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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 November, 2006

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: November 3, 2006   By:   /s/ Doug Ball
Doug Ball
Chief Financial Officer

 


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(ONCOLYTICS LOGO)
  210, 1167 Kensington Cr. N.W.
Calgary, Alberta
Canada T2N 1X7
 
FOR IMMEDIATE RELEASE
Oncolytics Biotech Inc. Announces 2006 Third Quarter Results
CALGARY, AB, — November 3, 2006 - Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) today announced its financial results and highlights for the three and nine month periods ended September 30, 2006.
Third Quarter Highlights
    Received approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to begin enrolment in a Phase II combination REOLYSIN®/radiation trial
 
    Commenced enrolment in both a Phase Ib combination REOLYSIN®/radiation clinical trial in the U.K. and a Phase I/II recurrent malignant gliomas (brain cancer) trial in the U.S.
 
    Completed enrolment in a Phase I U.S. systemic delivery trial for REOLYSIN®
 
    Presented a poster at the 1st Joint Meeting of European National Societies of Immunology entitled “Reovirus Activates Dendritic Cells (DC) and Promotes Innate Anti-Tumour Immunity.”
“Oncolytics is making significant progress in its human clinical program for REOLYSIN®, including the completion of enrolment in our systemic administration trial in the U.S. and the recent approval to begin a Phase II combination REOLYSIN®/radiation trial in the U.K.,” 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. as at and for the three and nine months ended September 30, 2006 and 2005, 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 our annual report for the year ended December 31, 2005. 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 our belief as to the potential of REOLYSIN® as a cancer therapeutic and our expectations as to the success of our research and development and manufacturing programs in 2006 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 our actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the need for and 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, our ability to successfully commercialize REOLYSIN®, uncertainties related to the research, development and manufacturing of pharmaceuticals, uncertainties related to competition, changes in technology, the regulatory process and general changes to the economic environment. Investors should consult our 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

 


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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. We do not undertake to update these forward-looking statements.
OVERVIEW
Oncolytics Biotech Inc. is a Development Stage Company
Since our inception in April of 1998, Oncolytics Biotech Inc. has been a development stage company and we have focused our research and development efforts on the development of REOLYSIN®, our potential cancer therapeutic. We have not been profitable since our inception and expect to continue to incur substantial losses as we continue research and development efforts. We do not expect to generate significant revenues until, if and when, our 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 we 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 pharmaceutical product, we rely upon our employees, contractors, consultants and collaborators and other third party relationships, including our 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 Oncolytics.
REOLYSIN ® Development Update for the Third Quarter of 2006
We continue to develop our lead product REOLYSIN® as a possible cancer therapy. Our goal each year is to advance REOLYSIN® through the various steps and stages of development required for potential pharmaceutical products. In order to achieve this goal, we actively manage the development of our clinical trial program, our pre-clinical and collaborative programs, our manufacturing process and REOLYSIN® supply, and our intellectual property.
Clinical Trial Program
During the third quarter of 2006, the following clinical trial activity occurred:
U.K. Phase II Combination REOLYSIN®/Radiation Clinical Trial
During the third quarter of 2006, we received a letter of approval from the U.K. Medicines and Healthcare products Regulatory Agency for our Clinical Trial Application to begin a Phase II clinical trial to evaluate the anti-tumour effects of intratumoural administration of REOLYSIN® in combination with low-dose radiation in patients with advanced cancers. Since receiving this letter of approval, we have been working with our investigators and the clinical trial sites to initiate patient enrollment which is expected to occur in the fourth quarter of 2006.
The trial is to be an open-label, single-arm, multi-centre Phase II study of REOLYSIN® delivered via intratumoural injection to patients during treatment with low-dose radiotherapy. Up to 40 evaluable patients, including approximately 20 patients with head and neck and esophageal cancers, and approximately 20 patients with other advanced cancers, will be treated with two intratumoural doses of REOLYSIN® at 1x1010 TCID50 with a constant localized radiation dose of 20 Gy in five consecutive daily fractions. Eligible patients include those who have been diagnosed with advanced or metastatic cancers including head, neck and esophageal tumours that are refractory (have not responded) to standard therapy or for which no curative standard therapy exists.

 


