fv10
As filed with the Securities and Exchange Commission on February 8, 2007.
Registration No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form F-10
REGISTRATION STATEMENT UNDER
THE SECURITIES ACT OF 1933
ONCOLYTICS BIOTECH INC.
(Exact name of Registrant as specified in its charter)
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Alberta
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2834 |
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Not Applicable |
(Province or other jurisdiction
of incorporation or organization)
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(Primary Standard Industrial Classification
Code Number)
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(I.R.S. Employer
Identification Number) |
Suite #210, 1167 Kensington Crescent N.W.
Calgary, Alberta
Canada T2N 1X7
(403) 670-7377
(Address and Telephone Number of Registrants Principal Executive Offices)
DL Services, Inc.
1420 Fifth Avenue, Suite 3400
Seattle, Washington 98101
(206) 903-8800
(Name, Address (including Zip Code) and Telephone Number (including Area Code) of Agent for Service in the United States)
Copies to:
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Douglas A. Ball
Oncolytics Biotech Inc.
210 1167 Kensington
Cr. N.W.
Calgary, Alberta
Canada T2N 1X7
Telephone: (403)
670-7377
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Randal Jones
Jason K. Brenkert
370, 17th
Street, Suite 4700
Denver, Colorado 80202
Telephone: (303)
629-3400
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Brent W. Kraus
Bennett Jones LLP
4500,
855 2nd Street SW
Calgary, Alberta
Canada T2P 4K7
Telephone: (403) 298-3071
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Approximate date of commencement of proposed sale of the securities to the public:
As soon as practicable after this Registration Statement becomes effective.
Province of Alberta, Canada
(Principal jurisdiction regulating this offering)
It is proposed that this filing shall become effective (check appropriate box):
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A.
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Upon filing with the Commission, pursuant to Rule 467(a)
(if in connection with an offering being made
contemporaneously in the United States and Canada). |
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B.
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At some future date (check the appropriate box below): |
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1. |
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pursuant to Rule 467(b) on _____ (date) at ______ (time) (designate
a time not sooner than 7 calendar days after filing). |
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pursuant to Rule 467(b) on ______ (date) at ______ (time) (designate
a time 7 calendar days or sooner after filing) because
the securities regulatory authority in the review
jurisdiction has issued a receipt or notification of
clearance on ______ (date). |
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pursuant to Rule 467(b) as soon as practicable after
notification of the Commission by the Registrant or the
Canadian securities regulatory authority of the review
jurisdiction that a receipt or notification of clearance
has been issued with respect hereto. |
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after the filing of the next amendment to this Form (if
preliminary material is being filed). |
If any of the securities being registered on this Form are to be offered on a delayed or continuous
basis pursuant to the home jurisdictions shelf prospectus offering procedures, check the following
box. o
CALCULATION OF REGISTRATION FEE
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Title of each class of |
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Proposed maximum |
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Amount of |
securities to be registered |
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aggregate offering price (12(2) |
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registration fee |
Common Shares(3)
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U.S.$10,125,728
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U.S.$1,084 |
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TOTAL
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U.S.$10,125,728
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U.S.$1,084 |
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(1) |
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Rule 457(o) permits the registration fee to be calculated on the basis of
the maximum offering price of all of the securities listed and, therefore,
the table does not specify by each class information as to the amount to be
registered or the proposed maximum offer price per security. The proposed
maximum initial offering price per security will be determined, from time
to time, by the Registrant. In no event will the aggregate initial
offering price of all securities issued from time to time pursuant to this
Registration Statement exceed U.S.$10,125,728. |
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Determined based on the proposed maximum aggregate offering price in
Canadian dollars of $12,000,000 converted into U.S. dollars based on the
noon exchange rate as report by the Federal Reserve Bank of New York on
February 7, 2007 of US$1.00 to Cdn$1.1851. |
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Subject to footnote (1), there are being registered hereunder an
indeterminate number of Common Shares as may be sold from time to time by
the Registrant. There are also being registered hereunder an indeterminate
number of Common Shares as may be issuable upon exercise of warrants. |
The Registrant hereby amends this Registration Statement on such date or dates as may be necessary
to delay its effective date until the registration statement shall become effective as provided in
Rule 467 under the Securities Act, or on such date as the Commission, acting pursuant to Section
8(a) of the Securities Act, may determine.
PART I
INFORMATION REQUIRED TO BE DELIVERED TO OFFEREES OR PURCHASERS
Preliminary Short Form Base Shelf Prospectus
A copy of this preliminary short form prospectus has been filed with the securities regulatory
authority in the province of Alberta but has not yet become final for the purpose of the sale of
securities. Information contained in this preliminary short form prospectus may not be complete
and may have to be amended. The securities may not be sold until a receipt for the short form
prospectus is obtained from the securities regulatory authority.
This short form prospectus has been filed under legislation in the province of Alberta 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. In addition, copies of documents incorporated by reference may be
obtained from the securities commissions or similar authorities in Canada through the SEDAR website
at www.sedar.com. See Documents Incorporated by Reference.
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New Issue
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Dated February 8, 2007 |
CDN. $12,000,000
COMMON SHARES
We may from time to time offer and issue our common shares, up to a total price of
Cdn. $12,000,000 (or the equivalent in other currencies or currency units) during the 25-month period
that this short form base shelf prospectus, including any amendments
hereto, remains valid. The distribution of
common shares 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.
This
prospectus qualifies common shares, including common shares issuable
on exercise of the common share purchase warrants issued under the
Unit Offering (as described herein). The specific terms of any offering of common shares will be set out in the applicable
prospectus supplement, including the currency in which the common shares will be issued and any
other specific terms. A prospectus supplement may include specific terms pertaining to the common
shares that are not within the alternatives and parameters described
in this prospectus.
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 common shares to which the prospectus
supplement pertains.
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.
We are permitted, under a multi-jurisdictional disclosure system adopted by the United States,
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 common shares may have tax consequences both in
the United States and Canada. This prospectus or any applicable prospectus supplement may not
describe these tax consequences fully. You should read the tax discussion in this prospectus and
any applicable prospectus supplement. See Canadian Federal Income Tax Considerations and United
States Federal 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, all of our directors and most 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.
