Amorfix Life Sciences, a product development company focused on misfolded protein diseases, today announced its operational and financial results for the three months ended June 30, 2010.
"We have had an excellent first quarter highlighted by significant product development deals such as the Biogen Idec and PREVENT licensing agreements that will advance our ALS antibodies and vaccine technologies," said Dr. Robert Gundel, Chief Executive Officer of Amorfix. "We will continue to pursue additional business deals and advance our growing innovative product pipeline for the treatment of neurodegenerative disease and cancer. In addition, we are working hard to grow the A(4) assay revenue stream and focused on the development of a human Alzheimer's disease diagnostic which has the potential to revolutionize how Alzheimer's disease is diagnosed and treated."
Recent Corporate Highlights
In July 2010, Amorfix announced the completion of a licensing agreement granting Biogen Idec (NASDAQ: BIIB) exclusive worldwide rights to Amorfix's lead amyotrophic lateral sclerosis (ALS) monoclonal antibodies. The antibodies have shown efficacy in animal models of ALS and Biogen Idec will now, at its expense, complete the development and prepare for clinical trials.
Under the agreement, Biogen Idec will receive the exclusive worldwide license to develop and commercialize Amorfix's Disease Specific Epitopes (DSE(TM)) antibodies for ALS while Amorfix retains all rights for diagnostics. Amorfix received an up-front payment of US$1 million and is eligible to receive milestone payments and royalties on sales.
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.
In June 2010, Amorfix and QED Bioscience entered into an agreement to develop high-affinity monoclonal antibodies against a number of targets for cancer. Under the agreement, QED will generate monoclonal antibodies against several DSE's on misfolded CD38 protein. The DSE's were identified by Amorfix using our proprietary ProMIS(TM) computational platform discovery technology. With our previous announcements of agreements with Epitomics and Aragen Biosciences, Amorfix now has three cancer antibody development projects underway.
In July 2010, Amorfix attended the International Conference on Alzheimer's Disease (ICAD 2010) to promote its A(4) assay and to present its paper on new findings important for preclinical research of Alzheimer's Disease (AD). Amorfix used its A(4) test to compare the rate of accumulation of aggregated Abeta in the brain tissue of various mouse models of AD from animals 1 month to 14 months of age. These new findings will provide researchers with the ability to assess drug effects at critical time points when aggregation is high or low or accelerating in mouse models of AD through the use of our A(4) testing services.
In July 2010. Amorfix and reMYND NV formed a partnership to offer the Amorfix A(4) amyloid testing service to reMYND's contract research clients. reMYND's offers an extensive portfolio of preclinical in-vivo efficacy, pharmacokinetic and safety testing of experimental Alzheimer therapies using proprietary mouse models of Alzheimer's disease.
Financial Results
For the three months ended June 30, 2010 the Company reported a net loss from operations of $1,724,745 ($0.04 per share) compared to net loss of $1,170,741 ($0.03 per share) for the three months ended June 30, 2009.
The Company recorded service revenue from the A(4) test and reagent sales of $23,773 in the current quarter.
Research and development expenses for the three months ended June 30, 2010 were $1,346,404 compared with $880,188 for the three months ended June 30, 2009. The increase was due mainly to severance costs associated with the decision to suspend commercialization of the vCJD program and higher costs on the ProMIS(TM) cancer antibody development program partially offset by lower third party costs on the vCJD and AD therapeutic programs compared to the first quarter of last year.
General and administration costs for the three months ended June 30, 2010 were $293,124 which was comparable to $290,808 in the three months ended June 30, 2009.
At June 30, 2010, the Company had working capital of $2,985,519 and 48,514,418 common shares outstanding.
Outlook
The Company's Fiscal 2011 research priorities continue to be:
- 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 through our partnerships with Biogen Idec and PREVENT; - Grow the revenue from our A(4) amyloid testing service for cell culture, tissue and blood in animal models of Alzheimer's disease; and - 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.
The Company is also announcing that Mr. Graham Strachan, Chair of the Board will not be standing for re-election at the Company's annual meeting and that Dr. Philippe Couillard has now assumed the role of Chair of the Board to effect a smooth transition. Dr. Couillard noted, "Mr. Strachan's excellent leadership and guidance since the inception of Amorfix in 2005 have been significant and are very much appreciated. We wish him well in his future endeavours."
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