TORONTO, June 22, 2012 /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, 2012, as well as financial results for the fourth quarter.
"Our focus in fiscal 2012 was to advance our cancer therapeutic programs, complete the development of our human CSF test for Alzheimers disease and establish a strategic partnership for sales and marketing of the A4 Preclinical Assay Service" said Dr. Robert Gundel, Chief Executive Officer of Amorfix. "We have established proof of concept of our anti-PrP antibody with studies that demonstrate specific, dose-related killing of ovarian tumor cells. In addition, we have recently completed studies that demonstrate that our anti-Fas antibodies selectively target and bind to misfolded Fas receptor protein expressed on the cell surface of cancer cells. The use of our ProMIS™ technology for the development of safe and effective cancer therapeutics represents a ground-breaking, novel approach and, therefore, these two important milestones help validate the technology and establish a level of credibility for Amorfix as a product development company. In addition, these studies are important for future collaborations and to establish strategic alliances with other pharma companies to bring these novel therapeutics to the market. Finally, we have licensed our preclinical assay for Alzheimer's disease to JSW Life Sciences, a leading CRO. We will be working closely with JSW to grow the A4 market and generate revenue for our Company".
2012 Development and Corporate Highlights
Cancer Therapeutic Program
On August 11, 2011, the Company announced that it had completed the initial characterization of its anti-PrP antibodies in cellular assay systems, which shows selective binding to certain tumour cells, but not to normal cells.
On November 11, 2011, the Company announced a collaboration with Helix BioPharma to produce antibody-urease conjugates which are toxic to cells. The Company has manufactured the PrP lead antibody to be used in these studies. Helix BioPharma has attached the urease to the lead antibody.
On April 4, 2012, the Company announced that it had completed a series of studies with its lead anti-PrP antibody that demonstrate specific, dose-related killing of ovarian tumor cells. The Company's tumor-specific anti-PrP antibody coupled to a toxic payload (urease) retained its specific binding to tumor cells without binding to normal ovarian cells.
On May 16, 2012 the Company announced that it had developed antibodies that selectively target and bind to misfolded Fas receptor protein expressed on the cell surface of cancer cells.
Alzheimer's disease Diagnostic Program
On September 30, 2011, the Company announced it had achieved 85 percent specificity and sensitivity with its clinical CSF diagnostic assay, the EP-AD Diagnostic Test. When the scores from the Amorfix test were correlated with scores from the MMSE (Mini-Mental State Examination, a clinical test used to measure disease severity), the results demonstrated that aggregates were not only found in cerebrospinal fluid (CSF) from late-stage AD, but also in patients with early stage AD or mild cognitive impairment (MCI). In addition, the data suggest that the Amorfix test is superior for identification of patients with MCI when compared to the measurements of monomeric Abeta 1-42 alone. These results support the Company's belief that its technology has the potential to identify patients with mild cognitive impairment (MCI) who may progress into Alzheimer's disease.
On January 9, 2012, the Company announced that it had signed a letter of intent with JSW-Lifesciences GmbH (JSW), a contract research organization specializing in Alzheimer's and other CNS diseases, to license its pre-clinical Alzheimer's disease diagnostic test, the Amorfix Aggregated Abeta Assay (the A4). JSW plans to add the A4 to its suite of preclinical research services provided to pharmaceutical companies and academic research institutions involved in Alzheimer's disease research and development.
On June 7, 2012 the Company announced that the licensing of the A4 technology to JSW was completed. The agreement includes a commitment to minimum annual sales and Amorfix will receive a percentage of net sales. The Agreement was signed after the completion of due diligence on the technology by JSW.
On January 17, 2012 and March 9, 2012, the Company completed a non-brokered private placement through the issuance of 3,364,887 units (Units) at a price of $0.225 per unit for gross proceeds of $757,100. Each Unit consists of one common share of Amorfix (a Share) and one common share purchase warrant of Amorfix (a Warrant). In connection with the Offering, Amorfix paid $19,466 in finder fees and issued 86,516 finder warrants.
Subsequent to year end, on May 14, 2012, the Company completed a non-brokered private placement through the issuance of 2,585,000 units (Units) at a price of $0.40 per unit for gross proceeds of $1,034,000. Each Unit consists of one common share of Amorfix (a Share) and one-half common share purchase warrant of Amorfix (a Warrant). In connection with the private placement, the Company paid $56,320 in finder fees and issued 140,800 finder warrants.
