MENLO PARK, CA--(Marketwire - November 8, 2007) - Corcept Therapeutics Incorporated (
NASDAQ:
CORT) today reported financial results for the third quarter ended
September 30, 2007.
For the third quarter of 2007, Corcept reported a net loss of $3.4 million,
or $0.09 per share, compared to a net loss of $6.4 million, or $0.28 per
share, for the third quarter of 2006. For the first nine months of 2007,
the company reported a net loss of $7.4 million, or $0.23 per share,
compared to a net loss of $20.1 million, or $0.93 per share, for the same
period in 2006.
During the third quarter of 2007, Corcept completed the private placement
of a total of approximately 4.8 million shares of its common stock at a
price of $2.10 per share. The aggregate net proceeds of this financing were
approximately $10.0 million after deducting issuance costs.
In September 2007, the Company received notification from the Food and Drug
Administration (FDA) that the FDA has opened the Investigational New Drug
application (IND) for CORLUX® for the treatment of Cushing's Syndrome.
In July 2007, the Company received Orphan Drug Designation from the FDA for
CORLUX for this indication. Drugs that receive Orphan Drug Designation
obtain seven years of marketing exclusivity from the date of drug 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.
In the communication regarding the opening of the IND, the FDA indicated
that a single 50-patient open label study may provide a reasonable basis
for the submission of a New Drug Application for CORLUX for the treatment
of Cushing's Syndrome. Corcept has begun qualifying potential sites for
this study and expects to open the trial for enrollment late in the fourth
quarter of 2007.
In July 2007, the Company executed an agreement with Xceleron Limited to
conduct a human microdosing study of one of Corcept's new chemical
entities, a selective GR-II antagonist, utilizing Xceleron's Accelerator
Mass Spectrometry technology. In early 2003, Corcept initiated a research
program to discover and patent selective GR-II antagonists to create a
pipeline of proprietary products. Three distinct series of GR-II
antagonists were identified that appear to be as potent as Corcept's lead
product CORLUX in blocking cortisol but, unlike CORLUX, do not appear to
block the progesterone or other steroid receptors. The human microdosing
study with Xceleron will evaluate one of the compounds that developed
particularly high plasma and brain concentrations in an animal
bioavailability study.
Joseph K. Belanoff, M.D., Corcept's Chief Executive Officer, commenting on
the Company's clinical progress, said, "We are pleased that the FDA has
allowed us to open our IND for CORLUX for the treatment of Cushing's
Syndrome and plan to begin enrollment in our Phase 3 study late in the
fourth quarter of 2007. We are finalizing the plans for our next Phase 3
study in psychotic depression and expect to begin enrollment in the first
quarter of 2008. We are also planning studies to confirm and expand our
recent finding that CORLUX appeared to mitigate the weight gain and
metabolic disturbances caused by Zyprexa. We look forward to seeing the
human bioavailability characteristics of our lead new chemical entity in
the first quarter of next year."
As of September 30, 2007, Corcept had cash, cash equivalents and marketable
securities of $20.6 million. The total cash used in the Company's operating
activities for the first nine months of 2007 was $7.7 million.
Commenting on Corcept's financial guidance for 2007, Anne LeDoux, Corcept's
Vice President and Controller, stated, "Based on the currently planned
timeline of our clinical development program and our discovery research
activities, we expect that cash used in operating activities in 2007 will
be between $11 million and $13 million. With the completion of the
financing during the third quarter of 2007, we believe that our current
funds will enable us to continue operations through the second quarter of
2008. We will need to raise additional capital in order to fund our
operations beyond that point."
Total operating expenses were $3.6 million for the third quarter of 2007
and $8.3 million for the first nine months of 2007, compared to $6.5
million and $21.8 million, respectively, in the same periods in 2006. In
the third quarter and first nine months of 2007, research and development
expenses decreased to $2.4 million and $5.2 million, respectively, from
$5.1 million and $17.9 million in the same periods of 2006. This decrease
was primarily related to the completion in late 2006 of the majority of
activities regarding our three Phase 3 trials evaluating CORLUX for
treating psychotic depression. Top-line results for two of these trials
were reported during 2006, with top-line results for the third Phase 3
trial, Study 06, being reported in March 2007.
