaction or transactions
considered to be an adventure or concern in the nature of trade.
This summary is not applicable to an investor, (i) an
interest in which is a tax shelter investment,
(ii) who has elected to determine its Canadian tax results
in accordance with the functional currency rules,
(iii) that is a financial institution for
purposes of the mark-to-market rules, or
(iv) is a specified financial institution, all
within the meaning of the Tax Act. Any such investor should
consult its own Canadian tax advisors with respect to the
acquisition, holding or disposition of the Common Shares and
Warrants.
This summary is based upon the current provisions of the Tax
Act, the regulations thereunder (the
Regulations), all specific proposals to amend
the Tax Act and the Regulations publicly announced by the
Canadian Minister of Finance prior to the date hereof (the
Proposed Amendments) and Counsels
understanding of the current published administrative policies
and practices of the Canada Revenue Agency (the
CRA). This summary is not exhaustive of all
possible Canadian federal income tax considerations and except
for the Proposed Amendments does not otherwise take into account
any changes in law, whether by legislative, governmental or
judicial action, nor does it take into account or consider any
provincial, territorial or foreign income tax considerations.
There can be no assurance that the Proposed Amendments will be
enacted in their current form or at all.
This summary is of a general nature only and is not intended to
be, nor should it be construed to be, legal or tax advice to any
particular investor. Accordingly, all prospective investors are
urged to consult their own tax advisors with respect to their
particular circumstances.
S-9
Residents
of Canada
This portion of the summary is applicable to an investor who,
for the purposes of the Tax Act and at all relevant times, is
resident or is deemed to be resident in Canada.
Allocation
of Purchase Price
For the purposes of the Tax Act, the purchase price of each Unit
under the Unit Offering must be allocated, on a reasonable
basis, between the Common Share and the Warrant acquired on the
acquisition of the Unit in order to determine the respective
cost of the Common Share and the Warrant to the investor.
Oncolytics believes that it is reasonable to allocate a nominal
value of the purchase price of each Unit to the Warrant.
However, such allocation is not binding upon the CRA.
The portion of the purchase price of each Unit allocated to the
Common Share and to the Warrant, respectively, will become an
investors acquisition cost of the Common Share and the
Warrant for income tax purposes. These amounts must generally be
averaged with the adjusted cost base of all other common shares
and common share purchase warrants of Oncolytics, respectively,
held by the investor as capital property to determine the
adjusted cost base of all such common shares and common share
purchase warrants to the investor.
Exercise
of Warrants
When a Warrant is exercised, the investors adjusted cost
base of the Common Share acquired thereby will (subject to
averaging with the investors adjusted cost base of all
common shares of Oncolytics held by the investor as capital
property at that time) be the aggregate of the investors
adjusted cost base of the Warrant and the exercise price paid on
the exercise of the Warrant.
Disposition
of Common Shares
In general, a disposition, or a deemed disposition, of a Common
Share, other than to us, will give rise to a capital gain (or a
capital loss) in the taxation year of the disposition equal to
the amount by which the proceeds of disposition of the Common
Share, as the case may be, net of any reasonable costs of
disposition, exceed (or are less than) the adjusted cost base of
the Common Share to the holder thereof.
Treatment
of Capital Gains and Capital Losses
In the year of disposition an investor will be required to
include one-half of the amount of any capital gain (a
taxable capital gain) in income, and will be
generally required to deduct one-half of the amount of any
capital loss (an allowable capital loss)
against taxable capital gains realized by the investor in the
year. Allowable capital losses not deducted in the taxation year
in which they are realized may be carried back and deducted in
any of the three preceding taxation years or carried forward and
deducted in any subsequent taxation year against taxable capital
gains realized in such years, to the extent and under the
circumstances specified in the Tax Act. A
Canadian-controlled private corporation (as defined
in the Tax Act) may be liable to an additional
62/3%
refundable tax under the Tax Act on certain investment income,
including taxable capital gains.
The amount of any capital loss realized on the disposition or
deemed disposition of a Common Share by an investor that is a
corporation may be reduced by the amount of dividends received
or deemed to have been received by it on the Common Share to the
extent and in the circumstances prescribed by the Tax Act.
Similar rules may apply where an investor that is a corporation
is a member of a partnership or is beneficiary of a trust that
owns Common Shares and where Common Shares are owned by a
partnership or trust of which a partnership or trust is a
partner or beneficiary. Investors to whom these rules may be
relevant should consult their own tax advisors.
Dividends
Dividends (including deemed dividends) received on Common Shares
will be included in computing the investors income. In the
case of an individual investor (other than certain trusts), such
dividends will generally be subject to the
gross-up and
dividend tax credit rules normally applicable to dividends
received from taxable Canadian corporations. Provided that
appropriate designations are made by us at the time the dividend
is paid, such
S-10
dividend will be treated as an eligible dividend for purposes of
the Tax Act and an investor will be entitled to an enhanced
gross up and dividend tax credit in respect of such dividend.
There may be limitations on our ability to designate dividends
as eligible dividends. In the case of a corporation, dividends
will generally be deductible in computing the corporations
taxable income. An investor that is a private
corporation, as defined in the Tax Act, or any other
corporation resident in Canada and controlled by or for the
benefit of an individual (other than a trust) or a related group
of individuals (other than trusts) will generally be liable to
pay a refundable tax at the rate of
332/3%
on dividends received (or deemed to be received) on Common
Shares to the extent such dividends are deductible in computing
its taxable income.
Alternative
Minimum Tax
A holder who is an individual (other than certain trusts) may be
liable for alternative minimum tax if the holder receives or is
deemed to receive taxable dividends or realizes a capital gain.
Non-Residents
of Canada
This portion of the summary is applicable to an investor who,
for the purposes of the Tax Act and at all relevant times, is
not, and has never been, resident in Canada and is not, and has
never been, deemed to be resident in Canada, does not use or
hold, and is not deemed to use or hold, the Warrants or Common
Shares received upon exercise of the Warrants in, or in the
course of, carrying on business in Canada, and is not an insurer
who carries on an insurance business in Canada and elsewhere (a
Non-Resident Holder).
Allocation
of the Purchase Price
A Non-Resident Holder will be required to allocate the purchase
price of each Unit between the Common Share and the Warrant in
the same manner described above under Residents of
Canada Allocation of Purchase Price.
Disposition
of Common Shares and Exercise of Warrants
A Non-Resident Holder will not be subject to tax under the Tax
Act on the exercise of Warrants.
A Non-Resident Holder will be subject to tax under the Tax Act
in respect of a disposition of Common Shares only to the extent
such Common Shares constitute taxable Canadian
property for purposes of the Tax Act and the Non-Resident
Holder is not afforded relief from such tax under an applicable
income tax treaty.
The Common Shares will normally not be taxable Canadian property
at a particular time provided that: (i) the Common Shares
are listed on a designated stock exchange at the particular time
(which includes the TSX and NASDAQ); (ii) the Non-Resident
Holder, persons with whom the Non-Resident Holder does not deal
at arms length (within the meaning of the Tax Act), or the
Non-Resident Holder together with such persons, did not own 25%
or more of the issued shares of any class or series of
Oncolytics at any time during the
60-month
period preceding the particular time; and (iii) such Common
Shares are not otherwise deemed under the Tax Act to be taxable
Canadian property at the particular time.
A Non-Resident Holder who is subject to tax under the Tax Act on
a disposition of Common Shares will generally be required to
compute such gains in the same manner described above under
Residents of Canada Disposition of Common
Shares or Warrants.
Dividends
Dividends paid or credited, or which are deemed to be paid or
credited, on the Common Shares will be subject to a Canadian
non-resident withholding tax of 25%, subject to reduction of
such rate under an applicable income tax treaty. For example,
Non-Resident Holders who are residents of the United States for
the purposes of the Canada-United States Tax Convention, 1980
and entitled to the benefit of the treaty will generally
have such rate of withholding reduced to 15% (or 5% if such
Non-Resident Holder is a company which owns at least 10% of the
voting stock of Oncolytics).
S-11
Non-Resident Holders should consult their tax advisors with
respect to the tax implications of acquiring Common Shares on
the exercise of Warrants in their jurisdiction of residence and
the application of any bilateral income tax treaty between
Canada and their jurisdiction of residence.
CERTAIN
UNITED STATES FEDERAL INCOME TAX CONSIDERATIONS
The following is a summary of certain material anticipated
U.S. federal income tax consequences to a U.S. Holder
(as defined below) arising from and relating to the acquisition
of Common Shares received on the exercise of Warrants under this
prospectus supplement.
This summary is for general information purposes only and does
not purport to be a complete analysis or listing of all
potential U.S. federal income tax consequences that may
apply to a U.S. Holder as a result of the acquisition of
Common Shares received on the exercise of Warrants. In addition,
this summary does not take into account the individual facts and
circumstances of any particular U.S. Holder that may affect
the U.S. federal income tax consequences to such
U.S. Holder. Accordingly, this summary is not intended to
be, and should not be construed as, legal or U.S. federal
income tax advice with respect to any U.S. Holder. Each
U.S. Holder should consult its own tax advisor regarding
the U.S. federal income, U.S. state and local, and
foreign tax consequences of the acquisition of Common Shares
received on the exercise of Warrants.
Notice Pursuant To IRS Circular 230: Anything contained in
this summary concerning any U.S. federal tax issue is not
intended or written to be used, and it cannot be used by a
U.S. Holder, for the purpose of avoiding federal tax
penalties under the Internal Revenue Code. This summary was
written to support the promotion or marketing of the
transactions or matters addressed by this prospectus supplement.
Each U.S. Holder should seek U.S. federal tax advice,
based on such U.S. Holders particular circumstances,
from an independent tax advisor.
No legal opinion from U.S. legal counsel or ruling from the
Internal Revenue Service (the IRS) has been
requested, or will be obtained, regarding the U.S. federal
income tax consequences of the acquisition of Common Shares
received on the exercise of Warrants. This summary is not
binding on the IRS, and the IRS is not precluded from taking a
position that is different from, and contrary to, the positions
taken in this summary. In addition, because the authorities on
which this summary is based are subject to various
interpretations, the IRS and the U.S. courts could disagree
with one or more of the positions taken in this summary.
Scope of
this Summary
Authorities
This summary is based on the Internal Revenue Code of 1986, as
amended (the Code), Treasury Regulations
(whether final, temporary, or proposed), published rulings of
the IRS, published administrative positions of the IRS, the
Convention Between Canada and the United States of America with
Respect to Taxes on Income and on Capital, signed
September 26, 1980, as amended (the
Canada-U.S. Tax Convention), and
U.S. court decisions that are applicable and, in each case,
as in effect and available, as of the date of this prospectus
supplement. Any of the authorities on which this summary is
based could be changed in a material and adverse manner at any
time, and any such change could be applied on a retroactive
basis. This summary does not discuss the potential effects,
whether adverse or beneficial, of any proposed legislation that,
if enacted, could be applied on a retroactive basis.
U.S.
Holders
For purposes of this summary, a U.S. Holder is
a beneficial owner of Warrants that, for U.S. federal
income tax purposes, is (a) an individual who is a citizen
or resident of the U.S., (b) a corporation, or any other
entity classified as a corporation for U.S. federal income
tax purposes, that is created or organized in or under the laws
of the U.S., any state in the U.S., or the District of Columbia,
(c) an estate if the income of such estate is subject to
U.S. federal income tax regardless of the source of such
income, or (d) a trust if (i) such trust has validly
elected to be treated as a U.S. person for
U.S. federal income tax purposes or (ii) a
U.S. court is able to exercise primary supervision over the
administration of such trust and one or more U.S. persons
have the authority to control all substantial decisions of such
trust.
S-12
Non-U.S.
Holders
For purposes of this summary, a
non-U.S. Holder
is a beneficial owner of Warrants other than a U.S. Holder.
This summary does not address the U.S. federal income tax
consequences to
non-U.S. Holders
of the acquisition of Common Shares received on the exercise of
Warrants. Accordingly, a
non-U.S. Holder
should consult its own tax advisor regarding the
U.S. federal income, U.S. state and local, and foreign
tax consequences (including the potential application of and
operation of any income tax treaties) of the acquisition of
Common Shares received on the exercise of Warrants.
U.S.
Holders Subject to Special U.S. Federal Income Tax
Rules Not Addressed
This summary does not address the U.S. federal income tax
consequences applicable to U.S. Holders that are subject to
special provisions under the Code, including the following
U.S. Holders: (a) U.S. Holders that are
tax-exempt organizations, qualified retirement plans, individual
retirement accounts, or other tax-deferred accounts;
(b) U.S. Holders that are financial institutions,
insurance companies, real estate investment trusts, or regulated
investment companies; (c) U.S. Holders that are
dealers in securities or currencies or U.S. Holders that
are traders in securities that elect to apply a mark-to-market
accounting method; (d) U.S. Holders that have a
functional currency other than the U.S. dollar;
(e) U.S. Holders that own units, warrants, or common
shares as part of a straddle, hedging transaction, conversion
transaction, constructive sale, or other arrangement involving
more than one position; (f) U.S. Holders that received
units, warrants, or common shares in connection with the
exercise of employee stock options or otherwise as compensation
for services; (g) U.S. Holders that hold units,
warrants, or common shares other than as a capital asset within
the meaning of Section 1221 of the Code;
(h) U.S. expatriates or former longer-term residents
of the U.S. or (i) U.S. Holders that own
(directly, indirectly, or constructively) 10% or more of the
total combined voting power of the outstanding shares of the
Corporation. U.S. Holders that are subject to special
provisions under the Code, including U.S. Holders described
immediately above, should consult their own tax advisor
regarding the U.S. federal income tax consequences of the
acquisition of Common Shares received on the exercise of
Warrants.
If an entity that is classified as a partnership for
U.S. federal income tax purposes holds Warrants, the
U.S. federal income tax consequences to such partnership
and the partners of such partnership generally will depend on
the activities of the partnership and the status of such
partners. Partners of entities that are classified as
partnerships for U.S. federal income tax purposes should
consult their own tax advisor regarding the U.S. federal
income tax consequences of the acquisition of Common Shares
received on the exercise of Warrants.
Other
Tax Consequences Not Addressed
This summary does not address the U.S. state and local,
U.S. federal estate and gift, U.S. federal alternative
minimum tax; or foreign tax consequences to U.S. Holders of
the acquisition of Common Shares received on the exercise of
Warrants. Each U.S. Holder should consult its own tax
advisor regarding the U.S. state and local,
U.S. federal estate and gift, and foreign tax consequences
of the acquisition of Common Shares received on the exercise of
Warrants.
U.S.
Federal Income Tax Consequences of the Exercise of
Warrants
A U.S. Holder should not recognize gain or loss on the
exercise of a Warrant and related receipt of a Common Share
(except if cash is received in lieu of the issuance of a
fractional Common Share). Subject to the passive foreign
investment company (PFIC) rules
discussed below, a U.S. Holders initial tax basis in
the Common Share received on the exercise of a Warrant should be
equal to the sum of (a) such U.S. Holders tax
basis in such Warrant plus (b) the exercise price paid by
such U.S. Holder on the exercise of such Warrant. A
U.S. Holders holding period for the Common Share
received on the exercise of a Warrant should begin on the date
that such Warrant is exercised by such U.S. Holder.
S-13
U.S. Federal
Income Tax Consequences of the Ownership and Disposition of
Common Shares
Distributions
on Common Shares
Subject to the PFIC rules discussed below, a U.S. Holder
that receives a distribution, including a constructive
distribution, with respect to the Common Shares will be required
to include the amount of such distribution in gross income as a
dividend (without reduction for any Canadian income tax withheld
from such distribution) to the extent of the current or
accumulated earnings and profits of the Corporation.
