-- Enrolled patients in our 50-patient open-label Phase 3 trial of CORLUX
in patients with Cushing's Syndrome, which is being conducted at leading
institutions throughout the United States.
-- Enrolled patients in our double-blind placebo controlled Phase 3 trial
of CORLUX in patients with psychotic depression. We have completed the
previously announced reduction in spending on this trial to conserve our
resources, and are now conducting the trial at eight clinical sites.
-- Presented positive results from studies of CORLUX and one of our next
generation selective GR-II antagonists, CORT 108297, at the American
Diabetes Association and the Collegium International Neuro-
Psychopharmacologicum annual meetings. These data demonstrated the
potential of GR-II antagonists to prevent weight gain and reduce abdominal
fat, fasting insulin, and triglycerides caused by antipsychotic drugs
widely used for the treatment of schizophrenia and bipolar disorder.
-- Published results from one of our earlier Phase 3 trials of CORLUX for
the treatment of psychotic depression in the journal Contemporary Clinical
Trials. The results demonstrate a statistically significant association
between CORLUX plasma concentration and response rate and also exhibit
meaningful variability across clinical sites. Both findings were
instructive in designing our ongoing Phase 3 trial in psychotic depression,
including an increase in dose administered and the addition of centralized
raters.
Second Quarter and Financial Results
For the second quarter of 2009, Corcept reported a net loss of $4.9
million, or $0.10 per share, compared to a net loss of $4.4 million, or
$0.09 per share, for the second quarter of 2008.
As of June 30, 2009, Corcept had cash, cash equivalents and marketable
securities of $14.4 million. The total cash used in the company's
operating activities for the first six months of 2009 was $9.9 million.
Total operating expenses increased to $4.9 million for the second quarter
of 2009, from $4.7 million for the same period in 2008. In the second
quarter of 2009, research and development expenses of $3.3 million were
flat with the second quarter of 2008. Increased spending on the clinical
trial for the treatment of Cushing's Syndrome and for development of our
new selective GR-II antagonists was offset by decreased spending associated
with the clinical trial for the treatment of the psychotic features of
psychotic depression, as we executed on our previously announced plan to
scale back that program.
General and administrative expenses increased to $1.5 million for the
second quarter of 2009, from $1.4 million for the same period in 2008,
primarily attributable to increases in staffing and consultancy expenses.
Outlook for the Remainder of 2009
We expect continued progress in the development of CORLUX and our series of
selective GR-II antagonists during the remainder of 2009. We remain on
track to complete enrollment in our Phase 3 pivotal trial of CORLUX in
Cushing's Syndrome by the end of 2009, generating data from the trial in
mid-2010. The FDA granted us Orphan Drug Designation for CORLUX for the
treatment of endogenous Cushing's Syndrome, which provides seven years of
marketing exclusivity from the date of approval, as well as tax credits for
clinical trial costs, marketing application filing fee waivers and
assistance from the FDA in the drug development process. We believe that
the Cushing's program provides us with a near-term value creation
opportunity for our shareholders.
We continue to enroll patients in our Phase 3 trial in psychotic
depression. As announced earlier this year, due to the relatively high
cost of this program, length of the trial, and our current financial
constraints, we scaled back our planned rate of spending, reduced the
number of clinical sites to eight, and extended the timeline for completion
of this trial.
Based on the positive results from several preclinical studies of our
next-generation selective GR-II antagonist, CORT 108297, for the mitigation
of weight gain and related metabolic disturbances, as well as positive
proof-of-concept data with CORLUX in humans, we plan to submit an IND for
CORT 108297 by year-end.
"We continue to focus on moving Cushing's Syndrome towards a New Drug
Application (NDA) submission, while advancing our other programs in a
deliberate, cost effective manner," added Dr. Belanoff. "We continue to
anticipate our current cash balance is sufficient to operate the company
into early 2010, even in the absence of any additional financing," said
Caroline Loewy, Chief Financial Officer of Corcept.
