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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 October

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


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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: October 28, 2005   By:   /s/ Doug Ball
Doug Ball
Chief Financial Officer

 


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(ONCOLYTICS LOGO)
Third Quarter Report
September 30, 2005
 
Oncolytics Biotech Inc.
TSX: ONC
NASDAQ: ONCY


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THIRD QUARTER REPORT
For the quarter ended September 30, 2005
Letter to Shareholders
In the third quarter of 2005, Oncolytics significantly advanced its REOLYSIN® clinical program, expanded its intellectual property position in Europe and Canada, and strengthened its management team with the appointment of Dr. Karl Mettinger.
Oncolytics’ clinical program has recently expanded and is currently enrolling patients in three clinical trials; our initial intravenous administration monotherapy studies in the UK and the USA, and our radiation cotherapy study in the UK. A fourth study, a recurrent malignant glioma monotherapy study, is approved in the US. Subsequent to the end of the quarter, we announced the conclusion of enrolment of our Canadian Phase I recurrent malignant glioma clinical trial.
In September, Oncolytics announced the appointment of Karl Mettinger, M.D., Ph.D. to the position of Chief Medical Officer. Dr. Mettinger has been involved with the clinical and regulatory approval of oncology, cardiovascular, and other products in the pharmaceutical industry for 20 years, including implementing clinical studies that enrolled more than 25,000 patients worldwide. As part of our senior medical and scientific management group which includes Dr. Gill and Dr. Coffey, Dr. Mettinger is expected to develop and implement the clinical trial program that best supports a registration path for REOLYSIN®.
Oncolytics secured two new patents in the quarter, including a 2nd European patent entitled ‘Method of Producing Infectious Reovirus’ and its first Canadian patent entitled ‘The use of ribozymes in the detection of adventitious agents.’ Subsequent to the quarter end, Oncolytics secured two additional Canadian patents that expand coverage for the use of REOLYSIN®. These patents complement similar patent coverage in the U.S., Europe and worldwide.
With the increased activity in our clinical program, and the addition of Dr. Mettinger’s expertise in this area, we are well-positioned to further advance REOLYSIN® through development.
I would like to thank our shareholders for their continued support and look forward to updating you.
-s- Brad Thompson, PhD
Brad Thompson, PhD
President and CEO
Oct. 26, 2005

 


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October 26, 2005
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 nine months ended September 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 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 except as required by law.
OVERVIEW
Oncolytics Biotech Inc. is a Development Stage Company
Since its inception in April of 1998, Oncolytics 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.

 


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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 third quarter of 2005, the Company’s net loss was $3,509,503 compared to $3,096,042 for the third quarter of 2004. In the third quarter of 2005, the Company experienced increases in its clinical trial and manufacturing and related process development expenses. In the third quarter, the Company commenced patient enrollment in its U.S. systemic (intravenous) and U.K. combination radiation therapy clinical trials. The Company has five active clinical trial studies of which four are enrolling patients. In anticipation of these additional trials and the need to supply ongoing enrollment and research efforts, the Company has continued to manufacture REOLYSIN® entering into multiple production supply contracts. Finally, the Company received two additional patents (one Canadian and one European) for a total of 13 U.S., two European, and one Canadian patents.
The Company exited the third quarter of 2005 with cash and cash equivalents (including short-term investments) of $28,206,326 compared to $33,919,223 as at December 31, 2004.
THIRD QUARTER RESULTS OF OPERATIONS
(for the three months ended September 30, 2005 and 2004)
Net loss for the three month period ended September 30, 2005 was $3,509,503 compared to $3,096,042 for 2004. The increase in the Company’s net loss in the third quarter of 2005 was due to increases in the Company’s operating activities as follows:
Research and Development Expenses (“R&D”)
                 
    2005     2004  
    $     $  
 
Manufacturing and related process development expenses
    1,767,524       1,160,983  
Clinical trial expenses
    372,825       184,347  
Pre-clinical trial expenses and research collaborations
    64,611       181,397  
Other R&D expenses
    613,103       705,654  
 
Research and development expenses
    2,818,063       2,232,381  
 
For the third quarter of 2005, R&D increased to $2,818,063 compared to $2,232,381 for the third quarter of 2004. The increase in R&D was due to the following:

 


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Manufacturing & Related Process Development Expenses (“M&P”)
                 
