YM BIOSCIENCES REPORTS 2007 YEAR END OPERATIONAL AND FINANCIAL RESULTS



    MISSISSAUGA, ON, Sept. 24 /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 the fourth quarter and the 2007 fiscal year, ended
June 30, 2007.
    "YM's business model, which unremittingly has been to diversify against
the risk of clinical failure, has made it possible for us to mitigate in part
just such an unfortunate event earlier this year with the disappointing
results of the tesmilifene trial. With recruitment in nimotuzumab's first
Phase III trial having been completed; the initiation of two additional late
stage trials this current quarter; with substantial international financial
and human resources supporting a broad and aggressive development program for
nimotuzumab; with AeroLEF(TM) having successfully completed its first
randomized trial and being prepared for its Phase III trials, we have seen the
benefits of adhering to our corporate strategy. This strategy permits us to
continue to take our late-stage products forward to surface their value," said
David Allan, Chairman and CEO of YM BioSciences. "Importantly, we start the
current fiscal year with more than US$65 million of cash available to support
our development programs."

    Nimotuzumab:

    Nimotuzumab, a humanized monoclonal antibody that targets the epidermal
growth factor receptor (EGFR), is currently in varying stages of development
in a number of trials, including colorectal cancer, adult and pediatric
glioma, non-small-cell lung cancer and pancreatic cancer. YM expects that the
range of indications will continue to broaden in 2008 as the group's
cooperative efforts expand. The drug is approved in a number of Latin American
countries as well as China and India.
    Daiichi Sankyo Co., Ltd. in Japan, Oncoscience AG in Europe, Kuhnil
Pharmaceutical Co. in South Korea and Innogene Kalbiotech in Southeast Asia
have sub-licenses for nimotuzumab from CIMYM Inc., YM's majority-owned
subsidiary. Cooperative trials have already been initiated with some of
CIMYM's licensees and YM anticipates that the licensees will increasingly
participate cooperatively to accelerate the rate of recruitment into trials of
common interest, reducing the costs of development for each participant,
permitting rapid recruitment and shortening the time to completion of clinical
trials.

    
    During Fiscal 2007:
    -  CIMYM BioSciences Inc. licensed the commercial rights for nimotuzumab
       to Daiichi Sankyo Co., Ltd. for the Japanese market. The agreement
       included a non-refundable up-front payment from Daiichi to the Company
       of $16.2 million.
    -  YM BioSciences USA received clearance from the US Treasury Department
       to import nimotuzumab into the US
    -  Daiichi Sankyo received clearance to initiate a clinical trial with
       the drug in Japan.
    -  YM initiated enrollment for a Phase II colorectal cancer trial in
       Canada. The first 50-patient cohort is expected to be completed in
       calendar 2007 following which data on the primary endpoints, response
       rate and safety, will be reported.
    -  YM received clearance to initiate a clinical trial in children with
       inoperable recurrent, treatment-resistant brain cancer in Canada.
    -  YM reported successful regulatory review of the manufacturing of
       nimotuzumab.
    -  YM reported preclinical data separately confirming that nimotuzumab
       binds to the EGF receptor and that it also potentiates radiotherapy in
       non-small-cell lung cancer cells.

    Subsequent to the end of the fiscal year:

    -  YM USA was cleared by the US FDA to expand its second-line clinical
       trial in children with inoperable, recurrent, treatment-resistant
       brain cancer into the US
    -  Oncoscience AG reported completion of patient enrolment in the
       Phase III, first-line, pediatric brain cancer trial.
    -  Oncoscience AG reported initiation of late-stage trials in adult
       glioma and pancreatic cancer.
    -  YM reported positive preliminary results of a Phase I/II trial of
       nimotuzumab in combination with radiation for the treatment of
       non-small-cell lung cancer (NSCLC).
    -  The first 20 patients were recruited into the Phase II colorectal
       trial by the date of this release.
    

