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Oncolytics Biotech® Inc. Announces 2012 Year End Results


CALGARY, March 14, 2013 /CNW/ - Oncolytics Biotech Inc. (TSX:ONC) (NASDAQ:ONCY) ("Oncolytics" or the "Company") today announced its financial results and operational highlights for the  year ended December 31, 2012.

"We were very pleased to present our first randomized clinical data from our head and neck cancer clinical study in 2012," said Dr. Brad Thompson, President and CEO of Oncolytics. "In addition, in order to support our program, which now includes seven randomized studies in different indications, we completed two financings over the last 14 months raising gross proceeds in excess of $50 million."

Selected Highlights

Since January 1, 2012, the Company has made a number of significant announcements including:

Clinical Trial Results


    --  Reporting initial positive top line data from the first
        endpoint in the double-blinded randomized Phase III clinical
        study examining REOLYSIN(®) in combination with carboplatin and
        paclitaxel in second-line patients with platinum-refractory,
        taxane-naïve head and neck cancers (REO 018). The endpoint
        examined initial percentage tumour changes between the
        pre-treatment and first post-treatment scans (typically
        performed at six weeks post-first treatment) of all patients
        enrolled in the study and was designed to assess early
        differences in response between loco-regional tumours and
        metastatic tumours, as classified and observed by the
        investigators;
    --  Reaching the primary endpoint in the first stage of a U.S.
        Phase 2 clinical trial in patients with squamous cell carcinoma
        of the lung (SCCLC) using intravenous administration of
        REOLYSIN in combination with carboplatin and paclitaxel (REO
        021) and subsequently reporting positive percent overall tumour
        shrinkage data;
    --  Poster presentations at the EORTC-NCI-AACR Symposium on
        Molecular Targets and Cancer Therapeutics reporting positive
        clinical data from a study in a Phase 2 clinical trial using
        intravenous administration of REOLYSIN in combination with
        paclitaxel and carboplatin in patients with non-small cell lung
        cancer (NSCLC) with Kras or EGFR-activated tumours (REO 016)
        and a U.S. Phase 2 clinical trial using intravenous
        administration of REOLYSIN( )in combination with gemcitabine
        (Gemzar(®)) in patients with advanced pancreatic cancer (REO
        017);
    --  Publication of a paper entitled "Cell Carriage, Delivery, and
        Selective Replication of an Oncolytic Virus in Tumor in
        Patients," in the June 13,( )2012 issue of the journal Science
        Translational Medicine (Vol. 4 Issue 138 138ra77), covering
        findings from a U.K. translational clinical trial (REO 013)
        investigating intravenous administration of REOLYSIN in
        patients with metastatic colorectal cancer prior to surgical
        resection of liver metastases. The researchers found that
        intravenously-administered reovirus could specifically target
        and infect metastatic liver tumors in 90% of the patients, even
        though all patients treated had had a pre-existing immunity to
        the virus;

Clinical Trial Program
    --  Expansion of enrollment in the first stage of a Phase III head
        and neck cancer clinical trial (REO 18) to include 167 patients
        and introduction of an additional patient segregation to
        differentiate between patients with local recurrent disease,
        with or without metastases, and patients with distal metastases
        while maintaining the blind;
    --  Completion of patient enrollment in a U.S. Phase 2 clinical
        trial evaluating intravenous administration of REOLYSIN in
        combination with paclitaxel and carboplatin in patients with
        non-small cell lung cancer (NSCLC) with Kras or EGFR-activated
        tumours (REO 016);
    --  Completion of patient enrollment in a U.S. Phase 2 clinical
        trial using intravenous administration of REOLYSIN in
        combination with gemcitabine (Gemzar(®)) in patients with
        advanced or metastatic pancreatic cancer (REO 017);
    --  Completion of enrollment in a U.K. Phase I clinical trial using
        intravenously-administered REOLYSIN in combination with
        cyclophosphamide in patients with advanced malignancies (REO
        012);
    --  Completion of enrollment in a U.S. Phase 1 clinical trial using
        intravenously-administered REOLYSIN in combination with FOLFIRI
        in patients with colorectal cancer (REO 022);
    --  Entry into multiple agreements whereby the NCIC Clinical Trials
        Group (CTG) at Queen's University in Kingston, Ontario, will
        sponsor and conduct randomized Phase II studies of REOLYSIN in
        patients with recurrent or metastatic castration resistant
        prostate cancer, advanced or metastatic colorectal cancer,
        advanced or metastatic non-small cell lung cancer, and advanced
        or metastatic breast cancer;

