suppl
Filed pursuant to General Instruction II.L of Form F-10
File No. 333-151513
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PROSPECTUS SUPPLEMENT |
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(To Base Shelf Prospectus dated June 16, 2008)
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November 20, 2009 |
1,955,000 Common Shares
This prospectus supplement relates to the qualification for distribution of: (i) up to
1,700,000 common shares (the Common Shares) of Oncolytics Biotech Inc. (the Corporation), issuable
from time to time on exercise of 1,700,000 common share purchase warrants (the Warrants (expected
to be issued by the Corporation on or about November 23, 2009); (ii) up to 255,000 Common Shares
issuable from time to time on exercise of 255,000 Warrants issuable pursuant to the exercise of an
over-allotment option granted to the Underwriters (as defined below); and (iii) such indeterminate
number of additional Common Shares that may be issuable by reason of the anti-dilution provisions
contained in the Warrant Indenture (as defined herein) governing the Warrants. See Terms of
Warrants and Plan of Distribution.
Investing in our securities involves risks that are described in the Risk Factors section
beginning on page S-22 of this prospectus supplement and page 4 of the accompanying short form
base shelf prospectus.
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 Note 22 to our consolidated
financial statements for the year ended December 31, 2008 in our annual report on Form 20-F as
filed with the United States Securities and Exchange Commission (the SEC) on March 6, 2009 and in
the note to our unaudited consolidated financial statements as at and for the nine months ended
September 30, 2009 in our report on Form 6K filed with the SEC on November 12, 2009, both of which
are incorporated by reference in this prospectus supplement and the accompanying short form base
shelf prospectus.
You should be aware that the purchase of Common Shares may have tax consequences both in the
United States and Canada. This prospectus supplement and the accompanying short form base shelf
prospectus may not describe these tax consequences fully. You should read the tax discussion in
this prospectus supplement and the accompanying short form base shelf prospectus. See Certain
Canadian Federal Income Tax Considerations and Certain United States Federal Income Tax
Considerations in this prospectus supplement and the accompanying short form base shelf
prospectus.
Your ability to enforce civil liabilities under United States federal securities laws may be
adversely affected 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.
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.
On November 18, 2009, we filed a prospectus supplement to a short form base shelf prospectus
dated June 16, 2008 with the securities commissions in the provinces of British Columbia, Alberta,
Manitoba and Ontario and a prospectus supplement to our registration statement on Form F-10 (File
No. 333-151513), principally filed on June 6, 2008, as amended June 17, 2008, with the United
States Securities and Exchange Commission (the SEC) relating to the offering (the Unit
Offering) by us of 4,887,500 units of the Corporation (the Units), each Unit consisting of one
Common Share and 0.4 of one Common Share purchase warrant. Each whole Warrant will entitle the
holder to purchase one Common Share at an exercise price of U.S. $3.50, subject to adjustment pursuant to the terms of the Warrant Indenture (as defined herein), at
any time until 4:30 p.m. (Calgary time) on the date that is five years from the date of the closing of
the Unit Offering. See Plan of Distribution. The Unit Offering is expected to be completed on or about November 23, 2009.
The exercise price of the Warrants was determined by negotiation between the Corporation and a
syndicate of underwriters (the Underwriters).
We have also granted the Underwriters an over-allotment option to purchase additional Common
Shares and/or Warrants in an amount up to 15% of the number of Common Shares and Warrants
underlying the Units sold pursuant to the Unit Offering at the same price as in the Unit Offering,
exercisable at any time up to 30 days from the closing of the Unit Offering.
Our outstanding Common Shares are listed for trading on the Toronto Stock Exchange (TSM)
under the trading symbol ONC and on the NASDAQ Capital Market (NASDAQ) under the trading
symbol ONCY. On November 19, 2009, the closing price of the Common Shares on the TSM was $2.92
and on NASDAQ was U.S.$2.79 per Common Share. The TSM has conditionally approved the listing of the
Common Shares. Listing for the Common Shares is subject to us fulfilling all of the requirements
of the TSM on or before January 2, 2010. Pursuant to its procedure, NASDAQ has confirmed that it
will not be objecting to the additional listing of the Common Shares.
Our head office and principal place of business is located at 210, 1167 Kensington Crescent
N.W., Calgary, Alberta, T2N 1X7. Our registered office is located at 4500 Bankers Hall East, 855 -
2nd Street S.W., Calgary, Alberta, T2P 4K7.
TABLE OF CONTENTS
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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 and certain other matters 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 about securities we
may offer from time to time, 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. To the extent that
there is a conflict between the information contained in this prospectus supplement, on the one
hand, and the accompanying short form base shelf prospectus, on the other hand, 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.
This prospectus supplement is part of a registration statement on Form F-10 relating to the
Units that we filed with the SEC. This prospectus supplement does not contain all of the
information contained in the registration statement, certain parts of which are omitted in
accordance with the rules and regulations of the SEC. You should
S-2
refer to the registration statement and the exhibits to the registration statement for further
information with respect to us and our securities.
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 consolidated financial statements incorporated by
reference in this prospectus supplement and in the accompanying short form base shelf prospectus
and in the documents incorporated by reference in this prospectus supplement and in the
accompanying short form base shelf prospectus may not be comparable to consolidated financial
statements prepared in accordance with U.S. GAAP. You should refer to Note 22 of our consolidated
financial statements for the year ended December 31, 2008 for a discussion of the principal
differences between our financial results determined under Canadian GAAP and under U.S. GAAP. For
our unaudited consolidated financial statements as at and for the three and nine months ended
September 30, 2009, you should refer to our reconciliation of our consolidated financial statements
as at and for the three and nine months ended September 30, 2009 to U.S. GAAP filed with the SEC on
November 12, 2009 and incorporated into this prospectus supplement by reference. See Documents
Incorporated by Reference.
This prospectus supplement is deemed to be incorporated by reference into the accompanying
short form base shelf prospectus solely for the purposes of the offering of the Common Shares issuable upon exercise of the Warrants, including those Warrants issuable pursuant to the exercise of the over-allotment option.
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 issuable upon exercise of the Warrants, including those Warrants issuable pursuant to the exercise of the over-allotment option.
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:
S-3
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our Annual Information Form, which is comprised of our Annual Report on Form 20-F
dated March 6, 2009, for the year ended December 31, 2008 (the AIF); |
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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 Management Proxy Circular dated March 18, 2009 relating to the annual and
special meeting of shareholders held on May 5, 2009; |
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our audited consolidated financial statements, together with the notes thereto, as
at December 31, 2008 and 2007 and for each of the years in the three year period ended
December 31, 2008 and for the cumulative period from inception on April 2, 1998 and the
auditors report thereon addressed to our shareholders; |
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our managements discussion and analysis of financial condition and results of
operations dated March 4, 2009, for the year ended December 31, 2008; |
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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, 2009 and for the
cumulative period from inception on April 2, 1998; |
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our managements discussion and analysis of financial condition and results of
operations dated November 4, 2009, for the three and nine months ended September 30,
2009; |
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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, 2009 to U.S. GAAP, filed on
November 12, 2009; |
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our material change report dated March 5, 2009 relating to our acquisition of all
the issued and outstanding shares of a private company; |
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our material change report dated May 13, 2009 relating to the completion of our
offering of units for gross proceeds of $6,900,000.00; and |
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our material change report dated October 7, 2009 relating to our agreement reached
with the U.S. Food and Drug Administration (the FDA) under the Special Protocol
Assessment (the SPA) process for the design of our Phase 3 trial examining REOLYSIN
in combination with paclitaxel and carboplatin in patients with platinum-refractory
head and neck cancers. |
Any documents of the type required by Section 11.1 of Form 44-101F1 Short Form Prospectus
promulgated under National Instrument 44-101 Short Form Prospectus Distributions of the Canadian
Securities Administrators to be incorporated by reference in a short form prospectus, including,
without limitation, any annual information form, comparative annual financial statements and the
auditors report thereon, comparative interim financial statements, managements discussion and
analysis of financial condition and results of operations, material change report (except a
confidential material change report), business acquisition report and information circular, if
filed by us with the securities commissions or similar authorities in the provinces of British
Columbia, Alberta, Manitoba and Ontario after the date of this prospectus supplement and prior to
the termination of the distribution of the Common Shares under this prospectus supplement shall be
deemed to be incorporated by reference in the accompanying base shelf prospectus for the purposes
of the offering of the Common Shares issuable from time to time on the exercise of the Warrants.
Any report filed by us with the SEC pursuant to section 13(a), 13(c), 14 or 15(d) of the
United States Securities Exchange Act of 1934, as amended (the Exchange Act), 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.
S-4
Any statement contained in the accompanying base shelf prospectus, in this prospectus
supplement or in a document incorporated or deemed to be incorporated by reference in the
accompanying base shelf prospectus will be deemed to be modified or superseded for purposes of this
prospectus supplement to the extent that a statement contained in this prospectus supplement or in
any other subsequently filed document which also is, or is deemed to be, incorporated by reference
into the accompanying base shelf prospectus modifies or supersedes that statement. The modifying
or superseding statement need not state that it has modified or superseded a prior statement or
include any other information set forth in the document that it modifies or supersedes. The making
of a modifying or superseding statement shall not be deemed an admission for any purposes that the
modified or superseded statement when made, constituted a misrepresentation, an untrue statement of
a material fact or an omission to state a material fact that is required to be stated or that is
necessary to make a statement not misleading in light of the circumstances in which it was made.
