TORONTO, June 11 /CNW/ - Amorfix Life Sciences, a company focused on the development of therapeutic monoclonal antibodies and diagnostics for the treatment of fatal neurodegenerative diseases and cancer, today announced its operational and financial results for the year ended March 31, 2010, as well as financial results for the fourth quarter.
"This is an exciting time for Amorfix as we begin fiscal 2011 with a broad pipeline of therapeutic and diagnostic programs with significant milestones planned for all programs this year," said Dr. Robert Gundel, Chief Executive Officer of Amorfix. "We have established excellent partnerships to develop novel antibody therapeutics against unique cancer targets for our ProMIS(TM) program which represents a significant opportunity to quickly create value for our company as safer and more effective cancer drugs are desperately needed. Our A(4) assay service revenue is growing and the experience gained from this development program has provided us with an opportunity to develop a very sensitive Alzheimer's diagnostic for human biofluid screening that may revolutionize the way this disease is diagnosed and treated. Our partnership with PREVENT to advance our ALS vaccine program into the clinic and our ALS and Alzheimer's disease (AD) therapeutic antibody programs represent other significant opportunities for the continued strengthening of our product pipeline of novel therapeutics for the treatment of human disease."
Recent Corporate Highlights
In May 2010, the Company announced the A4 assay could detect AD-associated aggregated Beta-amyloid in the blood from a mouse model of AD. This achievement represents the first time that aggregated ABeta has been measured in blood plasma from any animal model.
In May 2010, the company announced that it had entered into agreements with Epitomics, Inc. and Aragen Biosciences, Inc. to develop high-affinity monoclonal antibodies against a number of Disease Specific Epitope (DSE) targets for cancer predicted by Amorfix's proprietary ProMIS(TM) computational platform discovery technology.
In May 2010, the Company announced that although it has been successful in developing a significantly more sensitive test for the detection of vCJD in blood samples, the improvements to the test did not yield positive results, and the Company has reached an impasse until scientific understanding improves or more vCJD patient blood is available and accordingly the Company suspended the commercialization of the vCJD program allowing a more focussed effort on its other research programs.
In June 2010, the Company and Pan-Provincial Vaccine Enterprise Inc. (PREVENT) of Saskatoon, Saskatchewan, announced that the two groups have entered into a licensing agreement granting PREVENT exclusive worldwide rights to Amorfix's lead amyotrophic lateral sclerosis (ALS) vaccines. Under the license terms, PREVENT will develop vaccine formulations, finish preclinical studies for regulatory approvals and conduct clinical testing of the vaccines at their cost. Upon successful completion of Phase I clinical trials both parties have an option to lead the commercialization process under a cost-sharing and revenue-sharing arrangement which includes royalty payments.
For the three months ended March 31, 2010 the Company reported a net loss from operations of $1,249,460 ($0.03 per share) compared to net loss of $1,376,339 ($0.03 per share) for the three months ended March 31, 2009.
For the year ended March 31, 2010 the Company reported a net loss from operations of $4,857,038 ($0.10 per share) compared to a net loss of $5,148,133 ($0.12 per share) for the year ended March 31, 2009.
The Company recorded service revenue from the A(4) test and also recorded revenue related to a third party research agreement totalling $45,516.
Research and development (R&D) expenses for the three months ended March 31, 2010 were $891,991 compared with $1,064,393 for the three months ended March 31, 2009. The decrease was due mainly to lower external costs on its ProMIS(TM) program and lower stock-based compensation expenses.
R&D expenses for the year ended March 31, 2010 were $3,686,663 compared with $4,126,945 for the corresponding period in 2009. The decrease was due mainly to lower expenditures on the Company's vCJD, AD diagnostic and ALS therapeutic programs and lower stock-based compensation partially offset by increased expenditures related to its ProMIS(TM) program.
General and administrative expenses for the three months ended March 31, 2010 were $347,867 which is comparable to the costs of $323,108 that were incurred in the corresponding period in 2009.
General and administrative expenses for the year ended March 31, 2010 were $1,192,527 compared with $1,040,468 for the corresponding period in 2009. The increase for the year ended March 31, 2010 resulted mainly from higher stock-based compensation and shareholder communication expenses.
At March 31, 2010, the Company had working capital of $4,444,749 and 48,514,418 common shares outstanding.
The Company's Fiscal 2011 research priorities are to:
- Advance our ProMIS(TM) antibody program targeting disease specific
epitopes for both therapeutics and companion diagnostics for
cancer and other misfolded protein diseases to a lead compound for
late-stage preclinical development;
- Advance our novel antibodies and vaccines for the treatment of ALS
- Grow the revenue from our A(4) amyloid testing service for cell
culture, tissue and blood in animal models of Alzheimer's disease
- Complete development of a human Alzheimer's test adapting the A(4)
test protocol to detect aggregated Abeta, the hallmark of the
disease, in human plasma and cerebro-spinal fluid; and
The Company also announced that Dr. Neil Cashman, Chief Scientific Officer and founder, and Dr. Robert Gundel, Chief Executive Officer of the company have been appointed to the Board of Directors.
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 theranostics company developing therapeutic products and diagnostic devices targeting misfolded protein diseases including ALS, cancer, and Alzheimer's disease. Amorfix utilizes its computational discovery platform, ProMIS(TM), to predict novel Disease Specific Epitopes ("DSE") on the molecular surface of misfolded proteins. Amorfix's lead therapeutic programs include antibodies and vaccines to DSEs in ALS, Alzheimer's disease and cancer. Amorfix's proprietary Epitope Protection(TM) (EP) technology enables it to specifically identify very low levels of aggregated misfolded proteins (AMP) in a normal sample. The Company's diagnostic programs include an ultrasensitive method for the detection of aggregated Beta-Amyloid in brain tissue and blood of animal models of Alzheimer's disease, months prior to observable amyloid formation, and human blood screening tests for Alzheimer's and early liver cancer detection. 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: For further information: Dr. Robert Gundel, President and Chief Executive Officer, Amorfix Life Sciences Ltd., Tel: (416) 847-6957, Fax: (416) 847-6899, firstname.lastname@example.org; James Parsons, Chief Financial Officer, Amorfix Life Sciences Ltd., Tel: (416) 847-6929, Fax: (416) 847-6899, email@example.com