Management
    --  Appointment of Mr. Kirk Look to the role of Chief Financial
        Officer;
    --  Appointment of Dr. Alan Tuchman to the role of Chief Medical
        Officer and Senior Vice President, Clinical and Medical
        Development;

Financial
    --  Closing of a bought deal financing in February 2012, which was
        increased post-announcement from $15 million to $18.5 million,
        for gross proceeds of $21.3 million following the full exercise
        of the over-allotment option by the syndicate of underwriters;
        and
    --  Subsequent to year-end, closing of an underwritten public
        offering of 8.0 million common shares, at a public offering
        price of US$4.00 per common share for aggregate gross proceeds
        from the offering, before deducting underwriting discounts and
        commissions and offering expenses, of approximately US$32.0
        million.
                                     ONCOLYTICS BIOTECH INC.
                 CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
                                           December 31,    December 31,
                                             2012            2011
                                               $               $

Assets                                                              

Current assets                                                      

Cash and cash equivalents               19,323,541      32,918,751  

Short-term investments                   1,969,228       1,936,787  

Accounts receivable                         44,979          55,392  

Prepaid expenses                           331,094         721,576  

Total current assets                    21,668,842      35,632,506  
                                                                    

Non-current assets                                                   

Property and equipment                     409,248         392,111  

Total non-current assets                   409,248         392,111  
                                                                    
                                                                    

Total assets                            22,078,090      36,024,617  
                                                                    

Liabilities And Shareholders' Equity                                

Current Liabilities                                                 

Accounts payable and accrued             7,291,310       6,504,238  
liabilities

Total current liabilities                7,291,310       6,504,238  
                                                                    

Shareholders' equity                                                
                                                                    

Share capital                                                       

  Authorized: unlimited                                             

  Issued:                                                           

  December 31, 2012 - 76,710,285                                    

  December 31, 2011 -  71,251,335      198,155,091     177,282,566  

Warrants                                   376,892       2,653,627  

Contributed surplus                     24,126,265      21,142,519  

Accumulated other comprehensive loss      (57,115)       (117,501)  

Accumulated deficit                  (207,814,353)   (171,440,832)  

Total shareholders' equity              14,786,780      29,520,379  

Total liabilities and equity            22,078,090      36,024,617  
    
                                    ONCOLYTICS BIOTECH INC.
            CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
                                     2012           2011           2010

For the years ending                $              $              $
December 31,
                                                          

Expenses                                                               

Research and development     31,402,625     23,386,685     13,882,565  

Operating                     5,285,425      5,334,582      6,003,870  

Loss before the following  (36,688,050)   (28,721,267)   (19,886,435)  

Write down of asset             —      (735,681)        —  
available for sale

Change in fair value of         —         36,000    (4,841,949)  
warrant liability

Interest                        345,003        416,247         76,934  

Loss before income taxes   (36,343,047)   (29,004,701)   (24,651,450)  

Income tax expense             (30,474)       (40,000)        (7,611)  

Net loss                   (36,373,521)   (29,044,701)   (24,659,061)  
                                                                       

Other comprehensive gain         60,386         39,159      (156,660)  
(loss) - translation
adjustment
                                                                       

Net comprehensive loss     (36,313,135)   (29,005,542)   (24,815,721)  

Basic and diluted loss per       (0.48)         (0.41)         (0.39)  
common share
                                                                       

Weighted average number of   76,102,062     70,911,526     62,475,403  
shares (basic and diluted)
      
                                                               ONCOLYTICS BIOTECH INC.
                                            CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
                                                                                                       
                                                          Accumulated
                                                             Other
                                                         Comprehensive                                 
                  Share                    Contributed                    Accumulated
                Capital       Warrants      Surplus         Income          Deficit           Total
                     $             $              $               $               $              $     
                                                                                                       

As at         155,439,610     4,108,652     19,399,489       (156,660)   (142,396,131)     36,394,960  
December 31,
2010
                                                                                                       

Net loss and      —       —        —          39,159    (29,044,701)   (29,005,542)  
comprehensive
income

