CALGARY, May 8, 2014 /PRNewswire/ - Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) ("Oncolytics" or the "Company") today announced its financial results and operational highlights for the first quarter ended March 31, 2014.
"During the quarter we reported additional data from our head and neck study which will help us with the design of our proposed registration study for discussion with regulators," said Dr. Brad Thompson, President and CEO of Oncolytics. "We also took steps to improve our access to capital in order to support our clinical program, which continues to move ahead."
Selected Highlights
Since January 1, 2014, specific highlights announced by the Company include:
Clinical and Preclinical Data
-- Final data from the Company's randomized, double-blinded clinical study examining REOLYSIN® in combination with carboplatin and paclitaxel in patients with second-line, platinum-refractory, taxane-naïve head and neck cancers; -- A series of presentations by research collaborators at the 8th Annual International Conference on Oncolytic Virus Therapeutics held in Oxford, UK covering: o early clinical research showing that intravenously delivered REOLYSIN®can cross the blood brain barrier to access tumours in the brains of humans; o preclinical research examining the synergies associated with treatment in animal models with GM-CSF prior to administering REOLYSIN®; o preclinical research focused on identifying biomarkers predictive of sensitivity/resistance to reovirus in head and neck cancer cell lines; and o preclinical research into the treatment of hepatocellular carcinoma associated with infection by Hepatitis B and Hepatitis C.
Financial
-- At March 31, 2014 the Company reported $22.2 million in cash, cash equivalents and short-term investments; and -- Entry into a share purchase agreement with Lincoln Park Capital Fund, LLC that will provide an initial investment in Oncolytics of US$1.0 million and make available additional periodic investments of up to US$25.0 million over a 30-month term.
ONCOLYTICS BIOTECH INC.
INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)
March 31, December 31, As at 2014 2013 Assets Current assets Cash and cash equivalents 20,155,907 25,220,328 Short-term investments 2,031,685 2,001,644 Accounts receivable 43,507 105,853 Prepaid expenses 295,802 361,743 Total current assets 22,526,901 27,689,568 Non-current assets Property and equipment 508,782 532,459 Total non-current assets 508,782 532,459 Total assets 23,035,683 28,222,027 Liabilities And Shareholders' Equity Current Liabilities Accounts payable and accrued liabilities 4,833,423 6,008,661 Total current liabilities 4,833,423 6,008,661 Shareholders' equity Share capital Authorized: unlimited Issued: March 31, 2014 - 85,810,718 December 31, 2013 - 84,803,818 229,801,006 228,612,564 Warrants -- 376,892 Contributed surplus 25,172,701 24,491,212 Accumulated other comprehensive loss 61,004 79,698 Accumulated deficit (236,832,451) (231,347,000) Total shareholders' equity 18,202,260 22,213,366 Total liabilities and equity 23,035,683 28,222,027
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)
2014 2013 For the three month period ending March 31 $ $ Expenses Research and development 4,178,334 5,117,044 Operating 1,391,254 1,564,751 Operating loss (5,569,588) (6,681,795) Interest 87,987 74,959 Loss before income taxes (5,481,601) (6,606,836) Income tax expense (3,850) -- Net loss (5,485,451) (6,606,836) Other comprehensive income items that may be reclassified to net loss Translation adjustment (18,694) 34,188 Net comprehensive loss (5,504,145) (6,572,648) Basic and diluted loss per common share (0.06) (0.08) Weighted average number of shares (basic and 85,148,242 79,766,258 diluted)
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 198,155,091 24,126,265 376,892 (57,115) (207,814,353) 14,786,780 December 31, 2012 Net loss and -- -- -- 34,188 (6,606,836) (6,572,648) comprehensive loss Issued, 30,207,062 -- -- -- -- 30,207,062 pursuant to a public offering Exercise of 139,676 (34,687) -- -- -- 104,989 stock options Share based -- 120,856 -- -- -- 120,856 compensation As at March 228,501,829 24,212,434 376,892 (22,927) (214,421,189) 38,647,039 31, 2013 Accumulated Other Share Contributed Comprehensive Accumulated Capital Surplus Warrants Loss Deficit Total $ $ $ $ $ $ As at 228,612,564 24,491,212 376,892 79,698 (231,347,000) 22,213,366 December 31, 2013 Net loss and -- -- -- (18,694) (5,485,451) (5,504,145) comprehensive loss Issued, pursuant to Share Purchase Agreement 1,188,442 -- -- -- -- 1,188,442 Expired -- 376,892 (376,892) -- -- -- warrants Share based -- 304,597 -- -- -- 304,597 compensation As at March 229,801,006 25,172,701 -- 61,004 (236,832,451) 18,202,260 31, 2014
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
2014 2013 For the three month period ending March 31 $ $ Operating Activities Net loss for the period (5,485,451) (6,606,836) Amortization - property and equipment 39,657 24,581 Share based compensation 304,597 120,856 Unrealized foreign exchange loss 24,070 (307,653) Net change in non-cash working capital (1,046,951) (1,641,170) Cash used in operating activities (6,164,078) (8,410,222) Investing Activities Acquisition of property and equipment (15,980) (15,138) Purchase of short-term investments (30,041) (32,416) Cash used in investing activities (46,021) (47,554) Financing Activities Proceeds from Share Purchase Agreement 1,188,442 -- Proceeds from exercise of stock options and -- 104,989 warrants Proceeds from public offering -- 30,207,062 Cash provided by financing activities 1,188,442 30,312,051 Increase in cash (5,021,657) 21,854,275 Cash and cash equivalents, beginning of period 25,220,328 19,323,541 Impact of foreign exchange on cash and cash (42,764) 341,841 equivalents Cash and cash equivalents, end of period 20,155,907 41,519,657
To view the Company's First Quarter 2014 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/for-investors/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 2014 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.