Full Press Release Details
MENLO PARK, CA--(Marketwire - March 25, 2010) - 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 financial results for the fourth quarter and the full year
ended December 31, 2009, and updated its corporate progress and anticipated
milestones for 2010.
"The past year was one of significant progress and set the stage for the
achievement of four important milestones in 2010. We are pleased to have
already achieved the first of these last month with the initiation of the
initial Phase 1 study of our lead selective cortisol receptor (GR-II)
antagonist, CORT 108297," said Joseph Belanoff, M.D., Chief Executive
Officer of Corcept. "We are continuing to make progress toward our other
three goals, all of which relate to developing CORLUX for the treatment of
Cushing's Syndrome, a disease with a significant unmet medical need. We
now expect to complete enrollment in the Phase 3 study in April, as the
requisite 50 patients have now been dosed or identified. We expect to
announce results of this study in the fourth quarter of this year and we
remain on track to submit our New Drug Application (NDA) for the use of
CORLUX in Cushing's Syndrome by year end."
Fourth Quarter and Recent Development Highlights
-- Raised gross proceeds of $18 million in a private placement of our
stock and warrants, sufficient capital to support our operations
through early 2011. Participants in this financing included existing
investors Longitude Capital, Sutter Hill Ventures, Alta Partners, and
members of our Board of Directors, as well as new investors including
Federated Kauffman Funds.
-- Submitted our Investigational New Drug application to the FDA for our
lead selective cortisol receptor (GR-II) antagonist, CORT 108297, in
December 2009 and began a Phase 1 trial of the compound in February
-- Identified and began testing two additional cortisol receptor (GR-II)
antagonists. Initial preclinical studies of CORT 112716 and CORT
113083 generated positive results in animal models of olanzapine
induced weight gain and modulation of insulin sensitivity. These
compounds are from one of the three separately patented series of
selective GR-II antagonists that we have discovered.
In addition, we continued to make progress on:
-- Enrolling patients in our 50-patient open-label Phase 3 trial of CORLUX
in patients with Cushing's Syndrome, which is being conducted at 20
leading institutions throughout the United States.
-- Preparing for the submission of our NDA for CORLUX in Cushing's
Syndrome, including the design of a Risk Evaluation and Mitigation
Strategy (REMS), to enable submission by the end of 2010.
-- Developing detailed plans for the commercialization of CORLUX in the
-- Enrolling patients in our double-blind placebo controlled Phase 3 trial
of CORLUX in patients with psychotic depression at eight clinical
Fourth Quarter and 2009 Financial Results
For the fourth quarter of 2009, Corcept reported a net loss of $5.2
million, or $0.09 per share, compared to a net loss of $6.2 million, or
$0.13 per share, for the fourth quarter of 2008. For the full year 2009,
the company reported a net loss of $20.2 million, or $0.38 per share.
Corcept reported a net loss of $20.1 million, or $0.43 per share, for the
As of December 31, 2009, Corcept had cash and cash equivalents of $23.9
million. We used $18 million of cash to fund the company's operating
activities for the full year 2009.
Total operating expenses decreased to $5.2 million for the fourth quarter
of 2009, from $6.2 million for the same period in 2008. In the fourth
quarter of 2009, research and development expenses decreased to $3.8
million from $4.7 million in the fourth quarter of 2008. This decrease in
research and development expenses was due primarily to scaling back the
number of sites in the Phase 3 study of CORLUX for the treatment of
psychotic depression, which was announced in March 2009. The decreased
costs for this study were partially offset by increased costs associated
with clinical trials for CORLUX for the treatment of Cushing's Syndrome,
the conduct of drug-drug interaction studies for CORLUX, and our selective
GR-II antagonist program, including work necessary to enable the filing of
the IND for CORT 108297 with the FDA in December 2009. General and
administrative expenses were $1.4 million for the fourth quarter of 2009
and for the same period in 2008.
For the full year 2009, total operating expenses increased to $20.3 million
from $19.9 million for 2008. Research and development expenses for the
full year 2009 increased to $14.4 million from $14.2 million in 2008. This
increase was primarily due to activities related to the IND for CORT 108297
and the continuation of the Phase 3 trial and long-term extension study for
CORLUX for the treatment of Cushing's Syndrome that were only partially
offset by cost reductions from scaling back the Phase 3 study of CORLUX for
psychotic depression. General and administrative expenses increased to
$5.9 million for the full year 2009 from $5.7 million in 2008 due primarily
to increases in non-cash stock-based compensation.
Four Key Anticipated Milestones for 2010
In January 2010, we announced four key anticipated milestones for 2010. We
have initiated the Phase 1 study of CORT 108297 as planned and expect
continued progress in achieving our three remaining milestones this year.
-- We are continuing to aggressively pursue completion of enrollment in
our Phase 3 pivotal trial of CORLUX in Cushing's Syndrome. While the
timing of enrollment of patients with this orphan disease has been
difficult to forecast, we expect the final patients to be enrolled in
-- Based on the anticipated completion of enrollment into the Phase 3
study and the 6-month duration of treatment to address the endpoints
agreed to with the FDA, we expect to complete the trial of CORLUX for
Cushing's Syndrome and announce efficacy results in 4Q 2010.
-- We continue to expect to submit our NDA to the FDA in the fourth
quarter of 2010. Additional studies and preparation of documentation
in support of our NDA submission are ongoing, which should enable our
submission soon after the Phase 3 efficacy results are available.
"We believe that the Cushing's Syndrome program provides near-term value
creation 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,
which could be as early as 2011. Orphan Drug Designation also provides tax
credits for clinical trial costs, marketing application filing fee waivers
and assistance from the FDA in the drug development process," added Dr.