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Press release from CNW Group

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

Thursday, February 09, 2012

YM BioSciences Reports Operational and Financial Results for the Second Quarter of Fiscal 201207:03 EST Thursday, February 09, 2012MISSISSAUGA, ON, Feb. 9, 2012 /CNW/ - 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 second quarter of fiscal 2012, ended December 31, 2011."JAK inhibitors may ultimately prove valuable in the treatment of a wide range of blood disorders, cancers and inflammatory diseases, representing an immense opportunity for this emerging drug class. We recently reported multicenter data for our lead JAK inhibitor, CYT387, establishing its competitive safety and efficacy profile in patients with myelofibrosis," said Dr. Nick Glover, President and CEO of YM BioSciences. "The strength of our data positions us well to select the optimal course to further advance this opportunity."Updated results from the Phase I/II study of CYT387 in 166 patients with myelofibrosis were presented in a poster session at the 53rd Annual Meeting of the American Society of Hematology held in San Diego in December 2011. CYT387 demonstrated an  ability to render and maintain anemic myelofibrosis patients transfusion independent for clinically-relevant periods while also producing significant and durable improvements in their splenomegaly and constitutional symptoms. CYT387 was generally safe and well tolerated in myelofibrosis patients for dosing periods up to and exceeding two years, with minimal treatment-related myelosuppression observed.Financial Results (CDN dollars)The interim consolidated financial statements and comparative information for the second quarter of fiscal 2012 have been prepared in accordance with International Financial Reporting Standards ("IFRS"). Previously, up to June 30, 2011, the Company prepared its Interim and Annual Consolidated Financial Statements in accordance with Canadian Generally Accepted Accounting Principles ("Canadian GAAP").Revenue from out-licensing for the second quarter of fiscal 2012, ended December 31, 2011, was $0.4 million compared with $0.3 million for the second quarter of fiscal 2011. Revenue from out-licensing for the first six months of fiscal 2012 was $0.6 million and comparable to $0.6 million for the first six months of fiscal 2011.Net finance income was $1.5 million for the second quarter of fiscal 2012 compared to net finance costs of $4.6 million for the second quarter of fiscal 2011. Net finance income was $9.0 million for the first six months of fiscal 2012 compared to net finance costs of $8.3 million for the first six months of fiscal 2011. 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. The change in net finance income during the second fiscal quarter is primarily attributed to a change of $6.0 million in the fair value adjustment for USD warrants. For the first six months of fiscal 2012, the Company incurred a gain of $7.3 million compared to a loss of $7.5 million for the six months ended December 31, 2010 on the revaluation of warrants.Licensing and product development expenses were $7.3 million for the second quarter of fiscal 2012 compared with $5.2 million for the second quarter of fiscal 2011. Licensing and product development expenses were $13.7 million for the first six months of fiscal 2012 compared with $10.9 million for the first six months of fiscal 2011. Development expenses for CYT387 increased due to the expansion of the Phase I/II clinical trial in myelofibrosis, start-up costs associated with the BID (twice-daily dosing) study, pre-clinical development activities, and manufacturing of drug for these programs. Expenses for nimotuzumab continued to decrease.General and administrative expenses were $1.2 million for the second quarter of fiscal 2012 compared to $2.7 million for the second quarter of fiscal 2011. General and administrative expenses were $3.3 million for the first six months of fiscal 2012 compared to $5.0 million for the first six months of fiscal 2011, primarily due to severance and restructuring costs in 2010.Net loss for the second quarter of fiscal 2012 was $6.6 million ($0.06 per share) compared to $12.3 million ($0.14 per share) for the same period last year.As at December 31, 2011 the Company had cash and short-term deposits totaling $67.9 million and accounts payables and accrued liabilities totaling $3.7 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 December 31, 2011 are sufficient to support the Company's activities for at least the next 18 months.As at December 31, 2011 the Company had 116,711,448 common shares and 7,366,418 warrants outstanding.About YM BioSciencesYM 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. Positive interim results have been reported from a Phase I/II trial of CYT387 in 166 patients with myelofibrosis. This trial has completed enrollment while a 60 patient Phase II twice-daily dose escalation trial is currently 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)     December 31, 2011 June 30,2011July 1,2010AssetsCurrent assets:   Cash and cash equivalents  $ 21,538,285 $ 32,046,630 $ 19,460,141   Short-term deposits  46,410,762 47,611,922 26,184,991   Accounts receivable  284,435 205,900 161,184   Prepaid expenses  491,612 731,676 237,962   Total current assets 68,725,094 80,596,128 46,044,278Non-current assets:   Property and equipment   68,406 91,320 84,775   Intangible assets  4,883,690 7,137,698 11,645,714   Total non-current assets 4,952,096 7,229,018 11,730,489    Total assets $ 73,677,190 $ 87,825,146 $ 57,774,767Liabilities and EquityCurrent liabilities:   Accounts payable $ 1,537,001 $ 1,718,893 $ 699,277   Accrued liabilities  2,170,038 2,652,511 2,085,824   Share purchase warrants  7,212,460 14,476,681 6,358,480   Deferred revenue  594,072 594,072 1,523,916   Total current liabilities 