6-k
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.
20549
Form 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
For the month of
July 2005
Commission File Number 000-31062
Oncolytics Biotech Inc.
(Translation of registrants name into
English)
Suite 210, 1167 Kensington Crescent NW
Calgary, Alberta, Canada T2N 1X7
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports
under cover Form 20-F or Form 40-F.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(1): o
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a
Form 6-K if submitted solely to provide an attached annual report to security
holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(7): o
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a
Form 6-K if submitted to furnish a report or other document that the registrant
foreign private issuer must furnish and make public under the laws of the
jurisdiction in which the registrant is incorporated, domiciled or legally
organized (the registrants home country), or under the rules of the home
country exchange on which the registrants securities are traded, as long as
the report or other document is not a press release, is not required to be and
has not been distributed to the registrants security holders, and, if
discussing a material event, has already been the subject of a Form 6-K
submission or other Commission filing on EDGAR.
Indicate by check mark whether by furnishing the information contained in this
Form, the registrant is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of
1934.
If Yes is marked, indicate below the file number assigned to the registrant
in connection with
Rule 12g3-2(b): 82 -
TABLE OF CONTENTS
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
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Oncolytics
Biotech Inc.
(Registrant) |
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Date: July 27, 2005 |
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By: |
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/s/ Douglas A. Ball
Douglas A. Ball
Chief Financial Officer |
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210, 1167 Kensington Crescent NW
Calgary, Alberta
Canada T2N 1X7 |
FOR IMMEDIATE RELEASE
Oncolytics Biotech Inc. Announces 2005 Second Quarter Results
CALGARY,
AB, July 27, 2005 Oncolytics Biotech Inc. (Oncolytics) (TSX:ONC, NASDAQ:ONCY) today
announced its financial results and highlights for the three and six-month periods ending June 30,
2005.
Second Quarter Highlights
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Received FDA approval to commence a Phase I systemic administration study in the U.S. |
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Continued to enroll patients in the recurrent malignant glioma study in Canada and
systemic administration study in the U.K. |
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Completed significant preparatory work in advance of patient enrolment in the Phase I
systemic administration study and Phase I/II recurrent malignant glioma study in the U.S. |
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Subsequent to the quarter end, announced the issuance of a 2nd European
Patent entitled Method of Producing Infectious Reovirus. |
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Subsequent to the quarter end, announced that the first patient had been enrolled
in its combination REOLYSIN®/radiation clinical trial in the U.K. |
The Company is focused on the clinical trial activities necessary for the advancement of REOLYSIN®
as a potential treatment for a broad range of cancers and we are pleased with the progress made
during the quarter in this regard, said Dr. Brad Thompson, President and CEO of Oncolytics.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This discussion and analysis should be read in conjunction with the unaudited financial
statements of Oncolytics Biotech Inc. (Oncolytics or the Company) as at and for the three and
six months ended June 30, 2005 and 2004, and should also be read in conjunction with the audited
financial statements and Managements Discussion and Analysis of Financial Condition and Results of
Operations (MD&A) contained in Oncolytics annual report for the year ended December 31, 2004.
The financial statements have been prepared in accordance with Canadian generally accepted
accounting principles (GAAP).
FORWARD-LOOKING STATEMENTS
The following discussion contains forward-looking statements, within the meaning of Section
21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the
Companys belief as to the potential of REOLYSIN® as a cancer therapeutic, the Companys
expectation regarding the adequacy of its existing capital resources, and the Companys
expectations as to the success of its research and development programs in 2005 and beyond, future
financial position, business strategy and plans for future operations, and statements that are not
historical facts, involve known and unknown risks and uncertainties, which could cause the
Companys actual results to differ materially from
those in the forward-looking statements. Such risks and uncertainties include, among others, the
availability of funds and resources to pursue research and development projects, the efficacy of
REOLYSIN® as a cancer treatment, the success and timely completion of clinical studies and trials,
the Companys ability to successfully commercialize REOLYSIN®, uncertainties related to the
research and development of pharmaceuticals, uncertainties related to competition, changes in
technology, the regulatory process and general changes to the economic environment. Investors
should consult the Companys quarterly and annual filings with the Canadian and U.S. securities
commissions for additional information on risks and uncertainties relating to the forward-looking
statements. Forward looking statements are based on assumptions, projections, estimates and
expectations of management at the time such forward looking statements are made, and such
assumptions, projections, estimates and/or expectations could change or prove to be incorrect or
inaccurate. Investors are cautioned against placing undue reliance on forward-looking statements.
The Company does not undertake to update these forward-looking statements.
OVERVIEW
Oncolytics Biotech Inc. is a Development Stage Company
Since its inception in April of 1998, Oncolytics Biotech Inc. (the Company) has been a
development stage company and has focused its research and development efforts on the development
of REOLYSIN®, its potential cancer therapeutic. The Company has not been profitable since its
inception and expects to continue to incur substantial losses from its research and development.
The Company does not expect to generate significant revenues until, if and when, its cancer product
becomes commercially viable.