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The primary objective of the trial is to assess the anti-tumour activity of the combination of REOLYSIN® and low dose radiotherapy in treated and untreated lesions. Secondary objectives include the evaluation of viral replication, immune response to the virus and to determine the safety and tolerability of intratumoural administration of REOLYSIN® in patients with advanced cancers who are receiving radiation treatment.
U.K. Phase Ia/Ib Combination REOLYSIN®/Radiation Clinical Trial
During the third quarter of 2006, we commenced patient enrolment in our Phase Ib U.K. clinical trial investigating REOLYSIN® in combination with radiation therapy as a treatment for patients with advanced cancers. The Phase Ib trial will treat patients with a range of two to six intratumoural doses of REOLYSIN® at 1x1010 TCID50 with a constant radiation dose of 36 Gy in 12 fractions.
The primary objective of our Phase Ib trial is to determine the maximum tolerated dose, dose limiting toxicity, and safety profile of REOLYSIN® when administered intratumourally to patients receiving radiation treatment. A secondary objective is to examine any evidence of anti-tumour activity. Eligible patients include those who have been diagnosed with advanced or metastatic solid tumours that are refractory (have not responded) to standard therapy or for which no curative standard therapy exists. An additional group of patients is planned to be treated at the maximum dose regimen reached in the Ib trial.
Patient enrolment in our Ia combination REOLYSIN®/radiation trial was completed in June 2006. The Phase Ia trial tested two intratumoural treatments of REOLYSIN® at dosages of 1x108, 1x109, or 1x1010 TCID50 with a constant localized radiation dose of 20 Gy given in five fractions. A maximum tolerated dose was not reached and the combination treatment appears to have been well tolerated by the patients.
Interim results of the Ia trial were presented at the American Association for Cancer Research Annual Meeting in Washington, D.C. in April 2006. Preliminary analysis has demonstrated evidence of both local and systemic response.
U.S. Phase I Systemic Administration Clinical Trial
During the third quarter of 2006, we completed patient enrolment in our Phase I U.S. clinical trial investigating the systemic delivery of REOLYSIN® to treat patients with advanced cancers. A total of 18 patients were treated in the Phase I trial with REOLYSIN® at escalating dosages of 1x108, 3x108, 1x109, 3x109, 1x1010 or 3x1010 TCID50. A maximum tolerated dose was not reached and the treatment appears to have been well tolerated by the patients.
The clinical trial is an open-label, dose-escalation Phase I study in which a single dose of REOLYSIN® is administered intravenously to patients diagnosed with selected advanced or metastatic solid tumours that are refractory (have not responded) to standard therapy or for which no curative standard therapy exists. The primary objective of the study is to determine the maximum tolerated dose, dose limiting toxicity and safety profile of REOLYSIN®. Secondary objectives include the evaluation of viral replication, immune response to the virus and any evidence of anti-tumour activity.
U.S. Phase I/II Recurrent Malignant Glioma Clinical Trial
During the third quarter of 2006, we began patient enrolment in our clinical trial to investigate the use of REOLYSIN® for patients with recurrent malignant gliomas. This clinical trial is an open-label dose escalation Phase I/II trial in which a single dose of REOLYSIN® is administered by infusion to patients with recurrent malignant gliomas that are refractory to standard therapy. The administration involves the stereotactically-guided placement of a needle into the tumour, through which REOLYSIN® will be administered or infused into the tumour mass and surrounding tissue using a pump.
The primary objective of the study is to determine the maximum tolerated dose, dose limiting toxicity and safety profile of REOLYSIN®. Secondary objectives include the evaluation of viral replication, immune response to the virus and any evidence of anti-tumour activity.
Other Clinical Trial Activity
During the third quarter, we continued to develop our Phase II clinical trial program which included the assessment of different cancer indications and potential drug combinations, the interviewing and selection of investigators and clinical trial sites, and the contracting of Contract Research Organizations.

 


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Manufacturing and Process Development
In the first part of 2006, we completed the production runs that were ongoing at the end of 2005, providing us with sufficient product to complete our U.K. Phase II combination REOLYSIN®/radiation clinical trial and our existing Phase I clinical trials. At the same time, our process development activity helped improve virus yields from our manufacturing process. We completed the transfer of these improvements to our cGMP manufacturer at the beginning of the third quarter of 2006 and began production runs under this improved process. These production runs are expected to provide sufficient REOLYSIN® to expand our Phase II clinical trial program. Our process development activity has now shifted focus to the examination of the potential scale up of our manufacturing process.
Pre-Clinical Trial and Collaborative Program
We perform pre-clinical studies and engage in collaborations to help support our clinical trial programs and expand our intellectual property base. We continue with studies examining the interaction between the immune system and the reovirus, the use of the reovirus as a co-therapy with chemotherapeutics and radiation, the use of new RAS active viruses as potential therapeutics, and to consider other uses for the reovirus as a therapeutic.
Financial Impact
We estimated at the end of the second quarter of 2006 that our monthly cash usage for the year would average approximately $1,250,000. Our cash usage for the nine months ending September 30, 2006 was $8,456,752 from operating activities and $581,661 for the purchases of intellectual property and property and equipment. Our net loss for the nine month period ending September 30, 2006 was $9,407,419. We expect that our monthly cash usage will continue to increase through the fourth quarter of 2006 as we complete our ongoing production runs, continue to enroll patients in our ongoing clinical trials, and expand our clinical trial and collaborative programs. We now believe our average monthly cash usage will be less than $1,200,000 for 2006.
Cash Resources
We exited the second quarter of 2006 with cash resources totaling $31,495,254 (see “Liquidity and Capital Resources”).
Expected REOLYSIN ® Development for the Remainder of 2006
For the remainder of 2006, we expect to continue to enroll patients in our existing clinical trials. We also expect to conclude enrollment in the expanded maximum delivered dose cohort in our U.K. Phase I systemic administration clinical trial. Also, along with our existing REOLYSIN® /radiation Phase II clinical trial, we plan to move into REOLYSIN®/chemotherapy co-therapy Phase II clinical trials and REOLYSIN® monotherapy Phase II clinical trials. The REOLYSIN®/chemotherapy clinical trial program will consist of small dose escalation Phase I studies to assess the safety of each co-therapy drug combination followed by Phase II clinical trials.
Recent 2006 Progress
On September 9, 2006 a poster, prepared by one of our collaborators, entitled “Reovirus Activates Dendritic Cells and Promotes Innate Anti-Tumour Immunity” was presented at the 1st Joint Meeting of European National Societies of Immunology. The poster highlighted the researchers’ use of isolated human cells to examine whether the use of the reovirus as a direct tumour killing agent might also activate the innate immune system to play a role in the killing of tumour cells. The innate immune system is the broad, short-term and non-specific first-line immune response to an infection. The research showed that the reovirus can infect and activate immature human dendritic cells. The reovirus-activated dendritic cells triggered anti-tumour cytotoxicity when co-cultured with two other types of immune cells, natural killer cells and autologous T-cells. The researchers concluded that the reovirus may support early innate anti-tumour immunity as well as inducing direct tumour cell death.

