YM BioSciences reports third quarter 2005 operational and financial
results
MISSISSAUGA, ON, May 12 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,
AIM:YMBA), the cancer product development company with an advanced-stage
portfolio, today reported operational and financial results for the third
quarter of fiscal 2005, ended March 31, 2005.
"YM has delivered another successful quarter. TheraCIM hR3 yielded
positive results from a Phase II trial in children with brain cancer who had
failed all other treatments. Furthermore, YM has been advised that the
licensee of TheraCIM hR3 for China obtained approval for the drug in that
country. For the pivotal Phase III trial of our lead drug, tesmilifene,
recruitment approached 50% of the targeted 700 patients at the end of the
quarter and this milestone has now been surpassed," said David Allan, Chairman
and CEO of YM BioSciences. "Subsequent to the end of the quarter, we broadened
our product portfolio significantly with the acquisition of DELEX, adding an
additional late-stage product to our pipeline. We are poised to enter the new
fiscal year with a broad, diverse pipeline focused on the entire cancer market
that should generate a substantial volume of newsflow over the coming months."
Highlights:
- Expanded the development program for tesmilifene into gastric cancer
and into Asia, by partnering with Shin Poong (Seoul, Korea).
- Completed the protocol for a tesmilifene trial in metastatic breast
cancer in combination with Taxotere(R) and received approval to
initiate this trial.
- Reported that a Phase II trial in Europe in children with brain
cancer (glioma) utilizing TheraCIM hR3 as a monotherapy achieved an
overall response rate of 35.3%.
- An IND was issued by the FDA for a single-patient clinician
sponsored trial using TheraCIM hR3, a significant advancement in
YM's U.S. regulatory strategy for the drug.
- The licensee for TheraCIM hR3 in China received approval for the
drug in that country for the treatment of nasopharyngeal carcinomas
in combination with radiotherapy. TheraCIM hR3 has also been
approved in Argentina, Colombiaand Cuba for head and neck tumors in
combination with radiotherapy. Although YM's licensing rights for
TheraCIM hR3 do not extend into these territories, this is important
validation for this drug both for its therapeutic value and its
regulatory development.
- 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
cancer pain.
Milestone targets for balance of calendar 2005:
- Tesmilifene: dose first patient in Taxotere(R) Phase II trial
(patient screening underway)
- Tesmilifene: complete recruitment of Phase III metastatic breast
cancer in Q3
- Tesmilifene: complete recruitment of Taxotere(R) Phase II in
metastatic breast cancer
- TheraCIM/Theraloc: initiate randomized Phase III trial in glioma
- TheraCIM: initiate pharmacodynamic study
- AeroLEF(TM): initiate Phase IIb pain trial
- Norelin(TM): disclose data from Phase II extension trial
Enrollment for the Company's tesmilifene breast cancer registration trial
continued as planned, with an additional 144 patients enrolled during the
quarter. At the end of the third quarter, by March 31st, 320 patients had been
randomized to the trial. By May 12th, 414 patients, more than half of YM's
enrolment target, had been randomized from 18 countries in 102 hospitals which
are now participating in the trial. YM continues to anticipate that total
enrollment of the 700 patients planned for the trial will be completed in
calendar third quarter of 2005 and include some 109 hospitals in 20 countries.
A chart showing enrollment and the numbers of sites active is available on
YM BioSciences' website (www.ymbiosciences.com). If the enrolment target is
met and median survival mirrors that reported in the initial tesmilifene Phase
III trial, then the Company continues to anticipate that it may submit
tesmilifene for FDA approval in late calendar 2006 or early 2007 as a
consequence of an event-based interim analysis agreed to with the FDA.
Financial Results
Total revenue for the quarter ended March 31, 2005 was $203,108 compared
to $120,441 for the same period last year. Total revenue for the first nine
months of the 2005 fiscal year was $1,193,106 compared to $225,203 for the
first nine 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 March 31, 2005 were $4,483,146
compared to $3,138,782 for the same period last year. Total expenditures for
the first nine months of the 2005 fiscal year were $10,443,903 compared to
$5,268,784 for the first nine months of the corresponding period last year.
General and Administrative expenses for the quarter were $1,486,357 and
for the first nine months were $4,003,648 compared to $894,059 and $2,134,638
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 $2,996,789 for the third
quarter and $6,440,255 for the first nine months of the fiscal year compared
to $2,244,723 for the quarter and $3,134,146 for the first nine 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 fiscal third quarter was $4,277,762 and for the year to
date was $9,376,625 compared to $2,264,464 and $4,375,704 respectively for the
same periods last year.