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,
resulting in an incidence of over 3,000 new patients in the US. An
estimated 20,000 patients in the US have Cushing's Syndrome. Symptoms
vary, but most people have one or more of the following manifestations:
high blood sugar, diabetes, 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. There is
no
FDA-approved treatment for Cushing's Syndrome.
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 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 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. There is no FDA-approved treatment for the weight gain
associated with the use of antipsychotic medications.
About CORLUX
Corcept's first-generation compound, CORLUX, also known as mifepristone,
directly blocks the GR-II receptor and the progesterone receptor.
Intellectual property protection is in place to protect important methods
of use for CORLUX. Corcept retains worldwide rights to its intellectual
property related to CORLUX.
About CORT 108297
CORT 108297 is one of several potent, selective antagonists of the GR-II
(cortisol) receptor that we have discovered and for which Corcept owns
worldwide intellectual property rights. In in vitro binding affinity and
functional assays it does not have affinity for the PR (progesterone), ER
(estrogen), AR (androgen) or GR-I (mineralocorticoid) receptors.
About Corcept Therapeutics Incorporated
Corcept is a pharmaceutical company engaged in the development of drugs for
the treatment of severe metabolic and psychiatric disorders. The company
has two Phase 3 programs ongoing; CORLUX for the treatment of Cushing's
Syndrome and CORLUX for the treatment of the psychotic features of
psychotic depression. Corcept has also developed an extensive intellectual
property portfolio that covers the use of GR-II antagonists in the
treatment of a wide variety of psychiatric and metabolic disorders,
including the prevention of weight gain caused by the use of antipsychotic
medication.
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, the
timing of the introduction of CORLUX and future product candidates,
including CORT 108297, estimates of the timing of enrollment or completion
of our clinical trials and the anticipated results of those trials, the
ability to create value from CORLUX or other future product candidates and
our estimates regarding our capital requirements, spending plans and needs
for additional financing. 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
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,
2009 2008
------------ ------------
(Unaudited) (Note)
ASSETS:
Current assets:
Cash, cash equivalents and short-term
investments $ 14,447 $ 18,309
Other current assets 974 1,270
------------ ------------
Total current assets 15,421 19,579
Other assets 189 196
------------ ------------
Total assets $ 15,610 $ 19,775
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY:
Current liabilities:
Accounts payable $ 670 $ 1,304
Other current liabilities 1,468 1,558
------------ ------------
Total current liabilities 2,138 2,862
Capital lease obligation, long-term portion 1 6
Total stockholders' equity 13,471 16,907
------------ ------------
Total liabilities and stockholders' equity $ 15,610 $ 19,775
============ ============
Note: Derived from December 31, 2008 audited financial statements.
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,
-------------------- --------------------
2009 2008 2009 2008
Collaboration revenue $ 6 $ -- $ 30 $ --
--------- --------- --------- ---------
Operating expenses:
Research and development* 3,342 3,277 7,526 6,126
General and
administrative* 1,546 1,410 2,920 2,643
--------- --------- --------- ---------
Total operating expenses 4,888 4,687 10,446 8,769
--------- --------- --------- ---------
Loss from operations (4,882) (4,687) (10,416) (8,769)
--------- --------- --------- ---------
Interest and other income, net 6 298 92 455
Other expense (2) (7) (4) (11)
--------- --------- --------- ---------
Net loss $ (4,878) $ (4,396) $ (10,328) $ (8,325)
========= ========= ========= =========
Basic and diluted net loss per
share $ (0.10) $ (0.09) $ (0.21) $ (0.19)
========= ========= ========= =========
Shares used in computing basic
and diluted net loss per share 49,763 48,473 49,763 44,354
========= ========= ========= =========
*Includes non-cash stock-based
compensation of the following:
Research and development $ 68 $ 67 $ 132 $ 132
General and administrative 399 344 758 694
--------- --------- --------- ---------
Total non-cash
stock-based
compensation $ 467 $ 411 $ 890 $ 826
========= ========= ========= =========
Contact Information: CONTACT: Caroline Loewy Chief Financial Officer Corcept Therapeutics 650-688-8783 www.corcept.com