MENLO PARK, CA -- (MARKET WIRE) -- March 28, 2007 --Corcept Therapeutics Incorporated (
NASDAQ:
CORT) today reported financial results for the fourth quarter and the full
year ended December 31, 2006.
For the fourth quarter of 2006, Corcept reported a net loss of $3.9
million, or $0.16 per share, compared to a net loss of $5.2 million, or
$0.23 per share, for the fourth quarter of 2005. For the full year 2006,
the company reported a net loss of $24.9 million, or $1.09 per share. This
compares to a net loss of $20.1 million, or $0.89 per share, for the full
year 2005.
As of December 31, 2006, Corcept had cash, cash equivalents and marketable
securities of $9.5 million. The total cash used in the company's operating
activities for the full year 2006 was $23.2 million. Commenting on
Corcept's financial guidance for 2007, Fred Kurland, Corcept's Chief
Financial Officer, stated, "Based on the currently planned timeline of our
clinical development program and assuming that we are able to raise funds
for intended operations, we expect that net cash used in 2007 will be
between $10 million and $15 million. If we are not able to raise additional
funds, we will not be able to continue operations beyond the second quarter
of 2007."
Total operating expenses decreased to $4.1 million for the fourth quarter
of 2006, from $5.5 million for the same period in 2005. In the fourth
quarter of 2006, research and development expenses decreased to $2.9
million from $4.5 million in the fourth quarter of 2005. This decrease in
research and development expenses over the prior year period was primarily
related to decreased activity in the clinical development of CORLUX® for
the treatment of the psychotic features of psychotic major depression, or
PMD, because the first two of the company's three Phase 3 trials had
completed patient activity earlier in 2006.
General and administrative expenses increased to $1.1 million for the
fourth quarter of 2006, from $1.0 million for the same period in 2005,
primarily due to increases in stock-based and cash compensation.
During the quarter and year ended December 31, 2006, the company recognized
approximately $73,000 and $294,000, respectively, of revenue from the
collaboration with Eli Lilly and Company to conduct a proof-of-concept
clinical study evaluating the ability of CORLUX, a GR-II antagonist, to
mitigate weight gain associated with the use of olanzapine. No revenue had
been recognized during 2005.
Recently Announced Clinical Trial Results
On March 19, 2007, the company announced that Study 06, the last of three
Phase 3 trials evaluating CORLUX for treating the psychotic features of
PMD, did not achieve statistical significance with respect to its primary
endpoint. However, there was a statistically significant correlation
between plasma levels and clinical outcome achieved during treatment.
Further, the company reported that the incidence of serious adverse events
did not differ between placebo and any of the three CORLUX dose groups.
Patients whose plasma levels rose above a predetermined threshold
statistically separated from both those whose plasma levels were below the
threshold and those patients who received placebo. This confirmed a similar
finding in Study 07, another Phase 3 trial testing CORLUX for PMD completed
in 2006.
"While we are disappointed that the trial did not meet the primary
endpoint, we are particularly encouraged to have met the important
predefined threshold drug concentration endpoint with statistical
significance," said Joseph K. Belanoff, M.D., Corcept's Chief Executive
Officer. "This study confirms our previous observation that at higher
plasma levels the drug candidate is able to demonstrate desired clinical
effects. In particular, those patients in Study 06 who achieved a
predetermined level of 1661 nanograms of CORLUX per milliliter of plasma
separated from the placebo group with statistical significance."
Robert L. Roe, M.D., Corcept's President, said, "We believe that the
confirmation of a drug concentration threshold for efficacy as well as
other observations from Study 06 and the company's two recently completed
Phase 3 clinical trials will serve as a strong basis for the company's next
Phase 3 study. In the upcoming trial, planned to commence later in 2007, we
expect to use a dose level of 1200 mg once per day for seven days because,
in Study 06, 80% of the patients achieved a drug plasma level sufficient
for a strong clinical response at that dose. In our initial review of a
summary of the safety data, we have seen no difference between any of the
dose levels used in Study 06. We believe that this change in dose as well
as other modifications to the protocol should allow us to definitively
demonstrate the efficacy of CORLUX in the treatment of the psychotic
features of PMD."
About Psychotic Major Depression
PMD is a serious psychiatric disorder that affects approximately three
million people annually in the United States. It is more prevalent than
either schizophrenia or manic depressive illness. The disorder is
characterized by severe depression accompanied by delusions, hallucinations
or both. People with PMD are approximately 70 times more likely to commit
suicide than the general population and often require lengthy and expensive
hospital stays. There is no FDA-approved treatment for PMD.
