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YMB YM Bio.'b'ser1

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Share Name Share Symbol Market Type Share ISIN Share Description
YM Bio.'b'ser1 LSE:YMB London Ordinary Share CA9842382041 CLASS B PFD SHS SER 1 NPV
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.00 0.00% 0.00 -
Industry Sector Turnover Profit EPS - Basic PE Ratio Market Cap
0 0 N/A 0

Interim Results

13/02/2006 7:02am

UK Regulatory


    YM BioSciences reports second quarter 2006 operational and financial

    results

 

    MISSISSAUGA, ON, Feb. 10 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,

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

and financial results for the second quarter of fiscal 2006, ended

December 31, 2005.

    "Important times are ahead. All three of our late-stage products

advancing in the clinic with results to be reported this calendar year. For

our lead drug tesmilifene, the first of three planned interim analyses of data

from our pivotal Phase III metastatic and recurrent breast cancer trial could

occur in and around mid calendar 2006," said David Allan, Chairman and CEO of

YM BioSciences. "If survival results meet the levels set in the Special

Protocol Assessment agreed to with the FDA, data this year could be sufficient

to seek regulatory approval."

 

    Other highlights:

    -  Hypothesis of tesmilifene's mode of action authored by

       Dr. Mark Vincent has been published online in Medical Hypotheses,

       Vol. 66 No. 4 which together with supporting evidence from numerous

       academic laboratories in Canada and the USA suggests that tesmilifene

       is a unique molecule, selective for multiple drug resistant cancer

       cells, and positively impacts the most common chemotherapies across

       multiple tumour types. Drug resistance is widely recognized to be the

       "ultimate frontier in the fight against cancer." The article is

       available for viewing now online through Elsevier's online journal

       site www.sciencedirect.com.

    -  Entered into a collaborative agreement with Sanofi-Aventis to

       investigate the effect of combining tesmilifene and the blockbuster

       cancer drug Taxotere(R) (docetaxel) for women with rapidly progressing

       metastatic breast cancer. Enrolment is targeted for completion in

       calendar Q2, 2006 and pharmacokinetic data could be available by

       year-end with survival results possible by year-end 2007.

    -  Reported positive results in the November 2005 issue of the Journal of

       Urology from a Phase II trial of tesmilifene plus

       mixantrone/prednisone for the treatment of hormone refractory prostate

       cancer. This indication is now expected to be advanced with the first

       randomized trial in this indication and is expected to compare a

       standard of care mitoxantrone/prednisone used in Taxotere failures to

       the same regimen plus tesmilifene. The primary endpoints will be those

       in which the combination appeared to provide significant benefit in

       the single arm Phase II - namely the important reduction in pain

       suffered by patients at this stage and a reduction in PSA.

    -  Completed preparations for prospectively pivotal trials in children

       with inoperable brain cancer - pontine, or brain-stem glioma - for

       submission to the FDA and the European Regulatory Authority, EMEA.

    -  Partnered with Innogene Kalbiotech Ltd (IGK) of Singapore to expand

       the development program for nimotuzumab into Southeast Asia and

       Africa.

    -  Initiated a Phase IIb trial for AeroLEF(TM) subsequent to the end of

       the quarter. The trial could complete recruitment and report results

       within the first half of calendar 2006.

    -  Filed and received clearance for a "shelf" prospectus in Canada and

       the USA following the end of the quarter. A "shelf" facilitates

       financing by a company, reduces the time period during which a company

       must otherwise wait for a prospectus to be cleared, permits the sale

       to investors of shares without a "hold period" (thus significantly

       reducing the cost of capital) and permits the use of freely traded

       shares in the case of another acquisition by YM, again significantly

       reducing the prospective cost of capital. The "shelf" registration

       covers any financing during the forthcoming 25 months.

 

    Financial Results

    Total revenue for the quarter ended December 31, 2005 was $549,230

compared to $521,524 for the same period last year. Total revenue for the

first six months of the 2006 fiscal year was $792,237 compared to $989,998 for

the first six months of the corresponding period last year. Revenue consisted

of revenue generated from out-licensing agreements and interest income.

