YM BioSciences reports second quarter 2005 operational and
financial results
MISSISSAUGA, ON, Feb. 11 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,
AIM:YMBA), the cancer drug development company with an advanced-stage
portfolio, today reported operational and financial results for the second
quarter of fiscal 2005, ended December 31, 2004.
"During the second quarter we significantly advanced both of the
late-stage anti-cancer drugs in our portfolio. For tesmilifene, enrollment for
our pivotal breast cancer trial continued as planned and we made significant
progress towards broadening the market potential for this drug through
partnerships and by targeting additional cancer indications," said David
Allan, Chairman and CEO of YM BioSciences. "For TheraCIM hR3, our humanized
monoclonal antibody that targets the EGF receptor, progress was made on
numerous fronts; we announced clinical efficacy results from two cancer trials
and trials in additional indications were initiated to broaden the market
potential for this drug as well."
Second Quarter Highlights:
- Received regulatory approval to initiate a metastatic breast
cancer trial for tesmilifene in combination with Taxotere(R).
- Expanded the development program for tesmilifene into gastric
cancer and into Asia, by partnering with Shin Poong (Seoul, Korea)
subsequent to the end of the quarter.
- Obtained Orphan Drug Status for TheraCIM hR3 for glioma by the
FDA for the U.S.
- Oncoscience AG, YM's European development partner, initiated a
monotherapy trial for TheraCIM/Theraloc in metastatic
pancreatic cancer.
- YM's licensor, CIMAB, reported a 90.6% complete response from a
randomized Phase II pivotal nasopharyngeal cancer trial using
TheraCIM h-R3 in combination with radiation.
- Achieved the clinical milestone in a Phase II trial using
TheraCIM/Theraloc in pediatric glioma, being conducted by
Oncoscience AG, permitting the initiation of a pivotal trial for
the drug in this population.
Anticipated milestones for the next quarter ending March 31, 2005:
- Tesmilifene: initiate trial with Taxotere(R)
- TheraCIM/Theraloc: initiate randomized trial in pediatric glioma
- TheraCIM/Theraloc: start staged pivotal trial in adult glioma
- TheraCIM: initiate pharmacodynamic study
- Norelin(TM): data from Phase II extension trial
Milestone targets for balance of calendar 2005:
- Tesmilifene: complete recruitment Phase III metastatic breast
cancer in Q3
- TheraCIM/Theraloc: complete recruitment Phase III glioma
- Tesmilifene: complete recruitment Phase II Taxotere in metastatic
breast cancer
- Expand product pipeline
Enrollment for the Company's tesmilifene breast cancer registration trial
accelerated significantly in the second quarter. At the end of the quarter, by
December 31st, 176 patients had been enrolled in the trial and as at February
10th, 240 patients had been enrolled from 16 countries in 50 of the 74
hospitals which are now open. YM continues to anticipate that enrollment of
the 700 patients in the trial will be completed in calendar third quarter of
2005 and include some 90 hospitals in 20 countries. A chart showing enrollment
and the numbers of sites active is available on YM BioSciences' website under
"Products", then "Tesmilifene". If the enrolment target is met and survival
results are similar to those from the initial tesmilifene Phase III trial,
then the Company should be in position to submit tesmilifene for FDA approval
in late calendar 2006 or early 2007 based on an interim analysis of data, as
previously agreed to with the FDA through a Special Protocol Assessment.
Financial Results
Total revenue for the quarter ended December 31, 2004 was $521,524
compared to $53,156 for the same period last year. Total revenue for the first
six months of the 2005 fiscal year was $989,998 compared to $104,763 for the
first six months of the corresponding period last year. Revenue consisted of
revenue generated from out-licensing agreements and interest revenue. Total
expenditures for the quarter ended December 31, 2004 were $3,379,021 compared
to $1,328,324 for the same period last year. Total expenditures for the first
six months of the 2005 fiscal year were $5,960,757 compared to $2,216,002 for
the first six months of the corresponding period last year. General and
Administrative expenses for the quarter were $1,259,259 and for the first six
months were $2,517,291 compared to $763,486 and $1,326,579 respectively for
the same periods in the prior year. These increases were due principally to
the expensing of employee stock options commencing on July 1, 2004 and the
cost of obtaining a listing on AMEX. YM started trading on AMEX on
October 1, 2004. Licensing and Product Development expenses were $2,119,762
for the second quarter and $3,443,466 for the first six months of the fiscal
year compared to $564,838 for the quarter and $889,423 for the first six
months of last year. Expenditure increases were due primarily to the ramp-up
of the Phase III clinical trial for tesmilifene that commenced in March 2004.
Net loss for the second quarter was $2,830,164 and for the year to date
was $5,098,863 compared to $1,275,168 and $2,111,240 respectively for the same
periods last year.
As at December 31, 2004 the Company had cash and short-term deposits
totaling $33,785,404 and current liabilities of $813,399 compared to
$20,387,858 and $1,163,711 respectively at June 30, 2004. The Company
anticipates that the current cash reserves will be sufficient to support its
development program beyond the 2006 calendar year.
