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Corcept Therapeutics Announces Third Quarter 2008 Results
Thursday, November 13, 2008 9:01 AM


MENLO PARK, CA -- (Marketwire) -- 11/13/08 -- Corcept Therapeutics Incorporated (NASDAQ: CORT) today reported financial results for the third quarter ended September 30, 2008.

For the third quarter of 2008, Corcept reported a net loss of $5.6 million, or $0.11 per share, compared to a net loss of $3.4 million, or $0.09 per share, for the third quarter of 2007. For the first nine months of 2008, the company reported a net loss of $13.9 million, or $0.30 per share, compared to a net loss of $7.4 million, or $0.23 per share, for the same period in 2007.

On September 3, 2008, we announced that Eli Lilly and Company (Lilly) has agreed to fund studies to test the effectiveness of Corcept's selective GR-II receptor antagonist, CORT 108297, in rat models of olanzapine induced weight gain.

Corcept has 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. The Company has also discovered and filed patents for three different series of compounds which block cortisol's activity at the GR-II (cortisol) receptor but do not block the progesterone receptor. In May 2008, the Company reported that CORT 108297, a potential lead compound from one of these series, produced encouraging results in a human microdosing study. The compound was extremely well absorbed, demonstrated good bioavailability and had a half-life that appears compatible with once-a-day oral dosing.

CORLUX, our lead product candidate, now in Phase 3 studies for the treatment of psychotic depression and Cushing's Syndrome, is a potent blocker of both the GR-II (cortisol) receptor and the PR (progesterone) receptor. In 2005, we published the results of studies in rats that demonstrated that CORLUX both reduced the weight gain associated with the ongoing use of olanzapine and mitigated the weight gain associated with the initiation of treatment with olanzapine. In August of 2007, we announced that the positive results of a clinical trial in healthy men indicated that CORLUX mitigated the weight gain associated with the initiation of treatment with olanzapine. Lilly supplied olanzapine and provided the funds for this human proof of concept study. While we do not intend to develop CORLUX as a commercial product for the mitigation of antipsychotic-induced weight gain, it is an excellent clinical probe to demonstrate the effectiveness of GR-II antagonism in this indication.

"Weight gain and alterations in metabolic efficiency have been observed for many years in patients with high circulating cortisol," said Joseph K. Belanoff, M.D., Chief Executive Officer of Corcept Therapeutics. "While it is not fully understood why the group of medications known as atypical antipsychotic medications, including olanzapine (Zyprexa), risperidone (Risperdal), quetiapine (Seroquel) and clozapine (Clozaril), are associated with varying degrees of treatment emergent weight gain, hyperglycemia and diabetes mellitus, it is possible that a cortisol receptor antagonist may eventually prove to be useful in patients who need to take these medications. We believe that significant opportunities may exist for us to develop proprietary products in this area. Lilly has been vigilant in examining the metabolic changes associated with olanzapine; we are very pleased to continue our work with them and are appreciative of their support."

In regard to the Company's clinical program, Dr. Robert L. Roe, the company's President, commented, "We began enrolling patients in our Phase 3 trial of CORLUX for the psychotic features of psychotic depression during the second quarter and anticipate that we will have a sufficient number of patients enrolled by late 2009 to enable the data safety monitoring board, independent of the Company, to perform an interim analysis evaluating safety and top-line efficacy results from the first half of the study. We have also initiated sites and are enrolling patients into our Phase 3 pivotal study of CORLUX for the treatment of endogenous Cushing's Syndrome. Because only an estimated 10 to 15 of every one million people are newly diagnosed each year with Cushing's Syndrome, identification and enrollment of the 50 patients for the study is anticipated to be an extended process."

As of September 30, 2008, Corcept had cash, cash equivalents and marketable securities of $22.8 million. The total cash used in the company's operating activities for the first nine months of 2008 was $13.9 million.

Total operating expenses increased to $5.0 million for the third quarter of 2008 and $13.7 million for the first nine months of 2008, from $3.6 million and $8.3 million, respectively, for the same periods in 2007. In the third quarter and first nine months of 2008, research and development expenses increased to $3.3 million and $9.4 million, respectively, from $2.4 million and $5.2 million, respectively, in the same periods of 2007.



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