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Corcept Therapeutics Announces Fourth Quarter and Full Year 2008 Results and Update on Development Programs
Monday, March 30, 2009 9:01 AM


MENLO PARK, CA -- (Marketwire) -- 03/30/09 -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a pharmaceutical company engaged in the development of drugs for the treatment of severe psychiatric and metabolic disorders, today updated its corporate progress, reported financial results for the fourth quarter and the full year ended December 31, 2008, and outlined its corporate outlook for 2009.

"The past year has been one of significant progress across all of our development programs. We initiated Phase 3 trials of CORLUX® in psychotic depression and in Cushing's Syndrome -- indications for which there is significant unmet medical need. We also continued to advance our next-generation selective GR-II antagonists, generating important proof of concept data supporting their use for the mitigation of antipsychotic induced weight gain. We now have a large and growing body of data supporting the broad potential of GR-II antagonism in many important diseases," said Joseph Belanoff, M.D., Chief Executive Officer of Corcept. "We believe that each of these three programs has the potential to create significant value for our shareholders, and that it is advantageous to advance our Cushing's Syndrome and selective GR-II antagonist programs in order to assure that these programs reach key milestones even in the absence of additional financing. Consequently, we have decided to reduce the level of activity and extend the timeline for our Phase 3 psychotic depression study."

Fourth Quarter and Recent Development Highlights

--  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.  We believe
    that the addition of a third party centralized rating service to
    independently evaluate patients for entry into the study has improved the
    consistency of rating across clinical trial sites and will reduce the
    background noise that was experienced in earlier studies and is endemic to
    many psychopharmacologic studies; however, it has also caused enrollment of
    this trial to ramp up more slowly than previously projected.
--  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.
--  Announced positive results from a clinical study that tested whether
    CORLUX mitigates the weight gain associated with Risperdal®.  The data
    demonstrated that adding CORLUX to Risperdal treatment in healthy subjects
    resulted in a statistically significant reduction in weight gain compared
    to that seen in subjects receiving Risperdal alone.  Risperdal, a leading
    antipsychotic for the treatment of schizophrenia and bipolar disorder, is
    marketed by Johnson & Johnson.
--  Announced additional positive results from the CORLUX/Risperdal
    clinical study that demonstrate that the addition of CORLUX to Risperdal
    also results in less abdominal fat, lower fasting insulin levels and lower
    triglyceride levels than with Risperdal alone.
    

"We are pleased to have shown that CORLUX appears to mitigate the weight gain associated with Risperdal, just as CORLUX mitigated the weight gain associated with Zyprexa. This study provides evidence that the benefits of GR-II antagonism are not limited to concurrent use with Zyprexa and may, in fact, be applicable to the broad class of antipsychotics," said Dr. Robert L. Roe, M.D., President of Corcept. "We are also encouraged by the positive results of our pre-clinical studies of CORT 108297 when taken in combination with olanzapine, the active ingredient in Zyprexa. The use of GR-II antagonists to prevent weight gain commonly associated with the use of many antipsychotic drugs could provide a significant health and quality of life benefit to the millions of people currently taking these medications, and may have benefit for the treatment of other metabolic problems as well."

Fourth Quarter and 2008 Financial Results

For the fourth quarter of 2008, Corcept reported a net loss of $6.2 million, or $0.13 per share, compared to a net loss of $4.2 million, or $0.11 per share, for the fourth quarter of 2007. For the full year 2008, the company reported a net loss of $20.1 million, or $0.43 per share. This result compares to a net loss of $11.6 million, or $0.34 per share, for the full year 2007.

As of December 31, 2008, Corcept had cash, cash equivalents and marketable securities of $18.3 million. Our year-end cash balance did not include the proceeds of a note receivable of $6.0 million plus accrued interest which was collected in January 2009. The total cash used in the company's operating activities for the full year 2008 was $18.4 million.

Total operating expenses increased to $6.2 million for the fourth quarter of 2008, from $4.4 million for the same period in 2007. In the fourth quarter of 2008, research and development expenses increased to $4.7 million from $2.7 million in the fourth quarter of 2007.



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