TORONTO, Nov. 13, 2013 /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 and six months ended September 30, 2013.
"We continue to advance our pipeline of novel diagnostics and therapeutics and have made several significant advances over the past few months", said Dr. Robert Gundel, Amorfix President and Chief Executive Officer. "We recently reported that we can detect misfolded SOD1 in ALS patients with sporadic disease. This finding has both scientific and therapeutic importance for the ALS community. From a scientific perspective, it is well established that misfolded SOD1 is present in familial ALS patients, our test results now confirm the presence of misfolded SOD1 in sporadic ALS patients who make up approximately 90% of the patient population. In addition, our results suggest that patients with both sporadic and familial disease could benefit from misfolded SOD1 targeted therapy. Finally, from a commercial perspective, these results greatly expand the potential market for both our ALS diagnostic and antibody therapeutic."
"On the cancer therapeutic front, studies in animal models of ovarian cancer have demonstrated that our lead ovarian cancer antibody, AMF-1c-120, is able to seek out and bind to tumors and cause a significant reduction in tumor growth. We are excited about our results and we are working to advance our program and evaluate the effectiveness of AMF-1c-120 in combination with standard chemotherapeutics."
"We are continuing our business discussions with a number of leading pharmaceutical companies for platform technology deals and partnerships as well as licensing deals for our Alzheimer's disease diagnostic test and our cancer therapeutic antibody projects", said Dr. Robert Gundel, Amorfix President and CEO.
Recent Corporate Highlights
On August 14, 2013, the Company announced the results of recent preclinical studies which demonstrate that the Company's proprietary anti-ovarian cancer antibody, AMF-1c-120, when administered to live animals, targets and binds to tumors in a very localized and concentrated manner. This is a significant finding because it shows that the antibody retains its tumor-specific binding in a living body (in vivo).
On October 24, 2013, the Company announced that it has confirmed the presence of misfolded superoxide dismutase 1 (SOD1) in sporadic ALS. In the study conducted at Amorfix, using the Company's proprietary antibodies that bind specifically to misfolded SOD1, the company detected misfolded SOD1 in spinal cord samples obtained from subjects with sporadic ALS. Previous studies have shown the presence of misfolded SOD1 in familial ALS, which represents about 10% of all diagnoses. This current finding suggests that ALS patients with either familial or sporadic disease can be potentially identified by detection of misfolded SOD1 and subsequently treated with therapies that target misfolded SOD1.
Subsequent to September 30, the Company completed two private placements. On October 4, 2013, the Company completed a non-brokered private placement through the issuance 240,000 Common Shares of Amorfix and 240,000 Warrants. On November 1, 2013, the Company completed a non-brokered private placement through the issuance of 400,000 common shares of Amorfix (Shares) and 400,000 Warrants for gross proceeds of $112,000. The terms of the Warrants were the same for both private placements. Each full Warrant entitles the holder to purchase one Share at a price of $0.55 for a period of 24 months following the closing date of the Offering, subject to earlier expiry in the event (a trigger event) that, following the expiry of the four month hold period, the volume-weighted average price of Amorfix's common shares on the Toronto Stock Exchange (TSX) over a period of twenty consecutive trading days exceeds $1.00. On the occurrence of a trigger event, Amorfix may give notice to holders to accelerate the expiry to a date which is not less than 30 calendar days after such notice is sent to the holders. In conjunction with the October 4th offering, the company paid $6,720 in finder fees and issued 19,200 finder warrants which have the same terms as the Warrants.
On October 9, 2013, the Company announced the retirement of Michael Sonnenreich from the board of directors.
The Company is also announcing that it has terminated the research agreement with QPS for the validation of the EP-AD assay. The company continues to provide its EP-AD assay to pharmaceutical companies for evaluation purposes and remains committed to commercializing this assay for the early diagnosis of Alzheimer's disease.
For the three and six months ended September 30, 2013 the Company reported a net loss from operations of $464,258 ($0.01 per share) and $1,066,791 ($0.02) respectively, compared with a net loss from operations for the three and six months ended September 30, 2012 of $572,911 and $1,172,872 respectively.
Research and development expenses for the three months ended September 30, 2013 were $324,691 compared to $452,693 in the comparable period. Research and development expenses for the six months ended September 30, 2013 were $769,986 compared to $914,533 in the comparable period. The lower expenses were related mostly to lower salaries expense, reduced travel, reduced facilities expense and offset by higher stock option compensation.
General and administrative expenses for the three months ended September 30, 2013 were $164,472 compared to $121,235 in the comparable period last year. General and administrative expenses for the six months ended September 30, 2013 were $357,671 compared to $261,702 in the comparable period last year. The higher expenses are related to higher salaries expense and higher stock option compensation.
As at September 30, 2013, the Company had a cash balance of $13,412 and a working capital deficit of $443,139. The Company is actively pursuing a number of financing options and initiatives at this time and anticipates a successful interim solution shortly
The Company's Fiscal 2014 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 anti-PrP antibodies
- 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
Additional information about the Company, including the MD&A and financial results may be found on SEDAR at www.sedar.com.
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.
For further information:
Dr. Robert Gundel
President and Chief Executive Officer
Amorfix Life Sciences Ltd.
Tel: (416) 847-6957
Fax: (416) 847-6899
Chief Financial Officer
Amorfix Life Sciences Ltd.
Tel: (416) 644-7358
Fax: (416) 847-6899