6-k
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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 registrant’s 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.

     
Form 20-F   o   Form 40-F   þ

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 registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s 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 registrant’s 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.

     
Yes   o   No   þ

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b):   82 -                  



 


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Signatures
PRESS RELEASE 2005 SECOND QUARTER RESULTS


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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.

         
    Oncolytics Biotech Inc.
(Registrant)
 
         
 
Date: July 27, 2005   By:   /s/ Douglas A. Ball
Douglas A. Ball
Chief Financial Officer

 


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Oncolytics Biotech Logo 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
    Received FDA approval to commence a Phase I systemic administration study in the U.S.
    Continued to enroll patients in the recurrent malignant glioma study in Canada and systemic administration study in the U.K.
    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.
    Subsequent to the quarter end, announced the issuance of a 2nd European Patent entitled “Method of Producing Infectious Reovirus.”
    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.
MANAGEMENT’S 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 Management’s 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 Company’s belief as to the potential of REOLYSIN® as a cancer therapeutic, the Company’s expectation regarding the adequacy of its existing capital resources, and the Company’s 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 Company’s actual results to differ materially from

 


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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 Company’s 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 Company’s 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 Company’s 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.

 


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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 Company’s net loss were due to the following:
Research and Development Expenses (“R&D”)
                 
    2005   2004
    $   $
 
Manufacturing and related process development expenses
    978,298       823,601  
Clinical trial expenses
    549,505       123,150  
Pre-clinical trial and research collaboration expenses
    223,672       375,104  
Other R&D expenses
    299,232       174,079  
 
Research and development expenses
    2,050,707       1,495,934  
 
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”)
                 
    2005   2004
    $   $
 
Product manufacturing expenses
    949,169       446,504  
Technology transfer expenses
    ¾       289,318  
Process development expenses
    29,129       87,779  
 
Manufacturing and related process development expenses
    978,298       823,601  
 
During the second quarter of 2005, the Company’s 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 Company’s 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 Company’s 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
                 
    2005   2004
    $   $
 
Direct clinical trial expenses
    549,505       123,150  
 
During the second quarter of 2005, the Company’s 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.

 


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Pre-Clinical Trial and Research Collaboration Expenses
                 
    2005   2004
    $   $
 
Research collaboration expenses
    179,686       3,307  
Pre-clinical trial expenses
    43,986       371,797  
 
Pre-clinical trial expenses and research collaborations
    223,672       375,104  
 
During the second quarter of 2005, the Company’s 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 Company’s pre-clinical trial expenses decreased to $43,986 compared to $371,797 in the second quarter of 2004. The frequency of the Company’s 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 Company’s research collaborations, the Company may increase its pre-clinical trial activity.
Other R&D
                 
    2005   2004
    $   $
 
Other R&D
    299,232       174,079  
 
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 Company’s clinical trial applications, salary and benefits, and travel costs.
Operating Expenses
                 
    2005   2004
    $   $
 
Public company related expenses
    576,031       649,481  
Office expenses
    193,480       201,292  
 
Operating expenses
    769,511       850,773  
 
During the second quarter of 2005, the Company’s 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 Company’s 2004 annual report and annual general meeting and the timing of business development expenses.
Stock Based Compensation
                 
    2005   2004
    $   $
 
Stock based compensation
    8,404       734,670  
 
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.

 


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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 Company’s net loss were due to the following:
Research and Development Expenses (“R&D”)
                 
    2005   2004
    $   $
 
Manufacturing and related process development expenses
    1,816,906       2,200,031  
Clinical trial expenses
    781,852       248,794  
Pre-clinical trial and research collaboration expenses
    459,862       554,065  
Other R&D expenses
    622,351       447,441  
 
Research and development expenses
    3,680,971       3,450,331  
 
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”)
                 
    2005   2004
    $   $
 
Product manufacturing expenses
    1,751,198       1,574,377  
Technology transfer expenses
    ¾       457,198  
Process development expenses
    65,708       168,456  
 
Manufacturing and related process development expenses
    1,816,906       2,200,031  
 
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 Company’s 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 Company’s 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.

 


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Clinical Trial Programs
                 
    2005   2004
    $   $
 
Direct clinical trial expenses
    781,852       248,794  
 
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 Company’s 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
                 
    2005   2004
    $   $
 
Research collaboration expenses
    363,109       49,727  
Pre-clinical trial expenses
    96,753       504,338  
 
Pre-clinical trial expenses and research collaborations
    459,862       554,065  
 
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 Company’s 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 Company’s research collaborations, the Company may increase or decrease its pre-clinical trial activity.
Other R&D
                 
    2005   2004
    $   $
 
Other R&D
    622,351       447,441  
 
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 Company’s clinical trial applications, salary and benefits, and travel costs.

 


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Operating Expenses
                 
    2005   2004
    $   $
 
Public company related expenses
    1,094,134       1,111,499  
Office expenses
    431,693       436,234  
 
Operating expenses
    1,525,827       1,547,733  
 
During the six month period ending June 30, 2005, the Company’s 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 Company’s 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 Company’s 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 Company’s 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 Institute’s 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.

 


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SUMMARY OF QUARTERLY RESULTS
The following unaudited quarterly information is presented in thousands of dollars except for per share amounts:
                                                                 
    2005   2004   2003
    June   March   Dec.   Sept.   June   March   Dec.   Sept.
Revenue(1)
    168       245       205       194       183       117       127       102  
Net loss(2), (5)
    2,955       2,377       3,992       3,096       3,192       2,676       1,696       1,823  
Basic and diluted loss per common share(2), (5)
  $ 0.09     $ 0.07     $ 0.14     $ 0.11     $ 0.11     $ 0.10     $ 0.06     $ 0.07  
Total assets(3), (6)
    38,081       40,519       39,489       29,471       31,221       25,435       26,051       21,532  
Total cash(4), (6)
    31,975       34,713       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 Company’s 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 Company’s 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.

 


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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

 


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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

 


Table of Contents

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

 


Table of Contents

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 Company’s annual financial statements. Accordingly, these unaudited interim financial statements should be read in conjunction with the Company’s most recent annual financial statements. The information as at and for the year ended December 31, 2004 has been derived from the Company’s audited financial statements.
The accounting policies used in the preparation of these unaudited interim financial statements conform with those used in the Company’s 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  
 

 


Table of Contents

Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
June 30, 2005 (unaudited)
The following table summarizes the Company’s 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 period’s presentation.

 


Table of Contents

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
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