Exhibit 99.1
Press Release
Contacts: | Roger G. Stoll, Ph.D. | Jane Lin/Dian Griesel, Ph.D. | ||
| Chairman, President and CEO | The Investor Relations Group | |||
| Cortex Pharmaceuticals, Inc. | (212) 825-3210 | |||
| (949) 727-3157 |
Cortex Reports First Quarter Fiscal 2004 Results
IRVINE, CA (November 11, 2003) — Cortex Pharmaceuticals, Inc. (AMEX: COR) reported a net loss of $475,000 ($0.03 per share) for the quarter ended September 30, 2003. This compares with a net loss of $674,000 ($0.04 per share) for the corresponding prior year period.
Operating results for the quarter ended September 30, 2003 reflect increased revenues from the agreement with Servier. In October 2002, Servier agreed to supplement Cortex’s existing research support by an additional $4,000,000, to be paid in quarterly installments of $500,000 over a two-year period. In exchange for this support, Cortex agreed to expand Servier’s rights to the AMPAKINE® compounds to include anxiety disorders, in Servier’s licensed territories.
Excluding non-cash stock compensation charges, operating expenses for the quarter ended September 30, 2003 decreased relative to costs for the quarter ended September 30, 2002, primarily due to reduced personnel-related expenses.
During the quarter ended September 30, 2003, Cortex completed a private placement of its common stock for gross proceeds of $5,000,000. With this financing in place, Cortex immediately initiated further development of its second generation AMPAKINE compound, CX717.
“The initiation of toxicology studies for CX717 during the quarter was a very important milestone for us as we begin to take the necessary steps to advance our second-generation, more potent compounds into humans,” said Roger Stoll, President and CEO of Cortex.
Dr. Stoll continued, “We are pursuing an aggressive, two-prong strategy to develop our AMPAKINE technology. We will internally develop our second-generation compounds to treat orphan diseases such as narcolepsy and fragile X syndrome. Orphan disease filings typically involve reduced clinical development requirements as compared to standard regulatory filings, which allows for a faster and more economical development pathway. Concurrently, we will expand development of AMPAKINE compounds with existing and potentially new external collaborators to target larger indications.”
Cortex Pharmaceuticals, Inc.
Cortex, located in Irvine, California, is a neuroscience company focused on novel drug therapies for neurological and psychiatric disorders. The Company is pioneering a class of proprietary pharmaceuticals called AMPAKINE compounds, which act on the AMPA receptors on neurons to increase the strength of signals at connections between these brain cells. The loss of these
connections is thought to be responsible for memory and behavior problems in various neurological and psychiatric diseases. The AMPAKINE compounds are currently being evaluated in clinical trials for treatment of Alzheimer’s disease, Mild Cognitive Impairment, schizophrenia, fragile X syndrome, autism and sleep deprivation effects. Cortex has alliances with N.V. Organon for the treatment of schizophrenia and depression and with Les Laboratoires Servier for the development of AMPAKINE compounds to treat the neurodegenerative effects associated with aging and disease, including Mild Cognitive Impairment, Alzheimer’s disease and anxiety disorders.
Forward-Looking Statement
Note — This press release contains forward-looking statements concerning the Company’s research and development activities, clinical trials and business development plans. Actual results may differ materially, depending on a number of risk factors, including the risks that the Company may be unable to obtain additional capital needed to continue its operations; that the agreements with Organon and Servier will not result in any commercial products or that any additional milestone payments will be earned by the Company; that the Company may be unable to arrive at additional corporate partnerships with other pharmaceutical companies on acceptable terms and therefore be required to independently fund clinical development of AMPAKINE compounds through the sale of additional equity securities or otherwise; that the Company’s proposed products may at any time be found to be unsafe or ineffective for any or all of their proposed indications; that competitors may challenge or design around the Company’s patents or develop competing technologies; and that clinical studies may at any point be suspended or take substantially longer than anticipated to complete. As discussed in the Company’s Securities and Exchange Commission filings, the Company’s proposed products will require additional research, lengthy and costly clinical testing and regulatory approval. AMPAKINE compounds are investigational drugs and have not been approved for the treatment of any disease.
(table follows)
Cortex Pharmaceuticals, Inc.
Condensed Statements of Operations
(in thousands, except per share data)
(Unaudited)
Three months ended September 30, | ||||||||
| 2003 | 2002 | |||||||
Research, license and grant revenues | $ | 1,337 | $ | 1,122 | ||||
Operating expenses: | ||||||||
Research and development | 1,033 | 1,115 | ||||||
General and administrative | 460 | 628 | ||||||
Non-cash, stock compensation charges | 323 | 61 | ||||||
Total operating expenses | 1,816 | 1,804 | ||||||
Loss from operations | (479 | ) | (682 | ) | ||||
Interest income, net | 4 | 8 | ||||||
Net loss | $ | (475 | ) | $ | (674 | ) | ||
Net loss per share, basic and diluted | $ | (0.03 | ) | $ | (0.04 | ) | ||
Shares used in computing per share amounts | ||||||||
Basic and diluted | 18,321 | 16,849 | ||||||
Cortex Pharmaceuticals, Inc. Condensed Balance Sheets (in thousands)
| ||||||||
| September 30, 2003 | June 30, 2003 | |||||||
| (Unaudited) | ||||||||
Assets: | ||||||||
Cash and cash equivalents | $ | 4,469 | $ | 1,125 | ||||
Marketable securities | 200 | — | ||||||
Restricted cash | 40 | 84 | ||||||
Accounts receivable | 94 | 428 | ||||||
Other current assets | 98 | 211 | ||||||
| 4,901 | 1,848 | |||||||
Furniture, equipment and leasehold improvements, net | 276 | 298 | ||||||
Other assets | 33 | 33 | ||||||
Total assets | $ | 5,210 | $ | 2,179 | ||||
Liabilities and stockholders’ equity (deficit): | ||||||||
Accounts payable and accrued expenses | $ | 1,174 | $ | 1,335 | ||||
Unearned revenue — current | 988 | 2,017 | ||||||
Unearned revenue — non-current | — | 247 | ||||||
Stockholders’ equity (deficit) | 3,048 | (1,420 | ) | |||||
Total liabilities and stockholders’ equity (deficit) | $ | 5,210 | $ | 2,179 | ||||
More information atwww.cortexpharm.com
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