Oncolytics Biotech® Inc. Announces Third Quarter 2013 Results

CALGARY, Nov. 7, 2013 /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, 2013.

"In recent months we have reported positive data in our squamous cell and non-squamous cell lung clinical trials both in terms of tumour response and survival," said Dr. Brad Thompson, President and CEO of Oncolytics. "On the strength of this reported data, we intend to conduct randomized clinical studies in these indications that will further expand our lung cancer program."

Selected Highlights

Since June 30, 2013, the Company has made a number of announcements including:

Clinical Trial Results

  • Reporting positive final results from a U.S. Phase 2 study examining the use of REOLYSIN® in combination with carboplatin and paclitaxel in patients with stage IV non-small cell lung cancer (NSCLC) with Kras or EGFR-activated tumors (REO 016). Response evaluation for 36 evaluable patients showed 11 partial responses (PR) (30%) (EGFR amplified, five; BRAF two; Kras, three; EGFR mutated, one), 21 stable disease (SD), and four progressive disease (PD). The data also correlated a number of molecular abnormalities with best response, progression free survival (PFS) and one-year survival. Current data in these patients demonstrates that 20 of 36 evaluable patients (56%) survived a year or more. There were 13 patients with only EGFR mutations or amplifications, of whom nine (69.2%) survived a year or longer. Four of four (100%) patients with BRAF and EGFR amplification survived a year or longer; and

  • Reporting final tumour response and progression free survival ("PFS") data from 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). Of the 25 evaluable patients who had more than one cycle of therapy, 23 (92%) exhibited overall tumour shrinkage. When evaluated for best response, which is the best percentage response recorded on study compared to baseline, 10 patients (40%) had partial responses (PRs), while a further 14 (56%) showed stable disease (SD), and one (4%), had progressive disease (PD). Using RECIST criteria to evaluate best overall response, 10 patients (40%) had partial responses (PRs), 12 (48%) showed stable disease (SD) and three (12%), had progressive disease (PD).  31.8% of patients with sufficient follow up had a PFS greater than six months.



ONCOLYTICS BIOTECH INC.
INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)
 
  September 30,
2013
$
December 31,
2012
$
Assets    
Current assets    
Cash and cash equivalents 29,472,201   19,323,541  
Short-term investments 2,001,644   1,969,228  
Accounts receivable 35,402   44,979  
Prepaid expenses 471,318   331,094  
Total current assets 31,980,565   21,668,842  
         
Non-current assets    
Property and equipment 568,711   409,248  
Total non-current assets 568,711   409,248  
     
Total assets 32,549,276   22,078,090  
         
Liabilities And Shareholders' Equity    
Current Liabilities    
Accounts payable and accrued liabilities 4,913,395   7,291,310  
Total current liabilities 4,913,395   7,291,310  
         
Shareholders' equity    
Share capital         
  Authorized: unlimited        
  Issued:        
September 30, 2013 - 84,758,818    
December 31, 2012 - 76,710,285 228,513,564   198,155,091  
Warrants 376,892   376,892  
Contributed surplus 24,282,934   24,126,265  
Accumulated other comprehensive loss 17,011   (57,115  
Accumulated deficit (225,554,520)   (207,814,353)  
Total shareholders' equity 27,635,881   14,786,780  
Total liabilities and equity 32,549,276   22,078,090  


ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)
 
  Three Month
Period Ending
September 30,
2013
$
Three Month
Period Ending
September 30,
2012
$
Nine Month
Period Ending
September 30,
2013
$
Nine Month
Period Ending
September 30,
2012
$
Expenses        
  Research and development 5,001,972   8,129,328   13,923,323   24,673,201  
  Operating 1,222,157   1,175,227   4,107,650   3,485,368  
Operating loss (6,224,129)   (9,304,555)   (18,030,973)   (28,158,569)  
  Interest 110,479   74,053   290,806   287,509  
Loss before income taxes (6,113,650)   (9,230,502)   (17,740,167)   (27,871,060)  
  Income tax expense   (13,400)     (10,172)  
Net loss (6,113,650)   (9,243,902)   (17,740,167)   (27,881,232)  
Other comprehensive income items that may be
  reclassified to net loss
       
