1st Quarter Results

    YM BIOSCIENCES REPORTS FIRST QUARTER 2009 OPERATIONAL AND FINANCIAL RESULTS

    MISSISSAUGA, ON, Nov. 11 /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 first quarter of fiscal 2009, ended
September 30, 2008.
    "We are fortunate in this difficult economic environment to have
prudently gathered the cash resources which should allow us to continue
development of our lead products, nimotuzumab and AeroLEF(R), beyond fiscal
2009, as planned. Furthermore, the network of companies co-operating in the
development of nimotuzumab has resulted in a broad late-stage clinical program
for this drug for which YM bears only a fraction of the cost," said David
Allan, Chairman and CEO of YM BioSciences.

    Nimotuzumab:

    Nimotuzumab is an EGFR-targeting antibody that has displayed efficacy in
numerous clinical trials without producing Grade III/IV toxicities, including
rash, a severe and dose-limiting side-effect observed with all of the other
antibodies and small molecules targeting the EGF tyrosine kinase signaling
pathway. Nimotuzumab is currently undergoing three randomized trials being
conducted by YM's licensees in Europe and Asia. Complementing this activity,
YM BioSciences is concentrating its own registration pathway for nimotuzumab
on cancers treated with radiation-containing regimens, a strategy driven by
publicly announced data demonstrating a preferential opportunity for
nimotuzumab within such regimens.
    Designs for YM's programs are expected to be completed by the end of
calendar 2008 and will likely target two indications: brain metastases and
palliative non-small-cell lung cancer - indications where the unmet medical
need is clear, there is already supportive clinical evidence, patient
populations are substantial and the respective markets are uncrowded. While
expenditures will likely increase with this additional clinical activity, YM
believes it can advance this strategy materially within its existing
resources.

   
    -   During the quarter, Daiichi-Sankyo Co., Ltd. in Japan and Kuhnil
        Pharmaceutical Co. in Korea, jointly initiated an 80-patient Phase II
        randomized, open-label trial comparing nimotuzumab plus irinotecan to
        irinotecan alone in patients with advanced or recurrent gastric
        cancer refractory to 5-FU-containing regimens. Enrolment for this
        trial is expected to be completed in calendar 2009 and the primary
        endpoint of the study is to compare progression-free survival between
        the two arms.
    -   YM's licensee in Europe, OncoScience AG, continues to enrol patients
        in a randomized Phase III study evaluating nimotuzumab in adult
        glioma treated with temozolomide and radiation therapy.
    -   OncoScience AG is also enrolling patients in a randomized
        PhaseIIb/IIIa trial in patients with advanced pancreatic cancer that
        compares gemcitabine alone to gemcitabine plus nimotuzumab.
    -   An application for marketing nimotuzumab has been made by Oncoscience
        AG to the European Medicines Agency (EMEA) based on data from a
        single Phase II, open-label, single-arm, 45-patient trial in
        progressive pediatric diffuse, intrinsic pontine glioma (DIPG).
        Completion of recruitment in a single-arm, Phase III trial of
        nimotuzumab as first-line therapy for DIPG was reported by
        Oncoscience in August 2007 and preliminary data from this trial were
        released at ASCO in 2008. These data could be submitted to EMEA for
        marketing approval as a Type II variation to the current application,
        dependent upon the current application being accepted.
    -   YM continues to enrol children with DIPG into a Phase II trial at
        multiple sites in the US, Canada, and Israel, and recruitment could
        be completed in late calendar 2009.
   

    AeroLEF(TM):

    AeroLEF(R) is YM's proprietary, inhaled-delivery composition of free and
liposome-encapsulated fentanyl in development for the treatment of moderate to
severe pain, including cancer pain. YM completed an End-of Phase II meeting
with the US FDA in Fiscal 2008 and is in the process of discussing
AeroLEF's(R) registration strategy with regulatory bodies in Europe. Once this
milestone is achieved, the Company will establish the best options for
aggressive development and partnering of this unique product.

    Financial Results (CDN dollars)

