YM BioSciences reports fiscal year end 2010 operational and financial results
MISSISSAUGA, ON, Sept. 23 /CNW/ - YM BioSciences Inc. (NYSE Amex:YMI,
TSX:YM), today reported operational and financial results for its fiscal year
end, ended June 30, 20
"This has been a transformative year for YM. Our most notable development
was the merger of the public Australian company, Cytopia, into YM BioSciences,
completed in January, from which we gained two important clinical stage drug
candidates, CYT387 and CYT997, as well as a library of more than 4,000 novel
compounds in addition to the ongoing advancement of nimotuzumab by us and our
four licensees," said David Allan, Chairman and CEO of YM BioSciences. "Work
on CYT387, a potent, orally-administered JAK1/JAK2 inhibitor, has resulted in
favorable biological activity and safety data observed in recent months and as
such have announced the expansion of our current Phase I/II program in
myelofibrosis initiated at Mayo Clinic from 60 to up to 120 patients and the
inclusion of up to six centers in the United States, Canada and Australia. We
also look forward to the American Society of Hematology (ASH) meeting in
Orlando, Florida, in early December 2010, where detailed safety and
preliminary activity data for CYT387 are expected to be presented."
"During the fiscal period we raised an additional $20 million in two
financings that brought in a number of highly regarded life-sciences investors
as shareholders and we also recently announced the appointment of Dr. Nick
Glover as President and COO of YM. By strengthening both our balance sheet and
leadership team we have positioned YM to seize the significant new
opportunities that our expanded pipeline presents," added Mr. Allan.
<<
Highlights from Fiscal 2010:
CYT387
- Pivotal preclinical efficacy data for CYT387 in myeloproliferative
neoplasms were published in Blood, the Journal of the American
Society of Hematology (Blood, 24 June 2010, Vol. 115, No. 25, pp.
5232-5240).
- Subsequent to quarter end, Mayo Clinic concluded dose-escalation in
the Phase I portion of the Phase I/II clinical trial of CYT387 in
patients with myelofibrosis, a chronic debilitating condition where
the patient's bone marrow is replaced by scar tissue. In total, 21
patients were treated in Phase I, with no voluntary withdrawals
reported. CYT387 showed significant activity in reducing spleen size
and controlling constitutional symptoms in these patients. To date,
27 patients have been enrolled into the Phase II tranche bringing the
total number in the study to 48. Given the favorable biological
activity and safety data, the Company intends to expand enrolment for
the trial and include centers in the US, Canada and Australia,
subject to regulatory approval.
- Subsequent to quarter end, CYT387 was granted Orphan Drug Designation
by the US FDA. Orphan Drug Designation is granted to novel drugs or
biologics that treat a rare disease or condition affecting fewer than
200,000 patients in the US.
Nimotuzumab
- Wholly-owned subsidiary, YM BioSciences USA Inc. (YM-USA) received a
license from the US Department of the Treasury's Office of Foreign
Assets Control (OFAC) to further develop its humanized monoclonal
antibody, nimotuzumab, for patients with solid tumor cancers in the
US. YM-USA subsequently received FDA clearance to enroll patients
from US clinical sites into two ongoing randomized, double-blind
Phase II trials of its product, nimotuzumab. Subsequent to quarter
end, YM enrolled the first US patient in its randomized, double-blind
trial evaluating nimotuzumab in patients with brain metastases from
non-small-cell lung cancer (NSCLC) at the Florida Cancer Institute -
New Hope.
- YM reported that its licensee for nimotuzumab, Daiichi Sankyo Co.,
Ltd. in Japan advised that it has completed enrollment of a Phase II
trial evaluating nimotuzumab in combination with radiation
therapy/cisplatin/vinorelbine in first-line curative intent patients
with Stage III NSCLC. YM further anticipates that Daiichi Sankyo will
be in possession of data from its Phase II gastric cancer trial
evaluating nimotuzumab in combination with irinotecan in calendar
2010.
- YM reported in an oral presentation at the American Society for
Therapeutic Radiology and Oncology (ASTRO) 2009 Annual Meeting
positive 48-month survival data for its product, nimotuzumab. The
"BEST" trial was a randomized four-arm study treating patients with
inoperable, locoregionally-advanced, Stage III/IVa head and neck
cancer with radiation alone, chemoradiation alone, or radiation or
chemoradiation in combination with nimotuzumab.
- YM was advised that nimotuzumab had been approved for marketing in
Mexico, the 20th country to have approved the drug.
- YM anticipates reporting data from its North American Phase II
pediatric glioma trial in calendar 2010; that its licensee for
Europe, Oncoscience AG, will be in possession of European Phase III
adult glioma data for nimotuzumab in calendar 2010; and that it will
continue to support the scale-up and process enhancement for
manufacturing of nimotuzumab which are required for increased late-
stage clinical activity and in anticipation of requirements for
commercial volumes of product.
