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BioMS Medical announces second quarter 2009 results
Date:7/17/2009

Toronto Stock Exchange Symbol: MS

EDMONTON, July 17 /PRNewswire-FirstCall/ - BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced financial and operational results for the three and six months ended June 30, 2009.

"The pivotal phase III MAESTRO-01 trial has completed the last patient last visit, and we are expecting results from this study within the second half of this year. This is the first of our two pivotal trials evaluating dirucotide in patients with secondary progressive multiple sclerosis and with a positive outcome, our drug could represent a valuable new treatment for MS patients," said Kevin Giese, President and CEO of BioMS Medical.

Currently, BioMS is conducting two pivotal clinical trials and one open-label follow-on trial of dirucotide for the treatment of secondary progressive MS (SPMS):

    -   MAESTRO-01: This pivotal phase III trial is being conducted in Canada
        and Western Europe, involving 611 SPMS patients at 47 trial sites in
        ten countries. The primary clinical endpoint for MAESTRO-01 (and
        MAESTRO-03) is defined as a statistically and clinically significant
        increase in the time to progression of the disease as measured by the
        Expanded Disability Status Scale (EDSS), in patients with HLA-DR2
        and/or HLA-DR4 immune response genes.

    -   MAESTRO-02: Eligible patients who have successfully completed
        MAESTRO-01 may choose to receive dirucotide on an un-blinded basis in
        this open-label follow-on study regardless of whether they were
        previously on placebo or drug. To date, approximately 95% of the
        eligible patients who have successfully completed the MAESTRO-01
        trial have enrolled in this follow-on study.

    -   MAESTRO-03: Enrollment was initiated in June 2007 and completed on
        August 1, 2008 for this pivotal U.S. phase III trial of approximately
        510 SPMS patients at 67 sites across the U.S. To date, the DSMB has
        conducted four reviews of the data from this trial and recommended it
        continue.

Financial Results

The consolidated net income for the three months ended June 30, 2009 was $1.5 million or $0.02 per share compared with a consolidated net loss of ($0.4) million or ($0.00) per share for the previous year. The consolidated net income for the six months ended June 30, 2009 was $0.1 million or $0.00 per share compared with a consolidated net loss of ($7.1) million or ($0.08) per share for the same period in 2008.

Revenue earned from the collaboration agreement was $11.9 million for the three months and $25.0 million for the six months ended June 30, 2009 compared to $11.2 million and $24.0 million for the three and six months ended June 30, 2008. This revenue is the result of the amortization of the upfront payment and development milestone payment received from Lilly, associated with the positive interim analysis of the MAESTRO-01 clinical trial.

Total consolidated expenses for the three months ended June 30, 2009 were $10.3 million compared with $11.4 million for the three months June 30, 2008. Expenses related to direct research and development efforts accounted for $8.1 million or 79% of all expenses for the three months ended June 30, 2009 compared with $9.3 million or 82% for this period in 2008. Total consolidated expenses for the six months ended June 30, 2009 were $25.1 million as compared with $33.6 million in the six months June 30, 2008. Expenses related to direct research and development efforts accounted for $19.6 million or 78% of all expenses for the six months ended June 30, 2009 compared with $22.5 million or 67% for this period in 2008.

As at June 30, 2009, cash and cash equivalents and short-term investments totaled $67.5 million as compared to $90.4 million at December 31, 2008. As at June 30, 2009, the Company had working capital of $59.8 million as compared to $81.3 million at December 31, 2008. Management estimates that the current working capital is sufficient for the Company to meet its obligations in respect of the currently initiated clinical trials.

As at June 30, 2009 there were 91,008,923 Class "A" common shares of the Company issued and outstanding.

    About BioMS Medical Corp.
    -------------------------

BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical's lead technology, dirucotide, is for the treatment of multiple sclerosis and is being evaluated in two pivotal phase III clinical trials for Secondary Progressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States. In December 2007, BioMS entered into a licensing and development agreement granting Eli Lilly and Company exclusive worldwide rights to dirucotide in exchange for an $87 million upfront payment, milestone payments and escalating royalties on sales. For further information please visit our website at http://www.biomsmedical.com

This press release may contain forward-looking statements, which reflect the Corporation'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 Corporation'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 dirucotide will continue to demonstrate a satisfactory safety profile in ongoing and future clinical trials; and that BioMS Medical Corp. will complete the 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.

    BioMS Medical Corp.
    (A Development Stage Corporation)
    Interim Consolidated Balance Sheets
    (Unaudited)
    -------------------------------------------------------------------------

    (expressed in thousands of Canadian dollars)

                                                       June 30,  December 31,
                                                          2009          2008
                                                             $             $
                                                    (Unaudited)

    Assets

    Current assets
    Cash and cash equivalents                           64,864        87,826
    Short-term investments                               2,652         2,614
    Goods and services tax recoverable                      65           299
    Prepaid clinical trial costs                         1,914         2,227
    Other current assets                                   664           321
                                                  ---------------------------

                                                        70,159        93,287

    Prepaid clinical trial costs                           495           790

    Licensing costs                                      5,174         5,910

    Property and equipment                                 438           517
                                                  ---------------------------

                                                        76,266       100,504
                                                  ---------------------------
                                                  ---------------------------

    Liabilities

    Current liabilities
    Accounts payable and accrued liabilities            10,564        12,015
    Deferred revenue                                    20,615        45,605
                                                  ---------------------------

                                                        31,179        57,620
                                                  ---------------------------


    Shareholders' Equity

    Share capital                                      175,714       175,714

    Contributed surplus                                 10,937         8,839

    Accumulated deficit                               (141,564)     (141,669)
                                                  ---------------------------

