Prospectus Supplement dated December 4, 2008
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. In addition, copies of documents incorporated by
reference may be obtained from the securities commissions or similar authorities in Canada through
the SEDAR website at www.sedar.com. See Documents Incorporated by Reference.
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New Issue
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December 4, 2008 |
5,175,000 Common Shares
This prospectus supplement relates to the issuance of: (i) up to 2,500,000 of our common
shares (the Common Shares), issuable from time to time, on exercise of up to 2,500,000 common
share purchase warrants (expected to be issued by us on or about December 5, 2008 pursuant to the
2008 Unit Offering (as described below), (ii) up to 375,000 Common Shares issuable from time to
time, on exercise of 375,000 common share purchase warrants that may be issued on the exercise of
the over-allotment option granted to the underwriter pursuant to the 2008 Unit Offering; (iii) the
issuance of 2,300,000 Common Shares, issuable from time to time, on exercise of 2,300,000 common
share purchase warrants issued by us on February 22, 2007 in connection with our unit offering
under a short form prospectus dated February 14, 2007 (the 2007 Unit Offering); and (iv) such
indeterminate number of additional Common Shares that may be issuable by reason of the
anti-dilution provisions contained in the 2007 Warrant Indenture (as defined herein) and the 2008
Warrant Indenture (as defined herein). See Terms of 2008 Warrants and Terms of 2007 Warrants.
On December 1, 2008, 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 2008
Unit Offering) by us in the provinces of British Columbia, Alberta, Manitoba and Ontario of up to
2,875,000 units of the Corporation, each unit consisting of one Common Share and one common share
purchase warrant (the 2008 Warrants). Each 2008 Warrant will entitle the holder to purchase one
Common Share upon payment of Cdn. $1.80, 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 2008 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 $2.50 per share,
then, at our sole discretion, and upon us sending the holders of 2008 Warrants written notice of
such Accelerated Exercise Date and issuing a news release announcing such Accelerated Exercise
Date, the 2008 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 2008 Warrants and the date on which
such announcement is made by news release. The exercise price of the 2008 Warrants was determined
by negotiation between us and the underwriter for the 2008 Unit Offering. See Plan of
Distribution.
On February 14, 2007, we filed a short form prospectus with the securities commissions in the
provinces of British Columbia, Alberta, Manitoba and Ontario and a registration statement on
Form F-10 (File No. 333-140460)
with the SEC relating to the offering (the 2007 Unit Offering) by
us of 4,600,000 units of the Corporation, each unit consisting of one Common Share and one-half of
a common share purchase warrant (the 2007 Warrants, together with the 2008 Warrants, the
Warrants). The 2007 Unit Offering was completed on February 22, 2007. Each whole 2007 Warrant
entitles the holder to purchase one Common Share upon payment of Cdn. $3.50, subject to adjustment,
at any time until 5:00 p.m. (Calgary time) on February 22, 2010. The exercise price of the 2007
Warrants was determined by negotiation between us and the underwriter for the 2007 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
approved the listing of the Common Shares issuable on the exercise of the 2007 Warrants. The TSX
has conditionally approved the listing of the Common Shares issuable on the exercise of the 2008
Warrants. Listing for the 2008 Warrants is subject to us fulfilling all of the requirements of the
TSX on or before February 25, 2009. Pursuant to its procedure, the NASDAQ has verbally confirmed that it will not be objecting to the additional listing of the Common Shares issuable upon exercise of the 2007 Warrants.
We have also filed an application with the NASDAQ for the additional listing of the Common Shares issuable upon exercise of
the 2008 Warrants.
Investing in the Common Shares involves risks that are described in the Risk Factors section
beginning on page S-14 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 November 28, 2008, 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 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.
ii
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
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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). Therefore, our 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
S-1
supplement and in the accompanying short form base shelf prospectus 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 and nine months ended September 30, 2008, you
should refer to our reconciliation of our financial statements as at and for the three and nine
months ended September 30, 2008 to U.S. GAAP furnished to the SEC on the Corporations Current
Report on Form 6-K dated November 28, 2008 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:
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our Renewal Annual Information Form dated March 5, 2008, for the year ended
December 31, 2007 (the AIF); |
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our Management Proxy Circular dated March 23, 2007 relating to the annual and
special meeting of shareholders held on May 2, 2007; |
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our Management Proxy Circular dated March 20, 2008 relating to the annual and
special meeting of shareholders held on May 7, 2008; |
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our audited financial statements, together with the notes thereto, as at and for the
years ended December 31, 2007 and 2006 and the auditors report thereon addressed to
our shareholders; |
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our managements discussion and analysis of financial condition and results of
operations dated March 5, 2008, for the year ended December 31, 2007; |
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our unaudited interim consolidated financial statements, together with the notes
thereto, as at and for the three and nine months ended September 30, 2008; |
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our managements discussion and analysis of financial condition and results of
operations dated November 4, 2008, for the three and nine months ended September 30,
2008; and |
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the reconciliation of our unaudited interim consolidated financial statements as at
and for the three and nine months ended September 30, 2008 to U.S. GAAP, filed on
November 28, 2008 under the heading Other. |
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 this Offering.