    Total expenditures for the quarter ended December 31, 2005 were

$6,064,517 compared to $3,379,021 for the same period last year. Total

expenditures for the first six months of the 2006 fiscal year were $12,268,425

compared to $5,960,757 for the first six months of the corresponding period

last year. General and Administrative expenses for the second quarter were

$1,253,873 and for the first six months were $2,681,772 compared to $1,259,259

and $2,517,291 respectively for the same periods in the prior year. Licensing

and Product Development expenses for the second quarter were $4,810,644 and

for the first six months were $9,586,653 compared to $2,119,762 and $3,443,466

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 second quarter was $5,536,292 and for the year to date

was $11,460,138 compared to $2,830,164 and $5,098,863 respectively for the

same periods last year.

    As at December 31, 2005 the Company had cash and short-term deposits

totaling $20,300,992 and current liabilities of $3,335,168 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.

Published results from tesmilifene's first Phase III trial in the same

indication demonstrated a substantial increase in survival for women treated

with the combination of tesmilifene and chemotherapy compared to chemotherapy

alone, demonstrating that tesmilifene significantly enhanced the therapeutic

effect of chemotherapy. In addition to tesmilifene, YM BioSciences is

developing nimotuzumab, an anti-EGFr humanized monoclonal antibody, in a

number of indications. A Phase II monotherapy trial of nimotuzumab produced

cytotoxic efficacy and evidence of survival benefit in children with recurrent

brain cancer.

    In May 2005, the Company acquired DELEX Therapeutics Inc., a private

clinical stage biotechnology company developing AeroLEF(TM), a unique

inhalation delivered formulation of the established drug, fentanyl, to treat

acute pain including cancer pain. This product has completed a Phase IIa trial

with positive results and a randomized Phase IIb pain trial has been

initiated. YM BioSciences is also developing its anti-GnRH, anti-cancer

vaccine, Norelin(TM), for which Phase II data have been released. The Company

also has a portfolio of preclinical compounds shown to act as

chemopotentiators while protecting normal cells.

 

    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)

 

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

                                                 December 31,        June 30,

                                                        2005            2005

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

                                                         (Unaudited)

 

    Assets

 

    Current assets:

      Cash and cash equivalents                 $ 20,300,992    $    686,373

      Short-term deposits                                  -      29,882,472

      Marketable securities                            4,834           4,834

      Accounts receivable and prepaid expenses     1,805,143       1,751,373

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

                                                  22,110,969      32,325,052

 

    Capital assets                                   212,249         226,698

 

    Acquired technologies                          6,714,054       5,648,141

 

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

                                                $ 29,037,272    $ 38,199,891

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

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

 

    Liabilities and Shareholders' Equity

 

    Current liabilities:

      Accounts payable                          $  2,504,782    $  2,995,457

      Accrued liabilities                            830,386         830,158

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

                                                   3,335,168       3,825,615

 

    Deferred revenue                                 798,932         534,157

 

    Shareholders' equity:

      Share capital                               89,587,454      87,487,802

      Share purchase warrants                      5,222,203       5,313,283

      Contributed surplus                          2,305,547       1,790,928

      Deficit accumulated during the

       development stage                         (72,212,032)    (60,751,894)

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

                                                  24,903,172      33,840,119

 

    Going concern

    Commitments

    Subsequent events

 

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

                                                $ 29,037,272    $ 38,199,891

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

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

 

 

 

    YM BIOSCIENCES INC.

    (A DEVELOPMENT STAGE COMPANY)

 

    Interim Consolidated Statements of Operations

    (Expressed in Canadian dollars)

 

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

                                          Three months ended

                                             December 31,

                                          2005          2004

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

                                             (Unaudited)

 

    Out-licensing revenue         $    379,242   $    300,488

    Interest income                    169,988        221,036

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

                                       549,230        521,524

 

    Expenses:

      General and administrative     1,253,873      1,259,259

      Licensing and product

       development                   4,810,644      2,119,762

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

                                     6,064,517      3,379,021

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

 

    Loss before the undernoted      (5,515,287)    (2,857,497)

 

    Gain on sale of marketable

     securities                              -              -

 

    Unrealized loss on marketable

     securities                              -              -

 

    Unrealized gain (loss) on

     foreign exchange                  (21,005)        27,333

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

 

    Loss before income taxes        (5,536,292)    (2,830,164)

 

    Income taxes                             -              -

 

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

    Loss for the period           $ (5,536,292)  $ (2,830,164)