For the three months ended March 31, 2012 the Company reported a net loss from operations of $702,317 ($0.01 per share) compared to net loss of $799,778 ($0.02 per share) for the three months ended March 31, 2011.
For the year ended March 31, 2012 the Company reported a net loss from operations of $2,543,813 ($0.05 per share) compared to a net loss of $3,200,287 ($0.07 per share) for the year ended March 31, 2011.
For the three months ended March 31, 2012 revenue for services and sales was $nil, as compared to $24,953 in the comparative period.
For the year ended March 31, 2012 revenue for services and sales was $90,882 as compared to $119,900 in the comparative period. Substantially all of this revenue was for the Company's A4 test which the Company began marketing in the third quarter of fiscal 2010. For the year ended March 31, 2012, revenue from license fees was $nil compared to $1,030,600 for the comparable period. The Company entered into a license agreement with Biogen Idec MA (Biogen) in July 2010 and received a US$1,000,000 non-refundable fee.
Research and development (R&D) expenses for the three months ended March 31, 2012 were $526,049 compared with $609,094 for the three months ended March 31, 2011. The decrease was due mainly to lower program expenditures on its AD diagnostic and ProMIS programs.
R&D expenses for the year ended March 31, 2012 were $2,037,424 compared with $3,312,547 for the corresponding period in 2011. The decrease was due mainly to the Company having fewer employees than in the comparable period and to the severance costs incurred in June 2010 associated with the decision to suspend commercialization of the Company's vCJD program and also due to lower program expenditures on the ProMIS and ALS therapeutic programs and offset by an increase in expenses on the AD diagnostic program.
General and administrative costs for the three months ended March 31, 2012 were $181,045 compared to $219,499 in the comparable prior year period. The decrease for the three months ended March 31, 2012 resulted mainly from lower stock-based compensation expense.
General and administrative costs for the year ended March 31, 2012 were $610,771 compared to $1,083,906 in the comparable period. The decrease for the year ended March 31, 2012 resulted mainly from severance costs recorded in the comparable period and lower share based payment expense in the current period.
At March 31, 2012, the Company had working capital of $648,266 and 54,419,290 common shares outstanding. Management projects that its current working capital together with the net proceeds of the private placement completed in May 2012 will fund the Company's operations into the fourth calendar quarter of 2012. The Company is actively pursuing financing alternatives, but there is no assurance that these initiatives will be successful, timely or sufficient.
The Company's Fiscal 2013 research priorities, subject to the Company raising additional funds, are to:
- Complete proof of concept studies in animal models of ovarian cancer with anti PrP antibodies
- Complete the initial characterization of anti Fas antibodies in cellular assays followed by proof of concept studies in animal models of cancer once a lead candidate has been selected
- Continue, with a partner, validation of a human Alzheimer's disease test to detect aggregated Abeta, a hallmark of the disease, in human plasma and cerebrospinal fluid;
- Complete the research and development of an ALS diagnostic test.
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 a product development company developing therapeutic products and diagnostic devices targeting misfolded protein diseases including Alzheimer's Disease (AD), cancers, and ALS. Amorfix utilizes its computational discovery platform, ProMIS™, to predict novel Disease Specific Epitopes ("DSEs") on the molecular surface of misfolded proteins. Amorfix's lead programs include therapeutics and companion diagnostics for cancers, antibodies and vaccines to DSEs in ALS and AD diagnostic tests. In addition, Amorfix's proprietary Epitope Protection™ technology enables it to specifically identify very low levels of misfolded proteins in a biological sample. The Company's diagnostic programs include an ultrasensitive method for the detection of aggregated beta-Amyloid in brain tissue, CSF and blood from animal models of AD, months prior to observable amyloid formation, and development of a human screening test for 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.
For further information:
Dr. Robert Gundel
President and Chief Executive Officer
Amorfix Life Sciences Ltd.
Tel: (416) 847-6957
Fax: (416) 847-6899
Acting Chief Financial Officer
Amorfix Life Sciences Ltd.
Tel: (416) 847-6926
Fax: (416) 847-6899