EX-99.1 2 ex99.htm RELEASE ex99.htm

 

 

 
Third Quarter Report
 
September 30, 2011
 

 

 

 

 

 

 

 

 

 

 
 
 
 
Oncolytics Biotech Inc.
 
TSX:ONC
 
NASDAQ:ONCY
 

 
 

 

Oncolytics Q3 2011 Message to Shareholders
 

We achieved a number of important milestones during the third quarter of 2011. We expanded enrollment in our Phase III head and neck cancer trial, reported positive interim results in our Phase II non-small cell lung cancer trial and published additional preclinical work on the interaction of REOLYSIN® with approved chemotherapeutic agents.

Expansion of Enrolment in Our Phase III Head and Neck Cancer Trial

Completing enrollment in the first stage of our Phase III study in head and neck cancers will remain a key focus for the balance of 2011. We have increased the number of enrolling centres in both existing and new jurisdictions and currently have approval to conduct the trial in 12 countries: the United States (under a Special Protocol Assessment), Canada, the United Kingdom, Belgium, France, Germany, Spain, Italy, Greece, Hungary, Poland and Russia.

Positive Clinical Trial Results to Support Decisions on Additional Randomized Studies

In July, we presented positive interim results from our Phase II non-small cell lung cancer (NSCLC) trial at the 14th World Conference on Lung Cancer. The trial investigated the intravenous administration of REOLYSIN in combination with paclitaxel and carboplatin in patients with non-small cell lung cancer with Kras or EGFR-activated tumours.

The presentation was entitled “Phase II study of reovirus with paclitaxel (P) and carboplatin (C) in patients with metastatic non-small cell lung cancer (NSCLC) who have Kras or EGFR-activated tumours.”  The twenty-two patients in the study received intravenous REOLYSIN (3 x 1010TCID50) daily on days one through five, in combination with carboplatin and paclitaxel. Initial doses were carboplatin AUC 6 and paclitaxel 200 mg/m2 on day one of each twenty-one-day cycle. Doses were then reduced to carboplatin AUC 5 and paclitaxel 175 mg/m2.

At the time of reporting, the study had enrolled fifteen patients with Adenocarcinoma, three with Squamous Cell Carcinoma, one with Bronchioloalveolar Carcinoma and three with not otherwise specified non-small cell lung cancer. Molecular tumour demographics included nine Kras mutant, three EGFR mutant and 16 EGFR amplified tumours. Response evaluation in 21 patients showed six partial responses (PR; 28.6%), 13 stable disease (SD; 61.9%) and two progressive disease (PD; 9.5%). This signified a clinical benefit rate of 90.5% (complete response (CR) + PR + SD; in other words, the percentage of patients whose tumours had stabilized, regressed or disappeared) and a response rate of 28.6% (CR + PR). The investigators noted that the clinical benefit observed thus far was encouraging and warranted a follow-up randomized trial.

We have generated positive clinical data in a range of patient populations in the quarters since launching our clinical trial program. As we collect data from additional trials during the coming quarters, we will begin to make final decisions respecting further randomized studies to build upon our Phase III head and neck cancer study and our randomized Phase II ovarian and metastatic pancreatic cancer studies. These additional randomized studies will be directed at expanding the use of REOLYSIN beyond our expected first use for head and neck cancer.

Additional Preclinical Work Supportive of Our Chosen Treatment Combinations

In August, a report on a study investigating the timing of chemotherapy delivery to optimize the efficacy of systemic REOLYSIN appeared in the online version of Molecular Therapy, a publication of the American Society of Gene and Cell Therapy. The paper was authored by Kottke et al. and entitled “Precise Scheduling of Chemotherapy Primes VEGF-producing Tumors for Successful Systemic Oncolytic Virotherapy.” It described when best to administer taxanes with reovirus to optimize viral delivery to the tumour mass. The researchers determined that this drug combination yielded superior results to either treatment alone, and were able to reproducibly cure nearly half of the treated animals by employing this optimized schedule of paclitaxel/REOLYSIN.

Paclitaxel is being used in combination with REOLYSIN and carboplatin in our randomized Phase III head and neck trial and our randomized Phase II ovarian and pancreatic cancer trials. It is also being used, in combination with both REOLYSIN and carboplatin, in a range of other trials.

Through our additional preclinical work, we continue to strengthen our understanding of how REOLYSIN interacts with a range of currently approved chemotherapeutics.
 
 

 
Looking to the Future

We are looking forward to receiving results from our three ongoing randomized clinical studies and initiating two other randomized studies in the near future. These studies are important in determining the indications for which our first product approvals will be sought.

We want to thank all of our stakeholders for their continued support through an exciting 2011.

Brad Thompson
President and CEO

 
 

 
 

 

November 9, 2011

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

BASIS OF PRESENTATION AND TRANSITION TO IFRS

On January 1, 2011, we adopted International Financial Reporting Standards (“IFRS”) for Canadian publicly accountable enterprises.  Prior to the adoption of IFRS, we followed Canadian Generally Accepted Accounting Principles (“Canadian GAAP”).  While IFRS has many similarities to Canadian GAAP, some of our accounting policies have changed as a result of our transition to IFRS. The most significant accounting policy changes that have had an impact on the results of our operations are discussed in more detail in the Accounting Changes section of this Management Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”).

This MD&A should be read in conjunction with our unaudited consolidated interim financial statements as at and for the period ending September 30, 2011 which have been prepared using IFRS and should also be read in conjunction with the audited consolidated financial statements, which were prepared using Canadian GAAP, and MD&A contained in our annual report for the year ended December 31, 2010.

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 and under applicable Canadian provincial securities legislation.  Forward-looking statements, including our belief as to the potential of REOLYSIN®, a therapeutic reovirus, as a cancer therapeutic and our expectations as to the success of our research and development and manufacturing programs in 2011 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.
 
With respect to the forward-looking statements made within this MD&A, we have made numerous assumptions regarding among other things: our ability to obtain financing to fund our development program, our ability to receive regulatory approval to commence enrollment in our clinical trial program, the final results of our co-therapy clinical trials, our ability to maintain our supply of REOLYSIN and future expense levels being within our current expectations.
 
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 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 except as required by applicable law.
 
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 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 Oncolytics.

REOLYSIN Development Update for the Third Quarter of 2011

We continue to develop our lead product REOLYSIN as a potential cancer therapy.  Our goal each year is to advance REOLYSIN through the various steps and stages of development required for pharmaceutical products.  In order to achieve this goal, we actively manage the development of our clinical trial program, our manufacturing process and supply, our intellectual property and our pre-clinical and collaborative programs.

Clinical Trial Program

We began the third quarter of 2011 with 13 clinical trials which includes three randomized studies (our randomized Phase III head and neck trial, our randomized Phase II ovarian cancer trial, and our randomized Phase II pancreatic cancer trial).  Five of these 13 trials are funded by us with the remainder sponsored by the U.S. National Cancer Institute (“NCI”), the Cancer Therapy & Research Center at The University of Texas Health Center in San Antonio (“CTRC”), and the University of Leeds (“Leeds”).

During the third quarter of 2011, interim results from our Phase II non-small cell lung cancer were presented at the 14th World Conference on Lung Cancer.  Our interim results showed that 22 patients had been treated with REOLYSIN in combination with carboplatin and paclitaxel.  Of the 22 patients treated, 21 patients had been evaluated showing a clinical benefit rate of 90.5% and a response rate of 28.6%.

We exited the third quarter with 13 clinical trials.  Our clinical trial program currently encompasses various cancer indications including head and neck, non-small cell lung, ovarian, pancreatic, colorectal, melanoma, and squamous cell carcinoma of the lung among others.

Clinical Trial – Randomized Phase III Head and Neck Pivotal Trial

Our randomized Phase III head and neck pivotal trial continues to expand into additional jurisdictions and enroll patients.  We are now approved to enroll patients in 12 countries within North America and Europe including the U.S., under a Special Protocol Assessment, Canada, the U.K. and Belgium.

Clinical Trial – Results

U.S. Phase II Non-Small Cell Lung Cancer (“NSCLC”) Clinical Trial

During the third quarter of 2011, we announced that a presentation covering interim preliminary results from our Phase II clinical trial using intravenous administration of REOLYSIN in combination with paclitaxel and carboplatin in patients with NSCLC with Kras or EGFR-activated tumours was made at the International Association for the Study of Lung Cancer World Conference on Lung Cancer.

The presentation, entitled “Phase II study of reovirus with paclitaxel (P) and carboplatin (C) in patients with metastatic non-small cell lung cancer (NSCLC) who have Kras or EGFR-activated tumors”, was given by Dr. Miguel Villalona-Calero, principal investigator for the study, and indicated that 22 patients had received REOLYSIN (3x1010 TCID50) intravenously daily on days one to five, in combination with carboplatin and paclitaxel.

As of the date of the presentation, the study had enrolled patients with Adenocarcinoma (15), Squamous Cell Carcinoma (three), Bronchioloalveolar Carcinoma (one), and not otherwise specified non-small cell lung cancer (three).  Molecular tumor demographics included: nine Kras mutant, three EGFR mutant, 16 EGFR amplified.  Response evaluation in 21 patients showed six partial responses (“PR”) (28.6%), 13 stable disease (“SD”) (61.9%), two progressive disease (“PD”) (9.5%).  This translated into a clinical benefit rate (complete response (“CR”)+PR+SD) of 90.5% and a response rate (CR+PR) of 28.6%. The investigators noted that the clinical benefit noted so far is encouraging and that a follow up randomized clinical trial appears warranted.

Manufacturing and Process Development

During the third quarter of 2011, we completed the testing associated with the 100-litre cGMP production run from earlier in the year.  Our process development activity for the second quarter of 2011 continued to focus on process validation and formulation studies.  Our process development activities for the third quarter of 2011 focused on our master validation plan and included optimization and validation studies of our upstream and downstream processes.

Intellectual Property

At the end of the third quarter of 2011, we had been issued over 280 patents including 44 U.S. and 11 Canadian patents as well as issuances in other jurisdictions.  We also have approximately 240 patent applications filed in the U.S., Canada and other jurisdictions.  We have an extensive patent portfolio covering the oncolytic reovirus that we use in our clinical trial program including a composition of matter patent that expires in 2028.  Our patent portfolio also includes methods for treating proliferative disorders using modified adenovirus, HSV, parapoxvirus and vaccinia virus.

