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 2010 Year End Results

CALGARY, AB, March 17, 2011 --- Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) (“Oncolytics” or the “Company”) today announced its financial results and operational highlights for the year ended December 31, 2010.

“2010 was marked by the further expansion of our late-stage clinical program, particularly with respect to the addition of randomized trials and new indications,” said Dr. Brad Thompson, President and CEO of Oncolytics.

“Both during the year and subsequent to year end, we were able to significantly strengthen our balance sheet.  This will allow us to further our goal of moving REOLYSIN® through the last steps of product development.”

Selected Highlights

Since January 1, 2010 the Company has announced:

Clinical Trial Results
·  
A poster presentation at the ASCO 2010 Annual Meeting, entitled "A Phase I/II study of oncolytic reovirus plus carboplatin/paclitaxel in patients with advanced solid cancers with emphasis on squamous cell carcinoma of the head and neck (SCCHN),” showing that of 19 head and neck cancer patients evaluable for response, eight (42%) had partial responses and six (32%) had stable disease; mean overall survival in 24 treated head and neck cancer patients was more than eight months;
·  
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;
·  
Publication of a paper entitled "REO-10: A Phase I Study of Intravenous Reovirus and Docetaxel in Patients with Advanced Cancer," by Comins et al in the journal Clinical Cancer Research. The paper reported final results from a combination REOLYSIN and docetaxel trial designed to evaluate the anti-tumour effects of systemic administration of REOLYSIN in combination with docetaxel (Taxotere®) in patients with advanced cancers. A disease control rate (combined complete response, partial response and stable disease) of 88% was observed. The authors concluded that the combination of reovirus and docetaxel was safe, with evidence of objective disease response, and warrants further evaluation in a Phase II study;
·  
Start of enrollment and preliminary results from a U.S. Phase 2 clinical trial (REO 017) using intravenous administration of REOLYSIN in combination with gemcitabine (Gemzar®) in patients with advanced pancreatic cancer. Seventeen evaluable patients with pancreatic cancer were expected to be treated in the first stage and if three or more patients received clinical benefit, the study would then proceed to the next stage. This endpoint was met after six evaluable patients were enrolled.
 
 
 

 
Ongoing Clinical Program
·  
 
Approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to conduct a Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers;
·  
Receipt of a No Objection Letter from Health Canada to conduct its Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers;
·  
 
Receipt of approval from the Belgian Federal Agency for Medicines and Health Products (FAMHP) to conduct its Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers;
·  
Opening of enrollment in a Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers;
·  
The Cancer Therapy & Research Center at the University of Texas Health Science Center (CTRC) had started patient enrolment in a U.S. Phase 2 clinical trial using intravenous administration of REOLYSIN in combination with carboplatin and paclitaxel in patients with squamous cell carcinoma of the lungs (SCC lung cancer);
·  
Completion of Phase 1 patient enrollment in a Phase 1/2 clinical trial to investigate the use of REOLYSIN for patients with recurrent malignant gliomas (REO 007);
·  
The opening of enrollment in a U.S. Phase 1 study of REOLYSIN in combination with FOLFIRI (Folinic Acid (leucovorin) + Fluorouracil (5-FU) + Irinotecan) in patients with oxaliplatin refractory/intolerant Kras mutant colorectal cancer (REO 022);
·  
Start of enrollment in 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) and sponsored by The Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, U.S. NCI, which is part of the National Institutes of Health;
·  
The Children's Oncology Group (COG) intent to conduct a Phase 1 trial of REOLYSIN in combination with cyclophosphamide in pediatric patients with relapsed or refractory solid tumors sponsored by the NCI;
·  
Start of enrollment in a 2-Arm randomized Phase 2 study of carboplatin, paclitaxel plus REOLYSIN versus carboplatin and paclitaxel alone in the first line treatment of patients with recurrent or metastatic pancreatic cancer sponsored by the NCI;
·  
Completion of enrollment in a U.K. translational clinical trial investigating intravenous administration of REOLYSIN in patients with metastatic colorectal cancer prior to surgical resection of liver metastases (REO 013);


Intellectual Property
·  
Grant of the Company’s 35th U.S. Patent, No. 7,731,951 entitled "Viruses for the Treatment of Cellular Proliferative Disorders." The patent claims cover methods for treating cell proliferative disorders by administering modified vaccinia virus to proliferating cells having an activated Ras-pathway;
·  
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;
·  
The company now has 41 U.S. patents in total;

Financial
·  
Completion of a bought deal financing issuing 5,440,000 units of the Company at a price of $4.60 per Unit for gross proceeds to the Company of approximately $28.77 million;
·  
Pursuant to the acceleration of the expiry date of those warrants issued on November 23, 2009, the Company received proceeds of approximately US$6.8 million resulting from the exercise of 1,943,000 warrants; and
·  
The exercise of 1,322,750 warrants, issued in connection with the financing that closed on November 8, 2010, providing the Company with proceeds of approximately $8.2 million.

 
 

 

ONCOLYTICS BIOTECH INC.
 