 


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THIRD QUARTER RESULTS OF OPERATIONS
(for the three months ended September 30, 2006 and 2005)
Net loss for the three month period ending September 30, 2006 was $3,425,169 compared to $3,509,503 for the three month period ending September 30, 2005.
Research and Development Expenses (“R&D”)
                 
    2006   2005
    $   $
 
Manufacturing and related process development expenses
    1,259,716       1,767,524  
Clinical trial expenses
    688,435       372,825  
Pre-clinical trial and research collaboration expenses
    301,165       64,611  
Other R&D expenses
    456,430       613,103  
 
Research and development expenses
    2,705,746       2,818,063  
 
For the third quarter of 2006, R&D decreased to $2,705,746 compared to $2,818,063 for the third quarter of 2005. The decrease in R&D was due to the following:
Manufacturing & Related Process Development (“M&P”)
                 
    2006   2005
    $   $
 
Product manufacturing expenses
    896,776       1,655,390  
Technology transfer expenses
    184,761        
Process development expenses
    178,179       112,134  
 
Manufacturing and related process development expenses
    1,259,716       1,767,524  
 
Our M&P expenses for the third quarter of 2006 decreased to $1,259,716 compared to $1,767,524 for the third quarter of 2005. In the third quarter of 2006, we completed the technology transfer that commenced in the second quarter of 2006. Our process development studies, that had been ongoing since 2005, resulted in improvements in virus yields. Once this technology transfer was completed we began production runs that will be used to supply our expanding Phase II and Phase I/II clinical trials. During the third quarter of 2005, we were in the midst of a multiple run supply contract, producing REOLYSIN® for our Phase I trials and did not incur technology transfer related costs.
In the third quarter of 2006, we incurred process development activity primarily associated with scale up compared to virus yield studies in the third quarter of 2005.
Clinical Trial Program
                 
    2006   2005
    $   $
 
Direct clinical trial expenses
    639,719       371,768  
Other clinical trial expenses
    48,716       1,057  
 
Clinical trial expenses
    688,435       372,825  
 
During the third quarter of 2006, our direct clinical trial expenses increased to $639,719 compared to $371,768 for the third quarter of 2005. In the third quarter of 2006, we incurred direct clinical trial expenses in four clinical trials that were actively enrolling patients along with clinical site start up costs associated with our Phase II combination REOLYSIN®/radiation clinical trial in the U.K. In the third quarter of 2005, we incurred direct clinical trial expenses in only three clinical trials along with clinical site start up costs in the U.S.

 


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Pre-Clinical Trial Expenses and Research Collaborations
                 
    2006   2005
    $   $
 
Research collaboration expenses
    252,460       64,611  
Pre-clinical trial expenses
    48,705        
 
Pre-clinical trial expenses and research collaborations
    301,165       64,611  
 
During the third quarter of 2006, our research collaboration expenses were $252,460 compared to $64,611 in the third quarter of 2005. Our research collaboration activity continues to focus on the interaction of the immune system and the reovirus, the use of the reovirus as a co-therapy with chemotherapeutics and radiation, the use of new RAS active viruses as potential therapeutics, and to consider other uses of the reovirus as a therapeutic.
Other Research and Development Expenses
                 
    2006   2005
    $   $
 
R&D consulting fees
    70,323       384,725  
R&D salaries and benefits
    299,224       187,035  
Other R&D expenses
    86,883       41,343  
 
Other research and development expenses
    456,430       613,103  
 
During the third quarter of 2006, our R&D consulting fees decreased to $70,323 compared to $384,725 in 2005. In the third quarter of 2005 we incurred consulting costs associated with the recruitment of our Chief Medical Officer, the activities of our scientific advisory board and consulting activity in support of our clinical trial activities. In the third quarter of 2006, we only incurred consulting fees associated with our clinical trial activity.
Our R&D salaries and benefits costs were $299,224 in the third quarter of 2006 compared to $187,035 in the third quarter of 2005. The increase is a result of increases in compensation and staff levels along with the hiring of our Chief Medical Officer in the third quarter of 2005.
Operating Expenses
                 
    2006   2005
    $   $
 
Public company related expenses
    507,828       390,473  
Office expenses
    258,790       195,127  
 
Operating expenses
    766,618       585,600  
 
During the third quarter of 2006, our public company related expenses increased to $507,828 compared to $390,473 for the third quarter of 2005. During this period we engaged additional investor relations services compared to the third quarter of 2005. Our office expenses in the third quarter of 2006 increased to $258,790 compared to $195,127 in the third quarter of 2005. Our office expenses have increased due to increased compensation levels and a general increase in office costs.
Stock Based Compensation
                 
    2006   2005
    $   $
 
Stock based compensation
    34,671       4,173  
 
Stock based compensation for the third quarter of 2006 increased to $34,671 compared to $4,173 for the third quarter of 2005. In the third quarters of 2006 and 2005, we incurred stock based compensation associated with the vesting of previously granted options.

