MISSISSAUGA, ON, Nov. 14 /PRNewswire-FirstCall/ - YM BioSciences Inc. , the cancer product development company, today reported operational and financial results for the first quarter of fiscal 2006, ended September 30, 2005.
“Highlighting the quarter, we completed enrolment of the 700 patient pivotal trial for our lead drug tesmilifene for the treatment of metastatic and recurrent breast cancer. The first of three planned interim analyses of data from this trial will occur in mid calendar 2006 with the others expected during the balance of the year. If survival results in this pivotal trial are similar to those in the same patient population of the first tesmilifene Phase III trial then, through a Special Protocol Assessment agreed to with the FDA, the data could be sufficient to lead to marketing approval as early as 2007,” said David Allan, Chairman and CEO of YM BioSciences.
Other highlights: - Reported results in the November 2005 issue of the Journal of Urology from a Phase II trial of tesmilifene plus mixantrone/prednisone for the treatment of hormone refractory prostate cancer. The addition of tesmilifene produced a prostate specific antigen (PSA) decrease of greater than 50% in the majority of patients and yielded a two-year survival rate of 21% which compares favorably with historical outcomes. - YM partner, Oncoscience AG, reported updated data from a Phase II monotherapy trial of nimotuzumab in children with resistant or relapsed brain cancers. Nimotuzumab produced evidence of a survival benefit in children and demonstrated strong anti-tumour activity, and did not produce the toxicities of rash and diarrhea, normally associated with other drugs in this class. YM proposes to apply for an IND for a pivotal trial in children with recurrent brain cancer which could complete recruitment in 2006. YM recently received clearance to initiate a multi-center Phase I/II trial comparing the effects of the combination of nimotuzumab with radiation against radiation alone in patients with nonsmall-cell lung cancer unfit for chemotherapy. The drug is also undergoing a Phase II monotherapy trial in Europe in patients with advanced metastatic pancreatic cancer. - Received clearance to initiate a Phase IIb trial for AeroLEF(TM). The trial is expected to complete recruitment in the first calendar quarter of 2006 and report results in the following quarter. A Phase III trial is planned for 2006 subject to Phase II data. - Presented positive clinical trial results for its anti-GnRH prostate cancer vaccine, Norelin(TM) in hormone sensitive prostate cancer (HSPC). - Entered into an exclusive worldwide license agreement with the University of Saskatchewan for a portfolio of small molecule compounds that appear to be highly potent enhancers of the activities of existing chemotherapeutic treatments. Financial Results
Total revenue for the quarter ended September 30, 2005 was $243,007 compared to $468,474 for the same period last year. Revenue consisted of revenue generated from out-licensing agreements and interest revenue.
Total expenditures for the quarter ended September 30, 2005 were $6,203,908 compared to $2,581,736 for the same period last year. General and administrative expenses for the first quarter of the fiscal year were $1,427,899 compared to $1,258,032 for the same period in the prior year. Licensing and product development expenses were $4,766,009 for the first quarter of the fiscal year compared to $1,323,704 for the first quarter of last year due mainly to the rapid increase in recruitment for the tesmilifene pivotal Phase III clinical trial.
Net loss for the fiscal first quarter was $5,923,846 compared to $2,268,699 for the same period last year.
As at September 30, 2005 the Company had cash and short-term deposits totaling $24,914,798 and current liabilities of $3,305,300 compared to $30,568,845 and $3,825,615 respectively at June 30, 2005.
About YM BioSciences
YM BioSciences Inc. is a cancer product development company. Its lead drug, tesmilifene, is a small molecule chemopotentiator effective in enhancing all known classes of chemotherapies currently used to treat cancer. YM BioSciences recently completed enrolment in its 700 patient pivotal trial of tesmilifene for the treatment of rapidly progressing metastatic and recurrent breast cancer. An analysis of overall survival in a two-thirds majority subgroup of patients enrolled in a previous Phase III trial demonstrated that tesmilifene extended median survival in a similar patient population from 12.2 months to 29.7 months (143%; p equals 0.0016). If survival results in the ongoing pivotal trial are similar to those in the first tesmilifene Phase III trial then, through a Special Protocol Assessment agreed to with the FDA, the data could be sufficient to seek regulatory approval. The first of three planned interim analyses of data from this pivotal trial is expected occur in mid calendar 2006.