Any statement so modified or superseded shall not be deemed, except as so modified or superseded,
to constitute part of this prospectus supplement or the accompanying base shelf prospectus.
Upon a new annual information form and related audited annual financial statements and
managements discussion and analysis being filed by us with, and where required, accepted by, the
securities commission or similar regulatory authority in each of the provinces of British Columbia,
Alberta, Manitoba and Ontario during the term of this prospectus supplement, the previous annual
information form, the previous audited annual consolidated financial statements and related
managements discussion and analysis, all unaudited interim consolidated financial statements and
related managements discussion and analysis, material change reports and business acquisition
reports filed prior to the commencement of our financial year in which the new annual information
form and related audited annual consolidated financial statements and managements discussion and
analysis are filed shall be deemed no longer to be incorporated into the accompanying base shelf
prospectus for purposes of future offers and sales of Common Shares under this prospectus
supplement. Upon new interim consolidated financial statements and related managements discussion
and analysis being filed by us with the securities commission or similar regulatory authority in
each of the provinces of British Columbia, Alberta, Manitoba and Ontario during the term of this
prospectus supplement, all interim consolidated financial statements and related managements
discussion and analysis filed prior to the new interim consolidated financial statements and
related managements discussion and analysis shall be deemed no longer to be incorporated into the
accompanying base shelf prospectus for purposes of future offers and sales of Common Shares under
this prospectus supplement. Upon a new information circular relating to an annual meeting of
holders of Common Shares being filed by us with the securities commission or similar regulatory
authority in each of the provinces of British Columbia, Alberta, Manitoba and Ontario during the
term of this prospectus supplement, the information circular for the preceding annual meeting of
holders of Common Shares shall be deemed no longer to be incorporated into the accompanying base
shelf prospectus for purposes of future offers and sales of Common Shares under this prospectus
supplement.
DOCUMENTS FILED AS PART OF THE REGISTRATION STATEMENT
In addition to the documents specified in this prospectus supplement under Documents
Incorporated by Reference and in the accompanying base shelf prospectus under Documents Filed as
Part of the Registration Statement, the following documents have been or will be 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 form of Underwriting Agreement and the form of Warrant
Indenture (as defined herein).
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.
S-5
We have three direct wholly-owned subsidiaries: Oncolytics Biotech (Barbados) Inc.
(Oncolytics Barbados), which is incorporated pursuant to the laws of Barbados; Valens Pharma
Ltd., which is incorporated pursuant to the laws of the Province of Alberta; 145302 Alberta Ltd.,
which is incorporated pursuant to the laws of the Province of Alberta; and one indirect
wholly-owned subsidiary, Oncolytics Biotech (U.S.), Inc., which is incorporated pursuant to the
laws of Delaware.
OUR BUSINESS
We focus on the discovery and development of oncolytic viruses for the treatment of cancers
that have not been successfully treated with conventional therapeutics. Recent scientific advances
in oncology, virology, and molecular biology have created opportunities for new approaches to the
treatment of cancer. The product we are presently developing may represent a novel treatment for
Ras-mediated cancers which can be used as an alternative to existing cytotoxic or cytostatic
therapies or as an adjuvant therapy to conventional chemotherapy, radiation therapy, 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.
S-6
For both non-cancer cells and cancer cells with an activated Ras pathway, virus binding,
entry, and production of viral genes all proceed normally. In the case of normal cells however,
the viral genes cause the activation of the anti-viral response that is mediated by the host cells
PKR, thus blocking the replication of the reovirus. In cells with an activated Ras pathway, the
activation of PKR is prevented or reversed by an element of the Ras signal transduction pathway,
thereby allowing the replication of the reovirus in these cancer cells. The end result of this
replication is the death of the cancer cell. The action of the Ras pathway in allowing reovirus
replication to ensue can be mimicked in non-cancerous cells by treating these cells with the
chemical 2-aminopurine (2-AP) which prevents the activation of PKR.
RECENT DEVELOPMENTS
On October 2, 2009, we announced that we had reached an agreement with the FDA under the SPA
process for the design of a Phase 3 trial examining REOLYSIN in combination with paclitaxel and
carboplatin in patients with platinum-refractory head and neck cancers. The SPA is an agreement
between Oncolytics and the FDA that the design and planned analyses of the Phase 3 study is
adequately designed to provide the necessary data, that depending upon outcome, could support a
license application submission for REOLYSIN.
On October 26, 2009, we announced that pursuant to the provision of written notification on
September 23, 2009, of the accelerated expiry of those warrants issued on December 5, 2008, and
those warrants amended December 18, 2008, we had received proceeds of approximately $5.8 million
resulting from the exercise of all 3,235,000 warrants.
On November 3, 2009, we announced that pursuant to the accelerated expiry of those warrants
issued on May 13, 2009, we had received proceeds of approximately $9.1 million resulting from the
exercise of all 3,795,000 warrants.
On November 6, 2009, we announced updated results from a Phase II study of intravenous
REOLYSIN in patients with sarcomas metastatic to the lung in a poster presentation at the 15th
Annual Connective Tissue Oncology Society Meeting held in Miami Beach, Florida, from November 5th
to 7th. The poster 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. Kamalesh Sankhala, part of principal investigator Dr. Monica Mitas 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 investigators reported that the treatment had been well tolerated to date, and that 19 of
44 evaluable patients experienced stable disease ranging from two to 20 months, resulting in a
total clinical benefit rate (complete response + partial response + stable disease) of 43%. The
response objective for the study was three or more patients having prolonged stabilization of
disease (>6 months) or better, for the agent to be considered. The trial exceeded its
established objective with six patients experiencing stable disease for more than six months. Two
patients have experienced stable disease for more than 19 months. One has synovial cell sarcoma
that relapsed following surgery, while the other has Ewings Sarcoma and had previously progressed
following multiple treatments.
On November 17, 2009, we announced updated results from a Phase I/II U.K. trial (REO O11) of
REOLYSIN combined with paclitaxel/carboplatin for patients with advanced cancers in a poster
presentation at the 2009 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics conference held
in Boston, Massachusetts. The poster presentation was entitled Phase I/II Trial of Oncolytic
Reovirus (REOLYSIN) in Combination with Carboplatin/Paclitaxel in Patients with Advanced Solid
Cancers with Emphasis on Squamous Cell Carcinoma of the Head and Neck (SCCHN).
The investigators reported that the treatment had been well tolerated when administered
intravenously in combination with paclitaxel and carboplatin. Of 19 evaluable patients with head
and neck cancer, mostly SCCHN refractory to prior platinum-based chemotherapy for
recurrent/metastatic disease, eight experienced partial responses and six had stable disease. The
total clinic benefit rate (complete response + partial response + stable disease) observed in head
and neck cancer patients in the trial was 74%. Of four patients with malignant melanoma in the
trial, one experienced a partial response and one had stable disease.
S-7
On November 18, 2009, we filed a prospectus supplement to the short form base shelf prospectus
dated June 16, 2008 in respect of the Unit Offering.
CAPITALIZATION
The following table sets forth the consolidated capitalization of the Corporation as at
September 30, 2009 before and after giving effect to the Unit Offering.
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after giving effect to the |
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Description of Capital |
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Unit Offering(1),(5) |
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Common Shares(2) |
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$102,532,889 |
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$113,283,118 |
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(49,608,569 Common Shares) |
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(53,858,569 Common Shares) |
Warrants |
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$4,755,846 |
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$6,169,886 |
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(8,982,800 warrants)(3) |
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(10,682,800 warrants) |
Contributed Surplus |
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$13,377,964 |
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$13,377,964 |
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Notes:
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Based on the issuance of 4,250,000 Units pursuant to the Unit Offering for aggregate gross
proceeds of U.S.$12,750,000, less the Underwriters fee of U.S.$892,500 and expenses of the
Unit Offering, estimated at U.S.$300,000. |
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The Corporation has a stock option plan which permits a maximum of 4,385,575 Common Shares to
be reserved for issue pursuant to options granted. As at September 30, 2009, options to
purchase 3,780,493 Common Shares were outstanding. |
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The 8,982,800 warrants to purchase 8,982,800 Common Shares outstanding as at September 30, 2009 are
described in Note 8 of the Corporations interim financial statements for the period ended
September 30, 2009, which is incorporated by reference in this prospectus supplement. |
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At September 30, 2009, the Corporation has an accumulated deficit of $113,543,146. |
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Does not give effect to the warrants and options exercised subsequent to September 30, 2009.
