Full Press Release Details
MENLO PARK, CA--(Marketwire - August 13, 2007) - Corcept Therapeutics Incorporated (NASDAQ: CORT) today reported financial results for the second quarter ended June
For the second quarter of 2007, Corcept reported a net loss of $1.4
million, or $0.04 per share, compared to a net loss of $7.9 million, or
$0.35 per share, for the second quarter of 2006. For the first six months
of 2007, the company reported a net loss of $4.0 million, or $0.13 per
share, compared to a net loss of $14.6 million, or $0.64 per share, for the
same period in 2006.
In June 2007, we announced the preliminary top-line results of our
successful proof-of-concept study evaluating the ability of CORLUX to
mitigate weight gain associated with the use of olanzapine. This study in
healthy male volunteers was initiated during the first quarter of 2006. The
top line results demonstrated a statistically significant reduction in
weight gain in those subjects who took olanzapine plus CORLUX compared to
those who took olanzapine alone. Eli Lilly and Company provided olanzapine
and financial support for this study. The purpose of this study was to
explore the hypothesis that GR-II antagonists would mitigate weight gain
associated with atypical antipsychotic medications.
In July 2007, we received Orphan Drug Designation from the Food and Drug
Administration (FDA) for CORLUX for the treatment of Cushing's Syndrome.
Cushing's Syndrome is a disorder caused by prolonged exposure of the body's
tissues to high levels of the hormone cortisol. Sometimes called
"hypercortisolism," it is relatively rare and most commonly affects adults
aged 20 to 50. An estimated 10 to 15 of every one million people are
Orphan Drug Designation is a special status granted by the FDA to encourage
the development of treatments for diseases or conditions that affect fewer
than 200,000 patients in the United States. Drugs that receive Orphan Drug
Designation obtain seven years of marketing exclusivity from the date of
drug 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. While we have not yet determined our full development
plan for the use of CORLUX to treat Cushing's Syndrome, we plan to open an
Investigational New Drug application (IND) in the near future.
In July 2007, we also executed an agreement with Xceleron Limited to
conduct a human microdosing study of one of Corcept's new chemical
entities, a selective GR-II antagonist, utilizing Xceleron's Accelerator
Mass Spectrometry (AMS) technology. In early 2003, Corcept initiated a
research program to discover and patent selective GR-II antagonists to
create a pipeline of proprietary products. Three distinct series of GR-II
antagonists were identified that appear to be as potent as Corcept's lead
product CORLUX in blocking cortisol but, unlike CORLUX, do not appear to
block the progesterone or other steroid receptors. We will evaluate one of
the compounds that developed particularly high plasma and brain
concentrations in an animal bioavailability study in a human microdosing
study using Xceleron's AMS technology.
Joseph K. Belanoff, M.D., Corcept's Chief Executive Officer, commenting on
the company's clinical progress, said, "We made good progress this quarter
in moving forward with our GR-II antagonist program. We obtained positive
results of the weight-gain mitigation study and are pleased that we were
able to replicate in humans the positive findings regarding prevention of
olanzapine-induced weight gain that we had demonstrated in a rat model. We
also received Orphan Drug Designation for CORLUX for the treatment of
Cushing's Syndrome and began preparations with Xceleron for a human
microdosing study with one of our new compounds. While we were disappointed
with the top-line results of our Phase 3 trials of CORLUX for the psychotic
features of psychotic depression, which were reported in late 2006 and
early 2007, we are encouraged by the information that we did learn from the
trials, particularly regarding what appears to be the plasma level
necessary to achieve efficacy. We are planning for our next Phase 3 study,
which we expect will begin enrollment in the first quarter of 2008."
As of June 30, 2007, Corcept had cash, cash equivalents and marketable
securities of $11.9 million. The total cash used in the company's operating
activities for the first six months of 2007 was $6.4 million.
Commenting on Corcept's financial guidance for 2007, Anne LeDoux, Corcept's
Vice President and Controller, stated, "Based on the currently planned
timeline of our clinical development program and our discovery research
activities, we expect that cash used in operating activities in 2007 will
be between $11 million and $14 million. While we believe that our current
funds will enable us to continue operations into the first quarter of 2008;
we will need to raise additional capital in order to fund our operations
Total operating expenses were $2.0 million for the second quarter of 2007
and $4.7 million for the first half of 2007 compared to $8.2 million and
$15.3 million, respectively, in the same periods in 2006. In the second
quarter and first half of 2007, research and development expenses decreased
to $1.2 million and $2.8 million, respectively, from $7.0 million and $12.8
million in the same periods of 2006. This decrease was primarily related to
the completion in late 2006 of the majority of activities regarding our
three Phase 3 trials evaluating CORLUX for treating psychotic depression.
Top-line results for two of these trials were reported during 2006, with
top-line results for the third Phase 3 trial, Study 06, being reported in
General and administrative expenses decreased to $793,000 for the second
quarter and $1.9 million for the first half of 2007 from $1.2 million and
$2.5 million, respectively, for the same periods in 2006 due to decreases
in staffing and stock based compensation. The figures for the second
quarter and first half of 2007 included a reversal of stock compensation
expense of approximately $393,000 related to the resignation of an
administrative employee.
During the second quarter and first half of 2007, the company recognized
revenue of $374,000 and $482,000, respectively, from the collaboration with
Eli Lilly and Company to conduct a proof-of-concept clinical study
evaluating the ability of CORLUX to mitigate weight gain associated with
the use of olanzapine. Total revenue recognized under this agreement had
been $100,000 and $221,000 for the second quarter and the first half of
About Corcept Therapeutics Incorporated
Corcept Therapeutics Incorporated is a pharmaceutical company engaged in
the development of GR-II antagonists for the treatment of severe
psychiatric and metabolic diseases. Corcept's lead product, CORLUX, is
currently in Phase 3 clinical trials for the treatment of the psychotic
features of psychotic major depression, a serious psychiatric disorder that
affects approximately three million people annually in the United States.
Psychotic major depression, or PMD, is referred to in this release and