-- 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
2007.
-- 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
United States.
-- 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
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 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
between $21 million and $25 million."
About Psychotic Depression
Psychotic depression is a serious psychiatric disorder that affects
approximately three million people annually in the United States. It is
more prevalent than either schizophrenia or bipolar I disorder. The
disorder is characterized by severe depression accompanied by delusions,
hallucinations or both. People with psychotic depression are approximately
70 times more likely to commit suicide than the general population and
often require lengthy and expensive hospital stays. There is no
FDA-approved treatment for psychotic depression.
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 relatively rare
and most commonly affects adults aged 20 to 50. An estimated 10 to 15 of
every one million people are affected each year. Symptoms vary, but most
people have one or more of the following manifestations: high blood sugar,
high blood pressure, upper body obesity, rounded face, increased fat around
the neck, thinning arms and legs, severe fatigue and weak muscles.
Irritability, anxiety, cognitive disturbances and depression are common.
Cushing's Syndrome can affect every organ system in the body and can be
lethal if not treated effectively.
About Weight Gain associated with Antipsychotic Medications
The group of medications known as atypical antipsychotics, including
olanzapine, risperidone, clozapine and quetiapine, are widely used to treat
schizophrenia and bipolar disorder. All medications in this group are
associated with treatment emergent weight gain of varying degrees and carry
a warning label relating to treatment emergent hyperglycemia and diabetes
mellitus. Weight gain and alterations in metabolic efficiency have been
observed for many years in patients with abnormally high circulating
cortisol.
About Corcept Therapeutics Incorporated
Corcept Therapeutics Incorporated is a pharmaceutical company engaged in
the development of GR-II antagonist drugs 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 depression and Cushing's Syndrome. The Company is
also engaged in preparation for clinical trials to evaluate CORLUX for the
mitigation of weight gain induced by antipsychotic medications and
continued development work on its proprietary, selective GR-II antagonists.
For additional information about the company, please visit www.corcept.com.
Statements made in this news release, other than statements of historical
fact, are forward-looking statements, including, for example, statements
relating to Corcept's clinical development programs, and its spending plans
as well as the amount of funds that may be raised under the CEFF.
Forward-looking statements are subject to a number of known and unknown
risks and uncertainties that might cause actual results to differ
materially from those expressed or implied by such statements. For
example, there can be no assurances with respect to the pace of enrollment,
cost, rate of spending, completion or success of clinical trials; financial
projections may not be accurate; there can be no assurances that Corcept
will pursue further activities with respect to the clinical development of
CORLUX. These and other risk factors are set forth in the Company's SEC
filings, all of which are available from our website (www.corcept.com) or
from the SEC's website (www.sec.gov). We disclaim any intention or duty to
update any forward-looking statement made in this news release.
CORCEPT THERAPEUTICS INCORPORATED
CONDENSED BALANCE SHEETS
(in thousands)
December 31, December 31,
2007 2006
------------ ------------
(Note) (Note)
ASSETS:
Current assets:
Cash, cash equivalents and short-term
investments $ 17,366 $ 9,456
Other current assets 290 343
------------ ------------
Total current assets 17,656 9,799
Long-term investments -- --
Other assets 88 103
------------ ------------
Total assets $ 17,744 $ 9,902
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY:
Current liabilities:
Accounts payable $ 1,115 $ 916
Other current liabilities 1,879 2,597
------------ ------------
Total current liabilities 2,994 3,513
Capital lease obligation, long-term portion 16 29
Total stockholders' equity 14,734 6,360
------------ ------------
Total liabilities and stockholders' equity $ 17,744 $ 9,902
============ ============
Note: Derived from audited financial statements at that date.
CORCEPT THERAPEUTICS INCORPORATED
STATEMENT OF OPERATIONS
(in thousands, except per share amounts)
For the Three Months Year
Ended Ended
December 31, December 31,
------------------------ ------------------------
2007 2006 2007 2006
(Unaudited) (Unaudited) (Audited) (Audited)
Collaboration revenue $ -- $ 73 $ 482 $ 294
----------- ----------- ----------- -----------
Operating expenses:
Research and
development* 2,672 2,922 7,860 20,834
General and
administrative* 1,746 1,141 4,867 5,042
----------- ----------- ----------- -----------
Total operating
expenses 4,418 4,063 12,727 25,876
----------- ----------- ----------- -----------
Loss from operations (4,418) (3,990) (12,245) (25,582)
----------- ----------- ----------- -----------
Interest and other
income, net 235 110 688 719
Other expense, net (9) 4 (16) (10)
----------- ----------- ----------- -----------
Net loss $ (4,192) $ (3,876) $ (11,573) $ (24,873)
=========== =========== =========== ===========
Basic and diluted net
loss per share $ (0.11) $ (0.17) $ (0.34) $ (1.09)
=========== =========== =========== ===========
Shares used in
computing basic and
diluted net loss per
share 39,548 23,283 34,251 22,841
=========== =========== =========== ===========
*Includes non-cash
stock-based
compensation of the
following:
Research and
development $ 65 $ 80 $ 213 $ 535
General and
administrative 435 210 846 1,013
----------- ----------- ----------- -----------
Total non-cash
stock-based
compensation $ 500 $ 290 $ 1,059 $ 1,548
=========== =========== =========== ===========
Contact Information: CONTACT: Joseph Belanoff Chief Executive Officer Corcept Therapeutics 650-327-3270 www.corcept.com