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| Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
|---|---|---|---|---|---|
| YM Bio.'b'ser1 | LSE:YMB | London | Ordinary Share | CA9842382041 | CLASS B PFD SHS SER 1 NPV |
| Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.00 | 0.00% | 0.00 | - |
| Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
|---|---|---|---|---|---|
| 0 | 0 | N/A | 0 |
Hot Features
Premium
YM BIOSCIENCES REPORTS FISCAL THIRD QUARTER 2008 OPERATIONAL AND FINANCIAL
RESULTS
MISSISSAUGA, ON, May 8 /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 its third quarter of fiscal 2008, ended March 31, 2008.
"During the quarter we continued to advance nimotuzumab globally,
leveraging co-operative efforts of multiple partners and other licensees of
the drug," said David Allan, Chairman and CEO of YM BioSciences. "These
activities were highlighted by the acceptance of a poster at ASCO 2008
describing data from the Canadian arm of a Canadian/Korean trial in non-small
cell lung cancer, also known as NSCLC, and the enrollment of the first patient
in our US and Canadian Phase II trial investigating nimotuzumab in pediatric
patients with inoperable, treatment-resistant brain cancer."
Nimotuzumab
Nimotuzumab, a humanized monoclonal antibody that targets the epidermal
growth factor receptor (EGFR), is being developed globally, with 14 companies
now participating in the development of this drug. YM's financial interest in
nimotuzumab extends across the major pharmaceutical marketplaces of North
America, Europe and Japan and includes countries in South-East Asia and
Africa. YM has retained all rights to North America, Australia and New Zealand
while out-licensing rights to the drug in its remaining territories.
- In February 2008, YM enrolled the first patient in its Phase II trial
investigating nimotuzumab in pediatric patients with progressive
diffuse intrinsic pontine glioma (DIPG), an inoperable,
treatment-resistant brain cancer. Nine leading US pediatric clinical
centers and two Canadian centers are participating in the 44-patient
single-arm trial evaluating nimotuzumab as a monotherapy. The primary
endpoint of the trial is a target response rate of 15%, and
recruitment is expected to be completed in mid-2009.
- Preliminary results are expected in mid 2008 from the 59 patients in
the first of two possible tranches of YM's Phase II colorectal cancer
study. The trial is evaluating the combination of nimotuzumab with
irinotecan chemotherapy in irinotecan-resistant patients.
- YM continues to follow patients in Canada in a joint Phase I/II trial
with its licensee Kuhnil Pharma in Korea. The trial is evaluating
nimotuzumab in combination with external radiotherapy in patients
diagnosed with stage IIb, III or IV NSCLC unsuitable for radical
therapy. Kuhnil Pharma has completed enrolling patients into the
joint trial. Data from the YM patients in the trial will be presented
at ASCO 2008 in June and support the design of the international
Phase III trial in NSCLC that YM plans to initiate this year with
certain of its licensees and other nimotuzumab developers.
- In Europe, Oncoscience AG, is conducting late-stage trials in
first-line pediatric DIPG, adult glioma and pancreatic cancer. In
April 2008, nimotuzumab was accorded Orphan Drug Designation for
pancreatic cancer in Europe. Data from the first-line, single-arm
Phase III pediatric DIPG trial is scheduled for a poster presentation
(Poster No. 3D, S Hall A1) on June 1, 2008 at ASCO.
- In Japan, the Company's licensee, Daiichi-Sankyo Co., Ltd. is
preparing to conduct Phase II trials with nimotuzumab.
- YM's licensee in Singapore/Indonesia, Innogene Kalbiotech/P.T. Kalbe
Farma, has initiated a Special Access Program under which patients
are being treated with nimotuzumab for various tumour types and a
broad development program is underway in those substantial markets.
- At the 2008 ASCO annual meeting, poster presentations on a
pharmacodynamic study of nimotuzumab in patients with unresectable
squamous cell carcinoma of the head and neck (Poster No. 14D,
S Hall A1 on May 31, 2008), and additional results from the
escalating-dose Phase I portion of a Phase I/II NSCLC study
(Poster No. 15F, S Hall A1 on June 1, 2008) will be presented.
