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 2009 Third Quarter Results

CALGARY, AB, November 5, 2009 --- Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) (“Oncolytics” or the “Company”) today announced its financial results for the three and nine-month periods ended September 30, 2009.

“In the third quarter, we passed a number of key milestones in our evolving REOLYSIN® development program, including making progress on a number of Phase II clinical initiatives and in manufacturing,” said Dr. Brad Thompson, President and CEO of Oncolytics.  “Subsequent to quarter-end, we met our most important milestone to date in the advancement of our clinical program as we reached an agreement with the U.S. FDA on the design of a Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers.”

Selected Third Quarter Highlights:

During the quarter, the Company announced:

·  
Conclusion of patient enrollment in the Phase II component of the Company’s U.K. REOLYSIN and paclitaxel/carboplatin clinical trial (REO 11);
·  
Successful completion of the lyophilized (freeze-dried) formulation development program for REOLYSIN;
·  
Successful completion of an initial 100-litre production run of REOLYSIN under cGMP conditions;
·  
The grant of the Company’s 32nd U.S. Patent, No. 7,582,289, entitled “Viruses for the Treatment of Cellular Proliferative Disorders” with the claims covering methods of using modified parapoxvirus orf virus to treat Ras-mediated cancers;
·  
Acceleration of the warrant expiry date on warrants issued in connection with a financing completed in December 2008; and
·  
The start of enrollment in a U.S. Phase 2 clinical trial using intravenous administration of REOLYSIN in combination with paclitaxel and carboplatin in patients with metastatic melanoma being conducted at the Cancer Therapy & Research Center at the University of Texas Health Science Center (CTRC).    

 
 

 


 
Latest Highlights

Subsequent to quarter end, the Company announced:

·  
An agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for the design of a Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers;
·  
Acceleration of the warrant expiry date on warrants issued in connection with a financing completed in May 2009;
·  
Grant of the Company’s 33rd U.S. Patent, No. 7,608,257, entitled “Sensitization of Chemotherapeutic Agent Resistant Neoplastic Cells With a Virus.” The patent claims cover methods of using reovirus in combination with currently approved chemotherapeutic agents to treat patients that are refractory to those chemotherapeutic agents alone;
·  
The results of the two warrant expiry date acceleration programs for warrants issued and amended in December 2008 and issued in 2009, generating proceeds of approximately $14.9 million.

 
 

 

Oncolytics Biotech Inc.


CONSOLIDATED BALANCE SHEETS
(unaudited)



As at,

   
 
September 30, 2009
$
   
December 31, 2008
$
 
ASSETS
           
Current
           
Cash and cash equivalents
    9,654,719       7,429,895  
Short-term investments
    ¾       5,846,634  
Accounts receivable
    59,314       86,322  
Prepaid expenses
    306,926       179,668  
      10,020,959       13,542,519  
Capital assets
    218,988       263,926  
Intellectual property
    ¾       180,750  
      10,239,947       13,987,195  
LIABILITIES AND SHAREHOLDERS' EQUITY
               
Current
               
Accounts payable and accrued liabilities
    3,116,394       4,534,111  
                 
Shareholders' equity
               
Share capital
               
  Authorized: unlimited number of common shares
               
  Issued:49,608,569 (December 31, 2008 – 43,830,748)
    102,532,889       95,234,924  
Warrants
    4,755,846       3,425,110  
Contributed surplus
    13,377,964       13,349,801  
Deficit
    (113,543,146 )     (102,556,751 )
      7,123,553       9,453,084  
      10,239,947       13,987,195  
 



 
 

 

Oncolytics Biotech Inc.


CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)


 
 
 
 
 
 
 
 
Three Month Period Ending September 30, 2009
$
   
Three Month Period Ending September 30, 2008
$
   
Nine Month Period Ending September 30, 2009
$
   
Nine Month Period Ending September 30, 2008
$
   
Cumulative from inception on April 2,
1998 to September 30, 2009
$
 
Revenue
                             
Rights revenue
    ¾       ¾       ¾       ¾       310,000  
      ¾       ¾       ¾       ¾       310,000  
Expenses
                                       