    AeroLEF(TM):

    AeroLEF(TM) is a unique, inhaled-delivery composition of free and
liposome-encapsulated fentanyl in development for the treatment of moderate to
severe pain, including cancer pain. AeroLEF(TM) 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.

    
    During Fiscal 2007:
    -  YM announced that AeroLEF(TM) had met the primary endpoint in its
       first randomized, placebo-controlled Phase IIb trial enrolling opioid-
       naive patients with post-operative pain following orthopedic surgery.
       A statistically significant difference in pain relief and pain
       intensity to placebo (p=0.0194) was reported.
    -  YM received clearance from the FDA to initiate a Phase II trial in the
       US in opioid tolerant or opioid-naive patients. A successful trial
       would further extend the utility and medical breadth of the product if
       and when approved. Enrollment in its 50-patient trial is expected to
       start in calendar Q4, 2007.
    -  A request to the FDA for an End-of-Phase II meeting prior to calendar
       year-end 2007 to discuss Phase III trial designs was designed and,
       subsequent to the fiscal year-end, has been submitted.
    

    Tesmilifene:

    In January 2007, the Data Safety Monitoring Board (DSMB) overseeing the
'DEC' Phase III pivotal trial of tesmilifene in combination with epirubicin
and cyclophosphamide for the treatment of rapidly progressing metastatic
breast cancer completed the third planned interim analysis. Evaluating data
that included 351 patient events, the DSMB advised the Company that, although
there were no safety concerns and that the trial was well conducted, it was
highly unlikely to meet its primary efficacy endpoint. YM terminated the trial
and, with the exception of one further follow-up for confirmation expected in
calendar Q4 2007 and the ongoing collaborative trial with Sanofi-Aventis in
metastatic breast cancer for which pharmacokinetic data should be available by
calendar year-end 2007, we intend to undertake no further clinical
development.

    Financial Results (CDN dollars)

    Total revenue for the fiscal year ended June 30, 2007 was $7.6 million
compared to $2.5 million for the fiscal year ended June 30, 2006. Total
revenue for the fourth quarter ended June 30, 2007 was $1.9 million compared
to $1.1 million for the same quarter last year.
    Revenue from out-licensing increased by $3.3 million in fiscal 2007
compared to fiscal 2006 as a result of two out-licensing agreements entered
into during the year. The most significant agreement, signed with Daiichi
Pharmaceutical Co., Ltd. in July 2006, licensed the commercial rights for
nimotuzumab for Japan and included a non-refundable up-front payment from
Daiichi to the Company of $16.2 million. This initial license fee has been
recorded as deferred revenue and is being recognized over a period of four
years.
    Interest income for fiscal 2007 increased by $1.8 million compared to
fiscal 2006, attributable to the significant increase in cash which resulted
from the US$40 million prospectus-based financing in February 2006, the
acquisition of Eximias Pharmaceutical Corporation in May 2006, and the
licensing payment from Daiichi Pharmaceutical Co., Ltd.
    Total operating expenditures for the fiscal year ended June 30, 2007 were
$37.6 million compared to $28.1 million for the fiscal year ended June 30,
2006. Total operating expenditures for the fourth quarter ended June 30, 2007
were $6.5 million compared to $9.3 million for the same quarter in 2006.
    General and administrative expenses decreased to $7.0 million in fiscal
2007 compared to $8.0 million in fiscal 2006. This was mainly due to a
decrease in stock based compensation expense of $872,000.
    Licensing and product development expenses increased by $8.6 million from
$20.2 million in fiscal 2006 to $28.8 million in fiscal 2007. Costs associated
with development activities for nimotuzumab increased to $5.9 million compared
to $4.8 million in fiscal 2006 as a result of commissions and consulting fees
associated with obtaining the licensing agreement with Daiichi-Sankyo and
additional costs relating to pre-clinical and clinical studies. Costs
associated with development activities for AeroLEF(TM) decreased to
$2.9 million in fiscal 2007 compared to $4.1 million in fiscal 2006, mainly
due to decreased costs related to the Phase II trial in acute pain. Costs
related to development activities for tesmilifene for fiscal 2007 decreased to
$7.5 million in fiscal 2007 compared to $11.3 million in fiscal 2006, mainly
due to the closing down the Phase III trial and the settlement of holdback
amounts from the original contract for the trial.
    Employee compensation relating to licensing and product development
increased by $5.2 million for fiscal 2007 compared to fiscal 2006. The
increase is partly attributed to salaries and bonuses related to employees who
joined YM as part of the Eximias acquisition in May 2006. Also, during the
year the Company incurred expenses with respect to the termination of certain
US executives in February 2007.
    Total amortization with respect to intangible assets increased to
$1.9 million in fiscal 2007 compared to $1.3 million in fiscal 2006.
    On February 1, 2007 the Company recorded an impairment for the
unamortized portion of the workforce intangible asset that was acquired in the
Eximias acquisition on May 9, 2006. After the termination of the Phase III DEC
trial in metastatic breast cancer, management re-evaluated the workforce
intangible and determined it to be impaired because it is no longer a probable
future economic benefit. This resulted in a write-down of $1.8 million, the
net book value of the asset on the day of impairment.
    Net losses for the fiscal year and fourth quarter ended June 30, 2007
were $31.7 million ($0.57 per share) and $4.7 million ($0.08 per share)
respectively compared to $25.8 million ($0.59 per share) and $8.6 million
($0.16 per share) for the same periods last year.
    As at June 30, 2007 the Company had cash and cash equivalents and
short-term deposits totaling $75.6 million and payables and accrued
liabilities totaling $3.3 million compared to $88.3 million and $3.7 million
respectively at June 30, 2006.
    As at June 30, 2007 the Company had 58,216,309 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., 8,972,277
warrants, and 4,196,205 options.

