IRVINE, Calif.--(Business Wire)--
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 WWW.CORTEXPHARM.COM
Cortex Pharmaceuticals, Inc.
Mark A. Varney, Ph.D., 949-727-3157
President and CEO
or
The Investor Relations Group
Investors:
Erika Moran/ Dian Griesel, Ph.D.
Media:
Janet Vasquez
212-825-3210
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