YM BIOSCIENCES REPORTS SECOND QUARTER 2008 OPERATIONAL AND FINANCIAL RESULTS
MISSISSAUGA, ON, Feb. 7 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,
AIM:YMBA), an oncology company that identifies, develops and commercializes
differentiated products for patients worldwide, today reported operational and
financial results for the second quarter of fiscal 2008, ended December 31,
2007.
"Highlighting the second quarter, we completed enrollment in our Phase II
colorectal cancer study combining nimotuzumab with irinotecan which concluded
at 59 patients. We look forward to reporting data from this trial in the
coming quarter," said David Allan, Chairman and CEO of YM BioSciences. "Beyond
our direct efforts to develop nimotuzumab for North America, our
EGFR-targeting antibody is in a number of advanced clinical trials in a
coordinated effort by YM and its licensees globally to extend the number of
indications in which nimotuzumab has the prospect of being best-in-class."
Nimotuzumab:
Nimotuzumab, is a humanized monoclonal antibody that targets the
epidermal growth factor receptor (EGFR). The drug has principally been
developed to date within radiation-containing regimens in which it has
demonstrated significant efficacy without the serious side-effects of the
other drugs in its class. While the FDA recently required a competing
anti-EGFR antibody to carry a label warning that serious reactions could occur
when it is administered with radiation, to date nimotuzumab has not produced
any of these serious adverse events. Nimotuzumab together with radiation has
been approved in India and other jurisdictions in certain indications and
additional trials have explored the utility of this combination therapy in
pediatric glioma, adult glioma and non-small-cell lung cancer. As well,
studies investigating the prospects of a broadened approach into
chemotherapeutic applications are being conducted in colorectal and pancreatic
cancers. During the second quarter of fiscal 2008:
- YM's licensee in Japan, Daiichi-Sankyo Co., Ltd., advised that it had
completed its safety trial with nimotuzumab, permitting it to proceed
to more advanced trials in 2008.
- The Department of Medical Oncology, Kinki University School of
Medicine (Osaka, Japan) reported data on the synergistic cytotoxic
effect of nimotuzumab plus radiation on EGFR-expressing cancer cells
and the inhibition of ligand-dependant downstream signaling.
- YM's licensee in Europe, Oncoscience AG, expanded enrollment in both
its Phase III randomized trial in adult glioma and its Phase IIb/IIIa
randomized trial in patients with advanced pancreatic cancer. These
studies are designed to be supportive of registration.
- YM received clearance from Health Canada to extend the European Phase
IIb/IIIa pancreatic cancer study into Canada.
- YM completed enrollment of its Phase II colorectal cancer study
combining nimotuzumab with irinotecan in 59 patients. Data are
expected to be reported in the first half of calendar 2008.
In addition, data from the fully recruited Phase III trial conducted by
Oncoscience in Europe in children with inoperable brain cancer, if positive,
are expected to be submitted to the EMEA for marketing approval in 2008,
building on a submission based on earlier stage data that Oncoscience made to
EMEA in late 2007.
AeroLEF(TM):
AeroLEF(TM) is a proprietary, inhaled-delivery composition of free and
liposome-encapsulated fentanyl in development for the treatment of moderate to
severe pain, including cancer pain. AeroLEF(TM) uniquely permits patients to
identify and select the appropriate dose in real-time for each pain episode to
achieve both rapid onset and extended duration of analgesia.
YM received clearance from the U.S. Food and Drug Administration (FDA) in
2007 to initiate a Phase II Acute Pain Study (AP5) of AeroLEF(TM) in the US in
opioid-tolerant or opioid-na�ve patients. Subsequent to the end of the current
fiscal quarter, YM received a letter from the FDA informing the Company that
the Phase II study, upon re-review of data submitted for the IND application,
was placed on clinical hold. The FDA has requested additional safety
information on specific patients in previous clinical studies. The additional
requested data is limited to a group of patients that experienced oxygen
desaturation, an effect common to a class of opioids including fentanyl. None
of the patients of interest in the prior studies had required pharmacological
intervention for the events. The Company is conducting a subgroup analysis on
these patients for submission to the FDA in support of the resolution of the
matter. To date, no patients have been dosed in the US AP5 study and there are
no other clinical trials involving AeroLEF(TM) currently ongoing. The Company
is confident it can provide the information that the FDA has requested in a
timely manner.
Also subsequent to the end of the current quarter, YM reported that it
held its scheduled End-of-Phase 2 (EoP2) meeting with the FDA as planned to
discuss the designs of Phase III trials.
