TORONTO, June 28, 2013 /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 year ended March 31, 2013.
"We continue to advance our diagnostic and therapeutic antibody programs and have recently reached a number of critical milestones", said Dr. Robert Gundel, Amorfix President and Chief Executive Officer. "On the cancer front, we have established proof of concept for our lead antibody conjugate in ovarian cancer which validates the ProMIS™ discovery technology in terms of identifying disease specific epitopes (DSEs) for the generation of antibodies that bind only to tumor cells and not to normal cells. These results provide an important and necessary component to our data package demonstrating the utility of the technology for the generation of targeted therapeutics. With these data in hand we are confident that we can attract top tier pharmaceutical companies for product-based collaborations. The ProMIS™ approach for the development of novel therapeutics is unique to Amorfix and we are receiving increased recognition from leading cancer researchers. This is demonstrated by our recent collaboration with Dr. Pataer of MD Anderson and also by the invitation to present our technology at the April 2013 annual meeting of the American Association for Cancer Research (AACR). On the financial front, we have successfully raised capital to support the advancement of our programs in a challenging global market. This is a testament to the potential of our novel technology and innovative approach to the development of therapeutic antibodies and diagnostics that address large commercial market opportunities with high unmet medical needs".
Recent Corporate Highlights
On March 20, 2013, the Company announced the progress it had made towards developing a blood test for the diagnosis of ALS. The Company announced it had cloned ultra-high affinity antibodies that detect a misfolded version of the enzyme superoxide dismutase 1 (SOD1). This new antibody will be used to improve the sensitivity of the bead assay being developed by the company for the detection of SOD1 in plasma.
In two tranches, April 4th and April 22nd, 2013, the Company completed a non-brokered private placement (the Offering) pursuant to which a total of 1,250,000 Units were issued for total gross proceeds $325,000 under this Offering.
Each Unit consisted of one common shares of Amorfix (Shares) and one common share purchase warrant of Amorfix (Warrants). Each Warrant entitles the holder to purchase one Share at a price of CDN$ 0.50 for a period of 24 months following the closing date of the Offering, subject to earlier expiry in the event (a trigger event) that, following the expiry of the four month hold period, the volume-weighted average price of Amorfix's common shares on the Toronto Stock Exchange (TSX) over a period of twenty consecutive trading days exceeds $1.00. On the occurrence of a trigger event, Amorfix may give notice to holders to accelerate the expiry to a date which is not less than 30 calendar days after such notice is sent to the holders.
On April 9, 2013, Amorfix CSO Dr. Neil Cashman provided an update of the Company's ovarian cancer therapeutic antibody program at the annual meeting of the American Association for Cancer Research (AACR) in Washington, DC. The presentation was well received by the audience comprised of academic researchers and pharmaceutical industry scientists and executives.
On April 9, 2013 the Company reported the completion of the first in a series of studies with its anti-misfolded prion protein antibody in animal models of ovarian cancer with promising preliminary results on reducing tumor volume. In this initial study, the antibody urease conjugate showed a reduction in median and mean tumor volume as compared to the non-treated group. The Company also announced that it had completed a study that shows that the treatment of cancer cells with chemotherapeutic agents increases the amount of misfolded prion protein at the cell surface, and the subsequent binding of anti-prion protein antibodies while showing no increase in misfolded prion protein on the surface of normal ovarian cells. These important scientific findings are the first of its kind and suggests that a combination of standard chemotherapy drugs with antibodies directed against misfolded protein targets could provide a much more effective therapeutic benefit to cancer patients.
On April 25, 2013, the Company announced that it had signed a collaboration agreement with The University of Texas MD Anderson Cancer Center for the use of the Company's anti-cancer antibodies in a lung cancer research program. Under the agreement, Apar Pataer, M.D., Ph.D., associate professor of Thoracic and Cardiovascular Surgery at MD Anderson will use the Amorfix antibodies to identify misfolded proteins expressed on the surface of various human lung cancer cell lines. In addition, studies will be conducted to identify other potential candidate misfolded protein targets for analysis with the Company's proprietary ProMIS™ discovery technology to identify immunotherapeutic targets for the generation and development of therapeutic antibodies for use in the treatment of lung cancer.