General Risk Factors
Prospects for biotechnology companies in the research and development stage should generally
be regarded as speculative. It is not possible to predict, based upon studies in animals, or early
studies in humans, whether a new therapeutic will ultimately prove to be safe and effective in
humans, or whether necessary and sufficient data can be developed through the clinical trial
process to support a successful product application and approval.
If a product is approved for sale, product manufacturing at a commercial scale and significant
sales to end users at a commercially reasonable price may not be successful. There can be no
assurance that the Company will generate adequate funds to continue development, or will ever
achieve significant revenues or profitable operations. Many factors (e.g. competition, patent
protection, appropriate regulatory approvals) can influence the revenue and product profitability
potential.
In developing a product for approval, the Company will rely upon its employees, contractors,
consultants and collaborators and other third party relationships, including the ability to obtain
appropriate product liability insurance. There can be no assurance that these reliances and
relationships will continue as required.
In addition to developmental and operational considerations, market prices for securities of
biotechnology companies generally are volatile, and may or may not move in a manner consistent with
the progress being made by the Company.
Highlights
During the second quarter of 2005, the Companys net loss was $2,954,720 compared to
$3,191,888 for the second quarter of 2004. In the second quarter of 2005, the Company experienced
increases in its clinical trial, manufacturing and related process development expenses offset by a
reduction in stock based compensation. The Company received authorization to commence an
additional clinical trial in the U.S. during the second quarter of 2005 and now has five clinical
trial studies (either enrolling patients or approved). In anticipation of these additional trials
and the need to supply ongoing enrollment and research efforts, the Company has continued to
manufacture REOLYSIN®.
The Company exited the second quarter of 2005 with cash and cash equivalents (including short-term
investments) of $31,974,580 compared to $33,919,223 as at December 31, 2004.
SECOND QUARTER RESULTS OF OPERATIONS
(for the three months ended June 30, 2005 and 2004)
Net loss for the three month period ended June 30, 2005 was $2,954,720 compared to $3,191,888 for
2004. The changes in the Companys net loss were due to the following:
Research and Development Expenses (R&D)
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2005 |
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2004 |
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$ |
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$ |
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Manufacturing and related process development expenses |
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978,298 |
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823,601 |
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Clinical trial expenses |
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549,505 |
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123,150 |
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Pre-clinical trial and research collaboration expenses |
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223,672 |
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375,104 |
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Other R&D expenses |
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299,232 |
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174,079 |
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Research and development expenses |
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2,050,707 |
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1,495,934 |
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For the second quarter of 2005, R&D increased to $2,050,707 compared to $1,495,934 for the second
quarter of 2004. The increase in R&D was due to the following:
Manufacturing & Related Process Development Expenses (M&P)
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2005 |
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2004 |
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$ |
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$ |
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Product manufacturing expenses |
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949,169 |
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446,504 |
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Technology transfer expenses |
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¾ |
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289,318 |
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Process development expenses |
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29,129 |
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87,779 |
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Manufacturing and related process development expenses |
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978,298 |
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823,601 |
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During the second quarter of 2005, the Companys product manufacturing expenses increased to
$949,169 compared to $446,504 in the second quarter of 2004. The Company continues to have
clinical trial material made with its supplier, Cobra Biomanufacturing Plc (Cobra), as part of a
multiple production run supply contract entered into in the first quarter of 2005. These
production runs are intended to be used to supply the Companys five existing clinical trials,
additional studies being planned and are expected to continue through the remainder of 2005. As
well, the Company has contracted with Cobra to supply non-cGMP production runs to be used in
non-human research and collaborative studies.
In 2004, the Company entered into an agreement with Cobra to commence the manufacturing of
REOLYSIN® and therefore incurred expenses associated with the transfer of the Companys
manufacturing technology. This transfer was completed in 2004; consequently the Company did not
incur technology transfer expenses in the second quarter of 2005.
During the second quarter of 2005, the Company incurred process development expenses of $29,129
compared to $87,779 in the second quarter of 2004. Process development activity on the existing
manufacturing process was largely completed in 2004. The Company expects to continue to incur
process development costs as it looks to begin studies to continue to improve process yields.
Clinical Trial Programs
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2005 |
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2004 |
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$ |
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$ |
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Direct clinical trial expenses |
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549,505 |
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123,150 |
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During the second quarter of 2005, the Companys direct clinical trial expenses increased to
$549,505 compared to $123,150 in the second quarter of 2004. In the second quarter of 2005, the
Company received authorization to commence an additional U.S. clinical trial by the U.S. Food and
Drug Administration. At the end of the second quarter of 2005 the Company had five ongoing
clinical trials compared to two ongoing clinical trials in 2004. Therefore, the increase in direct
clinical trial expenses reflects continued enrollment in the U.K. systemic (intravenous) and
Canadian malignant glioma clinical trials and initiation costs associated with the two U.S.
clinical trial studies and the combination radiation therapy study in the U.K.
