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Ym Biosciences Reports Third Quarter 2009 Operational and Financial Results
Thursday, May 14, 2009 7:57 AM


(Source: Canada Newswire)trackingMISSISSAUGA, ON, May 14 /CNW/ - YM BioSciences Inc. (NYSE Amex:YMI, TSX:YM, AIM:YMBA), a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development, today reported operational and financial results for the third quarter of fiscal 2009, ended March 31, 2009.

"Just a few days ago we reported critically important data at the 100th AACR conference in Denver highlighting the mechanistic differences between nimotuzumab and the EGFR targeting antibody, Erbitux(R)," said David Allan, Chairman and CEO of YM BioSciences. "These data demonstrate that nimotuzumab is predisposed to bind to cancerous cells with high levels of EGFR on their surface while ignoring normal cells with low EGFR levels. For the competing drugs, binding is indiscriminate since they bind to low levels of EGFR and, as a result, these products cause severe toxicities as they interact with healthy tissues. With Erbitux(R) as the leading EGFR-targeting drug on the market and generating more than $1.5 billion in annual sales, these findings are profound and further define the significant opportunity for our lead product."

Nimotuzumab is being advanced globally on multiple fronts supported by a network of cooperative relationships. In total, more than 15 Phase II and Phase III trials are currently ongoing, ten of which are being conducted by YM or its licensees. During the third quarter of fiscal 2009:

- The National Cancer Centre of Singapore (NCCS) selected nimotuzumab

for evaluation in the adjuvant setting in a multinational Phase III

trial of more than 700 patients with cancers of the head and neck,

citing the drug's benign safety profile. The trial is being supported

by YM licensee, Innogene Kalbiotech Ltd., a subsidiary of the public

company, Kalbe Farma.

- Two of YM's licensees for nimotuzumab, Daiichi-Sankyo Co., Ltd. in

Japan and Kuhnil Pharmaceutical Co. in Korea, are conducting a Phase

II randomized, open-label trial evaluating nimotuzumab in patients

with advanced or recurrent gastric cancer.

- YM's licensee in Europe, Oncoscience AG, reported that it continues

to enroll patients into a randomized Phase III study evaluating

nimotuzumab in adult glioma patients and into a randomized Phase

IIb/IIIa trial in patients with advanced pancreatic cancer.

- YM and YM USA continued to enroll children with progressive, diffuse,

intrinsic pontine glioma (DIPG) into a Phase II trial at multiple

sites in the US, Canada and Israel and recruitment could be completed

in late calendar 2009 or early 2010.

YM continues to prepare its second late-stage product, AeroLEF(R), for further development internationally. After consulting with regulatory bodies in Europe and Canada, the Company is now determining the optimal clinical path forward and conducting discussions with potential partners.

Financial Results (CDN dollars)

Total revenue (out-licensing revenue and interest income) for the third quarter of fiscal 2009, ended March 31, 2009 was $1.0 million compared with $1.8 million for the third quarter of fiscal 2008. Total revenue for the first nine months of fiscal 2009 was $4.8 million compared with $5.5 million for the first nine months of fiscal 2008. The majority of YM's out-licensing revenue comes from five out-licensing agreements with third party licensees for nimotuzumab. The decrease in revenue for the third quarter of fiscal 2009 compared to the same period in the prior year is mainly attributable to a 12 month extension of the revenue recognition period for the initial payment from one of YM's licensees. The decrease in revenue for the nine months ended March 31, 2009 compared to the same period in the prior year is mainly as a result of the above mentioned extension and the ending of monthly revenue recognition for one other deferred revenue contract, partially offset by a milestone payment received this year from one of the Company's licensees. The Company also began receiving royalty payments from a limited sales program in Europe initiated in the fourth quarter of fiscal 2008. Interest income decreased as the Company draws on its cash balances to fund its operations and due to lower interest rates.

General and administrative expenses were $1.2 million for the third quarter of fiscal 2009 compared with $1.4 million for the third quarter of fiscal 2008. General and administrative expenses were $3.5 million for the first nine months of fiscal 2009 compared with $5.5 million for the first nine months of fiscal 2008. These decreases were mainly a result of stock option expenses decreasing as well as decreases in legal fees, salaries, consulting and investor relations expenditures.

Licensing and product development expenses were $3.3 million for the third quarter of fiscal 2009 compared with $4.3 million for the third quarter of fiscal 2008. Licensing and product development expenses were $11.5 million for the first nine months of fiscal 2009 compared with $12.1 million for the first nine months of fiscal 2008.

Costs associated with development activities for nimotuzumab remained at $1.5 million in the quarter compared to a year ago and increased by $1.1 million to $4.7 million for the nine months ended March 31, 2009. The increase in expenses is primarily related to preparation for the two new Phase II trials.

Costs associated with development activities for AeroLEF(TM) decreased by $0.2 million to $0.4 million for the three month period ended March 31, 2009 compared to the same period in the prior year. For the nine month period ended March 31, 2009 costs were $1.6 million, similar to the same period in the prior year.

Net loss for the third quarter of fiscal 2009 was $3.5 million ($0.06 per share) compared to $3.8 million ($0.07 per share) for the same period last year. Net loss for the first nine months of fiscal 2009 was $9.8 million ($0.18 per share) compared to $11.9 million ($0.21 per share) for the same period last year.




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