Amorfix announces second quarter 2010 results

TSX: AMF

TORONTO , Nov. 13 /CNW/ - Amorfix Life Sciences, a company focused on misfolded protein diseases, today reported its second quarter operating results and provided an update on the Company's diagnostic and therapeutic programs.

"We have six products/services under development and it is gratifying to see the EP-vCJD product nearing the final 10,000-sample assessment by the UK government and the strong interest by numerous pharmaceutical companies in our service to measure Alzheimer's-related amyloid formation in animals," said George Adams , President & Chief Executive Officer of Amorfix. "Our other four projects, Alzheimer's and ALS therapeutics, ProMIS(TM) prediction of novel targets in disease and the development of a screening test for liver cancer are all advancing on schedule. We have the financial resources to bring these projects through their next milestones."

    
    Development and Corporate Highlights

    vCJD
    ----
    -   In October 2009, the Company announced the detection of prions in
        blood from primates that were orally-infected with BSE and developed
        a primate version of variant Creutzfeldt-Jakob Disease (vCJD) over a
        6-8 year period. These results are promising although only a small
        number of blood samples could be obtained due to the limited number
        of these very rare primate samples. Biochemical detection of vCJD
        endogenous prions in cynomolgus primates has never before been
        reported. Amorfix now expects to be given access to test human vCJD
        patient samples with its EP-vCJD(TM) assay.

    -   In September 2009, Dr. George Adams presented Amorfix's EP-vCJD(TM)
        blood screening test at the Sixth World Federation of Haemophilia
        Global Forum on the Safety and Supply of Treatment Products for
        Bleeding Disorders in Montreal, Quebec. Early this year, the UK
        Health Protection Agency confirmed the first case of vCJD in one of
        the thousands of haemophiliac patients who received potentially
        contaminated plasma fractions. While the patient ultimately died of
        causes other than vCJD, this news has served to amplify the calls
        from haemophiliacs in the UK and around the world for their
        respective governments to protect the blood supply through routine
        testing of blood donations.

    -   In September 2009, the European In Vitro Diagnostics (IVD) Technical
        Group adopted the proposed requirements for a CE mark for a vCJD test
        for blood donations. The next level of approval is the Medical
        Devices Experts Group which will meet in December 2009 to consider
        these draft common technical specifications and guidelines for the
        test.

    -   In October 2009, the Company announced that it had tested 39,000
        blood donations in France as part of a large-scale study being
        conducted to demonstrate the feasibility of routine testing of blood
        donations for vCJD. The Amorfix test has demonstrated a specificity
        of 99.95%, exceeding the 99.85% specificity required by the UK Blood
        Transfusion Service.

    ALS/Alzheimer's Disease (AD)
    ----------------------------

    -   The Company continued on schedule to study its antibodies and
        vaccines in preclinical animal models of AD with first results
        expected first quarter calendar 2010.

    -   The Company continues to seek partners for its antibodies and
        vaccines to misfolded SOD1 in ALS having achieved all of its
        preclinical milestones for this indication by identifying and
        developing monoclonal antibodies to its Disease Specific Epitopes(TM)
        on misfolded SOD1 and by demonstrating increased survival in ALS
        mouse studies.

    -   In October 2009, the Company promoted its A4 assay service at the
        Society for Neuroscience meeting in Chicago, Illinois. The Company is
        seeking collaborations and offering the A4 test as a service to drug
        discovery companies and academic researchers working to discover new
        treatments for AD. Since the A4 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.

    -   In October 2009, the Company announced an agreement with Cedarlane
        Laboratories for the sale and distribution of its proprietary
        antibodies and reagents.
    

Financial Results

For the three months ended September 30, 2009 the Company reported a net loss of $1,286,905 ( $0.03 per share) compared to a net loss of $1,147,947 ( $0.03 per share) for the comparable period last year. For the six months ended September 30, 2009 the Company reported a net loss of $2,457,646 ( $0.05 per share) compared to a net loss of $2,754,131 ( $0.07 per share) for the six months ended September 30, 2008 .

Research and development expenditures for the three months ended September 30, 2009 were $979,045 compared to $890,514 for the three months ended September 30, 2008 , and for the six months ended September 30, 2009 were $1,859,233 compared to $2,257,681 for the comparable period last year. Research and development expenses increased in the three months ended September 30, 2009 due mainly to expenditures related to its ProMIS(TM) and AD therapeutic programs partially offset by lower vCJD and ALS therapeutic program expenses. Research and development expenses decreased for the six months ended September 30, 2009 due to lower staffing costs, and lower ALS and vCJD program expenses partially offset by increased expenditures related to its AD therapeutic and ProMIS(TM) programs.

General and administration costs for the three months ended September 30, 2009 were $306,759 compared to $253,814 for the three months ended September 30, 2008 , and for the six months ended September 30, 2009 were $597,567 compared to $517,438 for the comparable period last year. Higher expenses for the three and six months ended September 30, 2009 resulted mainly from higher stock-based compensation and investor relations expenses.

Cash burn (cash used in operating activities) of $1,065,586 for the three months ended September 30, 2009 was comparable to $1,036,042 for the three months ended September 30, 2008 . For the six months ended September 30, 2009 , the company's cash burn was $1,926,850 compared to $2,718,488 in the comparable period last year. The decreased cash burn for the six months ended September 30, 2009 was due primarily to lower research and development costs and a lower amount of accounts payable actually paid out in the period.

As at September 30, 2009 Amorfix had working capital of $5,925,271 compared to $4,458,065 as at March 31, 2009 .

As at September 30, 2009 the Company had 48,131,163 common shares outstanding.

    
    Outlook

    The Company's fiscal 2010 diagnostic priorities are to:

    -   complete the National Institute for Biological Standards and Control
        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 assessment and prevalence studies;

    -   generate assay performance data for the vCJD assay in collaboration
        with blood transfusion services in Europe and elsewhere;

    -   form collaborations to further validate the benefits of the A4
        amyloid assay and to pursue a service business providing this assay
        for testing preclinical samples; and

    -   complete development of the screening test for liver cancer in
        collaboration with BioMosaics and Sunnybrook Research Institute.

    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 using our ProMIS(TM) technology and seek development
        partnerships for the 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 misfolded protein diseases including ALS, Alzheimer's Disease, variant Creutzfeldt-Jakob Disease (vCJD) and Cancer. 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 utilizes its computational discovery platform, ProMIS(TM), to predict novel Disease Specific Epitopes ("DSE") on the molecular surface of misfolded proteins. ProMIS(TM) is an "in silico" rational selection approach that can be applied to any protein where the normal folding structure is at least partially known. Amorfix's lead therapeutic programs include antibodies and vaccines to DSEs in ALS, Alzheimer's disease and Cancer. The Company's diagnostic programs include a blood screening test for diagnosis of vCJD and an ultrasensitive method for the detection of aggregated Beta-Amyloid in brain tissue of animal models of Alzheimer's disease, months prior to plaque formation.

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.

%SEDAR: 00022789E

For further information: Dr. George Adams, President & Chief Executive Officer, Amorfix Life Sciences Ltd., Tel: [phone], Fax: [phone], [email protected]; James Parsons, Chief Financial Officer, Amorfix Life Sciences Ltd., Tel: [phone], Fax: [phone], [email protected]