Financial Impact

We estimated at the beginning of 2011 that our cash requirements to fund our operations would be approximately $29,000,000.  Our cash usage for the nine month period ending September 30, 2011 was $15,345,716 from operating activities and $111,194 for the acquisition of property and equipment.  Our net loss for the nine month period ending September 30, 2011 was $17,367,378.

Cash Resources

We exited the third quarter of 2011 with cash and short-term investments totaling $42,172,608 (see “Liquidity and Capital Resources”).

Updated REOLYSIN® Development for the Remainder of 2011

Our development activity for REOLYSIN for the remainder of 2011 continues to be made up of clinical, manufacturing, intellectual property and collaboration programs.  With the additional jurisdictions and clinical sites that have been added over the course of 2011, we still anticipate that we can complete stage 1 (approximately 80 patients) of our Phase III head and neck clinical trial.  We now expect that the commencement of stage 2 will occur in early 2012.  As well, we still expect to complete enrollment in our non-small cell lung cancer trial and support those clinical trials that are sponsored by CTRC, Leeds and the NCI.

Our 2011 manufacturing program continues to include an additional 100-litre cGMP production run along with the related fill, labeling, packaging and shipping of REOLYSIN to the various clinical sites.  As well, we plan on performing smaller process development studies examining formulation, stability and additional scale up as required by our master validation plan.  Our intellectual property program will remain in place for the remainder of 2011 and will include filings for additional patents along with monitoring activities required to protect our patent portfolio.  Finally, our 2011 collaboration program will selectively add studies and research that may be necessary to potentially expand our clinical program.

We now estimate that the cash requirements to fund our operations for 2011 will be approximately $24,000,000 (see “Liquidity and Capital Resources”).
 
 

 
ACCOUNTING CHANGES

Transition to IFRS
On January 1, 2011, we adopted IFRS for Canadian publicly accountable enterprises, as required by the Accounting Standards Board of Canada. Prior to the adoption of IFRS, we followed Canadian GAAP.  The most significant change to our accounting policies relates to the treatment of our warrants with an exercise price denominated in U.S. dollars.  The impact of this change has been fully disclosed in Note 3 of our unaudited interim consolidated financial statements.  There was no change in how we account for our research and development or operating activities and there was no impact on our cash, cash equivalents or short-term investment balances.

Although we adopted IFRS on January 1, 2011, we were required to restate our comparative 2010 annual and interim financial positions and results of operations, effective from January, 1, 2010. The 2010 comparative amounts have not been audited by our external auditor.  Note 4 of our unaudited interim consolidated financial statements as at and for the nine months ended September 30, 2011 outlines our IFRS accounting policies and Note 3 provides a complete list of our IFRS 1 elections; detailed reconciliations between Canadian GAAP and IFRS of shareholders’ equity as at January 1, September 30, and Dec. 31, 2010, respectively, and of net earnings and comprehensive income for the three and nine month periods ending September 30, 2010 and the twelve months ending December 31, 2010; and information regarding the impacts of IFRS transition on our cash flows.  A summary of the changes are outlined below in the following tables and respective notes:

 
 

 

 

 
 
Total equity
 
December 31,
2010
$
   
September 30, 2010
$
   
January 1,
2010
$
 
Total equity under CGAAP
    41,931,760       19,327,179       31,366,458  
Adjustment required to conform to IFRS:
                       
Revaluation of warrant liability
    (5,536,800 )     (3,694,950 )     (1,023,051 )
Total equity under IFRS
    36,394,960       15,632,229       30,343,407  

 
 
 
 
 
Comprehensive loss for the period
 
For the three month period ending September 30,
2010
$
   
For the nine month period ending September 30, 2010
$
   
For the year ending
December 31,
2010
$
 
Comprehensive loss under CGAAP
    4,009,022       12,502,207       19,973,772  
Adjustments required to conform to IFRS:
                       
Revaluation of warrant liability
    2,521,950       2,672,439       4,841,949  
Comprehensive loss under IFRS
    6,530,972       15,174,646       24,815,721  
Basic and diluted loss per common share, CGAAP
    0.07       0.20       0.32  
Basic and diluted loss per common share, IFRS
    0.11       0.24       0.39  
Weighted average number of common shares
    61,570,046       61,558,859       62,475,403  
 
Consolidated Statement of Cash Flows
 
In transitioning to IFRS, there was no impact on our net change in cash for the three and nine month periods ending September 30, 2010 or for the year ending December 31, 2010.
 
IFRS Transitional Arrangements
 
When preparing our consolidated statement of financial position under IFRS at January 1, 2010, our date of transition, the following optional exemption from full retrospective application of IFRS accounting policies was adopted:
 
Cumulative translation differences – cumulative translation differences resulting from the translation of our net investment in our U.S. subsidiary and the financial statements of our U.S. subsidiary have been set to zero at January 1, 2010.
 
Effects of IFRS
 
Warrants
IFRS requires warrants with an exercise price denominated in a currency other than the entity’s functional currency to be treated as a liability measured at fair value.  Changes in fair value are to be recorded in the consolidated statement of loss and comprehensive loss.

Classification of expenses within the statement of loss and comprehensive loss
Under IFRS, we have chosen to present our expenses based on the function of each expense rather than the nature of each expense.  As a result, stock based compensation, depreciation of capital assets, and foreign currency gains and losses are no longer separately presented on the statement of loss and comprehensive loss.  There is no impact on our net loss or comprehensive loss as a result of these classifications.

Foreign currency translation
Under IFRS, we record the impact of fluctuations in foreign currency exchange rates relating to our net investment in our U.S. subsidiary and any foreign currency effects on the translation of our U.S. subsidiaries financial statements as a separate component of equity and other comprehensive income.  Under CGAAP we treated our U.S. subsidiary as an integrated subsidiary with foreign currency translation differences recorded as part of our statement of loss.  The result of the transition to IFRS is a reclassification of the related foreign currency gains and losses from net loss to other comprehensive income.  There is no impact on our net comprehensive loss as a result of these re-classifications.

THIRD QUARTER RESULTS OF OPERATIONS
(for the three months ended September 30, 2011 and 2010)

Net loss for the three month period ending September 30, 2011 was $6,232,024 compared to $6,523,223 for the three month period ending September 30, 2010.

Research and Development Expenses (“R&D”)

    $ 2011     $ 2010  
Clinical trial expenses
    3,364,450       1,082,323  
Manufacturing and related process development expenses
    942,099       614,202  
Intellectual property expenditures
    144,777       352,965  
Research collaborations
    48,128       141,499  
Other R&D expenses
    829,027       597,124  
Scientific research and development repayment (refund)
    59,758       (287,506 )
Foreign exchange (gain) loss
    (254,288 )     209,110  
Stock based compensation
    181,183       1,675  
Research and development expenses
    5,315,134       2,711,392  

Clinical Trial Program

    $ 2011     $ 2010  
Direct clinical trial expenses
    1,119,742       592,484  
Phase III start up expenses
    2,244,708       489,839  
Clinical trial expenses
    3,364,450       1,082,323  

During the third quarter of 2011, our clinical trial expenses increased to $3,364,450 compared to $1,082,323 for the third quarter of 2010.  In the third quarters of 2011 and 2010, we incurred direct patient expenses related to the clinical trials that we are directly sponsoring.  We also continue to incur start up costs relating to our randomized Phase III head and neck cancer trial as we increase the number of jurisdictions and clinical sites initiated to enroll patients.  At the end of the third quarter of 2011, we were approved to commence enrollment in 12 countries throughout North America and Europe.

Manufacturing & Related Process Development (“M&P”)

    $ 2011     $ 2010  
Product manufacturing expenses
    553,997       456,971  
Process development expenses
    388,102       157,231  
Manufacturing and related process development expenses
    942,099       614,202  

In the third quarter of 2011, our product manufacturing expenses were $553,997 compared to $456,971 for the third quarter of 2010.  During the third quarter of 2011, we completed the testing of the 100-litre cGMP production run completed earlier in 2011 and continued to incur costs associated with the storage and shipping of our supply of REOLYSIN.  In the third quarter of 2010, we completed the fill and packaging process for the 100-litre cGMP run that was completed earlier in 2010 in addition to incurring shipping costs associated with supplying our clinical trial program.

Our process development expenses for the third quarter of 2011 were $388,102 compared to $157,231 for the third quarter of 2010.  Our process development activity for the third quarter of 2011 focused on optimization and validation studies of our upstream and downstream processes.  These studies are in support of our master validation plan anticipated to be required for product registration.  Our process development expenses for the third quarter of 2010 focused on optimization and validation studies.

Intellectual Property Expenses

    $ 2011     $ 2010  
Intellectual property expenses
    144,777       352,965  

Our intellectual property expenses for the third quarter of 2011 were $144,777 compared to $352,965 for the third quarter of 2010.  The change in intellectual property expenditures reflects the timing of filing costs associated with our expanded patent base.  At the end of the third quarter of 2011, we had been issued over 280 patents including 44 U.S. and 11 Canadian patents, as well as issuances in other jurisdictions.  We also have over 240 patent applications filed in the U.S., Canada and other jurisdictions.

Research Collaborations

    $ 2011     $ 2010  
Research collaborations
    48,128       141,499  

During the third quarter of 2011, our research collaboration expenses were $48,128 compared to $141,499.  Our research collaboration activity continues to focus on the interaction of the immune system and the reovirus and the use of the reovirus as a co-therapy with existing chemotherapeutics and radiation.

Other Research and Development Expenses

    $ 2011     $ 2010  
R&D consulting fees
    73,978       14,543  
R&D salaries and benefits
    673,099       517,172  
Other R&D expenses
    81,950       65,409  
Other research and development expenses
    829,027       597,124  

During the third quarter of 2011, our Other Research and Development expenses were $829,027 compared to $597,124 for the third quarter of 2010.  In the third quarter of 2011, our salaries and benefits costs increased compared to the third quarter of 2010 as we increased the number of employees and consultants in order to support our randomized Phase III head and neck clinical trial along with our other clinical trials.

Scientific Research and Development Repayment (Refund)
    $ 2011     $ 2010  
Scientific research and development repayment (refund)
    59,758       (287,506 )

During the third quarter of 2011, we were required to repay a portion of the Alberta scientific research and development refund we received in 2010.  As a result of a review of our Scientific Research and Experimental Development claim by the Canadian tax authorities, a portion of our claim relating to overhead and administrative costs was denied reducing our claim and the associated Alberta scientific research and development refund.  During the third quarter of 2010, we received scientific research and development refunds totaling $287,506 from the Alberta and Quebec governments.

