EX-99.1 2 pressreleaseq12013.htm FIRST QUARTER 2013 PRESS RELEASE Press Release Q1 2013


210, 1167 Kensington Cr. N.W.
Calgary, Alberta
Canada T2N 1X7
FOR IMMEDIATE RELEASE
 
Oncolytics Biotech® Inc. Announces First Quarter 2013 Results
 
CALGARY, AB, May 9, 2013 --- Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) (“Oncolytics” or the “Company”) today announced its financial results and operational highlights for the quarter ended March 31, 2013.
 
“We recently reported positive data from our squamous cell carcinoma of the lung study both with respect to the study's primary endpoint and tumour shrinkage, which supports the conduct of further studies in this indication,” said Dr. Brad Thompson, President and CEO of Oncolytics. “In late February we were also able to substantially strengthen our balance sheet through an offering of common shares for gross proceeds of US$32.0 million that will be principally used to fund our ongoing clinical program.”

Selected Highlights
 
Since January 1, 2013, the Company has made a number of significant announcements including:
 
Clinical Trial Results
•
Reaching the primary overall statistical 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 reporting positive percent overall tumour shrinkage data. The primary endpoint was met if nine or more patients in both stages combined had a partial response (PR) or better. This endpoint was met after 21 evaluable patients were treated on study, nine of which exhibited PRs, while a further nine showed stable disease (SD) and three, progressive disease (PD), for a response rate of 42.8% and a disease control rate (complete response (CR) + PR + SD) of 85.7%;

•
Reporting positive preliminary results from a Phase I study examining the intravenous administration of REOLYSIN in combination with FOLFIRI in patients with metastatic colorectal cancer (REO 022) in a poster presentation at the ASCO Gastrointestinal Cancers Symposium. Of the 18 patients evaluable for response there was one PR and nine had SD. The combined overall progression free survival (PFS) of FOLFIRI-naïve and FOLFIRI-failed patients was 7.4 months. The authors concluded that the combination of REOLYSIN and FOLFIRI was safe and well tolerated and resulted in disease control in the majority of evaluable patients, including patients that had previously progressed on Irinotecan;

Clinical Trial Program

•
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);

Management

•
Appointment of Dr. Jeremy Grushcow to the role of General Counsel; and





Financial

•
Closing of a U.S. underwritten public offering of 8.0 million common shares, at a price of US$4.00 per common share for gross proceeds, before deducting underwriting commissions and offering expenses, of approximately US$32.0 million.

ONCOLYTICS BIOTECH INC.
INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)

 
 
 
 
March 31,
2013
December 31,
2012
Assets
 
 
Current assets
 
 
Cash and cash equivalents
41,519,657

 
19,323,541

 
Short-term investments
2,001,644

 
1,969,228

 
Accounts receivable
77,976

 
44,979

 
Prepaid expenses
273,184

 
331,094

 
Total current assets
43,872,461

 
21,668,842

 
Non-current assets
 
 
Property and equipment
399,805

 
409,248

 
Total non-current assets
399,805

 
409,248

 
 
 
 
Total assets
44,272,266

 
22,078,090

 
Liabilities And Shareholders' Equity
 
 
Current Liabilities
 
 
Accounts payable and accrued liabilities
5,625,227

 
7,291,310

 
Total current liabilities
5,625,227

 
7,291,310

 
Shareholders' equity
 
 
Share capital
  Authorized: unlimited
  Issued:
  March 31, 2013 - 84,758,818
  December 31, 2012 - 76,710,285
228,501,829

 
198,155,091

 
Warrants
376,892

 
376,892

 
Contributed surplus
24,212,434

 
24,126,265

 
Accumulated other comprehensive loss
(22,927
)
 
(57,115
)
 
Accumulated deficit
(214,421,189
)
 
(207,814,353
)
 
Total shareholders' equity
38,647,039

 
14,786,780

 
Total liabilities and equity
44,272,266

 
22,078,090

 





ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)


For the three month period ending March 31,
 
2013
$
2012
$
Expenses
 
 
 
Research and development
 
5,117,044

 
7,490,544

 
Operating
 
1,564,751

 
1,088,051

 
Operating loss
 
(6,681,795
)
 
(8,578,595
)
 
Interest
 
74,959

 
120,067

 
Loss before income taxes
 
(6,606,836
)
 