    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
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.

    Conference Call Scheduled

    A conference call is planned for 9:00am EDT, on Monday September 24,
2007, to which participants may listen via an audio webcast, accessible
through the company's website at www.ymbiosciences.com or via telephone. The
telephone conference number is 416-644-3414 or toll-free at 1-800-733-7560.

    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.

    Summary financial statements attached:


    
    YM BIOSCIENCES INC.
    (A DEVELOPMENT STAGE COMPANY)

    Consolidated Balance Sheets
    (Amounts in Canadian dollars, unless otherwise noted)

    June 30, 2007 and 2006

    -------------------------------------------------------------------------
                                                         2007           2006
    -------------------------------------------------------------------------

    Assets

    Current assets:
      Cash and cash equivalents                 $   5,847,351  $   2,735,317
      Short-term deposits                          69,724,438     85,606,117
      Accounts receivable                             370,011      2,214,775
      Prepaid expenses                                347,010        318,338
      -----------------------------------------------------------------------
                                                   76,288,810     90,874,547

    Property and equipment                            325,040        304,985

    Intangible assets                               5,125,950      8,868,528
    -------------------------------------------------------------------------
                                                $  81,739,800  $ 100,048,060
    -------------------------------------------------------------------------
    -------------------------------------------------------------------------

    Liabilities and Shareholders' Equity

    Current liabilities:
      Accounts payable                          $   1,169,211  $   2,367,042
      Accrued liabilities                           2,103,755      1,350,923
      Deferred revenue                              4,702,132        738,297
      -----------------------------------------------------------------------
                                                    7,975,098      4,456,262

    Deferred revenue                                8,929,900        844,275

    Shareholders' equity:
      Share capital                               172,921,153    172,771,544
      Share purchase warrants                       4,553,308      4,597,988
      Contributed surplus                           5,657,082      3,944,492
      Deficit accumulated during the
       development stage                         (118,296,741)   (86,566,501)
      -----------------------------------------------------------------------
                                                   64,834,802     94,747,523
    Basis of presentation
    Commitments