There are certain risk factors that should be carefully reviewed by prospective purchasers.
See Risk Factors.
Our outstanding common shares 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.
We may sell the common shares to or through underwriters or dealers or directly to investors
or through agents. The prospectus supplement relating to a particular offering of common shares
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 common shares, 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 common shares sold to or through
underwriters will be named in the related prospectus supplement. Unless otherwise specified in any
applicable prospectus supplement, the common shares will not be listed on any securities exchange.
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. The
information contained in this prospectus is accurate only as of the
date of this prospectus,
regardless of the time of delivery of this prospectus or of any sale of our units.
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.
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TABLE OF CONTENTS
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DEFINITIONS AND OTHER MATTERS
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SPECIAL NOTICE REGARDING FORWARD-LOOKING STATEMENTS
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DOCUMENTS INCORPORATED BY REFERENCE
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WHERE YOU CAN FIND ADDITIONAL INFORMATION
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ENFORCEABILITY OF CIVIL LIABILITIES
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RISK FACTORS
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ONCOLYTICS BIOTECH INC.
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OUR BUSINESS
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RECENT DEVELOPMENTS
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USE OF PROCEEDS
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CAPITALIZATION
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DESCRIPTION OF SHARE CAPITAL
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PLAN OF DISTRIBUTION
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CANADIAN FEDERAL INCOME TAX CONSIDERATIONS
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UNITED STATES FEDERAL INCOME TAX CONSIDERATIONS
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LEGAL MATTERS
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AUDITOR
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PURCHASERS STATUTORY RIGHTS
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AUDITORS CONSENT
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CERTIFICATE OF THE CORPORATION
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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, in any applicable prospectus supplement may not be comparable to financial statements
prepared in accordance with U.S. GAAP. You should refer to Note 20 of our financial statements for
the year ended December 31, 2005 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 September 30, 2006 and for the three and nine months ended September 30, 2006, you should
refer to our reconciliation of our financial statements as at September 30, 2006 and for the three
and nine months ended September 30, 2006 to U.S. GAAP furnished to the SEC on the Companys Current
Report on Form 6-K dated February 5, 2007 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 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. In
addition, copies of documents incorporated by reference may be obtained from the securities
commissions or similar authorities in Canada through the SEDAR website at www.sedar.com.
We have filed the following documents with the securities commissions or similar regulatory
authorities in 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 2, 2006, for the year ended December 31,
2005 (the AIF); |
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our Management Proxy Circular dated March 24, 2006 relating to the annual and special
meeting of shareholders held on April 26, 2006, excluding those portions which are not
prescribed by applicable securities laws; |
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our audited financial statements, together with the accompanying notes to the financial
statements, for the fiscal years ended December 31, 2005 and 2004 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 2, 2006, for the year ended December 31, 2005; |
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our unaudited interim financial statements as at September 30, 2006 and for the three and
nine months ended September 30, 2006, together with the notes thereto; |
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our managements discussion and analysis of financial condition and results of operations
dated November 2, 2006, for the three and nine months ended September 30, 2006; and |
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the reconciliation of our financial statements as at September 30, 2006 and for the three
and nine months ended September 30, 2006 to U.S. GAAP, filed on February 5, 2007 under the
heading Other. |
Any documents of the type required by National Instrument 44-101 Short Form Prospectus
Distributions of the Canadian Securities Administrators to be incorporated by reference in a short
form prospectus, including any annual information form, comparative annual financial statements and
the auditors report thereon, comparative interim financial statements, managements discussion and
analysis of financial condition and results of operations, material change report (except a
confidential material change report), business acquisition report and information circular, if
filed by us with the securities commissions or similar authorities in the provinces of Canada after
the date of this prospectus shall be deemed to be
incorporated by reference in this prospectus.
Any report filed by
us with the SEC pursuant to section 13(a), 13(c), 14 or 15(d) of the United States Securities
Exchange Act of 1934 after the date of this prospectus shall be deemed to be incorporated by
reference into the registration statement of which this prospectus forms a part, if and to the
extent expressly provided in such report.
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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 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 annual financial statements being filed by us
with, and where required, accepted by, the applicable securities regulatory authorities during the
currency of this prospectus, the previous annual information form and all annual financial
statements, interim financial statements, material change reports and information circulars filed
prior to the commencement of our financial year in which the new annual information form is filed
shall be deemed no longer to be incorporated by reference into this prospectus for purposes of
future offers and sales of common shares hereunder.
One or more prospectus supplements containing the specific variable terms for an issue of
common shares and other information in relation to such common shares will be delivered to
purchasers of such common shares 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 common shares 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 common
shares. 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. Statements included or incorporated by reference in this prospectus about the
contents of any contract, agreement or other documents referred to are not necessarily complete,
and in each instance, you should refer to the exhibits for a more complete description of the
matter involved. Each such statement is qualified in its entirety by such reference.
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). All of our
directors, the majority of our officers, 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 common shares who reside in the United States to effect service within the
United States upon those directors, officers and experts who are not residents of the United
States. It may also be difficult for holders of common shares 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
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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 common shares
under this prospectus.
RISK FACTORS
A prospective purchaser of common shares 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 common shares.
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:
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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. |
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.
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.
- 5 -
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 (cGMP) 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 contracted by us to adhere to additional
manufacturing standards, even if not required by the FDA. Compliance with cGMP 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 cGMP requirements. If the manufacturing facilities contracted by us fail
to comply with the cGMP 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
- 6 -
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 the AIF and Recent Developments New Patents in this prospectus. 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
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 was 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.
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 we attempt
to enforce our own patents against other parties.
Our products may fail or cause harm, subjecting us to product liability claims, which are uninsured.
The sale and use of our products entail risk of product liability. We currently do not have
any product liability insurance. 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
affect 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.