Pre-Clinical Trial and Research Collaboration Expenses
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2005 |
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2004 |
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$ |
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$ |
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Research collaboration expenses |
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179,686 |
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3,307 |
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Pre-clinical trial expenses |
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43,986 |
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371,797 |
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Pre-clinical trial expenses and research collaborations |
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223,672 |
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375,104 |
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During the second quarter of 2005, the Companys research collaboration expenses increased to
$179,686 compared to $3,307 in the second quarter of 2004. The Company incurs research
collaboration expenses as it continues to investigate the interaction of the immune system and the
reovirus, the use of the reovirus as a co-therapy with existing chemotherapeutics and radiation and
the possibility of new uses for the reovirus in therapy. These expenses will fluctuate from period
to period depending on the progress of these collaborations.
During the second quarter of 2005 the Companys pre-clinical trial expenses decreased to $43,986
compared to $371,797 in the second quarter of 2004. The frequency of the Companys pre-clinical
studies change from period to period as the Company moves through its clinical trial program. As
well, depending on the results of the Companys research collaborations, the Company may increase
its pre-clinical trial activity.
Other R&D
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2005 |
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2004 |
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$ |
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$ |
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Other R&D |
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299,232 |
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174,079 |
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Other R&D expenses include compensation expenses for employees (excluding stock based
compensation), consultant fees, travel and other miscellaneous R&D expenses. During the second
quarter of 2005, other R&D expenses increased to $299,232 compared to $174,079 for the second
quarter of 2004. The increase relates to consulting fees associated with the preparation of the
Companys clinical trial applications, salary and benefits, and travel costs.
Operating Expenses
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2005 |
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2004 |
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$ |
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$ |
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Public company related expenses |
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576,031 |
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649,481 |
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Office expenses |
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193,480 |
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201,292 |
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Operating expenses |
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769,511 |
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850,773 |
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During the second quarter of 2005, the Companys operating expenses decreased to $769,511 compared
to $850,773 in the second quarter of 2004. The decline was a result of lower costs associated with
the Companys 2004 annual report and annual general meeting and the timing of business development
expenses.
Stock Based Compensation
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2005 |
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2004 |
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$ |
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$ |
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Stock based compensation |
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8,404 |
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734,670 |
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Stock based compensation for the second quarter of 2005 was $8,404 compared to $734,670 for the
second quarter of 2004. In 2005, stock based compensation was recorded relating to the vesting of
previously granted options. In the second quarter of 2004, the Company recorded stock based
compensation associated with the granting and vesting of stock options.
YEAR TO DATE RESULTS OF OPERATIONS
(for the six months ended June 30, 2005 and 2004)
Net loss for the six month period ended June 30, 2005 was $5,331,769 compared to $5,868,124 for
2004. The changes in the Companys net loss were due to the following:
Research and Development Expenses (R&D)
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2005 |
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2004 |
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$ |
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$ |
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Manufacturing and related process development expenses |
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1,816,906 |
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2,200,031 |
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Clinical trial expenses |
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781,852 |
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248,794 |
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Pre-clinical trial and research collaboration expenses |
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459,862 |
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554,065 |
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Other R&D expenses |
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622,351 |
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447,441 |
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Research and development expenses |
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3,680,971 |
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3,450,331 |
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For the six month period ending June 30, 2005, R&D increased to $3,680,971 compared to $3,450,331
for 2004. The increase in R&D was due to the following:
Manufacturing & Related Process Development Expenses (M&P)
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2005 |
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2004 |
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$ |
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$ |
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Product manufacturing expenses |
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1,751,198 |
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1,574,377 |
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Technology transfer expenses |
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¾ |
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457,198 |
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Process development expenses |
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65,708 |
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168,456 |
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Manufacturing and related process development expenses |
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1,816,906 |
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2,200,031 |
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Production manufacturing expenses were $1,751,198 for the six month period ending June 30, 2005
compared to $1,574,377 for the six month period ending June 30, 2004. The Company has continued to
focus on the production of REOLYSIN® in order to supply its expanding clinical trial program now
consisting of five clinical trial studies along with other research activity. In the first part of
2005, the Company extended its manufacturing agreement with Cobra to provide additional cGMP
production and clinical trial supply material through a multiple production run supply contract.
As well, the Company has contracted with Cobra to supply non-cGMP (good manufacturing practices)
product to be used in non-human research and collaborative studies.
In 2004, the Company entered into an agreement with Cobra to commence the manufacturing of
REOLYSIN® and therefore incurred expenses associated with the transfer of the Companys
manufacturing technology. This transfer was completed in 2004; consequently the Company did not
incur technology transfer expenses in 2005.
The Company expects that its product manufacturing expenses will continue to increase throughout
the remainder of 2005. The balance of the Companys current supply contract with Cobra will be
completed by the end of 2005 and it anticipates that additional production runs will be scheduled
in order to ensure a supply of REOLYSIN® for its clinical trial and collaborative programs.
In 2005, the Company incurred process development expenses of $65,708 compared to $168,456 in 2004.
Process development activity on the existing manufacturing process was largely completed in 2004.
The Company expects to continue to incur process development costs as it looks to begin studies to
continue to improve process yields.
