MISSISSAUGA, ON, May 12 /PRNewswire-FirstCall/ -- YM BioSciences Inc. , the cancer product development company, today reported operational and financial results for the third quarter of fiscal 2006, ended March 31, 2006.
"With multiple clinical trials ongoing for our three late-stage products, tesmilifene, nimotuzumab, and AeroLEF(TM), it is an exciting, active time at YM with numerous milestone events ahead. For tesmilifene, several early analyses of data from the ongoing pivotal trial will precede the conclusion of the trial which is expected in the first half of 2007. If any of these early analyses produces suitably positive results we will be in position to submit our lead drug, which received fast track designation during the quarter, for FDA approval," said David Allan, Chairman and CEO of YM BioSciences. "The acquisition of Eximias will enable YM to transform into a more fully integrated cancer company with the capability and flexibility to bring our well-advanced products to market. It will ensure YM is well positioned for the prospect of the success of tesmilifene without having to rely solely on a partner for manufacturing and marketing."
Highlights:
- Received FDA Fast Track designation for tesmilifene in advanced breast
cancer.
- Entered into a collaborative agreement with Sanofi-Aventis to
investigate the effect of combining tesmilifene and Taxotere(R)
(docetaxel) for the treatment of women with rapidly progressing
metastatic breast cancer. Enrolment is targeted for completion in
calendar Q3, 2006.
- Enrolled the first patient in YM's multi-center Phase I/II Non-Small-
Cell Lung Cancer (NSCLC) trial of nimotuzumab, our humanized anti-EGFr
monoclonal antibody. YM expects to complete recruitment for the NSCLC
trial in late 2007 or early 2008.
- YM BioSciences partner, Oncoscience AG, commenced patient treatment in
a Phase III trial in Germany with nimotuzumab. Oncoscience expects the
trial should be completed in the first half of 2007.
- Initiated a Phase IIb trial for AeroLEF(TM). The trial is expected to
report preliminary results within the first half of calendar 2006.
- Raised US $40 million through a "registered direct" offering of common
shares.
- Announced its acquisition of Eximias Pharmaceutical Corporation.
Financial Results
Total revenue for the quarter ended March 31, 2006 was $684,456 compared to $203,108 for the same period last year. Total revenue for the first nine months of the 2006 fiscal year was $1,476,693 compared to $1,193,106 for the corresponding nine-month period last year. Revenue consisted of revenue generated from out-licensing agreements and interest income.
Total expenditures for the quarter ended March 31, 2006 were $6,558,668 compared to $4,483,146 for the same period last year. Total expenditures for the first nine months of the 2006 fiscal year were $18,827,093 compared to $10,443,903 for the first nine months of the corresponding period last year.
General and Administrative expenses for the third quarter were $1,876,575 and for the first nine months were $4,558,347 compared to $1,486,357 and $4,003,648, respectively, for the same periods in the prior year. Licensing and Product Development expenses for the third quarter were $4,682,093 and for the first nine months were $14,268,746 compared to $2,996,789 and $6,440,255, respectively, for the same periods in the prior year. Expenditure increases were due primarily to the rapid progression of the tesmilifene Phase III clinical trial and the inclusion of costs associated with the development of the AeroLEF(TM) technology.
Net loss for the third quarter was $5,772,479 and for the year to date was $17,232,617 compared to $4,277,762 and $9,376,625 respectively for the same periods last year.
As at March 31, 2006 the Company had cash and short-term deposits totaling $63,407,634 and current liabilities of $3,686,028 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 currently undergoing a 700-patient pivotal Phase III trial in metastatic and recurrent breast cancer. In addition to tesmilifene, YM BioSciences is developing nimotuzumab, an anti- EGFr humanized monoclonal antibody, in a number of indications and AeroLEF(TM), a unique inhalation delivered formulation of the established drug, fentanyl, to treat acute pain including cancer pain. YM BioSciences is also developing its anti-GnRH, anti-cancer vaccine, Norelin(TM), and owns a portfolio of preclinical compounds.
