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Press release from PR Newswire

YM BioSciences Reports Operational and Financial Results for the First Quarter of Fiscal 2012

Friday, November 11, 2011

YM BioSciences Reports Operational and Financial Results for the First Quarter of Fiscal 201207:00 EST Friday, November 11, 2011 MISSISSAUGA, ON, Nov. 11, 2011 /PRNewswire/ - YM BioSciences Inc. (NYSE Amex: YMI, TSX: YM), a drug development company advancing a diverse portfolio of hematology and cancer-related products, today reported operational and financial results for its first quarter of fiscal 2012, ended September 30, 2011. "During the quarter, we completed enrollment for the 166 patient Phase I/II trial of our JAK1/JAK2 inhibitor, CYT387, in myelofibrosis. We look forward to presenting updated data from this study at the American Society of Hematology meeting in December 2011," said Dr. Nick Glover, President and CEO of YM BioSciences. "CYT387 has already demonstrated clinically meaningful and durable responses across a range of once-daily doses. Furthermore, the favorable efficacy and safety profile we have observed to date provides us with substantial dosing flexibility.  In order to complement our promising once-daily clinical results, during the quarter we initiated a Phase II dose-escalation trial intended to determine the maximum tolerated dose of CYT387 when administered twice-daily at higher doses than previously tested." Financial Results (CDN dollars) The interim consolidated financial statements and comparative information for the first quarter of fiscal 2012 have been prepared, for the first time, in accordance with International Financial Reporting Standards ("IFRS"). Previously, the Company prepared its Interim and Annual Consolidated Financial Statements in accordance with Canadian Generally Accepted Accounting Principles ("Canadian GAAP") up to June 30, 2011. Revenue from out-licensing for the first quarter of fiscal 2012, ended September 30, 2012, was $0.3 million compared with $0.3 million for the first quarter of fiscal 2011. Net finance income increased by $11.3 million for the first quarter of fiscal 2012 compared to the first quarter of fiscal 2011. This change is primarily attributed to a change of $8.8 million in the fair value adjustment for USD warrants. Under IFRS, warrants denominated in a different currency than the Company's functional currency must be classified as a financial liability and measured at fair value, with changes reflected in profit or loss. For the first quarter of fiscal 2012, the Company incurred a gain of $5.4 million on the revaluation of warrants compared to a loss of $3.4 million for the first quarter of fiscal 2011.  Foreign exchange resulted in a gain of $2.0 million for the first quarter of fiscal 2012 compared to a loss of $0.4 million for the first quarter of fiscal 2011, due to the increased value of the U.S dollar. Licensing and product development expenses were $6.5 million for the first quarter of fiscal 2012 compared with $5.7 million for the first quarter of fiscal 2011. Increased development expenses for CYT387 and CYT997, and increased spending on database services and stock option expenses were offset by decreased expenses for nimotuzumab and a decrease in employee compensation costs related to restructuring costs incurred during the first quarter of the prior fiscal year. General and administrative expenses were $2.2 million for the first quarter of fiscal 2012 compared with $2.2 million for the first quarter of fiscal 2011. Increases in G&A employee stock option expenses were offset by decreases in travel and employee compensation costs. Net loss for the first quarter of fiscal 2012 was $0.9 million ($0.01 per share) compared to $11.3 million ($0.14 per share) for the same period last year. As at September 30, 2011 the Company had cash and short-term deposits totaling $75.6 million and accounts payables and accrued liabilities totaling $4.4 million compared to $79.7 million and $4.4 million respectively at June 30, 2011.  Management believes that the cash and short-term deposits at September 30, 2011 are sufficient to support the Company's activities for at least the next 18 months. As at September 30, 2011 the Company had 116,711,448 common shares and 7,366,418 warrants outstanding. Notice of Meeting YM's Annual and Special Meeting of Shareholders will be held on November 22, 2011, at 4:00 p.m. ET at the offices of Norton Rose OR LLP, Boardrooms A & B, 38th Floor, 200 Bay Street, Royal Bank Plaza South Tower, Toronto, Ontario. The management proxy circular documents and annual financial documents were mailed to shareholders on October 28th, 2011, and are available online at www.ymbiosciences.com, www.edgar.com and www.sedar.com. About YM BioSciences YM BioSciences Inc. is a drug development company advancing three products: CYT387, a small molecule, dual inhibitor of the JAK1/JAK2 kinases; nimotuzumab, an EGFR-targeting monoclonal antibody; and CYT997, a vascular disrupting agent (VDA). CYT387 is an orally administered inhibitor of both the JAK1 and JAK2 kinases, which have been implicated in a number of immune cell disorders including myeloproliferative neoplasms and inflammatory diseases as well as certain cancers. CYT387 is currently in a 166 patient Phase I/II trial in myelofibrosis that has completed enrollment, as well as a 60 patient Phase II BID trial that is recruiting patients. Nimotuzumab is a humanized monoclonal antibody targeting