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 (Date of
earliest event reported): August 11,
2009
Corcept
Therapeutics Incorporated
(Exact
name of registrant as specified in its charter)
000-50679
(Commission File
Number)
|
Delaware
|
77-0487658
|
|
|
(State or
other jurisdiction of
|
(I.R.S.
Employer Identification No.)
|
|
|
incorporation)
|
149
Commonwealth Drive
Menlo
Park, CA 94025
(Address
of principal executive offices, with 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):
|
o
|
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
|
|
o
|
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|
|
o
|
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
|
|
o
|
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
|
Item
2.02 Results of Operations and Financial Condition
On August
11, 2009 the Company issued a press release announcing its financial results for
the quarter ended June 30, 2009. The press release is attached hereto
as Exhibit 99.1 and incorporated by reference.
This
information and the information contained in the press release attached as
Exhibit 99.1 shall not be deemed "filed" for purposes of Section 18 of the
Exchange Act of 1934, as amended, or otherwise subject to the liabilities of
that Section. This information and the information contained in the press
release attached as Exhibit 99.1 is not incorporated by reference into any
filings of Corcept Therapeutics Incorporated made under the Securities Act of
1933, as amended, whether made before or after the date of the Current Report,
regardless of any general incorporation language in the filing unless
specifically stated so therein.
Item
7.01 Regulation FD Disclosure
On August
11, 2009 the Company issued a press release announcing its financial results for
the quarter ended June 30, 2009. The press release is attached hereto
as Exhibit 99.1 and incorporated by reference.
This
information and the information contained in the press release attached as
Exhibit 99.1 shall not be deemed "filed" for purposes of Section 18 of the
Exchange Act of 1934, as amended, or otherwise subject to the liabilities of
that Section. This information and the information contained in the press
release attached as Exhibit 99.1 is not incorporated by reference into any
filings of Corcept Therapeutics Incorporated made under the Securities Act of
1933, as amended, whether made before or after the date of the Current Report,
regardless of any general incorporation language in the filing unless
specifically stated so therein.
Item
9.01 Financial Statements and Exhibits
(a)
Financial statements:
None
(b)
Pro forma financial information:
None
(c)
Shell company transactions:
None
(d)
Exhibits
99.1
Press Release of Corcept Therapeutics Incorporated
dated August 11, 2009.
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: August 12, 2009 | By: /s/ Caroline M. Loewy |
| Caroline M. Loewy | |
| Chief Financial Officer |
Exhibit 99.1
Corcept
Therapeutics Announces Second Quarter 2009 Results and Development
Highlights
MENLO
PARK, CA--(Marketwire - August 11, 2009) - Corcept Therapeutics Incorporated
(NASDAQ: CORT),
a pharmaceutical company engaged in the development of drugs for the treatment
of severe metabolic and psychiatric disorders, today reported financial results
for the second quarter ended June 30, 2009.
"During
the second quarter we continued to make progress in all of our development
programs. We enrolled patients in our Phase 3 trial of CORLUX® in Cushing's
Syndrome, a disease with a significant unmet medical need. We anticipate
completion of enrollment in the study this year and announcement of pivotal data
in mid-2010. We enrolled patients in our Phase 3 trial in psychotic depression,
another serious illness for which there is no FDA-approved treatment. We made
progress toward an Investigational New Drug (IND) application for our lead
next-generation GR-II antagonist, which we have been evaluating for the
mitigation of weight gain and metabolic disturbances associated with the use of
antipsychotic medications," said Joseph K. Belanoff, M.D., Chief Executive
Officer of Corcept. "We believe these programs demonstrate the broad potential
for our GR-II antagonist platform across a wide range of important metabolic and
psychiatric diseases and our strategy to bring these products efficiently to the
market."
Second
Quarter and Recent Development Highlights
During
the quarter we continued to execute on our strategy to move CORLUX toward the
market, demonstrate its broad potential in multiple indications, generate proof
of concept data for our next-generation selective GR-II antagonists and conserve
capital to support the operation of the company through the achievement of key
milestones. We:
-- Enrolled
patients in our 50-patient open-label Phase 3 trial of CORLUX in
patients with Cushing's Syndrome, which is being conducted at
leading
institutions
throughout the United States.
-- Enrolled
patients in our double-blind placebo controlled Phase 3 trial of CORLUX
in patients with psychotic depression. We have completed
the
previously
announced reduction in spending on this trial to conserve our resources,
and are now conducting the trial at eight clinical sites.
