-- Enrolled patients in our 50-patient open-label Phase 3 trial of CORLUX
in patients with Cushing's Syndrome.
-- Enrolled patients in our 450-patient double-blind placebo controlled
Phase 3 trial of CORLUX in patients with psychotic depression on the
previously announced scaled back basis to conserve capital in light of the
company's financial constraints.
-- Announced positive results from a human proof of concept study of
CORLUX, demonstrating the potential of GR-II antagonists to prevent weight
gain and reduce levels of abdominal fat, fasting insulin, and triglycerides
caused by initiation of treatment with Risperdal® (a leading
antipsychotic for the treatment of schizophrenia and bipolar disorder
marketed by Johnson & Johnson).
-- Announced positive results from two preclinical studies of one of our
next-generation selective GR-II antagonists, CORT 108297, demonstrating the
potential to both reduce weight gain caused by olanzapine and to prevent
weight gain caused by initiation of treatment with olanzapine. Olanzapine
is the active ingredient in Lilly's Zyprexa®, which is indicated for the
treatment of schizophrenia and bipolar disorder.
First Quarter and Financial Results
For the first quarter of 2009, Corcept reported a net loss of $5.5 million,
or $0.11 per share, compared to a net loss of $3.9 million, or $0.10 per
share, for the first quarter of 2008.
As of March 31, 2009, Corcept had cash, cash equivalents and marketable
securities of $20.6 million, which included the collection in February 2009
of a note receivable of $6.0 million plus accrued interest. The total cash
used in the company's operating activities for the first quarter of 2009
was $3.7 million.
Total operating expenses increased to $5.6 million for the first quarter of
2009, from $4.1 million for the same period in 2008. In the first quarter
of 2009, research and development expenses increased to $4.2 million from
$2.9 million in the first quarter of 2008. This increase in research and
development expenses was due primarily to the costs associated with the
clinical trials for the treatment of Cushing's Syndrome, the treatment of
the psychotic features of psychotic depression, and the mitigation of
weight gain caused by Risperdal, as well as increased spending with respect
to the research program related to the study of new selective GR-II
antagonists.
General and administrative expenses increased to $1.4 million for the first
quarter of 2009, from $1.2 million for the same period in 2008, primarily
attributable to increases in staffing and consultancy expenses.
Outlook for 2009
We expect continued progress in the development of CORLUX and our series of
selective GR-II antagonists during 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. We believe that the
Cushing's program provides us with the best near-term value creation
opportunity for our shareholders. 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 are continuing to enroll our Phase 3 trial in psychotic depression, on a
limited basis. As previously announced, due to the relatively high cost of
this program, length of the trial, and our current financial constraints,
we have scaled back our planned rate of spending 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 markers, as well as the positive
proof-of-concept data with CORLUX, we plan to file an Investigational New
Drug application (IND) for CORT 108297 by year-end.
"We continue to focus on Cushing's Syndrome and its near term opportunity,
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
with the number of currently treated patients in the US estimated to be in
excess of 3,000. 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 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 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 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 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 psychiatric and metabolic 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)
March 31, December 31,
2009 2008
------------ ------------
(Unaudited) (Note)
ASSETS:
Current assets:
Cash, cash equivalents and short-term
investments $ 20,644 $ 18,309
Other current assets 328 1,270
------------ ------------
Total current assets 20,972 19,579
Other assets 197 196
------------ ------------
Total assets $ 21,169 $ 19,775
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY:
Current liabilities:
Accounts payable $ 1,571 $ 1,304
Other current liabilities 1,712 1,558
------------ ------------
Total current liabilities 3,283 2,862
Capital lease obligation, long-term portion 4 6
Total stockholders' equity 17,882 16,907
------------ ------------
Total liabilities and stockholders' equity $ 21,169 $ 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
Ended March 31,
------------------
2009 2008
Collaboration revenue $ 24 $ --
-------- --------
Operating expenses:
Research and development* 4,184 2,850
General and administrative* 1,374 1,233
-------- --------
Total operating expenses 5,558 4,083
-------- --------
Loss from operations (5,534) (4,083)
-------- --------
Interest and other income, net 86 157
Other expense (2) (4)
-------- --------
Net loss $ (5,450) $ (3,930)
======== ========
Basic and diluted net loss per share $ (0.11) $ (0.10)
======== ========
Shares used in computing basic and diluted net loss per
share 49,763 40,235
======== ========
*Includes non-cash stock-based compensation of the
following:
Research and development $ 64 $ 64
General and administrative 360 350
-------- --------
Total non-cash stock-based compensation $ 424 $ 414
======== ========
Contact Information: CONTACT: Caroline Loewy Chief Financial Officer Corcept Therapeutics 650-688-8783 www.corcept.com