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

    %SEDAR: 00004652E




For further information:

For further information: Enquiries: Thomas Fechtner, the Trout Group
LLC, Tel. (646) 378-2931, Email: tfechtner@troutgroup.com; James Smith, the
Equicom Group Inc., Tel. (416) 815-0700 x 229, Email: jsmith@equicomgroup.com;
Nominated Adviser, Canaccord Adams Limited, Ryan Gaffney, Tel. +44 (0)20 7050
6500


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