See Prior Sales. |
MARKET FOR SECURITIES
Our outstanding Common Shares are listed and posted for trading on the TSM under the trading
symbol ONC and on NASDAQ under the trading symbol ONCY. The following table sets forth the
market price ranges and the aggregate volume of trading of the Common Shares on the TSM and NASDAQ
for the periods indicated:
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High |
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Low |
|
|
Close |
|
|
Volume |
|
|
High |
|
|
Low |
|
|
Close |
|
|
Volume |
|
|
|
($) |
|
|
($) |
|
|
($) |
|
|
(Shares) |
|
|
(U.S.$) |
|
|
(U.S.$) |
|
|
(U.S.$) |
|
|
(Shares) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
November |
|
|
1.90 |
|
|
|
1.35 |
|
|
|
1.44 |
|
|
|
694,411 |
|
|
|
1.64 |
|
|
|
1.12 |
|
|
|
1.17 |
|
|
|
1,106,707 |
|
December |
|
|
1.79 |
|
|
|
1.26 |
|
|
|
1.49 |
|
|
|
1,086,919 |
|
|
|
1.38 |
|
|
|
1.03 |
|
|
|
1.21 |
|
|
|
1,002,720 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
January |
|
|
1.69 |
|
|
|
1.44 |
|
|
|
1.56 |
|
|
|
475,217 |
|
|
|
1.41 |
|
|
|
1.15 |
|
|
|
1.26 |
|
|
|
605,857 |
|
February |
|
|
1.95 |
|
|
|
1.46 |
|
|
|
1.67 |
|
|
|
667,374 |
|
|
|
1.60 |
|
|
|
1.18 |
|
|
|
1.30 |
|
|
|
807,838 |
|
March |
|
|
1.75 |
|
|
|
1.41 |
|
|
|
1.57 |
|
|
|
332,754 |
|
|
|
1.40 |
|
|
|
1.14 |
|
|
|
1.26 |
|
|
|
679,705 |
|
April |
|
|
2.33 |
|
|
|
1.50 |
|
|
|
2.09 |
|
|
|
1,367,754 |
|
|
|
1.95 |
|
|
|
1.21 |
|
|
|
1.74 |
|
|
|
1,301,319 |
|
May |
|
|
2.10 |
|
|
|
1.80 |
|
|
|
1.94 |
|
|
|
1,056,300 |
|
|
|
1.81 |
|
|
|
1.48 |
|
|
|
1.74 |
|
|
|
755,208 |
|
June |
|
|
2.30 |
|
|
|
1.76 |
|
|
|
1.89 |
|
|
|
1,219,400 |
|
|
|
2.13 |
|
|
|
1.56 |
|
|
|
1.64 |
|
|
|
951,274 |
|
July |
|
|
2.25 |
|
|
|
1.61 |
|
|
|
1.96 |
|
|
|
1,280,600 |
|
|
|
2.12 |
|
|
|
1.40 |
|
|
|
1.86 |
|
|
|
1,387,652 |
|
August |
|
|
2.65 |
|
|
|
1.85 |
|
|
|
2.43 |
|
|
|
1,795,600 |
|
|
|
2.42 |
|
|
|
1.74 |
|
|
|
2.25 |
|
|
|
1,580,485 |
|
September |
|
|
3.65 |
|
|
|
2.18 |
|
|
|
3.13 |
|
|
|
3,494,066 |
|
|
|
3.38 |
|
|
|
2.02 |
|
|
|
2.93 |
|
|
|
3,408,893 |
|
October |
|
|
4.10 |
|
|
|
3.13 |
|
|
|
3.49 |
|
|
|
4,328,723 |
|
|
|
3.80 |
|
|
|
2.93 |
|
|
|
3.23 |
|
|
|
6,442,929 |
|
November 1 - 19 |
|
|
3.98 |
|
|
|
2.85 |
|
|
|
2.92 |
|
|
|
3,658,447 |
|
|
|
3.74 |
|
|
|
2.66 |
|
|
|
2.79 |
|
|
|
3,456,739 |
|
S-8
USE OF PROCEEDS
From time to time, when the Warrants are exercised, we may receive proceeds equal to the
aggregate exercise price of such Warrants. Assuming that all of the Warrants are exercised prior
to their expiry time and that no adjustment based on the anti-dilution provisions contained in the
Warrant certificate has taken place, the gross proceeds to us from the exercise of all of the Warrants sold in the Unit Offering (including those Warrants issuable pursuant to the exercise of the over-allotment option)
will be approximately U.S.$6,842,500.
We intend to use the net proceeds from the exercise of the Warrants for our research and
development program, our manufacturing activities in support of the program and general corporate
purposes.
The principal purposes in the research and development area will be the advancement of our
clinical trial program and the continued development of our manufacturing process. Our clinical
trial program has been designed and directed to test the safety and activity of REOLYSIN® either as
a mono-therapy or in combination with other approved chemotherapies.
We believe that our intended use of the net proceeds from the exercise of the Warrants is
consistent with our stated business objectives and strategic goals of developing oncolytic viruses
as potential cancer therapeutics and will further these objectives and will assist us in financing
our recently approved Phase 3 clinical trial examining REOLYSIN in combination with paclitaxel and
carboplatin in patients with platinum-refractory head and neck cancers, the other clinical
activities that form a part of our clinical program, the manufacturing activities in support of
our program and general corporate purposes.
PRIOR SALES
Other than as set forth below, no Common Shares or securities exchangeable or convertible into
Common Shares have been issued during the twelve month period preceding the date of this prospectus
supplement.
On December 5, 2008, we issued 2,650,000 units, each unit consisting of one Common Share and
one Common Share purchase warrant, at a price of $1.50 per unit. Each whole Common Share purchase
warrant entitles the holder to acquire one additional Common Share upon payment of $1.80 on or
before December 5, 2011, subject to an acceleration of the expiry date in certain circumstances.
On December 5, 2008, we issued 265,000 broker warrants at an exercise price of $1.80 per
Common Share.
On December 11, 2008, we granted options to acquire an aggregate of 15,500 Common Shares at an
exercise price of $1.45 per Common Share.
On December 18, 2008, we amended the terms of 320,000 previously issued broker warrants for
cash consideration of $41,600. The amendments included adjusting the exercise price from $5.65 to
$1.80 and extending the expiry date from December 29, 2008 to December 29, 2009, subject to
acceleration of the expiry date in certain circumstances.
On April 9, 2009, we issued 1,875,121 Common Shares in connection with the acquisition of all
the issued and outstanding securities of an inactive private company at an ascribed value of $1.69
(being the 20-day volume weighted average trading price of our Common Shares on the TSM up to and
including March 2, 2009).
On May 13, 3009, we issued 3,450,000 units, each unit consisting of one Common Share and one
Common Share purchase warrant, at a price of $2.00 per unit. Each whole Common Share purchase
warrant entitles the holder to acquire one additional Common Share upon payment of $2.40 on or
before May 13, 2012, subject to an acceleration of the expiry date in certain circumstances. In
addition, we issued 345,000 broker Common Share purchase warrants with an exercise price of $2.40
expiring on May 13, 2012, subject to acceleration of the expiry date in certain circumstances.
From January 20, 2009 to October 30, 2009, we issued 281,600 Common Shares on the exercise of
281,600 options at exercise prices between $0.85 and $2.70 per Common Share.
S-9
From May 6, 2009 to October 23, 2009, we issued 3,235,000 Common Shares on the exercise of
3,235,000 warrants at an exercise price of $1.80 per warrant.
From September 23, 2009 to November 2, 2009, we issued 3,795,000 Common Shares on the exercise
of 3,795,000 warrants at an exercise price of $2.40 per warrant.
TERMS OF WARRANTS
The Warrants will be governed by an indenture (the Warrant Indenture) to be entered into
between us and Computershare Trust Company of Canada, as agent for the holders of the Warrants.
The following is a summary of the material attributes and characteristics of the Warrants. This
summary does not, however, include a description of all of the terms of the Warrants, and is
subject to the detailed provisions of the Warrant Indenture.
Under the Unit Offering and
including those Warrants issuable pursuant to the exercise of the over-allotment option, up to 1,955,000 Warrants will be issued. Each Warrant will entitle
the holder to purchase one Common Share upon payment of U.S.$3.50, subject to adjustment as
summarized below, at any time until 4:30 p.m. (Calgary time) on the date that is five years
following the closing of the Unit Offering. If on any accelerated exercise date (Accelerated
Exercise Date) the 10 day volume weighted average trading price of our Common Shares on the TSM
exceeds U.S.$6.50 per share, then, at our sole discretion and upon us sending the holders of the
Warrants written notice of such Accelerated Exercise Date (the Notice) and issuing a news release
announcing such Accelerated Exercise Date, the Warrants shall only be exercisable for a period of
30 days following the later of the date on which such Notice is sent to holders of Warrants and the
date on which such announcement is made by news release. The Notice will be deemed to be sent by
us on the date the Notice is deposited in first class mail to the registered address of the holder
of the Warrants as reflected on the Warrant register maintained under the Warrant Indenture.
There is no market through which the Warrants may be sold and purchasers may not be able to
resell the Warrants purchased under the prospectus supplement. This may affect the pricing of the
Warrants in the secondary market, the transparency and availability of trading prices, the
liquidity of such Warrants, and the extent of issuer regulation. See Risk Factors.
It is anticipated that the
Corporation will arrange for an instant deposit of the Warrants forming part of the Units to or for the account of the
Underwriters through the book-entry facilities of CDS and DTC on the Closing Date. No certificate evidencing the Warrants
will be issued to purchasers, except in limited circumstances and registration will be made in the depositary services of
CDS and DTC. Purchasers will receive only a customer confirmation from the Underwriters or other registered dealer who is
a CDS or DTC participant and from or through whom a beneficial interest in the Warrants forming part of the Units is
purchased. Certificates for the Warrants forming part of the Units will be issued in fully registered form.
The Warrant Indenture will provide that the share ratio and exercise price of the Warrants
will be subject to adjustment in the event of a subdivision or consolidation of our Common Shares.
