fv10za
As filed
with the Securities and Exchange Commission on June 16, 2008
Registration
Statement No. 333-151513
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
F-10/A
Amendment No. 1
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
(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 |
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(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 No.) |
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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Kenneth G. Sam, Esq.
Jason K. Brenkert, Esq.
Dorsey & Whitney LLP
Republic Plaza Building, Suite 4700
370 Seventeenth Street
Denver, CO 80202-5647
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Brent W. Kraus
Bennett Jones LLP
4500, 855 2nd Street SW
Calgary, Alberta
Canada T2P 4K7
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Approximate date of proposed sale to the public:
From time to time after the effective date of this registration statement.
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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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. þ
Explanatory
Note: The Registrant hereby amends its Registration Statement on
Form F-10 filed with the Commission on June 6, 2008, to include the final short form base shelf prospectus filed with the Alberta Securities Commission on the date hereof, relating to the future
offering of securities of the Registrant in Canada and the United States.
The Registrant previously paid a registration fee of $5,866 in relation to the registration of
up to $149,238,881 aggregate maximum offering price of securities under the original Registration
Statement on Form F-10 filed with the Commission on June 6, 2008.
PART I
INFORMATION REQUIRED TO BE DELIVERED TO OFFEREES OR PURCHASERS
Base Shelf Prospectus
This short
form prospectus has been filed under legislation in each of the
provinces of British Columbia, Alberta, Manitoba and Ontario
that permits certain information about these securities to be
determined after this short form prospectus has become final and
that permits the omission from this short form prospectus of
that information. The legislation requires the delivery to
purchasers of a prospectus supplement containing the omitted
information within a specified period of time after agreeing to
purchase any of these securities.
This short form prospectus
constitutes a public offering of these securities only in those
jurisdictions where they may be lawfully offered for sale and
therein only by persons permitted to sell such securities. No
securities regulatory authority has expressed an opinion about
these securities and it is an offence to claim
otherwise.
Information has been
incorporated by reference in this short form prospectus from
documents filed with securities commissions or similar
authorities in Canada.
Copies of the
documents incorporated herein by reference may be obtained on
request without charge from the Corporate Secretary of
Oncolytics Biotech Inc. at 210, 1167 Kensington Crescent N.W.,
Calgary, Alberta T2N 1X7 telephone
(403) 670-7377,
and are available electronically at www.sedar.com. See
Documents Incorporated by Reference.
Final Short
Form Prospectus
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New
Issue |
Dated June 16, 2008 |
Cdn. $150,000,000
Common Shares
Subscription Receipts
Warrants
Debt Securities
Units
We may from time to time during the
25-month
period that this prospectus (the Prospectus),
including any amendments, remains valid, sell under this
Prospectus up to Cdn. $150,000,000 (or the equivalent in other
currencies or currency units) aggregate initial offering price
of our common shares (Common Shares),
subscription receipts (Subscription
Receipts), warrants to purchase Common Shares
(Warrants), senior or subordinated unsecured
debt securities (Debt Securities), and/or
units comprised of one or more of the other securities described
in this Prospectus in any combination, (Units
and, together with the Common Shares, Subscription Receipts,
Debt Securities and Warrants, the
Securities). We may offer Securities in such
amount and, in the case of the Subscription Receipts, Debt
Securities, Warrants and Units, with such terms, as we may
determine in light of market conditions. We may sell the
Subscription Receipts, Debt Securities and Warrants in one or
more series.
There are certain risk factors that should be carefully
reviewed by prospective purchasers. See Risk
Factors.
The specific variable terms of any offering of Securities will
be set forth in a supplement to this Prospectus relating to such
Securities (each, a Prospectus Supplement)
including where applicable: (i) in the case of the Common
Shares, the number of Common Shares offered, the currency (which
may be Canadian dollars or any other currency), the issue price
and any other specific terms; (ii) in the case of
Subscription Receipts, the number of Subscription Receipts
offered, the currency (which may be Canadian dollars or any
other currency), the issue price, the terms and procedures for
the
exchange of the Subscription Receipts and any other specific
terms; (iii) in the case of Warrants, the designation, the
number of Warrants offered, the currency (which may be Canadian
dollars or any other currency), number of the Common Shares that
may be acquired upon exercise of the Warrants, the exercise
price, dates and periods of exercise, adjustment procedures and
any other specific terms; (iv) in the case of Debt
Securities, the designation, aggregate principal amount and
authorized denominations of the Debt Securities, any limit on
the aggregate principal amount of the Debt Securities, the
currency (which may be Canadian dollars or any other currency),
the issue price (at par, at a discount or at a premium), the
issue and delivery date, the maturity date (including any
provisions for the extension of a maturity date), the interest
rate (either fixed or floating and, if floating, the method of
determination thereof), the interest payment date(s), the
provisions (if any) for subordination of the Debt Securities to
other indebtedness, any redemption provisions, any repayment
provisions, any terms entitling the holder to exchange or
convert the Debt Securities into other securities and any other
specific terms; and (v) in the case of Units, the
designation, the number of Units offered, the offering price,
the currency (which may be Canadian dollars or any other
currency), terms of the Units and of the securities comprising
the Units and any other specific terms.
We are permitted, as a foreign issuer in the United States,
under a multi-jurisdictional disclosure system adopted by the
United States and Canada, to prepare this Prospectus in
accordance with Canadian disclosure requirements. You should be
aware that such requirements are different from those of the
United States. We have prepared our financial statements
included or incorporated herein by reference in accordance with
Canadian generally accepted accounting principles, and they are
subject to Canadian auditing and auditor independence standards.
Thus, they may not be comparable to the financial statements of
United States companies. Information regarding the impact upon
our financial statements of significant differences between
Canadian and United States generally accepted accounting
principles is contained in the notes to the financial statements
incorporated by reference in this Prospectus.
You should be aware that the purchase of the Securities may
have tax consequences both in the United States and Canada. Such
consequences for investors who are resident in, or citizens of,
the United States may not be described fully herein. You should
read the tax discussion contained in the applicable Prospectus
Supplement with respect to a particular offering of securities.
See Certain Income Tax Considerations.
Your ability to enforce civil liabilities under United States
federal securities laws may be affected adversely by the fact
that we are incorporated under the laws of Canada, the majority
of our officers and directors and some of the experts named in
this Prospectus are residents of Canada, and a substantial
portion of our assets and the assets of such persons are located
outside the United States.
NEITHER THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION
(THE SEC) NOR ANY STATE SECURITIES COMMISSION HAS
APPROVED OR DISAPPROVED THESE SECURITIES NOR PASSED UPON THE
ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION TO
THE CONTRARY IS A CRIMINAL OFFENCE.
All shelf information permitted under applicable laws to be
omitted from this Prospectus will be contained in one or more
Prospectus Supplements that will be delivered to purchasers
together with this Prospectus. Each Prospectus Supplement will
be incorporated by reference into this Prospectus for the
purposes of securities legislation as of the date of the
Prospectus Supplement and only for the purposes of the
distribution of the Securities to which the Prospectus
Supplement pertains.
Our outstanding securities are listed for trading on the Toronto
Stock Exchange under the trading symbol ONC and on
the NASDAQ Capital Market under the trading symbol
ONCY. Unless otherwise specified in any applicable
Prospectus Supplement, the Subscription Receipts, Warrants, Debt
Securities, and Units will not be listed on any securities
exchange. There is no market through which the Subscription
Receipts, Warrants, Debt Securities or Units may be sold and
purchasers may not be able to resell the Subscription Receipts,
Warrants, Debt Securities or Units purchased under this
Prospectus. This may affect the pricing of these securities in
the secondary market, the transparency and availability of
trading prices, the liquidity of the securities, and the extent
of issuer regulation. See the Risk Factors section
of the applicable Prospectus Supplement.
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We may sell the Securities to or through underwriters, dealers,
placement agents or other intermediaries or directly to
purchasers or through agents. See Plan of
Distribution. The Prospectus Supplement relating to a
particular offering of Securities will identify each person who
may be deemed to be an underwriter with respect to such offering
and will set forth the terms of the offering of such Securities,
including, to the extent applicable, the initial public offering
price, the proceeds that we will receive, the underwriting
discounts or commissions and any other discounts or concessions
to be allowed or reallowed to dealers. The managing underwriter
or underwriters with respect to Securities sold to or through
underwriters, if any, will be named in the related Prospectus
Supplement.
Subject to applicable securities legislation, in connection with
any offering of Securities under this Prospectus, the
underwriters, if any, may over-allot or effect transactions
which stabilize or maintain the market price of the Securities
offered at a level above that which might otherwise prevail in
the open market. These transactions, if commenced, may be
discontinued at any time. See Plan of Distribution.
You should rely only on the information contained in this
Prospectus. We have not authorized anyone to provide you with
information different from that contained in this Prospectus.
Our head office and principal place of business is located at
210, 1167 Kensington Crescent N.W., Calgary, Alberta T2N 1X7.
Our registered office is located at 4500 Bankers Hall East,
855 2nd Street S.W., Calgary, Alberta T2P 4K7.
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DEFINITIONS
AND OTHER MATTERS
In this Prospectus and any Prospectus Supplement, unless
otherwise indicated, references to we,
us, our, Oncolytics or the
Corporation are to Oncolytics Biotech Inc. All
references to dollars, Cdn.$ or
$ are to Canadian dollars and all references to
U.S.$ are to United States dollars. Unless otherwise
indicated, all financial information included and incorporated
by reference in this Prospectus and any Prospectus Supplement is
determined using Canadian generally accepted accounting
principles.
We prepare our financial statements in accordance with Canadian
generally accepted accounting principles (Canadian
GAAP), which differ from United States generally
accepted accounting principles (U.S. GAAP).
Therefore, our financial statements incorporated by reference in
this Prospectus and any Prospectus Supplement and in the
documents incorporated by reference in this Prospectus and in
any applicable Prospectus Supplement may not be comparable to
financial statements prepared in accordance with U.S. GAAP. You
should refer to Note 21 of our financial statements for the
year ended December 31, 2007 for a discussion of the
principal differences between our financial results determined
under Canadian GAAP and under U.S. GAAP. For our financial
statements as at and for the three months ended March 31,
2008, you should refer to our reconciliation of our financial
statements as at and for the three months ended March 31,
2008 to U.S. GAAP furnished to the SEC on the Companys
Current Report on
Form 6-K
dated June 4, 2008 and incorporated into this Prospectus by
reference. See Documents Incorporated by Reference.
SPECIAL
NOTICE REGARDING FORWARD-LOOKING STATEMENTS
Some of the statements that we make contain forward-looking
statements reflecting our current beliefs, plans, estimates and
expectations. Readers are cautioned that these forward-looking
statements involve risks and uncertainties, including, without
limitation, clinical trial study delays, product development
delays, our ability to attract and retain
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business partners, future levels of government funding,
competition from other biotechnology companies and our ability
to obtain the capital required for research, product
development, operations and marketing. These factors should be
carefully considered and readers should not place undue reliance
on our forward-looking statements. Actual events may differ
materially from our current expectations due to risks and
uncertainties.
