CALGARY, March 4 /PRNewswire-FirstCall/ -- Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) ("Oncolytics" or the "Company") today reported its financial results for the year ended December 31, 2008.
"In 2008, we selected our first pivotal program for REOLYSIN(R)," said Dr. Brad Thompson, President and CEO of Oncolytics. "The selection of head and neck cancers was supported by interim results reported in our US and UK clinical studies, and the successful development of a manufacturing process capable of supplying REOLYSIN for large clinical studies."
Selected Highlights: Clinical Trial Results ---------------------- - Announced positive interim results from our Phase I/II UK combination REOLYSIN and carboplatin/paclitaxel trial. Of 14 patients evaluable for response, four had partial responses and five patients had stable disease. Of note, all partial responses and 4/5 stable diseases were in head and neck disease; - Announced positive interim results from our UK combination REOLYSIN and docetaxel trial. Of the 11 patients evaluable for response, five had partial or minor responses, and six patients had stable disease; and - Exceeded the primary statistical endpoint in our US multicentre, Phase 2 clinical trial to evaluate the intravenous administration of REOLYSIN in patients with various sarcomas that had metastasized to the lung. We reported that of 33 patients evaluable for response, five had stable disease for more than six months, and an additional 10 patients had stable disease ranging from 3-6 cycles (cycle = 28 days). Clinical Trial Progress ----------------------- - Selection of first pivotal program using REOLYSIN in combination with paclitaxel and carboplatin for patients with platinum-failed head & neck cancers; - Start of patient enrolment in five new trials: - NCI-sponsored Phase I/II systemic and peritoneal administration trial in patients with ovarian, peritoneal and fallopian tube cancers; - NCI-sponsored Phase II systemic administration trial in patients with metastatic melanoma; - UK Phase II REOLYSIN/paclitaxel/carboplatin trial for patients with refractory head and neck cancers; - US Phase II REOLYSIN/paclitaxel/carboplatin trial for patients with refractory head and neck cancers; - UK Phase I REOLYSIN/cyclophosphamide trial; - Approval for a US Phase II REOLYSIN/paclitaxel/carboplatin trial for Non-Small Cell Lung Cancer patients with K-RAS or EGFR-activated tumours; - Completion of patient enrolment in two trials: - UK Phase II local administration REOLYSIN and radiation trial for patients with various advanced cancers, including head & neck; - UK REOLYSIN and docetaxel clinical trial; - In early 2009, start of patient enrolment in a University of Leeds-sponsored translational clinical trial examining REOLYSIN in patients with metastatic colorectal cancer; and - In early 2009, Oncolytics and the Cancer Therapy & Research Center at The University of Texas Health Science Center in San Antonio, (CTRC at UTHSCSA) announced a broad preclinical and clinical collaboration involving up to five, open-label, Phase II studies exploring the use of REOLYSIN in combination with chemotherapy for various cancer indications. Manufacturing ------------- - Successfully transferred cGMP manufacturing process for REOLYSIN at the 40L scale and completed initial scale up of manufacturing process for REOLYSIN to commercial scale. Financial and Intellectual Property ----------------------------------- - In December, Oncolytics closed a public offering that added a net $3.4 million to Oncolytics' financial reserves, bringing the total to $13.3 million in cash and equivalents at December 31, 2008; and, - Secured five U.S. and three Canadian patents in 2008. Currently more than 200 patents have been issued worldwide, including 31 US and 9 Canadian.
"We are greatly encouraged by the clinical results we are seeing in our clinical trials, and by the continued enthusiasm displayed by our collaborators," said Dr. Thompson. "We look forward to taking REOLYSIN into to the final stages of development in 2009."