The Warrant Indenture will also provide that if there is: (i) any reclassification or change of our
Common Shares into other shares; (ii) any consolidation, amalgamation, arrangement or other
business combination of Oncolytics resulting in any reclassification or change of our Common Shares
into other shares; or (iii) any sale, lease, exchange or transfer of our assets in their entirety
or substantially in their entirety to another entity, then each holder of a Warrant which is
thereafter exercised shall receive, in lieu of Common Shares, the kind and number or amount of
other securities or property which such holder would have been entitled to receive as a result of
such event if such holder had exercised the Warrants prior to the Event.
We will also covenant in the Warrant Indenture that, during the period in which the Warrants
are exercisable, we will give public notice of our intention to fix a record date for the issuance
of rights, options or warrants (other than the Warrants comprising part of the Units) to all or
substantially all of the holders of our outstanding Common Shares at least 10 days prior to the
record date of such event.
S-10
To the extent that a holder of a Warrant would otherwise be entitled to purchase a fraction of
a Common Share, the Corporation, in lieu of issuing a fractional Common Share, shall pay to the
holder thereof within five business days of exercise an amount in Canadian dollars equal to the
difference between the Current Market Price of the Common Shares on the exercise date multiplied
by the fractional interest, provided that Oncolytics shall make only one payment for each
beneficial holder exercising such Warrants and shall not be required to make any payment that is
less than $10.00. Holders of Warrants do not have any voting or pre-emptive rights or any other
rights as shareholders of Oncolytics.
In the event the registration statement under the United States Securities Act of 1933, as
amended (the U.S. Securities Act) for the issuance of the Common Shares underlying the exercise
of the Warrants is not effective at the time of exercise of such Warrants, then the holders of such
Warrants resident in the United States or holding for the account or benefit of a person resident
in the United States or a U.S. person (as such terms are defined under Regulation S under the U.S.
Securities Act) shall be able to exercise such Warrants on a cashless basis. Holders of the
Warrants resident outside the United States and not holding for the account or benefit of a person
resident in the United States or a U.S. person may exercise the Warrants pursuant to Regulation S
under the U.S. Securities Act. All holders of Warrants that exercise Warrants when a registration
statement under the U.S. Securities Act is not effective will agree that the Unit Shares received
on such exercise will only be resold pursuant to a registration statement under the U.S. Securities
registering such resale or pursuant to an exemption from such registration requirements, including
but not limited to, the exclusion provided by Rule 904 of Regulation S under the U.S. Securities
Act.
Reference is made to the Warrant Indenture for the full text of the attributes of the
Warrants.
PLAN OF DISTRIBUTION
This prospectus supplement relates
to the qualification for distribution of: (i) up to 1,700,000 Common
Shares, issuable from time to time,
on exercise of 1,700,000 Warrants (expected to be issued by
the Corporation on or about, November 23, 2009); (ii) up to 255,000 Common Shares issuable from time
to time on exercise of 255,000 Warrants issuable pursuant to the exercise of an over-allotment
option granted to the Underwriters; and (iii) such indeterminate number of
additional Common Shares that may be issuable by reason of the anti-dilution provisions contained
in the Warrant Indenture governing the Warrants. See Terms of Warrants.
This prospectus supplement registers the offering of the securities to which it relates under
the U.S. Securities Act, in accordance with the multi-jurisdictional disclosure system adopted by
the SEC and the securities commission or similar regulatory authority in each of the provinces of
Canada. This prospectus supplement does not qualify the distribution of the Common Shares in any
province or territory of Canada.
Holders of Warrants resident in the United States who acquire Common Shares pursuant to the
exercise of Warrants in accordance with their terms and under the accompanying short form base
shelf prospectus and this prospectus supplement may have a right of action against us for any
misrepresentation in the accompanying base shelf prospectus and this prospectus supplement.
However, the existence and enforceability of such a right of action is not without doubt. By
contrast, holders of Warrants resident in Canada who may acquire Common Shares pursuant to the
exercise of Warrants in accordance with their respective terms and who will be deemed to acquire
such Common Shares under applicable Canadian prospectus exemptions, will not have any such right of
action with respect to such acquisition of Common Shares.
The Common Shares to which this prospectus supplement relates will be sold directly by us to
holders of Warrants, as the case may be, on the exercise of such Warrants. No underwriters,
dealers or agents will be involved in these sales.
On June 16, 2008, we filed a short form base shelf prospectus with the Alberta Securities
Commission, as principal regulator, and on June 6, 2008, as amended June 17, 2008, a registration
statement on Form F-10 (File No. 333-151513) with the SEC relating to the offering by the
Corporation from time to time during the 25 months that the short form base shelf prospectus,
including amendments thereto, remained valid of up to Cdn. $150,000,000
S-11
of Common Shares, subscription receipts, warrants, debt securities and units. The shelf
registration statement became effective with the SEC pursuant to Rule 467(a) of the U.S. Securities
Act on June 17, 2008.
On November 18, 2009, we filed a prospectus supplement to the short form base shelf prospectus
dated June 16, 2008 with the securities commissions in the provinces of British Columbia, Alberta,
Manitoba and Ontario and a registration statement on Form F-10 (File No. 333-151513) with the SEC
relating to the offering by us of (i) 4,250,000 Units, each Unit consisting of one Common Share and
0.4 of one Warrant. Each Warrant will entitle the holder to purchase one Common Share at an
exercise price of U.S. $3.50, subject to adjustment, at any time until 4:30 p.m. (Calgary time) on
the date that is 5 years from the date of the closing of the Unit Offering. In connection with the
Unit Offering, the Corporation entered into the Underwriting Agreement with the Underwriters to
purchase, prior to the deduction of the Underwriters fee and expenses, 4,250,000 Units at the price of $3.00 per Unit (with up to an additional 637,500 Common
Shares at a price of $2.95 per Common Share and up to 255,000 Warrants at a price of $0.05 per 0.4
of one Warrant pursuant to the exercise of the over-allotment option granted to the Underwriters in
connection with the Unit Offering). The exercise price of the Warrants was determined by
negotiation between us and the Underwriters. The Unit Offering is to be completed on or about
November 23, 2009.
It is a condition of closing of the Unit Offering that the shelf registration statement remain
effective with the SEC and that we file with the SEC this prospectus supplement registering the
offering of the Common Shares issuable from time to time on the exercise of the Warrants. No U.S.
Person, person within the United States or person holding Warrants for the account or benefit of a
U.S. Person or person within the United States may exercise the Warrants during any period of time
when a registration statement covering such Common Shares is not effective or an exemption from
such registration is not otherwise available. If a registration statement under the U.S. Securities
Act is not effective, the Warrants may be exercised on a net cashless basis. See Terms of
Warrants.
CERTAIN CANADIAN FEDERAL INCOME TAX CONSIDERATIONS
In the opinion of McCarthy Tétrault LLP, counsel to the Corporation (Counsel) the following,
as of the date hereof, is a fair and adequate summary of the principal Canadian federal income tax
considerations generally applicable to the acquisition, holding and disposition of Common Shares
issuable from time to time upon the exercise of Warrants, by a holder who acquires Warrants
pursuant to the Unit Offering and who, for purposes of the Income Tax Act (Canada) (the Tax Act)
and at all relevant times deals at arms length and is not affiliated with the Corporation or the
Underwriter and will hold the Common Shares as capital property. The Common Shares will generally
constitute capital property to a holder thereof unless the holder holds the Common Shares in the
course of carrying on a business or acquires the Common Shares in a transaction or transactions
considered to be an adventure in the nature of trade. Certain holders resident in Canada for
purposes of the Tax Act who might not otherwise be considered to hold their Common Shares as
capital property, in certain circumstances, may be entitled to make an irrevocable election under
subsection 39(4) of the Tax Act to have the Common Shares and every other Canadian security (as
defined in the Tax Act) owned by such holder in the taxation year of the election and in all
subsequent taxation years deemed to be capital property. Holders contemplating such election
should consult their own tax advisors for advice as to whether an election under subsection 39(4)
is available and/or advisable in their particular circumstances.
This summary is not applicable to a holder: (i) that is a financial institution (as defined
in the Tax Act ) for purposes of the mark-to-market rules); (ii) that is a specified financial
institution (as defined in the Tax Act); (iii) an interest in which is a tax shelter investment
(as defined in the Tax Act); (iv) to which the functional currency reporting rules in section 261
of the Tax Act apply; (v) that is exempt from tax under Part I of the Tax Act; or (vi) who holds or
subsequently acquires Common Shares acquired on the exercise of a stock option or other agreement
to issue or sell Common Shares received in respect of, in the course of, or by virtue of employment
with the Corporation or any corporation or mutual fund trust (as defined in the Tax Act) not
dealing at arms length with the Corporation. Such holders should consult their own tax advisors.
This summary is based upon the facts set out in the prospectus, the current provisions of the
Tax Act and the regulations thereunder (the Regulations), all specific proposals to amend the Tax
Act and the Regulations publicly announced by or on behalf of the Minister of Finance (Canada)
prior to the date hereof (the Proposed Amendments) and Counsels understanding of the current
published administrative practices of the Canada Revenue Agency (the CRA) which have been made
publicly available prior to the date hereof. Except for the
S-12
Proposed Amendments, this summary does not take into account or anticipate any changes in law
or administrative practice, nor does it take into account provincial or territorial tax laws of
Canada or the tax laws of any foreign jurisdiction. No assurance can be given that the Proposed
Amendments will be enacted as proposed (or at all) or that legislative, judicial or administrative
changes will not alter the statements made herein.
