fv10za
As filed
with the Securities and Exchange Commission on February 6, 2007
.
Registration No. 333-140460
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Amendment No. 1 to
Form F-10
REGISTRATION STATEMENT UNDER
THE SECURITIES ACT OF 1933
ONCOLYTICS BIOTECH INC.
(Exact name of Registrant as specified in its charter)
|
|
|
|
|
Alberta
|
|
2834
|
|
Not Applicable |
(Province or other jurisdiction
of incorporation or organization)
|
|
(Primary Standard Industrial Classification
Code Number)
|
|
(I.R.S. Employer
Identification Number) |
Suite #210, 1167 Kensington Crescent N.W.
Calgary, Alberta
Canada T2N 1X7
(403) 670-7377
(Address and Telephone Number of Registrants Principal Executive Offices)
DL Services, Inc.
1420 Fifth Avenue, Suite 3400
Seattle, Washington 98101
(206) 903-8800
(Name, Address (including Zip Code) and Telephone Number (including Area Code) of Agent for
Service
in the United States)
Copies to:
|
|
|
|
|
|
|
|
|
Douglas A. Ball
Oncolytics Biotech Inc.
210-1167 Kensington Cr.
N. W.
Calgary, Alberta
Canada T2N 1X7
Telephone: (403) 670-
7377
|
|
Randal Jones
Jason K. Brenkert
370, 17th
Street, Suite 4700
Denver, Colorado 80202
Telephone: (303) 629-
3400
|
|
Brent W. Kraus
Bennett Jones LLP
4500,
855 2nd
Street SW
Calgary, Alberta
Canada T2P 4K7
Telephone: (403) 298-3071
|
|
Kevin Keogh
White & Case LLP
1155 Avenue of the
Americas
New York, New York 10036
Telephone: (212) 819-8270
|
|
Iain Mant
Fasken Martineau DuMoulin
LLP
2100-1075 West Georgia
Street
Vancouver, British Columbia
Canada V6E 3G2
Telephone: (604) 631-4734 |
Approximate date of commencement of proposed sale of the securities to the public:
As soon as practicable after this Registration Statement becomes effective.
Province of Alberta, Canada
(Principal jurisdiction regulating this offering)
It is proposed that this filing shall become effective (check appropriate box):
A. |
o |
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). |
|
|
|
B. |
þ |
At some future date (check the appropriate box below): |
|
|
|
|
1. |
o |
pursuant to Rule 467(b) on (date) at (time) (designate a time not sooner than 7 calendar days after filing). |
|
|
2. |
o |
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). |
|
|
3. |
o |
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. |
|
|
4. |
þ |
after the filing of the next amendment to this Form (if preliminary material is being filed). |
If any of the securities being registered on this Form are to be offered on a delayed or continuous
basis pursuant to the home jurisdictions shelf prospectus offering procedures, check the following
box. o
The Registrant hereby amends this Registration Statement on such date or dates as may be necessary
to delay its effective date until the registration statement shall become effective as provided in
Rule 467 under the Securities Act, or on such date as the Commission, acting pursuant to Section
8(a) of the Securities Act, may determine.
Explanatory note: The Registrant hereby amends its Registration Statement on form F-10,
previously filed with the Commission on February 5, 2007, to include the amended and restated preliminary short form prospectus filed with the
Alberta Securities Commission, which contains the final pricing information for the offering of the Registrants units in Canada and the United States.
PART I
INFORMATION REQUIRED TO BE DELIVERED
TO OFFEREES OR PURCHASERS
A copy of
this amended and restated preliminary short form prospectus has
been filed with the securities regulatory authorities in each of
the provinces of Alberta, British Columbia, Manitoba and Ontario
but has not yet become final for the purpose of the sale of
securities. Information contained in this amended and restated
preliminary short form prospectus may not be complete and may
have to be amended. These securities may not be sold until a
receipt for the short form prospectus is obtained from the
securities regulatory authorities.
No securities regulatory
authority has expressed an opinion about these securities and it
is an offence to claim otherwise.
Information
contained herein is subject to completion or amendment. A
registration statement relating to these securities has been
filed with the U.S. Securities and Exchange Commission. These
securities may not be sold nor may offers to buy be accepted
prior to the time the registration statement becomes effective.
This prospectus shall not constitute an offer to sell or the
solicitation of an offer to buy nor shall there be any sale of
these securities in any U.S. state in which such offer,
solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such U.S.
state.
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
Suite 210, 1167 Kensington Crescent N.W., Calgary, Alberta
T2N 1X7, telephone
(403) 670-7377.
In addition, copies of documents incorporated by reference may
be obtained from the securities commissions or similar
authorities in Canada through the SEDAR website at
www.sedar.com. See Documents Incorporated by
Reference.
Amended and Restated Preliminary
Short Form Prospectus
|
|
New
Issue |
February 6,
2007
|
$12,000,000
4,000,000 Units
We are offering
4,000,000 units at a price of $3.00 per unit. Each
unit consists of one of our common shares and one-half of one
common share purchase warrant. One whole common share purchase
warrant will entitle the holder to purchase one of our common
shares upon payment of $3.50 at any time until 5:00 p.m.
(Calgary time) on the date that is 36 months following the
closing of this offering. The common shares and the warrants
comprising the units will separate immediately upon the closing
of this offering. See Details of the Offering. Our
outstanding common shares are listed for trading on the Toronto
Stock Exchange (the TSX) under the trading
symbol ONC and on the NASDAQ Capital Market
(NASDAQ) under the trading symbol
ONCY. On February 2, 2007, the last trading day
prior to the announcement of this offering, the closing price of
our common shares on the TSX was $3.25 and on NASDAQ was
U.S.$2.74 and on February 5, 2007, the closing price of our
common shares on the TSX was $3.25 and on NASDAQ was U.S.$2.73.
The offering price of our units was determined by negotiation
between us and the underwriter, Canaccord Capital Corporation.
There is no market through which the common share purchase
warrants may be sold and purchasers may not be able to resell
the common share purchase warrants purchased under this short
form prospectus. This may affect the pricing of the common share
purchase warrants in the secondary market, the transparency and
availability of trading prices, the liquidity of such warrants,
and the extent of issuer regulation. See Risk
Factors.
An investment in the units and
the underlying securities comprising the units should be
considered highly speculative due to the stage and nature of our
business and should only be made by persons who can afford a
total loss of their investment.
We are permitted, 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 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
U.S. companies. Information regarding the impact upon our
financial statements of significant differences between Canadian
and U.S. 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 units may have tax consequences both in the
United States and Canada. This prospectus may not describe these
tax consequences fully for investors who are resident in, or
citizens of, the United States. You should read the tax
discussion in this prospectus.
Your ability to enforce civil
liabilities under U.S. federal securities laws may be affected
adversely by the fact that we are incorporated under the laws of
Canada, the majority of our officers, all of our directors and
most of the experts named in this prospectus are residents of
Canada, and a substantial portion of our assets and the assets
of such persons are located outside the United States.
There are certain risk factors
that should be carefully reviewed by prospective purchasers. See
Risk Factors.
Price: $3.00 per Unit
|
|
|
|
|
|
|
|
|
|
|
Underwriters
|
|
Net Proceeds to
|
|
|
Price
|
|
Fee(1)
|
|
the
Corporation(2)(3)
|
Per unit
|
|
$3.00
|
|
$0.24
|
|
$2.76
|
Total offering
|
|
$12,000,000
|
|
$960,000
|
|
$11,040,000
|
Notes:
|
|
(1)
|
The underwriters fee represents 8% of the offering price.
|
|
(2)
|
Before deducting the expenses associated with this offering,
estimated to be $400,000. We will pay the expenses from the
proceeds of this offering.
|
|
(3)
|
The underwriter has been granted an option (the
Over-allotment Option), exercisable, in whole
or in part, not later than 30 days after closing of the
offering, to purchase up to 600,000 units at a price of
$3.00 per unit. This short form prospectus qualifies both
the grant of the Over-allotment Option and the issuance of the
units upon exercise of the Over-allotment Option. If the
Over-allotment Option is fully exercised, the total offering,
underwriters fee and net proceeds to the Corporation will
be $13,800,000, $1,104,000 and $12,696,000, respectively.
|
|
|
|
|
|
|
|
Underwriters Position
|
|
Maximum Size
|
|
Exercise Period
|
|
Exercise Price
|
Over-allotment Option
|
|
600,000 units
|
|
Exercisable not later than
30 days after closing of the offering
|
|
$3.00 per unit
|
Canaccord Capital Corporation, the
underwriter, as principal, conditionally offers these
securities, subject to prior sale, if, as and when issued by us
and accepted by the underwriter in accordance with the
conditions contained in the Underwriting Agreement referred to
under the heading Plan of Distribution and subject
to the approval of certain legal matters on behalf of us by
Bennett Jones LLP and Dorsey & Whitney LLP, and on
behalf of the underwriter by Fasken Martineau DuMoulin LLP and
White & Case LLP.
Subscriptions for the units will be
received subject to rejection or allotment in whole or in part
and the right is reserved to close the subscription books at any
time without notice. Definitive certificates representing the
common shares and the common share purchase warrants are
expected to be available for delivery at the closing of this
offering which is expected to occur on or about
February 22, 2007 or such other date as we and the
underwriter may mutually agree, but in any event not later than
March 22, 2007. In connection with this offering, the
underwriter may over-allot or effect transactions that stabilize
or maintain the market price of our common shares at a level
other than that which might otherwise prevail in the open
market. Such transactions, if commenced, may be discontinued at
any time. See Plan of Distribution.
In the opinion of our counsel,
Bennett Jones LLP, and counsel to the underwriter, Fasken
Martineau DuMoulin LLP (collectively,
Counsel), our common shares offered hereby
will, at the date hereof, be qualified investments under the
Income Tax Act (Canada) (the Tax Act)
and the regulations thereunder as in effect on the date hereof
for trusts governed by registered retirement savings plans,
registered retirement income funds, registered education savings
plans and deferred profit sharing plans (Exempt
Plans). In the opinion of Counsel, provided that we
deal at arms length (within the meaning of the Tax Act)
with each person who is an annuitant, a beneficiary, an employer
or a subscriber under, or in relation to, an Exempt Plan, as the
case be, our common share purchase warrants offered hereby will,
at the date hereof, be qualified investments under the Tax Act
and the regulations thereunder as in effect on the date hereof
for Exempt Plans.
Neither the U.S. Securities and
Exchange Commission nor any state securities commission has
approved or disapproved these securities or determined if this
prospectus is truthful or complete. Any representation to the
contrary is a criminal offence.
You should rely only on the
information contained in this prospectus. Neither we nor the
underwriter have authorized anyone to provide you with
information different from that contained in this prospectus. We
are offering to sell, and seeking offers to buy, our units only
in jurisdictions where, and to persons to whom, offers and sales
are lawfully permitted. The information contained in this
prospectus is accurate only as of the date of this prospectus,
regardless of the time of delivery of this prospectus or of any
sale of our units.
Our head office and principal place
of business is located at 210, 1167 Kensington Crescent N.W.,
Calgary, Alberta T2N 1X7. Our registered office is located at
4500 Bankers Hall East,
855-2nd Street
S.W., Calgary, Alberta T2P 4K7.
TABLE OF
CONTENTS
DEFINITIONS
AND OTHER MATTERS
In this prospectus, 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 is
determined using Canadian generally accepted accounting
principles.
This prospectus is part of a registration statement on
Form F-10
relating to the units that we filed with the
U.S. Securities and Exchange Commission (the
SEC). This prospectus does not contain all of
the information contained in the registration statement, certain
parts of which are omitted in accordance with the rules and
regulations of the SEC. You should refer to the registration
statement and the exhibits to the registration statement for
further information with respect to us and the units.
We prepare our financial statements in accordance with Canadian
generally accepted accounting principles (Canadian
GAAP), which differ from U.S. generally accepted
accounting principles (U.S. GAAP). Therefore,
our financial statements incorporated by reference in this
prospectus and in the documents incorporated by reference in
this prospectus may not be comparable to financial statements
prepared in accordance with U.S. GAAP. You should refer to
Note 20 of our financial statements for the year ended
December 31, 2005 for a discussion of the principal
differences between our financial results determined under
Canadian GAAP and under U.S. GAAP. For our financial statements
as at September 30, 2006, you should refer to our
reconciliation of our financial statements as at
September 30, 2006 and for the three and nine months ended
September 30, 2006 to U.S. GAAP furnished to the SEC on the
Companys Current Report on
Form 6-K
dated February 5, 2007 and incorporated into this document
by reference. See Documents Incorporated by
Reference.
SPECIAL
NOTICE REGARDING FORWARD-LOOKING STATEMENTS
Some of the statements that we make contain forward-looking
statements reflecting our current beliefs, plans, estimates and
expectations. Readers are cautioned that these forward-looking
statements involve risks and uncertainties, including, without
limitation, clinical trial study delays, product development
delays, our ability to attract and retain business partners,
future levels of government funding, competition from other
biotechnology companies and our ability to obtain the capital
required for research, product development, operations and
marketing. These factors should be carefully considered and
readers should not place undue reliance on our forward-looking
statements. Actual events may differ materially from our current
expectations due to risks and uncertainties.
2
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.
ELIGIBILITY
FOR INVESTMENT
The common shares and common share purchase warrants, as of the
date hereof, are eligible investments, where applicable, subject
to compliance with the prudent investment standards and general
investment provisions and restrictions of the statutes referred
to below (and, where applicable, regulations or guidelines
thereunder) and, in certain cases, subject to the satisfaction
of additional requirements relating to investment or lending
policies and procedures and, in certain cases, the filing of
such investment policies and procedures, under the following
statutes:
Insurance Companies Act (Canada)
Pension Benefits Standards Act, 1985 (Canada)
Cooperative Credit Associations Act (Canada)
Trust and Loan Companies Act (Canada)
Financial Institutions Act (British Columbia)
Pension Benefits Standards Act (British Columbia)
Alberta Heritage Savings Trust Fund Act
(Alberta)
Employment Pension Plans Act (Alberta)
Insurance Act (Alberta)
Loan and Trust Corporations Act (Alberta)
The Insurance Act (Manitoba)
The Pension Benefits Act (Manitoba)
The Trustee Act (Manitoba)
Loan and Trust Corporations Act (Ontario)
Pension Benefits Act (Ontario)
Trustee Act (Ontario)
In addition, in the opinion of Counsel, our common shares
offered hereby will, at the date hereof, be qualified
investments under the Tax Act and the regulations thereunder as
in effect on the date hereof for trusts governed by Exempt
Plans. In the opinion of Counsel, provided that we deal at
arms length (within the meaning of the Tax Act) with each
person who is an annuitant, a beneficiary, an employer or a
subscriber under, or in relation to, an Exempt Plan, as the case
may be, our common share purchase warrants offered hereby will,
at the date hereof, be qualified investments under the Tax Act
and the regulations thereunder as in effect on the date hereof
for Exempt Plans.
DOCUMENTS
INCORPORATED BY REFERENCE
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 our Corporate Secretary at Suite 210,
1167 Kensington Crescent N.W., Calgary, Alberta T2N 1X7,
telephone
(403) 670-7377.
In addition, copies of documents incorporated by reference may
be obtained from the securities commissions or similar
authorities in Canada through the SEDAR website at www.sedar.com.
