London, Sep. 25, 2009 (PR Newswire UK Disclose) --
YM BIOSCIENCES REPORTS FISCAL YEAR END 2009 OPERATIONAL AND FINANCIAL RESULTS
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. 