Amorfix announces fiscal 2015 first quarter results

TSX: AMF

TORONTO, Aug. 7, 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 months ended June 30, 2014.

"This has been a very busy and productive quarter for the Company as we continue to execute our business strategy to develop strategic alliances and partnerships and advance our internal product pipeline", said Dr. Robert Gundel, Amorfix President and Chief Executive Officer. "Last month at the International BIO Conference in San Diego we met with over 20 pharmaceutical companies to discuss research collaborations and strategic alliances around our ProMIS™ discovery technology. We have proven that our technology enables the generation of antibody therapeutics that selectively bind to tumor cells and not normal cells. Tumor selective binders are expected to have greater efficacy and less side effects compared to traditional antibody therapeutics. In addition, selective tumor binders can serve as a precise and efficient delivery system bringing tumor-killing toxins directly to the tumor, again, providing a means for more effective and safer cancer treatments. The latter represents a particular area of interest for Amorfix now as most big Pharmaceutical companies have developed exquisitely potent toxins to kill tumors and are looking for a way to specifically deliver these toxins to tumors.

We were recently granted a very broad patent covering antibody therapeutics binding to misfolded SOD1 for the treatment of ALS. This patent puts Amorfix in control of commercialization of any such antibody being developed for the treatment of ALS.

Finally, on the diagnostic front, we recently announced another scientific first as we now have the ability to separately measure levels of Abeta oligomers 40 and 42 in human cerebrospinal fluid (CSF). This greatly enhances the utility of our Alzheimer's disease diagnostic as a means of identifying early-stage Alzheimer's disease patients and as a useful biomarker tool for use in human clinical trials."

Recent Corporate Highlights

In April 2014, the Company completed a non-brokered private placement through the issuance of 3,320,333 common shares of Amorfix (Shares) and 3,320,333 Warrants for gross proceeds of $996,100. In conjunction with the offering, the Company paid $40,016 in finder fees and issued 133,385 finder warrants which have the same terms as the Warrants.

On July 16, 2014, the Company announced that it has been issued a broad patent covering antibodies that target misfolded SOD1 (mSOD1) for the treatment of ALS by the U.S. Patent and Trademark Office. This patent provides very broad patent protection for the Company's ALS therapeutic antibody product portfolio and puts Amorfix in a controlling position for commercialization of antibodies that target misfolded SOD1.

On July 17, 2014, the Company announced that its EP‑AD diagnostic assay for the early detection of Alzheimer's disease can now measure aggregated Aβ42 separately from aggregated Aβ40 in patient cerebrospinal fluid (CSF), greatly expanding the utility of the diagnostic assay. The ability to distinguish one form of the aggregated protein from another will help advance the scientific understanding of the role of aggregates in Alzheimer's disease progression and improve the targeting of new therapies to patients who are more likely to show therapeutic benefit.

Financial Results

The net loss for the three months ended June 30, 2014 was $918,002 compared to a loss of $602,533 for the three months ended June 30, 2013. The increased net loss in the current period results mainly from higher stock-based compensation expense, higher program expenditures on its cancer therapeutic program and higher professional fees.

For the three months ended June 30, 2014 revenue from services and sales was $35,850, as compared to $35,961 in the comparative period. Revenue earned from a research collaboration was $99,720 in the current period. There was no research revenue in the comparable period.

Research and development expenses for the three months ended June 30, 2014 were $538,272 compared to $445,295 in the comparable period. The increase in expenditures related mostly to higher expenditures on its cancer therapeutic program, and higher stock-based compensation.

General and administrative expenses for the three months ended June 30, 2014 were $515,300 compared to $193,199 in the comparable period. The increase in expenses for the three months ended June 30, 2014 resulted mainly from higher stock-based compensation expense related to the options granted in fiscal 2014 and higher professional fees incurred in the current period.

At June 30, 2014, the Company had working capital of $337,178. 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 Fiscal 2015 research priorities, 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]