CALGARY, Nov. 10 /CNW/ - 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 -   -   -   -   310,000
  -   -   -   -   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 -   -   -   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. -   -   -   -   (299,403)
Loss on sale of Transition Therapeutics Inc. -   -   -   -   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 -   -   -   -   (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 -   -   -   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   -   213,369   -   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)   -   (1,929,937)   -   (53,026,738)
Redemption of short-term investments -   -   -   5,846,634   48,998,380
Investment in BCY LifeSciences Inc. -   -   -   -   464,602
Investment in Transition Therapeutics Inc. -   -   -   -   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 -   -   -   1,800,120   1,800,120
Proceeds from private placements -   -   -   -   38,137,385
Proceeds from public offerings -   (59,893)   -   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)   -   (213,369)   -   (340,719)
Cash and cash equivalents, beginning of the period 23,205,961   11,983,352   32,448,939   7,429,895   -
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.