EX-99.1 2 ex991.htm ex991.htm


 

 

 

210, 1167 Kensington Cr. N.W
Calgary, Alberta
Canada T2N 1X7
 

For Immediate Release
Oncolytics Biotech® Inc. Reports Highlights and Financial Results for 2008

CALGARY, AB, March 4, 2009 --- Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) (“Oncolytics” or the “Company”) today reported its financial results for the year ended December 31, 2008.

“In 2008, we selected our first pivotal program for REOLYSIN®,” said Dr. Brad Thompson, President and CEO of Oncolytics.  “The selection of head and neck cancers was supported by interim results reported in our US and UK clinical studies, and the successful development of a manufacturing process capable of supplying REOLYSIN for large clinical studies.”

Selected Highlights:

Clinical Trial Results

·  
Announced positive interim results from our Phase I/II UK combination REOLYSIN and carboplatin/paclitaxel trial. Of 14 patients evaluable for response, four had partial responses and five patients had stable disease.  Of note, all partial responses and 4/5 stable diseases were in head and neck disease;

·  
Announced positive interim results from our UK combination REOLYSIN and docetaxel trial.  Of the 11 patients evaluable for response, five had partial or minor responses, and six patients had stable disease; and

·  
Exceeded the primary statistical endpoint in our US multicentre, Phase 2 clinical trial to evaluate the intravenous administration of REOLYSIN in patients with various sarcomas that had metastasized to the lung.  We reported that of 33 patients evaluable for response, five had stable disease for more than six months, and an additional 10 patients had stable disease ranging from 3-6 cycles (cycle = 28 days).

Clinical Trial Progress

·  
Selection of first pivotal program using REOLYSIN in combination with paclitaxel and carboplatin for patients with platinum-failed head & neck cancers;
·  
Start of patient enrolment in five new trials:
o  
NCI-sponsored Phase I/II systemic and peritoneal administration trial in patients with ovarian, peritoneal and fallopian tube cancers;
o  
NCI-sponsored Phase II systemic administration trial in patients with metastatic melanoma;
o  
UK Phase II REOLYSIN/paclitaxel/carboplatin trial for patients with refractory head and neck cancers;
o  
US Phase II REOLYSIN/paclitaxel/carboplatin trial for patients with refractory head and neck cancers;
o  
UK Phase I REOLYSIN/cyclophosphamide trial;

·  
Approval for a US Phase II REOLYSIN/paclitaxel/carboplatin trial for Non-Small Cell Lung Cancer patients with K-RAS or EGFR-activated tumours;

·  
Completion of patient enrolment in two trials:
o  
UK Phase II local administration REOLYSIN and radiation trial for patients with various advanced cancers, including head & neck;
o  
UK REOLYSIN and docetaxel clinical trial;

·  
In early 2009, start of patient enrolment in a University of Leeds-sponsored translational clinical trial examining REOLYSIN in patients with metastatic colorectal cancer; and

·  
In early 2009, Oncolytics and the Cancer Therapy & Research Center at The University of Texas Health Science Center in San Antonio, (CTRC at UTHSCSA) announced a broad preclinical and clinical collaboration involving up to five, open-label, Phase II studies exploring the use of REOLYSIN in combination with chemotherapy for various cancer indications.

Manufacturing

·  
Successfully transferred cGMP manufacturing process for REOLYSIN at the 40L scale and completed initial scale up of manufacturing process for REOLYSIN to commercial scale.

Financial and Intellectual Property

·  
In December, Oncolytics closed a public offering that added a net $3.4 million to Oncolytics’ financial reserves, bringing the total to $13.3 million in cash and equivalents at December 31, 2008; and,
·  
Secured five U.S. and three Canadian patents in 2008.  Currently more than 200 patents have been issued worldwide, including 31 US and 9 Canadian.

“We are greatly encouraged by the clinical results we are seeing in our clinical trials, and by the continued enthusiasm displayed by our collaborators,” said Dr. Thompson.  “We look forward to taking REOLYSIN into to the final stages of development in 2009.”

 
 

 

Oncolytics Biotech Inc.


CONSOLIDATED BALANCE SHEETS



As at December 31


    $ 2008     $ 2007  
ASSETS
               
Current
               
Cash and cash equivalents
    7,429,895       6,715,096  
Short-term investments
    5,846,634       18,498,733  
Accounts receivable
    86,322       80,085  
Prepaid expenses
    179,668       260,300  
      13,542,519       25,554,214  
Property and equipment
Intellectual property
    263,926 180,750       201,103 542,250  
      13,987,195       26,297,567  
LIABILITIES AND SHAREHOLDERS' EQUITY
               
Current
               
Accounts payable and accrued liabilities
    4,534,111       2,821,227  
                 
Commitments and contingency
               
Shareholders' equity
               
Share capital
               
    Authorized: unlimited
               
    Issued: 43,830,748 (2006 – 41,180,748)
    95,234,924       92,759,665  
Warrants
    3,425,110       5,346,260  
Contributed surplus
    13,349,801       10,376,962  
Deficit
    (102,556,751 )     (85,006,547 )
      9,453,084       23,476,340  
      13,987,195       26,297,567  

 
 

 

Oncolytics Biotech Inc.