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)
-------------------------------------------------------------------------
March 31, June 30,
2006 2005
-------------------------------------------------------------------------
(Unaudited)
Assets
Current assets:
Cash and cash equivalents $ 11,301,848 $ 686,373
Short-term deposits 52,105,786 29,882,472
Marketable securities 4,834 4,834
Accounts receivable and prepaid expenses 1,362,866 1,751,373
-----------------------------------------------------------------------
64,775,334 32,325,052
Capital assets 236,929 226,698
Acquired technologies 6,450,339 5,648,141
-------------------------------------------------------------------------
$ 71,462,602 $ 38,199,891
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $ 2,917,939 $ 2,995,457
Accrued liabilities 866,089 830,158
-----------------------------------------------------------------------
3,784,028 3,825,615
Deferred revenue 1,767,146 534,157
Shareholders' equity:
Share capital 136,435,893 87,487,802
Share purchase warrants 4,864,165 5,313,283
Contributed surplus 2,595,881 1,790,928
Deficit accumulated during the
development stage (77,984,511) (60,751,894)
-----------------------------------------------------------------------
65,911,428 33,840,119
Basis of presentation
Commitments
Subsequent event
-------------------------------------------------------------------------
$ 71,462,602 $ 38,199,891
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Statements of Operations
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
Three months ended Nine months ended
March 31, March 31,
2006 2005 2006 2005
-------------------------------------------------------------------------
(Unaudited) (Unaudited)
Out-licensing
revenue $ 498,861 $ 34,461 $ 966,611 $ 696,327
Interest income 185,595 168,647 510,082 496,779
-------------------------------------------------------------------------
684,456 203,108 1,476,693 1,193,106
Expenses:
General and
administrative 1,876,575 1,486,357 4,558,347 4,003,648
Licensing and
product
development 4,682,093 2,996,789 14,268,746 6,440,255
-----------------------------------------------------------------------
6,558,668 4,483,146 18,827,093 10,443,903
-------------------------------------------------------------------------
Loss before the
undernoted (5,874,212) (4,280,038) (17,350,400) (9,250,797)
Gain (loss) on
sale of marketable
securities - (2,139) - (2,139)
Unrealized loss
on marketable
securities - - - -
Unrealized gain
(loss) on foreign
exchange 101,733 4,415 117,783 (123,689)
-------------------------------------------------------------------------
Loss before income
taxes (5,772,479) (4,277,762) (17,232,617) (9,376,625)
Income taxes - - - -
-------------------------------------------------------------------------
Loss for the
period $ (5,772,479) $ (4,277,762) $(17,232,617) $ (9,376,625)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Basic and diluted
loss per common
share $ (0.13) $ (0.12) $ (0.42) $ (0.28)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Weighted average
number of common
shares outstanding,
excluding common
shares held in
escrow for
contingent
additional
payment related
to the Delex
acquisition 44,009,338 35,058,608 40,613,971 32,942,273
-------------------------------------------------------------------------
-------------------------------------------------------------------------
-------------------------------
Period from
inception on
August 17,
1994 to
March 31,
2006
-------------------------------
(Unaudited)
Out-licensing
revenue $ 1,714,631
Interest income 4,002,373
-------------------------------
5,717,004
Expenses:
General and
administrative 25,706,076
Licensing and
product
development 56,127,083
-----------------------------
81,833,159
-------------------------------
Loss before the
undernoted (76,116,155)
Gain (loss) on
sale of marketable
securities 638,332
Unrealized loss
on marketable
securities (1,827,038)
Unrealized gain
(loss) on foreign
exchange 117,783
-------------------------------
Loss before income
taxes (77,187,078)
Income taxes 7,300
-------------------------------
Loss for the
period $(77,194,378)
-------------------------------
-------------------------------
Basic and diluted
loss per common
share
-------------------------------
-------------------------------
Weighted average
number of common
shares outstanding,
excluding common
shares held in
escrow for
contingent
additional
payment related
to the Delex
acquisition
-------------------------------
-------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Statements of Deficit Accumulated During the
Development Stage
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
Three months ended Nine months ended
March 31, March 31,
2006 2005 2006 2005
-------------------------------------------------------------------------
(Unaudited) (Unaudited)
Deficit, beginning
of period $(72,212,032) $(49,991,462) $(60,751,894) $(44,319,267)
Cost of purchasing
shares for
cancellation in
excess of book
value - - - (573,332)
Loss for the
period (5,772,479) (4,277,762) (17,232,617) (9,376,625)
-------------------------------------------------------------------------
Deficit, end of