About Corcept Therapeutics Incorporated
Corcept Therapeutics Incorporated is a pharmaceutical company engaged in
the development of drugs for the treatment of severe psychiatric and
neurological diseases. Corcept's lead product, CORLUX, is currently in
Phase 3 clinical trials for the treatment of the psychotic features of PMD.
The drug is administered orally to PMD patients once per day for seven
days. CORLUX, a potent GR-II antagonist, appears to mitigate the effects
of the elevated and abnormal release patterns of cortisol seen in PMD. The
Company is also conducting a proof-of-concept study evaluating the ability
of CORLUX to mitigate weight gain associated with the use of olanzapine.
For additional information about the company, please visit
www.corcept.com.
Statements made in this news release, other than statements of historical
fact, are forward-looking statements, including, for example, statements
relating to Corcept's clinical development programs, its spending plans and
milestone dates for the financing. Forward-looking statements are subject
to a number of known and unknown risks and uncertainties that might cause
actual results to differ materially from those expressed or implied by such
statements. For example, there can be no assurances with respect to the
commencement, cost, rate of spending, completion or success of clinical
trials; there can be no assurance with respect to the consummation of
financing activities; financial projections may not be accurate; there can
be no assurances that the investigations for the Phase 3 clinical trials
will be completed, or that that Corcept will pursue further activities with
respect to clinical development of CORLUX. These and other risk factors
are set forth in the Company's SEC filings, all of which are available from
our website (
www.corcept.com) or from the SEC's website (
www.sec.gov). We
disclaim any intention or duty to update any forward-looking statement made
in this news release.
CORCEPT THERAPEUTICS INCORPORATED
CONDENSED BALANCE SHEETS
(in thousands)
December 31, December 31,
2006 2005
------------ ------------
(Unaudited) (Note)
ASSETS:
Current assets:
Cash, cash equivalents and short-term
investments $ 9,456 $ 29,080
Other current assets 343 425
------------ ------------
Total current assets 9,799 29,505
Long-term investments -- 539
Other assets 103 112
------------ ------------
Total assets $ 9,902 $ 30,156
============ ============
LIABILITIES AND STOCKHOLDERS EQUITY:
Current liabilities:
Accounts payable $ 916 $ 549
Other current liabilities 2,597 2,972
------------ ------------
Total current liabilities 3,513 3,521
Capital lease obligation, long-term portion 29 42
------------ ------------
Total liabilities: 3,542 3,563
Total stockholders equity 6,360 26,593
------------ ------------
Total liabilities and stockholders equity $ 9,902 $ 30,156
============ ============
Note: Derived from audited financial statements at that date.
CORCEPT THERAPEUTICS INCORPORATED
STATEMENT OF OPERATIONS
(in thousands, except per share amounts)
For the Three Months
Ended December 31, Year Ended December 31,
------------------------ ------------------------
2006 2005 2006 2005
(Unaudited) (Unaudited) (Unaudited) (Audited)
Collaboration revenue $ 73 $ -- $ 294 $ --
----------- ----------- ----------- -----------
Operating expenses:
Research and
development* 2,922 4,514 20,834 17,074
General and
administrative* 1,141 991 5,042 4,084
----------- ----------- ----------- -----------
Total operating
expenses 4,063 5,505 25,876 21,158
----------- ----------- ----------- -----------
Loss from operations (3,990) (5,505) (25,582) (21,158)
----------- ----------- ----------- -----------
Interest and other
income, net 110 275 719 1,117
Other expense, net 4 (17) (10) (52)
----------- ----------- ----------- -----------
Net loss $ (3,876) $ (5,247) $ (24,873) $ (20,093)
=========== =========== =========== ===========
Basic and diluted net
loss per share $ (0.16) $ (0.23) $ (1.09) $ (0.89)
=========== =========== =========== ===========
Shares used in
computing basic and
diluted net loss per
share 23,283 22,640 22,841 22,608
=========== =========== =========== ===========
*Includes non-cash
stock-based
compensation of the
following:
Research and
development $ 80 $ 41 $ 535 $ (26)
General and
administrative 210 153 1,013 799
----------- ----------- ----------- -----------
Total non-cash
stock-based
compensation $ 290 $ 194 $ 1,548 $ 773
=========== =========== =========== ===========
Contact Information: CONTACT:
Fred Kurland
Chief Financial Officer
Corcept Therapeutics
650-327-3270
Email Contact
www.corcept.com