Amorfix Announces First Quarter Fiscal 2013 Results
TSX: AMF
TORONTO, Aug. 14, 2012 /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, 2012.
"We are very proud of the progress we have made on all our programs. The science has never looked better, the programs are moving forward and we are attracting recognition from industry and the scientific community." said Amorfix President and CEO Dr. Robert Gundel. "We have completed the initial characterization of our Alzheimer's disease (AD) diagnostic and presented our results at the recent Alzheimer's Association International Conference (AAIC) meeting in Vancouver, BC. The EP-AD assay measures aggregated Ab oligomers in cerebrospinal fluid (CSF) and our data demonstrates that it is the most effective biochemical marker today for the identification of Mild Cognitive Impairment (MCI) with 94% sensitivity. MCI represents the characterization of the very early stages of Alzheimer's disease. When combined with other biochemical markers, the EP-AD test is the most effective marker for the identification of patients with AD, again with 94% sensitivity. We have increased our business development activities and are actively pursuing specific collaborations with a number of companies to further validate and advance the commercialization of the assay. "
"Our cancer therapeutic programs are advancing towards important milestones" said Dr. Neil Cashman, Amorfix founder and CSO. "We are preparing for proof of concept studies in an animal model for our PrP program and are actively conducting cytoxicity experiments with our proprietary tumor specific Fas receptor antibodies. These programs represent a unique approach towards the development of targeted cancer therapeutics."
Another significant milestone achieved this quarter is the completion of the licensing of the Company's preclinical assay to Austrian CRO JSW Life Sciences, a leading CRO in Alzheimer's research. JSW launched their marketing efforts for the Amorfix A4 assay in July at the AAIC which the Company expects will significantly increase its exposure to leading researchers.
Recent Corporate Highlights
On June 28, 2012, the Company announced that Dr. Marni Uger, Director of Research and Development, was selected to present a talk entitled "Amorfix EP-AD Diagnostic CSF Test for Accurate Identification of Alzheimer's Disease and Mild Cognitive Impairment", at the 2012 Alzheimer's Association International Conference (AAIC) in Vancouver, British Columbia.
Dr. Uger reviewed a comprehensive analysis of data from approximately 200 clinical samples using Amorfix's EP-AD CSF test, which measures the levels of aggregated Abeta in cerebrospinal fluid (CSF), a recognized biomarker for Alzheimer's disease (AD). The results show statistically significant differences in the levels of aggregated Abeta between samples from normal subjects and both mild cognitive impairment (MCI) and AD patients.
The Company also announced that it had found a statistically significant correlation between aggregated Abeta levels and mini-mental state examination (MMSE) scores in normal aged individuals. This suggests that the EP-AD test may be able to capture the transition from normal aging to MCI.
Financial Results
For the three months ended June 30, 2012 the Company reported a net loss from operations of $599,961 ($0.01 per share) compared to net loss of $529,484 ($0.01 per share) for the three months ended June 30, 2011. The increased loss in the current period was the result of lower revenues on its A4 service revenue and higher operating expenditures, mostly related to increased business development activities and higher program expenses for its cancer therapeutic program.
The Company measures cash burn as the net cash used in operations, which was $682,696 for the three months ended June 30, 2012 and is comparable to net cash used in operations of $695,164 for the three months ended June 30, 2011.
At June 30, 2012, the Company had working capital of $1,053,380 and 57,004,290 common shares outstanding. Management projects that its current working capital is sufficient to fund the Company's operations into the fourth calendar quarter of 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 2013 research priorities, subject to the Company raising additional funds, are to:
- Complete proof of concept studies in animal models of ovarian cancer with anti PrP antibodies
- Complete the initial characterization of anti Fas antibodies in cellular assays followed by proof of concept studies in animal models of cancer once a lead candidate has been selected
- Establish collaborations and partnerships for the use of the EP-AD Assay for use in clinical trials of Alzheimer's disease.
- Continue, with a partner, validation of a human Alzheimer's disease test to detect aggregated Ab, a hallmark of the disease, in human plasma and cerebrospinal fluid;
- Complete the research and development of an ALS diagnostic test.
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 an early-stage product development company developing therapeutic antibodies and diagnostics targeting misfolded protein diseases. Amorfix utilizes its computational discovery platform, ProMIS™, to predict novel Disease Specific Epitopes (DSEs) on the molecular surface of misfolded proteins. Using this technology, Amorfix is developing novel antibody therapeutics and companion diagnostics for cancer and amyotrophic lateral sclerosis (ALS). In addition, Amorfix has developed two proprietary technologies to specifically identify very low levels of misfolded proteins in a biological sample: Epitope Protection™ and AMFIA™, an ultra-sensitive dual-bead immunoassay. Use of these technologies has generated a cerebrospinal fluid (CSF) screening test for both Alzheimer's disease (AD) and mild cognitive impairment (MCI), and an ultrasensitive method for detecting the hallmark of AD, aggregated beta-Amyloid, in brain tissue, CSF and blood from animal models of 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.
Dr. Robert Gundel
President and Chief Executive Officer
Amorfix Life Sciences Ltd.
Tel: (416) 847-6957
Fax: (416) 847-6899
[email protected]
Janet Clennett
Chief Financial Officer
Amorfix Life Sciences Ltd.
Tel: (416) 847-6926
Fax: (416) 847-6899
[email protected]
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