Full Press Release Details
MENLO PARK, CA--(Marketwire - August 11, 2009) - Corcept Therapeutics Incorporated (NASDAQ: CORT), a pharmaceutical company engaged in the development of drugs for the
treatment of severe metabolic and psychiatric disorders, today reported
financial results for the second quarter ended June 30, 2009.
"During the second quarter we continued to make progress in all of our
development programs. We enrolled patients in our Phase 3 trial of
CORLUX in Cushing's Syndrome, a disease with a significant unmet medical
need. We anticipate completion of enrollment in the study this year and
announcement of pivotal data in mid-2010. We enrolled patients in our
Phase 3 trial in psychotic depression, another serious illness for which
there is no FDA-approved treatment. We made progress toward an
Investigational New Drug (IND) application for our lead next-generation
GR-II antagonist, which we have been evaluating for the mitigation of
weight gain and metabolic disturbances associated with the use of
antipsychotic medications," said Joseph K. 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 and our strategy to bring
these products efficiently to the market."
Second Quarter and Recent Development Highlights
During the quarter we continued to execute on our strategy to move CORLUX
toward the market, 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. We:
-- 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
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
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: