CALGARY, May 5 /PRNewswire-FirstCall/ – Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) (“Oncolytics” or the “Company”) today announced its financial results for the three-month period ended March 31, 2009.
“The first quarter of 2009 was highlighted by the announcement of very positive results in several of our combination REOLYSIN(R) clinical trials,” said Dr. Brad Thompson, President and CEO of Oncolytics. “We continue to report clinical benefit in the majority of patients treated with REOLYSIN in combination with chemotherapy or radiation, paving the way for our pivotal program to begin this year.”
Selected First Quarter Highlights: - Announced positive interim results from a U.K. Phase I/II combination REOLYSIN and paclitaxel/carboplatin trial for patients with advanced head and neck cancers. Of 12 evaluable patients, five patients had partial responses (PR) and four patients had stable disease (SD), for a clinical benefit rate (complete response + partial response + stable disease) of 75%; - Announced positive results from a U.K. combination REOLYSIN and docetaxel trial for patients with a variety of advanced cancers. Fifteen of the 17 evaluable patients experienced SD or better, including two PR, three minor responses and 10 SD, giving a clinical benefit rate of 88%; - Completed enrolment in a U.K. combination REOLYSIN and gemcitabine clinical trial. Of the ten patients evaluable for response, two patients (breast and nasopharyngeal) had PRs and five patients had SD, for a clinical benefit rate of 70%; - Started patient enrolment in a U.S. Phase 2 Combination REOLYSIN and paclitaxel/carboplatin clinical trial for patients with non-small cell lung cancer with K-RAS or EGFR-activated tumours. Eligible patients include those who have not received chemotherapy treatment for their metastatic or recurrent disease; - Started patient enrolment in a U.K. translational clinical trial investigating REOLYSIN in patients with metastatic colorectal cancer; and - Announced a multi-trial clinical research collaboration with the Cancer Therapy & Research Center at the University of Texas Health Science Center involving up to five, open-label, Phase 2 studies exploring the use of REOLYSIN(R) in combination with chemotherapy for various cancer indications. These indications are expected to include melanoma, pancreatic cancer, squamous cell lung, liver and K-RAS mutated colorectal cancers in combination with standard chemotherapeutics. Latest Highlights Subsequent to quarter end, the Company announced: - Positive results of a U.K. Phase II REOLYSIN and radiation combination clinical trial. Of 14 evaluable patients, 13 patients had SD or better in the treated target lesions, including four PRs and two minor responses, for a clinical benefit rate of 93% in the treated lesions; - The successful acquisition of PrivateCo., an inactive private company with net cash of $2.1 million; and - A proposed public offering consisting of up to 3.45 million units at $2.00 per unit, for gross proceeds of up to $6.9 million. Oncolytics Biotech Inc. INTERIM CONSOLIDATED BALANCE SHEETS (unaudited) As at, March 31, December 31, 2009 2008 $ $ ------------------------------------------------------------------------- ASSETS Current Cash and cash equivalents 7,366,481 7,429,895 Short-term investments 1,925,600 5,846,634 Accounts receivable 68,411 86,322 Prepaid expenses 101,025 179,668 ------------------------------------------------------------------------- 9,461,517 13,542,519 Property and equipment 249,971 263,926 Intellectual property 90,375 180,750 ------------------------------------------------------------------------- 9,801,863 13,987,195 ------------------------------------------------------------------------- ------------------------------------------------------------------------- LIABILITIES AND SHAREHOLDERS' EQUITY Current Accounts payable and accrued liabilities 4,273,538 4,534,111 ------------------------------------------------------------------------- Shareholders' equity Share capital Authorized: unlimited number of common shares Issued: 43,855,748 (December 31, 2008 - 43,830,748) 95,256,174 95,234,924 Warrants 3,425,110 3,425,110 Contributed surplus 13,361,438 13,349,801 Deficit (106,514,397) (102,556,751) ------------------------------------------------------------------------- 5,528,325 9,453,084 ------------------------------------------------------------------------- 9,801,863 13,987,195 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Oncolytics Biotech Inc. INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS (unaudited) Three Month Three Month Cumulative