MISSISSAUGA, ON, Feb. 10 /PRNewswire-FirstCall/ -- YM BioSciences Inc. , the cancer product development company, today reported operational and financial results for the second quarter of fiscal 2006, ended December 31, 2005.
"Important times are ahead. All three of our late-stage products advancing in the clinic with results to be reported this calendar year. For our lead drug tesmilifene, the first of three planned interim analyses of data from our pivotal Phase III metastatic and recurrent breast cancer trial could occur in and around mid calendar 2006," said David Allan, Chairman and CEO of YM BioSciences. "If survival results meet the levels set in the Special Protocol Assessment agreed to with the FDA, data this year could be sufficient to seek regulatory approval."
Other highlights:
- Hypothesis of tesmilifene's mode of action authored by
Dr. Mark Vincent has been published online in Medical Hypotheses,
Vol. 66 No. 4 which together with supporting evidence from numerous
academic laboratories in Canada and the USA suggests that tesmilifene
is a unique molecule, selective for multiple drug resistant cancer
cells, and positively impacts the most common chemotherapies across
multiple tumour types. Drug resistance is widely recognized to be the
"ultimate frontier in the fight against cancer." The article is
available for viewing now online through Elsevier's online journal
site http://www.sciencedirect.com/.
- Entered into a collaborative agreement with Sanofi-Aventis to
investigate the effect of combining tesmilifene and the blockbuster
cancer drug Taxotere(R) (docetaxel) for women with rapidly progressing
metastatic breast cancer. Enrolment is targeted for completion in
calendar Q2, 2006 and pharmacokinetic data could be available by
year-end with survival results possible by year-end 2007.
- Reported positive 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. This indication is now expected to be advanced with the first
randomized trial in this indication and is expected to compare a
standard of care mitoxantrone/prednisone used in Taxotere failures to
the same regimen plus tesmilifene. The primary endpoints will be those
in which the combination appeared to provide significant benefit in
the single arm Phase II - namely the important reduction in pain
suffered by patients at this stage and a reduction in PSA.
- Completed preparations for prospectively pivotal trials in children
with inoperable brain cancer - pontine, or brain-stem glioma - for
submission to the FDA and the European Regulatory Authority, EMEA.
- Partnered with Innogene Kalbiotech Ltd (IGK) of Singapore to expand
the development program for nimotuzumab into Southeast Asia and
Africa.
- Initiated a Phase IIb trial for AeroLEF(TM) subsequent to the end of
the quarter. The trial could complete recruitment and report results
within the first half of calendar 2006.
- Filed and received clearance for a "shelf" prospectus in Canada and
the USA following the end of the quarter. A "shelf" facilitates
financing by a company, reduces the time period during which a company
must otherwise wait for a prospectus to be cleared, permits the sale
to investors of shares without a "hold period" (thus significantly
reducing the cost of capital) and permits the use of freely traded
shares in the case of another acquisition by YM, again significantly
reducing the prospective cost of capital. The "shelf" registration
covers any financing during the forthcoming 25 months.
Financial Results
Total revenue for the quarter ended December 31, 2005 was $549,230 compared to $521,524 for the same period last year. Total revenue for the first six months of the 2006 fiscal year was $792,237 compared to $989,998 for the first six months of the corresponding period last year. Revenue consisted of revenue generated from out-licensing agreements and interest income.
Total expenditures for the quarter ended December 31, 2005 were $6,064,517 compared to $3,379,021 for the same period last year. Total expenditures for the first six months of the 2006 fiscal year were $12,268,425 compared to $5,960,757 for the first six months of the corresponding period last year. General and Administrative expenses for the second quarter were $1,253,873 and for the first six months were $2,681,772 compared to $1,259,259 and $2,517,291 respectively for the same periods in the prior year. Licensing and Product Development expenses for the second quarter were $4,810,644 and for the first six months were $9,586,653 compared to $2,119,762 and $3,443,466 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 second quarter was $5,536,292 and for the year to date was $11,460,138 compared to $2,830,164 and $5,098,863 respectively for the same periods last year.
As at December 31, 2005 the Company had cash and short-term deposits totaling $20,300,992 and current liabilities of $3,335,168 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. 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, in a number of indications. A Phase II monotherapy trial of nimotuzumab produced cytotoxic efficacy and evidence of survival benefit in children with recurrent brain cancer.
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 a randomized Phase IIb pain trial has been initiated. YM BioSciences is also developing its anti-GnRH, anti-cancer vaccine, Norelin(TM), for which Phase II data have been released. The Company also has a 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.
