YM BioSciences reports third quarter 2006 operational and financial

    results

 

    MISSISSAUGA, ON, May 12 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,

AIM:YMBA), the cancer product development company, today reported operational

and financial results for the third quarter of fiscal 2006, ended March 31,

2006.

    "With multiple clinical trials ongoing for our three late-stage products,

tesmilifene, nimotuzumab, and AeroLEF(TM), it is an exciting, active time at

YM with numerous milestone events ahead. For tesmilifene, several early

analyses of data from the ongoing pivotal trial will precede the conclusion of

the trial which is expected in the first half of 2007. If any of these early

analyses produces suitably positive results we will be in position to submit

our lead drug, which received fast track designation during the quarter, for

FDA approval," said David Allan, Chairman and CEO of YM BioSciences. "The

acquisition of Eximias will enable YM to transform into a more fully

integrated cancer company with the capability and flexibility to bring our

well-advanced products to market. It will ensure YM is well positioned for the

prospect of the success of tesmilifene without having to rely solely on a

partner for manufacturing and marketing."

 

    Highlights:

    -  Received FDA Fast Track designation for tesmilifene in advanced breast

       cancer.

    -  Entered into a collaborative agreement with Sanofi-Aventis to

       investigate the effect of combining tesmilifene and Taxotere(R)

       (docetaxel) for the treatment of women with rapidly progressing

       metastatic breast cancer. Enrolment is targeted for completion in

       calendar Q3, 2006.

    -  Enrolled the first patient in YM's multi-center Phase I/II Non-Small-

       Cell Lung Cancer (NSCLC) trial of nimotuzumab, our humanized anti-EGFr

       monoclonal antibody. YM expects to complete recruitment for the NSCLC

       trial in late 2007 or early 2008.

    -  YM BioSciences partner, Oncoscience AG, commenced patient treatment in

       a Phase III trial in Germany with nimotuzumab. Oncoscience expects the

       trial should be completed in the first half of 2007.

    -  Initiated a Phase IIb trial for AeroLEF(TM). The trial is expected to

       report preliminary results within the first half of calendar 2006.

    -  Raised US $40 million through a "registered direct" offering of common

       shares.

    -  Announced its acquisition of Eximias Pharmaceutical Corporation.

 

    Financial Results

    Total revenue for the quarter ended March 31, 2006 was $684,456 compared

to $203,108 for the same period last year. Total revenue for the first nine

months of the 2006 fiscal year was $1,476,693 compared to $1,193,106 for the

corresponding nine-month period last year. Revenue consisted of revenue

generated from out-licensing agreements and interest income.

    Total expenditures for the quarter ended March 31, 2006 were $6,558,668

compared to $4,483,146 for the same period last year. Total expenditures for

the first nine months of the 2006 fiscal year were $18,827,093 compared to

$10,443,903 for the first nine months of the corresponding period last year.

    General and Administrative expenses for the third quarter were $1,876,575

and for the first nine months were $4,558,347 compared to $1,486,357 and

$4,003,648, respectively, for the same periods in the prior year. Licensing

and Product Development expenses for the third quarter were $4,682,093 and for

the first nine months were $14,268,746 compared to $2,996,789 and $6,440,255,

respectively, for the same periods in the prior year. Expenditure increases

were due primarily to the rapid progression of the tesmilifene Phase III

clinical trial and the inclusion of costs associated with the development of

the AeroLEF(TM) technology.

    Net loss for the third quarter was $5,772,479 and for the year to date

was $17,232,617 compared to $4,277,762 and $9,376,625 respectively for the

same periods last year.

    As at March 31, 2006 the Company had cash and short-term deposits

totaling $63,407,634 and current liabilities of $3,686,028 compared to

$30,568,845 and $3,825,615 respectively at June 30, 2005.

 

    About YM BioSciences

    YM BioSciences Inc. is a cancer product development company. Its lead

drug, tesmilifene, is a small molecule chemopotentiator currently undergoing a

700-patient pivotal Phase III trial in metastatic and recurrent breast cancer.