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 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 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
S-3
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 the accompanying base shelf prospectus for purposes of future offers and sales of Common
Shares under this prospectus supplement. Upon new interim financial statements and related
managements discussion and analysis being filed by us with the securities commission or similar
regulatory authority in the provinces of British Columbia, Alberta, Manitoba and Ontario during the
term of this prospectus supplement, 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 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 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
2007 Warrants has been filed with the SEC as Exhibit 7.1 to the
registration statement on Form F-10 (File No. 333-140460) as filed with the SEC on February 15, 2007 as is hereby incorporated by reference into the
registration statement on Form F-10 (File No. 333-151513) to which this prospectus supplement relates.
The Warrant Indenture for the 2008 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 one direct wholly-owned subsidiary, Oncolytics Biotech (Barbados) Inc. (Oncolytics
Barbados), which is incorporated pursuant to the laws of Barbados 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
S-4
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 cell. The action of the Ras pathway in allowing reovirus
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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.
RECENT DEVELOPMENTS
On July 1, 2008, we completed an internal reorganization to provide additional international
flexibility and promote broadened opportunities for the Corporation. Pursuant to the internal
reorganization we transferred certain assets to our wholly-owned subsidiary, Oncolytics Barbados,
in consideration for additional shares in the capital of Oncolytics Barbados. The transferred
assets consisted of: (a) the rights to certain regulatory submissions; (b) certain non-Canadian
patents and patent applications; and (c) certain agreements to which we were a party, including,
clinical research management agreements, clinical trial agreements, research agreements
and manufacturing agreements. We also granted Oncolytics Barbados permission to use certain other
intellectual property rights not transferred by us to Oncolytics Barbados. Concurrently with the
asset transfer, the Corporation and Oncolytics Barbados entered into a trust agreement pursuant to
which we agreed to hold legal title to the transferred assets with beneficial title remaining with
Oncolytics Barbados.
As part of the internal reorganization, the Corporation and Oncolytics Barbados also entered
into a research and development agreement on July 1, 2008 pursuant to which we agreed to provide
certain services to Oncolytics Barbados, including: conducting research and development related to
the transferred assets; coordinating clinical trials and the handling of data generated by such
trials; pursuing regulatory approvals as required; coordinating the filing, prosecution and
maintenance of patent applications and patents; and coordinating the development and implementation
of manufacturing processes.
On October 7, 2008, we announced the issuance of our 29th U.S. patent, No. 7,431,931, entitled
Reovirus Clearance of Ras-Mediated Neoplastic Cells from Mixed Cellular Compositions. The
allowed claims cover methods of selectively removing cancer cells ex vivo from blood stem cells and
other organs using reovirus.
On November 6, 2008, we announced interim results of our U.S. REOLYSIN® Phase II
clinical trial in patients with bone and soft tissue sarcomas metastatic to the lung. The results
were delivered by Dr. Monica Mita of the Institute of Drug Development, the Cancer Therapy and
Research Center at the University of Texas Health Science Center, San Antonio, Texas, at the
Chemotherapy Foundation Symposium XXVI, held in New York from November 4-8, 2008.
At the time of the presentation, 35 patients had been enrolled in the study, and 29 were
evaluable. 21% (6/29) of the evaluable patients experienced stable disease (SD) for more than 16
weeks. The investigators concluded that the study has met its established objectives, and that
enrolment will continue to the full 52 patients.
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Tumour Type |
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Cycles |
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Best Response |
Synovial sarcoma
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SD |
Ewings sarcoma
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9* |
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SD |
Malignant Fibrous Histiocytoma
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7* |
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SD, tumor resection after cycle 4 |
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Tumour Type |
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Cycles |
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Best Response |
Leiomyosarcoma
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6 |
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SD |
Chordoma
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5* |
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SD |
Unspecified Spindle Cell
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5* |
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SD |
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patients still on study |
An oral presentation covering results of the trial (REO 014) was also delivered at the
Connective Tissue Oncology Society (CTOS) annual meeting, held in London, U.K. from November 13-15,
2008.
