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Press Release
CONTACT:
Fred Kurland
Chief Financial Officer
Corcept Therapeutics
650-327-3270
IR@corcept.com
CORCEPT THERAPEUTICS
ANNOUNCES THIRD QUARTER 2004 RESULTS
MENLO PARK, Calif.,
(October 28, 2004) -- Corcept Therapeutics Incorporated (NASDAQ: CORT)
today reported financial results for the third quarter and nine months
ended September 30, 2004.
For the third quarter of 2004, Corcept reported a net loss of $4.1 million,
or $0.18 per share compared to a net loss of $2.1 million, or $0.26 per
share for the third quarter of 2003. For the first nine months of 2004,
the company reported a net loss of $10.2 million, or $0.60 per share.
This compares to a net loss of $7.8 million or $0.99 per share for the
first nine months of 2003.
As of September 30, 2004, Corcept had cash, cash equivalents and marketable
securities of $51.8 million. The total cash used in the company's operating
activities for the third quarter and first nine months of 2004 was $3.4
million and $8.8 million, respectively.
Total operating expenses
were $4.3 million for the third quarter of 2004, which included $3.1 million
of research and development expenses. This compares to total operating
expenses of $2.2 million in the third quarter of 2003, which included
$1.5 million of research and development expenses. This increase in research
and development expenses over the prior year period was primarily related
to progress 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 $1.2 million in the third quarter
of 2004 from $614,000 for the same period in 2003. This increase was attributable
to an increase in non-cash stock-based compensation, and increases in
patent, legal and professional fees, as well as staffing and insurance
costs.
During the third quarter
of 2004, Corcept reached agreement with the Food and Drug Administration
(FDA) on Special Protocol Assessments (SPA's) for the design of two pivotal
Phase III clinical trials evaluating CORLUX for the treatment of the psychotic
features of PMD. The Company initiated the first of these trials in September
and the second one in October.
"We have accomplished
a great deal recently" said Joseph K. Belanoff, M.D., Corcept's Chief
Executive Officer. "As discussed above, we initiated our pivotal
clinical trials shortly after reaching the SPA agreements with the FDA.
We anticipate reporting initial results from both trials in the first
half of 2006." Due to the serious nature of PMD and the lack of approved
drugs for the disorder, the FDA has granted Fast Track designation for
CORLUX for the treatment of the psychotic features of PMD.
Commenting on Corcept's
financial guidance for the remainder of 2004, Fred Kurland, Corcept's
Chief Financial Officer, stated, "Now that we have started our pivotal
clinical trials, we anticipate an increase in the pace of our spending.
Through the end of the third quarter, our net cash used was just under
$9 million for 2004. We currently expect the net cash used to be between
$15 million and $17 million for 2004."
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 PMD clinical development program, the timing of results
of our clinical trials, our spending pace, and our expected expenses.
Forward-looking statements are subject to a number of known and unknown
risks and uncertainties which 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, 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. 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 CONSOLIDATED BALANCE SHEETS
(Unaudited)
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September 30,
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December
31,
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2004
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2003
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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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$48,906,027
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$11,577,283
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Other
current assets
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672,859
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165,341
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Total current assets
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49,578,886
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11,742,624
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Long-term
investments
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2,853,646
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-
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Other
assets
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56,500
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38,336
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Total
assets
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$52,489,032
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$11,780,960
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LIABILITIES
AND STOCKHOLDER’S EQUITY:
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Current
liabilities:
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Accounts
payable
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$ 980,479
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$ 321,806
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Other
current liabilities
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653,514
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692,180
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Total
current liabilities
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1,633,993
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1,013,986
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Other
liabilities
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-
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523,689
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Total
liabilities
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1,633,993
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1,537,675
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Convertible
preferred stock
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-
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41,715,974
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Stockholders’
equity:
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Common
stock
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22,687
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9,335
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Additional
paid-in capital
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101,410,794
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8,981,827
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Notes
receivable from stockholders
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(246,258)
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(246,258)
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Deferred
compensation
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(2,143,566)
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(2,279,524)
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Deficit
accumulated during the development stage
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(48,160,861)
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(37,937,426)
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Accumulated
other comprehensive loss
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(27,757)
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(643)
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Total
stockholders’ equity
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50,855,039
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(31,472,689)
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Total
liabilities and stockholders’ equity
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$52,489,032
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$11,780,960
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