YM BioSciences reports 2005 year end operational and financial results
MISSISSAUGA, Sept. 12 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,
AIM:YMBA), the cancer product development company, today reported operational
and financial results for the fourth quarter and the 2005 fiscal year, ended
June 30, 2005.
"Our primary focus during fiscal 2005 was to ensure the rapid enrolment
of the second and pivotal Phase III trial for tesmilifene in metastatic or
recurrent breast cancer. We have enrolled 662 patients to date, expect to
complete enrolment for this trial in the coming weeks and anticipate that the
first of three pre-selected interim analyses of data will occur in mid
calendar 2006," said David Allan, Chairman and CEO. "If survival results 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 conclude the trial based on these results permitting YM to
submit the drug for approval during 2006 or early 2007."
Tesmilifene highlights:
- Enrolled 662 patients to date in the 700 patient pivotal trial for
tesmilifene
- Phase II IND combining tesmilifene with taxanes in metastatic breast
cancer was approved
- Partnered with the Shin Poong Pharmaceutical Company of Seoul,
South Korea to expand the development program for tesmilifene into
gastric cancer
Nimotuzumab (TheraCIM) highlights:
- Orphan Drug Designation obtained for the use of nimotuzumab for
glioma in both Europe and the USA
- A rolling Phase I/II trial for nimotuzumab in patients with
metastatic pancreatic cancer was initiated by European development
partner Oncoscience AG.
- Results reported of a nimotuzumab trial conducted in China in
patients diagnosed with squamous cell nasopharyngeal carcinoma.
Patients treated with nimotuzumab combined with radiotherapy versus
radiotherapy alone demonstrated a 75% improvement in the complete
response rate (91% vs 52%), leading to the drug being approved in
that country.
- Results reported of a nimotuzumab Phase II monotherapy trial
conducted by Oncoscience AG in children with brain cancer in
Germany. The trial with nimotuzumab resulted in an overall response
rate to treatment of 35.3%.
- The FDA approved the use of nimotuzumab as a monotherapy for the
treatment of a child with advanced glioma under an
investigator-sponsored IND.
- Results presented in a poster at ASCO of an open label Phase I/II
trial conducted by CIMAB S.A. utilizing nimotuzumab in combination
with radiation to treat adults with high grade malignant glioma. Out
of 24 patients, four achieved complete response (complete
disappearance of tumour) and 21 patients achieved disease
stabilization or an objective response
- Partnered with Kuhnil Pharmaceutical Company of Seoul, Korea to
develop nimotuzumab for specific populations of patients with
non-small cell lung cancer (NSCLC). Subsequent to the end of the
fiscal year, Health Canada cleared YM's Clinical Trial Application
(CTA) for the multi-center Phase I/II NSCLC trial, which is planned
to be initiated in Canada and expanded to Korea
Other highlights:
- Acquired DELEX Therapeutics, a private company developing
AeroLEF(TM), a proprietary, inhalation-delivered formulation of
fentanyl for the treatment of acute pain, including breakthrough
cancer pain that has completed a Phase IIa trial with positive
results
- Completed a positive proof-of-concept study for Norelin(TM) in men
with hormone-dependent prostate cancer
- Acquired a portfolio of important earlier stage chemopotentiating
small molecules from the University of Saskatchewan (subsequent to
the end of the fiscal year)
- Raised more than $20 million
- Registered in the USA with the Securities and Exchange Commission
(SEC) and listed on the American Stock Exchange (AMEX)
"Our second anti-cancer drug, nimotuzumab, is undergoing an extensive
multi-national clinical program addressing a range of cancer indications. This
program reflects the creative strategies we are using to generate clinical
data through partnering efforts and by targeting orphan and orphan-like
markets typically overlooked by our competitors, thereby minimizing costs,
encouraging support from regulators, and maximizing market potential," added
Mr. Allan. "As a result of this strategy, we have positioned YM to possibly
have two pivotal trials underway during this current fiscal year."
