Full Press Release Details
MENLO PARK, CA--(Marketwire - March 27, 2008) - Corcept Therapeutics Incorporated (NASDAQ: CORT) today reported financial results for the fourth quarter and for the
full year ended December 31, 2007.
For the fourth quarter of 2007, Corcept reported a net loss of $4.2
million, or $0.11 per share, compared to a net loss of $3.9 million, or
$0.17 per share, for the fourth quarter of 2006. For the full year 2007,
the company reported a net loss of $11.6 million, or $0.34 per share. This
result compares to a net loss of $24.9 million, or $1.09 per share, for the
Clinical development activities during the fourth quarter of 2007 and early
2008 included the following:
-- Commencement in December 2007 of the pivotal Phase 3 clinical trial of
CORLUX , our lead product candidate, for the treatment of endogenous
Cushing's Syndrome. This is an open label study which will enroll 50
patients at approximately 25 sites in the United States. The Company
received Orphan Drug Designation for CORLUX for this indication in July
2007 and the Investigational New Drug application was opened in September
-- Commencement in March 2008 of the fourth Phase 3 clinical trial
evaluating CORLUX for the treatment of the psychotic features of psychotic
depression. This is a randomized, double-blind, placebo-controlled study
which will enroll up to 450 patients at approximately 25 sites in the
-- Preparations for clinical trials to further evaluate the mitigation of
weight gain induced by atypical antipsychotic medications. These trials
will evaluate the effectiveness of CORLUX in preventing weight gain
associated with risperidone and quetiapine.
-- Continued development of our selective, proprietary GR-II antagonists.
In November 2007, we commenced the clinical portion of our human
microdosing study using Xceleron's Accelerator Mass Spectrometry
technology. The clinical portion of this study was completed in March 2008,
and results are expected to be available in April 2008.
As of December 31, 2007, Corcept had cash, cash equivalents and marketable
securities of $17.4 million. The total cash used in the company's operating
activities for the full year 2007 was $11.0 million.
Total operating expenses increased to $4.4 million for the fourth quarter
of 2007, from $4.1 million for the same period in 2006. In the fourth
quarter of 2007, research and development expenses decreased to $2.7
million from $2.9 million in the fourth quarter of 2006. This decrease in
research and development expenses was due to changes in the clinical
development program for CORLUX as the costs associated with the Company's
earlier Phase 3 trials for the treatment of the psychotic features of
psychotic depression were only partially offset by the costs for the
preparations for the new Phase 3 trial in this indication and for the
Company's new clinical trial to evaluate CORLUX for Cushing's Syndrome.
General and administrative expenses increased to $1.7 million for the
fourth quarter of 2007, from $1.1 million for the same period in 2006,
primarily attributable to increases in stock-based compensation expense and
cash compensation and professional fees.
On March 25, 2008, Corcept sold approximately 8.9 million shares of its
common stock and warrants to purchase approximately 4.5 million shares of
its common stock 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. In
connection with the financing, Patrick Enright of Longitude Capital will
join the Company's board of directors. Mr. Enright is a Managing Director
and Founder of Longitude Capital, a venture capital firm, which specializes
in investments in life sciences companies. Thomas Weisel Partners served as
a financial advisor to the Company in this transaction.
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. 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
"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 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 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 a relatively slow process."
Commenting on Corcept's financial guidance for 2008, Anne LeDoux, Corcept's
Vice President and Controller, stated, "Based on the currently planned
timeline of our clinical development program and the recent completion of
these financing transactions, we expect that net cash used in 2008 will be