MISSISSAUGA, 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.