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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 2005 RESULTS
MENLO PARK, Calif.,
(November 8, 2005) -- Corcept Therapeutics Incorporated (NASDAQ: CORT)
today reported financial results for the third quarter ended September
30, 2005.
For the third quarter of 2005, Corcept reported a net loss of $5.2 million,
or $0.23 per share, compared to a net loss of $4.1 million, or $0.18 per
share, for the third quarter of 2004.
Total operating expenses were $5.5 million for the third quarter of 2005
compared to $4.3 million in the same period in 2004. In the third quarter
of 2005, research and development expenses increased to $4.5 million from
$3.1 million in the third 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 decreased to $1.0 million for the three months ended September
30, 2005, from $1.2 million for the three months ended September 30, 2004.
Decreases in stock based compensation and legal expenses were partially
offset by increases attributable to market research and staffing.
As of September 30,
2005, Corcept had cash, cash equivalents and marketable securities of
$33.4 million. The total cash used in the company's operating activities
for the first nine months of 2005 was $13.5 million.
Updating progress in the PMD clinical program, Joseph K. Belanoff, M.D.,
Chief Executive Officer of Corcept said, "During this past summer
we initiated steps to increase the pace of enrollment in our two U.S.-based
Phase III trials evaluating CORLUX for the treatment of the psychotic
features of PMD. As previously announced, we expect to report results
from our U.S.- based 07 trial in the first half of 2006, and results from
both our U.S.-based 06 trial and our European-based 09 trial in the second
half of 2006."
Dr. Belanoff added,
"We recently announced that we had signed an agreement with Eli Lilly
and Company in which Lilly has agreed to support a proof of concept clinical
study we will conduct. The study is designed to evaluate the ability of
CORLUX to mitigate weight gain associated with the use of olanzapine.
Under the agreement, Lilly will supply olanzapine and pay for the study.
Data resulting from the study will be shared with Lilly. This agreement
follows our announcement last April of the results from two preclinical
studies conducted in a rat model of olanzapine induced weight gain. These
studies demonstrated that CORLUX's GR-II antagonist action has the potential
to both reduce the weight gain associated with olanzapine and to prevent
the weight gain associated with the initiation of treatment with olanzapine.
We expect to report the results of this study in the first half of 2006."
Lastly, Dr. Belanoff
said, "We also recently announced our plans to close enrollment in
our Phase II clinical study to evaluate the safety and efficacy of CORLUX
in improving cognition in patients with mild to moderate Alzheimer's disease.
This was due to a slower than expected pace of enrollment. The study had
enrolled 80 patients; but was designed to enroll 160. We expect to report
the results of this trial in the first quarter of 2006."
Commenting on Corcept's
financial guidance for the remainder of 2005, Fred Kurland, Corcept's
Chief Financial Officer, stated, "Based on the timeline of our clinical
development program, we expect that net cash used in 2005 will be between
$17 million and $20 million. This differs from the guidance of $20 million
to $25 million we provided last quarter, primarily due to the slower than
expected pace of enrollment in our U.S.-based Phase III trials."
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."
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. 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 whether our issued
patents will be successfully challenged, there can be no assurances with
respect to commercial success; and financial projections may not be accurate;
there can be no assurances that the proof of concept study will be initiated
or 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)
| |
September 30,
2005
|
December 31,
2004
|
| |
(Unaudited)
|
(Note)
|
|
ASSETS:
|
|
|
|
Current assets:
|
|
|
|
Cash, cash equivalents and short-term investments
|
$ 29,811
|
$
37,401
|
|
Other current assets
|
830
|
838
|
|
Total current assets
|
30,641
|
38,239
|
|
|
|
|
|
Long-term
investments
|
3,549
|
9,486
|
|
Other
assets
|
131
|
47
|
|
Total assets
|
$
34,321
|
$
47,772
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDER’S EQUITY:
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|
|
|
Current
liabilities:
|
|
|
|
Accounts payable
|
$
833
|
$
550
|
|
Other current liabilities
|
1,823
|
1,274
|
|
Total current liabilities
|
2,656
|
1,824
|
|
Capital
lease obligation, long-term portion
|
45
|
-
|
|
Total
liabilities:
|
2,701
|
1,824
|
| |
|
|
|
Total
stockholders’ equity
|
31,620
|
45,948
|
| |
|
|
|
Total liabilities and stockholders’ equity
|
$
34,321
|
$ 47,772
|
Note: Derived from
audited consolidated financial statements at that date.
CORCEPT
THERAPEUTICS INCORPORATED
CONSOLIDATED STATEMENT OF OPERATIONS
(Unaudited)
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For
the Three Months Ended
September 30, |
For the Nine
MonthsEnded September 30, |
| |
| |
2005
|
2004
|
2005
|
2004
|
|
OPERATING
EXPENSES:
|
|
|
|
|
|
Research
and development*
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$ 4,521
|
$ 3,098
|
$ 12,560
|
$ 7,244
|
|
General
and administrative*
|
960
|
1,160
|
3,093
|
3,278
|
|
Total operating expenses
|
5,481
|
4,258
|
15,653
|
10,522
|
|
Interest
and other income, net
|
278
|
203
|
842
|
346
|
|
Non-operating
expense
|
(20)
|
(34)
|
(35)
|
(47)
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|
Net loss
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$
(5,223)
|
$
(4,089)
|
$
(14,846)
|
$ (10,223)
|
| |
|
|
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|
| |
|
|
|
|
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Basic and diluted net
loss per share
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$
(0.23)
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$
(0.18)
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$
(0.66)
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$
(0.60)
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Shares used in computing
basic and diluted net loss per share
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22,621
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22,532
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22,597
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17,058
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|
|
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*Includes non-cash stock-based compensation of the following:
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|
|
|
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Research and development
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$
53
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$
(141)
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$
(68)
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$ 118
|
|
General and administrative
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180
|
355
|
646
|
1,185
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Total non-cash stock-based compensation
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$
233
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$
214
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$
578
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$ 1,303
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