YM Biosciences reports first quarter 2007 operational and financial results
MISSISSAUGA, ON, Nov. 10 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,
AIM:YMBA), an oncology company that identifies, develops and commercializes
differentiated products for patients worldwide, today reported operational and
financial results for the first quarter of fiscal 2007, ended September 30,
2006.
"Our pivotal Phase III trial for tesmilifene is nearing completion, with
the third of a number of interim analyses anticipated shortly. We continue to
expect the complete set of mature data for our lead anti-cancer drug will be
available in calendar 2007," said David Allan, Chairman and CEO of
YM BioSciences. "For Nimotuzumab we were pleased to report that, during the
quarter, the Office of Foreign Assets Control (OFAC) of the U.S. Treasury
Department issued us a license that allows YM to import nimotuzumab into the
U.S. for the purpose of a clinical trial in children with inoperable brain
cancer. The OFAC license is a key achievement in our efforts to make
nimotuzumab available in the U.S. while we concurrently advance the drug
through a broad multi-national development program internationally with
numerous partners."
"We also made progress in the development of AeroLEF(TM), our unique,
inhaled-delivery composition of free and liposome encapsulated fentanyl for
the treatment of moderate to severe acute pain, including cancer pain," added
David Allan. "Recently presented results of the open-label portion of our
Phase IIb study demonstrated that patients are able to successfully
self-titrate AeroLEF(TM) for managing acute pain and we intend to further
expand the product's clinical development into patients with cancer pain."
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Highlights for the first quarter (July 1, 2006 - September 30, 2006):
Tesmilifene:
- The independent Data Safety Monitoring Board (DSMB) made its second
recommendation that the tesmilifene pivotal trial proceed as planned.
The Company believes that this demonstrates that the product
continues to be safe and indicates that the data have the prospect of
becoming positive as they mature.
Nimotuzumab:
- Received clearance from OFAC to import nimotuzumab for specific
clinical research in the U.S.
- Licensed the drug to Daiichi Pharmaceutical Co., Ltd., a wholly owned
subsidiary of Daiichi Sankyo Company, Limited, for Japan.
- Enrollment of patients in a Phase III trial in pediatric glioma in
Europe continues by YM partner Oncoscience AG and recruitment is
expected to be completed in the first half of calendar 2007.
- A multi-center Phase I/II trial comparing the effects of the
combination of nimotuzumab with radiation against radiation alone in
patients with non-small-cell lung cancer (NSCLC) unfit for
chemotherapy is also underway, with recruitment anticipated to be
completed by the end of 2007, or early 2008. This trial is being
conducted by YM and is expected to be expanded into South Korea
through YM partner Kuhnil Pharmaceutical Company of Seoul, Korea.
AeroLEF(TM):
- Results of the open-label portion of the Phase IIb study with
AeroLEF(TM) for the treatment of moderate to severe acute pain in
post-surgical patients were presented at the American Society of
Anesthesiologists Annual Meeting in October 2006. The data
demonstrated that clinically meaningful analgesia was achieved in
81%, 100% and 87.5% of treated pain episodes during doses 1, 2 and 3
respectively in the multi-dose study. Differences in median time to
effective analgesia, with shorter dosing times for doses 2 and 3,
suggests that patients were capable of safely self-limiting dosing to
uniquely match each distinct pain episode. Achievement of effective
analgesia was the reason for patients stopping dosing in 88% of
treated pain episodes. Multiple doses were well tolerated with all
treatment emergent events reported at mild ((greater than)70%) or
moderate.
- Interim results from the randomized, placebo-controlled portion of
Phase IIb trial were announced. That analysis of data from the first
67 patients from the trial indicated that AeroLEF(TM) provided
benefit when comparing the treatment arm to placebo, but not the
degree of difference that would permit an early stopping. Since the
study was powered to detect benefit at full recruitment it will
continue as planned to enroll the original target of 99 randomized
patients. The full data is anticipated early in calendar 2007.
Corporate highlights:
- YM BioSciences was declared, for the second year in a row, a finalist
of Canada's Top 10 Life Science Companies Competition subsequent to
the end of the quarter. In particular, the Company was again declared
one of Canada's top five Later Stage Companies within the
competition.
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Financial Results (CDN dollars)
Total revenue for the quarter ended September 30, 2006 was $1.7 million
compared to $243,000 for the same period last year. Revenue was generated from
out-licensing agreements and interest income. The increase in licensing
revenue is due to the licenses for nimotuzumab to Innogene Kalbiotech Private
Limited (January 2006) for countries in Southeast Asia and Africa and Daiichi
Pharmaceutical Co., Ltd. (July 2006) for Japan.
Total operating expenditures for the quarter ended September 30, 2006
were $9.7 million compared to $6.2 million for the same period last year.
General and administrative expenses for the first quarter of the fiscal year
were $1.9 million compared to $1.4 million for the same period in the prior
year. Licensing and product development expenses were $7.9 million for the
first quarter of the fiscal year compared to $4.8 million for the first
quarter of last year. The increases were due mainly to the addition of a
senior management team with the acquisition of Eximias in May and increased
expenditures on nimotuzumab.
Net loss for the fiscal first quarter was $8.1 million ($0.15 per share)
compared to $5.9 million ($0.15 per share) for the same period last year.
As at September 30, 2006 the Company had cash, cash equivalents and
short-term deposits totaling $93.9 million and current liabilities of
$1.6 million compared to $88.3 million and $3.7 million respectively at June
30, 2006.
As at September 30, 2006 the Company had 55,782,023 common shares
outstanding, 2,380,953 common shares held in escrow for contingent additional
payment related to the acquisition of DELEX Therapeutics Inc., and 9,022,277
warrants and 4,790,955 options outstanding.
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