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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 |
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YM BIOSCIENCES REPORTS SECOND QUARTER 2009 OPERATIONAL AND FINANCIAL RESULTS
MISSISSAUGA, ON, Feb. 13 /CNW/ - YM BioSciences Inc. (NYSE Alternext
US: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 2009, ended
December 31, 2008.
"During the quarter we prepared to initiate our two randomized Phase II
trials for nimotuzumab, which concentrate on two forms of cancer typically
treated with radiation-containing regimens. These trials are the cornerstone
of YM's registration program for this drug, driven by prior data indicating
nimotuzumab's potential to maximize the benefits of radiotherapy while
avoiding the toxic side-effects of the other EGFR-targeting drugs," said David
Allan, Chairman and CEO of YM BioSciences. "In addition to YM's internal
clinical strategy, we continue to benefit from the network of cooperative
relationships for the development of nimotuzumab which is undertaking a broad,
late-stage, clinical program for this drug."
Highlights for the second quarter of Fiscal 2009:
- YM received clearance from Canadian regulatory authorities to
initiate two Phase II, double-blind, randomized trials for its EGFR-
targeting antibody, nimotuzumab, in combination with radiation-based
treatments. Enrolment for both trials, one in patients with non-small
cell lung cancer (NSCLC) and the other in patients with brain
metastases from NSCLC, is expected to be initiated in Canada in the
first quarter of calendar 2009 and YM anticipates expanding the
trials into other countries.
- The National Cancer Centre of Singapore (NCCS) selected nimotuzumab
for evaluation in the adjuvant setting in a multinational Phase III
trial of more than 700 patients with cancers of the head and neck,
citing the drug's preferential safety profile compared with other
EGFR-targeting cancer drugs.
- Two of YM's licensees for nimotuzumab, Daiichi-Sankyo Co., Ltd. in
Japan and Kuhnil Pharmaceutical Co. in Korea, initiated an 80-patient
Phase II randomized, open-label trial evaluating nimotuzumab in
patients with advanced or recurrent gastric cancer.
- YM's licensee in Europe, Oncoscience AG, continued to enroll patients
in a randomized Phase III study evaluating nimotuzumab in adult
glioma patients and a randomized Phase IIb/IIIa trial in patients
with advanced pancreatic cancer.
- YM and YM USA continued to enroll children with progressive, diffuse,
intrinsic pontine glioma (DIPG) into a Phase II trial at multiple
sites in the US, Canada and Israel and recruitment could be completed
in late calendar 2009 or early 2010.
- YM continued to prepare its second late-stage product, AeroLEF(R),
for further development internationally, with a current focus on
establishing the registration pathway for the product in Europe and
conducting discussions with potential partners.
Financial Results (CDN dollars)
Total revenue (out-licensing revenue and interest income) for the second
quarter of fiscal 2009, ended December 31, 2008 was $2.2 million compared with
$1.9 million for the second quarter of fiscal 2008, ended December 31, 2007.
Total revenue for the first six months of fiscal 2009, ended December 31, 2008
was $3.9 million compared with $3.7 million for the first six months of fiscal
2008, ended December 31, 2007. The increase in revenue is due to the receipt
of a US$500 thousand milestone payment from one of the Company's licensees.
General and administrative expenses were $1.2 million for the second
quarter of fiscal 2009 compared with $2.1 million for the second quarter of
fiscal 2008. General and administrative expenses were $2.3 million for the
first six months of fiscal 2009 compared with $4.1 million for the first six
months of fiscal 2008.
Licensing and product development expenses were $4.4 million for the
second quarter of fiscal 2009 compared with $4.2 million for the second
quarter of fiscal 2008. Licensing and product development expenses were $8.3
million for the first six months of fiscal 2009 compared with $7.8 million for
the first six months of fiscal 2008.
Costs associated with development activities for nimotuzumab increased by
$1.2 million to $2.2 million and by $1.3 million to $3.3 million for the three
and six months ended December 31, 2008 respectively, compared to the same
periods in the prior year. The increase in expenses is related to preparation
for the two new clinical trials and final payments for the trial in colorectal
cancer.
