EX-99.1 2 ex99.htm PRESS RELEASE ex99.htm

 
210, 1167 Kensington Cr. N.W
Calgary, Alberta
Canada T2N 1X7
 


FOR IMMEDIATE RELEASE
 

Oncolytics Biotech® Inc. Announces Second Quarter 2010 Results

CALGARY, AB, July 29, 2010 --- 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, 2010.

“We have recently passed a number of key milestones in our clinical program, most notably the opening of enrollment in our Phase 3 head and neck cancer study, the expansion of the study to other jurisdictions internationally, and the reporting of positive results from an earlier study with an emphasis on squamous cell carcinoma of the head and neck,” said Dr. Brad Thompson, President and CEO of Oncolytics.  “While our Phase 3 study remains our primary focus, we have also successfully expanded our clinical program to include other indications as REOLYSIN® may be effective in treating a variety of cancers.”

Selected Highlights
Since April 1, 2010 the Company has announced:

Clinical Trial Results
·  
A poster presentation at the American Society of Clinical Oncology 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;
·  
 
Publication of a paper entitled "Two-Stage Phase I Dose-Escalation Study of Intratumoural Reovirus Type 3 Dearing and Palliative Radiotherapy in Patients with Advanced Cancers," in the online version of the journal Clinical Cancer Research that showed that 100% of 14 evaluable patients were stable disease or better (7 partial responses, and 7 stable disease);
·  
 
A poster presentation at the American Association for Cancer Research’s 101st Annual Meeting in Washington, DC entitled "Reovirus replication in ovarian and peritoneal tumors after intravenous administration," covering correlative results from a Phase 1/2 study with reovirus in patients with ovarian, primary peritoneal and fallopian tube carcinoma, sponsored by the National Cancer Institute under its Clinical Trials Agreement with Oncolytics;

Clinical Program
·  
Opening of enrollment in the 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;
·  
 
Start of enrollment in a U.S. Phase 2 clinical trial using intravenous administration of REOLYSIN in combination with gemcitabine (Gemzar®) in patients with advanced pancreatic cancer at the Cancer Therapy & Research Center at the University of Texas Health Science Center in San Antonio;
·  
Poster presentations at the ASCO 2010 Annual Meeting covering the structures of a "Phase II study of reovirus with paclitaxel (P) and carboplatin (C) in patients with metastatic non-small cell lung cancer (NSCLC) who have Kras or EGFR-activated tumors" and a "Phase I/II trial of reovirus serotype 3-Dearing strain in patients with recurrent ovarian cancer";
·  
 
The decision to initiate a U.S. Phase I 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);
·  
 
Completion of Phase I patient enrollment in a Phase I/II clinical trial to investigate the use of REOLYSIN for patients with recurrent malignant gliomas (REO 007);

Preclinical Program
·  
 
A paper entitled "Antiangiogenic cancer therapy combined with oncolytic virotherapy leads to regression of established tumors in mice," co-senior authored by Dr. Richard Vile of the Department of Immunology, Mayo Clinic, Rochester, Minnesota, USA, and Dr. Kevin Harrington of the Institute of Cancer Research, London, UK, was published in the online version of the Journal of Clinical Investigation;
·  
A poster presentation at the AACR Annual Meeting entitled "Molecular pathways associated with REOLYSIN and gemcitabine synergy in ras-mutated human HCT116 cells," covering work done to better understand the mechanisms associated with the cytotoxic synergies in this combined approach in colorectal cancer cell lines;
·  
A poster presentation at the AACR Annual Meeting entitled "The addition of REOLYSIN, an oncolytic reovirus, to irinotecan shows synergistic anticancer activity in colorectal cancer cell lines," covering research done in vitro into a novel therapeutic approach for treating patients with colorectal cancer tumors that harbor a mutation in the Kras oncogene that have failed first line therapy;
·  
A poster presentation at the AACR Annual Meeting entitled "Reovirus successfully purges multiple myeloma ex vivo and does not affect human CD34+ cell engraftment in a murine transplantation model," covering the utility of reovirus in treating hematological malignancies; and

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.

 
 

 


Oncolytics Biotech Inc.
CONSOLIDATED BALANCE SHEETS
(unaudited)

As at,

   
June 30,
2010
$
   
December 31, 2009
$
 
ASSETS
           
Current
           
Cash and cash equivalents
    23,205,961       32,448,939  
Short-term investments
    1,679,937       1,679,937  
Accounts receivable
    58,645       64,787  
Prepaid expenses
    718,418       507,408  
      25,662,961       34,701,071  
                 
Property and equipment
    222,312       208,320  
Long term investment
    684,000       684,000  
      26,569,273       35,593,391  
LIABILITIES AND SHAREHOLDERS' EQUITY
               
Current
               
Accounts payable and accrued liabilities
    3,639,572       4,226,933  
                 
Shareholders' equity
               
Share capital
               
    Authorized: unlimited number of common shares
               
    Issued: 61,569,969
      (December 31, 2009 – 61,549,969)
    131,980,274       131,908,274  
Warrants
    2,073,441       4,511,441  
Contributed surplus
    16,157,171       13,734,743  
Deficit
    (127,281,185 )     (118,788,000 )
      22,929,701       31,366,458  
      26,569,273       35,593,391  
 



