EX-99.1 2 ex99.htm RELEASE ex99.htm
210, 1167 Kensington Cr. N.W
Calgary, Alberta
Canada T2N 1X7

FOR IMMEDIATE RELEASE
 

Oncolytics Biotech® Inc. Announces Second Quarter 2011 Results

CALGARY, AB, July 28, 2011 --- 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.
 
FOR FURTHER INFORMATION PLEASE CONTACT:

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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