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Press Release
CONTACT:
Fred Kurland
Chief Financial Officer
Corcept Therapeutics
650-327-3270
IR@corcept.com
CORCEPT
THERAPEUTICS ANNOUNCES FIRST QUARTER 2005 RESULTS
MENLO PARK, Calif.,
(May 11, 2005) -- Corcept Therapeutics Incorporated (NASDAQ: CORT)
today reported financial results for the first quarter ended March 31,
2005.
For the first quarter of 2005, Corcept reported a net loss of $5.5 million,
or $0.24 per share, compared to a net loss of $2.6 million, or $0.29 per
share, for the first quarter of 2004.
Total operating expenses were $5.8 million for the first quarter of 2005
compared to $2.6 million in the same period in 2004. In the first quarter
of 2005, research and development expenses increased to $4.7 million from
$1.6 million in the first quarter of 2004. This increase in research and
development expenses over the prior year period was primarily related
to increased activity in the clinical development of CORLUX® for the
treatment of the psychotic features of psychotic major depression, or
PMD.
General and administrative
expenses increased to $1.1 million in the first quarter of 2005 from $1.0
million for the first quarter of 2004, attributable to increases in staffing,
insurance costs, professional fees and other costs related to being a
public company.
As of March 31, 2005,
Corcept had cash, cash equivalents and marketable securities of $41.1
million. The total cash used in the company's operating activities for
the first quarter was $5.7 million.
"Since the year
began, we have made progress in our clinical and preclinical programs",
said Joseph K. Belanoff, M.D., Chief Executive Officer of Corcept. "We
have initiated our third Phase III clinical trial evaluating CORLUX for
the treatment of the psychotic features of PMD. We have also initiated
a study to evaluate the safety and tolerability of retreatment with CORLUX."
Dr. Belanoff added,
"We recently completed preclinical studies showing that CORLUX has
the potential to both reduce the weight gain caused by olanzapine (the
active ingredient in the antipsychotic medication Zyprexa®) and to
prevent the weight gain caused by the initiation of treatment with olanzapine.
Enrollment continues in our phase II clinical trial in Alzheimer's disease.
We expect to report results on this trial in the first half of 2006."
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 the treatment of the psychotic
features of PMD."
Reiterating Corcept's
financial guidance for 2005, Fred Kurland, Corcept's Chief Financial Officer,
stated, "We continue to expect that net cash used in 2005 will be
between $25 million and $30 million."
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 III clinical trials for the treatment of the psychotic features
of psychotic major depression. 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. Corcept is also conducting a clinical trial to
evaluate the safety and efficacy of our product in improving cognition
in patients with mild to moderate Alzheimer's disease. 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 our clinical and preclinical 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;
and financial projections may not be accurate. 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.
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CORCEPT THERAPEUTICS INCORPORATED
CONDENSED BALANCE SHEETS
(in thousands)
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March 31,
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December 31,
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2005
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2004
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(Unaudited)
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(Note)
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ASSETS:
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Current assets:
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Cash,
cash equivalents and short-term investments
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$ 32,280
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$
37,401
|
|
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Other
current assets
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797
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838
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| |
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Total current assets
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33,077
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38,239
|
| |
|
|
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Long-term
investments
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8,801
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9,486
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Other
assets
|
51
|
47
|
| |
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Total
assets
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$ 41,929
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$ 47,772
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| |
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LIABILITIES
AND STOCKHOLDER’S EQUITY:
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Current
liabilities:
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Accounts
payable
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$
285
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$
550
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Other
current liabilities
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976
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1,274
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| |
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Total
current liabilities
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1,261
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1,824
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Total
stockholders’ equity
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40,668
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45,948
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| |
|
|
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| |
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Total
liabilities and stockholders’ equity
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$ 41,929
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$ 47,772
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Note: Derived from
audited consolidated financial statements at that date.
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CORCEPT THERAPEUTICS INCORPORATED
STATEMENT OF OPERATIONS
(in thousands, except per share data)
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For the Three Months Ended
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March 31,
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2005
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2004
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(Unaudited)
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OPERATING
EXPENSES:
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Research
and development*
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$
4,714
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$ 1,577
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General
and administrative*
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1,073
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993
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Total operating expenses
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5,787
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2,570
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Interest
and other income, net
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283
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25
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Interest
expense
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(8)
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(6)
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Net
loss
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$ (5,512)
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$ (2,551)
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Basic and diluted net
loss per share
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$ (0.24)
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$ (0.29)
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Shares used in computing
basic and diluted net loss per share
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22,576
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8,805
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*Includes non-cash stock-based compensation of the following:
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Research and development
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$
74
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$
141
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General and administrative
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253
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390
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Total non-cash stock-based compensation
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$ 327
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$ 531
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