- 7 -
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 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 affect 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 operating 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, 2005, we had an accumulated deficit of approximately $50.7 million and as at September 30,
2006, we had an accumulated deficit of approximately $60.1 million. We have incurred net losses of
approximately $12.8 million, $13.0 million, and $8.5 million for the years ended December 31, 2005,
2004, and 2003, respectively. For the nine months ended September 30, 2006, we incurred a net loss
of approximately $9.4 million. We anticipate that we will continue to incur significant losses
during 2007 and in the foreseeable future. We will not reach profitability until after successful
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 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, 2005, we had cash and cash equivalents (including short-term investments)
of $40.4 million and working capital of approximately $39.3 million. As at September 30, 2006, we
had cash and cash equivalents (including short-term investments) of $31.5 million and working
capital of approximately $30.4 million. We believe our existing capital resources are adequate to
fund our current plans for research and development activities well into 2008 without the use of
the proceeds from this offering. 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
- 8 -
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 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 commercially 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 will
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 and consulting expenses in foreign currencies (to
date mainly in the U.S. and the U.K.). Over the past year the Canadian dollar has appreciated to
these currencies 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.
- 9 -
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.
We believe we are a passive foreign investment company, which may have a material affect on
U.S. holders.
We believe we are a passive foreign investment company (PFIC), which may have a material
affect on U.S. holders. United States income tax legislation contains rules governing PFICs, which
can have significant tax effects on U.S. holders of foreign corporations. A U.S. holder who holds
stock in a foreign corporation during any year in which such corporation qualifies as a PFIC is
subject to United States federal income taxation under one of two alternative tax regimes at the
election of each such U.S. holders. The U.S. federal income tax consequences to a U.S. holder of
the acquisition, ownership, and disposition of common shares will depend on whether such U.S.
holder makes an election to treat the Corporation 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). You should consult your tax advisor as to the consequences of
acquiring, owning or disposing of our common shares.
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 issued and
outstanding 2,222,222 common shares to create 6,750,000 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.
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, 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
may 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.
- 10 -
The following schematic illustrates the molecular basis of how the reovirus kills cancer
cells.
For both non-cancer cells and cancer cells with an activated Ras pathway, virus binding,
entry, and production of viral genes all proceed normally. In the case of normal cells however,
the viral genes cause the activation of the anti-viral response that is mediated by the host cells
PKR, thus blocking the replication of the reovirus. In cells with an activated Ras pathway, the
activation of PKR is prevented or reversed by an element of the Ras signal transduction pathway,
thereby allowing the replication of the reovirus in these cancer cells. The end result of this
replication is the death of the cancer cell. The action of the Ras pathway in allowing reovirus
replication to ensue can be mimicked in non-cancerous cells by treating these cells with the
chemical 2-aminopurine (2-AP) which prevents the activation of PKR.
RECENT DEVELOPMENTS
REOLYSIN® Development
We continue to develop our lead product REOLYSIN® as a possible cancer therapy.
Our goal each year is to advance REOLYSIN® through the various steps and stages of
development required for potential pharmaceutical products. In order to achieve this goal, we
actively manage the development of our clinical trial program, our pre-clinical and collaborative
programs, our manufacturing process, REOLYSIN® supply, and our intellectual property.
Clinical Trial Program
We are directing a broad clinical trial program with the objective of developing
REOLYSIN® as a human cancer therapeutic. The clinical program includes human trials
using REOLYSIN® alone and in combination with radiation and chemotherapy, and delivered
via local administration and/or intravenous administration.
Based on indications of activity in our clinical trial program to date, Oncolytics Phase II
clinical trial program may include combination chemotherapy/REOLYSIN® trials including
colorectal, prostate, pancreatic and non-small cell lung cancer, and combination radiation/
REOLYSIN® trials in a number of tumour types. In addition, the U.S. National Cancer
Institute (NCI) has solicited proposals to conduct two trials using REOLYSIN® as a
monotherapy for melanoma and ovarian cancers.
- 11 -
Clinical Trial Chart
The following chart shows the states of clinical trials that have been completed or that are in
progress.
|
|
|
|
|
|
|
|
|
Trial Program and Cancer |
|
|
|
|
Delivery Method |
|
Indication |
|
Location |
|
Status |
Intravenous administration in combination with gemcitabine
|
|
pancreatic, lung, ovarian
|
|
United Kingdom
|
|
Approval to commence |
|
|
|
|
|
|
|
Intravenous administration in combination with docetaxel
|
|
bladder, prostate, lung, upper gastro-intestinal
|
|
United Kingdom
|
|
Approval to commence |
|
|
|
|
|
|
|
Intravenous
administration in
combination with
paclitaxel and
carboplatin
|
|
melanoma, lung, ovarian
|
|
United Kingdom
|
|
Approval to commence |
|
|
|
|
|
|
|
Local therapy in combination with radiation
|
|
Phase II various metastatic tumours, including head & neck
|
|
United Kingdom
|
|
Ongoing |
|
|
|
|
|
|
|
Local therapy in combination with radiation
|
|
Phase I various metastatic tumours
|
|
United Kingdom
|
|
Phase Ia complete Phase Ib ongoing |
|
|
|
|
|
|
|
Infusion monotherapy
|
|
Phase I/II recurrent malignant gliomas |
|
United States
|
|
Ongoing |
|
|
|
|
|
|
|
Intravenous administration monotherapy
|
|
Phase I various metastatic tumours |
|
United Kingdom
|
|
Complete |
|
|
|
|
|
|
|
Intravenous administration monotherapy |
|
Phase I various metastatic tumours
|
|
United States
|
|
Complete |
|
|
|
|
|
|
|
Local monotherapy
|
|
Phase I recurrent malignant gliomas |
|
Canada
|
|
Complete |
|
|
|
|
|
|
|
Local monotherapy |
|
T2 prostate cancer
|
|
Canada
|
|
Complete |
|
|
|
|
|
|
|
Local monotherapy
|
|
Phase I trial for various subcutaneous tumours
|
|
Canada
|
|
Complete |
U.K. Combination Gemcitabine and REOLYSIN® Clinical Trial
In January 2007, we received approval from the U.K. Medicines and Healthcare products
Regulatory Agency (the MHRA) to begin a clinical trial using intravenous administration of
REOLYSIN® in combination with gemcitabine (Gemzar®) in patients with advanced
cancers including pancreatic, lung and ovarian. The trial has two components. The first is an
open-label, dose-escalating, non-randomized study of REOLYSIN® given intravenously with
gemcitabine every three weeks. A standard dosage of gemcitabine will be delivered with escalating
dosages of REOLYSIN®. A maximum of three cohorts will be enrolled in the
REOLYSIN® dose escalation portion. The second component of the trial will immediately
follow and will include the enrolment of a further 12 patients at the maximum dosage of
REOLYSIN® in combination with a standard dosage of gemcitabine. 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 objective of the trial is to
determine the Maximum Tolerated Dose (MTD), Dose-Limiting
Toxicity (DLT), recommended dose and dosing schedule and safety profile of
REOLYSIN® when administered in combination with gemcitabine. 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.