To the extent that a distribution exceeds the current and
accumulated earnings and profits of the Corporation,
such distribution will be treated (a) first, as a tax-free
return of capital to the extent of a U.S. Holders tax
basis in the Common Shares and, (b) thereafter, as gain
from the sale or exchange of such Common Shares. However, the
Corporation does not intend to maintain the calculations of
earnings and profits in accordance with U.S. federal income
tax principles, and each U.S. Holder should therefore
assume that any distribution by the Corporation with respect to
the Common Shares will constitute ordinary dividend income. (See
more detailed discussion at Disposition of Common
Shares below). Dividends paid on the Common Shares
generally will not be eligible for the dividends received
deduction.
For taxable years beginning before January 1, 2011, a
dividend paid by the Corporation generally will be taxed at the
preferential tax rates applicable to long-term capital gains if
(a) the Corporation is a qualified foreign
corporation (as defined below), (b) the
U.S. Holder receiving such dividend is an individual,
estate, or trust, and (c) certain holding period
requirements are met.
The Corporation generally will be a qualified foreign
corporation under Section 1(h)(11) of the Code (a
QFC) if (a) the Corporation is eligible
for the benefits of the Canada-U.S. Tax Convention, or
(b) the Common Shares are readily tradable on an
established securities market in the U.S. However, even if
the Corporation satisfies one or more of such requirements, the
Corporation will not be treated as a QFC if the Corporation is a
PFIC (as defined below) for the taxable year during which the
Corporation pays a dividend or for the preceding taxable year.
As discussed below, the Corporation believes that it qualified
as a PFIC for the taxable year ended December 31, 2008, and
based on current business plans and financial projections, the
Corporation anticipates that it may qualify as a PFIC for
subsequent taxable years. (See more detailed discussion at
Passive Foreign Investment Company Rules below).
Accordingly, there can be no assurances that the Corporation
will be a QFC for the current or any future taxable year.
If the Corporation is not a PFIC, but a U.S. Holder
otherwise fails to qualify for the preferential tax rate
applicable to dividends discussed above, a dividend paid by the
Corporation to a U.S. Holder, including a U.S. Holder
that is an individual, estate, or trust, generally will be taxed
at ordinary income tax rates (and not at the preferential tax
rates applicable to long-term capital gains). The dividend rules
are complex, and each U.S. Holder should consult its own
tax advisor regarding the dividend rules.
Disposition
of Common Shares
A U.S. Holder will recognize gain or loss on the sale or
other taxable disposition of Common Shares in an amount equal to
the difference, if any, between (a) the amount of cash plus
the fair market value of any property received and (b) such
U.S. Holders tax basis in the Common Shares sold or
otherwise disposed of. Subject to the PFIC rules discussed
below, any such gain or loss generally will be capital gain or
loss, which will be long-term capital gain or loss if the Common
Shares are held for more than one year. Gain or loss recognized
by a U.S. Holder on the sale or other taxable disposition
of Common Shares generally will be treated as
U.S. source for purposes of applying the
U.S. foreign tax credit rules unless the gain is subject to
tax in Canada and is resourced as foreign source
under the Canada-U.S. Tax Convention and such
U.S. Holder elects to treat such gain or loss as
foreign source. (See more detailed discussion at
Foreign Tax Credit below).
Preferential tax rates apply to long-term capital gains of a
U.S. Holder that is an individual, estate, or trust. There
are currently no preferential tax rates for long-term capital
gains of a U.S. Holder that is a corporation. Deductions
for capital losses are subject to significant limitations under
the Code.
S-14
Receipt
of Foreign Currency
The amount of any distribution paid in foreign currency to a
U.S. Holder in connection with the ownership of Common
Shares, or on the sale, exchange or other taxable disposition of
Common Shares, generally will be equal to the U.S. dollar
value of such foreign currency based on the exchange rate
applicable on the date of receipt (regardless of whether such
foreign currency is converted into U.S. dollars at that
time). A U.S. Holder that receives foreign currency and
converts such foreign currency into U.S. dollars at a
conversion rate other than the rate in effect on the date of
receipt may have a foreign currency exchange gain or loss, which
generally would be treated as U.S. source ordinary income
or loss.
Taxable dividends with respect to Common Shares that are paid in
foreign currency will be included in the gross income of a
U.S. Holder as translated into U.S. dollars calculated
by reference to the exchange rate prevailing on the date of
actual or constructive receipt of the dividend, regardless of
whether the foreign currency is converted into U.S. dollars
at that time. If the foreign currency received is not converted
into U.S. dollars on the date of receipt, a
U.S. Holder will have a basis in the foreign currency equal
to its U.S. dollar value on the date of receipt. Any
U.S. Holder who receives payment in foreign currency and
engages in a subsequent conversion or other disposition of the
foreign currency may have a foreign currency exchange gain or
loss that would be treated as ordinary income or loss, and
generally will be U.S. source income or loss for foreign
tax credit purposes. Each U.S. Holder should consult its
own U.S. tax advisor regarding the U.S. federal income
tax consequences of receiving, owning, and disposing of foreign
currency.
Foreign
Tax Credit
A U.S. Holder that pays (whether directly or through
withholding) Canadian income tax with respect to dividends
received on the Common Shares generally will be entitled, at the
election of such U.S. Holder, to receive either a deduction
or a credit for such Canadian income tax paid. Generally, a
credit will reduce a U.S. Holders U.S. federal
income tax liability on a dollar-for-dollar basis, whereas a
deduction will reduce a U.S. Holders income subject
to U.S. federal income tax. This election is made on a
year-by-year
basis and applies to all foreign taxes paid (whether directly or
through withholding) by a U.S. Holder during a taxable year.
Complex limitations apply to the foreign tax credit, including
the general limitation that the credit cannot exceed the
proportionate share of a U.S. Holders
U.S. federal income tax liability that such
U.S. Holders foreign source taxable
income bears to such U.S. Holders worldwide taxable
income. In applying this limitation, a U.S. Holders
various items of income and deduction must be classified, under
complex rules, as either foreign source or
U.S. source. In addition, this limitation is
calculated separately with respect to specific categories of
income. Dividends received on the Common Shares generally will
constitute foreign source income and generally will
be categorized as passive income. The foreign tax
credit rules are complex, and each U.S. Holder should
consult its own tax advisor regarding the foreign tax credit
rules.
Information
Reporting; Backup Withholding Tax
Under U.S. federal income tax law and regulations, certain
categories of U.S. Holders must file information returns
with respect to their investment in, or involvement in, a
foreign corporation. Penalties for failure to file certain of
these information returns are substantial. U.S. Holders of
our Common Shares should consult with their own tax advisors
regarding the requirements of filing information returns, and if
applicable, any mark-to-market election or QEF
election (each as defined below).
Payments made within the U.S., or by a U.S. payor or
U.S. middleman, of dividends on, or proceeds arising from
the sale or other taxable disposition of, Common Shares
generally will be subject to information reporting and backup
withholding tax, at the rate of 28%, if a U.S. Holder
(a) fails to furnish such U.S. Holders correct
U.S. taxpayer identification number (generally on
Form W-9),
(b) furnishes an incorrect U.S. taxpayer
identification number, (c) is notified by the IRS that such
U.S. Holder has previously failed to properly report items
subject to backup withholding tax, or (d) fails to certify,
under penalty of perjury, that such U.S. Holder has
furnished its correct U.S. taxpayer identification number
and that the IRS has not notified such U.S. Holder that it
is subject to backup withholding tax. However, U.S. Holders
that are corporations generally are excluded from these
information reporting and backup withholding tax rules. Any
amounts withheld under the U.S. backup withholding tax
rules will
S-15
be allowed as a credit against a U.S. Holders
U.S. federal income tax liability, if any, or will be
refunded, if such U.S. Holder furnishes required
information to the IRS. Each U.S. Holder should consult its
own tax advisor regarding the information reporting and backup
withholding tax rules.
Passive
Foreign Investment Company Rules
If the Corporation is a passive foreign investment
company (as defined below), the preceding sections of this
summary may not describe the U.S. federal income tax
consequences to U.S. Holders of the acquisition, ownership,
and disposition of Common Shares.
The Corporation generally will be a PFIC under the
meaning of Section 1297 of the Code if, for a taxable year,
(a) 75% or more of the gross income of the Corporation for
such taxable year is passive income or (b) on average, 50%
or more of the assets held by the Corporation either produce
passive income or are held for the production of passive income,
based on the fair market value of such assets (or on the
adjusted tax basis of such assets, if the Corporation is not
publicly traded and either is a controlled foreign
corporation or makes an election). Passive
income includes, for example, dividends, interest, certain
rents and royalties, certain gains from the sale of stock and
securities, and certain gains from commodities transactions.
Active business gains arising from the sale of commodities
generally are excluded from passive income if substantially all
of a foreign corporations commodities are (a) stock
in trade of such foreign corporation or other property of a kind
which would properly be included in inventory of such foreign
corporation, or property held by such foreign corporation
primarily for sale to customers in the ordinary course of
business, (b) property used in the trade or business of
such foreign corporation that would be subject to the allowance
for depreciation under Section 167 of the Code, or
(c) supplies of a type regularly used or consumed by such
foreign corporation in the ordinary course of its trade or
business.
For purposes of the PFIC income test and asset test described
above, if the Corporation owns, directly or indirectly, 25% or
more of the total value of the outstanding shares of another
corporation, the Corporation will be treated as if it
(a) held a proportionate share of the assets of such other
corporation and (b) received directly a proportionate share
of the income of such other corporation. In addition, for
purposes of the PFIC income test and asset test described above,
passive income does not include any interest,
dividends, rents, or royalties that are received or accrued by
the Corporation from a related person (as defined in
Section 954(d)(3) of the Code), to the extent such items
are properly allocable to the income of such related person that
is not passive income.
In addition, if the Corporation is a PFIC and owns shares of
another foreign corporation that also is a PFIC (a
Subsidiary PFIC, under certain indirect ownership
rules, a disposition of the shares of such Subsidiary PFIC or a
distribution received from such Subsidiary PFIC generally will
be treated as an indirect disposition by a U.S. Holder or
an indirect distribution received by a U.S. Holder, subject
to the rules of Section 1291 of the Code discussed below.
To the extent that gain recognized on the actual disposition by
a U.S. Holder of the Common Shares or income recognized by
a U.S. Holder on an actual distribution received on the
Common Shares was
previously subject to U.S. federal income tax under these
indirect ownership rules, such amount generally should not be
subject to U.S. federal income tax.
The Corporation believes that it qualified as a PFIC for the
taxable year ended December 31, 2008, and based on current
business plans and financial projections, the Corporation
anticipates that it may qualify as a PFIC for subsequent taxable
years. The determination of whether the Corporation will be a
PFIC for any taxable year depends, in part, on the application
of complex U.S. federal income tax rules, which are subject
to differing interpretations. In addition, whether the
Corporation will be a PFIC for its current taxable year depends
on the assets and income of the Corporation over the course of
each such taxable year and, as a result, cannot be predicted
with certainty as of the date of this prospectus supplement.
Consequently, there can be no assurance regarding the
Corporations PFIC status for any taxable year during which
U.S. Holders hold the Common Shares, and there can be no
assurance that the IRS will not challenge the determination made
by the Corporation concerning its PFIC status.
Default
PFIC Rules Under Section 1291 of the
Code
If the Corporation is a PFIC, the U.S. federal income tax
consequences to a U.S. Holder of the acquisition,
ownership, and disposition of Common Shares will depend on
whether such U.S. Holder makes certain elections
S-16
described below.. A U.S. Holder that does not make any of
the elections described below will be subject to the default
PFIC rules discussed immediately below and will be referred to
in this summary as a Non-Electing U.S. Holder.
A Non-Electing U.S. Holder will be subject to the rules of
Section 1291 of the Code with respect to (a) any gain
recognized on the sale or other taxable disposition of Common
Shares and (b) any excess distribution paid on the Common
Shares. A distribution generally will be an excess
distribution to the extent that such distribution
(together with all other distributions received in the current
taxable year) exceeds 125% of the average distributions received
during the three preceding taxable years (or during a
U.S. Holders holding period for the Common Shares, if
shorter).
Under Section 1291 of the Code, any gain recognized on the
sale or other taxable disposition of Common Shares, and any
excess distribution paid on the Common Shares, must be ratably
allocated to each day in a Non-Electing U.S. Holders
holding period for the Common Shares. The amount of any such
gain or excess distribution allocated to prior years of such
Non-Electing U.S. Holders holding period for the
Common Shares (other than years prior to the first taxable year
of the Corporation beginning after December 31, 1986 for
which the Corporation was not a PFIC) will be subject to
U.S. federal income tax at the highest tax applicable to
ordinary income in each such prior year. A Non-Electing
U.S. Holder will be required to pay interest on the
resulting tax liability for each such prior year, calculated as
if such tax liability had been due in each such prior year. Such
a Non-Electing U.S. Holder that is not a corporation must
treat any such interest paid as personal interest,
which is not deductible. The amount of any such gain or excess
distribution allocated to the current year of such Non-Electing
U.S. Holders holding period for the Common Shares
will be treated as ordinary income in the current year, and no
interest charge will be incurred with respect to the resulting
tax liability for the current year.
If the Corporation is a PFIC for any taxable year during which a
Non-Electing U.S. Holder holds Common Shares, the
Corporation will continue to be treated as a PFIC with respect
to such Non-Electing U.S. Holder, regardless of whether the
Corporation ceases to be a PFIC in one or more subsequent years.
A Non-Electing U.S. Holder may terminate this deemed PFIC
status by electing to recognize gain (which will be taxed under
the rules of Section 1291 of the Code discussed above) as
if such Common Shares were sold on the last day of the last
taxable year for which the Corporation was a PFIC.
QEF
Election
A U.S. Holder that makes a QEF Election generally will not
be subject to the rules of Section 1291 of the Code
discussed above. However, a U.S. Holder that makes a QEF
Election will be subject to U.S. federal income tax on such
U.S. Holders pro rata share of (a) the net
capital gain of the Corporation and each Subsidiary PFIC, which
will be taxed as long-term capital gain to such
U.S. Holder, and (b) and the ordinary earnings of the
Corporation and each Subsidiary PFIC, which will be taxed as
ordinary income to such U.S. Holder. Generally, net
capital gain is the excess of (a) net long-term
capital gain over (b) net short-term capital loss, and
ordinary earnings are the excess of
(a) earnings and profits over (b) net
capital gain. A U.S. Holder that makes a QEF Election will
be subject to U.S. federal income tax on such amounts for
each taxable year in which the Corporation is a PFIC, regardless
of whether such amounts are actually distributed to such
U.S. Holder by the Corporation. However, a U.S. Holder
that makes a QEF Election may, subject to certain limitations,
elect to defer payment of current U.S. federal income tax
on such amounts, subject to an interest charge. If such
U.S. Holder is not a corporation, any such interest paid
will be treated as personal interest, which is not
deductible.
A U.S. Holder that makes a QEF Election generally
(a) may receive a tax-free distribution from the
Corporation to the extent that such distribution represents
earnings and profits of the Corporation that were
previously included in income by the U.S. Holder because of
such QEF Election and (b) will adjust such
U.S. Holders tax basis in the Common Shares to
reflect the amount included in income or allowed as a tax-free
distribution because of such QEF Election. In addition, a
U.S. Holder that makes a QEF Election generally will
recognize capital gain or loss on the sale or other taxable
disposition of our Common Shares.
