YM Biosciences reports first quarter 2006 operational and financial
results
MISSISSAUGA, ON, Nov. 14 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,
AIM:YMBA), the cancer product development company, today reported operational
and financial results for the first quarter of fiscal 2006, ended
September 30, 2005.
"Highlighting the quarter, we completed enrolment of the 700 patient
pivotal trial for our lead drug tesmilifene for the treatment of metastatic
and recurrent breast cancer. The first of three planned interim analyses of
data from this trial will occur in mid calendar 2006 with the others expected
during the balance of the year. If survival results in this pivotal trial are
similar to those in the same patient population of the first tesmilifene Phase
III trial then, through a Special Protocol Assessment agreed to with the FDA,
the data could be sufficient to lead to marketing approval as early as 2007,"
said David Allan, Chairman and CEO of YM BioSciences.
Other highlights:
- Reported results in the November 2005 issue of the Journal of Urology
from a Phase II trial of tesmilifene plus mixantrone/prednisone for
the treatment of hormone refractory prostate cancer. The addition of
tesmilifene produced a prostate specific antigen (PSA) decrease of
greater than 50% in the majority of patients and yielded a two-year
survival rate of 21% which compares favorably with historical
outcomes.
- YM partner, Oncoscience AG, reported updated data from a Phase II
monotherapy trial of nimotuzumab in children with resistant or
relapsed brain cancers. Nimotuzumab produced evidence of a survival
benefit in children and demonstrated strong anti-tumour activity, and
did not produce the toxicities of rash and diarrhea, normally
associated with other drugs in this class. YM proposes to apply for
an IND for a pivotal trial in children with recurrent brain cancer
which could complete recruitment in 2006. YM recently received
clearance to initiate a multi-center Phase I/II trial comparing the
effects of the combination of nimotuzumab with radiation against
radiation alone in patients with nonsmall-cell lung cancer unfit for
chemotherapy. The drug is also undergoing a Phase II monotherapy
trial in Europe in patients with advanced metastatic pancreatic
cancer.
- Received clearance to initiate a Phase IIb trial for AeroLEF(TM). The
trial is expected to complete recruitment in the first calendar
quarter of 2006 and report results in the following quarter. A Phase
III trial is planned for 2006 subject to Phase II data.
- Presented positive clinical trial results for its anti-GnRH prostate
cancer vaccine, Norelin(TM) in hormone sensitive prostate cancer
(HSPC).
- Entered into an exclusive worldwide license agreement with the
University of Saskatchewan for a portfolio of small molecule
compounds that appear to be highly potent enhancers of the activities
of existing chemotherapeutic treatments.
Financial Results
Total revenue for the quarter ended September 30, 2005 was $243,007
compared to $468,474 for the same period last year. Revenue consisted of
revenue generated from out-licensing agreements and interest revenue.
Total expenditures for the quarter ended September 30, 2005 were
$6,203,908 compared to $2,581,736 for the same period last year. General and
administrative expenses for the first quarter of the fiscal year were
$1,427,899 compared to $1,258,032 for the same period in the prior year.
Licensing and product development expenses were $4,766,009 for the first
quarter of the fiscal year compared to $1,323,704 for the first quarter of
last year due mainly to the rapid increase in recruitment for the tesmilifene
pivotal Phase III clinical trial.
Net loss for the fiscal first quarter was $5,923,846 compared to
$2,268,699 for the same period last year.
As at September 30, 2005 the Company had cash and short-term deposits
totaling $24,914,798 and current liabilities of $3,305,300 compared to
$30,568,845 and $3,825,615 respectively at June 30, 2005.
About YM BioSciences
YM BioSciences Inc. is a cancer product development company. Its lead
drug, tesmilifene, is a small molecule chemopotentiator effective in enhancing
all known classes of chemotherapies currently used to treat cancer.
YM BioSciences recently completed enrolment in its 700 patient pivotal trial
of tesmilifene for the treatment of rapidly progressing metastatic and
recurrent breast cancer. An analysis of overall survival in a two-thirds
majority subgroup of patients enrolled in a previous Phase III trial
demonstrated that tesmilifene extended median survival in a similar patient
population from 12.2 months to 29.7 months (143%; p equals 0.0016). If
survival results in the ongoing pivotal trial are similar to those in the
first tesmilifene Phase III trial then, through a Special Protocol Assessment
agreed to with the FDA, the data could be sufficient to seek regulatory
approval. The first of three planned interim analyses of data from this
pivotal trial is expected occur in mid calendar 2006.
In addition to tesmilifene, YM BioSciences is developing nimotuzumab, an
anti-EGFr humanized monoclonal antibody, in a number of indications. A Phase
II monotherapy trial of nimotuzumab produced cytotoxic effect and evidence of
survival benefit in children with brain cancer. YM BioSciences is also
developing its anti-GnRH, anti-cancer vaccine, Norelin(TM), for which Phase II
data have been released. In May 2005, the Company acquired DELEX Therapeutics
Inc., a private clinical stage biotechnology company developing AeroLEF(TM), a
unique inhalation delivered formulation of the established drug, fentanyl, to
treat acute pain including cancer pain. This product has completed a Phase IIa
trial with positive results and randomized a Phase IIb pain trial has been
cleared to start. The Company also has a broad portfolio of preclinical
compounds shown to act as chemopotentiators while protecting normal cells.
Except for historical information, this press release may contain
forward-looking statements, which reflect the Company's current expectation
regarding future events. These forward-looking statements involve risk and
uncertainties, which may cause but are not limited to, changing market
conditions, the successful and timely completion of clinical studies, the
establishment of corporate alliances, the impact of competitive products and
pricing, new product development, uncertainties related to the regulatory
approval process and other risks detailed from time to time in the Company's
ongoing quarterly and annual reporting.