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 holder. This summary is not exhaustive of all possible
Canadian federal income tax considerations applicable to an investment in Common Shares. The income
and other tax consequences of acquiring, holding and disposing of Common Shares will vary according
to the status of the holder, the province or provinces or territory or territories in which the
holder resides or carries on business and, generally, the holders own particular circumstances.
Accordingly, each prospective holder should obtain independent advice regarding the income tax
consequences of investing in the Common Shares with reference to the holders own particular
circumstances.
Currency
For the purposes of the Tax Act, all amounts relating to the acquisition, holding or
disposition of Common Shares and Warrants (including dividends received or deemed to have been
received, adjusted cost base and proceeds of disposition) must generally be converted into Canadian
dollars using the relevant exchange rate quoted by the Bank of Canada at noon on the relevant day
or such other rate or rates of exchange acceptable to the Minister of National Revenue (Canada).
Holders Resident in Canada
The following part of the summary is applicable to a holder who, at all relevant times, is or
is deemed to be resident in Canada for the purpose of the Tax Act and any applicable income tax
treaty or convention (a Canadian Holder).
Exercise of Warrants
No gain or loss will be realized by a Canadian Holder upon the exercise of a Warrant. A
Canadian Holders cost of a Common Share acquired on the exercise of a Warrant will be the
aggregate of the adjusted cost base to the Canadian Holder of the Warrant so exercised and the
exercise price paid for such Common Share under the terms of the Warrant. The cost of any Common
Share acquired on the exercise of a Warrant by a Canadian Holder will be averaged with the adjusted
cost base to the holder of any other Common Shares held by the Canadian Holder as capital property
at that time to determine the adjusted cost base of the Common Share so acquired.
Taxation of Dividends on Common Shares
Dividends (including deemed dividends) received on the Common Shares by a Canadian Holder who
is an individual (other than by certain trusts) will be included in the individuals income and
will generally be subject to the gross-up and the dividend tax credit rules normally applicable to
taxable dividends received from taxable Canadian corporations. To the extent the Corporation
designates the dividends as eligible dividends in the prescribed manner, the Canadian Holder will
be subject to the enhanced gross-up and dividend tax credit rules. There may be limitations on the
ability of the Corporation to designate dividends as eligible dividends. Taxable dividends
received by an individual (and certain trusts) may give rise to alternative minimum tax under the
Tax Act, depending on the individuals circumstances.
Dividends (including deemed dividends) received on the Common Shares by a Canadian Holder that
is a corporation will be included in computing the corporations income and will generally be
deductible in computing the corporations taxable income.
A Canadian Holder that is a private corporation, as defined in the Tax Act, or any other
corporation 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 331/3% refundable tax
under Part IV of the Tax Act on dividends received
S-13
(or deemed to be received) on the Common Shares to the extent such dividends are deductible in
computing its taxable income.
Disposition of Common Shares
A disposition or deemed disposition of a Common Share (other than to the Corporation) will
result in the Canadian Holder thereof realizing a capital gain (or a capital loss) in the taxation
year in which the disposition occurs equal to the amount by which the proceeds of disposition
exceed (or are less than) the aggregate of the Canadian Holders adjusted cost base of such shares
and reasonable costs of the disposition. The adjusted cost base of any Common Shares acquired
pursuant to the Unit Offering will generally be the average of the cost of all such shares
(including all other Common Shares held by the Canadian Holder) for the purpose of calculating
capital gains or capital losses on subsequent dispositions of such shares. If the Canadian Holder
is a corporation, any capital loss arising on a disposition of a share may in certain circumstances
be reduced by the amount of any dividends, including deemed dividends, which have been received on
the share. Analogous rules may apply to a partnership or trust of which a corporation, partnership
or trust is a member or beneficiary.
Taxation of Capital Gains and Capital Losses
One half of any such capital gain (a taxable capital gain) must be included in computing the
income of the Canadian Holder in the year of disposition, and one half of any such capital loss (an
allowable capital loss) generally must be applied to reduce taxable capital gains realized by the
Canadian Holder in the year of disposition. Allowable capital losses in excess of taxable capital
gains for the year of disposition generally may be applied by the Canadian Holder to reduce net
taxable capital gains realized in any of the three preceding years or in any subsequent year,
subject to various detailed provisions of the Tax Act including provisions that apply to corporate
holders after an acquisition of control.
The amount of any capital loss realized on the disposition or deemed disposition of a Common
Share by a Canadian Holder 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. Analogous rules may apply where a corporation is, directly or through a
trust or partnership, a member of a partnership or a beneficiary of a trust that owns Common
Shares. Canadian Holders to whom these rules may be relevant should consult their own tax advisors.
A subscriber that is a Canadian controlled private corporation (as defined in the Tax Act)
will be liable to pay an additional 62/3% refundable tax on its aggregate investment income for the
year, which is defined to include an amount in respect of taxable capital gains.
Alternative Minimum Tax
Individuals, including certain trusts, are subject to an alternative minimum tax. Generally,
dividends received or deemed to be received on the Common Shares and capital gains realized on a
disposition or deemed disposition of Common Shares or Warrants may increase a Canadian Holders
liability for alternative minimum tax. Canadian Holders should consult their own advisors with
respect to alternative minimum tax.
Holders Not Resident in Canada
This part of the summary is generally applicable to a holder who, at all relevant times, is
neither resident nor deemed to be resident in Canada for purposes of the Tax Act and any applicable
income tax treaty or convention, and who does not use or hold, and is not deemed to use or hold,
the Common Shares in connection with carrying on a business in Canada (a Non-Resident Holder).
Special rules not discussed in this summary may apply to a non-resident insurer carrying on an
insurance business in Canada and elsewhere; such insurers should consult their own tax advisors.
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Taxation of Dividends on Common Shares
Amounts paid or credited or deemed to be paid or credited to a Non-Resident Holder as, on
account or in lieu of, or in satisfaction of a dividend on the Common Shares will be subject to a
Canadian withholding tax under the Tax Act at a rate of 25%, subject to reduction under the
provisions of any applicable income tax treaty or convention. For example, under the Canada-United
States Tax Convention (1980) (the Canada-U.S. Treaty), the withholding tax rate in respect of a
dividend paid to a person who is the beneficial owner of the dividend and is resident in the United
States for purposes of, and entitled to full benefits under, the Canada-U.S. Treaty, is generally
reduced to 15% (unless the beneficial owner is a company that owns at least 10% of the voting stock
of the Corporation, in which case the rate is reduced to 5%).
Disposition of Common Shares
A Non-Resident Holder of Common Shares will not generally be subject to income tax under the
Tax Act in respect of the disposition or deemed disposition of such shares, provided that the
Common Shares are not, and are not deemed to be, taxable Canadian property (as defined in the Tax
Act) to the Non-Resident Holder at the time of disposition.
Generally, Common Shares will not be taxable Canadian property to a Non-Resident Holder at a
particular time provided that: (i) the Common Shares are listed on a designated stock exchange
(which currently includes the TSM and the NASDAQ) at that time; (ii) at no time during the sixty
(60) month period immediately preceding the disposition of such shares did the Non-Resident Holder,
either alone or together with one or more persons with whom the holder does not deal at arms
length, own or have an interest in or an option in respect of, 25% or more of the issued shares of
any class or series of shares in the capital of the Corporation; and (iii) the Common Shares were
not deemed under the Tax Act to be taxable Canadian property to the Non-Resident Holder.
In the event that the Common Shares constitute or are deemed to constitute taxable Canadian
property to any Non-Resident Holder, the tax consequences of realizing a capital gain on the
disposition of such shares or warrants as described above under the heading Holders Resident in
Canada Taxation of Capital Gains and Capital Losses generally will apply, subject to the
Non-Resident Holder being entitled to relief under the provisions of an applicable income tax
treaty or convention. Non-Resident Holders whose Common Shares may be taxable Canadian property
should consult with their own tax advisors for advice having regard to their particular
circumstances.
CERTAIN UNITED STATES FEDERAL INCOME TAX CONSIDERATIONS
The following is a summary of certain material anticipated U.S. federal income tax
consequences to a U.S. Holder (as defined below) arising from and relating to the ownership and
disposition 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 arising from and relating to the ownership and disposition of Common Shares received on the
exercise of Warrants. In addition, this summary does not take into account the individual facts
and circumstances of any particular U.S. Holder that may affect the U.S. federal income tax
consequences to such U.S. Holder. Accordingly, this summary is not intended to be, and should not
be construed as, legal or U.S. federal income tax advice with respect to any U.S. Holder. Each
U.S. Holder should consult its own tax advisor regarding the U.S. federal, U.S. state and local,
and foreign tax consequences arising from and relating to the ownership and disposition 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
arising from and relating to the ownership and disposition 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.
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NOTICE PURSUANT TO IRS CIRCULAR 230: NOTHING CONTAINED IN THIS SUMMARY CONCERNING ANY U.S.