Clinical Trial Programs
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2005 |
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2004 |
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$ |
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$ |
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Direct clinical trial expenses |
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781,852 |
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248,794 |
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Direct clinical trial expenses for the six month period ending June 30, 2005 were $781,852 compared
to $248,794 for the six month period ending June 30, 2004. The Companys clinical trial program
has continued to expand in 2005 with the addition of three new clinical trial studies in 2005 for a
total of five ongoing clinical trials. As a result, direct clinical trial expenses continue to
increase as patients are enrolled in the U.K. systemic (intravenous) and Canadian malignant glioma
clinical trials. As well, the Company has incurred trial site initiation costs associated with the
two U.S. clinical trial studies and the combination radiation therapy study in the U.K.
The Company expects its direct clinical trial expenses to continue to increase for the remainder of
2005. Patient enrollment for the U.K. combination radiation clinical trial and the two U.S.
clinical trials is expected to commence in 2005. The Company also expects to continue with patient
enrollment in the U.K. systemic clinical trial and the Canadian malignant glioma clinical trial.
Pre-Clinical Trial and Research Collaboration Expenses
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2005 |
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2004 |
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$ |
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$ |
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Research collaboration expenses |
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363,109 |
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49,727 |
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Pre-clinical trial expenses |
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96,753 |
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504,338 |
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Pre-clinical trial expenses and research collaborations |
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459,862 |
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554,065 |
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Research collaboration expenses for the six month period ending June 30, 2005 were $363,109
compared to $49,727 for the six month period ending June 30, 2004. In 2005, the Company has
expanded its research collaboration program to include studies investigating the interaction of the
immune system and the reovirus, the use of the reovirus as a co-therapy with existing
chemotherapeutics and radiation and the possibility of new uses for the reovirus in therapy. These
expenses will fluctuate from period to period depending on the progress of these collaborations.
Pre-clinical trial expenses for the six month period ending June 30, 2005 were $96,753 compared to
$504,338 for the six month period ending June 30, 2004. The frequency of the Companys
pre-clinical studies change from period to period as the Company moves through its clinical trial
program. As well, depending on the results of the Companys research collaborations, the Company
may increase or decrease its pre-clinical trial activity.
Other R&D
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2005 |
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2004 |
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$ |
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$ |
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Other R&D |
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622,351 |
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447,441 |
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Other R&D expenses for the six month period ending June 30, 2005 were $622,351 compared to $447,441
for the six month period ending June 30, 2004. The increase relates to consulting fees associated
with the preparation of the Companys clinical trial applications, salary and benefits, and travel
costs.
Operating Expenses
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2005 |
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2004 |
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$ |
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$ |
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Public company related expenses |
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1,094,134 |
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1,111,499 |
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Office expenses |
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431,693 |
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436,234 |
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Operating expenses |
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1,525,827 |
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1,547,733 |
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During the six month period ending June 30, 2005, the Companys operating expenses were $1,525,827
compared to $1,547,733 for the six month period ending June 30, 2004.
Commitments
As at June 30, 2005, the Company has committed to payments totaling $920,088 for activities
primarily related to product manufacturing and ongoing research collaborations. The Company
anticipates that these committed payments will occur in 2005. All of these committed payments are
considered to be part of the Companys normal course of business.
LIQUIDITY AND CAPITAL RESOURCES
Liquidity
As at June 30, 2005, the Company had cash and cash equivalents (including short-term
investments) and working capital positions (current assets less current liabilities) of $31,974,580
and $31,254,471 respectively compared to $33,919,223 and $33,268,097 respectively for December 31,
2004. The decrease at June 30, 2005 reflects the Companys cash outflows from research and
development expenses, operational expenses, and intellectual property expenditures offset by cash
inflows from the exercise of warrants and options that raised $3,308,287.
The Company desires to maintain adequate cash and short-term investment reserves to support its
planned activities which include its clinical trial program, production manufacturing, and its
intellectual property expansion and protection. The Company presently anticipates that its average
cash usage for 2005 will be approximately $1,000,000 per month and its existing capital resources
are adequate to fund its current plans for research and development activities through 2007.
Factors that will affect the Companys anticipated monthly burn rate include, but are not limited
to, the number of manufacturing runs required to supply its clinical trial program and the cost of
each run, the number of clinical trials ultimately approved, the timing of patient enrollment in
the approved clinical trials, the actual costs incurred to support the program, the number of
treatments each patient will receive, the timing of the U.S. National Cancer Institutes R&D
activity, and the level of pre-clinical activity undertaken.
In the event that the Company chooses to seek additional capital, the Company will look to fund
additional capital requirements primarily through the issue of additional equity. The Company
recognizes the challenges and uncertainty inherent in the capital markets and the potential
difficulties it might face in raising additional capital. Market prices and market demand for
securities in biotechnology companies are volatile and there are no assurances that the Company
would have the ability to raise funds when required.
Capital Expenditures
During the six month period ending June 30, 2005, the Company spent $464,759 on intellectual
property compared to $425,928 for the six month period ending June 30, 2004. The difference
relates to variances in filing fees on existing patent applications.