 


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YEAR TO DATE RESULTS OF OPERATIONS
(for the nine months ended September 30, 2006 and 2005)
Net loss for the nine month period ending September 30, 2006 was $9,407,419 compared to $8,841,272 for the nine month period ending September 30, 2005.
Research and Development Expenses (“R&D”)
                 
    2006   2005
    $   $
 
Manufacturing and related process development expenses
    2,751,207       3,584,430  
Clinical trial expenses
    1,920,467       1,154,677  
Pre-clinical trial and research collaboration expenses
    691,553       524,472  
Other R&D expenses
    1,219,460       1,235,455  
 
Research and development expenses
    6,582,687       6,499,034  
 
For the nine month period ending September 30, 2006, R&D increased to $6,582,687 compared to $6,499,034 for 2005. The increase in R&D was due to the following:
Manufacturing & Related Process Development (“M&P”)
                 
    2006   2005
    $   $
 
Product manufacturing expenses
    1,664,308       3,406,588  
Technology transfer expenses
    457,975       ¾  
Process development expenses
    628,924       177,842  
 
Manufacturing and related process development expenses
    2,751,207       3,584,430  
 
Our M&P expenses for the nine month period ending September 30, 2006 decreased to $2,751,207 compared to $3,584,430 in 2005. In the first part of 2006, we completed the production runs that were ongoing at the end of 2005, providing us with sufficient product to complete our U.K. Phase II combination REOLYSIN®/radiation clinical trial and our existing Phase I clinical trials. At the same time, our process development activity helped improve virus yields from our manufacturing process. We completed the transfer of the improvements in our process to our cGMP manufacturer at the beginning of the third quarter of 2006 and began campaigning production runs in order to provide us with sufficient REOLYSIN® to expand our Phase II clinical trial program. Our process development activity has now shifted focus to the examination of the potential scale up of our manufacturing process.
In 2005, we were focused on the production of REOLYSIN® to supply the clinical trials enrolling at that time and to provide a supply for the two U.S. monotherapy and the U.K. combination trials approved in the first half of 2005. Our process development activity commenced work on improving production yields in the third quarter of 2005.
We continue to believe that our manufacturing and related process development expenses for 2006 will be in line with 2005.
Clinical Trial Program
                 
    2006   2005
    $   $
 
Direct clinical trial expenses
    1,783,138       1,067,927  
Other clinical trial expenses
    137,329       86,750  
 
Clinical trial expenses
    1,920,467       1,154,677  
 
During the nine month period ending September 30, 2006, our direct clinical trial expenses increased to $1,783,138 compared to $1,067,927 for the nine month period ending September 30, 2005. During this period of 2006, we incurred direct patient costs in our four ongoing clinical trials along with clinical site start up costs associated with our U.K. phase II combination REOLYSIN®/radiation trial and our U.S. recurrent malignant glioma trial. In 2005, we were incurring direct patient costs

 


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associated with three enrolling clinical trial studies along with clinical site start up costs associated with our U.K. Phase Ia combination REOLYSIN®/radiation therapy and our U.S. systemic and glioma clinical trials.
We expect our clinical trial expenses will continue to increase for the remainder of 2006 compared to 2005. The increase in these expenses is expected to arise from enrollment in our existing clinical trial program and expansion into Phase II clinical trials.
Pre-Clinical Trial Expenses and Research Collaborations
                 
    2006   2005
    $   $
 
Research collaboration expenses
    634,199       427,719  
Pre-clinical trial expenses
    57,354       96,753  
 
Pre-clinical trial expenses and research collaborations
    691,553       524,472  
 
During the nine month period ending September 30, 2006, our research collaboration expenses were $634,199 compared to $427,719 for the nine month period ending September 30, 2005. Our research collaboration activity continues to focus on the interaction of the immune system and the reovirus, the use of the reovirus as a co-therapy with chemotherapeutics and radiation, the use of new RAS active viruses as potential therapeutics, and to consider other uses of the reovirus as a therapeutic.
During the nine month period ending September 30, 2006, our pre-clinical trial expenses were $57,354 compared to $96,753 for the nine month period ending September 30, 2005. The frequency of our pre-clinical trial expenses change from period to period as we move through our development program. As well, we may increase our pre-clinical activity depending on the results of our research collaborations.
For the remainder of 2006, we now expect that pre-clinical trial expenses and research collaborations will increase compared to 2005. We expect to continue expanding our collaborations in order to provide support for our expanding clinical trial program and identify new areas for investigation. Also, in our efforts to enter into additional combination therapy clinical trials we may be required to perform additional pre-clinical trial studies.
Other Research and Development Expenses
                 
    2006   2005
    $   $
 
R&D consulting fees
    134,650       550,594  
R&D salaries and benefits
    907,115       562,373  
Quebec scientific research and experimental development refund
    (52,344 )      
Other R&D expenses
    230,039       122,488  
 
