EX-99.1 2 ex99.htm RELEASE ex99.htm
210, 1167 Kensington Cr. N.W
Calgary, Alberta
Canada T2N 1X7

FOR IMMEDIATE RELEASE
 

Oncolytics Biotech® Inc. Announces Third Quarter 2011 Results

CALGARY, AB, November 10th, 2011 --- 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, 2011.

“During the quarter we achieved significant increases in the number of enrolling countries in the first stage of our Phase III head and neck cancer study,” said Dr. Brad Thompson, President and CEO of Oncolytics. “We currently have approval to conduct the trial in 12 countries in North America and Europe and are focusing on completing enrolment for this stage.”

Selected Highlights

Since July 1, 2011, the Company has made a number of significant announcements:

Clinical Trial Results
· 
The presentation of interim preliminary results from 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 at the International Association for the Study of Lung Cancer World Conference on Lung Cancer. As of the presentation date, 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%), translating into a clinical benefit rate (complete response (CR) + PR + SD) of 90.5% and a response rate (CR + PR) of 28.6%;

Preclinical Program
·  
The posting of a study in the online version of Molecular Therapy, a publication of The American Society of Gene and Cell Therapy, investigating the timing of chemotherapy delivery that optimizes the efficacy of systemic REOLYSIN. The paper, authored by Kottke et al., was entitled “Precise Scheduling of Chemotherapy Primes VEGF-producing Tumors for Successful Systemic Oncolytic Virotherapy.” It describes when best to administer taxanes with reovirus to optimize viral delivery to the tumor mass. The researchers demonstrated that this drug combination yielded superior results to either treatment alone. They were able to reproducibly cure nearly half of the treated animals by employing this optimized schedule of paclitaxel/REOLYSIN;
 
Corporate
·  
The appointment of Gerard Kennealey, MD as Senior Vice President of Clinical Development and Chief Medical Officer (CMO). Dr. Kennealey most recently held the position of Vice President of Scientific Affairs at Cephalon Inc.; and
·  
The appointment of George M. Gill, MD as Senior Vice President of Regulatory Affairs and Chief Safety Officer. Dr. Gill has been an officer of Oncolytics since 2002.

 
 

 

ONCOLYTICS BIOTECH INC.
 
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
 
(unaudited)
 
As at,
 
September 30,
2011
$
   
December 31,
2010
$
   
January 1,
2010
$
 
Assets
                 
Current assets
                 
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  
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
                684,000  
Total non-current assets
    269,580       226,911       892,320  
                         
                         
Asset held for sale
          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     —        5,536,800        1,023,051   
Total current liabilities
    3,477,615       8,037,482       5,249,984  
                         
                         
                         
                         
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
    177,240,848       155,439,610       131,908,274  
Warrants
    2,653,627       4,108,652       2,437,460  
Contributed surplus
    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  
                         
 
 
ONCOLYTICS BIOTECH INC.
 
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
 
(unaudited)
 

   
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
$
 
                         
Expenses
                       
Research and development
    5,315,134       2,711,392       13,769,876       8,990,422  
Operating
    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
                (735,681 )      
Change in fair value of warrant liability
          (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
    (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  



 
 

 

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
 
   
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  
                                       


 
 

 

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

 
 
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
    181,183       397,675       224,525       400,103  
  Change in fair value of warrant liability
          2,521,950       (36,000 )     2,672,439  
  Write down of asset available for sale
                735,681        
  Unrealized foreign exchange loss (gain)
    (121,391 )     204,241       98,736       84,591  
Net change in non-cash working capital
    (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  

 
To view the Company’s Third 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.
 
FOR FURTHER INFORMATION PLEASE CONTACT:

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
 

 

-30-