Applied NeuroSolutions, Inc.
David Ellison, CFO, 847-573-8000
Julie Huang (Investors), 212-850-5600
Jeff Siegel (media), 516-569-4271
ANNOUNCES 2005 RESULTS
- Company Provides Corporate Update -
Vernon Hills, IL, March 23, 2006 – Applied NeuroSolutions, a biopharmaceutical company focused on diagnostics and novel therapeutic targets for treatment of Alzheimer’s disease (AD), today announced results for the full-year ended December 31, 2005. Total revenues for the twelve months ended December 31, 2005 increased 90% to $480,000 compared to $253,000 in 2004. Net loss for the 2005 full-year was $2.62 million, or $0.028 per share, versus $2.80 million, or $0.032 per share, in 2004. Applied NeuroSolutions ended the year with $1.66 million in cash. The company currently spends approximately $675,000 each quarter.
John F. DeBernardis, Ph.D., President and Chief Executive Officer of Applied NeuroSolutions, said, “Our continued focus this year is to advance our cerebrospinal fluid (CSF) diagnostic test for Alzheimer’s disease towards commercialization both in the U.S. and overseas, and further advance our serum-based diagnostic test to the point of commercial viability. There is currently no FDA-approved diagnostic test to detect Alzheimer's disease. Today, the only definitive way to diagnose AD is from an autopsy. We continue to see promise in our technology and believe it has the potential to diagnose AD early so that the patients can have the best chance to treat the symptoms of the disease.”
Dr. DeBernardis continued, “Our long-range goal is to discover novel targets for AD therapeutics based on what we believe is a common intracellular phosphorylation pathway leading to the development of abnormal, destructive brain structures characteristic of AD. We have also developed proprietary reagents that allow us to identify and validate appropriate, disease-specific intervention points in this pathway that may suggest novel therapeutic approaches.” Dr. DeBernardis further commented that the company intends to partner its discovery capabilities with pharmaceutical companies to further their AD therapeutic development programs.
Applied NeuroSolutions’ technology is based on discoveries made by Dr. Peter Davies, Professor of Pathology and Neuroscience at the Albert Einstein College of Medicine and the company’s founding scientist. Applied NeuroSolutions has patents on the AD-related discoveries that are derived from Dr. Davies’ lab.
- The company appointed Jay B. Langner and Robert S. Vaters to the Board of Directors. Jay has been the Chairman of the Board of Trustees of Montefiore Medical Center for the past 21 years. Robert S. Vaters was the Executive Vice President of Strategy and Corporate Development of Inamed Corporation (NASDAQ: IMDC).
- Applied NeuroSolutions renewed agreements with founding scientist, Dr. Peter Davies.
- Applied NeuroSolutions raised awareness of the importance of diagnosing Alzheimer’s disease early and has received extensive media attention over the past year.
- Management continued its discussions with the FDA. Applied NeuroSolutions has already submitted its pre-Investigational Device Exemptions (IDE) package to the FDA and had its pre-IDE meeting with the FDA. Applied NeuroSolutions is currently working with its regulatory consultants and Alzheimer’s disease experts to incorporate FDA feedback from this meeting that would lead toward an IDE filing.
- The company is pursuing a CE mark in Europe, which would allow the test to be marketed in Europe.
- Researchers worldwide, in collaboration with Applied NeuroSolutions and Dr. Peter Davies, published four studies in peer-reviewed scientific journals in 2005; two additional studies conducted in 2005 were published in peer-reviewed scientific journals in early 2006. There were four studies initiated in 2005, which are currently ongoing, including a longitudinal mild cognitive impairment (MCI) study and a study of MCI and p-tau 231 levels.
- Applied NeuroSolutions entered into a research agreement with Nanosphere, Inc., a nanotechnology-based molecular diagnostics company, to assist in the development of a second-generation diagnostic test for AD, utilizing other bodily fluids, such as serum.
- bioMérieux, S.A., a leading international diagnostics group, continued to evaluate Applied NeuroSolutions’ technology. As announced in December 2004, Applied NeuroSolutions established a non-exclusive license agreement with bioMérieux, which allowed them to evaluate the technology before it elects to continue the agreement.
- Applied NeuroSolutions continued to hold ongoing discussions with large pharmaceutical companies, diagnostic companies and reference laboratories on potential applications of Applied NeuroSolutions’ technologies.
About Applied NeuroSolutions’ Alzheimer’s Disease Diagnostic Test
Increased amounts of the altered tau protein in cerebrospinal fluid (ptau-231) distinguish AD patients from those with other forms of cognitive impairment, providing an early diagnostic test and a method for following disease progression. Applied NeuroSolutions has developed an antibody-based test measuring the protein in the CSF of AD patients and is working on a second-stage blood serum-based test that is expected to be easier to perform and less expensive.
Currently there is no FDA-approved diagnostic test to detect AD and follow its progression. Confirmation of diagnosis is performed through a series of behavioral measurements and brain scans. Definitive diagnosis can be made only from examination of postmortem brain tissue samples. Applied NeuroSolutions’ test would provide a significant breakthrough in supporting definitive early diagnosis.
About Applied NeuroSolutions
Applied NeuroSolutions, Inc. (OTC BB: APNS) is developing products to both diagnose and discover novel therapeutic targets for Alzheimer's disease. The company’s technology is based on discoveries originating from the Albert Einstein College of Medicine. Applied NeuroSolutions has developed a cerebrospinal fluid (CSF) test to detect early-stage Alzheimer's disease with a 85%-95% accuracy in more than 3,500 patient samples. There are approximately 2 million new patients annually worldwide who are candidates for an AD CSF diagnostic test, according to the research firm Datamonitor. The company is also developing a blood serum-based screening test, as well as novel therapeutic targets for treatment of AD. Alzheimer's disease currently afflicts over 4 million Americans, and the market for AD therapy is expected to grow to 21 million patients by 2010 in the seven major pharmaceutical markets (USA, France, Germany, Italy, Spain, U.K. and Japan) according to BioPortfolio, Ltd. There is currently no FDA-approved diagnostic test to detect Alzheimer's disease. For more information, visit www.appliedneurosolutions.com.