EGFR with an enhanced side-effect profile over currently marketed EGFR-targeting antibodies. Nimotuzumab is being evaluated in numerous Phase II and III trials worldwide. CYT997 is an orally-available small molecule therapeutic with dual mechanisms of vascular disruption and cytotoxicity, and has completed a Phase II trial in glioblastoma multiforme. In addition to YM's three products, the Company has several preclinical research programs underway with candidates from its library of novel compounds identified through internal research conducted at YM BioSciences Australia. This press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, 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 or the ability to obtain drug product in sufficient quantity or at standards acceptable to health regulatory authorities to complete clinical trials or to meet commercial demand; and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that CYT387, nimotuzumab and CYT997 will generate positive efficacy and safety data in ongoing and future clinical trials, and that YM and its various licensees will complete their respective clinical trials and disclose data within the timelines communicated in this release. Except as required by applicable securities laws, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. YM BIOSCIENCES INC. Condensed Consolidated Interim Statements of Financial Position (Expressed in Canadian dollars, unless otherwise noted) (Unaudited)                                           September 30,        June 30,        July 1,             2011        2011        2010                               Assets                                                           Current assets:                               Cash and cash equivalents           $  28,886,736     $   32,046,630     $   19,460,141   Short-term deposits             46,758,807        47,611,922        26,184,991   Accounts receivable             267,366        205,900        161,184   Prepaid expenses             555,964        731,676        237,962   Total current assets             76,468,873        80,596,128        46,044,278                               Non-current assets:                               Property and equipment             79,036        91,320        84,775   Intangible assets             6,010,694        7,137,698        11,645,714   Total non-current assets             6,089,730        7,229,018        11,730,489                               Total assets            $  82,558,603     $   87,825,146     $   57,774,767                               Liabilities and Equity                                                           Current liabilities:                               Accounts payable           $  1,856,916     $   1,718,893     $   699,277   Accrued liabilities              2,563,788        2,652,511        2,085,824   Share purchase warrants              9,115,942        14,476,681        6,358,480   Deferred revenue             594,072        594,072        1,523,916   Total current liabilities             14,130,718        19,442,157        10,667,497                               Non-current liabilities:                               Deferred revenue             1,683,204        1,831,722        1,650,909   Total non-current liabilities             1,683,204        1,831,722        1,650,909                               Equity:                               Share capital             264,586,651        264,548,643        203,498,239   Contributed surplus             16,194,158        15,144,062        14,232,353   Deficit             (214,036,128)        (213,141,438)        (172,274,231)   Total equity             66,744,681        66,551,267        45,456,361                               Total liabilities and equity            $  82,558,603     $   87,825,146     $   57,774,767 Approved by the Board and authorized for issue on November 10, 2011: (signed)                     (signed) Tryon Williams, Director                       David G.P. Allan, Director YM BIOSCIENCES INC. Condensed Consolidated Interim Statements of Comprehensive Income (Expressed in Canadian dollars, unless otherwise noted) (Unaudited)                                 Three months ended           September 30,           2011      2010                       Revenue:                       Out-licensing            $  250,728     $   342,356                       Expenses:                       Licensing and product development             6,487,847        5,692,056   General and administrative             2,160,148        2,212,412             8,647,995        7,904,468                       Loss before the undernoted             (8,397,267)         (7,562,112)                       Finance income              7,502,577        62,606 Finance costs             -        (3,818,731)                       Net loss for the period and comprehensive loss           $  (894,690)     $   (11,318,237)                       Basic and diluted loss per common share            $  (0.01)     $   (0.14)                   . YM BIOSCIENCES INC. Condensed Consolidated Interim Statements of Changes in Equity (Expressed in Canadian dollars, unless otherwise noted) (Unaudited)                                                           Share capital       Contributed                             Number      Amount      surplus      Deficit      Total                                               Balance, July 1, 2010            80,359,623     $   203,498,239     $   14,232,353     $   (172,274,231)     $   45,456,361                                               Net loss for the period            -        -        -        (11,318,237)        (11,318,237)                                               Transactions with owners of the                                               Company, recognized directly                                               in equity:                                                 Share-based compensation            -        -        636,052        -        636,052     Shares issued on exercise                                                   of options            30,000        24,207        (9,207)        -       15,000 Total transactions with owners                                               of the Company            30,000        24,207        626,845        -        651,052                                               Balance, September 30, 2010            80,389,623     $   203,522,446     $   14,859,198     $   (183,592,468)     $   34,789,176                                                                                                                                                       Share capital        Contributed                             Number      Amount      surplus      Deficit      Total                                               Balance, June 30, 2011            116,681,948     $   264,548,643     $   15,144,062     $   (213,141,438)     $   66,551,267                                               Net loss for the period            -        -        -        (894,690)        (894,690)                                               Transactions with owners of the                                               Company, recognized directly                                               in equity:                                                 Share-based compensation            -        -        1,065,654        -        1,065,654     Shares issued on exercise                                                   of options            29,500        38,008        (15,558)        -        22,450 Total transactions with owners                                               of the Company            29,500        38,008        1,050,096        -        1,088,104                                               Balance, September 30, 2011            116,711,448     $   264,586,651     $   16,194,158     $   (214,036,128)     $   66,744,681 YM BIOSCIENCES INC. Condensed Consolidated Interim Statements of Cash Flows (Expressed in Canadian dollars, unless otherwise noted) (Unaudited)                                     Three months ended             September 30,             2011          2010                         Cash provided by (used in):                                               Operating activities:                         Net loss for the period            $  (894,690)       $   (11,318,237)   Items not involving cash:                           Depreciation of property and equipment             16,584          19,358     Amortization of intangible assets             1,127,004          1,127,004     Interest earned             (154,476)          (55,635)     Unrealized (gain)/loss on cash and                             cash equivalents             (1,983,577)          408,708     Gain on disposal of property and                             equipment             -          (10,744)     Share-based compensation             1,065,654          636,052     Change in fair value of share                             purchase warrants             (5,360,739)          3,411,897   Changes in non-cash working capital balances:                           Short-term deposits             (165,305)          (39,843)     Accounts receivable             (61,466)          (4,823)     Prepaid expenses             175,712          113,534     Accounts payable             138,023          (6,087)     Accrued liabilities              (88,723)          897,162     Deferred revenue             (148,518)          (303,477)   Net cash used in operating activities             (6,334,517)          (5,125,131)                         Investing activities:                         Proceeds from sale of short-term deposits             1,818,420          28,651,676   Purchase of short-term deposits             (800,000)          (27,500,000)   Interest earned             154,476          55,635   Additions to property and equipment             (4,300)          (52,694)   Net cash provided by investing activities             1,168,596          1,154,617                         Financing activities:                         Issuance of common shares on exercise of options             22,450          15,000   Net cash provided by financing activities             22,450          15,000                         Impact of foreign exchange rates on cash             1,983,577          (408,708)                         Decrease in cash and cash equivalents             (3,159,894)          (4,364,222)                         Cash and cash equivalents, beginning of period             32,046,630          19,460,141                         Cash and cash equivalents, end of period            $  28,886,736       $  $ 15,095,919       SOURCE YM BioSciences Inc.For further information: <p> <b>Enquiries:</b> </p> <p align="justify"> James Smith<br/> VP Corporate Communications<br/> YM BioSciences Inc.<br/> Tel. +1 905.361.9518<br/> <a href="mailto:jsmith@ymbiosciences.com">jsmith@ymbiosciences.com</a> </p>