We have filed the following documents with the securities
commissions or similar regulatory authorities in the provinces
of Canada and such documents are specifically incorporated by
reference in this prospectus:
|
|
|
|
|
our Renewal Annual Information Form dated March 2, 2006,
for the year ended December 31, 2005 (the
AIF);
|
|
|
|
our Management Proxy Circular dated March 24, 2006 relating
to the annual and special meeting of shareholders held on
April 26, 2006, excluding those portions which are not
prescribed by applicable securities laws;
|
|
|
|
our audited financial statements, together with the accompanying
notes to the financial statements, for the fiscal years ended
December 31, 2005 and 2004 and the auditors report
thereon addressed to our shareholders;
|
|
|
|
our managements discussion and analysis of financial
condition and results of operations dated March 2, 2006,
for the year ended December 31, 2005;
|
|
|
|
our unaudited interim financial statements as at
September 30, 2006 and for the three and nine months ended
September 30, 2006, together with the notes thereto;
|
3
|
|
|
|
|
our managements discussion and analysis of financial
condition and results of operations dated November 2, 2006,
for the three and nine months ended September 30, 2006; and
|
|
|
|
the reconciliation of our financial statements as at
September 30, 2006 and for the three and nine months ended
September 30, 2006 to U.S. GAAP, filed on
February 5, 2007 under the heading Other.
|
Any documents of the type required by National Instrument
44-101 Short Form Prospectus
Distributions of the Canadian Securities Administrators to
be incorporated by reference in a short form prospectus,
including any annual information form, comparative annual
financial statements and the auditors report thereon,
comparative interim financial statements, managements
discussion and analysis of financial condition and results of
operations, material change report (except a confidential
material change report), business acquisition report and
information circular, if filed by us with the securities
commissions or similar authorities in the provinces of Canada
after the date of this prospectus and before the termination of
the distribution, shall be deemed to be incorporated by
reference in this prospectus.
In addition, we incorporate by reference our reconciliation of
our financial statements as at September 30, 2006 and for
the three and nine months ended September 30, 2006 to U.S.
GAAP furnished to the SEC on our Current Report on
Form 6-K
dated February 5, 2007. 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 until the termination of this distribution 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 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.
WHERE YOU
CAN FIND ADDITIONAL INFORMATION
We have filed with the SEC a registration statement on
Form F-10
relating to the units. This prospectus, which constitutes a part
of the registration statement, does not contain all of the
information contained in the registration statement, certain
items of which are contained in the exhibits to the registration
statement as permitted by the rules and regulations of the SEC.
Statements included or incorporated by reference in this
prospectus about the contents of any contract, agreement or
other documents referred to are not necessarily complete, and in
each instance, you should refer to the exhibits for a more
complete description of the matter involved. Each such statement
is qualified in its entirety by such reference.
We file annual and quarterly financial information and material
change reports and other material with the SEC and with the
securities commissions or similar regulatory authorities in
Canada. Under a multi-jurisdictional disclosure system adopted
by the United States, documents and other information that we
file with the SEC may be prepared in accordance with the
disclosure requirements of Canada, which are different from
those of the United States. You may read and copy any document
that we have filed with the SEC at the SECs public
reference rooms in Washington, D.C. and Chicago, Illinois. You
may also obtain copies of those documents from the public
reference room of the SEC at 100 F Street, N.E.,
Washington, D.C. 20549 by paying a fee. You should call the SEC
at
1-800-SEC-0330
or access its website at www.sec.gov for further information
about the public reference rooms. You may read and download some
of the documents we have filed with the SECs Electronic
Data Gathering and Retrieval system at www.sec.gov. You may read
and download any public document that we have filed with the
securities commissions or similar regulatory authorities in
Canada at www.sedar.com.
4
ENFORCEABILITY
OF CIVIL LIABILITIES
We are a corporation existing under the Business Corporations
Act (Alberta). All of our directors, the majority of our
officers, and some of the experts named in this prospectus, are
residents of Canada or otherwise reside outside the United
States, and all, or a substantial portion of their assets and a
substantial portion of our assets, are located outside the
United States. We have appointed an agent for service of process
in the United States, but it may be difficult for holders of
units who reside in the United States to effect service within
the United States upon those directors, officers and experts who
are not residents of the United States. It may also be difficult
for holders of units 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, related to, or concerning
the offering of the units under this prospectus.
DOCUMENTS
FILED AS PART OF THE REGISTRATION STATEMENT
The following documents have been or will be filed with the SEC
as part of the registration statement of which this prospectus
forms a part: (i) the documents referred to under the
heading Documents Incorporated by Reference;
(ii) the Underwriting Agreement (as defined below);
(iii) the Warrant Indenture (as defined below);
(iv) consent of Ernst & Young LLP;
(v) consent of Bennett Jones LLP; (vi) consent of
Fasken Martineau DuMoulin LLP; and (vii) powers of attorney
from our directors and officers.
RISK
FACTORS
A prospective purchaser of our units 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 units.
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.
5
There are
inherent risks in pharmaceutical research and
development.
Pharmaceutical research and development is highly speculative
and involves a high and significant degree of risk. The
marketability of any product we develop will be affected by
numerous factors beyond our control, including but not limited
to:
|
|
|
|
|
the discovery of unexpected toxicities or lack of sufficient
efficacy of products which make them unattractive or unsuitable
for human use;
|
|
|
|
preliminary results as seen in animal and/or limited human
testing may not be substantiated in larger, controlled clinical
trials;
|
|
|
|
manufacturing costs or other production factors may make
manufacturing of products ineffective, impractical and
non-competitive;
|
|
|
|
proprietary rights of third parties or competing products or
technologies may preclude commercialization;
|
|
|
|
requisite regulatory approvals for the commercial distribution
of products may not be obtained; and
|
|
|
|
other factors may become apparent during the course of research,
up-scaling or manufacturing which may result in the
discontinuation of research and other critical projects.
|
Our products under development have never been manufactured on a
commercial scale, and there can be no assurance that such
products can be manufactured at a cost or in a quantity to
render such products commercially viable. Production and
utilization of our products may require the development of new
manufacturing technologies and expertise. The impact on our
business in the event that new manufacturing technologies and
expertise are required to be developed is uncertain. There can
be no assurance that we will successfully meet any of these
technological challenges, or others that may arise in the course
of development.
Pharmaceutical
products are subject to intense regulatory approval
processes.
The regulatory process for pharmaceuticals, which includes
preclinical studies and clinical trials of each compound to
establish its safety and efficacy, takes many years and requires
the expenditure of substantial resources. Moreover, if
regulatory approval of a drug is granted, such approval may
entail limitations on the indicated uses for which it may be
marketed. Failure to comply with applicable regulatory
requirements can, among other things, result in suspension of
regulatory approvals, product recalls, seizure of products,
operating restrictions and criminal prosecution. Further,
government policy may change, and additional government
regulations may be established that could prevent or delay
regulatory approvals for our products. In addition, a marketed
drug and its manufacturer are subject to continual review. Later
discovery of previously unknown problems with the product or
manufacturer may result in restrictions on such product or
manufacturer, including withdrawal of the product from the
market.
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
6
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
(cGMP) and other FDA, and local government
guidelines and regulations, including other international
regulatory requirements and guidelines. Additionally, certain of
our customers may require the manufacturing facilities
contracted by us to adhere to additional manufacturing
standards, even if not required by the FDA. Compliance with cGMP
regulations requires manufacturers to expend time, money and
effort in production, and to maintain precise records and
quality control to ensure that the product meets applicable
specifications and other requirements. The FDA and other
regulatory bodies periodically inspect drug-manufacturing
facilities to ensure compliance with applicable cGMP
requirements. If the manufacturing facilities contracted by us
fail to comply with the cGMP requirements, the facilities may
become subject to possible FDA or other regulatory action and
manufacturing at the facility could consequently be suspended.
We may not be able to contract suitable alternative or back-up
manufacturing facilities on terms acceptable to us or at all.
The FDA or other regulatory agencies may also require the
submission of any lot of a particular product for inspection. If
the lot product fails to meet the FDA requirements, then the FDA
could take any of the following actions: (i) restrict the
release of the product; (ii) suspend manufacturing of the
specific lot of the product; (iii) order a recall of the
lot of the product; or (iv) order a seizure of the lot of
the product.
We are subject to regulation by governments in many
jurisdictions and, if we do not comply with healthcare, drug,
manufacturing and environmental regulations, among others, our
existing and future operations may be curtailed, and we could be
subject to liability.
In addition to the regulatory approval process, we may be
subject to regulations under local, provincial, state, federal
and foreign law, including requirements regarding occupational
health, safety, laboratory practices, environmental protection
and hazardous substance control, and may be subject to other
present and future local, provincial, state, federal and foreign
regulations.
The
biotechnology industry is extremely competitive and we must
successfully compete with larger companies with substantially
greater resources.
Technological competition in the pharmaceutical industry is
intense and we expect competition to increase. Other companies
are conducting research on therapeutics involving the Ras
pathway as well as other novel treatments or therapeutics for
the treatment of cancer which may compete with our product. Many
of these competitors are more established, benefit from greater
name recognition and have substantially greater financial,
technical and marketing resources than us. In addition, many of
these competitors have significantly greater experience in
undertaking research, preclinical studies and human clinical
trials of new pharmaceutical products, obtaining regulatory
approvals and manufacturing and marketing such products. In
addition, there are several other companies and products with
which we may compete from time to time, and which may have
significantly better and larger resources than us. Accordingly,
our competitors may succeed in manufacturing and/or
commercializing products more rapidly or effectively, which
could have a material adverse effect on our business, financial
condition or results of operations.
We anticipate that we will face increased competition in the
future as new products enter the market and advanced
technologies become available. There can be no assurance that
existing products or new products developed by our competitors
will not be more effective, or be more effectively manufactured,
marketed and sold, than any that may be
7
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 the AIF
and Recent Developments New Patents in this
prospectus. Our success will depend, in part, on our ability to
obtain, enforce and maintain patent protection for our
technology in Canada, the United States and other countries. We
cannot be assured that patents will issue from any pending
applications or that claims now or in the future, if any,
allowed under issued patents will be sufficiently broad to
protect our technology. In addition, no assurance can be given
that any patents issued to or licensed by us will not be
challenged, invalidated, infringed or circumvented, or that the
rights granted thereunder will provide continuing competitive
advantages to us.
The patent positions of pharmaceutical and biotechnology firms,
including us, are generally uncertain and involve complex legal
and factual questions. In addition, it is not known whether any
of our current research endeavours will result in the issuance
of patents in Canada, the United States, or elsewhere, or if any
patents already issued will provide significant proprietary
protection or will be circumvented or invalidated. Since patent
applications in the United States and Canada may be maintained
in secrecy until at least 18 months after filing of the
original priority application, and since publication of
discoveries in the scientific or patent literature tends to lag
behind actual discoveries by several months, we cannot be
certain that we or any licensor were the first to create
inventions claimed by pending patent applications or that we or
the licensor was the first to file patent applications for such
inventions. Loss of patent protection could lead to generic
competition for these products, and others in the future, which
would materially and adversely affect our financial prospects
for these products.
Similarly, since patent applications filed before
November 29, 2000 in the United States may be maintained in
secrecy until the patents issue or foreign counterparts, if any,
publish, we cannot be certain that we or any licensor were the
first creator of inventions covered by pending patent
applications or that we or such licensor were the first to file
patent applications for such inventions. There is no assurance
that our patents, if issued, would be held valid or enforceable
by a court or that a competitors technology or product
would be found to infringe such patents.
Accordingly, we may not be able to obtain and enforce effective
patents to protect our proprietary rights from use by
competitors, and the patents of other parties could require us
to stop using or pay to use certain intellectual property, and
as such, our competitive position and profitability could suffer
as a result.
In addition, we may be required to obtain licenses under patents
or other proprietary rights of third parties. No assurance can
be given that any licenses required under such patents or
proprietary rights will be available on terms acceptable to us.
If we do not obtain such licenses, we could encounter delays in
introducing one or more of our products to the market while we
attempt to design around such patents, or could find that the
development, manufacture or sale of products requiring such
licenses could be foreclosed. In addition, we could incur
substantial costs in defending ourselves in suits brought
against us on such patents or in suits in which our attempts to
enforce our own patents against other parties.
Our
products may fail or cause harm, subjecting us to product
liability claims, which are uninsured.
The sale and use of our products entail risk of product
liability. We currently do not have any product liability
insurance. There can be no assurance that we will be able to
obtain appropriate levels of product liability insurance prior
to any sale of our pharmaceutical products. An inability to
obtain insurance on economically feasible terms or to otherwise
protect against potential product liability claims could inhibit
or prevent the commercialization of products developed by us.
The obligation to pay any product liability claim or a recall of
a product could have a material adverse effect on our business,
financial condition and future prospects.
We have
limited manufacturing experience and intend to rely on third
parties to commercially manufacture our products, if and when
developed.
To date, we have relied upon a contract manufacturer to
manufacture small quantities of
REOLYSIN®.
The manufacturer may encounter difficulties in scaling up
production, including production yields, quality control and
quality
8
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 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 operating revenues to offset our
research and development costs and accordingly have not
generated positive cash flow or made an operating profit. As of
December 31, 2005, we had an accumulated deficit of
approximately $50.7 million and as at September 30,
2006, we had an accumulated deficit of approximately
$60.1 million. We have incurred net losses of approximately
$12.8 million, $13.0 million, and $8.5 million
for the years ended December 31, 2005, 2004, and 2003,
respectively. For the nine months ended September 30, 2006,
we incurred a net loss of approximately $9.4 million. We
anticipate that we will continue to incur significant losses
during 2007 and in the foreseeable future. We will not reach
profitability until after successful commercialization of one or
more of our products. Even if one or more of our products are
profitably commercialized, the initial losses incurred by us may
never be recovered.
We may
need additional financing in the future to fund the research and
development of our products and to meet our ongoing capital
requirements.
As at December 31, 2005, we had cash and cash equivalents
(including short-term investments) of $40.4 million and
working capital of approximately $39.3 million. As at
September 30, 2006, we had cash and cash equivalents
(including
9
short-term investments) of $31.5 million and working
capital of approximately $30.4 million. We believe our
existing capital resources are adequate to fund our current
plans for research and development activities well into 2008
without the use of the proceeds from this offering. We
anticipate that we may need additional financing in the future
to fund research and development and to meet our ongoing capital
requirements. The amount of future capital requirements will
depend on many factors, including continued scientific progress
in our drug discovery and development programs, progress in our
pre-clinical and clinical evaluation of drug candidates, time
and expense associated with filing, prosecuting and enforcing
our patent claims and costs associated with obtaining regulatory
approvals. In order to meet such capital requirements, we will
consider contract fees, collaborative research and development
arrangements, and additional public or private financings
(including the incurrence of debt and the issuance of additional
equity securities) to fund all or a part of particular programs
as well as potential partnering or licensing opportunities.
There can be no assurance that additional funding will be
available or, if available, that it will be available on
commercially acceptable terms. If adequate funds are not
available on terms favorable to us, we may have to reduce
substantially or eliminate expenditures for research and
development, testing, production and marketing of our proposed
product, or obtain funds through arrangements with corporate
partners that require us to relinquish rights to certain of our
technologies or product. There can be no assurance that we will
be able to raise additional capital if our current capital
resources are exhausted.
The cost
of director and officer liability insurance may increase
substantially and may affect our ability to retain quality
directors and officers.
We carry liability insurance on behalf of our directors and
officers. Given a number of large director and officer liability
insurance claims in the U.S. equity markets, director and
officer liability insurance has become increasingly more
expensive with increased restrictions. Consequently, there is no
assurance that we will continue to be offered this insurance or
be able to obtain adequate coverage. The inability to acquire
the appropriate insurance coverage will limit our ability to
attract and maintain directors and officers as required to
conduct our business.
We are
dependent on our key employees and collaborators.
Our ability to develop the product will depend, to a great
extent, on our ability to attract and retain highly qualified
scientific personnel and to develop and maintain relationships
with leading research institutions. Competition for such
personnel and relationships is intense. We are highly dependent
on the principal members of our management staff as well as our
advisors and collaborators, the loss of whose services might
impede the achievement of development objectives. The persons
working with us are affected by a number of influences outside
of our control. The loss of key employees and/or key
collaborators may affect the speed and success of product
development.
