-- 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
April 12, 2008.
-- 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
of 2008, research and development expenses increased to $2.9 million from
$1.6 million in the first quarter of 2007. This increase in research and
development expenses was due to increases in the research program related
to the study of new selective GR-II antagonists and changes in the
development program for CORLUX as the costs associated with commencement of
new Phase 3 trials for the treatment of the psychotic features of psychotic
depression and Cushing's Syndrome and manufacturing development were only
partially offset by decreases in the costs associated with the earlier
trials completed in 2007.
General and administrative expenses increased to $1.2 million for the first
quarter of 2008, from $1.1 million for the same period in 2007, primarily
attributable to increases in stock-based compensation expense and cash
compensation.
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 and research 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 development of CORLUX,
CORT 108297, or any of its other selective GR-II antagonists. 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)
March 31, December 31,
2008 2007
------------ ------------
(Unaudited) (Note)
ASSETS:
Current assets:
Cash, cash equivalents and short-term
investments $ 31,791 $ 17,366
Other current assets 561 290
------------ ------------
Total current assets 32,352 17,656
Other assets 85 88
------------ ------------
Total assets $ 32,437 $ 17,744
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY:
Current liabilities:
Accounts payable $ 878 $ 1,115
Other current liabilities 1,431 1,879
------------ ------------
Total current liabilities 2,309 2,994
Capital lease obligation, long-term portion 14 16
Total stockholders' equity 30,114 14,734
------------ ------------
Total liabilities and stockholders' equity $ 32,437 $ 17,744
============ ============
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
Ended March 31,
------------------------
2008 2007
(Unaudited) (Unaudited)
Collaboration revenue $ -- $ 108
----------- -----------
Operating expenses:
Research and development* 2,850 1,601
General and administrative* 1,233 1,135
----------- -----------
Total operating expenses 4,083 2,736
----------- -----------
Loss from operations (4,083) (2,628)
----------- -----------
Interest and other income, net 157 96
Other expense (4) (3)
----------- -----------
Net loss $ (3,930) $ (2,535)
=========== ===========
Basic and diluted net loss per share $ (0.10) $ (0.10)
=========== ===========
Shares used in computing basic and diluted net
loss per share 40,235 25,932
=========== ===========
*Includes non-cash stock-based compensation of
the following:
Research and development $ 64 $ 29
General and administrative 350 221
----------- -----------
Total non-cash stock-based compensation $ 414 $ 250
=========== ===========
Contact Information: CONTACT: Joseph Belanoff Chief Executive Officer Corcept Therapeutics 650-327-3270 www.corcept.com