AMORFIX ANNOUNCES THIRD QUARTER FISCAL 2013 RESULTS AND FINANCING
TORONTO, Ontario - February 14, 2013 - 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 third quarter ended December 31, 2012 and a private placement financing.
"We continue to make good progress on all of our diagnostic and therapeutic programs" said Amorfix President and CEO Dr. Robert Gundel. "We have several companies currently evaluating our human Alzheimer's disease (AD) diagnostic test and we established an important collaboration with QPS to continue to optimize and validate the assay with the goal of commercialization as quickly as possible. In addition, we made an important first step towards the development of a commercially viable ALS diagnostic that has the potential to fill a critical need for early diagnosis of ALS and represents a significant market opportunity for Amorfix. Finally, our cancer therapeutic programs are advancing towards important value inflection points and, as evidenced by the invitation to present at the AACR, are now attracting the attention of the pharmaceutical industry and the scientific community."
Recent Corporate Highlights
On November 21, 2012 the Company announced that it is offering its Alzheimer's disease diagnostic EP-AD assay service to customers and that a number of pharmaceutical companies are currently evaluating the test in several pilot studies. These studies will expand our current database and experience with the assay and offer companies an opportunity to evaluate and utilize the test as a means of conducting better and more efficient clinical studies for the treatment of AD.
On December 6, 2012 the Company announced that it has established a collaboration with CNJ Holdings Inc., a wholly-owned subsidiary of Cangene Corporation, for the identification and development of therapeutic antibodies against proprietary disease specific epitopes (DSEs) identified using Amorfix's ProMIS™ discovery technology for the treatment of various oncology indications. This collaboration represents an important part of our overall strategy to create strategic alliances and partnerships with companies that have complimentary technology and expertise. The work we are conducting with Cangene represents an innovative approach to the identification of antibodies against a variety of oncology targets. This will feed new programs into our R&D pipeline while sharing the associated costs and risks with our partner.
On January 22, 2013 the Company provided on update on its ALS diagnostic program and announced that it is able to identify purified misfolded SOD(1) added to human plasma, an important first step in the development of the assay. The potential market for such a product is estimated to be as much as $250M and, as such, represents a very attractive opportunity for our Company.
On January 24, 2013 the Company announced that it has been selected to present an oral platform entitled "AMF-1c-120: an antibody specific for misfolded prion protein expressed on ovarian cancer cells", at the annual meeting of the American Association for Cancer Research (AACR) in Washington, DC on April 9, 2013. This represents an international scientific forum to present the results of our ovarian cancer studies to industry and academic scientists.
On January 29, 2013 the Company announced a collaboration with QPS Holdings, LLC, a leading global provider of discovery and development services for pharmaceutical, biotechnology and medical device companies, to further develop and validate its proprietary Alzheimer's disease diagnostic EP-AD assay. This collaboration will serve to finalize the optimization and validation of the assay; steps that are required as the program advances towards commercialization.
For the three months ended December 31, 2012 the Company reported a net loss from operations of $501,279 ($0.01 per share) compared to net loss of $731,287 ($0.01 per share) for the three months ended December 31, 2011. Research and development expenses for the three months ended December 31, 2012 were $413,928 compared to $580,221 in the comparable period. General and administrative expenses for the three months ended December 31, 2012 were $104,196 compared to $171,961 in the comparable prior year period.
For the nine months ended December 31, 2012 the Company reported a net loss from operations of $1,674,151 ($0.03 per share) compared with a net loss of $1,841,496 ($0.04 per share) for the nine months ended December 31, 2012. Research and development expenses for the nine months ended December 31, 2012 were $1,328,461 compared to $1,511,375 in the comparable period. General and administrative expenses for the nine months ended December 31, 2012 were $365,898 compared to $432,979 in the comparable period last year.
At December 31, 2012, the Company does not have sufficient working capital to continue its research and development programs. The Company is actively pursuing a number of financing options and initiatives at this time and anticipates a successful interim solution shortly. At December 31, 2012, the Company had 57,004,290 common shares outstanding.
Private Placement Financing
The Company has arranged a non-brokered private placement of units in the amount of US$200,000 (the "Offering"). Each unit is priced at US$40,000 and will consist of 100,000 common shares of Amorfix and 100,000 purchase warrants, with each whole warrant entitling the holder to purchase at any time during the two years from the issue date, subject to acceleration of the expiry date, one common share of Amorfix at a price of $0.650 per share.
All securities issued in connection with the Offering will be subject to a statutory hold period of four months from the date of issuance. The Offering is subject to approval of the TSX.
The Company's Fiscal 2013 and Fiscal 2014 research priorities, subject to the Company raising additional funds, are to:
• Initiate proof of concept studies in animal models of cancer with anti-Fas receptor antibodies
• Complete the validation of a human Alzheimer's disease test to detect aggregated Abeta, a hallmark of the disease, in cerebrospinal fluid
• Complete the research and development of an ALS diagnostic test
• Establish additional collaborations and partnerships for use of the ProMIS discovery technology to continue to build a compelling pipeline of novel antibody therapeutics for the treatment of cancer
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, ProMISTM, 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 ProtectionTM and AMFIATM, 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.
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ProMISTM, Epitope ProtectionTM and AMFIATM are trademarks of Amorfix Life Sciences Ltd.