    -------------------------------------------------------------------------
                                                $  81,739,800  $ 100,048,060
    -------------------------------------------------------------------------
    -------------------------------------------------------------------------



    YM BIOSCIENCES INC.
    (A DEVELOPMENT STAGE COMPANY)

    Consolidated Statements of Operations and
    Deficit Accumulated During the Development Stage
    (Amounts in Canadian dollars, unless otherwise noted)

    -------------------------------------------------------------------------
                                                                 Period from
                                                                inception on
                                                                   August 17,
                                                                        1994
                                  Years ended June 30,            to June 30,
                           2007           2006           2005           2007
    -------------------------------------------------------------------------
    Revenue       $   4,407,890  $   1,151,135  $     748,020  $   6,307,045
    Interest
     income           3,239,540      1,397,558        703,873      8,129,389
    -------------------------------------------------------------------------
                      7,647,430      2,548,693      1,451,893     14,436,434

    Expenses:
      General and
       admini-
       strative       6,978,336      7,951,470      6,314,357     36,086,535
      Licensing
       and product
       development   28,758,469     20,188,577     10,981,950     90,796,383
      Impairment of
       intangible
       assets         1,829,538              -              -      1,829,538
      -----------------------------------------------------------------------
                     37,566,343     28,140,047     17,296,307    128,712,456
    -------------------------------------------------------------------------

    Loss before
     the under-
     noted          (29,918,913)   (25,591,354)   (15,844,414)  (114,276,022)

    Loss on
     foreign
     exchange          (142,552)      (220,630)             -       (363,182)

    Loss on
     marketable
     securities               -         (2,623)       (14,881)    (1,191,329)
    -------------------------------------------------------------------------

    Loss before
     income taxes   (30,061,465)   (25,814,607)   (15,859,295)  (115,830,533)

    Income taxes      1,668,775              -              -      1,676,075
    -------------------------------------------------------------------------

    Loss for
     the period     (31,730,240)   (25,814,607)   (15,859,295)  (117,506,608)

    Deficit,
     beginning
     of period      (86,566,501)   (60,751,894)   (44,319,267)             -

    Cost of
     purchasing
     shares for
     cancellation
     in excess of
     book value               -              -       (573,332)      (790,133)

    -------------------------------------------------------------------------
    Deficit,
     end of
     period       $(118,296,741) $ (86,566,501) $ (60,751,894) $(118,296,741)
    -------------------------------------------------------------------------
    -------------------------------------------------------------------------

    Basic and
     diluted loss
     per common
     share        $       (0.57) $       (0.59) $       (0.47)
    -------------------------------------------------------------------------
    -------------------------------------------------------------------------

    Weighted
     average
     number of
     common
     shares
     outstanding     55,804,674     43,755,160     34,046,450

    Excludes
     common shares
     held in
     escrow for
     contingent
     additional
     payment
     related to
     the
     acquisition
     of Delex
     Therapeutics
     Inc.             2,380,953      2,380,953      2,777,778
    -------------------------------------------------------------------------
    -------------------------------------------------------------------------


    YM BIOSCIENCES INC.
    (A DEVELOPMENT STAGE COMPANY)

    Consolidated Statements of Cash Flows
    (Amounts in Canadian dollars, unless otherwise noted)
    -------------------------------------------------------------------------
                                                                 Period from
                                                                inception on
                                                                   August 17,
                                                                        1994
                                  Years ended June 30,            to June 30,
                           2007           2006           2005           2007
    -------------------------------------------------------------------------
    Cash provided
     by (used in):