As at March 31, 2005 the Company had cash and short-term deposits
totaling $31,081,073 and current liabilities of $1,018,028 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
current development program through the end of the 2006 fiscal year.
About YM BioSciences
YM BioSciences Inc. is a cancer product 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 hR3, 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 that is in earlier stage clinical trials.
YM BioSciences recently 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 cancer pain.
This product has completed a Phase IIa trial with positive results and DELEX
has sufficient resources to advance AeroLEF(TM) through a Phase IIb pain trial
planned for 2005.
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)
Interim Consolidated Balance Sheets
(Expressed in Canadian dollars)
(Unaudited)
-------------------------------------------------------------------------
March 31, June 30,
2005 2004
-------------------------------------------------------------------------
Assets
Current assets:
Cash and cash equivalents $ 1,049,702 $ 5,493,907
Short-term deposits 30,031,371 14,893,951
Marketable securities 17,576 19,715
Accounts receivable and prepaid expenses 137,582 463,838
-----------------------------------------------------------------------
31,236,231 20,871,411
Capital assets 16,042 11,381
-------------------------------------------------------------------------
$ 31,252,273 $ 20,882,792
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $ 773,876 $ 993,272
Accrued liabilities 244,152 170,439
Current portion of deferred revenue 206,770 -
-----------------------------------------------------------------------
1,224,798 1,163,711
Deferred revenue 379,079 -
Shareholders' equity:
Share capital 77,512,058 59,841,914
Share and unit purchase warrants 5,319,607 3,627,239
Contributed surplus 1,085,955 569,195
Deficit accumulated during the
development stage (54,269,224) (44,319,267)
-----------------------------------------------------------------------
29,648,396 19,719,081
Commitments
Subsequent event
-------------------------------------------------------------------------
$ 31,252,273 $ 20,882,792
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Statements of Operations
(Expressed in Canadian dollars)
(Unaudited)
-------------------------------------------------------------------------
Three months ended Nine months ended
March 31, March 31,
2005 2004 2005 2004
-------------------------------------------------------------------------
Out-licencing
revenue $ 34,461 $ - $ 696,327 $ -
Interest income 168,647 120,441 496,779 225,203
-------------------------------------------------------------------------
203,108 120,441 1,193,106 225,203
Expenses:
General and
administrative 1,486,357 894,059 4,003,648 2,134,638
Licencing and
product
development 2,996,789 2,244,723 6,440,255 3,134,146
-------------------------------------------------------------------------
4,483,146 3,138,782 10,443,903 5,268,784
-------------------------------------------------------------------------
Loss before the
undernoted (4,280,038) (3,018,341) (9,250,797) (5,043,581)
Net gain (loss)
on marketable
securities (2,139) 638,332 (2,139) 638,332
Unrealized gain
(loss) on foreign
exchange 4,415 115,545 (123,689) 29,545
-------------------------------------------------------------------------
Loss before
income taxes (4,277,762) (2,264,464) (9,376,625) (4,375,704)
Income taxes - - - -
-------------------------------------------------------------------------
Loss for the
period $ (4,277,762) $ (2,264,464) $ (9,376,625) $ (4,375,704)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Basic and diluted
loss per common
share $ (0.12) $ (0.10) $ (0.28) $ (0.22)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Weighted average
number of common
shares
outstanding 35,058,608 22,427,475 32,942,273 19,952,844
-------------------------------------------------------------------------
-------------------------------------------------------------------------
-------------------------------
From inception
on August 17,
1994 to
March 31,
2005
-------------------------------
Out-licencing
revenue $ 696,327
Interest income 3,285,197
-------------------------------
3,981,524
Expenses:
General and
administrative 18,837,019
Licencing and
product
development 37,316,642
-----------------------------
56,153,661
-----------------------------
Loss before the
undernoted (52,172,137)
Net gain (loss)
on marketable
securities (1,175,965)
Unrealized gain
(loss) on foreign
exchange (123,689)
-------------------------------
Loss before
income taxes (53,471,791)
Income taxes 7,300
-------------------------------
Loss for the
period $(53,479,091)
-------------------------------
-------------------------------
Basic and diluted
loss per common
share
-------------------------------
-------------------------------
Weighted average
number of common
shares
outstanding
-------------------------------
-------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Statements of Deficit Accumulated During
the Development Stage
(Expressed in Canadian dollars)
(Unaudited)
-------------------------------------------------------------------------