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Balance Sheets
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
September 30, June 30,
2005 2005
-------------------------------------------------------------------------
(Unaudited)
Assets
Current assets:
Cash and cash equivalents $ 24,914,798 $ 686,373
Short-term deposits - 29,882,472
Marketable securities 4,834 4,834
Accounts receivable and prepaid expenses 2,000,422 1,751,373
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26,920,054 32,325,052
Capital assets 220,765 226,698
Acquired technologies 6,981,897 5,648,141
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$ 34,122,716 $ 38,199,891
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Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $ 2,515,503 $ 2,995,457
Accrued liabilities 789,797 830,158
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3,305,300 3,825,615
Deferred revenue 887,440 534,157
Shareholders' equity:
Share capital 89,214,586 87,487,802
Share purchase warrants 5,313,283 5,313,283
Contributed surplus 2,077,847 1,790,928
Deficit accumulated during the development
stage (66,675,740) (60,751,894)
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29,929,976 33,840,119
Going concern
Commitments
Subsequent event
-------------------------------------------------------------------------
$ 34,122,716 $ 38,199,891
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YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Statements of Operations
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Period from
inception on
August 17,
Three months ended 1994 to
September 30, September 30,
2005 2004 2005
-------------------------------------------------------------------------
(Unaudited) (Unaudited)
Revenue $ 88,508 $ 361,378 $ 836,528
Interest income 154,499 107,096 3,646,790
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243,007 468,474 4,483,318
Expenses:
General and administrative 1,427,899 1,258,032 22,575,628
Licensing and product
development 4,776,009 1,323,704 46,634,346
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6,203,908 2,581,736 69,209,974
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Loss before the undernoted (5,960,901) (2,113,262) (64,726,656)
Unrealized gain (loss) on
foreign exchange 37,055 (155,437) 37,055
Unrealized loss on marketable
securities - - (1,827,038)
Gain on sale of marketable
securities - - 638,332
-------------------------------------------------------------------------
Loss before income taxes (5,923,846) (2,268,699) (65,878,307)
Income taxes - - 7,300
-------------------------------------------------------------------------
Loss for the period $ (5,923,846) $ (2,268,699) $(65,885,607)
-------------------------------------------------------------------------
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Basic and diluted loss per
common share $ (0.15) $ (0.08)
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Weighted average number of
common shares outstanding,
excluding 2,380,953 common
shares held in escrow for
contingent additional
payment related to the
Delex acquisition 38,788,715 28,689,212
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YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Statements of Deficit Accumulated During the
Development Stage
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Period from
inception on
August 17,
Three months ended 1994 to
September 30, September 30,
2005 2004 2005
-------------------------------------------------------------------------
(Unaudited) (Unaudited)
Deficit, beginning of period $(60,751,894) $(44,319,267) $ -
Cost of purchasing shares for
cancellation in excess of book
value - - (790,133)
Loss for the period (5,923,846) (2,268,699) (65,885,607)
-------------------------------------------------------------------------
Deficit, end of period $(66,675,740) $(46,587,966) $(66,675,740)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Statements of Cash Flows
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Period from
inception on
August 17,
Three months ended 1994 to
September 30, September 30,
2005 2004 2005
-------------------------------------------------------------------------
(Unaudited) (Unaudited)
Cash provided by (used in):
Operating activities:
Loss for the period $ (5,923,846) $ (2,268,699) $(65,885,607)
Items not involving cash:
Depreciation of capital
assets 12,564 784 283,228
Amortization of acquired
technologies 228,528 - 366,288
Gain on sale of marketable
securities - - (638,332)
Unrealized loss on
marketable securities - - 1,827,039
Stock-based employee
compensation 286,919 169,172 2,135,069
Stock-based consideration 100,000 - 292,750
Change in non-cash operating
working capital:
Accounts receivable and
prepaid expenses (249,049) 54,703 (1,080,803)
Accounts payable, accrued
liabilities and deferred
revenue (265,032) (13,558) 3,294,895
-----------------------------------------------------------------------
(5,809,916) (2,057,598) (59,405,473)
Financing activities:
Net proceeds on issuance of
shares and share warrants - 18,972,307 80,654,111
Repayment of debenture - - (1,469,425)
Issue of common shares on
exercise of options 162,500 47,417 1,816,193
Issue of common shares on
exercise of warrants - - 654,750
Redemption of preferred
shares - - (2,630,372)
Repurchase of common shares - - (1,029,679)
-----------------------------------------------------------------------
162,500 19,019,724 77,995,578
Investing activities:
Additions to capital assets (6,631) - (303,993)
Short-term deposits, net 29,882,472 14,893,951 -
Proceeds on sale of
marketable securities - - 1,402,239
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29,875,841 14,893,951 1,098,246
-------------------------------------------------------------------------
Increase in cash and cash
equivalents 24,228,425 31,856,077 19,688,351
Cash assumed on purchase of
Delex - - 5,226,447
Cash and cash equivalents,
beginning of period 686,373 5,493,907 -
-------------------------------------------------------------------------
Cash and cash equivalents,
end of period $ 24,914,798 $ 37,349,984 $ 24,914,798
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Supplemental cash flow
information:
Non-cash items:
Issuance of 396,825 shares
from escrow on Delex
acquisition $ 1,464,284 $ - $ 11,326,981
Issuance of 26,316 common
shares in exchange for
licensed patents 100,000 - 100,000
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For further information: Enquiries: James Smith, the Equicom Group Inc.,
Tel. (416) 815-0700 x 229, Fax (416) 815-0080, Email:
jsmith(at)equicomgroup.com; YM BioSciences Inc., Tel. (905) 629-9761, Fax
(905) 629-4959, Email: ir(at)ymbiosciences.com
(YM. YMI)
END
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