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 12,
2010
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)
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o
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|
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o
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
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o
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
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Item
2.02 Results of Operations and Financial Condition
On August
12, 2010, Corcept Therapeutics Incorporated (the “Company”), issued a press
release announcing its financial results for the quarter ended June 30,
2010. The press release is attached hereto as Exhibit 99.1 and
incorporated by reference herein.
The
information in this Item 2.02 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 or Sections 11 and 12(a)(2) of the Securities Act of 1933, as
amended. The information in this Item 2.02 and the information contained in the
press release attached as Exhibit 99.1 shall not be incorporated by reference
into any filing with the U.S. Securities and Exchange Commission made by the
Company, whether made before or after the date hereof, regardless of any general
incorporation language in the filing unless specifically stated so
therein.
Item
7.01 Regulation FD Disclosure
On August
12, 2010, the Company issued a press release announcing its financial results
for the quarter ended June 30, 2010. The press release is attached
hereto as Exhibit 99.1 and incorporated by reference herein.
The
information in this Item 7.01 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 or Sections 11 and 12(a)(2) of the Securities Act of 1933, as
amended. The information in this Item 7.01 and the information contained in the
press release attached as Exhibit 99.1 is not incorporated by reference into any
filing with the U.S. Securities and Exchange Commission made by the Company,
whether made before or after the date hereof, regardless of any general
incorporation language in the filing unless specifically stated so
therein.
Item
9.01 Financial Statements and Exhibits
(d)
Exhibits
The
following exhibit is furnished with this Current Report on Form
8-K:
99.1
Press Release of Corcept Therapeutics Incorporated
dated August 12, 2010.
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 16, 2010 | By: /s/ Caroline M. Loewy |
| Caroline M. Loewy | |
| Chief Financial Officer |
Exhibit 99.1
Corcept
Therapeutics Announces Second Quarter Results and Corporate and Development
Update
MENLO
PARK, CA--(Marketwire - August 12, 2010) - Corcept Therapeutics Incorporated
(NASDAQ: CORT), a pharmaceutical company
engaged in the discovery and development of drugs for the treatment of severe
metabolic and psychiatric disorders, reported financial results today for the
second quarter ended June 30, 2010, and updated its anticipated milestones for
2010.
"We are
pleased with our accomplishments during the second quarter. We completed
enrollment of our Phase 3 study of CORLUX for Cushing's Syndrome and
strengthened our financial position with two important financing transactions,"
said Joseph Belanoff, M.D., Chief Executive Officer of Corcept. "With enrollment
of the trial completed in June, we expect to announce the top-line results of
the Cushing's Syndrome study in December."
Corporate and Development
Highlights
|
·
|
Completed
enrollment of the planned 50 patients in our open-label Phase 3 trial of
CORLUX in patients with Cushing’s Syndrome, which is being conducted at 20
leading medical facilities throughout the United
States.
|
|
·
|
In
April, raised gross proceeds of $7.7 million through the exercise of
warrants that were issued in October 2009 and the private placement of new
warrants. Participants in this financing included existing
investors Longitude Capital, Sutter Hill Ventures, Federated Kauffman
Funds, and members of our Board of
Directors.
|
|
·
|
In
June, raised gross proceeds of $15 million through an underwritten public
offering of 5 million shares of common stock at $3 per share to new
institutional investors.
|
|
·
|
Selected
a second compound, CORT 113083, from one of our three patented series of
selective GR-II antagonists and began activities toward an Investigational
New Drug (IND) filing in 2011.
|
In
addition, we continued to make progress on:
|
·
|
Preparing
for the submission of our NDA for CORLUX in Cushing’s Syndrome, including
the design of a Risk Evaluation and Mitigation Strategy (REMS), to enable
submission in the first quarter of
2011.
|
|
·
|
Developing
detailed plans for the commercialization of CORLUX in the United
States.
|
|
·
|
Enrolling
patients in our double-blind placebo controlled Phase 3 trial of CORLUX in
patients with psychotic depression at eight clinical
sites.
|
Second Quarter Financial
Results
For the
second quarter of 2010, Corcept reported a net loss of $5.7 million, or $0.09
per share, compared to a net loss of $4.9 million, or $0.10 per share, for the
second quarter of 2009.
Total
operating expenses increased to $6.4 million for the second quarter of 2010,
from $4.9 million for the same period in 2009. In the second quarter of 2010,
research and development expenses increased to $4.6 million from $3.3 million in
the second quarter of 2009. This increase in research and development expenses
was due primarily to increased costs associated with clinical trials for CORLUX
for the treatment of Cushing's Syndrome, the conduct of drug-drug interaction
studies for CORLUX and other NDA supportive activities, and our selective GR-II
antagonist program, including a Phase 1 study of CORT 108297. This was partly
offset by the completion of our CORLUX and Risperdal trial for the treatment of
antipsychotic induced weight gain, and scaling back the number of sites in the
Phase 3 study of CORLUX for the treatment of psychotic depression. General and
administrative expenses increased to $1.9 million for the second quarter of 2010
from $1.5 million for the same period in 2009, due to additional resources
focused on commercial planning for the potential launch of CORLUX in Cushing's
Syndrome.
Our cash
balance as of June 30, 2010 was $35.4 million, up from $23.9 million at December
31, 2009. "We anticipate that our current cash balance is sufficient to fund the
company into the third quarter of 2011," said Caroline Loewy, Chief Financial
Officer of Corcept.
Four Key Anticipated Milestones for
2010
In
January 2010, we announced four key anticipated milestones for 2010. We have
achieved two of those milestones with the initiation of a Phase 1 study of CORT
108297 in February and the completion of enrollment of the planned 50 patients
in our Phase 3 study of CORLUX for the treatment of Cushing's Syndrome in June.
