EX-99.1 2 exhibit99.htm Q2 PRESS RELEASE exhibit99.htm
 
 
210, 1167 Kensington Cr. N.W
Calgary, Alberta
Canada T2N 1X7

 
FOR IMMEDIATE RELEASE
 

Oncolytics Biotech® Inc. Announces 2009 Second Quarter Results

CALGARY, AB, July 29, 2009 --- Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) (“Oncolytics” or the “Company”) today announced its financial results for the three and six-month periods ended June 30, 2009.

“Clinical results from our monotherapy and combination clinical trials with REOLYSIN® continued to emerge in the second quarter,” said Dr. Brad Thompson, President and CEO of Oncolytics.   “The results of these trials, and the response and clinical benefit rates as reported by our investigators, reinforce our belief that REOLYSIN has the potential to significantly improve treatment outcomes in patients with a broad range of cancers.”

Selected Second Quarter Highlights

·  
Presented updated U.S. Phase II sarcoma trial data at the American Society of Clinical Oncology (ASCO) annual meeting.  The interim results demonstrated that the treatment was well tolerated, with 15 of 36, or 42% of evaluable patients experiencing stable disease (SD) for more than 16 weeks, including five patients who had SD for more than 24 weeks.  Patient enrolment was completed in May;

·  
Presented a poster at ASCO demonstrating that the combination of REOLYSIN and gemcitabine in a U.K. Phase I trial was well tolerated, and resulted in disease control for a majority of the patients.  Of the ten patients evaluable for response, two patients (breast and nasopharyngeal) had partial responses (PRs) and/or clinical responses and five patients had SD for 4-8 cycles, for a total disease control rate (CR (Complete Response)+PR+SD) of 70%;

·  
Presented a poster at ASCO that indicated REOLYSIN was well tolerated and demonstrated anti-tumour activity in a U.S. Phase I systemic administration monotherapy trial.  Of 18 patients treated in the trial, eight demonstrated SD or better as measured by Response Evaluation Criteria in Solid Tumors (RECIST) including a patient with progressive breast cancer who experienced a PR (34% shrinkage in tumor volume);

·  
Announced positive results of a U.K. Phase II REOLYSIN and radiation combination clinical trial.  Of 14 evaluable patients, 13 patients had SD or better in the treated target lesions, including four PRs and two minor responses, for a clinical benefit rate of 93% in the treated lesions;

·  
Successfully completed the acquisition of an inactive private company with net cash of $2.1 million by issuing 1,875,121 common shares, and completed a public offering consisting of 3.45 million units at $2.00 per unit, for gross proceeds of $6.9 million;

·  
In early July, completed patient enrolment in the Phase II component of our U.K. REOLYSIN and paclitaxel/carboplatin clinical trial; and,

·  
In mid-July, announced that we had completed the lyophilization (freeze-drying) formulation development program for REOLYSIN.

 
 

 
Oncolytics Biotech Inc.


CONSOLIDATED BALANCE SHEETS
(unaudited)

As at,

   
June 30,
2009
$
   
December 31, 2008
$
 
ASSETS
           
Current
           
Cash and cash equivalents
    11,983,352       7,429,895  
Short-term investments
    ¾       5,846,634  
Accounts receivable
    102,659       86,322  
Prepaid expenses
    435,485       179,668  
      12,521,496       13,542,519  
                 
Property and equipment
    233,435       263,926  
Intellectual property
    ¾       180,750  
      12,754,931       13,987,195  
LIABILITIES AND SHAREHOLDERS' EQUITY
               
Current
               
Accounts payable and accrued liabilities
    3,228,045       4,534,111  
                 
Shareholders' equity
               
Share capital
               
    Authorized: unlimited number of common shares
               
    Issued: 49,395,169
      (December 31, 2008 – 43,830,748)
    102,203,004       95,234,924  
Warrants
    4,803,054       3,425,110  
Contributed surplus
    13,369,982       13,349,801  
Deficit
    (110,849,154 )     (102,556,751 )
      9,526,886       9,453,084  
      12,754,931       13,987,195  


 
 

 

Oncolytics Biotech Inc.


CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)


 
 
 
 
 
 
 
 
Three Month Period Ending June 30, 2009
$
   
Three Month Period Ending June 30, 2008
$
   
Six Month Period Ending June 30, 2009
$
   
Six Month Period Ending June 30, 2008
$
   
Cumulative from inception on April 2,
1998 to June 30, 2009
$
 
Revenue
                             
Rights revenue
    ¾       ¾       ¾       ¾       310,000  
      ¾       ¾       ¾       ¾       310,000  
Expenses
                                       
Research and development
    3,239,210       4,046,904       6,051,865       6,440,301       80,583,642  
Operating
    980,721       1,319,498       1,967,485       2,370,392       26,804,510  
Stock based compensation
    8,544       18,023       20,181       37,616       4,789,025  
Foreign exchange loss/gain
    3,103       (58,347 )     59,138       (49,085 )     648,565  
Amortization – intellectual property
    90,375       90,375       180,750       180,750       3,615,000  
Amortization – property and equipment
    16,536       12,194       33,840       23,380       530,991  
      4,338,489       5,428,647       8,313,259       9,003,354       116,971,733  
Loss before the following:
    4,338,489       5,428,647       8,313,259       9,003,354       116,661,733  
                                         
Interest income
    (3,732 )     (174,117 )     (20,856 )     (354,451 )     (6,554,861 )
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
    4,334,757       5,254,530       8,292,403       8,648,903       111,964,154  
Future income tax recovery
    ¾       ¾       ¾       ¾       (1,115,000 )
Net loss and comprehensive loss
for the period
    4,334,757       5,254,530       8,292,403       8,648,903       110,849,154  
Basic and diluted loss per share
    0.09       0.13       0.18       0.21          
Weighted average number of shares (basic and diluted)
    47,449,182       41,180,748       45,659,353       41,180,748          



 
 

 

Oncolytics Biotech Inc.


CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)


   
Three Month Period Ending June 30, 2009
$
   
Three Month Period Ending June 30, 2008
$
   
Six Month Period Ending June 30, 2009
$
   
Six Month Period Ending June 30, 2008
$
   
Cumulative from inception on April 2, 1998 to June 30, 2009
$
 
OPERATING ACTIVITIES
                             
Net loss for the period
    (4,334,757 )     (5,254,530 )     (8,292,403 )     (8,648,903 )     (110,849,154 )
Deduct non-cash items
                                       
Amortization – intellectual property
    90,375       90,375       180,750       180,750       3,615,000  
Amortization – property and equipment
    16,536       12,194       33,840       23,380       530,991  
Stock based compensation
    8,544       18,023       20,181       37,616       4,789,025  
Other non-cash items
    ¾       ¾       ¾       ¾       1,383,537  
Net changes in non-cash working capital
    (1,414,201 )     1,157,662       (1,578,220 )     1,182,343       2,689,901  
      (5,633,503 )     (3,976,276 )     (9,635,852 )     (7,224,814 )     (97,840,700 )
INVESTING ACTIVITIES
                                       
Capital assets
    ¾       (56,080 )     (3,349 )     (58,745 )     (817,093 )
Purchase of short-term investments
    ¾       (115,009 )     ¾       (252,196 )     (49,416,864 )
Redemption of short-term investments
    1,925,600       5,000,000       5,846,634       9,000,000       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  
      1,925,600       4,828,911       5,843,285       8,689,059       1,761,368  
FINANCING ACTIVITIES
                                       
Proceeds from exercise of warrants and stock options
    351,835       ¾       373,085       ¾       15,674,153  
Proceeds from acquisition of private company
    1,800,120       ¾       1,800,120       ¾       1,800,120  
Proceeds from private placements
    ¾       ¾       ¾       ¾       38,137,385  
Proceeds from public offerings
    6,172,819       ¾       6,172,819       ¾       52,451,026  
      8,324,774       ¾       8,346,024       ¾       108,062,684  
Increase in cash and cash equivalents during the period
    4,616,871       852,635       4,553,457       1,464,245       11,983,352  
Cash and cash equivalents, beginning of the period
    7,366,481       7,326,706       7,429,895       6,715,096       ¾  
Cash and cash equivalents, end of the period
    11,983,352       8,179,341       11,983,352       8,179,341       11,983,352  




 
To view the 2009 Second 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 second 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 Phase I/II and Phase II human trials using REOLYSIN, its proprietary formulation of the human reovirus, alone and in combination with radiation or chemotherapy.  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 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:

Oncolytics Biotech Inc.
Cathy Ward
210, 1167 Kensington Cr NW
Calgary, Alberta T2N 1X7
Tel: 403.670.7377
Fax: 403.283.0858
cathy.ward@oncolytics.ca
 
The Equicom Group
Nick Hurst
325, 300 5th Ave. SW
Calgary, Alberta T2P 3C4
Tel: 403.538.4845
Fax: 403.237.6916
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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