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YM BIOSCIENCES REPORTS FISCAL YEAR END 2009 OPERATIONAL AND FINANCIAL RESULTS


//health-fitness.news-articles.net/content/2009/ .. -end-2009-operational-and-financial-results.html
Published in Health and Fitness on Friday, September 25th 2009 at 4:05 GMT by Market Wire   Print publication without navigation


 - Daiichi Sankyo Co., Ltd., CIMYM's licensee for nimotuzumab in Japan, and YM's licensee in Korea, Kuhnil Pharmaceutical Co., are currently collaborating on a Phase II randomized, open-label trial they are conducting that is evaluating nimotuzumab plus irinotecan compared to irinotecan alone in patients with advanced or recurrent gastric cancer refractory to 5-FU-containing regimens which is designed to complete recruitment in calendar 2009. Daiichi has also launched a Phase II trial in first-line NSCLC bringing to three the number of NSCLC indications being investigated by our direct consortium. - Randomized, Phase II, double-blind trials in brain metastases from non-small cell lung cancer (NSCLC) and in NSCLC patients ineligible for radical chemotherapy were initiated in Canada; recruitment commenced in March 2009 for NSCLC and in September for the brain metastases trial. A Phase II, second-line, single-arm trial in children with progressive diffuse intrinsic pontine glioma (DIPG) is ongoing at multiple sites in the US, Canada, and Israel. - Oncoscience AG (OSAG), CIMYM's licensee for Europe, reports that it continues to recruit for a Phase III trial in adult glioma and a Phase II/III trial in pancreatic cancer. - Innogene Kalbiotech PTE Ltd. (IGK), a subsidiary of Kalbe Farma, the largest public Southeast Asian pharmaceutical company and a CIMYM licensee, reported marketing approval in the Philippines and Indonesia, bringing to 21 the number of countries that are now reported as having approved the drug for sale in specific indications. In January 2009, the National Cancer Centre of Singapore announced that it was launching a worldwide Phase III, 710-patient trial of nimotuzumab in the adjuvant setting in head and neck cancer in cooperation with IGK. This trial is in addition to the on-going investigator-initiated Phase II trial in locally advanced head and neck cancer and the initiation of a Phase II trial in cervical cancer. - Subsequent to the end of the fiscal year, YM received a license from the US Department of the Treasury's Office of Foreign Assets Control (OFAC) to further develop its lead product, nimotuzumab, for patients in the United States. YM's first priority is discussion with the FDA on its two IND submissions to include US citizens in the randomized, double-blind Phase II trial of nimotuzumab in NSCLC patients ineligible for radical chemotherapy and the parallel Phase II trial in patients with brain metastases from NSCLC, both of which YM initiated in Canada during the 2009 fiscal year. Development plans may also include extending one of the Phase III trials being conducted worldwide into the US, such as the multinational 710-patient Phase III trial of nimotuzumab in the adjuvant setting in head and neck cancer. 
 YM BIOSCIENCES INC. Consolidated Balance Sheets (Expressed in Canadian dollars, unless otherwise noted) June 30, 2009 and 2008 ------------------------------------------------------------------------- 2009 2008 ------------------------------------------------------------------------- Assets Current assets: Cash $ 2,337,716 $ 3,119,189 Short-term deposits 39,713,042 54,981,737 Accounts receivable 564,584 403,371 Prepaid expenses 352,850 375,133 ----------------------------------------------------------------------- 42,968,192 58,879,430 Property and equipment 96,876 128,400 Intangible assets 3,004,868 4,065,409 ------------------------------------------------------------------------- $ 46,069,936 $ 63,073,239 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Liabilities and Shareholders' Equity Current liabilities: Accounts payable $ 431,028 $ 307,588 Accrued liabilities 486,723 1,715,024 Deferred revenue 2,549,568 4,623,340 ----------------------------------------------------------------------- 3,467,319 6,645,952 Deferred revenue 2,898,292 4,414,256 Shareholders' equity: Share capital 172,921,153 172,921,153 Share purchase warrants - 3,150,539 Contributed surplus 13,035,123 9,123,824 Deficit (146,251,951) (133,182,485) ----------------------------------------------------------------------- 39,704,325 52,013,031 Basis of presentation Commitments ------------------------------------------------------------------------- $ 46,069,936 $ 