Exercise of    21,487,080   (1,455,025)        —         —         —     20,032,055  
warrants

Exercise of       355,876       —       (62,473)         —         —        293,403  
stock options

Share based       —       —      1,805,503         —         —      1,805,503  
compensation
                                                                                                       

As at         177,282,566     2,653,627     21,142,519       (117,501)   (171,440,832)     29,520,379  
December 31,
2011
                                                                                                       

Net loss and      —       —        —          60,386    (36,373,521)   (36,313,135)  
comprehensive
income

Issued,        19,386,903       376,892        —         —         —     19,763,795  
pursuant to a
bought deal
financing

Expiry of         —   (2,653,627)      2,653,627         —         —        —  
warrants

Exercise of     1,485,622       —      (400,632)         —         —      1,084,990  
stock options

Share based       —       —        730,751         —         —        730,751  
compensation
                                                                                                       

As at         198,155,091       376,892     24,126,265        (57,115)   (207,814,353)     14,786,780  
December 31,
2012
    
                                       ONCOLYTICS BIOTECH INC.
                         CONSOLIDATED STATEMENTS OF CASH FLOWS

For the years ending 2012 2011 2010 December 31, $ $ $

Operating Activities

Net loss for the year (36,373,521) (29,044,701) (24,659,061)

Amortization - property 109,275 92,590 63,156 and equipment

Share based compensation 730,751 1,805,503 3,251,041

Change in fair value of — (36,000) 4,841,949 warrant liability

Write down of asset — 735,681 — available for sale

Unrealized foreign 89,890 115,234 343,821 exchange loss

Net change in non-cash 1,187,967 3,790,510 (1,717,978) working capital

Cash used in operating (34,255,638) (22,541,183) (17,877,072) activities

Investing Activities

Acquisition of property (126,412) (257,790) (81,846) and equipment

Acquisition of investment — — (51,681)

Redemption (purchase) of (32,441) 1,672,459 (1,929,309) short-term investments

Cash provided by (used in) (158,853) 1,414,669 (2,062,836) investing activities

Financing Activities

Proceeds from exercise of 1,084,990 14,824,658 528,211 stock options and warrants

Proceeds from public 19,763,795 — 26,759,921 offering

Cash provided by financing 20,848,785 14,824,658 27,288,132 activities

Increase (decrease) in (13,565,706) (6,301,856) 7,348,224 cash

Cash and cash equivalents, 32,918,751 39,296,682 32,448,939 beginning of year

Impact of foreign exchange (29,504) (76,075) (500,481) on cash and cash equivalents

Cash and cash equivalents, 19,323,541 32,918,751 39,296,682 end of year

To view the Company's Fiscal 2012 Consolidated Financial Statements, related Notes to Consolidated Financial Statements, and Management's Discussion and Analysis, please see the Company's quarterly filings which will be available on www.sedar.comand on www.oncolyticsbiotech.com. 

About Oncolytics Biotech Inc. Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Oncolytics' clinical program includes a variety of human trials including a Phase III trial in head and neck cancers using REOLYSIN, its proprietary formulation of the human reovirus. For further information about Oncolytics, please visit: www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the Company's belief as to the potential of REOLYSIN as a cancer therapeutic; the Company's expectations as to the success of its research and development programs in 2013 and beyond, the Company's planned operations, the value of the additional patents and intellectual property; the Company's expectations related to the applications of the patented technology; the Company's expectations as to adequacy of its existing capital resources; the design, timing, success of planned clinical trial programs; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize REOLYSIN, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws. 

The Equicom Group Nick Hurst 300 - 5th Ave. SW, 10th Floor Calgary, Alberta T2P 3C4 Tel: 403.218.2835 Fax: 403.218.2830 nhurst@equicomgroup.com 

Dian Griesel, Inc. Susan Forman 396 West Broadway, 2nd Floor New York, NY  10012 Tel:  212.825.3210 Fax:  212.825.3229 sforman@dgicomm.com 

SOURCE: Oncolytics Biotech Inc.

To view this news release in HTML formatting, please use the following URL: http://www.newswire.ca/en/releases/archive/March2013/14/c4836.html

CO: Oncolytics Biotech Inc. ST: Alberta NI: BTC ERN

-0- Mar/14/2013 10:30 GMT

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