The procedure for making a QEF Election, and the
U.S. federal income tax consequences of making a QEF
Election, will depend on whether such QEF Election is timely. A
QEF Election will be treated as timely if such QEF
Election is made for the first year in the
U.S. Holders holding period for the Common Shares in
which the
S-17
Corporation was a PFIC. A U.S. Holder may make a timely QEF
Election by filing the appropriate QEF Election documents at the
time such U.S. Holder files a U.S. federal income tax
return for such first year in respect of the Corporation and
each Subsidiary PFIC, if any. However, if the Corporation was a
PFIC in a prior year, then in addition to filing the QEF
Election documents, a U.S. Holder must elect to recognize
(a) gain (which will be taxed under the rules of
Section 1291 of the Code discussed above) as if the Common
Shares were sold on the qualification date or (b) if the
Corporation were also a controlled foreign
corporation under the meaning of Section 957 of the
Code, such U.S. Holders pro rata share of the
post-1986 earnings and profits of the Corporation as
of the qualification date. The qualification date is
the first day of the first taxable year in which the Corporation
was a QEF with respect to such U.S. Holder. The election to
recognize such gain or earnings and profits can only
be made if such U.S. Holders holding period for the
Common Shares includes the qualification date. By electing to
recognize such gain or earnings and profits, such
U.S. Holder will be deemed to have made a timely QEF
Election. In addition, under very limited circumstances, a
U.S. Holder may make a retroactive QEF Election if such
U.S. Holder failed to file the QEF Election documents in a
timely manner.
A QEF Election will apply to the taxable year for which such QEF
Election is made and to all subsequent taxable years, unless
such QEF Election is invalidated or terminated or the IRS
consents to revocation of such QEF Election. If a
U.S. Holder makes a QEF Election and, in a subsequent
taxable year, the Corporation ceases to be a PFIC, the QEF
Election will remain in effect (although it will not be
applicable) during those taxable years in which the Corporation
is not a PFIC. Accordingly, if the Corporation becomes a PFIC in
another subsequent taxable year, the QEF Election will be
effective and the U.S. Holder will be subject to the QEF
rules described above during any such subsequent taxable year in
which the Corporation qualifies as a PFIC. In addition, the QEF
Election will remain in effect (although it will not be
applicable) with respect to a U.S. Holder even after such
U.S. Holder disposes of all of such U.S. Holders
direct and indirect interest in the Common Shares. Accordingly,
if such U.S. Holder reacquires an interest in the
Corporation, such U.S. Holder will be subject to the QEF
rules described above for each taxable year in which the
Corporation is a PFIC.
However, under Treasury Regulations, if a U.S. Holder holds
an option, warrant or other right to acquire stock of a PFIC,
the holding period with respect to shares of stock of the PFIC
acquired upon exercise of such option, warrant or other right
shall include the period that the option, warrant or other right
was held. Thus, U.S. Holders will be treated as having held
Common Shares received on exercise of Warrants for the entire
period during which the Warrants were held. In order to be
effective with respect to the Common Shares, a QEF Election
would have to be made for the first year in which the
U.S. Holders holding period for the shares begins,
however, under applicable rules, a U.S. Holder will not be
able to make a QEF Election that would apply to a Warrant or the
Common Share that may be received on exercise of a Warrant. The
general effect of these Treasury Regulations is that
(a) under the special taxation rules for PFICs discussed
above, excess distributions and gains realized on the
disposition of Common Shares received upon exercise of Warrants
will be spread over the entire holding period for the Warrants
and the Common Shares received on their exercise and
(b) even if a U.S. Holder makes a QEF Election upon
exercise of Warrants and receipt of the Common Shares, that
election generally will not be a timely and effective QEF
Election with respect to the Common Shares received on exercise.
Thus, the default PFIC rules discussed above will continue to
apply. However, a U.S. Holder receiving Common Shares upon
exercise of a warrant generally will be eligible to make an
effective QEF Election as of the first day of the taxable year
of such U.S. Holder beginning after the receipt of such
Common Shares if such U.S. Holder also makes an election to
recognize gain (which will be taxed under the PFIC rules
described above) as if such Common Shares were sold on such date
at fair market value. In addition, under the Treasury
Regulations, a disposition, other than by exercise, of a warrant
generally will be subject to the special taxation rules for
PFICs discussed above.
The Corporation will make available to U.S. Holders, upon
their written request, timely and accurate information as to its
status as a PFIC, and will provide to a U.S. Holder all
information and documentation that a U.S. Holder making a
QEF Election with respect to the Corporation is required to
obtain for U.S. federal income tax purposes. However,
U.S. Holders should be aware that the Corporation can
provide no assurances that it will provide any such information
relating to any Subsidiary PFIC. Because the Company may own
shares in one or more Subsidiary PFICs, and may acquire shares
in one or more Subsidiary PFICs in the future, they will
continue to be subject to the rules discussed above with respect
to the taxation of gains and excess distributions with respect
to any Subsidiary PFIC for which the U.S. Holders do not
obtain the required information. Each U.S. Holder should
S-18
consult his, her or its own tax advisor regarding the
availability of, and procedure for making, a QEF Election with
respect to the Company and any Subsidiary PFIC.
Mark-to-Market
Election
A U.S. Holder may make a Mark-to-Market Election only if
the Common Shares are marketable stock. The Common Shares
generally will be marketable stock if the Common
Shares are regularly traded on (a) a national securities
exchange that is registered with the Securities and Exchange
Commission, (b) the national market system established
pursuant to section 11A of the Securities and Exchange Act
of 1934, or (c) a foreign securities exchange that is
regulated or supervised by a governmental authority of the
country in which the market is located, provided that
(i) such foreign exchange has trading volume, listing,
financial disclosure, and other requirements and the laws of the
country in which such foreign exchange is located, together with
the rules of such foreign exchange, ensure that such
requirements are actually enforced and (ii) the rules of
such foreign exchange ensure active trading of listed stocks.
A U.S. Holder that makes a Mark-to-Market Election
generally will not be subject to the rules of Section 1291
of the Code discussed above. However, if a U.S. Holder
makes a Mark-to-Market Election after the beginning of such
U.S. Holders holding period for the Common Shares and
such U.S. Holder has not made a timely QEF Election, the
rules of Section 1291 of the Code discussed above will
apply to certain dispositions of, and distributions on, the
Common Shares.
A U.S. Holder that makes a Mark-to-Market Election will
include in ordinary income, for each taxable year in which the
Corporation is a PFIC, an amount equal to the excess, if any, of
(a) the fair market value of the Common Shares as of the
close of such taxable year over (b) such
U.S. Holders tax basis in such Common Shares. A
U.S. Holder that makes a Mark-to-Market Election will be
allowed a deduction in an amount equal to the lesser of
(a) the excess, if any, of (i) such
U.S. Holders adjusted tax basis in the Common Shares
over (ii) the fair market value of such Common Shares as of
the close of such taxable year or (b) the excess, if any,
of (i) the amount included in ordinary income because of
such Mark-to-Market Election for prior taxable years over
(ii) the amount allowed as a deduction because of such
Mark-to-Market Election for prior taxable years.
A U.S. Holder that makes a Mark-to-Market Election
generally also will adjust such U.S. Holders tax
basis in the Common Shares to reflect the amount included in
gross income or allowed as a deduction because of such
Mark-to-Market Election. In addition, upon a sale or other
taxable disposition of our Common Shares, a U.S. Holder
that makes a Mark-to-Market Election will recognize ordinary
income or loss (not to exceed the excess, if any, of
(a) the amount included in ordinary income because of such
Mark-to-Market Election for prior taxable years over
(b) the amount allowed as a deduction because of such
Mark-to-Market Election for prior taxable years).
A Mark-to-Market Election applies to the taxable year in which
such Mark-to-Market Election is made and to each subsequent
taxable year, unless the Common Shares cease to be
marketable stock or the IRS consents to revocation
of such election. Each U.S. Holder should consult its own
tax advisor regarding the availability of, and procedure for
making, a Mark-to-Market Election.
Although a U.S. Holder may be eligible to make a
Mark-to-Market Election with respect to the Common Shares, no
such election may be made with respect to the stock of any
Subsidiary PFIC that such U.S. Holder is treated as owning
because such stock is not marketable. Hence, the Mark-to-Market
Election will not be effective to eliminate the interest charge
described above.
Other
PFIC Rules
Under Section 1291(f) of the Code, the IRS has issued
proposed Treasury Regulations that, subject to certain
exceptions, would cause a U.S. Holder that had not made a
timely QEF Election to recognize gain (but not loss) upon
certain transfers of Common Shares that would otherwise be
tax-deferred (e.g., gifts and exchanges pursuant to corporate
reorganizations). However, the specific U.S. federal income
tax consequences to a U.S. Holder may vary based on the
manner in which Common Shares are transferred.
Certain additional adverse rules will apply with respect to a
U.S. Holder if the Corporation is a PFIC, regardless of
whether such U.S. Holder makes a QEF Election. For example
under Section 1298(b)(6) of the Code, a
S-19
U.S. Holder that uses Common Shares as security for a loan
will, except as may be provided in Treasury Regulations, be
treated as having made a taxable disposition of such Common
Shares.
The PFIC rules are complex, and each U.S. Holder should
consult its own tax advisor regarding the PFIC rules and how the
PFIC rules may affect the U.S. federal income tax
consequences of the acquisition, ownership, and disposition of
Common Shares.
RISK
FACTORS
Prospective purchasers of Common Shares should consider
carefully the risk factors set out herein and contained in and
incorporated by reference in the accompanying base shelf
prospectus. Discussions of certain risks affecting Oncolytics in
connection with its business are provided in our annual
disclosure documents filed with the various securities
regulatory authorities which are incorporated by reference in
the accompanying base shelf prospectus.
Barbados law differs from the laws in effect in Canada and
may afford less protection to holders of our securities.
Certain of our assets and intellectual property are held by our
wholly-owned subsidiary, Oncolytics Barbados, which is organized
under the laws of Barbados. It may not be possible to enforce
court judgments obtained in Canada against Oncolytics Barbados
in Barbados based on the civil liabilities provisions of
applicable securities laws. In addition, there is some doubt as
to whether the courts of Barbados would recognize or enforce
judgments of Canadian courts obtained against us or our
directors or officers based on the civil liabilities provisions
of Canadian securities laws or hear actions against us or those
persons based on such laws.
Changes in law could adversely affect our business and
corporate structure.
There can be no assurances that there will not occur changes in
corporate, tax, property and other laws in Canada
and/or
Barbados (or the interpretation thereof by regulatory or tax
authorities) which may materially and adversely affect our
businesses and corporate structure.
LEGAL
MATTERS AND INTEREST OF EXPERTS
The auditors of the Corporation are Ernst & Young LLP,
Chartered Accountants, 1000, 440 2nd Avenue
S.W., Calgary, Alberta, T2P 5E9. Ernst & Young LLP is
independent of Oncolytics in accordance with the Rules of
Professional Conduct as outlined by the Institute of Chartered
Accountants of Alberta. Ernst & Young LLP is
registered with the U.S. Public Company Accounting
Oversight Board.
Certain legal matters relating to offering of the Common Shares
issuable from time to time on the exercise of the Warrants will
be passed upon by Bennett Jones LLP with respect to certain
Canadian legal matters and by Dorsey & Whitney LLP
with respect to certain U.S. legal matters on behalf of the
Corporation. As at the date hereof, the partners and associates
of Bennett Jones LLP, as a group, and the partners and
associates of Dorsey & Whitney LLP, as a group, each
beneficially own directly or indirectly, less than 1% of the
Common Shares.
In addition, none of the aforementioned persons or firms, nor
any director, officer or employee of any of the aforementioned
persons or firms is or is expected to be elected, appointed or
employed as a director, officer or employee of the Corporation
or any associate or affiliate of the Corporation.
S-20
Base Shelf Prospectus
This short
form prospectus has been filed under legislation in each of the
provinces of British Columbia, Alberta, Manitoba and Ontario
that permits certain information about these securities to be
determined after this short form prospectus has become final and
that permits the omission from this short form prospectus of
that information. The legislation requires the delivery to
purchasers of a prospectus supplement containing the omitted
information within a specified period of time after agreeing to
purchase any of these securities.
This short form prospectus
constitutes a public offering of these securities only in those
jurisdictions where they may be lawfully offered for sale and
therein only by persons permitted to sell such securities. No
securities regulatory authority has expressed an opinion about
these securities and it is an offence to claim
otherwise.
Information has been
incorporated by reference in this short form prospectus from
documents filed with securities commissions or similar
authorities in Canada.
Copies of the
documents incorporated herein by reference may be obtained on
request without charge from the Corporate Secretary of
Oncolytics Biotech Inc. at 210, 1167 Kensington Crescent N.W.,
Calgary, Alberta T2N 1X7 telephone
(403) 670-7377,
and are available electronically at www.sedar.com. See
Documents Incorporated by Reference.
Final Short
Form Prospectus
|
|
New
Issue |
Dated June 16, 2008 |
Cdn. $150,000,000
Common Shares
Subscription Receipts
Warrants
Debt Securities
Units
We may from time to time during the
25-month
period that this prospectus (the Prospectus),
including any amendments, remains valid, sell under this
Prospectus up to Cdn. $150,000,000 (or the equivalent in other
currencies or currency units) aggregate initial offering price
of our common shares (Common Shares),
subscription receipts (Subscription
Receipts), warrants to purchase Common Shares
(Warrants), senior or subordinated unsecured
debt securities (Debt Securities), and/or
units comprised of one or more of the other securities described
in this Prospectus in any combination, (Units
and, together with the Common Shares, Subscription Receipts,
Debt Securities and Warrants, the
Securities). We may offer Securities in such
amount and, in the case of the Subscription Receipts, Debt
Securities, Warrants and Units, with such terms, as we may
determine in light of market conditions. We may sell the
Subscription Receipts, Debt Securities and Warrants in one or
more series.
There are certain risk factors that should be carefully
reviewed by prospective purchasers. See Risk
Factors.
The specific variable terms of any offering of Securities will
be set forth in a supplement to this Prospectus relating to such
Securities (each, a Prospectus Supplement)
including where applicable: (i) in the case of the Common
Shares, the number of Common Shares offered, the currency (which
may be Canadian dollars or any other currency), the issue price
and any other specific terms; (ii) in the case of
Subscription Receipts, the number of Subscription Receipts
offered, the currency (which may be Canadian dollars or any
other currency), the issue price, the terms and procedures for
the
exchange of the Subscription Receipts and any other specific
terms; (iii) in the case of Warrants, the designation, the
number of Warrants offered, the currency (which may be Canadian
dollars or any other currency), number of the Common Shares that
may be acquired upon exercise of the Warrants, the exercise
price, dates and periods of exercise, adjustment procedures and
any other specific terms; (iv) in the case of Debt
Securities, the designation, aggregate principal amount and
authorized denominations of the Debt Securities, any limit on
the aggregate principal amount of the Debt Securities, the
currency (which may be Canadian dollars or any other currency),
the issue price (at par, at a discount or at a premium), the
issue and delivery date, the maturity date (including any
provisions for the extension of a maturity date), the interest
rate (either fixed or floating and, if floating, the method of
determination thereof), the interest payment date(s), the
provisions (if any) for subordination of the Debt Securities to
other indebtedness, any redemption provisions, any repayment
provisions, any terms entitling the holder to exchange or
convert the Debt Securities into other securities and any other
specific terms; and (v) in the case of Units, the
designation, the number of Units offered, the offering price,
the currency (which may be Canadian dollars or any other
currency), terms of the Units and of the securities comprising
the Units and any other specific terms.
We are permitted, as a foreign issuer in the United States,
under a multi-jurisdictional disclosure system adopted by the
United States and Canada, to prepare this Prospectus in
accordance with Canadian disclosure requirements. You should be
aware that such requirements are different from those of the
United States. We have prepared our financial statements
included or incorporated herein by reference in accordance with
Canadian generally accepted accounting principles, and they are
subject to Canadian auditing and auditor independence standards.
Thus, they may not be comparable to the financial statements of
United States companies. Information regarding the impact upon
our financial statements of significant differences between
Canadian and United States generally accepted accounting
principles is contained in the notes to the financial statements
incorporated by reference in this Prospectus.
