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 2010 Results

CALGARY, AB, November 10, 2010 --- 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, 2010.

“We are excited to be conducting our first Phase 3 study,” said Dr. Brad Thompson, President and CEO of Oncolytics.  “Moving into the fourth quarter the Company’s fundamentals remain strong and we are well positioned to execute on our clinical strategy in 2011 and beyond.”

Selected Highlights
Since July 1, 2010 the Company has announced:

Clinical Program
·  
Receipt of a No Objection Letter from Health Canada to conduct the Company’s Phase 3 trial examining REOLYSIN® in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers at centres in Canada;
·  
A randomized Phase 2 trial of weekly paclitaxel versus weekly paclitaxel with REOLYSIN in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer to be conducted by the Gynecologic Oncology Group (GOG). The Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, U.S. National Cancer Institute (NCI), which is part of the National Institutes of Health, will sponsor the trial under its Clinical Trials Agreement with Oncolytics;
· 
A presentation of interim data from a U.K. translational clinical trial investigating intravenous administration of REOLYSIN in patients with metastatic colorectal cancer prior to surgical resection of liver metastases. The researchers concluded that reovirus can be successfully delivered specifically to colorectal liver metastases following intravenous administration as a monotherapy and that pre-operative treatment was safe, suggesting that application of oncolytic viral therapy can be widened to the neoadjuvant setting;

Preclinical Program
· 
An abstract, entitled “REOLYSIN induces endoplasmic reticular stress in multiple myeloma and enhances the activity of bortezomib”, indicating that the combination of REOLYSIN and bortezomib significantly reduced tumor burden in both xenograft and syngeneic multiple myeloma mouse models. The authors concluded that REOLYSIN is a promising anticancer agent that displays activity against multiple myeloma alone and in combination with bortezomib and warrants further investigation for the treatment of multiple myeloma and other malignancies;


 
 

 

Intellectual Property
·  
Grant of U.S. Patent, No. 7,803,385 entitled "Reoviruses Having Modified Sequences." This is a composition of matter patent that covers the reovirus variant the Company is using in its clinical trial program and expires in 2028; and

Financial
·  
Completion of a bought deal financing issuing 6,256,000 units of the Company at a price of $4.60 per Unit for gross proceeds to the Company of approximately $28.77 million.

Oncolytics Biotech Inc.

INTERIM CONSOLIDATED BALANCE SHEETS
(unaudited)
As at,
   
September 30,
2010
$
   
December 31, 2009
$
 
ASSETS
           
Current
           
Cash and cash equivalents
    16,098,135       32,448,939  
Short-term investments
    3,609,874       1,679,937  
Accounts receivable
    30,791       64,787  
Prepaid expenses
    499,261       507,408  
      20,238,061       34,701,071  
                 
Property and equipment
    215,032       208,320  
Long term investment
    684,000       684,000  
      21,137,093       35,593,391  
LIABILITIES AND SHAREHOLDERS' EQUITY
               
Current
               
Accounts payable and accrued liabilities
    1,809,914       4,226,933  
                 
Shareholders' equity
               
Share capital
               
    Authorized: unlimited number of common shares
               
    Issued: 61,573,469
      (December 31, 2009 – 61,549,969)
    131,992,086       131,908,274  
Warrants
    2,073,441       4,511,441  
Contributed surplus
    16,551,859       13,734,743  
Deficit
    (131,290,207 )     (118,788,000 )
      19,327,179       31,366,458  
      21,137,093       35,593,391  


 
 

 

Oncolytics Biotech Inc.

