MENLO PARK, CA--(Marketwire - August 13, 2008) - Corcept Therapeutics Incorporated (
NASDAQ:
CORT) today reported financial results for the second quarter ended June
30, 2008.
For the second quarter of 2008, Corcept reported a net loss of $4.4
million, or $0.09 per share, compared to a net loss of $1.4 million, or
$0.04 per share, for the second quarter of 2007. For the first six months
of 2008, the company reported a net loss of $8.3 million, or $0.19 per
share, compared to a net loss of $4.0 million, or $0.13 per share, for the
same period in 2007.
On May 1, 2008, we announced that our lead selective GR-II antagonist, CORT
108297, produced encouraging results in a human microdosing study. CORT
108297 is a non-steroidal, potent, competitive antagonist at the GR-II
(cortisol) receptor that does not have affinity for the PR (progesterone)
receptor. The compound was extremely well absorbed, demonstrated good
bioavailability and had a half-life that appears compatible with once-a-day
oral dosing.
Commenting on the microdosing study, Joseph K. Belanoff, M.D., Chief
Executive Officer of the company, said, "There is increasing evidence that
excess cortisol may play a role in the pathogenesis of several important
metabolic diseases including diabetes, obesity and hypertension, in
addition to Cushing's Syndrome and psychiatric illnesses. CORT 108297, a
selective GR-II antagonist, would have advantages over drugs that also
block the progesterone receptor, especially in diseases that require
chronic therapy. Separating antagonist activity at the cortisol receptor
from the progesterone receptor is a significant achievement in medicinal
chemistry."
In regard to the company's clinical program, Dr. Robert L. Roe, the
company's President, commented, "We have begun to enroll patients in our
Phase 3 trial of CORLUX for the psychotic features of psychotic depression
and anticipate that we will have a sufficient number of patients enrolled
by late 2009 to enable the data safety monitoring board, independent of the
Company, to perform an interim analysis evaluating safety and top-line
efficacy results from the first half of the study. We have also initiated
sites and are screening patients for enrollment into our Phase 3 pivotal
study of CORLUX for the treatment of endogenous Cushing's Syndrome.
Because only an estimated 10 to 15 of every one million people are newly
diagnosed each year with Cushing's Syndrome, identification and enrollment
of the 50 patients for the study is anticipated to be an extended process."
As of June 30, 2008, Corcept had cash, cash equivalents and marketable
securities of $26.1 million. The total cash used in the company's
operating activities for the first six months of 2008 was $9.9 million.
Total operating expenses increased to $4.7 million for the second quarter
of 2008 and $8.8 million for the first half of 2008, from $2.0 million and
$4.7 million, respectively, for the same periods in 2007. In the second
quarter and first half of 2008, research and development expenses increased
to $3.3 million and $6.1 million, respectively, from $1.2 million and $2.8
million, respectively, in the same periods of 2007. This increase in
research and development expenses was due to increases in the research
program related to the study of new selective GR-II antagonists and changes
in the development program for CORLUX as the costs associated with
commencement of new Phase 3 trials for the treatment of the psychotic
features of psychotic depression and Cushing's Syndrome and manufacturing
development were only partially offset by decreases in the costs associated
with the earlier trials completed in 2007.
General and administrative expenses increased to $1.4 million for the
second quarter and $2.6 million for the first half of 2008, from $793,000
and $1.9 million, respectively, for the same periods in 2007, primarily
attributable to increases in stock-based compensation expense and cash
compensation. The figures for the second quarter and first half of 2007
included a reversal of stock compensation expense of approximately $393,000
related to the resignation of an administrative employee.
Commenting on Corcept's financial guidance for 2008, Anne LeDoux, Corcept's
Vice President and Controller, stated, "Based on the currently planned
timeline of our clinical development program, we expect that cash used in
operations in 2008 will be between $21 million and $25 million."
About Psychotic Depression
Psychotic depression is a serious psychiatric disorder that affects
approximately three million people annually in the United States. It is
more prevalent than either schizophrenia or bipolar I disorder. The
disorder is characterized by severe depression accompanied by delusions,
hallucinations or both. People with psychotic depression 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 psychotic depression.
