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Corcept Therapeutics Announces First Quarter 2009 Results and Development Highlights
Monday, May 11, 2009 9:05 AM


MENLO PARK, CA -- (Marketwire) -- 05/11/09 -- 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® 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® (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®, 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.



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