Financial Results (CDN dollars)
Total revenue for the second quarter of fiscal 2008, ended December 31,
2007 was $1.9 million compared with $2.0 million for the second quarter of
fiscal 2007, ended December 31, 2006. Total revenue for the first six months
of fiscal 2008 was $3.7 million compared with $3.8 million for the first six
months of fiscal 2007. Revenue from out-licensing was $1.2 million for second
quarter of fiscal 2008 compared with $1.2 million for the second quarter of
fiscal 2007. Interest income for the second quarter of fiscal 2008 was
$0.7 million compared with $0.8 million for the second quarter of fiscal 2007.
Total operating expenditures for the second quarter of fiscal 2008 were
$6.3 million compared to $10.4 million for the second quarter of fiscal 2007.
Total operating expenditures for the first six months of fiscal 2008 were
$11.9 million compared with $20.2 million for the first six months of fiscal
2007. General and administrative expenses were $2.1 million for the second
quarter of fiscal 2008 compared with $2.0 million for the second quarter of
fiscal 2007. Licensing and product development expenses decreased to
$4.2 million for the second quarter of fiscal 2008 compared to $8.5 million
for the second quarter of fiscal 2007. The change is mainly the result of
reduced development activity for tesmilifene, for which a Phase III trial was
terminated in January 2007, and reduced clinical development costs for
nimotuzumab and AeroLEF(TM), for both of which certain trials have finished
and others are just starting up.
Net loss for the second quarter of fiscal 2008 was $4.5 million ($0.08
per share) compared to $8.4 million ($0.15 per share) for the same period last
year. Net loss for the first six months of fiscal 2008 was $8.1 million ($0.15
per share) compared to $18.1 million ($0.32 per share) for the same period
last year.
As at December 31, 2007 the Company had cash and cash equivalents and
short-term deposits totaling $65.9 million and payables and accrued
liabilities totaling $2.2 million compared to $75.6 million and $3.3 million
respectively at June 30, 2007.
As at December 31, 2007 the Company had 58,216,309 common shares
outstanding, of which 2,380,953 common shares are held in escrow for
contingent additional payment related to the acquisition of Delex Therapeutics
Inc., 5,799,765 warrants, and 6,117,245 options.
About YM BioSciences
YM BioSciences Inc. is an oncology company that identifies, develops and
commercializes differentiated products for patients worldwide. The Company has
two late-stage products: nimotuzumab, a humanized monoclonal antibody that
targets the epidermal growth factor receptor (EGFR) and is approved in several
countries for treatment of various types of head and neck cancer; and
AeroLEF(TM), a proprietary, inhaled-delivery composition of free and
liposome-encapsulated fentanyl in development for the treatment of moderate to
severe pain, including cancer pain.
This press release may contain forward-looking statements, which reflect
the Company's current expectation regarding future events. These
forward-looking statements involve risks and uncertainties that may cause
actual results, events or developments to be materially different from any
future results, events or developments expressed or implied by such
forward-looking statements. Such factors include, 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. Certain of the assumptions
made in preparing forward-looking statements include but are not limited to
the following: that nimotuzumab will continue to demonstrate a competitive
safety profile in ongoing and future clinical trials; that AeroLEF(TM) will
continue to generate positive efficacy and safety data in future clinical
trials; and that YM and its various partners will complete their respective
clinical trials within the timelines communicated in this release. We
undertake no obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events or
otherwise.
