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BioMS Medical Announces First quarter 2009 results

May 11, 2009

Toronto Stock Exchange Symbol: MS

EDMONTON, May 11 /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 first quarter, ended March 31, 2009.

“We remain on track to obtain the results from MAESTRO-01, the first of our two pivotal trials evaluating dirucotide in patients with secondary progressive multiple sclerosis, in the second half of 2009,” said Kevin Giese, President and CEO of BioMS Medical. “We have demonstrated in previous trials that dirucotide has shown to be well tolerated and has the capacity to slow the progression of disease in certain genetically pre-disposed MS patients. If our pivotal trials confirm these results, we believe dirucotide could represent the first drug with blockbuster potential for the treatment of secondary progressive multiple sclerosis.”

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: On January 22, 2007, BioMS announced that this pivotal
       phase III trial, being conducted in Canada and Western Europe, had
       completed full recruitment of 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.

       On April 21, 2009 the DSMB conducted a scheduled safety analysis and
       recommended that the trial continue to completion. To date, there have
       been ten positive safety reviews from the Data Safety Monitoring Board
       (DSMB) and this was the final scheduled review by the DSMB prior to
       the completion of the trial. BioMS anticipates results from the trial
       will be reported in the second half of 2009.

    -  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. 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

Revenue of $13.1 million was recorded for the three-months ended March 31, 2009 compared to $12.8 million for the three-months ended March 31, 2008. The revenue is the result of the amortization of the upfront payment and development milestone received from the licensing and development agreement with Lilly.

Total consolidated expenses for the first quarter ended March 31, 2009 were $14.8 million compared to $22.2 million for the first quarter of 2008. Research and development expenses for the first quarter of 2009 totaled $11.5 million compared to $13.1 million for the first quarter of 2008. The decrease in expenses was the net result of: increased costs for the MAESTRO-03 trial; increased costs for the MAESTRO-02 trial as patients entered the trial; increased investigative and analysis costs associated with the completion of the MINDSET-01 trial, and; additional expenses related to alliance management and support. Expenses in the first quarter of 2008 also included a licensing bonus payment related to the licensing and development agreement with Lilly.

The consolidated net loss for the three-months ended March 31, 2009 was $1.4 million or ($0.02) per share compared to a consolidated net loss of $6.7 million or ($0.07) per share for the three-months ended March 31, 2008.

As at March 31, 2009, cash and cash equivalents and short-term investments totaled $78.4 million compared to $90.4 million at December 31, 2008. As at March 31, 2009, the Company had working capital of $69.3 million 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 March 31, 2009 there were 91,009,323 Class “A” common shares of the Company issued and outstanding.

BioMS Medical will hold its Annual General Meeting on Wednesday May 27, 2009, at 2:00 p.m. (MT) at the Delta Edmonton South Hotel in Edmonton, Alberta.

    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                          March 31,   December 31,
    of Canadian dollars)                                 2009           2008
                                                            $              $
                                                   (Unaudited)

    Assets

    Current assets
    Cash and cash equivalents                          75,729         87,826
    Short-term investments                              2,633          2,614
    Goods and services tax recoverable                     91            299
    Prepaid clinical trial costs                        2,161          2,227
    Other current assets                                  177            321
                                                   --------------------------

                                                       80,791         93,287

    Prepaid clinical trial costs                          693            790

    Licensing costs                                     5,542          5,910

    Property and equipment                                475            517
                                                   --------------------------

                                                       87,501        100,504
                                                   --------------------------
                                                   --------------------------

    Liabilities

    Current liabilities
    Accounts payable and accrued liabilities           11,370         12,015
    Deferred revenue                                   32,548         45,605
                                                   --------------------------

                                                       43,918         57,620
                                                   --------------------------

    Shareholders' Equity

    Share capital                                     175,714        175,714

    Contributed surplus                                10,937          8,839

    Accumulated deficit                              (143,068)      (141,669)
                                                   --------------------------