    Total revenue for the first quarter of fiscal 2009, ended September 30,
2008 was $1.7 million compared with $1.8 million for the first quarter of
fiscal 2008, ended September 30, 2007. Revenue from licensees was $1.2 million
for first quarter of fiscal 2009 compared with $1.1 million for the first
quarter of fiscal 2008. Interest income for the first quarter of fiscal 2009
was $0.4 million compared with $0.7 million for the first quarter of fiscal
2008. The increase in revenue is due to royalty revenues the Company received
from a limited sales program in Europe. YM's out-licensing revenue comes from
various of the five out-licensing agreements with third party licensees.
    Total operating expenditures for the first quarter of fiscal 2009 were
$5.0 million compared to $5.6 million for the first quarter of fiscal 2008.
General and administrative expenses were $1.1 million for the first quarter of
fiscal 2009 compared with $2.0 million for the first quarter of fiscal 2008.
Stock option expense has decreased from $1.0 million for the three months
ended September 30, 2007 to $190 thousand for the three months ended September
30, 2008. Licensing and product development expenses increased to $3.8 million
for the first quarter of fiscal 2009 compared to $3.5 million for the first
quarter of fiscal 2008.
    Costs associated with development activities for nimotuzumab increased by
$187 thousand to $1.0 million for the three months ended September 30, 2008
compared to the three months ended September 30, 2007. Expenses in the first
quarter for fiscal 2009 are related to the phase II clinical trial in
pediatric diffuse brain stem glioma and manufacturing. Expenses in the first
quarter of fiscal 2008 were primarily associated with the Phase II clinical
trial in colorectal cancer.
    Costs associated with development activities for AeroLEF(TM) increased by
$249 thousand to $513 thousand for the three months ended September 30, 2008
compared to $264 thousand for the three months ended September 30, 2007. Last
year, the costs include transferring the manufacturing to a contract
manufacturer in the U.S.A, wrapping up the phase IIb study in acute pain, and
preparing the submissions to the U.S. F.D.A. This year's costs mainly consist
of consulting costs related to the new marketing and regulatory initiatives in
Europe.
    Costs related to development activities for tesmilifene for the three
months ended September 30, 2008 decreased by $160 thousand to $284 thousand
compared to $444 thousand for the three months in the prior year. Costs for
the three months ended September 30, 2008 consisted mainly of winding down the
DEC study, completing the pharmacokinetics studies, and maintaining the patent
portfolio. Our current plans call for an increase in expenditures for both
nimotuzumab and AeroLEF(TM) but the timing will be subject to regulatory
approvals.
    Net loss for the first quarter of fiscal 2009 was $3.2 million ($0.06 per
share) compared to $3.6 million ($0.06 per share) for the same period last
year.
    As at September 30, 2008 the Company had cash and cash equivalents and
short-term deposits totaling $54.6 million and payables and accrued
liabilities totaling $2.5 million compared to $58.1 million and $2.0 million
respectively at June 30, 2008. The Company's short-term deposits are bankers'
acceptances issued by Canadian Schedule A banks, maturing in less than one
year. Taking into consideration the restricted and unrestricted cash and
short-term deposits, management believes that the cash and short-term deposits
at September 30, 2008 are sufficient to support the Company's activities
beyond the next year. The Company plans to expend funds to continue the
development of nimotuzumab and AeroLEF(TM). There are also ongoing activities
directed at out-licensing commercial rights for these products and for
tesmilifene.
    As at September 30, 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.

    AGM Announcement

    YM BioSciences' Annual and Special Meeting of Shareholders will be held
on November 20th, 2008 at 4:00 p.m. at the Gallery of the TSX Broadcast &
Conference Centre, The Exchange Tower, 130 King Street West, Toronto, Ontario.

    About YM BioSciences

    YM BioSciences Inc. is a company that identifies, develops and
commercializes differentiated products principally in the area of oncology for
patients worldwide. The Company is developing nimotuzumab, a humanized
monoclonal antibody, and AeroLEF(R), a proprietary, inhaled-delivery
composition of free and liposome-encapsulated fentanyl. Nimotuzumab is in
development targeting multiple tumour types in combination with radiation,
chemoradiation and chemotherapy. The drug, which is approved for marketing in
eight countries, is significantly differentiated from all other currently
marketed EGFR-targeting agents because of a remarkably benign side-effect
profile. In approximately 3,000 patients treated worldwide, to date, no Grade
III/IV rash has been reported and reports of any of the other side-effects
that are typical of EGFR-targeting molecules have been rare. AeroLEF(R) is in
development for the treatment of moderate to severe pain, including cancer
pain. The product completed a randomized trial in 2007 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.

    Summary financial statements attached:

   
    YM BIOSCIENCES INC.
    Interim Consolidated Balance Sheets
    (Expressed in Canadian dollars)

    -------------------------------------------------------------------------
                                                September 30,        June 30,
                                                        2008            2008
    -------------------------------------------------------------------------
                                                  (Unaudited)

    Assets

    Current assets:
      Cash and cash equivalents                $  12,972,210   $   3,119,189
      Short-term deposits                         41,641,052      54,981,737
      Accounts receivable                            449,143         403,371
      Prepaid expenses                               439,201         375,133
      -----------------------------------------------------------------------
                                                  55,501,606      58,879,430

    Property and equipment                           122,473         128,400

    Intangible assets                              3,800,273       4,065,409

    -------------------------------------------------------------------------
                                               $  59,424,352   $  63,073,239
    -------------------------------------------------------------------------
    -------------------------------------------------------------------------