Costs associated with development activities for AeroLEF(TM) decreased by
$0.2 million to $0.6 million for the three month period ended December 31,
2008 compared to the same period in the prior year. For the six month period
ended December 31, 2008 costs were $1.1 million, similar to the same period in
the prior year.
Net loss for the second quarter of fiscal 2009 was $3.2 million ($0.06
per share) compared to $4.5 million ($0.08 per share) for the same period last
year. Net loss for the first six months of fiscal 2009 was $6.3 million ($0.11
per share) compared to $8.1 million ($0.15 per share) for the same period last
year.
As at December 31, 2008 the Company had cash and cash equivalents and
short-term deposits totaling $50.1 million and payables and accrued
liabilities totaling $2.1 million compared to $58.1 million and $2.0 million
respectively at June 30, 2008.
As at December 31, 2008 the Company had 58,216,309 common shares
outstanding, of which 2,380,953 common shares are held in escrow to be
released contingent upon the completion of certain milestones.
About YM BioSciences
YM BioSciences Inc. is a therapeutic product development company that
identifies and advances a diverse portfolio of promising cancer-related
products at various stages of development. The Company is currently developing
two late-stage products: nimotuzumab, an EGFR-targeting Affinity-Optimized
Antibody(TM), and AeroLEF(R), a proprietary, inhaled-delivery composition of
free and liposome-encapsulated fentanyl. YM's proven regulatory and clinical
trial expertise allows for the effective advancement of its products with
reduced risk, via a diversified business model, towards approval and
commercialization worldwide.
Nimotuzumab is in development targeting multiple tumor types in
combination with radiation, chemoradiation and chemotherapy. The humanized
monoclonal antibody, which is approved for marketing in twelve of countries,
is significantly differentiated from all other EGFR-targeting agents because
of a remarkably benign side-effect profile. In more than 3,500 patients
reported as having been treated worldwide to date, no Grade III/IV incidents
of rash or Grade IV radiation dermatitis haves been reported, and any of the
other side-effects that are typical of EGFR-targeting molecules have been
rare. YM is developing AeroLEF(R) for the treatment of moderate to severe
acute pain. The product completed a randomized Phase II trial and is being
prepared for late-stage development internationally.
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(R) 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.
Interim Consolidated Balance Sheets
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
December 31, June 30,
2008 2008
-------------------------------------------------------------------------
(Unaudited)
Assets
Current assets:
Cash and cash equivalents $ 8,154,413 $ 3,119,189
Short-term deposits 41,978,641 54,981,737
Accounts receivable 721,357 403,371
Prepaid expenses 358,044 375,133
-----------------------------------------------------------------------
51,212,455 58,879,430
Property and equipment 105,960 128,400
Intangible assets 3,535,138 4,065,409
-------------------------------------------------------------------------
$ 54,853,553 $ 63,073,239
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $ 469,734 $ 307,588
Accrued liabilities 1,595,903 1,715,024
Deferred revenue 4,133,228 4,623,340
-----------------------------------------------------------------------
6,198,865 6,645,952
Deferred revenue 2,592,698 4,414,256
Shareholders' equity:
Share capital 172,921,153 172,921,153
Share purchase warrants 54,775 3,150,539
Contributed surplus 12,599,144 9,123,824
Deficit (139,513,082) (133,182,485)
-----------------------------------------------------------------------
46,061,990 52,013,031
Basis of presentation
Commitments
-------------------------------------------------------------------------
$ 54,853,553 $ 63,073,239
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
Interim Consolidated Statements of Operations and Comprehensive Income
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
Three months ended Six months ended
December 31, December 31,
2008 2007 2008 2007
-------------------------------------------------------------------------
(Unaudited) (Unaudited)
Out-licensing
