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Corcept Therapeutics Announces Second Quarter 2009 Results and Development Highlights
Tuesday, August 11, 2009 9:01 AM


MENLO PARK, CA -- (Marketwire) -- 08/11/09 -- 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.



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