Summary financial statements attached:
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Balance Sheets
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
December 31, June 30,
2007 2007
-------------------------------------------------------------------------
(Unaudited)
Assets
Current assets:
Cash and cash equivalents $ 11,519,666 $ 5,847,351
Short-term deposits 54,374,575 69,724,438
Accounts receivable 893,868 370,011
Prepaid expenses 233,683 347,010
-------------------------------------------------------------------------
67,021,792 76,288,810
Capital assets 166,251 325,040
Intangible assets 4,595,679 5,125,950
-------------------------------------------------------------------------
$ 71,783,722 $ 81,739,800
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $ 618,030 $ 1,169,211
Accrued liabilities 1,582,535 2,103,755
Deferred revenue 4,623,340 4,702,132
-------------------------------------------------------------------------
6,823,905 7,975,098
Deferred revenue 6,725,925 8,929,900
Shareholders' equity:
Share capital 172,921,153 172,921,153
Share purchase warrants 4,553,308 4,553,308
Contributed surplus 7,160,369 5,657,082
Deficit accumulated during the
development stage (126,400,938) (118,296,741)
-------------------------------------------------------------------------
58,233,892 64,834,802
Basis of presentation
Commitments
-------------------------------------------------------------------------
$ 71,783,722 $ 81,739,800
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YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Statements of Operations
(Expressed in Canadian dollars)
---------------------------------------------------------
Three months ended
December 31,
2007 2006
---------------------------------------------------------
(Unaudited)
Out-licensing revenue $ 1,155,833 $ 1,196,126
Interest income 727,242 801,673
---------------------------------------------------------
1,883,075 1,997,799
Expenses:
General and
administrative 2,075,506 1,950,975
Licensing and
product development 4,220,627 8,466,106
Impairment - -
-------------------------------------------------------
6,296,133 10,417,081
---------------------------------------------------------
Loss before the undernoted (4,413,058) (8,419,282)
Gain (loss) on foreign
exchange (29,773) 112,891
Gain on short-term deposits 33,086 -
Loss on marketable
securities - -
Loss on disposal of capital
assets (70,143) -
---------------------------------------------------------
Loss before income taxes (4,479,888) (8,306,391)
Income taxes - 46,080
---------------------------------------------------------
Loss and comprehensive
loss for the period $ (4,479,888) $ (8,352,471)
---------------------------------------------------------
---------------------------------------------------------
Basic and diluted loss per
common share $ (0.08) $ (0.15)
---------------------------------------------------------
---------------------------------------------------------
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 55,835,356 55,782,023
---------------------------------------------------------
---------------------------------------------------------
-------------------------------------------------------------------------
Period from
inception on
August 17,
Six months ended 1994 to
December 31, December 31,
2007 2006 2007
-------------------------------------------------------------------------
(Unaudited) (Unaudited)
Out-licensing revenue $ 2,282,766 $ 2,056,824 $ 8,589,811
Interest income 1,417,634 1,696,385 9,547,023
-------------------------------------------------------------------------
3,700,400 3,753,209 18,136,834
Expenses:
General and
administrative 4,109,516 3,831,865 40,196,051
Licensing and
product development 7,765,486 16,330,971 98,561,869
Impairment - - 1,829,538
-----------------------------------------------------------------------
11,875,002 20,162,836 140,587,458
-------------------------------------------------------------------------
Loss before the undernoted (8,174,602) (16,409,627) (122,450,624)
Gain (loss) on foreign
exchange 14,132 27,074 (349,050)
Gain on short-term deposits 126,416 - 126,416
Loss on marketable
securities - - (1,191,329)
Loss on disposal of capital
assets (70,143) - (70,143)
-------------------------------------------------------------------------
Loss before income taxes (8,104,197) (16,382,553) (123,934,730)
Income taxes - 1,668,775 1,676,075
-------------------------------------------------------------------------
Loss and comprehensive
loss for the period $ (8,104,197) $ (18,051,328) $(125,610,805)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Basic and diluted loss per
common share $ (0.15) $ (0.32)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
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 55,835,356 55,782,009
-------------------------------------------------------------------------
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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,
2007 2006
---------------------------------------------------------
(Unaudited)
Deficit accumulated during
the development stage,
beginning of period $(121,921,050) $ (96,265,358)
Cost of purchasing shares
for cancellation in excess
of book value - -
Loss for the period (4,479,888) (8,352,471)
---------------------------------------------------------
Deficit accumulated during
the development stage, end
of period $(126,400,938) $(104,617,829)
---------------------------------------------------------
---------------------------------------------------------
-------------------------------------------------------------------------
Period from
inception on
August 17,
Six months ended 1994 to
December 31, December 31,
2007 2006 2007
-------------------------------------------------------------------------
(Unaudited) (Unaudited)
Deficit accumulated during
the development stage,
beginning of period $(118,296,741) $ (86,566,501) $ -