You should be aware that the purchase of the Securities may
have tax consequences both in the United States and Canada. Such
consequences for investors who are resident in, or citizens of,
the United States may not be described fully herein. You should
read the tax discussion contained in the applicable Prospectus
Supplement with respect to a particular offering of securities.
See Certain Income Tax Considerations.
Your ability to enforce civil liabilities under United States
federal securities laws may be affected adversely by the fact
that we are incorporated under the laws of Canada, the majority
of our officers and directors and some of the experts named in
this Prospectus are residents of Canada, and a substantial
portion of our assets and the assets of such persons are located
outside the United States.
NEITHER THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION
(THE SEC) NOR ANY STATE SECURITIES COMMISSION HAS
APPROVED OR DISAPPROVED THESE SECURITIES NOR PASSED UPON THE
ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION TO
THE CONTRARY IS A CRIMINAL OFFENCE.
All shelf information permitted under applicable laws to be
omitted from this Prospectus will be contained in one or more
Prospectus Supplements that will be delivered to purchasers
together with this Prospectus. Each Prospectus Supplement will
be incorporated by reference into this Prospectus for the
purposes of securities legislation as of the date of the
Prospectus Supplement and only for the purposes of the
distribution of the Securities to which the Prospectus
Supplement pertains.
Our outstanding securities are listed for trading on the Toronto
Stock Exchange under the trading symbol ONC and on
the NASDAQ Capital Market under the trading symbol
ONCY. Unless otherwise specified in any applicable
Prospectus Supplement, the Subscription Receipts, Warrants, Debt
Securities, and Units will not be listed on any securities
exchange. There is no market through which the Subscription
Receipts, Warrants, Debt Securities or Units may be sold and
purchasers may not be able to resell the Subscription Receipts,
Warrants, Debt Securities or Units purchased under this
Prospectus. This may affect the pricing of these securities in
the secondary market, the transparency and availability of
trading prices, the liquidity of the securities, and the extent
of issuer regulation. See the Risk Factors section
of the applicable Prospectus Supplement.
ii
We may sell the Securities to or through underwriters, dealers,
placement agents or other intermediaries or directly to
purchasers or through agents. See Plan of
Distribution. The Prospectus Supplement relating to a
particular offering of Securities will identify each person who
may be deemed to be an underwriter with respect to such offering
and will set forth the terms of the offering of such Securities,
including, to the extent applicable, the initial public offering
price, the proceeds that we will receive, the underwriting
discounts or commissions and any other discounts or concessions
to be allowed or reallowed to dealers. The managing underwriter
or underwriters with respect to Securities sold to or through
underwriters, if any, will be named in the related Prospectus
Supplement.
Subject to applicable securities legislation, in connection with
any offering of Securities under this Prospectus, the
underwriters, if any, may over-allot or effect transactions
which stabilize or maintain the market price of the Securities
offered at a level above that which might otherwise prevail in
the open market. These transactions, if commenced, may be
discontinued at any time. See Plan of Distribution.
You should rely only on the information contained in this
Prospectus. We have not authorized anyone to provide you with
information different from that contained in this Prospectus.
Our head office and principal place of business is located at
210, 1167 Kensington Crescent N.W., Calgary, Alberta T2N 1X7.
Our registered office is located at 4500 Bankers Hall East,
855 2nd Street S.W., Calgary, Alberta T2P 4K7.
iii
TABLE OF
CONTENTS
|
|
|
|
|
|
|
Page
|
|
|
|
|
1
|
|
|
|
|
1
|
|
|
|
|
2
|
|
|
|
|
3
|
|
|
|
|
3
|
|
|
|
|
4
|
|
|
|
|
9
|
|
|
|
|
10
|
|
|
|
|
11
|
|
|
|
|
13
|
|
|
|
|
13
|
|
|
|
|
13
|
|
|
|
|
13
|
|
|
|
|
14
|
|
|
|
|
14
|
|
|
|
|
15
|
|
|
|
|
17
|
|
|
|
|
18
|
|
|
|
|
19
|
|
|
|
|
20
|
|
|
|
|
20
|
|
|
|
|
20
|
|
|
|
|
20
|
|
|
|
|
20
|
|
DEFINITIONS
AND OTHER MATTERS
In this Prospectus and any Prospectus Supplement, unless
otherwise indicated, references to we,
us, our, Oncolytics or the
Corporation are to Oncolytics Biotech Inc. All
references to dollars, Cdn.$ or
$ are to Canadian dollars and all references to
U.S.$ are to United States dollars. Unless otherwise
indicated, all financial information included and incorporated
by reference in this Prospectus and any Prospectus Supplement is
determined using Canadian generally accepted accounting
principles.
We prepare our financial statements in accordance with Canadian
generally accepted accounting principles (Canadian
GAAP), which differ from United States generally
accepted accounting principles (U.S. GAAP).
Therefore, our financial statements incorporated by reference in
this Prospectus and any Prospectus Supplement and in the
documents incorporated by reference in this Prospectus and in
any applicable Prospectus Supplement may not be comparable to
financial statements prepared in accordance with U.S. GAAP. You
should refer to Note 21 of our financial statements for the
year ended December 31, 2007 for a discussion of the
principal differences between our financial results determined
under Canadian GAAP and under U.S. GAAP. For our financial
statements as at and for the three months ended March 31,
2008, you should refer to our reconciliation of our financial
statements as at and for the three months ended March 31,
2008 to U.S. GAAP furnished to the SEC on the Companys
Current Report on
Form 6-K
dated June 4, 2008 and incorporated into this Prospectus by
reference. See Documents Incorporated by Reference.
SPECIAL
NOTICE REGARDING FORWARD-LOOKING STATEMENTS
Some of the statements that we make contain forward-looking
statements reflecting our current beliefs, plans, estimates and
expectations. Readers are cautioned that these forward-looking
statements involve risks and uncertainties, including, without
limitation, clinical trial study delays, product development
delays, our ability to attract and retain
1
business partners, future levels of government funding,
competition from other biotechnology companies and our ability
to obtain the capital required for research, product
development, operations and marketing. These factors should be
carefully considered and readers should not place undue reliance
on our forward-looking statements. Actual events may differ
materially from our current expectations due to risks and
uncertainties.
Our statements of belief, estimates,
expectations and other similar statements are based
primarily upon our results derived to date from our research and
development program with animals and early stage human results
and upon which we believe we have a reasonable scientific basis
to expect the particular results to occur. It is not possible to
predict, based upon studies in animals or early stage human
results, whether a new therapeutic will be proved to be safe and
effective in humans. There can be no assurance that the
particular result expected by us will occur. Except as required
by applicable securities laws, we undertake no obligation to
update publicly any forward-looking statements for any reason
after the date of this Prospectus or to conform these statements
to actual results or to changes in our expectations.
DOCUMENTS
INCORPORATED BY REFERENCE
Information has been incorporated by reference in this
Prospectus from documents filed with securities commissions or
similar authorities in Canada. Copies of the documents
incorporated herein by reference may be obtained on request
without charge from our Corporate Secretary at 210, 1167
Kensington Crescent N.W., Calgary, Alberta T2N 1X7
telephone
(403) 670-7377,
and are available electronically at www.sedar.com.
We have filed the following documents with the securities
commissions or similar regulatory authorities in certain of the
provinces of Canada and such documents are specifically
incorporated by reference in this Prospectus:
|
|
|
|
|
our Renewal Annual Information Form dated March 5, 2008,
for the year ended December 31, 2007 (the
AIF);
|
|
|
|
our Management Proxy Circular dated March 23, 2007 relating
to the annual and special meeting of shareholders held on
May 2, 2007;
|
|
|
|
our Management Proxy Circular dated March 20, 2008 relating
to the annual and special meeting of shareholders held on
May 7, 2008;
|
|
|
|
our audited financial statements, together with the notes
thereto, for the years ended December 31, 2007 and 2006 and
the auditors report thereon addressed to our shareholders;
|
|
|
|
our managements discussion and analysis of financial
condition and results of operations dated March 5, 2008,
for the year ended December 31, 2007;
|
|
|
|
our unaudited interim consolidated financial statements as at
and for the three months ended March 31, 2008, together
with the notes thereto;
|
|
|
|
our managements discussion and analysis of financial
condition and results of operations dated April 30, 2008,
for the three months ended March 31, 2008; and
|
|
|
|
the reconciliation of our consolidated financial statements as
at and for the three months ended March 31, 2008 to U.S.
GAAP, filed on June 3, 2008 under the heading
Other.
|
Any documents of the type required by National Instrument
44-101 Short Form Prospectus Distributions of
the Canadian Securities Administrators to be incorporated by
reference in a short form prospectus, including any annual
information form, comparative annual financial statements and
the auditors report thereon, comparative interim financial
statements, managements discussion and analysis of
financial condition and results of operations, material change
report (except a confidential material change report), business
acquisition report and information circular, if filed by us with
the securities commissions or similar authorities in the
provinces of Canada after the date of this Prospectus shall be
deemed to be incorporated by reference in this Prospectus.
Any report filed by us with the SEC pursuant to section 13(a),
13(c), 14 or 15(d) of the United States Securities Exchange Act
of 1934 after the date of this Prospectus shall be deemed to be
incorporated by reference into the registration statement of
which this Prospectus forms a part, if and to the extent
expressly provided in such report.
Any statement contained in this Prospectus or in a document
incorporated or deemed to be incorporated by reference herein
will be deemed to be modified or superseded for purposes of this
Prospectus to the extent that a statement contained in this
Prospectus or in any other subsequently filed document which
also is, or is deemed to be, incorporated by reference into this
Prospectus modifies or supersedes that statement. The modifying
or superseding statement need not state that it has modified or
superseded a prior statement or include any other
2
information set forth in the document that it modifies or
supersedes. The making of a modifying or superseding statement
shall not be deemed an admission for any purposes that the
modified or superseded statement when made, constituted a
misrepresentation, an untrue statement of a material fact or an
omission to state a material fact that is required to be stated
or that is necessary to make a statement not misleading in light
of the circumstances in which it was made. Any statement so
modified or superseded shall not be deemed, except as so
modified or superseded, to constitute part of this
Prospectus.
Upon a new annual information form and related audited annual
financial statements and managements discussion and
analysis being filed by us with, and where required, accepted
by, the securities commission or similar regulatory authority in
each of the provinces of British Columbia, Alberta, Manitoba and
Ontario during the term of this Prospectus, the previous annual
information form, the previous audited annual financial
statements and related managements discussion and
analysis, all unaudited interim financial statements and related
managements discussion and analysis, material change
reports and business acquisition reports filed prior to the
commencement of our financial year in which the new annual
information form and related audited annual financial statements
and managements discussion and analysis are filed shall be
deemed no longer to be incorporated into this Prospectus for
purposes of future offers and sales of Securities under this
Prospectus. Upon new interim financial statements and related
managements discussion and analysis being filed by us with
the securities commission or similar regulatory authority in
each of the provinces of British Columbia, Alberta, Manitoba and
Ontario during the term of this Prospectus, all interim
financial statements and related managements discussion
and analysis filed prior to the new interim consolidated
financial statements and related managements discussion
and analysis shall be deemed no longer to be incorporated into
this Prospectus for purposes of future offers and sales of
Securities under this Prospectus. Upon a new information
circular relating to an annual meeting of holders of Common
Shares being filed by us with the securities commission or
similar regulatory authority in each of the provinces of British
Columbia, Alberta, Manitoba and Ontario during the term of this
Prospectus, the information circular for the preceding annual
meeting of holders of Common Shares shall be deemed no longer to
be incorporated into this Prospectus for purposes of future
offers and sales of Securities under this Prospectus.
One or more Prospectus Supplements containing the specific
variable terms for an issue of the Securities and other
information in relation to such Securities will be delivered to
purchasers of such Securities together with this Prospectus and
will be deemed to be incorporated by reference into this
Prospectus as of the date of the Prospectus Supplement solely
for the purposes of the offering of the Securities covered by
any such Prospectus Supplement.
WHERE YOU
CAN FIND ADDITIONAL INFORMATION
We have filed with the SEC a registration statement on
Form F-10
relating to the Securities. This Prospectus, which constitutes a
part of the registration statement, does not contain all of the
information contained in the registration statement, certain
items of which are contained in the exhibits to the registration
statement as permitted by the rules and regulations of the SEC.
We file annual and quarterly financial information and material
change reports and other material with the SEC and with the
securities commissions or similar regulatory authorities in
Canada. Under a multi-jurisdictional disclosure system adopted
by the United States, documents and other information that we
file with the SEC may be prepared in accordance with the
disclosure requirements of Canada, which are different from
those of the United States. You may read and copy any document
that we have filed with the SEC at the SECs public
reference rooms in Washington, D.C. and Chicago, Illinois. You
may also obtain copies of those documents from the public
reference room of the SEC at 100 F Street, N.E., Washington,
D.C. 20549 by paying a fee. You should call the SEC at
1-800-SEC-0330
or access its website at www.sec.gov for further information
about the public reference rooms. You may read and download some
of the documents we have filed with the SECs Electronic
Data Gathering and Retrieval system at www.sec.gov. You may read
and download any public document that we have filed with the
securities commissions or similar regulatory authorities in
Canada at www.sedar.com.
ENFORCEABILITY
OF CIVIL LIABILITIES
We are a corporation existing under the Business Corporations
Act (Alberta). The majority of our officers and directors
and some of the experts named in this Prospectus, are residents
of Canada or otherwise reside outside the United States, and
all, or a substantial portion of their assets and a substantial
portion of our assets, are located outside the United States. We
have appointed an agent for service of process in the United
States, but it may be difficult for holders of Securities who
reside in the United States to effect service within the United
States upon those directors, officers and
3
experts who are not residents of the United States. It may also
be difficult for holders of Securities who reside in the United
States to realize in the United States upon judgments of courts
of the United States predicated upon our civil liability and the
civil liability of our directors, officers and experts under the
United States federal securities laws. We have been advised by
our Canadian counsel, Bennett Jones LLP, that a judgment of a
United States court predicated solely upon civil liability under
United States federal securities laws would probably be
enforceable in Canada if the United States court in which the
judgment was obtained has a basis for jurisdiction in the matter
that would be recognized by a Canadian court for the same
purposes. We have also been advised by Bennett Jones LLP,
however, that there is substantial doubt whether an action could
be brought in Canada in the first instance on the basis of
liability predicated solely upon United States federal
securities laws.
We filed with the SEC, concurrently with our registration
statement on
Form F-10,
an appointment of agent for service of process on
Form F-X.
Under the
Form F-X,
we appointed DL Services, Inc. at 1420, Fifth Avenue,
Suite 3400, Seattle, Washington 98101 as our agent for
service of process in the United States in connection with any
investigation or administrative proceeding conducted by the SEC,
and any civil suit or action brought against or involving us in
a United States court arising out of or related to or concerning
the offering of the Securities under this Prospectus.
RISK
FACTORS
A prospective purchaser of Securities should carefully
consider the list of risk factors set forth below as well as the
other information contained in and incorporated by reference in
this Prospectus before purchasing our Securities.
All of
our potential products, including
REOLYSIN®,
are in the research and development stage and will require
further development and testing before they can be marketed
commercially.
Prospects for companies in the biotechnology industry generally
may be regarded as uncertain given the nature of the industry
and, accordingly, investments in biotechnology companies should
be regarded as speculative. We are currently in the research and
development stage on one product,
REOLYSIN®,
for human application, the riskiest stage for a company in the
biotechnology industry. It is not possible to predict, based
upon studies in animals and early stage human clinical trials
whether
REOLYSIN®
will prove to be safe and effective in humans.