Other research and development expenses
    1,219,460       1,235,455  
 
During the nine month period ending September 30, 2006, our R&D consulting fees decreased to $134,650 compared to $550,594 in 2005. In this period of 2005, we incurred consulting costs associated with the recruiting of our Chief Medical Officer and our two U.S. clinical trial applications. In 2006 we have not incurred this type of consulting service.
Our R&D salaries and benefits costs were $907,115 for the nine month period ending September 30, 2006 compared to $562,373 for the nine month period ending September 30, 2005. The increase is a result of increases in salary levels along with the hiring of our Chief Medical Officer in the third quarter of 2005.
We expect that our Other Research and Development Expenses for the remainder of 2006 will remain consistent with 2005. We expect that salaries and benefits will increase as 2006 should include a complete year of salary and benefit costs for our Chief Medical Officer. This increase should be offset by a decline in our R&D consulting fees as we do not expect to require the same level of consulting services in 2006 as we incurred in 2005. However, we may choose to engage additional consultants to assist us in the development of protocols and regulatory filings for our additional combination therapy and Phase II clinical trial studies, possibly causing our R&D consulting expenses to increase.

 


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Operating Expenses
                 
    2006   2005
    $   $
 
Public company related expenses
    2,007,464       1,484,605  
Office expenses
    782,183       626,822  
 
Operating expenses
    2,789,647       2,111,427  
 
During the nine month period ending September 30, 2006, our public company related expenses increased to $2,007,464 compared to $1,484,605 for the nine month period ending September 30, 2005. The increase in public company related expenses was a result of incurring financial advisory services, executive search consulting fees associated with the appointment of two new directors and an increase in our investor relations activity in 2006 compared to 2005.
During the nine month period ending September 30, 2006, our office expenses increased to $782,183 compared to $626,822 for the nine month period ending September 30, 2005. Our office expenses have increased due to increased compensation levels and a general increase in office costs.
Stock Based Compensation
                 
    2006   2005
    $   $
 
Stock based compensation
    293,880       25,952  
 
Stock based compensation for the nine month period ending September 30, 2006 increased to $293,880 compared to $25,952 for the nine month period ending September 30, 2005. During this period in 2006, we incurred stock based compensation associated with the issue and immediate vesting of stock options to our two newly appointed directors and the vesting of previously granted options.
Commitments
As at September 30, 2006, we are committed to payments totaling $1,624,000 during the remainder of 2006 for activities related to clinical trial activity and collaborations. All of these committed payments are considered to be part of our normal course of business.
SUMMARY OF QUARTERLY RESULTS
The following unaudited quarterly information is presented in thousands of dollars except for per share amounts:
                                                                 
    2006   2005   2004
    Sept.   June   March   Dec.   Sept.   June   March   Dec.
Revenue(1)
    320       335       292       160       211       168       245       205  
Net loss(4)
    3,425       2,988       2,995       3,941       3,510       2,955       2,377       3,992  
Basic and diluted loss per common share(4)
  $ 0.09     $ 0.08     $ 0.08     $ 0.12     $ 0.11     $ 0.09     $ 0.07     $ 0.14  
Total assets(2), (5)
    37,980       40,828       43,660       46,294       34,538       38,081       40,519       39,489  
Total cash(3), (5)
    31,495       34,501       37,687       40,406       28,206       31,975       34,713       33,919  
Total long-term debt(6)
    150       150       150       150       150       150       150       150  
Cash dividends declared(7)
  Nil     Nil     Nil     Nil     Nil     Nil     Nil     Nil  
 
(1)   Revenue is comprised of interest income and income from short term investments.
 
(2)   Subsequent to the acquisition of Oncolytics Biotech Inc. by SYNSORB in April 1999, we applied push down accounting. See note 2 to the audited financial statements for 2005.
 
(3)   Included in total cash are cash and cash equivalents plus short-term investments.
 
(4)   Included in net loss and loss per common share between September 2006 and Sept 2004 are quarterly stock based compensation expenses of $34,671, $222,376, $36,833, $38,152, $4,173, $8,404, $13,375, and $1,870,596, respectively.

 


Table of Contents

(5)   We issued 150,000 common shares in 2006 for cash proceeds of $127,500 (2005 – 4,321,252 common shares for cash proceeds of $18,789,596; 2004 – 4,685,775 common shares for $23,495,961).
 
(6)   The long-term debt recorded represents repayable loans from the Alberta Heritage Foundation.
 