Foreign Exchange (Gain) Loss

    $ 2011     $ 2010  
Foreign exchange (gain) loss
    (254,288 )     209,110  

During the third quarter of 2011, our foreign exchange gain was $254,288 compared to a foreign exchange loss of $209,110 for the third quarter of 2010.  The foreign exchange loss/(gain) is primarily a result of the fluctuations in the U.S. dollar exchange rate used on the translation of our U.S. currency that was received from our U.S. denominated financing in 2009 and the exercise of U.S. denominated warrants in 2011.

Stock Based Compensation

    $ 2011     $ 2010  
Stock based compensation
    181,183       1,675  

Stock based compensation for the third quarter of 2011 was $181,183 compared to $1,675 for the third quarter of 2010.  During the third quarter of 2011, we incurred stock based compensation associated with the grant of 81,000 stock options to employees and officers associated with our research and development activities.  During the third quarter of 2010, we incurred stock based compensation associated with the vesting of options previously granted.
 
 

 
Operating Expenses

    $ 2011     $ 2010  
Public company related expenses
    641,783       586,785  
Office expenses
    356,294       308,874  
Amortization of property and equipment
    21,258       15,981  
Stock based compensation
          396,000  
Operating expenses
    1,019,335       1,307,640  

During the third quarter of 2011, our public company related expenses were $641,783 compared to $586,785 for the third quarter of 2010.  In the third quarter of 2011 our investor relations, public relations, and business development activities increased compared to the third quarter of 2010.

Our office expense activity during the third quarter of 2011 remained consistent compared to the third quarter of 2010.

Stock based compensation attributed to operating expenses for the third quarter of 2010 was $396,000 which relate to stock options granted to employees, officers, and directors associated with our operating activities during the third quarter of 2010.  This did not occur during the third quarter of 2011.

Change in Warrant Liability

    $ 2011     $ 2010  
Change in fair value of warrant liability
          2,521,950  

During the three month period ending September 30, 2010 the fair value of our warrants with an exercise price denominated in the US dollar increased due to a rise in our stock price causing these warrants to be in the money.  As a result of this change in fair value, our consolidated net loss increased by $2,521,950 for the three month period ending September 30, 2010.  These warrants had either been exercised or had expired before the beginning of the third quarter of 2011.

YEAR TO DATE RESULTS OF OPERATIONS
(for the nine months ended September 30, 2011 and 2010)

Net loss for the nine month period ending September 30, 2011 was $17,367,378 compared to $15,045,868 for the nine month period ending September 30, 2010.

Research and Development Expenses (“R&D”)

    $ 2011     $ 2010  
Clinical trial expenses
    6,153,811       2,994,105  
Manufacturing and related process development expenses
    3,563,989       3,625,691  
Intellectual property expenditures
    638,148       677,133  
Research collaboration expenses
    199,582       157,613  
Other R&D expenses
    2,953,933       1,734,052  
Scientific research and development repayment (refund)
    59,758       (287,506 )
Foreign exchange loss (gain)
    (23,870 )     85,231  
Stock based compensation
    224,525       4,103  
Research and development expenses
    13,769,876       8,990,422  

Clinical Trial Program

    $ 2011     $ 2010  
Direct clinical trial expenses
    2,402,781       1,841,524  
Phase III start up expenses
    3,751,030       1,152,581  
Clinical trial expenses
    6,153,811       2,994,105  

During the nine month period ending September 30, 2011, our clinical trial expenses increased to $6,153,811 compared to $2,994,105 for the nine month period ending September 30, 2010.  During this period of 2011, we continue to expand the number of jurisdictions and clinical sites that are approved to enroll patients in our randomized Phase III head and neck cancer clinical trial.  Phase III start up expenses include regulatory filing fees, site investigation and initiation costs and product shipment expenses which are required prior to commencing enrollment in the various jurisdictions and related clinical sites.  At the end of the nine month period ending September 30, 2011, we are approved to enroll patients in 12 countries within North America and Europe including the U.S., Canada, the U.K. and Belgium.

We expect our clinical trial expenses to increase in 2011 compared to 2010.  We expect to complete enrollment in stage 1 of our Phase III pivotal trial and enter into stage 2.  We also still expect to complete enrollment in our Phase II NSCLC study.  Finally, we will continue to support our clinical research collaboration with CTRC, our Clinical Agreement with the NCI and our clinical trial with Leeds.

Manufacturing & Related Process Development (“M&P”)

    $ 2011     $ 2010  
Product manufacturing expenses
    2,589,402       3,013,313  
Process development expenses
    974,587       612,378  
Manufacturing and related process development expenses
    3,563,989       3,625,691  

Our M&P expenses for the nine month period ending September 30, 2011 were $3,563,989 compared to $3,625,691 for the nine month period ending September 30, 2010.

During the nine month period ending September 30, 2011, we completed the bulk production and related testing, vial, fill and packaging activities for one 100-litre cGMP production run.  During the nine month period ending September 30, 2010, we completed the bulk harvest for two 100-litre cGMP production runs along with the related vial, fill and packaging activities for only one of these runs.

Our process development expenses for the nine month period ending September 30, 2011 were $974,587 compared to $612,378 for the nine month period ending September 30, 2010.  During the nine month period ending September 30, 2011 we focused on optimization and validation studies of our upstream and downstream processes.  These studies are in support of our master validation plan anticipated to be required for product registration.  Our process development expenses for the third quarter of 2010 focused on optimization and validation studies.

We still expect our M&P expenses for 2011 to increase compared to 2010.  We expect to complete an additional 100-litre cGMP production run including fill and finish activities in 2011.  We also expect to continue to perform a number of small scale process development studies focusing on our master validation plan.

Intellectual Property Expenses

    $ 2011     $ 2010  
Intellectual property expenses
    638,148       677,133  

Our intellectual property expenses for the nine month period ending September 30, 2011 were $638,148 compared to $677,133 for the nine month period ending September 30, 2010.  The change in intellectual property expenditures reflects the timing of filing costs associated with our expanded patent base.  At the end of the third quarter of 2011, we had been issued over 280 patents including 44 U.S. and 11 Canadian patents, as well as issuances in other jurisdictions.  We also have over 240 patent applications filed in the U.S., Canada and other jurisdictions.
 
 
Research Collaborations

    $ 2011     $ 2010  
Research collaborations
    199,582       157,613  

During the nine month period ending September 30, 2011, our research collaboration expenses were $199,582 compared to $157,613 for the nine month period ending September 30, 2010.  Our research collaboration activity continues to focus on the interaction of the immune system and the reovirus and the use of the reovirus as a co-therapy with existing chemotherapeutics and radiation.

We still expect that pre-clinical trial expenses and research collaborations in 2011 will remain consistent with 2010.  We expect to complete our ongoing collaborative program carried over from 2010 and will continue to be selective in the types of new collaborations we enter into in 2011.
 
 

 
Other Research and Development Expenses

    $ 2011     $ 2010  
R&D consulting fees
    237,415       59,821  
R&D salaries and benefits
    2,408,794       1,481,493  
Other R&D expenses
    307,724       192,738  
Other research and development expenses
    2,953,933       1,734,052  

During the nine month period ending September 30, 2011, our Other Research and Development expenses were $2,953,933 compared to $1,734,052 for the nine month period ending September 30, 2010.  In the nine month period ending September 30, 2011, we have increased the number of employees and consultants as we have expanded our randomized Phase III head and neck clinical trial into other jurisdictions and increased the number of enrolling clinical sites.  This increase allows us to support this trial along with our expanding clinical trial program.  We also incurred severance costs associated with the change in our Chief Medical Officer that did not occur in 2010.

We now expect that our Other R&D expenses in 2011 will increase compared to 2010 reflecting the increase in employees and consultants.

Scientific Research and Development Repayment (Refund)
    $ 2011     $ 2010  
Scientific research and development repayment (refund)
    59,758       (287,506 )

As noted above, during the third quarter of 2011, we were required to repay a portion of the Alberta scientific research and development refund we received in 2010.  During the third quarter of 2010, we received scientific research and development refunds totaling $287,506 from the Alberta and Quebec governments.

Foreign Exchange (Gain) Loss

    $ 2011     $ 2010  
Foreign exchange (gain) loss
    (23,870 )     85,231  

For the nine month period ending September 30, 2011, our foreign exchange gain was $23,870 compared to a foreign exchange loss of $85,231 for the nine month period ending September 30, 2010.  The foreign exchange loss/(gain) is primarily a result of the fluctuations in the U.S. dollar exchange rate used on the translation of our U.S. currency that was received from our U.S. denominated financing in 2009 and the exercise of U.S. denominated warrants in 2011.  At the end of the nine month period ending September 30, 2011, the Canadian dollar had weakened resulting in the foreign exchange gain.  During the nine month period ending September 30, 2010, the Canadian dollar strengthened resulting in a foreign exchange loss.

Stock Based Compensation

    $ 2011     $ 2010  
Stock based compensation
    224,525       4,103  

Stock based compensation for the nine month period ending September 30, 2011 was $224,525 compared to $4,103 for the nine month period ending September 30, 2010.  We incurred stock based compensation associated with the grant of stock options to employees and officers associated with our research and development activities.  During the nine month period ending September 30, 2010, we incurred stock based compensation associated with the vesting of options previously granted.


Operating Expenses

    $ 2011     $ 2010  
Public company related expenses
    2,180,769       2,049,548  
Office expenses
    965,675       928,854  
Amortization of property and equipment
    68,525       45,487  
Stock based compensation
          396,000  
Operating expenses
    3,214,969       3,419,889  

During the nine month period ending September 30, 2011, our operating expenses were $3,214,969 compared to $3,419,889 for the nine month period ending September 30, 2010.  For the nine month period ending September 30, 2011, our operating costs have remained relatively consistent compared to the nine month period ending September 30, 2010 except for investor and public relation costs which have increased in 2011.

Asset Available for Sale

    $ 2011     $ 2010  
Write down of asset available for sale
    735,681        

 
At the beginning of 2011, we began the process to sell our investment in BCBC.  At the end of the third quarter, despite our efforts to sell this investment, we have been unsuccessful in completing a sale under current market conditions.  As a result, we have written down our investment in BCBC to $nil recognizing a write down of $735,681.  We plan to continue to pursue potential future buyers.