REOLYSIN®
will require additional research and development, including
extensive additional clinical testing, before we will be able to
obtain the approvals of the relevant regulatory authorities in
applicable countries to market
REOLYSIN®
commercially. There can be no assurance that the research and
development programs we conducted will result in
REOLYSIN®
or any other products becoming commercially viable products, and
in the event that any product or products result from the
research and development program, it is unlikely they will be
commercially available for a number of years.
To achieve profitable operations we, alone or with others, must
successfully develop, introduce and market our products. To
obtain regulatory approvals for products being developed for
human use, and to achieve commercial success, human clinical
trials must demonstrate that the product is safe for human use
and that the product shows efficacy. Unsatisfactory results
obtained from a particular study relating to a program may cause
us to abandon our commitment to that program or the product
being tested. No assurances can be provided that any current or
future animal or human test, if undertaken, will yield
favourable results. If we are unable to establish that
REOLYSIN®
is a safe, effective treatment for cancer, we may be required to
abandon further development of the product and develop a new
business strategy.
There are
inherent risks in pharmaceutical research and
development.
Pharmaceutical research and development is highly speculative
and involves a high and significant degree of risk. The
marketability of any product we develop will be affected by
numerous factors beyond our control, including but not limited
to:
|
|
|
|
|
the discovery of unexpected toxicities or lack of sufficient
efficacy of products which make them unattractive or unsuitable
for human use;
|
|
|
|
preliminary results as seen in animal and/or limited human
testing may not be substantiated in larger, controlled clinical
trials;
|
|
|
|
manufacturing costs or other production factors may make
manufacturing of products ineffective, impractical and
non-competitive;
|
|
|
|
proprietary rights of third parties or competing products or
technologies may preclude commercialization;
|
4
|
|
|
|
|
requisite regulatory approvals for the commercial distribution
of products may not be obtained; and
|
|
|
|
other factors may become apparent during the course of research,
up-scaling or manufacturing which may result in the
discontinuation of research and other critical projects.
|
Our products under development have never been manufactured on a
commercial scale, and there can be no assurance that such
products can be manufactured at a cost or in a quantity to
render such products commercially viable. Production and
utilization of our products may require the development of new
manufacturing technologies and expertise. The impact on our
business in the event that new manufacturing technologies and
expertise are required to be developed is uncertain. There can
be no assurance that we will successfully meet any of these
technological challenges, or others that may arise in the course
of development.
Pharmaceutical
products are subject to intense regulatory approval
processes.
The regulatory process for pharmaceuticals, which includes
preclinical studies and clinical trials of each compound to
establish its safety and efficacy, takes many years and requires
the expenditure of substantial resources. Moreover, if
regulatory approval of a drug is granted, such approval may
entail limitations on the indicated uses for which it may be
marketed. Failure to comply with applicable regulatory
requirements can, among other things, result in suspension of
regulatory approvals, product recalls, seizure of products,
operating restrictions and criminal prosecution. Further,
government policy may change, and additional government
regulations may be established that could prevent or delay
regulatory approvals for our products. In addition, a marketed
drug and its manufacturer are subject to continual review. Later
discovery of previously unknown problems with the product or
manufacturer may result in restrictions on such product or
manufacturer, including withdrawal of the product from the
market and risk of litigation.
The U.S. Food and Drug Administration (the
FDA) in the United States and similar
regulatory authorities in other countries may deny approval of a
new drug application if required regulatory criteria are not
satisfied, or may require additional testing. Product approvals
may be withdrawn if compliance with regulatory standards is not
maintained or if problems occur after the product reaches the
market. The FDA and similar regulatory authorities in other
countries may require further testing and surveillance programs
to monitor the pharmaceutical product that has been
commercialized. Non-compliance with applicable requirements can
result in fines and other judicially imposed sanctions,
including product withdrawals, product seizures, injunction
actions and criminal prosecutions.
In addition to our own pharmaceuticals, we may supply active
pharmaceutical ingredients and advanced pharmaceutical
intermediates for use in our customers drug products. The
final drug products in which the pharmaceutical ingredients and
advanced pharmaceutical intermediates are used, however, are
subject to regulation for safety and efficacy by the FDA and
other jurisdictions, as the case may be. Such products must be
approved by such agencies before they can be commercially
marketed. The process of obtaining regulatory clearance for
marketing is uncertain, costly and time consuming. We cannot
predict how long the necessary regulatory approvals will take or
whether our customers will ever obtain such approval for their
products. To the extent that our customers do not obtain the
necessary regulatory approvals for marketing new products, our
product sales could be adversely affected.
The FDA and other governmental regulators have increased
requirements for drug purity and have increased environmental
burdens upon the pharmaceutical industry. Because pharmaceutical
drug manufacturing is a highly regulated industry, requiring
significant documentation and validation of manufacturing
processes and quality control assurance prior to approval of the
facility to manufacture a specific drug, there can be
considerable transition time between the initiation of a
contract to manufacture a product and the actual initiation of
manufacture of that product. Any lag time in the initiation of a
contract to manufacture product and the actual initiation of
manufacture could cause us to lose profits or incur liabilities.
The pharmaceutical regulatory regime in Europe and other
countries is, by and large, generally similar to that of the
United States. We could face similar risks in these other
jurisdictions, as the risks described above.
Our operations and products may be subject to other government
manufacturing and testing regulations.
Securing regulatory approval for the marketing of therapeutics
by the FDA in the United States and similar regulatory agencies
in other countries is a long and expensive process, which can
delay or prevent product development and marketing. Approval to
market products may be for limited applications or may not be
received at all.
The products we anticipate manufacturing will have to comply
with the FDAs current Good Manufacturing Practices
(GMP) and other FDA, and local government
guidelines and regulations, including other international
regulatory requirements and guidelines. Additionally, certain of
our customers may require the manufacturing facilities
5
contracted by us to adhere to additional manufacturing
standards, even if not required by the FDA. Compliance with GMP
regulations requires manufacturers to expend time, money and
effort in production, and to maintain precise records and
quality control to ensure that the product meets applicable
specifications and other requirements. The FDA and other
regulatory bodies periodically inspect drug-manufacturing
facilities to ensure compliance with applicable GMP
requirements. If the manufacturing facilities contracted by us
fail to comply with the GMP requirements, the facilities may
become subject to possible FDA or other regulatory action and
manufacturing at the facility could consequently be suspended.
We may not be able to contract suitable alternative or back-up
manufacturing facilities on terms acceptable to us or at all.
The FDA or other regulatory agencies may also require the
submission of any lot of a particular product for inspection. If
the lot product fails to meet the FDA requirements, then the FDA
could take any of the following actions: (i) restrict the
release of the product; (ii) suspend manufacturing of the
specific lot of the product; (iii) order a recall of the
lot of the product; or (iv) order a seizure of the lot of
the product.
We are subject to regulation by governments in many
jurisdictions and, if we do not comply with healthcare, drug,
manufacturing and environmental regulations, among others, our
existing and future operations may be curtailed, and we could be
subject to liability.
In addition to the regulatory approval process, we may be
subject to regulations under local, provincial, state, federal
and foreign law, including requirements regarding occupational
health, safety, laboratory practices, environmental protection
and hazardous substance control, and may be subject to other
present and future local, provincial, state, federal and foreign
regulations.
The
biotechnology industry is extremely competitive and we must
successfully compete with larger companies with substantially
greater resources.
Technological competition in the pharmaceutical industry is
intense and we expect competition to increase. Other companies
are conducting research on therapeutics involving the Ras
pathway as well as other novel treatments or therapeutics for
the treatment of cancer which may compete with our product. Many
of these competitors are more established, benefit from greater
name recognition and have substantially greater financial,
technical and marketing resources than us. In addition, many of
these competitors have significantly greater experience in
undertaking research, preclinical studies and human clinical
trials of new pharmaceutical products, obtaining regulatory
approvals and manufacturing and marketing such products. In
addition, there are several other companies and products with
which we may compete from time to time, and which may have
significantly better and larger resources than us. Accordingly,
our competitors may succeed in manufacturing and/or
commercializing products more rapidly or effectively, which
could have a material adverse effect on our business, financial
condition or results of operations.
We anticipate that we will face increased competition in the
future as new products enter the market and advanced
technologies become available. There can be no assurance that
existing products or new products developed by our competitors
will not be more effective, or be more effectively manufactured,
marketed and sold, than any that may be developed or sold by us.
Competitive products may render our products obsolete and
uncompetitive prior to recovering research, development or
commercialization expenses incurred with respect to any such
products.
We rely
on patents and proprietary rights to protect our
technology.
Our success will depend, in part, on our ability to obtain
patents, maintain trade secret protection and operate without
infringing the rights of third parties. We have patents in the
United States, Canada and Europe and have filed applications for
patents in the United States and under the PCT, allowing us to
file in other jurisdictions. See Narrative
Description Patent and Patent Application
Summary in our AIF. Our success will depend, in part, on
our ability to obtain, enforce and maintain patent protection
for our technology in Canada, the United States and other
countries. We cannot be assured that patents will issue from any
pending applications or that claims now or in the future, if
any, allowed under issued patents will be sufficiently broad to
protect our technology. In addition, no assurance can be given
that any patents issued to or licensed by us will not be
challenged, invalidated, infringed or circumvented, or that the
rights granted thereunder will provide continuing competitive
advantages to us.
The patent positions of pharmaceutical and biotechnology firms,
including us, are generally uncertain and involve complex legal
and factual questions. In addition, it is not known whether any
of our current research endeavours will result in the issuance
of patents in Canada, the United States, or elsewhere, or if any
patents already issued will provide significant proprietary
protection or will be circumvented or invalidated. Since patent
applications in the United States
6
and Canada may be maintained in secrecy until at least
18 months after filing of the original priority
application, and since publication of discoveries in the
scientific or patent literature tends to lag behind actual
discoveries by several months, we cannot be certain that we or
any licensor were the first to create inventions claimed by
pending patent applications or that we or the licensor were the
first to file patent applications for such inventions. Loss of
patent protection could lead to generic competition for these
products, and others in the future, which would materially and
adversely affect our financial prospects for these products and
which could have a material adverse effect on our business,
financial condition or results of operations.
Similarly, since patent applications filed before
November 29, 2000 in the United States may be maintained in
secrecy until the patents issue or foreign counterparts, if any,
publish, we cannot be certain that we or any licensor were the
first creator of inventions covered by pending patent
applications or that we or such licensor were the first to file
patent applications for such inventions. There is no assurance
that our patents, if issued, would be held valid or enforceable
by a court or that a competitors technology or product
would be found to infringe such patents.
Accordingly, we may not be able to obtain and enforce effective
patents to protect our proprietary rights from use by
competitors, and the patents of other parties could require us
to stop using or pay to use certain intellectual property, and
as such, our competitive position and profitability could suffer
as a result.
In addition, we may be required to obtain licenses under patents
or other proprietary rights of third parties. No assurance can
be given that any licenses required under such patents or
proprietary rights will be available on terms acceptable to us.
If we do not obtain such licenses, we could encounter delays in
introducing one or more of our products to the market while we
attempt to design around such patents, or could find that the
development, manufacture or sale of products requiring such
licenses could be foreclosed. In addition, we could incur
substantial costs in defending ourselves in suits brought
against us on such patents or in suits in which our attempts to
enforce our own patents against other parties.
Our
products may fail or cause harm, subjecting us to product
liability claims.
Use of our product during current clinical trials may entail
risk of product liability. We maintain clinical trial liability
insurance; however, it is possible this coverage may not provide
full protection against all risks. Given the scope and
complexity of the clinical development process, the uncertainty
of product liability litigation, and the shrinking capacity of
insurance underwriters, it is not possible at this time to
assess the adequacy of current clinical trial coverage, nor the
ability to secure continuing coverage at the same level and at
reasonable cost in the foreseeable future. While we carry, and
intend to continue carrying amounts believed to be appropriate
under the circumstances, it is not possible at this time to
determine the adequacy of such coverage.
In addition, the sale and commercial use of our product entails
risk of product liability. We currently do not carry any product
liability insurance for this purpose. There can be no assurance
that we will be able to obtain appropriate levels of product
liability insurance prior to any sale of our pharmaceutical
products. An inability to obtain insurance on economically
feasible terms or to otherwise protect against potential product
liability claims could inhibit or prevent the commercialization
of products developed by us. The obligation to pay any product
liability claim or a recall of a product could have a material
adverse effect on our business, financial condition and future
prospects.
We have
limited manufacturing experience and intend to rely on third
parties to commercially manufacture our products, if and when
developed.
To date, we have relied upon a contract manufacturer to
manufacture small quantities of
REOLYSIN®.
The manufacturer may encounter difficulties in scaling up
production, including production yields, quality control and
quality assurance. Only a limited number of manufacturers can
supply therapeutic viruses and failure by the manufacturer to
deliver the required quantities of
REOLYSIN®
on a timely basis at a commercially reasonable price may have a
material adverse effect on us. We have completed a program for
the development of a commercial process for manufacturing
REOLYSIN®
and have filed a number of patent applications related to the
process. There can be no assurance that we will successfully
obtain sufficient patent protection related to our manufacturing
process.
New
products may not be accepted by the medical community or
consumers.
Our primary activity to date has been research and development
and we have no experience in marketing or commercializing
products. We will likely rely on third parties to market our
products, assuming that they receive regulatory approvals. If we
rely on third parties to market our products, the commercial
success of such product may be outside of our control. Moreover,
there can be no assurance that physicians, patients or the
medical community will accept
7
our product even if it proves to be safe and effective and is
approved for marketing by Health Canada, the FDA and other
regulatory authorities. A failure to successfully market our
product would have a material adverse effect on our revenue.
Our
technologies may become obsolete.
The pharmaceutical industry is characterized by rapidly changing
markets, technology, emerging industry standards and frequent
introduction of new products. The introduction of new products
embodying new technologies, including new manufacturing
processes, and the emergence of new industry standards may
render our products obsolete, less competitive or less
marketable. The process of developing our products is extremely
complex and requires significant continuing development efforts
and third party commitments. Our failure to develop new
technologies and products and the obsolescence of existing
technologies could adversely affect our business.
We may be unable to anticipate changes in our potential customer
requirements that could make our existing technology obsolete.
Our success will depend, in part, on our ability to continue to
enhance our existing technologies, develop new technology that
addresses the increasing sophistication and varied needs of the
market, and respond to technological advances and emerging
industry standards and practices on a timely and cost-effective
basis. The development of our proprietary technology entails
significant technical and business risks. We may not be
successful in using our new technologies or exploiting our niche
markets effectively or adapting our businesses to evolving
customer or medical requirements or preferences or emerging
industry standards.
We are
highly dependent on third party relationships for research and
clinical trials.
We rely upon third party relationships for assistance in the
conduct of research efforts, pre-clinical development and
clinical trials, and manufacturing. In addition, we expect to
rely on third parties to seek regulatory approvals for and to
market our product. Although we believe that our collaborative
partners will have an economic motivation to commercialize our
product included in any collaborative agreement, the amount and
timing of resources diverted to these activities generally is
expected to be controlled by the third party. Furthermore, if we
cannot maintain these relationships, our business may suffer.
We have
no operating revenues and a history of losses.
To date, we have not generated sufficient revenues to offset our
research and development costs and accordingly have not
generated positive cash flow or made an operating profit. As of
December 31, 2007, we had an accumulated deficit of
$80.5 million and we incurred net losses of
$15.6 million, $14.3 million, and $12.8 million,
for the years ended December 31, 2007, 2006 and 2005,
respectively. As at March 31, 2008, we had an accumulated
deficit of $83.3 million and in the three month period then
ended we incurred a net loss of $3.3 million. We anticipate
that we will continue to incur significant losses during 2008
and in the foreseeable future. We do not expect to reach
profitability at least until after successful and profitable
commercialization of one or more of our products. Even if one or
more of our products are profitably commercialized, the initial
losses incurred by us may never be recovered.
We may
not be able to obtain third-party reimbursement for the cost of
our product.