11,513,571 19,442,157 10,667,497Non-current liabilities:   Deferred revenue  1,534,686 1,831,722 1,650,909   Total non-current liabilities 1,534,686 1,831,722 1,650,909Equity:   Share capital   264,586,651 264,548,643 203,498,239   Contributed surplus  16,636,188 15,144,062 14,232,353   Deficit (220,593,906) (213,141,438) (172,274,231)   Total equity 60,628,933 66,551,267 45,456,361    Total liabilities and equity $ 73,677,190 $ 87,825,146 $ 57,774,767Approved by the Board and authorized for issue on February 8, 2012:Tryon Williams, DirectorDavid G.P. Allan, DirectorYM BIOSCIENCES INC.Condensed Consolidated Interim Statements of Comprehensive Income(Expressed in Canadian dollars, unless otherwise noted)(Unaudited)    Three months endedDecember 31,Six months endedDecember 31, 2011201020112010Revenue:       Out-licensing   $ 380,117 $ 251,417 $ 630,845 $ 593,773Expenses:       Licensing and product development  7,260,481 5,246,698 13,748,328 10,938,754   General and administrative  1,154,883 2,742,199 3,315,031 4,954,611 8,415,364 7,988,897 17,063,359 15,893,365Loss before the undernoted  (8,035,247) (7,737,480) (16,432,514) (15,299,592)Finance income  2,058,174 86,892 8,980,046  149,498Finance costs  (580,705) (4,679,605) - (8,498,335)Other income  - 24,916  - 24,916     Net loss for the period and comprehensive loss  $ (6,557,778) $ (12,305,277) $ (7,452,468) $ (23,623,513)Basic and diluted loss per common share  $ (0.06) $ (0.14) $ (0.06) $ (0.29)YM BIOSCIENCES INC.Condensed Consolidated Interim Statements of Changes in Equity(Expressed in Canadian dollars, unless otherwise noted)(Unaudited) Share capitalContributed   Number Amount surplus Deficit TotalBalance, July 1, 2010 80,359,623 $ 203,498,239 $ 14,232,353 $ (172,274,231) $ 45,456,361Net loss for the period - - - (23,623,513) (23,623,513)Transactions with owners of the Company,recognized directly in equity:        Share-based compensation - - 1,044,198 - 1,044,198   Shares issued on exercise of options 319,309 425,589 (171,780) - 253,809   Shares issued on exercise of warrants 527,343 1,599,312 - - 1,599,312   Shares issued pursuant to prospectus offering 28,750,000 43,334,523 - - 43,334,523Total transactions with owners of the Company 29,596,652 45,359,424 872,418 - 46,231,842Balance, December 31, 2010 109,956,275 $ 248,857,663 $ 15,104,771 $ (195,897,744) $ 68,064,690       Share capital Contributed   NumberAmountsurplus DeficitTotalBalance, June 30, 2011 116,681,948 $ 264,548,643 $ 15,144,062 $ (213,141,438) $ 66,551,267Net loss for the period - - - (7,452,468) (7,452,468)Transactions with owners of the Company,recognized directly in equity:        Share-based compensation - - 1,507,684 - 1,507,684   Shares issued on exercise of options 29,500 38,008 (15,558) - 22,450Total transactions with owners of the Company 29,500 38,008 1,492,126 - 1,530,134Balance, December 31, 2011 116,711,448 $ 264,586,651 $ 16,636,188 $ (220,593,906) $ 60,628,933 YM BIOSCIENCES INC.Condensed Consolidated Interim Statements of Cash Flows(Expressed in Canadian dollars, unless otherwise noted)(Unaudited)      Three months endedDecember 31,  Six months ended  December 31,     2011  2010  2011  2010Cash provided by (used in):            Operating activities:                 Net loss for the period   $  (6,557,778) $  (12,305,277) $  (7,452,468) $  (23,623,513)     Items not involving cash:                    Depreciation of property and equipment    16,550   19,789   33,134   39,147        Amortization of intangible assets    1,127,004   1,127,004   2,254,008   2,254,008        Interest earned    (154,692)   (82,740)   (309,168)   (138,375)        Unrealized (gain) loss on cash and cash equivalents    576,919   601,654   (1,406,658)   1,010,362        Gain on disposal of property and equipment    -   -   -   (10,744)        Share-based compensation    442,030   408,145   1,507,684   1,044,198        Change in fair value of share purchase warrants    (1,903,482)   4,076,077   (7,264,221)   7,487,973  Changes in non-cash working capital balances:                    Short-term deposits    (139,972)   (66,524)   (305,277)   (106,367)        Accounts receivable     (17,069)   (37,156)   (78,535)   (41,979)        Prepaid expenses    64,352   (370,250)   240,064   (256,716)        Accounts payable    (319,915)   718,772   (181,892)   712,684        Accrued liabilities     (393,750)   631,723   (482,473)   1,528,885        Deferred revenue    (148,518)   (148,518)   (297,036)   (451,995)  Net cash used in operating activities    (7,408,321)   (5,427,301)    (13,742,838)   (10,552,432)Investing activities:              Proceeds from sale of short-term deposits    33,988,017   20,202,541    35,806,437   48,854,217  Purchase of short-term deposits    (33,500,000)   (48,514,540)   (34,300,000)   (76,014,540)  Interest earned    154,692   82,740    309,168   138,375  Additions to property and equipment    (5,920)   -   (10,220)   (52,694)  Net cash provided by (used in) investing activities   636,789   (28,229,259)   1,805,385   (27,074,642)Financing activities:              Issuance of common shares on exercise of options    -   238,809   22,450   253,809  Issue of common shares on exercise warrants    -   850,159   -   850,159  Net proceeds from issuance of shares    -   43,334,523    -   43,334,523  Net cash provided by financing activities    -   44,423,491   22,450   44,438,491Impact of foreign exchange rates on cash    (576,919)   (601,654)   1,406,658   (1,010,362)Increase (decrease) in cash and cash equivalents    (7,348,451)   10,165,277   (10,508,345)   5,801,055Cash and cash equivalents, beginning of period    28,886,736   15,095,919   32,046,630   19,460,141Cash and cash equivalents, end of period  $  21,538,285 $  25,261,196 $  21,538,285 $  25,261,196  For further information: James Smith VP Corporate Communications YM BioSciences Inc. Tel. +1 905.361.9518 jsmith@ymbiosciences.com