Bradmer announces 2008 second quarter operational and financial results



    TSX: BMR

    TORONTO, Aug. 11 /CNW/ - Bradmer Pharmaceuticals Inc., a clinical
oncology company specializing in the development and commercialization of
cancer therapies, today announced its 2008 second quarter operational and
financial results.

    
    Operational Highlights

    During the three months ended June 30, 2008 and the period subsequent to
this date, the Company achieved the following milestones:

    -  Submitted and received approval from the Food and Drug Administration
       (FDA) on manufacturing and clinical dossiers to support the launch of
       the Phase III GLASS-ART clinical trial;

    -  Received permission from the FDA to proceed with the launch of the
       Phase III GLASS-ART Trial evaluating Neuradiab as a front-line therapy
       for GBM;

    -  Initiated enrollment in the GLASS-ART Trial;

    -  Signed contracts with and activated an initial cohort of U.S. clinical
       trial sites, with a pipeline of additional sites being activated in
       line with previously stated site recruitment goals (greater than 30);

    -  Successfully released a 2nd GMP drug substance batch for use in
       clinical trials and filed the related update to FDA;

    -  Submitted new data from the previous Phase II trial indicating that
       the mean time to progression free survival was 77 weeks, which
       compares favorably with other published results in newly diagnosed
       GBM.

    "The initiation of the Phase III trial of Neuradiab represents the single
most important milestone that Bradmer has achieved. The investment in time and
resources that we made to prepare for the trial has enabled us to successfully
kick-off this important multicenter GBM trial," said Alan M. Ezrin, Ph.D.,
President and Chief Executive Officer of Bradmer. "Now that patient enrollment
is ongoing at the initial sites, we intend to expand the active sites to more
than 30 centers by the end of 2008. The run in phase of 60 patients is
designed to demonstrate that Neuradiab treatment is applicable across multiple
centers and patients receive treatment that is consistent with the protocol.
Successfully achieving the run phase will demonstrate to potential partners
that the trial is appropriately designed to provide a definitive answer on the
benefit of Neuradiab in the newly diagnosed GBM population."
    The Phase III trial will investigate Neuradiab as an adjuvant therapy to
the current standard of care which consists of surgery, external beam
radiation and temozolomide. The randomized trial is designed to enroll 760
patients with newly diagnosed GBM.

    Financial Highlights

    Amounts in US dollars, unless specified otherwise, and results expressed
in accordance with Canadian Generally Accepted Accounting Principles (Canadian
GAAP).

    For the three-month period ended June 30, 2008, the Company recorded a net
loss of $3,418,000, or $0.25 per share, based on the weighted average
outstanding shares of 13,488,215. This compares to a net loss of $1,781,000,
or $0.21 per share for the three-month period ended June 30, 2007, based on
the weighted average outstanding shares of 8,353,674. For the six-month period
ended June 30, 2008, the Company recorded a net loss of $6,575,000, or $0.49
per share, based on the weighted average outstanding shares of 13,488,215.
This compares to a net loss of $3,635,000, or $0.45 per share for the
six-month period ended June 30, 2007, based on the weighted average
outstanding shares of 8,069,091. The change in net loss related to planned
research and development spending with regard to the Company's lead clinical
program, Neuradiab, in preparation for the proposed clinical trial, as well as
the growth in the Company's administrative functions in anticipation of the
clinical trial launch.
    Research and development expenses for the three-month period ended June
30, 2008 were $2,565,000, an increase of $1,298,000 from $1,267,000 in the
same period of 2007. The increase was primarily due to increased support costs
from the new clinical research organization (CRO), ICON Clinical Research, for
the Phase III clinical development program. The expenses incurred in 2008 were
primarily related to drug manufacturing contracts of $324,000, as well as
amounts expensed to clinical research organizations of $1,048,000. During the
period, the Company expanded drug manufacturing analytical support and secured
the agreement of a cohort of sites to participate in the U.S. clinical trial.
    General and administrative expenses were $905,000 in the three-month
period ended June 30, 2008, compared to $594,000 in the prior year as the
Company added additional administrative support. The share of stock-based
compensation, a noncash item, included in general and administrative expenses
was $99,000 for the quarter, as compared to $73,000 for the same period in
2007. Interest income decreased to $68,000 for the quarter from $78,000 in the
same period of 2007. The impact of the increase in cash balances was more than
offset by the significant decline in interest rates over the past year.
    As at June 30, 2008, Bradmer had available cash and cash equivalents and
short-term investments totaling $13,320,000 as compared with $19,469,000 as at
December 31, 2007. The decrease in cash was related to the operating costs
incurred in the first half of the year. The Company expects that cash on hand
at June 30, 2008 will be sufficient to fund operations through the next 12
months and beyond, inclusive of clinical trial and infrastructure costs during
such period.
    Operational activities for the three-month period ended June 30, 2008 were
financed by cash on hand and the proceeds of the public offering completed in
June 2007.
    As at June 30, 2008, there were 13,488,215 common shares issued and
outstanding.