Change in Warrant Liability

    $ 2011     $ 2010  
Change in fair value of warrant liability
    (36,000 )     2,672,439  

During the nine month period ending September 30, 2010 the fair value of our warrants with an exercise price denominated in the US dollar increased due to a rise in our stock price causing these warrants to be in the money.  As a result of this change in fair value, our consolidated net loss increased by $2,672,439 for the nine month period ending September 30, 2010.  In January 2011, all of these warrants were either exercised or expired.  The warrants that expired unexercised reduced our consolidated net loss for the nine month period ending September 30, 2011 by $36,000.

Commitments

As at September 30, 2011, we are committed to payments totaling $3,108,000 for activities related to manufacturing, 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:


   
2011
   
2010
   
2009(6)
 
(unaudited)
 
Sept.
   
June
   
March
   
Dec.
   
Sept.
   
June
   
March
   
Dec.
 
Revenue
                                               
Net loss (1), (3)
    6,232       7,164       3,971       9,613       6,524       3,984       4,538       5,245  
Basic and diluted loss per common share(1), (3)
  $ 0.09     $ 0.10     $ 0.06     $ 0.15     $ 0.11     $ 0.06     $ 0.07     $ 0.09  
Total assets(4)
    43,053       49,690       54,945       44,432       21,137       26,569       30,159       35,593  
Total cash(2), (4)
    42,173       48,570       53,521       42,906       19,708       24,885       28,823       34,129  
Total long-term debt
                                               
Cash dividends declared(5)
 
Nil
   
Nil
   
Nil
   
Nil
   
Nil
   
Nil
   
Nil
   
Nil
 

(1)  
Included in net loss and net loss per share between September 2011 and November 2009 are warrant revaluation charges of $nil, $nil, ($36,000), $2,169,510, $2,522,490, ($391,540), $541,489, and $nil, respectively.
(2)  
Included in total cash are cash and cash equivalents plus short-term investments.
(3)  
Included in net loss and loss per common share between September 2011 and November 2009 are quarterly stock based compensation expenses of $181,183, $40,469, $2,873, $2,850,938, $397,675, $1,399, $1,029, and $396,110, respectively.
(4)  
We issued 3,281,616 common shares for net cash proceeds of $14,793,582 in 2011 (2010 – 6,408,333 common shares for net cash proceeds of $27,288,132; 2009 – 17,524,211 common shares for net cash proceeds of $37,052,900).
(5)  
We have not declared or paid any dividends since incorporation.
(6)  
Represents Canadian GAAP figures.

LIQUIDITY AND CAPITAL RESOURCES

Liquidity

   
September 30,
2011
$
   
December 31, 2010
$
 
Cash and cash equivalents
    40,243,302       39,296,682  
Short-term investments
    1,929,306       3,609,246  
Working capital
    39,305,653       35,432,368  

The decrease in our cash and cash equivalent and short term investment positions reflects the cash usage from our operating activities of $15,345,716 along with the cash provided by financing activities of $14,793,582 for the nine month ending September 30, 2011.

We desire to maintain adequate cash and short-term investment reserves to support our planned activities which include our clinical trial program, product manufacturing, administrative costs, and our intellectual property expansion and protection.  To date, we have mainly funded our operations through the issue of additional capital via public and private offerings.

As a result of the exercise of existing warrants we raised over $14.7 million to be used to support our clinical trial, manufacturing, intellectual property and collaboration programs in the first half of 2011.  We now anticipate that the expected cash requirements to fund our operations in 2011 will be approximately $24 million.

We continue to manage our research and development plan with the objective of ensuring optimal use of our existing resources.  Additional activities continue to be subject to adequate resources and we believe we will have sufficient cash resources to fund our presently planned operations into 2012.  Factors that will affect our anticipated cash usage for the remainder of 2011 and into 2012, and for which additional funding might be required include, but are not limited to, expansion in our clinical trial program, the timing of patient enrollment in our approved clinical trials, the actual costs incurred to support each clinical trial, the number of treatments each patient will receive, the timing of R&D activity with our clinical trial research collaborations, the number, timing and costs of manufacturing runs required to conclude the validation process and supply product to our clinical trial program, and the level of collaborative activity undertaken.

During the nine month period ending September 30, 2011, we have been able to raise funds primarily through the exercise of previously issued warrants.  During 2010, we were able to raise funds through a bought deal public offering along with the exercise of existing warrants and options.  We have no assurances that we will be able to raise funds through the sale of our common shares, consequently, we will continue to evaluate all types of financing arrangements.

We also want to be in a position to evaluate potential financings and be able to accept appropriate financings when available.  As a result, we renewed our base shelf prospectus in 2010 which qualified for distribution up to $150,000,000 of common shares, subscription receipts, warrants, and/or units.  Establishing our base shelf provides us with additional flexibility when seeking capital as, under certain circumstances, it shortens the time period to close a financing and is expected to increase the number of potential investors that may be prepared to invest in our company.  We have been able to take advantage of our base shelf with the bought deal financing in 2010 along with the exercise of previously issued warrants raising approximately $41.7 million.  Our current base shelf expires in July 2012 and our present intention would be to renew it prior to its expiry.

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.  As at September 30, 2011, we have $1,929,306 (December 31, 2010 - $3,609,246) invested under this policy and we are currently earning interest at an effective rate of 0.85% (December 31, 2010 – 0.30%)
 

OTHER MD&A REQUIREMENTS

We have 71,239,918 common shares outstanding at November 9, 2011.  If all of our warrants (2,170,110) and options (4,656,994) were exercised we would have 78,067,022 common shares outstanding.
 
 
Additional information relating to Oncolytics Biotech Inc. is available on SEDAR at www.sedar.com.

Controls and Procedures
 
There were no changes in our internal controls over financial reporting during the nine month period ending September 30, 2011 that materially affected or are reasonably likely to materially affect, internal controls over financial reporting.

 
 

 


 

 

 

 

 

 

 
Interim Condensed Consolidated Financial Statements
 
Oncolytics Biotech® Inc.
 
(unaudited)
 
September 30, 2011
 

 

 

 

 

 

 
 

 

ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)
 
As at,
 Notes    
September 30,
2011
$
   
December 31,
2010
$
(note 3)
   
January 1,
2010
$
(note 3)
 
Assets
                     
Current assets
                     
Cash and cash equivalents
 6      40,243,302      39,296,682      32,448,939  
 Short-term investments  6      1,929,306      3,609,246      1,679,937  
Accounts receivable
        77,511       284,988       64,787  
Prepaid expenses
        533,149       278,934       507,408  
Total current assets
        42,783,268       43,469,850       34,701,071  
                             
Non-current assets
                           
Property and equipment
        269,580       226,911       208,320  
Long term investment  7                   684,000   
Total non-current assets
        269,580       226,911       892,320  
                             
 Asset held for sale  7             735,681         
 Total assets         43,052,848       44,432,442       35,593,391  
                             
 
Liabilities And Shareholders’ Equity
                           
                             
Current Liabilities
                           
Accounts payable and accrued liabilities
        3,477,615       2,500,682       4,226,933  
 Warrant liability  8       —        5,536,800        1,023,051   
Total current liabilities
        3,477,615       8,037,482       5,249,984  
                             
 Commitments and contingencies  11, and 12                    
                             
 Shareholders' equity                            
Share capital
 Authorized: unlimited
 Issued:
 September 30, 2011 – 71,239,918
 December 31, 2010 – 67,958,302
 January 1, 2010 – 61,549,969
 8       177,240,848       155,439,610        131,908,274   
 Warrants  8       2,653,627       4,108,652        2,437,460   
 Contributed surplus  9       19,572,183       19,399,489        13,734,743   
Accumulated other comprehensive loss
        (127,916 )     (156,660 )      
Deficit
        (159,763,509 )     (142,396,131 )     (117,737,070 )
Total shareholders’ equity
        39,575,233       36,394,960       30,343,407  
Total liabilities and equity
        43,052,848       44,432,442       35,593,391  

See accompanying notes
 
 
 

 
ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)

 
   
Notes
   
Three Month Period Ending
September 30, 2011
$
   
Three Month Period Ending
September 30, 2010
$
(note 3)
   
Nine Month Period Ending,
September 30, 2011
$
   
Nine Month Period Ending, September 30,
2010
$
(note 3)
 
                               
Expenses
                             
Research and development
    16       5,315,134       2,711,392       13,769,876       8,990,422  
Operating
    16       1,019,335       1,307,640       3,214,969       3,419,889  
              6,334,469       4,019,032       16,984,845       12,410,311  
Loss before the following
            (6,334,469 )     (4,019,032 )     (16,984,845 )     (12,410,311 )
                                         
                                         
Write down of asset available for sale
    7                   (735,681 )      
Change in fair value of warrant liability
    8             (2,521,950 )     36,000       (2,672,439 )
Interest
            102,445       17,759       317,148       36,882  
Loss before income taxes
            (6,232,024 )     (6,523,223 )     (17,367,378 )     (15,045,868 )
Income taxes
                               
Net loss
            (6,232,024 )     (6,523,223 )     (17,367,378 )     (15,045,868 )
Other comprehensive loss (gain) – translation adjustment
            (9,587 )     (7,749 )     28,744       (128,778 )
Net comprehensive loss
            (6,241,611 )     (6,530,972 )     (17,338,634 )     (15,174,646 )
Basic and diluted loss per share
    10       (0.09 )     (0.11 )     (0.25 )     (0.24 )
Weighted average number of shares (basic and  diluted)
            71,221,218       61,570,046       70,800,114       61,558,859  

See accompanying notes
 
 

 
PART I                      
 
ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(unaudited)

 
   
For the nine month period ending, September 30, 2011
   
Share capital
 
Contributed Surplus
 
Warrants
 
Accumulated Other Comprehensive Income
 
Deficit
 
Total Equity
    $     $     $     $      $     $    
As at December 31, 2010
    155,439,610     19,399,489     4,108,652     (156,660 )   (142,396,131    36,394,960  
                                       
Net loss and comprehensive loss for the period
                28,744     (17,367,378 )    (17,338,634 )
Exercise of warrants
    21,487,080         (1,455,025 )            20,032,055  
Exercise of stock options
    314,158     (51,831 )                262,327  
Stock based compensation
        224,525                  224,525  
As at September 30, 2011
    177,240,848     19,572,183     2,653,627     (127,916 )   (159,763,509 )    39,575,233  
     
   
For the nine month period ending, September 30, 2010 (note 3)
   
