(Source: Canada Newswire)

MISSISSAUGA, ON, Sept. 25 /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 its fiscal year
end, ended June 30, 2009.
"Just weeks ago we received clearance from the US Treasury
Department to extend our US clinical program for nimotuzumab,
permitting us to conduct trials in any cancer indication. Obtaining
this clearance will be a transformative event for nimotuzumab and
highlights the significant efforts made by YM staff in fiscal 2009
to advance our lead drug in an aligned effort with our licensees,"
said David Allan, Chairman and CEO of YM BioSciences. "Although
encouraging data was presented at ASCO 2009 describing the efficacy
of nimotuzumab but without advanced toxicities, we anticipate that,
once a broader group of key US oncologists gain experience
investigating nimotuzumab in their patients, the benefits of our
drug and its potential for best-in-class status will be more fully
appreciated by this community, as well as by potential partners and
investors."
Nimotuzumab is being advanced globally on multiple fronts
supported by a network of cooperative relationships. In total, 32
Phase II and III clinical trials are currently ongoing, 11 of which
are being conducted by YM's majority owned subsidiary, CIMYM
BioSciences Inc., or its licensees.
- Daiichi Sankyo Co., Ltd., CIMYM's licensee for nimotuzumab in
Japan,
and YM's licensee in Korea, Kuhnil Pharmaceutical Co., are
currently
collaborating on a Phase II randomized, open-label trial they are
conducting that is evaluating nimotuzumab plus irinotecan
compared to
irinotecan alone in patients with advanced or recurrent gastric
cancer refractory to 5-FU-containing regimens which is designed
to
complete recruitment in calendar 2009. Daiichi has also launched
a
Phase II trial in first-line NSCLC bringing to three the number
of
NSCLC indications being investigated by our direct consortium.
- Randomized, Phase II, double-blind trials in brain metastases
from
non-small cell lung cancer (NSCLC) and in NSCLC patients
ineligible
for radical chemotherapy were initiated in Canada; recruitment
commenced in March 2009 for NSCLC and in September for the brain
metastases trial. A Phase II, second-line, single-arm trial in
children with progressive diffuse intrinsic pontine glioma (DIPG)
is
ongoing at multiple sites in the US, Canada, and Israel.
- Oncoscience AG (OSAG), CIMYM's licensee for Europe, reports
that it
continues to recruit for a Phase III trial in adult glioma and a
Phase II/III trial in pancreatic cancer.
- Innogene Kalbiotech PTE Ltd. (IGK), a subsidiary of Kalbe
Farma, the
largest public Southeast Asian pharmaceutical company and a CIMYM
licensee, reported marketing approval in the Philippines and
Indonesia, bringing to 21 the number of countries that are now
reported as having approved the drug for sale in specific
indications. In January 2009, the National Cancer Centre of
Singapore
announced that it was launching a worldwide Phase III, 710-
patient
trial of nimotuzumab in the adjuvant setting in head and neck
cancer
in cooperation with IGK. This trial is in addition to the on-
going
investigator-initiated Phase II trial in locally advanced head
and
neck cancer and the initiation of a Phase II trial in cervical
cancer.
- Subsequent to the end of the fiscal year, YM received a
license from
the US Department of the Treasury's Office of Foreign Assets
Control
(OFAC) to further develop its lead product, nimotuzumab, for
patients
in the United States. YM's first priority is discussion with the
FDA
on its two IND submissions to include US citizens in the
randomized,
double-blind Phase II trial of nimotuzumab in NSCLC patients
ineligible for radical chemotherapy and the parallel Phase II
trial
in patients with brain metastases from NSCLC, both of which YM
initiated in Canada during the 2009 fiscal year. Development
plans
may also include extending one of the Phase III trials being
conducted worldwide into the US, such as the multinational
710-patient Phase III trial of nimotuzumab in the adjuvant
setting in
head and neck cancer.
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 prospective partners around the Phase III strategy.
The Company continues to evaluate opportunities to amplify and
diversify its development portfolio through potential licensing,
acquisition or M&A activity. YM filed and received clearance for a
"shelf" prospectus in Canada and the USA subsequent to the end of
the fiscal year. 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.
Cancellation of AIM Listing
YM also announces that trading of the Company's Common Shares on
the AIM market of the London Stock Exchange ("AIM") will be
cancelled on October 26, 2009. YM shares have traded on AIM since
2002, however the majority of its shareholder base and liquidity now
result from its Canadian and US listings. Therefore YM has concluded
that the additional costs associated with maintaining a listing on
AIM were not justifiable given its North American focused
shareholder base. The cancellation of trading of its common shares
on AIM will be effective from 7:00 a.m. (GMT) on Monday, October 26,
2009 (the "Cancellation Date").
Following the cancellation of the Company's Common Shares on AIM,
shareholders may continue to hold their shares and continue to trade
such shares on either the TSX under the symbol 'YM' or the NYSE Amex
under the symbol 'YMI'. YM does not expect the liquidity or
marketability of its common shares to be materially affected by the
AIM delisting.
Financial Results (CDN dollars)
Total revenue for the fiscal year ended June 30, 2009 was $5.6
million compared with $7.4 million for fiscal 2008. Total revenue
for the fourth quarter of fiscal 2009 was $0.8 million compared with
$2.0 million for the fourth quarter of fiscal 2008. Revenue from out-
licensing was $4.5 million for fiscal 2009 compared with $4.9
million for fiscal 2008. The decrease is mainly attributable to the
12 month extension of the revenue recognition period for the initial
payment from Daiichi Pharmaceutical Co., Ltd, as a result of a
revision to the estimated period of the collaboration. The majority
of YM's out-licensing revenue comes from five out-licensing
agreements with third party licensees. YM also began receiving
royalty payments from a limited sales program in Europe in the
fourth quarter of fiscal 2008.