SUMMARY OF QUARTERLY RESULTS
The following unaudited quarterly information is presented in thousands of dollars except for
per share amounts:
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2005 |
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2004 |
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2003 |
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June |
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March |
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Dec. |
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Sept. |
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June |
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March |
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Dec. |
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Sept. |
Revenue(1) |
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168 |
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|
245 |
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|
205 |
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|
194 |
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|
183 |
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|
117 |
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|
127 |
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|
102 |
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Net loss(2), (5) |
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2,955 |
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|
2,377 |
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|
3,992 |
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|
|
3,096 |
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|
3,192 |
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|
|
2,676 |
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|
1,696 |
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|
|
1,823 |
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Basic and diluted loss per
common share(2), (5) |
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$ |
0.09 |
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$ |
0.07 |
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$ |
0.14 |
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$ |
0.11 |
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$ |
0.11 |
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$ |
0.10 |
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$ |
0.06 |
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$ |
0.07 |
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Total assets(3), (6) |
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38,081 |
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40,519 |
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39,489 |
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29,471 |
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31,221 |
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25,435 |
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|
26,051 |
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|
21,532 |
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Total cash(4), (6) |
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31,975 |
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34,713 |
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|
|
33,919 |
|
|
|
23,806 |
|
|
|
25,522 |
|
|
|
20,298 |
|
|
|
20,753 |
|
|
|
15,843 |
|
Total long-term debt(7) |
|
|
150 |
|
|
|
150 |
|
|
|
150 |
|
|
|
150 |
|
|
|
150 |
|
|
|
150 |
|
|
|
150 |
|
|
|
150 |
|
Cash dividends
declared(8) |
|
|
Nil |
|
|
|
Nil |
|
|
|
Nil |
|
|
|
Nil |
|
|
|
Nil |
|
|
|
Nil |
|
|
|
Nil |
|
|
|
Nil |
|
|
|
|
(1) |
|
Revenue is comprised of interest income and income from short term investments. |
|
(2) |
|
Included in net loss and net loss per share between June 2005 and September 2003 is a
quarterly gain (loss) on sale of investment of $nil, $765, $nil, ($12,817), ($646),
$47,648, $264,453, and $nil, respectively. |
|
(3) |
|
Subsequent to the acquisition of the Company by SYNSORB in April 1999, the Company
applied push down accounting. See note 2 to the audited financial statements for 2004. |
|
(4) |
|
Included in total cash are cash and cash equivalents plus short-term investments. |
|
(5) |
|
Included in net loss and loss per common share between June 2005 and September 2003 are
quarterly stock based compensation expenses of $8,404, $13,375, $1,870,596, $48,878,
$734,670 $5,426, $490,364, and $437,554, respectively. |
|
(6) |
|
The Company issued 1,031,252 common shares for cash proceeds of $3,308,287 in the six
months ending June 30, 2005 (2004 4,685,775 common shares for $23,495,961 and 2003
5,062,978 common shares for $16,004,981). In addition, 21,459 common shares were issued in
September 2004 as partial consideration for the cancellation of a portion of the Companys
contingent payments (see note 9 to the audited financial statements for 2004). |
|
(7) |
|
The long-term debt recorded represents repayable loans from the Alberta Heritage
Foundation. |
|
(8) |
|
The Company has not declared or paid any dividends since incorporation. |
OTHER MD&A REQUIREMENTS
The Company has 32,946,748 common shares outstanding at July 27, 2005. If all of the
Companys warrants and options were exercised the Company would have 38,003,358 common shares
outstanding.
Additional information relating to the Company is available on SEDAR at www.sedar.com.
Oncolytics Biotech Inc.
BALANCE SHEETS
As at,
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2005 |
|
2004 |
|
|
$ |
|
$ |
|
|
(unaudited) |
|
(unaudited) |
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
7,911,281 |
|
|
|
12,408,516 |
|
Short-term investments [note 3] |
|
|
24,063,299 |
|
|
|
21,510,707 |
|
Accounts receivable |
|
|
67,931 |
|
|
|
47,767 |
|
Prepaid expenses |
|
|
755,274 |
|
|
|
250,365 |
|
|
|
|
|
|
|
32,797,785 |
|
|
|
34,217,355 |
|
|
|
|
|
|
|
|
|
|
Capital assets |
|
|
5,283,209 |
|
|
|
5,259,286 |
|
|
|
|
|
|
|
|
|
|
Investments [note 3] |
|
|
¾ |
|
|
|
12,000 |
|
|
|
|
|
|
|
38,080,994 |
|
|
|
39,488,641 |
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS EQUITY |
|
|
|
|
|
|
|
|
Current |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
|
1,543,314 |
|
|
|
949,258 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Alberta Heritage Foundation loan |
|
|
150,000 |
|
|
|
150,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders equity |
|
|
|
|
|
|
|
|
Share capital [note 2] |
|
|
|
|
|
|
|
|
Authorized: unlimited number of common shares
|
|
|
|
|
|
|
|
|
Issued: 32,946,748 (December 31, 2004 31,915,496) |
|
|
70,749,480 |
|
|
|
66,643,325 |
|
Warrants [note 2] |
|
|
2,549,762 |
|
|
|
3,347,630 |
|
Contributed surplus [note 2] |
|
|
6,370,918 |
|
|
|
6,349,139 |
|
Deficit |
|
|
(43,282,480 |
) |
|
|
(37,950,711 |
) |
|
|
|
|
|
|
36,387,680 |
|
|
|
38,389,383 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
38,080,994 |
|
|
|
39,488,641 |
|
|
|
|
See accompanying notes
Oncolytics Biotech Inc.