Anticipated Milestones for fiscal 2006:
- Complete enrollment for pivotal tesmilifene trial
- Oncoscience to initiate pivotal nimotuzumab trials in adult and
paedeatric glioma
- Oncoscience to report results of the first portion of the Phase I/II
nimotuzumab metastatic pancreatic trial
- Initiate nimotuzumab Phase I/II NSCLC trial
- Initiate and complete Phase IIb efficacy trial for AeroLEF(TM)
- First review of tesmilifene pivotal data possible under Sequential
Analysis
Financial Results
During the fiscal year ended June 30, 2005, the Company expended
$17.3 million on the development and commercialization of licensed products
and on administration, compared to $8.7 million for the fiscal year ended
June 30, 2004. The loss for the fiscal year ended June 30, 2005 was
$15.9 million or ($0.47) per share, compared to $7.7 million or ($0.36) per
share for the fiscal year ended June 30, 2004.
During the 2005 fiscal year, the Company funded licensing and product
development activities totaling $11.0 million compared to $5.1 million for the
previous year. Licensing and product development expenses increased this year
due to progression of the tesmilifene Phase III clinical trial, increased
out-licensing activity, and the inclusion of Delex results for two months.
General and administrative expenses for the 2005 fiscal year totaled
$6.3 million compared to $3.6 million for the prior year. General and
administrative expenses increased in 2005 over 2004 due to higher legal costs,
stock-exchange and investor-related costs and stock-based compensation
expense.
Total expenditures for the fourth quarter ended June 30, 2005 were
$6.9 million compared to $3.4 million for the same quarter last year. General
and administrative expenses for the fourth quarter of 2005 were $2.3 million
compared to $1.5 million for the fourth quarter of 2004. This year includes an
increase in expenditures for tesmilifene of approximately $2.3 million
principally for the Phase III clinical trial in metastatic and recurrent
breast cancer that commenced March, 2004. Licensing and product development
expenses were $4.6 million for the fourth quarter of 2005 compared to
$1.9 million for the same quarter last year, principally due to increased
stock exchange and investor-related expenses. The Company's stock began
trading on AMEX on October 1, 2004. Net loss for the three months ended
June 30, 2005 was $6.7 million or ($0.18) per share compared to $3.0 million
or ($0.10) per share for the same period last year.
As at June 30, 2005 the Company had cash and short-term deposits totaling
$30.6 million and current liabilities of $3.8 million compared with
$20.4 million and $1.2 million respectively as at June 30, 2004. On
September 30, 2004 the Company completed a bought deal public offering for
total gross proceeds of $20.8 million (net $18.6 million). The Company
anticipates that it has sufficient cash to support its current development
program to beyond the end of fiscal 2006.
As at June 30, 2005 the Company had 41,362,066 common shares outstanding,
10,745,007 warrants, and 3,169,330 options.
AGM Announcement
YM BioSciences' Annual and Special Meeting of Shareholders will be held
on November 17th, 2005 at 10:00 a.m. in the auditorium of the TSX Broadcast &
Conference Centre, The Exchange Tower, 130 King Street West, Toronto, Ontario.
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, YM BioSciences is developing nimotuzumab, an
anti-EGFr humanized monoclonal antibody for which Phase II clinical data were
released in 2005 in pediatric glioma and nasopharyngeal cancer, and for which
Phase III IND applications have been filed. The Company is also developing an
anti-GnRH anti-cancer vaccine, Norelin(TM), for which Phase II data have been
released. In May 2005, YM BioSciences acquired DELEX Therapeutics Inc., a
private, clinical stage company developing AeroLEF(TM), a unique inhalation
delivered formulation of the established drug, fentanyl, to treat acute pain
including cancer pain. This product has been cleared by regulatory authorities
to advance AeroLEF(TM) through a Phase IIb pain trial in 2005. The Company
also has a broad portfolio of preclinical compounds shown to act as
chemopotentiators while protecting normal cells, consistent with YM's clinical
expansion with the chemopotentiator tesmilifene.