In addition to tesmilifene, YM BioSciences is developing nimotuzumab, an anti-

EGFr humanized monoclonal antibody, in a number of indications and

AeroLEF(TM), a unique inhalation delivered formulation of the established

drug, fentanyl, to treat acute pain including cancer pain. YM BioSciences is

also developing its anti-GnRH, anti-cancer vaccine, Norelin(TM), and owns a

portfolio of preclinical compounds.

 

    Except for historical information, this press release may contain       

forward-looking statements, which reflect the Company's current expectation

regarding future events. These forward-looking statements involve risk and

uncertainties, which may cause 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.

 

    Summary financial statements attached:

 

   

    YM BIOSCIENCES INC.

    (A DEVELOPMENT STAGE COMPANY)

 

    Interim Consolidated Balance Sheets

    (Expressed in Canadian dollars)

 

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

                                                     March 31,       June 30,

                                                         2006           2005

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

                                                          (Unaudited)

    Assets

 

    Current assets:

      Cash and cash equivalents                  $ 11,301,848   $    686,373

      Short-term deposits                          52,105,786     29,882,472

      Marketable securities                             4,834          4,834

      Accounts receivable and prepaid expenses      1,362,866      1,751,373

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

                                                   64,775,334     32,325,052

 

    Capital assets                                    236,929        226,698

 

    Acquired technologies                           6,450,339      5,648,141

 

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

                                                 $ 71,462,602   $ 38,199,891

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

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

 

    Liabilities and Shareholders' Equity

 

    Current liabilities:

      Accounts payable                           $  2,917,939   $  2,995,457

      Accrued liabilities                             866,089        830,158

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

                                                    3,784,028      3,825,615

 

    Deferred revenue                                1,767,146        534,157

 

    Shareholders' equity:

      Share capital                               136,435,893     87,487,802

      Share purchase warrants                       4,864,165      5,313,283

      Contributed surplus                           2,595,881      1,790,928

      Deficit accumulated during the

       development stage                          (77,984,511)   (60,751,894)

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

                                                   65,911,428     33,840,119

 

    Basis of presentation

    Commitments

    Subsequent event

 

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

                                                 $ 71,462,602   $ 38,199,891

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

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

 

 

 

    YM BIOSCIENCES INC.

    (A DEVELOPMENT STAGE COMPANY)

 

    Interim Consolidated Statements of Operations

    (Expressed in Canadian dollars)

 

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

                              Three months ended          Nine months ended

                                   March 31,                   March 31,

                              2006          2005          2006          2005

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

                                  (Unaudited)                 (Unaudited)

 

    Out-licensing

     revenue          $    498,861  $     34,461  $    966,611  $    696,327

    Interest income        185,595       168,647       510,082       496,779

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

                           684,456       203,108     1,476,693     1,193,106

 

    Expenses:

      General and

       administrative    1,876,575     1,486,357     4,558,347     4,003,648

      Licensing and

       product

       development       4,682,093     2,996,789    14,268,746     6,440,255

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

                         6,558,668     4,483,146    18,827,093    10,443,903

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

 

    Loss before the

     undernoted         (5,874,212)   (4,280,038)  (17,350,400)   (9,250,797)

 

    Gain (loss) on

     sale of marketable

     securities                  -        (2,139)            -        (2,139)

 

    Unrealized loss

     on marketable

     securities                  -             -             -             -

 

    Unrealized gain

     (loss) on foreign

     exchange              101,733         4,415       117,783      (123,689)

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

 

    Loss before income

     taxes              (5,772,479)   (4,277,762)  (17,232,617)   (9,376,625)

 

    Income taxes                 -             -             -             -

 

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

    Loss for the

     period           $ (5,772,479) $ (4,277,762) $(17,232,617) $ (9,376,625)

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

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

 

    Basic and diluted

     loss per common

     share            $      (0.13) $      (0.12) $      (0.42) $      (0.28)

 

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

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

 

    Weighted average

     number of common

     shares outstanding,

     excluding common

     shares held in

     escrow for

     contingent

     additional

     payment related

     to the Delex

     acquisition        44,009,338    35,058,608    40,613,971    32,942,273

 

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

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

 

