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Oncolytics Biotech® Inc. Announces Second Quarter 2011 Results


News provided by

Oncolytics Biotech Inc.

Jul 28, 2011, 07:00 ET

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CALGARY, AB, July 28, 2011 /PRNewswire/ - Oncolytics Biotech Inc. (TSX:ONC) (NASDAQ:ONCY) ("Oncolytics" or the "Company") today announced its financial results and operational highlights for the quarter ended June 30, 2011.

"We continue to build upon and progress through our research and development in an effort to maximize the future commercial potential of REOLYSIN®. In Q2, we focused our efforts on expanding our Phase III clinical trial in head and neck cancer, and expanding our clinical trial program by announcing a U.S. National Cancer Institute-sponsored clinical trial in multiple myeloma," said Dr. Brad Thompson, President and CEO of Oncolytics. "We also received positive data from early stage studies in metastatic colorectal and non-small cell lung cancer studies, and secured a leading manufacturer for the clinical and commercial supply of REOLYSIN®, both significant steps forward in our plans to expand our development program."

Selected Highlights

Since April 1, 2011 the Company has announced:

Clinical Trial Results

  • Interim data from a U.K. translational clinical trial (REO 013) investigating intravenous administration of REOLYSIN in patients with metastatic colorectal cancer prior to surgical resection of liver metastases. On initial histological analysis of the 10 treated patients, there was evidence of selective delivery of virus to tumour versus normal liver and viral replication in the majority (seven) of patients;
  • A presentation covering 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. Response evaluation as of the date of presentation 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%;

Ongoing Clinical Program

  • 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, has agreed to sponsor a Phase I study of REOLYSIN alone in patients with relapsed multiple myeloma;
  • A commercial supply agreement with SAFC, a Division of Sigma-Aldrich Corporation, for the commercial manufacture of REOLYSIN. Under the terms of the agreement, SAFC will perform process validation of the product, will continue to supply clinical requirements and will supply commercial material upon approval of the product; and

Corporate

  • The appointment of George M. Gill, MD as Chief Medical Officer. Dr. Gill has been Senior Vice President of Clinical Safety and Regulatory Affairs and an officer of Oncolytics since 2002.
ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)
 
As at,   June 30,
2011
$
December 31,
2010
$
January 1,
2010
$
Assets        
Current assets        
Cash and cash equivalents   46,640,231 39,296,682 32,448,939
Short-term investments   1,929,306 3,609,246 1,679,937
Accounts receivable   51,421 284,988 64,787
Prepaid expenses   840,444 278,934 507,408
Total current assets   49,461,402 43,469,850 34,701,071
         
Non-current assets        
Property and equipment   228,751 226,911 208,320
Long term investment   — — 684,000
Total non-current assets   228,751 226,911 892,320
 
Asset held for sale   — 735,681 —
Total assets   49,690,153 44,432,442 35,593,391
         
Liabilities And Shareholders' Equity    
         
Current Liabilities        
Accounts payable and accrued liabilities   4,186,139 2,500,682 4,226,933
Warrant liability   — 5,536,800 1,023,051
Total current liabilities   4,186,139 8,037,482 5,249,984
         
Shareholders' equity        
Share capital
  Authorized: unlimited
  Issued:
  June 30, 2011 - 71,214,318
  December 31, 2010 - 67,958,302
  January 1, 2010 - 61,549,969
  177,179,742 155,439,610 131,908,274
Warrants   2,653,627 4,108,652 2,437,460
Contributed surplus   19,397,121 19,399,489 13,734,743
Accumulated other comprehensive
  loss
  (194,991) (156,660) —
Deficit   (153,531,485) (142,396,131) (117,737,070)
Total shareholders' equity   45,504,014 36,394,960 30,343,407
Total Liabilities And Equity   49,690,153 44,432,442 35,593,391
ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)
           
