Oncolytics Biotech® Inc. Announces Third Quarter 2012 Results

CALGARY, Nov. 8, 2012 /PRNewswire/ - Oncolytics Biotech Inc. (TSX: ONC) (NASDAQ: ONCY) ("Oncolytics" or the "Company") today announced its financial results and operational highlights for the quarter ended September 30, 2012.

"We continue to make progress across the entire breadth of our clinical program and completed enrollment in multiple trials this quarter," said Dr. Brad Thompson, President and CEO of Oncolytics. "Our near term focus remains on completing the initial follow-up on the expanded 167 patient group enrolled in the REO 018 study so that we can receive our first randomized clinical data for REOLYSIN®."

Selected Highlights
During the quarter the Company has made a number of significant announcements:

Management

  • Appointment of Dr. Alan Tuchman to the role of Chief Medical Officer and Senior Vice President, Clinical and Medical Development.

Clinical Trial Program

  • Expanded enrollment in the first stage of our Phase III head and neck cancer clinical trial (REO 18) to include 167 patients, all of whom have now been enrolled, and introduced 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;

  • Reaching the primary endpoint in the first stage of a U.S. Phase II 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);

  • 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); and

  • Completion of enrollment in a U.S. Phase I clinical trial using intravenously-administered REOLYSIN in combination with FOLFIRI in patients with colorectal cancer (REO 022).

Since September 30, 2012, the Company also announced completion of patient enrollment in a U.S. Phase II clinical trial using intravenous administration of REOLYSIN in combination with gemcitabine (Gemzar®) in patients with advanced or metastatic pancreatic cancer (REO 017).

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)
                 
        September 30,       December 31,
 
      2012
$
      2011
$
Assets                
Current assets                
Cash and cash equivalents       26,007,318       32,918,751
Short-term investments       1,969,228       1,936,787
Accounts receivable       89,842       55,392
Prepaid expenses       592,927       721,576
Total current assets       28,659,315       35,632,506
                 
Non-current assets                
Property and equipment       426,983       392,111
Total non-current assets       426,983       392,111
                 
Total assets       29,086,298       36,024,617
                 
Liabilities And Shareholders' Equity                
Current Liabilities                
Accounts payable and accrued liabilities       6,711,147       6,504,238
Total current liabilities       6,711,147       6,504,238
                 
Shareholders' equity                
Share capital                   
  Authorized: unlimited
Issued:
               
September 30, 2012 - 76,661,085                
December 31, 2011 - 71,251,335       198,049,608       177,282,566
Warrants       3,030,519       2,653,627
Contributed surplus       20,700,110       21,142,519
Accumulated other comprehensive loss       (83,022)       (117,501)
Accumulated deficit       (199,322,064)       (171,440,832)
Total shareholders' equity       22,375,151       29,520,379
Total liabilities and equity       29,086,298       36,024,617

 
 
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)
                         
      Three Month
Period
Ending
September
30, 2012
$
    Three Month
Period Ending
September 30,
2011
$
    Nine Month
Period
Ending
September
30, 2012
$
    Nine Month
Period Ending
September 30,
2011
$
                         
Expenses                        
Research and development     8,129,328     5,315,134     24,673,201     13,769,876
Operating     1,175,227     1,019,335     3,485,368     3,214,969
Operating loss     (9,304,555)     (6,334,469)     (28,158,569)     (16,984,845)
Write down of asset available for sale                 (735,681)
Change in fair value of warrant liability                 36,000
Interest     74,053     102,445     287,509     317,148
Loss before income taxes     (9,230,502)     (6,232,024)     (27,871,060)     (17,367,378)
Income tax expense     (13,400)         (10,172)    
Net loss     (9,243,902)     (6,232,024)     (27,881,232)     (17,367,378)
Other comprehensive (loss) income - translation
adjustment
    (47,462)     (9,587)     34,479     28,744
                         
Net comprehensive loss     (9,291,364)     (6,241,611)     (27,846,753)     (17,338,634)
Basic and diluted loss per common share     (0.12)     (0.09)     (0.37)     (0.25)
Weighted average number of shares (basic and diluted)     76,607,281     71,221,218     75,903,566     70,800,114

 

 
 
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
                         
      Three Month
Period
Ending
September
30, 2012
$
   
Three Month
Period Ending
September 30,
2011
$
   
Nine Month
Period
Ending
September
30, 2012
$
 
Nine Month
Period Ending
September 30,
2011
$
                         
Operating Activities                        
Net loss for the period     (9,243,902)     (6,232,024)     (27,881,232)     (17,367,378)  
Amortization - property and equipment     26,422     21,258     83,993     68,525  
Share based compensation     (121,685)     181,183     (49,489)     224,525  
Change in fair value of warrant liability                 (36,000)  
Write down of asset available for sale                 735,681  
Unrealized foreign exchange loss     983     (121,391)     17,145     98,736  
Net change in non-cash working capital     1,514,620     (427,319)     301,108     930,195  
Cash used in operating activities     (7,823,562)     (6,578,293)     (27,528,475)     (15,345,716)  
                         
Investing Activities                          
Acquisition of property and equipment     (25,238)     (62,087)     (118,865)     (111,194)  
Purchase of short-term investments             (32,441)     1,679,940  
Cash used in investing activities     (25,238)     (62,087)     (151,306)     1,568,746  
                         
Financing Activities                        
Proceeds from exercise of stock options and warrants     101,750     54,985     987,219     14,793,582
Proceeds from public offering             19,763,795    
Cash provided by financing activities     101,750     54,985     20,751,014     14,793,582
Increase in cash     (7,747,050)     (6,585,395)     (6,928,767)     1,016,612
Cash and cash equivalents, beginning of period     33,802,813     46,640,231     32,918,751     39,296,682
Impact of foreign exchange on cash and cash equivalents     (48,445)     188,466     17,334     (69,992)
Cash and cash equivalents, end of period     26,007,318     40,243,302     26,007,318     40,243,302

To view the Company's Third Quarter 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.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 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 2012 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.



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