Full Press Release Details
MENLO PARK, CA--(Marketwire - May 12, 2008) - Corcept Therapeutics Incorporated (NASDAQ: CORT) today reported financial results for the first quarter ended March
For the first quarter of 2008, Corcept reported a net loss of $3.9 million,
or $0.10 per share, compared to a net loss of $2.5 million, or $0.10 per
share, for the first quarter of 2007.
In March 2008, we announced the commencement of our fourth Phase 3 trial,
Study 14, evaluating CORLUX for the treatment of the psychotic features
of psychotic depression. This trial is a randomized, double-blinded,
placebo-controlled study which will enroll up to 450 patients at
approximately 25 sites in the United States. In connection with this study
we also announced the signing of an agreement with MedAvante, Inc., a
provider of centralized clinical rating services.
The Study 14 protocol incorporates learnings from the three most recently
completed Phase 3 trials. In Study 06, Corcept prospectively tested and
confirmed that patients whose plasma levels rose above a predetermined
threshold statistically separated from both those patients whose plasma
levels were below the threshold and those patients who received placebo;
this threshold was established from data produced in earlier studies. As
expected, patients who took 1200 mg of CORLUX developed higher drug plasma
levels than patients who received lower doses. Further, there was no
discernable difference in the incidence of adverse events between placebo
and any of the three CORLUX dose groups in Study 06. Based on this
information, Study 14 will use a CORLUX dose of 1200 mg once per day for
seven days. The study's primary endpoint will be a comparison of the
number of patients who meet response criteria at both days 7 and 56, as has
been used in Corcept's previous studies of psychotic depression.
MedAvante's centralized rating services are expected to increase the
accuracy and consistency of the psychiatric assessments. A review of past
studies has also led to refinement of clinical site selection.
On May 1, 2008, we announced that our lead selective GR-II antagonist, CORT
108297, produced promising results in a human microdosing study. CORT
108297 is a non-steroidal, potent, competitive antagonist at the GR-II
(cortisol) receptor. In in vitro binding affinity and functional assays it
does not have affinity for the PR (progesterone), ER (estrogen), AR
(androgen) or GR-I (mineralocorticoid) receptors. The compound was
extremely well absorbed, demonstrated good bioavailability and had a
half-life that appears compatible with once-a-day oral dosing.
During the first quarter of 2008, Corcept completed two financing
-- On March 25, 2008, we sold approximately 8.9 million shares of common
stock and warrants to purchase approximately 4.5 million additional shares
in a private transaction that generated approximately $25 million in net
proceeds, after deducting costs of issuance. This financing was led by a
new investor, Longitude Capital. Paperboy Ventures LLC, Sutter Hill
Ventures and Alta Partners, LLP, all of which are significant shareholders
in Corcept, as well as various entities and individuals related to these
firms and other accredited investors, including entities affiliated with
members of the board of directors also invested. Patrick Enright of
Longitude Capital was named to the Board of Directors as of April 1, 2008.
The registration statement covering these shares was filed with the SEC on
-- In addition, on March 25, 2008, the Company entered into a Committed
Equity Financing Facility (CEFF) with Kingsbridge Capital Limited
(Kingsbridge), a private investment group. Under the terms of the
agreement, Kingsbridge has committed to provide up to $60 million of
capital through the purchase of newly-issued shares of the Company's common
stock during the three years after the resale registration statement
related to the CEFF securities has been declared effective by the
Securities and Exchange Commission. The registration statement covering
these shares was filed with the SEC on April 14, 2008. Under the terms of
the agreement, the exact timing and amount of any CEFF financings will be
determined solely by the Company, subject to certain conditions. Under
NASDAQ rules, the Company will be able to sell up to a maximum of
approximately 9.6 million shares pursuant to this agreement. The actual
amount of funds that can be raised under this agreement will be dependent
on the number of shares actually sold under the agreement and the market
value of the Company's stock during the pricing periods of each sale.
"These financing transactions provide the resources necessary for us to
enroll patients in our Phase 3 clinical studies for our lead product,
CORLUX, for the treatment of the psychotic features of psychotic depression
and for the treatment of Cushing's Syndrome, to conduct our studies in the
management of antipsychotic weight gain and to accelerate the development
of our selective GR-II antagonists," remarked Joseph K. Belanoff, M.D.,
Chief Executive Officer of the Company. In regard to the results of the
microdosing study, Dr. Belanoff commented, "There is increasing evidence
that excess cortisol may play a role in the pathogenesis of several
important metabolic diseases including diabetes, obesity and hypertension,
in addition to Cushing's Syndrome and psychiatric illnesses. A selective
cortisol antagonist will have clear advantages should it be demonstrated
that cortisol receptor blockade has clinical utility. Separating
antagonist activity at the cortisol receptor from the progesterone receptor
is a significant achievement in medicinal chemistry."
In commenting on the clinical program, Dr. Robert L. Roe, the Company's
President, said, "We believe that CORLUX has the potential to provide an
important therapeutic benefit for patients with psychotic depression and
for patients with Cushing's Syndrome. Our new Phase 3 clinical trial in
psychotic depression has been designed to incorporate the learnings from
our earlier Phase 3 trials and thereby optimize the potential for CORLUX to
demonstrate a rapid and sustained reduction in psychotic symptoms. We have
initiated sites and have begun to enroll patients in this study. We have
also initiated sites and are screening patients for enrollment into our
Phase 3 pivotal study of CORLUX for the treatment of endogenous Cushing's
Syndrome. We were pleased to have received Orphan Drug Designation for
CORLUX for the treatment of Cushing's Syndrome, a rare but severe disorder
that can affect every organ system in the body and can be lethal if not
treated effectively. Because this syndrome affects only an estimated 10 to
15 of every one million people, identification and enrollment of the 50
patients for the study is anticipated to be an extended process."
As of March 31, 2008, Corcept had cash, cash equivalents and marketable
securities of $31.8 million. The total cash used in the company's operating
activities for the first quarter of 2008 was $4.5 million.
Total operating expenses increased to $4.1 million for the first quarter of
2008, from $2.7 million for the same period in 2007. In the first quarter