On November 14, 2008, Dr. Anders Kolb of the Nemours Center for Childhood Cancer Research
delivered a poster entitled Systemic Administration of REOLYSIN Inhibits Growth of Human Sarcoma
Xenografts Alone and in Combination with Cisplatin and Radiation at the CTOS meeting.
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In the study, mice were engrafted with a variety of sarcoma cell lines including
rhabdomyosarcoma, Ewings sarcoma, synovial sarcoma and osteosarcoma, then treated with
REOLYSIN® or REOLYSIN® in combination with either cisplatin or radiation.
The researchers concluded that in all tumour lines evaluated,
REOLYSIN® exhibits significant antitumour activity, including a complete response
in a rhabdomyosarcoma line. The combination of REOLYSIN® and radiation is effective in
inhibiting the growth of rhabdomyosarcoma and Ewings sarcoma xenografts, and the combination of
REOLYSIN® and cisplatin is effective in Ewings sarcoma, osteosarcoma and synovial
sarcoma xenografts.
On November 18, 2008, we announced the issuance of our 30th U.S. patent, No. 7,452,723,
entitled Methods for Preventing Reovirus Recognition for the Treatment of Cellular Proliferative
Disorders. The allowed claims relate to kits comprised of reovirus and an immune suppressive
agent that are designed to prevent reovirus recognition by the immune system.
On December 1, 2008, we filed a prospectus supplement to the short form base shelf prospectus
dated June 16, 2008 in respect of the 2008 Unit Offering.
CAPITALIZATION
On September 30, 2008 and December 4, 2008, we had 41,180,748 Common Shares issued and
outstanding. If all of our stock options and warrants outstanding as of
December 4, 2008 were exercised, we would have
49,271,241 Common Shares issued and outstanding. Following the 2008 Unit Offering, we
will have up to 43,680,748 Common Shares issued and outstanding (up to 54,521,241 Common Shares on
a fully-diluted basis). Following the 2008 Unit Offering, and assuming the over-allotment option
granted to the underwriter pursuant to the 2008 Unit Offering is exercised in full, we will have
44,055,748 Common Shares issued and outstanding (55,308,741 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:
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|
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|
|
|
|
|
|
|
|
|
|
TSX |
|
NASDAQ |
|
|
High |
|
Low |
|
Close |
|
Volume |
|
High |
|
Low |
|
Close |
|
Volume |
|
|
($) |
|
($) |
|
($) |
|
(Shares) |
|
(U.S.$) |
|
(U.S.$) |
|
(U.S.$) |
|
(Shares) |
Period |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
|
6,682,910 |
|
|
|
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 1-3 |
|
|
1.41 |
|
|
|
1.34 |
|
|
|
1.41 |
|
|
|
108,151 |
|
|
|
1.38 |
|
|
|
1.07 |
|
|
|
1.10 |
|
|
|
68,337 |
|
S-7
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 respective expiry times and that no adjustment based on the anti-dilution provisions
contained in the 2008 Warrant Indenture and the 2007 Warrant Indenture has taken place, the net
proceeds to us will be approximately $13,742,500.
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 principle 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 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 GMP 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
On December 12, 2007, we granted options to acquire an aggregate of 431,493 Common Shares at
an exercise price of $2.22 per Common Share. 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 supplement.
TERMS OF 2008 WARRANTS
The 2008 Warrants will be governed by an indenture (the 2008 Warrant Indenture) to be
entered into between us and Computershare Trust Company of Canada, as agent for the holders of the
2008 Warrants. The following is a summary of the material attributes and characteristics of the
2008 Warrants. The following description of the terms of the Warrant Indenture is subject to the
detailed provisions of the Warrant Indenture.
Under the 2008 Unit Offering, up to 2,875,000 2008 Warrants may be issued. Each 2008 Warrant
will entitle the holder to purchase one Common Share upon payment of $1.80, 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 2008 Unit Offering. If on any Accelerated Exercise Date the 10 day volume weighted average
trading price of our Common Shares on the TSX exceeds $2.50 per share, then, at our sole discretion
and upon us sending the holders of the 2008 Warrants written notice of such Accelerated Exercise
Date (the Notice) and issuing a news release announcing such Accelerated Exercise Date, the 2008
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 2008 Warrants and the date on which such announcement is made by
news
S-8
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 2008 Warrants as reflected on the 2008 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) or
person holding 2008 Warrants for the benefit of or for the account of a U.S. Person is permitted to
exercise 2008 Warrants during any period of time prior to the expiration date of the 2008 Warrants
during which a registration statement under the U.S. Securities Act, relating to the Common Shares
underlying the 2008 Warrants, is not effective. As a condition to closing the 2008 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 2008 Warrants and the date on
which no 2008 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 2008 Warrants in
the United States, in accordance with the 2008 Warrant Indenture.
