Cortex Reports Operating Results for March 31, 2005.IRVINE, Calif. -- Increased Expenses Reflect Amounts for Advancing AMPAKINE(R) CX717 Cortex Pharmaceuticals, Inc. (AMEX AMEX See: American Stock Exchange : COR) reported a net loss of $2,648,000, or $0.08 per share for the quarter ended March 31, 2005 compared with a net loss of $874,000, or $0.03 per share for the corresponding prior year period. In November 2004 the Company's Audit Committee, under authority from the Board of Directors, approved a change in the Company's fiscal year-end Fiscal Year-End The completion of a one-year, or 12-month, accounting period. Notes: The reason that a company's fiscal year often differs from the calendar year and does not close on Dec 31, is due to the nature of company's needs. from June 30 to December 31. A report covering the transitional six-month period ended December 31, 2004 was filed on a Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. . Revenues of $699,000 for the quarter ended March 31, 2005 decreased from $1,166,000 for the prior year period due to the end of scheduled support under the October 2002 amendment to the Company's collaborative agreement with Servier. Cortex continues to receive approximately $2,200,000 of annual research support from Servier under the original terms of the agreement, as extended at the end of 2003. Operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. of $3,425,000 for the quarter ended March 31, 2005 included increased expenses for the clinical development of AMPAKINE compound CX717, which recently completed early Phase IIa clinical trials in sleep deprived subjects. As reported earlier, preliminary top-line analysis of the study data suggests that CX717, when compared to placebo, increased wakefulness wakefulness believed to occur when the tonic flow of impulses from the reticular activating system exceeds the critical level for sustaining consciousness; reduction of reticular activating system activity is the basis of the pharmacological induction of sedation. in a dose-related fashion, impacted the performance in individuals particularly affected by sleep deprivation sleep deprivation Sleep disorders A prolonged period without the usual amount of sleep. See Driver fatigue, Poor sleeping hygiene, Sleep disorders, Sleep-onset insomnia. and showed little effect on those whose performance was not impaired. Given the large data set associated with this CX717 study, Cortex plans to have follow-up disclosure to its shareholders once all the data has been completely analyzed by the Company and its investigators. A very important issue that has come to the attention of Cortex is that the slides shown on the webcast of Dr. Stoll's presentation were not the same as those actually presented at the Rodman rod·man n. One who carries and employs a leveling rod under the supervision of a surveyor. & Renshaw 2nd Annual Global Healthcare Conference in Paris, France on May 4, 2005. Cortex has contacted the site to correct this problem and the slides from his presentation have now replaced the material previously shown on the webcast. The top-line data from the sleep deprivation trial can now be found as shown at the conference with link shown below: http://www.wsw.com/webcast/rrshq5/cor/ Cortex Pharmaceuticals, Inc. Cortex, located in Irvine, California Irvine is an incorporated city in Orange County, California, United States. It is a planned city, mainly developed by the Irvine Company since the 1960s. Formally incorporated on December 28 1971, the 69.7 square mile (180.5 km²) city has a population of 202,079 (as of 2007). , is a neuroscience neu·ro·sci·ence n. Any of the sciences, such as neuroanatomy and neurobiology, that deal with the nervous system. neuroscience the embryology, anatomy, physiology, biochemistry and pharmacology of the nervous system. company focused on novel drug therapies for neurological neurological, neurologic pertaining to or emanating from the nervous system or from neurology. neurological assessment evaluation of the health status of a patient with a nervous system disorder or dysfunction. and psychiatric psy·chi·at·ric adj. Of or relating to psychiatry. psychiatric adjective Pertaining to psychiatry, mental disorders 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 Alzheimer's disease (ăls`hī'mərz, ôls–), degenerative disease of nerve cells in the cerebral cortex that leads to atrophy of the brain and senile dementia. . Many psychiatric diseases, including schizophrenia schizophrenia (skĭt'səfrē`nēə), group of severe mental disorders characterized by reality distortions resulting in unusual thought patterns and behaviors. , occur as a result of imbalances in the brain's neurotransmitter neurotransmitter, chemical that transmits information across the junction (synapse) that separates one nerve cell (neuron) from another nerve cell or a muscle. Neurotransmitters are stored in the nerve cell's bulbous end (axon). system. These imbalances may be improved by using the AMPAKINE technology. Cortex has alliances with N.V. Organon or·ga·non or or·ga·num n. pl. or·ga·nons or or·ga·nums or or·ga·na 1. An organ. 2. A set of principles for use in scientific investigation. organon pl. organa [Gr.] organ. for the treatment of schizophrenia The concept of a cure as such in the treatment of schizophrenia remains controversial, as there is no consensus on the definition of "treatment" in the case of schizophrenia, although some criteria for the remission of symptoms have recently been suggested. 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 mild cognitive impairment (MCI), n memory loss generally associated with aging; does not affect normal independent functioning of an individual. , Alzheimer's disease and anxiety disorders Anxiety disorders A group of distinct psychiatric disorders characterized by marked emotional distress and social impairment, including generalized anxiety disorder, panic disorder, obsessive-compulsive disorder, and posttraumatic stress disorder. . Forward-Looking Statement forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. 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.
Cortex Pharmaceuticals, Inc.
Condensed Statements of Operations
(in thousands, except per share data)
(Unaudited)
Three months ended
March 31,
--------------------
2005 2004
-------- --------
Research, license and grant revenues $ 699 $ 1,166
Operating expenses:
Research and development 2,636 1,164
General and administrative 783 622
Non-cash, stock compensation charges 6 182
--------- ---------
Total operating expenses 3,425 1,968
--------- ---------
Loss from operations (2,726) (802)
Interest income, net 161 32
Change in fair value of common
stock warrants (64) --
Amortization of capitalized financing costs (19) (104)
---------- ---------
Net loss $ (2,648) $ (874)
========== =========
Net loss per share, basic and
diluted $ (0.08) $ (0.03)
========== =========
Shares used in computing per share amounts
Basic and diluted 32,626 25,553
Cortex Pharmaceuticals, Inc.
Condensed Balance Sheets
(in thousands)
March 31,
2005 December 31,
(Unaudited) 2004
----------- ------------
Assets:
Cash and cash equivalents $ 3,130 $ 9,157
Marketable securities 22,323 18,838
Accounts receivable 40 42
Other current assets 301 318
---------- ---------
25,794 28,355
Furniture, equipment and
leasehold improvements, net 450 388
Capitalized financing costs -- 1,136
Other assets 33 33
---------- --------
Total assets $ 26,277 $ 29,912
========== ========
Liabilities and stockholders' equity:
Accounts payable and accrued expenses $ 1,540 $ 1,907
Unearned revenue -- current 830 377
Non-current liabilities 32 23
Common stock warrants -- 3,958
Stockholders' equity 23,875 23,647
--------- --------
Total liabilities and stockholders'
equity $ 26,277 $ 29,912
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MORE INFORMATION AT www.cortexpharm.com |
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