Cortex Pharmaceuticals, Inc. (NYSE Amex: COR) reported a net
loss of $3,130,000, or $0.07 per share for the quarter ended
December 31, 2008 compared with a net loss of $3,273,000, or $0.07
per share for the corresponding prior year period. These reported
losses included non-cash stock-based compensation charges for the
quarters ended December 31, 2008 and 2007 of approximately $236,000
and $533,000, respectively.
For the fiscal year ended December 31, 2008, Cortex reported a
net loss of $14,596,000, or $0.31 per share compared to a net loss
of $12,969,000, or $0.31 per share for the corresponding prior year
period. These losses included non-cash stock-based compensation
charges for the years ended December 31, 2008 and 2007 of
approximately $1,299,000 and $2,237,000, respectively.
Year-to-date operating results reflect increased clinical
development expenses, including amounts for the Company�s two Phase
IIa trials of its AMPAKINE� CX717 as a treatment for respiratory
depression. As recently reported, in both studies CX717
demonstrated positive effects, preventing the respiratory
depression induced by opiates. One of the studies also evaluated
the effect of CX717 on the opiate�s pain-relieving effects. These
results demonstrated that the analgesic effects of alfentanil were
maintained by CX717 in a pain model, suggesting utility of CX717
for reversal and prevention of respiratory depression induced by
opioids, without negatively impacting the analgesic properties of
the opioid. Independent market research has suggested that the
annual market for such products could be in excess of $1 billion in
the U.S. alone.
Cortex has completed Phase I clinical testing of the AMPAKINE
compound, CX1739, in the U.K. CX1739 was well tolerated, and did
not affect vital signs, cardiovascular parameters or blood clinical
chemistry, and exhibited linear exposure with increasing doses. As
recently reported, Cortex received approval from the U.K.
regulatory authority to initiate a small, proof-of-concept clinical
study with CX1739 in patients with moderate-to-severe sleep apnea.
Cortex anticipates receiving top-line results from this study
around mid-2009.
Cortex also reported that its Annual Report on Form 10-K for the
year ended December 31, 2008 will include a going concern
qualification from its independent auditors. As reported earlier,
Cortex recently implemented significant capital preserving
initiatives, including a restructuring of its organization that
involved a reduction of approximately 50% of its personnel and
reduced salaries for the company�s executive officers. With these
steps, Cortex reduced its spending requirements to better align its
resources to focus on development of its clinical programs for
CX717 and CX1739.
Cortex estimates that its restructuring efforts will provide
annual operating savings in excess of $2.5 million. Additionally,
the focus on product development and away from basic research
allows the company to potentially accelerate the development of its
key assets currently in advanced stages, CX1739, CX1942, CX2007 and
i.v. CX717. Cortex also has several on-going discussions related to
other strategic alternatives such as licensing, partnering and
M&A opportunities; however, there can be no assurance that a
transaction will be finalized from these discussions.
Cortex Pharmaceuticals, Inc.
Cortex, located in Irvine, California, is a neuroscience company
focused on novel drug therapies for treating psychiatric disorders,
neurological diseases and brain-mediated breathing disorders.
Cortex 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. For additional information regarding
Cortex, please visit the Company�s website at
http://www.cortexpharm.com.
Forward-Looking Statement
Note � This press release contains forward-looking statements
concerning the Company�s research and development activities. Words
such as �believes,� �anticipates,� �plans,� �expects,� �indicates,�
�will,� �intends,� �potential,� �suggests,� �assuming,� �designed�
and similar expressions are intended to identify forward-looking
statements. These statements are based on the Company�s current
beliefs and expectations. The success of such activities depends on
a number of factors, including the risks that the Company may not
generate sufficient cash from operations and from external
financing to continue as a going concern; that the Company may not
be successful in securing any licensing, partnering or M&A
arrangements; 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 patents may not issue from the Company�s
patent applications; that competitors may challenge or design
around the Company�s patents or develop competing technologies;
that the Company may have insufficient resources to undertake
proposed clinical studies; and that preclinical or 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 preclinical
and clinical testing and regulatory approval. AMPAKINE compounds
are investigational drugs and have not been approved for the
treatment of any disease. Readers are cautioned not to place undue
reliance on these forward-looking statements that speak only as of
the date of this press release. The Company undertakes no
obligation to update publicly any forward-looking statements to
reflect new information, events or circumstances after the date of
this press release or to reflect the occurrence of unanticipated
events.
(tables follow)
Cortex Pharmaceuticals,
Inc.
Condensed Statements of
Operations
(in thousands, except per share
data)
� � � � �
Three months ended
Fiscal year ended
December 31, December 31, 2008 2007
2008
2007
(Unaudited)
(Unaudited)
�
� Revenues $ � $ � $
�
�
$
�
� Operating expenses (A): Research and development 2,021 2,384
10,780 9,327 General and administrative � 1,151 � 1,141 � 4,259 �
4,320 Total operating expenses � 3,172 � 3,525 � 15,039 � 13,647
Loss from operations (3,172 ) (3,525 ) (15,039 ) (13,647 ) Interest
income, net � 42 � 252 � 443 � 678 Net loss $ (3,130 ) $ (3,273 ) $
(14,596 ) $ (12,969 ) � Loss per share: Basic and diluted $ (0.07 )
$ (0.07 ) $ (0.31 ) $ (0.31 ) � Shares used in computing per share
amounts Basic and diluted 47,592 47,524 47,572 42,133 � (A)
Operating expenses include the following non-cash stock
compensation charges: Research and development $ 76 $ 333 $ 722 $
1,371 General and administrative � 160 � 200 � 577 � 866 $ 236 $
533 $ 1,299 $ 2,237 �
Cortex Pharmaceuticals,
Inc.
Condensed Balance
Sheets
(in thousands)
� � December 31, � December 31, 2008 2007 Assets: Cash and cash
equivalents $ 1,431 $ 4,021 Marketable securities 2,710 13,263
Other current assets � 155 � 247 4,296 17,531 Furniture, equipment
and leasehold improvements, net 809 851 Other � 47 � 47 Total
assets $ 5,152 $ 18,429 � Liabilities and Stockholders� Equity:
Accounts payable and accrued expenses $ 1,755 $ 1,727 Deferred rent
liability �
25
Stockholders� equity � 3,397 � 16,677 Total liabilities and
stockholders� equity $ 5,152 $ 18,429
MORE INFORMATION AT
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