Oncolytics Biotech® Inc. Announces Second Quarter 2011 Results
CALGARY, AB, July 28, 2011 /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, 2011.
"We continue to build upon and progress through our research and development in an effort to maximize the future commercial potential of REOLYSIN®. In Q2, we focused our efforts on expanding our Phase III clinical trial in head and neck cancer, and expanding our clinical trial program by announcing a U.S. National Cancer Institute-sponsored clinical trial in multiple myeloma," said Dr. Brad Thompson, President and CEO of Oncolytics. "We also received positive data from early stage studies in metastatic colorectal and non-small cell lung cancer studies, and secured a leading manufacturer for the clinical and commercial supply of REOLYSIN®, both significant steps forward in our plans to expand our development program."
Since April 1, 2011 the Company has announced:
Clinical Trial Results
-- Interim data 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. On initial histological analysis of the 10 treated patients, there was evidence of selective delivery of virus to tumour versus normal liver and viral replication in the majority (seven) of patients; -- A presentation covering interim preliminary results from a Phase 2 clinical trial using 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 at the International Association for the Study of Lung Cancer World Conference on Lung Cancer. Response evaluation as of the date of presentation in 21 patients showed six partial responses (PR) (28.6%), 13 stable disease (SD) (61.9%), and two progressive disease (PD) (9.5%), translating into a clinical benefit rate (complete response (CR)+PR+SD) of 90.5% and a response rate (CR+PR) of 28.6%;
Ongoing Clinical Program
-- The Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, U.S. National Cancer Institute (NCI), which is part of the National Institutes of Health, has agreed to sponsor a Phase I study of REOLYSIN alone in patients with relapsed multiple myeloma; -- A commercial supply agreement with SAFC, a Division of Sigma-Aldrich Corporation, for the commercial manufacture of REOLYSIN. Under the terms of the agreement, SAFC will perform process validation of the product, will continue to supply clinical requirements and will supply commercial material upon approval of the product; and
-- The appointment of George M. Gill, MD as Chief Medical Officer. Dr. Gill has been Senior Vice President of Clinical Safety and Regulatory Affairs and an officer of Oncolytics since 2002.
ONCOLYTICSBIOTECH INC. CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (unaudited) June 30, December 31, January 1, 2011 2010 2010 As at, $ $ $ Assets Current assets Cash and cash 46,640,231 39,296,682 32,448,939 equivalents Short-term 1,929,306 3,609,246 1,679,937 investments Accounts receivable 51,421 284,988 64,787 Prepaid expenses 840,444 278,934 507,408 Total current assets 49,461,402 43,469,850 34,701,071 Non-current assets Property and 228,751 226,911 208,320 equipment Long term investment 684,000 Total non-current 228,751 226,911 892,320 assets Asset held for sale 735,681 Total assets 49,690,153 44,432,442 35,593,391 Liabilities And Shareholders Equity Current Liabilities Accounts payable and accrued 4,186,139 2,500,682 4,226,933 liabilities Warrant liability 5,536,800 1,023,051 Total current liabilities 4,186,139 8,037,482 5,249,984 Shareholders equity Share capital Authorized: unlimited Issued: June 30, 2011 - 71,214,318 December 31, 2010 - 67,958,302 January 1, 2010 - 61,549,969 177,179,742 155,439,610 131,908,274 Warrants 2,653,627 4,108,652 2,437,460 Contributed surplus 19,397,121 19,399,489 13,734,743 Accumulated other comprehensive loss (194,991) (156,660) Deficit (153,531,485) (142,396,131) (117,737,070) Total shareholders equity 45,504,014 36,394,960 30,343,407 Total Liabilities And Equity 49,690,153 44,432,442 35,593,391
