Full Press Release Details
MENLO PARK, CA--(Marketwire - May 11, 2009) - Corcept Therapeutics Incorporated (NASDAQ: CORT), a pharmaceutical company engaged in the development of drugs for the
treatment of severe psychiatric and metabolic disorders, today reported
financial results for the first quarter ended March 31, 2009.
"During the first quarter we continued to make progress across all of our
development programs. We enrolled patients in our Phase 3 trials of
CORLUX in Cushing's Syndrome and psychotic depression -- indications for
which there are significant unmet medical needs. We also generated
confirmatory proof of concept data for the use of GR-II antagonists for the
mitigation of weight gain and metabolic disturbances associated with the
use of antipsychotic medications," said Joseph Belanoff, M.D., Chief
Executive Officer of Corcept. "We believe these programs demonstrate the
broad potential for our GR-II antagonist platform across a wide range of
important metabolic and psychiatric diseases."
First Quarter and Recent Development Highlights
During the quarter we continued to execute on our strategy to move CORLUX
toward the market expeditiously, demonstrate its broad potential in
multiple indications, generate proof of concept data for our
next-generation selective GR-II antagonists and conserve capital to support
the operation of the company through the achievement of key milestones.
-- 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
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
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.
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,"
"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
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,