TORONTO, Feb. 10, 2012 /CNW/ - 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 third quarter ended December 31, 2011.
"This quarter was filled with outstanding scientific advances and steady progress forward for all of our research programs" said Dr. Robert Gundel, Amorfix President and Chief Executive Officer. "Our collaboration with Helix BioPharma is on track to provide proof of concept data for our cancer therapeutic antibody program and the FAS receptor program continues to look very encouraging as we are now preparing to test for binding and biological effects in a variety of cellular assay systems. We entered into an LOI to license our AD preclinical assay to JSW, a well recognized CRO, which will allow us to focus more time on our research programs. We have initiated a new program to develop a diagnostic blood test for ALS. At the present time, clinicians must rely on a combination of clinical findings and imaging technology to confirm the diagnosis, as there is no diagnostic test or biomarker at their disposal. The availability of a simple blood test has the potential to dramatically improve the ability of clinicians to diagnose ALS at its beginning stages and offer therapeutic intervention at a time when it could be most beneficial. Finally, in January 2012, we closed the first tranche of a private placement and raised gross proceeds of $677,820. We are continuing our fundraising efforts to bring our programs to revenue generating milestones."
Recent Corporate Highlights
On November 17, 2011, the Company announced that it is developing a blood test to be used as a diagnostic tool for amyotrophic lateral sclerosis (ALS). Initial ground breaking scientific study results from Amorfix Chief Scientific Officer Dr. Neil Cashman and colleagues at UBC demonstrate that misfolded SOD1 is present in the blood of ALS patients. The Company plans to capitalize on this discovery and existing scientific expertise to develop a simple blood test that measures misfolded SOD1 in blood. The Company has established key intellectual property around misfolded SOD1 and its potential role in neurodegenerative disease which covers the generation and use of any diagnostic, therapeutic or vaccine involving misfolded SOD1.
On January 9, 2012 the Company announced that it has signed a letter of intent with JSW-Lifesciences GmbH, a contract research organization specializing in Alzheimer's and other CNS diseases, to license its pre-clinical Alzheimer's disease diagnostic test, the Amorfix Aggregated Abeta Assay (the A4). JSW plans to add the A4 to its suite of preclinical research services provided to pharmaceutical companies and academic research institutions involved in Alzheimer's disease research and development.
On January 18, 2012 the Company announced that it has closed the first tranche of a non-brokered private placement (the Offering) pursuant to which a total of 3,012,532 units (Units) were issued at a price of $0.225 per unit for gross proceeds of $677,820. Each Unit consists of one common share of Amorfix (a Share) and one common share purchase warrant of Amorfix (a Warrant). Each Warrant entitles the holder to purchase one Share at a price of $0.50 for a period of 36 months following the closing date of the Offering, and is subject to earlier expiry under certain conditions.
The net loss for the three months ended December 31, 2011 was $731,287 compared to a net loss of $810,029 for the three months ended December 31, 2010. The net loss for the nine months ended December 31, 2011 was $1,841,496 compared to a net loss of $2,400,509 for the nine months ended December 31, 2010.
For the three and nine months ended December 31, 2011 revenue from services and sales was $18,554 and $90,882, respectively as compared to $10,048 and $94,947 in the comparative periods. Substantially all of this revenue was from the Company's A4 test. Revenue from license fees was $nil for the nine months ended December 31, 2011 compared to $1,030,600 for the comparative period. The Company entered into a license agreement with Biogen Idec in July 2010 and received a US$1,000,000 non-refundable fee.
Research and development expenditures for the three months ended December 31, 2011 were $580,221 which is comparable to expenditures of $609,185 in the comparable period. Research and development expenditures for the nine months ended December 31, 2011 were $1,511,375 compared to $2,703,453 in the comparable period. Research and development expenditures decreased in the nine months ended December 31, 2011 mainly from the Company having fewer employees than in the comparable period, to the severance costs incurred in June 2010 associated with the decision to suspend commercialization of the Company's vCJD program, and lower expenditures related to the ProMIS and ALS therapeutic programs, offset by higher expenses on the AD diagnostic program.
General and administrative costs for the three months ended December 31, 2011 were $171,961 compared to $219,670 in the comparable period and for the nine months ended December 31, 2011 were $432,979 compared to $864,407 in the comparable period. The decrease for the three and nine months ended December 31, 2011 resulted mainly from the severance costs incurred in the comparable periods and higher share based payment expense recorded in the comparable periods.
At December 31, 2011, the Company had working capital of $619,211 and 50,609,959 common shares outstanding. Management projects that its current working capital together with the net proceeds of the financing completed in January 2012 will fund the Company's operations into the first quarter of fiscal 2013. The Company is actively pursuing financing alternatives, but there is no assurance that these initiatives will be successful, timely or sufficient.
The Company's Fiscal 2012 and 2013 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;
- Complete the licensing of the company's A4 preclinical test.
- 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;
- Complete development of an ALS diagnostic test.
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 product development company developing therapeutic products and diagnostic devices targeting misfolded protein diseases including Alzheimer's Disease (AD), cancers, and ALS. Amorfix utilizes its computational discovery platform, ProMIS™, to predict novel Disease Specific Epitopes ("DSEs") on the molecular surface of misfolded proteins. Cancer immunotherapies have in the past been directed against targets which are also present on normal cells, whereas Amorfix's innovative ProMIS platform identifies targets present only on cancer cells, retaining efficacy with improved safety. Amorfix's lead programs include therapeutics and companion diagnostics for cancers, antibodies and vaccines to DSEs in ALS, as well as AD and ALS diagnostic tests. Amorfix's proprietary Epitope Protection™ technology enables it to specifically identify very low levels of misfolded proteins in a biological sample. The Company's diagnostic programs include an ultrasensitive method for the detection of aggregated beta-Amyloid in brain tissue, CSF and blood from animal models of AD, months prior to observable amyloid formation and the development of a human screening test for AD and a blood test to diagnose ALS. 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.
For further information:
Dr. Robert Gundel
President and Chief Executive Officer
Amorfix Life Sciences Ltd.
Tel: (416) 847-6957
Fax: (416) 847-6899
Acting Chief Financial Officer
Amorfix Life Sciences Ltd.
Tel: (416) 847-6926
Fax: (416) 847-6899