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
 
As at December 31,
  $ 2010     $ 2009  
Assets
               
Current assets
               
Cash and cash equivalents
    39,296,682       32,448,939  
Short-term investments
    3,609,246       1,679,937  
Accounts receivable
    284,988       64,787  
Prepaid expenses
    278,934       507,408  
Total current assets
    43,469,850       34,701,071  
                 
Non-current assets
               
Property and equipment
    226,911       208,320  
Asset held for sale
    735,681       684,000  
Total non-current assets
    962,592       892,320  
                 
Total assets
    44,432,442       35,593,391  
                 
                 
Liabilities And Shareholders’ Equity
               
                 
                 
Current Liabilities
               
Accounts payable and accrued liabilities
    2,500,682       4,226,933  
Total current liabilities
    2,500,682       4,226,933  
                 
                 
                 
Shareholders’ equity
               
Share capital
  Authorized: unlimited
  Issued 67,958,302 (2009 – 61,549,969)
    155,227,915       131,908,274  
Warrants
    6,066,128       4,511,441  
Contributed surplus
    19,399,489       13,734,743  
Deficit
    (138,761,772 )     (118,788,000 )
                 
Total shareholders’ equity
    41,931,760       31,366,458  
                 
Total Liabilities And Equity
    44,432,442       35,593,391  
                 


 
 

 

ONCOLYTICS BIOTECH INC.
 
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
 

For the periods ending December 31,
  $ 2010     $ 2009     $ 2008    
Cumulative from inception on April 2, 1998 to December 31, 2010
$
 
Revenue
                             
Rights revenue
                      310,000  
                                 
                                 
Expenses
                               
Research and development
    12,191,809       11,606,514       13,351,875       98,330,100  
Operating
    4,190,403       3,782,507       4,311,575       32,809,935  
Stock based compensation
    3,251,041       424,273       64,039       8,444,158  
Foreign exchange loss (gain)
    346,686       179,716       (68,283 )     1,115,829  
Amortization - intellectual property
          180,750       361,500       3,615,000  
Amortization - property and equipment
    63,156       64,930       48,754       625,237  
      20,043,095       16,238,690       18,069,460       144,940,259  
                                 
Loss before the following
    (20,043,095 )     (16,238,690 )     (18,069,460 )     (144,630,259 )
                                 
Interest
    76,934       29,441       519,256       6,640,380  
Gain on sale of BCY LifeSciences Inc.
                      299,403  
Loss on sale of Transition Therapeutics Inc.
                      (2,156,685 )
Loss before income taxes
    (19,966,161 )     (16,209,249 )     (17,550,204 )     (139,847,161 )
                                 
Income taxes (recovery)
    7,611       22,000             (1,085,389 )
Net loss and comprehensive loss
    (19,973,772 )     (16,231,249 )     (17,550,204 )     (138,761,772 )
Basic and diluted loss per common share
    (0.32 )     (0.33 )     (0.42 )      


 
 

 

 
ONCOLYTICS BIOTECH INC.
 
 
CONSOLIDATED STATEMENTS OF CASH FLOWS
 
For the periods ending December 31,
  $ 2010     $ 2009     $ 2008    
Cumulative from inception on April 2, 1998 to December 31, 2010
$
 
Cash Flows
                             
Operating Activities
                             
Net loss and comprehensive loss for the period
    (19,973,772 )     (16,231,249 )     (17,550,204 )     (138,761,772 )
Amortization - intellectual property
          180,750       361,500       3,615,000  
Amortization - property and equipment
    63,156       64,930       48,754       625,237  
Stock based compensation
    3,251,041       424,273       64,039       8,444,158  
Other non-cash items
    343,821       110,800             1,838,158  
Net change in non-cash working capital
    (1,717,978 )     (613,383 )     1,787,279       1,936,760  
Cash used in operating activities
    (18,033,732 )     (16,063,879 )     (15,288,632 )     (122,302,459 )
                                 
Investing Activities
                               
Acquisition of property and equipment
    (81,846 )     (9,324 )     (111,577 )     (904,914 )
Purchase of intellectual property
    (51,681 )                 (51,681 )
Purchase of short-term investments
    (1,929,309 )     (1,679,937 )     (347,901 )     (53,026,110 )
Redemption of short-term investments
          5,846,634       13,000,000       48,998,380  
Investment in BCY
                      464,602  
Investment in Transition Therapeutics Inc.
                      2,532,343  
Cash provided by (used in) investing activities
    (2,062,836 )     4,157,373       12,540,522       (1,987,380 )
                                 
Financing Activities
                               
Proceeds from exercise of stock options and warrants
    528,211       15,210,210       41,600       31,039,489  
Proceeds from private placements
                      38,137,385  
Proceeds from acquisition of private company
          1,800,120             1,800,120  
Proceeds from public offering
    26,759,921       20,042,570       3,421,309       93,080,698  
Cash provided by financing activities
    27,288,132       37,052,900       3,462,909       164,057,692  
                                 
Increase in cash
    7,191,564       25,146,394       714,799       39,767,853  
Cash and cash equivalents, beginning of period
    32,448,939       7,429,895       6,715,096        
Impact of foreign exchange on cash and cash equivalents
    (343,821 )     (127,350 )           (471,171 )
Cash and cash equivalents, end of period
    39,296,682       32,448,939       7,429,895       39,296,682  
 
To view the Company’s 2010 Consolidated Financial Statements, related Notes to Consolidated Financial Statements, and Management’s Discussion and Analysis, please see the Company’s year end 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
 

 

-30-