Amorfix announces 2009 year end results



    TSX: AMF

    TORONTO, June 11 /CNW/ - Amorfix Life Sciences, a company focused on
treatments and diagnostics for misfolded protein diseases, today announced its
operational and financial results for the year ended March 31, 2009, as well
as financial results for the fourth quarter.

    
    2009 Development and Corporate Highlights

    vCJD
    ----
    
    In January 2009, Amorfix announced that 10,000 blood donations in France
had been tested using its EP-vCJD(TM) test as part of an ongoing large-scale
study to demonstrate the feasibility of routine testing for vCJD in a blood
transfusion center. The plasma samples were collected using standard
procedures from routine blood donors, and anonymously tested for vCJD by staff
at the EFS-Alsace Blood Transfusion Centre in Strasbourg, France. Six samples
were repeat positive, consistent with a specificity of 99.94%, assuming the
six samples were in fact negative and falsely scored positive. This
specificity for the 1st-generation Amorfix test is equivalent to the
specificity achieved by the current 3rd-generation blood screening tests for
HIV antibodies presently in use worldwide in blood transfusion centres to
assure the safety of blood.
    In December 2008, Amorfix announced it achieved excellent results in two
blinded trials of human blood samples using its EP-vCJD(TM) blood test as part
of a validation process conducted by the National Institute for Biological
Standards and Control (NIBSC) in the United Kingdom. In this trial, NIBSC
provided Amorfix with 500 frozen blinded human plasma samples which included
random samples spiked with vCJD brain prions. The EP-vCJDTM test successfully
detected all (100% sensitivity) of the spiked samples down to a 1 in 100,000
dilution of 10% brain homogenate (1/1,000,000 dilution of vCJD brain).
    Amorfix is the leading company in the NIBSC process to further validate
the EP-vCJD(TM) Blood Screening Assay by testing rare blood samples from vCJD
patients to demonstrate the test can detect human blood prions, as well as
human brain and spleen prions. Subsequent to year end, Amorfix announced that
it was advised that it will be required to test additional prion-infected
animal samples, supplied by NIBSC, prior to being granted access to the human
vCJD blood samples. Amorfix expects that this additional animal testing may be
completed by the end of the summer.
    On March 18, 2009, the UK National Health Service (NHS) published a
framework tender under which, when awarded, the NHS may request the supply of
blood test kits for a 10,000 sample assessment panel, a 50,000 sample
prevalence study, and unlimited kits for routine testing.

    
    ALS/AD
    -------
    
    In the fiscal third quarter, Amorfix announced that its Disease Specific
Epitope (DSE) monoclonal antibody treatments, against misfolded superoxide
dismutase-1 (SOD1) protein, demonstrated statistically significant improvement
in survival over controls in a mouse model of Amyotrophic Lateral Sclerosis
(ALS). Amorfix is seeking a partnership to humanize the antibodies and
initiate clinical trials. As vaccines have different development timelines and
require special expertise compared to the antibodies, Amorfix is seeking a
separate partner to develop the vaccines. A special Committee of the Board of
Directors has been formed to oversee this process.
    In July 2008, Amorfix announced the receipt of a Canadian Institutes of
Health Research (CIHR) grant of $227,500 to support preclinical studies to
evaluate Amorfix's DSE antibodies and vaccines for the treatment of
Alzheimer's Disease (AD) in collaboration with Dr. Cashman at the University
of British Columbia. Amorfix expects to have results from these studies by the
end of the 2010 fiscal year.
    Subsequent to year end, Amorfix announced that the Amorfix Aggregated
Abeta Assay (A(4)) has been shown to detect Abeta amyloid in human and animal
brain tissue. The initial validation results for the A(4) test will be
presented at the International Congress on AD this summer and the company will
be offering the A(4) test as a service to drug discovery companies and
academic researchers working to discover new treatments for AD. Since the A(4)
test is able to detect amyloid build up in animals much earlier than
conventional methods, the company believes the test will accelerate the
development and evaluation of new treatments for AD.

    
    Cancer
    ------
    
    Subsequent to year end, Amorfix announced that it plans to expand its
portfolio of diagnostic tests through collaboration with companies and
academic groups with established biomarkers that can be developed into
screening tests. On April 23, 2009, Amorfix announced a collaboration with
BioMosaics and Sunnybrook Research Institute (SRI) to develop and
commercialize a blood-based assay for early detection of hepatocellular
carcinoma (HCC) or primary liver cancer. The collaboration utilizes
BioMosaics' and SRI's expertise in the cancer biomarker area and the assay
development capability at Amorfix.

    
    Other Misfolded Protein Diseases
    --------------------------------
    
    Subsequent to year end, Amorfix announced the extension of its
therapeutics program to target proteins which may be misfolded in diseases
where cells are under stress and more likely to produce misfolded proteins
like cancer. The company plans to establish strategic alliances to expand its
capabilities to develop immunotherapeutics to numerous proteins and will
announce these alliances as they are formed.