Period Period from inception Ending Ending on April 2, March 31, March 31, 1998 to March 2009 2008 31, 2009 $ $ $ ------------------------------------------------------------------------- Revenue Rights revenue - - 310,000 ------------------------------------------------------------------------- Expenses Research and development 2,812,655 2,393,397 77,344,432 Operating 986,764 1,050,894 25,823,789 Stock-based compensation 11,637 19,593 4,780,481 Foreign exchange loss 56,035 9,262 645,462 Amortization - intellectual property 90,375 90,375 3,524,625 Amortization - property and equipment 17,304 11,186 514,455 ------------------------------------------------------------------------- 3,974,770 3,574,707 112,633,244 ------------------------------------------------------------------------- Loss before the following 3,974,770 3,574,707 112,323,244 Interest income (17,124) (180,334) (6,551,129) Gain on sale of BCY LifeSciences Inc. - - (299,403) Loss on sale of Transition Therapeutics Inc. - - 2,156,685 ------------------------------------------------------------------------- Loss before income taxes 3,957,646 3,394,373 107,629,397 Future income tax recovery - - (1,115,000) ------------------------------------------------------------------------- Net loss and comprehensive loss for the period 3,957,646 3,394,373 106,514,397 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Basic and diluted loss per share (0.09) (0.08) ----------------------------------------------------------- ----------------------------------------------------------- Weighted average number of shares (basic and diluted) 43,849,637 41,180,748 ----------------------------------------------------------- ----------------------------------------------------------- Oncolytics Biotech Inc. INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) Cumulative Three Month Three Month from Period Period inception on Ending Ending April 2, 1998 March 31, March 31, to March 31, 2009 2008 2009 $ $ $ ------------------------------------------------------------------------- OPERATING ACTIVITIES Net loss for the period (3,957,646) (3,394,373) (106,514,397) Add / (deduct) non-cash items Amortization - intellectual property 90,375 90,375 3,524,625 Amortization - property and equipment 17,304 11,186 514,455 Stock-based compensation 11,637 19,593 4,780,481 Other non-cash items - - 1,383,537 Net change in non-cash working capital (164,019) 24,681 4,104,102 ------------------------------------------------------------------------- Cash used in operating activities (4,002,349) (3,248,538) (92,207,197) ------------------------------------------------------------------------- INVESTING ACTIVITIES Purchase of property and equipment (3,349) (2,665) (817,093) Purchase of short-term investments (8,966) (137,187) (49,425,830) Redemption of short-term investments 3,930,000 4,000,000 47,081,746 Investment in BCY LifeSciences Inc. - - 464,602 Investment in Transition Therapeutics Inc. - - 2,532,343 ------------------------------------------------------------------------- Cash provided by (used in) investing activities 3,917,685 3,860,148 (164,232) ------------------------------------------------------------------------- FINANCING ACTIVITIES Proceeds from exercise of warrants and stock options 21,250 - 15,322,318 Proceeds from private placements - - 38,137,385 Proceeds from public offerings - 46,278,207 ------------------------------------------------------------------------- Cash provided by financing activities 21,250 - 99,737,910 ------------------------------------------------------------------------- Net increase (decrease) in cash and cash equivalents during the period (63,414) 611,610 7,366,481 Cash and cash equivalents, beginning of the period 7,429,895 6,715,096 - ------------------------------------------------------------------------- Cash and cash equivalents, end of the period 7,366,481 7,326,706 7,366,481 ------------------------------------------------------------------------- -------------------------------------------------------------------------
To view the 2009 First Quarter Report which includes the Consolidated Financial Statements, related Notes to Consolidated Financial Statements, and Management’s Discussion and Analysis, please see the Company’s first quarter 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 Phase I/II and Phase II human trials using REOLYSIN, its proprietary formulation of the human reovirus, alone and in combination with radiation or chemotherapy. 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 2009 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 May 5, 2009