FEDERAL TAX ISSUE IS INTENDED OR WRITTEN TO BE USED, AND IT CANNOT BE USED, BY A U.S. HOLDER (AS
DEFINED BELOW), FOR THE PURPOSE OF AVOIDING U.S. FEDERAL TAX PENALTIES UNDER THE U.S. CODE (AS
DEFINED BELOW). THIS SUMMARY WAS WRITTEN TO SUPPORT THE PROMOTION OR MARKETING OF THE TRANSACTIONS
OR MATTERS ADDRESSED BY THIS DOCUMENT. EACH U.S. HOLDER SHOULD SEEK U.S. FEDERAL TAX ADVICE, BASED
ON SUCH U.S. HOLDERS PARTICULAR CIRCUMSTANCES, FROM AN INDEPENDENT TAX ADVISOR.
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 document. 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 or prospective 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 or prospective basis.
U.S. Holders
For purposes of this summary, the term U.S. Holder means a beneficial owner of Common Shares
received on the exercise of Warrants under this prospectus supplement that is for U.S. federal
income tax purposes: an individual who is a citizen or resident of the U.S.; a corporation (or
other entity taxable as a corporation) organized under the laws of the U.S., any state thereof or
the District of Columbia; an estate whose income is subject to U.S. federal income taxation
regardless of its source; or a trust that (1) is subject to the primary supervision of a court
within the U.S. and the control of one or more U.S. persons for all substantial decisions or (2)
has a valid election in effect under applicable Treasury regulations to be treated as a U.S.
person.
Non-U.S. Holders
For purposes of this summary, a non-U.S. Holder is a beneficial owner of Common Shares or
Warrants that is not a U.S. Holder. This summary does not address the U.S. federal income tax
consequences to non-U.S. Holders a arising from and relating to the ownership and disposition of
Common Shares received on the exercise of Warrants. Accordingly, a non-U.S. Holder should consult
its own tax advisor regarding the U.S. federal income, U.S. state and local, and foreign tax
consequences (including the potential application of and operation of any income tax treaties)
arising from and relating to the ownership and disposition of Common Shares received on the
exercise of Warrants.
U.S. Holders Subject to Special U.S. Federal Income Tax Rules Not Addressed
This summary does not address the U.S. federal income tax consequences applicable to U.S.
Holders that are subject to special provisions under the Code, including the following U.S.
Holders: (a) U.S. Holders that are tax-exempt organizations, qualified retirement plans, individual
retirement accounts, or other tax-deferred accounts; (b) U.S. Holders that are financial
institutions, insurance companies, real estate investment trusts, or regulated investment
companies; (c) U.S. Holders that are dealers in securities or currencies or U.S. Holders that are
traders in securities that elect to apply a mark-to-market accounting method; (d) U.S. Holders that
have a functional currency other than the U.S. dollar; (e) U.S. Holders that own Common Shares as
part of a straddle, hedging transaction, conversion transaction, constructive sale, or other
arrangement involving more than one position; (f) U.S. Holders that acquired Common Shares in
connection with the exercise of employee stock options or otherwise as compensation for services;
(g) U.S. Holders that hold Common Shares other than as a capital asset within the
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meaning of Section 1221 of the Code; (h) U.S. expatriates or former longer-term residents of
the U.S. or (i) U.S. Holders that own (directly, indirectly, or by attribution) 10% or more of the
total combined voting power of the outstanding shares of Oncolytics. U.S. Holders that are subject
to special provisions under the Code, including U.S. Holders described immediately above, should
consult their own tax advisor regarding the U.S. federal, U.S. state and local, and foreign tax
consequences arising from and relating to the ownership and disposition of Common Shares.
If an entity that is classified as a partnership for U.S. federal income tax purposes holds
Common Shares, the U.S. federal income tax consequences to such partnership and the partners of
such partnership generally will depend on the activities of the partnership and the status of such
partners. Partners of entities that are classified as partnerships for U.S. federal income tax
purposes should consult their own tax advisor regarding the U.S. federal income tax consequences
arising from and relating to the ownership and disposition of Common Shares.
Tax Consequences Not Addressed
This summary does not address the U.S. state and local, U.S. federal estate and gift, U.S.
federal alternative minimum tax or foreign tax consequences to U.S. Holders arising from and
relating to the ownership and disposition of Common Shares received on the exercise of Warrants.
Each U.S. Holder should consult its own tax advisor regarding the U.S. state and local, U.S.
federal estate and gift, U.S. federal alternative minimum tax and foreign tax consequences arising
from and relating to the ownership and disposition of Common Shares received on the exercise of
Warrants.
Passive Foreign Investment Company Rules
If Oncolytics is considered a passive foreign investment company under the meaning of
Section 1297 of the Code (a PFIC) at any time during a U.S. Holders holding period, the
following sections will generally describe the U.S. federal income tax consequences to the U.S.
Holder arising from and relating to the ownership and disposition of Common Shares received on the
exercise of Warrants.
PFIC Status of Oncolytics
Oncolytics generally will be a PFIC if, for a tax year, (a) 75% or more of the gross income of
Company for such tax year is passive income or (b) 50% or more of the assets held by Oncolytics
either produce passive income or are held for the production of passive income, based on the fair
market value of such assets. Gross income generally means all revenues less the cost of goods
sold, and 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.
For purposes of the PFIC income test and asset test described above, if Oncolytics owns,
directly or indirectly, 25% or more of the total value of the outstanding shares of another
corporation, Oncolytics 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 Oncolytics 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.
Under certain attribution rules, if Oncolytics is a PFIC, U.S. Holders will be deemed to own
their proportionate share of any subsidiary of Oncolytics which is also a PFIC (a Subsidiary
PFIC), and will be deemed to receive their proportionate share of (i) a distribution on the
shares of a Subsidiary PFIC and (ii) a disposition of shares of a Subsidiary PFIC, both as if such
U.S. Holders directly held the shares of such Subsidiary PFIC.
Oncolytics believes that it qualified as a PFIC for the tax year ended December 31, 2008, and
based on current business plans and financial projections, Oncolytics anticipates that it may
qualify as a PFIC for the subsequent taxable years. The determination of whether Oncolytics (or a
Subsidiary PFIC) was, or will be, a PFIC
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for a tax year depends, in part, on the application of complex U.S. federal income tax rules,
which are subject to differing interpretations. In addition, whether Oncolytics (or a Subsidiary
PFIC) will be a PFIC for any tax year depends on the assets and income of Oncolytics (and each
Subsidiary PFIC) over the course of each such tax year and, as a result, cannot be predicted with
certainty as of the date of this document. Accordingly, there can be no assurance that the IRS
will not challenge any determination made by Oncolytics (or a Subsidiary PFIC) concerning its PFIC
status or that Oncolytics (and each Subsidiary PFIC) was not, or will not be, a PFIC for any tax
year. Each U.S. Holder should consult its own tax advisor regarding the PFIC status of Oncolytics
and each Subsidiary PFIC.
Default PFIC Rules under Section 1291 of the Code
If Oncolytics is a PFIC, the U.S. federal income tax consequences to a U.S. Holder of the
ownership and disposition of Common Shares will depend on whether such U.S. Holder makes an
election to treat Oncolytics as a qualified electing fund or QEF under Section 1295 of the Code
(a QEF Election) or a mark-to-market election under Section 1296 of the Code (a Mark-to-Market
Election). A U.S. Holder that does not make either a QEF Election or a Mark-to-Market Election
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 received 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 tax year) exceeds 125% of the average distributions received during the
three preceding tax 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 (including an indirect disposition of the stock of a Subsidiary PFIC), and any
excess distribution received on Common Shares (or an excess distribution by a Subsidiary PFIC
that is deemed to be received by a U.S. Holder), must be ratably allocated to each day in a
Non-Electing U.S. Holders holding period for the respective 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 generally 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 Oncolytics is a PFIC for any tax year during which a Non-Electing U.S. Holder holds Common
Shares, Oncolytics will continue to be treated as a PFIC with respect to such Non-Electing U.S.
Holder, regardless of whether Oncolytics ceases to be a PFIC in one or more subsequent tax 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 tax year for which Oncolytics was a PFIC.
Under proposed Treasury Regulations, if a U.S. holder has an option, warrant, or other right
to acquire stock of a PFIC (such as the Warrants), such option, warrant or right is considered to
be PFIC stock subject to the default rules of Section 1291 of the Code. Under rules described
below, the holding period for a Common Share received upon exercise of a Warrant will begin on the
date a U.S. Holder acquires the Warrant. This will impact the availability of the QEF Election and
Mark-to-Market Election with respect to the Common Share received upon exercise of the Warrant.
See discussion below under QEF Election and under Market-to-Market Election.
QEF Election
A U.S. Holder that makes a QEF Election for the first tax year in which its holding period of
its Common Shares begins, generally, will not be subject to the rules of Section 1291 of the Code
discussed above with respect to its Common Shares. However, a U.S. Holder that makes a QEF
Election will be subject to U.S. federal income tax
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on such U.S. Holders pro rata share of (a) the net capital gain of Oncolytics, which will be
long-term capital gain to such U.S. Holder, and (b) and the ordinary earnings of Oncolytics, which
will be taxed as ordinary income to such U.S. Holder. Generally, net capital gain is the excess
of (a) net long-term capital gain over (b) net short-term capital loss, and ordinary earnings are
the excess of (a) earnings and profits over (b) net capital gain. A U.S. Holder that makes a QEF
Election will be subject to U.S. federal income tax on such amounts for each tax year in which
Oncolytics is a PFIC, regardless of whether such amounts are actually distributed to such U.S.
