Amorfix Life Sciences, a product development company focused on the development of diagnostics and therapeutics for misfolded protein diseases, today announced its operational and financial results for the three and six months ended September 30, 2010.
"We are very pleased with the steady progress we have made this quarter on all of our diagnostic and therapeutic programs, said Dr. Robert Gundel, Chief Executive Officer of Amorfix. "We have achieved significant milestones for our A4 assay and will continue to work diligently to grow the A4 preclinical service revenue while, in parallel, advancing the development of our human diagnostic test for Alzheimer's disease. Our cancer antibody programs are moving forward as planned. We have initiated testing of candidate antibodies in a variety of cellular systems and, as part of our overall strategy to focus only on the most promising programs, we will drive these programs to go/no go decision points as quickly as possible. "
Recent Corporate Highlights
On September 16, 2010, the Company announced that its A4 test has been validated by the publication of a research study, conducted by scientists at ReMynd and Amorfix, in a peer-reviewed scientific publication.
On October 7, 2010 the Company accepted an invitation to become a member of the Alzheimer's Disease Neuroimaging Initiative (ADNI). Membership in ADNI will provide Amorfix access to leading research in the Alzheimer's field and access to human clinical samples necessary to validate its A4 assay as a potential human diagnostic test.
On October 21, 2010, the Company and Biotrofix, Inc., a contract research organization specializing in pharmacology testing in small animal models of CNS and vascular diseases, announced that they have successfully detected the presence of aggregated Abeta in the cerebral spinal fluid (CSF) from transgenic mice using the Amorfix A4 test.
The Company's ProMIS™ program, to develop antibodies for cancers associated with misfolding proteins, is continuing with its three partners. High affinity antibodies to some of its target proteins have been produced which the Company is currently testing in a variety of cellular assay systems to characterize their biological activity. The Company expects to have the results of its animal model proof of concept studies at the end of the second quarter of calendar 2011.
In the quarter ended September 30, 2010 the Company completed the testing of the prototype blood-based assay for the early detection of primary liver cancer it developed as part of a collaboration with BioMosaics. The results of the testing met the specificity and sensitivity criteria set forth in the research agreement. The Company has completed the technology transfer of the prototype assay to BioMosaics who will continue the development and subsequent commercialization. Amorfix maintains the rights to royalties on commercial product sales.
The company is also announcing that the animal model studies for the research project to develop both antibodies and vaccines against misfolded SOD1 for the treatment of Alzheimer's disease have been completed and the results do not support continuing development. Accordingly, the Company has stopped research on this program.
Financial Results
The net loss for the three months ended September 30, 2010 was $25,728 compared to $1,286,905 for the three months ended September 30, 2009. For the six months ended September 30, 2010, the net loss was $1,750,473 compared to $2,457,646 for the six months ended September 30, 2009.
For the three and six months ended September 30, 2010, revenue from license fees was $1,030,600 compared to $nil for the comparable periods. The Company entered into a license agreement with Biogen Idec in July 2010 and received a US$1,000,000 non-refundable fee. For the three and six months ended September 30, 2010 revenue for services and sales was $61,126 and $84,899, respectively as compared to $nil in both comparative periods. Substantially all of this revenue was for its A4 test which the Company began marketing in the third quarter of fiscal 2010.
Research and development expenditures for the three months ended September 30, 2010 were $650,084 compared to $979,045 for the three months ended September 30, 2009. Research and development expenditures decreased for the three months ended September 30, 2010 due mainly to reduced staffing levels and program expenses associated with the decision to suspend commercialization of the Company's vCJD program in June 2010. Research and development expenditures for the six months ended September 30, 2010 were $1,996,488 compared to $1,859,233 for the six months ended September 30, 2009. Research and development expenses increased for the six months ended September 30, 2010 due to severance costs, recorded in the three months ended June 30, 2010, associated with the suspension of the vCJD program and higher expenditures related to its ProMIS™ cancer antibody development program. This increase was partially offset by lower staffing levels in the three months ended September 30, 2010, lower stock-based compensation, and lower expenses on its AD Therapeutic program.
General and administrative costs for the three months ended September 30, 2010 were $447,577 compared to $306,759 in the comparable prior year period and for the six months ended September 30, 2010 were $740,701 compared to $597,567 for the six months ended September 30, 2009. The increase for the three and six months ended September 30, 2010 resulted mainly from severance costs and higher consulting fees, partially offset by lower stock-based compensation.
At September 30, 2010, the Company had working capital of $3,189,897 and 48,514,418 common shares outstanding.
Outlook
The Company's Fiscal 2011 research priorities continue to be:
- Advance our ProMIS™ 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 through our partnerships with Biogen Idec and PREVENT;
- Grow the revenue from our A4 amyloid testing service for cell culture, tissue, CSF and blood in animal models of Alzheimer's disease; and
- Complete development of a human Alzheimer's test adapting the A4 test protocol to detect aggregated Abeta, the hallmark of the disease, in human CSF and plasma.
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