                                                        45,087        42,884
                                                  ---------------------------

                                                        76,266       100,504
                                                  ---------------------------
                                                  ---------------------------



    BioMS Medical Corp.
    (A Development Stage Corporation)
    Interim Consolidated Statements of Operations and Comprehensive Loss
    (Unaudited)
    -------------------------------------------------------------------------

    (expressed in thousands of Canadian dollars and shares, except per share
     amounts)

                      Cumulative
                            from             Six-month           Three-month
                    inception to          period ended          period ended
                         June 30,              June 30,              June 30,
                        ---------  --------------------  --------------------
                            2009       2009       2008       2009       2008
                               $          $          $          $          $

    Revenue earned from
     collaboration
     partner              77,551     24,990     24,000     11,933     11,231
    Less: Research and
     development
     expenses           (171,732)   (19,647)   (22,482)    (8,138)    (9,339)
                        ---------  --------------------  --------------------

                         (94,181)     5,343      1,518      3,795      1,892

    General and
     administrative
     expenses            (47,215)    (4,610)   (10,388)    (1,762)    (1,693)

    Amortization of
     licensing costs     (12,491)      (736)      (736)      (368)      (368)

    Amortization of
     property and
     equipment              (602)       (85)       (43)       (42)       (31)
                        ---------  --------------------  --------------------

    Income (loss) from
     operations         (154,489)       (88)    (9,649)     1,623       (200)
                        ---------  --------------------  --------------------

    Other income
     (expense)
    Investment income      9,045        266      1,323         96        594
    Foreign exchange
     gain (loss)           5,507        (73)     1,239       (215)      (796)
                        ---------  --------------------  --------------------

                          14,552        193      2,562       (119)      (202)
                        ---------  --------------------  --------------------
    Net income (loss)
     and comprehensive
     income (loss)      (139,937)       105     (7,087)     1,504       (402)
                        ---------  --------------------  --------------------
                        ---------  --------------------  --------------------

    Basic and diluted
     net income (loss)
     per common share                  0.00      (0.08)      0.02       0.00
                                   --------------------  --------------------
                                   --------------------  --------------------

    Basic weighted
     average number of
     common shares
     outstanding                     91,009     91,311     91,009     91,217
                                   --------------------  --------------------
                                   --------------------  --------------------
    Diluted weighted
     average number of
     common shares
     outstanding                     91,563     91,311     91,356     91,217
                                   --------------------  --------------------
                                   --------------------  --------------------



    BioMS Medical Corp.
    (A Development Stage Corporation)
    Interim Consolidated Statements of Cash Flows
    (Unaudited)
    -------------------------------------------------------------------------

    (expressed in thousands of Canadian dollars)

                      Cumulative
                            from             Six-month           Three-month
                    inception to          period ended          period ended
                         June 30,              June 30,              June 30,
                        ---------  --------------------  --------------------
                            2009       2009       2008       2009       2008
                               $          $          $          $          $

    Cash provided by
     (used in)

    Operating activities
    Net income (loss)   (139,937)       105     (7,087)     1,504       (402)
    Items not involving
     cash
      Stock-based
       compensation       10,976      2,098      2,168          -        264
      Amortization of
       licensing costs    12,491        736        736        368        368
      Amortization of
       property and
       equipment             602         85         43         42         31
      Loss on disposal
       of property and
       equipment              11          -          7          -          2
                        ---------  --------------------  --------------------

                        (115,857)     3,024     (4,133)     1,914        263
    Net change in
     non-cash working
     capital items        23,628    (27,491)    61,986    (14,135)   (10,317)
                        ---------  --------------------  --------------------
                         (92,229)   (24,467)    57,853    (12,221)   (10,054)
                        ---------  --------------------  --------------------
    Investing activities
    Purchase of property
     and equipment        (1,052)        (7)       (29)        (6)       (29)
    Net (purchase of)
     proceeds from
     short-term
     investments          (2,652)       (38)     2,205        (19)     1,093
    Licensing costs       (6,467)         -          -          -          -
                        ---------  --------------------  --------------------
                         (10,171)       (45)     2,176        (25)     1,064
                        ---------  --------------------  --------------------

    Financing activities
    Proceeds from
     issuance of share
     capital             178,729          -         91          -         91
    Repurchase of
     share capital        (3,552)         -       (989)         -       (953)
    Share issue costs    (12,312)         -          -          -          -
                        ---------  --------------------  --------------------
                         162,865          -       (898)         -       (862)
                        ---------  --------------------  --------------------

    Foreign exchange
     gain on cash and
     cash equivalents
     held in foreign
     currency              4,399      1,550      1,239      1,381       (796)
                        ---------  --------------------  --------------------

    (Decrease) increase
     in cash and cash
     equivalents          64,864    (22,962)    60,370    (10,865)   (10,648)

    Cash and cash
     equivalents -
     Beginning of
     period                    -     87,826     35,428     75,729    106,446
                        ---------  --------------------  --------------------

    Cash and cash
     equivalents -
     End of period        64,864     64,864     95,798     64,864     95,798
                        ---------  --------------------  --------------------
                        ---------  --------------------  --------------------

    Cash and cash
     equivalents
     consists of
    Bank accounts          1,282      1,282      1,261      1,282      1,261
    Interest bearing
     deposits and
     securities           63,582     63,582     94,798     63,582     94,537
                        ---------  --------------------  --------------------
                          64,864     64,864     95,798     64,864     95,798
                        ---------  --------------------  --------------------
                        ---------  --------------------  --------------------


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SOURCE BioMS Medical Corp.
Copyright©2009 PR Newswire.
All rights reserved

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