Share capital
 
Contributed Surplus
 
Warrants
   Accumulated Other Comprehensive Income
Deficit
 
Total Equity
    $     $     $     $   $       $    
As at January 1, 2010
    131,908,274     13,734,743     2,437,460         (117,737,070 )    30,343,407  
                                       
Net loss and comprehensive loss for the period
                (128,778 )   (15,045,868 )    (15,174,646 )
Expired warrants
        2,438,000     (2,438,000 )            —  
Exercise of stock options
    83,812     (20,987 )                62,825  
Stock based compensation
        400,103                  400,103  
Other
            540              540  
As at September 30, 2010
    131,992,086     16,551,859         (128,778 )   (132,782,938 )    15,632,229  
                                       
See accompanying notes

 
 

 

ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)

 
 
 
Notes
   
Three Month Period Ending
September 30, 2011
$
   
Three Month Period Ending
September 30, 2010
$
   
Nine Month Period Ending,
September 30, 2011
$
   
Nine Month Period Ending, September 30,
2010
$
 
Cash Flows
                             
Operating Activities
                             
Net loss for the period
          (6,232,024 )     (6,523,223 )     (17,367,378 )     (15,045,868 )
  Amortization - property and equipment
          21,258       15,981       68,525       45,487  
  Stock based compensation
    16       181,183       397,675       224,525       400,103  
  Change in fair value of warrant liability
    8             2,521,950       (36,000 )     2,672,439  
  Write down of asset available for sale
    7                   735,681        
  Unrealized foreign exchange loss (gain)
    16       (121,391 )     204,241       98,736       84,591  
Net change in non-cash working capital
    15       (427,319 )     (1,582,647 )     930,195       (2,374,876 )
Cash used in operating activities
            (6,578,293 )     (4,966,023 )     (15,345,716 )     (14,218,124 )
                                         
Investing Activities
                                       
Redemption (purchase) of short-term investments
                  (1,929,937 )     1,679,940       (1,929,937 )
Acquisition of property and equipment
            (62,087 )     (8,701 )     (111,194 )     (52,199 )
Cash provided by (used in) investing activities
            (62,087 )     (1,938,638 )     1,568,746       (1,982,136 )
                                         
Financing Activities
                                       
Proceeds from exercise of stock options and warrants
            54,985       8,825       14,793,582       62,825  
Cash provided by financing activities
            54,985       8,825       14,793,582       62,825  
                                         
Increase (decrease) in cash
            (6,585,395 )     (6,895,836 )     1,016,612       (16,137,435 )
Cash and cash equivalents, beginning of period
            46,640,231       23,205,961       39,296,682       32,448,939  
Impact of foreign exchange on cash and cash equivalents
            188,466       (211,990 )     (69,992 )     (213,369 )
Cash and cash equivalents, end of period
            40,243,302       16,098,135       40,243,302       16,098,135  
See accompanying notes
 

 
 

 
ONCOLYTICS BIOTECH INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
September 30, 2011



 
Note 1: Incorporation and Nature of Operations
 
 
Oncolytics Biotech Inc. was incorporated on April 2, 1998 under the Business Corporations Act (Alberta) as 779738 Alberta Ltd.  On April 8, 1998, we changed our name to Oncolytics Biotech Inc.
 
Our interim consolidated financial statements for the period ended September 30, 2011, were authorized for issue in accordance with a resolution of the directors on November 9, 2011.  We are a limited company incorporated and domiciled in Canada.  Our shares are publicly traded and our registered office is located at 210, 1167 Kensington Crescent NW, Calgary, Alberta, Canada.
 
We are a development stage biopharmaceutical company that focuses on the discovery and development of pharmaceutical products for the treatment of cancers that have not been successfully treated with conventional therapeutics.  Our product being developed may represent a novel treatment for Ras mediated cancers which can be used as an alternative to existing cytotoxic or cytostatic therapies, as an adjuvant therapy to conventional chemotherapy, radiation therapy, or surgical resections, or to treat certain cellular proliferative disorders for which no current therapy exists.
 
Note 2: Basis of Financial Statement Presentation
 
 
Our consolidated financial statements include our financial statements and the financial statements of our subsidiaries and are presented in Canadian dollars, our functional currency.
 
The accounts are prepared on the historical cost basis, except for certain assets and liabilities which are measured at fair value as explained in the notes to these financial statements.
 
These consolidated financial statements have been prepared in compliance with International Accounting Standard 34 Interim Financial Reporting and IFRS 1 First-time Adoption of International Financial Reporting Standards. The notes presented in these interim consolidated financial statements include only significant events and transactions occurring since our last fiscal year end and are not fully inclusive of all matters required to be disclosed in our annual audited consolidated financial statements.  Accordingly, these interim consolidated financial statements should be read in conjunction with our most recent annual audited consolidated financial statements.
 
Basis of consolidation
 
Our accounts include the accounts of Oncolytics Biotech Inc. and our subsidiaries.  Subsidiaries are entities over which we have control, being the power to govern the financial and operating policies of the investee entity so as to obtain benefits from its activities.  Accounting policies of subsidiaries are consistent with our accounting policies and all intra-group transactions, balances, income and expenses are eliminated on consolidation.
 
A change in ownership interest of a subsidiary, without a change in control, is accounted for as an equity transaction.

 
 

 
ONCOLYTICS BIOTECH INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
September 30, 2011


 
Note 3: Adoption of IFRS
 
 
Our accounting policies outlined in Note 4 have been applied in preparing our consolidated financial statements as at and for the period ended September 30, 2011, the comparative information presented as at and for the period ended September 30, 2010, as at December 31, 2010, and in the preparation of our opening IFRS balance sheet at January 1, 2010 (our date of transition).
 
In preparing our opening balance sheet, we have adjusted amounts reported previously in our consolidated financial statements prepared in accordance with Canadian Generally Accepted Accounting Principles in place prior to the adoption of IFRS (“CGAAP”).  An explanation of how the transition from CGAAP to IFRS has affected our financial position, financial performance and cash flows is set out in the tables below and in the respective notes.
 

 
 
Total equity
 
December 31,
2010
$
   
September 30, 2010
$
   
January 1,
2010
$
 
Total equity under CGAAP
    41,931,760       19,327,179       31,366,458  
Adjustment required to conform to IFRS:
                       
Revaluation of warrant liability
    (5,536,800 )     (3,694,950 )     (1,023,051 )
Total equity under IFRS
    36,394,960       15,632,229       30,343,407  

 
 
 
 
 
Comprehensive loss for the period
 
For the three month period ending September 30,
2010
$
   
For the nine month period ending September 30, 2010
$
   
For the year ending
December 31,
2010
$
 
Comprehensive loss under CGAAP
    4,009,022       12,502,207       19,973,772  
Adjustments required to conform to IFRS:
                       
Revaluation of warrant liability
    2,521,950       2,672,439       4,841,949  
Comprehensive loss under IFRS
    6,530,972       15,174,646       24,815,721  
Basic and diluted loss per common share, CGAAP
    0.07       0.20       0.32  
Basic and diluted loss per common share, IFRS
    0.11       0.24       0.39  
Weighted average number of common shares
    61,570,046       61,558,859       62,475,403  
 
Consolidated Statement of Cash Flows
 
In transitioning to IFRS, there was no impact on our net change in cash for the three and nine month periods ending September 30, 2010 or for the year ending December 31, 2010.
 
IFRS Transitional Arrangements
 
When preparing our consolidated statement of financial position under IFRS at January 1, 2010, our date of transition, the following optional exemption from full retrospective application of IFRS accounting policies has been adopted:
 
Cumulative translation differences – cumulative translation differences resulting from the translation of our net investment in our U.S. subsidiary and the financial statements of our U.S. subsidiary have been set to zero at January 1, 2010.
 
Effects of IFRS
 
Warrants
IFRS requires warrants with an exercise price denominated in a currency other than the entity’s functional currency to be treated as a liability measured at fair value.  Changes in fair value are to be recorded in the consolidated statement of loss and comprehensive loss.

Classification of expenses within the statement of loss and comprehensive loss
Under IFRS, we have chosen to present our expenses based on the function of each expense rather than the nature of each expense.  As a result, stock based compensation, depreciation of capital assets, and foreign currency gains and losses are no longer separately presented on the statement of loss and comprehensive loss.  There is no impact on our net loss or comprehensive loss as a result of these classifications.

Foreign currency translation
Under IFRS, we record the impact of fluctuations in foreign currency exchange rates relating to our net investment in our U.S. subsidiary and any foreign currency effects on the translation of our U.S. subsidiary’s financial statements as a separate component of equity and other comprehensive income.  Under CGAAP we treated our U.S. subsidiary as an integrated subsidiary with foreign currency translation differences recorded as part of our statement of loss.  The result of the transition to IFRS is a reclassification of the related foreign currency gains and losses from net loss to other comprehensive income.  There is no impact on our net comprehensive loss as a result of these re-classifications.
 
Note 4: Summary of Significant Accounting Policies
 
The consolidated financial statements have, in management’s opinion, been properly prepared within reasonable limits of materiality and within the framework of the significant accounting policies summarized below.
 
Property and equipment
 
Property and equipment are recorded at cost.  Depreciation is provided on bases and at rates designed to amortize the cost of the assets over their estimated useful lives.  Depreciation is recorded using the declining balance method at the following annual rates:
 
Office equipment and furniture
    20 %
Medical equipment
    20 %
Computer equipment
    30 %
Leasehold improvements
 
Straight-line over the term of the lease
 
 
Intellectual property
 
Intellectual property acquired through our investment in BCBC was included in Asset Held for Sale on the December 31, 2010 balance sheet, at cost.  During the nine month period ending September 30, 2011, this amount was written off.
 
Foreign currency translation
 
The financial statements for each of our subsidiaries are prepared using their functional currency.  The functional currency is the currency of the primary economic environment in which an entity operates.  Our presentation currency is the Canadian dollar which is also Oncolytics Biotech Inc.’s functional currency.  Foreign currency transactions are translated into the functional currency using exchange rates prevailing at the dates of the transactions.  Exchange differences resulting from the settlement of such transactions and from the translation at exchange rates ruling at the statement of financial position date of monetary assets and liabilities denominated in currencies other than the functional currency are recognized directly in the consolidated statement of loss.
 