(7)   We have not declared or paid any dividends since incorporation.
LIQUIDITY AND CAPITAL RESOURCES
Liquidity
As at September 30, 2006, we had cash and cash equivalents (including short-term investments) and working capital positions of $31,495,254 and $30,400,183, respectively compared to $40,406,167 and $39,301,444, respectively for December 31, 2005. The decrease in 2006 reflects cash usage from operating activities and purchases of intellectual property of $8,456,752 and $552,319, respectively with cash inflows from financing activities of $127,500.
We desire to maintain adequate cash and short-term investment reserves to support our planned activities which include our clinical trial program, product manufacturing, collaborations, administrative costs, and our intellectual property expansion and protection. For the remainder of 2006, we expect our monthly cash usage to continue to increase as we manufacture REOLYSIN®, enroll patients in our ongoing clinical trials, and expand our clinical trial and collaborative programs. We expect that our average monthly cash usage for 2006 will be less than $1,200,000 per month and we believe our existing capital resources are adequate to fund our current plans for research and development activities well into 2008. Factors that will affect our anticipated average monthly burn rate include, but are not limited to, the number of manufacturing runs and activities required to supply our 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 each clinical trial, 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 we choose to seek additional capital, we will look to fund additional capital requirements primarily through the issue of additional equity. We recognize the challenges and uncertainty inherent in the capital markets and the potential difficulties we might face in raising additional capital. Market prices and market demand for securities in biotechnology companies are volatile and there are no assurances that we will have the ability to raise funds when required.
Capital Expenditures
We spent $187,283 on intellectual property in the third quarter of 2006 compared to $242,223 in the third quarter of 2005. The change in intellectual property expenditures reflects the timing of filing costs associated with our expanded patent base. As well, we have benefited from a stronger Canadian dollar as our patent costs are typically incurred in U.S. currency. As at the end of the third quarter of 2006, we had been issued 17 U.S., five Canadian and three European patents.
Investing Activities
Under our Investment Policy, we are permitted to invest in short-term instruments with a rating no less than R-1 (DBRS) with terms less than two years. We have $27,538,168 invested under this policy and we are currently earning interest at an effective rate of 3.89% (2005 – 2.86%).
OTHER MD&A REQUIREMENTS
We have 36,386,748 common shares outstanding at November 2, 2006. If all of our warrants (2,672,000) and options (3,584,550) were exercised we would have 42,643,298 common shares outstanding.
Additional information relating to Oncolytics Biotech Inc. is available on SEDAR at www.sedar.com.

 


Table of Contents

Oncolytics Biotech Inc.
BALANCE SHEETS
(unaudited)
As at,
                 
    September 30,   December 31,
    2006   2005
    $   $
 
ASSETS
               
Current
               
Cash and cash equivalents
    3,957,086       3,511,357  
Short-term investments
    27,538,168       36,894,810  
Accounts receivable
    37,640       47,390  
Prepaid expenses
    1,231,697       540,368  
 
 
    32,764,591       40,993,925  
 
               
Property and equipment
    152,358       189,863  
 
               
Intellectual property
    5,063,265       5,110,538  
 
 
               
 
    37,980,214       46,294,326  
 
 
               
LIABILITIES AND SHAREHOLDERS’ EQUITY
               
Current
               
Accounts payable and accrued liabilities
    2,364,408       1,692,481  
 
Alberta Heritage Foundation loan
    150,000       150,000  
 
 
               
Shareholders’ equity
               
Share capital [note 2]
               
Authorized: unlimited number of common shares
               
Issued: 36,386,748 (December 31, 2005 – 36,236,748)
    84,681,904       84,341,212  
Warrants [note 2]
    4,216,740       4,429,932  
Contributed surplus [note 3]
    6,707,123       6,413,243  
Deficit
    (60,139,961 )     (50,732,542 )
 
 
    35,465,806       44,451,845  
 
 
               
 
    37,980,214       46,294,326  
 
See accompanying notes

 


Table of Contents

Oncolytics Biotech Inc.
STATEMENTS OF LOSS AND DEFICIT
(unaudited)
                                         
                                    Cumulative
    Nine Month   Nine Month   Three Month   Three Month   from inception
    Period   Period   Period   Period   on April 2,
    Ending   Ending   Ending   Ending   1998 to
    September   September   September   September   September 30,
    30, 2006   30, 2005   30, 2006   30, 2005   2006
    $   $   $   $   $
 
Revenue
                                       
Rights revenue
    ¾       ¾       ¾       ¾       310,000  
Interest income
    947,364       623,615       320,454       210,978       4,516,560  
 
 
    947,364       623,615       320,454       210,978       4,826,560  
 
 
                                       
Expenses
                                       
Research and development
    6,582,687       6,499,034       2,705,746       2,818,063       39,418,192  
Operating
    2,789,647       2,111,427       766,618       585,600       15,880,338  
Stock based compensation [note 3]
    293,880       25,952       34,671       4,173       4,055,979  
Foreign exchange loss/(gain)
    (2,703 )     198,481       5,129       97,997       610,875  
Amortization – intellectual property
    647,893       580,949       220,774       199,131       3,810,684  
Amortization – property and equipment
    43,379       51,334       12,685       17,042       398,425  
 
 
    10,354,783       9,467,177       3,745,623       3,722,006       64,174,493  
 
 
                                       
Loss before the following:
    9,407,419       8,843,562       3,425,169       3,511,028       59,347,933  
 
                                       
Gain on sale of BCY LifeSciences Inc.
    ¾       (765 )     ¾       ¾       (299,403 )
 
                                       
Loss on sale of Transition Therapeutics Inc.
    ¾       ¾       ¾       ¾       2,156,685  
 
 
                                       
Loss before taxes
    9,407,419       8,842,797       3,425,169       3,511,028       61,205,215  
 
                                       
Capital tax
    ¾       (1,525 )     ¾       (1,525 )     49,746  
 
                                       
Future income tax recovery
    ¾       ¾       ¾       ¾       (1,115,000 )
 
 
                                       
Net loss for the period
    9,407,419       8,841,272       3,425,169       3,509,503       60,139,961  
 
                                       
Deficit, beginning of period
    50,732,542       37,950,711       56,714,792       43,282,480       ¾  
 