We presently carry key man insurance in the amounts of
$1,500,000, $1,000,000 and $500,000 for Dr. Thompson,
Dr. Coffey and Mr. Ball, respectively.
Our share
price may be highly volatile.
Market prices for securities of biotechnology companies
generally are volatile. This increases the risk of securities
litigation. Factors such as announcements (publicly made or at
scientific conferences) of technological innovations, new
commercial products, patents, the development of proprietary
rights, results of clinical trials, regulatory actions,
publications, quarterly financial results, our financial
position, public concern over the safety of biotechnology,
future sales of shares by us or our current shareholders and
other factors could have a significant effect on the market
price and volatility of the common shares.
We incur
some of our expenses in foreign currencies and therefore we are
exposed to foreign currency exchange rate
fluctuations.
We incur some of our manufacturing, clinical and consulting
expenses in foreign currencies (to date mainly in the U.S. and
the UK). Over the past year the Canadian dollar has appreciated
to these currencies thereby decreasing the Canadian dollar
equivalent. However, if this trend reverses, our Canadian dollar
equivalent costs will increase.
Also, as we expand to other foreign jurisdictions there may be
an increase in our foreign exchange exposure.
10
We earn
interest income on our excess cash reserves and are exposed to
changes in interest rates.
We invest our excess cash reserves in investment vehicles that
provide a rate of return with little risk to principal. As
interest rates change the amount of interest income we earn will
be directly impacted.
We
believe we are a passive foreign investment company, which may
have a material affect on U.S. holders.
We believe we are a passive foreign investment
company (PFIC), which may have a
material affect on U.S. holders. United States income tax
legislation contains rules governing PFICs, which can have
significant tax effects on U.S. holders of foreign corporations.
A U.S. holder who holds stock in a foreign corporation during
any year in which such corporation qualifies as a PFIC is
subject to United States federal income taxation under one of
two alternative tax regimes at the election of each such U.S.
holder. The U.S. federal income tax consequences to a U.S.
holder of the acquisition, ownership, and disposition of common
shares will depend on whether such U.S. holder makes an election
to treat the Corporation as a qualified electing
fund or QEF under Section 1295 of the
Code (a QEF Election) or a
mark-to-market
election under Section 1296 of the Code (a
Mark-to-Market
Election). You should consult your tax advisor as to
the consequences of acquiring, owning or disposing of our common
shares.
There is
no market for the common share purchase warrants offered under
this prospectus.
There is no market through which the common share purchase
warrants may be sold and purchasers may not be able to resell
the common share purchase warrants purchased under this short
form prospectus. This may affect the pricing of the common share
purchase warrants in the secondary market, the transparency and
availability of trading prices, the liquidity of such warrants,
and the extent of issuer regulation.
ONCOLYTICS
BIOTECH INC.
Oncolytics Biotech Inc. was incorporated pursuant to the
provisions of the Business Corporations Act (Alberta) on
April 2, 1998 as 779738 Alberta Ltd. On April 8, 1998,
we amended our articles and changed our name to Oncolytics
Biotech Inc. On July 29, 1999, we further amended our
articles by removing the private company restrictions and
subdividing our issued and outstanding 2,222,222 common shares
to create 6,750,000 common shares. Our head office and principal
place of business is located at 210, 1167 Kensington Crescent
N.W., Calgary, Alberta T2N 1X7. Our registered office is located
at 4500 Bankers Hall East, 855-2nd Street S.W., Calgary, Alberta
T2P 4K7.
OUR
BUSINESS
We focus on the discovery and development of oncolytic viruses
for the treatment of cancers that have not been successfully
treated with conventional therapeutics. Recent scientific
advances in oncology, virology, and molecular biology have
created opportunities for new approaches to the treatment of
cancer. The product we are presently developing may represent a
novel treatment for Ras mediated cancers which can be used as an
alternative to existing cytotoxic or cytostatic therapies, as an
adjuvant therapy to conventional chemotherapy, radiation
therapy, or surgical resections. It could also potentially be
used to treat certain cellular proliferative disorders for which
no current therapy exists.
Our technologies are based primarily on discoveries in the
Department of Microbiology and Infectious Diseases at the
University of Calgary in the 1990s. Oncolytics was formed
in 1998 to explore the natural oncolytic capability of the
reovirus, a virus that preferentially replicates in cells with
an activated Ras pathway.
The lead product being developed by us may represent a novel
treatment for certain tumour types and some cellular
proliferative disorders. Our lead product is a virus that is
able to replicate specifically in, and hence kill, certain
tumour cells both in tissue culture as well as in a number of
animal models without damaging normal cells.
Our potential product for human use,
REOLYSIN®,
is developed from the reovirus. This virus has been demonstrated
to replicate specifically in tumour cells bearing an activated
Ras pathway. Activating mutations of Ras occur in approximately
thirty per cent of all human tumours directly, but considering
its central role in signal transduction, activation of the Ras
pathway may play a role in approximately two-thirds of all
tumours.
11
The functionality of
REOLYSIN®
is based upon the finding that tumours bearing an activated Ras
pathway are deficient in their ability to activate the
anti-viral response mediated by the host cellular protein,
Protein Kinase R (PKR). Since PKR is
responsible for preventing reovirus replication, tumour cells
lacking the activity of PKR are susceptible to reovirus
infections. As normal cells do not possess Ras activations,
these cells are able to thwart reovirus infections by the
activity of PKR. In a tumour cell with an activated Ras pathway,
reovirus is able to freely replicate and hence kill the host
tumour cell. The result of this replication is progeny viruses
that are then free to infect surrounding cancer cells. This
cycle of infection, replication and cell death is believed to be
repeated until there are no longer any tumour cells carrying an
activated Ras pathway available.
The following schematic illustrates the molecular basis of how
the reovirus kills cancer cells.
For both non-cancer cells, and cancer cells with an activated
Ras pathway, virus binding, entry, and production of viral genes
all proceed normally. In the case of normal cells however, the
viral genes cause the activation of the anti-viral response that
is mediated by the host cells PKR, thus blocking the
replication of the reovirus. In cells with an activated Ras
pathway, the activation of PKR is prevented or reversed by an
element of the Ras signal transduction pathway, thereby allowing
the replication of the reovirus in these cancer cells. The end
result of this replication is the death of the cancer cell. The
action of the Ras pathway in allowing reovirus replication to
ensue can be mimicked in non-cancerous cells by treating these
cells with the chemical
2-aminopurine
(2-AP) which
prevents the activation of PKR.
RECENT
DEVELOPMENTS
REOLYSIN®
Development
We continue to develop our lead product
REOLYSIN®
as a possible cancer therapy. Our goal each year is to advance
REOLYSIN®
through the various steps and stages of development required for
potential pharmaceutical products. In order to achieve this
goal, we actively manage the development of our clinical trial
program, our pre-clinical and collaborative programs, our
manufacturing process,
REOLYSIN®
supply, and our intellectual property.
Clinical
Trial Program
We are directing a broad clinical trial program with the
objective of developing
REOLYSIN®
as a human cancer therapeutic. The clinical program includes
human trials using
REOLYSIN®
alone and in combination with radiation and chemotherapy, and
delivered via local administration and/or intravenous
administration.
Based on indications of activity in our clinical trial program
to date, Oncolytics Phase II clinical trial program may
include combination
chemotherapy/REOLYSIN®
trials including colorectal, prostate, pancreatic and non-small
cell lung
12
cancer, and combination radiation/
REOLYSIN®
trials in a number of tumour types. In addition, the U.S.
National Cancer Institute (NCI) has solicited
proposals to conduct two trials using
REOLYSIN®
as a monotherapy for melanoma and ovarian cancers.
Clinical
Trial Chart
The following chart shows the states of clinical trials that
have been completed or that are in progress.
|
|
|
|
|
|
|
|
|
Trial Program and Cancer
|
|
|
|
|
Delivery Method
|
|
Indication
|
|
Location
|
|
Status
|
|
Intravenous administration in
combination with gemcitabine
|
|
pancreatic, lung, ovarian
|
|
United Kingdom
|
|
Approval to commence
|
Intravenous administration in
combination with docetaxel
|
|
bladder, prostate, lung, upper
gastro-intestinal
|
|
United Kingdom
|
|
Approval to commence
|
Intravenous administration in
combination with paclitaxel and carboplatin
|
|
melanoma, lung, ovarian
|
|
United Kingdom
|
|
Approval to commence
|
Local therapy in combination with
radiation
|
|
Phase II various metastatic
tumours, including head & neck
|
|
United Kingdom
|
|
Ongoing
|
Local therapy in combination with
radiation
|
|
Phase I various metastatic tumours
|
|
United Kingdom
|
|
Phase Ia complete
Phase Ib ongoing
|
Infusion monotherapy
|
|
Phase I/II recurrent malignant
gliomas
|
|
United States
|
|
Ongoing
|
Intravenous administration
monotherapy
|
|
Phase I various metastatic tumours
|
|
United Kingdom
|
|
Complete
|
Intravenous administration
monotherapy
|
|
Phase I various metastatic tumours
|
|
United States
|
|
Complete
|
Local monotherapy
|
|
Phase I recurrent malignant gliomas
|
|
Canada
|
|
Complete
|
Local monotherapy
|
|
T2 prostate cancer
|
|
Canada
|
|
Complete
|
Local monotherapy
|
|
Phase I trial for various
subcutaneous tumours
|
|
Canada
|
|
Complete
|
U.K.
Combination Gemcitabine and
REOLYSIN®
Clinical Trial
In January 2007, we received approval from the U.K. Medicines
and Healthcare products Regulatory Agency (the
MHRA) to begin a clinical trial using
intravenous administration of
REOLYSIN®
in combination with gemcitabine
(Gemzar®)
in patients with advanced cancers including pancreatic, lung and
ovarian. The trial has two components. The first is an
open-label, dose-escalating, non-randomized study of
REOLYSIN®
given intravenously with gemcitabine every three weeks. A
standard dosage of gemcitabine will be delivered with escalating
dosages of
REOLYSIN®.
A maximum of three cohorts will be enrolled in the
REOLYSIN®
dose escalation portion. The second component of the trial will
immediately follow and will include the enrolment of a further
12 patients at the maximum dosage of
REOLYSIN®
in combination with a standard dosage of gemcitabine. Eligible
patients include those who have been diagnosed with advanced or
metastatic solid tumours including pancreatic, lung and ovarian
cancers that are refractory (have not
13
responded) to standard therapy or for which no curative standard
therapy exists. The primary objective of the trial is to
determine the MTD, DLT, recommended dose and dosing schedule and
safety profile of
REOLYSIN®
when administered in combination with gemcitabine. Secondary
objectives include the evaluation of immune response to the drug
combination, the bodys response to the drug combination
compared to chemotherapy alone and any evidence of anti-tumour
activity.
U.K.
Combination Docetaxel and
REOLYSIN®
Clinical Trial
In January 2007, we received approval from the MHRA for our
Clinical Trial Application to begin a clinical trial using
intravenous administration of
REOLYSIN®
in combination with docetaxel
(Taxotere®)
in patients with advanced cancers including bladder, prostate,
lung and upper gastro-intestinal. The trial has two components.
The first is an open-label, dose-escalating, non-randomized
study of
REOLYSIN®
given intravenously with docetaxel every three weeks. A standard
dosage of docetaxel will be delivered with escalating dosages of
REOLYSIN®.
A maximum of three cohorts will be enrolled in the
REOLYSIN®
dose escalation portion. The second component of the trial will
immediately follow and will include the enrolment of a further
12 patients at the maximum dosage of
REOLYSIN®
in combination with a standard dosage of docetaxel. Eligible
patients include those who have been diagnosed with advanced or
metastatic solid tumours such as bladder, lung, prostate or
upper gastro-intestinal cancers that are refractory (have not
responded) to standard therapy or for which no curative standard
therapy exists. The primary objective of the trial is to
determine the Maximum Tolerated Dose (MTD),
Dose-Limiting Toxicity (DLT), recommended
dose and dosing schedule and safety profile of
REOLYSIN®
when administered in combination with docetaxel. Secondary
objectives include the evaluation of immune response to the drug
combination, the bodys response to the drug combination
compared to chemotherapy alone and any evidence of anti-tumour
activity.
U.K.
Combination Paclitaxel and Carboplatin with
REOLYSIN®
Clinical Trial
In December 2006, the MHRA approved a clinical trial using
intravenous administration of
REOLYSIN®
in combination with paclitaxel and carboplatin in patients with
advanced cancers including melanoma, lung and ovarian. The trial
has two components. The first is an open-label, dose-escalating,
non-randomized study of
REOLYSIN®
given intravenously with paclitaxel and carboplatin every three
weeks. Standard dosages of paclitaxel and carboplatin will be
delivered with escalating dosages of
REOLYSIN®.
A maximum of three cohorts will be enrolled in the
REOLYSIN®
dose escalation portion. The second component of the trial will
immediately follow and will include the enrolment of a further
12 patients at the maximum dosage of
REOLYSIN®
in combination with standard dosages of paclitaxel and
carboplatin. Eligible patients include those who have been
diagnosed with advanced or metastatic solid tumours including
melanoma, lung and ovarian that are refractory (have not
responded) to standard therapy or for which no curative standard
therapy exists. The primary objective of the trial is to
determine the MTD, DLT, recommended dose and dosing schedule and
safety profile of
REOLYSIN®
when administered in combination with paclitaxel and
carboplatin. Secondary objectives include the evaluation of
immune response to the drug combination, the bodys
response to the drug combination compared to chemotherapy alone
and any evidence of anti-tumour activity.
U.K.
Phase II Combination
REOLYSIN®/radiation
Clinical Trial
In December 2006, we commenced enrolment in our Phase II U.K.
clinical trial to evaluate the anti-tumour effects of
intratumoural administration of
REOLYSIN®
in combination with low-dose radiation in patients with advanced
cancers.
The trial is an open-label, single-arm, multi-centre Phase II
study of
REOLYSIN®
delivered via intratumoural injection to patients during
treatment with low-dose radiotherapy. Up to 40 evaluable
patients, including approximately 20 patients with head and neck
and esophageal cancers, and approximately 20 patients with other
advanced cancers, will be treated with two intratumoural doses
of
REOLYSIN®
at
1x1010
TCID50
with a constant localized radiation dose of 20 Gy in five
consecutive daily fractions. Eligible patients include those who
have been diagnosed with advanced or metastatic cancers
including head, neck and esophageal tumours that are refractory
(have not responded) to standard therapy or for which no
curative standard therapy exists.
The primary objective of the trial is to assess the anti-tumour
activity of the combination of
REOLYSIN®
and low dose radiotherapy in treated and untreated lesions.
Secondary objectives include the evaluation of viral
replication, immune response to the virus and to determine the
safety and tolerability of intratumoural administration of
REOLYSIN®
in patients with advanced cancers who are receiving radiation
treatment.
14
U.K.
Phase Ia/Ib Combination
REOLYSIN®/Radiation
Clinical Trial
During the third quarter of 2006, we commenced patient enrolment
in our Phase Ib U.K. clinical trial investigating
REOLYSIN®
in combination with radiation therapy as a treatment for
patients with advanced cancers. The Phase Ib trial will treat
patients with a range of two to six intratumoural doses of
REOLYSIN®
at
1x1010
TCID50
with a constant radiation dose of 36 Gy in 12 fractions.
The primary objective of our Phase Ib trial is to determine the
maximum tolerated dose, dose limiting toxicity, and safety
profile of
REOLYSIN®
when administered intratumourally to patients receiving
radiation treatment. A secondary objective is to examine any
evidence of anti-tumour activity. Eligible patients include
those who have been diagnosed with advanced or metastatic solid
tumours that are refractory (have not responded) to standard
therapy or for which no curative standard therapy exists. An
additional group of patients is planned to be treated at the
maximum dose regimen reached in the Ib trial.