CONSOLIDATED STATEMENTS OF LOSS AND COMPREHESIVE LOSS


For the periods ended December 31


    $ 2008     $ 2007     $ 2006    
Cumulative from inception on April 2,
1998 to December 31, 2008
$
 
Revenue
                             
Rights revenue
    ¾       ¾       ¾       310,000  
      ¾       ¾       ¾       310,000  
Expenses
                               
Research and development
    13,351,875       12,385,743       11,378,998       74,531,777  
Operating
    4,311,575       3,826,195       3,630,144       24,837,025  
Stock based compensation
    64,039       539,156       403,550       4,768,844  
Foreign exchange (gain) loss
    (68,283 )     8,862       35,270       589,427  
Amortization – intellectual property
    361,500       361,500       361,500       3,434,250  
Amortization – property and equipment
    48,754       40,714       52,638       497,151  
      18,069,460       17,162,170       15,862,100       108,658,474  
Loss before the following
    18,069,460       17,162,170       15,862,100       108,348,474  
Interest income
    (519,256 )     (1,211,744 )     (1,233,809 )     (6,534,005 )
Gain on sale of BCY LifeSciences Inc.
    ¾       ¾       ¾       (299,403 )
Loss on sale of Transition Therapeutics Inc.
    ¾       ¾       ¾       2,156,685  
Loss before income taxes
    17,550,204       15,950,426       14,628,291       103,671,751  
Future income tax recovery
    ¾       ¾       ¾       (1,115,000 )
Net loss and comprehensive loss for the period
    17,550,204       15,950,426       14,628,291       102,556,751  
Basic and diluted loss per share
    (0.42 )     (0.39 )     (0.40 )        


 
 

 

Oncolytics Biotech Inc.

CONSOLIDATED STATEMENTS OF CASH FLOWS

For the periods ended December 31
    $ 2008     $ 2007     $ 2006    
Cumulative from inception on April 2,
1998 to December 31, 2008
$
 
OPERATING ACTIVITIES
                             
Net loss and comprehensive loss for the period
    (17,550,204 )     (15,950,426 )     (14,628,291 )     (102,556,751 )
Add/(deduct) non-cash items
                               
Amortization – intellectual property
    361,500       361,500       361,500       3,434,250  
Amortization – property and equipment
    48,754       40,714       52,638       497,151  
Stock based compensation
    64,039       539,156       403,550       4,768,844  
Other non-cash items
                      1,383,537  
Net change in non-cash working
capital
    1,787,279       586,964       812,622       4,268,121  
Cash used in operating activities
    (15,288,632 )     (14,422,092 )     (12,997,981 )     (88,204,848 )
INVESTING ACTIVITIES
                               
Acquisition of property and equipment
    (111,577 )     (92,221 )     (35,838 )     (813,744 )
Purchase of short-term investments
    (347,901 )     (949,496 )     (1,035,427 )     (49,416,864 )
Redemption of short-term investments
    13,000,000       6,573,000       13,808,000       43,151,746  
Investment in BCY LifeSciences Inc.
                      464,602  
Investment in Transition Therapeutics Inc.
                      2,532,343  
Cash provided by (used in) investing activities
    12,540,522       5,531,283       12,736,735       (4,081,917 )
FINANCING ACTIVITIES
                               
Proceeds from exercise of stock options and warrants
    41,600       51,000       241,400       15,301,068  
Proceeds from private placements
                      38,137,385  
Proceeds from public offerings
    3,421,309       12,063,394             46,278,207  
Cash provided by financing activities
    3,462,909       12,114,394       241,400       99,716,660  
Net increase (decrease) in cash and cash equivalents during the period
    714,799       3,223,585       (19,846 )     7,429,895  
Cash and cash equivalents, beginning of period
    6,715,096       3,491,511       3,511,357        
Cash and cash equivalents, end of period
    7,429,895       6,715,096       3,491,511       7,429,895  
Cash interest received
    769,529       1,392,866       940,100          
 





 
 

 


To view the Company’s Financial Statements and Management’s Discussion and Analysis, please see the Company’s 2008 Annual Filings which will be available on www.sedar.com and 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 and under applicable Canadian provincial securities legislation.  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 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 the Company’s planned expansion of such 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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