Holder by Oncolytics. However, for any tax year in which Oncolytics is a PFIC and has no net
income or gain, U.S. Holders that have made a QEF Election would not have any income inclusions as
a result of the QEF Election. If a U.S. Holder that made a QEF Election has an income inclusion,
such a U.S. Holder may, subject to certain limitations, elect to defer payment of current U.S.
federal income tax on such amounts, subject to an interest charge. If such U.S. Holder is not a
corporation, any such interest paid will be treated as personal interest, which is not
deductible.
A U.S. Holder that makes a QEF Election generally (a) may receive a tax-free distribution from
Oncolytics to the extent that such distribution represents earnings and profits of Oncolytics
that were previously included in income by the U.S. Holder because of such QEF Election and (b)
will adjust such U.S. Holders tax basis in the Common Shares to reflect the amount included in
income or allowed as a tax-free distribution because of such QEF Election. In addition, a U.S.
Holder that makes a QEF Election generally will recognize capital gain or loss on the sale or other
taxable disposition of Common Shares.
The procedure for making a QEF Election, and the U.S. federal income tax consequences of
making a QEF Election, will depend on whether such QEF Election is timely. A QEF Election will be
treated as timely if such QEF Election is made for the first year in the U.S. Holders holding
period for the Common Shares in which Oncolytics was a PFIC. A U.S. Holder may make a timely QEF
Election by filing the appropriate QEF Election documents at the time such U.S. Holder files a U.S.
federal income tax return for such year.
A QEF Election will apply to the tax year for which such QEF Election is made and to all
subsequent tax years, unless such QEF Election is invalidated or terminated or the IRS consents to
revocation of such QEF Election. If a U.S. Holder makes a QEF Election and, in a subsequent tax
year, Oncolytics ceases to be a PFIC, the QEF Election will remain in effect (although it will not
be applicable) during those tax years in which Oncolytics is not a PFIC. Accordingly, if
Oncolytics becomes a PFIC in another subsequent tax year, the QEF Election will be effective and
the U.S. Holder will be subject to the QEF rules described above during any subsequent tax year in
which Oncolytics qualifies as a PFIC.
As discussed above, under proposed Treasury Regulations, if a U.S. holder has an option,
warrant or other right to acquire stock of a PFIC (such as the Warrants), such option, warrant or
right is considered to be PFIC stock subject to the default rules of Section 1291 of the Code.
However, a holder of an option, warrant or other right to acquire stock of a PFIC may not make a
QEF Election that will apply to the option, warrant or other right or to acquire PFIC stock. In
addition, under proposed 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 will include the period that the
option, warrant or other right was held.
Consequently, if a U.S. Holder of Common Share received upon exercise of a Warrant makes a QEF
Election, such election generally will not be treated as a timely QEF Election with respect to such
Common Share and the rules of Section 1291 of the Code discussed above will continue to apply with
respect to such U.S. Holders Common Shares. However, a U.S. Holder of Common Shares received upon
exercise of a Warrant should be eligible to make a timely QEF Election if such U.S. Holder elects
in the tax year in which such Common Shares are received 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 first day of such year for fair market value. Each U.S. Holder should consult its own tax
advisor regarding the application of the PFIC rules to the Common Shares received upon exercise of
the Warrants.
Oncolytics will make available to U.S. Holders, upon their written request, timely and
accurate information as to its status as a PFIC, and will provide to a U.S. Holder all information
and documentation that a U.S. Holder making a QEF Election with respect Oncolytics is required to
obtain for U.S. federal income tax purposes. However, U.S. Holders should be aware that Oncolytics
can provide no assurances that it will provide any such
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information relating to any Subsidiary PFIC. Because Oncolytics may own shares in one or more
Subsidiary PFICs, and may acquire shares in one or more Subsidiary PFICs in the future, they will
continue to be subject to the rules discussed above with respect to the taxation of gains and
excess distributions with respect to any Subsidiary PFIC for which the U.S. Holders do not obtain
the required information. Each U.S. Holder should consult his, her or its own tax advisor
regarding the availability of, and procedure for making, a QEF Election with respect to Oncolytics
and any Subsidiary PFIC.
Mark-to-Market Election
A U.S. Holder may make a Mark-to-Market Election only if the Common Shares are marketable
stock. The Common Shares generally will be marketable stock if the Common Shares are regularly
traded on (a) a national securities exchange that is registered with the Securities and Exchange
Commission, (b) the national market system established pursuant to section 11A of the Securities
and Exchange Act of 1934, or (c) a foreign securities exchange that is regulated or supervised by a
governmental authority of the country in which the market is located, provided that (i) such
foreign exchange has trading volume, listing, financial disclosure, and other requirements and the
laws of the country in which such foreign exchange is located, together with the rules of such
foreign exchange, ensure that such requirements are actually enforced and (ii) the rules of such
foreign exchange ensure active trading of listed stocks. If such stock is traded on such a
qualified exchange or other market, such stock generally will be regularly traded for any
calendar year during which such stock is traded, other than in de minimis quantities, on at least
15 days during each calendar quarter.
A U.S. Holder that makes a Mark-to-Market Election with respect to its Common Shares generally
will not be subject to the rules of Section 1291 of the Code discussed above with respect to the
Common Shares. However, if a U.S. Holder does not make a Mark-to-Market Election beginning in the
first tax year of such U.S. Holders holding period for the Common Shares or such U.S. Holder has
not made a timely QEF Election, the rules of Section 1291 of the Code discussed above will apply to
certain dispositions of, and distributions on, the Common Shares.
A U.S. Holder that makes a Mark-to-Market Election will include in ordinary income, for each
tax year in which Oncolytics is a PFIC, an amount equal to the excess, if any, of (a) the fair
market value of the Common Shares, as of the close of such tax year over (b) such U.S. Holders tax
basis in such Common Shares. A U.S. Holder that makes a Mark-to-Market Election will be allowed a
deduction in an amount equal to the excess, if any, of (i) such U.S. Holders adjusted tax basis in
the Common Shares, over (ii) the fair market value of such Common Shares (but only to the extent of
the net amount of previously included income as a result of the Mark-to-Market Election for prior
tax years).
A U.S. Holder that makes a Mark-to-Market Election generally also will adjust such U.S.
Holders tax basis in the Common Shares to reflect the amount included in gross income or allowed
as a deduction because of such Mark-to-Market Election. In addition, upon a sale or other taxable
disposition of Common Shares, a U.S. Holder that makes a Mark-to-Market Election will recognize
ordinary income or ordinary loss (not to exceed the excess, if any, of (a) the amount included in
ordinary income because of such Mark-to-Market Election for prior tax years over (b) the amount
allowed as a deduction because of such Mark-to-Market Election for prior tax years).
A Mark-to-Market Election applies to the tax year in which such Mark-to-Market Election is
made and to each subsequent tax year, unless the Common Shares cease to be marketable stock or
the IRS consents to revocation of such election. Each U.S. Holder should consult its own tax
advisor regarding the availability of, and procedure for making, a Mark-to-Market Election.
Although a U.S. Holder may be eligible to make a Mark-to-Market Election with respect to the
Common Shares, no such election may be made with respect to the stock of any Subsidiary PFIC that a
U.S. Holder is treated as owning, because such stock is not marketable. Hence, the Mark-to-Market
Election will not be effective to eliminate the interest charge described above with respect to
deemed dispositions of Subsidiary PFIC stock or distributions from a Subsidiary PFIC.
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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 Oncolytics 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.
In addition, a U.S. Holder who acquires Common Shares from a decedent will not receive a step
up in tax basis of such Common Shares to fair market value.
Special rules also apply to the amount of foreign tax credit that a U.S. Holder may claim on a
distribution from a PFIC. Subject to such specific rules, foreign taxes paid with respect to any
distribution in respect of stock in a PFIC are generally eligible for the foreign tax credit. The
rules relating to distributions by a PFIC and their eligibility for the foreign tax credit are
complicated, and a U.S. Holder should consult with their own tax advisor regarding the availability
of the foreign tax credit with respect to distributions by a PFIC.
The PFIC rules are complex, and each U.S. Holder should consult its own tax advisor regarding
the PFIC rules and how the PFIC rules may affect the U.S. federal income tax consequences of the
ownership and disposition of Common Shares.
U.S. Federal Income Tax Consequences of the Ownership and Disposition of Common Shares
General Taxation of Distributions
Subject to the PFIC rules discussed above, a U.S. Holder that receives a distribution,
including a constructive distribution, with respect to a Common Share 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 Oncolytics, as computed for U.S. federal income tax purposes. To the extent that a
distribution exceeds the current and accumulated earnings and profits of Oncolytics, such
distribution will be treated first as a tax-free return of capital to the extent of a U.S. Holders
tax basis in the Common Shares and thereafter as gain from the sale or exchange of such Common
Shares. (See Sale or Other Taxable Disposition of Common Shares below). However, Oncolytics
may not maintain the calculations of earnings and profits in accordance with U.S. federal income
tax principles, and each U.S. Holder should therefore assume that any distribution by Oncolytics
with respect to the Common Shares will constitute ordinary dividend income. Dividends received on
Common Shares generally will not be eligible for the dividends received deduction.