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)
Consolidated Balance Sheets
(Amounts in Canadian dollars, unless otherwise noted)
June 30, 2005 and 2004
-------------------------------------------------------------------------
2005 2004
-------------------------------------------------------------------------
(Restated -
note 1(n))
Assets
Current assets:
Cash and cash equivalents $ 686,373 $ 5,493,907
Short-term deposits 29,882,472 14,893,951
Marketable securities 4,834 19,715
Accounts receivable and prepaid expenses 1,751,373 463,838
-----------------------------------------------------------------------
32,325,052 20,871,411
Capital assets 226,698 11,381
Acquired technologies 5,648,141 -
-------------------------------------------------------------------------
$ 38,199,891 $ 20,882,792
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $ 2,995,457 $ 993,272
Accrued liabilities 830,158 170,439
Current portion of deferred revenue 206,770 -
-----------------------------------------------------------------------
4,032,385 1,163,711
Deferred revenue 327,387 -
Shareholders' equity:
Share capital 87,487,802 59,841,914
Share purchase warrants 5,313,283 3,627,239
Contributed surplus 1,790,928 569,195
Deficit accumulated during the
development stage (60,751,894) (44,319,267)
-----------------------------------------------------------------------
33,840,119 19,719,081
Commitments
-------------------------------------------------------------------------
$ 38,199,891 $ 20,882,792
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Consolidated Statements of Operations and
Deficit Accumulated During the Development Stage
(Amounts in Canadian dollars, unless otherwise noted)
-------------------------------------------------------------------------
From
inception on
August 17,
1994 to
Years ended June 30, June 30,
2005 2004 2003 2005
-------------------------------------------------------------------------
(Restated - note 1(n))
Revenue $ 748,020 $ - $ - $ 748,020
Interest income 703,873 347,187 273,232 3,492,291
-------------------------------------------------------------------------
1,451,893 347,187 273,232 4,240,311
Expenses:
General and
administrative 6,314,357 3,610,848 1,936,364 21,147,729
Licensing and
product
development 10,981,950 5,066,569 3,965,385 41,858,337
-----------------------------------------------------------------------
17,296,307 8,677,417 5,901,749 63,006,066
-------------------------------------------------------------------------
Loss before the
undernoted (15,844,414) (8,330,230) (5,628,517) (58,765,755)
Gain on sale of
marketable
securities - 638,332 - 638,332
Unrealized loss on
marketable
securities (14,881) - (1,812,158) (1,827,038)
-------------------------------------------------------------------------
Loss before
income taxes (15,859,295) (7,691,898) (7,440,675) (59,954,461)
Income taxes - - - 7,300
-------------------------------------------------------------------------
Loss for the
period (15,859,295) (7,691,898) (7,440,675) (59,961,761)
Deficit,
beginning of
period, as
restated (44,319,267) (36,470,665) (28,969,893) -
Cost of
purchasing
shares for
cancellation
in excess of
book value (573,332) (156,704) (60,097) (790,133)
-------------------------------------------------------------------------
Deficit, end of
period $(60,751,894) $(44,319,267) $(36,470,665) $(60,751,894)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Basic and diluted
loss per common
share $ (0.47) $ (0.36) $ (0.56)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Weighted average
number of common
shares outstanding
(excludes 2,777,778
common shares held
in escrow for
contingent
additional payment
related to the
acquisition of
Delex Therapeutics
Inc.) 34,046,450 21,353,479 13,218,177
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Consolidated Statements of Cash Flows
(Amounts in Canadian dollars, unless otherwise noted)
-------------------------------------------------------------------------
From
inception on
August 17,
1994 to
Years ended June 30, June 30,
2005 2004 2003 2005
-------------------------------------------------------------------------
(Restated - note 1(n))
Cash provided by
(used in):
Operating
activities:
Loss for the
period $(15,859,295) $ (7,691,898) $ (7,440,675) $(59,961,761)
Items not
involving cash:
Depreciation
of capital
assets 11,717 14,910 59,640 270,664
Amortization
of acquired
technologies 137,760 - - 137,760
Unrealized loss
on marketable
securities 14,881 - 1,812,158 1,827,039
Gain on sale of
marketable
securities - (638,332) - (638,332)
Stock-based
compensation 1,278,955 500,375 68,820 1,848,150
Non-cash
issuance of
warrants 192,750 - - 192,750
Change in
non-cash
operating
working capital:
Accounts
receivable and
prepaid
expenses (367,916) (295,651) 21,927 (831,754)
Accounts payable
and accrued
liabilities and
deferred
revenue 2,396,216 841,128 (51,803) 3,559,927
-----------------------------------------------------------------------
(12,194,932) (7,269,468) (5,529,933) (53,595,557)
Financing
activities:
Repayment of
debenture (1,469,425) - - (1,469,425)
Issuance of
common shares
on exercise of
options 109,318 1,544,375 - 1,653,693
Issuance of
common shares
on exercise of
warrants 432,402 222,348 - 654,750
Redemption of
