Financial Highlights
Shares Outstanding: 47.5M
Authorized Shares: 75.0M
Average 30-day vol: 599,200 shares (10/12/07)
52-Week Range: $0.56 - $3.47
Market Cap: $38M
Fiscal Year End: December 31, 2007
Approx. Cash Pos: $21.0M (as of 8/31/07)
Symbol: (AMEX: COR)
|
Address:
CORTEX PHARMACEUTICALS, INC.
15231 Barranca Parkway
Irvine, California 92618
Phone: (949) 727-3157
Fax: (949) 727-3657
www.cortexpharm.com
|
Corporate Overview
Cortex Pharmaceuticals, Inc. is a neuroscience company focused on the discovery and clinical development of AMPAKINE® molecules, a platform that represents a new approach to treating psychiatric and neurological disorders. AMPAKINE compounds are small drug-like molecules that positively modulate the AMPA–type glutamate receptor complex, amplifying the effect of glutamate at the synapse, leading to excitation of brain circuits.
AMPAKINE compounds fall into two categories, low and high impact compounds, defined by the site to which they bind on the AMPA receptor complex. Cortex’s lead low impact AMPAKINE, CX717, has demonstrated “Proof-of-Concept” in adult ADHD patients in a small pilot Phase IIa study. A Phase IIb clinical protocol is currently being reviewed by the FDA to allow the Company to undertake a larger study to validate the initial findings in adult ADHD patients. CX717 is also being tested in a pilot Phase II study in Alzheimer’s disease to investigate changes in brain metabolism by PET imaging. Several follow-on molecules to CX717 have completed or are undergoing toxicology testing; Cortex anticipates filing an IND or equivalent for CX701 by the end of 4Q07, with additional low impact molecules following closely behind it.
The Company anticipates having up to three AMPAKINE compounds in clinical studies by late 2008. This is being accomplished through a reorganization of R&D activities, the addition of several key technical and clinical personnel, and the ability of the Company to raise capital. Cortex raised $20 million in 2007 and $80 million over the last five years.
Cortex’s business plan focuses on out-licensing internally developed AMPAKINE compounds for the very large CNS diseases such as ADHD, Alzheimer’s and Parkinson’s disease, while retaining the smaller indications and orphan diseases for internal development. The Company has already out-licensed two AMPAKINE compounds to Organon (Org24448 and Org26576) for the indications of schizophrenia and depression, respectively, which will be acquired by Schering Plough by the end of 2007.
Top Investment Highlights
- Cortex develops AMPAKINE® drugs for the treatment of neurological and psychiatric disorders.
- In May, 2007, The Company negotiated an exclusive worldwide license with the University of Alberta, BC that claims the use of AMPAKINE® compounds for the prevention or reversal of respiratory depression induced by inappropriate dosing of opiates and barbiturates without inhibition of the analgesic or sedative effects.
- In July, 2007, The FDA’s Neurological Drug Products Division restored the full dosing range for CX717 in the ongoing Phase II PET Scan Study in mild-to-moderate Alzheimer’s disease.
- Four new composition-of-matter patent applications have been submitted covering AMPAKINE compounds, extending patent protection to the platform technology out to 2027.
- Cortex raised approx. $20 million in 2007 through two separate registered direct offerings (January and August, 2007).
- In October, 2007, Cortex announced the appointment of Pierre V. Tran, M.D., MMM, Chief Medical Officer and Vice President of Clinical Development.
Technology
AMPAKINE compounds facilitate the activity of the AMPA receptor, which are activated by the glutamate, to selectively amplify brain circuits. Since AMPA receptors are expressed widely within the brain, AMPAKINE compounds may have wide utility in the treatment of neurological and psychiatric disorders.
Cortex’s AMPAKINE platform technology is composed of two groups of compounds that we have designated as “low impact” and “high impact.” AMPAKINE compounds like CX614 and CX929 bind to the well characterized cyclothiazide binding site, and are referred to as high impact compounds. In contrast, compounds like CX717, CX701, Org24448 and Org26576 bind to a different modulatory site on the AMPA receptor complex and impact the response in unique ways. The low impact series of compounds are unique to Cortex. Both types of compounds positively modulate the AMPA receptor function, but the high impact compounds also activate the expression of growth factors within the brain. This effect imparts these compounds with the potential for disease modifying activity.
Data from preclinical animal models suggest that AMPAKINE compounds might be effective in treating schizophrenia, depression, ADHD, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease, and Fragile X. Recent work also suggests that AMPAKINE compounds activate respiratory drive in the brain stem to prevent or reverse respiratory depression induced by inappropriate dosing of opiates and barbiturates without inhibition of the analgesic and sedative effects.
Alliances
Cortex out-licensed the exclusive worldwide rights to Org24448 and Org26576 for the treatment of schizophrenia and depression. Organon is expected to be acquired by Schering Plough by the end of 2007. Cortex would receive developmental milestone payments and royalties on sales of these products.
In December 2006, Cortex terminated its research collaboration with Laboratories Servier on AMPAKINE research. Servier may select up to three compounds for clinical development from our previous collaboration; Cortex would receive developmental milestone payments and royalties on sales of such product.
Management
|
Roger G. Stoll, Ph.D.,
President, Chief Executive Officer,
and Chairman
|
Dr. Stoll has over 30 years of experience in the pharmaceutical, medical devices, and diagnostic industries. In his career he has held positions such as CEO of Ohmeda, which was the anesthesia and critical care business of BOC Group and was on the board of directors of The BOC Group (now Linde), managed the worldwide Diagnostic Business Group for Bayer, AG. Earlier held positions of increasing responsibility including President of American Critical Care Division of American Hospital Supply Corp (now Baxter) and he started his career at The Upjohn company where he conducted clinical pharmacology and drug metabolism studies. He received his Ph.D. from the University of Connecticut.
|
Mark Varney, Ph.D.
Chief Scientific Officer and
Chief Operating Officer
|
Dr. Varney has spent over 15 years in the pharmaceutical industry, holding senior level positions at Sepracor, Inc., where he was Vice President and head of Discovery, and at Bionomics, Ltd., where he was Vice President of Drug Discovery. Prior to that he spent several years at Sibia which later became part of Merck, Inc. He received his Ph.D. degree from Oxford University, UK.
