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Oncolytics Biotech(R) Inc. Announces 2009 Third Quarter Results

^{Published on 2009-11-05 04:36:07 - Market Wire}
 

 Selected Third Quarter Highlights: During the quarter, the Company announced: - Conclusion of patient enrollment in the Phase II component of the Company's U.K. REOLYSIN and paclitaxel/carboplatin clinical trial (REO 11); - Successful completion of the lyophilized (freeze-dried) formulation development program for REOLYSIN; - Successful completion of an initial 100-litre production run of REOLYSIN under cGMP conditions; - The grant of the Company's 32nd U.S. Patent, No. 7,582,289, entitled "Viruses for the Treatment of Cellular Proliferative Disorders" with the claims covering methods of using modified parapoxvirus orf virus to treat Ras-mediated cancers; - Acceleration of the warrant expiry date on warrants issued in connection with a financing completed in December 2008; and - The start of enrollment in a U.S. Phase 2 clinical trial using intravenous administration of REOLYSIN in combination with paclitaxel and carboplatin in patients with metastatic melanoma being conducted at the Cancer Therapy & Research Center at the University of Texas Health Science Center (CTRC). Latest Highlights Subsequent to quarter end, the Company announced: - An agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for the design of a Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers; - Acceleration of the warrant expiry date on warrants issued in connection with a financing completed in May 2009; - Grant of the Company's 33rd U.S. Patent, No. 7,608,257, entitled "Sensitization of Chemotherapeutic Agent Resistant Neoplastic Cells With a Virus." The patent claims cover methods of using reovirus in combination with currently approved chemotherapeutic agents to treat patients that are refractory to those chemotherapeutic agents alone; - The results of the two warrant expiry date acceleration programs for warrants issued and amended in December 2008 and issued in 2009, generating proceeds of approximately $14.9 million. Oncolytics Biotech Inc. CONSOLIDATED BALANCE SHEETS (unaudited) As at, September 30, December 31, 2009 2008 $ $ ------------------------------------------------------------------------- ASSETS Current Cash and cash equivalents 9,654,719 7,429,895 Short-term investments - 5,846,634 Accounts receivable 59,314 86,322 Prepaid expenses 306,926 179,668 ------------------------------------------------------------------------- 10,020,959 13,542,519 Capital assets 218,988 263,926 Intellectual property - 180,750 ------------------------------------------------------------------------- 10,239,947 13,987,195 ------------------------------------------------------------------------- ------------------------------------------------------------------------- LIABILITIES AND SHAREHOLDERS' EQUITY Current Accounts payable and accrued liabilities 3,116,394 4,534,111 ------------------------------------------------------------------------- Shareholders' equity Share capital Authorized: unlimited number of common shares Issued: 49,608,569 (December 31, 2008 - 43,830,748) 102,532,889 95,234,924 Warrants 4,755,846 3,425,110 Contributed surplus 13,377,964 13,349,801 Deficit (113,543,146) (102,556,751) ------------------------------------------------------------------------- 7,123,553 9,453,084 ------------------------------------------------------------------------- 10,239,947 13,987,195 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Oncolytics Biotech Inc. CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS (unaudited) Three Month Three Month Nine Month Period Period Period Ending Ending Ending September September September 30, 2009 30, 2008 30, 2009 $ $ $ ------------------------------------------------------------------------- Revenue Rights revenue - - - ------------------------------------------------------------------------- - - - ------------------------------------------------------------------------- Expenses Research and development 1,954,367 3,210,294 8,006,232 Operating 736,024 880,438 2,703,509 Stock based compensation 7,982 17,339 28,163 Foreign exchange loss/(gain) (16,793) 29,026 42,345 Amortization - intellectual property - 90,375 180,750 Amortization - property and equipment 15,772 11,853 49,612 ------------------------------------------------------------------------- 2,697,352 4,239,325 11,010,611 ------------------------------------------------------------------------- Loss before the following: 2,697,352 4,239,325 11,010,611 Interest income (3,360) (98,493) (24,216) Gain on sale of BCY LifeSciences Inc. - - - Loss on sale of Transition Therapeutics Inc. - - - ------------------------------------------------------------------------- Loss before income taxes 2,693,992 4,140,832 10,986,395 Future income tax recovery - - - ------------------------------------------------------------------------- Net loss and comprehensive loss for the period 2,693,992 4,140,832 10,986,395 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Basic and diluted loss per share 0.05 0.10 0.23 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Weighted average number of shares (basic and diluted) 49,465,849 41,180,748 46,942,128 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Cumulative from Nine Month inception Period on April 2, Ending 1998 to September September 30, 2008 30, 