Based on the timing of completion of enrollment and the 24-week duration of
treatment to address the endpoints agreed to with the FDA, we are on track to
announce top-line efficacy results in December, achieving our third key
milestone. Our fourth milestone, our NDA submission to the FDA, is anticipated
in the first quarter of 2011.
"This is
a transformational year for Corcept, driven by the achievement of several
important milestones, most particularly in our Cushing's Syndrome program. We
believe that the Cushing's Syndrome program provides near-term value creation
for our shareholders. 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, which could be as early as
2011," added Dr. Belanoff.
About Cushing's
Syndrome
Endogenous
Cushing's Syndrome is caused by prolonged exposure of the body's tissues to high
levels of the hormone cortisol and is generated by tumors that produce cortisol
or ACTH. Cushing's Syndrome is an orphan indication which 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 over 3,000 new
patients in the United States. An estimated 20,000 patients in the United States
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 also common. Cushing's Syndrome can affect every
organ system in the body and can be lethal if not treated
effectively.
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
Weight Gain Caused by Antipsychotic Medications
The group
of medications known as second-generation antipsychotics, including olanzapine
(Zyprexa), risperidone (Risperdal), quetiapine (Seroquel) and clozapine
(Clozaril), 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 also carry warning labels 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 cortisol (GR-II) receptor and the progesterone (PR) 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 and CORT 113083
CORT
108297 and CORT 113083 are two of several potent, selective antagonists of the
cortisol (GR-II) receptor that we have discovered and for which Corcept owns
worldwide intellectual property rights. In in vitro binding affinity and
functional assays neither of these compounds have affinity for the progesterone
(PR), estrogen (ER), androgen (AR) or mineralocorticoid (GR-I)
receptors.
About
Corcept Therapeutics Incorporated
Corcept
is a pharmaceutical company engaged in the discovery and development of drugs
for the treatment of severe metabolic and psychiatric disorders. The company has
two ongoing Phase 3 programs: CORLUX for the treatment of Cushing's Syndrome,
and CORLUX for the treatment of the psychotic features of psychotic depression.
Corcept also has a Phase 1 program for CORT 108297 and an IND-enabling program
for CORT 113083. Corcept has 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, as well as
composition of matter patents for our selective GR-II antagonists.
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 and
CORT 113083, 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, CORT 113083 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,
2010
|
December
31,
2009
|
|||||||
|
(Unaudited)
|
(Note)
|
|||||||
|
ASSETS:
|
||||||||
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Current
assets:
|
|
|
||||||
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Cash
and cash equivalents
|
$ | 35,385 | $ | 23,867 | ||||
|
Other
current assets
|
621 | 553 | ||||||
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Total
current assets
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36,006 | 24,420 | ||||||
|
|
||||||||
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Other
assets
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91 | 91 | ||||||
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Total
assets
|
$ | 36,097 | $ | 24,511 | ||||
|
|
||||||||
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY:
|
||||||||
|
Current
liabilities:
|
||||||||
|
Accounts
payable
|
$ | 1,173 | $ | 1,270 | ||||
|
Other
current liabilities
|
1,686 | 1,149 | ||||||
|
Total current
liabilities
|
2,859 | 2,419 | ||||||
|
Total
stockholders’ equity
|
33,238 | 22,092 | ||||||
|
Total liabilities and
stockholders’ equity
|
$ | 36,097 | $ | 24,511 | ||||
Note: Derived
from audited financial statements at that date.
CORCEPT
THERAPEUTICS INCORPORATED
CONDENSED
STATEMENTS OF OPERATIONS
(in
thousands, except per share amounts)
(Unaudited)
|
|
For
the Three Months Ended
June
30,
|
For
the Six Months Ended
June 30,
|
||||||||||||||
|
2010
|
2009
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2010
|
2009
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|||||||||||||
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Collaboration
revenue
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$ | - | $ | 6 | $ | - | $ | 30 | ||||||||
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Operating
expenses:
|
||||||||||||||||
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Research
and development*
|
4,574 | 3,342 | 9,063 | 7,526 | ||||||||||||
|
General
and administrative*
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1,871 | 1,546 | 3,446 | 2,920 | ||||||||||||
|
Total operating
expenses
|
6,445 | 4,888 | 12,509 | 10,446 | ||||||||||||
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Loss
from operations
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(6,445 | ) | (4,882 | ) | (12,509 | ) | (10,416 | ) | ||||||||
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Interest
and other income, net
|
753 | 6 | 755 | 92 | ||||||||||||
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Other
expense
|
(3 | ) | (2 | ) | (14 | ) | (4 | ) | ||||||||
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Net loss
|
$ | (5,695 | ) | $ | (4,878 | ) | $ | (11,768 | ) | $ | (10,328 | ) | ||||
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Basic
and diluted net loss per share
|
$ | (0.09 | ) | $ | (0.10 | ) | $ | (0.18 | ) | $ | (0.21 | ) | ||||
|
Shares
used in computing basic and diluted net loss per share
|
66,142 | 49,763 | 64,408 | 49,763 | ||||||||||||
|
*Includes
non-cash stock-based compensation of the following:
|
||||||||||||||||
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Research and
development
|
$ | 62 | $ | 68 | $ | 125 | $ | 132 | ||||||||
|
General and
administrative
|
440 | 399 | 861 | 758 | ||||||||||||
|
Total non-cash stock-based
compensation
|
$ | 502 | $ | 467 | $ | 986 | $ | 890 | ||||||||
CONTACT:
Caroline
Loewy
Chief
Financial Officer
Corcept
Therapeutics
650-688-8783
cloewy@corcept.com
www.corcept.com