Our statements of belief, estimates,
expectations and other similar statements are based
primarily upon our results derived to date from our research and
development program with animals and early stage human results
and upon which we believe we have a reasonable scientific basis
to expect the particular results to occur. It is not possible to
predict, based upon studies in animals or early stage human
results, whether a new therapeutic will be proved to be safe and
effective in humans. There can be no assurance that the
particular result expected by us will occur. Except as required
by applicable securities laws, we undertake no obligation to
update publicly any forward-looking statements for any reason
after the date of this Prospectus or to conform these statements
to actual results or to changes in our expectations.
DOCUMENTS
INCORPORATED BY REFERENCE
Information has been incorporated by reference in this
Prospectus from documents filed with securities commissions or
similar authorities in Canada. Copies of the documents
incorporated herein by reference may be obtained on request
without charge from our Corporate Secretary at 210, 1167
Kensington Crescent N.W., Calgary, Alberta T2N 1X7
telephone
(403) 670-7377,
and are available electronically at www.sedar.com.
We have filed the following documents with the securities
commissions or similar regulatory authorities in certain of the
provinces of Canada and such documents are specifically
incorporated by reference in this Prospectus:
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our Renewal Annual Information Form dated March 5, 2008,
for the year ended December 31, 2007 (the
AIF);
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our Management Proxy Circular dated March 23, 2007 relating
to the annual and special meeting of shareholders held on
May 2, 2007;
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our Management Proxy Circular dated March 20, 2008 relating
to the annual and special meeting of shareholders held on
May 7, 2008;
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our audited financial statements, together with the notes
thereto, for the years ended December 31, 2007 and 2006 and
the auditors report thereon addressed to our shareholders;
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our managements discussion and analysis of financial
condition and results of operations dated March 5, 2008,
for the year ended December 31, 2007;
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our unaudited interim consolidated financial statements as at
and for the three months ended March 31, 2008, together
with the notes thereto;
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our managements discussion and analysis of financial
condition and results of operations dated April 30, 2008,
for the three months ended March 31, 2008; and
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the reconciliation of our consolidated financial statements as
at and for the three months ended March 31, 2008 to U.S.
GAAP, filed on June 3, 2008 under the heading
Other.
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Any documents of the type required by National Instrument
44-101 Short Form Prospectus Distributions of
the Canadian Securities Administrators to be incorporated by
reference in a short form prospectus, including any annual
information form, comparative annual financial statements and
the auditors report thereon, comparative interim financial
statements, managements discussion and analysis of
financial condition and results of operations, material change
report (except a confidential material change report), business
acquisition report and information circular, if filed by us with
the securities commissions or similar authorities in the
provinces of Canada after the date of this Prospectus shall be
deemed to be incorporated by reference in this Prospectus.
Any report filed by us with the SEC pursuant to section 13(a),
13(c), 14 or 15(d) of the United States Securities Exchange Act
of 1934 after the date of this Prospectus shall be deemed to be
incorporated by reference into the registration statement of
which this Prospectus forms a part, if and to the extent
expressly provided in such report.
Any statement contained in this Prospectus or in a document
incorporated or deemed to be incorporated by reference herein
will be deemed to be modified or superseded for purposes of this
Prospectus to the extent that a statement contained in this
Prospectus or in any other subsequently filed document which
also is, or is deemed to be, incorporated by reference into this
Prospectus modifies or supersedes that statement. The modifying
or superseding statement need not state that it has modified or
superseded a prior statement or include any other
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information set forth in the document that it modifies or
supersedes. The making of a modifying or superseding statement
shall not be deemed an admission for any purposes that the
modified or superseded statement when made, constituted a
misrepresentation, an untrue statement of a material fact or an
omission to state a material fact that is required to be stated
or that is necessary to make a statement not misleading in light
of the circumstances in which it was made. Any statement so
modified or superseded shall not be deemed, except as so
modified or superseded, to constitute part of this
Prospectus.
Upon a new annual information form and related audited annual
financial statements and managements discussion and
analysis being filed by us with, and where required, accepted
by, the securities commission or similar regulatory authority in
each of the provinces of British Columbia, Alberta, Manitoba and
Ontario during the term of this Prospectus, the previous annual
information form, the previous audited annual financial
statements and related managements discussion and
analysis, all unaudited interim financial statements and related
managements discussion and analysis, material change
reports and business acquisition reports filed prior to the
commencement of our financial year in which the new annual
information form and related audited annual financial statements
and managements discussion and analysis are filed shall be
deemed no longer to be incorporated into this Prospectus for
purposes of future offers and sales of Securities under this
Prospectus. Upon new interim financial statements and related
managements discussion and analysis being filed by us with
the securities commission or similar regulatory authority in
each of the provinces of British Columbia, Alberta, Manitoba and
Ontario during the term of this Prospectus, all interim
financial statements and related managements discussion
and analysis filed prior to the new interim consolidated
financial statements and related managements discussion
and analysis shall be deemed no longer to be incorporated into
this Prospectus for purposes of future offers and sales of
Securities under this Prospectus. Upon a new information
circular relating to an annual meeting of holders of Common
Shares being filed by us with the securities commission or
similar regulatory authority in each of the provinces of British
Columbia, Alberta, Manitoba and Ontario during the term of this
Prospectus, the information circular for the preceding annual
meeting of holders of Common Shares shall be deemed no longer to
be incorporated into this Prospectus for purposes of future
offers and sales of Securities under this Prospectus.
One or more Prospectus Supplements containing the specific
variable terms for an issue of the Securities and other
information in relation to such Securities will be delivered to
purchasers of such Securities together with this Prospectus and
will be deemed to be incorporated by reference into this
Prospectus as of the date of the Prospectus Supplement solely
for the purposes of the offering of the Securities covered by
any such Prospectus Supplement.
WHERE YOU
CAN FIND ADDITIONAL INFORMATION
We have filed with the SEC a registration statement on
Form F-10
relating to the Securities. This Prospectus, which constitutes a
part of the registration statement, does not contain all of the
information contained in the registration statement, certain
items of which are contained in the exhibits to the registration
statement as permitted by the rules and regulations of the SEC.
We file annual and quarterly financial information and material
change reports and other material with the SEC and with the
securities commissions or similar regulatory authorities in
Canada. Under a multi-jurisdictional disclosure system adopted
by the United States, documents and other information that we
file with the SEC may be prepared in accordance with the
disclosure requirements of Canada, which are different from
those of the United States. You may read and copy any document
that we have filed with the SEC at the SECs public
reference rooms in Washington, D.C. and Chicago, Illinois. You
may also obtain copies of those documents from the public
reference room of the SEC at 100 F Street, N.E., Washington,
D.C. 20549 by paying a fee. You should call the SEC at
1-800-SEC-0330
or access its website at www.sec.gov for further information
about the public reference rooms. You may read and download some
of the documents we have filed with the SECs Electronic
Data Gathering and Retrieval system at www.sec.gov. You may read
and download any public document that we have filed with the
securities commissions or similar regulatory authorities in
Canada at www.sedar.com.
ENFORCEABILITY
OF CIVIL LIABILITIES
We are a corporation existing under the Business Corporations
Act (Alberta). The majority of our officers and directors
and some of the experts named in this Prospectus, are residents
of Canada or otherwise reside outside the United States, and
all, or a substantial portion of their assets and a substantial
portion of our assets, are located outside the United States. We
have appointed an agent for service of process in the United
States, but it may be difficult for holders of Securities who
reside in the United States to effect service within the United
States upon those directors, officers and
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experts who are not residents of the United States. It may also
be difficult for holders of Securities who reside in the United
States to realize in the United States upon judgments of courts
of the United States predicated upon our civil liability and the
civil liability of our directors, officers and experts under the
United States federal securities laws. We have been advised by
our Canadian counsel, Bennett Jones LLP, that a judgment of a
United States court predicated solely upon civil liability under
United States federal securities laws would probably be
enforceable in Canada if the United States court in which the
judgment was obtained has a basis for jurisdiction in the matter
that would be recognized by a Canadian court for the same
purposes. We have also been advised by Bennett Jones LLP,
however, that there is substantial doubt whether an action could
be brought in Canada in the first instance on the basis of
liability predicated solely upon United States federal
securities laws.
We filed with the SEC, concurrently with our registration
statement on
Form F-10,
an appointment of agent for service of process on
Form F-X.
Under the
Form F-X,
we appointed DL Services, Inc. at 1420, Fifth Avenue,
Suite 3400, Seattle, Washington 98101 as our agent for
service of process in the United States in connection with any
investigation or administrative proceeding conducted by the SEC,
and any civil suit or action brought against or involving us in
a United States court arising out of or related to or concerning
the offering of the Securities under this Prospectus.
RISK
FACTORS
A prospective purchaser of Securities should carefully
consider the list of risk factors set forth below as well as the
other information contained in and incorporated by reference in
this Prospectus before purchasing our Securities.
All of
our potential products, including
REOLYSIN®,
are in the research and development stage and will require
further development and testing before they can be marketed
commercially.
Prospects for companies in the biotechnology industry generally
may be regarded as uncertain given the nature of the industry
and, accordingly, investments in biotechnology companies should
be regarded as speculative. We are currently in the research and
development stage on one product,
REOLYSIN®,
for human application, the riskiest stage for a company in the
biotechnology industry. It is not possible to predict, based
upon studies in animals and early stage human clinical trials
whether
REOLYSIN®
will prove to be safe and effective in humans.
REOLYSIN®
will require additional research and development, including
extensive additional clinical testing, before we will be able to
obtain the approvals of the relevant regulatory authorities in
applicable countries to market
REOLYSIN®
commercially. There can be no assurance that the research and
development programs we conducted will result in
REOLYSIN®
or any other products becoming commercially viable products, and
in the event that any product or products result from the
research and development program, it is unlikely they will be
commercially available for a number of years.
To achieve profitable operations we, alone or with others, must
successfully develop, introduce and market our products. To
obtain regulatory approvals for products being developed for
human use, and to achieve commercial success, human clinical
trials must demonstrate that the product is safe for human use
and that the product shows efficacy. Unsatisfactory results
obtained from a particular study relating to a program may cause
us to abandon our commitment to that program or the product
being tested. No assurances can be provided that any current or
future animal or human test, if undertaken, will yield
favourable results. If we are unable to establish that
REOLYSIN®
is a safe, effective treatment for cancer, we may be required to
abandon further development of the product and develop a new
business strategy.
There are
inherent risks in pharmaceutical research and
development.