Holders of 2008 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 2008 Warrants will have no pre-emptive rights to acquire our securities. If all of the 2008
Warrants were exercised, we would be required to issue 2,875,000 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 2008 Unit Offering.
TERMS OF 2007 WARRANTS
The
2007 Warrants are governed by an indenture (the 2007 Warrant Indenture) entered into by
us and Computershare Trust Company of Canada on February 12, 2007, as trustee for the holders of
the 2007 Warrants. The following is a summary of the material attributes and characteristics of
the 2007 Warrants. The following description of the terms of the 2007 Warrant Indenture is subject
to the detailed provisions of the 2007 Warrant Indenture.
Under the 2007 Unit Offering, 2,300,000 2007 Warrants were issued. Each whole 2007 Warrant
entitled the holder to purchase one Common Share upon payment of Cdn. $3.50, subject to adjustment,
at any time until 5:00 p.m. (Calgary time) on February 22, 2010.
No U.S. Person (as that term is defined by Regulation S under the U.S. Securities Act) or
person holding 2007 Warrants for the benefit of or for the account of a U.S. Person is permitted to
exercise 2007 Warrants during any period of time prior to the expiration date of the 2007 Warrants
during which a registration statement under the U.S. Securities Act, relating to the Common Shares
underlying the 2007 Warrants, is not effective. As a condition to closing the 2007 Unit Offering,
we agreed to use reasonable efforts to maintain the registration statement on Form F-10 (File
No. 333-140529) 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 2007 Warrants and the date on
which no 2007 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 2007 Warrants in
the United States, in accordance with the 2007 Warrant Indenture.
Holders of 2007 Warrants do not have any voting rights or any other rights which a holder of
Common Shares has (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
2007 Warrants do not have any pre-emptive rights to acquire our securities. If all of the 2007
Warrants were exercised, we would be required to issue 2,300,000 Common Shares (subject to
adjustment in certain circumstances).
S-9
PLAN OF DISTRIBUTION
This prospectus supplement relates to the issuance of: (i) up to 2,500,000 Common Shares,
issuable from time to time, on exercise of 2,500,000 common share purchase warrants (expected to be
issued by us on or about December [5], 2008 pursuant to the 2008 Unit Offering (as described
below), (ii) up to 375,000 Common Shares issuable from time to time, on exercise of 375,000 common
share purchase warrants that may be issued on the
exercise of the over-allotment option granted to the underwriter pursuant to the 2008 Unit
Offering; (iii) the issuance of 2,300,000 Common Share, issuable from time to time, on exercise of
2,300,000 common share purchase warrants issued by us pursuant to the 2007 Unit Offering and
(iv) such indeterminate number of additional Common Shares that may be issuable by reason of the
anti-dilution provisions contained in the 2007 Warrant Indenture and 2008 Warrant Indenture
governing the 2007 Warrants and 2008 Warrants, respectively. See Terms of 2008 Warrants and
Terms of 2007 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 respective 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.
2008 Warrants
On June 16, 2008, we filed a
short form base shelf prospectus with the Alberta Securities
Commission 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 was declared effective by the SEC on February 15, 2007.
On December 1, 2008, 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
2,875,000 units of the Corporation, each unit consisting of one Common Share and one common share
purchase warrant and (ii) up to 287,500 broker warrants. Each 2008 Warrant will entitle the holder
to purchase one Common Share upon payment of Cdn. $1.80, 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 2008
Unit Offering. If on the Accelerated Exercise Date the 10 -day volume weighted average trading
price of the Common Shares on the TSX exceeds $2.50 per share, then, at our sole discretion, and
upon us sending the holders of 2008 Warrants written notice of such Accelerated Exercise Date and
issuing a news release announcing such Accelerated Exercise Date, the 2008 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 2008 Warrants and the date on which such announcement is made by news release.
The exercise price of the 2008 Warrants was determined by negotiation between us and the
underwriter for the 2008 Unit Offering. Each broker warrant is exercisable, in whole or in part,
within 3 years of the initial closing date of the 2008 Unit Offering (subject to acceleration),
into one Common Share at an exercise price of $1.80. The 2008 Unit Offering is expected to be
completed on or about December 5, 2008.