U.K. Combination Docetaxel and REOLYSIN® Clinical Trial
In January 2007, we received approval from the MHRA for our Clinical Trial Application to
begin a clinical trial using intravenous administration of REOLYSIN® in combination with
docetaxel (Taxotere®) in patients
with advanced cancers including bladder, prostate, lung and upper gastro-intestinal. The
trial has two components. The first is an open-label, dose-escalating, non-randomized study of
REOLYSIN® given intravenously with docetaxel every three weeks. A standard dosage of
docetaxel will be delivered with escalating dosages of REOLYSIN®. A maximum of three
cohorts will be enrolled in the REOLYSIN® dose escalation portion. The second component
of the trial will immediately follow and will include the enrolment of a further 12 patients at the
- 12 -
maximum dosage of REOLYSIN® in combination with a standard dosage of docetaxel.
Eligible patients include those who have been diagnosed with advanced or metastatic solid tumours
such as bladder, lung, prostate or upper gastro-intestinal 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 MTD, DLT, recommended dose and dosing schedule and safety profile of REOLYSIN® when
administered in combination with docetaxel. 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.
U.K. Combination Paclitaxel and Carboplatin with REOLYSIN® Clinical Trial
In December 2006, the MHRA approved a clinical trial using intravenous administration of
REOLYSIN® in combination with paclitaxel and carboplatin in patients with advanced
cancers including melanoma, lung and ovarian. 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 will
be delivered with escalating dosages of REOLYSIN®. A maximum of three cohorts will be
enrolled in the REOLYSIN® dose escalation portion. The second component of the trial
will immediately follow and will include the enrolment of a further 12 patients at the maximum
dosage of REOLYSIN® in combination with standard dosages of paclitaxel and carboplatin.
Eligible patients include those who have been diagnosed with advanced or metastatic solid tumours
including melanoma, lung and ovarian 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 MTD, DLT, 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.
U.K.
Phase II Combination
REOLYSIN®/Radiation Clinical Trial
In December 2006, we commenced enrolment in our Phase II U.K. clinical trial to evaluate the
anti-tumour effects of intratumoural administration of REOLYSIN® in combination with
low-dose radiation in patients with advanced cancers.
The trial is an open-label, single-arm, multi-centre Phase II study of REOLYSIN®
delivered via intratumoural injection to patients during treatment with low-dose radiotherapy. Up
to 40 evaluable patients, including approximately 20 patients with head and neck and esophageal
cancers, and approximately 20 patients with other advanced cancers, will be treated with two
intratumoural doses of REOLYSIN® at 1x1010 TCID50 with a constant
localized radiation dose of 20 Gy in five consecutive daily fractions. Eligible patients include
those who have been diagnosed with advanced or metastatic cancers including head, neck and
esophageal tumours 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 assess the anti-tumour activity of the combination of
REOLYSIN® and low dose radiotherapy in treated and untreated lesions. Secondary
objectives include the evaluation of viral replication, immune response to the virus and to
determine the safety and tolerability of intratumoural administration of REOLYSIN® in
patients with advanced cancers who are receiving radiation treatment.
U.K. Phase Ia/Ib Combination REOLYSIN®/Radiation Clinical Trial
During the third quarter of 2006, we commenced patient enrolment in our Phase Ib U.K. clinical
trial investigating REOLYSIN® in combination with radiation therapy as a treatment for
patients with advanced cancers. The Phase Ib trial will treat patients with a range of two to six
intratumoural doses of REOLYSIN® at 1x1010 TCID50 with a constant
radiation dose of 36 Gy in 12 fractions.
The
primary objective of our Phase Ib trial is to determine the MTD, DLT, and safety profile of REOLYSIN® when administered intratumourally to
patients receiving radiation
treatment. A secondary objective is to examine any evidence of anti-tumour activity.
Eligible patients include those who have been diagnosed with advanced or metastatic solid tumours
that are refractory (have not responded) to standard therapy or for which no curative standard
therapy exists. An additional group of patients is planned to be treated at the maximum dose
regimen reached in the Ib trial.
- 13 -
Patient enrolment in our Ia combination REOLYSIN®/radiation trial was completed in
June 2006. The Phase Ia trial tested two intratumoural treatments of REOLYSIN® at
dosages of 1x108, 1x109, or 1x1010 TCID50 with a
constant localized radiation dose of 20 Gy given in five fractions. A maximum tolerated dose was
not reached and the combination treatment appears to have been well tolerated by the patients.
Interim results of the Phase Ia trial were presented at the American Association for Cancer
Research Annual Meeting in Washington, D.C. in April 2006. Preliminary analysis has demonstrated
evidence of both local and systemic response.
U.S. Phase I/II Recurrent Malignant Glioma Clinical Trial
During the third quarter of 2006, we began patient enrolment in our clinical trial to
investigate the use of REOLYSIN® for patients with recurrent malignant gliomas. This
clinical trial is an open-label dose escalation Phase I/II trial in which a single dose of
REOLYSIN® is administered by infusion to patients with recurrent malignant gliomas that
are refractory to standard therapy. The administration involves the stereotactically-guided
placement of a needle into the tumour, through which REOLYSIN® will be administered or
infused into the tumour mass and surrounding tissue using a pump.