Pharmaceutical research and development is highly speculative
and involves a high and significant degree of risk. The
marketability of any product we develop will be affected by
numerous factors beyond our control, including but not limited
to:
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the discovery of unexpected toxicities or lack of sufficient
efficacy of products which make them unattractive or unsuitable
for human use;
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preliminary results as seen in animal and/or limited human
testing may not be substantiated in larger, controlled clinical
trials;
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manufacturing costs or other production factors may make
manufacturing of products ineffective, impractical and
non-competitive;
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proprietary rights of third parties or competing products or
technologies may preclude commercialization;
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requisite regulatory approvals for the commercial distribution
of products may not be obtained; and
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other factors may become apparent during the course of research,
up-scaling or manufacturing which may result in the
discontinuation of research and other critical projects.
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Our products under development have never been manufactured on a
commercial scale, and there can be no assurance that such
products can be manufactured at a cost or in a quantity to
render such products commercially viable. Production and
utilization of our products may require the development of new
manufacturing technologies and expertise. The impact on our
business in the event that new manufacturing technologies and
expertise are required to be developed is uncertain. There can
be no assurance that we will successfully meet any of these
technological challenges, or others that may arise in the course
of development.
Pharmaceutical
products are subject to intense regulatory approval
processes.
The regulatory process for pharmaceuticals, which includes
preclinical studies and clinical trials of each compound to
establish its safety and efficacy, takes many years and requires
the expenditure of substantial resources. Moreover, if
regulatory approval of a drug is granted, such approval may
entail limitations on the indicated uses for which it may be
marketed. Failure to comply with applicable regulatory
requirements can, among other things, result in suspension of
regulatory approvals, product recalls, seizure of products,
operating restrictions and criminal prosecution. Further,
government policy may change, and additional government
regulations may be established that could prevent or delay
regulatory approvals for our products. In addition, a marketed
drug and its manufacturer are subject to continual review. Later
discovery of previously unknown problems with the product or
manufacturer may result in restrictions on such product or
manufacturer, including withdrawal of the product from the
market and risk of litigation.
The U.S. Food and Drug Administration (the
FDA) in the United States and similar
regulatory authorities in other countries may deny approval of a
new drug application if required regulatory criteria are not
satisfied, or may require additional testing. Product approvals
may be withdrawn if compliance with regulatory standards is not
maintained or if problems occur after the product reaches the
market. The FDA and similar regulatory authorities in other
countries may require further testing and surveillance programs
to monitor the pharmaceutical product that has been
commercialized. Non-compliance with applicable requirements can
result in fines and other judicially imposed sanctions,
including product withdrawals, product seizures, injunction
actions and criminal prosecutions.
In addition to our own pharmaceuticals, we may supply active
pharmaceutical ingredients and advanced pharmaceutical
intermediates for use in our customers drug products. The
final drug products in which the pharmaceutical ingredients and
advanced pharmaceutical intermediates are used, however, are
subject to regulation for safety and efficacy by the FDA and
other jurisdictions, as the case may be. Such products must be
approved by such agencies before they can be commercially
marketed. The process of obtaining regulatory clearance for
marketing is uncertain, costly and time consuming. We cannot
predict how long the necessary regulatory approvals will take or
whether our customers will ever obtain such approval for their
products. To the extent that our customers do not obtain the
necessary regulatory approvals for marketing new products, our
product sales could be adversely affected.
The FDA and other governmental regulators have increased
requirements for drug purity and have increased environmental
burdens upon the pharmaceutical industry. Because pharmaceutical
drug manufacturing is a highly regulated industry, requiring
significant documentation and validation of manufacturing
processes and quality control assurance prior to approval of the
facility to manufacture a specific drug, there can be
considerable transition time between the initiation of a
contract to manufacture a product and the actual initiation of
manufacture of that product. Any lag time in the initiation of a
contract to manufacture product and the actual initiation of
manufacture could cause us to lose profits or incur liabilities.
The pharmaceutical regulatory regime in Europe and other
countries is, by and large, generally similar to that of the
United States. We could face similar risks in these other
jurisdictions, as the risks described above.
Our operations and products may be subject to other government
manufacturing and testing regulations.
Securing regulatory approval for the marketing of therapeutics
by the FDA in the United States and similar regulatory agencies
in other countries is a long and expensive process, which can
delay or prevent product development and marketing. Approval to
market products may be for limited applications or may not be
received at all.
The products we anticipate manufacturing will have to comply
with the FDAs current Good Manufacturing Practices
(GMP) and other FDA, and local government
guidelines and regulations, including other international
regulatory requirements and guidelines. Additionally, certain of
our customers may require the manufacturing facilities
5
contracted by us to adhere to additional manufacturing
standards, even if not required by the FDA. Compliance with GMP
regulations requires manufacturers to expend time, money and
effort in production, and to maintain precise records and
quality control to ensure that the product meets applicable
specifications and other requirements. The FDA and other
regulatory bodies periodically inspect drug-manufacturing
facilities to ensure compliance with applicable GMP
requirements. If the manufacturing facilities contracted by us
fail to comply with the GMP requirements, the facilities may
become subject to possible FDA or other regulatory action and
manufacturing at the facility could consequently be suspended.
We may not be able to contract suitable alternative or back-up
manufacturing facilities on terms acceptable to us or at all.
The FDA or other regulatory agencies may also require the
submission of any lot of a particular product for inspection. If
the lot product fails to meet the FDA requirements, then the FDA
could take any of the following actions: (i) restrict the
release of the product; (ii) suspend manufacturing of the
specific lot of the product; (iii) order a recall of the
lot of the product; or (iv) order a seizure of the lot of
the product.
We are subject to regulation by governments in many
jurisdictions and, if we do not comply with healthcare, drug,
manufacturing and environmental regulations, among others, our
existing and future operations may be curtailed, and we could be
subject to liability.
In addition to the regulatory approval process, we may be
subject to regulations under local, provincial, state, federal
and foreign law, including requirements regarding occupational
health, safety, laboratory practices, environmental protection
and hazardous substance control, and may be subject to other
present and future local, provincial, state, federal and foreign
regulations.
The
biotechnology industry is extremely competitive and we must
successfully compete with larger companies with substantially
greater resources.
Technological competition in the pharmaceutical industry is
intense and we expect competition to increase. Other companies
are conducting research on therapeutics involving the Ras
pathway as well as other novel treatments or therapeutics for
the treatment of cancer which may compete with our product. Many
of these competitors are more established, benefit from greater
name recognition and have substantially greater financial,
technical and marketing resources than us. In addition, many of
these competitors have significantly greater experience in
undertaking research, preclinical studies and human clinical
trials of new pharmaceutical products, obtaining regulatory
approvals and manufacturing and marketing such products. In
addition, there are several other companies and products with
which we may compete from time to time, and which may have
significantly better and larger resources than us. Accordingly,
our competitors may succeed in manufacturing and/or
commercializing products more rapidly or effectively, which
could have a material adverse effect on our business, financial
condition or results of operations.
We anticipate that we will face increased competition in the
future as new products enter the market and advanced
technologies become available. There can be no assurance that
existing products or new products developed by our competitors
will not be more effective, or be more effectively manufactured,
marketed and sold, than any that may be developed or sold by us.
Competitive products may render our products obsolete and
uncompetitive prior to recovering research, development or
commercialization expenses incurred with respect to any such
products.
We rely
on patents and proprietary rights to protect our
technology.
Our success will depend, in part, on our ability to obtain
patents, maintain trade secret protection and operate without
infringing the rights of third parties. We have patents in the
United States, Canada and Europe and have filed applications for
patents in the United States and under the PCT, allowing us to
file in other jurisdictions. See Narrative
Description Patent and Patent Application
Summary in our AIF. Our success will depend, in part, on
our ability to obtain, enforce and maintain patent protection
for our technology in Canada, the United States and other
countries. We cannot be assured that patents will issue from any
pending applications or that claims now or in the future, if
any, allowed under issued patents will be sufficiently broad to
protect our technology. In addition, no assurance can be given
that any patents issued to or licensed by us will not be
challenged, invalidated, infringed or circumvented, or that the
rights granted thereunder will provide continuing competitive
advantages to us.
The patent positions of pharmaceutical and biotechnology firms,
including us, are generally uncertain and involve complex legal
and factual questions. In addition, it is not known whether any
of our current research endeavours will result in the issuance
of patents in Canada, the United States, or elsewhere, or if any
patents already issued will provide significant proprietary
protection or will be circumvented or invalidated. Since patent
applications in the United States
6
and Canada may be maintained in secrecy until at least
18 months after filing of the original priority
application, and since publication of discoveries in the
scientific or patent literature tends to lag behind actual
discoveries by several months, we cannot be certain that we or
any licensor were the first to create inventions claimed by
pending patent applications or that we or the licensor were the
first to file patent applications for such inventions. Loss of
patent protection could lead to generic competition for these
products, and others in the future, which would materially and
adversely affect our financial prospects for these products and
which could have a material adverse effect on our business,
financial condition or results of operations.
Similarly, since patent applications filed before
November 29, 2000 in the United States may be maintained in
secrecy until the patents issue or foreign counterparts, if any,
publish, we cannot be certain that we or any licensor were the
first creator of inventions covered by pending patent
applications or that we or such licensor were the first to file
patent applications for such inventions. There is no assurance
that our patents, if issued, would be held valid or enforceable
by a court or that a competitors technology or product
would be found to infringe such patents.
Accordingly, we may not be able to obtain and enforce effective
patents to protect our proprietary rights from use by
competitors, and the patents of other parties could require us
to stop using or pay to use certain intellectual property, and
as such, our competitive position and profitability could suffer
as a result.
In addition, we may be required to obtain licenses under patents
or other proprietary rights of third parties. No assurance can
be given that any licenses required under such patents or
proprietary rights will be available on terms acceptable to us.
If we do not obtain such licenses, we could encounter delays in
introducing one or more of our products to the market while we
attempt to design around such patents, or could find that the
development, manufacture or sale of products requiring such
licenses could be foreclosed. In addition, we could incur
substantial costs in defending ourselves in suits brought
against us on such patents or in suits in which our attempts to
enforce our own patents against other parties.
Our
products may fail or cause harm, subjecting us to product
liability claims.
Use of our product during current clinical trials may entail
risk of product liability. We maintain clinical trial liability
insurance; however, it is possible this coverage may not provide
full protection against all risks. Given the scope and
complexity of the clinical development process, the uncertainty
of product liability litigation, and the shrinking capacity of
insurance underwriters, it is not possible at this time to
assess the adequacy of current clinical trial coverage, nor the
ability to secure continuing coverage at the same level and at
reasonable cost in the foreseeable future. While we carry, and
intend to continue carrying amounts believed to be appropriate
under the circumstances, it is not possible at this time to
determine the adequacy of such coverage.
In addition, the sale and commercial use of our product entails
risk of product liability. We currently do not carry any product
liability insurance for this purpose. There can be no assurance
that we will be able to obtain appropriate levels of product
liability insurance prior to any sale of our pharmaceutical
products. An inability to obtain insurance on economically
feasible terms or to otherwise protect against potential product
liability claims could inhibit or prevent the commercialization
of products developed by us. The obligation to pay any product
liability claim or a recall of a product could have a material
adverse effect on our business, financial condition and future
prospects.