S-10
It is a condition of closing of the 2008 Unit Offering that the shelf registration statement
be declared effective by 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
2008 Warrants.
2007 Warrants
On February 14, 2007, we filed a short form prospectus with the securities commissions in the
provinces of British Columbia, Alberta, Manitoba and Ontario and a registration statement on
Form F-10 (File No. 333-140460)
with the SEC relating to the offering by us of 4,600,000 units, each unit consisting of one
Common Share and one-half of a common share purchase warrant. Each whole common share purchase
warrant will entitle the holder to purchase one Common Share upon payment of Cdn. $3.50, subject to
adjustment, at any time until 5:00 p.m. (Calgary time) on February 22, 2010. The 2007 Unit
Offering was completed on February 22, 2007.
On February 15, 2007, we filed a short form base shelf prospectus with the Alberta Securities
Commission and a registration statement on Form F-10 (File No. 333-140529) 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. $12,000,000 of common
shares. The shelf registration statement was declared effective by the SEC on February 15, 2007.
It is a condition of closing of the 2007 Unit Offering that the shelf registration statement be
declared effective by the SEC and that we file with the SEC a prospectus supplement registering the
offering of the Common Shares issuable from time to time on the exercise of the 2007 Warrants. We
filed a prospectus supplement with the Alberta Securities Commission and a registration statement
on Form F-10 (File No. 333-140529) with the SEC relating to the issuance of up to 2,300,000 Common
Shares issuable from time to time on the exercise of the 2007 Warrants (the Previous Prospectus
Supplement). This prospectus supplement replaces and supersedes the Previous Prospectus
Supplement and qualifies the issuance of up to 2,300,000 Common Shares issuable on the exercise of
the 2007 Warrants.
United States Securities Law Compliance
No U.S. Person or person holding Warrants on behalf or for the account of a U.S. Person may
exercise the Warrants during any period of time when a registration statement covering such Common
Shares is not effective. See Terms of 2008 Warrants and Terms of 2007 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 a purchase of Common
Shares acquired on the exercise of Warrants. This summary is based upon the current provisions of
the Income Tax Act (Canada) (the Tax Act), the regulations thereunder (the Regulations), all
specific proposals to amend the Tax Act and the Regulations publicly announced by the Government of
Canada prior to the date hereof (the Proposed Amendments) and Counsels understanding of the
prevailing administrative views 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 applicable only to investors who acquire such Common Shares on the exercise of
the Warrants and who for the purposes of the Tax Act and at all relevant times, will hold the
Common Shares and Warrants acquired as capital property, deal at arms length, and are not
affiliated with us and do not use or hold, and are not deemed to use or hold, their Common Shares
and Warrants in, or in the course of, carrying on a business in Canada. 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 does not apply to investors who are financial institutions or specified financial
institutions for the purposes of the Tax Act. Such investors should consult their own tax
advisors for advice.
S-11
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.
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. Certain investors
who are resident in Canada for
the purposes of the Tax Act whose Common Shares might not otherwise qualify as capital
property may be entitled to make an irrevocable election in accordance with subsection 39(4) of the
Tax Act to have such Common Shares and every Canadian Security (as defined in the Tax Act) owned
by such investor in the taxation year of the election and in all subsequent taxation years treated
as capital property. This election is not applicable to Warrants.
Exercise of Warrants
An investor will not realize a gain or a loss upon the exercise of a Warrant. For the
purposes of the Tax Act, when a Warrant is exercised, the investors adjusted cost base of the
Common Share acquired thereby will (subject to averaging) 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, net of any reasonable costs of
disposition, exceed (or are less than) the adjusted cost base of the Common Share, to the holder
thereof. The tax treatment of capital gains and capital losses are described in greater detail
below under Treatment of Capital Gains and Capital Losses.
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 required to deduct one-half of
the amount of any capital loss (an allowable capital loss) against taxable capital gains realized
by the investor. 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 capital gain realized
by an investor who is an individual (including certain trusts) may give rise to alternative minimum
tax. A Canadian-controlled private corporation (as defined in the Tax Act) may be liable to an
additional 6 2/3% 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 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
S-12
designate dividends as eligible dividends. In the case of a corporation, such 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
331/3% under Part IV of the Tax Act 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
In general terms, a holder who is an individual (other than certain trusts) that receives or
is deemed to receive taxable dividends on the Common Shares or realizes a capital gain on the
disposition of the Common Shares or Warrants may realize an increase in the holders liability for
alternative minimum tax.
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,
Common Shares 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).
Exercise of Warrants and Disposition of Common Shares
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.
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 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).
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.
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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 financial advisor, legal counsel, or accountant
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.
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.