The
primary objective of the study is to determine the MTD, DLT and safety profile of REOLYSIN®. Secondary objectives include the evaluation of
viral replication, immune response to the virus and any evidence of anti-tumour activity.
U.K. Phase I Systemic Administration Clinical Trial
Further results of our U.K. Phase I Systemic Administration Clinical Trial were presented at
the 18th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in
November 2006 in Prague, Czech Republic. A poster entitled A Phase I Study of Wild-Type Reovirus,
Which Selectively Replicates in Cells Expressing Activated Ras, Administered Intravenously to
Patients with Advanced Cancer was presented by Dr. Timothy Yap of The Royal Marsden Foundation
Trust and the Institute of Cancer Research.
Results indicated that REOLYSIN® can be delivered systemically to various tumour
types and cause virus-mediated tumour responses. A total of 33 patients were treated in the trial
to a maximum daily dose of 1x1011 TCID50. Of 32 patients assessed,
anti-tumour activity was noted in seven patients. Two patients with colorectal cancer had tumour
stabilization (one for three months, the other classified as stable disease for six months) and had
CEA tumour marker reduction of 27% and 60% respectively. One patient with metastatic prostate
cancer had stable disease for four months, had a 50% decrease in PSA, and had extensive
product-induced necrosis with associated intratumoural viral replication in metastatic lesions in
the lymph nodes. One patient with metastatic bladder cancer had stable disease for four months and
had a minor tumour response in a metastatic lesion in a lymph node. A patient with pancreatic
cancer and a patient with NSCL cancer had stable disease for four months. A patient with
endometrial cancer had stable disease for five months.
U.S. Phase I Systemic Administration Clinical Trial
During the third quarter of 2006, we completed patient enrolment in our Phase I U.S. clinical
trial investigating the systemic delivery of REOLYSIN® to treat patients with advanced
cancers. A total of 18 patients were treated in the Phase I trial with REOLYSIN® at
escalating dosages of 1x108, 3x108, 1x109, 3x109,
1x1010 or
3x1010
TCID50.
A MTD was not reached
and the treatment appears to have been well tolerated by the patients.
The clinical trial is an open-label, dose-escalation Phase I study in which a single dose of
REOLYSIN® is administered intravenously to patients diagnosed with selected advanced or
metastatic solid tumours that are refractory (have not responded) to standard therapy or for which
no curative standard therapy exists. The primary objective of the
study is to determine the MTD, DLT and safety profile of
REOLYSIN®. Secondary objectives include the evaluation of viral replication, immune
response to the virus and any evidence of anti-tumour activity.
- 14 -
Pre-Clinical Trial and Collaborative Program
We perform pre-clinical studies and engage in collaborations to help support our clinical
trial programs and expand our intellectual property base. We continue with studies examining the
interaction between the immune system and the reovirus, the use of the reovirus as a co-therapy
with chemotherapeutics and radiation, the use of new RAS active viruses as potential therapeutics,
and to consider other uses for the reovirus as a therapeutic.
In January 2007, Dr. Sheila Fraser of St. Jamess University Hospital in Leeds, U.K. presented
an abstract entitled Reovirus as a Potentially Immunogenic as well as Cytotoxic Therapy for
Metastatic Colorectal Cancer at the Society of Academic & Research Surgery Conference in
Cambridge, U.K. The investigators tested reovirus in vitro against recently resected colorectal
cancer liver metastases. The results showed that a significant proportion of tumour cell cultures
showed susceptibility to death following reovirus infection, and also demonstrated effective
replication of reovirus within these cells. In addition, dendritic cells that prime the immune
system to fight cancer cells were activated by exposure to the reovirus. The investigators
concluded that the data supports the development of reovirus as a novel therapy for colorectal
cancer, with the potential to direct the immune system to target cancer cells.
In
November 2006, Dr. Shizuko Sei of SAIC-Frederick Inc.,
prime contractor to the National Cancer
Institute at Frederick (NCI-F) presented a poster at the 18th EORTC-NCI-AACR symposium
on Molecular Targets and Cancer Therapeutics in Prague, Czech Republic. The poster was entitled
Synergistic Antitumor Activity of Oncolytic Reovirus and Chemotherapeutic Agents against Non-small
Cell Lung Cancer (NSCLC). The research focused on work conducted by the NCI with reovirus in
combination with a number of common chemotherapeutic agents. In general, the combination of
reovirus with cisplatin, gemcitabine, mitomycin or vinblastine was synergistic against NSCLC cell
lines sensitive to anti-cancer drugs. The combination of reovirus and paclitaxel was uniformly
synergistic in all six cell lines examined, including in those with high-level resistance to
paclitaxel or reovirus. The data suggest that the combination of reovirus and paclitaxel may help
in promoting cell-death signaling, resulting in a more efficient and synergistic anti-cancer effect
against these cell lines than using each agent on its own.
On September 9, 2006 a poster, prepared by one of our collaborators, entitled Reovirus
Activates Dendritic Cells and Promotes Innate Anti-Tumour Immunity was presented at the 1st Joint
Meeting of European National Societies of Immunology. The poster highlighted the researchers use
of isolated human cells to examine whether the use of the reovirus as a direct tumour killing agent
might also activate the innate immune system to play a role in the killing of tumour cells. The
innate immune system is the broad, short-term and non-specific first-line immune response to an
infection. The research showed that the reovirus can infect and activate immature human dendritic
cells. The reovirus-activated dendritic cells triggered anti-tumour cytotoxicity when co-cultured
with two other types of immune cells, natural killer cells and autologous T-cells. The researchers
concluded that the reovirus may support early innate anti-tumour immunity as well as inducing
direct tumour cell death.
Other Clinical Trial Activity
We continue to develop our Phase II clinical trial program which includes the assessment of
different cancer indications and potential drug combinations, the interviewing and selection of
investigators and clinical trial sites, and the contracting of Contract Research Organizations.
