MENLO PARK, CA -- (Marketwire) -- 05/11/09 -- 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.
We:
-- 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.