revenue $ 1,832,224 $ 1,155,833 $ 3,047,169 $ 2,282,766
Interest
income 365,067 727,242 807,688 1,417,634
-------------------------------------------------------------------------
2,197,291 1,883,075 3,854,857 3,700,400
Expenses:
General and
admini-
strative 1,193,209 2,075,506 2,340,587 4,109,516
Licensing
and product
development 4,421,428 4,220,627 8,266,612 7,765,486
-----------------------------------------------------------------------
5,614,637 6,296,133 10,607,199 11,875,002
-------------------------------------------------------------------------
Loss before the
undernoted (3,417,346) (4,413,058) (6,752,342) (8,174,602)
Gain (loss) on
foreign exchange 79,684 (29,773) 91,887 14,132
Realized gain
on short-term
deposits - 110,337 - 133,290
Unrealized gain
(loss) on
short-term
deposits 163,277 (77,251) 22,718 (6,874)
Loss on disposal
of property and
equipment - (70,143) - (70,143)
Other income - - 307,140 -
-------------------------------------------------------------------------
Loss and
comprehensive
loss for the
period $ (3,174,385) $ (4,479,888) $ (6,330,597) $ (8,104,197)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Basic and
diluted loss
per common
share $ (0.06) $ (0.08) $ (0.11) $ (0.15)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Weighted average
number of
common shares
outstanding 55,835,356 55,835,356 55,835,356 55,835,356
Excludes common
shares held
in escrow for
contingent
additional
payment related
to the
acquisition
of Delex
Therapeutics
Inc. 2,380,953 2,380,953 2,380,953 2,380,953
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
Interim Consolidated Statements of Deficit
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
Three months ended Six months ended
December 31, December 31,
2008 2007 2008 2007
-------------------------------------------------------------------------
(Unaudited) (Unaudited)
Deficit,
beginning of
period $(136,338,697) $(121,921,050) $(133,182,485) $(118,296,741)
Loss for
the period (3,174,385) (4,479,888) (6,330,597) (8,104,197)
-------------------------------------------------------------------------
Deficit, end
of period $(139,513,082) $(126,400,938) $(139,513,082) $(126,400,938)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
Interim Consolidated Statements of Cash Flows
(Expressed in Canadian dollars)
Three months ended Six months ended
December 31, December 31,
2008 2007 2008 2007
-------------------------------------------------------------------------
(Unaudited) (Unaudited)
Cash provided by
(used in):
Operating
activities:
Loss for the
period $ (3,174,385) $ (4,479,888) $ (6,330,597) $ (8,104,197)
Items not
involving
cash:
Amortization
of property
and equipment 18,844 51,436 37,476 85,583
Amortization
of intangible
assets 265,136 265,136 530,271 530,271
Loss on disposal
of property
and equipment - 70,143 - 70,143
Unrealized
loss (gain)
on financial
instruments (163,277) 77,251 (22,718) 6,874
Stock-based
compensation 189,223 456,659 379,556 1,503,287
Change in
non-cash
operating
working
capital:
Accounts
receivable
and prepaid
expenses (191,057) (427,522) (300,897) (410,530)
Accounts
payable,
accrued
liabilities
and deferred
revenue (1,585,637) (1,160,302) (2,268,645) (3,355,168)
-----------------------------------------------------------------------
(4,641,153) (5,147,087) (7,975,554) (9,673,737)
Investing
activities:
Short-term
deposits, net (174,312) (3,951,708) 13,025,814 15,342,989
Additions to
property and
equipment and
intangible
assets (2,332) (35,933) (15,036) (35,933)
Proceeds from
sale of
property and
equipment - 38,996 - 38,996
-----------------------------------------------------------------------
(176,644) (3,948,645) 13,010,778 15,346,052
-------------------------------------------------------------------------
Increase
(decrease) in
cash and cash
equivalents (4,817,797) (9,095,732) 5,035,224 5,672,315
Cash and cash
equivalents,
beginning of
period 12,972,210 20,615,398 3,119,189 5,847,351
-------------------------------------------------------------------------
Cash and cash
equivalents,
end of
period $ 8,154,413 $ 11,519,666 $ 8,154,413 $ 11,519,666
-------------------------------------------------------------------------
-------------------------------------------------------------------------
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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