(8,458,528
)
 
Income tax expense
 
—

 
—

 
Net loss
 
(6,606,836
)
 
(8,458,528
)
 
Other comprehensive income items that may be reclassified to net loss
 
 
Translation adjustment
 
34,188

 
(34,259
)
 
Net comprehensive loss
 
(6,572,648
)
 
(8,492,787
)
 
Basic and diluted loss per common share
 
(0.08
)
 
(0.11
)
 
Weighted average number of shares (basic and diluted)
 
79,766,258

 
74,552,824

 






ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(unaudited)

 
Share Capital
Contributed Surplus
Warrants
Accumulated Other Comprehensive Loss
Accumulated Deficit
Total
 
$
$
$
$
$
$
As at December 31, 2011
177,282,566

 
21,142,519

 
2,653,627

 
(117,501
)
 
(171,440,832
)
 
29,520,379

 
 
 
 
 
 
 
 
Net loss and comprehensive loss
—

 
—

 
—

 
(34,259
)
 
(8,458,528
)
 
(8,492,787
)
 
Issued, pursuant to a bought deal financing
19,418,551

 
—

 
376,892

 
—

 
—

 
19,795,443

 
Exercise of stock options
670,719

 
(208,136
)
 
—

 
—

 
—

 
462,583

 
 
 
 
 
 
 
 
Share based compensation
—

 
13,853

 
—

 
—

 
—

 
13,853

 
As at March 31, 2012
197,371,836

 
20,948,236

 
3,030,519

 
(151,760
)
)
(179,899,360
)
)
41,299,471

 
 
 
 
 
 
 
 
 
Share Capital
Contributed Surplus
Warrants
Accumulated Other Comprehensive Loss
Accumulated Deficit
Total
 
$
$
$
$
$
$
 
 
 
 
 
 
 
As at December 31, 2012
198,155,091

 
24,126,265

 
376,892

 
(57,115
)
 
(207,814,353
)
 
14,786,780

 
 
 
 
 
 
 
 
Net loss and comprehensive loss
—

 
—

 
—

 
34,188

 
(6,606,836
)
 
(6,572,648
)
 
Issued, pursuant to a public offering
30,207,062

 
—

 
—

 
—

 
—

 
30,207,062

 
Exercise of stock options
139,676

 
(34,687
)
 
—

 
—

 
—

 
104,989

 
 
 
 
 
 
 
 
Share based compensation
—

 
120,856

 
—

 
—

 
—

 
120,856

 
As at March 31, 2013
228,501,829

 
24,212,434

 
376,892

 
(22,927
)
)
(214,421,189
)
)
38,647,039

 





ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
 

For the three month period ending March,
 
2013
$
 
2012
$
 
 
 
 
 
Operating Activities
 
 
 
 
Net loss for the period
 
(6,606,836
)
 
 
(8,458,528
)
 
Amortization - property and equipment
 
24,581

 
 
28,061

 
Share based compensation
 
120,856

 
 
13,853

 
Unrealized foreign exchange loss
 
(307,653
)
 
 
(45,009
)
 
Net change in non-cash working capital
 
(1,641,170
)
 
 
(39,453
)
 
Cash used in operating activities
 
(8,410,222
)
 
 
(8,501,076
)
 
Investing Activities
 
 
 
 
Acquisition of property and equipment
 
(15,138
)
 
 
(31,932
)
 
Purchase of short-term investments
 
(32,416
)
 
 
(32,441
)
 
Cash used in investing activities
 
(47,554
)
 
 
(64,373
)
 
Financing Activities
 
 
 
 
Proceeds from exercise of stock options and warrants
 
104,989

 
 
462,583

 
Proceeds from public offering
 
30,207,062

 
 
19,795,443

 
Cash provided by financing activities
 
30,312,051

 
 
20,258,026

 
Increase in cash
 
21,854,275

 
 
11,692,577

 
Cash and cash equivalents, beginning of period
 
19,323,541

 
 
32,918,751

 
Impact of foreign exchange on cash and cash equivalents
 
341,841

 
 
10,750

 
Cash and cash equivalents, end of period
 
41,519,657

 
 
44,622,078

 

To view the Company's Fiscal 2013 First Quarter 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/financials.
 
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@tmxequicom.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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