63,073,239 ------------------------------------------------------------------------- ------------------------------------------------------------------------- YM BIOSCIENCES INC. Consolidated Statements of Operations and Comprehensive Loss and Deficit (Expressed in Canadian dollars, unless otherwise noted) ------------------------------------------------------------------------- Years ended June 30, 2009 2008 2007 ------------------------------------------------------------------------- Out-licensing revenue $ 4,543,280 $ 4,859,085 $ 4,407,890 Interest income 1,070,264 2,584,080 3,239,540 ------------------------------------------------------------------------- 5,613,544 7,443,165 7,647,430 Expenses: Licensing and product development 14,172,845 15,631,550 28,758,469 General and administrative 4,839,870 6,831,955 6,978,336 Impairment of intangible assets - - 1,829,538 ----------------------------------------------------------------------- 19,012,715 22,463,505 37,566,343 ------------------------------------------------------------------------- Loss before the undernoted (13,399,171) (15,020,340) (29,918,913) Gain (loss) on foreign exchange 67,075 32,463 (142,552) Gain (loss) on short-term deposits (40,200) 172,276 - Loss on disposal of property and equipment - (70,143) - Other income 307,140 - - ------------------------------------------------------------------------- Loss before income taxes (13,065,156) (14,885,744) (30,061,465) Current income taxes 4,310 - 1,668,775 ------------------------------------------------------------------------- Loss and comprehensive loss for the year (13,069,466) (14,885,744) (31,730,240) Deficit, beginning of year (133,182,485) (118,296,741) (86,566,501) ------------------------------------------------------------------------- Deficit, end of year $(146,251,951) $(133,182,485) $(118,296,741) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Basic and diluted loss per common share $ (0.23) $ (0.27) $ (0.57) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Weighted average number of common shares outstanding 55,835,356 55,835,356 55,804,674 Excludes common shares held in escrow for contingent additional payment related to the acquisition of Delex Therapeutics Inc. 2,380,953 2,380,953 2,380,953 ------------------------------------------------------------------------- ------------------------------------------------------------------------- YM BIOSCIENCES INC. Consolidated Statements of Cash Flows (Expressed in Canadian dollars, unless otherwise noted) ------------------------------------------------------------------------- Years ended June 30, 2009 2008 2007 ------------------------------------------------------------------------- Cash provided by (used in): Operating activities: Loss for the year $ (13,069,466) $ (14,885,744) $ (31,730,240) Items not involving cash: Amortization of property and equipment 91,896 125,271 107,107 Amortization of intangible assets 1,060,541 1,060,541 1,913,040 Impairment of intangible assets - - 1,829,538 Loss on disposal of property and equipment - 70,143 - Unrealized loss on short-term deposits 41,912 - - Stock-based compensation 760,760 2,063,973 1,716,913 Change in non-cash operating working capital: Accounts receivable and prepaid expenses (138,930) (61,483) 1,816,092 Accounts payable, accrued liabilities and deferred revenue (4,694,597) (5,844,790) 11,604,460 ----------------------------------------------------------------------- (15,947,884) (17,472,089) (12,743,090) Financing activities: Issuance of common shares on exercise of options - - 11,232 Issuance of common shares on exercise of warrants - - 89,375 ----------------------------------------------------------------------- - - 100,607 Investing activities: Short-term deposits, net 15,226,783 14,742,701 15,881,679 Additions to property and equipment (60,372) (37,770) (127,162) Proceeds from sale of property and equipment - 38,996 - ----------------------------------------------------------------------- 15,166,411 14,743,927 15,754,517 ------------------------------------------------------------------------- Increase (decrease) in cash and cash equivalents (781,473) (2,728,162) 3,112,034 Cash and cash equivalents, beginning of year 3,119,189 5,847,351 2,735,317 ------------------------------------------------------------------------- Cash and cash equivalents, end of year $ 2,337,716 $ 3,119,189 $ 5,847,351 ------------------------------------------------------------------------- ------------------------------------------------------------------------- 

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