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Second Quarter Results YM BioSciences reports second quarter 2005 operational and financial results MISSISSAUGA, ON, Feb. 11 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM, AIM:YMBA), the cancer drug development company with an advanced-stage portfolio, today reported operational and financial results for the second quarter of fiscal 2005, ended December 31, 2004. "During the second quarter we significantly advanced both of the late-stage anti-cancer drugs in our portfolio. For tesmilifene, enrollment for our pivotal breast cancer trial continued as planned and we made significant progress towards broadening the market potential for this drug through partnerships and by targeting additional cancer indications," said David Allan, Chairman and CEO of YM BioSciences. "For TheraCIM hR3, our humanized monoclonal antibody that targets the EGF receptor, progress was made on numerous fronts; we announced clinical efficacy results from two cancer trials and trials in additional indications were initiated to broaden the market potential for this drug as well." Second Quarter Highlights: - Received regulatory approval to initiate a metastatic breast cancer trial for tesmilifene in combination with Taxotere(R). - Expanded the development program for tesmilifene into gastric cancer and into Asia, by partnering with Shin Poong (Seoul, Korea) subsequent to the end of the quarter. - Obtained Orphan Drug Status for TheraCIM hR3 for glioma by the FDA for the U.S. - Oncoscience AG, YM's European development partner, initiated a monotherapy trial for TheraCIM/Theraloc in metastatic pancreatic cancer. - YM's licensor, CIMAB, reported a 90.6% complete response from a randomized Phase II pivotal nasopharyngeal cancer trial using TheraCIM h-R3 in combination with radiation. - Achieved the clinical milestone in a Phase II trial using TheraCIM/Theraloc in pediatric glioma, being conducted by Oncoscience AG, permitting the initiation of a pivotal trial for the drug in this population. Anticipated milestones for the next quarter ending March 31, 2005: - Tesmilifene: initiate trial with Taxotere(R) - TheraCIM/Theraloc: initiate randomized trial in pediatric glioma - TheraCIM/Theraloc: start staged pivotal trial in adult glioma - TheraCIM: initiate pharmacodynamic study - Norelin(TM): data from Phase II extension trial Milestone targets for balance of calendar 2005: - Tesmilifene: complete recruitment Phase III metastatic breast cancer in Q3 - TheraCIM/Theraloc: complete recruitment Phase III glioma - Tesmilifene: complete recruitment Phase II Taxotere in metastatic breast cancer - Expand product pipeline Enrollment for the Company's tesmilifene breast cancer registration trial accelerated significantly in the second quarter. At the end of the quarter, by December 31st, 176 patients had been enrolled in the trial and as at February 10th, 240 patients had been enrolled from 16 countries in 50 of the 74 hospitals which are now open. YM continues to anticipate that enrollment of the 700 patients in the trial will be completed in calendar third quarter of 2005 and include some 90 hospitals in 20 countries. A chart showing enrollment and the numbers of sites active is available on YM BioSciences' website under "Products", then "Tesmilifene". If the enrolment target is met and survival results are similar to those from the initial tesmilifene Phase III trial, then the Company should be in position to submit tesmilifene for FDA approval in late calendar 2006 or early 2007 based on an interim analysis of data, as previously agreed to with the FDA through a Special Protocol Assessment. Financial Results Total revenue for the quarter ended December 31, 2004 was $521,524 compared to $53,156 for the same period last year. Total revenue for the first six months of the 2005 fiscal year was $989,998 compared to $104,763 for the first six months of the corresponding period last year. Revenue consisted of revenue generated from out-licensing agreements and interest revenue. Total expenditures for the quarter ended December 31, 2004 were $3,379,021 compared to $1,328,324 for the same period last year. Total expenditures for the first six months of the 2005 fiscal year were $5,960,757 compared to $2,216,002 for the first six months of the corresponding period last year. General and Administrative expenses for the quarter were $1,259,259 and for the first six months were $2,517,291 compared to $763,486 and $1,326,579 respectively for the same periods in the prior year. These increases were due principally to the expensing of employee stock options commencing on July 1, 2004 and the cost of obtaining a listing on AMEX. YM started trading on AMEX on October 1, 2004. Licensing and Product Development expenses were $2,119,762 for the second quarter and $3,443,466 for the first six months of the fiscal year compared to $564,838 for the quarter and $889,423 for the first six months of last year. Expenditure increases were due primarily to the ramp-up of the Phase III clinical trial for tesmilifene that commenced in March 2004. Net loss for the second quarter was $2,830,164 and for the year to date was $5,098,863 compared to $1,275,168 and $2,111,240 respectively for the same periods last year. As at December 31, 2004 the Company had cash and short-term deposits totaling $33,785,404 and current liabilities of $813,399 compared to $20,387,858 and $1,163,711 respectively at June 30, 2004. The Company anticipates that the current cash reserves will be sufficient to support its development program beyond the 2006 calendar year. Notice of TheraCIM/Theraloc Results Conference Call YM and Oncoscience AG