YM BIOSCIENCES REPORTS THIRD QUARTER 2009 OPERATIONAL AND FINANCIAL RESULTS
MISSISSAUGA, ON, May 14 /CNW/ - YM BioSciences Inc. (NYSE Amex:YMI,
TSX:YM, AIM:YMBA), a life sciences product development company that identifies
and advances a diverse portfolio of promising cancer-related products at
various stages of development, today reported operational and financial
results for the third quarter of fiscal 2009, ended March 31, 2009.
"Just a few days ago we reported critically important data at the 100th
AACR conference in Denver highlighting the mechanistic differences between
nimotuzumab and the EGFR targeting antibody, Erbitux(R)," said David Allan,
Chairman and CEO of YM BioSciences. "These data demonstrate that nimotuzumab
is predisposed to bind to cancerous cells with high levels of EGFR on their
surface while ignoring normal cells with low EGFR levels. For the competing
drugs, binding is indiscriminate since they bind to low levels of EGFR and, as
a result, these products cause severe toxicities as they interact with healthy
tissues. With Erbitux(R) as the leading EGFR-targeting drug on the market and
generating more than $1.5 billion in annual sales, these findings are profound
and further define the significant opportunity for our lead product."
Nimotuzumab is being advanced globally on multiple fronts supported by a
network of cooperative relationships. In total, more than 15 Phase II and
Phase III trials are currently ongoing, ten of which are being conducted by YM
or its licensees. During the third quarter of fiscal 2009:
- 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 benign safety profile. The trial is being supported
by YM licensee, Innogene Kalbiotech Ltd., a subsidiary of the public
company, Kalbe Farma.
- Two of YM's licensees for nimotuzumab, Daiichi-Sankyo Co., Ltd. in
Japan and Kuhnil Pharmaceutical Co. in Korea, are conducting a Phase
II randomized, open-label trial evaluating nimotuzumab in patients
with advanced or recurrent gastric cancer.
- YM's licensee in Europe, Oncoscience AG, reported that it continues
to enroll patients into a randomized Phase III study evaluating
nimotuzumab in adult glioma patients and into 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 continues to prepare its second late-stage product, AeroLEF(R), for
further development internationally. After consulting with regulatory bodies
in Europe and Canada, the Company is now determining the optimal clinical path
forward and conducting discussions with potential partners.
Financial Results (CDN dollars)
Total revenue (out-licensing revenue and interest income) for the third
quarter of fiscal 2009, ended March 31, 2009 was $1.0 million compared with
$1.8 million for the third quarter of fiscal 2008. Total revenue for the first
nine months of fiscal 2009 was $4.8 million compared with $5.5 million for the
first nine months of fiscal 2008. The majority of YM's out-licensing revenue
comes from five out-licensing agreements with third party licensees for
nimotuzumab. The decrease in revenue for the third quarter of fiscal 2009
compared to the same period in the prior year is mainly attributable to a 12
month extension of the revenue recognition period for the initial payment from
one of YM's licensees. The decrease in revenue for the nine months ended March
31, 2009 compared to the same period in the prior year is mainly as a result
of the above mentioned extension and the ending of monthly revenue recognition
for one other deferred revenue contract, partially offset by a milestone
payment received this year from one of the Company's licensees. The Company
also began receiving royalty payments from a limited sales program in Europe
initiated in the fourth quarter of fiscal 2008. Interest income decreased as
the Company draws on its cash balances to fund its operations and due to lower
interest rates.
General and administrative expenses were $1.2 million for the third
quarter of fiscal 2009 compared with $1.4 million for the third quarter of
fiscal 2008. General and administrative expenses were $3.5 million for the
first nine months of fiscal 2009 compared with $5.5 million for the first nine
months of fiscal 2008. These decreases were mainly a result of stock option
expenses decreasing as well as decreases in legal fees, salaries, consulting
and investor relations expenditures.
Licensing and product development expenses were $3.3 million for the
third quarter of fiscal 2009 compared with $4.3 million for the third quarter
of fiscal 2008. Licensing and product development expenses were $11.5 million
for the first nine months of fiscal 2009 compared with $12.1 million for the
first nine months of fiscal 2008.