Notice of TheraCIM/Theraloc Results Conference Call
YM and Oncoscience AG will host a teleconference on data from their
Phase II trial in children with brain cancer (glioma) presented at the
European High-Grade Glioma Meeting immediately following that conference on
Monday, February 28, 2005 at 1:00pm EST and may be accessed by calling
+1-416-695-7860 (from Europe) or 1-800-565-5185 (in North America) and
utilizing the participant code 261890.
About YM BioSciences
YM BioSciences Inc. is a cancer drug development company. Its lead drug,
tesmilifene, is a small molecule chemopotentiator currently undergoing a
700-patient pivotal Phase III trial in metastatic and recurrent breast cancer.
Published results from tesmilifene's first Phase III trial in the same
indication demonstrated a substantial increase in survival for women treated
with the combination of tesmilifene and chemotherapy compared to chemotherapy
alone, demonstrating that tesmilifene significantly enhanced the therapeutic
effect of chemotherapy. In addition to tesmilifene, the Company is developing
TheraCIM h-R3, an EGFr humanized monoclonal antibody on which Phase II
clinical data have recently been released in pediatric glioma and
nasopharyngeal cancer, and for which Phase III IND applications have been
filed. The Company also has a GnRH anti-cancer vaccine in that is in earlier
stage clinical trials.
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.
Summary financial statements attached:
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Consolidated Balance Sheet
(Expressed in Canadian dollars)
(Unaudited)
-------------------------------------------------------------------------
December 31, June 30,
2004 2004
-------------------------------------------------------------------------
Assets
Current assets:
Cash and cash equivalents $ 33,785,404 $ 5,493,907
Short-term deposits - 14,893,951
Marketable securities 19,715 19,715
Accounts receivable and prepaid expenses 245,753 463,838
-----------------------------------------------------------------------
34,050,872 20,871,411
Capital assets 12,365 11,381
-------------------------------------------------------------------------
$ 34,063,237 $ 20,882,792
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $ 693,056 $ 993,272
Accrued liabilities 120,343 170,439
-----------------------------------------------------------------------
813,399 1,163,711
Shareholders' equity:
Share capital 77,117,230 59,841,914
Share and unit purchase warrants 5,208,720 3,627,239
Contributed surplus 915,350 569,195
Deficit accumulated during the
development stage (49,991,462) (44,319,267)
-----------------------------------------------------------------------
33,249,838 19,719,081
Commitments
-------------------------------------------------------------------------
$ 34,063,237 $ 20,882,792
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Consolidated Statement of Operations
(Expressed in Canadian dollars)
(Unaudited)
-------------------------------------------------------------------------
Three months ended Six months ended
December 31, December 31,
2004 2003 2004 2003
-------------------------------------------------------------------------
Out-licencing
revenue $ 300,488 $ - $ 661,866 $ -
Interest income 221,036 53,156 328,132 104,762
-------------------------------------------------------------------------
521,524 53,156 989,998 104,762
Expenses:
General and
administrative 1,259,259 763,486 2,517,291 1,326,579
Licensing and
product
development 2,119,762 564,838 3,443,466 889,423
-----------------------------------------------------------------------
3,379,021 1,328,324 5,960,757 2,216,002
-------------------------------------------------------------------------
Loss before the
undernoted (2,857,497) (1,275,168) (4,970,759) (2,111,240)
Net loss on
marketable
securities - - - -
Unrealized gain
(loss) on foreign
exchange 27,333 - (128,104) -
-------------------------------------------------------------------------
Loss before
income taxes (2,830,164) (1,275,168) (5,098,863) (2,111,240)
Income taxes - - - -
--------------------------------------------------------------------------
Loss for the
period $ (2,830,164) $ (1,275,168) $ (5,098,863) $ (2,111,240)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Basic and diluted
loss per common
share $ (0.08) $ (0.07) $ (0.16) $ (0.12)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Weighted average
number of common
shares outstanding 35,125,107 17,418,892 31,906,888 17,430,393
-------------------------------------------------------------------------
-------------------------------------------------------------------------
-------------------------------
From inception
on August 17,
1994 to
December 31,
2004
-------------------------------
Out-licencing
revenue $ 661,866
Interest income 3,116,550
-------------------------------
3,778,416
Expenses:
General and
administrative 17,350,662
Licensing and
product
development 34,319,853
-----------------------------
51,670,515
-------------------------------
Loss before the
undernoted (47,892,099)
Net loss on
marketable
securities (1,173,826)
Unrealized gain
(loss) on foreign
exchange (128,104)
-------------------------------
Loss before
income taxes (49,194,029)
Income taxes 7,300
-------------------------------
Loss for the
period $(49,201,329)
-------------------------------
-------------------------------
Basic and diluted
loss per common
share
-------------------------------