Exceptions to this are where the monetary items form part of the net investment in a foreign operation.  These exchange differences are initially recognized in equity.  The statement of financial position of foreign operations is translated into Canadian dollars using the exchange rate at the statement of financial position date and the income statements are translated into Canadian dollars using the average exchange rate for the period.  Where this average is not a reasonable approximation of the
 
 

 
cumulative effect of the rates prevailing on the transaction dates, the exchange rate on the transaction date is used.  Exchange differences on translation into Canadian dollars are recognized as a separate component of equity.  On disposal of a foreign operation, any cumulative exchange differences held in equity are transferred to the consolidated statement of loss.
 
Research and development costs
 
Research costs are expensed as incurred.  Development costs that meet specific criteria related to technical, market and financial feasibility will be capitalized.  To date, all development costs have been expensed.
 
Investment tax credits and government assistance
 
Investment tax credits and government assistance relating to qualifying scientific research and experimental development expenditures that are recoverable in the current period are accounted for as a reduction in research and development expenditures.  Investment tax credits not recoverable in the current period are accrued provided there is reasonable assurance that the credits will be realized.
 
Loss per common share
 
Basic loss per common share is determined using the weighted average number of common shares outstanding during the period.
 
We use the treasury stock method to calculate diluted loss per common share.  Under this method, diluted loss per common share is computed in a manner consistent with basic loss per common share except that the weighted average common shares outstanding are increased to include additional common shares from the assumed exercise of options and warrants, if dilutive.  The number of additional common shares is calculated by assuming that any outstanding “in the money” options and warrants were exercised at the later of the beginning of the period or the date of issue and that the proceeds from such exercises were used to acquire shares of common stock at the average market price during the reporting period.
 
Stock based compensation
 
Stock option plan
We have one stock option plan (the “Plan”) available to officers, directors, employees, consultants and suppliers with grants under the Plan approved from time to time by our Board of Directors (the “Board”).  Under the Plan, the exercise price of each option equals the trading price of our stock on the date of grant in accordance with Toronto Stock Exchange guidelines.  Vesting is provided for at the discretion of the Board and the expiration of options is to be no greater than 10 years from the date of grant.

Officers, directors and employees
We use the fair value based method of accounting for employee awards granted under the Plan.  We calculate the fair value of each stock option grant using the Black Scholes Option Pricing Model and the fair value is recorded over the option’s vesting period.
 
Non-employees
Stock based compensation to non-employees is recorded at the fair value of the goods received or the services rendered.  The fair value is measured at the date we obtain the goods or the date the counterparty renders the service.  If the fair value of the goods or services cannot be reliably valued the fair value of the options granted will be used.
 
Financial instruments
 
Financial assets

Financial assets are comprised of cash and cash equivalents, accounts receivable, short-term investments and long term investment.  Financial assets are initially recorded at fair market value and are classified as follows:

Cash and cash equivalents
Cash and cash equivalents consist of cash on hand and interest bearing deposits with our bank and have been designated as held for trading.

Accounts receivable
Accounts receivable have been classified as loans and receivables.
 
 

 
Short-term investments
We determine the appropriate classification of our short-term investments at the time of purchase and re-evaluate such classification as of each balance sheet date.  We classify our short-term investments as held-to-maturity as we have the positive intent and ability to hold the securities to maturity.  Held-to-maturity securities are stated at original cost, adjusted for amortization of premiums and accretion of discounts to maturity computed under the effective interest rate method.  Such amortization and interest on securities classified as held-to-maturity are included in interest income.

Long term investment
We classified our long term investment as available-for-sale.

Impairment of financial assets
We assess at each reporting date whether there is any objective evidence that a financial asset or a group of financial assets is impaired. A financial asset or a group of financial assets is deemed to be impaired if, and only if, there is objective evidence of impairment as a result of one or more events that has occurred after the initial recognition of the asset (an incurred ‘loss event’) and that loss event has an impact on the estimated future cash flows of the financial asset or the group of financial assets that can be reliably estimated.

Financial liabilities

Trade accounts payable
Trade accounts payable are non interest-bearing and recorded at fair market value.  They are classified as Other Financial Liabilities and are subsequently measured at amortized cost using the effective interest rate method.

Warrant liability
Warrants with an exercise price denominated in a foreign currency are recorded as a Warrant Liability and classified as fair value through profit and loss.  The Warrant Liability is initially measured at estimated fair value with subsequent changes in fair value recorded as a gain or loss in the consolidated statement of loss and comprehensive loss.  These warrants have not been listed on an exchange and therefore do not trade on an active market.

Fair Value Measurement
The accounting guidance for fair value measurements prioritizes the inputs used in measuring fair value into the following hierarchy:
 
Level 1 – Quoted prices (unadjusted) in active markets for identical assets or liabilities;
 
Level 2 – Inputs other than quoted prices included within Level 1 that are either directly or indirectly observable;
 
Level 3 - Unobservable inputs in which little or no market activity exists, therefore requiring an entity to develop its own assumptions about the assumptions that market participants would use in pricing.
 
The fair value of our Warrant Liability is based on level 2 (significant observable inputs).

Transaction Costs

Transaction costs are expensed as incurred for financial instruments designated as held for trading.  Transaction costs for other financial instruments are recognized as part of the financial instrument’s carrying value.
 
Asset held for sale

Assets are classified as held for sale if their carrying amount will be recovered primarily through a sale as opposed to continued use.  Assets classified as held for sale are measured at the lower of their carrying amount and fair value less costs to sell. Depreciation ceases when an asset is classified as held for sale.
 
Deferred income taxes
 
We follow the liability method of accounting for income taxes.  Under the liability method, deferred income taxes are recognized for the difference between financial statement carrying values and the respective income tax basis of assets and liabilities (temporary differences).  Deferred income tax assets and liabilities are measured using substantively enacted income tax rates and laws expected to apply in the years in which temporary differences are expected to be recovered or settled.  The effect on deferred income tax assets and liabilities of a change in tax rates is charged or credited to income, except when it is related to items charged or credited to either other comprehensive income or directly to equity.

Accounting Standards and Interpretations Issued but Not Yet Effective
 
Financial Instruments
In November 2009, the International Accounting Standard Board (“IASB”) issued IFRS 9 Financial Instruments which replaced the classification and measurement requirements in IAS 39 Financial Instruments: Recognition and Measurement for financial assets.  In October 2010, the IASB issued additions to IFRS 9 regarding financial liabilities.  The new standard is effective for annual periods beginning on or after January 1, 2013 with earlier adoption permitted.  We do not anticipate that there will be a material impact on our financial position or results of operations.
 
Fair Value Measurements
In June 2011, the IASB issued IFRS 13 Fair Value Measurements, which establishes a single source of guidance for all fair value measurements required by other IFRS; clarifies the definition of fair value; and enhances disclosures about fair value measurements. IFRS 13 applies when other IFRS require or permit fair value measurements or disclosures.  IFRS 13 specifies how we should measure fair value and disclose fair value information.  It does not specify when an entity should measure an asset, a liability or its own equity instrument at fair value.  IFRS 13 is effective for annual periods beginning on or after January 1, 2013.  Earlier application is permitted.  We are currently assessing the impact of adopting IFRS 13 on our condensed consolidated financial statements.

Presentation of Financial Statements
In June 2011, the IASB issued amendments to IAS 1 Presentation of Financial Statements to improve the consistency and clarity of the presentation of items of comprehensive income by requiring that items presented in Other Comprehensive Income (“OCI”) be grouped on the basis of whether they are at some point reclassified from OCI to net earnings or not. The amendments to IAS 1 are effective for annual periods beginning on or after July 1, 2012. Earlier application is permitted.   We are currently assessing the impact of adopting the amendments to IAS 1 on our condensed consolidated financial statements.
 
Note 5:  Significant Judgments, Estimates and Assumptions
 
 
Judgments
 
The preparation of our consolidated financial statements requires us to make judgments, estimates and assumptions that affect the reported amount of expenses, assets, liabilities, and the disclosure of contingent liabilities, at the end of the reporting period.  However, uncertainty about these assumptions and estimates could result in outcomes that require a material adjustment to the carrying amount of the asset or liability affected in future periods.
 
Estimates and assumptions
 
Because a precise determination of many assets and liabilities is dependent upon future events, the preparation of financial statements in conformity with IFRS requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting periods.  Actual results could differ from those estimates and such differences could be significant.  Significant estimates made by management affecting our consolidated financial statements include:
 
Stock based compensation
We measure our stock based compensation expense by reference to the fair value of the stock options at the date at which they are granted.  Estimating fair value for granted stock options requires determining the most appropriate valuation model which is dependent on the terms and conditions of the grant.  This estimate also requires determining the most appropriate inputs to the valuation model including the expected life of the option, volatility dividend yield, and rate of forfeitures and making assumptions about them.  The assumptions and model used for estimating fair value for stock based compensation transactions are disclosed in note 8 of our audited 2010 consolidated financial statements.

Warrant liability
We measured our initial warrant liability and subsequent revaluations of our warrant liability by reference to the fair value of the warrants at the date at which they were granted and subsequently revalued at each reporting date.  Estimating fair value for these warrants required determining the most appropriate valuation model which is dependent on the terms and conditions of the grant.  This estimate also requires determining the most appropriate inputs to the valuation model including the expected life of the warrants, volatility and dividend yield and making assumptions about them.

Asset held for sale
In June 2011, we wrote down our asset held for sale to $nil.  We have used management judgment pertaining to the timing and potential results of the ongoing sales process.  We concluded, under current market conditions, that we would not be able to complete a sale in a timely manner.  As well, assumptions have been made and estimates used in assessing the fair value of the associated intellectual property.

Taxes
Uncertainties exist with respect to the interpretation of complex tax regulations and the amount and timing of future taxable income.  Currently, we are accumulating tax loss carry forward balances in various tax jurisdictions creating a deferred tax asset.  Deferred tax assets are recognized for all unused tax losses to the extent that it is probable that taxable profit will be available against which the losses can be utilized. Management judgment is required to determine the amount of deferred tax assets that can be recognized, based upon the likely timing and the level of future taxable profits together with future tax planning strategies.

To date we have determined that none of our deferred tax assets should be recognized.  Our deferred tax assets are mainly comprised of our net operating losses from prior years, prior year research and development expenses, and investment tax credits.  These tax pools relate to entities that have a history of losses, have varying expiry dates, and may not be used to offset taxable income within our other subsidiaries.  As well, there are no taxable temporary differences or any tax planning opportunities available that could partly support the recognition of these losses as deferred tax assets.
 