2009 $ $ ----------------------------------------------------------- Revenue Rights revenue - 310,000 ----------------------------------------------------------- - 310,000 ----------------------------------------------------------- Expenses Research and development 9,650,595 82,538,009 Operating 3,250,830 27,540,534 Stock based compensation 54,955 4,797,007 Foreign exchange loss/(gain) (20,059) 631,772 Amortization - intellectual property 271,125 3,615,000 Amortization - property and equipment 35,233 546,763 ----------------------------------------------------------- 13,242,679 119,669,085 ----------------------------------------------------------- Loss before the following: 13,242,679 119,359,085 Interest income (452,944) (6,558,221) Gain on sale of BCY LifeSciences Inc. - (299,403) Loss on sale of Transition Therapeutics Inc. - 2,156,685 ----------------------------------------------------------- Loss before income taxes 12,789,735 114,658,146 Future income tax recovery - (1,115,000) ----------------------------------------------------------- Net loss and comprehensive loss for the period 12,789,735 113,543,146 ----------------------------------------------------------- ----------------------------------------------------------- Basic and diluted loss per share 0.31 --------------------------------------------- --------------------------------------------- Weighted average number of shares (basic and diluted) 41,180,748 --------------------------------------------- --------------------------------------------- Oncolytics Biotech Inc. CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) Three Month Three Month Nine Month Period Period Period Ending Ending Ending September September September 30, 2009 30, 2008 30, 2009 $ $ $ ------------------------------------------------------------------------- OPERATING ACTIVITIES Net loss for the period (2,693,992) (4,140,832) (10,986,395) Deduct non-cash items Amortization - intellectual property - 90,375 180,750 Amortization - property and equipment 15,772 11,853 49,612 Stock based compensation 7,982 17,339 28,163 Other non-cash items - - - Net changes in non-cash working capital 60,253 (1,217,916) (1,517,967) ------------------------------------------------------------------------- (2,609,985) (5,239,181) (12,245,837) ------------------------------------------------------------------------- INVESTING ACTIVITIES Capital assets (1,325) (10,927) (4,674) Purchase of short-term investments - (62,435) - Redemption of short-term investments - 9,813,364 5,846,634 Investment in BCY LifeSciences Inc. - - - Investment in Transition Therapeutics Inc. - - - ------------------------------------------------------------------------- (1,325) 9,740,002 5,841,960 ------------------------------------------------------------------------- FINANCING ACTIVITIES Proceeds from exercise of warrants and stock options 342,570 - 715,835 Proceeds from acquisition of private company - 1,800,120 Proceeds from private placements - - - Proceeds from public offerings (59,893) - 6,112,746 ------------------------------------------------------------------------- 282,677 - 8,628,701 ------------------------------------------------------------------------- Increase (decrease) in cash and cash equivalents during the period (2,328,633) 4,500,821 2,224,824 Cash and cash equivalents, beginning of the period 11,893,352 8,179,341 7,429,895 ------------------------------------------------------------------------- Cash and cash equivalents, end of the period 9,654,719 12,680,162 9,654,719 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Cumulative from Nine Month inception Period on April 2, Ending 1998 to September September 30, 2008 30, 2009 $ $ ----------------------------------------------------------- OPERATING ACTIVITIES Net loss for the period (12,789,735) (113,543,146) Deduct non-cash items Amortization - intellectual property 271,125 3,615,000 Amortization - property and equipment 35,233 546,763 Stock based compensation 54,955 4,797,007 Other non-cash items - 1,383,537 Net changes in non-cash working capital (35,573) 2,750,154 ----------------------------------------------------------- (12,463,995) (100,450,685) ----------------------------------------------------------- INVESTING ACTIVITIES Capital assets (69,672) (818,418) Purchase of short-term investments (314,631) (49,416,864) Redemption of short-term investments 18,813,364 48,998,380 Investment in BCY LifeSciences Inc. - 464,602 Investment in Transition Therapeutics Inc. - 2,532,343 ----------------------------------------------------------- 18,429,061 1,760,043 ----------------------------------------------------------- FINANCING ACTIVITIES Proceeds from exercise of warrants and stock options - 16,016,903 Proceeds from acquisition of private company - 1,800,120 Proceeds from private placements - 38,137,385 Proceeds from public offerings - 52,390,953 ----------------------------------------------------------- - 108,345,361 ----------------------------------------------------------- Increase (decrease) in cash and cash equivalents during the period 5,965,066 9,654,719 Cash and cash equivalents, beginning of the period 6,715,096 - ----------------------------------------------------------- Cash and cash equivalents, end of the period 12,680,162 9,654,719 ----------------------------------------------------------- -----------------------------------------------------------