 
 

 

Oncolytics Biotech Inc.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)


 
 
 
 
 
 
 
 
Three Month Period Ending June 30, 2010
$
   
Three Month Period Ending June 30, 2009
$
   
Six Month Period Ending June 30, 2010
$
   
Six Month Period Ending June 30, 2009
$
   
Cumulative from inception on April 2,
1998 to June 30, 2010
$
 
Revenue
                             
Rights revenue
    ¾       ¾       ¾       ¾       310,000  
      ¾       ¾       ¾       ¾       310,000  
Expenses
                                       
Research and development
    3,561,168       3,239,210       6,400,481       6,051,865       92,538,772  
Operating
    1,133,319       980,721       2,082,743       1,967,485       30,702,275  
Stock based compensation
    1,399       8,544       2,428       20,181       5,195,545  
Foreign exchange loss/(gain)
    (349,229 )     3,103       (2,850 )     59,138       766,293  
Amortization – intellectual property
    ¾       90,375       ¾       180,750       3,615,000  
Amortization – property and equipment
    14,621       16,536       29,506       33,840       591,587  
      4,361,278       4,338,489       8,512,308       8,313,259       133,409,472  
Loss before the following:
    4,361,278       4,338,489       8,512,308       8,313,259       133,099,472  
                                         
Interest income
    (9,304 )     (3,732 )     (19,123 )     (20,856 )     (6,582,569 )
Gain on sale of BCY LifeSciences Inc.
    ¾       ¾       ¾       ¾       (299,403 )
Loss on sale of Transition Therapeutics Inc.
    ¾       ¾       ¾       ¾       2,156,685  
Loss before income taxes
    4,351,974       4,334,757       8,493,185       8,292,403       128,374,185  
Future income tax recovery
    ¾       ¾       ¾       ¾       (1,093,000 )
Net loss and comprehensive loss
for the period
    4,351,974       4,334,757       8,493,185       8,292,403       127,281,185  
Basic and diluted loss per share
    0.07       0.09       0.14       0.18          
Weighted average number of shares (basic and diluted)
    61,556,343       47,449,182       61,553,173       45,659,353          





 
 

 



Oncolytics Biotech Inc.


CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)


   
Three Month Period Ending June 30, 2010
$
   
Three Month Period Ending June 30, 2009
$
   
Six Month Period Ending June 30, 2010
$
   
Six Month Period Ending June 30, 2009
$
   
Cumulative from inception on April 2, 1998 to June 30, 2010
$
 
OPERATING ACTIVITIES
                             
Net loss for the period
    (4,351,974 )     (4,334,757 )     (8,493,185 )     (8,292,403 )     (127,281,185 )
Deduct non-cash items
                                       
Amortization – intellectual property
    ¾       90,375       ¾       180,750       3,615,000  
Amortization – property and equipment
    14,621       16,536       29,506       33,840       591,587  
Stock based compensation
    1,399       8,544       2,428       20,181       5,195,545  
Other non-cash items
    (415,280 )     ¾       (46,483 )     ¾       1,447,854  
Net changes in non-cash working capital
    384,452       (1,414,201 )     (792,229 )     (1,578,220 )     2,862,509  
      (4,366,782 )     (5,633,503 )     (9,299,963 )     (9,635,852 )     (113,568,690 )
INVESTING ACTIVITIES
                                       
Capital assets
    (39,851 )     ¾       (43,498 )     (3,349 )     (866,566 )
Purchase of short-term investments
    ¾       ¾       ¾       ¾       (51,096,801 )
Redemption of short-term investments
    ¾       1,925,600       ¾       5,846,634       48,998,380  
Investment in BCY LifeSciences Inc.
    ¾       ¾       ¾       ¾       464,602  
Investment in Transition Therapeutics Inc.
    ¾       ¾       ¾       ¾       2,532,343  
      (39,851 )     1,925,600       (43,498 )     5,843,285       31,958  
FINANCING ACTIVITIES
                                       
Proceeds from exercise of warrants and stock options
    54,000       351,835       54,000       373,085       30,565,278  
Proceeds from acquisition of private company
    ¾       1,800,120       ¾       1,800,120       1,800,120  
Proceeds from private placements
    ¾       ¾       ¾       ¾       38,137,385  
Proceeds from public offerings
    ¾       6,172,819       ¾       6,172,819       66,320,777  
      54,000       8,324,774       54,000       8,346,024       136,823,560  
                                         
(Decrease) increase in cash and cash equivalents during the period
    (4,352,633 )     4,616,871       (9,289,461 )     4,553,457       23,286,828  
Impact of foreign exchange on cash and cash equivalents
    415,280       ¾       46,483       ¾       (80,867 )
Cash and cash equivalents, beginning of the period
    27,143,314       7,366,481       32,448,939       7,429,895       ¾  
Cash and cash equivalents, end of the period
    23,205,961       11,983,352       23,205,961       11,983,352       23,205,961  


 
 

 


 
To view the Company’s Second 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 III 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.
 
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-