    2005     2004  
    $     $  
 
Product manufacturing expenses
    1,655,390       640,630  
Technology transfer expenses
          78,602  
Process development expenses
    112,134       441,751  
 
Manufacturing and related process development expenses
    1,767,524       1,160,983  
 
During the third quarter of 2005, the Company’s product manufacturing expenses increased to $1,655,390 compared to $640,630 in the third quarter of 2004. The Company uses Cobra Biomanufacturing Plc (“Cobra”) to manufacture clinical material in order to supply its U.S. clinical trials and to ensure supply for future clinical trial activity. In the third quarter of 2005, in addition to the existing multiple production run supply contract, the Company entered into additional production run supply contracts. The Company presently anticipates that this manufacturing activity will continue into 2006.
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 third quarter of 2005.
During the third quarter of 2005, the Company incurred process development expenses of $112,134 compared to $441,751 in the third quarter of 2004. In the third quarter of 2005, the Company incurred process development costs associated with improving the process yields. Process development activity in 2004 was a result of the technology transfer to Cobra.
Clinical Trial Programs
                 
    2005     2004  
    $     $  
 
Direct clinical trial expenses
    372,825       184,347  
 
During the third quarter of 2005, the Company’s direct clinical trial expenses increased to $372,825 compared to $184,347 in the third quarter of 2004. The Company has five ongoing clinical trials in 2005 compared to two clinical trials in 2004. Therefore, in the third quarter of 2005, the increase in direct clinical trial expenses reflects patient enrollment in the U.K. systemic (intravenous) and combination radiation therapy studies as well as other direct clinical trial costs associated with its two U.S. and Canadian studies.
Pre-Clinical Trial Expenses and Research Collaborations
                 
    2005     2004  
    $     $  
 
Research collaboration expenses
    64,611       122,816  
Pre-clinical trial expenses
          58,581  
 
Pre-clinical trial expenses and research collaborations
    64,611       181,397  
 
During the third quarter of 2005, the Company’s research collaboration expenses were $64,611 compared to $122,816 for the third quarter of 2004. The Company incurs research collaboration expenses as it continues to investigate various characteristics and potential applications of the reovirus, such as 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 third quarter of 2005, the Company did not incur any preclinical trial expenses compared to $58,581 in the third quarter of 2004. The frequency of the Company’s pre-clinical studies change from period to period

 


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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  
    $     $  
 
Cancellation of contingent payment obligation
          400,000  
Other R&D
    613,103       305,654  
 
Other R&D
    613,103       705,654  
 
During the third quarter of 2004, the Company reduced its future contingent payment obligation by entering into an agreement that cancelled a portion of its future contingent obligation to one of its non-management founding shareholders for consideration of $400,000 (cash and shares). In the third quarter of 2005, there was no such activity.
Other R&D expenses include compensation expenses for employees (excluding stock based compensation) consulting fees, travel and other miscellaneous R&D expenses. In the third quarter of 2005, other R&D expenses were $613,103 compared to $305,654 for the third quarter of 2004. The increase in other R&D expenses mainly reflects an increase in consulting activity and related costs, costs associated with the activities of the scientific advisory board and employee compensation levels.
Operating Expenses
                 
    2005     2004  
    $     $  
 
Public company related expenses
    390,473       360,763  
Office expenses
    195,127       204,703  
 
Operating expenses
    585,600       565,466  
 
For the third quarter of 2005, the Company’s operating expenses were $585,600 compared to $565,466 for the third quarter of 2004. The Company’s operating activities have remained consistent and therefore the related operating costs have remained stable.
Foreign Exchange Loss
                 
    2005     2004  
    $     $  
 
Foreign exchange loss
    97,997       239,881  
 
The Company acquires investments in foreign currency to pay for anticipated expenses that are to be incurred in the United States (“U.S.”) and the United Kingdom (“U.K.”). As a result of recent movements in the U.S. and U.K. exchange rates the Company recorded a foreign exchange loss of $97,997 for the third quarter of 2005 compared to $239,881 for the third quarter of 2004.