Note 6: Cash Equivalents and Short Term Investments
 
 
Cash Equivalents

Cash equivalents consist of interest bearing term deposits with our bank totaling $35,732,719 (December 31, 2010 – $34,337,595; January 1, 2010 - $15,518,939).  The current annual interest rate earned on these deposits is 1.1% (December 31, 2010 – 1.06%; January 1, 2010 – 0.30%).
 
Short-Term Investments

Short-term investments which consist of guaranteed investment certificates are liquid investments that are readily convertible to known amounts of cash and are subject to an insignificant risk of changes in value.  The objectives for holding short-term investments are to invest our excess cash resources in investment vehicles that provide a better rate of return compared to our interest bearing bank account with limited risk to the principal invested.  We intend to match the maturities of these short-term investments with the cash requirements of the Company’s activities and treat these as held-to-maturity short-term investments.

   
Face
Value
$
   
 
Original Cost
$
 
 
Accrued Interest
$
 
Carrying
Value
$
   
Fair
Value
$
   
Effective Interest Rate
%
 
September 30, 2011
                               
Short-term investments
    1,929,306       1,929,306  
Nil
    1,929,306       1,929,306       1.68 %
                                           
December 31, 2010
                                         
Short-term investments
    3,609,246       3,609,246  
Nil
    3,609,246       3,609,246       0.30 %

Fair value is determined by using published market prices provided by our investment advisor.

 
Note 7: Asset Held for Sale
 
 
In 2009, we acquired all of the convertible preferred shares of British Canadian Biosciences Corp. (“BCBC”), a privately held biotechnology company specializing in the development of peptides for the treatment of a variety of conditions, including cancer.  In February 2010, we completed the conversion of our preferred share holding in BCBC into common shares.  As a result of this conversion we owned 10% of the issued common shares of BCBC.  The common shares of BCBC do not have a quoted market price in an active market.  BCBC’s only asset is intellectual property.
 
In the fourth quarter of 2010, BCBC concluded that it was unable to obtain additional financing to support its business and subsequently suspended operations.  In November 2010, we purchased an additional 60% of the common shares of BCBC for $51,681 which included cash and the settlement of certain trade accounts payable.  As the operations of BCBC had been suspended, its only remaining asset was intellectual property.  In conjunction with this purchase, we assessed the cost of our investment against the estimated fair value of BCBC using a cash flow analysis and determined that the estimated fair value of our investment was in excess of our cost.  At the end of 2010, we began the process to sell BCBC and as a result we had reflected our investment in BCBC’s intellectual property as an asset held for sale.  As at June 30, 2011, despite our efforts to sell our investment in BCBC, we were unsuccessful in completing a sale.  As a result, we wrote down our investment in BCBC to $nil, but continue to pursue potential future buyers.
 
Note 8: Share Capital
 
 
Authorized:
 
Unlimited number of no par value common shares
Issued:
 
Shares
   
Warrants
 
   
Number
   
Amount
$
   
Number
   
Equity Amount
$
   
Liability Amount
$
 
Balance, January 1, 2010
    61,549,969       131,908,274       4,255,000       2,437,460       1,023,051  
Issued for cash pursuant to November 8, 2010 bought deal financing (a)
    6,256,000       22,639,720       3,503,360       4,120,202        
Exercise of warrants
    119,900       787,507       (119,900 )     (11,010 )     (328,200 )
Expired warrants
                (2,300,000 )     (2,438,000 )      
Exercise of stock options
    32,433       104,109                    
Revaluation of warrant liability
                            4,841,949  
Balance, December 31, 2010
    67,958,302       155,439,610       5,338,460       4,108,652       5,536,800  
Exercise of US$3.50 warrants
    1,833,600       11,897,142       (1,833,600 )           (5,500,800 )
Exercise of warrants
    1,322,750       9,589,938       (1,322,750 )     (1,455,025 )      
Exercise of stock options
    125,266       314,158                    
Expired warrants
                (12,000 )           (36,000 )
Balance, September 30, 2011
    71,239,918       177,240,848       2,170,110       2,653,627        

 
(a)  
Pursuant to a bought deal financing, 6,256,000 units were issued at an issue price of $4.60 per unit for gross proceeds of $28,777,600.  Each unit included one common share (ascribed value of $4.05) and 0.50 of one common share purchase warrant (ascribed value of $0.55).  The ascribed value was determined using the relative fair value method.  Each common share purchase warrant entitles the holder to acquire one common share in the capital of the Company upon payment of $6.15 per share until November 8, 2012.  Share issue costs for this offering were $2,697,081.  In addition, we issued 375,360 common share purchase warrants with an exercise price of $4.60 that expires on November 8, 2012 to the brokerage firm assisting with the transaction.  The ascribed value of these broker warrants was $679,402 ($1.81 per broker warrant) and has been included in the share issue costs above.  The ascribed values of the warrants were determined using Black Scholes.
 
Warrants – liability
 
Under IFRS, the prescribed accounting treatment for warrants with an exercise price denominated in a foreign currency is to treat these warrants as a liability measured at fair value with subsequent changes in fair value accounted for through the consolidated statement of loss.  The fair value of these warrants is determined using the Black Scholes Option Pricing Model.  Our warrants with an exercise price of U.S.$3.50 meet this requirement and we have presented the value of these warrants as a deemed current liability on the consolidated statement of financial position.  As these warrants are exercised, the value of the recorded warrant liability is included in our share capital along with the proceeds from the exercise.  If these warrants expire, the related warrant liability is reversed through the statement of loss.  There is no cash flow impact as a result of the accounting treatment for changes in the fair value of the warrant liability or when warrants expire unexercised.
 
As at September 30, 2011, our warrant liability is $nil (December 31, 2010 - $5,536,800; January 1, 2010 - $1,023,051) as these warrants were either exercised or expired on January 24, 2011.
 
 

 
Warrants – equity
 
The following table summarizes the weighted average assumptions used in the Black Scholes Option Pricing Model with respect to the valuation of warrants and broker warrants issued:
 
   
2010
 
       
Risk-free interest rate
    1.40 %
Expected hold period to exercise
    2.00  
Volatility in the price of the Company’s shares
    61.9 %
Dividend yield
 
Zero
 
 
The following table summarizes our outstanding warrants as at September 30, 2011:
Exercise Price
   
Outstanding, Beginning of the Period
   
Granted During the Period
   
Exercised During the Period
   
Expired During the Period
   
Outstanding, End of Period
   
Weighted Average Remaining Contractual Life (years)
 
$ 4.60       375,360                         375,360       1.08  
$ 6.15       3,117,500             (1,322,750 )           1,794,750       1.08  
$ US3.50       1,845,600             (1,833,600 )     (12,000 )            
          5,338,460             (3,156,350 )     (12,000 )     2,170,110       1.08  


 
Note 9: Share Based Payments
 
 
Stock Option Plan
 
We have issued stock options to acquire common stock through our stock option plan of which the following are outstanding at September 30:
   
2011
   
2010
 
   
 
Stock Options
   
Weighted Average Exercise Price
$
   
 
Stock Options
   
Weighted Average Exercise Price
$
 
Outstanding, beginning of the period
    4,703,760       4.53       3,936,543       4.72  
Granted during the period
    193,000       5.22       315,000       3.12  
Cancelled during the period
    (90,000 )     9.47       (308,350 )     10.00  
Exercised during the period
    (125,266 )     2.09       (23,500 )     2.67  
Outstanding, end of the period
    4,681,494       4.52       3,919,693       4.19  
Options exercisable, end of the period
    4,537,160       4.51       3,869,526       4.21  
 
The following table summarizes information about the stock options outstanding and exercisable at September 30, 2011:

Range of Exercise Prices
   
Number Outstanding
   
Weighted Average Remaining Contractual Life (years)
   
Weighted Average Exercise Price
$
   
Number Exercisable
   
Weighted Average Exercise Price
$
 
$ 1.45 - $2.37       675,827       4.7       2.11       655,660       2.11  
$ 2.70 - $3.60       1,393,417       5.4       3.14       1,381,750       3.14  
$ 4.00 - $5.00       1,415,750       4.0       4.91       1,303,250       4.83  
$ 6.72 - $9.76       1,196,500       7.0       7.05       1,196,500       7.05  
          4,681,494       5.3       4.52       4,537,160       4.51  
 
The outstanding options vest annually or after the completion of certain milestones.  We have reserved 6,154,997 common shares for issuance relating to outstanding stock options.
 
Compensation expense related to options granted to employees and directors was $224,525 (2010 – $400,103) in the nine month period ending September 30.

The estimated fair value of stock options issued during the period was determined using the Black Scholes Option Pricing Model using the following weighted average assumptions and fair value of options:
 
   
2011
 
       
Risk-free interest rate
    2.10 %
Expected hold period to exercise
 
3.7 years
 
Volatility in the price of the Company’s shares
    54.57 %
Rate of forfeiture
    0.00 %
Dividend yield
 
Nil
 
Weighted average fair value of options
    2.19  
 
We use historical data to estimate the expected dividend yield and expected volatility of our stock in determining the fair value of the stock options. The risk-free interest rate is based on the Government of Canada marketable bond rate in effect at the time of grant and the expected life of the options represents the estimated length of time the options are expected to remain outstanding.
 
Note 10: Loss Per Common Share
 
 
Loss per common share is calculated using the weighted average number of common shares outstanding for the three and nine month period ending September 30, 2011 of 71,221,218 and 70,800,114, respectively (2010 – 61,570,046 and 61,558,859, respectively).  The effect of any potential exercise of our stock options and warrants outstanding during the year has been excluded from the calculation of diluted loss per common share, as it would be anti-dilutive.
 
Note 11: Commitments
 
 
We are committed to payments totaling $3,108,000 for activities related to our clinical trial program and collaborations.
 
We are committed to rental payments (excluding our portion of operating costs and rental taxes) under the terms of a lease for office premises which expires on May 31, 2016.  Annual payments under the terms of this lease are as follows:
   
Amount
$
 
2011
    21,306  
2012
    88,792  
2013
    91,332  
2014
    94,888  
2015
    97,428  
2016
    40,595  
      434,341  
 
Under a clinical trial agreement entered into with the Alberta Cancer Board (“ACB”), we have agreed to repay the amount funded under the agreement together with a royalty, to a combined maximum amount of $400,000 plus an overhead repayment of $100,000, upon sales of a specified product.  We agreed to repay the ACB in annual installments in an amount equal to the lesser of: (a) 5% of gross sales of a specified product; or (b) $100,000 per annum.
 