    Outlook

    Bradmer's operational objective is clear: execute a multi-center
randomized trial evaluating Neuradiab in newly diagnosed GBM patients. During
the remainder of 2008, the Company intends to execute on the following
components of its operational plan:

    -  Continue the execution of clinical trial contracts with leading GBM
       treatment centers across the U.S.;

    -  Submit the first Data Safety Monitoring Board summary to the FDA on
       the initial 30 patients enrolling; and

    -  Complete the run-in phase for 60 patients and submit Data Safety
       Monitoring Board data to the FDA.
    

    Additional information about the Company, including the MD&A and
financial results may be found on SEDAR at www.sedar.com.

    About Neuradiab(TM)

    Neuradiab is a monoclonal antibody, conjugated to radioactive iodine,
used to treat glioblastoma multiforme (GBM), the most common and most advanced
form of brain cancer. Neuradiab delivers tumor-killing radiation specifically
to residual brain tumor cells after surgery, with minimal impact on normal
brain tissue. During the course of development at Duke University, over
US $60 million in research grants and related support has produced a series of
Phase I and Phase II clinical trials on Neuradiab and other closely related
technologies. Approximately 200 brain cancer patients, including over 160 with
GBM, have been treated with the Neuradiab therapy regimen, and survival
benefits have significantly exceeded historical controls in each completed
trial. Neuradiab has been formerly referred to in literature as 131-I
anti-tenascin monoclonal antibody 81c6.
    Each year up to 30,000 new cases of GBM are diagnosed in the world's
seven largest healthcare markets. The current standard of care for GBM
patients is surgical resection followed by radiation and temozolomide. GBM
tumors typically have infiltrating edges that are very difficult to completely
remove with surgery. The Neuradiab therapy is delivered directly into the
surgical resection cavity in a separate procedure after the initial surgery.
Neuradiab delivers a concentrated level of radiation specifically to the
remaining cancer cells by targeting tenascin. Tenascin is a protein over-
expressed in 99% of GBM cells but absent from normal brain cells.

    About Bradmer Pharmaceuticals Inc. (www.bradmerpharma.com)

    Bradmer Pharmaceuticals is a biopharmaceutical company focused on the
development and commercialization of new and innovative cancer therapies.
Bradmer's lead clinical candidate, Neuradiab, was developed at Duke University
Medical Center as a proprietary therapy for a particularly aggressive form of
brain cancer, glioblastoma multiforme. To date, over US$60 million in grants
and related support has driven research and development of the licensed
treatment, which has been delivered to over 200 patients with promising
results and has completed Phase II clinical trials at Duke University. Bradmer
is currently in the process of organizing a pivotal multi-center clinical
trial of the licensed treatment. Neuradiab has been granted Orphan Drug Status
by both the U.S. Food and Drug Administration and the European Medicines
Agency.

    Bradmer Pharmaceuticals Inc.'s common shares have not been registered
under the Securities Act of 1933, as amended (the "Securities Act") or any
state regulatory agency in the United States. The resale or transfer by a U.S.
investor of such common shares of Bradmer Pharmaceuticals Inc. is subject to
the requirements of Rule 904 of Regulation S of the Securities Act or such
other applicable exemption thereunder, and other applicable state securities
laws.

    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 risks and
uncertainties, which may include but are not limited to, the receipt of all
regulatory approvals required to conduct the proposed clinical trial of
Neuradiab, 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.

    
    Financials results included below:


    Bradmer Pharmaceuticals Inc.
    Balance Sheets
    US $

                                                  June 30,      December 31,
                                                    2008            2007
                                              --------------   --------------
    Assets                                                       (audited)

    Current
      Cash and cash equivalents               $   3,288,210    $  19,469,337
      Short-term investments                     10,031,944                -
      Amounts receivable                             18,069          143,722
      Prepaid expenses and other assets              51,665           24,029
                                              --------------   --------------

                                                 13,389,888       19,637,088

    Patent rights                                   689,978          685,165
                                              --------------   --------------

                                              $  14,079,866    $  20,322,253
                                              -------------------------------
                                              -------------------------------

    Liabilities

    Current
      Accounts payable and accrued
       liabilities                            $   1,887,053    $   1,835,492
                                              --------------   --------------

    Shareholders' Equity

    Capital stock                                31,026,728       31,026,728

    Warrants                                        881,488          881,488

    Contributed surplus                             996,295          714,981

    Deficit                                     (20,711,698)     (14,136,436)
                                              --------------   --------------