    Financial Results

    For the three months ended March 31, 2009 the company reported a net loss
from operations of $1,376,339 ($0.03 per share) compared to net loss of
$1,920,439 ($0.05 per share) for the three months ended March 31, 2008.
    For the year ended March 31, 2009 the company reported a net loss from
operations of $5,148,133 ($0.12 per share) compared to a net loss of
$7,189,981 ($0.17 per share) for the year ended March 31, 2008.
    Research and development (R&D) expenses for the three months ended March
31, 2009 were $1,064,393 compared with $1,680,454 for the three months ended
March 31, 2008. The decrease was due mainly to staff reductions and reduced
program expenses relating to the deferral of vCJD commercialization efforts
and the ALS program offset by an increase in new research initiatives related
to misfolded protein therapies.
    R&D expenses for the year ended March 31, 2009 were $4,126,945 compared
with $6,240,108 for the corresponding period in 2008. The decrease was due
mainly to staffing reductions and reduced program expense reductions relating
to the deferral of the commercialization efforts of the vCJD program until the
UK NIBSC program is completed, lower program and salary expenses relating to
the ALS program partially offset by an increase in new research initiatives
related to misfolded protein therapies.
    General and administrative expenses for the three months ended March 31,
2009 were $323,108 compared with $283,435 for the corresponding period in
2008. The increase was due mainly to higher stock-based compensation expenses
partially offset by lower salaries expense.
    General and administrative expenses for the year ended March 31, 2009
were $1,040,468 compared with $1,259,197 for the corresponding period in 2008.
The decrease resulted mainly from lower professional and stock exchange fees
than in the comparable period where higher costs were incurred with the
graduation to the TSX exchange.
    At March 31, 2009, the company had working capital of $4,458,065 and
42,541,181 common shares outstanding. Subsequent to the fiscal year end, the
company announced the completion of a private placement financing of units
consisting of one common share and one-half common share purchase warrant for
gross proceeds to Amorfix of $3.3 million.

    
    Outlook

    The company's fiscal 2010 diagnostic priorities are to:

    -   complete the NIBSC process to validate the performance of the
        EP-vCJD(TM) Blood Screening Assay using human vCJD patient samples
        and to manufacture and supply diagnostic kits for prevalence studies;

    -   continue to generate assay performance data in France for the vCJD
        assay in a blood transfusion center;

    -   form collaborations to further validate the benefits of the A(4)
        amyloid assay and to launch a service business providing this assay
        for testing preclinical samples; and

    -   complete development of a screening test for liver cancer in
        collaboration with BioMosaics and SRI.

    The company's 2010 therapeutic priorities are to:

    -   engage new partners for the ALS vaccine and antibody DSE programs;

    -   complete proof-of-concept preclinical studies for Alzheimer's Disease
        targeting misfolded SOD1;

    -   leverage the company's core capability of identifying misfolded
        protein targets and to seek development partnerships for new
        therapeutic targets.
    

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

    About Amorfix

    Amorfix Life Sciences Ltd. (TSX:AMF) is a theranostics company developing
therapeutic products and diagnostic devices targeting brain-wasting diseases
including ALS, Alzheimer's Disease, Parkinson's Disease and variant
Creutzfeldt-Jakob Disease (vCJD). Amorfix's proprietary Epitope Protection(TM)
(EP) technology enables it to specifically identify very low levels of
aggregated misfolded proteins (AMP) in a sample of normal protein. Aggregated
misfolded proteins are a common element of many brain wasting diseases and the
ability to identify AMPs and understand their structure and mechanism of
folding are the first steps to developing new treatments for these devastating
diseases. Amorfix's lead programs are a diagnostic blood screening test for
vCJD and a therapy for ALS.

    
    The TSX has not reviewed and does not accept responsibility for the
    adequacy or accuracy of this release.
    

    This information release may contain certain forward-looking information.
Such information involves known and unknown risks, uncertainties and other
factors that may cause actual results, performance or achievements to be
materially different from those implied by statements herein, and therefore
these statements should not be read as guarantees of future performance or
results. All forward-looking statements are based on the Company's current
beliefs as well as assumptions made by and information currently available to
it as well as other factors. Readers are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the date of this
press release. Due to risks and uncertainties, including the risks and
uncertainties identified by the Company in its public securities filings,
actual events may differ materially from current expectations. The Company
disclaims any intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events or
otherwise.

    
    Amorfix Life Sciences Ltd.