We have
limited manufacturing experience and intend to rely on third
parties to commercially manufacture our products, if and when
developed.
To date, we have relied upon a contract manufacturer to
manufacture small quantities of
REOLYSIN®.
The manufacturer may encounter difficulties in scaling up
production, including production yields, quality control and
quality assurance. Only a limited number of manufacturers can
supply therapeutic viruses and failure by the manufacturer to
deliver the required quantities of
REOLYSIN®
on a timely basis at a commercially reasonable price may have a
material adverse effect on us. We have completed a program for
the development of a commercial process for manufacturing
REOLYSIN®
and have filed a number of patent applications related to the
process. There can be no assurance that we will successfully
obtain sufficient patent protection related to our manufacturing
process.
New
products may not be accepted by the medical community or
consumers.
Our primary activity to date has been research and development
and we have no experience in marketing or commercializing
products. We will likely rely on third parties to market our
products, assuming that they receive regulatory approvals. If we
rely on third parties to market our products, the commercial
success of such product may be outside of our control. Moreover,
there can be no assurance that physicians, patients or the
medical community will accept
7
our product even if it proves to be safe and effective and is
approved for marketing by Health Canada, the FDA and other
regulatory authorities. A failure to successfully market our
product would have a material adverse effect on our revenue.
Our
technologies may become obsolete.
The pharmaceutical industry is characterized by rapidly changing
markets, technology, emerging industry standards and frequent
introduction of new products. The introduction of new products
embodying new technologies, including new manufacturing
processes, and the emergence of new industry standards may
render our products obsolete, less competitive or less
marketable. The process of developing our products is extremely
complex and requires significant continuing development efforts
and third party commitments. Our failure to develop new
technologies and products and the obsolescence of existing
technologies could adversely affect our business.
We may be unable to anticipate changes in our potential customer
requirements that could make our existing technology obsolete.
Our success will depend, in part, on our ability to continue to
enhance our existing technologies, develop new technology that
addresses the increasing sophistication and varied needs of the
market, and respond to technological advances and emerging
industry standards and practices on a timely and cost-effective
basis. The development of our proprietary technology entails
significant technical and business risks. We may not be
successful in using our new technologies or exploiting our niche
markets effectively or adapting our businesses to evolving
customer or medical requirements or preferences or emerging
industry standards.
We are
highly dependent on third party relationships for research and
clinical trials.
We rely upon third party relationships for assistance in the
conduct of research efforts, pre-clinical development and
clinical trials, and manufacturing. In addition, we expect to
rely on third parties to seek regulatory approvals for and to
market our product. Although we believe that our collaborative
partners will have an economic motivation to commercialize our
product included in any collaborative agreement, the amount and
timing of resources diverted to these activities generally is
expected to be controlled by the third party. Furthermore, if we
cannot maintain these relationships, our business may suffer.
We have
no operating revenues and a history of losses.
To date, we have not generated sufficient revenues to offset our
research and development costs and accordingly have not
generated positive cash flow or made an operating profit. As of
December 31, 2007, we had an accumulated deficit of
$80.5 million and we incurred net losses of
$15.6 million, $14.3 million, and $12.8 million,
for the years ended December 31, 2007, 2006 and 2005,
respectively. As at March 31, 2008, we had an accumulated
deficit of $83.3 million and in the three month period then
ended we incurred a net loss of $3.3 million. We anticipate
that we will continue to incur significant losses during 2008
and in the foreseeable future. We do not expect to reach
profitability at least until after successful and profitable
commercialization of one or more of our products. Even if one or
more of our products are profitably commercialized, the initial
losses incurred by us may never be recovered.
We may
not be able to obtain third-party reimbursement for the cost of
our product.
Uncertainty exists regarding the reimbursement status of
newly-approved pharmaceutical products and reimbursement may not
be available for
REOLYSIN®.
Any reimbursements granted may not be maintained or limits on
reimbursements available from third-party payors may reduce the
demand for, or negatively affect the price of, these products.
If
REOLYSIN®
does not qualify for reimbursement, if reimbursement levels
diminish, or if reimbursement is denied, our sales and
profitability would be adversely affected.
We may
need additional financing in the future to fund the research and
development of our products and to meet our ongoing capital
requirements.
As at December 31, 2007, we had cash and cash equivalents
(including short-term investments) of $25.2 million and
working capital of approximately $22.4 million. As at
March 31, 2008, we had cash and cash equivalents (including
short-term investments) of $22.0 million and working
capital of approximately $19.5 million. We anticipate that
we may need additional financing in the future to fund research
and development and to meet our ongoing capital requirements.
The amount of future capital requirements will depend on many
factors, including continued scientific progress in our drug
discovery and development programs, progress in our pre-clinical
and clinical evaluation of drug candidates, time and expense
associated with filing, prosecuting and enforcing our patent
claims and costs associated with obtaining regulatory approvals.
In order to meet such capital requirements, we will consider
contract fees, collaborative research and development
arrangements, and additional public or private financings
(including the incurrence of debt and the issuance
8
of additional equity securities) to fund all or a part of
particular programs as well as potential partnering or licensing
opportunities. There can be no assurance that additional funding
will be available or, if available, that it will be available on
acceptable terms. If adequate funds are not available on terms
favorable to us, we may have to reduce substantially or
eliminate expenditures for research and development, testing,
production and marketing of our proposed product, or obtain
funds through arrangements with corporate partners that require
us to relinquish rights to certain of our technologies or
product. There can be no assurance that we will be able to raise
additional capital if our current capital resources are
exhausted.
The cost
of director and officer liability insurance may increase
substantially and may affect our ability to retain quality
directors and officers.
We carry liability insurance on behalf of our directors and
officers. Given a number of large director and officer liability
insurance claims in the U.S. equity markets, director and
officer liability insurance has become increasingly more
expensive with increased restrictions. Consequently, there is no
assurance that we will continue to be offered this insurance or
be able to obtain adequate coverage. The inability to acquire
the appropriate insurance coverage may limit our ability to
attract and maintain directors and officers as required to
conduct our business.
We are
dependent on our key employees and collaborators.
Our ability to develop the product will depend, to a great
extent, on our ability to attract and retain highly qualified
scientific personnel and to develop and maintain relationships
with leading research institutions. Competition for such
personnel and relationships is intense. We are highly dependent
on the principal members of our management staff, as well as our
advisors and collaborators, the loss of whose services might
impede the achievement of development objectives. The persons
working with us are affected by a number of influences outside
of our control. The loss of key employees and/or key
collaborators may affect the speed and success of product
development.
We presently carry key man insurance in the amounts of
$1,500,000, $1,000,000 and $500,000 for Dr. Thompson,
Dr. Coffey and Mr. Ball, respectively.
Our share
price may be highly volatile.
Market prices for securities of biotechnology companies
generally are volatile. This increases the risk of securities
litigation. Factors such as announcements (publicly made or at
scientific conferences) of technological innovations, new
commercial products, patents, the development of proprietary
rights, results of clinical trials, regulatory actions,
publications, quarterly financial results, our financial
position, public concern over the safety of biotechnology,
future sales of shares by us or our current shareholders and
other factors could have a significant effect on the market
price and volatility of the Common Shares.
We incur
some of our expenses in foreign currencies and therefore we are
exposed to foreign currency exchange rate
fluctuations.
We incur some of our manufacturing, clinical, collaborative and
consulting expenses in foreign currencies (primarily the U.S.
dollar and the British Pound (BP). Over the
past few years the Canadian dollar has appreciated relative to
the U.S. dollar and the BP thereby decreasing the Canadian
dollar equivalent. However, if this trend reverses, our Canadian
dollar equivalent costs will increase.
Also, as we expand to other foreign jurisdictions there may be
an increase in our foreign exchange exposure.
We earn
interest income on our excess cash reserves and are exposed to
changes in interest rates.
We invest our excess cash reserves in investment vehicles that
provide a rate of return with little risk to principal. As
interest rates change the amount of interest income we earn will
be directly impacted.
ONCOLYTICS
BIOTECH INC.
Oncolytics Biotech Inc. was incorporated pursuant to the
provisions of the Business Corporations Act (Alberta) on
April 2, 1998 as 779738 Alberta Ltd. On April 8, 1998,
we amended our articles and changed our name to Oncolytics
Biotech Inc. On July 29, 1999, we further amended our
articles by removing the private company restrictions and
subdividing our 2,222,222 Common Shares issued and outstanding
into 6,750,000 Common Shares. On February 9, 2007, we
further amended our articles to permit for our shareholder
meetings to be held at any place in Alberta or at any other
location as determined by our directors.
9
Our head office and principal place of business is located at
210, 1167 Kensington Crescent N.W., Calgary, Alberta T2N 1X7.
Our registered office is located at 4500 Bankers Hall East,
855 2nd Street S.W., Calgary, Alberta T2P 4K7.
OUR
BUSINESS
We focus on the discovery and development of oncolytic viruses
for the treatment of cancers that have not been successfully
treated with conventional therapeutics. Recent scientific
advances in oncology, virology, and molecular biology have
created opportunities for new approaches to the treatment of
cancer. The product we are presently developing may represent a
novel treatment for Ras-mediated cancers which can be used as an
alternative to existing cytotoxic or cytostatic therapies or as
an adjuvant therapy to conventional chemotherapy, radiation
therapy, or surgical resections. It could also potentially be
used to treat certain cellular proliferative disorders for which
no current therapy exists.
Our technologies are based primarily on discoveries in the
Department of Microbiology and Infectious Diseases at the
University of Calgary in the 1990s. Oncolytics was formed
in 1998 to explore the natural oncolytic capability of the
reovirus, a virus that preferentially replicates in cells with
an activated Ras pathway.
The lead product being developed by us may represent a novel
treatment for certain tumour types and some cellular
proliferative disorders. Our lead product is a virus that is
able to replicate specifically in, and hence kill, certain
tumour cells both in tissue culture as well as in a number of
animal models without damaging normal cells.
Our potential product for human use,
REOLYSIN®,
is developed from the reovirus. This virus has been demonstrated
to replicate specifically in tumour cells bearing an activated
Ras pathway. Activating mutations of Ras occur in approximately
thirty per cent of all human tumours directly, but considering
its central role in signal transduction, activation of the Ras
pathway has been shown to play a role in approximately
two-thirds of all tumours.