Costs associated with development activities for nimotuzumab remained at
$1.5 million in the quarter compared to a year ago and increased by $1.1
million to $4.7 million for the nine months ended March 31, 2009. The increase
in expenses is primarily related to preparation for the two new Phase II
trials.
Costs associated with development activities for AeroLEF(TM) decreased by
$0.2 million to $0.4 million for the three month period ended March 31, 2009
compared to the same period in the prior year. For the nine month period ended
March 31, 2009 costs were $1.6 million, similar to the same period in the
prior year.
Net loss for the third quarter of fiscal 2009 was $3.5 million ($0.06 per
share) compared to $3.8 million ($0.07 per share) for the same period last
year. Net loss for the first nine months of fiscal 2009 was $9.8 million
($0.18 per share) compared to $11.9 million ($0.21 per share) for the same
period last year.
As at March 31, 2009 the Company had cash and cash equivalents and
short-term deposits totaling $46.6 million and payables and accrued
liabilities totaling $1.9 million compared to $58.1 million and $2.0 million
respectively at June 30, 2008.
As at March 31, 2009 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 life sciences product development company that
identifies and advances a 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 has proven regulatory and clinical
trial expertise and a diversified business model designed to reduce risk while
advancing clinical products toward international approval, marketing and
commercialization.
Nimotuzumab is a humanized monoclonal antibody in development worldwide,
targeting multiple tumor types primarily in combination with radiation and
chemoradiation. It is significantly differentiated from all other currently
marketed EGFR-targeting agents due to its remarkably benign side-effect
profile. Nimotuzumab's anti-tumor activity has led to its approval for
marketing in more than 12 countries. In more than 3,500 patients reported as
having been treated with nimotuzumab worldwide to date, no Grade IV incidents
of radiation dermatitis have been described, severe rash has not been observed
and reports of the other severe side-effects that are typical of
EGFR-targeting molecules have been rare. Nimotuzumab is licensed to YM's
majority-owned subsidiary, CIMYM BioSciences Inc., by CIMAB S.A., and was
developed at the Center of Molecular Immunology. YM is developing AeroLEF for
the treatment of moderate to severe acute pain. The product is differentiated
from other approaches using fentanyl because patients can individually control
the analgesia required for their differing intensities of pain. AeroLEF met
all endpoints in a randomized Phase II trial and is currently 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)
-------------------------------------------------------------------------
March 31, June 30,
2009 2008
-------------------------------------------------------------------------
(Unaudited)
Assets
Current assets:
Cash and cash equivalents $ 8,917,872 $ 3,119,189
Short-term deposits 37,688,943 54,981,737
Accounts receivable 280,479 403,371
Prepaid expenses 543,664 375,133
-------------------------------------------------------------------------
47,430,958 58,879,430
Property and equipment 105,268 128,400
Intangible assets 3,270,003 4,065,409
-------------------------------------------------------------------------
$ 50,806,229 $ 63,073,239
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $ 636,680 $ 307,588
Accrued liabilities 1,302,123 1,715,024
Deferred revenue 2,562,696 4,623,340
-------------------------------------------------------------------------
4,501,499 6,645,952
Deferred revenue 3,522,556 4,414,256
Shareholders' equity:
Share capital 172,921,153 172,921,153
Share purchase warrants - 3,150,539
Contributed surplus 12,848,942 9,123,824
Deficit (142,987,921) (133,182,485)
-------------------------------------------------------------------------
42,782,174 52,013,031
Basis of presentation
Commitments
-------------------------------------------------------------------------
$ 50,806,229 $ 63,073,239
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
Interim Consolidated Statements of Operations and Comprehensive Income
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
Three months ended Nine months ended
March 31, March 31,
2009 2008 2009 2008
-------------------------------------------------------------------------