Three months ended Nine months ended
March 31, March 31,
2005 2004 2005 2004
-------------------------------------------------------------------------
Deficit, beginning
of period:
As previously
reported $(49,991,462) $(38,533,600) $(43,779,888) $(36,411,810)
Adjustment to
reflect change
in accounting
for employee
stock options - (205,009) (539,379) (58,855)
-----------------------------------------------------------------------
As restated (49,991,462) (38,738,609) (44,319,267) (36,470,665)
Cost of purchasing
shares for
cancellation
in excess of
book value - - (573,332) (156,704)
Loss for the
period (4,277,762) (2,264,464) (9,376,625) (4,375,704)
-------------------------------------------------------------------------
Deficit, end
of period $(54,269,224) $(41,003,073) $(54,269,224) $(41,003,073)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
-------------------------------
From inception
on August 17,
1994 to
March 31,
2005
-------------------------------
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 (53,479,091)
-------------------------------
Deficit, end
of period $(54,269,224)
-------------------------------
-------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Statements of Cash Flows
(Expressed in Canadian dollars)
(Unaudited)
-------------------------------------------------------------------------
Three months ended Nine months ended
March 31, March 31,
2005 2004 2005 2004
-------------------------------------------------------------------------
Cash provided by
(used in):
Operating activities:
Loss for the
period $ (4,277,762) $ (2,264,464) $ (9,376,625) $ (4,375,704)
Items not
involving cash:
Depreciation 1,010 - 2,730 14,910
Gain on sale of
marketable
securities - (638,332) - (638,332)
Unrealized loss
on marketable
securities 2,139 - 2,139 -
Stock-based
compensation
(note 2) 170,605 157,232 516,760 319,636
Non-cash
issuance
of warrants 192,750 - 192,750 -
Change in non-cash
operating working
capital:
Accounts
receivable
and prepaid
expenses 108,171 (39,975) 326,256 34,212
Accounts payable,
accrued
liabilities
and deferred
revenue 790,478 958,392 440,166 1,138,006
-----------------------------------------------------------------------
(3,012,609) (1,827,147) (7,895,824) (3,507,272)
Financing activities:
Net proceeds
from issuance
of shares and
warrants - - 18,972,307 17,047,001
Exercise of
warrants 312,965 - 312,965 -
Exercise of
options - 27,125 91,067 27,125
Redemption of
preferred shares - - - -
Purchase of shares
for cancellation - - (779,909) (230,379)
-----------------------------------------------------------------------
312,965 27,125 18,596,430 16,843,747
Investing activities:
Purchase of
short-term
deposits (30,031,371) (14,893,951) (30,031,371) (14,893,951)
Redemption of
short-term
deposits - - 14,893,951 -
Proceeds on
sale of
marketable
securities - 1,402,239 - 1,402,239
Additions to
capital assets (4,687) - (7,391) (3,724)
-----------------------------------------------------------------------
(30,036,058) (13,491,712) (15,144,811) (13,495,436)
-------------------------------------------------------------------------
Increase
(decrease) in
cash and cash
equivalents (32,735,702) (15,291,734) (4,444,205) (158,961)
Cash and cash
equivalents,
beginning of
period 33,785,404 22,808,239 5,493,907 7,675,466
-------------------------------------------------------------------------
Cash and cash
equivalents,
end of period $ 1,049,702 $ 7,516,505 $ 1,049,702 $ 7,516,505
-------------------------------------------------------------------------
-------------------------------------------------------------------------
-------------------------------
From inception
on August 17,
1994 to
March 31,
2005
-------------------------------
Cash provided by
(used in):
Operating activities:
Loss for the
period $(53,479,091)
Items not
involving cash:
Depreciation 261,677
Gain on sale of
marketable
securities (638,332)
Unrealized loss
on marketable
securities 1,814,297
Stock-based
compensation
(note 2) 1,085,955
Non-cash
issuance
of warrants 192,750
Change in non-cash
operating working
capital:
Accounts
receivable
and prepaid
expenses (137,582)
Accounts payable,
accrued
liabilities
and deferred
revenue 1,603,877
-------------------------------
(49,296,449)
Financing activities:
Net proceeds
from issuance
of shares and
warrants 80,964,645
Exercise of
warrants 312,965
Exercise of
options 1,635,442
Redemption of
preferred shares (2,630,372)
Purchase of shares
for cancellation (1,029,678)
-------------------------------
79,253,002
Investing activities:
Purchase of
short-term
deposits (44,925,322)
Redemption of
short-term
deposits 14,893,951
Proceeds on
sale of
marketable
securities 1,402,239
Additions to
capital assets (277,719)
-------------------------------
(28,906,851)
-------------------------------
Increase
(decrease) in
cash and cash
equivalents 1,049,702
Cash and cash
equivalents,
beginning of
period -
-------------------------------
Cash and cash
equivalents,
end of period $ 1,049,702
-------------------------------
-------------------------------
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
(YMBA)
END
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