Note 12: Contingencies
 
Assumption Agreement
 
During 1999, the Company entered into an agreement that assumed certain obligations (the “Assumption Agreement”) in connection with a Share Purchase Agreement (the “Agreement”) between SYNSORB and the former shareholders of the Company to make milestone payments and royalty payments.
 
As of September 30, 2011, a milestone payment was still outstanding for $1.0 million, due within 90 days of the first receipt from an Appropriate Regulatory Authority, for marketing approval to sell REOLYSIN® to the public or the approval of a new drug application for REOLYSIN®.
 
This milestone payment, when payable, will be accounted for as research and development expense and will not be deductible for income tax purposes.
 
In addition to the milestone payment, payments may become due and payable in accordance with the Agreement upon realization of sales of REOLYSIN®.   If we receive royalty payments or other payments as a result of entering into partnerships or other arrangements for the development of the reovirus technology, we are obligated to pay to the founding shareholders 11.75% of the royalty payments and other payments received.  Alternatively, if we develop the reovirus treatment to the point where it may be marketed at a commercial level, the payments referred to in the foregoing sentence will be amended to a royalty payment of 2.35% of Net Sales received by the Company for such products.
 
BRI “Work in Kind” Contribution
 
We entered into an engineering and process development agreement with the Biotechnology Research Institute of the National Research Council of Canada (“BRI”).  The terms of this Agreement include a “work in kind” contribution from BRI.  In exchange for this “work in kind” contribution, we agreed to provide a royalty, contingent upon receiving Sales Revenue, at the lesser of 0.5% of Sales Revenue or $20,000 per year.  The total royalty under this Agreement is equal to two times the “work in kind” contribution.  As of September 30, 2011, we estimate that the accumulated work in kind totals approximately $301,000.
 
Note 13: Capital Disclosures
 
Our objective when managing capital is to maintain adequate cash resources to support planned activities which include the clinical trial program, product manufacturing, administrative costs and intellectual property expansion and protection.  We include shareholders’ equity, any warrant liability, cash and cash equivalents and short-term investments in the definition of capital.

   
September 30, 2011
$
   
December 31, 2010
$
   
January 1, 2010
$
 
Cash and cash equivalents
    40,243,302       39,296,682       32,448,939  
Short-term investments
    1,929,306       3,609,246       1,679,937  
Warrant liability
          5,536,800       1,023,051  
Shareholders’ equity
    39,575,233       36,394,960       30,343,407  

 
At September 30, 2011, we do not have any debt other than trade accounts payable and we have potential contingent obligations relating to the completion of our research and development of REOLYSIN®.

In managing our capital, we estimate our future cash requirements by preparing a budget and a multi-year plan annually for review by our Board of Directors (the “Board”).  The budget establishes the approved activities for the upcoming year and estimates the costs associated with these activities.  The multi-year plan estimates future activity along with the potential cash requirements and is based on our assessment of our current clinical trial progress along with the expected results from the coming year’s activity.  Budget to actual variances are prepared and reviewed by management and are presented quarterly to the Board.

Historically, funding for our plan is primarily managed through the issuance of additional common shares and common share purchase warrants that upon exercise are converted to common shares.  Management regularly monitors the capital markets attempting to balance the timing of issuing additional equity with our progress through our clinical trial program, general market conditions, and the availability of capital.  There are no assurances that funds will be made available to us when required.

On June 10, 2010, we renewed our existing short form base shelf prospectus (the “Base Shelf”) that qualifies for distribution up to $150,000,000 of common shares, subscription receipts, warrants, or units (the “Securities”).  Under our Base Shelf, we may sell Securities to or through underwriters, dealers, placement agents or other intermediaries and also may sell Securities directly to purchasers or through agents, subject to obtaining any applicable exemption from registration requirements.  The distribution of Securities may be effected from time to time in one or more transactions at a fixed price or prices, which may be changed, at market prices prevailing at the time of sale, or at prices related to such prevailing market prices to be negotiated with purchasers and as set forth in an accompanying Prospectus Supplement.

Renewing our Base Shelf provides us with additional flexibility when managing our cash resources as, under certain circumstances, it shortens the time period required to close a financing and is expected to increase the number of potential investors that may be prepared to invest in our company.  Funds received from a Prospectus Supplement will be used in line with our Board approved budget and multi-year plan.  The Base Shelf expires on July 10, 2012 and we have registered 9,759,360 units under this shelf.

We are not subject to externally imposed capital requirements and there have been no changes in how we define or manage our capital.
 
Note 14: Financial Instruments
 
 
Our financial instruments consist of cash and cash equivalents, short-term investments, accounts receivable, accounts payable, and warrant liability.  As at September 30, 2011, there are no significant differences between the carrying values of these amounts and their estimated market values due to their short-term maturities.
 
Credit risk
Credit risk is the risk of financial loss if a counterparty to a financial instrument fails to meet its contractual obligations.  We are exposed to credit risk on our cash and cash equivalents and short-term investments in the event of non-performance by counterparties, but we do not anticipate such non-performance.  Our maximum exposure to credit risk at the end of the period is the carrying value of our cash and cash equivalents and short-term investments.
 
We mitigate our exposure to credit risk by maintaining our primary operating and investment bank accounts with Schedule I banks in Canada.  For our foreign domiciled bank accounts, we use referrals or recommendations from our Canadian banks to open foreign bank accounts and these accounts are used solely for the purpose of settling accounts payable or payroll.
 
We also mitigate our exposure to credit risk by restricting our portfolio to investment grade securities with short-term maturities and by monitoring the credit risk and credit standing of counterparties.  Currently, 100% of our short-term investments are in guaranteed investment certificates.
 
Interest rate risk
Interest rate risk is the risk that future cash flows of a financial instrument will fluctuate because of changes in market interest rates.  We are exposed to interest rate risk through our cash and cash equivalents and our portfolio of short-term investments.  We mitigate this risk through our investment policy that only allows investment of excess cash resources in investment grade vehicles while matching maturities with our operational requirements.
 
Fluctuations in market rates of interest do not have a significant impact on our results of operations due to the short term to maturity of the investments held.
 
Currency risk
Currency risk is the risk that future cash flows of a financial instrument will fluctuate because of changes in foreign exchange rates.  We are exposed to currency risk from the purchase of goods and services primarily in the U.S., the U.K and the European Union and to the extent cash is held in foreign currencies.  The impact of a $0.01 increase in the value of the U.S. dollar against the Canadian dollar would have increased our net loss in 2011 by approximately $81,801.  The impact of a $0.10 increase in the value of the British pound against the Canadian dollar would have increased our net loss in 2011 by approximately $182,829.  The impact of a $0.10 increase in the value of the Euro against the Canadian dollar would have decreased our net loss in 2011 by approximately $141,640.
 
We mitigate our foreign exchange risk through the purchase of foreign currencies in sufficient amounts to settle our foreign accounts payable.
 
Balances in foreign currencies at September 30, 2011 are as follows:
   
U.S. dollars
$
   
British pounds
£
   
Euro
 
Cash and cash equivalents
    2,973,862       293,915       238,848  
Accounts payable
    (709,212 )     (392,355 )     (195,539 )
      2,264,650       (98,440 )     43,309  
 
Liquidity risk
Liquidity risk is the risk that we will encounter difficulty in meeting obligations associated with financial liabilities.  We manage liquidity risk through the management of our capital structure as outlined in Note 13.  Accounts payable are all due within the current operating period.
 
 

 
Note 15: Additional Cash Flow Disclosures
 
 
Net Change In Non-Cash Working Capital
   
Three Month Period Ended September 30, 2011
$
   
Three Month Period Ended September 30, 2010
$
   
Nine Month Period Ended September 30, 2011
$
   
Nine Month Period Ended September 30, 2010
$
 
Change in:
                       
Accounts receivable
    (26,090 )     27,854       207,477       33,996  
Prepaid expenses
    307,295       219,157       (254,215 )     8,147  
Accounts payable and accrued liabilities
    (708,524 )     (1,829,658 )     976,933       (2,417,019 )
Net change associated with operating activities
    (427,319 )     (1,582,647 )     930,195       (2,374,876 )

 
Note 16:  Other Expenses and Adjustments
 

We present our expenses based on the function of each expense and therefore include realized foreign exchange gains and losses, unrealized non-cash foreign exchange gains and losses, and non-cash stock based compensation associated with research and development activity as a component of research and development expenses and amortization of property and equipment and stock based compensation associated with operating activities as a component of operating expenses.

   
Three Month Period Ended September 30, 2011
$
   
Three Month Period Ended September 30, 2010
$
   
Nine Month Period Ended September 30, 2011
$
   
Nine Month Period Ended September 30, 2010
$
 
Included in research and development expenses:
                       
Realized foreign exchange loss (gain)
    (132,897 )     4,869       (122,606 )     (13,505 )
Unrealized non-cash foreign exchange loss (gain)
    (121,391 )     204,241       98,736       84,591  
Non-cash stock based compensation
    181,183       1,675       224,525       4,103  
                                 
Included in operating expenses
                               
Amortization of property and equipment
    21,258       15,981       68,525       45,487  
Non-cash stock based compensation
          396,000             396,000  

 
 

 

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
Calgary, Alberta, Canada T2N 1X7
tel: 403.670.7377 fax: 403.283.0858
www.oncolyticsbiotech.com

Officers

Brad Thompson, PhD
Chairman, President and CEO
Doug Ball, CA
Chief Financial Officer
Matt Coffey, PhD
Chief Operating Officer
Claire S. Padgett, MT, MS
Vice President of Clinical Operations
George M. Gill, MD
Chief Medical Officer
Senior Vice President, Clinical and Regulatory Affairs
Mary Ann Dillahunty, JD, MBA
Vice President, Intellectual Property

Directors

Brad Thompson, PhD
Chairman, President and CEO, Oncolytics Biotech Inc.
Matt Coffey, PhD
Chief Operating Officer
Ger van Amersfoort
Biotech Consultant
William A. Cochrane, OC, MD
Biotech Consultant
Jim Dinning
Chairman, Western Financial Group
Ed Levy, PhD
Adjunct Professor, University of British Columbia
J. Mark Lievonen, FCA
President, Sanofi Pasteur Limited
Bob Schultz, FCA
Corporate Director
Fred A. Stewart, QC
President, Fred Stewart and Associates Inc.