form424b3.htm
Filed
Pursuant to Rule 424(b)(3)
Registration
No. 333-141881
Prospectus
Supplement No. 1
(to
Prospectus dated May 15, 2007)
This
Prospectus Supplement No. 1 supplements and amends the prospectus dated May
15,
2007, or the Prospectus. The Prospectus relates to the sale from time to time
of
up to 6,892,527 shares of common stock of Corcept Therapeutics Incorporated
by
certain selling stockholders. We will not receive any of the proceeds from
the
sale of shares by the selling stockholders.
On
June
21, 2007, we filed with the Securities and Exchange Commission a Current Report
on Form 8-K announcing positive results from our proof of concept study
evaluating the ability of CORLUX to mitigate weight gain associated with
Olanzapine. Also on
June 21, 2007, we filed with the Securities and Exchange Commission a Current
Report on Form 8-K/A amending such Current Report on Form 8-K for the sole
purpose of correcting an error in the state of incorporation as reflected on
the
cover page thereto.
This
Prospectus Supplement No. 1 should be read in conjunction with, and delivered
with, the Prospectus and is qualified by reference to the Prospectus except
to
the extent that the information in this Prospectus Supplement No. 1 supersedes
the information contained in the Prospectus.
Our
common stock is traded on the Nasdaq Capital Market under the symbol “CORT.” On
June 20, 2007, the closing price of our common stock was $1.42.
Investing
in our common stock involves risk. See “Risk Factors” beginning on page 4 of the
Prospectus.
Neither
the Securities and Exchange Commission nor any state securities commission
has
approved or disapproved of these securities or determined if the Prospectus
or
this Prospectus Supplement No. 1 is truthful or complete. Any representation
to
the contrary is a criminal offense.
The
date
of this Prospectus Supplement No. 1 is June 21, 2007.
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Form
8-K/A
Current
Report
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of
1934
Date
of
Report: June 21, 2007
(Date
of
earliest event reported)
Corcept
Therapeutics Incorporated
(Exact
name of registrant as specified in its charter)
Delaware
|
000-50679
|
77-0487658
|
(State
or other jurisdiction of incorporation or
organization)
|
(Commission
File Number)
|
(I.R.S.
Employer Identification
No.)
|
149
Commonwealth Drive
Menlo
Park, CA
|
|
94025
|
(Address
of principal executive offices)
|
|
(zip
code)
|
(650)
327-3270
(Registrant's
telephone number, including area code)
(Former
name or former address, if changed since last report)
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
|
£
|
Written
communications pursuant to Rule 425 under the Securities Act (17
CFR
230.425)
|
|
£
|
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|
|
£
|
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR
240.14d-2(b))
|
|
£
|
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR
240.13e-4(c))
|
Explanatory
statement: This Form 8-K/A if being filed solely for the purpose of
correcting an error in the state of incorporation as reflected on the cover
page
of the Form 8-K filed on June 21, 2007.
Item
8.01 Other Events
On
June
21, 2007 Corcept Therapeutics Incorporated issued a press release announcing
positive results from its proof of concept study evaluating the ability of
CORLUX® to
mitigate weight gain associated with Olanzapine.
Item
9:01Financial Statements and Exhibits.
|
(a)
|
Financial
statements:
|
None
|
(b)
|
Pro
forma financial
information:
|
None
|
(c)
|
Shell
company transactions:
|
None
99.1
Press Release of Corcept Therapeutics Incorporated dated June
21, 2007
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
|
CORCEPT
THERAPEUTICS INCORPORATED
|
|
|
|
|
|
|
Date: June
21, 2007
|
By:
/s/ Anne
LeDoux
|
|
Anne LeDoux
|
|
Vice President &
Controller
|
Exhibit
Index
Exhibit
No.
|
Description
|
|
|
99.1
|
Press
Release of Corcept Therapeutics Incorporated dated June 21,
2007
|
|
CONTACT:
|
Joseph
K. Belanoff, M.D.
|
Chief
Executive Officer
|
Corcept
Therapeutics
|
650-327-3270
|
IR@corcept.com
|
www.corcept.com
|
Corcept
Therapeutics Announces Positive Results from its Proof of Concept Study
Evaluating the Ability of CORLUX® to Mitigate
Weight
Gain Associated With Olanzapine
Menlo
Park, Calif., (June 21, 2007) -- Corcept Therapeutics (NASDAQ:CORT)
today announced that preliminary top line results indicated a statistically
significant reduction in weight gain in those subjects who took olanzapine
plus
CORLUX compared to those who took olanzapine alone in a randomized, two week,
double-blind, placebo controlled, proof of concept study.