               
  Translation adjustment (33,513)   (47,462)   74,126   34,479  
                   
Net comprehensive loss (6,147,163)   (9,291,364)   (17,666,041)   (27,846,753)  
Basic and diluted loss per common share (0.07)   (0.12)   (0.21)   (0.37)  
Weighted average number of shares (basic and diluted) 84,758,818   76,607,281   83,112,919   75,903,566  

 


ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(unaudited)
 
  Share Capital
$
Contributed
Surplus
$
Warrants
$
Accumulated Other
Comprehensive
Loss
$
Accumulated
Deficit
$
Total
$
As at December 31, 2011 177,282,566   21,142,519   2,653,627   (117,501)   (171,440,832)   29,520,379  
             
Net loss and comprehensive loss       34,479   (27,881,232)   (27,846,753)  
Issued, pursuant to a bought deal financing 19,386,903     376,892       19,763,795  
Exercise of stock options 1,380,139   (392,920)         987,219  
             
Share based compensation   (49,489)         (49,489)  
As at September 30, 2012 198,049,608   20,700,110   3,030,519   (83,022)   (199,322,064)   22,375,151  
             
  Share Capital Contributed Surplus Warrants Accumulated Other
Comprehensive
Loss
Accumulated Deficit Total
  $ $ $ $ $ $
             
As at December 31, 2012 198,155,091   24,126,265   376,892   (57,115)   (207,814,353)   14,786,780  
             
Net loss and comprehensive loss       74,126   (17,740,167)   (17,666,041)  
Issued, pursuant to a bought deal financing 30,218,797           30,218,797  
Exercise of stock options 139,676   (34,687)         104,989  
             
Share based compensation   191,356         191,356  
As at September 30, 2013 228,513,564   24,282,934   376,892   17,011   (225,554,520)   27,635,881  



ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)  
 
  Three Month Period
Ending September 30,
2013
$
Three Month
Period Ending
September 30,
2012
$
Nine Month Period
Ending September
30, 2013
$
Nine Month Period
Ending September
30, 2012
$
         
Operating Activities        
Net loss for the period (6,113,650)   (9,243,902)   (17,740,167)   (27,881,232)  
Amortization - property and equipment 41,205   26,422   91,351   83,993  
Share based compensation (59,497)   (121,685)   191,356   (49,489)  
Unrealized foreign exchange loss (gain) 34,179   983   (63,670)   17,145  
Net change in non-cash working capital (412,109)   1,514,620   (2,508,562)   301,108  
Cash used in operating activities (6,509,872)   (7,823,562)   (20,029,692)   (27,528,475)  
Investing Activities        
Acquisition of property and equipment (103,512)   (25,238)   (250,814)   (118,865)  
Purchase of short-term investments     (32,416)   (32,441)  
Cash used in investing activities (103,512)   (25,238)   (283,230)   (151,306)  
Financing Activities        
Proceeds from exercise of stock options and warrants   101,750   104,989   987,219  
Proceeds from public offering     30,218,797   19,763,795  
Cash provided by financing activities   101,750   30,323,786   20,751,014  
Increase in cash (6,613,384)   (7,747,050)   10,010,864   (6,928,767)  
Cash and cash equivalents, beginning of period 36,153,277   33,802,813   19,323,541   32,918,751  
Impact of foreign exchange on cash and cash equivalents (67,692)   (48,445)   137,796   17,334  
Cash and cash equivalents, end of period 29,472,201   26,007,318   29,472,201   26,007,318  


To view the Company's Fiscal 2013 Third Quarter 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/financials

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. 

SOURCE Oncolytics Biotech Inc.




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