The functionality of
REOLYSIN®
is based upon the finding that tumours bearing an activated Ras
pathway are deficient in their ability to activate the
anti-viral response mediated by the host cellular protein,
Protein Kinase R (PKR). Since PKR is
responsible for preventing reovirus replication, tumour cells
lacking the activity of PKR are susceptible to reovirus
infections. As normal cells do not possess Ras activations,
these cells are able to thwart reovirus infections by the
activity of PKR. In a tumour cell with an activated Ras pathway,
reovirus is able to freely replicate and hence kill the host
tumour cell. The result of this replication is progeny viruses
that are then free to infect surrounding cancer cells. This
cycle of infection, replication and cell death is believed to be
repeated until there are no longer any tumour cells carrying an
activated Ras pathway available.
The following schematic illustrates the molecular basis of how
the reovirus kills cancer cells.
For both non-cancer cells and cancer cells with an activated Ras
pathway, virus binding, entry, and production of viral genes all
proceed normally. In the case of normal cells however, the viral
genes cause the activation of the anti-viral response that is
mediated by the host cells PKR, thus blocking the
replication of the reovirus. In cells with an activated Ras
pathway, the activation of PKR is prevented or reversed by an
element of the Ras signal transduction pathway, thereby allowing
the replication of the reovirus in these cancer cells. The end
result of this replication is the death of the cancer
10
cell. The action of the Ras pathway in allowing reovirus
replication to ensue can be mimicked in non-cancerous cells by
treating these cells with the chemical
2-aminopurine
which prevents the activation of PKR.
RECENT
DEVELOPMENTS
REOLYSIN®
Development since the First Quarter of 2008
Clinical
Trial Program
Clinical
Trials Results
In June 2008, we announced that interim results of our Phase II
study of intravenous
REOLYSIN®
in patients with sarcomas metastatic to the lung were presented
at the American Society of Clinical Oncology annual meeting. The
presentation, entitled A Phase II Study of Intravenous
REOLYSIN (Wild-type Reovirus) in the Treatment of Patients with
Bone and Soft Tissue Sarcomas Metastatic to the Lung was
delivered by Dr. Monica Mita, the study principal
investigator and her team at the Institute of Drug Development,
the Cancer Therapy and Research Center at the University of
Texas Health Science Center, San Antonio, Texas.
The interim results demonstrated that the treatment has been
well tolerated to date, with 8 of 16 evaluable patients
experiencing stable disease for periods ranging from two to more
than ten,
28-day
cycles. As previously announced by Oncolytics, the third patient
treated in the study was demonstrated to have stable disease by
RECIST criteria for more than six months as measured by
CT scan. A PET scan taken at the same time showed that any
residual mass was metabolically inert.
In April 2008, we completed patient enrolment in the dose
escalation portion and reported positive interim results from
our U.K. clinical trial to evaluate the anti-tumour effects of
systemic administration of
REOLYSIN®
in combination with paclitaxel and carboplatin in patients with
advanced cancers including head and neck, melanoma, lung and
ovarian.
Four of the first eight patients treated in the study to date
have a diagnosis of carcinoma of the head and neck. All three
head and neck patients evaluated to date have had excellent
clinical and radiological responses without appreciable
toxicity. Preliminary assessment after recruitment of the first
two cohorts has suggested that patients with head and neck
carcinomas may represent a group of patients in whom the
combination of carboplatin/paclitaxel and
REOLYSIN®
is active.
In the first cohort, the patient with head and neck cancer
received 8 cycles of treatment (the maximum allowed) and
achieved a clinical complete response. In the second cohort, the
two patients with head and neck cancers with widespread
disseminated disease have each received six cycles of treatment
to date and both have achieved significant partial responses.
Two of the three patients, including the patient with the
clinical complete response, had previously received
cisplatin/5-FU treatment and all three had previously received
radiotherapy.
The trial has two components. The first is an open-label,
dose-escalating, non-randomized study of
REOLYSIN®
given intravenously with paclitaxel and carboplatin every three
weeks. Standard dosages of paclitaxel and carboplatin were
delivered to patients with escalating dosages of
REOLYSIN®
intravenously. The second component of the trial includes the
enrolment of a further 12 patients at the maximum dosage of
REOLYSIN®
in combination with a standard dosage of paclitaxel and
carboplatin.
Eligible patients include those who have been diagnosed with
advanced or metastatic solid tumours such as head and neck,
melanoma, lung and ovarian cancers that are refractory (have not
responded) to standard therapy or for which no curative standard
therapy exists. The primary objective of the trial is to
determine the Maximum Tolerated Dose, Dose-Limiting Toxicity,
recommended dose and dosing schedule and safety profile of
REOLYSIN®
when administered in combination with paclitaxel and
carboplatin. Secondary objectives include the evaluation of
immune response to the drug combination, the bodys
response to the drug combination compared to chemotherapy alone
and any evidence of anti-tumour activity.
Clinical
Trials Approved to Commence
In May 2008, we announced that we received a letter of approval
from the U.K. Medicines and Healthcare Products Regulatory
Agency for our Clinical Trial Application to begin a Phase II
clinical trial using intravenous administration of
REOLYSIN®
in combination with paclitaxel and carboplatin in patients with
advanced head and neck cancers. The principal investigator is
Dr. Kevin Harrington of The Institute of Cancer Research
and The Royal Marsden NHS Foundation Trust.
11
This trial is a 14 patient, single arm, open-label,
dose-targeted, non-randomized, multi-centre trial of
REOLYSIN®
given intravenously in combination with a standard dosage of
paclitaxel and carboplatin. Patients with a variety of advanced
cancers, including head and neck cancers, will continue to be
treated in the ongoing U.K. combination paclitaxel and
carboplatin trial.
Eligible patients include those with advanced or metastatic head
and neck cancer that are refractory to standard therapy or for
which no curative standard therapy exists. The primary objective
of the Phase II trial is to measure tumour responses and
duration of response, and to describe any evidence of antitumour
activity. The secondary objective is to determine the safety and
tolerability of
REOLYSIN®
when administered in combination with paclitaxel and carboplatin
to patients with advanced or metastatic head and neck cancer.
Clinical
Trials Actively Enrolling
In June 2008, we announced that we commenced patient enrolment
in the Phase II clinical trial described above under
Clinical Trials Approved to
Commence using intravenous administration of
REOLYSIN®
in combination with paclitaxel and carboplatin in patients with
advanced head and neck cancers.
In May 2008, we announced that we had begun patient enrolment in
a clinical trial using intravenous administration of
REOLYSIN®
in combination with cyclophosphamide, a chemotherapeutic agent
as well as immune modulator, in patients with advanced cancers.
The Principal Investigators are Dr. James Spicer of
Kings College in London, Dr. Johann de Bono and
Dr. Kevin Harrington of The Royal Marsden NHS Foundation
Trust and The Institute of Cancer Research, London, and
Professor Hardev Pandha of the Royal Surrey County Hospital NHS
Trust, Surrey and Mount Alvernia Hospitals.
The trial is an open-label, dose-escalating, non-randomized
trial of
REOLYSIN®
given intravenously with escalating doses of cyclophosphamide. A
standard dose of
REOLYSIN®
is administered intravenously over five consecutive days, while
an intravenous dose of cyclophosphamide is administered three
days before
REOLYSIN®
treatment and continues through the course of the treatment
cycle. The total number of patients studied will depend on the
number of dose levels tested, but it is anticipated to be
approximately 30 patients.
Eligible patients include those who have been diagnosed with
advanced or metastatic solid tumours including pancreatic, lung
and ovarian cancers that are refractory (have not responded) to
standard therapy or for which no curative standard therapy
exists. The primary objectives of the trial include determining
the Minimum Effective Immunomodulatory Dose of cyclophosphamide
to obtain successful immune modulation. Secondary objectives
include determining the safety profile of the combination and
gathering any evidence of anti-tumour activity.
Manufacturing
Program
In May 2008, we announced that we had successfully transferred
GMP production for
REOLYSIN®
at the 40-litre batch size to SAFC
Pharmatm,
a Division of Sigma-Aldrich Corporation. This follows the
successful scale-up from 20 litres to 40 litres announced by us
last year.
Yields at the 40-litre scale should provide sufficient doses to
support future development plans leading to registration and
also anticipated early stage commercial requirements.
Development work to support further scale-up to the 100-litre
level is currently underway.
Collaborations
In April 2008, we announced that Prof. Alan Melcher and his
research group at St. Jamess University Hospital in Leeds,
U.K. published the results of their work with reovirus in the
May 1, 2008 online issue of The Journal of Immunology. The
paper is entitled Reovirus Activates Human Dendritic Cells
to Promote Innate Antitumor Immunity.
The researchers studied the ability of reovirus to activate
human dendritic cells (DC), key regulators of
both innate and adaptive immune responses. The data demonstrated
that reovirus directly activates human DC, which in turn
stimulate innate killing of cancer cells by natural killer and T
cells, suggesting a novel potential role for T cells in
oncolytic virus-induced local tumor cell death. Combined with
the viruss ability to directly kill cancer cells, the
researchers concluded that reovirus recognition by DC may
enhance the efficacy of reovirus as a therapeutic agent.
In April 2008, we announced that Prof. Alan Melcher and his
research group at St. Jamess University Hospital in
Leeds, U.K. published the results of their work in the April 10
online issue of Gene Therapy. The paper is entitled
Inflammatory Tumour Cell Killing by Oncolytic Reovirus for
the Treatment of Melanoma.
12
The investigators showed that reovirus effectively kills and
replicates in both human melanoma cell lines and freshly
resected tumours. They demonstrated that reovirus melanoma
killing is more potent than, and distinct from, chemotherapy or
radiotherapy-induced cell death. They concluded that reovirus is
suitable for clinical testing in melanoma.
In April 2008, we announced that an oral presentation by
Dr. Chandini Thirukkumaran of the Tom Baker Cancer Centre,
Calgary, entitled Targeting Multiple Myeloma with
Oncolytic Viral Therapy was presented at the American
Association for Cancer Research (AACR) Annual
Meeting in April.
The presentation covered preclinical work using reovirus as a
purging agent during autologous (harvested from the patient
themselves) hematopoietic stem cell transplants for multiple
myeloma. The results demonstrated that up to 70% of multiple
myeloma cell lines tested showed reovirus sensitivity and
reovirus induced cell death mediated through apoptosis.
The investigators concluded that this preclinical data supports
initiating a Phase I purging trial using reovirus against
multiple myeloma.
In April 2008, we announced that a poster presentation by
Dr. Anders Kolb of the Nemours Center for Childhood Cancer
Research entitled Radiation in Combination with Reolysin
for Pediatric Sarcomas was presented at AACR.
The poster covers preclinical work using reovirus in combination
with radiation in mice implanted with pediatric rhabdomyosarcoma
and Ewings sarcoma tumours. The results demonstrated that
the combination of reovirus and radiation significantly enhanced
efficacy compared to either treatment alone in terms of tumour
regression and event-free survival.
USE OF
PROCEEDS
Unless otherwise indicated in an applicable Prospectus
Supplement relating to an offering of Securities, we will use
the net proceeds we receive from the sale of Securities for
general corporate purposes, which may include our clinical trial
program and our manufacturing activities in support of such
program. The amount of net proceeds to be used for any purpose
will be described in the applicable Prospectus Supplement.