 


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YEAR TO DATE RESULTS OF OPERATIONS
(for the nine months ended September 30, 2005 and 2004)
Net loss for the nine month period ended September 30, 2005 was $8,841,272 compared to $8,964,166 for 2004. The decrease in the Company’s net loss was due to the following:
Research and Development Expenses (“R&D”)
                 
    2005     2004  
    $     $  
 
Manufacturing and related process development expenses
    3,584,430       3,361,014  
Clinical trial expenses
    1,154,677       433,139  
Pre-clinical trial expenses and research collaborations
    524,472       735,463  
Other R&D expenses
    1,235,455       1,153,096  
 
Research and development expenses
    6,499,034       5,682,712  
 
For the nine month period ending September 30, 2005, R&D increased to $6,499,034 compared to $5,682,712 for 2004. The increase in R&D was due to the following:
Manufacturing & Related Process Development (“M&P”)
                 
    2005     2004  
    $     $  
 
Product manufacturing expenses
    3,406,588       2,215,007  
Technology transfer expenses
          535,800  
Process development expenses
    177,842       610,207  
 
Manufacturing and related process development expenses
    3,584,430       3,361,014  
 
Production manufacturing expenses were $3,406,588 for the nine month period ending September 30, 2005 compared to $2,215,007 for the nine month period ending September 30, 2004. The Company has continued to focus on the production of REOLYSIN® in order to supply its expanding clinical trial program along with other research activity. In the first part of 2005, the Company entered into a multiple cGMP (“good manufacturing practices”) production run supply contract with Cobra. In the third quarter of 2005, the Company continued to expand its cGMP production contracts by adding additional manufacturing runs. As well, the Company contracted Cobra to supply non-cGMP 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 contracts 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 existing and future clinical trial and collaborative programs.
Process development expenses were $177,842 for the nine month period ending September 30, 2005 compared to $610,207 for the nine month period ending September 30, 2004. In 2005, the Company has incurred process development costs associated with improving the process yields. Process development activity in 2004 was a result of the technology transfer to Cobra.

 


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Clinical Trial Programs
                 
    2005     2004  
    $     $  
 
Direct clinical trial expenses
    1,154,677       433,139  
 
Direct clinical trial expenses for the nine month period ending September 30, 2005 were $1,154,677 compared to $433,139 for the nine month period ending September 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. As a result, direct clinical trial expenses continue to increase as patients are enrolled in the Company’s two systemic (intravenous) trials in the U.K. and U.S., the combination radiation therapy trial in the U.K. and the Canadian malignant glioma clinical trial. 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. In the third quarter of 2005 patient enrollment commenced in the U.K. combination radiation therapy and the U.S. systemic (intravenous) clinical trials. As well, the Company expects that the U.S. malignant glioma trial will commence patient enrollment before the end of 2005.
Pre-Clinical Trial and Research Collaboration Expenses
                 
    2005     2004  
    $     $  
 
Research collaboration expenses
    427,719       172,546  
Pre-clinical trial expenses
    96,753       562,917  
 
Pre-clinical trial expenses and research collaborations
    524,472       735,463  
 
Research collaboration expenses for the nine month period ending September 30, 2005 were $427,719 compared to $172,546 for the nine month period ending September 30, 2004. In 2005, the Company has expanded its research collaboration program to include studies investigating various characteristics and potential applications of the reovirus, such as 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 nine month period ending September 30, 2005 were $96,753 compared to $562,917 for the nine month period ending September 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  
    $     $  
 
Cancellation of contingent payment obligation
          400,000  
Other R&D
    1,235,455       753,096  
 
Other R&D
    1,235,455       1,153,096  
 
Other R&D expenses include compensation expenses for employees (excluding stock based compensation) consulting fees, travel and other miscellaneous R&D expenses. For the nine month period ending September 30, 2005, other R&D expenses were $1,235,455 compared to $753,906 for the nine month period ending September 30, 2004. The increase in other R&D expenses mainly reflects an increase in consulting activity and related costs, costs associated with the activities of the scientific advisory board and employee compensation levels.