Uncertainty exists regarding the reimbursement status of
newly-approved pharmaceutical products and reimbursement may not
be available for
REOLYSIN®.
Any reimbursements granted may not be maintained or limits on
reimbursements available from third-party payors may reduce the
demand for, or negatively affect the price of, these products.
If
REOLYSIN®
does not qualify for reimbursement, if reimbursement levels
diminish, or if reimbursement is denied, our sales and
profitability would be adversely affected.
We may
need additional financing in the future to fund the research and
development of our products and to meet our ongoing capital
requirements.
As at December 31, 2007, we had cash and cash equivalents
(including short-term investments) of $25.2 million and
working capital of approximately $22.4 million. As at
March 31, 2008, we had cash and cash equivalents (including
short-term investments) of $22.0 million and working
capital of approximately $19.5 million. We anticipate that
we may need additional financing in the future to fund research
and development and to meet our ongoing capital requirements.
The amount of future capital requirements will depend on many
factors, including continued scientific progress in our drug
discovery and development programs, progress in our pre-clinical
and clinical evaluation of drug candidates, time and expense
associated with filing, prosecuting and enforcing our patent
claims and costs associated with obtaining regulatory approvals.
In order to meet such capital requirements, we will consider
contract fees, collaborative research and development
arrangements, and additional public or private financings
(including the incurrence of debt and the issuance
8
of additional equity securities) to fund all or a part of
particular programs as well as potential partnering or licensing
opportunities. There can be no assurance that additional funding
will be available or, if available, that it will be available on
acceptable terms. If adequate funds are not available on terms
favorable to us, we may have to reduce substantially or
eliminate expenditures for research and development, testing,
production and marketing of our proposed product, or obtain
funds through arrangements with corporate partners that require
us to relinquish rights to certain of our technologies or
product. There can be no assurance that we will be able to raise
additional capital if our current capital resources are
exhausted.
The cost
of director and officer liability insurance may increase
substantially and may affect our ability to retain quality
directors and officers.
We carry liability insurance on behalf of our directors and
officers. Given a number of large director and officer liability
insurance claims in the U.S. equity markets, director and
officer liability insurance has become increasingly more
expensive with increased restrictions. Consequently, there is no
assurance that we will continue to be offered this insurance or
be able to obtain adequate coverage. The inability to acquire
the appropriate insurance coverage may limit our ability to
attract and maintain directors and officers as required to
conduct our business.
We are
dependent on our key employees and collaborators.
Our ability to develop the product will depend, to a great
extent, on our ability to attract and retain highly qualified
scientific personnel and to develop and maintain relationships
with leading research institutions. Competition for such
personnel and relationships is intense. We are highly dependent
on the principal members of our management staff, as well as our
advisors and collaborators, the loss of whose services might
impede the achievement of development objectives. The persons
working with us are affected by a number of influences outside
of our control. The loss of key employees and/or key
collaborators may affect the speed and success of product
development.
We presently carry key man insurance in the amounts of
$1,500,000, $1,000,000 and $500,000 for Dr. Thompson,
Dr. Coffey and Mr. Ball, respectively.
Our share
price may be highly volatile.
Market prices for securities of biotechnology companies
generally are volatile. This increases the risk of securities
litigation. Factors such as announcements (publicly made or at
scientific conferences) of technological innovations, new
commercial products, patents, the development of proprietary
rights, results of clinical trials, regulatory actions,
publications, quarterly financial results, our financial
position, public concern over the safety of biotechnology,
future sales of shares by us or our current shareholders and
other factors could have a significant effect on the market
price and volatility of the Common Shares.
We incur
some of our expenses in foreign currencies and therefore we are
exposed to foreign currency exchange rate
fluctuations.
We incur some of our manufacturing, clinical, collaborative and
consulting expenses in foreign currencies (primarily the U.S.
dollar and the British Pound (BP). Over the
past few years the Canadian dollar has appreciated relative to
the U.S. dollar and the BP thereby decreasing the Canadian
dollar equivalent. However, if this trend reverses, our Canadian
dollar equivalent costs will increase.
Also, as we expand to other foreign jurisdictions there may be
an increase in our foreign exchange exposure.
We earn
interest income on our excess cash reserves and are exposed to
changes in interest rates.
We invest our excess cash reserves in investment vehicles that
provide a rate of return with little risk to principal. As
interest rates change the amount of interest income we earn will
be directly impacted.
ONCOLYTICS
BIOTECH INC.
Oncolytics Biotech Inc. was incorporated pursuant to the
provisions of the Business Corporations Act (Alberta) on
April 2, 1998 as 779738 Alberta Ltd. On April 8, 1998,
we amended our articles and changed our name to Oncolytics
Biotech Inc. On July 29, 1999, we further amended our
articles by removing the private company restrictions and
subdividing our 2,222,222 Common Shares issued and outstanding
into 6,750,000 Common Shares. On February 9, 2007, we
further amended our articles to permit for our shareholder
meetings to be held at any place in Alberta or at any other
location as determined by our directors.
9
Our head office and principal place of business is located at
210, 1167 Kensington Crescent N.W., Calgary, Alberta T2N 1X7.
Our registered office is located at 4500 Bankers Hall East,
855 2nd Street S.W., Calgary, Alberta T2P 4K7.
OUR
BUSINESS
We focus on the discovery and development of oncolytic viruses
for the treatment of cancers that have not been successfully
treated with conventional therapeutics. Recent scientific
advances in oncology, virology, and molecular biology have
created opportunities for new approaches to the treatment of
cancer. The product we are presently developing may represent a
novel treatment for Ras-mediated cancers which can be used as an
alternative to existing cytotoxic or cytostatic therapies or as
an adjuvant therapy to conventional chemotherapy, radiation
therapy, or surgical resections. It could also potentially be
used to treat certain cellular proliferative disorders for which
no current therapy exists.
Our technologies are based primarily on discoveries in the
Department of Microbiology and Infectious Diseases at the
University of Calgary in the 1990s. Oncolytics was formed
in 1998 to explore the natural oncolytic capability of the
reovirus, a virus that preferentially replicates in cells with
an activated Ras pathway.
The lead product being developed by us may represent a novel
treatment for certain tumour types and some cellular
proliferative disorders. Our lead product is a virus that is
able to replicate specifically in, and hence kill, certain
tumour cells both in tissue culture as well as in a number of
animal models without damaging normal cells.
Our potential product for human use,
REOLYSIN®,
is developed from the reovirus. This virus has been demonstrated
to replicate specifically in tumour cells bearing an activated
Ras pathway. Activating mutations of Ras occur in approximately
thirty per cent of all human tumours directly, but considering
its central role in signal transduction, activation of the Ras
pathway has been shown to play a role in approximately
two-thirds of all tumours.
The functionality of
REOLYSIN®
is based upon the finding that tumours bearing an activated Ras
pathway are deficient in their ability to activate the
anti-viral response mediated by the host cellular protein,
Protein Kinase R (PKR). Since PKR is
responsible for preventing reovirus replication, tumour cells
lacking the activity of PKR are susceptible to reovirus
infections. As normal cells do not possess Ras activations,
these cells are able to thwart reovirus infections by the
activity of PKR. In a tumour cell with an activated Ras pathway,
reovirus is able to freely replicate and hence kill the host
tumour cell. The result of this replication is progeny viruses
that are then free to infect surrounding cancer cells. This
cycle of infection, replication and cell death is believed to be
repeated until there are no longer any tumour cells carrying an
activated Ras pathway available.
The following schematic illustrates the molecular basis of how
the reovirus kills cancer cells.
For both non-cancer cells and cancer cells with an activated Ras
pathway, virus binding, entry, and production of viral genes all
proceed normally. In the case of normal cells however, the viral
genes cause the activation of the anti-viral response that is
mediated by the host cells PKR, thus blocking the
replication of the reovirus. In cells with an activated Ras
pathway, the activation of PKR is prevented or reversed by an
element of the Ras signal transduction pathway, thereby allowing
the replication of the reovirus in these cancer cells. The end
result of this replication is the death of the cancer
10
cell. The action of the Ras pathway in allowing reovirus
replication to ensue can be mimicked in non-cancerous cells by
treating these cells with the chemical
2-aminopurine
which prevents the activation of PKR.
RECENT
DEVELOPMENTS
REOLYSIN®
Development since the First Quarter of 2008
Clinical
Trial Program
Clinical
Trials Results
In June 2008, we announced that interim results of our Phase II
study of intravenous
REOLYSIN®
in patients with sarcomas metastatic to the lung were presented
at the American Society of Clinical Oncology annual meeting. The
presentation, entitled A Phase II Study of Intravenous
REOLYSIN (Wild-type Reovirus) in the Treatment of Patients with
Bone and Soft Tissue Sarcomas Metastatic to the Lung was
delivered by Dr. Monica Mita, the study principal
investigator and her team at the Institute of Drug Development,
the Cancer Therapy and Research Center at the University of
Texas Health Science Center, San Antonio, Texas.
The interim results demonstrated that the treatment has been
well tolerated to date, with 8 of 16 evaluable patients
experiencing stable disease for periods ranging from two to more
than ten,
28-day
cycles. As previously announced by Oncolytics, the third patient
treated in the study was demonstrated to have stable disease by
RECIST criteria for more than six months as measured by
CT scan. A PET scan taken at the same time showed that any
residual mass was metabolically inert.
In April 2008, we completed patient enrolment in the dose
escalation portion and reported positive interim results from
our U.K. clinical trial to evaluate the anti-tumour effects of
systemic administration of
REOLYSIN®
in combination with paclitaxel and carboplatin in patients with
advanced cancers including head and neck, melanoma, lung and
ovarian.
Four of the first eight patients treated in the study to date
have a diagnosis of carcinoma of the head and neck. All three
head and neck patients evaluated to date have had excellent
clinical and radiological responses without appreciable
toxicity. Preliminary assessment after recruitment of the first
two cohorts has suggested that patients with head and neck
carcinomas may represent a group of patients in whom the
combination of carboplatin/paclitaxel and
REOLYSIN®
is active.
In the first cohort, the patient with head and neck cancer
received 8 cycles of treatment (the maximum allowed) and
achieved a clinical complete response. In the second cohort, the
two patients with head and neck cancers with widespread
disseminated disease have each received six cycles of treatment
to date and both have achieved significant partial responses.
Two of the three patients, including the patient with the
clinical complete response, had previously received
cisplatin/5-FU treatment and all three had previously received
radiotherapy.
The trial has two components. The first is an open-label,
dose-escalating, non-randomized study of
REOLYSIN®
given intravenously with paclitaxel and carboplatin every three
weeks. Standard dosages of paclitaxel and carboplatin were
delivered to patients with escalating dosages of
REOLYSIN®
intravenously. The second component of the trial includes the
enrolment of a further 12 patients at the maximum dosage of
REOLYSIN®
in combination with a standard dosage of paclitaxel and
carboplatin.
Eligible patients include those who have been diagnosed with
advanced or metastatic solid tumours such as head and neck,
melanoma, lung and ovarian cancers that are refractory (have not
responded) to standard therapy or for which no curative standard
therapy exists. The primary objective of the trial is to
determine the Maximum Tolerated Dose, Dose-Limiting Toxicity,
recommended dose and dosing schedule and safety profile of
REOLYSIN®
when administered in combination with paclitaxel and
carboplatin. Secondary objectives include the evaluation of
immune response to the drug combination, the bodys
response to the drug combination compared to chemotherapy alone
and any evidence of anti-tumour activity.
Clinical
Trials Approved to Commence
In May 2008, we announced that we received a letter of approval
from the U.K. Medicines and Healthcare Products Regulatory
Agency for our Clinical Trial Application to begin a Phase II
clinical trial using intravenous administration of
REOLYSIN®
in combination with paclitaxel and carboplatin in patients with
advanced head and neck cancers. The principal investigator is
Dr. Kevin Harrington of The Institute of Cancer Research
and The Royal Marsden NHS Foundation Trust.
11
This trial is a 14 patient, single arm, open-label,
dose-targeted, non-randomized, multi-centre trial of
REOLYSIN®
given intravenously in combination with a standard dosage of
paclitaxel and carboplatin. Patients with a variety of advanced
cancers, including head and neck cancers, will continue to be
treated in the ongoing U.K. combination paclitaxel and
carboplatin trial.
Eligible patients include those with advanced or metastatic head
and neck cancer that are refractory to standard therapy or for
which no curative standard therapy exists. The primary objective
of the Phase II trial is to measure tumour responses and
duration of response, and to describe any evidence of antitumour
activity. The secondary objective is to determine the safety and
tolerability of
REOLYSIN®
when administered in combination with paclitaxel and carboplatin
to patients with advanced or metastatic head and neck cancer.
Clinical
Trials Actively Enrolling
In June 2008, we announced that we commenced patient enrolment
in the Phase II clinical trial described above under
Clinical Trials Approved to
Commence using intravenous administration of
REOLYSIN®
in combination with paclitaxel and carboplatin in patients with
advanced head and neck cancers.
In May 2008, we announced that we had begun patient enrolment in
a clinical trial using intravenous administration of
REOLYSIN®
in combination with cyclophosphamide, a chemotherapeutic agent
as well as immune modulator, in patients with advanced cancers.
The Principal Investigators are Dr. James Spicer of
Kings College in London, Dr. Johann de Bono and
Dr. Kevin Harrington of The Royal Marsden NHS Foundation
Trust and The Institute of Cancer Research, London, and
Professor Hardev Pandha of the Royal Surrey County Hospital NHS
Trust, Surrey and Mount Alvernia Hospitals.
The trial is an open-label, dose-escalating, non-randomized
trial of
REOLYSIN®
given intravenously with escalating doses of cyclophosphamide. A
standard dose of
REOLYSIN®
is administered intravenously over five consecutive days, while
an intravenous dose of cyclophosphamide is administered three
days before
REOLYSIN®
treatment and continues through the course of the treatment
cycle. The total number of patients studied will depend on the
number of dose levels tested, but it is anticipated to be
approximately 30 patients.
Eligible patients include those who have been diagnosed with
advanced or metastatic solid tumours including pancreatic, lung
and ovarian cancers that are refractory (have not responded) to
standard therapy or for which no curative standard therapy
exists. The primary objectives of the trial include determining
the Minimum Effective Immunomodulatory Dose of cyclophosphamide
to obtain successful immune modulation. Secondary objectives
include determining the safety profile of the combination and
gathering any evidence of anti-tumour activity.
Manufacturing
Program
In May 2008, we announced that we had successfully transferred
GMP production for
REOLYSIN®
at the 40-litre batch size to SAFC
Pharmatm,
a Division of Sigma-Aldrich Corporation. This follows the
successful scale-up from 20 litres to 40 litres announced by us
last year.
Yields at the 40-litre scale should provide sufficient doses to
support future development plans leading to registration and
also anticipated early stage commercial requirements.
Development work to support further scale-up to the 100-litre
level is currently underway.
Collaborations
In April 2008, we announced that Prof. Alan Melcher and his
research group at St. Jamess University Hospital in Leeds,
U.K. published the results of their work with reovirus in the
May 1, 2008 online issue of The Journal of Immunology. The
paper is entitled Reovirus Activates Human Dendritic Cells
to Promote Innate Antitumor Immunity.
The researchers studied the ability of reovirus to activate
human dendritic cells (DC), key regulators of
both innate and adaptive immune responses. The data demonstrated
that reovirus directly activates human DC, which in turn
stimulate innate killing of cancer cells by natural killer and T
cells, suggesting a novel potential role for T cells in
oncolytic virus-induced local tumor cell death. Combined with
the viruss ability to directly kill cancer cells, the
researchers concluded that reovirus recognition by DC may
enhance the efficacy of reovirus as a therapeutic agent.