Manufacturing and Process Development
We
have completed the production runs that should provide us with
sufficient product to complete our U.K. Phase II combination REOLYSIN®/radiation
clinical trial and our existing Phase I clinical trials. At the same time, our process development
activity helped improve virus yields from our manufacturing process. We completed the transfer of
these improvements to our cGMP manufacturer at the beginning of the third quarter of 2006 and began
production runs under this improved process. These production runs are expected to provide
sufficient REOLYSIN® to expand our Phase II clinical trial program. Our process
development activity has now shifted focus to the examination of the potential scale up of our
manufacturing process.
- 15 -
New Patents
The
following table sets forth certain patent issuances in select jurisdictions since the
filing of our AIF:
|
|
|
|
|
|
|
|
|
Title |
|
Ownership |
|
Inventors |
|
Status of Patent |
Patent Number U.S. 6,994,858
Reovirus Clearance of
Ras-Mediated Neoplastic Cells
from Mixed Cellular
Compositions
|
|
Oncolytics Biotech
Inc.
|
|
Dr. Don Morris
Dr. Bradley G. Thompson
Dr. Matthew C. Coffey
|
|
Filing date:
Issued:
|
|
May 3, 2001
February 7, 2006 |
|
|
|
|
|
|
|
|
|
Patent Number U.S. 7,014,847
Methods for Preventing Reovirus
Recognition for the Treatment
of Cellular Proliferative
Disorders
|
|
Oncolytics Biotech
Inc.
|
|
Dr. Bradley G. Thompson
Dr. Matthew C. Coffey
|
|
Filing date:
Issued:
|
|
March 28, 2003
March 21, 2006 |
|
|
|
|
|
|
|
|
|
Patent Number U.S. 7,049,127
Method of Producing Infectious
Reovirus
|
|
Oncolytics Biotech
Inc.
|
|
Dr. Bradley G. Thompson
Dr. Matthew C. Coffey
|
|
Filing date:
Issued:
|
|
December 11,
2003
May 23, 2006 |
|
|
|
|
|
|
|
|
|
Patent Number U.S. 7,052,832
Methods for the Treatment of
Cellular Proliferative
Disorders
|
|
Oncolytics Biotech
Inc.
|
|
Dr. Matthew C. Coffey
|
|
Filing date:
Issued:
|
|
November 6, 2001
May 30, 2006 |
|
|
|
|
|
|
|
|
|
Patent Number U.S. 7,163,678
Reovirus for the Treatment of
Ral-Mediated Cellular
Proliferative Disorders
|
|
Oncolytics Biotech
Inc.
|
|
Dr. Patrick W .K. Lee
Dr. Kara L. Norman
|
|
Filing date:
Issued:
|
|
November 6, 2003
January 16, 2007 |
|
|
|
|
|
|
|
|
|
Canadian Patent Number 2,415,750
Methods for Preventing Reovirus
Recognition for the Treatment
of Cellular Proliferative
Disorders
|
|
Oncolytics Biotech
Inc.
|
|
Dr. Bradley G. Thompson
Dr. Matthew C. Coffey
|
|
Filing date:
Issued:
|
|
July 20, 2001
March 28, 2006 |
|
|
|
|
|
|
|
|
|
European
Patent Number: 1,498,129
Use of Adenoviruses Mutated in
the VA Genes for Cancer
Treatment
|
|
Oncolytics Biotech
Inc.
|
|
Dr. Ramon Alemany
Dr. Manel M. Cascallo
|
|
Filing date:
Issued:
|
|
March 25, 2003
November 16,
2005 |
New Directors and Officer
Ed Levy and Ger J. van Amersfoort were appointed to our board of directors on May 17, 2006 and
June 15, 2006, respectively. On January 23, 2007, Mary Ann Dillahunty was appointed as our Vice
President, Intellectual Property.
Unit Offering
On February 5, 2007, we filed a preliminary short form prospectus and on February 6, 2007, we
filed an amended and restated preliminary short form prospectus with the securities commission in the provinces of British Columbia, Alberta, Manitoba and Ontario, and we filed a
registration statement on Form F-10 (File No. 333-140460 ) with the SEC relating to an offering
(the Unit Offering) by us of units (Units). Each Unit consists of one common share and
one-half of a common share purchase warrant. Each whole common share purchase warrant will entitle
the holder to purchase one of our common shares upon payment of $3.50 at any time until 5:00 p.m.
(Calgary time) on the date that is 36 months following the closing of the Unit Offering. The
common shares and common share purchase warrants comprising the Units will separate immediately
upon the closing of the Unit Offering, which is expected to be completed on or about February 22,
2007.
In connection with the Unit Offering, we entered into an underwriting agreement dated February
6, 2007 (the Underwriting Agreement) with Canaccord Capital Corporation (the Underwriter),
pursuant to which we agreed to sell and the Underwriter agreed to purchase from us 4,000,000 Units
at a price of $3.00 per Unit. Under the Underwriting Agreement, the Underwriter has an option to
purchase up to an additional 600,000 Units from us,
solely to cover over-allotments in the Unit Offering, if any, for a period of 30 days after
the date of the final prospectus for the Unit Offering. The Underwriter will receive a fee equal
to 8.0% of the gross proceed realized under the Unit Offering.
- 16 -
The estimated net proceeds to be received by us from the sale of the Units will be $10,640,000
after deducting the Underwriters fee of $960,000 and the estimated expenses of the Unit Offering
of $400,000. If the over-allotment option is exercised in full, the estimated net proceeds to be
received by us from the sale of the Units subject to the over-allotment option will be $12,296,000
after deducting the underwriters fee of $1,104,000 and the estimated expenses of the Unit Offering
of $400,000.
It is a condition of the closing of the Unit Offering that the registration statement of which
this shelf prospectus forms a part be declared effective by the SEC and that we have filed with the
SEC a prospectus supplement registering the offering of the common shares issuable from time to
time on the exercise of the common share purchase warrants.
USE OF PROCEEDS
Unless otherwise indicated in an applicable prospectus supplement relating to an offering of
common shares, we will use the net proceeds we receive from the sale of common shares for general
corporate purposes, which may include our clinical trial program and
our manufacturing activities in support of the program. The amount of net proceeds to be used for any purpose will be described in the applicable prospectus supplement.