(Unaudited) (Unaudited)
Out-licensing
revenue $ 776,127 $ 1,155,835 $ 3,823,296 $ 3,438,601
Interest
income 201,635 622,029 1,009,323 2,039,663
-------------------------------------------------------------------------
977,762 1,777,864 4,832,619 5,478,264
Expenses:
General and
adminis-
trative 1,190,039 1,416,872 3,530,626 5,526,388
Licensing
and product
development 3,259,177 4,286,792 11,525,789 12,052,278
-------------------------------------------------------------------------
4,449,216 5,703,664 15,056,415 17,578,666
-------------------------------------------------------------------------
Loss before
the undernoted (3,471,454) (3,925,800) (10,223,796) (12,100,402)
Gain on
foreign
exchange 51,122 15,584 143,009 29,716
Gain (loss)
on short-
term deposits (54,507) 91,569 (31,789) 217,985
Loss on
disposal
of property and
equipment - - - (70,143)
Other income - - 307,140 -
-------------------------------------------------------------------------
Loss and
comprehensive
loss for
the period $ (3,474,839) $ (3,818,647) $ (9,805,436) $ (11,922,844)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Basic and
diluted loss
per common
share $ (0.06) $ (0.07) $ (0.18) $ (0.21)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Weighted
average
number of
common
shares
outstanding 55,835,356 55,835,356 55,835,356 55,835,356
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
Interim Consolidated Statements of Deficit
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
Three months ended Nine months ended
March 31, March 31,
2009 2008 2009 2008
-------------------------------------------------------------------------
(Unaudited) (Unaudited)
Deficit,
beginning
of period $(139,513,082) $(126,400,938) $(133,182,485) $(118,296,741)
Loss for
the period (3,474,839) (3,818,647) (9,805,436) (11,922,844)
-------------------------------------------------------------------------
Deficit, end
of period $(142,987,921) $(130,219,585) $(142,987,921) $(130,219,585)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
Interim Consolidated Statements of Cash Flows
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
Three months ended Nine months ended
March 31, March 31,
2009 2008 2009 2008
-------------------------------------------------------------------------
(Unaudited) (Unaudited)
Cash provided
by (used in):
Operating
activities:
Loss for
the period $ (3,474,839) $ (3,818,647) $ (9,805,436) $ (11,922,844)
Items not
involving
cash:
Amortiza-
tion of
property
and
equipment 19,806 20,781 57,282 106,364
Amortiza-
tion of
intangible
assets 265,135 265,135 795,406 795,406
Loss on
disposal
of property
and
equipment - - - 70,143
Unrealized
loss
(gain) on
short-term
deposits 56,219 (98,443) 33,501 (91,569)
Stock-based
compensation 195,023 324,704 574,579 1,827,991
Change in
non-cash
operating
working
capital:
Accounts
receivable
and
prepaid
expenses 255,258 257,614 (45,639) (152,916)
Accounts
payable,
accrued
liabili-
ties and
deferred
revenue (767,508) (849,632) (3,036,153) (4,204,800)
-------------------------------------------------------------------------
(3,450,906) (3,898,488) (11,426,460) (13,572,225)
Investing
activities:
Short-term
deposits,
net 4,233,479 (4,980,923) 17,259,293 10,362,066
Additions
to property
and
equipment
and
intangible
assets (19,114) - (34,150) (35,933)
Proceeds
from sale
of property
and
equipment - - - 38,996
-------------------------------------------------------------------------
4,214,365 (4,980,923) 17,225,143 10,365,129
-------------------------------------------------------------------------
Increase
(decrease)
in cash and
cash
equivalents 763,459 (8,879,411) 5,798,683 (3,207,096)
Cash and
cash
equivalents,
beginning
of period 8,154,413 11,519,666 3,119,189 5,847,351
-------------------------------------------------------------------------
Cash and
cash
equivalents,
end of
period $ 8,917,872 $ 2,640,255 $ 8,917,872 $ 2,640,255
-------------------------------------------------------------------------
-------------------------------------------------------------------------
%SEDAR: 00004652E
For further information: Enquiries: James Smith, the Equicom Group Inc.,
Tel. (416) 815-0700 x 229, Email: jsmith@equicomgroup.com; Thomas Fechtner,
the Trout Group LLC, Tel. (646) 378-2931, Email: tfechtner@troutgroup.com;
Nominated Adviser, Canaccord Adams Limited, Ryan Gaffney, Tel. +44 (0)20 7050
6500
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