-------------------------------
Weighted average
number of common
shares outstanding
-------------------------------
-------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Consolidated Statement of Deficit Accumulated During the Development
Stage
(Expressed in Canadian dollars)
(Unaudited)
-------------------------------------------------------------------------
Three months ended Six months ended
December 31, December 31,
2004 2003 2004 2003
-------------------------------------------------------------------------
Deficit, beginning
of period:
As previously
reported $(46,587,966) $(37,194,751) $(43,779,888) $(36,411,810)
Adjustment to
reflect change
in accounting
for employee
stock options - (115,101) (539,379) (58,855)
-----------------------------------------------------------------------
As restated (46,587,966) (37,309,852) (44,319,267) (36,470,665)
Cost of purchasing
shares for
cancellation
in excess of
book value (573,332) (153,589) (573,332) (156,704)
Loss for the
period (2,830,164) (1,275,168) (5,098,863) (2,111,240)
-------------------------------------------------------------------------
Deficit, end
of period $(49,991,462) $(38,738,609) $(49,991,462) $(38,738,609)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
-------------------------------
From inception
on August 17,
1994 to
December 31,
2004
-------------------------------
Deficit, beginning
of period:
As previously
reported $ -
Adjustment to
reflect change
in accounting
for employee
stock options -
-------------------------------
As restated -
Cost of purchasing
shares for
cancellation
in excess of
book value (790,133)
Loss for the
period (49,201,329)
-------------------------------
Deficit, end
of period $(49,991,462)
-------------------------------
-------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Consolidated Statement of Cash Flows
(Expressed in Canadian dollars)
(Unaudited)
-------------------------------------------------------------------------
Three months ended Six months ended
December 31, December 31,
2004 2003 2004 2003
-------------------------------------------------------------------------
Cash provided by
(used in):
Operating activities:
Loss for the
period $ (2,830,164) $ (1,275,168) $ (5,098,863) $ (2,111,240)
Items not
involving cash:
Depreciation 936 - 1,720 14,910
Gain on sale of
marketable
securities - - - -
Unrealized loss
on marketable
securities - - - -
Stock-based
compensation 176,983 106,158 346,155 162,404
Change in non-cash
operating working
capital:
Accounts
receivable and
prepaid expenses 163,382 45,585 218,085 74,187
Accounts payable
and accrued
liabilities (336,754) 209,680 (350,312) 179,614
-----------------------------------------------------------------------
(2,825,617) (913,745) (4,883,215) (1,680,125)
Financing activities:
Net proceeds
from issuance
of shares
and warrants - 17,047,001 18,972,307 17,047,001
Exercise of
options 43,650 - 91,067 -
Redemption of
preferred shares - - - -
Purchase of shares
for cancellation (779,909) (225,259) (779,909) (230,379)
-----------------------------------------------------------------------
(736,259) 16,821,742 18,283,465 16,816,622
Investing activities:
Maturity of
short-term deposits - - 14,893,951 -
Proceeds on sale of
marketable
securities - - - -
Additions to
capital assets (2,704) (1,565) (2,704) (3,724)
-----------------------------------------------------------------------
(2,704) (1,565) 14,891,247 (3,724)
-------------------------------------------------------------------------
Increase (decrease)
in cash and cash
equivalents (3,564,580) 15,906,432 28,291,497 15,132,773
Cash and cash
equivalents,
beginning of
period 37,349,984 6,901,807 5,493,907 7,675,466
-------------------------------------------------------------------------
Cash and cash
equivalents,
end of period $ 33,785,404 $ 22,808,239 $ 33,785,404 $ 22,808,239
-------------------------------------------------------------------------
-------------------------------------------------------------------------
-------------------------------
From inception
on August 17,
1994 to
December 31,
2004
-------------------------------
Cash provided by
(used in):
Operating activities:
Loss for the
period $(49,201,329)
Items not
involving cash:
Depreciation 260,667
Gain on sale of
marketable
securities (638,332)
Unrealized loss
on marketable
securities 1,812,158
Stock-based
compensation 915,350
Change in non-cash
operating working
capital:
Accounts
receivable and
prepaid expenses (245,753)
Accounts payable
and accrued
liabilities 813,399
-----------------------------
(46,283,840)
Financing activities:
Net proceeds
from issuance
of shares
and warrants 80,964,645
Exercise of
options 1,635,442
Redemption of
preferred shares (2,630,372)
Purchase of shares
for cancellation (1,029,678)
-----------------------------
78,940,037
Investing activities:
Maturity of
short-term
deposits -
Proceeds on sale
of marketable
securities 1,402,239
Additions to
capital assets (273,032)
-----------------------------
1,129,207
-------------------------------
Increase (decrease)
in cash and cash
equivalents 33,785,404
Cash and cash
equivalents,
beginning of
period -
-------------------------------
Cash and cash
equivalents,
end of period $ 33,785,404
-------------------------------
-------------------------------
For further information: 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
(YMBA YM. YMI)
END
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