Cost of purchasing shares
for cancellation in excess
of book value - - (790,133)
Loss for the period (8,104,197) (18,051,328) (125,610,805)
-------------------------------------------------------------------------
Deficit accumulated during
the development stage, end
of period $(126,400,938) $(104,617,829) $(126,400,938)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Statements of Cash Flows
(Expressed in Canadian dollars)
---------------------------------------------------------
Three months ended
December 31,
2007 2006
---------------------------------------------------------
(Unaudited)
Cash provided by (used in):
Operating activities:
Loss for the period $ (4,479,888) $ (8,352,471)
Items not involving cash:
Amortization of capital
assets 51,436 25,352
Amortization of
intangible assets 265,136 633,050
Impairment of
intangible asset - -
Loss on disposal of
capital assets 70,143 -
Loss on marketable
securities - -
Unrealized gain on
financial
instruments 77,251 -
Stock-based employee
compensation 456,659 473,369
Stock-based
consideration - -
Warrants-based
consideration - -
Change in non-cash
operating working
capital:
Accounts receivable and
prepaid expenses (427,522) (193,290)
Accounts payable,
accrued liabilities
and deferred revenue (1,160,302) (452,558)
-------------------------------------------------------
(5,147,087) (7,866,548)
Financing activities:
Issuance of common shares
on exercise of warrants - -
Repayment of debenture - -
Net proceeds from
issuance of shares and
warrants - -
Issuance of common
shares on exercise of
options - -
Redemption of preferred
shares - -
Purchase of shares for
cancellation - -
-------------------------------------------------------
- -
Investing activities:
Purchase and sale of
short-term deposits,
net (3,951,708) (13,888,114)
Proceeds on sale of
marketable securities - -
Additions to capital and
intangible assets (35,933) (66,647)
Proceeds from sale of
capital assets 38,996 -
-------------------------------------------------------
(3,948,645) (13,954,761)
---------------------------------------------------------
Increase (decrease) in cash
and cash equivalents (9,095,732) (21,821,309)
Net cash assumed on
acquisition - -
Cash and cash equivalents,
beginning of period 20,615,398 42,285,660
---------------------------------------------------------
Cash and cash equivalents,
end of period $ 11,519,666 $ 20,464,351
---------------------------------------------------------
---------------------------------------------------------
Supplemental cash flow
information:
Non-cash items:
Issuance of shares from
escrow on Delex
acquisition $ - $ -
Issuance of common
shares on Eximias
acquisition - -
Issuance of common
shares in exchange
for licensed patents - -
---------------------------------------------------------
---------------------------------------------------------
-------------------------------------------------------------------------
Period from
inception on
August 17,
Six months ended 1994 to
December 31, December 31,
2007 2006 2007
-------------------------------------------------------------------------
(Unaudited) (Unaudited)
Cash provided by (used in):
Operating activities:
Loss for the period $ (8,104,197) $ (18,051,328) $(125,610,805)
Items not involving cash:
Amortization of capital
assets 85,583 50,699 524,372
Amortization of
intangible assets 530,271 1,266,101 3,850,229
Impairment of
intangible asset - - 1,829,538
Loss on disposal of
capital assets 70,143 - 70,143
Loss on marketable
securities - - 1,191,329
Unrealized gain on
financial
instruments 6,874 - 6,874
Stock-based employee
compensation 1,503,287 992,584 7,656,763
Stock-based
consideration - - 292,750
Warrants-based
consideration - - 54,775
Change in non-cash
operating working
capital:
Accounts receivable and
prepaid expenses (410,530) 674,964 (98,829)
Accounts payable,
accrued liabilities
and deferred revenue (3,355,168) 12,790,945 10,308,186
-----------------------------------------------------------------------
(9,673,737) (2,276,035) (99,924,675)
Financing activities:
Issuance of common shares
on exercise of warrants - 1,875 4,371,555
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 - - 2,516,246
Redemption of preferred
shares - - (2,630,372)
Purchase of shares for
cancellation - - (1,029,679)
-----------------------------------------------------------------------
- 1,875 125,035,054
Investing activities:
Purchase and sale of
short-term deposits,
net 15,342,989 20,071,471 (54,187,524)
Proceeds on sale of
marketable securities - - 1,404,450
Additions to capital and
intangible assets (35,933) (68,277) (613,248)
Proceeds from sale of
capital assets 38,996 - 38,996
-----------------------------------------------------------------------
15,346,052 20,003,194 (53,357,326)
-------------------------------------------------------------------------
Increase (decrease) in cash
and cash equivalents 5,672,315 17,729,034 (28,246,947)
Net cash assumed on
acquisition - - 39,766,613
Cash and cash equivalents,
beginning of period 5,847,351 2,735,317 -
-------------------------------------------------------------------------
Cash and cash equivalents,
end of period $ 11,519,666 $ 20,464,351 $ 11,519,666
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Supplemental cash flow
information:
Non-cash items:
Issuance of shares from
escrow on Delex
acquisition $ - $ - $ 11,326,981
Issuance of common
shares on Eximias
acquisition - - 35,063,171
Issuance of common
shares in exchange
for licensed patents - - 100,000
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For further information: Enquiries: Thomas Fechtner, the Trout Group LLC,
Tel. (646) 378-2931, Email: tfechtner(at)troutgroup.com; James Smith, the
Equicom Group Inc., Tel. (416) 815-0700 x 229, Email:
jsmith(at)equicomgroup.com; Nominated Adviser: Canaccord Adams Limited, Ryan
Gaffney, Tel. +44 (0)20 7050 6500
(YM. YMI YMBA)
END
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