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 US 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-naive patients. During the fiscal third quarter, YM
reported that it received a letter from the US FDA informing the Company that
the planned Phase II Acute Pain Study (AP5) of AeroLEF(TM) had been placed on
clinical hold. The Company is currently preparing its response to the FDA and
expects to submit its response in the coming weeks.
Three posters describing research conducted on AreoLEF(TM) will be
presented at the 27th Annual Scientific Meeting of the American Pain Society
(APS), which takes place May 8-10, 2008 in Tampa, Florida. (Poster No.'s 243,
264 and 265)
Financial Results (CDN dollars)
Total revenue for the third quarter of fiscal 2008, ended March 31, 2008
was $1.8 million compared with $2.0 million for the third quarter of fiscal
2007, ended March 31, 2007. Total revenue for the first nine months of fiscal
2008 was $5.5 million compared with $5.7 million for the first nine months of
fiscal 2007. Revenue from out-licensing was $1.2 million for third quarter of
fiscal 2008 compared with $1.2 million for the third quarter of fiscal 2007.
Interest income for the third quarter of fiscal 2008 was $0.6 million compared
with $0.8 million for the third quarter of fiscal 2007.
Total operating expenditures for the third quarter of fiscal 2008 were
$5.7 million compared to $10.9 million for the third quarter of fiscal 2007.
Total operating expenditures for the first nine months of fiscal 2008 were
$17.6 million compared with $31.0 million for the first nine months of fiscal
2007. General and administrative expenses were $1.4 million for the third
quarter of fiscal 2008 compared with $1.7 million for the third quarter of
fiscal 2007. Licensing and product development expenses were $4.3 million for
the third quarter of fiscal 2008 compared to $7.3 million for the third
quarter of fiscal 2007. The large decreases are mainly the result of reduced
development activity for tesmilifene, for which a Phase III trial was
terminated in January 2007. The Company's current clinical development plans
for nimotuzumab and AeroLEF(TM) anticipate an increase in expenditures, the
timing of which is subject to regulatory approvals.
The net loss for the third quarter of fiscal 2008 was $3.8 million ($0.07
per share) compared to $8.9 million ($0.16 per share) for the same period last
year. The net loss for the first nine months of fiscal 2008 was $11.9 million
($0.21 per share) compared to $27.0 million ($0.48 per share) for the same
period last year.
As at March 31, 2008 the Company had cash and cash equivalents and
short-term deposits totaling $62.1 million and payables and accrued
liabilities totaling $2.5 million compared to $75.6 million and $3.3 million
respectively at June 30, 2007.
As at March 31, 2008 the Company had 55,835,356 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.
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 brain
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.
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Balance Sheets
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
March 31, June 30,
2008 2007
-------------------------------------------------------------------------
(Unaudited)
Assets
Current assets:
Cash and cash equivalents $ 2,640,255 $ 5,847,351
Short-term deposits 59,453,941 69,724,438
Accounts receivable 653,236 370,011
Prepaid expenses 216,701 347,010
-----------------------------------------------------------------------
62,964,133 76,288,810
Capital assets 145,470 325,040
Intangible assets 4,330,544 5,125,950
-------------------------------------------------------------------------
$ 67,440,147 $ 81,739,800
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $ 1,252,058 $ 1,169,211
Accrued liabilities 1,254,710 2,103,755
Deferred revenue 4,623,340 4,702,132
-----------------------------------------------------------------------
7,130,108 7,975,098
Deferred revenue 5,570,090 8,929,900
Shareholders' equity:
Share capital 172,921,153 172,921,153
Share purchase warrants 3,150,539 4,553,308
Contributed surplus 8,887,842 5,657,082
Deficit accumulated during the
development stage (130,219,585) (118,296,741)
-----------------------------------------------------------------------
54,739,949 64,834,802
Basis of presentation
Commitments
-------------------------------------------------------------------------
$ 67,440,147 $ 81,739,800
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Statements of Operations
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
Three months ended
March 31,
2008 2007
-------------------------------------------------------------------------