Patient enrolment in our Ia combination
REOLYSIN®/radiation
trial was completed in June 2006. The Phase Ia trial tested two
intratumoural treatments of
REOLYSIN®
at dosages of
1x108,
1x109,
or
1x1010
TCID50
with a constant localized radiation dose of 20 Gy given in five
fractions. A maximum tolerated dose was not reached and the
combination treatment appears to have been well tolerated by the
patients.
Interim results of the Phase Ia trial were presented at the
American Association for Cancer Research Annual Meeting in
Washington, D.C. in April 2006. Preliminary analysis has
demonstrated evidence of both local and systemic response.
U.S.
Phase I/II Recurrent Malignant Glioma Clinical
Trial
During the third quarter of 2006, we began patient enrolment in
our clinical trial to investigate the use of
REOLYSIN®
for patients with recurrent malignant gliomas. This clinical
trial is an open-label dose escalation Phase I/II trial in
which a single dose of
REOLYSIN®
is administered by infusion to patients with recurrent malignant
gliomas that are refractory to standard therapy. The
administration involves the stereotactically-guided placement of
a needle into the tumour, through which
REOLYSIN®
will be administered or infused into the tumour mass and
surrounding tissue using a pump.
The primary objective of the study is to determine the maximum
tolerated dose, dose limiting toxicity and safety profile of
REOLYSIN®.
Secondary objectives include the evaluation of viral
replication, immune response to the virus and any evidence of
anti-tumour activity.
U.K.
Phase I Systemic Administration Clinical Trial
Further results of our U.K. Phase I Systemic Administration
Clinical Trial were presented at the
18th
EORTC-NCI-AACR Symposium on Molecular Targets and Cancer
Therapeutics in November 2006 in Prague, Czech Republic. A
poster entitled A Phase I Study of Wild-Type Reovirus,
Which Selectively Replicates in Cells Expressing Activated Ras,
Administered Intravenously to Patients with Advanced
Cancer was presented by Dr. Timothy Yap of The Royal
Marsden Foundation Trust and the Institute of Cancer Research.
Results indicated that
REOLYSIN®
can be delivered systemically to various tumour types and cause
virus-mediated tumour responses. A total of 33 patients were
treated in the trial to a maximum daily dose of
1x1011
TCID50.
Of 32 patients assessed, anti-tumour activity was noted in
seven patients. Two patients with colorectal cancer had tumour
stabilization (one for three months, the other classified as
stable disease for six months) and had CEA tumour marker
reduction of 27% and 60% respectively. One patient with
metastatic prostate cancer had stable disease for four months,
had a 50% decrease in PSA, and had extensive product-induced
necrosis with associated intratumoural viral replication in
metastatic lesions in the lymph nodes. One patient with
metastatic bladder cancer had stable disease for four months and
had a minor tumour response in a metastatic lesion in a lymph
node. A patient with pancreatic cancer and a patient with NSCL
cancer had stable disease for four months. A patient with
endometrial cancer had stable disease for five months.
U.S.
Phase I Systemic Administration Clinical Trial
During the third quarter of 2006, we completed patient enrolment
in our Phase I U.S. clinical trial investigating the systemic
delivery of
REOLYSIN®
to treat patients with advanced cancers. A total of 18 patients
were treated in the Phase I
15
trial with
REOLYSIN®
at escalating dosages of
1x108,
3x108,
1x109,
3x109,
1x1010
or
3x1010
TCID50.
A maximum tolerated dose was not reached and the treatment
appears to have been well tolerated by the patients.
The clinical trial is an open-label, dose-escalation Phase I
study in which a single dose of
REOLYSIN®
is administered intravenously to patients diagnosed with
selected advanced or metastatic solid tumours that are
refractory (have not responded) to standard therapy or for which
no curative standard therapy exists. The primary objective of
the study is to determine the maximum tolerated dose, dose
limiting toxicity and safety profile of
REOLYSIN®.
Secondary objectives include the evaluation of viral
replication, immune response to the virus and any evidence of
anti-tumour activity.
Pre-Clinical
Trial and Collaborative Program
We perform pre-clinical studies and engage in collaborations to
help support our clinical trial programs and expand our
intellectual property base. We continue with studies examining
the interaction between the immune system and the reovirus, the
use of the reovirus as a co-therapy with chemotherapeutics and
radiation, the use of new RAS active viruses as potential
therapeutics, and to consider other uses for the reovirus as a
therapeutic.
In January 2007, Dr. Sheila Fraser of St. Jamess
University Hospital in Leeds, U.K. presented an abstract
entitled Reovirus as a Potentially Immunogenic as well as
Cytotoxic Therapy for Metastatic Colorectal Cancer at the
Society of Academic & Research Surgery Conference in
Cambridge, U.K. The investigators tested reovirus in
vitro against recently resected colorectal cancer liver
metastases. The results showed that a significant proportion of
tumour cell cultures showed susceptibility to death following
reovirus infection, and also demonstrated effective replication
of reovirus within these cells. In addition, dendritic cells
that prime the immune system to fight cancer cells were
activated by exposure to the reovirus. The investigators
concluded that the data supports the development of reovirus as
a novel therapy for colorectal cancer, with the potential to
direct the immune system to target cancer cells.
In November 2006, Dr. Shizuko Sei of SAIC-Frederick Inc.,
prime contractor the National Cancer Institute at Frederick
(NCI-F) presented a poster at the
18th
EORTC-NCI-AACR symposium on Molecular Targets and Cancer
Therapeutics in Prague, Czech Republic. The poster was entitled
Synergistic Antitumor Activity of Oncolytic Reovirus and
Chemotherapeutic Agents against Non-small Cell Lung Cancer
(NSCLC). The research focused on work conducted by the NCI
with reovirus in combination with a number of common
chemotherapeutic agents. In general, the combination of reovirus
with cisplatin, gemcitabine, mitomycin or vinblastine was
synergistic against NSCLC cell lines sensitive to anti-cancer
drugs. The combination of reovirus and paclitaxel was uniformly
synergistic in all six cell lines examined, including in those
with high-level resistance to paclitaxel or reovirus. The data
suggest that the combination of reovirus and paclitaxel may help
in promoting cell-death signaling, resulting in a more efficient
and synergistic anti-cancer effect against these cell lines than
using each agent on its own.
On September 9, 2006 a poster, prepared by one of our
collaborators, entitled Reovirus Activates Dendritic Cells
and Promotes Innate Anti-Tumour Immunity was presented at
the 1st Joint Meeting of European National Societies of
Immunology. The poster highlighted the researchers use of
isolated human cells to examine whether the use of the reovirus
as a direct tumour killing agent might also activate the innate
immune system to play a role in the killing of tumour cells. The
innate immune system is the broad, short-term and non-specific
first-line immune response to an infection. The research showed
that the reovirus can infect and activate immature human
dendritic cells. The reovirus-activated dendritic cells
triggered anti-tumour cytotoxicity when co-cultured with two
other types of immune cells, natural killer cells and autologous
T-cells. The researchers concluded that the reovirus may support
early innate anti-tumour immunity as well as inducing direct
tumour cell death.
Other
Clinical Trial Activity
We continue to develop our Phase II clinical trial program which
includes the assessment of different cancer indications and
potential drug combinations, the interviewing and selection of
investigators and clinical trial sites, and the contracting of
Contract Research Organizations.
Manufacturing
and Process Development
We have completed the production runs that should provide us
with sufficient product to complete our U.K. Phase II
combination
REOLYSIN®/radiation
clinical trial and our existing Phase I clinical trials. At the
same time, our process
16
development activity helped improve virus yields from our
manufacturing process. We completed the transfer of these
improvements to our cGMP manufacturer at the beginning of the
third quarter of 2006 and began production runs under this
improved process. These production runs are expected to provide
sufficient
REOLYSIN®
to expand our Phase II clinical trial program. Our process
development activity has now shifted focus to the examination of
the potential scale up of our manufacturing process.
New
Patents
The following table sets forth certain patent issuances in
select jurisdictions since the filing of our AIF:
|
|
|
|
|
|
|
|
|
Title
|
|
Ownership
|
|
Inventors
|
|
Status of Patent
|
|
Patent Number U.S. 6,994,858
Reovirus Clearance of Ras-Mediated Neoplastic Cells from Mixed
Cellular Compositions
|
|
Oncolytics Biotech Inc.
|
|
Dr. Don Morris
Dr. Bradley G. Thompson
Dr. Matthew C. Coffey
|
|
Filing date:
Issued:
|
|
May 3, 2001
February 7, 2006
|
Patent Number U.S. 7,014,847
Methods for Preventing Reovirus Recognition for the Treatment of
Cellular Proliferative Disorders
|
|
Oncolytics Biotech Inc.
|
|
Dr. Bradley G. Thompson
Dr. Matthew C. Coffey
|
|
Filing date:
Issued:
|
|
March 28, 2003
March 21, 2006
|
Patent Number U.S. 7,049,127 Method
of Producing Infectious Reovirus
|
|
Oncolytics Biotech Inc.
|
|
Dr. Bradley G. Thompson
Dr. Matthew C. Coffey
|
|
Filing date:
Issued:
|
|
December 11, 2003
May 23, 2006
|
Patent Number U.S. 7,052,832
Methods for the Treatment of Cellular Proliferative Disorders
|
|
Oncolytics Biotech Inc.
|
|
Dr. Matthew C. Coffey
|
|
Filing date:
Issued:
|
|
November 6, 2001
May 30, 2006
|
Patent Number U.S. 7,163,678
Reovirus for the Treatment of Ral-Mediated Cellular
Proliferative Disorders
|
|
Oncolytics Biotech Inc.
|
|
Dr. Patrick W.K. Lee
Dr. Kara L. Norman
|
|
Filing date:
Issued:
|
|
November 6, 2003
January 16, 2007
|
Canadian Patent Number 2,415,750
Methods for Preventing Reovirus Recognition for the Treatment of
Cellular Proliferative Disorders
|
|
Oncolytics Biotech Inc.
|
|
Dr. Bradley G. Thompson
Dr. Matthew C. Coffey
|
|
Filing date:
Issued:
|
|
July 20, 2001
March 28, 2006
|
European Patent Number: 1,498,129
Use of Adenoviruses Mutated in the VA Genes for Cancer Treatment
|
|
Oncolytics Biotech Inc.
|
|
Dr. Ramon Alemany
Dr. Manel M. Cascallo
|
|
Filing date:
Issued:
|
|
March 25, 2003
November 16, 2005
|
New
Directors and Officer
Ed Levy and Ger J. van Amersfoort were appointed to our board of
directors on May 17, 2006 and June 15, 2006,
respectively. On January 23, 2007, Mary Ann Dillahunty was
appointed as our Vice President, Intellectual Property.
USE OF
PROCEEDS
Assuming that the Over-allotment Option is not exercised, the
estimated net proceeds to be received by us from the sale of the
units will be $10,640,000 after deducting the
underwriters fee of $960,000 and the estimated
expenses of the offering of $400,000. If the Over-allotment
Option is exercised in full, the estimated net proceeds to be
received by us from the sale of the units will be
$12,296,000 after deducting the underwriters fee of
$1,104,000 and the estimated expenses of the offering of
$400,000. The net proceeds for this offering will be used by us
for our clinical trial program, our manufacturing activities in
support of the program and general corporate purposes.
17
CAPITALIZATION
On September 30, 2006, we had 36,386,748 common shares
issued and outstanding. Since September 30, 2006, we have
issued 134,000 common shares pursuant to the exercise of stock
options. As at February 6, 2007, we have 36,520,748 common
shares issued and outstanding. If all of our warrants and
options outstanding as of February 6, 2007 were exercised,
we would have 42,830,698 common shares issued and outstanding.
Following this offering, we will have 40,520,748 common
shares issued and outstanding (48,830,698 common shares on
a fully-diluted basis). Following this offering and assuming the
Over-allotment Option is exercised in full, we will have
41,120,748 common shares issued and outstanding
(49,730,698 common shares on a fully-diluted basis).
DETAILS
OF THE OFFERING
This offering consists of 4,000,000 units at a price of
$3.00 per unit. Each unit consists of one common share and
one-half of one common share purchase warrant. Each whole common
share purchase warrant will entitle the holder to purchase one
of our common shares upon payment of $3.50 at any time
until 5:00 p.m. (Calgary time) on the date that is
36 months following the closing of this offering. The
common shares and the common share purchase warrants comprising
the units will separate immediately on the closing of the
offering.
Common
Shares
We are authorized to issue an unlimited number of common shares.
Each common share entitles the holder to one vote per share held
at meetings of shareholders, to receive such dividends as
declared by us and to receive our remaining property and assets
upon dissolution or winding 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.
Warrants
The common share purchase warrants will be governed by an
indenture (the Warrant Indenture) to be
entered into between us and Computershare Trust Company of
Canada, as agent for the holders of the common share purchase
warrants. The following descriptions are subject to the detailed
provisions of the Warrant Indenture.
Each whole warrant will entitle the holder to purchase one of
our common shares at a price of $3.50, subject to adjustment as
summarized below. All rights under any common share purchase
warrants that for any reason have not been exercised by
5:00 p.m. (Calgary time) on the date that is 36 months
following the closing of this offering will terminate and the
certificate representing such common share purchase warrant will
be void.
There is no market through which the common share purchase
warrants may be sold and purchasers may not be able to resell
the common share purchase warrants purchased under this
prospectus. This may affect the pricing of the common share
purchase warrants in the secondary market, the transparency and
availability of trading prices, the liquidity of such common
share purchase warrants, and the extent of issuer regulation.
Common share purchase warrants will be evidenced by fully
registered certificates. A register of holders will be
maintained at the principal office of Computershare
Trust Company of Canada in Calgary, Alberta. One or more
certificates may be exchanged for one or more certificates of
different denominations evidencing in the aggregate the same
number of common share purchase warrants as the certificate or
certificates being exchanged.
The Warrant Indenture will provide that the share ratio and
exercise price of the common share purchase warrants will be
subject to adjustment in the event of a subdivision or
consolidation of our common shares. The Warrant Indenture will
also provide that if there is (a) any reclassification or
change of our common shares into other shares, (b) any
consolidation, amalgamation, arrangement or other business
combination of Oncolytics resulting in any reclassification or
change of our common shares into other shares, or (c) any
sale, lease, exchange or transfer of our assets as an entity or
substantially as an entirety to another entity, then each holder
of a common share purchase warrant which is thereafter exercised
shall receive, in lieu of common shares, the kind and number or
amount of other securities or property which such holder would
have been entitled to receive as a result of such event if such
holder had exercised the common share purchase warrants prior to
the event.
We will also covenant in the Warrant Indenture that, during the
period in which the common share purchase warrants are
exercisable, we will give public notice of our intention to fix
a record date for the issuance of rights, options or
18
warrants (other than the common share purchase warrants
comprising part of the units) to all or substantially all of the
holders of our outstanding common shares at least 14 days
prior to the record date of such event.
To the extent that the holder of a common share purchase warrant
would otherwise be entitled to purchase a fraction of a common
share, Oncolytics, in lieu of issuing a fractional common share,
shall pay to the holder thereof within five business days of
exercise an amount in Canadian dollars equal to the difference
between the Current Market Price of the common
shares on the exercise date multiplied by the fractional
interest, provided that Oncolytics shall make only one payment
for each beneficial holder exercising such common share purchase
warrants and shall not be required to make any payment that is
less than $10.00. Holders of common share purchase warrants do
not have any voting or pre-emptive rights or any other rights as
shareholders of Oncolytics.
