Quantcast

BioMS Medical Announces 2008 Year End Results

March 17, 2009

Toronto Stock Exchange Symbol: MS

EDMONTON, March 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 year ended December 31, 2008.

“Dirucotide has demonstrated the ability to safely affect MS progression in previous studies and we look forward to the results of the Canadian/European trial (MAESTRO-01) in the second half of this year,” said Kevin Giese, President and CEO of BioMS Medical. “Our hope is that the results of this trial will confirm that dirucotide is able to significantly slow the progression of MS, specifically in patients with secondary progressive multiple sclerosis.”

Currently, BioMS is conducting two 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. To date, there have been nine positive safety
           reviews from the Data Safety Monitoring Board (DSMB). 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 August 13, 2008, the DSMB conducted a scheduled interim
           analysis of efficacy and safety and recommended that the trial
           continue to completion. The interim analysis evaluated the first
           200 patients to complete MAESTRO-01 and assessed the likelihood of
           the study reaching its primary endpoint at the end of the trial.
           Based on the DSMB decision, Eli Lilly and Company (Lilly) provided
           a US $10 million milestone payment to BioMS as part of the terms
           of the licensing and collaboration agreement.

           BioMS anticipates MAESTRO-01 will be completed in 2009 with
           results from the trial expected in the second half of this year.

        -  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 three reviews of the data from this
           trial and recommended it continue. The next DSMB review is
           expected to take place in the second quarter of fiscal 2009.

        -  MINDSET-01: MINDSET-01 was a randomized, double-blind study that
           recruited 218 relapsing-remitting MS patients at 24 trial sites in
           six countries across Europe. BioMS recently announced that the top
           line results of this exploratory study did not meet its primary
           endpoint of effecting annualized relapse rate or associated
           secondary magnetic resonance imaging (MRI) endpoints. Dirucotide
           did meet certain secondary endpoints related to the progression of
           the disease, including mean change from baseline in the EDSS and
           the MS Functional Composite (MSFC) score. Changes in EDSS and MSFC
           are primary and secondary outcomes in the ongoing phase III SPMS
           trials.

           The data also showed that dirucotide was generally well tolerated.
           The most common side effects reported were redness and burning
           sensation at the injection site. No patients withdrew due to
           adverse events.

           Eligible patients in this trial are now receiving dirucotide on an
           un-blinded basis to the end of their 27th month in the trial.

Licensing and Development Agreement with Lilly

On December 17, 2007, BioMS entered into a licensing and development agreement (the “Agreement”) granting Lilly exclusive worldwide rights to dirucotide. The transaction closed on January 25, 2008 and BioMS received an upfront payment of US $87 million. In September 2008, BioMS received a development milestone payment of US $10 million as a result of the positive interim analysis from the DSMB for MASESTRO-01. BioMS has the potential to receive future development and sales milestones up to US $400 million and escalating royalties on sales if dirucotide is commercialized.

Not later than sixty (60) days following receipt of the final written report of the results of the MAESTRO-01 trial, Lilly shall notify BioMS in writing whether Lilly will terminate the Agreement or alternatively Lilly shall bear 100% of any and all continuing development costs incurred by Lilly or BioMS for dirucotide.

HYC750 and BioCyDex

On May 9, 2008, BioMS entered into a Royalty and Assignment Agreement with Orcrist Bio. Inc. for HYC750, a technology based on hyaluronic acid that has a number of potential therapeutic uses and is being developed as a treatment for the side effects of chemotherapy. BioMS held an exclusive worldwide license to HYC750 from the University of Alberta. As a result of the Royalty and Assignment Agreement, BioMS terminated its license with the University of Alberta and the University entered into a direct license with Orcrist. BioMS assigned all BioMS owned patents relating to HYC750 and transfered all HYC750 assets to Orcrist. Under the terms of the agreement, BioMS will receive certain milestone payments in addition to a royalty on net sales of products which otherwise would have infringed on patents related to the HYC750 technology.

BioMS also ceased all development activities with respect to BioCyDex. Future development or licensing activities will be the responsibility of BioCyDex.

Financial Results

The consolidated net loss for the year ended December 31, 2008 was $0.5 million or ($0.01) per share compared with a consolidated net loss of $47.2 million or ($0.56) per share for the previous year. The consolidated net income for the three months ended December 31, 2008 was $0.3 million or $0.01 per share compared with a net loss of ($11.7) million or ($0.13) per share for the previous year.

Revenue of $52.6 million was recorded for the year ended December 31, 2008 compared to $Nil for the year ended December 31, 2007. The revenue is the result of the amortization of the upfront payment and development milestone received from the Agreement with Lilly. Investment income earned on funds invested for the year ended December 31, 2008 increased to $2.4 million from $1.6 million for 2007 due to the increase in cash and cash equivalents as a result of the Agreement with Lilly. The increase was partially offset by a general reduction in interest rates experienced in the market. The investment income is earned from the short-term investment of cash reserves in low risk term deposits and bankers acceptance notes.

Total consolidated expenses for the year ended December 31, 2008 were $61.9 million compared with $48.0 million for 2007. Total consolidated expenses for the three months ended December 31, 2008 totaled $16.5 million as compared to $12.1 million in the same quarter the previous year.

Research and development expenses for the year ended December 31, 2008 totaled $46.5 million compared with $38.9 million in 2007. Research and development expenses were $13.9 million for the three months ended December 31, 2008 compared to $9.3 million for the same quarter the previous year. The increase in expenses was the net result of: achieving full enrolment of clinical sites and patients in the MAESTRO-03 trial; increased costs for the MAESTRO-02 trial as patients enter the trial; reduced costs of the MAESTRO-01 and MINDSET-01 trials as more patients complete these trials; a decrease in drug manufacturing expenses as the manufacture of validation batches is completed; a licensing bonus payment related to the Agreement with Lilly, and; additional expenses related to alliance management and support.