General and administrative expenses decreased to $1.2 million for the third
quarter and $3.1 million for the first nine months of 2007 from $1.4
million and $3.9 million, respectively, for the same periods in 2006 due to
decreases in staffing and stock based compensation costs and in legal and
professional fees. The figure for the first nine months of 2007 includes a
reversal of stock compensation expense of approximately $393,000 related to
the resignation of an administrative employee during the second quarter of
2007.
Corcept recognized revenue from the collaboration with Eli Lilly and
Company of $482,000 and $221,000, respectively, for the nine months ended
September 30, 2007 and 2006.
About Corcept Therapeutics Incorporated
Corcept Therapeutics Incorporated is a pharmaceutical company engaged in
the development of GR-II antagonists 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, a serious psychiatric disorder that
affects approximately three million people annually in the United States.
There is no FDA-approved treatment for psychotic depression. The drug is
administered orally to psychotic depression patients once per day for seven
days. CORLUX, a potent GR-II antagonist, appears to mitigate the effects
of the elevated and abnormal release patterns of cortisol seen in psychotic
depression. In June 2007, Corcept announced positive results from its
proof of concept study evaluating the ability of CORLUX to mitigate weight
gain associated with Zyprexa, a commonly used antipsychotic medication. In
June 2007 the Company received Orphan Drug Designation for CORLUX for the
treatment of Cushing's Syndrome and, in July 2007, the FDA opened the
Company's IND for this indication. 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, including its ability
to demonstrate the efficacy of CORLUX, its spending plans, including
expectations with respect to cash used in operating activities in 2007, and
plans 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
commencement, cost, rate of spending, completion or success of clinical
trials; there can be no assurance with respect to the consummation of
financing activities; financial projections may not be accurate; or there
can be no assurances that Corcept will pursue further activities with
respect to clinical development of CORLUX or with respect to development of
its new chemical entities. 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 SHEET
(in thousands)
September 30, December 31,
2007 2006
----------- -----------
(Unaudited) (Note)
ASSETS:
Current assets:
Cash, cash equivalents and short-term
investments $ 20,582 $ 9,456
Other current assets 430 343
----------- ----------
Total current assets 21,012 9,799
Other assets 92 103
----------- ----------
Total assets $ 21,104 $ 9,902
=========== ==========
LIABILITIES AND STOCKHOLDER'S EQUITY:
Current liabilities:
Accounts payable $ 1,666 $ 916
Other current liabilities 997 2,597
----------- ----------
Total current liabilities 2,663 3,513
Capital lease obligation, long-term portion 19 29
----------- ----------
Total liabilities 2,682 3,542
Total stockholders' equity 18,422 6,360
----------- ----------
Total liabilities and stockholders' equity $ 21,104 $ 9,902
=========== ==========
Note: Derived from audited financial statements at that date.
CORCEPT THERAPEUTICS INCORPORATED
STATEMENT OF OPERATIONS
(in thousands, except per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
------------------------------------------
2007 2006 2007 2006
-------- -------- -------- ---------
Collaboration revenue $ - $ - $ 482 $ 221
-------- -------- -------- ---------
Operating expenses:
Research and development* 2,426 5,147 5,188 17,912
General and administrative* 1,192 1,402 3,120 3,900
-------- -------- -------- ---------
Total operating expenses 3,618 6,549 8,308 21,812
-------- -------- -------- ---------
Loss from operations (3,618) (6,549) (7,826) (21,591)
-------- -------- -------- ---------
Interest and other income, net 191 154 453 609
Other expense (1) (8) (7) (14)
-------- -------- -------- ---------
Net loss $ (3,428) $ (6,403) $ (7,380) $ (20,996)
======== ======== ======== =========
Basic and diluted net loss per
share $ (0.09) $ (0.28) $ (0.23) $ (0.93)
======== ======== ======== =========
Shares used in computing basic
and diluted net loss per share 36,608 22,719 32,466 22,691
======== ======== ======== =========
*Includes non-cash stock-based
compensation of the following:
Research and development $ 64 $ 103 $ 149 $ 455
General and administrative 299 274 411 803
-------- -------- -------- ---------
Total non-cash stock-based
compensation $ 363 $ 377 $ 560 $ 1,258
======== ======== ======== =========
Contact Information: CONTACT:
Joseph Belanoff
Chief Executive Officer
Corcept Therapeutics
650-327-3270
www.corcept.com