(Unaudited)
Out-licensing revenue $ 1,155,835 $ 1,175,533
Interest income 622,029 809,174
-------------------------------------------------------------------------
1,777,864 1,984,707
Expenses:
General and administrative 1,416,872 1,721,673
Licensing and product development 4,286,792 7,318,303
Impairment - 1,829,538
-----------------------------------------------------------------------
5,703,664 10,869,514
-------------------------------------------------------------------------
Loss before the undernoted (3,925,800) (8,884,807)
Gain (loss) on foreign exchange 15,584 (44,267)
Gain on short-term deposits 91,569 -
Loss on sale of marketable securities - -
Loss on disposal of capital assets - -
-------------------------------------------------------------------------
Loss before income taxes (3,818,647) (8,929,074)
Income taxes - -
-------------------------------------------------------------------------
Loss and comprehensive loss for the period $ (3,818,647) $ (8,929,074)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Basic and diluted loss per common share $ (0.07) $ (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
Therapeutics Inc. acquisition 55,835,356 55,819,986
-------------------------------------------------------------------------
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Period from
inception on
August 17,
Nine months ended 1994 to
March 31, March 31,
2008 2007 2008
-------------------------------------------------------------------------
(Unaudited) (Unaudited)
Out-licensing revenue $ 3,438,601 $ 3,232,357 $ 9,745,646
Interest income 2,039,663 2,505,559 10,169,052
-------------------------------------------------------------------------
5,478,264 5,737,916 19,914,698
Expenses:
General and administrative 5,526,388 5,553,538 41,612,923
Licensing and product
development 12,052,278 23,649,274 102,848,661
Impairment - 1,829,538 1,829,538
-----------------------------------------------------------------------
17,578,666 31,032,350 146,291,122
-------------------------------------------------------------------------
Loss before the undernoted (12,100,402) (25,294,434) (126,376,424)
Gain (loss) on foreign exchange 29,716 (17,193) (333,466)
Gain on short-term deposits 217,985 - 217,985
Loss on sale of marketable
securities - - (1,191,329)
Loss on disposal of capital
assets (70,143) - (70,143)
-------------------------------------------------------------------------
Loss before income taxes (11,922,844) (25,311,627) (127,753,377)
Income taxes - 1,668,775 1,676,075
-------------------------------------------------------------------------
Loss and comprehensive loss
for the period $ (11,922,844) $ (26,980,402) $(129,429,452)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Basic and diluted loss per
common share $ (0.21) $ (0.48)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Weighted average number of
common shares outstanding,
excluding 2,380,953 common
shares held in escrow for
contingent additional
payment related to the
Delex Therapeutics Inc.
acquisition 55,835,356 55,794,483
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Statements of Deficit Accumulated During the
Development Stage
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
Three months ended
March 31,
2008 2007
-------------------------------------------------------------------------
(Unaudited)
Deficit accumulated during the development
stage, beginning of period $(126,400,938) $(104,617,829)
Cost of purchasing shares for cancellation
in excess of book value - -
Loss for the period (3,818,647) (8,929,074)
-------------------------------------------------------------------------
Deficit accumulated during the development
stage, end of period $(130,219,585) $(113,546,903)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Period from
inception on
August 17,
Nine months ended 1994 to
March 31, March 31,
2008 2007 2008
-------------------------------------------------------------------------
(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 (11,922,844) (26,980,402) (129,429,452)
-------------------------------------------------------------------------
Deficit accumulated during
the development stage,
end of period $(130,219,585) $(113,546,903) $(130,219,585)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Statements of Cash Flows
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
Three months ended
March 31,
2008 2007
-------------------------------------------------------------------------
(Unaudited)
Cash provided by (used in):
Operating activities:
Loss for the period $ (3,818,647) $ (8,929,074)
Items not involving cash:
Amortization of capital assets 20,781 27,410
Amortization of intangible assets 265,135 387,104
