Full Press Release Details
MENLO PARK, CA--(Marketwire - November 10, 2009) - Corcept Therapeutics Incorporated (NASDAQ: CORT), a pharmaceutical company engaged in the discovery and development of
drugs for the treatment of severe metabolic and psychiatric disorders,
today reported on recent development highlights and financial results for
the third quarter ended September 30, 2009.
"We continued to advance all of our programs during the third quarter. We
enrolled patients in our Phase 3 trial of CORLUX in Cushing's Syndrome,
a disease with a significant unmet medical need, with the goal of
completing enrollment by year-end and announcing pivotal data in mid-2010.
We have also enrolled patients in our Phase 3 trial of CORLUX in psychotic
depression, another serious illness for which there is no FDA-approved
treatment," said Joseph K. Belanoff, M.D., Chief Executive Officer of
Corcept. "We are nearing completion of work supporting our Investigational
New Drug (IND) application for our lead selective GR-II antagonist, CORT
108297, which we have been evaluating for the mitigation of weight gain and
metabolic disturbances associated with the use of antipsychotic
medications. Finally, with the closing of our financing in October, we now
have sufficient capital to operate the company through the end of 2010."
During the third quarter and early fourth quarter, we have continued to
execute on our strategy to move CORLUX toward the market, demonstrate its
potential in two key indications, generate proof of concept data for our
next-generation selective GR-II antagonists and secure financial resources
to fund our operations through the achievement of key milestones. During
-- 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.
-- Raised gross proceeds of $18 million in a private placement of our
stock and warrants, providing sufficient capital to support our operations
through year-end 2010, by which time we plan to submit a New Drug
Application (NDA) for CORLUX for Cushing's Syndrome. Existing investors,
including Longitude Capital, Sutter Hill Ventures and Alta Partners,
participated in this financing and were joined by new investors, including
Federated Kauffman Funds.
-- Began preparations for the commercialization of CORLUX in the United
States. Management has begun to evaluate the most effective way to make
this potential treatment available to patients.
-- 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 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 International
Society of Psychoneuroendocrinology (ISPNE) and the World Congress of
Biological Psychiatry (WFSBP) annual meetings. These data demonstrated the
potential of GR-II antagonists to prevent weight gain and reduce abdominal
fat, fasting insulin, and triglycerides associated with the use of
antipsychotic medication widely used for the treatment of schizophrenia and
Third Quarter Financial Results
For the third quarter of 2009, we reported a net loss of $4.7 million, or
$0.09 per share, compared to a net loss of $5.6 million, or $0.11 per
share, for the third quarter of 2008.
As of September 30, 2009, we had cash, cash equivalents and marketable
securities of $10.7 million. The total cash used in the company's
operating activities for the first nine months of 2009 was $13.6 million.
We completed a private placement of stock and warrants generating $18.0
million of gross proceeds in October, after the end of the quarter.
Total operating expenses decreased to $4.7 million for the third quarter of
2009, from $5.0 million for the same period in 2008. Research and
development expenses decreased to $3.1 million for the third quarter of
2009, from $3.3 million for the same period in 2008. Increased spending on
the clinical trial of CORLUX 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.
General and administrative expenses decreased to $1.5 million for the third
quarter of 2009, from $1.7 million for the same period in 2008,
attributable to a decrease in legal costs that were partially offset by
increases in staffing and consultancy expenses.
There were no significant other non-operating expenses in 3Q 2009.
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. Our goal remains
the completion of 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 potential tax
credits related to product development expenses.
We continue to enroll patients in our Phase 3 trial in psychotic
depression. In the first quarter of this year, due to the relatively high
cost of this program and length of the trial, we scaled back spending,
reduced the number of clinical sites to eight 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 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 and initiate a Phase 1 study in the first quarter
"We continue to focus on moving our program for CORLUX towards an NDA
submission for the treatment of Cushing's Syndrome and putting plans in
place for the commercialization of CORLUX, while advancing our other
programs in a cost effective manner," added Dr. Belanoff. "We anticipate
that our current cash balance is sufficient to operate the company through
the end of 2010, including, subject to the results of our clinical trial,
our CORLUX NDA submission," said Caroline Loewy, Chief Financial Officer of
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 an orphan
indication which 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 over 3,000 new patients in the US. An estimated