GAPped 10%
YM BioSciences reports second quarter 2006 operational and financial results
Friday February 10, 5:45 pm ET
MISSISSAUGA, ON, Feb. 10 /PRNewswire-FirstCall/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM, AIM:YMBA), the cancer product development company, today reported operational and financial results for the second quarter of fiscal 2006, ended December 31, 2005.
"Important times are ahead. All three of our late-stage products advancing in the clinic with results to be reported this calendar year. For our lead drug tesmilifene, the first of three planned interim analyses of data from our pivotal Phase III metastatic and recurrent breast cancer trial could occur in and around mid calendar 2006," said David Allan, Chairman and CEO of YM BioSciences. "If survival results meet the levels set in the Special Protocol Assessment agreed to with the FDA, data this year could be sufficient to seek regulatory approval."
Other highlights:
- Hypothesis of tesmilifene's mode of action authored by
Dr. Mark Vincent has been published online in Medical Hypotheses,
Vol. 66 No. 4 which together with supporting evidence from numerous
academic laboratories in Canada and the USA suggests that tesmilifene
is a unique molecule, selective for multiple drug resistant cancer
cells, and positively impacts the most common chemotherapies across
multiple tumour types. Drug resistance is widely recognized to be the
"ultimate frontier in the fight against cancer." The article is
available for viewing now online through Elsevier's online journal
site www.sciencedirect.com.
- Entered into a collaborative agreement with Sanofi-Aventis to
investigate the effect of combining tesmilifene and the blockbuster
cancer drug Taxotere® (docetaxel) for women with rapidly progressing
metastatic breast cancer. Enrolment is targeted for completion in
calendar Q2, 2006 and pharmacokinetic data could be available by
year-end with survival results possible by year-end 2007.
- Reported positive 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. This indication is now expected to be advanced with the first
randomized trial in this indication and is expected to compare a
standard of care mitoxantrone/prednisone used in Taxotere failures to
the same regimen plus tesmilifene. The primary endpoints will be those
in which the combination appeared to provide significant benefit in
the single arm Phase II - namely the important reduction in pain
suffered by patients at this stage and a reduction in PSA.
- Completed preparations for prospectively pivotal trials in children
with inoperable brain cancer - pontine, or brain-stem glioma - for
submission to the FDA and the European Regulatory Authority, EMEA.
- Partnered with Innogene Kalbiotech Ltd (IGK) of Singapore to expand
the development program for nimotuzumab into Southeast Asia and
Africa.
- Initiated a Phase IIb trial for AeroLEF(TM) subsequent to the end of
the quarter. The trial could complete recruitment and report results
within the first half of calendar 2006.
- Filed and received clearance for a "shelf" prospectus in Canada and
the USA following the end of the quarter. A "shelf" facilitates
financing by a company, reduces the time period during which a company
must otherwise wait for a prospectus to be cleared, permits the sale
to investors of shares without a "hold period" (thus significantly
reducing the cost of capital) and permits the use of freely traded
shares in the case of another acquisition by YM, again significantly
reducing the prospective cost of capital. The "shelf" registration
covers any financing during the forthcoming 25 months.
Financial Results
Total revenue for the quarter ended December 31, 2005 was $549,230 compared to $521,524 for the same period last year. Total revenue for the first six months of the 2006 fiscal year was $792,237 compared to $989,998 for the first six months of the corresponding period last year. Revenue consisted of revenue generated from out-licensing agreements and interest income.
Total expenditures for the quarter ended December 31, 2005 were $6,064,517 compared to $3,379,021 for the same period last year. Total expenditures for the first six months of the 2006 fiscal year were $12,268,425 compared to $5,960,757 for the first six months of the corresponding period last year. General and Administrative expenses for the second quarter were $1,253,873 and for the first six months were $2,681,772 compared to $1,259,259 and $2,517,291 respectively for the same periods in the prior year. Licensing and Product Development expenses for the second quarter were $4,810,644 and for the first six months were $9,586,653 compared to $2,119,762 and $3,443,466 respectively for the same periods in the prior year. Expenditure increases were due primarily to the rapid progression of the tesmilifene Phase III clinical trial and the inclusion of costs associated with the development of the AeroLEF(TM) technology.
Net loss for the second quarter was $5,536,292 and for the year to date was $11,460,138 compared to $2,830,164 and $5,098,863 respectively for the same periods last year.
As at December 31, 2005 the Company had cash and short-term deposits totaling $20,300,992 and current liabilities of $3,335,168 compared to $30,568,845 and $3,825,615 respectively at June 30, 2005.
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