period $(77,984,511) $(54,269,224) $(77,984,511) $(54,269,224)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
-------------------------------
Period from
inception on
August 17,
1994 to
March 31,
2006
-------------------------------
(Unaudited)
Deficit, beginning
of period $ -
Cost of purchasing
shares for
cancellation in
excess of book
value (790,133)
Loss for the
period (77,194,378)
-------------------------------
Deficit, end of
period $(77,984,511)
-------------------------------
-------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Statements of Cash Flows
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
Three months ended Nine months ended
March 31, March 31,
2006 2005 2006 2005
-------------------------------------------------------------------------
(Unaudited) (Unaudited)
Cash provided by
(used in):
Operating activities:
Loss for the
period $ (5,772,479) $ (4,277,762) $(17,232,617) $ (9,376,625)
Items not
involving cash:
Amortization of
capital assets 16,151 1,010 41,320 2,730
Amortization of
acquired
technology 263,715 - 760,086 -
Gain on sale of
marketable
securities - 2,139 - 2,139
Unrealized loss
on marketable
securities - - - -
Stock-based
employee
compensation 644,676 170,605 1,195,417 516,760
Stock-based
consideration - 192,750 100,000 192,750
Warrants-based
consideration 54,775 - 54,775 -
Change in non-
cash operating
working capital:
Accounts
receivable
and prepaid
expenses 442,277 108,171 388,507 326,256
Accounts payable,
accrued
liabilities
and deferred
revenue 1,417,075 790,478 1,093,402 440,166
-----------------------------------------------------------------------
(2,933,810) (3,012,609) (13,599,110) (7,895,824)
Financing activities:
Issuance of common
shares on
exercise of
warrants 2,912,559 312,965 3,098,474 312,965
Repayment of
debenture - - - -
Net proceeds from
issuance of
shares and
warrants 42,622,618 - 42,622,618 18,972,307
Issuance of
common shares
on exercise of
options 546,108 - 768,358 91,067
Redemption of
preferred
shares - - - -
Purchase of
shares for
cancellation - - - (779,909)
-----------------------------------------------------------------------
46,081,285 312,965 46,489,450 18,596,430
Investing activities:
Purchase short-
term deposits,
net (52,105,786) (30,031,371) (22,223,314) (15,137,420)
Proceeds on sale
of marketable
securities - - - -
Additions to
capital assets (40,833) (4,687) (51,551) (7,391)
-----------------------------------------------------------------------
(52,146,619) (30,036,058) (22,274,865) (15,144,811)
-------------------------------------------------------------------------
Increase (decrease)
in cash and cash
equivalents (8,999,144) (32,735,702) 10,615,475 (4,444,205)
Cash assumed on
purchase of Delex - - - -
Cash and cash
equivalents,
beginning of
period 20,300,992 33,785,404 686,373 5,493,907
-------------------------------------------------------------------------
Cash and cash
equivalents,
end of period $ 11,301,848 $ 1,049,702 $ 11,301,848 $ 1,049,702
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Supplemental cash
flow information:
Non-cash items:
Issuance of
shares on
Delex
acquisition $ - $ - $ 1,464,284 $ -
Issuance of
26,316 common
shares in
exchange for
licensed
patents - - 100,000 -
-------------------------------------------------------------------------
-------------------------------------------------------------------------
-------------------------------
Period from
inception on
August 17,
1994 to
March 31,
2006
-------------------------------
(Unaudited)
Cash provided by
(used in):
Operating activities:
Loss for the
period $(77,194,378)
Items not
involving cash:
Amortization of
capital assets 311,985
Amortization of
acquired
technology 897,846
Gain on sale of
marketable
securities (638,332)
Unrealized loss
on marketable
securities 1,827,038
Stock-based
employee
compensation 3,043,567
Stock-based
consideration 292,750
Warrants-based
consideration 54,775
Change in non-
cash operating
working capital:
Accounts
receivable
and prepaid
expenses (443,247)
Accounts payable,
accrued
liabilities
and deferred
revenue 4,653,328
-----------------------------
(67,194,668)
Financing activities:
Issuance of common
shares on
exercise of
warrants 3,753,226
Repayment of
debenture (1,469,425)
Net proceeds from
issuance of
shares and
warrants 123,276,729
Issuance of
common shares
on exercise of
options 2,422,052
Redemption of
preferred
shares (2,630,372)
Purchase of
shares for
cancellation (1,029,679)
-----------------------------
124,322,531
Investing activities:
Purchase short-
term deposits,
net (52,105,786)
Proceeds on sale
of marketable
securities 1,402,239
Additions to
capital assets (348,915)
-----------------------------
(51,052,462)
-------------------------------
Increase (decrease)
in cash and cash
equivalents 6,075,401
Cash assumed on
purchase of Delex 5,226,447
Cash and cash
equivalents,
beginning of
period -
-------------------------------
Cash and cash
equivalents,
end of period $ 11,301,848
-------------------------------
-------------------------------
Supplemental cash
flow information:
Non-cash items:
Issuance of
shares on
Delex
acquisition $ 11,326,981
Issuance of
26,316 common
shares in
exchange for
licensed
patents 100,000
-------------------------------
-------------------------------