It is a closing condition of this offering that we file and
clear a short form base shelf prospectus with the Alberta
Securities Commission and concurrently, pursuant to the
multi-jurisdictional disclosure system, file and bring effective
a registration statement on
Form F-10
with the SEC. Further, it is a closing condition of the closing
of this offering that we file with the Alberta Securities
Commission a prospectus supplement and with the SEC a
post-effective amendment to the registration statement
registering the offering of our common shares issuable from time
to time on the exercise of the common share purchase warrants.
We have agreed to use reasonable efforts to maintain the base
shelf prospectus and the registration statement, or another
registration statement under the United States Securities Act of
1933, as amended (the Securities Act),
relating to the common shares underlying the common share
purchase warrants, effective until the earlier of the expiration
date of the common share purchase warrants and the date on which
no common share purchase warrants remain outstanding. No U.S.
Person or person holding common share purchase warrants for the
benefit of or for the account of a U.S. Person will be permitted
to exercise common share purchase warrants during any period of
time prior to the expiration date of the common share purchase
warrants during which no registration statement under the
Securities Act is effective. If no registration statement under
the Securities Act is effective, we will notify the holders of
the common share purchase warrants in the United States, in
accordance with the Warrant Indenture.
Reference is made to the Warrant Indenture for the full text of
the attributes of the common share purchase warrants.
PLAN OF
DISTRIBUTION
Under an underwriting agreement dated February 6, 2007 (the
Underwriting Agreement) between us and the
underwriter, we have agreed to sell and the underwriter has
agreed to purchase on February 22, 2007 or on such other
date as we and the underwriter may mutually agree, but in any
event not later than March 22, 2007 (subject to the
termination rights described below), all but not less than all
of the 4,000,000 units offered hereby at a price of
$3.00 per unit for total consideration of
$12,000,000 payable in cash to us against delivery of
certificates representing the common shares and common share
purchase warrants comprising the units. The obligations of the
underwriter under the Underwriting Agreement may be terminated
at its discretion upon the occurrence of certain stated events.
The underwriter is, however, obligated to take up and pay for
all of the units if any of the units are purchased under the
Underwriting Agreement.
The offering price was determined by negotiation between us and
the underwriter. We have agreed to pay to the underwriter a fee
equal to 8% of the gross proceeds of the offering, equal to
$0.24 per unit in consideration of services rendered by it
in connection with this offering. All fees payable to the
underwriter will be paid on account of services rendered in
connection with the offering and will be paid from the proceeds
from the offering.
We have granted the underwriter the Over-allotment Option,
exercisable, in whole or in part, for a period of up to
30 days after closing of the offering, to purchase up to an
additional 600,000 units, each unit consisting of one of our
common shares and one-half of one common share purchase warrant,
at the offering price, to cover over-allotments, if any, and for
market stabilization purposes. The grant of the Over-allotment
Option and the issuance of the units upon exercise of the
Over-allotment Option are qualified for distribution under this
prospectus. If the Over-allotment Option is exercised in full,
the total offering, the underwriters fee and the net
proceeds to the Corporation (before payment of the expenses of
the offering) will be $13,800,000, $1,104,000 and
$12,696,000, respectively.
This offering is being made concurrently in Canada and the
United States pursuant to the multi-jurisdictional disclosure
system implemented by the securities regulatory authorities in
Canada and the United States. The units will be offered in
Canada and the United States through the underwriter either
directly or through its U.S. or Canadian broker-dealer affiliate
or agent registered in each jurisdiction, as applicable. Subject
to applicable law, the underwriter may offer the units outside
of Canada and the United States.
19
We have agreed to indemnify the underwriter and its directors,
officers, employees and agents against certain liabilities,
including liabilities under the Securities Act and Canadian
provincial securities legislation, in connection with the
offering or to contribute to payments that the underwriter may
be required to make in respect thereof.
We have agreed not to issue or announce the issuance of any
equity securities or any securities convertible into,
exchangeable for or exercisable to acquire equity securities
without the prior consent of the underwriter until a date which
is 90 days after the closing date of this offering, other
than pursuant to: (i) presently outstanding rights, or
agreements, including options, warrants and other convertible
securities and any rights which have been granted, issued or
will be issued under the offering, subject to any necessary
regulatory approval; (ii) presently outstanding options
granted to officers, directors, employees or consultants of the
Corporation or any subsidiary thereof pursuant to the
Oncolytics stock option plan (the Option
Plan); (iii) the Option Plan; or
(iv) arms length corporate alliances, partnerships,
mergers or acquisitions.
Pursuant to a rule of the Ontario Securities Commission, the
underwriter may not, throughout the period of distribution under
this prospectus, bid for or purchase our common shares. The
foregoing restriction is subject to exceptions, on the condition
that the bid or purchase is not engaged in for the purpose of
creating actual or apparent active trading in, or raising the
price of, our common shares. These exceptions include a bid or
purchase permitted under the Universal Market Integrity Rules
for Canadian Marketplaces of Market Regulation Services
Inc. relating to market stabilization and passive market-making
activities and a bid or purchase made for and on behalf of a
customer where the order was not solicited during the period of
distribution. Under the first-mentioned exception, in connection
with the offering, the underwriter may over-allot or effect
transactions which stabilize or maintain the market price for
the common shares at levels other than those which might
otherwise prevail in the open market. Those transactions, if
commenced, may be discontinued at any time.
Our common shares are listed on the TSX under the trading symbol
ONC and on the NASDAQ under the trading symbol
ONCY. On February 2, 2007, the last trading day
prior to the announcement of this offering, the closing price of
our common shares on the TSX was $3.25 and on NASDAQ was
U.S.$2.74 and on February 5, 2007, the closing price of our
common shares on the TSX was $3.25 and on NASDAQ was
U.S.$2.74. We have applied to list the (i) common shares
comprising part of the units; (ii) common shares issuable
upon exercise of the common share purchase warrants comprising
part of the units; and (iii) the common shares to be issued
on the exercise of the Over-allotment Option on the TSX and
NASDAQ. Listing will be subject to the Corporation fulfilling
the applicable listing requirements of the TSX and NASDAQ.
United
States Securities Law Compliance
It is a closing condition of the closing of this offering that
we file and clear a short form base shelf prospectus with the
Alberta Securities Commission and concurrently, pursuant to the
multi-jurisdictional disclosure system, file and bring effective
a registration statement on
Form F-10
with the SEC. Further, it is a closing condition of the closing
of this offering that we file with the Alberta Securities
Commission a prospectus supplement and with the SEC a
post-effective amendment to the registration statement
registering the offering of our common shares issuable from time
to time on the exercise of the Warrants. No U.S. Person or
person holding Warrants on behalf or for the account of a U.S.
Person may exercise the Warrants during any period of time when
a registration statement covering such common shares is not
effective. See Details of the Offering
Warrants.
CANADIAN
FEDERAL INCOME TAX CONSIDERATIONS
In the opinion of Counsel, the following is a general summary of
the principal Canadian federal income tax considerations
generally applicable to an investment in units pursuant to this
offering. This summary is based upon the current provisions of
the Tax Act, the regulations thereunder (the
Regulations), all specific proposals to amend
the Tax Act and the Regulations publicly announced by the
Government of Canada prior to the date hereof (the
Proposed Amendments) and Counsels
understanding of the prevailing administrative views of the
Canada Revenue Agency (the CRA). This summary
is not exhaustive of all possible Canadian federal income tax
considerations and except for the Proposed Amendments does not
otherwise take into account any changes in law, whether by
legislative, governmental or judicial action, nor does it take
into account or consider any provincial, territorial or foreign
income tax considerations. There can be no assurance that the
Proposed Amendments will be enacted in their current form or at
all.
20
This summary is applicable only to investors who acquire such
units pursuant to this offering and who for the purposes of the
Tax Act and at all relevant times will hold the common shares
and common share purchase warrants acquired under this offering
as capital property, deal at arms length, and are not
affiliated with us and do not use or hold, and are not deemed to
use or hold, their common shares and common share purchase
warrants in, or in the course of, carrying on a business in
Canada. Common shares and common share purchase warrants will
generally constitute capital property to an investor provided
that the investor does not hold such securities in the course of
carrying on a business and has not acquired such securities in a
transaction or transactions considered to be an adventure or
concern in the nature of trade. This summary does not apply to
investors who are financial institutions or
specified financial institutions for the purposes of
the Tax Act. Such investors should consult their own tax
advisors for advice.
This summary is of a general nature only and is not intended to
be, nor should it be construed to be, legal or tax advice to any
particular investor. Accordingly, all prospective investors are
urged to consult their own tax advisors with respect to their
particular circumstances.
Residents
of Canada
This portion of the summary is applicable to an investor who,
for the purposes of the Tax Act and at all relevant times, is
resident or is deemed to be resident in Canada. Certain
investors who are resident in Canada for the purposes of the Tax
Act whose common shares might not otherwise qualify as capital
property may be entitled to make an irrevocable election in
accordance with subsection 39(4) of the Tax Act to have such
common shares treated as capital property.
Allocation
of Purchase Price
For the purposes of the Tax Act, the purchase price of each unit
offered hereby must be allocated, on a reasonable basis, between
the common share and the one-half of a common share purchase
warrant acquired on the acquisition of the unit in order to
determine the respective cost of the common share and the
fractional common share purchase warrant to the investor.
Oncolytics believes that it is reasonable to allocate a nominal
value of the purchase price of each unit to the fractional
common share purchase warrant. Purchasers will be required to
allocate, on a reasonable basis, the purchase price of a unit
between the common share and the one-half of a common share
purchase warrant. However, such allocation is not binding upon
the CRA.
The portion of the purchase price of each unit allocated to the
common share and to the one-half common share purchase warrant,
respectively, will become an investors acquisition cost of
the common share and the one-half common share purchase warrant
for income tax purposes. These amounts must generally be
averaged with the adjusted cost base of all other common shares
and common share purchase warrants, respectively, held by the
investor as capital property to determine the adjusted cost base
of all such common shares and common share purchase warrants to
the investor.
Exercise
of Common Share Purchase Warrants
An investor will not realize a gain or a loss upon the exercise
of a common share purchase warrant. For the purposes of the Tax
Act, when a common share purchase warrant is exercised, the
investors adjusted cost base of the common share acquired
thereby will (subject to averaging) be the aggregate of the
investors adjusted cost base of the common share purchase
warrant and the exercise price paid on the exercise of the
common share purchase warrant.
Expiry of
Common Share Purchase Warrants
The expiry of an unexercised common share purchase warrant will
generally result in a capital loss to the investor equal to the
adjusted cost base of the common share purchase warrant
immediately prior to the expiry. The tax treatment of capital
losses is described in greater detail below under
Treatment of Capital Gains and Capital Losses.
Disposition
of Common Shares or Common Share Purchase Warrants
In general, a disposition, or a deemed disposition, of a common
share, other than to us, or a common share purchase warrant,
other than on the exercise thereof, will give rise to a capital
gain (or a capital loss) in the taxation year of the disposition
equal to the amount by which the proceeds of disposition of the
common share or common share purchase warrant, as the case may
be, net of any reasonable costs of disposition, exceed (or are
less than) the adjusted cost base of the common share or common
share purchase warrant, as the case may be, to the holder
thereof. The tax treatment of capital gains and capital losses
are described in greater detail below under Treatment of
Capital Gains and Capital Losses.
21
Treatment
of Capital Gains and Capital Losses
In the year of disposition an investor will be required to
include one-half of the amount of any capital gain (a
taxable capital gain) in income, and will be
required to deduct one-half of the amount of any capital loss
(an allowable capital loss) against taxable capital
gains realized by the investor. Allowable capital losses not
deducted in the taxation year in which they are realized may be
carried back and deducted in any of the three preceding taxation
years or carried forward and deducted in any subsequent taxation
year against taxable capital gains realized in such years, to
the extent and under the circumstances specified in the Tax Act.
A capital gain realized by an investor who is an individual
(including certain trusts) may give rise to alternative minimum
tax. A Canadian-controlled private corporation (as
defined in the Tax Act) may be liable to an additional
62/3%
refundable tax under the Tax Act on certain investment income,
including taxable capital gains.
The amount of any capital loss realized on the disposition or
deemed disposition of a common share by an investor that is a
corporation may be reduced by the amount of dividends received
or deemed to have been received by it on the common share to the
extent and in the circumstances prescribed by the Tax Act.
Similar rules may apply where an investor that is a corporation
is a member of a partnership or is beneficiary of a trust that
owns common shares and where common shares are owned by a
partnership or trust of which a partnership or trust is a
partner or beneficiary. Investors to whom these rules may be
relevant should consult their own tax advisors.
Dividends
Dividends (including deemed dividends) received on common shares
will be included in computing the investors income. On
June 29, 2006, the Government of Canada released draft
legislation which would provide for an enhanced dividend tax
credit for eligible dividends (as discussed in such draft
legislation) paid by us on common shares acquired by individuals
pursuant to this offering. In the case of an individual
investor, such dividends will generally be subject to the
gross-up and dividend tax credit rules normally applicable to
dividends received from taxable Canadian corporations. In the
case of a corporation, such dividends will generally be
deductible in computing the corporations taxable income.
An investor that is a private corporation, as
defined in the Tax Act, or any other corporation resident in
Canada and controlled by or for the benefit of an individual
(other than a trust) or a related group of individuals (other
than trusts) will generally be liable to pay a refundable tax at
the rate of
331/3%
under Part IV of the Tax Act on dividends received (or
deemed to be received) on common shares to the extent such
dividends are deductible in computing its taxable income.
Non-Residents
of Canada
This portion of the summary is applicable to an investor who,
for the purposes of the Tax Act and at all relevant times, is
not, and has never been, resident in Canada and is not, and has
never been, deemed to be resident in Canada, does not use or
hold, and is not deemed to use or hold, common shares in, or in
the course of, carrying on business in Canada, and is not an
insurer who carries on an insurance business in Canada and
elsewhere (a Non-Resident Holder).
Allocation
of the Purchase Price
A Non-Resident Holder will be required to allocate the purchase
price of each unit between the common share and the one-half of
a common share purchase warrant in the same manner described
above under Residents of Canada Allocation of
Purchase Price.
Disposition
of Common Shares and Common Share Purchase Warrants
A Non-Resident Holder will be subject to tax under the Tax Act
in respect of a disposition of common shares only to the extent
such common shares constitute taxable Canadian
property for purposes of the Tax Act and the Non-Resident
Holder is not afforded relief from such tax under an applicable
income tax treaty.
The common shares will normally not be taxable Canadian property
at a particular time provided that: (i) the common shares
are listed on a prescribed stock exchange at the particular time
(which includes the TSX); (ii) the Non-Resident Holder,
persons with whom the Non-Resident Holder does not deal at
arms length (within the meaning of the Tax Act), or the
Non-Resident Holder together with such persons, did not own 25%
or more of the issued shares of any class or series of
Oncolytics at any time during the
60-month
period preceding the particular time; and (iii) such common
shares are not otherwise deemed under the Tax Act to be taxable
Canadian property at the particular time.
22
A Non-Resident Holder will not be subject to tax under the Tax
Act on the exercise of common share purchase warrants. A
disposition of common share purchase warrants (other than on the
exercise thereof) will be subject to tax under the Tax Act only
to the extent that such common share purchase warrants
constitute taxable Canadian property for purposes of
the Tax Act and the Non-Resident Holder is not afforded relief
under an applicable income tax treaty.
The common share purchase warrants will normally not be taxable
Canadian property at a particular time provided that:
(i) the common shares are listed on a prescribed stock
exchange at the particular time (which includes the TSX);
(ii) the common share purchase warrants held by the
Non-Resident Holder, together with any other options or rights
held by the Non-Resident Holder to acquire our shares , were not
exerciseable into 25% or more of the issued shares of any class
or series of Oncolytics at any time during the
60-month
period preceding the particular time; and (iii) the
Non-Resident Holder, persons with whom the Non-Resident Holder
does not deal at arms length (within the meaning of the
Tax Act), or the Non-Resident Holder together with such persons,
did not own 25% or more of the issued shares of any class or
series of Oncolytics at any time during the
60-month
period preceding the particular time.