 


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Operating Expenses
                 
    2005     2004  
    $     $  
 
Public company related expenses
    1,484,605       1,472,261  
Office expenses
    626,822       640,622  
 
Operating expenses
    2,111,427       2,112,883  
 
For the nine month period ending September 30, 2005, the Company’s operating expenses decreased to $2,111,427 compared to $2,112,883 for the nine month period ending September 30, 2004. The Company has not had to increase its administrative costs to support the increase in its research and development activity.
Stock Based Compensation
                 
    2005     2004  
    $     $  
 
Stock based compensation
    25,952       788,974  
 
Stock based compensation recorded during the nine month period ending September 30, 2005 was $25,952 compared to $788,974 for the nine month period ending September 30, 2004. The decline has been a result of the reduction in the number of stock options granted in 2005 compared to 2004. As well, the options that were granted in 2004 vested immediately requiring compensation expense to be recorded on the grant date. The options that have been issued in 2005 vest over four years requiring compensation expense to be recorded over the vesting period.
Foreign Exchange Loss
                 
    2005     2004  
    $     $  
 
Foreign exchange loss
    198,481       353,964  
 
The Company acquires investments in foreign currency to pay for anticipated expenses that are to be incurred in the United States (“U.S.”) and the United Kingdom (“U.K.”). As a result of recent movements in the U.S. and U.K. exchange rates the Company recorded a foreign exchange loss of $198,481 for the nine month period ending September 30, 2005 compared to $353,964 for the nine month period ending September 30, 2004.
Commitments
As at September 30, 2005, the Company has committed to payments totaling $1,818,500 for activities primarily related to product manufacturing and ongoing research collaborations. The Company anticipates that these committed payments will occur over the next twelve months. All of these committed payments are considered to be part of the Company’s normal course of business.

 


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LIQUIDITY AND CAPITAL RESOURCES
Liquidity
As at September 30, 2005, the Company had cash and cash equivalents (including short-term investments) and working capital positions (current assets less current liabilities) of $28,206,326 and $27,778,367 respectively compared to $33,919,223 and $33,268,097 respectively for December 31, 2004. The decrease at September 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 $3,384,787.
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. The Company continues to assess its clinical trial program and related manufacturing needs as further information becomes available. Any change in these activities would have implications on the Company’s cash requirements.
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 nine month period ending September 30, 2005, the Company spent $706,982 on intellectual property compared to $766,317 for the nine month period ending September 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 the notes and per share amounts:
                                                                 
    2005     2004     2003  
    Sept.     June     March     Dec.     Sept.     June     March     Dec.  
Revenue(1)
    211       168       245       205       194       183       117       127  
Net loss(2), (5)
    3,510       2,955       2,377       3,992       3,096       3,192       2,676       1,696  
Basic and diluted loss per common share(2), (5)
  $ 0.11     $ 0.09     $ 0.07     $ 0.14     $ 0.11     $ 0.11     $ 0.10     $ 0.06  
Total assets(3), (6)
    34,538       38,081       40,519       39,489       29,471       31,221       25,435       26,051  
Total cash(4), (6)
    28,206       31,975       34,713       33,919       23,806       25,522       20,298       20,753  
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 September 2005 and December 2003 is a quarterly gain (loss) on sale of investment of $nil, $nil, $765, $nil, ($12,817), ($646), $47,648, and $264,453, 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 $4,173, $8,404, $13,375, $1,870,596, $48,878, $734,670 $5,426, and $490,364, respectively.
 
(6)   The Company issued 1,121,252 common shares for cash proceeds of $3,384,787 in the nine months ending September 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 33,036,748 common shares outstanding as at October 26, 2005. If all of the Company’s warrants and options were exercised the Company would have 37,536,098 common shares outstanding.

 


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Financial Statements
Oncolytics Biotech Inc.
September 30, 2005

 


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Oncolytics Biotech Inc.
BALANCE SHEETS
(unaudited)
As at,
                 
    September 30,     December 31,  
    2005     2004  
    $     $  
     
ASSETS
               
Current
               
Cash and cash equivalents
    4,042,312       12,408,516  
Short-term investments
    24,164,014       21,510,707  
Accounts receivable
    48,450       47,767  
Prepaid expenses
    953,171       250,365  
     
 
    29,207,947       34,217,355  
 
               
Capital assets
    5,330,483       5,259,286  
 
               
Investments [note 4]
          12,000  
 
               
 
    34,538,430       39,488,641  
     
LIABILITIES AND SHAREHOLDERS’ EQUITY
               
Current
               
Accounts payable and accrued liabilities
    1,429,580       949,258  
     
Alberta Heritage Foundation loan
    150,000       150,000  
     
 
               
Shareholders’ equity
               
Share capital [note 2]
               
