- Completed dosing for 166 patient CYT387 Phase I/II nine-month trial -
- Completed enrolment of 61 patient CYT387 Phase II BID trial -
MISSISSAUGA, ON, Sept. 21, 2012 /PRNewswire/ - YM BioSciences Inc. (NYSE MKT: YMI, TSX: YM), a drug development company advancing hematology and cancer related
products, today reported operational and financial results for its 2012
fiscal year, ended June 30, 2012.
"We made significant progress with CYT387 during Fiscal 2012,
highlighted by our reporting at ASH 2011 of positive interim data that
potentially differentiates our drug from other JAK inhibitors.
Leveraging these data, over the last several months we conducted
productive discussions with regulatory authorities in the US and Europe
which have affirmed the range of options available for the pivotal
program for CYT387," said Dr. Nick Glover, President and CEO of YM
BioSciences. "We continue to conduct a robust business development
campaign aimed at exploring potential opportunities to further develop
and commercialize the drug with other companies, seeking relationships
that will focus on realizing the broader commercial opportunity for
CYT387."
Fiscal 2012 Highlights:
CYT387:
-
In December 2011, interim results for all 166 patients enrolled in the
Phase I/II trial were reported in a poster session at ASH 2011. In this
multicenter setting, CYT387 enabled more than half of the patients with
myelofibrosis who were initially dependent on transfusions to become
transfusion independent for clinically relevant periods of time. CYT387
also continued to produce significant and durable reductions of
splenomegaly and improvements of constitutional symptoms for many
patients. CYT387 was safe and well tolerated, with daily dosing up to
and exceeding two and a half years.
-
In June 2012, all eligible patients completed the core study of the
Phase I/II trial by receiving drug for nine months. These patients are
eligible to continue receiving drug in the ongoing extension trial.
-
In July 2012, enrolment was completed for the complementary Phase II BID
(twice-daily dosing) trial of CYT387 initiated in September 2011. This
trial was designed to further explore the range of potential dosing for
CYT387 and recruited a total of 61 patients at six sites across North
America. A review of clinical data obtained across multiple doses and
schedules indicates that the optimal dose for CYT387 is 300mg given
once-daily. Additional findings from the BID study will augment the
data from the 166 patient Phase I/II study and facilitate further
investigation of the spleen, constitutional symptom and anemia
responses observed to date.
-
In mid-calendar 2012, meetings with US and European regulators were
conducted where potential pivotal Phase III clinical trial designs to
support marketing approval for CYT387 were discussed. YM believes these
discussions were productive, confirming that several options were
available for the pivotal clinical development program of CYT387.
-
YM is exploring potential opportunities to further develop and
commercialize CYT387 with other companies, seeking relationships that
will focus on realizing the broader commercial opportunity for CYT387
in myelofibrosis and beyond. In February 2012, YM raised US$80.5
million, providing the Company with flexibility to weigh any business
development opportunities that arise against the prospect of retaining
full control over commercial economics by advancing CYT387 further into
pivotal trials on its own.
CYT387 Next Steps:
-
Final nine-month data from the ongoing 166 patient Phase I/II trial are
expected to be reported by the end of calendar 2012.
-
Interim data from the extension trial, in which patients who have
completed the 166 patient Phase I/II trial are able to continue
long-term treatment with CYT387, are expected to be reported by the end
of calendar 2012.
-
Initial data from the Phase II BID trial are expected to be reported by
the end of calendar 2012.
-
Having reported positive interim data in December 2011 from a 166
patient Phase I/II trial of CYT387 in myelofibrosis, YM conducted
productive discussions with regulatory authorities in the US and Europe
which have affirmed the range of options available for the pivotal
program for CYT387. YM is now preparing for pivotal trials under
scenarios where the drug is developed either with or without another
company.
Nimotuzumab:
-
YM has been advised by Daiichi Sankyo Co., Ltd., CIMYM's sub-licensee
for nimotuzumab in Japan, that they are evaluating the drug in a Phase
II gastric cancer program together with Kuhnil Pharma Co. Ltd., CIMYM's
sub-licensee in South Korea, and in a Phase II non-small cell lung
cancer (NSCLC) program.
-
YM has been advised by Oncoscience AG (OSAG), CIMYM's sub-licensee for
Europe, that they are evaluating nimotuzumab in Phase III glioma and
pancreatic cancer programs.
-
YM has been advised by Innogene Kalbiotech PTE Ltd. (IGK), a CIMYM
sub-licensee, that they are evaluating nimotuzumab in Phase II and III
head and neck cancer programs and a Phase II cervical cancer program.
CYT997:
-
A single-arm intravenous Phase Ib/II study in patients with relapsed
glioblastoma multiforme was closed to enrolment in February 2011.