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

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

 

    Basic and diluted loss per

     common share                 $      (0.14)  $      (0.08)

 

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

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

 

    Weighted average number of

     common shares outstanding,

     excluding 2,380,953 common

     shares held in escrow for

     contingent additional

     payment related to the

     Delex acquisition              39,139,493     35,125,107

 

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

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

 

 

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

                                                                 Period from

                                                                inception on

                                                                   August 17,

                                           Six months ended          1994 to

                                              December 31,       December 31,

                                          2005           2004           2005

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

                                             (Unaudited)          (Unaudited)

 

    Out-licensing revenue         $    467,750   $    661,866   $  1,215,770

    Interest income                    324,487        328,132      3,816,778

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

                                       792,237        989,998      5,032,548

 

    Expenses:

      General and administrative     2,681,772      2,517,291     23,829,501

      Licensing and product

       development                   9,586,653      3,443,466     51,444,990

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

                                    12,268,425      5,960,757     75,274,491

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

 

    Loss before the undernoted     (11,476,188)    (4,970,759)   (70,241,943)

 

    Gain on sale of marketable

     securities                              -              -        638,332

 

    Unrealized loss on marketable

     securities                              -              -     (1,827,038)

 

    Unrealized gain (loss) on

     foreign exchange                   16,050       (128,104)        16,050

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

 

    Loss before income taxes       (11,460,138)    (5,098,863)   (71,414,599)

 

    Income taxes                              -             -          7,300

 

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

    Loss for the period           $(11,460,138)  $ (5,098,863)  $(71,421,899)

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

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

 

    Basic and diluted loss per

     common share                 $      (0.29)  $      (0.16)

 

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

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

 

    Weighted average number of

     common shares outstanding,

     excluding 2,380,953 common

     shares held in escrow for

     contingent additional

     payment related to the

     Delex acquisition              38,964,104     31,906,888

 

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

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

 

 

 

    YM BIOSCIENCES INC.

    (A DEVELOPMENT STAGE COMPANY)

 

    Interim Consolidated Statements of Deficit Accumulated During the

     Development Stage

    (Expressed in Canadian dollars)

 

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

                                           Three months ended

                                              December 31,

                                          2005           2004

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

                                              (Unaudited)

 

    Deficit, beginning of period  $(66,675,740)  $(46,587,966)

 

    Cost of purchasing shares

     for cancellation in excess

     of book value                           -       (573,332)

 

    Loss for the period             (5,536,292)    (2,830,164)

 

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

    Deficit, end of period        $(72,212,032)  $(49,991,462)

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

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

 

 

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

                                                                 Period from

                                                                inception on

                                                                   August 17,

                                            Six months ended         1994 to

                                              December 31,       December 31,

                                          2005           2004           2005

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

                                              (Unaudited)         (Unaudited)

 

    Deficit, beginning of period  $(60,751,894)  $(44,319,267)  $          -

 

    Cost of purchasing shares

     for cancellation in excess

     of book value                           -       (573,332)      (790,133)

 

    Loss for the period            (11,460,138)    (5,098,863)   (71,421,899)

 

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

    Deficit, end of period        $(72,212,032)  $(49,991,462)  $(72,212,032)

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

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

 

 

 

    YM BIOSCIENCES INC.

    (A DEVELOPMENT STAGE COMPANY)

 

    Interim Consolidated Statements of Cash Flows

    (Expressed in Canadian dollars)

 

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

                                           Three months ended

                                              December 31,

                                          2005           2004

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

                                              (Unaudited)

 

    Cash provided by (used in):

 

    Operating activities:

      Loss for the period         $ (5,536,292)  $ (2,830,164)

      Items not involving cash:

        Amortization of capital

         assets                         12,605            936

        Amortization of acquired

         technology                    267,843              -

        Gain on sale of marketable

         securities                          -              -

        Unrealized loss on

         marketable securities               -              -

        Stock-based employee

         compensation                  263,822        176,983

        Stock-based consideration            -              -

      Change in non-cash operating

       working capital:

        Accounts receivable and

         prepaid expenses              195,279        163,382

        Accounts payable, accrued

         liabilities and deferred

         revenue                       (58,640)      (336,754)

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

                                    (4,855,383)    (2,825,617)

 