                                                 12,192,813       18,486,761
                                              -------------------------------

                                              $  14,079,866    $  20,322,253
                                              -------------------------------



    Bradmer Pharmaceuticals Inc.
    Statements of Operations and Deficit
    US $

                      Three Months   Three Months   Six Months    Six Months
                          Ended          Ended         Ended         Ended
                         June 30,       June 30,      June 30,      June 30,
                           2008           2007          2008          2007
                      -------------------------------------------------------

    Expenses
      Research &
       development    $  2,564,935  $  1,267,295  $  4,833,041     2,671,299
      General &
       administration      905,481       594,412     1,860,393     1,115,145
      Amortization
       of patent
       rights               15,009        11,791        29,802        23,444
      Foreign
       exchange
       (gain)/loss             473       (13,711)       11,400       (11,113)
                      -------------------------------------------------------

                         3,485,898     1,859,787     6,734,636     3,798,775

    Interest income         68,124        78,428       159,374       163,919
                      -------------------------------------------------------

    Net loss            (3,417,774)   (1,781,359)   (6,575,262)   (3,634,856)

    Deficit at
     beginning of
     period            (17,293,924)   (6,554,338)  (14,136,436)   (4,700,841)
                      -------------------------------------------------------

    Deficit at end
     of period        $(20,711,698) $ (8,335,697)  (20,711,698)   (8,335,697)
                      -------------------------------------------------------
                      -------------------------------------------------------

    Basic and
     diluted net
     loss per share   $      (0.25) $      (0.21) $      (0.49)        (0.45)
                      -------------------------------------------------------
                      -------------------------------------------------------

    Weighted average
     number of shares   13,488,215     8,353,674  $ 13,488,215     8,069,091
                      -------------------------------------------------------



    Bradmer Pharmaceuticals Inc.
    Statements of Cash Flows
    US $

                      Three Months   Three Months   Six Months    Six Months
                          Ended          Ended         Ended         Ended
                         June 30,       June 30,      June 30,      June 30,
                           2008           2007          2008          2007
                      -------------------------------------------------------

    Cash flows from
     operating
     activities
      Net loss for
       the period     $ (3,417,774) $ (1,781,359) $ (6,575,262) $ (3,634,856)
      Add items not
       affecting cash
        Amortization
         of patents         15,009        11,791        29,802        23,444
        Stock-based
         compensation      145,447       106,026       281,314       189,703
        Accrued
         Interest on
         short-term
         investments       (31,944)            -       (31,944)            -
                      -------------------------------------------------------

                        (3,289,262)   (1,663,542)   (6,296,090)   (3,421,709)

      Changes in
       non-cash working
       capital items
        Amounts
         receivable        103,762       (40,107)      125,653       (39,419)
        Prepaid
         expenses           19,854        15,778       (27,636)      (34,955)
        Accounts
         payable and
         accrued
         liabilities      (185,616)      159,028        51,561      (602,587)
                      -------------------------------------------------------

                        (3,351,262)   (1,528,843)   (6,146,512)   (4,098,670)
                      -------------------------------------------------------

    Cash flows from
     investing
     activities
      Investment in
       patent rights       (12,902)       (6,998)      (34,615)     (105,642)
      Purchase of
       short-term
       investments     (10,000,000)            -   (10,000,000)            -
                      -------------------------------------------------------
                       (10,012,902)       (6,998)  (10,034,615)     (105,642)
                      -------------------------------------------------------

    Cash flows from
     financing
     activities
      Issuance of
       capital stock,
       net of share
       issue costs               -    19,588,150             -    19,588,150
                      -------------------------------------------------------

    (Decrease)/
     increase in
     cash during
     the period        (13,364,164)   18,052,309   (16,181,127)   15,383,838

    Cash at beginning
     of period          16,652,374     6,144,956    19,469,337     8,813,427
                      -------------------------------------------------------

    Cash and cash
     equivalents at
     end of period    $  3,288,210  $ 24,197,265     3,288,210  $ 24,197,265
                      -------------------------------------------------------
    

    %SEDAR: 00023367E




For further information:

For further information: Bradmer Pharmaceuticals Inc.: Brian Brohman,
Chief Business Officer, Phone: (502) 657-6038, Fax: (502) 657-6039, E-mail:
bbrohman@bradmerpharma.com, Internet: www.bradmerpharma.com; Investor
Relations: Ross Marshall, The Equicom Group Inc., Phone: (416) 815-0700 (Ext.
238), Fax: (416) 815-0080, E-mail: rmarshall@equicomgroup.com

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BRADMER PHARMACEUTICALS INC.

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