Amorfix announces second quarter fiscal 2012 results

TSX: AMF

TORONTO, Nov. 14, 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 second quarter ended September 30, 2011.

"We have made significant advancements in our therapeutic and diagnostic programs this quarter," said Dr. Robert Gundel, Amorfix President and Chief Executive Officer. "We have achieved a significant milestone related to our Alzheimer's disease diagnostic and we will continue to develop this assay as a tool to identify early-symptomatic patients who could best benefit from treatment. This is where there is a recognized need by the medical community and we believe our diagnostic shows great promise.  We are currently seeking a development partner to make this important new diagnostic tool available to clinicians as quickly as possible. In addition, our therapeutic antibody programs are moving forward and we now have tumour specific antibodies for several of our therapeutic targets. The recent collaboration with Helix BioPharma will enable the development of antibody-toxin conjugate therapeutics that specifically seek out tumours and selectively deliver the toxin killing the tumour but sparing normal tissue."

Recent Corporate Highlights

On September 30, 2011, the Company announced it has achieved 85 percent specificity and sensitivity with its EP-AD CSF Diagnostic Test. When the scores from the Amorfix test were correlated with scores from the MMSE (Mini-Mental State Examination, a clinical test used to measure disease severity), the results demonstrated that aggregates were not only found in cerebrospinal fluid (CSF) from late-stage Alzheimer's disease (AD), but also in patients with early stage AD or mild cognitive impairment (MCI). In addition, the data suggest that the Amorfix test is superior for identification of patients with MCI when compared to the measurements of monomeric Abeta 1-42 alone.

On November 11, 2011, the Company announced that it has entered into an agreement with Helix BioPharma, a biotechnology company that has a toxin conjugate with properties that suggest it will bind successfully to its PrP lead antibody.  The company expects to initiate cell based studies in the fourth quarter of this fiscal year and if successful, will then initiate in vivo proof of concept studies.

Financial Results

The net loss for the three months ended September 30, 2011 was $580,725 compared to net income of $83,101 for the three months ended September 30, 2010. The net loss for the six months ended September 30, 2011 was $1,110,209 compared to a net loss of $1,590,480 for the six months ended September 30, 2010.

For the three and six months ended September 30, 2011 revenue from services and sales was $39,466 and $72,328, respectively as compared to $61,126 and $84,899 in the comparative periods. Substantially all of this revenue was from the Company's A4 test. Revenue from license fees was $nil for the three and six months ended September 30, 2011 compared to $1,030,600 for the comparative periods. The Company entered into a license agreement with Biogen Idec in July 2010 and received a US$1,000,000 non-refundable fee.

Research and development expenditures for the three months ended September 30, 2011 were $515,210 compared to $638,491 in the comparable period. Research and development expenditures decreased mainly from reduced staffing associated with the decision to suspend commercialization of the Company's vCJD program in June 2010 and by lower expenditures related to the ALS and ProMIS programs.

Research and development expenditures for the six months ended September 30, 2011 were $931,154 compared to $2,094,268 in the comparable period. Research and development expenditures decreased mainly from the Company having fewer employees than in the comparable period, to the severance costs incurred in June 2010 associated with the decision to suspend commercialization of the Company's vCJD program, and lower expenditures related to the ProMIS program.

General and administrative costs for the three months ended September 30, 2011 were $109,649 compared to $383,525 in the comparable period and for the six months ended September 30, 2011 were $261,018 compared to $644,737 in the comparable period. The decrease for the three and six months ended September 30, 2011 resulted mainly from the severance costs incurred in the comparable periods and higher share based payment expense recorded in the comparable periods.

At September 30, 2011, the Company had working capital of $1,242,421 and 50,609,959 common shares outstanding.  Management projects that its current working capital will fund the Company's operations into the fourth quarter of fiscal 2012.  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 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, in human plasma and cerebro-spinal 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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