Summary financial statements attached:
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Balance Sheets
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
December 31, June 30,
2005 2005
-------------------------------------------------------------------------
(Unaudited)
Assets
Current assets:
Cash and cash equivalents $ 20,300,992 $ 686,373
Short-term deposits - 29,882,472
Marketable securities 4,834 4,834
Accounts receivable and prepaid expenses 1,805,143 1,751,373
-----------------------------------------------------------------------
22,110,969 32,325,052
Capital assets 212,249 226,698
Acquired technologies 6,714,054 5,648,141
-------------------------------------------------------------------------
$ 29,037,272 $ 38,199,891
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $ 2,504,782 $ 2,995,457
Accrued liabilities 830,386 830,158
-----------------------------------------------------------------------
3,335,168 3,825,615
Deferred revenue 798,932 534,157
Shareholders' equity:
Share capital 89,587,454 87,487,802
Share purchase warrants 5,222,203 5,313,283
Contributed surplus 2,305,547 1,790,928
Deficit accumulated during the
development stage (72,212,032) (60,751,894)
-----------------------------------------------------------------------
24,903,172 33,840,119
Going concern
Commitments
Subsequent events
-------------------------------------------------------------------------
$ 29,037,272 $ 38,199,891
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Statements of Operations
(Expressed in Canadian dollars)
----------------------------------------------------------
Three months ended
December 31,
2005 2004
----------------------------------------------------------
(Unaudited)
Out-licensing revenue $ 379,242 $ 300,488
Interest income 169,988 221,036
----------------------------------------------------------
549,230 521,524
Expenses:
General and administrative 1,253,873 1,259,259
Licensing and product
development 4,810,644 2,119,762
--------------------------------------------------------
6,064,517 3,379,021
----------------------------------------------------------
Loss before the undernoted (5,515,287) (2,857,497)
Gain on sale of marketable
securities - -
Unrealized loss on marketable
securities - -
Unrealized gain (loss) on
foreign exchange (21,005) 27,333
----------------------------------------------------------
Loss before income taxes (5,536,292) (2,830,164)
Income taxes - -
----------------------------------------------------------
Loss for the period $ (5,536,292) $ (2,830,164)
----------------------------------------------------------
----------------------------------------------------------
Basic and diluted loss per
common share $ (0.14) $ (0.08)
----------------------------------------------------------
----------------------------------------------------------
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 39,139,493 35,125,107
----------------------------------------------------------
----------------------------------------------------------
-------------------------------------------------------------------------
Period from
inception on
August 17,
Six months ended 1994 to
December 31, December 31,
2005 2004 2005
-------------------------------------------------------------------------
(Unaudited) (Unaudited)
Out-licensing revenue $ 467,750 $ 661,866 $ 1,215,770
Interest income 324,487 328,132 3,816,778
-------------------------------------------------------------------------
792,237 989,998 5,032,548
Expenses:
General and administrative 2,681,772 2,517,291 23,829,501
Licensing and product
development 9,586,653 3,443,466 51,444,990
-----------------------------------------------------------------------
12,268,425 5,960,757 75,274,491
-------------------------------------------------------------------------
Loss before the undernoted (11,476,188) (4,970,759) (70,241,943)
Gain on sale of marketable
securities - - 638,332
Unrealized loss on marketable
securities - - (1,827,038)
Unrealized gain (loss) on
foreign exchange 16,050 (128,104) 16,050
-------------------------------------------------------------------------
Loss before income taxes (11,460,138) (5,098,863) (71,414,599)
Income taxes - - 7,300
-------------------------------------------------------------------------
Loss for the period $(11,460,138) $ (5,098,863) $(71,421,899)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Basic and diluted loss per
common share $ (0.29) $ (0.16)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
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 38,964,104 31,906,888
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Statements of Deficit Accumulated During the
Development Stage
(Expressed in Canadian dollars)
---------------------------------------------------------
Three months ended
December 31,
2005 2004
----------------------------------------------------------
(Unaudited)
Deficit, beginning of period $(66,675,740) $(46,587,966)
Cost of purchasing shares
for cancellation in excess
of book value - (573,332)
Loss for the period (5,536,292) (2,830,164)
----------------------------------------------------------
Deficit, end of period $(72,212,032) $(49,991,462)
----------------------------------------------------------