 

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

                       Period from

                      inception on

                         August 17,

                           1994 to

                          March 31,

                              2006

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

                        (Unaudited)

 

    Out-licensing

     revenue          $  1,714,631

    Interest income      4,002,373

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

                         5,717,004

 

    Expenses:

      General and

       administrative   25,706,076

      Licensing and

       product

       development      56,127,083

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

                        81,833,159

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

 

    Loss before the

     undernoted        (76,116,155)

 

    Gain (loss) on

     sale of marketable

     securities            638,332

 

    Unrealized loss

     on marketable

     securities         (1,827,038)

 

    Unrealized gain

     (loss) on foreign

     exchange              117,783

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

 

    Loss before income

     taxes             (77,187,078)

 

    Income taxes             7,300

 

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

    Loss for the

     period           $(77,194,378)

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

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

 

    Basic and diluted

     loss per common

     share

 

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

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

 

    Weighted average

     number of common

     shares outstanding,

     excluding common

     shares held in

     escrow for

     contingent

     additional

     payment related

     to the Delex

     acquisition

 

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

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

 

 

 

    YM BIOSCIENCES INC.

    (A DEVELOPMENT STAGE COMPANY)

 

    Interim Consolidated Statements of Deficit Accumulated During the

    Development Stage

    (Expressed in Canadian dollars)

 

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

                              Three months ended          Nine months ended

                                   March 31,                   March 31,

                              2006          2005          2006          2005

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

                                  (Unaudited)                 (Unaudited)

 

    Deficit, beginning

     of period        $(72,212,032) $(49,991,462) $(60,751,894) $(44,319,267)

 

    Cost of purchasing

     shares for

     cancellation in

     excess of book

     value                       -             -             -      (573,332)

 

    Loss for the

     period             (5,772,479)   (4,277,762)  (17,232,617)   (9,376,625)

 

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

    Deficit, end of

     period           $(77,984,511) $(54,269,224) $(77,984,511) $(54,269,224)

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

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

 

 

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

                       Period from

                      inception on

                         August 17,

                           1994 to

                          March 31,

                              2006

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

                        (Unaudited)

 

    Deficit, beginning

     of period        $          -

 

    Cost of purchasing

     shares for

     cancellation in

     excess of book

     value                (790,133)

 

    Loss for the

     period            (77,194,378)

 

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

    Deficit, end of

     period           $(77,984,511)

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

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

 

 

 

    YM BIOSCIENCES INC.

    (A DEVELOPMENT STAGE COMPANY)

 

    Interim Consolidated Statements of Cash Flows

    (Expressed in Canadian dollars)

 

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

                              Three months ended          Nine months ended

                                   March 31,                   March 31,

                              2006          2005          2006          2005

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

                                  (Unaudited)                 (Unaudited)

    Cash provided by

     (used in):

 

    Operating activities:

      Loss for the

       period         $ (5,772,479) $ (4,277,762) $(17,232,617) $ (9,376,625)

      Items not

       involving cash:

        Amortization of

         capital assets     16,151         1,010        41,320         2,730

        Amortization of

         acquired

         technology        263,715             -       760,086             -

        Gain on sale of

         marketable

         securities              -         2,139             -         2,139

        Unrealized loss

         on marketable

         securities              -             -             -             -

        Stock-based

         employee

         compensation      644,676       170,605     1,195,417       516,760

        Stock-based

         consideration           -       192,750       100,000       192,750

        Warrants-based

         consideration      54,775             -        54,775             -

        Change in non-

         cash operating

         working capital:

        Accounts

         receivable

         and prepaid

         expenses          442,277       108,171       388,507       326,256

        Accounts payable,

         accrued

         liabilities

         and deferred

         revenue         1,417,075       790,478     1,093,402       440,166

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

                        (2,933,810)   (3,012,609)  (13,599,110)   (7,895,824)

 

    Financing activities:

      Issuance of common

       shares on

       exercise of

       warrants          2,912,559       312,965     3,098,474       312,965

      Repayment of

       debenture                 -             -             -             -

      Net proceeds from

       issuance of

       shares and

       warrants         42,622,618             -    42,622,618    18,972,307

      Issuance of

       common shares

       on exercise of

       options             546,108             -       768,358        91,067

      Redemption of

       preferred

       shares                    -             -             -             -

      Purchase of

       shares for

       cancellation              -             -             -      (779,909)

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

                        46,081,285       312,965    46,489,450    18,596,430

 

    Investing activities:

      Purchase short-

       term deposits,

       net             (52,105,786)  (30,031,371)  (22,223,314)  (15,137,420)

      Proceeds on sale

       of marketable

       securities                -             -             -             -

      Additions to

       capital assets      (40,833)       (4,687)      (51,551)       (7,391)

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

                       (52,146,619)  (30,036,058)  (22,274,865)  (15,144,811)

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

 

    Increase (decrease)

     in cash and cash

     equivalents        (8,999,144)  (32,735,702)   10,615,475    (4,444,205)

 

    Cash assumed on

     purchase of Delex           -             -             -             -

 

    Cash and cash

     equivalents,

     beginning of

     period             20,300,992    33,785,404       686,373     5,493,907

 

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

    Cash and cash

     equivalents,

     end of period    $ 11,301,848  $  1,049,702  $ 11,301,848  $  1,049,702

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

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

 

    Supplemental cash

     flow information:

      Non-cash items:

        Issuance of

         shares on

         Delex

         acquisition  $          -  $          -  $  1,464,284  $          -

        Issuance of

         26,316 common

         shares in

         exchange for

         licensed

         patents                 -             -       100,000             -

 

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

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

 

 

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

                       Period from

                      inception on

                         August 17,

                           1994 to

                          March 31,

                              2006

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

                        (Unaudited)

 

    Cash provided by

     (used in):

 

    Operating activities:

      Loss for the

       period         $(77,194,378)

      Items not

       involving cash:

        Amortization of

         capital assets    311,985

        Amortization of

         acquired

         technology        897,846

        Gain on sale of

         marketable

         securities       (638,332)

        Unrealized loss

         on marketable

         securities      1,827,038

        Stock-based

         employee

         compensation    3,043,567

        Stock-based

         consideration     292,750

        Warrants-based

         consideration      54,775

        Change in non-

         cash operating

         working capital:

        Accounts

         receivable

         and prepaid

         expenses         (443,247)

        Accounts payable,

         accrued

         liabilities

         and deferred

         revenue         4,653,328

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

                       (67,194,668)

 

    Financing activities:

      Issuance of common

       shares on

       exercise of

       warrants          3,753,226

      Repayment of

       debenture        (1,469,425)

      Net proceeds from

       issuance of

       shares and

       warrants        123,276,729

      Issuance of

       common shares

       on exercise of

       options           2,422,052

      Redemption of

       preferred

       shares           (2,630,372)

      Purchase of

       shares for

       cancellation     (1,029,679)

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

                       124,322,531

 

    Investing activities:

      Purchase short-

       term deposits,

       net             (52,105,786)

      Proceeds on sale

       of marketable

       securities        1,402,239

      Additions to

       capital assets     (348,915)

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

                       (51,052,462)

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

 

    Increase (decrease)

     in cash and cash

     equivalents         6,075,401

 

    Cash assumed on

     purchase of Delex   5,226,447

 

    Cash and cash

     equivalents,

     beginning of

     period                      -

 

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

    Cash and cash

     equivalents,

     end of period    $ 11,301,848

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

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

 

    Supplemental cash

     flow information:

      Non-cash items:

        Issuance of

         shares on

         Delex

         acquisition  $ 11,326,981

        Issuance of

         26,316 common

         shares in

         exchange for

         licensed

         patents           100,000

 

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

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

 

   

    For further information: Thomas Fechtner, The Trout Group LLC, Tel.

(212) 477-9007 x31, Fax (212) 460-9028, Email: tfechtner(at)troutgroup.com;

James Smith, the Equicom Group Inc., Tel. (416) 815-0700 x 229, Fax          

(416) 815-0080, Email: jsmith(at)equicomgroup.com

    (YM. YMI YMBA)



END



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