will host a teleconference on data from their Phase II trial in children with brain cancer (glioma) presented at the European High-Grade Glioma Meeting immediately following that conference on Monday, February 28, 2005 at 1:00pm EST and may be accessed by calling +1-416-695-7860 (from Europe) or 1-800-565-5185 (in North America) and utilizing the participant code 261890. About YM BioSciences YM BioSciences Inc. is a cancer drug development company. Its lead drug, tesmilifene, is a small molecule chemopotentiator currently undergoing a 700-patient pivotal Phase III trial in metastatic and recurrent breast cancer. Published results from tesmilifene's first Phase III trial in the same indication demonstrated a substantial increase in survival for women treated with the combination of tesmilifene and chemotherapy compared to chemotherapy alone, demonstrating that tesmilifene significantly enhanced the therapeutic effect of chemotherapy. In addition to tesmilifene, the Company is developing TheraCIM h-R3, an EGFr humanized monoclonal antibody on which Phase II clinical data have recently been released in pediatric glioma and nasopharyngeal cancer, and for which Phase III IND applications have been filed. The Company also has a GnRH anti-cancer vaccine in that is in earlier stage clinical trials. Except for historical information, this press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting. Summary financial statements attached: YM BIOSCIENCES INC. (A DEVELOPMENT STAGE COMPANY) Consolidated Balance Sheet (Expressed in Canadian dollars) (Unaudited) ------------------------------------------------------------------------- December 31, June 30, 2004 2004 ------------------------------------------------------------------------- Assets Current assets: Cash and cash equivalents $ 33,785,404 $ 5,493,907 Short-term deposits - 14,893,951 Marketable securities 19,715 19,715 Accounts receivable and prepaid expenses 245,753 463,838 ----------------------------------------------------------------------- 34,050,872 20,871,411 Capital assets 12,365 11,381 ------------------------------------------------------------------------- $ 34,063,237 $ 20,882,792 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Liabilities and Shareholders' Equity Current liabilities: Accounts payable $ 693,056 $ 993,272 Accrued liabilities 120,343 170,439 ----------------------------------------------------------------------- 813,399 1,163,711 Shareholders' equity: Share capital 77,117,230 59,841,914 Share and unit purchase warrants 5,208,720 3,627,239 Contributed surplus 915,350 569,195 Deficit accumulated during the development stage (49,991,462) (44,319,267) ----------------------------------------------------------------------- 33,249,838 19,719,081 Commitments ------------------------------------------------------------------------- $ 34,063,237 $ 20,882,792 ------------------------------------------------------------------------- ------------------------------------------------------------------------- YM BIOSCIENCES INC. (A DEVELOPMENT STAGE COMPANY) Consolidated Statement of Operations (Expressed in Canadian dollars) (Unaudited) ------------------------------------------------------------------------- Three months ended Six months ended December 31, December 31, 2004 2003 2004 2003 ------------------------------------------------------------------------- Out-licencing revenue $ 300,488 $ - $ 661,866 $ - Interest income 221,036 53,156 328,132 104,762 ------------------------------------------------------------------------- 521,524 53,156 989,998 104,762 Expenses: General and administrative 1,259,259 763,486 2,517,291 1,326,579 Licensing and product development 2,119,762 564,838 3,443,466 889,423 ----------------------------------------------------------------------- 3,379,021 1,328,324 5,960,757 2,216,002 ------------------------------------------------------------------------- Loss before the undernoted (2,857,497) (1,275,168) (4,970,759) (2,111,240) Net loss on marketable securities - - - - Unrealized gain (loss) on foreign exchange 27,333 - (128,104) - ------------------------------------------------------------------------- Loss before income taxes (2,830,164) (1,275,168) (5,098,863) (2,111,240) Income taxes - - - - -------------------------------------------------------------------------- Loss for the period $ (2,830,164) $ (1,275,168) $ (5,098,863) $ (2,111,240) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Basic and diluted loss per common share $ (0.08) $ (0.07) $ (0.16) $ (0.12) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Weighted average number of common shares outstanding 35,125,107 17,418,892 31,906,888 17,430,393 ------------------------------------------------------------------------- ------------------------------------------------------------------------- ------------------------------- From inception on August 17, 1994 to December 31, 2004 ------------------------------- Out-licencing revenue $ 661,866 Interest income 3,116,550 ------------------------------- 3,778,416 Expenses: General and administrative 17,350,662 Licensing and product development 34,319,853 ----------------------------- 51,670,515 ------------------------------- Loss before the undernoted (47,892,099) Net loss on marketable securities (1,173,826) Unrealized gain (loss) on foreign exchange (128,104) ------------------------------- Loss before income taxes (49,194,029) Income taxes 7,300 ------------------------------- Loss for the period $(49,201,329) ------------------------------- ------------------------------- Basic and diluted loss per common share ------------------------------- ------------------------------- Weighted