Impairment of intangible asset - 1,829,538
Loss on disposal of capital assets - -
Loss on marketable securities - -
Unrealized gain on short-term deposits (98,443) -
Stock-based employee compensation 324,704 440,965
Stock-based consideration - -
Warrants-based consideration - -
Change in non-cash operating working capital:
Accounts receivable and prepaid expenses 257,614 1,025,781
Accounts payable, accrued liabilities
and deferred revenue (849,632) 391,221
-----------------------------------------------------------------------
(3,898,488) (4,827,055)
Financing activities:
Issuance of common shares on exercise
of warrants - 87,500
Repayment of debenture - -
Net proceeds from issuance of shares
and warrants - -
Issuance of common shares on exercise
of options - 11,232
Redemption of preferred shares - -
Purchase of shares for cancellation - -
-----------------------------------------------------------------------
- 98,732
Investing activities:
Purchase and sale of short-term
deposits, net (4,980,923) (4,494,783)
Proceeds on sale of marketable securities - -
Additions to capital and intangible assets - (54,244)
Proceeds from sale of capital assets - -
-----------------------------------------------------------------------
(4,980,923) (4,549,027)
-------------------------------------------------------------------------
Increase (decrease) in cash and cash
equivalents (8,879,411) (9,277,350)
Net cash assumed on acquisition - -
Cash and cash equivalents, beginning
of period 11,519,666 20,464,351
-------------------------------------------------------------------------
Cash and cash equivalents, end of period $ 2,640,255 $ 11,187,001
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Supplemental cash flow information:
Non-cash items:
Issuance of shares from escrow on Delex
Therapeutics Inc. acquisition $ - $ -
Issuance of common shares on Eximias
acquisition - -
Issuance of common shares in exchange
for licensed patents - -
-------------------------------------------------------------------------
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Period from
inception on
August 17,
Nine months ended 1994 to
March 31, March 31,
2008 2007 2008
-------------------------------------------------------------------------
(Unaudited) (Unaudited)
Cash provided by (used in):
Operating activities:
Loss for the period $ (11,922,844) $ (26,980,402) $(129,429,452)
Items not involving cash:
Amortization of capital
assets 106,364 78,109 545,153
Amortization of intangible
assets 795,406 1,653,205 4,115,364
Impairment of intangible
asset - 1,829,538 1,829,538
Loss on disposal of
capital assets 70,143 - 70,143
Loss on marketable
securities - - 1,191,329
Unrealized gain on
short-term deposits (91,569) - (91,569)
Stock-based employee
compensation 1,827,991 1,433,550 7,981,467
Stock-based consideration - - 292,750
Warrants-based consideration - - 54,775
Change in non-cash operating
working capital:
Accounts receivable and
prepaid expenses (152,916) 1,700,745 158,785
Accounts payable, accrued
liabilities and deferred
revenue (4,204,800) 13,182,165 9,458,554
-----------------------------------------------------------------------
(13,572,225) (7,103,090) (103,823,163)
Financing activities:
Issuance of common shares
on exercise of warrants - 89,375 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 - 11,232 2,516,246
Redemption of preferred
shares - - (2,630,372)
Purchase of shares for
cancellation - - (1,029,679)
-----------------------------------------------------------------------
- 100,607 125,035,054
Investing activities:
Purchase and sale of
short-term deposits, net 10,362,066 15,576,688 (59,168,447)
Proceeds on sale of
marketable securities - - 1,404,450
Additions to capital and
intangible assets (35,933) (122,521) (613,248)
Proceeds from sale of
capital assets 38,996 - 38,996
-----------------------------------------------------------------------
10,365,129 15,454,167 (58,338,249)
-------------------------------------------------------------------------
Increase (decrease) in cash
and cash equivalents (3,207,096) 8,451,684 (37,126,358)
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 $ 2,640,255 $ 11,187,001 $ 2,640,255
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Supplemental cash flow
information:
Non-cash items:
Issuance of shares from
escrow on Delex
Therapeutics Inc.
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
-------------------------------------------------------------------------
-------------------------------------------------------------------------
For further information: 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
(YMBA)
END
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