    Operating
     activities:
      Loss for the
       period     $ (31,730,240) $ (25,814,607) $ (15,859,295) $(117,506,608)
      Items not
       involving
       cash:
        Deprecia-
         tion of
         property
         and
         equipment      107,107         61,017         11,717        438,789
        Amortiza-
         tion of
         intangible
         assets       1,913,040      1,269,158        137,760      3,319,958
        Impairment
         of
         intangible
         assets       1,829,538              -              -      1,829,538
        Loss on
         sale of
         marketable
         securities           -          2,623         14,881      1,191,329
        Stock-based
         compensa-
         tion         1,716,913      2,588,413      1,278,955      6,153,476
        Stock-based
         consider-
         ation                -        100,000        192,750        292,750
        Warrants-
         based
         consider-
         ation                -         54,775              -         54,775
      Change in
       non-cash
       operating
       working
       capital:
        Accounts
         receivable
         and
         prepaid
         expenses     1,816,092       (672,639)      (367,916)       311,701
        Accounts
         payable
         and accrued
         liabilities
         and
         deferred
         revenue     11,604,460     (1,599,032)     2,396,216     13,663,354
    -------------------------------------------------------------------------
                    (12,743,090)   (24,010,292)   (12,194,932)   (90,250,938)

    Financing
     activities:
      Repayment of
       debentures             -              -     (1,469,425)    (1,469,425)
      Issuance of
       common shares
       on exercise
       of options        11,232        851,322        109,318      2,516,246
      Issuance of
       common shares
       on exercise
       of warrants       89,375      3,627,430        432,402      4,371,555
      Redemption of
       preferred
       shares                 -              -              -     (2,630,372)
      Purchase of
       shares for
       cancellation           -              -       (779,909)    (1,029,679)
      Net proceeds
       from issuance
       of shares and
       warrants               -     42,622,618     18,884,120    123,276,729
    -------------------------------------------------------------------------
                        100,607     47,101,370     17,176,506    125,035,054

    Investing
     activities:
      Short-term
       deposits,
       net           15,881,679    (55,529,720)   (14,988,521)   (69,530,513)
      Proceeds on
       sale of
       marketable
       securities             -          2,211              -      1,404,450
      Additions to
       property and
       equipment and
       intangible
       assets          (127,162)       (54,791)       (27,034)      (577,315)
    -------------------------------------------------------------------------
                     15,754,517    (55,582,300)   (15,015,555)   (68,703,378)
    -------------------------------------------------------------------------

    Increase
     (decrease) in
     cash and cash
     equivalents      3,112,034    (32,491,222)   (10,033,981)   (33,919,262)

    Net cash assumed
     on acquisition           -     34,540,166      5,226,447     39,766,613

    Cash and cash
     equivalents,
     beginning of
     period           2,735,317        686,373      5,493,907              -
    -------------------------------------------------------------------------
    Cash and cash
     equivalents,
     end of
     period       $   5,847,351  $   2,735,317  $     686,373  $   5,847,351
    -------------------------------------------------------------------------
    -------------------------------------------------------------------------
    Non-cash
     items:
      Issuance of
       common
       shares on
       Delex
       acquisi-
       tion       $           -  $   1,464,284  $   9,862,697  $  11,326,981
      Issuance of
       common
       shares on
       Eximias
       acquisi-
       tion                   -     35,063,171              -     35,063,171
      Issuance of
       common
       shares in
       exchange
       for licensed
       patents                -        100,000              -        100,000
    

    %SEDAR: 00004652E




For further information:

For further information: Enquiries: Thomas Fechtner, the Trout Group
LLC, Tel. (212) 477-9007 x31, Fax (212) 460-9028, Email:
tfechtner@troutgroup.com; James Smith, the Equicom Group Inc., Tel. (416)
815-0700 x 229, Fax (416) 815-0080, Email: jsmith@equicomgroup.com; Nominated
Adviser, Canaccord Adams Limited, Ryan Gaffney, Tel. +44 (0)20 7050 6500


Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

CNW Membership

Fill out a CNW membership form or contact us at 1 (877) 269-7890

Learn about CNW services

Request more information about CNW products and services or call us at 1 (877) 269-7890