Subsequent preclinical work was recently completed involving the
examination of repeated low doses of CYT997, the envisioned optimal
dosing regimen for this drug, in a mouse breast cancer model. Based on
the results obtained in this preclinical model, in conjunction with the
earlier clinical trial data, YM has decided not to pursue further
clinical development of CYT997 at this time.
Summary Financial Results (CDN dollars)
The interim consolidated financial statements and comparative
information for fiscal 2012 have been prepared in accordance with
International Financial Reporting Standards ("IFRS"). The Company's
Consolidated Financial Statements were previously prepared in
accordance with Canadian Generally Accepted Accounting Principles
("Canadian GAAP").
Revenue, generated from out-licensing, for the fourth quarter of fiscal
2012 ended June 30, 2012 was $0.3 million compared with $0.2 million
for the fourth quarter of fiscal 2011. Revenue for fiscal 2012 of $1.1
million is comparable to $1.0 million for fiscal 2011.
Net finance income was $2.2 million for the fourth quarter of fiscal
2012 compared to net finance costs of $0.5 million for the fourth
quarter of fiscal 2011. Net finance income was $11.4 million for fiscal
2012 compared to net finance costs of $10.3 million for fiscal 2011.
The changes in net finance income are primarily attributable to changes
in the fair value adjustment for USD warrants. Under IFRS, warrants
denominated in a different currency than the Company's functional
currency must be classified as a financial liability and measured at
fair value, with changes reflected in profit or loss. For the fourth
quarter of fiscal 2012, the Company incurred a gain of $0.4 million on
the revaluation of warrants, compared to a loss of $0.8 million for the
fourth quarter of fiscal 2011. For fiscal 2012, the Company incurred a
gain of $7.3 million on the revaluation of warrants, compared to a loss
of $9.4 million for fiscal 2011.
Licensing and product development expenses were $7.1 million for the
fourth quarter of fiscal 2012 compared with $7.4 million for the fourth
quarter of fiscal 2011. Licensing and product development expenses were
$26.6 million for fiscal 2012 compared with $23.8 million for fiscal
2011. Development expenses for CYT387 increased due to the extension of
the Phase I/II clinical trial in myelofibrosis, start-up costs
associated with the BID study, pre-clinical development activities, and
manufacturing of drug for these programs. Expenses for nimotuzumab
continued to decrease.
General and administrative expenses were $1.4 million for the fourth
quarter of fiscal 2012 compared to $1.2 million for the fourth quarter
of fiscal 2011. General and administrative expenses were $6.2 million
for fiscal 2012 compared to $7.7 million for fiscal 2011, primarily due
to reduced salary expense after the reorganization termination payments
in fiscal 2011.
Net loss for the fourth quarter of fiscal 2012 was $6.1 million ($0.04
per share) compared to $8.9 million ($0.08 per share) for the same
period last year. Net loss for fiscal 2012 was $20.3 million ($0.16 per
share) compared to $40.9 million ($0.42 per share) for fiscal 2011.
As at June 30, 2012 the Company had cash and short-term deposits
totaling $132.5 million and accounts payable and accrued liabilities
totaling $3.1 million compared to $79.7 million and $4.4 million
respectively at June 30, 2011.
As at June 30, 2012 the Company had 157,546,793 common shares and
7,366,418 warrants outstanding.
Notice of Meeting:
YM's Annual Meeting of Shareholders will be held on November 20, 2012,
at 4:00 p.m. ET at the offices of Norton Rose OR LLP, Boardrooms A & B,
38th Floor, 200 Bay Street, Royal Bank Plaza South Tower, Toronto,
Ontario. The management proxy circular documents and annual financial
documents are expected to be mailed to shareholders on October 8, 2012,
and will be available online at www.ymbiosciences.com, www.sec.gov and www.sedar.com.
About YM BioSciences
YM BioSciences Inc. is a drug development company primarily focused on
advancing CYT387, an orally administered inhibitor of both the JAK1 and
JAK2 kinases, which have been implicated in a number of hematological
and immune cell disorders including myeloproliferative neoplasms and
inflammatory diseases as well as certain cancers. Positive interim
results have been reported from a Phase I/II trial of CYT387 in 166
patients with myelofibrosis. YM's portfolio also includes nimotuzumab,
a humanized monoclonal antibody targeting EGFR with an enhanced
side-effect profile over currently marketed EGFR-targeting antibodies.
Nimotuzumab is being evaluated in numerous Phase II and III trials
worldwide. In addition, YM has several preclinical programs underway
with candidates from its library of novel compounds identified through
internal research conducted at YM BioSciences Australia.