About Cushing's Syndrome
Cushing's Syndrome is caused by prolonged exposure of the body's tissues to
high levels of the hormone cortisol. Cushing's Syndrome is relatively rare
and most commonly affects adults aged 20 to 50. An estimated 10 to 15 of
every one million people are newly diagnosed with this syndrome each year.
Symptoms vary, but most people have one or more of the following
manifestations: high blood sugar, high blood pressure, upper body obesity,
rounded face, increased fat around the neck, thinning arms and legs, severe
fatigue and weak muscles. Irritability, anxiety, cognitive disturbances
and depression are common. Cushing's Syndrome can affect every organ
system in the body and can be lethal if not treated effectively.
About Weight Gain associated with Antipsychotic Medications
The group of medications known as atypical antipsychotics, including
olanzapine, risperidone, clozapine and quetiapine, are widely used to treat
schizophrenia and bipolar disorder. All medications in this group are
associated with treatment emergent weight gain of varying degrees and carry
a warning label relating to treatment emergent hyperglycemia and diabetes
mellitus. Weight gain and alterations in metabolic efficiency have been
observed for many years in patients with abnormally high circulating
cortisol.
About Corcept Therapeutics Incorporated
Corcept Therapeutics Incorporated is a pharmaceutical company engaged in
the development of GR-II antagonist drugs for the treatment of severe
psychiatric and metabolic diseases. Corcept's lead product, CORLUX, is
currently in Phase 3 clinical trials for the treatment of the psychotic
features of psychotic depression and Cushing's Syndrome. The Company is
also engaged in preparation for clinical trials to evaluate CORLUX for the
mitigation of weight gain induced by antipsychotic medications and
continued development work on its proprietary, selective GR-II antagonists.
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 and research programs, and its
spending plans as well as the amount of funds that may be raised under the
CEFF. 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 pace of enrollment,
cost, rate of spending, completion or success of clinical trials; financial
projections may not be accurate; there can be no assurances that Corcept
will pursue further activities with respect to the development of CORLUX,
CORT 108297, or any of its other selective GR-II antagonists. 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)
June 30, December 31,
2008 2007
----------- -----------
(Unaudited) (Note)
ASSETS:
Current assets:
Cash, cash equivalents and short-term investments $ 26,123 $ 17,366
Other current assets 1,638 290
----------- -----------
Total current assets 27,761 17,656
Other assets 82 88
----------- -----------
Total assets $ 27,843 $ 17,744
=========== ===========
LIABILITIES AND STOCKHOLDERS' EQUITY:
Current liabilities:
Accounts payable $ 1,098 $ 1,115
Other current liabilities 819 1,879
----------- -----------
Total current liabilities 1,917 2,994
Capital lease obligation, long-term portion 12 16
Total stockholders' equity 25,914 14,734
----------- -----------
Total liabilities and stockholders' equity $ 27,843 $ 17,744
=========== ===========
Note: Derived from audited financial statements at that date.
CORCEPT THERAPEUTICS INCORPORATED
STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
For the Three Months For the Six Months
Ended June 30, Ended June 30,
------------------ ------------------
2008 2007 2008 2007
Collaboration revenue $ -- $ 374 $ -- $ 482
Operating expenses:
Research and development* 3,277 1,160 6,126 2,761
General and administrative* 1,410 793 2,643 1,928
-------- -------- -------- --------
Total operating expenses 4,687 1,953 8,769 4,689
-------- -------- -------- --------
Loss from operations (4,687) (1,579) (8,769) (4,207)
-------- -------- -------- --------
Interest and other income, net 298 164 455 261
Other expense (7) (2) (11) (6)
-------- -------- -------- --------
Net loss $ (4,396) $ (1,417) $ (8,325) $ (3,952)
======== ======== ======== ========
Basic and diluted net loss per
share $ (0.09) $ (0.04) $ (0.19) $ (0.13)
======== ======== ======== ========
Shares used in computing basic
and diluted net loss per share 48,473 34,742 44,354 30,361
======== ======== ======== ========
*Includes non-cash stock-based
compensation of the following:
Research and development $ 67 $ 56 $ 132 $ 85
General and administrative 344 (108) 694 113
-------- -------- -------- --------
Total non-cash stock-based
compensation $ 411 $ (52) $ 826 $ 198
======== ======== ======== ========
Contact Information: CONTACT:
Joseph Belanoff
Chief Executive Officer
Corcept Therapeutics
650-327-3270
www.corcept.com