Corcept Therapeutics Announces First Quarter 2009 Results and Development Highlights

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Mon May 11, 2009 9:06am EDT

  MENLO PARK, CA, May 11 (MARKET WIRE) -- 
Corcept Therapeutics Incorporated (NASDAQ: CORT), a pharmaceutical
company engaged in the development of drugs for the treatment of severe
psychiatric and metabolic disorders, today reported financial results for
the first quarter ended March 31, 2009.

    "During the first quarter we continued to make progress across all of our
development programs. We enrolled patients in our Phase 3 trials of
CORLUX(R) in Cushing's Syndrome and psychotic depression -- indications
for which there are significant unmet medical needs. We also generated
confirmatory proof of concept data for the use of GR-II antagonists for
the mitigation of weight gain and metabolic disturbances associated with
the use of antipsychotic medications," said Joseph 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."

    First Quarter and Recent Development Highlights

    During the quarter we continued to execute on our strategy to move CORLUX
toward the market expeditiously, 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.

--  Enrolled patients in our 450-patient double-blind placebo controlled
    Phase 3 trial of CORLUX in patients with psychotic depression on the
    previously announced scaled back basis to conserve capital in light of the
    company's financial constraints.

--  Announced positive results from a human proof of concept study of
    CORLUX, demonstrating the potential of GR-II antagonists to prevent weight
    gain and reduce levels of abdominal fat, fasting insulin, and triglycerides
    caused by initiation of treatment with Risperdal(R) (a leading
    antipsychotic for the treatment of schizophrenia and bipolar disorder
    marketed by Johnson & Johnson).

--  Announced positive results from two preclinical studies of one of our
    next-generation selective GR-II antagonists, CORT 108297, demonstrating the
    potential to both reduce weight gain caused by olanzapine and to prevent
    weight gain caused by initiation of treatment with olanzapine.  Olanzapine
    is the active ingredient in Lilly's Zyprexa(R), which is indicated for the
    treatment of schizophrenia and bipolar disorder.
    

    
First Quarter and Financial Results

    For the first quarter of 2009, Corcept reported a net loss of $5.5
million, or $0.11 per share, compared to a net loss of $3.9 million, or
$0.10 per share, for the first quarter of 2008.

    As of March 31, 2009, Corcept had cash, cash equivalents and marketable
securities of $20.6 million, which included the collection in February
2009 of a note receivable of $6.0 million plus accrued interest. The
total cash used in the company's operating activities for the first
quarter of 2009 was $3.7 million.

    Total operating expenses increased to $5.6 million for the first quarter
of 2009, from $4.1 million for the same period in 2008. In the first
quarter of 2009, research and development expenses increased to $4.2
million from $2.9 million in the first quarter of 2008. This increase in
research and development expenses was due primarily to the costs
associated with the clinical trials for the treatment of Cushing's
Syndrome, the treatment of the psychotic features of psychotic
depression, and the mitigation of weight gain caused by Risperdal, as
well as increased spending with respect to the research program related
to the study of new selective GR-II antagonists.

    General and administrative expenses increased to $1.4 million for the
first quarter of 2009, from $1.2 million for the same period in 2008,
primarily attributable to increases in staffing and consultancy expenses.

    Outlook for 2009

    We expect continued progress in the development of CORLUX and our series
of selective GR-II antagonists during 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. We believe that the
Cushing's program provides us with the best near-term value creation
opportunity 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, 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 are continuing to enroll our Phase 3 trial in psychotic depression, on
a limited basis. As previously announced, due to the relatively high cost
of this program, length of the trial, and our current financial
constraints, we have scaled back our planned rate of spending 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 markers, as well as the
positive proof-of-concept data with CORLUX, we plan to file an
Investigational New Drug application (IND) for CORT 108297 by year-end.

    "We continue to focus on Cushing's Syndrome and its near term opportunity,
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 with the number of currently treated patients in the US
estimated to be in excess of 3,000. 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 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 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 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 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 psychiatric and metabolic 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)

                                                   March 31,  December 31,
                                                      2009        2008
                                                 ------------ ------------
                                                  (Unaudited)    (Note)

ASSETS:
Current assets:
  Cash, cash equivalents and short-term
   investments                                    $     20,644 $     18,309
  Other current assets                                     328        1,270
                                                  ------------ ------------
    Total current assets                                20,972       19,579

Other assets                                               197          196
                                                  ------------ ------------
    Total assets                                  $     21,169 $     19,775
                                                  ============ ============

LIABILITIES AND STOCKHOLDERS' EQUITY:
Current liabilities:
  Accounts payable                                $      1,571 $      1,304
  Other current liabilities                              1,712        1,558
                                                  ------------ ------------
    Total current liabilities                            3,283        2,862

Capital lease obligation, long-term portion                  4            6

Total stockholders' equity                              17,882       16,907
                                                  ------------ ------------

    Total liabilities and stockholders' equity    $     21,169 $     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 March 31,
                                                       ------------------
                                                         2009      2008

Collaboration revenue                                  $     24  $     --
                                                       --------  --------
Operating expenses:
  Research and development*                               4,184     2,850
  General and administrative*                             1,374     1,233
                                                       --------  --------
    Total operating expenses                              5,558     4,083
                                                       --------  --------

Loss from operations                                     (5,534)   (4,083)
                                                       --------  --------

Interest and other income, net                               86       157
Other expense                                                (2)       (4)
                                                       --------  --------
    Net loss                                           $ (5,450) $ (3,930)
                                                       ========  ========

Basic and diluted net loss per share                   $  (0.11) $  (0.10)
                                                       ========  ========
Shares used in computing basic and diluted net loss per
 share                                                   49,763    40,235
                                                       ========  ========

*Includes non-cash stock-based compensation of the
 following:
    Research and development                           $     64  $     64
    General and administrative                              360       350
                                                       --------  --------
      Total non-cash stock-based compensation          $    424  $    414
                                                       ========  ========


    


CONTACT:
Caroline Loewy
Chief Financial Officer
Corcept Therapeutics
650-688-8783
Email Contact
www.corcept.com

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