Amorfix announces second quarter results for period ending September 30, 2014

TSX: AMF

TORONTO, Nov. 12, 2014 /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 three and six months ended September 30, 2014. 

"We continue to focus on advancing our diagnostic and therapeutic programs forward and have made good progress this quarter", said Dr. Robert Gundel, Amorfix President and Chief Executive Officer.  "We recently announced another scientific first for our Alzheimer's disease diagnostic program as we now have the ability to measure levels of aggregated Abeta 40 and Abeta 42 separately in clinical cerebrospinal fluid.  This unique feature of the EP-AD diagnostic assay has attracted the attention of potential pharma partners and we are in discussions with three major pharmaceutical companies for the use of our assay." 

"On the cancer front, we have identified multiple myeloma as another potential clinical indication for our anti-PrP antibody program.   Our collaboration with Trellis Biosciences has produced a promising set of antibodies generated against disease specific epitopes on CD38.  We are currently evaluating the binding properties of these antibodies in cellular assay systems with the goal of identifying a lead candidate for further evaluation in preclinical development."

"Our agreement with Biogen Idec to develop antibody therapeutics for the treatment of ALS has ended and we have the rights back to these antibodies.  This, combined with our recently granted broad patent covering all antibody therapeutics for the treatment of ALS and our ALS blood test diagnostic represent a very attractive combination of assets that put Amorfix in a leading position in this field.  We are in the process of identifying a new strategic partner for the continued development of these programs." 

"Our Business Development activity has stepped up and we are now in discussion with eight leading pharmaceutical companies for the license and use of our ProMIS Discovery technology.  Our goal is to announce one licensing deal by the end of this year."     

Recent Corporate Highlight

• During the three months ended September 30, 2014, Amorfix conducted a study that demonstrated increased misfolded PrP on myeloma cells which suggests that myeloma may be an additional indication for Amorfix's AMF-1c-120 antibody. Amorfix is currently planning further studies with myeloma cells.
• The Company's second generation of its diagnostic assay for the early detection of Alzheimer's disease provides for separate measurement of two forms of the aggregated abeta protein, and demonstrates increased sensitivity. The Aβ40 assay is now 10 times more sensitive than original for the measurement of Aβ40 aggregates and the Aβ42 assay is now 30 times more sensitive than the original assay for the measurement of Aβ42.
• On October 20, 2014 the Company closed the first tranche of a non-brokered private placement (the Offering) pursuant to which 1,260,000 common shares of Amorfix (Shares) and 1,260,000 Warrants were issued for gross proceeds of CDN$352,800.
• On October 21, 2014 the Company announced that it will get the rights back for development and commercialization of the ALS antibody therapeutics originally licensed to Biogen-Idec effective January 14, 2015.

Financial Results

The net loss for the three months ended September 30, 2014 was $701,820 compared to a loss of $464,258 for the three months ended September 30, 2013.  The net loss for the six months ended September 30, 2014 was $1,619,822 compared to a loss of $1,066,791 for the six months ended September 30, 2013.  The increased net loss in the current quarter and in the six-month period ended results mainly from higher share-based compensation expense, higher program expenditures on its cancer therapeutic program and higher professional fees.

For the three months ended September 30, 2014 revenue from services and sales was $11,709, as compared to $24,905 in the comparative period.   For the six months ended September 30, 2014 revenue from services and sales was $47,559, as compared to $60,866 in the comparative period.     Revenue earned from a research collaboration was $46,766 in the current period and was $146,486 for the six month-period ended September 30, 2014.  There was no research revenue in the comparable period.

Research and development expenses for the three months ended September 30, 2014 were $424,106 compared to $324,691 in the comparable period. The increase in expenditures related mostly to higher expenditures on its cancer therapeutic program. Research and development expenses for the six months ended September 30, 2014 were $962,378 compared to $769,986 in the comparable period. The increase in expenditures related mostly to higher expenditures on its cancer therapeutic program and higher share-based compensation.

General and administrative expenses for the three months ended September 30, 2014 were $336,189 compared to $164,472 in the comparable period. General and administrative expenses for the six months ended September 30, 2014 were $851,489 compared to $357,671 in the comparable period.  The increase in expenses for the three months ended September 30, 2014 and for the six month period ended September 30, 2014 resulted mainly from higher share-based compensation expense related to the options granted in fiscal 2014 and higher professional fees incurred in the current fiscal periods.

The Company measures cash burn as the net cash used in operations, which was $988,769 for the six months ended September 30, 2014, as compared to net cash used in operations of $785,874 for the six month-period ended September 30, 2013. The increase in the cash used in operations was due to higher expenditures on its cancer therapeutic program and higher professional fees.

At September 30, 2014, the Company had working capital deficit of $171,683. Presently, 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. 

Outlook

The Company's research priorities for the next year, subject to the Company raising additional funds, are to:

• 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
• Complete the research and development of an ALS diagnostic test and ready for out-license.
• Initiate further studies in animal models of ovarian cancer with AMF-1c-120 antibody.
• Initiate proof of concept studies in animal models of cancer with anti-Fas receptor antibodies
• Complete the validation of the EP-AD Alzheimer's disease diagnostic and, in collaboration with our pharma partner, participate in the evaluation of a novel therapeutic for the treatment of Alzheimer's disease.

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: [phone], Fax: [phone], [email protected]; Warren Whitehead, Chief Financial Officer, Amorfix Life Sciences Ltd., Tel: [phone], Fax: [phone], [email protected]