STATEMENTS OF LOSS AND DEFICIT
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
from inception |
|
|
Six Month |
|
Six Month |
|
Three Month |
|
Three Month |
|
on April 2, |
|
|
Period Ending |
|
Period Ending |
|
Period Ending |
|
Period Ending |
|
1998 to |
|
|
June 30, |
|
June 30, |
|
June 30, |
|
June 30, |
|
June 30, |
|
|
2005 |
|
2004 |
|
2005 |
|
2004 |
|
2005 |
|
|
$ |
|
$ |
|
$ |
|
$ |
|
$ |
|
|
(unaudited) |
|
(unaudited) |
|
(unaudited) |
|
(unaudited) |
|
(unaudited) |
|
|
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rights revenue |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
310,000 |
|
Interest income |
|
|
412,637 |
|
|
|
300,815 |
|
|
|
167,979 |
|
|
|
183,459 |
|
|
|
3,198,377 |
|
|
|
|
|
|
|
412,637 |
|
|
|
300,815 |
|
|
|
167,979 |
|
|
|
183,459 |
|
|
|
3,508,377 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
3,680,971 |
|
|
|
3,450,331 |
|
|
|
2,050,707 |
|
|
|
1,495,934 |
|
|
|
27,207,499 |
|
Operating |
|
|
1,525,827 |
|
|
|
1,547,733 |
|
|
|
769,511 |
|
|
|
850,773 |
|
|
|
11,531,621 |
|
Foreign exchange loss |
|
|
100,484 |
|
|
|
113,925 |
|
|
|
83,918 |
|
|
|
108,491 |
|
|
|
460,454 |
|
Stock based compensation [note 2] |
|
|
21,779 |
|
|
|
740,096 |
|
|
|
8,404 |
|
|
|
734,670 |
|
|
|
3,719,774 |
|
Amortization |
|
|
416,110 |
|
|
|
363,856 |
|
|
|
210,159 |
|
|
|
184,833 |
|
|
|
3,077,956 |
|
|
|
|
|
|
|
5,745,171 |
|
|
|
6,215,941 |
|
|
|
3,122,699 |
|
|
|
3,374,701 |
|
|
|
45,997,304 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before the following: |
|
|
5,332,534 |
|
|
|
5,915,126 |
|
|
|
2,954,720 |
|
|
|
3,191,242 |
|
|
|
42,488,927 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Gain) loss on sale of BCY LifeSciences
Inc. [note 3] |
|
|
(765 |
) |
|
|
(47,002 |
) |
|
|
¾ |
|
|
|
646 |
|
|
|
(299,403 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss on sale of Transition Therapeutics Inc. |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
2,156,685 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before taxes |
|
|
5,331,769 |
|
|
|
5,868,124 |
|
|
|
2,954,720 |
|
|
|
3,191,888 |
|
|
|
44,346,209 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital tax (recovery) |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
51,271 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Future income tax recovery |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
(1,115,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss for the period |
|
|
5,331,769 |
|
|
|
5,868,124 |
|
|
|
2,954,720 |
|
|
|
3,191,888 |
|
|
|
43,282,480 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit, beginning of period |
|
|
37,950,711 |
|
|
|
24,994,592 |
|
|
|
40,327,760 |
|
|
|
27,670,828 |
|
|
|
¾ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit, end of period |
|
|
43,282,480 |
|
|
|
30,862,716 |
|
|
|
43,282,480 |
|
|
|
30,862,716 |
|
|
|
43,282,480 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share |
|
|
0.16 |
|
|
|
0.21 |
|
|
|
0.09 |
|
|
|
0.11 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares |
|
|
32,559,975 |
|
|
|
28,100,033 |
|
|
|
32,849,229 |
|
|
|
28,944,326 |
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes
Oncolytics Biotech Inc.
STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
from inception |
|
|
Six Month |
|
Six Month |
|
Three Month |
|
Three Month |
|
on April 2, |
|
|
Period Ending |
|
Period Ending |
|
Period Ending |
|
Period Ending |
|
1998 to |
|
|
June 30, |
|
June 30, |
|
June 30, |
|
June 30, |
|
June 30, |
|
|
2005 |
|
2004 |
|
2005 |
|
2004 |
|
2005 |
|
|
$ |
|
$ |
|
$ |
|
$ |
|
$ |
|
|
(unaudited) |
|
(unaudited) |
|
(unaudited) |
|
(unaudited) |
|
(unaudited) |
|
|
|
OPERATING ACTIVITIES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss for the period |
|
|
(5,331,769 |
) |
|
|
(5,868,124 |
) |
|
|
(2,954,720 |
) |
|
|
(3,191,888 |
) |
|
|
(43,282,480 |
) |
Deduct non-cash items |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization |
|
|
416,110 |
|
|
|
363,856 |
|
|
|
210,159 |
|
|
|
184,833 |
|
|
|
3,077,956 |
|
Stock based compensation |
|
|
21,779 |
|
|
|
740,096 |
|
|
|
8,404 |
|
|
|
734,670 |
|
|
|
3,719,774 |
|
(Gain) loss on sale of BCY LifeSciences Inc. |
|
|
(765 |
) |
|
|
(47,002 |
) |
|
|
¾ |
|
|
|
646 |
|
|
|
(299,403 |
) |
Foreign exchange loss |
|
|
38,650 |
|
|
|
110,353 |
|
|
|
8,171 |
|
|
|
110,353 |
|
|
|
304,632 |
|
Cancellation of contingent payment obligation
settled in common shares |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
150,000 |
|
Loss on sale of Transition Therapeutics Inc. |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
2,156,685 |
|
Future income tax recovery |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
(1,115,000 |
) |
Net changes in non-cash working capital |
|
|
108,929 |
|
|
|
(383,405 |
) |
|
|
(57,516 |
) |
|
|
(1,523,988 |
) |
|
|
617,162 |
|
|
|
|
|
|
|
(4,747,066 |
) |
|
|
(5,084,226 |
) |
|
|
(2,785,502 |
) |
|
|
(3,685,374 |
) |
|
|
(34,670,674 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INVESTING ACTIVITIES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intellectual property |
|
|
(464,759 |
) |
|
|
(425,928 |
) |
|
|
(167,363 |
) |
|
|
(295,388 |
) |
|
|
(4,088,394 |
) |
Other capital assets |
|
|
(15,220 |
) |
|
|
(7,893 |
) |
|
|
(9,622 |
) |
|
|
(6,295 |
) |
|
|
(541,422 |
) |
Purchase of short-term investments |
|
|
(5,333,838 |
) |
|
|
(6,462,831 |
) |
|
|
(125,959 |
) |
|
|
(6,217,565 |
) |
|
|
(30,222,625 |
) |
Redemption of short-term investments |
|
|
2,747,396 |
|
|
|
2,000,000 |
|
|
|
2,303,651 |
|
|
|
1,000,000 |
|
|
|
5,861,396 |
|
Investment in BCY LifeSciences Inc. |
|
|
7,965 |
|
|
|
133,609 |
|
|
|
¾ |
|
|
|
1,959 |
|
|
|
464,602 |
|
Investment
in Transition Therapeutics Inc. |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
2,532,343 |
|
|
|
|
|
|
|
(3,058,456 |
) |
|
|
(4,763,043 |
) |
|
|
2,000,707 |
|
|
|
(5,517,289 |
) |
|
|
(25,994,100 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FINANCING ACTIVITIES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alberta Heritage Foundation loan |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
150,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from exercise of warrants and stock options |
|
|
3,308,287 |
|
|
|
4,041,021 |
|
|
|
232,400 |
|
|
|
3,096,276 |
|
|
|
14,890,568 |
|
Proceeds from private placements |
|
|
¾ |
|
|
|
6,223,763 |
|
|
|
¾ |
|
|
|
6,223,763 |
|
|
|
22,741,983 |
|
Proceeds from public offerings |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
30,793,504 |
|
|
|
|
|
|
|
3,308,287 |
|
|
|
10,264,784 |
|
|
|
232,400 |
|
|
|
9,320,039 |
|
|
|
68,576,055 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase (decrease) in cash and cash equivalents
during the period |
|
|
(4,497,235 |
) |
|
|
417,515 |
|
|
|
(552,395 |
) |
|
|
117,376 |
|
|
|
7,911,281 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents, beginning of the period |
|
|
12,408,516 |
|
|
|
2,641,127 |
|
|
|
8,463,676 |
|
|
|
2,941,266 |
|
|
|
¾ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents, end of the period |
|
|
7,911,281 |
|
|
|
3,058,642 |
|
|
|
7,911,281 |
|
|
|
3,058,642 |
|
|
|
7,911,281 |
|
|
|
|
See accompanying notes
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
June 30, 2005 (unaudited)
1. ACCOUNTING POLICIES
These unaudited interim financial statements do not include all of the disclosures included in
the Companys annual financial statements. Accordingly, these unaudited interim financial
statements should be read in conjunction with the Companys most recent annual financial
statements. The information as at and for the year ended December 31, 2004 has been derived from
the Companys audited financial statements.
The accounting policies used in the preparation of these unaudited interim financial statements
conform with those used in the Companys most recent annual financial statements.