    Three Month Period Ending
June 30, 2011
$
Three Month Period Ending
June 30, 2010
$
Six Month Period Ending,
June 30, 2011
$
Six Month Period Ending,
June 30, 2010
$
           
Expenses          
Research and development   5,483,131 3,237,216 8,454,742 6,279,030
Operating   1,068,623 1,147,940 2,195,634 2,112,249
    6,551,754 4,385,156 10,650,376 8,391,279
Loss before the following   (6,551,754) (4,385,156) (10,650,376) (8,391,279)
           
Write down of asset available for sale   (735,681) — (735,681) —
Change in fair value of warrant liability   — 391,000 36,000 (150,489)
Interest   123,197 9,304 214,703 19,123
Loss before income taxes   (7,164,238) (3,984,852) (11,135,354) (8,522,645)
           
Income taxes   — — — —
Net loss   (7,164,238) (3,984,852) (11,135,354) (8,522,645)
Other comprehensive loss - translation adjustment   (75,211) 23,878 (38,331) (121,029)
Net comprehensive loss   (7,239,449) (3,960,974) (11,173,685) (8,643,674)
Basic and diluted loss per share   (0.10) (0.06) (0.16) (0.14)
Weighted average number of shares (basic and  diluted)   71,209,164 61,556,343 70,586,073 61,553,173
ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(unaudited)
 
  For the six month period ending, June 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 — — — (38,331) (11,135,354) (11,173,685)
Exercise of warrants 21,487,080 — (1,455,025) — — 20,032,055
Exercise of stock options 253,052 (45,710) — — — 207,342
Stock based compensation — 43,342 — — — 43,342
As at June 30, 2011 177,179,742 19,397,121 2,653,627 (194,991) (153,531,485) 45,504,014
  For the six month period ending, June 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 — — — (121,029) (8,522,645) (8,643,674)
Expired warrants — 2,438,000 (2,438,000) — — —
Exercise of stock options 72,000 (18,000) — — — 54,000
Stock based compensation — 2,428 — — — 2,428
Other — — 540 — — 540
As at June 30, 2010 131,980,274 16,157,171 — (121,029) (126,259,715) 21,756,701
             
ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
           
      Three Month Period Ending
June 30, 2011
$
Three Month Period Ending
June 30, 2010
$
Six Month Period Ending,
June 30, 2011
$
Six Month Period Ending,
June 30, 2010
$
Cash Flows          
Operating Activities          
Net loss for the period   (7,164,238) (3,984,852) (11,135,354) (8,522,645)
  Amortization - property and equipment   29,992 14,621 47,267 29,506
  Stock based compensation   40,469 1,399 43,342 2,428
  Change in fair value of warrant liability   — (391,000) (36,000) 150,489
  Write down of asset available for sale   735,681 — 735,681 —
  Unrealized foreign exchange loss (gain)   28,978 (293,534) 220,127 (74,546)
Net change in non-cash working capital   1,417,496 384,452 1,357,514 (792,229)
Cash used in operating activities   (4,911,622) (4,268,914) (8,767,423) (9,206,997)
           
Investing Activities          
Redemption of short-term investments   1,679,940 — 1,679,940 —
Acquisition of property and equipment   (33,831) (39,851) (49,107) (43,498)
Cash provided by (used in) investing activities   1,646,109 (39,851) 1,630,833 (43,498)
           
Financing Activities          
Proceeds from exercise of stock options and warrants   23,300 54,000 14,738,597 54,000
Cash provided by financing activities   23,300 54,000 14,738,597 54,000
           
Increase (decrease) in cash   (3,242,213) (4,254,765) 7,602,007 (9,196,495)
Cash and cash equivalents, beginning of period   49,912,873 27,143,314 39,296,682 32,448,939
Impact of foreign exchange on cash and cash
  equivalents
  (30,429) 410,378 (258,458) 46,483
Cash and cash equivalents, end of period   46,640,231 23,298,927 46,640,231 23,298,927

To view the Company's Second 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.

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