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Press Release
CONTACT:
Fred Kurland
Chief Financial Officer
Corcept Therapeutics
650-327-3270
IR@corcept.com
www.corcept.com
CORCEPT
THERAPEUTICS ANNOUNCES FIRST QUARTER 2006 RESULTS
MENLO
PARK, Calif., (May 9, 2006) -- Corcept Therapeutics Incorporated (NASDAQ:
CORT) today reported financial results for the first quarter ended March
31, 2006.
For
the first quarter of 2006, Corcept reported a net loss of $6.7 million,
or $0.30 per share, compared to a net loss of $5.5 million, or $0.24 per
share, for the first quarter of 2005.
Total
operating expenses were $7.1 million for the first quarter of 2006 compared
to $5.8 million in the same period in 2005. In the first quarter of 2006,
research and development expenses increased to $5.8 million from $4.7
million in the first quarter of 2005. This increase was primarily related
to increased activity in the clinical development of CORLUX® for treating
the psychotic features of psychotic major depression, or PMD.
General and administrative
expenses increased to $1.3 million for the three months ended March 31,
2006, from $1.1 million for the three months ended March 31, 2005 due
to increases in legal and professional fees, staffing and stock based
compensation.
As of March 31 2006,
Corcept had cash, cash equivalents and marketable securities of $23.9
million. The total cash used in the company's operating activities for
the first three months of 2006 was $5.7 million.
Total revenue was $121,000 for the first quarter of 2006 from the collaboration
with Eli Lilly and Company ("Lilly") in which Lilly is providing
the Company funding to support the costs of a clinical study that has
been initiated. The results of this study are expected to be reported
in the second half of 2006. Total revenues from this collaboration are
expected to be between $500,000 and $1.0 million. There were no revenues
recorded prior to 2006.
Updating progress in the PMD clinical program, Joseph K. Belanoff, M.D.,
Chief Executive Officer of Corcept said, "Last week we announced
the completion of patient enrollment in the first of our three Phase 3
trials evaluating CORLUX for treating the psychotic features of PMD. We
expect to report results from this trial, Study 07, in August 2006. We
also plan to report the results of our other two Phase 3 trials, Study
09 and Study 06, in the third and fourth quarters, respectively."
Commenting on Corcept's
financial guidance for the first quarter of 2006 Fred Kurland, Corcept's
Chief Financial Officer, stated, "Based on the timeline of our clinical
development program, we expect that net cash used in 2006 will be between
$20 million and $25 million."
Dr. Belanoff further
stated, "We believe that our cash and marketable securities will
enable us to complete, as currently planned, the clinical development
of our lead product candidate, CORLUX, for treating of the psychotic features
of PMD."
About Psychotic
Major Depression
PMD is a serious psychiatric disorder that affects about three million
people in the United States every year. It is more prevalent than either
schizophrenia or manic depression. 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 focused
on developing drugs for treating severe psychiatric and neurological diseases.
Corcept's lead product, CORLUX, is in Phase 3 clinical trials for treating
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 reduce the effects of the elevated and abnormal release patterns
of cortisol seen in PMD. The company has also initiated a proof-of-concept
study to evaluate the ability of CORLUX to mitigate weight gain associated
with the use of olanzapine. For more information, 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 our clinical development programs, the expected timing of
results of our clinical trials, our spending pace, and our expected financial
results. 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
assurances with respect to the regulatory process or regulatory approvals;
there can be no assurances with respect to commercial success; financial
projections may not be accurate; there can be no assurances that the proof
of concept study will be completed, that the study will be successful,
or that Corcept will decide to pursue further activities with respect
to weight gain associated with olanzapine or other antipsychotic medications.
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)
| |
March 31,
2006
|
December
31,
2005
|
| |
| |
(Unaudited)
|
(Note)
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ASSETS:
|
|
|
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Current
assets:
|
|
|
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Cash, cash equivalents
and short-term investments
|
$
23,940
|
$
29,080
|
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Other current
assets
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1,550
|
425
|
|
Total
current assets
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25,490
|
29,505
|
|
|
|
|
|
Long-term investments
|
—
|
539
|
|
Other assets
|
112
|
112
|
|
Total assets
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$
25,602
|
$
30,156
|
|
|
|
|
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LIABILITIES
AND STOCKHOLDER’S EQUITY:
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|
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Current liabilities:
|
|
|
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Accounts payable
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$
1,231
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$ 549
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Other current liabilities
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3,964
|
2,972
|
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Total current liabilities
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5,195
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3,521
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Capital lease
obligation, long-term portion
|
39
|
42
|
|
Total liabilities
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5,234
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3,563
|
| |
|
|
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Total stockholders’
equity
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20,368
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26,593
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| |
|
|
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Total liabilities and stockholders’ equity
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$
25,602
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$
30,156
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Note: Derived from
audited financial statements at that date.
CORCEPT
THERAPEUTICS INCORPORATED
STATEMENT OF OPERATIONS
(in thousands, except per share data)
(Unaudited)
| |
For the Three
Months
Ended
March
31,
|
| |
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2006
|
2005
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Collaboration
revenue
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$
121
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$
—
|
| |
|
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Operating expenses:
|
|
|
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Research and
development*
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5,784
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4,714
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General and
administrative*
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1,316
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1,073
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Total operating expenses
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7,100
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5,787
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| |
|
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Loss from operations
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(6,979)
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(5,787)
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Interest and
other income, net
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252
|
283
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Other expense
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(3)
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(8)
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Net loss
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$
(6,730)
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$
(5,512)
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| |
|
|
| |
|
|
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Basic
and diluted net loss per share
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$
(0.30)
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$
(0.24)
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Shares
used in computing basic and diluted net loss per share
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22,658
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22,576
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*Includes non-cash
stock-based compensation of the following:
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Research and development
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$
193
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$
74
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General and administrative
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280
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253
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Total
non-cash stock-based compensation
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$
473
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$
327
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