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, 2011, as well as financial results for the fourth quarter.
"Our focus in fiscal 2011 has remained on building our product pipeline of novel diagnostics and therapeutic antibodies" said Dr. Robert Gundel, Chief Executive Officer of Amorfix. "We have made tremendous progress in the development of therapeutic antibodies for the treatment of cancer which demonstrates the value of our proprietary discovery technology, ProMIS. We have developed antibodies that have the desired property of only binding to tumour cells and not to normal cells and, thus, have the potential to be much more effective and safer treatments. We will further validate this technology in the upcoming fiscal year when we conduct proof of concept animal studies for one of our targets. We are committed to position our ProMIS discovery technology as a novel way of developing targeted therapeutics. The medical community, patients and our industry are in need of a new approach that identifies ways of developing therapeutics that can overcome the issues associated with more traditional approaches.
In addition, our Alzheimer's diagnostic program is moving forward and we are optimizing the assay for use as a new tool to accurately diagnose this devastating disease. A major stumbling block to treatment of Alzheimer's disease is the absence of robust biomarkers for early detection and monitoring during clinical trials. There is a need for more sensitive and reliable diagnostics to assess the levels of biomarkers in order for current therapeutics to be effective, and for enrolment into clinical trials. The Company has developed the EP-AD Diagnostic CSF Test as a quantitative and ultra-sensitive biomarker assay for detection of oligomeric Aβ in human CSF and have recently announced (January 2011) that AB amyloid had been detected by the assay in patients diagnosed with Alzheimer's disease. We believe our assay technology also has the potential to identify patients with mild cognitive impairment (MCI) who may progress into Alzheimer's disease and we will be evaluating this potential once we have fully optimized this innovative diagnostic tool.
The Company's Alzheimer's diagnostic's program was recently featured on the television program Today in America with Terry Bradshaw. The program highlighted the need for an accurate means of diagnosing Alzheimer's disease and the pioneering work being conducted at Amorfix to develop a new diagnostic. The program segment is posted on the Amorfix website for viewing. In addition, we will be presenting preliminary data of our EP-AD Diagnostic Test at the upcoming ICAD meeting in Paris this July. We expect this to be a very well attended session with great interest from industry and academic groups from around the world.
Our A4 preclinical assay provides AD researchers with a tool that can detect and quantify aggregated Abeta in a variety of different animal models. We will continue to seek new partners in the upcoming fiscal year to help promote this test to pharmaceutical companies and contract research organizations."
Recent Corporate Highlights
In March 2011, the Company presented a paper at the 10th International Conference on Alzheimer's and Parkinson's Diseases (ADPD 2011) that took place in Barcelona. The ADPD conference is held every two years to bring together leading researchers and clinicians studying Alzheimer's and Parkinson's diseases. The paper, entitled "Detection of β-Amyloid Aggregates in CSF From Transgenic Animal Models of Alzheimer's Disease Using the Amorfix Aggregated Abeta Assay (A4)", is the result of collaborations with reMYND NV, the Karolinska Institute, and the University of Southern Denmark. The results of this study confirm the results of previous work performed in collaboration with Biotrofix, Inc.
In May 2011, the Company announced that three patents to key targets for misfolded SOD1 have now been approved by the United States Patent and Trademark Office. Amorfix's successful patenting of the SOD1 targets have particular importance for treatment of amyotrophic lateral sclerosis (ALS) or Lou Gehrig's disease, a key Amorfix program. Dr. Neil Cashman, the Chief Scientific Officer of Amorfix, has identified and validated misfolding-exposed regions of SOD1 as novel targets for ALS immunotherapy. In 2010 these targets were sublicensed to Biogen-Idec Corporation for the development of ALS antibody therapeutics and to the Pan provincial Vaccine Enterprise (PREVENT) for the development of vaccine applications.
The Company is announcing that it will be presenting a poster on Sunday July 17th, 2011 at the Alzheimer's Association International Conference on Alzheimer's disease to be held from July 16-21 in Paris, France. The poster presentation entitled "Development of An Ultra Sensitive Assay for Detection of Aggregated Beta Amyloid in Human CSF", will present preliminary data generated using the Company's EP-AD Diagnostic CSF Test. Proof-of-concept validation suggests that this assay shows promise as a potential diagnostic biomarker assay for Alzheimer's disease.
The Company is also announcing that it has terminated its previously announced $2.5M private placement offering and is now actively pursuing other financing alternatives.
Financial Results
For the three months ended March 31, 2011 the Company reported a net loss from operations of $784,549 ($0.02 per share) compared to net loss of $1,249,460 ($0.03 per share) for the three months ended March 31, 2010.
For the year ended March 31, 2011 the Company reported a net loss from operations of $3,330,437 ($0.07 per share) compared to a net loss of $4,857,038 ($0.10 per share) for the year ended March 31, 2010.
For the three months ended March 31, 2011 revenue for services and sales was $24,953 as compared to $605 for the three months ended March 31, 2010. For the year ended March 31, 2011 revenue for services and sales was $119,900 as compared to $45,516 for the year ended March 31, 2010. Substantially all of this revenue was for its A4 test which the Company began marketing in the third quarter of fiscal 2010.
For the year ended March 31, 2011 revenue from license fees was $1,030,600 compared to $nil for the year ended March 31, 2010. The Company entered into a license agreement with Biogen Idec in July 2010 and received a US$1,000,000 non-refundable fee. All of the revenue related to this license agreement was recognized in the quarter ended September 30, 2010.
Research and development (R&D) expenses for the three months ended March 31, 2011 were $575,474 compared with $891,991 for the three months ended March 31, 2010. The decrease was due mainly to lower stock-based compensation, lower salaries and program expenditures related to the suspension of the vCJD and AD therapeutic programs offset by higher program expenditures for both the AD diagnostic and ProMIS programs.
R&D expenses for the year ended March 31, 2011 were $3,156,835 compared with $3,686,663 for the corresponding period in 2010. The decrease was due mainly to lower stock-based compensation, lower employee related and program expenditures related to the suspension of the vCJD and AD therapeutic programs offset by higher program expenditures for both the AD diagnostic and ProMIS programs.
General and administrative expenses for the three months ended March 31, 2011 were $216,506 compared with $347,867 for the three months ended March 31, 2010. The decrease for the three months ended March 31, 2011 resulted mainly from lower stock-based compensation.
General and administrative expenses for the year ended March 31, 2011 were $1,163,329 compared with $1,192,527 for the corresponding period in 2010. The decrease for the year ended March 31, 2011 resulted mainly from lower stock-based compensation partially offset by severance costs and higher consulting fees.
At March 31, 2011, the Company had working capital of $2,270,470 and 50,609,959 common shares outstanding. Management projects that its current working capital will fund the Company's operations to December 2011. The Company is actively pursuing financing alternatives, but there is no assurance that these initiatives will be successful, timely or sufficient.
Outlook
The Company's Fiscal 2012 research priorities, subject to the Company raising additional funds, are to:
- Advance our ProMISTM 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;
- Grow the revenue from our A4 amyloid testing service for cell culture, tissue and blood in animal models of Alzheimer's disease (AD);
- Complete development of a human Alzheimer's test adapting the A4 test protocol to detect aggregated Abeta, the hallmark of the disease, in human plasma and cerebro-spinal fluid;
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