 
                                       
Deficit, end of period
    60,139,961       46,791,983       60,139,961       46,791,983       60,139,961  
 
 
                                       
Basic and diluted loss per share
    0.26       0.27       0.09       0.11          
         
 
                                       
Weighted average number of shares
    36,317,687       32,702,843       36,368,270       32,983,922          
         
     See accompanying notes

 


Table of Contents

Oncolytics Biotech Inc.
STATEMENTS OF CASH FLOWS
(unaudited)
                                         
                    Three   Three   Cumulative
    Nine Month   Nine Month   Month   Month   from inception
    Period   Period   Period   Period   on April 2,
    Ending   Ending   Ending   Ending   1998 to
    September   September   September   September   September 30,
    30, 2006   30, 2005   30, 2006   30, 2005   2006
    $   $   $   $   $
 
OPERATING ACTIVITIES
                                       
Net loss for the period
    (9,407,419 )     (8,841,272 )     (3,425,169 )     (3,509,503 )     (60,139,961 )
Deduct non-cash items Amortization – intellectual property
    647,893       580,949       220,774       199,131       3,810,684  
Amortization – property and equipment
    43,379       51,334       12,685       17,042       398,425  
Stock based compensation
    293,880       25,952       34,671       4,173       4,055,979  
Other non-cash items [note 4]
    ¾       73,790       ¾       35,905       1,383,537  
Net changes in non-cash working capital [note 4]
    (34,485 )     (188,531 )     261,875       (297,460 )     1,058,514  
 
 
    (8,456,752 )     (8,297,778 )     (2,895,164 )     (3,550,712 )     (49,432,822 )
 
 
                                       
INVESTING ACTIVITIES
                                       
Intellectual property
    (552,319 )     (706,982 )     (187,283 )     (242,223 )     (5,208,989 )
Property and equipment
    (29,342 )     (31,134 )     (8,294 )     (15,914 )     (616,853 )
Purchase of short-term investments
    (801,358 )     (5,470,458 )     (261,480 )     (136,620 )     (47,885,398 )
Redemption of short-term investments
    10,158,000       2,747,396       ¾       ¾       19,928,746  
Investment in BCY LifeSciences Inc.
    ¾       7,965       ¾       ¾       464,602  
Investment in Transition Therapeutics Inc.
    ¾       ¾       ¾       ¾       2,532,343  
 
 
    8,774,981       (3,453,213 )     (457,057 )     (394,757 )     (30,785,549 )
 
 
                                       
FINANCING ACTIVITIES
                                       
Alberta Heritage Foundation loan
    ¾       ¾       ¾       ¾       150,000  
Proceeds from exercise of warrants and stock options
    127,500       3,384,787       85,000       76,500       15,094,568  
Proceeds from private placements
    ¾       ¾       ¾       ¾       38,137,385  
Proceeds from public offerings
    ¾       ¾       ¾       ¾       30,793,504  
 
 
    127,500       3,384,787       85,000       76,500       84,175,457  
 
 
                                       
Increase (decrease) in cash and cash equivalents during the period
    445,729       (8,366,204 )     (3,267,221 )     (3,868,969 )     3,957,086  
Cash and cash equivalents, beginning of the period
    3,511,357       12,408,516       7,224,307       7,911,281       ¾  
 
Cash and cash equivalents, end of the period
    3,957,086       4,042,312       3,957,086       4,042,312       3,957,086  
 
     See accompanying notes

 


Table of Contents

Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
September 30, 2006 (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, 2005 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, 2004
    31,915,496       66,643,325       2,855,340       3,347,630  
Issued for cash pursuant to December 29, 2005 private placement
    3,200,000       14,176,000       1,920,000       2,908,800  
Exercise of warrants
    771,252       3,417,271       (771,252 )     (329,984 )
Expired warrants
          1,496,514       (1,219,288 )     (1,496,514 )
Exercise of options
    350,000       297,500              
Share issue costs
          (1,689,398 )            
 
Balance, December 31, 2005
    36,236,748       84,341,212       2,784,800       4,429,932  
Exercise of options
    150,000       127,500              
Expired warrants
          213,192       (112,800 )     (213,192 )
 
Balance, September 30, 2006
    36,386,748       84,681,904       2,672,000       4,216,740  
 

 


Table of Contents

Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
September 30, 2006 (unaudited)
The following table summarizes the Company’s outstanding warrants as at September 30, 2006:
                                                 
                                            Weighted
                                            Average
    Outstanding,   Granted   Exercised   Expired           Remaining
Exercise   Beginning of   During the   During the   During the   Outstanding,   Contractual
Price   the Period   Period   Period   Period   End of Period   Life (years)
 
$5.65
    320,000                         320,000       2.25  
$6.15
    1,600,000                         1,600,000       2.25  
$7.06
    112,800                   (112,800 )            
$8.00
    752,000                         752,000       1.15  
 
 
    2,784,800                   (112,800 )     2,672,000       1.94  
 
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 at September 30:
                                 
    2006   2005
            Weighted           Weighted
            Average           Average
    Stock   Share Price   Stock   Share Price
    Options   $   Options   $
 
Outstanding at beginning of period
    3,634,550       4.66       3,805,550       4.39  
Granted during period
    100,000       3.85       200,000       3.18  
Cancelled during period
                (21,000 )     4.95  
Exercised during period
    (150,000 )     0.85       (350,000 )     0.85  
                         