In April 2008, we announced that Prof. Alan Melcher and his
research group at St. Jamess University Hospital in
Leeds, U.K. published the results of their work in the April 10
online issue of Gene Therapy. The paper is entitled
Inflammatory Tumour Cell Killing by Oncolytic Reovirus for
the Treatment of Melanoma.
12
The investigators showed that reovirus effectively kills and
replicates in both human melanoma cell lines and freshly
resected tumours. They demonstrated that reovirus melanoma
killing is more potent than, and distinct from, chemotherapy or
radiotherapy-induced cell death. They concluded that reovirus is
suitable for clinical testing in melanoma.
In April 2008, we announced that an oral presentation by
Dr. Chandini Thirukkumaran of the Tom Baker Cancer Centre,
Calgary, entitled Targeting Multiple Myeloma with
Oncolytic Viral Therapy was presented at the American
Association for Cancer Research (AACR) Annual
Meeting in April.
The presentation covered preclinical work using reovirus as a
purging agent during autologous (harvested from the patient
themselves) hematopoietic stem cell transplants for multiple
myeloma. The results demonstrated that up to 70% of multiple
myeloma cell lines tested showed reovirus sensitivity and
reovirus induced cell death mediated through apoptosis.
The investigators concluded that this preclinical data supports
initiating a Phase I purging trial using reovirus against
multiple myeloma.
In April 2008, we announced that a poster presentation by
Dr. Anders Kolb of the Nemours Center for Childhood Cancer
Research entitled Radiation in Combination with Reolysin
for Pediatric Sarcomas was presented at AACR.
The poster covers preclinical work using reovirus in combination
with radiation in mice implanted with pediatric rhabdomyosarcoma
and Ewings sarcoma tumours. The results demonstrated that
the combination of reovirus and radiation significantly enhanced
efficacy compared to either treatment alone in terms of tumour
regression and event-free survival.
USE OF
PROCEEDS
Unless otherwise indicated in an applicable Prospectus
Supplement relating to an offering of Securities, we will use
the net proceeds we receive from the sale of Securities for
general corporate purposes, which may include our clinical trial
program and our manufacturing activities in support of such
program. The amount of net proceeds to be used for any purpose
will be described in the applicable Prospectus Supplement.
CAPITALIZATION
On March 31, 2008, we had 41,180,748 Common Shares issued
and outstanding. Since March 31, 2008, we have issued no
Common Shares pursuant to the exercise of stock options and no
warrants have expired. As at June 16, 2008, we have
41,180,748 Common Shares issued and outstanding. After giving
effect to the exercise of all our Common Share purchase warrants
and options, we would have 49,271,241 Common Shares issued and
outstanding as at June 16, 2008.
PRIOR
SALES
On October 29, 2007, we issued 60,000 Common Shares on the
exercise of 60,000 options at an exercise price of $0.85 per
Common Share. We granted options to acquire an aggregate of
1,050 Common Shares at an exercise price of $2.35 per
Common Share and options to acquire an aggregate of
431,493 Common Shares at an exercise price of $2.22 per
Common Share on October 30, 2007 and December 12,
2007, respectively. No other Common Shares or securities
exchangeable or convertible into Common Shares have been issued
during the twelve month period preceding the date of this
Prospectus.
DESCRIPTION
OF SHARE CAPITAL
Authorized
Capital
Our authorized capital consists of an unlimited number of Common
Shares.
Common
Shares
The holders of our Common Shares are entitled to one vote per
share at meetings of shareholders, to receive such dividends as
declared by us and to receive our remaining property and assets
upon dissolution or wind up. Our Common Shares are not subject
to any future call or assessment and there are no pre-emptive,
conversion or redemption rights attached to such shares.
13
DESCRIPTION
OF SUBSCRIPTION RECEIPTS
The following description of the terms of Subscription Receipts
sets forth certain general terms and provisions of Subscription
Receipts in respect of which a Prospectus Supplement may be
filed. The particular terms and provisions of Subscription
Receipts offered by any Prospectus Supplement, and the extent to
which the general terms and provisions described below may apply
thereto, will be described in the Prospectus Supplement filed in
respect of such Subscription Receipts.
Subscription Receipts may be offered separately or in
combination with one or more other Securities. The Subscription
Receipts will be issued under a subscription receipt agreement.
A copy of the subscription receipt agreement will be filed by us
with the applicable securities commission or similar regulatory
authorities after it has been entered into by us and will be
available electronically at www.sedar.com.
Pursuant to the subscription receipt agreement, original
purchasers of Subscription Receipts will have a contractual
right of rescission against Oncolytics, following the issuance
of the underlying Common Share or other securities to such
purchasers upon the surrender or deemed surrender of the
Subscription Receipts, to receive the amount paid for the
Subscription Receipts in the event that this Prospectus and any
amendment thereto contains a misrepresentation or is not
delivered to such purchaser, provided such remedy for rescission
is exercised within 180 days from the closing date of the
offering of Subscription Receipts.
The description of general terms and provisions of Subscription
Receipts described in any Prospectus Supplement will include,
where applicable:
|
|
|
|
|
the number of Subscription Receipts offered;
|
|
|
|
the price at which the Subscription Receipts will be offered;
|
|
|
|
if other than Canadian dollars, the currency or currency unit in
which the Subscription Receipts are denominated;
|
|
|
|
the procedures for the exchange of the Subscription Receipts
into Common Shares or other securities;
|
|
|
|
the number of Common Shares or other securities that may be
obtained upon exercise of each Subscription Receipt;
|
|
|
|
the designation and terms of any other Securities with which the
Subscription Receipts will be offered, if any, and the number of
Subscription Receipts that will be offered with each Security;
|
|
|
|
the terms applicable to the gross proceeds from the sale of the
Subscription Receipts plus any interest earned thereon;
|
|
|
|
the material tax consequences of owning the Subscription
Receipts; and
|
|
|
|
any other material terms, conditions and rights (or limitations
on such rights) of the Subscription Receipts.
|
We reserve the right to set forth in a Prospectus Supplement
specific terms of the Subscription Receipts that are not within
the options and parameters set forth in this Prospectus. In
addition, to the extent that any particular terms of the
Subscription Receipts described in a Prospectus Supplement
differ from any of the terms described in this Prospectus, the
description of such terms set forth in this Prospectus shall be
deemed to have been superseded by the description of such
differing terms set forth in such Prospectus Supplement with
respect to such Subscription Receipts.
DESCRIPTION
OF WARRANTS
The following description of the terms of Warrants sets forth
certain general terms and provisions of Warrants in respect of
which a Prospectus Supplement may be filed. The particular terms
and provisions of Warrants offered by any Prospectus Supplement,
and the extent to which the general terms and provisions
described below may apply thereto, will be described in the
Prospectus Supplement filed in respect of such Warrants.
Warrants may be offered separately or in combination with one or
more other Securities.
The description of general terms and provisions of Warrants
described in any Prospectus Supplement will include, where
applicable:
|
|
|
|
|
the designation and aggregate number of Warrants offered;
|
|
|
|
the price at which the Warrants will be offered;
|
|
|
|
if other than Canadian dollars, the currency or currency unit in
which the Warrants are denominated;
|
14
|
|
|
|
|
the designation and terms of the Common Shares that may be
acquired upon exercise of the Warrants;
|
|
|
|
the date on which the right to exercise the Warrants will
commence and the date on which the right will expire;
|
|
|
|
the number of Common Shares that may be purchased upon exercise
of each Warrant and the price at which and currency or
currencies in which that amount of securities may be purchased
upon exercise of each Warrant;
|
|
|
|
the designation and terms of any Securities with which the
Warrants will be offered, if any, and the number of the Warrants
that will be offered with each Security;
|
|
|
|
the date or dates, if any, on or after which the Warrants and
the related Securities will be transferable separately;
|
|
|
|
the minimum or maximum amount, if any, of Warrants that may be
exercised at any one time;
|
|
|
|
whether the Warrants will be subject to redemption or call, and,
if so, the terms of such redemption or call provisions; and
|
|
|
|
any other material terms, conditions and rights (or limitations
on such rights) of the Warrants.
|
We reserve the right to set forth in a Prospectus Supplement
specific terms of the Warrants that are not within the options
and parameters set forth in this Prospectus. In addition, to the
extent that any particular terms of the Warrants described in a
Prospectus Supplement differ from any of the terms described in
this Prospectus, the description of such terms set forth in this
Prospectus shall be deemed to have been superseded by the
description of such differing terms set forth in such Prospectus
Supplement with respect to such Warrants.
DESCRIPTION
OF DEBT SECURITIES
The following description sets forth certain general terms and
provisions of the Debt Securities and is not intended to be
complete. The particular terms and provisions of the Debt
Securities and a description of how the general terms and
provisions described below may apply to the Debt Securities will
be included in the applicable Prospectus Supplement. The
following description is subject to the detailed provisions of
the applicable Trust Indenture. Accordingly, reference
should also be made to the applicable Trust Indenture, a
copy of which will be filed by us with the securities commission
or similar regulatory authority in each of the provinces of
British Columbia, Alberta, Manitoba and Ontario after it has
been entered into by us and will be available electronically at
www.sedar.com.
The Debt Securities will be issued under one or more indentures
(each, a Trust Indenture), in each case
between ourselves and a financial institution authorized to
carry on business as a trustee (each, a
Trustee).
Debt Securities may be offered separately or in combination with
one or more other Securities. We may, from time to time, issue
debt securities and incur additional indebtedness other than
through the issuance of Debt Securities pursuant to this
Prospectus.
General
The Debt Securities may be issued from time to time in one or
more series. We may specify a maximum aggregate principal amount
for the Debt Securities of any series and, unless otherwise
provided in the applicable Prospectus Supplement, a series of
Debt Securities may be reopened for issuance of additional Debt
Securities of such series.
Any Prospectus Supplement for Debt Securities supplementing this
Prospectus will contain the specific terms and other information
with respect to the Debt Securities being offered thereby,
including:
|
|
|
|
|
the designation, aggregate principal amount and authorized
denominations of such Debt Securities;
|
|
|
|
any limit upon the aggregate principal amount of such Debt
Securities;
|
|
|
|
the currency or currency units for which such Debt Securities
may be purchased and the currency or currency units in which the
principal and any interest is payable (in either case, if other
than Canadian dollars);
|
|
|
|
the issue price (at par, at a discount or at a premium) of such
Debt Securities;
|
|
|
|
the date or dates on which such Debt Securities will be issued
and delivered;
|
|
|
|
the date or dates on which such Debt Securities will mature,
including any provision for the extension of a maturity date, or
the method of determination of such date(s);
|
|
|
|
the rate or rates per annum (either fixed or floating) at which
such Debt Securities will bear interest (if any) and, if
floating, the method of determination of such rate;
|
15
|
|
|
|
|
the date or dates from which any such interest will accrue and
on which such interest will be payable and the record date or
dates for the payment of such interest, or the method of
determination of such date(s);
|
|
|
|
if applicable, the provisions for subordination of such Debt
Securities to other indebtedness of the Corporation;
|
|
|
|
the Trustee under the Trust Indenture pursuant to which
such Debt Securities are to be issued;
|
|
|
|
any redemption term or terms under which such Debt Securities
may be defeased whether at or prior to maturity;
|
|
|
|
any repayment or sinking fund provisions;
|
|
|
|
any events of default applicable to such Debt Securities;
|
|
|
|
whether such Debt Securities are to be issued in registered form
or in the form of temporary or permanent global securities and
the basis of exchange, transfer and ownership thereof;
|
|
|
|
any exchange or conversion terms and any provisions for the
adjustment thereof;
|
|
|
|
if applicable, our ability to satisfy all or a portion of any
redemption of such Debt Securities, any payment of any interest
on such Debt Securities or any repayment of the principal owing
upon the maturity of such Debt Securities through the issuance
of securities by us or of any other entity, and any
restriction(s) on the persons to whom such securities may be
issued;
|
|
|
|
the provisions applicable to the modification of the terms of
the Trust Indenture; and
|
|
|
|
any other specific material terms or covenants applicable to
such Debt Securities.
|
We reserve the right to include in a Prospectus Supplement
specific terms pertaining to the Debt Securities which are not
within the options and parameters set forth in this Prospectus.
In addition, to the extent that any particular terms of the Debt
Securities described in a Prospectus Supplement differ from any
of the terms described in this Prospectus, the description of
such terms set forth in this Prospectus shall be deemed to have
been superseded by the description of such differing terms set
forth in such Prospectus Supplement with respect to such Debt
Securities.
Ranking
The Debt Securities will be direct unsecured obligations of
Oncolytics. The Debt Securities will be senior or subordinated
indebtedness of Oncolytics as described in the applicable
Prospectus Supplement. If the Debt Securities are senior
indebtedness, they will rank equally and rateably with all other
unsecured indebtedness of Oncolytics from time to time issued
and outstanding which is not subordinated. If the Debt
Securities are subordinated indebtedness, they will be
subordinated to senior indebtedness of Oncolytics as described
in the applicable Prospectus Supplement, and they will rank
equally and rateably with other subordinated indebtedness of
Oncolytics from time to time issued and outstanding as described
in the applicable Prospectus Supplement. We reserve the right to
specify in a Prospectus Supplement whether a particular series
of subordinated Debt Securities is subordinated to any other
series of subordinated Debt Securities.
Registration
of Debt Securities
Debt
Securities in Book Entry Form
Debt Securities of any series may be issued in whole or in part
in the form of one or more global securities (each a
Global Security and together Global
Securities) registered in the name of a designated
clearing agency (a Depositary) or its nominee
and held by or on behalf of the Depositary in accordance with
the terms of the applicable Trust Indenture. The specific
terms of the depositary arrangement with respect to any portion
of a series of Debt Securities to be represented by a Global
Security will, to the extent not described herein, be described
in the Prospectus Supplement relating to such series.
A Global Security may not be transferred, except as a whole
between the Depositary and a nominee of the Depositary or as
between nominees of the Depositary, or to a successor Depositary
or nominee thereof, until it is wholly exchanged for Debt
Securities in certificated non-book-entry form in accordance
with the terms of the applicable Trust Indenture. So long
as the Depositary for a Global Security, or its nominee, is the
registered owner of such Global Security, such Depositary or
such nominee, as the case may be, will be considered the sole
owner or holder of the Debt Securities represented by such
Global Security for all purposes under the applicable
Trust Indenture and payments of principal of and interest,
if any, on the Debt Securities represented by a Global Security
will be made by us to the Depositary or its nominee.
16
Subject to such exceptions, if any, as may be provided for in
the Trust Indenture and described in the applicable
Prospectus Supplement, owners of beneficial interests in a
Global Security will not be entitled to have the Debt Securities
represented by such Global Security registered in their names,
will not receive or be entitled to receive physical delivery of
such Debt Securities in certificated non-book-entry form, will
not be considered the owners or holders thereof under the
applicable Trust Indenture and will be unable to pledge
Debt Securities as security. The laws of some states in the
United States may require that certain purchasers of Debt
Securities take physical delivery of such Debt Securities in
definitive form.
Principal and interest payments, if any, on the Debt Securities
represented by a Global Security registered in the name of a
Depositary or its nominee will be made to such Depositary or its
nominee, as the case may be, as the registered owner of such
Global Security. Neither Oncolytics, the Trustee nor any paying
agent for such Debt Securities will have any responsibility or
liability for any aspect of the records relating to or payments
made on account of beneficial ownership interests in such Global
Security or for maintaining, supervising or reviewing any
records relating to such beneficial ownership interests.
Oncolytics, any underwriters, dealers or agents and any Trustee
identified in an accompanying Prospectus Supplement, as
applicable, will not have any liability or responsibility for:
(i) records maintained by the Depositary relating to
beneficial ownership interests in the Debt Securities held by
the Depositary or the book-entry accounts maintained by the
Depositary; (ii) maintaining, supervising or reviewing any
records relating to any such beneficial ownership interests; or
(iii) any advice or representation made by or with respect
to the Depositary and contained in this Prospectus or in any
Prospectus Supplement or Trust Indenture with respect to
the rules and regulations of the Depositary or at the direction
of Depositary participants.
