Amorfix announces fiscal 2009 third quarter results



    TSX: AMF

    TORONTO, Feb. 11 /CNW/ - Amorfix Life Sciences, a company focused on
treatments and diagnostics for brain wasting diseases, today announced its
operational and financial results for the three and nine months ended December
31, 2008.

    Q3-2009 Development and Corporate Highlights

    In October 2008 and December 2008 Amorfix announced that its Disease
Specific Epitope (DSE) monoclonal antibody treatments demonstrated
statistically significant improvement in survival over controls in a mouse
model of Amyotrophic Lateral Sclerosis (ALS) and Amorfix's achievement of its
second and third milestones under a 2006 research agreement with Biogen Idec,
resulting in Biogen's investment in Amorfix in the amount of US$225,000. On
February 10, 2009, Biogen allowed its option to license Amorfix SOD1
technologies for use in the treatment of ALS to lapse. Amorfix will continue
to develop vaccines and antibodies for ALS and is now free to fully engage
other companies that have expressed interest in partnering to bring the
treatments to the clinic.
    On December 19, 2008, Amorfix announced its first issued U.S. patent from
titled "ALS-Specific Peptide Composition". This patent covers one of the key
disease specific epitopes (DSE) in the SOD1 "Jekyll and Hyde" protein which
Amorfix has shown is exposed when it misfolds. Amorfix DSE(TM) antibodies bind
to this region and the Company believes neutralizes the toxic effects of SOD1
giving the longevity extension Amorfix has previously reported in animal
models of ALS.
    In December 2008, Amorfix announced it achieved perfect 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 the most recent trial,
NIBSC provided Amorfix with 500 frozen blinded human plasma samples which
included random samples spiked with vCJD brain prions. The EP-vCJD(TM) 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). The test scored one sample initially positive (initial reactivity of
99.8%), but upon repeat testing correctly identified the sample as negative
(specificity of 100%). In the first blinded trial, Amorfix tested 1,000 fresh
UK plasma samples with identical perfect results.
    On January 13, 2009, Amorfix announced 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 currently in use worldwide in blood transfusion centres to
assure the safety of blood. The study will now be expanded to test blood
donations in two additional centers in France.

    Financial Results

    For the three months ended December 31, 2008 the Company reported a net
loss of $1,017,663 ($0.02 per share) compared to a net loss of $1,477,264
($0.04 per share) for the comparable period last year. For the nine months
ended December 31, 2008 the Company reported a net loss of $3,771,794 ($0.09
per share) compared to a net loss of $5,269,542 ($0.13 per share) for the nine
months ended December 31, 2007.
    Research and development expenditures for the three months ended December
31, 2008 were $804,871 compared to $1,358,132 for the three months ended
December 31, 2007, and for the nine months ended December 31, 2008 were
$3,062,552 compared to $4,559,654 for the comparable period last year. The
decrease in both current year periods was due to lower vCJD program expenses
associated with scale up and commercialization in fiscal 2009 and lower
expenses due to staffing reductions made in June 2008 related to the deferral
of commercialization work for vCJD until the UK NIBSC validation process is
complete, and other cash conservation initiatives.
    General and administration costs for the three months ended December 31,
2008 were $199,922 compared to $190,064 for the three months ended December
31, 2007, and for the nine months ended December 31, 2008 were $717,360
compared to $975,762 for the comparable period last year. Slightly higher
expenses for the three months ended December 31, 2008 resulted from lower
salaries expense and consultant fees related to cost saving initiatives offset
by higher stock-based compensation expense. Lower expenses for the nine months
ended December 31, 2008 resulted mainly from lower stock-based compensation
expense and lower exchange filing fees. In July 2007, Amorfix graduated to the
TSX exchange and incurred significant exchange filing fees associated with
that transaction.
    Cash burn (cash used in operating activities) was $809,588 for the three
months ended December 31, 2008 compared to $1,258,030 for the three months
ended December 31, 2007. For the nine months ended December 31, 2008, the
Company's cash burn was $3,528,076 as compared with $4,234,811 in the
comparable period last year. The decreased cash burn for the three and nine
months ended December 31, 2008 from the comparable periods in 2007 was due
mostly from lower development and operating costs, offset by a higher amount
of accounts payable that was paid out in the nine months ended December 31,
2008.
    As at December 31, 2008 the Company had working capital of $5,353,091
compared to $8,119,896 as at March 31, 2008.
    As at December 31, 2008 the Company had 42,541,181 common shares
outstanding.