    Financing activities:

      Issuance of common shares

       on exercise of warrants         185,916              -

      Repayment of debenture                 -              -

      Net proceeds from issuance

       of shares and warrants                -              -

      Issuance of common shares

       on exercise of options           59,750         43,650

      Redemption of preferred

       shares                                -              -

      Purchase of shares for

       cancellation                          -       (779,909)

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

                                       245,666       (736,259)

 

    Investing activities:

      Maturity of short-term

       deposits, net                         -              -

      Proceeds on sale of

       marketable securities                 -              -

      Additions to capital assets       (4,089)        (2,704)

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

                                        (4,089)        (2,704)

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

 

    Increase (decrease) in cash

     and cash equivalents           (4,613,806)    (3,564,580)

 

    Cash assumed on purchase

     of Delex                                -              -

 

    Cash and cash equivalents,

     beginning of period            24,914,798     37,349,984

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

    Cash and cash equivalents,

     end of period                $ 20,300,992   $ 33,785,404

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

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

    Supplemental cash flow

     information:

      Non-cash items:

        Issuance of shares on

         Delex acquisition        $          -   $          -

        Issuance of 26,316 common

         shares in exchange for

         licensed patents                    -              -

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

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

 

 

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

                                                                 Period from

                                                                inception on

                                                                   August 17,

                                           Six months ended          1994 to

                                              December 31,       December 31,

                                          2005           2004           2005

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

                                              (Unaudited)         (Unaudited)

 

    Cash provided by (used in):

 

    Operating activities:

      Loss for the period         $(11,460,138)  $ (5,098,863)  $(71,421,899)

      Items not involving cash:

        Amortization of capital

         assets                         25,169          1,720        295,833

        Amortization of acquired

         technology                    496,371              -        634,131

        Gain on sale of marketable

         securities                          -              -       (638,332)

        Unrealized loss on

         marketable securities               -              -      1,827,039

        Stock-based employee

         compensation                  550,741        346,155      2,398,891

        Stock-based consideration      100,000              -        292,750

      Change in non-cash operating

       working capital:

        Accounts receivable and

         prepaid expenses              (53,770)       218,085       (885,524)

        Accounts payable, accrued

         liabilities and deferred

         revenue                      (323,672)      (350,312)     3,236,255

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

                                   (10,665,299)    (4,883,215)   (64,260,856)

 

    Financing activities:

      Issuance of common shares

       on exercise of warrants         185,916              -        840,666

      Repayment of debenture                 -              -     (1,469,425)

      Net proceeds from issuance

       of shares and warrants                -     18,972,307     80,654,111

      Issuance of common shares

       on exercise of options          222,250         91,067      1,875,943

      Redemption of preferred

       shares                                -              -     (2,630,372)

      Purchase of shares for

       cancellation                          -       (779,909)    (1,029,679)

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

                                       408,166     18,283,465     78,241,244

 

    Investing activities:

      Maturity of short-term

       deposits, net                29,882,472     14,893,951              -

      Proceeds on sale of

       marketable securities                 -              -      1,402,239

      Additions to capital assets      (10,720)        (2,704)      (308,082)

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

                                    29,871,752     14,891,247      1,094,157

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

 

    Increase (decrease) in cash

    and cash equivalents            19,614,619     28,291,497     15,074,545

 

    Cash assumed on purchase

     of Delex                                -              -      5,226,447

 

    Cash and cash equivalents,

     beginning of period               686,373      5,493,907              -

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

    Cash and cash equivalents,

     end of period                $ 20,300,992   $ 33,785,404   $ 20,300,992

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

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

    Supplemental cash flow

     information:

      Non-cash items:

        Issuance of shares on

         Delex acquisition        $  1,464,284   $          -   $ 11,326,981

        Issuance of 26,316 common

         shares in exchange for

         licensed patents              100,000              -        100,000

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

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

 

 

    /For further information: Enquiries: Thomas Fechtner, The Trout Group

LLC, Tel. (212) 477-9007 x31, Fax (212) 460-9028, Email:

tfechtner(at)troutgroup.com; Carolyn McEwen, YM BioSciences Inc.,

Tel. (905) 629-9761, Fax (905) 629-4959, Email: ir(at)ymbiosciences.com/

    (YMBA)

 

 

 

 

 



END



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