In addition to tesmilifene, YM BioSciences is developing nimotuzumab, an anti-EGFr humanized monoclonal antibody, in a number of indications. A Phase II monotherapy trial of nimotuzumab produced cytotoxic effect and evidence of survival benefit in children with brain cancer. YM BioSciences is also developing its anti-GnRH, anti-cancer vaccine, Norelin(TM), for which Phase II data have been released. In May 2005, the Company acquired DELEX Therapeutics Inc., a private clinical stage biotechnology company developing AeroLEF(TM), a unique inhalation delivered formulation of the established drug, fentanyl, to treat acute pain including cancer pain. This product has completed a Phase IIa trial with positive results and randomized a Phase IIb pain trial has been cleared to start. The Company also has a broad portfolio of preclinical compounds shown to act as chemopotentiators while protecting normal cells.
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.
YM BIOSCIENCES INC. (A DEVELOPMENT STAGE COMPANY) Interim Consolidated Balance Sheets (Expressed in Canadian dollars) ------------------------------------------------------------------------- ------------------------------------------------------------------------- September 30, June 30, 2005 2005 ------------------------------------------------------------------------- (Unaudited) Assets Current assets: Cash and cash equivalents $ 24,914,798 $ 686,373 Short-term deposits - 29,882,472 Marketable securities 4,834 4,834 Accounts receivable and prepaid expenses 2,000,422 1,751,373 ----------------------------------------------------------------------- 26,920,054 32,325,052 Capital assets 220,765 226,698 Acquired technologies 6,981,897 5,648,141 ------------------------------------------------------------------------- $ 34,122,716 $ 38,199,891 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Liabilities and Shareholders’ Equity Current liabilities: Accounts payable $ 2,515,503 $ 2,995,457 Accrued liabilities 789,797 830,158 ----------------------------------------------------------------------- 3,305,300 3,825,615 Deferred revenue 887,440 534,157 Shareholders’ equity: Share capital 89,214,586 87,487,802 Share purchase warrants 5,313,283 5,313,283 Contributed surplus 2,077,847 1,790,928 Deficit accumulated during the development stage (66,675,740) (60,751,894) ----------------------------------------------------------------------- 29,929,976 33,840,119 Going concern Commitments Subsequent event ------------------------------------------------------------------------- $ 34,122,716 $ 38,199,891 ------------------------------------------------------------------------- ------------------------------------------------------------------------- YM BIOSCIENCES INC. (A DEVELOPMENT STAGE COMPANY) Interim Consolidated Statements of Operations (Expressed in Canadian dollars) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Period from inception on August 17, Three months ended 1994 to September 30, September 30, 2005 2004 2005 ------------------------------------------------------------------------- (Unaudited) (Unaudited) Revenue $ 88,508 $ 361,378 $ 836,528 Interest income 154,499 107,096 3,646,790 ------------------------------------------------------------------------- 243,007 468,474 4,483,318 Expenses: General and administrative 1,427,899 1,258,032 22,575,628 Licensing and product development 4,776,009 1,323,704 46,634,346 ----------------------------------------------------------------------- 6,203,908 2,581,736 69,209,974 ------------------------------------------------------------------------- Loss before the undernoted (5,960,901) (2,113,262) (64,726,656) Unrealized gain (loss) on foreign exchange 37,055 (155,437) 37,055 Unrealized loss on marketable securities - - (1,827,038) Gain on sale of marketable securities - - 638,332 ------------------------------------------------------------------------- Loss before income taxes (5,923,846) (2,268,699) (65,878,307) Income taxes - - 7,300 ------------------------------------------------------------------------- Loss for the period $ (5,923,846) $ (2,268,699) $(65,885,607) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Basic and diluted loss per common share $ (0.15) $ (0.08) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Weighted average number of common shares outstanding, excluding 2,380,953 common shares held in escrow for contingent additional payment related to the Delex acquisition 38,788,715 28,689,212 ------------------------------------------------------------------------- ------------------------------------------------------------------------- YM BIOSCIENCES INC. (A DEVELOPMENT STAGE COMPANY) Interim Consolidated Statements of Deficit Accumulated During the Development Stage (Expressed in Canadian dollars) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Period from inception on August 17, Three months ended 1994 to September 30, September 30, 2005 2004 2005 ------------------------------------------------------------------------- (Unaudited) (Unaudited) Deficit, beginning of period $(60,751,894) $(44,319,267) $ - Cost of purchasing shares for cancellation in excess of book value - - (790,133) Loss for the period (5,923,846) (2,268,699) (65,885,607) ------------------------------------------------------------------------- Deficit, end of period $(66,675,740) $(46,587,966) $(66,675,740) ------------------------------------------------------------------------- ------------------------------------------------------------------------- YM BIOSCIENCES INC. (A DEVELOPMENT STAGE COMPANY) Interim Consolidated Statements of Cash Flows (Expressed in Canadian dollars) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Period from inception on August 17, Three months ended 1994 to September 30, September 30, 2005 2004 2005 ------------------------------------------------------------------------- (Unaudited) (Unaudited) Cash provided by (used in): Operating activities: Loss for the period $ (5,923,846) $ (2,268,699) $(65,885,607) Items not involving cash: Depreciation of capital assets 12,564 784 283,228 Amortization of acquired technologies 228,528 - 366,288 Gain on sale of marketable securities - - (638,332) Unrealized loss on marketable securities - - 1,827,039 Stock-based employee compensation 286,919 169,172 2,135,069 Stock-based consideration 100,000 - 292,750 Change in non-cash operating working capital: Accounts receivable and prepaid expenses (249,049) 54,703 (1,080,803) Accounts payable, accrued liabilities and deferred revenue (265,032) (13,558) 3,294,895 ----------------------------------------------------------------------- (5,809,916) (2,057,598) (59,405,473) Financing activities: Net proceeds on issuance of shares and share warrants - 18,972,307 80,654,111 Repayment of debenture - - (1,469,425) Issue of common shares on exercise of options 162,500 47,417 1,816,193 Issue of common shares on exercise of warrants - - 654,750 Redemption of preferred shares - - (2,630,372) Repurchase of common shares - - (1,029,679) ----------------------------------------------------------------------- 162,500 19,019,724 77,995,578 Investing activities: Additions to capital assets (6,631) - (303,993) Short-term deposits, net 29,882,472 14,893,951 - Proceeds on sale of marketable securities - - 1,402,239 ----------------------------------------------------------------------- 29,875,841 14,893,951 1,098,246 ------------------------------------------------------------------------- Increase in cash and cash equivalents 24,228,425 31,856,077 19,688,351 Cash assumed on purchase of Delex - - 5,226,447 Cash and cash equivalents, beginning of period 686,373 5,493,907 - ------------------------------------------------------------------------- Cash and cash equivalents, end of period $ 24,914,798 $ 37,349,984 $ 24,914,798 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Supplemental cash flow information: Non-cash items: Issuance of 396,825 shares from escrow on Delex acquisition $ 1,464,284 $ - $ 11,326,981 Issuance of 26,316 common shares in exchange for licensed patents 100,000 - 100,000 ------------------------------------------------------------------------- -------------------------------------------------------------------------
YM BioSciences Inc.
CONTACT: Enquiries: James Smith, the Equicom Group Inc., Tel. (416)815-0700 x 229, Fax (416) 815-0080, Email: jsmith@equicomgroup.com; YMBioSciences Inc., Tel. (905) 629-9761, Fax (905) 629-4959, Email:ir@ymbiosciences.com
