Oncolytics Biotech(R) Inc. Announces Second Quarter 2012 Results
CALGARY, Aug. 2, 2012 /PRNewswire/ – Oncolytics Biotech Inc. (TSX:ONC,
NASDAQ:ONCY) (“Oncolytics” or the “Company”) today announced its
financial results and operational highlights for the quarter ended
June 30, 2012.
“Early in the quarter, we announced that we had completed enrollment in
the first, 80-patient stage of our Phase III trial in head and neck
cancers,” said Dr. Brad Thompson, President and CEO of Oncolytics. “We
continued to make progress on this key clinical initiative during the
quarter with our independent Data Monitoring Committee recommending the
trial proceed based on a review of the safety data. We continue to
await the results of an ongoing data review which will enable us to
determine the next steps for the study.”
Since March 31, 2012, the Company has made a number of significant
Clinical Trial Program
-- Completion of enrollment in the first, 80-patient stage of its Phase III clinical trial examining REOLYSIN® in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers (REO 018); -- Review by Company's independent Data Monitoring Committee (DMC) of the safety data for the first stage of the Company's Phase III trial in head and neck cancers and received a recommendation that enrollment continue in the study while awaiting the ongoing data review; -- Entry into an agreement whereby the NCIC Clinical Trials Group (CTG) at Queen's University in Kingston, Ontario, will sponsor and conduct a randomized Phase II study of REOLYSIN in patients with advanced or metastatic colorectal cancer enrolling up to 100 patients; -- Entry into an agreement whereby the NCIC CTG will sponsor and conduct a randomized Phase II study of REOLYSIN in patients with advanced or metastatic non-small cell lung cancer enrolling up to 150 patients; -- Entry into an agreement whereby the NCIC CTG will sponsor and conduct a randomized Phase II study of REOLYSIN in patients with advanced or metastatic breast cancer enrolling up to 100 patients; and
Clinical Trial Results
-- 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.
ONCOLYTICS BIOTECH INC. INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (unaudited) June 30, December 31, 2012 2011 $ $ Assets Current assets Cash and cash equivalents 33,802,813 32,918,751 Short-term investments 1,969,228 1,936,787 Accounts receivable 89,574 55,392 Prepaid expenses 699,348 721,576 Total current assets 36,560,963 35,632,506 Non-current assets Property and equipment 428,167 392,111 Total non-current assets 428,167 392,111 Total assets 36,989,130 36,024,617 Liabilities And Shareholders' Equity Current Liabilities Accounts payable and accrued liabilities 5,302,680 6,504,238 Total current liabilities 5,302,680 6,504,238 Shareholders' equity Share capital Authorized: unlimited Issued: June 30, 2012 - 76,606,085 December 31, 2011 - 71,251,335 197,947,858 177,282,566 Warrants 3,030,519 2,653,627 Contributed surplus 20,821,795 21,142,519 Accumulated other comprehensive loss (35,560) (117,501) Accumulated deficit (190,078,162) (171,440,832) Total shareholders' equity 31,686,450 29,520,379 Total liabilities and equity 36,989,130 36,024,617
ONCOLYTICS BIOTECH INC. INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS (unaudited) Three Month Three Month Six Month Six Month Period Period Period Period Ending June Ending June Ending June Ending June 30, 30, 30, 30, 2012 2011 2012 2011 $ $ $ $ Expenses Research and development 9,053,329 5,483,131 16,543,873 8,454,742 Operating 1,222,090 1,068,623 2,310,141 2,195,634 Operating loss (10,275,419) (6,551,754) (18,854,014) (10,650,376) Write down of asset available for sale -- (735,681) -- (735,681) Change in fair value of warrant liability -- -- -- 36,000 Interest 93,389 123,197 213,456 214,703 Loss before income taxes (10,182,030) (7,164,238) (18,640,558) (11,135,354) Income tax expense 3,228 -- 3,228 -- Net loss (10,178,802) (7,164,238) (18,637,330) (11,135,354) Other comprehensive loss (income) - translation adjustment 116,200 (75,211) 81,941 (38,331) Net comprehensive loss (10,062,602) (7,239,449) (18,555,389) (11,173,685) Basic and diluted loss per common share (0.13) (0.10) (0.25) (0.16) Weighted average number of shares (basic and diluted) 76,542,861 71,209,164 75,547,842 70,586,073
ONCOLYTICS BIOTECH INC. INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) Three Month Three Month Six Month Six Month Period Period Period Period Ending June Ending June Ending June Ending June 30, 30, 30, 30, 2012 2011 2012 2011 $ $ $ $ Operating Activities Net loss for the period (10,178,802) (7,164,238) (18,637,330) (11,135,354) Amortization - property and equipment 29,510 29,992 57,571 47,267 Share based compensation 58,343 40,469 72,196 43,342 Change in fair value of warrant liability -- -- -- (36,000) Write down of asset available for sale -- 735,681 -- 735,681 Unrealized foreign exchange loss 61,171 28,978 16,162 220,127 Net change in non-cash working capital (1,174,059) 1,417,496 (1,213,512) 1,357,514 Cash used in operating activities (11,203,837) (4,911,622) (19,704,913) (8,767,423) Investing Activities Acquisition of property and equipment (61,695) (33,831) (93,627) (49,107) Purchase of short-term investments -- 1,679,940 (32,441) 1,679,940 Cash used in investing activities (61,695) 1,646,109 (126,068) 1,630,833 Financing Activities Proceeds from exercise of stock options and warrants 422,886 23,300 885,469 14,738,597 Proceeds from public offering (31,648) -- 19,763,795 -- Cash provided by financing activities 391,238 23,300 20,649,264 14,738,597 Increase in cash (10,874,294) (3,242,213) 818,283 7,602,007 Cash and cash equivalents, beginning of period 44,622,078 49,912,873 32,918,751 39,296,682 Impact of foreign exchange on cash and cash equivalents 55,029 (30,429) 65,779 (258,458) Cash and cash equivalents, end of period 33,802,813 46,640,231 33,802,813 46,640,231
To view the Company’s Second Quarter 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 2012 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.