At December 31, 2008, cash and cash equivalents and short-term investments totaled $90.4 million as compared to $37.9 million at December 31, 2007. At December 31, 2008, the Company had working capital of $81.3 million as compared to $32.8 million at December 31, 2007. 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 December 31, 2008 there were 91,009,323 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)
    Consolidated Balance Sheet
    December 31, 2008 and 2007
    -------------------------------------------------------------------------

    (expressed in thousands of Canadian dollars)

                                                             2008       2007
                                                                $          $
    Assets

    Current assets
    Cash and cash equivalents                              87,826     35,428
    Short-term investments                                  2,614      2,528
    Goods and services tax recoverable                        299        484
    Prepaid clinical trial costs                            2,227      3,206
    Other current assets                                      321         76
                                                        ---------------------

                                                           93,287     41,722

    Prepaid clinical trial costs                              790      1,976

    Licensing costs                                         5,910      7,382

    Property and equipment                                    517        330
                                                        ---------------------

                                                          100,504     51,410
                                                        ---------------------
                                                        ---------------------

    Liabilities

    Current liabilities
    Accounts payable and accrued liabilities               12,015      8,918
    Deferred revenue                                       45,605          -
                                                        ---------------------

                                                           57,620      8,918
                                                        ---------------------

    Shareholders' Equity

    Share capital                                         175,714    176,423

    Contributed surplus                                     8,839      6,680

    Accumulated deficit                                  (141,669)  (140,611)
                                                        ---------------------

                                                           42,884     42,492
                                                        ---------------------

                                                          100,504     51,410
                                                        ---------------------
                                                        ---------------------

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

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

                                       Cumulative from
                                          inception to           Years
                                           December 31,    ended December 31,
                                           ------------   -------------------
                                                  2008       2008       2007
                                                     $          $          $

    Research and development
    Revenue earned from
     collaboration partner                      52,561     52,561          -
    Research and development expenses         (152,085)   (46,502)   (38,907)
                                           ------------   -------------------

                                               (99,524)     6,059    (38,907)

    General and administrative expenses        (42,605)   (13,790)    (7,490)

    Amortization of licensing costs            (11,755)    (1,472)    (1,472)

    Amortization of property and equipment        (517)      (125)      (134)
                                           ------------   -------------------

    Loss from operations                      (154,401)    (9,328)   (48,003)

    Other income (expense)
    Investment income                            8,779      2,436      1,644
    Foreign exchange gain (loss)                 5,580      6,429       (849)
                                           ------------   --------- ---------

                                                14,359      8,865        795
                                           ------------   -------------------
    Net loss and comprehensive loss           (140,042)      (463)   (47,208)
                                           ------------   -------------------
                                           ------------   -------------------

    Basic and diluted net loss
     per common share                                       (0.01)     (0.56)
                                                          -------------------
                                                          -------------------

    Basic and diluted weighted average
     number of common shares outstanding                   91,187     85,042
                                                          -------------------
                                                          -------------------

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

    (expressed in thousands of Canadian dollars)

                                       Cumulative from
                                          inception to           Years
                                           December 31,    ended December 31,
                                           ------------   -------------------
                                                  2008       2008       2007
                                                     $          $          $

    Cash provided by (used in)

    Operating activities
    Net loss                                  (140,042)      (463)   (47,208)
    Items not involving cash
      Stock-based compensation                   8,878      2,198      1,921
      Amortization of licensing costs           11,755      1,472      1,472
      Amortization of property
       and equipment                               517        125        134
      Loss on disposal of property
       and equipment                                11         11          -
                                           ------------   --------   --------

                                              (118,881)     3,343    (43,681)
    Net change in non-cash working
     capital items
      Goods and services tax recoverable          (299)       185        (28)
      Prepaid and other current assets          (2,548)       734       (571)
      Advanced clinical trial costs               (790)     1,186     (1,976)
      Accounts payable and accrued
       liabilities                               9,151       (601)       933
      Deferred revenue                          45,605     45,605          -
                                           ------------   --------   --------

                                               (67,762)    50,452    (45,323)
                                           ------------   --------   --------

    Investing activities
    Purchase of property and equipment          (1,045)      (323)      (109)
    Net (purchase of) proceeds from
     short-term investments                     (2,614)       (86)     3,149
    Licensing costs                             (6,467)         -          -
                                           ------------   --------   --------

                                               (10,126)      (409)     3,040
                                           ------------   --------   --------

    Financing activities
    Proceeds from issuance of share capital    178,729         91     44,512
    Repurchase of share capital                 (3,552)    (1,434)       (36)
    Share issue costs                          (12,312)         -     (3,332)
                                           ------------   --------   --------

                                               162,865     (1,343)    41,144
                                           ------------   --------   --------

    Foreign exchange gain (loss) on
     cash and cash equivalents
     held in foreign currency                    2,849      3,698       (849)
                                           ------------   --------   --------

    Increase (decrease) in
     cash and cash equivalents                  87,826     52,398     (1,988)

    Cash and cash equivalents
     - Beginning of period                           -     35,428     37,416
                                           ------------   --------   --------

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

    Cash and cash equivalents consists of
    Bank accounts                                  610        610      1,139
    Interest bearing deposits
     and securities                             87,216     87,216     34,289
                                           ------------   --------   --------

                                                87,826     87,826     35,428
                                           ------------   --------   --------
                                           ------------   --------   --------

SOURCE BioMS Medical Corp.


Source: newswire



comments powered by Disqus