ONCOLYTICSBIOTECH INC. CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS (unaudited) ThreeMonth ThreeMonth SixMonth Six PeriodEnding PeriodEnding PeriodEnding, MonthPeriodEnding, June 30, 2011 June30, 2010 June30, 2011 June 30, 2010 $ $ $ $ Expenses Research and 5,483,131 3,237,216 8,454,742 6,279,030 development Operating 1,068,623 1,147,940 2,195,634 2,112,249 6,551,754 4,385,156 10,650,376 8,391,279 Loss before the (6,551,754) (4,385,156) (10,650,376) (8,391,279) following Write down of asset available for sale (735,681) (735,681) Change in fair value of warrant liability 391,000 36,000 (150,489) Interest 123,197 9,304 214,703 19,123 Loss before income (7,164,238) (3,984,852) (11,135,354) (8,522,645) taxes Income taxes Net loss (7,164,238) (3,984,852) (11,135,354) (8,522,645) Other comprehensive loss - translation adjustment (75,211) 23,878 (38,331) (121,029) Net comprehensive (7,239,449) (3,960,974) (11,173,685) (8,643,674) loss Basic and diluted loss per share (0.10) (0.06) (0.16) (0.14) Weighted average number of shares (basic and diluted) 71,209,164 61,556,343 70,586,073 61,553,173
ONCOLYTICS BIOTECH INC. CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY (unaudited) For the six month period ending, June 30, 2011 Accumulated Other Share Contributed Comprehensive capital Surplus Warrants Income Deficit Total Equity $ $ $ $ $ $ As at 155,439,610 19,399,489 4,108,652 (156,660) (142,396,131) 36,394,960 December 31, 2010 Net loss and (38,331) (11,135,354) (11,173,685) comprehensive loss for the period Exercise of 21,487,080 (1,455,025) 20,032,055 warrants Exercise of 253,052 (45,710) 207,342 stock options Stock based 43,342 43,342 compensation As at June 177,179,742 19,397,121 2,653,627 (194,991) (153,531,485) 45,504,014 30, 2011 For the six month period ending, June 30, 2010 Accumulated Other Share Contributed Comprehensive Total capital Surplus Warrants Income Deficit Equity $ $ $ $ $ $ As at January 131,908,274 13,734,743 2,437,460 (117,737,070) 30,343,407 1, 2010 Net loss and (121,029) (8,522,645) (8,643,674) comprehensive loss for the period Expired 2,438,000 (2,438,000) warrants Exercise of 72,000 (18,000) 54,000 stock options Stock based 2,428 2,428 compensation Other 540 540 As at June 131,980,274 16,157,171 (121,029) (126,259,715) 21,756,701 30, 2010
ONCOLYTICS BIOTECH INC. CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) Three Month ThreeMonth Six Month SixMonthPeriodEnding, PeriodEnding PeriodEnding PeriodEnding, June 30, 2010 June 30,2011 June 30,2010 June 30, 2011 $ $ $ $ Cash Flows Operating Activities Net loss for the (7,164,238) (3,984,852) (11,135,354) (8,522,645) period Amortization - 29,992 14,621 47,267 29,506 property and equipment Stock based 40,469 1,399 43,342 2,428 compensation Change in fair (391,000) (36,000) 150,489 value of warrant liability Write down of 735,681 735,681 asset available for sale Unrealized 28,978 (293,534) 220,127 (74,546) foreign exchange loss (gain) Net change in 1,417,496 384,452 1,357,514 (792,229) non-cash working capital Cash used in (4,911,622) (4,268,914) (8,767,423) (9,206,997) operating activities Investing Activities Redemption of 1,679,940 1,679,940 short-term investments Acquisition of (33,831) (39,851) (49,107) (43,498) property and equipment Cash provided by 1,646,109 (39,851) 1,630,833 (43,498) (used in) investing activities Financing Activities Proceeds from 23,300 54,000 14,738,597 54,000 exercise of stock options and warrants Cash provided by 23,300 54,000 14,738,597 54,000 financing activities Increase (3,242,213) (4,254,765) 7,602,007 (9,196,495) (decrease) in cash Cash and cash 49,912,873 27,143,314 39,296,682 32,448,939 equivalents, beginning of period Impact of foreign exchange on cash and cash equivalents (30,429) 410,378 (258,458) 46,483 Cash and cash 46,640,231 23,298,927 46,640,231 23,298,927 equivalents, end of period
To view the Company's Second Quarter 2011 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 3 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 2011 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.
Released July 28, 2011