6-K

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 6-K

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934

For the month of November 2008

Commission File Number 000-31062

Oncolytics Biotech Inc.

(Translation of registrant’s name into English)

Suite 210, 1167 Kensington Crescent NW
Calgary, Alberta, Canada T2N 1X7

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

     
Form 20-F   þ   Form 40-F   o

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):   o

Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):   o

Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.

Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

     
Yes   o   No   þ

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b):   82 -             

 

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

         
    Oncolytics Biotech Inc.
(Registrant)
 
         
 
Date: November 5, 2008   By:   /s/ Doug Ball
Doug Ball
Chief Financial Officer

 

 

     
(ONCOLYTICS LOGO)
  210, 1167 Kensington Cr. N.W
Calgary, Alberta
Canada T2N 1X7
FOR IMMEDIATE RELEASE
Oncolytics Biotech Inc. Announces 2008 Third Quarter Results
CALGARY, AB, November 4, 2008 — Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) (“Oncolytics” or the “Company”) today announced its financial results for the three and nine-month periods ended September 30, 2008.
Recent Pivotal Trial Decision
Oncolytics made a decision in early November to pursue a pivotal (Phase II/III) randomized trial using the combination of REOLYSIN® with paclitaxel/carboplatin in refractory patients with head and neck cancers. The decision was made following a review of results by the Company’s Board of Directors from the Company’s ongoing U.K. Phase I and Phase II combination REOLYSIN® and paclitaxel/carboplatin clinical trials. The results were presented November 1, 2008 at the International Society for Biological Therapy of Cancer (iSBTc) annual meeting in San Diego, CA.
Selected Third Quarter Highlights:
  •   Treatment of the 200th patient in clinical studies with REOLYSIN®;
 
  •   Completion of patient enrolment in the dose escalation portion of its U.K. clinical trial to evaluate the anti-tumour effects of systemic administration of REOLYSIN® in combination with docetaxel (Taxotere®) in patients with advanced cancers including bladder, prostate, lung and upper gastro-intestinal;
 
  •   The U.S. National Cancer Institute (NCI), part of the National Institutes of Health, started enrolment in a Phase II clinical trial for patients with metastatic melanoma using systemic administration of REOLYSIN®;
 
  •   The start of patient enrolment in a U.S. Phase II clinical trial using intravenous administration of REOLYSIN® in combination with paclitaxel and carboplatin in patients with advanced head and neck cancers;
 
  •   Initiation of a U.S. Phase II clinical trial using intravenous administration of REOLYSIN® in combination with paclitaxel and carboplatin in patients with NSCLC with K-RAS or EGFR-activated tumours;
 
  •   The grant of the Company’s 28th U.S. patent which covers methods of purifying reassorted reovirus from an FDA-approved cell line.

 

 

Latest Highlights
Subsequent to quarter end, the Company announced:
  •   Eight of nine refractory head and neck cancer patients treated to date have experienced either a partial response or stabilization of disease in our Phase I and Phase II U.K. combination REOLYSIN® and carboplatin/paclitaxel trials;
 
  •   Nine of eleven evaluable patients have experienced stable disease or better for at least four cycles in our U.K. combination REOLYSIN® and docetaxel trial;
 
  •   The selection of refractory head and neck cancers for the Company’s first pivotal trial;
 
  •   Results of two preclinical studies which demonstrated synergy in vitro and in vivo with the combination of REOLYSIN® and chemotherapy;
 
  •   Results of a preclinical study demonstrating that a single IV administration of ReoT3D can result in substantial tumor growth delay in melanoma-bearing nude mice;
 
  •   The grant of the Company’s 29th U.S. patent, which covers methods of selectively removing cancer cells ex vivo from blood stem cells and other organs using reovirus; and,
 
  •   Successful completion of initial scale-up of its manufacturing process for REOLYSIN® to the 100L commercial scale from the current 40L level.

 

 

Oncolytics Biotech Inc.
CONSOLIDATED BALANCE SHEETS
(unaudited)
As at,
                 
            December 31,
    September   2007
    30, 2008   $
    $   [Restated]
 
ASSETS
                
Current
                
Cash and cash equivalents
     12,680,162       6,715,096  
Short-term investments
     ¾       18,498,733  
Accounts receivable
     47,891       80,085  
Prepaid expenses
     307,697       260,300  
     
 
     13,035,750       25,554,214  
 
                
Property and equipment
     235,542       201,103  
 
                
Intellectual property
     271,125       542,250  
     
 
 
     13,542,417       26,297,567  
 
 
                
LIABILITIES AND SHAREHOLDERS’ EQUITY
                
Current
                
Accounts payable and accrued liabilities
     2,800,857       2,821,227  
     
 
                
Shareholders’ equity
                
Share capital
                
Authorized: unlimited number of common shares
Issued: 41,180,748 (December 31, 2007 - 41,180,748)
     92,759,665       92,759,665  
Warrants
     5,346,260       5,346,260  
Contributed surplus
     10,431,917       10,376,962  
Deficit
     (97,796,282 )     (85,006,547 )
     
 
                
 
     10,741,560       23,476,340  
 
 
                
 
     13,542,417       26,297,567  
 

 

 

Oncolytics Biotech Inc.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)
                                         
                                    Cumulative
                            Nine Month   from inception
    Three Month   Three Month   Nine Month   Period   on April 2,
    Period   Period Ending   Period   Ending   1998 to
    Ending   September 30,   Ending   September   September 30,
    September   2007   September   30, 2007   2008
    30, 2008   $   30, 2008   $   $
    $   [Restated]   $   [Restated]   [Restated]
 