For tax years beginning before January 1, 2011, a dividend paid to a U.S. Holder who is an
individual, estate or trust by Oncolytics generally will be taxed at the preferential tax rates
applicable to long-term capital gains if Oncolytics is a qualified foreign corporation as defined
under Section 1(h)(11) of the Code (QFC) and certain holding period requirements for the Common
Shares are met. Oncolytics generally will be a QFC if Oncolytics is eligible for the benefits of
the Canada-U.S. Tax Convention or the Common Shares are readily tradable on an established
securities market in the U.S. However, even if Oncolytics satisfies one or more of these
requirements, Oncolytics will not be treated as a QFC if Oncolytics is a PFIC for the tax year
during which it pays a dividend or for the preceding tax year. (See the section above under the
heading Passive Foreign Investment Company Rules). Accordingly, Oncolytics does not expect to be
a QFC in the current tax year and it may not be a QFC for subsequent tax years.
S-21
If Oncolytics is not considered a PFIC, but a dividend paid to a U.S. Holder otherwise fails
to qualify for the preferential tax rates discussed above, such a dividend generally will be taxed
at ordinary income tax rates (and not at the preferential tax rates applicable to long-term capital
gains).
Sale or Other Taxable Disposition of Common Shares
Subject to the PFIC rules discussed above, upon the sale or other taxable disposition of
Common Shares, a U.S. Holder generally will recognize capital gain or loss in an amount equal to
the difference between the amount of cash plus the fair market value of any property received and
such U.S. Holders tax basis in such Common Shares sold or otherwise disposed of. Subject to the
PFIC rules discussed above, gain or loss recognized on such sale or other disposition generally
will be long-term capital gain or loss if, at the time of the sale or other disposition, the Common
Shares have been 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.
Preferential 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.
Receipt of Foreign Currency
The amount of any distribution paid to a U.S. Holder in foreign currency, or on the sale,
exchange or other taxable disposition of Common Shares, generally will be equal to the U.S. dollar
value of such foreign currency based on the exchange rate applicable on the date of receipt
(regardless of whether such foreign currency is converted into U.S. dollars at that time). If the
foreign currency received is not converted into U.S. dollars on the date of receipt, a U.S. Holder
will have a basis in the foreign currency equal to its U.S. dollar value on the date of receipt.
Any U.S. Holder who receives payment in foreign currency and engages in a subsequent conversion or
other disposition of the foreign currency may have a foreign currency exchange gain or loss that
would be treated as ordinary income or loss, and generally will be U.S. source income or loss for
foreign tax credit purposes. Each U.S. Holder should consult its own U.S. tax advisor regarding
the U.S. federal income tax consequences of receiving, owning, and disposing of foreign currency.
Foreign Tax Credit
Subject to the PFIC rules discussed above, a U.S. Holder who pays (whether directly or through
withholding) Canadian income tax with respect to dividends paid 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 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
paid by Oncolytics generally will constitute foreign source income and generally will be
categorized as passive category income. The foreign tax credit rules are complex, and each U.S.
Holder should consult its own tax advisor regarding the foreign tax credit rules.
S-22
Subject to certain specific rules, foreign income and withholding taxes paid with respect to
any distribution in respect of stock in a PFIC should qualify for the foreign tax credit. The
rules relating to distributions by a PFIC are complex, and a U.S. Holder should consult with its
own tax advisor with respect to any distribution received from a PFIC.
Backup Withholding and Information Reporting
Under U.S. federal income tax law and regulations, certain categories of U.S. Holders must
file information returns with respect to their investment in, or involvement in, a foreign
corporation. Penalties for failure to file certain of these information returns are substantial.
U.S. Holders of Common Shares, should consult with their own tax advisors regarding the
requirements of filing information returns, and, if applicable mark-to-market and QEF elections.
Payments made within the U.S. of dividends on, and proceeds arising from the sale or other
taxable disposition of, Common Shares generally may be subject to information reporting and backup
withholding 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, or (d) fails to certify, under penalties 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. However,
certain exempt persons, such as corporations, generally are excluded from these information
reporting and backup withholding 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 in a timely
manner. Each U.S. Holder should consult its own tax advisor regarding application of the
information reporting and backup withholding rules to them.
RISK FACTORS
Prospective purchasers of Units 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.
There can be no assurance as to the liquidity of the Warrants or that a trading market for the
Warrants will develop.
There is currently no public market through which the Warrants may be sold and we do not
intend to apply for the listing of the Warrants on any securities exchanges. This may affect the
pricing of the Warrants in the secondary market, the transparency and availability of trading
prices, the liquidity of the Warrants, and the extent of issuer regulation.
Barbados law differs from the laws in effect in Canada and may afford less protection to
holders of our securities.
Certain of our assets and intellectual property are held by our wholly-owned subsidiary,
Oncolytics Barbados, which is organized under the laws of Barbados. It may not be possible to
enforce court judgments obtained in Canada against Oncolytics Barbados in Barbados based on the
civil liabilities provisions of applicable securities laws. In addition, there is some doubt as to
whether the courts of Barbados would recognize or enforce judgments of Canadian courts obtained
against us or our directors or officers based on the civil liabilities provisions of Canadian
securities laws or hear actions against us or those persons based on such laws.
S-23
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.
The Corporation may fail to achieve and maintain adequate internal control over financial
reporting pursuant to the requirements of the Sarbanes-Oxley Act and equivalent Canadian
legislation.
The Corporation documented and tested during its most recent fiscal year its internal control
procedures in order to satisfy the requirements of Section 404 of the Sarbanes-Oxley Act (SOX)
and equivalent Canadian legislation. SOX requires an annual assessment by management of the
effectiveness of the Corporations internal controls over financial reporting and an attestation
report by the Corporations independent auditors addressing this assessment. The Corporation may
fail to achieve and maintain the adequacy of its internal controls over financial reporting as such
standards are modified, supplemented, or amended from time to time, and the Corporation may not be
able to ensure that it can conclude, on an ongoing basis, that it has effective internal controls
over financial reporting in accordance with Section 404 of SOX. The Corporations failure to
satisfy the requirements of Section 404 of SOX on an ongoing, timely basis could result in the loss
of investor confidence in the reliability of its financial statements, which in turn could harm the
Corporations business and negatively impact the trading price of the common shares or the market
value of its other securities. In addition, any failure to implement required new or improved
controls, or difficulties encountered in their implementation, could harm the Corporations
operating results or cause it to fail to meet its reporting obligations. Future acquisitions of
companies, if any, may provide the Corporation with challenges in implementing the required
processes, procedures and controls in its acquired operations. No evaluation can provide complete
assurance that the Corporations internal controls over financial reporting will detect or uncover
all failures of persons within the Corporation to disclose material information otherwise required
to be reported. The effectiveness of the Corporations processes, procedures and controls could
also be limited by simple errors or faulty judgments. In addition, if the Corporation expands, the
challenges involved in implementing appropriate internal controls over financial reporting will
increase and will require that the Corporation continue to improve its internal controls over
financial reporting.
Because the Corporation is a Canadian corporation and the majority of its directors and
officers are resident in Canada, it may be difficult for investors in the United States to enforce
civil liabilities against the Corporation based solely upon the federal securities laws of the
United States.
The Corporation is a Canadian corporation, with its principal place of business in Canada. A
majority of the Corporations directors and officers and some or all of the experts named in the
registration statement to which this prospectus supplement relates are residents of Canada and a
significant portion of the Corporations assets and the assets of a majority of the Corporations
directors and officers and the experts named in this prospectus supplement are located outside the
United States. Consequently, it may be difficult for U.S. investors to effect service of process
within the United States upon the Corporation or its directors or officers or such experts who are
not residents of the United States, or to realize in the United States upon judgments of courts of
the United States predicated upon civil liabilities under the U.S. Securities Act of 1933, as
amended. Investors should not assume that Canadian courts (1) would enforce judgments of U.S.
courts obtained in actions against the Corporation or such directors, officers or experts
predicated upon the civil liability provisions of the U.S. federal securities laws or the
securities or blue sky laws of any state within the United States or (2) would enforce, in
original actions, liabilities against the Corporation or such directors, officers or experts
predicated upon the U.S. federal securities laws or any such state securities or blue sky laws.
In addition, the protections afforded by Canadian securities laws may not be available to investors
in the United States.
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.
S-24
Certain legal matters relating to the issuance of common shares upon the exercise of Warrants
will be passed upon by McCarthy Tétrault 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 McCarthy Tétrault LLP, as a group, 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.
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
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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
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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
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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.
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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.
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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.
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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 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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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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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.
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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
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January
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2.04
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1.66
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1.95
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538,887
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2.04
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1.69
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1.93
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622,530
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February
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2.26
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1.82
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1.90
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564,976
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2.27
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1.85
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1.94
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588,210
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March
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2.01
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1.70
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1.83
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376,635
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2.02
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1.70
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1.84
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618,300
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April
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2.50
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1.78
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1.96
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1,159,535
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2.46
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1.76
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1.94
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1,138,020
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May
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2.18
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1.60
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2.15
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6,683,183
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2.21
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1.62
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2.15
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897,410
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June (1-13)
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2.40
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2.00
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2.14
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452,450
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2.39
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2.01
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2.08
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692,140
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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;
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the consent of our Canadian counsel Bennett Jones LLP;
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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.
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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.
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