The applicable Prospectus Supplement will identify the
applicable Depositary for any Debt Securities represented by a
Global Security.
Debt
Securities in Registered Form
Debt Securities of any series may be issued in whole or in part
in registered form as provided in the applicable
Trust Indenture.
In the event that the Debt Securities are issued in certificated
non-book-entry form, principal and interest, if any, will be
payable, the transfer of such Debt Securities will be
registerable and such Debt Securities will be exchangeable for
Debt Securities in other denominations of a like aggregate
principal amount at the office or agency maintained by us.
Payment of principal and interest, if any, on Debt Securities in
certificated non-book-entry form may be made by check mailed to
the address of the holders entitled thereto.
Subject to the foregoing limitations, Debt Securities of any
authorized form or denomination issued under the applicable
Trust Indenture may be transferred or exchanged for Debt
Securities of any other authorized form or denomination or
denominations, any such transfer or exchange to be for an
equivalent aggregate principal amount of Debt Securities of the
same series, carrying the same rate of interest and same
redemption and other provisions as the Debt Securities so
transferred or exchanged. Exchanges of Debt Securities of any
series may be made at the offices of the applicable Trustee and
at such other places as we may from time to time designate with
the approval of the applicable Trustee and may be specified in
the applicable Prospectus Supplement. Unless otherwise specified
in the applicable Prospectus Supplement, the applicable Trustee
will be the registrar and transfer agent for any Debt Securities
issued in certificated non-book-entry form under the applicable
Trust Indenture.
DESCRIPTION
OF UNITS
We may issue Units comprised of one or more of the other
Securities described in this Prospectus in any combination. Each
Unit will be issued so that the holder of the Unit is also the
holder of each Security included in the Unit. Thus, the holder
of a Unit will have the rights and obligations of a holder of
each included Security. The unit agreement, if any, under which
a Unit is issued may provide that the Securities included in the
Unit may not be held or transferred separately, at any time or
at any time before a specified date.
The particular terms and provisions of Units offered by any
Prospectus Supplement, and the extent to which the general terms
and provisions described below may apply thereto, will be
described in the Prospectus Supplement filed in respect of such
Units.
17
The particular terms of each issue of Units will be described in
the related Prospectus Supplement. This description will
include, where applicable:
|
|
|
|
|
the designation and aggregate number of Units offered;
|
|
|
|
the price at which the Units will be offered;
|
|
|
|
if other than Canadian dollars, the currency or currency unit in
which the Units are denominated;
|
|
|
|
the terms of the Units and of the Securities comprising the
Units, including whether and under what circumstances those
securities may be held or transferred separately;
|
|
|
|
the number of Securities that may be purchased upon exercise of
each Unit and the price at which and currency or currency unit
in which that amount of Securities may be purchased upon
exercise of each Unit;
|
|
|
|
any provisions for the issuance, payment, settlement, transfer
or exchange of the Units or of the Securities comprising the
Units; and
|
|
|
|
any other material terms, conditions and rights (or limitations
on such rights) of the Units.
|
We reserve the right to set forth in a Prospectus Supplement
specific terms of the Units that are not within the options and
parameters set forth in this Prospectus. In addition, to the
extent that any particular terms of the Units described in a
Prospectus Supplement differ from any of the terms described in
this Prospectus, the description of such terms set forth in this
Prospectus shall be deemed to have been superseded by the
description of such differing terms set forth in such Prospectus
Supplement with respect to such Units.
MARKET
FOR SECURITIES
Our outstanding Common Shares are listed and posted for trading
on the Toronto Stock Exchange under the trading symbol
ONC and on the NASDAQ Capital Market under the
trading symbol ONCY. The following table sets forth
the market price ranges and the aggregate volume of trading of
the Common Shares on the Toronto Stock Exchange and NASDAQ
Capital Market for the periods indicated:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Toronto Stock Exchange
|
|
|
|
|
|
NASDAQ Capital Market
|
|
|
|
High
|
|
|
Low
|
|
|
Close
|
|
|
Volume
|
|
|
High
|
|
|
Low
|
|
|
Close
|
|
|
Volume
|
|
Period
|
|
($)
|
|
|
($)
|
|
|
($)
|
|
|
(Shares)
|
|
|
(U.S.$)
|
|
|
(U.S.$)
|
|
|
(U.S.$)
|
|
|
(Shares)
|
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May
|
|
|
2.39
|
|
|
|
2.12
|
|
|
|
2.19
|
|
|
|
880,135
|
|
|
|
2.17
|
|
|
|
1.98
|
|
|
|
2.06
|
|
|
|
1,026,481
|
|
June
|
|
|
2.55
|
|
|
|
2.05
|
|
|
|
2.15
|
|
|
|
755,603
|
|
|
|
2.47
|
|
|
|
1.92
|
|
|
|
2.08
|
|
|
|
1,746,620
|
|
July
|
|
|
2.21
|
|
|
|
1.68
|
|
|
|
1.91
|
|
|
|
1,512,581
|
|
|
|
2.08
|
|
|
|
1.59
|
|
|
|
1.79
|
|
|
|
1,296,480
|
|
August
|
|
|
1.95
|
|
|
|
1.54
|
|
|
|
1.62
|
|
|
|
514,617
|
|
|
|
1.85
|
|
|
|
1.50
|
|
|
|
1.55
|
|
|
|
592,767
|
|
September
|
|
|
1.90
|
|
|
|
1.42
|
|
|
|
1.90
|
|
|
|
1,046,083
|
|
|
|
1.90
|
|
|
|
1.44
|
|
|
|
1.89
|
|
|
|
1,172,901
|
|
October
|
|
|
2.46
|
|
|
|
1.67
|
|
|
|
2.30
|
|
|
|
2,614,255
|
|
|
|
2.53
|
|
|
|
1.75
|
|
|
|
2.44
|
|
|
|
2,470,044
|
|
November
|
|
|
2.65
|
|
|
|
2.10
|
|
|
|
2.28
|
|
|
|
600,779
|
|
|
|
2.77
|
|
|
|
2.08
|
|
|
|
2.29
|
|
|
|
1,038,246
|
|
December
|
|
|
2.38
|
|
|
|
1.67
|
|
|
|
1.70
|
|
|
|
355,628
|
|
|
|
2.38
|
|
|
|
1.67
|
|
|
|
1.72
|
|
|
|
795,031
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
January
|
|
|
2.04
|
|
|
|
1.66
|
|
|
|
1.95
|
|
|
|
538,887
|
|
|
|
2.04
|
|
|
|
1.69
|
|
|
|
1.93
|
|
|
|
622,530
|
|
February
|
|
|
2.26
|
|
|
|
1.82
|
|
|
|
1.90
|
|
|
|
564,976
|
|
|
|
2.27
|
|
|
|
1.85
|
|
|
|
1.94
|
|
|
|
588,210
|
|
March
|
|
|
2.01
|
|
|
|
1.70
|
|
|
|
1.83
|
|
|
|
376,635
|
|
|
|
2.02
|
|
|
|
1.70
|
|
|
|
1.84
|
|
|
|
618,300
|
|
April
|
|
|
2.50
|
|
|
|
1.78
|
|
|
|
1.96
|
|
|
|
1,159,535
|
|
|
|
2.46
|
|
|
|
1.76
|
|
|
|
1.94
|
|
|
|
1,138,020
|
|
May
|
|
|
2.18
|
|
|
|
1.60
|
|
|
|
2.15
|
|
|
|
6,683,183
|
|
|
|
2.21
|
|
|
|
1.62
|
|
|
|
2.15
|
|
|
|
897,410
|
|
June (1-13)
|
|
|
2.40
|
|
|
|
2.00
|
|
|
|
2.14
|
|
|
|
452,450
|
|
|
|
2.39
|
|
|
|
2.01
|
|
|
|
2.08
|
|
|
|
692,140
|
|
18
PLAN OF
DISTRIBUTION
We may sell Securities to or through underwriters, dealers,
placement agents or other intermediaries and also may sell
Securities directly to purchasers or through agents, subject to
obtaining any applicable exemption from registration
requirements.
The distribution of Securities may be effected from time to time
in one or more transactions at a fixed price or prices, which
may be changed, at market prices prevailing at the time of sale,
or at prices related to such prevailing market prices to be
negotiated with purchasers and as set forth in an accompanying
Prospectus Supplement.
In connection with the sale of Securities, underwriters may
receive compensation from us or from purchasers of Securities
for whom they may act as agents in the form of discounts,
concessions or commissions. Underwriters, dealers, placement
agents or other intermediaries that participate in the
distribution of Securities may be deemed to be underwriters and
any discounts or commissions received by them from us and any
profit on the resale of Securities by them may be deemed to be
underwriting discounts and commissions under applicable
securities legislation.
If so indicated in the applicable Prospectus Supplement, we may
authorize dealers or other persons acting as our agents to
solicit offers by certain institutions to purchase the
Securities directly from us pursuant to contracts providing for
payment and delivery on a future date. These contracts will be
subject only to the conditions set forth in the applicable
Prospectus Supplement or supplements, which will also set forth
the commission payable for solicitation of these contracts.
The Prospectus Supplement relating to any offering of Securities
will also set forth the terms of the offering of the Securities,
including, to the extent applicable, the initial offering price,
the proceeds to us, the underwriting discounts or commissions,
and any other discounts or concessions to be allowed or
reallowed to dealers. Underwriters with respect to any offering
of Securities sold to or through underwriters will be named in
the Prospectus Supplement relating to such offering.
Holders of Warrants resident in the United States who acquire
Common Shares pursuant to the exercise of Warrants in accordance
with their terms and under this Prospectus and any applicable
Prospectus Supplement may have a right of action against the
Corporation for any misrepresentation in this Prospectus or any
applicable Prospectus Supplement. However, the existence and
enforceability of such a right of action is not without doubt.
By contrast, holders of Warrants resident in Canada who may
acquire Common Shares pursuant to the exercise of Warrants in
accordance with their terms and who will be deemed to acquire
such Common Shares under applicable Canadian prospectus
exemptions, will not have any such right of action.
Under agreements which may be entered into by us, underwriters,
dealers, placement agents and other intermediaries who
participate in the distribution of Securities may be entitled to
indemnification by us against certain liabilities, including
liabilities under applicable securities legislation. The
underwriters, dealers, placement agents and other intermediaries
with whom we enter into agreements may be customers of, engage
in transactions with or perform services for us in the ordinary
course of business.
Any offering of Subscription Receipts, Debt Securities, Warrants
or Units will be a new issue of securities with no established
trading market. Unless otherwise specified in the applicable
Prospectus Supplement, the Subscription Receipts, Debt
Securities, Warrants or Units will not be listed on any
securities exchange. Unless otherwise specified in the
applicable Prospectus Supplement, there is no market through
which the Subscription Receipts, Debt Securities, Warrants or
Units may be sold and purchasers may not be able to resell
Subscription Receipts, Debt Securities, Warrants or Units
purchased under this Prospectus or any Prospectus Supplement.
This may affect the pricing of the Subscription Receipts, Debt
Securities, Warrants or Units in the secondary market, the
transparency and availability of trading prices, the liquidity
of the securities, and the extent of issuer regulation.
Certain dealers may make a market in the Subscription Receipts,
Debt Securities, Warrants or Units, as applicable, but will not
be obligated to do so and may discontinue any market making at
any time without notice. No assurance can be given that any
dealer will make a market in the Subscription Receipts, Debt
Securities, Warrants or Units or as to the liquidity of the
trading market, if any, for the Subscription Receipts, Debt
Securities, Warrants or Units.
Subject to applicable securities legislation, in connection with
any offering of Securities under this Prospectus, the
underwriters, if any, may over-allot or effect transactions
which stabilize or maintain the market price of the Securities
offered at a level above that which might otherwise prevail in
the open market. These transactions, if commenced, may be
discontinued at any time.
19
Notwithstanding the filing of this Prospectus, our short form
base shelf prospectus dated February 15, 2007 and the
related prospectus supplement dated February 16, 2007
(collectively, the 2007 Base Shelf
Prospectus) will remain in full force and effect and
continue to qualify the Common Shares issuable to U.S. residents
on exercise of the Common Share purchase warrants issued in
connection with our Unit offering under a short form prospectus
dated February 14, 2007 (the 2007 Unit
Offering) until such time as the 2007 Base Shelf
Prospectus expires in accordance with applicable securities
laws. In the event that the 2007 Base Shelf Prospectus expires
prior to the exercise of all the Common Shares purchase warrants
issued to U.S. residents in connection with the 2007 Unit
Offering, we may use this Prospectus to qualify the remaining
Common Shares issuable to U.S. residents on the exercise of
Common Share purchase warrants issued in connection with the
2007 Unit Offering. If such a determination is made, the
applicable prospectus supplement will set out the relevant facts
to qualify such Common Shares. We may also use this Prospectus
to qualify Common Shares issuable to U.S. residents on the
exercise of future Common Share purchase warrants issued by us.
CERTAIN
INCOME TAX CONSIDERATIONS
The applicable prospectus supplement may describe certain
Canadian federal income tax consequences which may be applicable
to a purchaser of Securities offered thereunder, and may also
include a discussion of certain United States federal income tax
consequences to the extent applicable.
LEGAL
MATTERS
Unless otherwise specified in the Prospectus Supplement, certain
legal matters relating to the offering of the securities will be
passed upon for us by Bennett Jones LLP and Dorsey &
Whitney LLP. In addition, certain legal matters in connection
with any offering of securities will be passed upon for any
underwriters, dealers or agents by counsel to be designated at
the time of the offering by such underwriters, dealers or agents
with respect to matters of Canadian and United States law.
The partners and associates of Bennett Jones LLP, as a group,
and the partners and associates of Dorsey & Whitney
LLP, as a group, each beneficially own, directly or indirectly,
less than 1% of our securities.
AUDITOR
Our financial statements as at December 31, 2007 and 2006
incorporated by reference into this Prospectus have been audited
by Ernst & Young LLP, independent auditors, as
indicated in their report dated February 15, 2008 and are
incorporated herein in reliance upon the authority of said firm
as experts in accounting and auditing in giving said report.
Ernst & Young LLP has been our auditor since inception
in 1998.
DOCUMENTS
FILED AS PART OF THE REGISTRATION STATEMENT
The following documents have been filed with the SEC as part of
the registration statement of which this Prospectus is a part
insofar as required by the SECs
Form F-10:
|
|
|
|
|
the documents listed under Documents Incorporated by
Reference in this Prospectus;
|
|
|
|
the consent of our auditors Ernst & Young LLP;
|
|
|
|
the consent of our Canadian counsel Bennett Jones LLP;
|
|
|
|
powers of attorney from our directors and officers; and
|
|
|
|
Form F-X
Appointment of Agent for Service of Proceeds and Undertaking.
|
PURCHASERS
STATUTORY RIGHTS
Securities legislation in certain of the provinces of Canada
provides purchasers with the right to withdraw from an agreement
to purchase securities. This right may be exercised within two
business days after receipt or deemed receipt of a prospectus,
the accompanying prospectus supplement relating to securities
purchased by a purchaser and any amendment thereto. The
legislation further provides a purchaser with remedies for
rescission or damages if the prospectus, the accompanying
prospectus supplement relating to securities purchased by a
purchaser or any amendment contains a misrepresentation or are
not delivered to the purchaser, provided that the remedies for
rescission or damages are exercised by the purchaser within the
time limit prescribed by the securities legislation in the
purchasers province. The purchaser should refer to any
applicable provisions of the securities legislation of the
purchasers province for the particulars of these rights or
consult with a legal advisor.
20