-- Presented
positive results from studies of CORLUX and one of our next generation
selective GR-II antagonists, CORT 108297, at the American
Diabetes
Association and the Collegium International Neuro-Psychopharmacologicum
annual meetings. These data demonstrated the
potential
of GR-II antagonists to prevent weight gain and reduce abdominal fat,
fasting insulin, and triglycerides caused by antipsychotic drugs
widely
used for the treatment of schizophrenia and bipolar disorder.
-- Published
results from one of our earlier Phase 3 trials of CORLUX for the
treatment of psychotic depression in the journal Contemporary
Clinical
Trials. The
results demonstrate a statistically significant association between
CORLUX plasma concentration and response rate and also exhibit
meaningful
variability across clinical sites. Both findings were instructive
in designing our ongoing Phase 3 trial in psychotic depression,
including
an increase in dose administered and the addition of centralized raters.
Second
Quarter and Financial Results
For the
second quarter of 2009, Corcept reported a net loss of $4.9 million, or $0.10
per share, compared to a net loss of $4.4 million, or $0.09 per share, for the
second quarter of 2008.
As of
June 30, 2009, Corcept had cash, cash equivalents and marketable securities of
$14.4 million. The total cash used in the company's operating activities for the
first six months of 2009 was $9.9 million.
Total
operating expenses increased to $4.9 million for the second quarter of 2009,
from $4.7 million for the same period in 2008. In the second quarter of 2009,
research and development expenses of $3.3 million were flat with the second
quarter of 2008. Increased spending on the clinical trial for the treatment of
Cushing's Syndrome and for development of our new selective GR-II antagonists
was offset by decreased spending associated with the clinical trial for the
treatment of the psychotic features of psychotic depression, as we executed on
our previously announced plan to scale back that program.
General
and administrative expenses increased to $1.5 million for the second quarter of
2009, from $1.4 million for the same period in 2008, primarily attributable to
increases in staffing and consultancy expenses.
Outlook
for the Remainder of 2009
We expect
continued progress in the development of CORLUX and our series of selective
GR-II antagonists during the remainder of 2009. We remain on track to complete
enrollment in our Phase 3 pivotal trial of CORLUX in Cushing's Syndrome by the
end of 2009, generating data from the trial in mid-2010. The FDA granted us
Orphan Drug Designation for CORLUX for the treatment of endogenous Cushing's
Syndrome, which provides seven years of marketing exclusivity from the date of
approval, as well as tax credits for clinical trial costs, marketing application
filing fee waivers and assistance from the FDA in the drug development process.
We believe that the Cushing's program provides us with a near-term value
creation opportunity for our shareholders.
We
continue to enroll patients in our Phase 3 trial in psychotic depression. As
announced earlier this year, due to the relatively high cost of this program,
length of the trial, and our current financial constraints, we scaled back our
planned rate of spending, reduced the number of clinical sites to eight, and
extended the timeline for completion of this trial.
Based on
the positive results from several preclinical studies of our next-generation
selective GR-II antagonist, CORT 108297, for the mitigation of weight gain and
related metabolic disturbances, as well as positive proof-of-concept data with
CORLUX in humans, we plan to submit an IND for CORT 108297 by
year-end.
"We
continue to focus on moving Cushing's Syndrome towards a New Drug Application
(NDA) submission, while advancing our other programs in a deliberate, cost
effective manner," added Dr. Belanoff. "We continue to anticipate our current
cash balance is sufficient to operate the company into early 2010, even in the
absence of any additional financing," said Caroline Loewy, Chief Financial
Officer of Corcept.
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 newly diagnosed with this syndrome each year, resulting in an incidence of
over 3,000 new patients in the US. An estimated 20,000 patients in the US have
Cushing's Syndrome. Symptoms vary, but most people have one or more of the
following manifestations: high blood sugar, diabetes, 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. There is
no FDA-approved treatment for Cushing's Syndrome.
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 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
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. There is no FDA-approved
treatment for the weight gain associated with the use of antipsychotic
medications.
About
CORLUX
Corcept's
first-generation compound, CORLUX, also known as mifepristone, directly blocks
the GR-II receptor and the progesterone receptor. Intellectual property
protection is in place to protect important methods of use for CORLUX. Corcept
retains worldwide rights to its intellectual property related to
CORLUX.