Research and development
    1,954,367       3,210,294       8,006,232       9,650,595       82,538,009  
Operating
    736,024       880,438       2,703,509       3,250,830       27,540,534  
Stock based compensation
    7,982       17,339       28,163       54,955       4,797,007  
Foreign exchange loss/(gain)
    (16,793 )     29,026       42,345       (20,059 )     631,772  
Amortization – intellectual property
    ¾       90,375       180,750       271,125       3,615,000  
Amortization – property and equipment
    15,772       11,853       49,612       35,233       546,763  
      2,697,352       4,239,325       11,010,611       13,242,679       119,669,085  
Loss before the following:
    2,697,352       4,239,325       11,010,611       13,242,679       119,359,085  
                                         
Interest income
    (3,360 )     (98,493 )     (24,216 )     (452,944 )     (6,558,221 )
Gain on sale of BCY LifeSciences Inc.
    ¾       ¾       ¾       ¾       (299,403 )
Loss on sale of Transition Therapeutics Inc.
    ¾       ¾       ¾       ¾       2,156,685  
Loss before income taxes
    2,693,992       4,140,832       10,986,395       12,789,735       114,658,146  
Future income tax recovery
    ¾       ¾       ¾       ¾       (1,115,000 )
Net loss and comprehensive loss
for the period
    2,693,992       4,140,832       10,986,395       12,789,735       113,543,146  
Basic and diluted loss per share
    0.05       0.10       0.23       0.31          
Weighted average number of shares (basic and diluted)
    49,465,849       41,180,748       46,942,128       41,180,748          



 
 

 

Oncolytics Biotech Inc.


CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)


   
Three Month Period Ending September 30, 2009
$
   
Three Month Period Ending September 30, 2008
$
   
Nine Month Period Ending September 30, 2009
$
   
Nine Month Period Ending September 30, 2008
$
   
Cumulative from inception on April 2, 1998 to September 30, 2009
$
 
OPERATING ACTIVITIES
                             
Net loss for the period
    (2,693,992 )     (4,140,832 )     (10,986,395 )     (12,789,735 )     (113,543,146 )
Deduct non-cash items
                                       
Amortization – intellectual property
    ¾       90,375       180,750       271,125       3,615,000  
Amortization – property and equipment
    15,772       11,853       49,612       35,233       546,763  
Stock based compensation
    7,982       17,339       28,163       54,955       4,797,007  
Other non-cash items
    ¾       ¾       ¾       ¾       1,383,537  
Net changes in non-cash working capital
    60,253       (1,217,916 )     (1,517,967 )     (35,573 )     2,750,154  
      (2,609,985 )     (5,239,181 )     (12,245,837 )     (12,463,995 )     (100,450,685 )
INVESTING ACTIVITIES
                                       
Capital assets
    (1,325 )     (10,927 )     (4,674 )     (69,672 )     (818,418 )
Purchase of short-term investments
    ¾       (62,435 )     ¾       (314,631 )     (49,416,864 )
Redemption of short-term investments
    ¾       9,813,364       5,846,634       18,813,364       48,998,380  
Investment in BCY LifeSciences Inc.
    ¾       ¾       ¾       ¾       464,602  
Investment in Transition Therapeutics Inc.
    ¾       ¾       ¾       ¾       2,532,343  
      (1,325 )     9,740,002       5,841,960       18,429,061       1,760,043  
FINANCING ACTIVITIES
                                       
Proceeds from exercise of warrants and stock options
    342,570       ¾       715,835       ¾       16,016,903  
Proceeds from acquisition
of private company
    ¾               1,800,120               1,800,120  
Proceeds from private placements
    ¾       ¾       ¾       ¾       38,137,385  
Proceeds from public offerings
    (59,893 )     ¾       6,112,746       ¾       52,390,953  
      282,677       ¾       8,628,701       ¾       108,345,361  
Increase (decrease) in cash and cash equivalents during the period
    (2,328,633 )     4,500,821       2,224,824       5,965,066       9,654,719  
Cash and cash equivalents, beginning of the period
    11,893,352       8,179,341       7,429,895       6,715,096       ¾  
Cash and cash equivalents, end of the period
    9,654,719       12,680,162       9,654,719       12,680,162       9,654,719  

 
 

 

 
To view the 2009 Third Quarter Report which includes the Consolidated Financial Statements, related Notes to Consolidated Financial Statements, and Management’s Discussion and Analysis, please see the Company’s third quarter 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 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 2009 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
 

 

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