Oncolytics Biotech® Inc. Announces Third Quarter 2011 Results

CALGARY, Nov. 10, 2011 /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, 2011.

"During the quarter we achieved significant increases in the number of enrolling countries in the first stage of our Phase III head and neck cancer study," said Dr. Brad Thompson, President and CEO of Oncolytics. "We currently have approval to conduct the trial in 12 countries in North America and Europe and are focusing on completing enrolment for this stage."

Selected Highlights

Since July 1, 2011, the Company has made a number of significant announcements:

Clinical Trial Results

  • The presentation of interim preliminary results from a Phase 2 clinical trial using intravenous administration of REOLYSIN® in combination with paclitaxel and carboplatin in patients with non-small cell lung cancer (NSCLC) with Kras or EGFR-activated tumours at the International Association for the Study of Lung Cancer World Conference on Lung Cancer. As of the presentation date, response evaluation in 21 patients showed six partial responses (PR) (28.6%), 13 stable disease (SD) (61.9%) and two progressive disease (PD) (9.5%), translating into a clinical benefit rate (complete response (CR) + PR + SD) of 90.5% and a response rate (CR + PR) of 28.6%;

Preclinical Program

  • The posting of a study in the online version of Molecular Therapy, a publication of The American Society of Gene and Cell Therapy, investigating the timing of chemotherapy delivery that optimizes the efficacy of systemic REOLYSIN. The paper, authored by Kottke et al., was entitled "Precise Scheduling of Chemotherapy Primes VEGF-producing Tumors for Successful Systemic Oncolytic Virotherapy." It describes when best to administer taxanes with reovirus to optimize viral delivery to the tumor mass. The researchers demonstrated that this drug combination yielded superior results to either treatment alone. They were able to reproducibly cure nearly half of the treated animals by employing this optimized schedule of paclitaxel/REOLYSIN;

Corporate

  • The appointment of Gerard Kennealey, MD as Senior Vice President of Clinical Development and Chief Medical Officer (CMO). Dr. Kennealey most recently held the position of Vice President of Scientific Affairs at Cephalon Inc.; and
  • The appointment of George M. Gill, MD as Senior Vice President of Regulatory Affairs and Chief Safety Officer. Dr. Gill has been an officer of Oncolytics since 2002.

ONCOLYTICS BIOTECH INC.

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

(unaudited)

As at, September 30,
2011
$
December 31,
2010
$
January 1,
2010
$
Assets      
Current assets      
Cash and cash equivalents 40,243,302 39,296,682 32,448,939
Short-term investments 1,929,306 3,609,246 1,679,937
Accounts receivable 77,511 284,988 64,787
Prepaid expenses 533,149 278,934 507,408
Total current assets 42,783,268 43,469,850 34,701,071
       
Non-current assets      
Property and equipment 269,580 226,911 208,320
Long term investment - - 684,000
Total non-current assets 269,580 226,911 892,320
       
       
Asset held for sale - 735,681 -
Total assets 43,052,848 44,432,442 35,593,391
       
Liabilities And Shareholders' Equity      
       
Current Liabilities      
Accounts payable and accrued liabilities 3,477,615 2,500,682 4,226,933
Warrant liability - 5,536,800 1,023,051
Total current liabilities 3,477,615 8,037,482 5,249,984
       
       
Shareholders' equity      
Share capital      
  Authorized: unlimited
Issued:
September 30, 2011 - 71,239,918
December 31, 2010 - 67,958,302
January 1, 2010 - 61,549,969


177,240,848


155,439,610


131,908,274
Warrants 2,653,627 4,108,652 2,437,460
Contributed surplus 19,572,183 19,399,489 13,734,743
Accumulated other comprehensive loss (127,916) (156,660) -
Deficit (159,763,509) (142,396,131) (117,737,070)
Total shareholders' equity 39,575,233 36,394,960 30,343,407
Total liabilities and equity 43,052,848 44,432,442 35,593,391

ONCOLYTICS BIOTECH INC.

CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS

(unaudited)

  Three Month
Period Ending
September 30,
2011
$
  Three Month
Period Ending
September 30,
2010
$
  Nine Month
Period Ending,
September 30,
2011
$
  Nine Month
Period Ending,
September 30,
2010
$
               
Expenses              
Research and development 5,315,134   2,711,392   13,769,876   8,990,422
Operating 1,019,335   1,307,640   3,214,969   3,419,889
  6,334,469   4,019,032   16,984,845   12,410,311
               
Loss before the following (6,334,469)   (4,019,032)   (16,984,845)   (12,410,311)
               
               
Write down of asset available for sale -   -   (735,681)   -
Change in fair value of warrant liability -   (2,521,950)   36,000   (2,672,439)
Interest 102,445   17,759   317,148   36,882
Loss before income taxes (6,232,024)   (6,523,223)   (17,367,378)   (15,045,868)
               
Income taxes -   -   -   -
Net loss (6,232,024)   (6,523,223)   (17,367,378)   (15,045,868)
Other comprehensive loss (gain) -
translation adjustment
(9,587)   (7,749)   28,744   (128,778)
Net comprehensive loss (6,241,611)   (6,530,972)   (17,338,634)   (15,174,646)
Basic and diluted loss per share (0.09)   (0.11)   (0.25)   (0.24)
Weighted average number of shares
(basic and  diluted)
71,221,218   61,570,046   70,800,114   61,558,859

ONCOLYTICS BIOTECH INC.

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

(unaudited)

  For the nine month period ending, September 30, 2011
  Share capital Contributed
Surplus
Warrants Accumulated
Other
Comprehensive
Income
Deficit Total Equity
  $ $ $ $ $ $
As at December 31, 2010 155,439,610 19,399,489 4,108,652 (156,660) (142,396,131) 36,394,960
             
Net loss and comprehensive loss for the period 28,744 (17,367,378) (17,338,634)
Exercise of warrants 21,487,080 (1,455,025) 20,032,055
Exercise of stock options 314,158 (51,831) 262,327
Stock based compensation 224,525 224,525
As at September 30, 2011 177,240,848 19,572,183 2,653,627 (127,916) (159,763,509) 39,575,233
   
  For the nine month period ending, September 30, 2010
  Share capital Contributed
Surplus
Warrants Accumulated
Other
Comprehensive
Income
Deficit Total Equity
  $ $ $ $ $ $
As at January 1, 2010 131,908,274 13,734,743 2,437,460 (117,737,070) 30,343,407
             
Net loss and comprehensive loss for the period (128,778) (15,045,868) (15,174,646)
Expired warrants 2,438,000 (2,438,000)
Exercise of stock options 83,812 (20,987) 62,825
Stock based compensation 400,103 400,103
Other 540 540
As at September 30, 2010 131,992,086 16,551,859 (128,778) (132,782,938) 15,632,229

ONCOLYTICS BIOTECH INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

  Three Month
Period Ending
September 30,
2011
$
Three Month
Period Ending
September 30,
2010
$
Nine Month
Period Ending,
September 30,
2011
$
Nine Month
Period Ending,
September 30,
2010
$
Cash Flows        
Operating Activities        
Net loss for the period (6,232,024) (6,523,223) (17,367,378) (15,045,868)
  Amortization - property and equipment 21,258 15,981 68,525 45,487
  Stock based compensation 181,183 397,675 224,525 400,103
  Change in fair value of warrant liability - 2,521,950 (36,000) 2,672,439
  Write down of asset available for sale - - 735,681 -
  Unrealized foreign exchange loss (gain) (121,391) 204,241 98,736 84,591
Net change in non-cash working capital (427,319) (1,582,647) 930,195 (2,374,876)
Cash used in operating activities (6,578,293) (4,966,023) (15,345,716) (14,218,124)
         
Investing Activities        
Redemption (purchase) of short-term investments - (1,929,937) 1,679,940 (1,929,937)
Acquisition of property and equipment (62,087) (8,701) (111,194) (52,199)
Cash provided by (used in) investing activities (62,087) (1,938,638) 1,568,746 (1,982,136)
         
Financing Activities        
Proceeds from exercise of stock options and warrants 54,985 8,825 14,793,582 62,825
Cash provided by financing activities 54,985 8,825 14,793,582 62,825
         
Increase (decrease) in cash (6,585,395) (6,895,836) 1,016,612 (16,137,435)
Cash and cash equivalents, beginning of period 46,640,231 23,205,961 39,296,682 32,448,939
Impact of foreign exchange on cash and cash equivalents 188,466 (211,990) (69,992) (213,369)
Cash and cash equivalents, end of period 40,243,302 16,098,135 40,243,302 16,098,135

To view the Company's Third Quarter 2011 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 2011 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.

 

SOURCE Oncolytics Biotech Inc.

For further information:

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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