average number of common shares outstanding ------------------------------- ------------------------------- YM BIOSCIENCES INC. (A DEVELOPMENT STAGE COMPANY) Consolidated Statement of Deficit Accumulated During the Development Stage (Expressed in Canadian dollars) (Unaudited) ------------------------------------------------------------------------- Three months ended Six months ended December 31, December 31, 2004 2003 2004 2003 ------------------------------------------------------------------------- Deficit, beginning of period: As previously reported $(46,587,966) $(37,194,751) $(43,779,888) $(36,411,810) Adjustment to reflect change in accounting for employee stock options - (115,101) (539,379) (58,855) ----------------------------------------------------------------------- As restated (46,587,966) (37,309,852) (44,319,267) (36,470,665) Cost of purchasing shares for cancellation in excess of book value (573,332) (153,589) (573,332) (156,704) Loss for the period (2,830,164) (1,275,168) (5,098,863) (2,111,240) ------------------------------------------------------------------------- Deficit, end of period $(49,991,462) $(38,738,609) $(49,991,462) $(38,738,609) ------------------------------------------------------------------------- ------------------------------------------------------------------------- ------------------------------- From inception on August 17, 1994 to December 31, 2004 ------------------------------- Deficit, beginning of period: As previously reported $ - Adjustment to reflect change in accounting for employee stock options - ------------------------------- As restated - Cost of purchasing shares for cancellation in excess of book value (790,133) Loss for the period (49,201,329) ------------------------------- Deficit, end of period $(49,991,462) ------------------------------- ------------------------------- YM BIOSCIENCES INC. (A DEVELOPMENT STAGE COMPANY) Consolidated Statement of Cash Flows (Expressed in Canadian dollars) (Unaudited) ------------------------------------------------------------------------- Three months ended Six months ended December 31, December 31, 2004 2003 2004 2003 ------------------------------------------------------------------------- Cash provided by (used in): Operating activities: Loss for the period $ (2,830,164) $ (1,275,168) $ (5,098,863) $ (2,111,240) Items not involving cash: Depreciation 936 - 1,720 14,910 Gain on sale of marketable securities - - - - Unrealized loss on marketable securities - - - - Stock-based compensation 176,983 106,158 346,155 162,404 Change in non-cash operating working capital: Accounts receivable and prepaid expenses 163,382 45,585 218,085 74,187 Accounts payable and accrued liabilities (336,754) 209,680 (350,312) 179,614 ----------------------------------------------------------------------- (2,825,617) (913,745) (4,883,215) (1,680,125) Financing activities: Net proceeds from issuance of shares and warrants - 17,047,001 18,972,307 17,047,001 Exercise of options 43,650 - 91,067 - Redemption of preferred shares - - - - Purchase of shares for cancellation (779,909) (225,259) (779,909) (230,379) ----------------------------------------------------------------------- (736,259) 16,821,742 18,283,465 16,816,622 Investing activities: Maturity of short-term deposits - - 14,893,951 - Proceeds on sale of marketable securities - - - - Additions to capital assets (2,704) (1,565) (2,704) (3,724) ----------------------------------------------------------------------- (2,704) (1,565) 14,891,247 (3,724) ------------------------------------------------------------------------- Increase (decrease) in cash and cash equivalents (3,564,580) 15,906,432 28,291,497 15,132,773 Cash and cash equivalents, beginning of period 37,349,984 6,901,807 5,493,907 7,675,466 ------------------------------------------------------------------------- Cash and cash equivalents, end of period $ 33,785,404 $ 22,808,239 $ 33,785,404 $ 22,808,239 ------------------------------------------------------------------------- ------------------------------------------------------------------------- ------------------------------- From inception on August 17, 1994 to December 31, 2004 ------------------------------- Cash provided by (used in): Operating activities: Loss for the period $(49,201,329) Items not involving cash: Depreciation 260,667 Gain on sale of marketable securities (638,332) Unrealized loss on marketable securities 1,812,158 Stock-based compensation 915,350 Change in non-cash operating working capital: Accounts receivable and prepaid expenses (245,753) Accounts payable and accrued liabilities 813,399 ----------------------------- (46,283,840) Financing activities: Net proceeds from issuance of shares and warrants 80,964,645 Exercise of options 1,635,442 Redemption of preferred shares (2,630,372) Purchase of shares for cancellation (1,029,678) ----------------------------- 78,940,037 Investing activities: Maturity of short-term deposits - Proceeds on sale of marketable securities 1,402,239 Additions to capital assets (273,032) ----------------------------- 1,129,207 ------------------------------- Increase (decrease) in cash and cash equivalents 33,785,404 Cash and cash equivalents, beginning of period - ------------------------------- Cash and cash equivalents, end of period $ 33,785,404 ------------------------------- ------------------------------- For further information: James Smith, the Equicom Group Inc., Tel. (416) 815-0700 x 229, Fax (416) 815-0080, Email: jsmith(at)equicomgroup.com; YM BioSciences Inc., Tel. (905) 629-9761, Fax (905) 629-4959, Email: ir(at)ymbiosciences.com (YMBA YM. YMI) END

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