A Non-Resident Holder who is subject to tax under the Tax Act on
a disposition of common shares or common share purchase warrants
will generally be required to compute such gains in the same
manner described above under Residents of
Canada Disposition of Common Shares or Common Share
Purchase Warrants.
Dividends
Dividends paid or credited, or which are deemed to be paid or
credited, on the common shares will be subject to a Canadian
non-resident withholding tax of 25%, subject to reduction of
such rate under an applicable income tax treaty. For example,
Non-Resident Holders who are residents of the United States for
the purposes of the Canada-United States Tax Convention,
1980 will generally have such rate of withholding reduced to
15% (or 5% if such Non-Resident Holder owns at least 10% of the
voting stock of Oncolytics).
Non-Resident Holders should consult their tax advisors with
respect to the tax implications of acquiring shares pursuant to
this offering in their jurisdiction of residence and the
application of any bilateral income tax treaty between Canada
and their jurisdiction of residence.
U.S.
FEDERAL INCOME TAX CONSIDERATIONS
The following is a summary of certain material anticipated U.S.
federal income tax consequences to a U.S. Holder (as defined
below) arising from and relating to the acquisition of units
purchased pursuant to this U.S. Preliminary Placement
Memorandum, the exercise, disposition, and lapse of warrants
acquired through such units, and the acquisition, ownership, and
disposition of common shares acquired through such units.
This summary is for general information purposes only and does
not purport to be a complete analysis or listing of all
potential U.S. federal income tax consequences that may apply to
a U.S. Holder as a result of the acquisition of units purchased
pursuant to this U.S. Preliminary Placement Memorandum, the
exercise, disposition, and lapse of warrants, or the
acquisition, ownership, and disposition of common shares. In
addition, this summary does not take into account the individual
facts and circumstances of any particular U.S. Holder that may
affect the U.S. federal income tax consequences to such U.S.
Holder. Accordingly, this summary is not intended to be, and
should not be construed as, legal or U.S. federal income tax
advice with respect to any U.S. Holder. Each U.S. Holder should
consult its own financial advisor, legal counsel, or accountant
regarding the U.S. federal income, U.S. state and local, and
foreign tax consequences of the acquisition of units purchased
pursuant to this U.S. Preliminary Placement Memorandum, the
exercise, disposition, and lapse of warrants, and the
acquisition, ownership, and disposition of common shares.
No legal opinion from U.S. legal counsel or ruling from the
Internal Revenue Service (the IRS) has been
requested, or will be obtained, regarding the U.S. federal
income tax consequences of the acquisition of units purchased
pursuant to this U.S. Preliminary Placement Memorandum, the
exercise, disposition, and lapse of warrants, or the
acquisition, ownership, and disposition of common shares. This
summary is not binding on the IRS, and the IRS is not precluded
from taking a position that is different from, and contrary to,
the positions taken in this summary. In addition, because the
authorities on which this summary is based are subject to
various interpretations, the IRS and the U.S. courts could
disagree with one or more of the positions taken in this summary.
23
Notice Pursuant To IRS Circular 230: Anything
contained in this summary concerning any U.S. federal tax issue
is not intended or written to be used, and it cannot be used by
a U.S. Holder, for the purpose of avoiding federal tax penalties
under the Internal Revenue Code. This summary was written to
support the promotion or marketing of the transactions or
matters addressed by this U.S. Preliminary Placement Memorandum.
Each U.S. Holder should seek U.S. federal tax advice, based on
such U.S. Holders particular circumstances, from an
independent tax advisor.
Scope of
this Summary
Authorities
This summary is based on the Internal Revenue Code of 1986, as
amended (the Code), Treasury Regulations
(whether final, temporary, or proposed), published rulings of
the IRS, published administrative positions of the IRS, the
Convention Between Canada and the United States of America with
Respect to Taxes on Income and on Capital, signed
September 26, 1980, as amended (the Canada-U.S.
Tax Convention), and U.S. court decisions that are
applicable and, in each case, as in effect and available, as of
the date of this U.S. Preliminary Placement Memorandum. Any of
the authorities on which this summary is based could be changed
in a material and adverse manner at any time, and any such
change could be applied on a retroactive basis. This summary
does not discuss the potential effects, whether adverse or
beneficial, of any proposed legislation that, if enacted, could
be applied on a retroactive basis.
U.S.
Holders
For purposes of this summary, a U.S. Holder is a
beneficial owner of units, warrants, or common shares acquired
through such units, as the case may be, that, for U.S. federal
income tax purposes, is (a) an individual who is a citizen
or resident of the U.S., (b) a corporation, or any other
entity classified as a corporation for U.S. federal income tax
purposes, that is created or organized in or under the laws of
the U.S., any state in the U.S., or the District of Columbia,
(c) an estate if the income of such estate is subject to
U.S. federal income tax regardless of the source of such income,
or (d) a trust if (i) such trust has validly elected
to be treated as a U.S. person for U.S. federal income tax
purposes or (ii) a U.S. court is able to exercise primary
supervision over the administration of such trust and one or
more U.S. persons have the authority to control all substantial
decisions of such trust.
Non-U.S.
Holders
For purposes of this summary, a non-U.S. Holder is a
beneficial owner of units, warrants, or common shares other than
a U.S. Holder. This summary does not address the U.S. federal
income tax consequences to non-U.S. Holders of the acquisition
of units purchased pursuant to this U.S. Preliminary Placement
Memorandum, the exercise, disposition, and lapse of warrants, or
the acquisition, ownership, and disposition of common shares.
Accordingly, a non-U.S. Holder should consult its own financial
advisor, legal counsel, or accountant regarding the U.S. federal
income, U.S. state and local, and foreign tax consequences
(including the potential application of and operation of any
income tax treaties) of the acquisition of units purchased
pursuant to this U.S. Preliminary Placement Memorandum, the
exercise, disposition, and lapse of warrants, and the
acquisition, ownership, and disposition of common shares.
U.S.
Holders Subject to Special U.S. Federal Income Tax
Rules Not Addressed
This summary does not address the U.S. federal income tax
consequences applicable to U.S. Holders that are subject to
special provisions under the Code, including the following U.S.
Holders: (a) U.S. Holders that are tax-exempt
organizations, qualified retirement plans, individual retirement
accounts, or other tax-deferred accounts; (b) U.S. Holders
that are financial institutions, insurance companies, real
estate investment trusts, or regulated investment companies;
(c) U.S. Holders that are dealers in securities or
currencies or U.S. Holders that are traders in securities that
elect to apply a
mark-to-market
accounting method; (d) U.S. Holders that have a
functional currency other than the U.S. dollar;
(e) U.S. Holders that are liable for the alternative
minimum tax under the Code; (f) U.S. Holders that own
units, warrants, or common shares as part of a straddle, hedging
transaction, conversion transaction, constructive sale, or other
arrangement involving more than one position; (g) U.S.
Holders that acquired units, warrants, or common shares in
connection with the exercise of employee stock options or
otherwise as compensation for services; (h) U.S. Holders
that hold units, warrants, or common shares other than as a
capital asset within the meaning of Section 1221 of the
Code; or (i) U.S. Holders that own (directly, indirectly,
or constructively) 10% or more of the total combined voting
power of the outstanding shares of the Corporation.
U.S. Holders that are subject to special provisions under
the Code, including
24
U.S. Holders described immediately above, should consult
their own financial advisor, legal counsel or accountant
regarding the U.S. federal income tax consequences of the
acquisition of units purchased pursuant to this U.S. Preliminary
Placement Memorandum, the exercise, disposition, and lapse of
warrants, and the acquisition, ownership, and disposition of
common shares.
If an entity that is classified as a partnership for U.S.
federal income tax purposes holds units, warrants, or common
shares, the U.S. federal income tax consequences to such
partnership and the partners of such partnership generally will
depend on the activities of the partnership and the status of
such partners. Partners of entities that are classified as
partnerships for U.S. federal income tax purposes should consult
their own financial advisor, legal counsel or accountant
regarding the U.S. federal income tax consequences of the
acquisition of units purchased pursuant to this U.S. Preliminary
Placement Memorandum, the exercise, disposition, and lapse of
warrants, and the acquisition, ownership, and disposition of
common shares.
Tax
Consequences Other than U.S. Federal Income Tax Consequences Not
Addressed
This summary does not address the U.S. state and local, U.S.
federal estate and gift, or foreign tax consequences to
U.S. Holders of the acquisition of units purchased pursuant
to this U.S. Preliminary Placement Memorandum, the exercise,
disposition, and lapse of warrants, or the acquisition,
ownership, and disposition of common shares. Each
U.S. Holder should consult its own financial advisor, legal
counsel, or accountant regarding the U.S. state and
local, U.S. federal estate and gift, and foreign tax
consequences of the acquisition of units purchased pursuant to
this U.S. Preliminary Placement Memorandum, the exercise,
disposition, and lapse of warrants, and the acquisition,
ownership, and disposition of common shares.
U.S.
Federal Income Tax Consequences of the Acquisition of
Units
For U.S. federal income tax purposes, the acquisition of a unit
by a U.S. Holder will be treated as the acquisition of an
investment unit consisting of two components: one
common share and one-half of one warrant. The purchase price for
each unit will be allocated between these two components in
proportion to their relative fair market values on the date that
the unit is purchased by the U.S. Holder. This allocation of the
purchase price for each unit will establish a U.S. Holders
initial tax basis in the common share and the one-half of one
warrant that comprise each unit for U.S. federal income tax
purposes.
For this purpose, the Corporation will allocate U.S.$2.09 of the
purchase price for each unit to the common share and U.S.$0.45
of the purchase price for each unit to the one-half of one
warrant. The IRS will not be bound by the Corporations
allocation of the purchase price for each unit between the
common share and the one-half of one warrant, and accordingly,
the IRS may allocate the purchase price for each unit between
the common share and the one-half of one warrant in a manner
that is different than the allocation set forth above. Each U.S.
Holder should consult its own financial advisor, legal counsel,
or accountant regarding the allocation of the purchase price for
each unit between the common share and the one-half of one
warrant.
U.S.
Federal Income Tax Consequences of the Exercise and Disposition
of Warrants
Exercise
of Warrants
A U.S. Holder should not recognize gain or loss on the exercise
of a warrant and related receipt of a common share (except if
cash is received in lieu of the issuance of a fractional common
share). A U.S. Holders initial tax basis in the common
share received on the exercise of a warrant should be equal to
the sum of (a) such U.S. Holders tax basis in such
warrant plus (b) the exercise price paid by such U.S.
Holder on the exercise of such warrant. A U.S. Holders
holding period for the common share received on the exercise of
a warrant should begin on the date that such warrant is
exercised by such U.S. Holder.
Disposition
of Warrants
A U.S. Holder will recognize gain or loss on the sale or other
taxable disposition of a warrant in an amount equal to the
difference, if any, between (a) the amount of cash plus the
fair market value of any property received and (b) such
U.S. Holders tax basis in the warrant sold or
otherwise disposed of. Subject to the passive foreign
investment company rules discussed below, any such gain or
loss generally will be a capital gain or loss (provided that the
common share to be issued on the exercise of such warrant would
have been a capital asset within the meaning of
Section 1221 of the Code if acquired by the U.S. Holder),
which will be long-term capital gain or loss if the warrant is
held for more than one year.
25
Expiration
of Warrants Without Exercise
Upon the lapse or expiration of a warrant, a U.S. Holder
will recognize a loss in an amount equal to such
U.S. Holders tax basis in the warrant. Any such loss
generally will be a capital loss (provided that the common share
to be issued on the exercise of such warrant would have been a
capital asset if acquired by the U.S. Holder). Any such capital
loss will be short-term capital loss or long-term capital loss,
depending on whether the warrants are held for more than one
year. Deductions for capital losses are subject to complex
limitations under the Code.
Certain
Adjustments to the Warrants
Under Section 305 of the Code, an adjustment to the number
of common shares that will be issued on the exercise of the
warrants, or an adjustment to the exercise price of the
warrants, may be treated as a constructive distribution to a
U.S. Holder of the warrants if, and to the extent that,
such adjustment has the effect of increasing such
U.S. Holders proportionate interest in the
earnings and profits or assets of the Corporation,
depending on the circumstances of such adjustment (for example,
if such adjustment is to compensate for a distribution of cash
or other property to shareholders of the Corporation). (See more
detailed discussion of the rules applicable to distributions
made by the Corporation at Distributions on Common
Shares below).
U.S.
Federal Income Tax Consequences of the Acquisition, Ownership,
and Disposition of Common Shares
Distributions
on Common Shares
General
Taxation of Distributions
Subject to the passive foreign investment company
rules discussed below, a U.S. Holder that receives a
distribution, including a constructive distribution, with
respect to the common shares will be required to include the
amount of such distribution in gross income as a dividend
(without reduction for any Canadian income tax withheld from
such distribution) to the extent of the current or accumulated
earnings and profits of the Corporation. To the
extent that a distribution exceeds the current and accumulated
earnings and profits of the Corporation, such
distribution will be treated (a) first, as a tax-free
return of capital to the extent of a U.S. Holders tax
basis in the common shares and, (b) thereafter, as gain
from the sale or exchange of such common shares. (See more
detailed discussion at Disposition of Common Shares
below). Dividends paid on the common shares generally will not
be eligible for the dividends received deduction.
Reduced
Tax Rates for Certain Dividends
For taxable years beginning before January 1, 2011, a
dividend paid by the Corporation generally will be taxed at the
preferential tax rates applicable to long-term capital gains if
(a) the Corporation is a qualified foreign
corporation (as defined below), (b) the U.S. Holder
receiving such dividend is an individual, estate, or trust, and
(c) such dividend is paid on common shares that have been
held by such U.S. Holder for at least 61 days during the
121-day
period beginning 60 days before the ex-dividend
date.
The Corporation generally will be a qualified foreign
corporation under Section 1(h)(11) of the Code (a
QFC) if (a) the Corporation is eligible
for the benefits of the Canada-U.S. Tax Convention, or
(b) the common shares are readily tradable on an
established securities market in the U.S. However, even if the
Corporation satisfies one or more of such requirements, the
Corporation will not be treated as a QFC if the Corporation is a
passive foreign investment company (as defined
below) for the taxable year during which the Corporation pays a
dividend or for the preceding taxable year.
As discussed below, the Corporation anticipates that it may
qualify as a passive foreign investment company for
the taxable year ending December 31, 2007 and subsequent
taxable years, depending on the assets and income of the
Corporation over the course of the taxable year ending
December 31, 2007. (See more detailed discussion at
Additional Rules that May Apply to U.S.
Holders Passive Foreign Investment Corporation
below). Accordingly, there can be no assurances that the
Corporation will be a QFC for the current or any future taxable
year or that the Corporation will be able to certify that it is
a QFC in accordance with the certification procedures issued by
the Treasury and the IRS.
If the Corporation is not a QFC, a dividend paid by the
Corporation to a U.S. Holder, including a U.S. Holder that is an
individual, estate, or trust, generally will be taxed at
ordinary income tax rates (and not at the preferential tax rates
applicable to long-term capital gains). The dividend rules are
complex, and each U.S. Holder should consult its own financial
advisor, legal counsel, or accountant regarding the dividend
rules.
26
Distributions
Paid in Foreign Currency
The amount of a distribution paid to a U.S. Holder in foreign
currency generally will be equal to the U.S. dollar value of
such distribution based on the exchange rate applicable on the
date of receipt. A U.S. Holder that does not convert foreign
currency received as a distribution into U.S. dollars on the
date of receipt generally will have a tax basis in such foreign
currency equal to the U.S. dollar value of such foreign currency
on the date of receipt. Such a U.S. Holder generally will
recognize ordinary income or loss on the subsequent sale or
other taxable disposition of such foreign currency (including an
exchange for U.S. dollars).