 
                               
Outstanding at end of period
    3,584,550       4.79       3,634,550       4.48  
                         
 
                               
Options exercisable at end of period
    3,352,050       4.91       3,387,050       4.77  
                         

 


Table of Contents

Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
September 30, 2006 (unaudited)
The following table summarizes information about the stock options outstanding and exercisable at September 30, 2006:
                                         
            Weighted   Weighted           Weighted
            Average   Average           Average
Range of           Remaining   Exercise           Exercise
Exercise   Number   Contractual   Price   Number   Price
Prices   Outstanding   Life (years)   $   Exercisable   $
 
$0.75 - $1.00
    482,550       3.1       0.85       482,550       0.85  
$1.65 - $2.37
    281,000       6.2       1.85       261,000       1.85  
$2.70 - $3.50
    728,750       7.3       3.13       528,750       3.11  
$4.00 - $5.00
    1,240,750       8.0       4.86       1,228,250       4.86  
$6.77 - $9.76
    708,500       5.4       8.66       708,500       8.66  
$12.15 - $13.50
    143,000       4.1       12.63       143,000       12.63  
 
 
                                       
 
    3,584,550       6.4       4.79       3,352,050       4.91  
 
The outstanding options vest annually or after the completion of certain milestones. The Company has reserved 3,662,461 common shares for issuance relating to outstanding stock options.
As the Company is following the fair value based method of accounting for stock options, the Company recorded compensation expense of $34,671 and $293,880 for the three and nine month periods ending September 30, 2006, respectively (September 30, 2005 $4,173 and $25,952, respectively) with respect to the granting of options in the period and vesting of options issued in prior periods with an offsetting credit to contributed surplus.
The estimated fair value of stock options issued during the nine month period ending September 30, 2006 was determined using the Black-Scholes model using the following weighted average assumptions and fair value of options:
                 
    2006   2005
 
Risk-free interest rate
    4.24 %     3.27 %
Expected hold period to exercise
  3.5 years   3.5 years
Volatility in the price of the Company’s shares
    64 %     64 %
Dividend yield
  Zero   Zero
Weighted average fair value of options
  $ 1.86     $ 1.51  
 

 


Table of Contents

Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
September 30, 2006 (unaudited)
4.   ADDITIONAL CASH FLOW DISCLOSURE
Net Change In Non-Cash Working Capital
For the periods ending:
                                         
                                    Cumulative
    Nine   Nine   Three   Three   from
    Month   Month   Month   Month   inception
    Period   Period   Period   Period   on April 2,
    Ending   Ending   Ending   Ending   1998 to
    September   September   September   September   September
    30, 2006   30, 2005   30, 2006   30, 2005   30, 2006
    $   $   $   $   $
 
Change in:
                                       
Accounts receivable
    9,750       (683 )     16,507       19,481       (37,640 )
Prepaid expenses
    (691,329 )     (702,806 )     (233,919 )     (197,897 )     (1,231,697 )
Accounts payable and accrued liabilities
    671,927       480,322       457,687       (113,734 )     2,364,408  
 
Change in non-cash working capital
    (9,652 )     (223,167 )     240,275       (292,150 )     1,095,071  
Net change associated with investing activities
    (24,833 )     34,636       21,600       (5,310 )     (36,557 )
 
Net change associated with operating activities
    (34,485 )     (188,531 )     261,875       (297,460 )     1,058,514  
 
Other Non-Cash Items
                                         
    Nine   Nine   Three   Three   Cumulative
    Month   Month   Month   Month   from
    Period   Period   Period   Period   inception on
    Ending   Ending   Ending   Ending   April 2,
    September   September   September   September   1998 to
    30, 2006   30, 2005   30, 2006   30, 2005   September 30, 2006
    $   $   $   $   $
 
Foreign exchange loss
          74,555             35,905       425,186  
Donation of medical equipment
                            66,069  
Loss on sale of Transition Therapeutics Inc.
                            2,156,685  
Gain on sale of BCY LifeSciences Inc.
          (765 )                 (299,403 )
Cancellation of contingent payment obligation settled in common shares
                            150,000  
Future income tax recovery
                            (1,115,000 )
 
 
          73,790             35,905       1,383,537  
 
5.   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 oncolytic viruses as potential cancer therapeutics. Oncolytics’ clinical program includes a variety of Phase I and Phase I/II human trials using REOLYSIN®, its proprietary formulation of the human reovirus, alone and in combination with radiation. For further information about Oncolytics, please visit www.oncolyticsbiotech.com.
FOR FURTHER INFORMATION PLEASE CONTACT:
         
For Canada:
  For Canada:   For United States:
Oncolytics Biotech Inc.
  The Equicom Group   The Investor Relations Group
Cathy Ward
  Nick Hurst   Damian McIntosh
210, 1167 Kensington Cr NW
  20 Toronto Street   11 Stone St, 3rd Floor
Calgary, Alberta T2N 1X7
  Toronto, Ontario M5C 2B8   New York, NY 10004
Tel: 403.670.7377
  Tel: 403.538.4845   Tel: 212.825.3210
Fax: 403.283.0858
  Fax: 416.815.0080   Fax: 212.825.3229
cathy.ward@oncolytics.ca
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