2. SHARE CAPITAL
Authorized:
Unlimited number of common shares
Issued:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares |
|
Warrants |
|
|
|
|
|
|
Amount |
|
|
|
|
|
Amount |
|
|
Number |
|
$ |
|
Number |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2003 |
|
|
27,208,262 |
|
|
|
44,712,589 |
|
|
|
3,258,155 |
|
|
|
1,598,250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued for cash pursuant to April 7, 2004
private placement |
|
|
1,077,100 |
|
|
|
5,924,050 |
|
|
|
646,260 |
|
|
|
1,028,631 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued for cash pursuant to pursuant to
November 23, 2004 public offering |
|
|
1,504,000 |
|
|
|
8,693,120 |
|
|
|
864,800 |
|
|
|
1,521,672 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued pursuant to cancellation of contingent
payment |
|
|
21,459 |
|
|
|
150,000 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of warrants |
|
|
1,907,175 |
|
|
|
8,178,546 |
|
|
|
(1,907,175 |
) |
|
|
(798,096 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expired warrants |
|
|
¾ |
|
|
|
2,827 |
|
|
|
(6,700 |
) |
|
|
(2,827 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of options |
|
|
197,500 |
|
|
|
778,951 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share issue costs |
|
|
¾ |
|
|
|
(1,796,758 |
) |
|
|
¾ |
|
|
|
¾ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2004 |
|
|
31,915,496 |
|
|
|
66,643,325 |
|
|
|
2,855,340 |
|
|
|
3,347,630 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of options |
|
|
260,000 |
|
|
|
221,000 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of warrants |
|
|
771,252 |
|
|
|
3,417,271 |
|
|
|
(771,252 |
) |
|
|
(329,984 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expired warrants |
|
|
¾ |
|
|
|
467,884 |
|
|
|
(573,028 |
) |
|
|
(467,884 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance June 30, 2005 |
|
|
32,946,748 |
|
|
|
70,749,480 |
|
|
|
1,511,060 |
|
|
|
2,549,762 |
|
|
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
June 30, 2005 (unaudited)
The following table summarizes the Companys outstanding warrants as at June 30, 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Outstanding, |
|
Granted |
|
Exercised |
|
Expired |
|
|
|
|
|
Remaining |
|
|
Beginning of |
|
During the |
|
During the |
|
During the |
|
Outstanding, |
|
Contractual |
Exercise Price |
|
the Period |
|
Period |
|
Period |
|
Period |
|
End of Period |
|
Life(years) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$4.00 |
|
|
768,972 |
|
|
|
¾ |
|
|
|
768,972 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$5.00 |
|
|
45,558 |
|
|
|
¾ |
|
|
|
2,280 |
|
|
|
43,278 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$6.25 |
|
|
529,750 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
529,750 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$7.00 |
|
|
107,710 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
107,710 |
|
|
|
0.25 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$7.06 |
|
|
112,800 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
112,800 |
|
|
|
0.90 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$7.75 |
|
|
538,550 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
538,550 |
|
|
|
0.25 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$8.00 |
|
|
752,000 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
752,000 |
|
|
|
2.40 |
|
|
|
|
|
2,855,340 |
|
|
|
¾ |
|
|
|
771,252 |
|
|
|
573,028 |
|
|
|
1,511,060 |
|
|
|
|
|
|
Stock Based Compensation
As the Company is following the fair value based method of accounting for stock options, the
Company recorded compensation expense of $8,404 and $21,779 for the three and six month periods
ending June 30, 2005 respectively, (June 30, 2004 $734,670 and $740,096 respectively) with
respect to the vesting of options issued in prior periods with an offsetting credit to contributed
surplus.
3. INVESTMENTS
During the three and six month periods ending June 30, 2005, the Company sold nil and 120,000
(June 30, 2004 21,000 and 697,945) of its BCY LifeSciences Inc. (BCY) shares for net cash
proceeds of $nil and $7,965 (June 30, 2004 $1,959 and $133,609) recording a gain (loss) on sale
of investment of $nil and $765 (June 30, 2004 ($646) and $47,002), respectively. As at June 30,
2005, the Company still owned 80,000 common shares of BCY with a book value of $4,800. These
common shares will be released from escrow in February 2006; consequently the remaining investment
in BCY has been reclassified as a short-term investment.
4. COMPARATIVE FIGURES
Certain comparative figures have been reclassified to conform with the current periods
presentation.
About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN®, its
proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics
researchers have demonstrated that the reovirus is able to selectively kill cancer cells and, in
vitro, kill human cancer cells that are derived from many types of cancer including breast,
prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment
results in a number of animal models. Phase I clinical trial results have indicated that REOLYSIN®
was well tolerated and that the reovirus demonstrated activity in tumours injected with REOLYSIN®.
FOR FURTHER INFORMATION PLEASE CONTACT:
|
|
|
|
|
For Canada: |
|
For Canada: |
|
For United States: |
Oncolytics Biotech Inc. |
|
The Equicom Group Inc. |
|
The Investor Relations Group |
Doug Ball, CFO |
|
Joanna Longo |
|
Gino De Jesus or Dian Griesel, Ph.D. |
210, 1167 Kensington Cr NW |
|
20 Toronto Street |
|
11 Stone Street, 3rd Floor |
Calgary, Alberta T2N 1X7 |
|
Toronto, Ontario M5C 2B8 |
|
New York, NY 10004 |
|
Tel: 403.670.7377 |
|
Tel: 416.815.0700 ext. 233 |
|
Tel: 212.825.3210 |
Fax: 403.283.0858 |
|
Fax: 416.815.0080 |
|
Fax: 212.825.3229 |
www.oncolyticsbiotech.com |
|
jlongo@equicomgroup.com |
|
mail@investorrelationsgroup.com |
-30-