Disposition
of Common Shares
A U.S. Holder will recognize gain or loss on the sale or other
taxable disposition of common shares in an amount equal to the
difference, if any, between (a) the amount of cash plus the
fair market value of any property received and (b) such
U.S. Holders tax basis in the common shares sold or
otherwise disposed of. Subject to the passive foreign
investment company rules discussed below, any such gain or
loss generally will be capital gain or loss, which will be
long-term capital gain or loss if the common shares are held for
more than one year. Gain or loss recognized by a
U.S. Holder on the sale or other taxable disposition of
common shares generally will be treated as U.S.
source for purposes of applying the U.S. foreign tax
credit rules. (See more detailed discussion at Foreign Tax
Credit below).
Preferential tax rates apply to long-term capital gains of a
U.S. Holder that is an individual, estate, or trust. There are
currently no preferential tax rates for long-term capital gains
of a U.S. Holder that is a corporation. Deductions for capital
losses are subject to significant limitations under the Code.
Foreign
Tax Credit
A U.S. Holder that pays (whether directly or through
withholding) Canadian income tax with respect to dividends
received on the common shares generally will be entitled, at the
election of such U.S. Holder, to receive either a deduction or a
credit for such Canadian income tax paid. Generally, a credit
will reduce a U.S. Holders U.S. federal income tax
liability on a
dollar-for-dollar
basis, whereas a deduction will reduce a U.S. Holders
income subject to U.S. federal income tax. This election is made
on a
year-by-year
basis and applies to all foreign taxes paid (whether directly or
through withholding) by a U.S. Holder during a taxable year.
Complex limitations apply to the foreign tax credit, including
the general limitation that the credit cannot exceed the
proportionate share of a U.S. Holders U.S. federal income
tax liability that such U.S. Holders foreign
source taxable income bears to such U.S. Holders
worldwide taxable income. In applying this limitation, a U.S.
Holders various items of income and deduction must be
classified, under complex rules, as either foreign
source or U.S. source. In addition, this
limitation is calculated separately with respect to specific
categories of income. Dividends received on the common shares
generally will constitute foreign source income and
generally will be categorized as passive income. The
foreign tax credit rules are complex, and each U.S. Holder
should consult its own financial advisor, legal counsel, or
accountant regarding the foreign tax credit rules.
Information
Reporting; Backup Withholding Tax
Payments made within the U.S., or by a U.S. payor or U.S.
middleman, of dividends on, or proceeds arising from the sale or
other taxable disposition of, common shares generally will be
subject to information reporting and backup withholding tax, at
the rate of 28%, if a U.S. Holder (a) fails to furnish such
U.S. Holders correct U.S. taxpayer identification number
(generally on
Form W-9),
(b) furnishes an incorrect U.S. taxpayer identification
number, (c) is notified by the IRS that such U.S. Holder
has previously failed to properly report items subject to backup
withholding tax, or (d) fails to certify, under penalty of
perjury, that such U.S. Holder has furnished its correct
U.S. taxpayer identification number and that the IRS has
not notified such U.S. Holder that it is subject to backup
withholding tax. However, U.S. Holders that are
corporations generally are excluded from these information
reporting and backup withholding tax rules. Any amounts withheld
under the U.S. backup withholding tax rules will be allowed as a
credit against a U.S. Holders U.S. federal
income tax liability, if any, or will be refunded, if such U.S.
Holder furnishes required information to the IRS. Each U.S.
Holder should consult its own financial advisor, legal counsel,
or accountant regarding the information reporting and backup
withholding tax rules.
27
Information
Filing Required by Certain U.S. Holders
A U.S. Holder may be required to file Form 926 with the IRS
if (a) immediately after acquiring the units pursuant to
this U.S. Preliminary Placement Memorandum, such U.S. Holder
owns, directly or indirectly, at least 10% of the total voting
power or the total value of the outstanding shares of the
Corporation or (b) the purchase price of the units, when
aggregated with all other transfers of cash by such U.S. Holder
(or any person related to such U.S. Holder) to the Corporation
within the preceding 12 month period, exceeds U.S.$100,000.
A U.S. Holder that fails to properly and timely file
Form 926 with the IRS generally will be subject to a
penalty equal to 10% of the purchase price for the units
(subject to a maximum penalty of U.S.$100,000, unless the
failure to file is due to intentional disregard). Each U.S.
Holder should consult its own financial advisor, legal counsel,
or accountant regarding the information reporting requirements
that may apply with respect to the acquisition of the units.
Additional
Rules that May Apply to U.S. Holders
If the Corporation is a passive foreign investment
company (as defined below), the preceding sections of this
summary may not describe the U.S. federal income tax
consequences to U.S. Holders of the acquisition, ownership, and
disposition of common shares.
Passive
Foreign Investment Corporation
The Corporation generally will be a passive foreign
investment company under Section 1297 of the Code (a
PFIC) if, for a taxable year, (a) 75% or
more of the gross income of the Corporation for such taxable
year is passive income or (b) on average, 50% or more of
the assets held by the Corporation either produce passive income
or are held for the production of passive income, based on the
fair market value of such assets (or on the adjusted tax basis
of such assets, if the Corporation is not publicly traded and
either is a controlled foreign corporation or makes
an election). Passive income includes, for example,
dividends, interest, certain rents and royalties, certain gains
from the sale of stock and securities, and certain gains from
commodities transactions. Active business gains arising from the
sale of commodities generally are excluded from passive income
if substantially all of a foreign corporations commodities
are (a) stock in trade of such foreign corporation or other
property of a kind which would properly be included in inventory
of such foreign corporation, or property held by such foreign
corporation primarily for sale to customers in the ordinary
course of business, (b) property used in the trade or
business of such foreign corporation that would be subject to
the allowance for depreciation under Section 167 of the
Code, or (c) supplies of a type regularly used or consumed
by such foreign corporation in the ordinary course of its trade
or business.
For purposes of the PFIC income test and asset test described
above, if the Corporation owns, directly or indirectly, 25% or
more of the total value of the outstanding shares of another
corporation, the Corporation will be treated as if it
(a) held a proportionate share of the assets of such other
corporation and (b) received directly a proportionate share
of the income of such other corporation. In addition, for
purposes of the PFIC income test and asset test described above,
passive income does not include any interest,
dividends, rents, or royalties that are received or accrued by
the Corporation from a related person (as defined in
Section 954(d)(3) of the Code), to the extent such items
are properly allocable to the income of such related person that
is not passive income.
In addition, if the Corporation is a PFIC and owns shares of
another foreign corporation that also is a PFIC, under certain
indirect ownership rules, a disposition of the shares of such
other foreign corporation or a distribution received from such
other foreign corporation generally will be treated as an
indirect disposition by a U.S. Holder or an indirect
distribution received by a U.S. Holder, subject to the rules of
Section 1291 of the Code discussed below. To the extent
that gain recognized on the actual disposition by a U.S. Holder
of the common shares or income recognized by a U.S. Holder on an
actual distribution received on the common shares was previously
subject to U.S. federal income tax under these indirect
ownership rules, such amount generally should not be subject to
U.S. federal income tax.
The Corporation anticipates that it may qualify as a PFIC for
the taxable year ending December 31, 2007 and for
subsequent taxable years. Whether the Corporation will, in fact,
qualify as a PFIC for the taxable year ending December 31,
2007 will depend on the assets and income of the Corporation
over the course of the taxable year ending December 31,
2007 and, as a result, cannot be predicted with certainty as of
the date of this U.S. Preliminary Private Placement Memorandum.
Each U.S. Holder should consult its own financial advisor, legal
counsel, or accountant regarding whether the Corporation will
qualify as a PFIC for the taxable year ending December 31,
2007 and in subsequent taxable years.
28
Default
PFIC Rules Under Section 1291 of the
Code
If the Corporation is a PFIC, the U.S. federal income tax
consequences to a U.S. Holder of the acquisition, ownership, and
disposition of common shares will depend on whether such U.S.
Holder makes an election to treat the Corporation as a
qualified electing fund or QEF under
Section 1295 of the Code (a QEF
Election) or a
mark-to-market
election under Section 1296 of the Code (a
Mark-to-Market
Election). A U.S. Holder that does not make either a
QEF Election or a
Mark-to-Market
Election will be referred to in this summary as a
Non-Electing U.S. Holder.
A Non-Electing U.S. Holder will be subject to the rules of
Section 1291 of the Code with respect to (a) any gain
recognized on the sale or other taxable disposition of common
shares and (b) any excess distribution paid on the common
shares. A distribution generally will be an excess
distribution to the extent that such distribution
(together with all other distributions received in the current
taxable year) exceeds 125% of the average distributions received
during the three preceding taxable years (or during a U.S.
Holders holding period for the common shares, if shorter).
Under Section 1291 of the Code, any gain recognized on the
sale or other taxable disposition of common shares, and any
excess distribution paid on the common shares, must be ratably
allocated to each day in a Non-Electing U.S. Holders
holding period for the common shares. The amount of any such
gain or excess distribution allocated to prior years of such
Non-Electing U.S. Holders holding period for the common
shares (other than years prior to the first taxable year of the
Corporation beginning after December 31, 1986 for which the
Corporation was not a PFIC) will be subject to U.S. federal
income tax at the highest tax applicable to ordinary income in
each such prior year. A Non-Electing U.S. Holder will be
required to pay interest on the resulting tax liability for each
such prior year, calculated as if such tax liability had been
due in each such prior year. Such a Non-Electing U.S. Holder
that is not a corporation must treat any such interest paid as
personal interest, which is not deductible. The
amount of any such gain or excess distribution allocated to the
current year of such Non-Electing U.S. Holders holding
period for the common shares will be treated as ordinary income
in the current year, and no interest charge will be incurred
with respect to the resulting tax liability for the current year.
If the Corporation is a PFIC for any taxable year during which a
Non-Electing U.S. Holder holds common shares, the Corporation
will continue to be treated as a PFIC with respect to such
Non-Electing U.S. Holder, regardless of whether the Corporation
ceases to be a PFIC in one or more subsequent years. A
Non-Electing U.S. Holder may terminate this deemed PFIC status
by electing to recognize gain (which will be taxed under the
rules of Section 1291 of the Code discussed above) as if
such common shares were sold on the last day of the last taxable
year for which the Corporation was a PFIC.
QEF
Election
A U.S. Holder that makes a QEF Election generally will not be
subject to the rules of Section 1291 of the Code discussed
above. However, a U.S. Holder that makes a QEF Election will be
subject to U.S. federal income tax on such U.S. Holders
pro rata share of (a) the net capital gain of the
Corporation, which will be taxed as long-term capital gain to
such U.S. Holder, and (b) the ordinary earnings of the
Corporation, which will be taxed as ordinary income to such U.S.
Holder. Generally, net capital gain is the excess of
(a) net long-term capital gain over (b) net short-term
capital loss, and ordinary earnings are the excess
of (a) earnings and profits over (b) net
capital gain. A U.S. Holder that makes a QEF Election will be
subject to U.S. federal income tax on such amounts for each
taxable year in which the Corporation is a PFIC, regardless of
whether such amounts are actually distributed to such U.S.
Holder by the Corporation. However, a U.S. Holder that makes a
QEF Election may, subject to certain limitations, elect to defer
payment of current U.S. federal income tax on such amounts,
subject to an interest charge. If such U.S. Holder is not a
corporation, any such interest paid will be treated as
personal interest, which is not deductible.
A U.S. Holder that makes a QEF Election generally (a) may
receive a tax-free distribution from the Corporation to the
extent that such distribution represents earnings and
profits of the Corporation that were previously included
in income by the U.S. Holder because of such QEF Election and
(b) will adjust such U.S. Holders tax basis in the
common shares to reflect the amount included in income or
allowed as a tax-free distribution because of such QEF Election.
In addition, a U.S. Holder that makes a QEF Election generally
will recognize capital gain or loss on the sale or other taxable
disposition of common shares.
The procedure for making a QEF Election, and the U.S. federal
income tax consequences of making a QEF Election, will depend on
whether such QEF Election is timely. A QEF Election will be
treated as timely if such QEF Election is made for
the first year in the U.S. Holders holding period for the
common shares in which the Corporation was a PFIC.
29
A U.S. Holder may make a timely QEF Election by filing the
appropriate QEF Election documents at the time such
U.S. Holder files a U.S. federal income tax return for such
first year. However, if the Corporation was a PFIC in a prior
year, then in addition to filing the QEF Election documents, a
U.S. Holder must elect to recognize (a) gain (which will be
taxed under the rules of Section 1291 of the Code discussed
above) as if the common shares were sold on the qualification
date or (b) if the Corporation was also a CFC, such U.S.
Holders pro rata share of the post-1986 earnings and
profits of the Corporation as of the qualification date.
The qualification date is the first day of the first
taxable year in which the Corporation was a QEF with respect to
such U.S. Holder. The election to recognize such gain or
earnings and profits can only be made if such U.S.
Holders holding period for the common shares includes the
qualification date. By electing to recognize such gain or
earnings and profits, such U.S. Holder will be
deemed to have made a timely QEF Election. In addition, under
very limited circumstances, a U.S. Holder may make a retroactive
QEF Election if such U.S. Holder failed to file the QEF Election
documents in a timely manner.
A QEF Election will apply to the taxable year for which such QEF
Election is made and to all subsequent taxable years, unless
such QEF Election is invalidated or terminated or the IRS
consents to revocation of such QEF Election. If a U.S. Holder
makes a QEF Election and, in a subsequent taxable year, the
Corporation ceases to be a PFIC, the QEF Election will
remain in effect (although it will not be applicable) during
those taxable years in which the Corporation is not a PFIC.
Accordingly, if the Corporation becomes a PFIC in another
subsequent taxable year, the QEF Election will be effective and
the U.S. Holder will be subject to the QEF rules described above
during any such subsequent taxable year in which the Corporation
qualifies as a PFIC. In addition, the QEF Election will remain
in effect (although it will not be applicable) with respect to a
U.S. Holder even after such U.S. Holder disposes of all of such
U.S. Holders direct and indirect interest in the common
shares. Accordingly, if such U.S. Holder reacquires an interest
in the Corporation, such U.S. Holder will be subject to the QEF
rules described above for each taxable year in which the
Corporation is a PFIC.
Each U.S. Holder should consult its own financial advisor, legal
counsel, or accountant regarding the availability of, and
procedure for making, a QEF Election. The Corporation will make
available to U.S. Holders, upon their request, timely and
accurate information as to its status as a PFIC and will use
commercially reasonable efforts to provide to a purchaser
acquiring common shares pursuant to this Private Placement
Memorandum that is a U.S. Holder all information that a U.S.
Holder making a QEF Election is required to obtain for U.S.
federal income tax purposes.
Under applicable Treasury Regulations, a person that holds an
option, warrant, or other right to acquire shares of a PFIC may
not make a QEF Election that will apply to either (a) the
option, warrant, or other right or (b) the shares of the
PFIC subject to the option, warrant, or other right. In
addition, under Treasury Regulations, if a person holds an
option, warrant, or other right to acquire shares of a PFIC, the
holding period with respect to the shares of the PFIC acquired
on the exercise of such option, warrant, or other right will
include the period that the option, warrant, or other right was
held.