CAPITALIZATION
On March 31, 2008, we had 41,180,748 Common Shares issued
and outstanding. Since March 31, 2008, we have issued no
Common Shares pursuant to the exercise of stock options and no
warrants have expired. As at June 16, 2008, we have
41,180,748 Common Shares issued and outstanding. After giving
effect to the exercise of all our Common Share purchase warrants
and options, we would have 49,271,241 Common Shares issued and
outstanding as at June 16, 2008.
PRIOR
SALES
On October 29, 2007, we issued 60,000 Common Shares on the
exercise of 60,000 options at an exercise price of $0.85 per
Common Share. We granted options to acquire an aggregate of
1,050 Common Shares at an exercise price of $2.35 per
Common Share and options to acquire an aggregate of
431,493 Common Shares at an exercise price of $2.22 per
Common Share on October 30, 2007 and December 12,
2007, respectively. No other Common Shares or securities
exchangeable or convertible into Common Shares have been issued
during the twelve month period preceding the date of this
Prospectus.
DESCRIPTION
OF SHARE CAPITAL
Authorized
Capital
Our authorized capital consists of an unlimited number of Common
Shares.
Common
Shares
The holders of our Common Shares are entitled to one vote per
share at meetings of shareholders, to receive such dividends as
declared by us and to receive our remaining property and assets
upon dissolution or wind up. Our Common Shares are not subject
to any future call or assessment and there are no pre-emptive,
conversion or redemption rights attached to such shares.
13
DESCRIPTION
OF SUBSCRIPTION RECEIPTS
The following description of the terms of Subscription Receipts
sets forth certain general terms and provisions of Subscription
Receipts in respect of which a Prospectus Supplement may be
filed. The particular terms and provisions of Subscription
Receipts offered by any Prospectus Supplement, and the extent to
which the general terms and provisions described below may apply
thereto, will be described in the Prospectus Supplement filed in
respect of such Subscription Receipts.
Subscription Receipts may be offered separately or in
combination with one or more other Securities. The Subscription
Receipts will be issued under a subscription receipt agreement.
A copy of the subscription receipt agreement will be filed by us
with the applicable securities commission or similar regulatory
authorities after it has been entered into by us and will be
available electronically at www.sedar.com.
Pursuant to the subscription receipt agreement, original
purchasers of Subscription Receipts will have a contractual
right of rescission against Oncolytics, following the issuance
of the underlying Common Share or other securities to such
purchasers upon the surrender or deemed surrender of the
Subscription Receipts, to receive the amount paid for the
Subscription Receipts in the event that this Prospectus and any
amendment thereto contains a misrepresentation or is not
delivered to such purchaser, provided such remedy for rescission
is exercised within 180 days from the closing date of the
offering of Subscription Receipts.
The description of general terms and provisions of Subscription
Receipts described in any Prospectus Supplement will include,
where applicable:
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the number of Subscription Receipts offered;
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the price at which the Subscription Receipts will be offered;
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if other than Canadian dollars, the currency or currency unit in
which the Subscription Receipts are denominated;
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the procedures for the exchange of the Subscription Receipts
into Common Shares or other securities;
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the number of Common Shares or other securities that may be
obtained upon exercise of each Subscription Receipt;
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the designation and terms of any other Securities with which the
Subscription Receipts will be offered, if any, and the number of
Subscription Receipts that will be offered with each Security;
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the terms applicable to the gross proceeds from the sale of the
Subscription Receipts plus any interest earned thereon;
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the material tax consequences of owning the Subscription
Receipts; and
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any other material terms, conditions and rights (or limitations
on such rights) of the Subscription Receipts.
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We reserve the right to set forth in a Prospectus Supplement
specific terms of the Subscription Receipts that are not within
the options and parameters set forth in this Prospectus. In
addition, to the extent that any particular terms of the
Subscription Receipts described in a Prospectus Supplement
differ from any of the terms described in this Prospectus, the
description of such terms set forth in this Prospectus shall be
deemed to have been superseded by the description of such
differing terms set forth in such Prospectus Supplement with
respect to such Subscription Receipts.
DESCRIPTION
OF WARRANTS
The following description of the terms of Warrants sets forth
certain general terms and provisions of Warrants in respect of
which a Prospectus Supplement may be filed. The particular terms
and provisions of Warrants offered by any Prospectus Supplement,
and the extent to which the general terms and provisions
described below may apply thereto, will be described in the
Prospectus Supplement filed in respect of such Warrants.
Warrants may be offered separately or in combination with one or
more other Securities.
The description of general terms and provisions of Warrants
described in any Prospectus Supplement will include, where
applicable:
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the designation and aggregate number of Warrants offered;
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the price at which the Warrants will be offered;
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if other than Canadian dollars, the currency or currency unit in
which the Warrants are denominated;
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14
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the designation and terms of the Common Shares that may be
acquired upon exercise of the Warrants;
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the date on which the right to exercise the Warrants will
commence and the date on which the right will expire;
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the number of Common Shares that may be purchased upon exercise
of each Warrant and the price at which and currency or
currencies in which that amount of securities may be purchased
upon exercise of each Warrant;
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the designation and terms of any Securities with which the
Warrants will be offered, if any, and the number of the Warrants
that will be offered with each Security;
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the date or dates, if any, on or after which the Warrants and
the related Securities will be transferable separately;
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the minimum or maximum amount, if any, of Warrants that may be
exercised at any one time;
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whether the Warrants will be subject to redemption or call, and,
if so, the terms of such redemption or call provisions; and
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any other material terms, conditions and rights (or limitations
on such rights) of the Warrants.
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We reserve the right to set forth in a Prospectus Supplement
specific terms of the Warrants that are not within the options
and parameters set forth in this Prospectus. In addition, to the
extent that any particular terms of the Warrants described in a
Prospectus Supplement differ from any of the terms described in
this Prospectus, the description of such terms set forth in this
Prospectus shall be deemed to have been superseded by the
description of such differing terms set forth in such Prospectus
Supplement with respect to such Warrants.
DESCRIPTION
OF DEBT SECURITIES
The following description sets forth certain general terms and
provisions of the Debt Securities and is not intended to be
complete. The particular terms and provisions of the Debt
Securities and a description of how the general terms and
provisions described below may apply to the Debt Securities will
be included in the applicable Prospectus Supplement. The
following description is subject to the detailed provisions of
the applicable Trust Indenture. Accordingly, reference
should also be made to the applicable Trust Indenture, a
copy of which will be filed by us with the securities commission
or similar regulatory authority in each of the provinces of
British Columbia, Alberta, Manitoba and Ontario after it has
been entered into by us and will be available electronically at
www.sedar.com.
The Debt Securities will be issued under one or more indentures
(each, a Trust Indenture), in each case
between ourselves and a financial institution authorized to
carry on business as a trustee (each, a
Trustee).
Debt Securities may be offered separately or in combination with
one or more other Securities. We may, from time to time, issue
debt securities and incur additional indebtedness other than
through the issuance of Debt Securities pursuant to this
Prospectus.
General
The Debt Securities may be issued from time to time in one or
more series. We may specify a maximum aggregate principal amount
for the Debt Securities of any series and, unless otherwise
provided in the applicable Prospectus Supplement, a series of
Debt Securities may be reopened for issuance of additional Debt
Securities of such series.
Any Prospectus Supplement for Debt Securities supplementing this
Prospectus will contain the specific terms and other information
with respect to the Debt Securities being offered thereby,
including:
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the designation, aggregate principal amount and authorized
denominations of such Debt Securities;
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any limit upon the aggregate principal amount of such Debt
Securities;
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the currency or currency units for which such Debt Securities
may be purchased and the currency or currency units in which the
principal and any interest is payable (in either case, if other
than Canadian dollars);
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the issue price (at par, at a discount or at a premium) of such
Debt Securities;
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the date or dates on which such Debt Securities will be issued
and delivered;
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the date or dates on which such Debt Securities will mature,
including any provision for the extension of a maturity date, or
the method of determination of such date(s);
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the rate or rates per annum (either fixed or floating) at which
such Debt Securities will bear interest (if any) and, if
floating, the method of determination of such rate;
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15
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the date or dates from which any such interest will accrue and
on which such interest will be payable and the record date or
dates for the payment of such interest, or the method of
determination of such date(s);
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if applicable, the provisions for subordination of such Debt
Securities to other indebtedness of the Corporation;
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the Trustee under the Trust Indenture pursuant to which
such Debt Securities are to be issued;
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any redemption term or terms under which such Debt Securities
may be defeased whether at or prior to maturity;
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any repayment or sinking fund provisions;
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any events of default applicable to such Debt Securities;
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whether such Debt Securities are to be issued in registered form
or in the form of temporary or permanent global securities and
the basis of exchange, transfer and ownership thereof;
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any exchange or conversion terms and any provisions for the
adjustment thereof;
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if applicable, our ability to satisfy all or a portion of any
redemption of such Debt Securities, any payment of any interest
on such Debt Securities or any repayment of the principal owing
upon the maturity of such Debt Securities through the issuance
of securities by us or of any other entity, and any
restriction(s) on the persons to whom such securities may be
issued;
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the provisions applicable to the modification of the terms of
the Trust Indenture; and
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any other specific material terms or covenants applicable to
such Debt Securities.
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We reserve the right to include in a Prospectus Supplement
specific terms pertaining to the Debt Securities which are not
within the options and parameters set forth in this Prospectus.
In addition, to the extent that any particular terms of the Debt
Securities described in a Prospectus Supplement differ from any
of the terms described in this Prospectus, the description of
such terms set forth in this Prospectus shall be deemed to have
been superseded by the description of such differing terms set
forth in such Prospectus Supplement with respect to such Debt
Securities.
Ranking
The Debt Securities will be direct unsecured obligations of
Oncolytics. The Debt Securities will be senior or subordinated
indebtedness of Oncolytics as described in the applicable
Prospectus Supplement. If the Debt Securities are senior
indebtedness, they will rank equally and rateably with all other
unsecured indebtedness of Oncolytics from time to time issued
and outstanding which is not subordinated. If the Debt
Securities are subordinated indebtedness, they will be
subordinated to senior indebtedness of Oncolytics as described
in the applicable Prospectus Supplement, and they will rank
equally and rateably with other subordinated indebtedness of
Oncolytics from time to time issued and outstanding as described
in the applicable Prospectus Supplement. We reserve the right to
specify in a Prospectus Supplement whether a particular series
of subordinated Debt Securities is subordinated to any other
series of subordinated Debt Securities.
Registration
of Debt Securities
Debt
Securities in Book Entry Form
Debt Securities of any series may be issued in whole or in part
in the form of one or more global securities (each a
Global Security and together Global
Securities) registered in the name of a designated
clearing agency (a Depositary) or its nominee
and held by or on behalf of the Depositary in accordance with
the terms of the applicable Trust Indenture. The specific
terms of the depositary arrangement with respect to any portion
of a series of Debt Securities to be represented by a Global
Security will, to the extent not described herein, be described
in the Prospectus Supplement relating to such series.