INTERIM CONSOLIDATED STATEMENTS OF LOSS
AND COMPREHENSIVE LOSS
(unaudited)

 
 
 
 
 
 
 
 
Three Month Period Ending September 30, 2010
$
   
Three Month Period Ending September 30, 2009
$
   
Nine Month Period Ending September 30, 2010
$
   
Nine Month Period Ending September 30, 2009
$
   
Cumulative from inception on April 2,
1998 to September 30, 2010
$
 
Revenue
                             
Rights revenue
    ¾       ¾       ¾       ¾       310,000  
      ¾       ¾       ¾       ¾       310,000  
Expenses
                                       
Research and development
    2,500,607       1,954,367       8,901,088       8,006,232       95,039,379  
Operating
    895,659       736,024       2,978,402       2,703,509       31,597,934  
Stock based compensation
    397,675       7,982       400,103       28,163       5,593,220  
Foreign exchange loss/(gain)
    216,859       (16,793 )     214,009       42,345       983,152  
Amortization – intellectual property
    ¾       ¾       ¾       180,750       3,615,000  
Amortization – property and equipment
    15,981       15,772       45,487       49,612       607,568  
      4,026,781       2,697,352       12,539,089       11,010,611       137,436,253  
Loss before the following:
    4,026,781       2,697,352       12,539,089       11,010,611       137,126,253  
                                         
Interest income
    (17,759 )     (3,360 )     (36,882 )     (24,216 )     (6,600,328 )
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
    4,009,022       2,693,992       12,502,207       10,986,395       132,383,207  
Future income tax recovery
    ¾       ¾       ¾       ¾       (1,093,000 )
Net loss and comprehensive loss
for the period
    4,009,022       2,693,992       12,502,207       10,986,395       131,290,207  
Basic and diluted loss per share
    0.07       0.05       0.20       0.23          
Weighted average number of shares (basic and diluted)
    61,570,046       49,465,849       61,558,859       46,942,128          



 
 

 


Oncolytics Biotech Inc.

INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)

   
Three Month Period Ending September 30, 2010
$
   
Three Month Period Ending September 30, 2009
$
   
Nine Month Period Ending September 30, 2010
$
   
Nine Month Period Ending September 30, 2009
$
   
Cumulative from inception on April 2, 1998 to September 30, 2009
$
 
OPERATING ACTIVITIES
                             
Net loss for the period
    (4,009,022 )     (2,693,992 )     (12,502,207 )     (10,986,395 )     (131,290,207 )
Deduct non-cash items
                                       
Amortization – intellectual property
    ¾       ¾       ¾       180,750       3,615,000  
Amortization – property and equipment
    15,981       15,772       45,487       49,612       607,568  
Stock based compensation
    397,675       7,982       400,103       28,163       5,593,220  
Other non-cash items
    211,990       ¾       213,369       ¾       1,707,706  
Net changes in non-cash working capital
    (1,582,647 )     60,253       (2,374,876 )     (1,517,967 )     1,279,862  
      (4,966,023 )     (2,609,985 )     (14,218,124 )     (12,245,837 )     (118,486,851 )
INVESTING ACTIVITIES
                                       
Capital assets
    (8,701 )     (1,325 )     (52,199 )     (4,674 )     (875,267 )
Purchase of short-term investments
    (1,929,937 )     ¾       (1,929,937 )     ¾       (53,026,738 )
Redemption of short-term investments
    ¾       ¾       ¾       5,846,634       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  
      (1,938,638 )     (1,325 )     (1,982,136 )     5,841,960       (1,906,680 )
FINANCING ACTIVITIES
                                       
Proceeds from exercise of warrants and stock options
    8,825       342,570       62,825       715,835       30,574,103  
Proceeds from acquisition
of private company
    ¾       ¾       ¾       1,800,120       1,800,120  
Proceeds from private placements
    ¾       ¾       ¾       ¾       38,137,385  
Proceeds from public offerings
    ¾       (59,893 )     ¾       6,112,746       66,320,777  
      8,825       282,677       62,825       8,628,701       136,832,385  
Increase (decrease) in cash and cash equivalents during the period
    (6,895,836 )     (2,328,633 )     (16,137,435 )     2,224,824       16,438,854  
Impact of foreign exchange on cash and cash equivalents
    (211,990 )     ¾       (213,369 )     ¾       (340,719 )
Cash and cash equivalents, beginning of the period
    23,205,961       11,983,352       32,448,939       7,429,895       ¾  
Cash and cash equivalents, end of the period
    16,098,135       9,654,719       16,098,135       9,654,719       16,098,135  


 
 

 


 
To view the Company’s Third Quarter 2010 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 2010 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:

For Canada:
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
 
For the United States:
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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