Oncolytics Biotech® Inc. Announces First Quarter 2011 Results

CALGARY, May 12 /CNW/ - Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) ("Oncolytics" or the "Company") today announced its financial results and operational highlights for the quarter ended March 31, 2011.

"In order to maximize the future commercial potential for REOLYSIN®, we continue to expand and advance our clinical program through a combination of our own trials and sponsored initiatives that allow us to cost effectively expand the scope of our clinical work," said Dr. Brad Thompson, President and CEO of Oncolytics. "In the quarter we reported positive results from multiple trials and our strengthened balance sheet will enable us to expand the number of randomized studies we are running in 2011."

Selected Highlights

Since January 1, 2011 the Company has announced:

Clinical Trial Results

  • Preliminary results from a U.S. Phase 2 clinical trial (REO 017) using intravenous administration of REOLYSIN in combination with gemcitabine (Gemzar®) in patients with advanced pancreatic cancer. Seventeen evaluable patients with pancreatic cancer were expected to be treated in the first stage and if three or more patients received clinical benefit, the study would then proceed to the next stage. This endpoint was met after six evaluable patients were enrolled;
  • Completion of enrollment and interim data 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. On initial histological analysis of the 10 treated patients, there was evidence of selective delivery of virus to tumour versus normal liver and viral replication in the majority (seven) of patients;

Ongoing Clinical Program

  • The opening of enrollment in a U.S. Phase 1 study of REOLYSIN in combination with FOLFIRI (Folinic Acid (leucovorin) + Fluorouracil (5-FU) + Irinotecan) in patients with oxaliplatin refractory/intolerant Kras mutant colorectal cancer (REO 022);
  • Start of enrollment in a 2-Arm randomized Phase 2 study of carboplatin, paclitaxel plus REOLYSIN versus carboplatin and paclitaxel alone in the first line treatment of patients with recurrent or metastatic pancreatic cancer sponsored by the NCI;
  • Completion of enrollment in a U.S. Phase 2 clinical trial using intravenous administration of REOLYSIN in combination with paclitaxel and carboplatin in patients with advanced head and neck cancers (REO 015);

Financial

  • Pursuant to the acceleration of the expiry date of those warrants issued on November 23, 2009, the Company received proceeds of approximately US$6.8 million resulting from the exercise of 1,943,000 warrants; and
  • The exercise of 1,322,750 warrants, issued in connection with the financing that closed on November 8, 2010, providing the Company with proceeds of approximately $8.2 million.

ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)
                         
As at,           March 31,
2011
$
    December 31,
2010
$
    January 1,
2010
$
Assets                        
Current assets                        
Cash and cash equivalents           49,912,873     39,296,682     32,448,939
Short-term investments           3,609,246     3,609,246     1,679,937
Accounts receivable           72,653     284,988     64,787
Prepaid expenses           389,839     278,934     507,408
Total current assets           53,984,611     43,469,850     34,701,071
                         
Non-current assets                        
Property and equipment           224,912     226,911     208,320
Long term investments                   684,000
Total non-current assets           224,912     226,911     892,320
                         
Asset held for sale           735,681     735,681    
Total assets           54,945,204     44,432,442     35,593,391
                         
Liabilities And Shareholders' Equity                        
                         
Current Liabilities                        
Accounts payable and accrued liabilities           2,339,270     2,500,682     4,226,933
Warrant liability           5,536,800     1,023,051      
Total current liabilities           2,339,270     8,037,482     5,249,984
                         
Shareholders' equity                        
Share capital
                       
  Authorized: unlimited                        
  Issued:                        
  March 31, 2011 - 71,207,318                        
  December 31, 2010 - 67,958,302                        
  January 1, 2010 - 61,549,969             177,147,062       155,439,610       131,908,274
Warrants           2,653,627     4,108,652     2,437,460
Contributed surplus           19,366,032     19,399,489     13,734,743
Accumulated other comprehensive loss           (193,540)     (156,660)    
Deficit           (146,367,247)     (142,396,131)     (117,737,070)
Total shareholders' equity           52,605,934     36,394,960     30,343,407
Total Liabilities And Equity           54,945,204     44,432,442     35,593,391
                         

ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)
                     
For the three month period ending March 31,           2011
$
      2010
$
                     
Expenses                    
Research and development           2,971,611       3,041,814
Operating           1,127,011       964,309
            4,098,622       4,006,123
Loss before the following           (4,098,622)       (4,006,123)
                     
Change in fair value of warrant liability           36,000       (541,489)
Interest           91,506       9,819
Loss before income taxes           (3,971,116)       (4,537,793)
                     
Income taxes                
Net loss           (3,971,116)       (4,537,793)
Other comprehensive loss - translation adjustment           (36,880)       (144,907)
Net comprehensive loss           (4,007,996)       (4,682,700)
Basic and diluted loss per share           (0.06)       (0.07)
Weighted average number of shares (basic and diluted)           69,956,058       61,549,969
                     

ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(unaudited)
                                     
        For the three month period ending, March 31, 2010
        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                 (144,907)     (4,537,793)     (4,682,700)
Expired warrants           2,438,000     (2,438,000)          
Stock based compensation           1,029               1,029
Other               540           540
As at March 31, 2010       131,908,274     16,173,772       (144,907)     (122,274,863)     25,662,276
                                     
        For the three month period ending, March 31, 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                 (36,880)     (3,971,116)     (4,007,996)
Exercise of warrants       21,487,080         (1,455,025)           20,032,055
Exercise of stock options       220,372     (36,330)               184,042
Stock based compensation           2,873               2,873
As at March 31, 2011       177,147,062     19,366,032     2,653,627   (193,540)     (146,367,247)     52,605,934
                                     

ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
                     
For the three month period ending March 31,            2011
$
      2010
$
Cash Flows                    
Operating Activities                    
Net loss for the period           (3,971,116)       (4,537,793)
Amortization - property and equipment           17,275       14,885
Stock based compensation           2,873       1,029
Change in fair value of warrant liability           (36,000)       541,489
Unrealized foreign exchange loss           191,149       218,988
Net change in non-cash working capital           (59,982)       (1,176,681)
Cash used in operating activities           (3,855,801)       (4,938,083)
                     
Investing Activities                    
Acquisition of property and equipment           (15,276)       (3,647)
Cash used in investing activities           (15,276)       (3,647)
                     
Financing Activities                    
Proceeds from exercise of stock options and warrants           14,715,297      
Cash provided by financing activities           14,715,297      
                     
Increase (decrease) in cash           10,844,220       (4,941,730)
Cash and cash equivalents, beginning of period           39,296,682       32,448,939
Impact of foreign exchange on cash and cash equivalents           (228,029)       (363,895)
Cash and cash equivalents, end of period           49,912,873       27,143,314

To view the Company's First Quarter 2011 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.com and 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 3 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 2011 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.

 

SOURCE Oncolytics Biotech Inc.

For further information:

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
          The Investor Relations Group
Erika Moran
11 Stone St, 3rd Floor
New York, NY  10004
Tel:  212.825.3210
Fax:  212.825.3229
emoran@investorrelationsgroup.com

 


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