Oncolytics Biotech(R) 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
Since January 1, 2013, the Company has made a number of significant
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-naÃ¯ve 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.
ONCOLYTICS BIOTECH INC. INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (unaudited) March 31, December 31, 2013 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 2013 2012 March 31, $ $ 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) Accumulated Other Share Contributed Comprehensive Accumulated Capital Surplus Warrants Loss 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 Accumulated Other Share Contributed Comprehensive Accumulated Capital Surplus Warrants Loss 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 2013 2012 March, $ $ 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
SOURCE Oncolytics Biotech Inc.