Authorized: unlimited
               
Issued: 33,036,748 common shares
(December 31, 2004 — 31,915,496 common shares)
    70,825,980       66,643,325  
Warrants [note 2]
    2,549,762       3,347,630  
Contributed surplus [note 3]
    6,375,091       6,349,139  
Deficit
    (46,791,983 )     (37,950,711 )
     
 
    32,958,850       38,389,383  
     
 
               
 
    34,538,430       39,488,641  
     
See accompanying notes

 


Table of Contents

Oncolytics Biotech Inc.
STATEMENTS OF LOSS AND DEFICIT
(unaudited)
                                         
                                    Cumulative from  
                                    inception  
    Nine Month     Nine Month     Three Month     Three Month     on April 2,  
    Period Ending     Period Ending     Period Ending     Period Ending     1998 to  
    September 30,     September 30,     September 30,     September 30,     September 30,  
    2005     2004     2005     2004     2005  
    $     $     $     $     $  
     
Revenue
                                       
Rights revenue
                            310,000  
Interest income
    623,615       494,816       210,978       194,001       3,409,355  
     
 
    623,615       494,816       210,978       194,001       3,719,355  
     
Expenses
                                       
Research and development
    6,499,034       5,682,712       2,818,063       2,232,381       29,940,562  
Operating
    2,111,427       2,112,883       585,600       565,466       12,202,221  
Stock based compensation [note 3]
    25,952       788,974       4,173       48,878       3,723,947  
Foreign exchange loss
    198,481       353,964       97,997       239,881       558,451  
Amortization
    632,283       554,476       216,173       190,620       3,294,129  
     
 
    9,467,177       9,493,009       3,722,006       3,277,226       49,719,310  
     
 
                                       
Loss before the following:
    8,843,562       8,998,193       3,511,028       3,083,225       45,999,955  
 
                                       
(Gain) loss on sale and write down of BCY LifeSciences Inc. [note 4]
    (765 )     (34,185 )           12,817       (299,403 )
 
                                       
Loss on sale of Transition Therapeutics Inc.
                            2,156,685  
     
 
                                       
Loss before taxes
    8,842,797       8,964,008       3,511,028       3,096,042       47,857,237  
 
                                       
Capital tax (recovery)
    (1,525 )     158       (1,525 )           49,746  
 
                                       
Future income tax recovery
                            (1,115,000 )
     
 
                                       
Net loss for the period
    8,841,272       8,964,166       3,509,503       3,096,042       46,791,983  
 
                                       
Deficit, beginning of period
    37,950,711       24,994,592       43,282,480       30,862,716        
     
 
                                       
Deficit, end of period
    46,791,983       33,958,758       46,791,983       33,958,758       46,791,983  
     
 
                                       
Basic and diluted loss per share
    0.27       0.31       0.11       0.11          
             
 
                                       
Weighted average number of shares
    32,702,843       28,552,643       32,983,922       29,448,859          
             
See accompanying notes

 


Table of Contents

Oncolytics Biotech Inc.
STATEMENTS OF CASH FLOWS
(unaudited)
                                         
                                    Cumulative from  
                                    inception on  
    Nine Month     Nine Month Period     Three Month Period     Three Month Period     April 2,  
    Period Ending     Ending September     Ending September     Ending September     1998 to September  
    September 30, 2005     30, 2004     30, 2005     30, 2004     30, 2005  
    $     $     $     $     $  
     
OPERATING ACTIVITIES
                                       
Net loss for the period
    (8,841,272 )     (8,964,166 )     (3,509,503 )     (3,096,042 )     (46,791,983 )
Deduct non-cash items
                                       
Amortization
    632,283       554,476       216,173       190,620       3,294,129  
Non-cash compensation
    25,952       788,974       4,173       48,878       3,723,947  
Foreign exchange loss
    74,555       353,964       35,905       239,881       340,537  
Cancellation of contingent payment obligation settled in common shares
          150,000             150,000       150,000  
(Gain) loss on sale and write down of BCY LifeSciences Inc.
    (765 )     (34,185 )           12,817       (299,403 )
Loss on sale of Transition Therapeutics Inc.
                            2,156,685  
Future income tax recovery
                            (1,115,000 )
Net changes in non-cash working capital
    (188,531 )     198,946       (297,460 )     633,728       319,702  
     
