Exhibit 99.1
PRESS RELEASE
Company Contact: | Investor Contact: | |||
Roger G. Stoll, Ph.D. | Damian McIntosh/ Dian Griesel, Ph.D. | |||
Chairman, President and CEO | The Investor Relations Group | |||
Cortex Pharmaceuticals, Inc. | 212.825.3210 | |||
949.727.3157 |
CORTEX REPORTS FOURTH QUARTERAND
YEAR END OPERATING RESULTS
IRVINE, CA (March 16, 2006) — Cortex Pharmaceuticals, Inc. (AMEX: COR) reported a net loss of $3,739,000, or $0.11 per share for the quarter ended December 31, 2005 compared with a net loss of $2,535,000, or $0.09 per share for the corresponding prior year period. For the fiscal year ended December 31, 2005, Cortex reported a net loss of $11,606,000, or $0.36 per share compared to a net loss of $6,234,000, or $0.23 per share for the corresponding prior year period.
Increased net losses in the current year periods primarily reflect increased research and development expenses, including amounts for the development of AMPAKINE® compound CX717, which recently completed a multi-center Phase IIa study in Attention Deficit Hyperactivity Disorder (“ADHD”) and for expenses related to the Alzheimer’s disease PET scan study being conducted at the University of Michigan.
As recently announced, results for treatment of adults with ADHD demonstrated that CX717 provided a clinically relevant response on the ADHD Rating Scale (“ADHD-RS”), the primary outcome measure for the study in adult patients with ADHD. The overall ADHD-RS score, which evaluates both the inattentiveness and hyperactivity symptoms, showed a positive trend in the 800 mg of CX717 twice daily dose group (n = 22), with a statistically significant effect on the hyperactivity subscale (p=0.050) compared to placebo. CX717 was well tolerated, with no serious adverse events or other significant safety concerns and exhibited no increase in blood pressure or heart rate.
“These are exciting times for Cortex. In the coming months we plan to continue to move forward with CX717 for the ADHD indication and develop plans for conducting a study with larger patient populations to further define the therapeutic dose and frequency of dosing,” said Roger G. Stoll, Ph.D., Chairman, President and CEO of Cortex. “We also plan to continue to work toward a licensing agreement for CX717 with a large pharmaceutical partner.”
Increased administrative expenses in the current year as compared to the prior year related primarily to fees for preparing the Company’s assessment of its internal control system as of December 31, 2005, as required by The Sarbanes-Oxley Act of 2002.
Decreased revenues for the fiscal year ended December 31, 2005 as compared to the prior year period reflect the end of research support from the October 2002 amendment to Cortex’s collaborative agreement with Servier.
Cortex’s Annual Meeting of Stockholders will be held on May 10, 2006 in southern California. The time and location will be included in the Company’s proxy statement that will be filed within the coming weeks.
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 to increase the strength of signals at connections between brain cells. The loss of these connections is thought to be responsible for memory and behavior problems in Alzheimer’s disease. Many psychiatric diseases, including schizophrenia, occur as a result of imbalances in the brain’s neurotransmitter system. These imbalances may be improved by using the AMPAKINE technology. 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. The success of such activities depends on a number of factors, including the risks 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.
(tables follow)
Cortex Pharmaceuticals, Inc.
Condensed Statements of Operations
(in thousands, except per share data)
Three months ended December 31, | Fiscal year ended December 31, | |||||||||||||||
2005 | 2004 | 2005 | 2004 | |||||||||||||
(Unaudited) | (Unaudited) | (Unaudited) | ||||||||||||||
Revenues | $ | 606 | $ | 721 | $ | 2,577 | $ | 4,275 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 3,360 | 2,885 | 11,179 | 8,173 | ||||||||||||
General and administrative | 1,097 | 866 | 3,391 | 2,666 | ||||||||||||
Non-cash stock compensation charges | 49 | 102 | 167 | 368 | ||||||||||||
Total operating expenses | 4,506 | 3,853 | 14,737 | 11,207 | ||||||||||||
Loss from operations | (3,900 | ) | (3,132 | ) | (12,160 | ) | (6,932 | ) | ||||||||
Interest income, net | 161 | 98 | 637 | 303 | ||||||||||||
Change in fair value of common stock warrants | — | 499 | (83 | ) | 395 | |||||||||||
Net loss | $ | (3,739 | ) | $ | (2,535 | ) | $ | (11,606 | ) | $ | (6,234 | ) | ||||
Loss per share: | ||||||||||||||||
Basic and diluted | $ | (0.11 | ) | $ | (0.09 | ) | $ | (0.36 | ) | $ | (0.23 | ) | ||||
Shares used in computing per share amounts | ||||||||||||||||
Basic and diluted | 32,702 | 28,355 | 32,665 | 27,644 |
Cortex Pharmaceuticals, Inc.
Condensed Balance Sheets
(in thousands)
December 31, 2005 | December 31, 2004 | |||||
Assets: | ||||||
Cash and cash equivalents | $ | 2,063 | $ | 9,157 | ||
Marketable securities | 15,198 | 18,838 | ||||
Accounts receivable | 15 | 42 | ||||
Other current assets | 241 | 318 | ||||
17,517 | 28,355 | |||||
Furniture, equipment and leasehold improvements, net | 439 | 388 | ||||
Capitalized financing costs | — | 1,136 | ||||
Other | 33 | 33 | ||||
Total assets | $ | 17,989 | $ | 29,912 | ||
Liabilities and Stockholders’ Equity: | ||||||
Accounts payable and accrued expenses | $ | 2,681 | $ | 1,907 | ||
Unearned revenue — current | 126 | 377 | ||||
Deferred rent liability | 50 | 23 | ||||
Common stock warrants | — | 3,958 | ||||
Stockholders’ equity | 15,132 | 23,647 | ||||
Total liabilities and stockholders’ equity | $ | 17,989 | $ | 29,912 | ||
MOREINFORMATIONATWWW.CORTEXPHARM.COM
# # # # #