Non-U.S. Holders
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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 financial advisor, legal counsel, or accountant 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 are liable for the alternative minimum tax under the Code; (f) 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; (g) 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; (h) 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; (i) U.S. expatriates or former longer-term residents of the U.S. or (j) 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 financial
advisor, legal counsel or accountant 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 financial advisor, legal counsel or accountant regarding the U.S.
federal income tax consequences of the acquisition of Common Shares received on the exercise of
Warrants.
Tax Consequences Other than U.S. Federal Income Tax Consequences Not Addressed
This summary does not address the U.S. state and local, U.S. federal estate and gift, 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 financial advisor, legal counsel, or
accountant 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). 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.
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Distributions on Common Shares
General Taxation of Distributions
Subject to the passive foreign investment company 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.
(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.
Reduced Tax Rates for Certain Dividends
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) such dividend is paid on Common Shares that have been held by such U.S.
Holder for at least 61 days during the 121-day period beginning 60 days before the ex-dividend
date.
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 passive foreign investment
company (as defined below) for the taxable year during which the Corporation pays a dividend or
for the preceding taxable year.
As discussed below, based on current business plans and available financial information, the
Corporation anticipates that it may qualify as a passive foreign investment company for the
taxable year ending December 31, 2008 and subsequent taxable years, depending on the assets and
income of the Corporation over the course of the taxable year ending December 31, 2008. (See more
detailed discussion at Additional Rules that May Apply to U.S. Holders Passive Foreign
Investment Corporation below). Accordingly, there can be no assurances that the Corporation will
be a QFC for the current or any future taxable year or that the Corporation will be able to certify
that it is a QFC in accordance with the certification procedures issued by the Treasury and the
IRS.
If the Corporation is not a QFC, 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 financial
advisor, legal counsel, or accountant regarding the dividend rules.
Distributions Paid in Foreign Currency
The amount of a distribution paid to a U.S. Holder in foreign currency generally will be equal
to the U.S. dollar value of such distribution based on the exchange rate applicable on the date of
receipt. A U.S. Holder that does not convert foreign currency received as a distribution into U.S.
dollars on the date of receipt generally will have a tax basis in such foreign currency equal to
the U.S. dollar value of such foreign currency on the date of receipt. Such a U.S. Holder generally
will recognize ordinary income or loss on the subsequent sale or other taxable disposition of such
foreign currency (including an exchange for U.S. dollars).
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
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received and (b) such U.S. Holders tax basis in the Common Shares
sold or otherwise disposed of. Subject to the passive foreign investment company 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.
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 financial advisor, legal counsel, or accountant regarding the foreign tax
credit rules.
Information Reporting; Backup Withholding Tax
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 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
financial advisor, legal counsel, or accountant regarding the information reporting and backup
withholding tax rules.
Information Filing Required by Certain U.S. Holders
A U.S. Holder may be required to file Form 926 with the IRS if (a) immediately after the
exercise of the Warrants, such U.S. Holder owns, directly or indirectly, at least 10% of the total
voting power or the total value of the outstanding shares of the Corporation or (b) the exercise
price of the Warrants, when aggregated with all other transfers of cash by such U.S. Holder (or any
person related to such U.S. Holder) to the Corporation within the preceding 12 month period,
exceeds U.S.$100,000. A U.S. Holder that fails to properly and timely file Form 926 with the IRS
generally will be subject to a penalty equal to 10% of the amount of cash transferred to the
corporation (subject to a maximum penalty of U.S.$100,000, unless the failure to file is due to
intentional disregard). The Form 926 filing requirement is subject to numerous limitations and
exceptions, and each U.S. Holder should consult
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its own financial advisor, legal counsel, or
accountant regarding the information reporting requirements that may apply with respect to the
exercise of the Warrants.
Additional Rules that May Apply to U.S. Holders
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.
Passive Foreign Investment Corporation
The Corporation generally will be a passive foreign investment company under Section 1297 of
the Code (a PFIC) 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, under certain indirect ownership rules, a disposition of the shares of such other
foreign corporation or a distribution received from such other foreign corporation 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.
Based on current business plans and available financial information, the Corporation
anticipates that it may qualify as a PFIC for the taxable year ending December 31, 2008 and for
subsequent taxable years. Whether the Corporation will, in fact, qualify as a PFIC for the taxable
year ending December 31, 2008 will depend on the assets and income of the Corporation over the
course of the taxable year ending December 31, 2008 and, as a result, cannot be predicted with
certainty as of the date of this prospectus supplement. Each U.S. Holder should consult its own
financial advisor, legal counsel, or accountant regarding whether the Corporation will qualify as a
PFIC for the taxable year ending December 31, 2008 and in subsequent taxable years.