    Outlook

    The Company continues to focus its resources on commercialization of its
lead diagnostic program with the priorities to expand large-scale testing,
continue the verification process, and to promote prevalence testing of blood
donors. For our therapeutic programs, the company will focus on advancing the
ALS therapies with a new commercial partner, generating additional preclinical
vaccine data in Dr. Cashman's academic lab, conducting animal studies with its
novel therapies for Alzheimer's disease and expanding its therapeutic pipeline
to other diseases where misfolded proteins are thought to have a
disease-causing role.
    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

                                                   December 31,     March 31,
                                                          2008          2008
                                                             $             $
                                                    (unaudited)

    Assets

    Current assets
    Cash and cash equivalents                        1,300,477     2,212,776
    Marketable securities                            4,010,493     6,467,490
    Amounts receivable                                  78,239       198,026
    Tax credits receivable                             620,000       400,082
    Prepaid expenses and deposits                       69,360       136,855
                                                  ---------------------------

    Total current assets                             6,078,569     9,415,229

    Property and equipment, net                        505,526       575,053
                                                  ---------------------------

                                                     6,584,095     9,990,282
                                                  ---------------------------
                                                  ---------------------------

    Liabilities

    Current liabilities
    Accounts payable and accrued liabilities           725,478     1,295,333
                                                  ---------------------------

    Total current liabilities                          725,478     1,295,333
                                                  ---------------------------
    Shareholders' equity

    Common shares                                   19,467,462    19,194,840
    Other equity                                     3,445,047     2,815,838
    Contributed surplus                                224,311       187,777
    Accumulated other comprehensive (loss) income         (656)        2,247
    Deficit                                        (17,277,547)  (13,505,753)
                                                  ---------------------------

                                                     5,858,617     8,694,949
                                                  ---------------------------

                                                     6,584,095     9,990,282
                                                  ---------------------------
                                                  ---------------------------



    Amorfix Life Sciences Ltd.
    (a development stage company)
    Statements of Operations and Comprehensive Loss
    (Unaudited)

                                  Three months ended       Nine months ended
                                      December 31,            December 31,
                                    2008        2007        2008        2007
                                       $           $           $           $

    Revenues
    Interest earned               54,206     111,820     188,584     371,742
    -------------------------------------------------------------------------

    Expenses
    Research and development     804,871   1,358,132   3,062,552   4,559,654
    General and administrative   199,922     190,064     717,360     975,762
    Amortization of property
     and equipment                67,076      28,168     180,466      72,709
    Amortization of technology
     rights                            -      12,720           0      33,159
    -------------------------------------------------------------------------
                               1,071,869   1,589,084   3,960,378   5,641,284
    -------------------------------------------------------------------------

    Loss before the
     undernoted               (1,017,663) (1,477,264) (3,771,794) (5,269,542)
    Costs related to reverse
     takeover                          -           -           -           -
    -------------------------------------------------------------------------

    Loss for the period       (1,017,663) (1,477,264) (3,771,794) (5,269,542)
    -------------------------------------------------------------------------
    -------------------------------------------------------------------------

    Other comprehensive
     income (loss)
    Unrealized gain (loss) on
     available-for-sale
     marketable securities        (2,986)     26,470      (2,903)     16,391
    -------------------------------------------------------------------------
    Comprehensive loss for
     the period               (1,020,649) (1,450,794) (3,774,697) (5,253,151)
    -------------------------------------------------------------------------
    -------------------------------------------------------------------------

    Basic and diluted loss
     per common share              (0.02)      (0.04)      (0.09)      (0.13)
    -------------------------------------------------------------------------
    -------------------------------------------------------------------------

    Weighted average number
     of common shares out-
     standing                 42,052,754  41,508,217  41,803,625  41,183,744
    -------------------------------------------------------------------------



    Amorfix Life Sciences Ltd.
    (a development stage company)
    Statements of Cash Flows
    (Unaudited)

                                  Three months ended       Nine months ended
                                      December 31,            December 31,
                                    2008        2007        2008        2007
                                       $           $           $           $

    Cash provided by (used in)
    Operating activities
    Loss for the period       (1,017,663) (1,477,264) (3,771,794) (5,269,542)
      Amortization of
       property and equipment     67,076      28,168     180,466      72,709
      Amortization of technology
       rights                          -      12,720           -      33,159
      Stock-based compensation   225,317     126,706     665,743     732,284
      Other non-cash expenses          -           -           -           -
      Changes in non-cash
       working capital           (84,318)     51,640    (602,491)    196,579
    -------------------------------------------------------------------------
                                (809,588) (1,258,030) (3,528,076) (4,234,811)
    -------------------------------------------------------------------------

    Investing activities
    Purchase of marketable
     securities               (1,171,489)   (247,638) (4,726,771)   (247,638)
    Maturity or sale of
     marketable securities     1,795,825     498,508   7,180,865   4,569,918
    Purchase of property and
     equipment                         -     (64,478)   (110,939)   (209,633)
    Purchase of technology
     rights                            -           -           -     (15,000)
    -------------------------------------------------------------------------
                                 624,336     186,392   2,343,155   4,097,647
    -------------------------------------------------------------------------

    Financing activities
    Issuance of common shares,
     net of cash issue costs     272,622           -     272,622     160,944
    Issuance of common share
     units, net of cash issue
     costs                             -           -           -           -
    Issuance of common shares
     on exercise of warrants           -           -           -     523,408
    Issuance of common shares
     on exercise of options            -      97,500           -     115,500
    Other financing activities         -           -           -           -
    -------------------------------------------------------------------------
                                 272,622      97,500     272,622     799,852
    -------------------------------------------------------------------------
    Net increase (decrease)
     in cash                      87,370    (974,138)   (912,299)    662,688
    Cash - beginning of
     period                    1,213,107   3,297,420   2,212,776   1,660,594
    -------------------------------------------------------------------------
    Cash - end of period       1,300,477   2,323,282   1,300,477   2,323,282
    -------------------------------------------------------------------------
    

    %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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