EX-99.1 CHARTER 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 2012 Year End Results
 
 
CALGARY, AB, March 14, 2013 --- 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, 2012.
 
“We were very pleased to present our first randomized clinical data from our head and neck cancer clinical study in 2012,” said Dr. Brad Thompson, President and CEO of Oncolytics. “In addition, in order to support our program, which now includes seven randomized studies in different indications, we completed two financings over the last 14 months raising gross proceeds in excess of $50 million.”

Selected Highlights
 
Since January 1, 2012, the Company has made a number of significant announcements including:

Clinical Trial Results
 
·  
Reporting initial positive top line data from the first endpoint in the double-blinded randomized Phase III clinical study examining REOLYSIN® in combination with carboplatin and paclitaxel in second-line patients with platinum-refractory, taxane-naïve head and neck cancers (REO 018). The endpoint examined initial percentage tumour changes between the pre-treatment and first post-treatment scans (typically performed at six weeks post-first treatment) of all patients enrolled in the study and was designed to assess early differences in response between loco-regional tumours and metastatic tumours, as classified and observed by the investigators;

·  
Reaching the primary endpoint in the first stage of a U.S. Phase 2 clinical trial in patients with squamous cell carcinoma of the lung (SCCLC) using intravenous administration of REOLYSIN in combination with carboplatin and paclitaxel (REO 021) and subsequently reporting positive percent overall tumour shrinkage data;

·  
Poster presentations at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics reporting positive clinical data from a study in 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 (REO 016) and a U.S. Phase 2 clinical trial using intravenous administration of REOLYSIN in combination with gemcitabine (Gemzar®) in patients with advanced pancreatic cancer (REO 017);

·  
Publication of a paper entitled "Cell Carriage, Delivery, and Selective Replication of an Oncolytic Virus in Tumor in Patients," in the June 13, 2012 issue of the journal Science Translational Medicine (Vol. 4 Issue 138 138ra77), covering findings 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. The researchers found that intravenously-administered reovirus could specifically target and infect metastatic liver tumors in 90% of the patients, even though all patients treated had had a pre-existing immunity to the virus;

Clinical Trial Program

·  
Expansion of enrollment in the first stage of a Phase III head and neck cancer clinical trial (REO 18) to include 167 patients and introduction of an additional patient segregation to differentiate between patients with local recurrent disease, with or without metastases, and patients with distal metastases while maintaining the blind;

·  
Completion of patient enrollment in a U.S. Phase 2 clinical trial evaluating 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 (REO 016);

·  
Completion of patient enrollment in a U.S. Phase 2 clinical trial using intravenous administration of REOLYSIN in combination with gemcitabine (Gemzar®) in patients with advanced or metastatic pancreatic cancer (REO 017);

·  
Completion of enrollment in a U.K. Phase I clinical trial using intravenously-administered REOLYSIN in combination with cyclophosphamide in patients with advanced malignancies (REO 012);

·  
Completion of enrollment in a U.S. Phase 1 clinical trial using intravenously-administered REOLYSIN in combination with FOLFIRI in patients with colorectal cancer (REO 022);

·  
Entry into multiple agreements whereby the NCIC Clinical Trials Group (CTG) at Queen's University in Kingston, Ontario, will sponsor and conduct randomized Phase II studies of REOLYSIN in patients with recurrent or metastatic castration resistant prostate cancer, advanced or metastatic colorectal cancer, advanced or metastatic non-small cell lung cancer, and advanced or metastatic breast cancer;

Management

·  
Appointment of Mr. Kirk Look to the role of Chief Financial Officer;

·  
Appointment of Dr. Alan Tuchman to the role of Chief Medical Officer and Senior Vice President, Clinical and Medical Development;

Financial

·  
Closing of a bought deal financing in February 2012, which was increased post-announcement from $15 million to $18.5 million, for gross proceeds of $21.3 million following the full exercise of the over-allotment option by the syndicate of underwriters; and

·  
Subsequent to year-end, closing of an underwritten public offering of 8.0 million common shares, at a public offering price of US$4.00 per common share for aggregate gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, of approximately US$32.0 million.


ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION


 
December 31,
December 31,
 
2012
$
2011
$
Assets
    
Current assets
    
Cash and cash equivalents
19,323,541
  
32,918,751
  
Short-term investments
1,969,228
  
1,936,787
  
Accounts receivable
44,979
  
55,392
  
Prepaid expenses
331,094
  
721,576
  
Total current assets
21,668,842
  
35,632,506
  
Non-current assets
    
Property and equipment
409,248
  
392,111
  
Total non-current assets
409,248
  
392,111
  
     
Total assets
22,078,090
  
36,024,617
  
Liabilities And Shareholders’ Equity
    
Current Liabilities
    
Accounts payable and accrued liabilities
7,291,310
  
6,504,238
  
Total current liabilities
7,291,310
  
6,504,238
  
Shareholders’ equity
    
Share capital
  Authorized: unlimited
  Issued:
  December 31, 2012 – 76,710,285
  December 31, 2011 –  71,251,335
198,155,091
  
