Amorfix Announces First Quarter Fiscal 2012 Results

TSX: AMF

TORONTO, Sept. 13, 2011 /CNW/ - Amorfix Life Sciences, a product development company focused on diagnostics and therapeutics for misfolded protein diseases, today announced its operational and financial results for the first quarter ended June 30, 2011.

"Our diagnostic and antibody therapeutic programs are advancing according to plan," said Dr. Robert Gundel, Amorfix Life Sciences President and Chief Executive Officer.  "We have demonstrated that our ProMIS discovery technology is capable of identifying disease specific epitopes and we now have antibodies that specifically bind to  tumour cells but not to normal cells.  This demonstration represents a significant scientific advancement for the field as well as a big step forward in our efforts to develop antibody therapeutics that are more effective and with less side effects as compared to existing treatments.  In addition, our progress remains steady with the AD diagnostic and our initial data was very well received when presented to the scientific audience at this year's ICAD meeting in Paris.  We are executing our development plan with near term milestones in sight."

Recent Corporate Highlights

On July 17th, 2011, the Company presented a paper at the Alzheimer's Association International Conference on Alzheimer's disease in Paris, France. The poster presentation entitled "Development of An Ultra Sensitive Assay for Detection of Aggregated Beta Amyloid in Human CSF", is the first presentation of preliminary data generated using the Company's EP-AD Diagnostic CSF Test. This paper is the result of a collaboration with Dr. Kaj Blennow from the Sahlgrenska University Hospital in Sweden.   This preliminary proof-of-concept validation was performed with a total of thirty-five human CSF samples from Alzheimer's disease (AD) patients and control subjects. The identity of the samples was blinded to Amorfix and was only revealed following the completion of data analysis. The results obtained from the EP-AD Diagnostic CSF Test were as follows:  The assay correctly identified 12/17 AD and 14/18 Control CSF samples (74% sensitivity and 79% specificity, respectively).

On August 8, 2011, the Company announced that it has completed the initial characterization of its anti-PrP antibodies in cellular assay systems, which shows selective binding to certain tumour cells, but not to normal cells.  Based on these initial results, the Company will be preparing to test the antibodies alone and as antibody-toxin conjugates to advance the program into proof of concept studies in animal models of cancer. The Company is continuing to develop antibodies for two other targets, Fas receptor and CD38, and expects to begin characterization in the fourth calendar quarter of 2011.

On August 29, 2011, The Company and The Pan-Provincial Vaccine Enterprise Inc. (PREVENT), a national Centre of Excellence for Commercialization and Research (CECR), announced the signing of an exclusive license agreement for the use of Amorfix's proprietary ProMIS technology in developing vaccines for the treatment of diseases caused by the formation of misfolded prion (PrP).   PREVENT has licenced ProMIS targets in the prion protein for two distinct applications: as prophylactic vaccine targets to block infection by prions (as in chronic wasting disease of deer and elk), and as therapeutic vaccine targets for cancers in which the normal prion protein structure is disrupted.

The Company is also announcing that it will be holding its Annual General Meeting on Wednesday October 19th, 2011 at its offices at 3403 American Drive, Mississauga, Ontario.  The Company has received permission from the TSX to extend the meeting beyond six months from the end of the fiscal year due to a financing transaction it was considering that could have required shareholder approval.  The Company continues to pursue a variety of financing options.

Financial Results

For the three months ended June 30, 2011 the Company reported a net loss from operations of $529,484 ($0.01 per share) compared to net loss of $1,673,581 ($0.03 per share) for the three months ended June 30, 2010.

For the three months ended June 30, 2011 revenue for services and sales was $32,862 as compared to $23,773 for the three months ended June 30, 2010.  Substantially all of this revenue was for its A4 test which the Company began marketing in the third quarter of fiscal 2010.

Research and development (R&D) expenses for the three months ended June 30, 2011 were $415,944 compared with $1,455,777 for the three months ended June 30, 2010. The decrease resulted mainly from higher program and salary expenses in the comparable period associated with the vCJD program and the severance costs and accelerated amortization of leaseholds and equipment recorded in the comparable period associated with the suspension of the vCJD program.

General and administrative expenses for the three months ended June 30, 2011 were $151,369 compared with $261,212 for the three months ended June 30, 2010. The decrease for the three months ended June 30, 2011 resulted mainly from lower share based payment expense and lower professional fees than in the comparable period.

At June 30, 2011, the Company had working capital of $1,786,107 and 50,609,959 common shares outstanding.  Management projects that its current working capital will fund the Company's operations to December 2011.  The Company is actively pursuing financing alternatives, but there is no assurance that these initiatives will be successful, timely or sufficient.

Outlook

The Company's Fiscal 2012 research priorities, subject to the Company raising additional funds, are to:

  • Advance our ProMISTM antibody program targeting disease specific epitopes for both therapeutics and companion diagnostics for cancer and other misfolded protein diseases to a lead compound for late-stage preclinical development;
  • Grow the revenue from our A4 amyloid testing service for cell culture, tissue and blood in animal models of Alzheimer's disease (AD);
  • Complete development of a human Alzheimer's test adapting the A4 test protocol to detect aggregated Abeta, the hallmark of the disease, and cerebrospinal fluid;

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 product development company developing therapeutic products and diagnostic devices targeting misfolded protein diseases including Alzheimer's Disease (AD), cancers, and ALS. Amorfix utilizes its computational discovery platform, ProMIS™, to predict novel Disease Specific Epitopes ("DSEs") on the molecular surface of misfolded proteins. Amorfix's lead programs include therapeutics and companion diagnostics for cancers, antibodies and vaccines to DSEs in ALS and AD diagnostic tests. In addition, Amorfix's proprietary Epitope Protection™ technology enables it to specifically identify very low levels of misfolded proteins in a biological sample. The Company's diagnostic programs include an ultrasensitive method for the detection of aggregated beta-Amyloid in brain tissue, CSF and blood from animal models of AD, months prior to observable amyloid formation, and development of a human screening test for AD. For more information about Amorfix, visit www.amorfix.com.

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. 

SOURCE Amorfix Life Sciences Ltd.

For further information:

Dr. Robert Gundel
President and Chief Executive Officer     
Amorfix Life Sciences Ltd.
Tel: (416) 847-6957
Fax: (416) 847-6899
bob.gundel@amorfix.com
Janet Clennett
Acting Chief Financial Officer
Amorfix Life Sciences Ltd.
Tel: (416) 847-6926
Fax: (416) 847-6899
Janet.clennett@amorfix.com

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Amorfix Life Sciences Ltd.

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