Oncolytics Biotech Inc. CONSOLIDATED BALANCE SHEETS As at December 31 2008 2007 $ $ ------------------------------------------------------------------------- ASSETS Current Cash and cash equivalents 7,429,895 6,715,096 Short-term investments 5,846,634 18,498,733 Accounts receivable 86,322 80,085 Prepaid expenses 179,668 260,300 ------------------------------------------------------------------------- 13,542,519 25,554,214 Property and equipment 263,926 201,103 Intellectual property 180,750 542,250 ------------------------------------------------------------------------- 13,987,195 26,297,567 ------------------------------------------------------------------------- ------------------------------------------------------------------------- LIABILITIES AND SHAREHOLDERS' EQUITY Current Accounts payable and accrued liabilities 4,534,111 2,821,227 ------------------------------------------------------------------------- Commitments and contingency Shareholders' equity Share capital Authorized: unlimited Issued: 43,830,748 (2006 - 41,180,748) 95,234,924 92,759,665 Warrants 3,425,110 5,346,260 Contributed surplus 13,349,801 10,376,962 Deficit (102,556,751) (85,006,547) ------------------------------------------------------------------------- 9,453,084 23,476,340 ------------------------------------------------------------------------- 13,987,195 26,297,567 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Oncolytics Biotech Inc. CONSOLIDATED STATEMENTS OF LOSS AND COMPREHESIVE LOSS For the periods ended December 31 Cumulative from inception on April 2, 1998 to December 31, 2008 2007 2006 2008 $ $ $ $ ------------------------------------------------------------------------- Revenue Rights revenue - - - 310,000 ------------------------------------------------------------------------- - - - 310,000 ------------------------------------------------------------------------- Expenses Research and development 13,351,875 12,385,743 11,378,998 74,531,777 Operating 4,311,575 3,826,195 3,630,144 24,837,025 Stock based compensation 64,039 539,156 403,550 4,768,844 Foreign exchange (gain) loss (68,283) 8,862 35,270 589,427 Amortization - intellectual property 361,500 361,500 361,500 3,434,250 Amortization - property and equipment 48,754 40,714 52,638 497,151 ------------------------------------------------------------------------- 18,069,460 17,162,170 15,862,100 108,658,474 ------------------------------------------------------------------------- Loss before the following 18,069,460 17,162,170 15,862,100 108,348,474 Interest income (519,256) (1,211,744) (1,233,809) (6,534,005) Gain on sale of BCY LifeSciences Inc. - - - (299,403) Loss on sale of Transition Therapeutics Inc. - - - 2,156,685 ------------------------------------------------------------------------- Loss before income taxes 17,550,204 15,950,426 14,628,291 103,671,751 Future income tax recovery - - - (1,115,000) ------------------------------------------------------------------------- Net loss and comprehensive loss for the period 17,550,204 15,950,426 14,628,291 102,556,751 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Basic and diluted loss per share (0.42) (0.39) (0.40) ----------------------------------------------------------- ----------------------------------------------------------- Oncolytics Biotech Inc. CONSOLIDATED STATEMENTS OF CASH FLOWS For the periods ended December 31 Cumulative from inception on April 2, 1998 to December 31, 2008 2007 2006 2008 $ $ $ $ ------------------------------------------------------------------------- OPERATING ACTIVITIES Net loss and comprehensive loss for the period (17,550,204) (15,950,426) (14,628,291) (102,556,751) Add/(deduct) non-cash items Amortization - intellectual property 361,500 361,500 361,500 3,434,250 Amortization - property and equipment 48,754 40,714 52,638 497,151 Stock based compensation 64,039 539,156 403,550 4,768,844 Other non-cash items - - - 1,383,537 Net change in non-cash working capital 1,787,279 586,964 812,622 4,268,121 ------------------------------------------------------------------------- Cash used in operating activities (15,288,632) (14,422,092) (12,997,981) (88,204,848) ------------------------------------------------------------------------- INVESTING ACTIVITIES Acquisition of property and equipment (111,577) (92,221) (35,838) (813,744) Purchase of short-term investments (347,901) (949,496) (1,035,427) (49,416,864) Redemption of short-term investments 13,000,000 6,573,000 13,808,000 43,151,746 Investment in BCY LifeSciences Inc. - - - 464,602 Investment in Transition Therapeutics Inc. - - - 2,532,343 ------------------------------------------------------------------------- Cash provided by (used in) investing activities 12,540,522 5,531,283 12,736,735 (4,081,917) ------------------------------------------------------------------------- FINANCING ACTIVITIES Proceeds from exercise of stock options and warrants 41,600 51,000 241,400 15,301,068 Proceeds from private placements - - - 38,137,385 Proceeds from public offerings 3,421,309 12,063,394 - 46,278,207 ------------------------------------------------------------------------- Cash provided by financing activities 3,462,909 12,114,394 241,400 99,716,660 ------------------------------------------------------------------------- Net increase (decrease) in cash and cash equivalents during the period 714,799 3,223,585 (19,846) 7,429,895 Cash and cash equivalents, beginning of period 6,715,096 3,491,511 3,511,357 - ------------------------------------------------------------------------- Cash and cash equivalents, end of period 7,429,895 6,715,096 3,491,511 7,429,895 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Cash interest received 769,529 1,392,866 940,100 ------------------------------------------------------------------------- -------------------------------------------------------------------------
To view the Company's Financial Statements and Management's Discussion and Analysis, please see the Company's 2008 Annual Filings which will be available on http://www.sedar.com/ and http://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 Phase I/II and Phase II human trials using REOLYSIN(R), its proprietary formulation of the human reovirus, alone and in combination with radiation or chemotherapy. For further information about Oncolytics please visit http://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 and under applicable Canadian provincial securities legislation. 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 2009 and beyond, 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 the Company's planned expansion of such 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.