On June 5, 2013, the Company announced that it completed a second series of studies with its lead ovarian cancer antibody in a preclinical ovarian cancer animal model. In this study there was a statistically significant decrease in tumor volume compared to control animals.
The Company recently terminated its agreement with PREVENT for the development of an ALS vaccine and will be seeking an alternative development partner for this technology for completion of preclinical studies and a more rapid advancement into clinical development.
On June 26, 2013 the Company announced that it closed the first tranche of a non-brokered private placement (the Offering) pursuant to which 1.5 units (Units) were issued at a price of CDN$350,000 per unit for gross proceeds of CDN$525,000. The total amount that can be raised under the Offering is $1,400,000.
Each Unit consists of one million common shares of Amorfix (Shares) and one million common share purchase warrants of Amorfix (Warrants). Each Warrant entitles the holder to purchase one Share at a price of CDN$ 0.55 for a period of 24 months following the closing date of the Offering, subject to earlier expiry in the event (a trigger event) that, following the expiry of the four month hold period, the volume-weighted average price of Amorfix's common shares on the Toronto Stock Exchange (TSX) over a period of twenty consecutive trading days exceeds $1.00. On the occurrence of a trigger event, Amorfix may give notice to holders to accelerate the expiry to a date which is not less than 30 calendar days after such notice is sent to the holders.
In connection with the Offering, Amorfix will pay CDN$42,000 in finder fees and issue 40,000 finder warrants which have the same terms as the Warrants.
For the year ended March 31, 2013 the Company reported a net loss from operations of $2,230,902 ($0.04 per share) compared with a net loss of $2,543,813 ($0.05 per share) for the year ended March 31, 2012. The reduced net loss results mostly from lower program expenditures on its AD diagnostic program and lower stock based compensation. Research and development expenses for the year ended December 31, 2013 were $1,798,302 compared to $2,037,424 in the comparable period. General and administrative expenses for the year ended March 31, 2013 were $484,442 compared to $610,771 in the comparable period last year.
For the three months ended March 31, 2013 the Company reported a net loss from operations of $556,751 ($0.01 per share) compared to net loss of $702,317 ($0.01 per share) for the three months ended March 31, 2012. The decreased net loss in the current period results mainly form lower program expenditures and lower stock-based compensation. Research and development expenses for the three months ended March 31, 2013 were $469,841 compared to $526,049 in the comparable period. General and administrative expenses for the three months ended March 31, 2013 were $118,544 compared to $177,792 in the comparable prior year period.
At March 31, 2013, the Company had a working capital deficit of $328,015. Subsequent to year end the Company completed two private placement offerings for combined gross proceeds of $850,000. Presently, the Company does not have sufficient working capital to continue its research and development programs. The Company is actively pursuing a number of financing options and initiatives at this time and anticipates a successful interim solution shortly.
The Company's Fiscal 2014 research priorities, subject to the Company raising additional funds, are to:
- Establish additional collaborations and partnerships for use of the ProMIS™ discovery technology to continue to build a compelling pipeline of novel antibody therapeutics for the treatment of cancer
- Complete the research and development of an ALS diagnostic test
- Initiate further studies in animal models of ovarian cancer with anti-PrP antibodies
- Initiate proof of concept studies in animal models of cancer with anti-Fas receptor antibodies
- Complete the validation of a human Alzheimer's disease test to detect aggregated Abeta, a hallmark of the disease, in cerebrospinal fluid
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 an early-stage product development company developing therapeutic antibodies and diagnostics targeting misfolded protein diseases. Amorfix utilizes its computational discovery platform, ProMIS™, to predict novel Disease Specific Epitopes (DSEs) on the molecular surface of misfolded proteins. Using this technology, Amorfix is developing novel antibody therapeutics and companion diagnostics for cancer and amyotrophic lateral sclerosis (ALS). In addition, Amorfix has developed two proprietary technologies to specifically identify very low levels of misfolded proteins in a biological sample: Epitope Protection™ and AMFIA™, an ultra-sensitive dual-bead immunoassay. Use of these technologies has generated a cerebrospinal fluid (CSF) screening test for both Alzheimer's disease (AD) and mild cognitive impairment (MCI), and an ultrasensitive method for detecting the hallmark of AD, aggregated beta-Amyloid, in brain tissue, CSF and blood from animal models of AD. 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.
SOURCE Amorfix Life Sciences Ltd.