Accordingly, a U.S. Holder of the warrants may not make a QEF
Election that will apply to either the warrants or the common
shares subject to the warrants. The general effect of these
special rules is that (a) excess distributions paid on
common shares acquired on exercise of the warrants, and gains
recognized on the sale or other taxable disposition of common
shares acquired on exercise of the warrants, will be spread over
a U.S. Holders entire holding period for such warrants and
common shares (pursuant to the rules of Section 1291 of the
Code discussed above) and (b) if a U.S. Holder makes a QEF
Election on the exercise of the warrants and receipt of the
common shares, that election generally will not be a timely QEF
Election with respect to such common shares (and the rules of
Section 1291 of the Code discussed above will continue to
apply). It appears, however, that a U.S. Holder receiving common
shares on the exercise of the warrants should be eligible to
make an effective QEF Election as of the first day of the
taxable year of such U.S. Holder beginning after the receipt of
such common shares if such U.S. Holder also makes an election to
recognize gain (which will be taxed under the rules of
Section 1291 of the Code discussed above) as if such common
shares were sold on such date at fair market value. In addition,
gain recognized on the sale or other taxable disposition (other
than by exercise) of the warrants by a U.S. Holder will be
subject to the rules of Section 1291 of the Code discussed
above. Each U.S. Holder should consult its own financial
advisor, legal counsel, or accountant regarding the application
of the PFIC rules to the warrants and the common shares.
received on exercise of the warrants.
Mark-to-Market
Election
A U.S. Holder may make a
Mark-to-Market
Election only if the common shares are marketable stock. The
common shares generally will be marketable stock if
the common shares are regularly traded on a qualified exchange
or other market. For this purpose, a qualified exchange or
other market includes (a) a national securities
exchange that is
30
registered with the Securities and Exchange Commission,
(b) the national market system established pursuant to
section 11A of the Securities and Exchange Act of 1934, or
(c) a foreign securities exchange that is regulated or
supervised by a governmental authority of the country in which
the market is located, provided that (i) such foreign
exchange has trading volume, listing, financial disclosure,
surveillance, and other requirements designed to prevent
fraudulent and manipulative acts and practices, remove
impediments to and perfect the mechanism of a free, open, fair,
and orderly market, and protect investors (and the laws of the
country in which the foreign exchange is located and the rules
of the foreign exchange ensure that such requirements are
actually enforced) and (ii) the rules of such foreign
exchange effectively promote active trading of listed stocks. If
the common shares are traded on such a qualified exchange or
other market, the common shares generally will be
regularly traded for any calendar year during which
the common shares are traded, other than in de minimis
quantities, on at least 15 days during each calendar
quarter.
A U.S. Holder that makes a
Mark-to-Market
Election generally will not be subject to the rules of
Section 1291 of the Code discussed above. However, if a
U.S. Holder makes a
Mark-to-Market
Election after the beginning of such U.S. Holders
holding period for the common shares and such U.S. Holder has
not made a timely QEF Election, the rules of Section 1291
of the Code discussed above will apply to certain dispositions
of, and distributions on, the common shares.
A U.S. Holder that makes a
Mark-to-Market
Election will include in ordinary income, for each taxable year
in which the Corporation is a PFIC, an amount equal to the
excess, if any, of (a) the fair market value of the common
shares as of the close of such taxable year over (b) such
U.S. Holders adjusted tax basis in such common shares. A
U.S. Holder that makes a
Mark-to-Market
Election will be allowed a deduction in an amount equal to the
lesser of (a) the excess, if any, of (i) such U.S.
Holders adjusted tax basis in the common shares over
(ii) the fair market value of such common shares as of the
close of such taxable year or (b) the excess, if any, of
(i) the amount included in ordinary income because of such
Mark-to-Market
Election for prior taxable years over (ii) the amount
allowed as a deduction because of such
Mark-to-Market
Election for prior taxable years.
A U.S. Holder that makes a
Mark-to-Market
Election generally also will adjust such U.S. Holders tax
basis in the common shares to reflect the amount included in
gross income or allowed as a deduction because of such
Mark-to-Market Election. In addition, upon a sale or other
taxable disposition of common shares, a U.S. Holder that makes a
Mark-to-Market
Election will recognize ordinary income or loss (not to exceed
the excess, if any, of (a) the amount included in ordinary
income because of such
Mark-to-Market
Election for prior taxable years over (b) the amount
allowed as a deduction because of such
Mark-to-Market
Election for prior taxable years).
A
Mark-to-Market
Election applies to the taxable year in which such
Mark-to-Market
Election is made and to each subsequent taxable year, unless the
common shares cease to be marketable stock or the
IRS consents to revocation of such election. Each U.S. Holder
should consult its own financial advisor, legal counsel, or
accountant regarding the availability of, and procedure for
making, a
Mark-to-Market
Election.
Other
PFIC Rules
Under Section 1291(f) of the Code, the IRS has issued
proposed Treasury Regulations that, subject to certain
exceptions, would cause a U.S. Holder that had not made a timely
QEF Election to recognize gain (but not loss) upon certain
transfers of common shares that would otherwise be tax-deferred
(e.g., gifts and exchanges pursuant to corporate
reorganizations). However, the specific U.S. federal income tax
consequences to a U.S. Holder may vary based on the manner in
which common shares are transferred.
Certain additional adverse rules will apply with respect to a
U.S. Holder if the Corporation is a PFIC, regardless of whether
such U.S. Holder makes a QEF Election. For example under
Section 1298(b)(6) of the Code, a U.S. Holder that uses
common shares as security for a loan will, except as may be
provided in Treasury Regulations, be treated as having made a
taxable disposition of such common shares.
The PFIC rules are complex, and each U.S. Holder should consult
its own financial advisor, legal counsel, or accountant
regarding the PFIC rules and how the PFIC rules may affect the
U.S. federal income tax consequences of the acquisition,
ownership, and disposition of common shares.
31
LEGAL
MATTERS
Certain legal matters relating to the securities offered hereby
will be passed upon on behalf of us by Bennett Jones LLP and
Dorsey & Whitney LLP and on behalf of the underwriter
by Fasken Martineau DuMoulin LLP and White & Case LLP.
The partners and associates of each of Bennett Jones LLP and
Fasken Martineau DuMoulin LLP, as a group, beneficially own,
directly or indirectly, less than 1% of our securities.
LEGAL
PROCEEDINGS
We are not involved in or aware of any present or pending legal
proceedings against us involving us jointly or separately as a
party.
AUDITORS,
TRANSFER AGENT AND REGISTRAR
Our auditors are Ernst & Young LLP, Chartered
Accountants, 1000, 440-2nd Avenue S.W., Calgary, Alberta
T2P 5E9.
The transfer agent and registrar for our common shares is
Computershare Trust Company of Canada at its principal
offices in the cities of Calgary, Alberta and Toronto, Ontario.
STATUTORY
RIGHTS OF WITHDRAWAL AND RESCISSION
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
and any amendment. In several of the provinces, securities
legislation further provides a purchaser with remedies for
rescission or, in some jurisdictions, damages if the prospectus
and any amendment contains a misrepresentation or is 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 of 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 adviser.
32
AUDITORS
CONSENT
We consent to the use of our report dated February 8, 2006
to the shareholders of Oncolytics Biotech Inc.
(Oncolytics) incorporated by reference in the short
form prospectus dated
February l ,
2007 of Oncolytics relating to the sale and issuance of
4,000,000 units.
|
|
Calgary,
Canada
|
(signed) l
|
|
|
February l ,
2007
|
Chartered
Accountants
|
33
PART II
INFORMATION NOT REQUIRED TO BE DELIVERED TO
OFFEREES OR PURCHASERS
Under the Business Corporations Act (Alberta), Oncolytics Biotech Inc. (the Corporation) may
indemnify a director or officer, a former director or officer, or a person who acts or acted at the
Corporations request as a director or officer or a body corporate of which the Corporation is or
was a shareholder or creditor, and the directors or
officers heirs and legal representatives,
against all costs, charges and expenses, including an amount paid to settle an action or satisfy a
judgment, reasonably incurred by the individual in respect of any civil, criminal or administrative
action or proceeding to which the individual is involved because of that association with the
Corporation or other entity, and the Corporation may advance moneys to such an individual for the
costs, charges and expenses of such a proceeding. The Corporation may not indemnify such an
individual unless the individual acted honestly and in good faith with a view to the best interests
of the Corporation, or, as the case may be, to the best interests of the other entity for which the
individual acted as a director or officer or in a similar capacity at the Corporations request,
and, in the case of a criminal or administrative action or proceeding that is enforced by a
monetary penalty, the individual had reasonable grounds for believing that the individuals conduct
was lawful. In addition, the individual must repay any moneys advanced by the Corporation if the
individual has not fulfilled the conditions set out in the preceding sentence. Such indemnification
or advance of moneys may be made in connection with a derivative action only with court approval.
Such an individual is entitled to indemnification from the Corporation as a matter of right if the
individual was not judged by the court or other competent authority to have committed any fault or
omitted to do anything that the individual ought to have done, and the individual fulfilled the
conditions set forth above.
In accordance with and subject to the Business Corporations Act (Alberta), the by-laws of the
Corporation provide that the Corporation shall indemnify a director or officer, a former director
or officer, or a person who acts or acted at the Corporations request as a director or officer, or
a body corporate of which the Corporation is or was a shareholder or creditor, and the directors
or officers heirs and legal representatives, against all costs, charges and expenses, including an
amount paid to settle an action or satisfy a judgment, reasonably incurred by him in respect of any
civil, criminal or administrative action or proceeding to which he is made a party by reason of
being or having been a director or officer of the Corporation or other entity if he acted honestly
and in good faith with a view to the best interests of the Corporation or, as the case may be, to
the best interests of the other entity for which he acted as a director or officer at the
Corporations request, and, in the case of a criminal or administrative action or proceeding that
is enforced by monetary penalty, he had reasonable grounds for believing that his conduct was
lawful. The Corporation shall also indemnify such person in such other circumstances as the
Business Corporations Act (Alberta) permits or requires.
The Corporation maintains a directors & officers insurance policy for the benefit of the
directors and officers of the Corporation and its subsidiaries against liability incurred by them
in their official capacities for which they become obligated to pay to the extent permitted by
applicable law.
Insofar as indemnification for liabilities arising under the U.S. Securities Act of 1933, as
amended, may be permitted to directors, officers or persons controlling the Corporation pursuant to
the foregoing provisions, the Corporation has been informed that, in the opinion of the U.S.
Securities and Exchange Commission, such indemnification is against public policy as expressed in
the Securities Act and is therefore unenforceable.
II-1
EXHIBITS
|
|
|
Exhibit |
|
|
Number |
|
Description |
|
|
|
3.1 |
|
Form of Underwriting Agreement dated as of February 6, 2007* |
|
|
|
4.1 |
|
Renewal Annual Information Form dated March 2, 2006, for the year ended December
31, 2005, incorporated by reference to the Corporations Annual Report of Form
40-F, filed with the Commission on March 3, 2006 |
|
|
|
4.2 |
|
Audited financial statements, together with the accompanying notes to the
financial statements, for the fiscal years ended December 31, 2005 and 2004 and
the auditors report thereon addressed to the Corporations shareholders,
incorporated by reference to the Corporations Annual Report on Form 40-F, filed
with the Commission on March 3, 2006 |
|
|
|
4.3 |
|
Management Proxy Circular dated March 24, 2006 relating to the annual and special
meeting of shareholders held on April 26, 2006, excluding those portions which are
not prescribed by Canadian securities law to be included in the Canadian
Prospectus, incorporated by reference to the Corporations Current Report on Form
6-K, furnished to the Commission on March 31, 2006 |
|
|
|
4.4 |
|
Managements discussion and analysis of financial condition and results of
operations dated March 2, 2006, for the year ended December 31, 2005, incorporated
by reference to the Corporations Annual Report on Form 40-F, filed with the
Commission on March 3, 2006 |
|
|
|
4.5 |
|
Unaudited interim financial statements as at September 30, 2006 and for the three
and nine months ended September 30, 2006, together with the notes thereto,
incorporated by reference to the Corporations Current Report on Form 6-K,
furnished to the Commission on November 3, 2006 |
|
|
|
4.6 |
|
Managements discussion and analysis of financial condition and results of
operations dated November 2, 2006, for the three and nine months ended September
30, 2006, incorporated by reference to the Corporations Current Report on Form
6-K, furnished to the Commission on November 3, 2006 |
|
|
|
4.7 |
|
Reconciliation of financial statements as at September 30, 2006 and for the three
and nine months ended September 30, 2006, incorporated by reference to the
Corporations Current Report on Form 6-K, furnished to the Commission on February
5, 2007 |
|
|
|
5.1 |
|
Consent of Ernst & Young LLP dated February 5, 2007 |
|
|
|
5.2 |
|
Consent of Bennett Jones LLP dated February 5, 2007 |
|
|
|
5.3 |
|
Consent of Fasken Martineau DuMoulin LLP dated February 5, 2007 |
|
|
|
6.1 |
|
Powers of Attorney (included on the signature pages of this Registration Statement) |
|
|
|
7.1 |
|
Warrant Indenture, dated as of February ___, 2007, between the Corporation and
Computershare Trust Company of Canada, as trustee* |
|
|
|
* |
|
To be filed by amendment |
II-2
PART III
UNDERTAKING AND CONSENT TO SERVICE OF PROCESS
Item 1. Undertaking
The Registrant undertakes to make available, in person or by telephone, representatives to respond
to inquiries made by the Commission staff, and to furnish promptly, when requested to do so by the
Commission staff, information relating to the securities registered pursuant to this Form F-10 or
to transactions in said securities.
Item 2. Consent to Service of Process
Concurrently with the filing of this Registration Statement on Form F-10, the Registrant is
filing with the Commission a written irrevocable consent and power of attorney on Form F-X.
Any change to the name and address of the agent for service of the Registrant will be communicated
promptly to the Commission by amendment to Form F-X referencing the file number of this
Registration Statement.
III-1
Signatures
Pursuant to the requirements of the Securities Act, the Registrant certifies that it has
reasonable grounds to believe that it meets all of the requirements for filing on Form F-10 and has
duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto
duly authorized, in the City of Calgary, Province of Alberta, Canada, on February 6, 2007.
|
|
|
|
|
|
ONCOLYTICS BIOTECH INC.
|
|
|
By: |
/s/ Bradley G. Thompson |
|
|
|
Bradley G. Thompson |
|
|
|
Chief Executive Officer |
|
|
Pursuant to the requirements of the Securities Act, this Registration Statement has been signed by
or on behalf of the following persons in the capacities indicated on February 6, 2007:
|
|
|
|
Signature |
|
Title |
|
|
|
|
/s/ Bradley G. Thompson*Bradley G. Thompson |
|
President, Chief Executive Officer and Chairman of the Board (Principal Executive Officer) |
|
|
|
/s/ Douglas A. Ball* Douglas A. Ball |
|
Chief Financial Officer and Director (Principal Financial and Accounting Officer) |
|
|
|
/s/ William A. Cochrane* William A. Cochrane |
|
Director |
|
|
|
/s/ Ger J. van Amersfoort* Ger J. van Amersfoort |
|
Director |
III-2
|
|
|
|
Signature |
|
Title |
|
|
|
|
/s/ Robert B. Schultz* Robert B. Schultz |
|
Director |
|
|
|
/s/ Fred A. Stewart* Fred A. Stewart |
|
Director |
|
|
|
/s/ Ed Levy* Ed Levy |
|
Director |
|
|
|
/s/ J. Mark Lievonen* J. Mark Lievonen |
|
Director |
|
|
|
/s/ Jim Dinning* Jim Dinning |
|
Director |
|
|
|
By:
/s/ Douglas A. Ball*
Douglas A. Ball |
|
|
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 February 5, 2007.
III-3
Authorized representative
Pursuant to the requirements of Section 6(a) of the Securities Act of 1933, the Authorized
Representative has signed this Registration Statement, solely in his capacity as the duly
authorized representative of Oncolytics Biotech Inc. in the United States, in the State of
California, on February 6, 2007.
|
|
|
|
|
|
|
|
|
By:
|
|
|
|
|
|
/s/ Karl Mettinger |
|
|
|
Name: |
Karl Mettinger |
|
|
|
Title: |
Chief Medical Officer |
|
|
III-4