 
    (8,297,778 )     (6,951,991 )     (3,550,712 )     (1,820,118 )     (38,221,386 )
     
INVESTING ACTIVITIES
                                       
Intellectual property
    (706,982 )     (766,317 )     (242,223 )     (340,389 )     (4,330,617 )
Other capital assets
    (31,134 )     (8,793 )     (15,914 )     (900 )     (557,336 )
Purchase of short-term investments
    (5,470,458 )     (6,602,415 )     (136,620 )     (187,231 )     (30,359,245 )
Redemption of short-term investments
    2,747,396       3,114,000             1,114,000       5,861,396  
Investment in BCY LifeSciences Inc.
    7,965       133,609                   464,602  
Investment in Transition Therapeutics Inc.
                            2,532,343  
     
 
    (3,453,213 )     (4,129,916 )     (394,757 )     585,480       (26,388,857 )
     
FINANCING ACTIVITIES
                                       
Alberta Heritage Foundation loan
                            150,000  
Proceeds from exercise of warrants and stock options
    3,384,787       4,717,914       76,500       676,893       14,967,068  
Proceeds from private placements
          6,223,763                   22,741,983  
Proceeds from public offerings
                            30,793,504  
     
 
    3,384,787       10,941,677       76,500       676,893       68,652,555  
     
(Decrease) increase in cash and cash equivalents during the period
    (8,366,204 )     (140,230 )     (3,868,969 )     (557,745 )     4,042,312  
 
                                       
Cash and cash equivalents, beginning of the period
    12,408,516       2,641,127       7,911,281       3,058,642        
     
 
                                       
Cash and cash equivalents, end of the period
    4,042,312       2,500,897       4,042,312       2,500,897       4,042,312  
     
See accompanying notes

 


Table of Contents

Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
September 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              
 
                               
Exercise of warrants
    1,907,175       8,178,546       (1,907,175 )     (798,096 )
 
                               
Expired warrants
          2,827       (6,700 )     (2,827 )
 
                               
Exercise of options
    197,500       778,951              
 
                               
Share issue costs
          (1,796,758 )            
 
 
                               
Balance, December 31, 2004
    31,915,496       66,643,325       2,855,340       3,347,630  
 
                               
Exercise of options
    350,000       297,500              
 
                               
Exercise of warrants
    771,252       3,417,271       (771,252 )     (329,984 )
 
                               
Expired warrants
          467,884       (573,028 )     (467,884 )
 
 
                               
Balance September 30, 2005
    33,036,748       70,825,980       1,511,060       2,549,762  
 

 


Table of Contents

Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
September 30, 2005 (unaudited)
The following table summarizes the Company’s outstanding warrants as at September 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             768,972                    
$5.00
    45,558             2,280       43,278              
$6.25
    529,750                   529,750              
$7.00
    107,710                         107,710       0.02  
$7.06
    112,800                         112,800       0.65  
$7.75
    538,550                         538,550       0.02  
$8.00
    752,000                         752,000       2.15  
 
 
    2,855,340             771,252       573,028       1,511,060       1.17  
 
3. STOCK BASED COMPENSATION
Stock Option Plan
The Company has issued stock options to acquire common stock through its stock option plan of which the following are outstanding:
                                 
    September 30, 2005     September 30, 2004  
            Weighted Average             Weighted Average  
            Share Price             Share Price  
    Stock Options     $     Stock Options     $  
 
Outstanding at beginning of period
    3,805,550       4.39       2,800,800       3.81  
Granted during period
    200,000       3.18       284,500       7.66  
Cancelled during period
    (21,000 )     4.95              
Exercised during period
    (350,000 )     0.85       (197,500 )     2.31  
                       
Outstanding at end of period
    3,634,550       4.48       2,887,800       4.12  
                       
Options exercisable at end of period
    3,387,050       4.77       2,783,133       4.19  
                       

 


Table of Contents

Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
September 30, 2005 (unaudited)
The following table summarizes information about the stock options outstanding and exercisable at September 30, 2005:
                                         
            Weighted     Weighted             Weighted  
            Average     Average             Average  
            Remaining     Exercise             Exercise  
Range of   Number     Contractual     Price     Number     Price  
Exercise Prices   Outstanding     Life (years)     $     Exercisable     $  
 