A Global Security may not be transferred, except as a whole
between the Depositary and a nominee of the Depositary or as
between nominees of the Depositary, or to a successor Depositary
or nominee thereof, until it is wholly exchanged for Debt
Securities in certificated non-book-entry form in accordance
with the terms of the applicable Trust Indenture. So long
as the Depositary for a Global Security, or its nominee, is the
registered owner of such Global Security, such Depositary or
such nominee, as the case may be, will be considered the sole
owner or holder of the Debt Securities represented by such
Global Security for all purposes under the applicable
Trust Indenture and payments of principal of and interest,
if any, on the Debt Securities represented by a Global Security
will be made by us to the Depositary or its nominee.
16
Subject to such exceptions, if any, as may be provided for in
the Trust Indenture and described in the applicable
Prospectus Supplement, owners of beneficial interests in a
Global Security will not be entitled to have the Debt Securities
represented by such Global Security registered in their names,
will not receive or be entitled to receive physical delivery of
such Debt Securities in certificated non-book-entry form, will
not be considered the owners or holders thereof under the
applicable Trust Indenture and will be unable to pledge
Debt Securities as security. The laws of some states in the
United States may require that certain purchasers of Debt
Securities take physical delivery of such Debt Securities in
definitive form.
Principal and interest payments, if any, on the Debt Securities
represented by a Global Security registered in the name of a
Depositary or its nominee will be made to such Depositary or its
nominee, as the case may be, as the registered owner of such
Global Security. Neither Oncolytics, the Trustee nor any paying
agent for such Debt Securities will have any responsibility or
liability for any aspect of the records relating to or payments
made on account of beneficial ownership interests in such Global
Security or for maintaining, supervising or reviewing any
records relating to such beneficial ownership interests.
Oncolytics, any underwriters, dealers or agents and any Trustee
identified in an accompanying Prospectus Supplement, as
applicable, will not have any liability or responsibility for:
(i) records maintained by the Depositary relating to
beneficial ownership interests in the Debt Securities held by
the Depositary or the book-entry accounts maintained by the
Depositary; (ii) maintaining, supervising or reviewing any
records relating to any such beneficial ownership interests; or
(iii) any advice or representation made by or with respect
to the Depositary and contained in this Prospectus or in any
Prospectus Supplement or Trust Indenture with respect to
the rules and regulations of the Depositary or at the direction
of Depositary participants.
The applicable Prospectus Supplement will identify the
applicable Depositary for any Debt Securities represented by a
Global Security.
Debt
Securities in Registered Form
Debt Securities of any series may be issued in whole or in part
in registered form as provided in the applicable
Trust Indenture.
In the event that the Debt Securities are issued in certificated
non-book-entry form, principal and interest, if any, will be
payable, the transfer of such Debt Securities will be
registerable and such Debt Securities will be exchangeable for
Debt Securities in other denominations of a like aggregate
principal amount at the office or agency maintained by us.
Payment of principal and interest, if any, on Debt Securities in
certificated non-book-entry form may be made by check mailed to
the address of the holders entitled thereto.
Subject to the foregoing limitations, Debt Securities of any
authorized form or denomination issued under the applicable
Trust Indenture may be transferred or exchanged for Debt
Securities of any other authorized form or denomination or
denominations, any such transfer or exchange to be for an
equivalent aggregate principal amount of Debt Securities of the
same series, carrying the same rate of interest and same
redemption and other provisions as the Debt Securities so
transferred or exchanged. Exchanges of Debt Securities of any
series may be made at the offices of the applicable Trustee and
at such other places as we may from time to time designate with
the approval of the applicable Trustee and may be specified in
the applicable Prospectus Supplement. Unless otherwise specified
in the applicable Prospectus Supplement, the applicable Trustee
will be the registrar and transfer agent for any Debt Securities
issued in certificated non-book-entry form under the applicable
Trust Indenture.
DESCRIPTION
OF UNITS
We may issue Units comprised of one or more of the other
Securities described in this Prospectus in any combination. Each
Unit will be issued so that the holder of the Unit is also the
holder of each Security included in the Unit. Thus, the holder
of a Unit will have the rights and obligations of a holder of
each included Security. The unit agreement, if any, under which
a Unit is issued may provide that the Securities included in the
Unit may not be held or transferred separately, at any time or
at any time before a specified date.
The particular terms and provisions of Units offered by any
Prospectus Supplement, and the extent to which the general terms
and provisions described below may apply thereto, will be
described in the Prospectus Supplement filed in respect of such
Units.
17
The particular terms of each issue of Units will be described in
the related Prospectus Supplement. This description will
include, where applicable:
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the designation and aggregate number of Units offered;
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the price at which the Units will be offered;
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if other than Canadian dollars, the currency or currency unit in
which the Units are denominated;
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the terms of the Units and of the Securities comprising the
Units, including whether and under what circumstances those
securities may be held or transferred separately;
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the number of Securities that may be purchased upon exercise of
each Unit and the price at which and currency or currency unit
in which that amount of Securities may be purchased upon
exercise of each Unit;
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any provisions for the issuance, payment, settlement, transfer
or exchange of the Units or of the Securities comprising the
Units; and
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any other material terms, conditions and rights (or limitations
on such rights) of the Units.
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We reserve the right to set forth in a Prospectus Supplement
specific terms of the Units that are not within the options and
parameters set forth in this Prospectus. In addition, to the
extent that any particular terms of the Units described in a
Prospectus Supplement differ from any of the terms described in
this Prospectus, the description of such terms set forth in this
Prospectus shall be deemed to have been superseded by the
description of such differing terms set forth in such Prospectus
Supplement with respect to such Units.
MARKET
FOR SECURITIES
Our outstanding Common Shares are listed and posted for trading
on the Toronto Stock Exchange under the trading symbol
ONC and on the NASDAQ Capital Market under the
trading symbol ONCY. The following table sets forth
the market price ranges and the aggregate volume of trading of
the Common Shares on the Toronto Stock Exchange and NASDAQ
Capital Market for the periods indicated:
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Toronto Stock Exchange
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NASDAQ Capital Market
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High
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Low
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Close
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Volume
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High
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Low
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Close
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Volume
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Period
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($)
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($)
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($)
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(Shares)
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(U.S.$)
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(U.S.$)
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(U.S.$)
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(Shares)
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2007
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May
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2.39
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2.12
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2.19
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880,135
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2.17
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1.98
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2.06
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1,026,481
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June
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2.55
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2.05
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2.15
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755,603
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2.47
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1.92
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2.08
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1,746,620
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July
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2.21
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1.68
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1.91
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1,512,581
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2.08
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1.59
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1.79
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1,296,480
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August
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1.95
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1.54
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1.62
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514,617
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1.85
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1.50
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1.55
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592,767
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September
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1.90
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1.42
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1.90
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1,046,083
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1.90
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1.44
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1.89
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1,172,901
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October
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2.46
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1.67
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2.30
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2,614,255
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2.53
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1.75
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2.44
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2,470,044
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November
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2.65
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2.10
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2.28
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600,779
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2.77
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2.08
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2.29
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1,038,246
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December
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2.38
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1.67
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1.70
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355,628
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2.38
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1.67
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1.72
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795,031
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2008
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|
|
|
January
|
|
|
2.04
|
|
|
|
1.66
|
|
|
|
1.95
|
|
|
|
538,887
|
|
|
|
2.04
|
|
|
|
1.69
|
|
|
|
1.93
|
|
|
|
622,530
|
|
February
|
|
|
2.26
|
|
|
|
1.82
|
|
|
|
1.90
|
|
|
|
564,976
|
|
|
|
2.27
|
|
|
|
1.85
|
|
|
|
1.94
|
|
|
|
588,210
|
|
March
|
|
|
2.01
|
|
|
|
1.70
|
|
|
|
1.83
|
|
|
|
376,635
|
|
|
|
2.02
|
|
|
|
1.70
|
|
|
|
1.84
|
|
|
|
618,300
|
|
April
|
|
|
2.50
|
|
|
|
1.78
|
|
|
|
1.96
|
|
|
|
1,159,535
|
|
|
|
2.46
|
|
|
|
1.76
|
|
|
|
1.94
|
|
|
|
1,138,020
|
|
May
|
|
|
2.18
|
|
|
|
1.60
|
|
|
|
2.15
|
|
|
|
6,683,183
|
|
|
|
2.21
|
|
|
|
1.62
|
|
|
|
2.15
|
|
|
|
897,410
|
|
June (1-13)
|
|
|
2.40
|
|
|
|
2.00
|
|
|
|
2.14
|
|
|
|
452,450
|
|
|
|
2.39
|
|
|
|
2.01
|
|
|
|
2.08
|
|
|
|
692,140
|
|
18
PLAN OF
DISTRIBUTION
We may sell Securities to or through underwriters, dealers,
placement agents or other intermediaries and also may sell
Securities directly to purchasers or through agents, subject to
obtaining any applicable exemption from registration
requirements.
The distribution of Securities may be effected from time to time
in one or more transactions at a fixed price or prices, which
may be changed, at market prices prevailing at the time of sale,
or at prices related to such prevailing market prices to be
negotiated with purchasers and as set forth in an accompanying
Prospectus Supplement.
In connection with the sale of Securities, underwriters may
receive compensation from us or from purchasers of Securities
for whom they may act as agents in the form of discounts,
concessions or commissions. Underwriters, dealers, placement
agents or other intermediaries that participate in the
distribution of Securities may be deemed to be underwriters and
any discounts or commissions received by them from us and any
profit on the resale of Securities by them may be deemed to be
underwriting discounts and commissions under applicable
securities legislation.
If so indicated in the applicable Prospectus Supplement, we may
authorize dealers or other persons acting as our agents to
solicit offers by certain institutions to purchase the
Securities directly from us pursuant to contracts providing for
payment and delivery on a future date. These contracts will be
subject only to the conditions set forth in the applicable
Prospectus Supplement or supplements, which will also set forth
the commission payable for solicitation of these contracts.
The Prospectus Supplement relating to any offering of Securities
will also set forth the terms of the offering of the Securities,
including, to the extent applicable, the initial offering price,
the proceeds to us, the underwriting discounts or commissions,
and any other discounts or concessions to be allowed or
reallowed to dealers. Underwriters with respect to any offering
of Securities sold to or through underwriters will be named in
the Prospectus Supplement relating to such offering.
Holders of Warrants resident in the United States who acquire
Common Shares pursuant to the exercise of Warrants in accordance
with their terms and under this Prospectus and any applicable
Prospectus Supplement may have a right of action against the
Corporation for any misrepresentation in this Prospectus or any
applicable Prospectus Supplement. However, the existence and
enforceability of such a right of action is not without doubt.