About
CORT 108297
CORT
108297 is one of several potent, selective antagonists of the GR-II (cortisol)
receptor that we have discovered and for which Corcept owns worldwide
intellectual property rights. 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.
About
Corcept Therapeutics Incorporated
Corcept
is a pharmaceutical company engaged in the development of drugs for the
treatment of severe metabolic and psychiatric disorders. The company has two
Phase 3 programs ongoing; CORLUX for the treatment of Cushing's Syndrome and
CORLUX for the treatment of the psychotic features of psychotic depression.
Corcept has also developed an extensive intellectual property portfolio that
covers the use of GR-II antagonists in the treatment of a wide variety of
psychiatric and metabolic disorders, including the prevention of weight gain
caused by the use of antipsychotic medication.
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, the timing of the
introduction of CORLUX and future product candidates, including CORT 108297,
estimates of the timing of enrollment or completion of our clinical trials and
the anticipated results of those trials, the ability to create value from CORLUX
or other future product candidates and our estimates regarding our capital
requirements, spending plans and needs for additional financing. 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 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)
|
June
30,
2009
|
December
31,
2008
|
|||||||
|
(Unaudited)
|
(Note)
|
|||||||
|
ASSETS:
|
||||||||
|
Current
assets:
|
||||||||
|
Cash,
cash equivalents and short-term investments
|
$ | 14,447 | $ | 18,309 | ||||
|
Other
current assets
|
974 | 1,270 | ||||||
|
Total
current assets
|
15,421 | 19,579 | ||||||
|
Other
assets
|
189 | 196 | ||||||
|
Total
assets
|
$ | 15,610 | $ | 19,775 | ||||
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY:
|
||||||||
|
Current
liabilities:
|
||||||||
|
Accounts
payable
|
$ | 670 | $ | 1,304 | ||||
|
Other
current liabilities
|
1,468 | 1,558 | ||||||
|
Total current
liabilities
|
2,138 | 2,862 | ||||||
|
Capital
lease obligation, long-term portion
|
1 | 6 | ||||||
|
Total
stockholders’ equity
|
13,471 | 16,907 | ||||||
|
Total liabilities and
stockholders’ equity
|
$ | 15,610 | $ | 19,775 | ||||
Note: Derived
from December 31, 2008 audited financial statements.
CORCEPT
THERAPEUTICS INCORPORATED
STATEMENTS
OF OPERATIONS
(in
thousands, except per share amounts)
(Unaudited)
|
For
the Three Months Ended
June 30,
|
For
the Six Months Ended
June 30,
|
|||||||||||||||
|
2009
|
2008
|
2009
|
2008
|
|||||||||||||
|
Collaboration
revenue
|
$ | 6 | $ | — | $ | 30 | $ | — | ||||||||
|
Operating
expenses:
|
||||||||||||||||
|
Research
and development*
|
3,342 | 3,277 | 7,526 | 6,126 | ||||||||||||
|
General
and administrative*
|
1,546 | 1,410 | 2,920 | 2,643 | ||||||||||||
|
Total operating
expenses
|
4,888 | 4,687 | 10,446 | 8,769 | ||||||||||||
|
Loss
from operations
|
(4,882 | ) | (4,687 | ) | (10,416 | ) | (8,769 | ) | ||||||||
|
Interest
and other income, net
|
6 | 298 | 92 | 455 | ||||||||||||
|
Other
expense
|
(2 | ) | (7 | ) | (4 | ) | (11 | ) | ||||||||
|
Net loss
|
$ | (4,878 | ) | $ | (4,396 | ) | $ | (10,328 | ) | $ | (8,325 | ) | ||||
|
Basic
and diluted net loss per share
|
$ | (0.10 | ) | $ | (0.09 | ) | $ | (0.21 | ) | $ | (0.19 | ) | ||||
|
Shares
used in computing basic and diluted net loss per share
|
49,763 | 48,473 | 49,763 | 44,354 | ||||||||||||
|
*Includes
non-cash stock-based compensation of the following:
|
||||||||||||||||
|
Research and
development
|
$ | 68 | $ | 67 | $ | 132 | $ | 132 | ||||||||
|
General and
administrative
|
399 | 344 | 758 | 694 | ||||||||||||
|
Total non-cash stock-based
compensation
|
$ | 467 | $ | 411 | $ | 890 | $ | 826 | ||||||||
CONTACT:
Caroline
Loewy
Chief
Financial Officer
Corcept
Therapeutics
650-688-8783
cloewy@corcept.com
www.corcept.com