Amorfix Life Sciences, a company focused on misfolded protein diseases, today reported its second quarter operating results and provided an update on the Company's diagnostic and therapeutic programs.
"We have six products/services under development and it is gratifying to see the EP-vCJD product nearing the final 10,000-sample assessment by the UK government and the strong interest by numerous pharmaceutical companies in our service to measure Alzheimer's-related amyloid formation in animals," said George Adams, President & Chief Executive Officer of Amorfix. "Our other four projects, Alzheimer's and ALS therapeutics, ProMIS(TM) prediction of novel targets in disease and the development of a screening test for liver cancer are all advancing on schedule. We have the financial resources to bring these projects through their next milestones."
Development and Corporate Highlights vCJD ---- - In October 2009, the Company announced the detection of prions in blood from primates that were orally-infected with BSE and developed a primate version of variant Creutzfeldt-Jakob Disease (vCJD) over a 6-8 year period. These results are promising although only a small number of blood samples could be obtained due to the limited number of these very rare primate samples. Biochemical detection of vCJD endogenous prions in cynomolgus primates has never before been reported. Amorfix now expects to be given access to test human vCJD patient samples with its EP-vCJD(TM) assay. - In September 2009, Dr. George Adams presented Amorfix's EP-vCJD(TM) blood screening test at the Sixth World Federation of Haemophilia Global Forum on the Safety and Supply of Treatment Products for Bleeding Disorders in Montreal, Quebec. Early this year, the UK Health Protection Agency confirmed the first case of vCJD in one of the thousands of haemophiliac patients who received potentially contaminated plasma fractions. While the patient ultimately died of causes other than vCJD, this news has served to amplify the calls from haemophiliacs in the UK and around the world for their respective governments to protect the blood supply through routine testing of blood donations. - In September 2009, the European In Vitro Diagnostics (IVD) Technical Group adopted the proposed requirements for a CE mark for a vCJD test for blood donations. The next level of approval is the Medical Devices Experts Group which will meet in December 2009 to consider these draft common technical specifications and guidelines for the test. - In October 2009, the Company announced that it had tested 39,000 blood donations in France as part of a large-scale study being conducted to demonstrate the feasibility of routine testing of blood donations for vCJD. The Amorfix test has demonstrated a specificity of 99.95%, exceeding the 99.85% specificity required by the UK Blood Transfusion Service. ALS/Alzheimer's Disease (AD) ---------------------------- - The Company continued on schedule to study its antibodies and vaccines in preclinical animal models of AD with first results expected first quarter calendar 2010. - The Company continues to seek partners for its antibodies and vaccines to misfolded SOD1 in ALS having achieved all of its preclinical milestones for this indication by identifying and developing monoclonal antibodies to its Disease Specific Epitopes(TM) on misfolded SOD1 and by demonstrating increased survival in ALS mouse studies. - In October 2009, the Company promoted its A4 assay service at the Society for Neuroscience meeting in Chicago, Illinois. The Company is seeking collaborations and offering the A4 test as a service to drug discovery companies and academic researchers working to discover new treatments for AD. Since the A4 test is able to detect amyloid build up in animals much earlier than conventional methods, the company believes the test will accelerate the development and evaluation of new treatments for AD. - In October 2009, the Company announced an agreement with Cedarlane Laboratories for the sale and distribution of its proprietary antibodies and reagents.
For the three months ended September 30, 2009 the Company reported a net loss of $1,286,905 ($0.03 per share) compared to a net loss of $1,147,947 ($0.03 per share) for the comparable period last year. For the six months ended September 30, 2009 the Company reported a net loss of $2,457,646 ($0.05 per share) compared to a net loss of $2,754,131 ($0.07 per share) for the six months ended September 30, 2008.
Research and development expenditures for the three months ended September 30, 2009 were $979,045 compared to $890,514 for the three months ended September 30, 2008, and for the six months ended September 30, 2009 were $1,859,233 compared to $2,257,681 for the comparable period last year. Research and development expenses increased in the three months ended September 30, 2009 due mainly to expenditures related to its ProMIS(TM) and AD therapeutic programs partially offset by lower vCJD and ALS therapeutic program expenses. Research and development expenses decreased for the six months ended September 30, 2009 due to lower staffing costs, and lower ALS and vCJD program expenses partially offset by increased expenditures related to its AD therapeutic and ProMIS(TM) programs.
General and administration costs for the three months ended September 30, 2009 were $306,759 compared to $253,814 for the three months ended September 30, 2008, and for the six months ended September 30, 2009 were $597,567 compared to $517,438 for the comparable period last year. Higher expenses for the three and six months ended September 30, 2009 resulted mainly from higher stock-based compensation and investor relations expenses.
Cash burn (cash used in operating activities) of $1,065,586 for the three months ended September 30, 2009 was comparable to $1,036,042 for the three months ended September 30, 2008. For the six months ended September 30, 2009, the company's cash burn was $1,926,850 compared to $2,718,488 in the comparable period last year. The decreased cash burn for the six months ended September 30, 2009 was due primarily to lower research and development costs and a lower amount of accounts payable actually paid out in the period.
As at September 30, 2009 Amorfix had working capital of $5,925,271 compared to $4,458,065 as at March 31, 2009.
As at September 30, 2009 the Company had 48,131,163 common shares outstanding.
Outlook The Company's fiscal 2010 diagnostic priorities are to: - complete the National Institute for Biological Standards and Control process to validate the performance of the EP-vCJD(TM) Blood Screening Assay using human vCJD patient samples and to manufacture and supply diagnostic kits for assessment and prevalence studies; - generate assay performance data for the vCJD assay in collaboration with blood transfusion services in Europe and elsewhere; - form collaborations to further validate the benefits of the A4 amyloid assay and to pursue a service business providing this assay for testing preclinical samples; and - complete development of the screening test for liver cancer in collaboration with BioMosaics and Sunnybrook Research Institute. The company's 2010 therapeutic priorities are to: - engage new partners for the ALS vaccine and antibody DSE programs; - complete proof-of-concept preclinical studies for Alzheimer's Disease targeting misfolded SOD1; - leverage the company's core capability of identifying misfolded protein targets using our ProMIS(TM) technology and seek development partnerships for the new therapeutic targets.