In
this
study, 57 lean, healthy men (body mass index of 25 or less) were randomized
to
receive either olanzapine plus placebo (n=22), olanzapine plus CORLUX (n=24)
or
CORLUX plus placebo (n=11). This study took place in an institutional
setting where daily weights were recorded and a range of metabolic parameters
were measured. In the two week study, subjects in the olanzapine
alone group gained an average of 2.5 pounds more than subjects in the olanzapine
plus CORLUX group and 2.2 pounds more than subjects in the CORLUX alone group,
highly statistically significant differences (p<.001). The
difference in weight gain trajectory was apparent in the first days of the
study, reaching statistical significance during the first week. A
preliminary review also indicates that for those patients who experienced a
rise
in fasting insulin and rise in triglycerides while taking olanzapine, the
addition of CORLUX appears to have a beneficial effect; further analyses of
these variables will be completed in the coming weeks. Although no unexpected
study drug related adverse events were seen in any group, a complete review
of
all safety data has not yet been completed.
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. It is possible
that a cortisol receptor antagonist like CORLUX may affect these characteristics
in patients who take atypical antipsychotic medication" said Joseph K. Belanoff,
M.D., Chief Executive Officer of Corcept. "This study begins to give
us some insight into the possible causes of weight gain associated with atypical
antipsychotic medications, and potentially may lead us towards a
treatment."
Corcept
previously announced results from two preclinical studies conducted in a rat
model of olanzapine induced weight gain. These studies demonstrated
that CORLUX reduced both the weight gain associated with ongoing olanzapine
use
and prevented the weight gain associated with the initiation of treatment with
olanzapine. "Because findings in animal studies do not always translate into
human experience, we are pleased to see that the effect of CORLUX in our proof
of concept study appears to replicate the experimental animal data,” said Robert
L. Roe, M.D, President of Corcept.
Eli
Lilly
and Company supported this proof of concept clinical study through an
Investigator Initiated Trial grant and provided olanzapine for the
study.
The
combination of olanzapine and CORLUX is not approved for any indication and
Lilly has no plans to pursue the use of combination CORLUX and olanzapine
commercially. The purpose of this study was to explore the hypothesis
that GR-II antagonists might mitigate weight gain associated with atypical
antipsychotic medications.
Intellectual
Property Portfolio
Corcept
has developed an extensive intellectual property portfolio that covers the
use
of GR-II antagonists in the treatment of severe psychotic and metabolic
disorders, including the prevention of weight gain caused by the use of
antipsychotic medications. The company has also discovered and filed
patents for three different series of compounds which block cortisol's activity
at the GR-II receptor but do not block the progesterone
receptor. "Eventually, we hope to test and develop our new GR-II
antagonists in a wide variety of disorders including the mitigation of weight
gain associated with atypical antipsychotics," said James N. Wilson, Chairman
of
the Board of Corcept.
About
Corcept Therapeutics Incorporated
Corcept
Therapeutics Incorporated is a pharmaceutical company engaged in the development
of drugs for severe psychiatric and metabolic disorders. The
company’s lead program is the development of CORLUX for the treatment of the
psychotic symptoms of psychotic depression. 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. 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 commencement, cost, rate of spending, completion or success
of
clinical trials; financial projections may not be accurate; there can be no
assurances that the investigations for future clinical trials will be completed,
or that Corcept will pursue further activities with respect to 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.
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Form
8-K
Current
Report
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of
1934
Date
of
Report: June 21, 2007
(Date
of
earliest event reported)
Corcept
Therapeutics Incorporated
(Exact
name of registrant as specified in its charter)
CA
|
000-50679
|
77-0487658
|
(State
or other jurisdiction of incorporation or
organization)
|
(Commission
File Number)
|
(I.R.S.
Employer Identification
No.)
|
149
Commonwealth Drive
Menlo
Park, CA
|
|
94025
|
(Address
of principal executive offices)
|
|
(zip
code)
|
(650)
327-3270
(Registrant's
telephone number, including area code)
(Former
name or former address, if changed since last report)
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
|
£
|
Written
communications pursuant to Rule 425 under the Securities Act (17
CFR
230.425)
|
|
£
|
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|
|
£
|
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR
240.14d-2(b))
|
|
£
|
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR
240.13e-4(c))
|
Item
8.01 Other Events
On
June
21, 2007 Corcept Therapeutics Incorporated issued a press release announcing
positive results from its proof of concept study evaluating the ability of
CORLUX® to
mitigate weight gain associated with Olanzapine.