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 described below.. A U.S. Holder that does not make any of the elections
described below will be subject to the
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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.
Elections
Rather than being subject to the default PFIC rules described above, a U.S. Holder of Common
Shares generally may either (i) make a ''qualified electing fund election under section 1295 of
the Code (a QEF Election), to be taxed currently on such U.S. Holders pro rata portion of the
Corporations income and gain, whether or not such income or gain is distributed in the form of
distributions on the Common Shares or otherwise, or (ii) make a ''mark-to-market election under
section 1296 of the Code (a Mark-to-Market Election) and thereby agree, for the year of the
election and each subsequent taxable year, to recognize ordinary gain or ordinary loss (limited to
the amount of prior ordinary gain), based on the increase or decrease in market value of the Common
Shares for such taxable year. The U.S. Holders basis in the Common Shares generally would be
adjusted to reflect any such income or loss amounts.
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, but 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 rules 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 special
taxation rules and applicable interest charge with respect to PFICs discussed above will continue
to apply. However, a U.S. Holder
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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.
A U.S. Holder of Common Shares 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 (i) a national securities exchange that is registered with the Securities
and Exchange Commission, (ii) the national market system established pursuant to section 11A of the
Securities and Exchange Act of 1934 or (iii) a foreign securities exchange that is regulated or
supervised by a governmental authority of the country in which the market is located, provided that
(x) 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 (y) the rules of
such foreign exchange ensure active trading of listed stocks. Because of the rules which treat
holders of Warrants as holding Common Shares received on exercise for the period during which they
held the Warrants, a U.S. Holder will be treated as making a Mark-to-Market Election after the
beginning of such U.S. Holders holding period for the Common Shares. Since the U.S. Holder also is
not treated as having made a timely QEF Election under these same rules, the tax regime and
interest charge of Section 1291 described above will apply to dispositions of and distributions on
the Common Shares received on exercise of Warrants during the year in which the Mark-to-Market
Election is made. U.S. Holders should consult their own tax advisors with respect to the
Mark-to-Market Election.
In order for a U.S. Holder of Common Shares to be able to make a QEF Election, the Corporation
also would have to provide certain information regarding such U.S. Holders pro rata share of the
Corporations ordinary earnings and net capital gain. In the event the Corporation is or becomes a
PFIC, the Corporation will make available to U.S. Holders, upon their request, timely and accurate
information as to its status as a PFIC and will use commercially reasonable efforts to provide to a
purchaser acquiring Common Shares pursuant to this prospectus supplement that is a U.S. Holder all
information that a U.S. Holder making a QEF Election is required to obtain for U.S. federal income
tax purposes.
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 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 financial advisor,
legal counsel, or accountant 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.
S-20
Bermuda 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 Bermuda. It may not be possible to
enforce court judgments obtained in Canada against Oncolytics Barbados in Bermuda based on the
civil liabilities provisions of applicable securities laws. In addition, there is some doubt as to
whether the courts of Bermuda would recognize or enforce judgments of Canada 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 the Offering 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-21
AUDITORS CONSENT
We have read the prospectus supplement of Oncolytics Biotech Inc. (the Corporation) dated
December 4, 2008 relating to the issuance of up to 5,175,000 Common Shares of the
Corporation (the Prospectus). We have complied with Canadian generally accepted standards for an
auditors involvement with offering documents.
We consent to the incorporation by reference in the above-mentioned Prospectus of our report
to the shareholders of the Corporation on the balance sheets of the Corporation as at December 31,
2007 and 2006 and the statements of loss and comprehensive loss and cash flows for each of the
years in the three year period ended December 31, 2007 and for the cumulative period from inception
on April 2, 1998. Our report is dated February 15, 2008.
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Calgary, Canada
December 4, 2008
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(Signed) Ernst & Young LLP
Chartered Accountants |
S-22
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
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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
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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:
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our Renewal Annual Information Form dated March 5, 2008,
for the year ended December 31, 2007 (the
AIF);
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our Management Proxy Circular dated March 23, 2007 relating
to the annual and special meeting of shareholders held on
May 2, 2007;
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our Management Proxy Circular dated March 20, 2008 relating
to the annual and special meeting of shareholders held on
May 7, 2008;
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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;
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our managements discussion and analysis of financial
condition and results of operations dated March 5, 2008,
for the year ended December 31, 2007;
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our unaudited interim consolidated financial statements as at
and for the three months ended March 31, 2008, together
with the notes thereto;
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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
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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.