177,282,566
  
Warrants
376,892
  
2,653,627
  
Contributed surplus
24,126,265
  
21,142,519
  
Accumulated other comprehensive loss
(57,115
)
(117,501
)
Accumulated deficit
(207,814,353
)
(171,440,832
)
Total shareholders’ equity
14,786,780
  
29,520,379
  
Total liabilities and equity
22,078,090
  
36,024,617
  




ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS


For the years ending December 31,
2012
$
2011
$
2010
$
Expenses
      
Research and development
31,402,625
  
23,386,685
  
13,882,565
  
Operating
5,285,425
  
5,334,582
  
6,003,870
  
Loss before the following
(36,688,050
)
(28,721,267
)
(19,886,435
)
Write down of asset available for sale
—
  
(735,681
)
—
  
Change in fair value of warrant liability
—
  
36,000
  
(4,841,949
)
Interest
345,003
  
416,247
  
76,934
  
Loss before income taxes
(36,343,047
)
(29,004,701
)
(24,651,450
)
Income tax expense
(30,474
)
(40,000
)
(7,611
)
Net loss
(36,373,521
)
(29,044,701
)
(24,659,061
)
Other comprehensive gain (loss) - translation adjustment
60,386
  
39,159
  
(156,660
)
Net comprehensive loss
(36,313,135
)
(29,005,542
)
(24,815,721
)
Basic and diluted loss per common share
(0.48
)
(0.41
)
(0.39
)
Weighted average number of shares (basic and diluted)
76,102,062
  
70,911,526
  
62,475,403
  

ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

       
Accumulated Other Comprehensive Income
    
 
Share Capital
Warrants
Contributed Surplus
Accumulated Deficit
Total
 
$
$
$
$
$
$
             
As at December 31, 2010
155,439,610
  
4,108,652
  
19,399,489
  
(156,660
)
(142,396,131
)
36,394,960
  
             
Net loss and comprehensive income
—
  
—
  
—
  
39,159
  
(29,044,701
)
(29,005,542
)
Exercise of warrants
21,487,080
  
(1,455,025
)
—
  
—
  
—
  
20,032,055
  
Exercise of stock options
355,876
  
—
  
(62,473
)
—
  
—
  
293,403
  
Share based compensation
—
  
—
  
1,805,503
  
—
  
—
  
1,805,503
  
             
As at December 31, 2011
177,282,566
  
2,653,627
  
21,142,519
  
(117,501
)
(171,440,832
)
29,520,379
  
             
Net loss and comprehensive income
—
—
—
60,386
  
(36,373,521
)
(36,313,135
)
Issued, pursuant to a bought deal financing
19,386,903
  
376,892
  
—
—
—
19,763,795
  
Expiry of warrants
—
(2,653,627
)
2,653,627
  
—
—
—
Exercise of stock options
1,485,622
  
—
(400,632
)
—
—
1,084,990
  
Share based compensation
—
—
730,751
  
—
—
730,751
  
             
As at December 31, 2012
198,155,091
  
376,892
  
24,126,265
  
(57,115
)
(207,814,353
)
14,786,780
  
 
 






ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
 
 

For the years ending December 31,
2012
$
2011
$
2010
$
       
Operating Activities
      
Net loss for the year
(36,373,521
)
(29,044,701
)
(24,659,061
)
Amortization - property and equipment
109,275
  
92,590
  
63,156
  
Share based compensation
730,751
  
1,805,503
  
3,251,041
  
Change in fair value of warrant liability
—
  
(36,000
)
4,841,949
  
Write down of asset available for sale
—
  
735,681
  
—
  
Unrealized foreign exchange loss
89,890
  
115,234
  
343,821
  
Net change in non-cash working capital
1,187,967
  
3,790,510
  
(1,717,978
)
Cash used in operating activities
(34,255,638
)
(22,541,183
)
(17,877,072
)
Investing Activities
      
Acquisition of property and equipment
(126,412
)
(257,790
)
(81,846
)
Acquisition of investment
—
  
—
  
(51,681
)
Redemption (purchase) of short-term investments
(32,441
)
1,672,459
  
(1,929,309
)
Cash provided by (used in) investing activities
(158,853
)
1,414,669
  
(2,062,836
)
Financing Activities
      
Proceeds from exercise of stock options and warrants
1,084,990
  
14,824,658
  
528,211
  
Proceeds from public offering
19,763,795
  
—
  
26,759,921
  
Cash provided by financing activities
20,848,785
  
14,824,658
  
27,288,132
  
Increase (decrease) in cash
(13,565,706
)
(6,301,856
)
7,348,224
  
Cash and cash equivalents, beginning of year
32,918,751
  
39,296,682
  
32,448,939
  
Impact of foreign exchange on cash and cash equivalents
(29,504
)
(76,075
)
(500,481
)
Cash and cash equivalents, end of year
19,323,541
  
32,918,751
  
39,296,682
  


To view the Company's Fiscal 2012 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 2013 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
Dian Griesel, Inc.
Susan Forman
396 West Broadway, 2nd Floor
New York, NY  10012
Tel:  212.825.3210
Fax:  212.825.3229
sforman@dgicomm.com
  
 
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