    (a development stage company)

    Balance Sheets
    As at March 31
                                                          2009          2008
                                                             $             $
    Assets

    Current assets
    Cash and cash equivalents                          564,568     2,212,776
    Marketable securities                            4,160,798     6,467,490
    Amounts receivable                                  52,663       198,026
    Tax credits receivable                             211,082       400,082
    Prepaid expenses and deposits                       64,963       136,855
                                                   --------------------------

    Total current assets                             5,054,074     9,415,229

    Property and equipment, net                        463,110       575,053
                                                   --------------------------

                                                     5,517,184     9,990,282
                                                   --------------------------
                                                   --------------------------

    Liabilities

    Current liabilities
    Accounts payable and accrued liabilities           596,009     1,295,333
                                                   --------------------------

    Total current liabilities                          596,009     1,295,333
                                                   --------------------------

    Shareholders' Equity

    Common shares                                   19,467,462    19,194,840
    Other equity                                     3,970,704     2,815,838
    Contributed surplus                                225,297       187,777
    Accumulated other comprehensive income              18,598         2,247
    Deficit                                        (18,760,886)  (13,505,753)
                                                   --------------------------

                                                     4,921,175     8,694,949
                                                   --------------------------
                                                     5,517,184     9,990,282
                                                   --------------------------
                                                   --------------------------



    Amorfix Life Sciences Ltd.

    (a development stage company)
    Statements of Operations and Comprehensive Loss
                                                                 Period from
                                                                  January 23,
                                                                        2004
                                      Year ended    Year ended    (inception)
                                        March 31,     March 31,  to March 31,
                                            2009          2008          2009
                                               $             $             $
    Revenue
    Interest earned                      244,499       477,615     1,012,322
                                     ----------------------------------------

    Expenses
    Research and development           4,126,945     6,240,108    14,941,921
    General and administrative         1,040,468     1,259,197     3,780,962
    Amortization of property
     and equipment                       225,219       122,418       407,319
    Amortization of technology
     rights                                    -        45,873        56,313
                                     ----------------------------------------

                                       5,392,632     7,667,596    19,186,515
                                     ----------------------------------------

    Loss before the undernoted        (5,148,133)   (7,189,981)  (18,174,193)

    Costs related to reverse
     takeover                                  -             -       479,693
                                     ----------------------------------------

    Loss for the period               (5,148,133)   (7,189,981)  (18,653,886)
                                     ----------------------------------------
                                     ----------------------------------------

    Other comprehensive income
    Unrealized gain on
     available-for-sale marketable
     securities                           16,351        52,247
                                     --------------------------

    Comprehensive loss for the year   (5,131,782)   (7,137,734)
                                     --------------------------
                                     --------------------------
    Basic and diluted loss per
     common share                          (0.12)        (0.17)
                                     --------------------------
                                     --------------------------

    Weighted average number of
     common shares outstanding        41,985,488    41,297,742
                                     --------------------------
                                     --------------------------



    Amorfix Life Sciences Ltd.

    (a development stage company)
    Statements of Cash Flows
                                                                 Period from
                                                                  January 23,
                                                                        2004
                                      Year ended    Year ended    (inception)
                                        March 31,     March 31,  to March 31,
                                            2009          2008          2009
                                               $             $             $
    Cash provided by (used in)

    Operating activities

    Loss for the period               (5,148,133)   (7,189,981)  (18,653,886)
    Amortization of property and
     equipment                           225,219       122,418       407,319
    Amortization of technology
     rights                                    -        45,873        56,313
    Stock-based compensation           1,085,386       916,983     3,013,924
    Other non-cash expenses                    -             -       235,115
    Changes in non-cash working
     capital                            (293,069)      542,419       176,839
                                     ----------------------------------------

                                      (4,130,597)   (5,562,288)  (14,764,376)
                                     ----------------------------------------

    Investing activities

    Purchase of marketable
     securities                       (6,159,771)   (1,608,840)  (27,833,681)
    Maturity or sale of marketable
     securities                        8,482,814     7,386,197    23,691,481
    Purchase of property
     and equipment                      (113,276)     (492,739)     (870,429)
    Purchase of technology rights              -       (15,000)      (56,313)
                                     ----------------------------------------

                                       2,209,767     5,269,618    (5,068,942)
                                     ----------------------------------------
    Financing activities

    Issuance of common shares, net
     of cash issue costs                 272,622       160,944     4,655,751
    Issuance of common share units,
     net of cash issue costs                   -             -    11,973,069
    Issuance of common shares on
     exercise of agent options and
     warrants                                  -       568,408     2,980,920
    Issuance of common shares on
     exercise of options                       -       115,500       521,368
    Other financing activities                 -             -       266,778
                                     ----------------------------------------

                                         272,622       844,852    20,397,886
                                     ----------------------------------------
    Net (decrease) increase in cash
     and cash equivalents during
     the period                       (1,648,208)      552,182       564,568

    Cash and cash equivalents -
     Beginning of period               2,212,776     1,660,594             -
                                     ----------------------------------------

    Cash and cash equivalents -
     End of period                       564,568     2,212,776       564,568
                                     ----------------------------------------
                                     ----------------------------------------
    

    %SEDAR: 00022789E




For further information:

For further information: Dr. George Adams, President & Chief Executive
Officer, Amorfix Life Sciences Ltd., Tel: (416) 847-6959, Fax: (416) 847-6899,
george.adams@amorfix.com; James Parsons, Chief Financial Officer, Amorfix Life
Sciences Ltd., Tel: (416) 847-6929, Fax: (416) 847-6899,
james.parsons@amorfix.com

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Amorfix Life Sciences Ltd.

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