CAPITALIZATION
On September 30, 2006, we had 36,386,748 common shares issued and outstanding. Since
September 30, 2006, we have issued 134,000 common shares pursuant to the exercise of stock options.
As at February 8, 2007, we have 36,520,748 common shares issued and
outstanding. After giving effect to the exercise of all our
warrants and options and after giving effect to the Unit Offering, we would have
49,730,698 common shares issued and outstanding as at
February 8, 2007.
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.
As at December 31, 2005, we had 3,634,550 outstanding stock
options and 2,784,800 common share purchase
warrants and as at September 30, 2006, we had 3,584,550 outstanding stock options and 2,784,800
common share purchase warrants.
PLAN OF DISTRIBUTION
We may sell common shares to or through underwriters or dealers and also may sell common
shares directly to purchasers or through agents.
The distribution of common shares 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 common shares, underwriters may receive compensation from us or
from purchasers of common shares for whom they may act as agents in the form of discounts,
concessions or commissions. Underwriters, dealers and agents that participate in the distribution
of common shares may be deemed to be underwriters and any discounts or commissions received by them
from us and any profit on the resale of common shares 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 common
shares directly from us pursuant to contracts providing for payment and delivery on a future date.
These contracts will be subject only to the conditions
- 17 -
set forth in the applicable prospectus
supplement or supplements, which will also set forth the commission payable for solicitation of
these contracts.
This
prospectus qualifies common shares, including common shares issuable
on exercise of the common share purchase warrants issued under the
Unit Offering. The prospectus supplement relating to any offering of common shares will set forth the
terms of the offering of the common shares, 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 common shares sold to or through underwriters will be named in the prospectus
supplement relating to such offering.
Under agreements which may be entered into by us, underwriters, dealers and agents who
participate in the distribution of common shares may be entitled to indemnification by us against
certain liabilities, including liabilities under applicable securities legislation. The
underwriters, dealers and agents 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.
CANADIAN FEDERAL INCOME TAX CONSIDERATIONS
The applicable prospectus supplement will describe certain Canadian federal income tax
consequences to an investor acquiring any common shares offered thereunder.
UNITED STATES FEDERAL INCOME TAX CONSIDERATIONS
The applicable prospectus supplement will also describe certain United States federal income
tax consequences to an investor acquiring any common shares offered thereunder.
LEGAL MATTERS
Unless otherwise specified in the prospectus supplement, certain legal matters relating to the
offering of the common shares 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 common shares 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 each of Bennett Jones LLP and Dorsey & Whitney LLP, as a group,
beneficially own, directly or indirectly, less than 1% of our securities.
AUDITOR
Our financial statements as at December 31, 2005 and 2004 incorporated by reference into this
prospectus have been audited by Ernst & Young LLP, independent auditors, as indicated in their
report dated February 8, 2006 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.
PURCHASERS STATUTORY RIGHTS
Securities legislation in the Province of Alberta 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 Alberta. 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.
- 18 -
PART II
INFORMATION NOT REQUIRED TO BE DELIVERED TO OFFEREES OR PURCHASERS
Under the Business Corporations Act (Alberta), Oncolytics Biotech Inc. (the Corporation) may
indemnify a director or officer, a former director or officer, or a person who acts or acted at the
Corporations request as a director or officer or a body corporate of which the Corporation is or
was a shareholder or creditor, and the directors or officers heirs and legal representatives,
against all costs, charges and expenses, including an amount paid to settle an action or satisfy a
judgment, reasonably incurred by the individual in respect of any civil, criminal or administrative
action or proceeding to which the individual is involved because of that association with the
Corporation or other entity, and the Corporation may advance moneys to such an individual for the
costs, charges and expenses of such a proceeding. The Corporation may not indemnify such an
individual unless the individual acted honestly and in good faith with a view to the best interests
of the Corporation, or, as the case may be, to the best interests of the other entity for which the
individual acted as a director or officer or in a similar capacity at the Corporations request,
and, in the case of a criminal or administrative action or proceeding that is enforced by a
monetary penalty, the individual had reasonable grounds for believing that the individuals conduct
was lawful. In addition, the individual must repay any moneys advanced by the Corporation if the
individual has not fulfilled the conditions set out in the preceding sentence. Such indemnification
or advance of moneys may be made in connection with a derivative action only with court approval.
Such an individual is entitled to indemnification from the Corporation as a matter of right if the
individual was not judged by the court or other competent authority to have committed any fault or
omitted to do anything that the individual ought to have done, and the individual fulfilled the
conditions set forth above.
In accordance with and subject to the Business Corporations Act (Alberta), the by-laws of the
Corporation provide that the Corporation shall indemnify a director or officer, a former director
or officer, or a person who acts or acted at the Corporations request as a director or officer, or
a body corporate of which the Corporation is or was a shareholder or creditor, and the directors
or officers heirs and legal representatives, against all costs, charges and expenses, including an
amount paid to settle an action or satisfy a judgment, reasonably incurred by him in respect of any
civil, criminal or administrative action or proceeding to which he is made a party by reason of
being or having been a director or officer of the Corporation or other entity if he acted honestly
and in good faith with a view to the best interests of the Corporation or, as the case may be, to
the best interests of the other entity for which he acted as a director or officer at the
Corporations request, and, in the case of a criminal or administrative action or proceeding that
is enforced by monetary penalty, he had reasonable grounds for believing that his conduct was
lawful. The Corporation shall also indemnify such person in such other circumstances as the
Business Corporations Act (Alberta) permits or requires.
The Corporation maintains a directors & officers insurance policy for the benefit of the
directors and officers of the Corporation and its subsidiaries against liability incurred by them
in their official capacities for which they become obligated to pay to the extent permitted by
applicable law.
Insofar as indemnification for liabilities arising under the U.S. Securities Act of 1933, as
amended, may be permitted to directors, officers or persons controlling the Corporation pursuant to
the foregoing provisions, the Corporation has been informed that, in the opinion of the U.S.
