Amorfix announces fiscal 2014 year end results

TSX: AMF

TORONTO, June 13, 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 year ended March 31, 2014. 

"We continue to execute our strategy of creating strategic alliances and partnerships to advance our product pipeline of novel diagnostics and antibody therapeutics", said Dr. Robert Gundel, Amorfix President and Chief Executive Officer.  "Earlier this quarter we announced our agreement to partner with a major global pharmaceutical company to complete the optimization and validation of our Alzheimer's disease diagnostic. The EP-AD diagnostic assay measures aggregated Abeta oligomers, a hallmark of Alzheimer's disease, in patient cerebral spinal fluid and can accurately identify individuals (95% specificity) with mild cognitive impairment who are likely to develop Alzheimer's disease.  In addition, this quarter we entered into a research collaboration agreement with Trellis Biosciences, an innovative antibody development company with proprietary technology that can accurately identify and detect high quality human antibodies.  This collaboration is focused on developing therapeutic antibodies against misfolded CD38, a cell surface protein thought to have a significant role in leukemia and lymphoma.  We are in discussions with numerous pharmaceutical companies for platform technology deals for use of our ProMIS™ discovery and Epitope Protection™ technologies for additional partnerships and strategic alliances.  Finally, we continue to advance our ovarian cancer and melanoma programs through preclinical development and expect to complete the proof of concept in animal models and select a lead candidate for the melanoma program by year end."

Recent Corporate Highlights

On January 22, 2014, the Company announced it has entered into an agreement with a major global pharmaceutical company to optimize and validate the EP-AD Alzheimer's disease diagnostic prior to using the assay as part of a clinical trial to investigate the effects of a novel therapeutic for the treatment of Alzheimer's disease. 

In January and Feb 2014, the Company completed a non-brokered private placement through the issuance of 3,600,000 common shares of Amorfix (Shares) and 3,600,000 Warrants for gross proceeds of $1,008,000. Each full Warrant entitles the holder to purchase one Share at a price of $0.45 for a period of 24 months following the closing date of the Offering, subject to an earlier expiry provision. 

On March 17, 2014, the Company announced it has entered into a collaboration with Trellis Bioscience to develop antibodies against misfolded CD38 protein as a treatment for haematological malignancies including leukemia and lymphoma.  The company's discovery platform, called CellSpot™, enables discovery of very rare high quality human antibodies usually not detectable with standard techniques.  Together with Amorfix's ProMIS™ technology, the companies will isolate and develop fully human therapeutic antibodies that will target only cancer cells and not healthy ones. Under the terms of the collaboration, Amorfix will have an exclusive option to develop any resulting antibodies.

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. Each full Warrant entitles the holder to purchase one Share at a price of $0.50 for a period of 24 months following the closing date of the Offering, subject to an earlier expiry provision. 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 June 2 2014 the Company received a Notice of Allowance from the United States Patent and Trademark Office for a broad-based patent covering the use of antibody therapeutics for the treatment of ALS. The patent also includes coverage for several disease specific epitopes used to generate misfolded SOD1 specific antibodies to treat ALS. 

Earlier this week the Company announced that Mr. William Wyman has been appointed Chairman of the Board of Directors.  Mr. Wyman began his career at the management consulting firm Booz Allen and Hamilton and eventually became President of the Management Consulting Group, a member of the executive committee, and a member of the Board of Directors.  Mr. Wyman co-founded the management consulting firm, Oliver Wyman & Co. which eventually merged with the consulting group at Marsh & McLennan under the Oliver Wyman name.  Mr. Wyman was a board member at Donaldson, Lufkin and Jenrette and has served as a director/advisor to more than a dozen public and private companies.  He also has served as an advisor to several private equity partnerships.

Financial Results

The net loss for the year ended March 31, 2014 was $2,253,341 as compared to the net loss of $2,230,902 for the year ended March 31, 2013.   The Company measures cash burn as the net cash used in operations, which was $1,798,737 for the year ended March 31, 2014 as compared to net cash used in operations of $2,005,242 for the year ended March 31, 2013.    The decrease in the cash burn rate is mostly the result of lower cash-based expenses due to cost containment decisions.   

For the year ended March 31, 2014 revenue from services and sales was $139,968 as compared to $49,516 in the comparative period.  Revenue for the current year related mostly to the Company's EP-AD diagnostic test.  In addition, through research collaboration, the Company recognized $8,354 in research revenue for the year ended March 31, 2014.  There was no research revenue in the prior year.

Research and development expenses for the year ended March 31, 2014 were $1,408,961 compared to $1,798,302 in the year ended March 31, 2013.  The decrease in expenditures related mostly to lower expenses on its cancer therapeutics and ALS diagnostic research programs, lower facility costs, lower salaries and travel, partially offset by higher stock-based compensation expense. 

General and administrative expenses for the year ended March 31, 2014 were $992,702 compared to $484,442 in the year ended March 31, 2013.  The increase in expenditures resulted mostly from higher stock-based compensation and higher salaries.

The net loss for the three months ended March 31, 2014 was $750,837 compared to a loss of $556,751 for the three months ended March 31, 2013.  The increased net loss in the current period results mainly from higher stock-based compensation expense, lower program expenditures and higher travel costs.

For the three months ended March 31, 2014 revenue from services and sales was $43,512, as compared to $31,634 in the comparative period.    Research revenue was $8,354 in the current period.  There was no research revenue in the comparable period.

Research and development expenses for the three months ended March 31, 2014 were $343,143 compared to $469,841 in the comparable period. The decrease in expenditures related mostly to lower wages, lower expenditures on its ALS and cancer programs and offset by higher stock-based compensation expense.

General and administrative expenses for the three months ended March 31, 2014 were $459,560 compared to $118,544 in the comparable period. The increase for the three months ended March 31, 2014 resulted mainly from higher stock-based compensation expense and higher travel costs.

As at March 31, 2014, the Company had a cash balance of $136,826 and a working capital deficit of $90,371. In April 2014, the Company completed, in three tranches, a private placement offering for combined gross proceeds of $996,100.  The Company is actively pursuing a number of financing options and initiatives at this time and is optimistic of a successful interim solution

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 and Epitope Protection™ technologies to continue to build a compelling pipeline of diagnostics and antibody therapeutics for the treatment of misfolded protein diseases.
• 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.
• Evaluate lung cancer as a potential clinical indications for AMF-1c-120 development.
• Initiate proof of concept studies in animal models of melanoma with anti-Fas receptor antibodies and select a lead candidate for development.
• Identify and complete the initial evaluation of anti-CD38 antibodies as therapeutics for the treatment of leukemia and lymphoma.
• Complete the validation of the EP-AD Alzheimer's disease diagnostic and, in collaboration with our pharmaceutical 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]