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