TORONTO, March 16, 2015 /CNW/ - Amorfix Life Sciences Ltd., a biotechnology company focused on diagnostics and therapeutics for misfolded protein diseases, in particular neurodegenerative diseases, today announced that its Board of Directors has formally authorized the Company to review all strategic alternatives available to it. The Company's management has been charged, among other things, with the responsibility for exploring alternative ways to maximize shareholder value, including transactions involving the sale of all or part of the assets of the Company.
"The Board of Directors fully appreciates that the Company's limited cash resources and liquidity constraints has affected the Company's ability to maintain operations in the future," said Mr. William Wyman, Chairman of Amorfix. "We had hoped to address that situation with additional debt or equity financings of the Company, but have been unable to do so. As a result, Amorfix will consider selling all or a portion of its assets or consider other strategic alternatives to further develop its neuro-biological and other scientific initiatives and maximize long-term shareholder value."
The Company has had numerous discussions with potential investors in recent months, many of whom ultimately declined to invest based on a variety of factors, citing a reluctance to invest in a public biotechnology company at an early stage of the Company's progress toward clinical trials, among other reasons. The Board of Directors will consider any and all strategic proposals, including proposals that would transfer the Company's assets into a privately held entity in such a manner that would provide the Company and its shareholders with a continuing equity stake in the private entity's business, although the Board of Directors has not ruled out any strategic alternatives at this stage.
"I regret that the Company has not yet been able to raise sufficient funds to execute our intended business plan," said Dr. Robert Gundel, Amorfix President and CEO. "However, I continue to believe that there is vast potential surrounding the Company's development of diagnostic and therapeutic technologies that, if leveraged properly, could have a significant impact on the detection and treatment of multiple diseases and result in shareholders receiving a reasonable return on their investments."
The Company will continue to maintain its core neurodegenerative disease assets for ALS and Alzheimer's disease until one or more strategic transactions are consummated. For ALS, these assets include therapeutic antibodies that block misfolded SOD1 and a simple blood test diagnostic for early detection of the disease. For Alzheimer's disease, the company has developed a 'best in class' diagnostic that can accurately identify patients with early-stage disease.
No timetable has been set for the Company's process for reviewing strategic alternatives. No decision has been made to enter into any transaction at this time, and there can be no assurance that the Company will enter into such a transaction in the future. Such a transaction, if one were to occur, could require formal shareholder approval, in which case detailed proxy or other solicitation material would be made available to shareholders. Amorfix does not expect to comment further or update the market with any additional information on the process unless and until its Board of Directors has approved a specific transaction or otherwise deems disclosure appropriate or necessary. There is no assurance that this strategic alternatives review will result in Amorfix changing its current business plan, pursuing a particular transaction, or completing any such transaction.
The Company currently intends to retain its listing as a public company on the TSX unless a so-called "going-private transaction" is consummated. There can be no assurance that any such transaction will be consummated. Any inquiries or proposals with respect to strategic alternatives should be directed to Robert Gundel, the President and Chief Executive Officer of the Company, or to Warren Whitehead, the Company's Chief Financial Officer at the phone numbers and e-mail addresses listed below.
Amyotrophic lateral sclerosis (ALS) is a fatal neuromuscular disease that afflicts approximately 30,000 individuals in North America, with 5,000 new cases per year. ALS, also known as Lou Gehrig's disease, produces weakness and atrophy in the muscles that control movement, speech, swallowing, and respiration. These muscles weaken and atrophy due to degeneration of motor nerve cells in the spinal cord and brain. Half of affected individuals die within three years and survival over five years is less than 20%. There is currently no cure for ALS, and current treatments have limited effects.
About Amorfix SOD1 Antibodies for the treatment of ALS
In ALS patients, the propagation of aggregated misfolded SOD1 protein kills the nerve cells that supply muscles. As a result, the patient becomes progressively paralyzed and unable to breathe. Neil Cashman, Amorfix CSO, discovered that misfolded SOD1 exposes regions of the protein that are buried in the properly folded form, and that specifically targeting these misfolded regions has the ability to neutralize the toxicity to nerve cells. Amorfix has developed therapeutic antibodies that recognize only the harmful, misfolded SOD1 and spare normal SOD1 protein to preserve its normal protective activity. The Company is also developing a simple blood test diagnostic for early detection of ALS and has a granted US patent covering all therapeutic antibodies that bind to misfolded SOD1 to be used for the treatment of ALS.
About Alzheimer's disease
More than 35 million people worldwide have Alzheimer's disease or other types of dementia. Alzheimer's disease is the most common type of dementia and accounts for an estimated 60–80% of cases. As the population around the world ages, the incidence of Alzheimer's disease is predicted to increase significantly. Alzheimer's disease progresses through three defined phases: a stage characterized by amyloid (oligomeric Aβ) build-up in the brain without any symptoms of the disease, mild cognitive impairment (MCI) mainly affecting memory function, and full-blown Alzheimer's disease. However, loss of memory is common in normal aging, and does not necessarily indicate Alzheimer's disease. The predominant theory is that a build up of plaques in the brain caused by the clumping and accumulation of Aβ lead to neuronal cell death and the onset of Alzheimer's disease symptoms. The Company has developed a diagnostic that can identify patients with MCI who are destine to develop Alzheimer's disease with 95% sensitivity by measuring the levels of aggregated Aβ42 and aggregated Aβ40 in patient cerebrospinal fluid (CSF). The ability to separately measure Aβ42 and Aβ40 is unique to the Amorfix EP-AD diagnostic and allows a greater understanding of the role of aggregated Aβ proteins in Alzheimer's disease.
Cancer is a major public health problem in the United States and many other parts of the world. There are more than 1.5 million new cancer cases and almost 600,000 deaths from cancer projected to occur this year in the United States alone representing 1 out of 4 deaths. While the incidence of certain types of cancer have shown a decline in recent years, cancer remains a leading cause of death throughout the world. Typical treatments for cancer include surgery, radiation therapy and chemotherapy.
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.
For further information: Dr. Robert Gundel, President and Chief Executive Officer, Amorfix Life Sciences Ltd., Tel: (416) 847-6957, Fax: (416) 847-6899, [email protected]; Warren Whitehead, Chief Financial Officer, Amorfix Life Sciences Ltd., Tel: (416) 644-7358, Fax: (416) 847-6899, [email protected]