Oncolytics Biotech® Inc. Announces First Quarter 2013 Results

CALGARY, May 9, 2013 /PRNewswire/ - 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);


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


  • 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.

      March 31,
      December 31,
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              
  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

For the three month period ending March 31,     2013
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

    Share Capital   Contributed
  Warrants   Accumulated Other
    $   $   $   $   $   $
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
  Warrants   Accumulated Other
    $   $   $   $   $   $
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


For the three month period ending March,     2013
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.

SOURCE Oncolytics Biotech Inc.