Item
9:01Financial Statements and Exhibits.
|
(e)
|
Financial
statements:
|
None
|
(f)
|
Pro
forma financial
information:
|
None
|
(g)
|
Shell
company transactions:
|
None
99.1
Press Release of Corcept Therapeutics Incorporated dated June
21, 2007
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
|
CORCEPT
THERAPEUTICS INCORPORATED
|
|
|
|
|
|
|
Date: June
21, 2007
|
By:
/s/ Anne
LeDoux
|
|
Anne LeDoux
|
|
Vice President &
Controller
|
Exhibit
Index
Exhibit
No.
|
Description
|
|
|
99.2
|
Press
Release of Corcept Therapeutics Incorporated dated June 21,
2007
|
|
CONTACT:
|
Joseph
K. Belanoff, M.D.
|
Chief
Executive Officer
|
Corcept
Therapeutics
|
650-327-3270
|
IR@corcept.com
|
www.corcept.com
|
Corcept
Therapeutics Announces Positive Results from its Proof of Concept Study
Evaluating the Ability of CORLUX® to Mitigate
Weight
Gain Associated With Olanzapine
Menlo
Park, Calif., (June 21, 2007) -- Corcept Therapeutics (NASDAQ:CORT)
today announced that preliminary top line results indicated a statistically
significant reduction in weight gain in those subjects who took olanzapine
plus
CORLUX compared to those who took olanzapine alone in a randomized, two week,
double-blind, placebo controlled, proof of concept study.
In
this
study, 57 lean, healthy men (body mass index of 25 or less) were randomized
to
receive either olanzapine plus placebo (n=22), olanzapine plus CORLUX (n=24)
or
CORLUX plus placebo (n=11). This study took place in an institutional
setting where daily weights were recorded and a range of metabolic parameters
were measured. In the two week study, subjects in the olanzapine
alone group gained an average of 2.5 pounds more than subjects in the olanzapine
plus CORLUX group and 2.2 pounds more than subjects in the CORLUX alone group,
highly statistically significant differences (p<.001). The
difference in weight gain trajectory was apparent in the first days of the
study, reaching statistical significance during the first week. A
preliminary review also indicates that for those patients who experienced a
rise
in fasting insulin and rise in triglycerides while taking olanzapine, the
addition of CORLUX appears to have a beneficial effect; further analyses of
these variables will be completed in the coming weeks. Although no unexpected
study drug related adverse events were seen in any group, a complete review
of
all safety data has not yet been completed.
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. It is possible
that a cortisol receptor antagonist like CORLUX may affect these characteristics
in patients who take atypical antipsychotic medication" said Joseph K. Belanoff,
M.D., Chief Executive Officer of Corcept. "This study begins to give
us some insight into the possible causes of weight gain associated with atypical
antipsychotic medications, and potentially may lead us towards a
treatment."
Corcept
previously announced results from two preclinical studies conducted in a rat
model of olanzapine induced weight gain. These studies demonstrated
that CORLUX reduced both the weight gain associated with ongoing olanzapine
use
and prevented the weight gain associated with the initiation of treatment with
olanzapine. "Because findings in animal studies do not always translate into
human experience, we are pleased to see that the effect of CORLUX in our proof
of concept study appears to replicate the experimental animal data,” said Robert
L. Roe, M.D, President of Corcept.
Eli
Lilly
and Company supported this proof of concept clinical study through an
Investigator Initiated Trial grant and provided olanzapine for the
study.
The
combination of olanzapine and CORLUX is not approved for any indication and
Lilly has no plans to pursue the use of combination CORLUX and olanzapine
commercially. The purpose of this study was to explore the hypothesis
that GR-II antagonists might mitigate weight gain associated with atypical
antipsychotic medications.
Intellectual
Property Portfolio
Corcept
has developed an extensive intellectual property portfolio that covers the
use
of GR-II antagonists in the treatment of severe psychotic and metabolic
disorders, including the prevention of weight gain caused by the use of
antipsychotic medications. The company has also discovered and filed
patents for three different series of compounds which block cortisol's activity
at the GR-II receptor but do not block the progesterone
receptor. "Eventually, we hope to test and develop our new GR-II
antagonists in a wide variety of disorders including the mitigation of weight
gain associated with atypical antipsychotics," said James N. Wilson, Chairman
of
the Board of Corcept.
About
Corcept Therapeutics Incorporated
Corcept
Therapeutics Incorporated is a pharmaceutical company engaged in the development
of drugs for severe psychiatric and metabolic disorders. The
company’s lead program is the development of CORLUX for the treatment of the
psychotic symptoms of psychotic depression. 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. 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 commencement, cost, rate of spending, completion or success
of
clinical trials; financial projections may not be accurate; there can be no
assurances that the investigations for future clinical trials will be completed,
or that Corcept will pursue further activities with respect to 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.