By contrast, holders of Warrants resident in Canada who may
acquire Common Shares pursuant to the exercise of Warrants in
accordance with their terms and who will be deemed to acquire
such Common Shares under applicable Canadian prospectus
exemptions, will not have any such right of action.
Under agreements which may be entered into by us, underwriters,
dealers, placement agents and other intermediaries who
participate in the distribution of Securities may be entitled to
indemnification by us against certain liabilities, including
liabilities under applicable securities legislation. The
underwriters, dealers, placement agents and other intermediaries
with whom we enter into agreements may be customers of, engage
in transactions with or perform services for us in the ordinary
course of business.
Any offering of Subscription Receipts, Debt Securities, Warrants
or Units will be a new issue of securities with no established
trading market. Unless otherwise specified in the applicable
Prospectus Supplement, the Subscription Receipts, Debt
Securities, Warrants or Units will not be listed on any
securities exchange. Unless otherwise specified in the
applicable Prospectus Supplement, there is no market through
which the Subscription Receipts, Debt Securities, Warrants or
Units may be sold and purchasers may not be able to resell
Subscription Receipts, Debt Securities, Warrants or Units
purchased under this Prospectus or any Prospectus Supplement.
This may affect the pricing of the Subscription Receipts, Debt
Securities, Warrants or Units in the secondary market, the
transparency and availability of trading prices, the liquidity
of the securities, and the extent of issuer regulation.
Certain dealers may make a market in the Subscription Receipts,
Debt Securities, Warrants or Units, as applicable, but will not
be obligated to do so and may discontinue any market making at
any time without notice. No assurance can be given that any
dealer will make a market in the Subscription Receipts, Debt
Securities, Warrants or Units or as to the liquidity of the
trading market, if any, for the Subscription Receipts, Debt
Securities, Warrants or Units.
Subject to applicable securities legislation, in connection with
any offering of Securities under this Prospectus, the
underwriters, if any, may over-allot or effect transactions
which stabilize or maintain the market price of the Securities
offered at a level above that which might otherwise prevail in
the open market. These transactions, if commenced, may be
discontinued at any time.
19
Notwithstanding the filing of this Prospectus, our short form
base shelf prospectus dated February 15, 2007 and the
related prospectus supplement dated February 16, 2007
(collectively, the 2007 Base Shelf
Prospectus) will remain in full force and effect and
continue to qualify the Common Shares issuable to U.S. residents
on exercise of the Common Share purchase warrants issued in
connection with our Unit offering under a short form prospectus
dated February 14, 2007 (the 2007 Unit
Offering) until such time as the 2007 Base Shelf
Prospectus expires in accordance with applicable securities
laws. In the event that the 2007 Base Shelf Prospectus expires
prior to the exercise of all the Common Shares purchase warrants
issued to U.S. residents in connection with the 2007 Unit
Offering, we may use this Prospectus to qualify the remaining
Common Shares issuable to U.S. residents on the exercise of
Common Share purchase warrants issued in connection with the
2007 Unit Offering. If such a determination is made, the
applicable prospectus supplement will set out the relevant facts
to qualify such Common Shares. We may also use this Prospectus
to qualify Common Shares issuable to U.S. residents on the
exercise of future Common Share purchase warrants issued by us.
CERTAIN
INCOME TAX CONSIDERATIONS
The applicable prospectus supplement may describe certain
Canadian federal income tax consequences which may be applicable
to a purchaser of Securities offered thereunder, and may also
include a discussion of certain United States federal income tax
consequences to the extent applicable.
LEGAL
MATTERS
Unless otherwise specified in the Prospectus Supplement, certain
legal matters relating to the offering of the securities will be
passed upon for us by Bennett Jones LLP and Dorsey &
Whitney LLP. In addition, certain legal matters in connection
with any offering of securities will be passed upon for any
underwriters, dealers or agents by counsel to be designated at
the time of the offering by such underwriters, dealers or agents
with respect to matters of Canadian and United States law.
The partners and associates of Bennett Jones LLP, as a group,
and the partners and associates of Dorsey & Whitney
LLP, as a group, each beneficially own, directly or indirectly,
less than 1% of our securities.
AUDITOR
Our financial statements as at December 31, 2007 and 2006
incorporated by reference into this Prospectus have been audited
by Ernst & Young LLP, independent auditors, as
indicated in their report dated February 15, 2008 and are
incorporated herein in reliance upon the authority of said firm
as experts in accounting and auditing in giving said report.
Ernst & Young LLP has been our auditor since inception
in 1998.
DOCUMENTS
FILED AS PART OF THE REGISTRATION STATEMENT
The following documents have been filed with the SEC as part of
the registration statement of which this Prospectus is a part
insofar as required by the SECs
Form F-10:
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the documents listed under Documents Incorporated by
Reference in this Prospectus;
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the consent of our auditors Ernst & Young LLP;
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the consent of our Canadian counsel Bennett Jones LLP;
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powers of attorney from our directors and officers; and
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Form F-X
Appointment of Agent for Service of Proceeds and Undertaking.
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PURCHASERS
STATUTORY RIGHTS
Securities legislation in certain of the provinces of Canada
provides purchasers with the right to withdraw from an agreement
to purchase securities. This right may be exercised within two
business days after receipt or deemed receipt of a prospectus,
the accompanying prospectus supplement relating to securities
purchased by a purchaser and any amendment thereto. The
legislation further provides a purchaser with remedies for
rescission or damages if the prospectus, the accompanying
prospectus supplement relating to securities purchased by a
purchaser or any amendment contains a misrepresentation or are
not delivered to the purchaser, provided that the remedies for
rescission or damages are exercised by the purchaser within the
time limit prescribed by the securities legislation in the
purchasers province. The purchaser should refer to any
applicable provisions of the securities legislation of the
purchasers province for the particulars of these rights or
consult with a legal advisor.
20
AUDITORS
CONSENT
We have read the short form base shelf prospectus of Oncolytics
Biotech Inc. (the Corporation) dated
June 16, 2008 relating to the qualification for
distribution of up to $150,000,000 aggregate initial offering
price of common shares, subscription receipts, warrants, debt
securities and/or units of the Corporation (the
Prospectus). We have complied with Canadian
generally accepted standards for an auditors involvement
with offering documents.
We consent to the incorporation by reference in the Prospectus
of our report to the shareholders of the Corporation on the
balance sheets of the Corporation as at December 31, 2007
and 2006 and the statements of loss and comprehensive loss and
cash flows for each of the years in the three year period ended
December 31, 2007 and for the cumulative period from
inception on April 2, 1998. Our report is dated
February 15, 2008.
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Calgary, Canada
June 16, 2008
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(Signed) Ernst & Young LLP
Chartered Accountants
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21
CERTIFICATE
OF THE CORPORATION
Dated:
June 16, 2008
This short form prospectus, together with the documents
incorporated in this prospectus by reference, will, as of the
date of the last supplement to this prospectus relating to the
securities offered by this prospectus and the supplement(s),
constitute full, true and plain disclosure of all material facts
relating to the securities offered by this prospectus and the
supplement(s) as required by the securities legislation in the
provinces of British Columbia, Alberta, Manitoba and Ontario.
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|
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(Signed)
Bradley G. Thompson
Chief Executive Officer
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|
(Signed)
Douglas A. Ball
Chief Financial Officer
|
|
On behalf of the Board of Directors of
Oncolytics
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|
|
|
(Signed) Jim
Dinning
Director
|
|
(Signed) Fred
A. Stewart
Director
|
C-1
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
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Exhibit |
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Number |
|
Description |
|
|
|
4.1
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|
Renewal Annual Information Form dated March 5, 2008, for the year ended December
31, 2007, incorporated by reference to the Corporations Current Report on Form
6-K, furnished to the Commission on April 7, 2008. |
|
|
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4.2
|
|
Audited financial statements, together with the accompanying notes to the
financial statements, for the fiscal years ended December 31, 2007 and 2006 and
the auditors report thereon addressed to the Corporations shareholders,
incorporated by reference to the Corporations Annual Report on Form 20-F, filed
with the Commission on May 23, 2008 |
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4.3
|
|
Management Proxy Circular dated March 20, 2008 relating to the annual and special
meeting of shareholders held on May 7, 2008, 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 April 8, 2008. |
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4.4
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|
Managements discussion and analysis of financial condition and results of
operations dated March 5, 2008, for the year ended December 31, 2007, included as
part of the Corporations Annual Report to Shareholders, incorporated by reference
to the Corporations Current Report on Form 6-K, furnished to the Commission on
April 8, 2008. |
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4.5
|
|
Unaudited interim financial statements as at and for the three months ended March
31, 2008, together with the notes thereto, incorporated by reference to the
Corporations Current Report on Form 6-K, furnished to the Commission on May 1,
2008. |
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4.6
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|
Managements discussion and analysis of financial condition and results of
operations dated April 30, 2008, for the three months ended March 31, 2008,
incorporated by reference to the Corporations Current Report on Form 6-K,
furnished to the Commission on May 1, 2008 |
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4.7
|
|
Reconciliation of financial statements as at and for the three months ended March
31, 2008, incorporated by reference to the Corporations Current Report on Form
6-K, furnished to the Commission on June 4, 2008 |
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5.1
|
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Consent of Ernst & Young LLP
dated June 16, 2008 |
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5.2
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Consent of Bennett Jones LLP dated
June 16, 2008 |
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6.1
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Powers of Attorney (included on the
signature pages of this Registration Statement), incorporated by
reference to the signature page of the Corporations
Registration Statement on Form F-10 as filed with the Commission
on June 6, 2008. |
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
June 16, 2008.
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ONCOLYTICS BIOTECH INC.
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By: |
/s/ Bradley G. Thompson
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Bradley G. Thompson |
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Chief Executive Officer |
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|
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
June 16, 2008:
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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 |
Ger J. van Amersfoort |
|
Director |
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|
Signature |
|
Title |
/s/ Robert B. Schultz*
Robert B. Schultz |
|
Director |
/s/ Fred A. Stewart*
Fred A. Stewart |
|
Director |
Ed Levy |
|
Director |
/s/ J. Mark Lievonen*
J. Mark Lievonen |
|
Director |
/s/ Jim Dinning*
Jim Dinning |
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Director |
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*By: |
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/s/ Douglas A. Ball |
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Douglas A. Ball |
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Pursuant to powers of attorney executed by the persons named above
whose signatures are marked by an asterisk, Douglas A. Ball, as
attorney-in-fact, does hereby sign this amendment to the registration
statement on behalf of each such person, in each case in the capacity
indicated, on the date indicated. Such powers of attorney were filed
as a part of the signature block of the Registrants Form F-10, filed
with the Commission on June 6, 2008.
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 June 16, 2008.
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By: |
/s/ Karl Mettinger
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Name: |
Karl Mettinger |
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|
Title: |
Chief Medical Officer |
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