                                                       43,583         42,884
                                                   --------------------------

                                                       87,501        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
                                     inception to   Three-month period ended
                                         March 31,                  March 31,
                                     -------------  -------------------------

                                             2009           2009        2008
                                                $              $           $

    Revenue earned from
     collaboration partner                 65,618         13,057      12,769
    Less: Research and development
     expenses                            (163,594)       (11,509)    (13,143)
                                     -------------  -------------------------

                                          (97,976)         1,548        (374)

    General and administrative
     expenses                             (45,453)        (2,848)     (8,695)

    Amortization of licensing costs       (12,123)          (368)       (368)

    Amortization of property and
     equipment                               (560)           (43)        (12)
                                     -------------  -------------------------

    Loss from operations                 (156,112)        (1,711)     (9,449)

    Other income
    Investment income                       8,949            170         729
    Foreign exchange gain                   5,722            142       2,035
                                     -------------  -------------  ----------

                                           14,671            312       2,764
                                     -------------  -------------------------
    Net loss and comprehensive loss      (141,441)        (1,399)     (6,685)
                                     -------------  -------------------------
                                     -------------  -------------------------

    Basic and diluted net loss per
     common share                                          (0.02)      (0.07)
                                                    -------------------------

    Basic and diluted weighted
     average number of common
     shares outstanding                                   91,009      91,405
                                                    -------------------------

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

    (expressed in thousands of
    Canadian dollars)

                                             Cumulative
                                                   from
                                           inception to   Three-month period
                                               March 31,    ended March 31,
                                           -------------  -------------------

                                                   2009        2009     2008
                                                      $           $        $
    Cash provided by (used in)

    Operating activities
    Net loss                                   (141,441)     (1,399)  (6,685)
    Items not involving cash
      Stock-based compensation                   10,976       2,098    1,904
      Amortization of licensing costs            12,123         368      368
      Amortization of property
       and equipment                                560          43       12
      Loss on disposal of property and
       equipment                                     11           -        5
                                           -------------  -------------------

                                               (117,771)      1,110   (6,431)
    Net change in non-cash
     working capital items
      Goods and services tax recoverable            (91)        208      (90)
      Prepaid and other current assets           (2,404)        144     (267)
      Prepaid clinical trial costs                 (627)        163      975
      Accounts payable and
       accrued liabilities                        8,337        (814)    (894)
      Deferred revenue                           32,548     (13,057)  74,614
                                           -------------  -------------------

                                                (80,008)    (12,246)  67,907
                                           -------------  -------------------

    Investing activities
    Purchase of property and equipment           (1,046)         (1)       -
    Net (purchase of) proceeds
     from short-term investments                 (2,633)        (19)   1,112
    Licensing costs                              (6,467)          -        -
                                           -------------  -------------------

                                                (10,146)        (20)   1,112
                                           -------------  -------------------

    Financing activities
    Proceeds from issuance of
     share capital                              178,729           -        -
    Repurchase of share capital                  (3,552)          -      (36)
    Share issue costs                           (12,312)          -        -
                                           -------------  -------------------

                                                162,865           -      (36)
                                           -------------  -------------------

    Foreign exchange gain on cash and
     cash equivalents held in foreign
     currency                                     3,018         169    2,035
                                           -------------  -------------------

    (Decrease) increase in cash and
     cash equivalents                            75,729     (12,097)  71,018

    Cash and cash equivalents
     - Beginning of period                            -      87,826   35,428
                                           -------------  -------------------

    Cash and cash equivalents
     - End of period                             75,729      75,729  106,446
                                           -------------  -------------------
                                           -------------  -------------------

    Cash and cash equivalents consists of
    Bank accounts                                   846         846      519
    Interest bearing deposits and
     securities                                  74,883      74,883  105,927
                                           -------------  -------------------

                                                 75,729      75,729  106,446
                                           -------------  -------------------
                                           -------------  -------------------

SOURCE BioMS Medical Corp.


Source: newswire



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