$0.75 - $1.00
    632,550       4.1       0.85       632,550       0.85  
$1.65 - $2.37
    281,000       7.2       1.85       246,000       1.87  
$2.70 - $3.33
    678,750       8.1       3.10       478,750       3.06  
$4.00 - $5.00
    1,190,750       9.0       4.89       1,178,250       4.89  
$6.77 - $9.76
    708,500       6.4       8.66       708,500       8.66  
$12.15 - $13.50
    143,000       5.1       12.63       143,000       12.63  
 
 
    3,634,550       6.6       4.48       3,387,050       4.77  
  
As the Company is following the fair value based method of accounting for stock options, the Company recorded compensation expense of $4,173 and $25,952 for the three and nine month periods ending September 30, 2005 respectively, (September 30, 2004 — $48,878 and $788,974 respectively) with respect to the vesting of options issued in prior periods with an offsetting credit to contributed surplus.
The estimated fair value of stock options issued during the period was determined using the Black-Scholes model using the following weighted average assumptions and fair value of options:
                 
    2005     2004  
 
Risk-free interest rate
    3.27%       2.83%  
Expected hold period to exercise
  3.5 years   2 years
Volatility in the price of the Company’s shares
    64%       71%  
Dividend yield
  Zero   Zero
Weighted average fair value of options
    $1.51       $2.26  
 
In 2002, the Company granted 48,000 share incentive rights to a non-employee which, when exercised by the holder, would require payment in cash or shares, at the sole option of the Company for amounts in excess of $2.31 based on the weighted average trading price for the ten trading days prior to the exercise. The Company accounted for this transaction with a non-employee at fair value determined using the Black-Scholes model. The related compensation expense recorded in 2003 was $81,530, with an offsetting credit to contributed surplus. During the third quarter of 2005, these share incentive rights were surrendered. In accordance with generally accepted accounting principles, no credit to expense was recorded as a result of the surrender.

 


Table of Contents

Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
September 30, 2005 (unaudited)
4. INVESTMENTS
During the three and nine month periods ending September 30, 2005, the Company sold nil and 120,000 (September 30, 2004 — nil and 697,945) of its BCY LifeSciences Inc. (“BCY”) shares for net cash proceeds of $nil and $7,965 (September 30, 2004 — nil and $133,609) recording a gain on sale (write down) of investment of $nil and $765 (September 30, 2004 — ($12,817) and $34,815), respectively. As at September 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.
5. COMPARATIVE FIGURES
Certain comparative figures have been reclassified to conform with the current period’s presentation.
6. SUBSEQUENT EVENT
On October 7, 2005, 538,550 warrants with an exercise price of $7.75 and 107,710 broker warrants with an exercise price of $7.00 expired unexercised. These warrants were issued as part of the Company’s April 7, 2004 private placement.

 


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Shareholder Information
For public company filings please go to www.sedar.com or contact us at:
Oncolytics Biotech Inc.
Suite 210, 1167 Kensington Crescent NW
tel: 403.670.7377 fax: 403.283.0858
Calgary, Alberta, Canada T2N 1X7
www.oncolyticsbiotech.com
Officers
Brad Thompson, PhD
Chairman, President and CEO
Doug Ball, CA
Chief Financial Officer
Matt Coffey, PhD
Chief Scientific Officer
Karl Mettinger, MD, PhD
Chief Medical Officer
George Gill, MD
Senior Vice President, Clinical and Regulatory Affairs
Directors
Brad Thompson, PhD
Chairman, President and CEO, Oncolytics Biotech Inc.
Doug Ball, CA
CFO, Oncolytics Biotech Inc.
William. A. Cochrane, OC, MD
Biotech Consultant
Jim Dinning
Chairman, Western Financial Group
J. Mark Lievonen, CA
President, Sanofi Pasteur Limited
Tony Noujaim, PhD
CEO and Chairman, ViRexx Medical Corp.
Bob Schultz, FCA
Chairman, Rockwater Capital Corporation
Fred Stewart, QC
President, Fred Stewart and Associates Inc.

 


Table of Contents

Oncolytics Biotech Inc.
Suite 210, 1167 Kensington Crescent NW, Calgary, AB T2N 1X7
Phone: (403) 670.7377 Fax: (403) 283.0858
www.oncolyticsbiotech .com