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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:
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the discovery of unexpected toxicities or lack of sufficient
efficacy of products which make them unattractive or unsuitable
for human use;
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preliminary results as seen in animal and/or limited human
testing may not be substantiated in larger, controlled clinical
trials;
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manufacturing costs or other production factors may make
manufacturing of products ineffective, impractical and
non-competitive;
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proprietary rights of third parties or competing products or
technologies may preclude commercialization;
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requisite regulatory approvals for the commercial distribution
of products may not be obtained; and
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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.
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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:
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the number of Subscription Receipts offered;
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the price at which the Subscription Receipts will be offered;
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if other than Canadian dollars, the currency or currency unit in
which the Subscription Receipts are denominated;
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the procedures for the exchange of the Subscription Receipts
into Common Shares or other securities;
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the number of Common Shares or other securities that may be
obtained upon exercise of each Subscription Receipt;
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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;
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the terms applicable to the gross proceeds from the sale of the
Subscription Receipts plus any interest earned thereon;
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the material tax consequences of owning the Subscription
Receipts; and
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any other material terms, conditions and rights (or limitations
on such rights) of the Subscription Receipts.
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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:
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the designation and aggregate number of Warrants offered;
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the price at which the Warrants will be offered;
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if other than Canadian dollars, the currency or currency unit in
which the Warrants are denominated;
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14
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the designation and terms of the Common Shares that may be
acquired upon exercise of the Warrants;
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the date on which the right to exercise the Warrants will
commence and the date on which the right will expire;
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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;
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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;
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the date or dates, if any, on or after which the Warrants and
the related Securities will be transferable separately;
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the minimum or maximum amount, if any, of Warrants that may be
exercised at any one time;
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whether the Warrants will be subject to redemption or call, and,
if so, the terms of such redemption or call provisions; and
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any other material terms, conditions and rights (or limitations
on such rights) of the Warrants.
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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:
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the designation, aggregate principal amount and authorized
denominations of such Debt Securities;
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any limit upon the aggregate principal amount of such Debt
Securities;
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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);
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the issue price (at par, at a discount or at a premium) of such
Debt Securities;
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the date or dates on which such Debt Securities will be issued
and delivered;
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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);
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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;
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15
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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);
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if applicable, the provisions for subordination of such Debt
Securities to other indebtedness of the Corporation;
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the Trustee under the Trust Indenture pursuant to which
such Debt Securities are to be issued;
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any redemption term or terms under which such Debt Securities
may be defeased whether at or prior to maturity;
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any repayment or sinking fund provisions;
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any events of default applicable to such Debt Securities;
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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;
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any exchange or conversion terms and any provisions for the
adjustment thereof;
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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;
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the provisions applicable to the modification of the terms of
the Trust Indenture; and
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any other specific material terms or covenants applicable to
such Debt Securities.
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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:
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the designation and aggregate number of Units offered;
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the price at which the Units will be offered;
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if other than Canadian dollars, the currency or currency unit in
which the Units are denominated;
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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;
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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;
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any provisions for the issuance, payment, settlement, transfer
or exchange of the Units or of the Securities comprising the
Units; and
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any other material terms, conditions and rights (or limitations
on such rights) of the Units.
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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:
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Toronto Stock Exchange
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NASDAQ Capital Market
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High
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Low
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Close
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Volume
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High
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Low
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Close
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Volume
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Period
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($)
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($)
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($)
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(Shares)
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(U.S.$)
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(U.S.$)
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(U.S.$)
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(Shares)
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2007
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May
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2.39
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2.12
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2.19
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880,135
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2.17
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1.98
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2.06
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1,026,481
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June
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2.55
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2.05
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2.15
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755,603
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2.47
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1.92
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2.08
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1,746,620
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July
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2.21
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1.68
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1.91
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1,512,581
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2.08
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1.59
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1.79
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1,296,480
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August
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1.95
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1.54
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1.62
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514,617
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1.85
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1.50
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1.55
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592,767
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September
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1.90
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1.42
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1.90
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1,046,083
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1.90
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1.44
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1.89
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1,172,901
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October
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2.46
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1.67
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2.30
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2,614,255
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2.53
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1.75
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2.44
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2,470,044
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November
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2.65
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2.10
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2.28
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600,779
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2.77
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2.08
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2.29
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1,038,246
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December
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2.38
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1.67
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1.70
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355,628
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2.38
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1.67
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1.72
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795,031
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|
|
|
|
|
|
|
|
|
|
|
|
|
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:
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the documents listed under Documents Incorporated by
Reference in this Prospectus;
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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
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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