CYT997
- A poster presentation at the 2009 AACR-NCI-EORTC Molecular Targets
and Cancer Therapeutics conference in Boston, Massachusetts,
demonstrated CYT997's potent vascular disrupting effects and enhanced
antitumor effects in combination with cisplatin in preclinical
models. In August 2010, Phase I clinical trial results of CYT997 were
published in the premier cancer journal, the British Journal of
Cancer, demonstrating that CYT997 was well tolerated at doses that
were associated with changes in plasma and imaging biomarkers
consistent with vascular disruption in tumors.
Corporate Highlights
- Created YM Australia from the merger into YM of an Australian
biotechnology company, Cytopia Ltd., a company focused on the
discovery and development of new drugs to treat cancer and other
diseases.
- Raised US$17.5 million in March 2010, followed by a subsequent
investment of US$3.2 million made in June by a leading international
health-care-specific investment fund management company specifically
in support of the CYT387 program.
- Appointed Dr. Nick Glover to the newly created position of President
and Chief Operating Officer. Dr. Glover will provide broad leadership
to the Company and have primary responsibility for its operations and
infrastructure, in particular the development and commercialization
of YM's pipeline. The Company also announces that Mr. Robert Watson
has resigned as a director of YM BioSciences effective September
2010, that Mr. Sean Thompson, Vice President, Corporate Development,
has left YM BioSciences, effective August 2010, and that Ms. Wendy
Chapman and Dr. Ernest Wong have been appointed as Vice President,
Clinical Operations and Vice President, Business Development
respectively.
- Terminated all further expenditures related to the AeroLEF(R)
program.
>>
Financial Results (CDN dollars)
Total revenue (out-licensing revenue and interest income) for the fiscal
year ended June 30, 2010 was $2.7 million compared to $5.6 million for fiscal
2009. Total revenue for the fourth quarter of fiscal 2010 was $0.5 million
compared to $0.8 million for the fourth quarter of fiscal 2009. Revenue from
out-licensing was $2.6 million for fiscal 2010 compared to $4.5 million for
fiscal 2009. The decrease is mainly attributable to the full recognition of
all contracts related to the development of tesmilifene because all of YM's
obligations under the licensing agreement have been met.
Licensing and product development expenses were $17.0 million for the
fiscal year ended June 30, 2010 compared with $14.2 million for fiscal 2009.
Licensing and product development expenses were $7.6 million for the fourth
quarter of fiscal 2010 compared to $2.6 million for the fourth quarter of
fiscal 2009. The increases were almost entirely the consequence of non-cash
write-off of the AeroLEF intangible assets and the amortization of the Cytopia
intangible asset.
Costs associated with development activities for nimotuzumab were $5.6
million for the fiscal year ended June 30, 2010 compared to $6.0 million for
the previous year. Costs associated with development activities for
nimotuzumab were $1.8 million for the fourth quarter of fiscal 2010, compared
with $1.3 million for the same quarter of the previous year. The minor
differences mainly relate to two clinical trials, one for brain metastases
from non-small cell lung cancer (NSCLC) and the other for NSCLC patients
ineligible for radical chemotherapy. Recruitment into both trials lags
expectations and the targeted recruitment period is under review as a
consequence. Total development expenses decreased as result of the conclusion
of the Phase II pediatric pontine glioma and colorectal trials.
Costs associated with development activities for AeroLEF were $0.6
million for the fiscal year ended June 30, 2010 compared to $1.7 million for
the previous year. Costs associated with development activities for AeroLEF
were $0.1 million for the fourth quarter of fiscal 2010, compared to $0.2
million the previous year. In June 2010, the Company decided to no longer
pursue the AeroLEF program, and to terminate the development program
associated with the product. Accordingly, the net asset remaining on the
balance sheet was written off in Q4 of fiscal 2010.
General and administrative expenses were $6.9 million for the fiscal year
ended June 30, 2010 compared to $4.8 million for the previous year with the
majority of the increase accounted for by acquisition costs and non-cash
expenses. General and administrative expenses for the fourth quarter of fiscal
2010 were $1.8 million compared to $1.3 million for the same quarter in the
prior year. This increase is largely attributable to increased travel and
salaries with the acquisition of YM Australia.
Net losses for the fiscal year and fourth quarter ended June 30, 2010
were $21.0 million ($0.33 per share) and $8.6 million ($0.11 per share)
respectively, compared to $13.1 million ($0.23 per share) and $3.3 million
($0.06 per share) for the same periods last year.
As at June 30, 2010 the Company had cash and short-term deposits
totalling $45.6 million and accounts payables and accrued liabilities
totalling $2.8 million compared to $42.1 million and $0.9 million respectively
at June 30, 2009. Management believes that the cash and short-term deposits at
June 30, 2010 are sufficient to support the Company's activities for at least
the next twelve months.
As at June 30, 2010 the Company had 80,359,623 common shares and
8,166,480 warrants outstanding.
The Company's annual financial statements and management's discussion and
analysis will be available on www.sedar.com, www.edgar.com and at
www.ymbiosciences.com
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