Securities and Exchange Commission, such indemnification is against public policy as expressed in
the Securities Act and is therefore unenforceable.
II-1
EXHIBITS
|
|
|
Exhibit
|
|
|
Number |
|
Description |
4.1
|
|
Renewal Annual Information Form dated March 2, 2006, for the year ended December
31, 2005, incorporated by reference to the Corporations Annual Report of Form
40-F, filed with the Commission on March 3, 2006 |
|
|
|
4.2
|
|
Audited financial statements, together with the accompanying notes to the
financial statements, for the fiscal years ended December 31, 2005 and 2004 and
the auditors report thereon addressed to the Corporations shareholders,
incorporated by reference to the Corporations Annual Report on Form 40-F, filed
with the Commission on March 3, 2006 |
|
|
|
4.3
|
|
Management Proxy Circular dated March 24, 2006 relating to the annual and special
meeting of shareholders held on April 26, 2006, excluding those portions which are
not prescribed by Canadian securities law to be included in the Canadian
Prospectus, incorporated by reference to the Corporations Current Report on Form
6-K, furnished to the Commission on March 31, 2006 |
|
|
|
4.4
|
|
Managements discussion and analysis of financial condition and results of
operations dated March 2, 2006, for the year ended December 31, 2005, incorporated
by reference to the Corporations Annual Report on Form 40-F, filed with the
Commission on March 3, 2006 |
|
|
|
4.5
|
|
Unaudited interim financial statements as at September 30, 2006 and for the three
and nine months ended September 30, 2006, together with the notes thereto,
incorporated by reference to the Corporations Current Report on Form 6-K,
furnished to the Commission on November 3, 2006 |
|
|
|
4.6
|
|
Managements discussion and analysis of financial condition and results of
operations dated November 2, 2006, for the three and nine months ended September
30, 2006, incorporated by reference to the Corporations Current Report on Form
6-K, furnished to the Commission on November 3, 2006 |
|
|
|
4.7
|
|
Reconciliation of financial statements as at September 30, 2006 and for the three
and nine months ended September 30, 2006, incorporated by reference to the
Corporations Current Report on Form 6-K, furnished to the Commission on February
5, 2007 |
|
|
|
5.1
|
|
Consent of Ernst & Young LLP
dated February 8, 2007 |
|
|
|
5.2
|
|
Consent of Bennett Jones LLP dated
February 8, 2007 |
|
|
|
6.1
|
|
Powers of Attorney (included on the signature pages of this Registration Statement) |
II-2
PART III
UNDERTAKING AND CONSENT TO SERVICE OF PROCESS
Item 1. Undertaking
The Registrant undertakes to make available, in person or by telephone, representatives to respond
to inquiries made by the Commission staff, and to furnish promptly, when requested to do so by the
Commission staff, information relating to the securities registered pursuant to this Form F-10 or
to transactions in said securities.
Item 2. Consent to Service of Process
Concurrently with the filing of this Registration Statement on Form F-10, the Registrant is
filing with the Commission a written irrevocable consent and power of attorney on Form F-X.
Any change to the name and address of the agent for service of the Registrant will be communicated
promptly to the Commission by amendment to Form F-X referencing the file number of this
Registration Statement.
III-1
Signatures
Pursuant to the requirements of the Securities Act, the Registrant certifies that it has
reasonable grounds to believe that it meets all of the requirements for filing on Form F-10 and has
duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto
duly authorized, in the City of Calgary, Province of Alberta, Canada, on February 8, 2007.
|
|
|
|
|
|
ONCOLYTICS BIOTECH INC.
|
|
|
By: |
/s/ Bradley G. Thompson
|
|
|
|
Bradley G. Thompson |
|
|
|
Chief Executive Officer |
|
|
Each person whose signature appears below constitutes and appoints Bradley G. Thompson and Douglas
A. Ball, and each of them, either of whom may act without the joinder of the other, as his true and
lawful attorney-in-fact and agent, with full power of substitution and resubstitution, for him and
in his name, place and stead, in any and all capacities, to sign any or all amendments (including
post-effective amendments) to this Registration Statement and registration statements filed
pursuant to Rule 429 under the Securities Act, and to file the same, with all exhibits thereto and
other documents in connection therewith, with the U.S. Securities and Exchange Commission, granting
unto said attorneys-in-fact and agents, each acting alone, full power and authority to do and
perform each and every act and thing requisite and necessary to be done, as fully to all intents
and purposes as he might or could do in person, hereby ratifying and confirming all that said
attorneys-in-fact and agents, each acting alone, or their substitute or substitutes may lawfully do
or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act, this Registration Statement has been signed by
or on behalf of the following persons in the capacities indicated on February 8, 2007:
|
|
|
Signature |
|
Title |
|
|
|
/s/ Bradley G. Thompson
Bradley G. Thompson
|
|
President, Chief Executive Officer and Chairman
of the Board
(Principal Executive Officer) |
|
|
|
/s/ Douglas A. Ball
Douglas A. Ball
|
|
Chief Financial Officer and Director
(Principal Financial and Accounting Officer) |
|
|
|
/s/ William A. Cochrane
William A. Cochrane
|
|
Director |
|
|
|
/s/ Ger J. van Amersfoort
Ger J. van Amersfoort
|
|
Director |
III-2
|
|
|
/s/ Robert B. Schultz
Robert B. Schultz
|
|
Director |
|
|
|
/s/ Fred A. Stewart
Fred A. Stewart
|
|
Director |
|
|
|
|
|
Director |
|
|
|
|
|
Director |
J. Mark Lievonen
|
|
|
|
|
|
/s/ Jim Dinning
Jim Dinning
|
|
Director |
III-3
Authorized representative
Pursuant to the requirements of Section 6(a) of the Securities Act of 1933, the Authorized
Representative has signed this Registration Statement, solely in his capacity as the duly
authorized representative of Oncolytics Biotech Inc. in the United States, in the State of
California, on February 8, 2007.
|
|
|
|
|
|
|
|
|
By: |
/s/ Karl Mettinger
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Name: |
Karl Mettinger |
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Title: |
Chief Medical Officer |
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III-4