    Liabilities and Shareholders' Equity

    Current liabilities:
      Accounts payable                         $   1,163,169   $     307,588
      Accrued liabilities                          1,332,270       1,715,024
      Deferred revenue                             4,261,511       4,623,340
      -----------------------------------------------------------------------
                                                   6,756,950       6,645,952

    Deferred revenue                               3,620,250       4,414,256

    Shareholders' equity:
      Share capital                              172,921,153     172,921,153
      Share purchase warrants                      3,150,539       3,150,539
      Contributed surplus                          9,314,157       9,123,824
      Deficit                                   (136,338,697)   (133,182,485)
      -----------------------------------------------------------------------
                                                  49,047,152      52,013,031

    Basis of presentation
    Commitments

    -------------------------------------------------------------------------
                                               $  59,424,352   $  63,073,239
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    -------------------------------------------------------------------------


    YM BIOSCIENCES INC.
    Interim Consolidated Statements of Operations and Comprehensive Income
    (Expressed in Canadian dollars)

    -------------------------------------------------------------------------
                                                         Three months ended
                                                            September 30,
                                                        2008            2007
    -------------------------------------------------------------------------
                                                            (Unaudited)

    Out-licensing revenue                      $   1,214,945   $   1,126,933
    Interest income                                  442,621         690,392
    -------------------------------------------------------------------------
                                                   1,657,566       1,817,325

    Expenses:
      General and administrative                   1,147,378       2,034,010
      Licensing and product development            3,845,184       3,544,859
      -----------------------------------------------------------------------
                                                   4,992,562       5,578,869
    -------------------------------------------------------------------------

    Loss before the undernoted                    (3,334,996)     (3,761,544)

    Gain on foreign exchange                          12,203          43,905

    Realized gain on short-term deposits                   -          93,330

    Unrealized loss on short-term deposits          (140,559)              -

    Other income                                     307,140               -
    -------------------------------------------------------------------------

    Loss before income taxes                      (3,156,212)     (3,624,309)

    Income taxes                                           -               -

    -------------------------------------------------------------------------
    Loss and comprehensive loss for the period $  (3,156,212)  $  (3,624,309)
    -------------------------------------------------------------------------
    -------------------------------------------------------------------------

    Basic and diluted loss per common share    $       (0.06)  $       (0.06)

    -------------------------------------------------------------------------
    -------------------------------------------------------------------------

    Weighted average number of common
     shares outstanding                           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
    -------------------------------------------------------------------------
    -------------------------------------------------------------------------


    YM BIOSCIENCES INC.
    Interim Consolidated Statements of Deficit
    (Expressed in Canadian dollars)

    -------------------------------------------------------------------------
                                                         Three months ended
                                                            September 30,
                                                        2008            2007
    -------------------------------------------------------------------------
                                                            (Unaudited)

    Deficit, beginning of period               $(133,182,485)  $(118,296,741)

    Loss for the period                           (3,156,212)     (3,624,309)

    -------------------------------------------------------------------------
    Deficit, end of period                     $(136,338,697)  $(121,921,050)
    -------------------------------------------------------------------------
    -------------------------------------------------------------------------


    YM BIOSCIENCES INC.
    Interim Consolidated Statements of Cash Flows
    (Expressed in Canadian dollars)

    -------------------------------------------------------------------------
                                                         Three months ended
                                                            September 30,
                                                        2008            2007
    -------------------------------------------------------------------------
                                                             (Unaudited)

    Cash provided by (used in):

    Operating activities:
      Loss for the period                      $  (3,156,212)  $  (3,624,309)
      Items not involving cash:
        Depreciation of property and equipment        18,631          34,147
        Amortization of intangible assets            265,136         265,135
        Unrealized loss (gain) on financial
         instruments                                 140,559         (70,377)
        Stock-based compensation                     190,333       1,046,628
    Change in non-cash operating working capital:
      Accounts receivable and prepaid expenses      (109,840)         16,992
      Accounts payable, accrued liabilities
       and deferred revenue                         (683,008)     (2,194,866)
    -------------------------------------------------------------------------
                                                  (3,334,401)     (4,526,650)

    Investing activities:
      Short-term deposits, net                    13,200,126      19,294,697
      Additions to property and equipment            (12,704)              -
    -------------------------------------------------------------------------
                                                  13,187,422      19,294,697
    -------------------------------------------------------------------------

    Increase in cash and cash equivalents          9,853,021      14,768,047

    Cash and cash equivalents, beginning of
     period                                        3,119,189       5,847,351

    -------------------------------------------------------------------------
    Cash and cash equivalents, end of period   $  12,972,210   $  20,615,398
    -------------------------------------------------------------------------
    -------------------------------------------------------------------------

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. [phone] x 229, Email: jsmith(at)equicomgroup.com; Nominated
Adviser, Canaccord Adams Limited, Ryan Gaffney, Tel. [phone]
(YM. YMI YMBA)




END