preferred shares - - (80,372) (2,630,372)
Repurchase of
common shares (779,909) (230,379) (19,390) (1,029,679)
Net proceeds from
issuance of
shares and
special
warrants 18,884,120 17,047,001 - 80,654,111
-----------------------------------------------------------------------
17,176,506 18,583,345 (99,762) 77,833,078
Investing
activities:
Short-term
deposits, net (14,988,521) (14,893,951) - (29,882,472)
Proceeds on sale
of marketable
securities - 1,402,239 - 1,402,239
Restricted cash - - 600,000 -
Additions to
capital assets (27,034) (3,724) (2,361) (297,362)
-----------------------------------------------------------------------
(15,015,555) (13,495,436) 597,639 (28,777,595)
-------------------------------------------------------------------------
Decrease in cash
and cash
equivalents (10,033,981) (2,181,559) (5,032,056) (4,540,074)
Cash assumed on
acquisition of
Delex 5,226,447 - - 5,226,447
Cash and cash
equivalents,
beginning of
period 5,493,907 7,675,466 12,707,522 -
-------------------------------------------------------------------------
Cash and cash
equivalents, end
of period $ 686,373 $ 5,493,907 $ 7,675,466 $ 686,373
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Non-cash items:
Issuance of
3,412,698 common
shares on Delex
acquisition $ 9,862,697 $ - $ - $ 9,862,697
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Excerpt to notes to consolidated financial statements
(Amounts in Canadian dollars, unless otherwise noted)
-------------------------------------------------------------------------
1. Significant accounting policies (continued):
(n) Changes in accounting policies:
(i) Stock-based compensation:
Prior to July 1, 2004, the Company applied the fair
value-based method of accounting prescribed by The Canadian
Institute of Chartered Accountants' ("CICA") Handbook Section
3870, Stock-based Compensation and Other Stock-based
Payments, only to stock based compensation provided to
non-employees and applied the settlement method of accounting
to stock options granted to employees and directors.
CICA Handbook Section 3870, Stock-based Compensation and
Other Stock-based Payments, was amended to require entities
to account for stock-based compensation to employees using
the fair value-based method. In accordance with one of the
transitional options permitted under amended Section 3870,
the Company retroactively applied the fair value-based method
to all employee stock options granted on or after July 1,
2002, and has restated prior periods. The effect of
retroactively adopting the fair value-based method is to
increase general and administrative expenses and the loss for
the period by $480,524 and $58,855 for the years ended June
30, 2004 and 2003, respectively, with corresponding increases
to the deficit and contributed surplus. This change had the
effect of increasing the annual basic and diluted loss per
share by $0.02 in 2004 with no change in 2003.
This retroactive change in accounting policy also affected
disclosures made in note 8, stock-based compensation, and to
note 12, Canadian and United States accounting policy
differences.
(ii) Consolidation of variable interest entities:
In June 2003, the CICA issued Accounting Guideline 15,
Consolidation of Variable Interest Entities ("AcG-15"). The
guideline is harmonized with Financial Accounting Standards
Board Interpretation No. 46R, Consolidation of Variable
Interest Entities ("Fin 46R") and provides guidance for
applying the principles in Section 1590, Subsidiaries, to
those entities (defined as variable interest entities
("VIEs") and more commonly referred to as special purposes
entities), in which either there is insufficient equity to
permit the entity to finance its activities without
additional subordinated financial support from other parties
or the equity investors lack one or more specified essential
characteristics of a controlling financial interest (i.e.,
voting control, an obligation to absorb expected losses or
the right to receive expected residual returns). AcG-15
requires consolidation of VIEs by the primary beneficiary.
The primary beneficiary is defined as the party which has
exposure to the majority of the VIEs expected losses and/or
expected residual returns. AcG-15, as amended, is effective
for all annual and interim periods beginning on or after
November 1, 2004.
Effective January 1, 2005, the Company has adopted AcG-15
retroactively since the date of inception of the joint
ventures. In accordance with AcG-15, the Company determined
that each of its investments in joint ventures is a VIE and
the Company is the primary beneficiary since inception of the
entities. As set out in note 1(a) of the Company's annual
financial statements, the Company proportionately
consolidated the joint ventures and made provision for any
advances to the joint ventures that did not eliminate on
consolidation, such that the Company has recorded 100% of the
results of operations and cash flows of these entities since
their inception. Accordingly, there is no effect on the
Company's financial position or results of operations as a
result of the Company retroactively adopting AcG-15 at
January 1, 2005.
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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