Revenue
                                        
Rights revenue
     ¾       ¾       ¾       ¾       310,000  
 
 
     ¾       ¾       ¾       ¾       310,000  
 
 
                                        
Expenses
                                        
Research and development
     3,210,294       3,134,340       9,650,595       9,621,760       70,750,311  
Operating
     880,438       812,939       3,250,830       2,711,962       23,856,466  
Stock based compensation
     17,339       38,909       54,955       142,878       4,759,760  
Foreign exchange loss/gain
     29,026       18,917       (20,059 )     2,829       637,651  
Amortization — intellectual property
     90,375       90,375       271,125       271,125       3,343,875  
Amortization — property and equipment
     11,853       10,197       35,233       30,061       483,630  
           
 
     4,239,325       4,105,677       13,242,679       12,780,615       103,831,693  
 
 
                                        
Loss before the following:
     4,239,325       4,105,677       13,242,679       12,780,615       103,521,693  
 
                                        
Interest income
     (98,493 )     (319,221 )     (452,944 )     (946,826 )     (6,467,693 )
 
                                        
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
     4,140,832       3,786,456       12,789,735       11,833,789       98,911,282  
 
                                        
Future income tax recovery
     ¾       ¾       ¾       ¾       (1,115,000 )
           
 
                                        
Net loss and comprehensive loss for the period
     4,140,832       3,786,456       12,789,735       11,833,789       97,796,282  
 
 
                                        
Basic and diluted loss per share
     0.10       0.09       0.31       0.29          
         
 
                                        
Weighted average number of shares (basic and diluted)
     41,180,748       41,120,748       41,180,748       40,181,777          
         

 

 

Oncolytics Biotech Inc.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
                                         
                                    Cumulative
                            Nine Month   from inception
    Three Month   Three Month   Nine Month   Period   on April 2,
    Period   Period Ending   Period   Ending   1998 to
    Ending   September 30,   Ending   September   September 30,
    September   2007   September   30, 2007   2008
    30, 2008   $   30, 2008   $   $
    $   [Restated]   $   [Restated]   [Restated]
 
OPERATING ACTIVITIES
                                        
 
                                        
Net loss for the period
     (4,140,832 )     (3,786,456 )     (12,789,735 )     (11,833,789 )     (97,796,282 )
Deduct non-cash items
                                       
Amortization — intellectual property
     90,375       90,375       271,125       271,125       3,343,875  
Amortization — property and equipment
     11,853       10,197       35,233       30,061       483,630  
Stock based compensation
     17,339       38,909       54,955       142,878       4,759,760  
Other non-cash items
     ¾       ¾       ¾       ¾       1,383,537  
Net changes in non-cash working capital
     (1,217,916 )     316,534       (35,573 )     (46,262 )     2,445,269  
           
 
     (5,239,181 )     (3,330,441 )     (12,463,995 )     (11,435,987 )     (85,380,211 )
 
 
                                        
INVESTING ACTIVITIES
                                        
Capital assets
     (10,927 )     (11,386 )     (69,672 )     (49,691 )     (771,839 )
Purchase of short-term investments
     (62,435 )     (255,688 )     (314,631 )     (742,853 )     (49,383,594 )
Redemption of short-term investments
     9,813,364       ¾       18,813,364       ¾       48,965,110  
Investment in BCY LifeSciences Inc.
     ¾       ¾       ¾       ¾       464,602  
Investment in Transition Therapeutics Inc.
     ¾       ¾       ¾       ¾       2,532,343  
           
 
     9,740,002       (267,074 )     18,429,061       (792,544 )     1,806,622  
 
 
                                        
FINANCING ACTIVITIES
                                        
Proceeds from exercise of warrants and stock options
     ¾       ¾       ¾       ¾       15,259,468  
Proceeds from private placements
     ¾       ¾       ¾       ¾       38,137,385  
Proceeds from public offerings
     ¾       ¾       ¾       12,063,394       42,856,898  
           
 
     ¾       ¾       ¾       12,063,394       96,253,751  
 
 
                                        
Increase (decrease) in cash and cash equivalents during the period
     4,500,821       (3,597,515 )     5,965,066       (165,137 )     12,680,162  
 
                                        
Cash and cash equivalents, beginning of the period
     8,179,341       6,923,889       6,715,096       3,491,511       ¾  
           
 
Cash and cash equivalents, end of the period
     12,680,162       3,326,374       12,680,162       3,326,374       12,680,162  
 

 

 

To view the 2008 Third Quarter Report which includes the Consolidated Financial Statements, related Notes to Consolidated Financial Statements, and Management’s Discussion and Analysis, please see the Company’s third quarter 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 Phase I/II and Phase II human trials using REOLYSIN®, its proprietary formulation of the human reovirus, alone and in combination with radiation or chemotherapy. 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 2008 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:
         
Oncolytics Biotech Inc.
  The Equicom Group   The Investor Relations Group
Cathy Ward
  Nick Hurst   Erika Moran
210, 1167 Kensington Cr NW
  325, 300 5th Ave. SW   11 Stone St, 3rd Floor
Calgary, Alberta T2N 1X7
  Calgary, Alberta T2P 3C4   New York, NY 10004
Tel: 403.670.7377
  Tel: 403.538.4845   Tel: 212.825.3210
Fax: 403.283.0858
  Fax: 403.237.6916   Fax: 212.825.3229
cathy.ward@oncolytics.ca
  nhurst@equicomgroup.com   emoran@investorrelationsgroup.com
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