----------------------------------------------------------
-------------------------------------------------------------------------
Period from
inception on
August 17,
Six months ended 1994 to
December 31, December 31,
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 - (573,332) (790,133)
Loss for the period (11,460,138) (5,098,863) (71,421,899)
-------------------------------------------------------------------------
Deficit, end of period $(72,212,032) $(49,991,462) $(72,212,032)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Statements of Cash Flows
(Expressed in Canadian dollars)
----------------------------------------------------------
Three months ended
December 31,
2005 2004
----------------------------------------------------------
(Unaudited)
Cash provided by (used in):
Operating activities:
Loss for the period $ (5,536,292) $ (2,830,164)
Items not involving cash:
Amortization of capital
assets 12,605 936
Amortization of acquired
technology 267,843 -
Gain on sale of marketable
securities - -
Unrealized loss on
marketable securities - -
Stock-based employee
compensation 263,822 176,983
Stock-based consideration - -
Change in non-cash operating
working capital:
Accounts receivable and
prepaid expenses 195,279 163,382
Accounts payable, accrued
liabilities and deferred
revenue (58,640) (336,754)
--------------------------------------------------------
(4,855,383) (2,825,617)
Financing activities:
Issuance of common shares
on exercise of warrants 185,916 -
Repayment of debenture - -
Net proceeds from issuance
of shares and warrants - -
Issuance of common shares
on exercise of options 59,750 43,650
Redemption of preferred
shares - -
Purchase of shares for
cancellation - (779,909)
--------------------------------------------------------
245,666 (736,259)
Investing activities:
Maturity of short-term
deposits, net - -
Proceeds on sale of
marketable securities - -
Additions to capital assets (4,089) (2,704)
--------------------------------------------------------
(4,089) (2,704)
----------------------------------------------------------
Increase (decrease) in cash
and cash equivalents (4,613,806) (3,564,580)
Cash assumed on purchase
of Delex - -
Cash and cash equivalents,
beginning of period 24,914,798 37,349,984
----------------------------------------------------------
Cash and cash equivalents,
end of period $ 20,300,992 $ 33,785,404
----------------------------------------------------------
----------------------------------------------------------
Supplemental cash flow
information:
Non-cash items:
Issuance of shares on
Delex acquisition $ - $ -
Issuance of 26,316 common
shares in exchange for
licensed patents - -
----------------------------------------------------------
----------------------------------------------------------
-------------------------------------------------------------------------
Period from
inception on
August 17,
Six months ended 1994 to
December 31, December 31,
2005 2004 2005
-------------------------------------------------------------------------
(Unaudited) (Unaudited)
Cash provided by (used in):
Operating activities:
Loss for the period $(11,460,138) $ (5,098,863) $(71,421,899)
Items not involving cash:
Amortization of capital
assets 25,169 1,720 295,833
Amortization of acquired
technology 496,371 - 634,131
Gain on sale of marketable
securities - - (638,332)
Unrealized loss on
marketable securities - - 1,827,039
Stock-based employee
compensation 550,741 346,155 2,398,891
Stock-based consideration 100,000 - 292,750
Change in non-cash operating
working capital:
Accounts receivable and
prepaid expenses (53,770) 218,085 (885,524)
Accounts payable, accrued
liabilities and deferred
revenue (323,672) (350,312) 3,236,255
-----------------------------------------------------------------------
(10,665,299) (4,883,215) (64,260,856)
Financing activities:
Issuance of common shares
on exercise of warrants 185,916 - 840,666
Repayment of debenture - - (1,469,425)
Net proceeds from issuance
of shares and warrants - 18,972,307 80,654,111
Issuance of common shares
on exercise of options 222,250 91,067 1,875,943
Redemption of preferred
shares - - (2,630,372)
Purchase of shares for
cancellation - (779,909) (1,029,679)
-----------------------------------------------------------------------
408,166 18,283,465 78,241,244
Investing activities:
Maturity of short-term
deposits, net 29,882,472 14,893,951 -
Proceeds on sale of
marketable securities - - 1,402,239
Additions to capital assets (10,720) (2,704) (308,082)
-----------------------------------------------------------------------
29,871,752 14,891,247 1,094,157
-------------------------------------------------------------------------
Increase (decrease) in cash
and cash equivalents 19,614,619 28,291,497 15,074,545
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 $ 20,300,992 $ 33,785,404 $ 20,300,992
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Supplemental cash flow
information:
Non-cash items:
Issuance of shares on
Delex acquisition $ 1,464,284 $ - $ 11,326,981
Issuance of 26,316 common
shares in exchange for
licensed patents 100,000 - 100,000
-------------------------------------------------------------------------
-------------------------------------------------------------------------
