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Press Release CONTACT: CORCEPT THERAPEUTICS ANNOUNCES FOURTH QUARTER 2006 RESULTS MENLO
PARK, Calif.,
(March 28, 2007) -- Corcept Therapeutics Incorporated (NASDAQ: CORT) today
reported financial results for the fourth quarter and the full year ended
December 31, 2006. Total operating expenses decreased to $4.1 million for the fourth quarter of 2006, from $5.5 million for the same period in 2005. In the fourth quarter of 2006, research and development expenses decreased to $2.9 million from $4.5 million in the fourth quarter of 2005. This decrease in research and development expenses over the prior year period was primarily related to decreased activity in the clinical development of CORLUX® for the treatment of the psychotic features of psychotic major depression, or PMD, because the first two of the company’s three Phase 3 trials had completed patient activity earlier in 2006. General and administrative
expenses increased to $1.1 million for the fourth quarter of 2006, from
$1.0 million for the same period in 2005, primarily due to increases in
stock-based and cash compensation. Recently Announced Clinical Trial Results On March 19, 2007, the company announced that Study 06, the last of three Phase 3 trials evaluating CORLUX for treating the psychotic features of PMD, did not achieve statistical significance with respect to its primary endpoint. However, there was a statistically significant correlation between plasma levels and clinical outcome achieved during treatment. Further, the company reported that the incidence of serious adverse events did not differ between placebo and any of the three CORLUX dose groups. Patients whose plasma levels rose above a predetermined threshold statistically separated from both those whose plasma levels were below the threshold and those patients who received placebo. This confirmed a similar finding in Study 07, another Phase 3 trial testing CORLUX for PMD completed in 2006. “While we are disappointed that the trial did not meet the primary endpoint, we are particularly encouraged to have met the important predefined threshold drug concentration endpoint with statistical significance,” said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer. “This study confirms our previous observation that at higher plasma levels the drug candidate is able to demonstrate desired clinical effects. In particular, those patients in Study 06 who achieved a predetermined level of 1661 nanograms of CORLUX per milliliter of plasma separated from the placebo group with statistical significance.” Robert L. Roe, M.D., Corcept’s President said, “We believe that the confirmation of a drug concentration threshold for efficacy as well as other observations from Study 06 and the company’s two recently completed Phase 3 clinical trials will serve as a strong basis for the company’s next Phase 3 study. In the upcoming trial, planned to commence later in 2007, we expect to use a dose level of 1200 mg once per day for seven days because, in Study 06, 80% of the patients achieved a drug plasma level sufficient for a strong clinical response at that dose. In our initial review of a summary of the safety data, we have seen no difference between any of the dose levels used in Study 06. We believe that this change in dose as well as other modifications to the protocol should allow us to definitively demonstrate the efficacy of CORLUX in the treatment of the psychotic features of PMD.” About Psychotic Major Depression PMD is a serious psychiatric disorder that affects approximately three million people annually in the United States. It is more prevalent than either schizophrenia or manic depressive illness. The disorder is characterized by severe depression accompanied by delusions, hallucinations or both. People with PMD 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 PMD. About Corcept Therapeutics Incorporated Corcept Therapeutics Incorporated is a pharmaceutical company engaged in the development of drugs for the treatment of severe psychiatric and neurological diseases. Corcept’s lead product, CORLUX, is currently in Phase 3 clinical trials for the treatment of the psychotic features of PMD. The drug is administered orally to PMD patients once per day for seven days. CORLUX, a potent GR-II antagonist, appears to mitigate the effects of the elevated and abnormal release patterns of cortisol seen in PMD. The Company is also conducting a proof-of-concept study evaluating the ability of CORLUX to mitigate weight gain associated with the use of olanzapine. For additional information about the company, please visit www.corcept.com. 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 programs, it’s spending plans and milestone
dates for the 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 commencement,
cost, rate of spending, completion or success of clinical trials; there
can be no assurance with respect to the consummation of financing activities;
financial projections may not be accurate; there can be no assurances
that the investigations for the Phase 3 clinical trials will be completed,
or that that Corcept will pursue further activities with respect to clinical
development of CORLUX. 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
Note: Derived from audited financial statements at that date. CORCEPT
THERAPEUTICS INCORPORATED
|
For the Three Months EndedDecember 31, |
Year EndedDecember 31, |
||||||
|
2006 |
2005 |
2006 |
2005 |
||||
| (Unaudited) |
(Unaudited) |
(Unaudited) |
(Audited) |
||||
| Collaboration revenue |
$ 73 |
$ — |
$ 294 |
$ — |
|||
| Operating expenses: |
|||||||
| Research and development* |
2,922 |
4,514 |
20,834 |
17,074 |
|||
| General and administrative* |
1,141 |
991 |
5,042 |
4,084 |
|||
| Total operating expenses |
4,063 |
5,505 |
25,876 |
21,158 |
|||
| Loss from operations |
(3,990) |
(5,505) |
(25,582) |
(21,158) |
|||
| Interest and other income, net |
110 |
275 |
719 |
1,117 |
|||
| Other expense, net |
4 |
(17) |
(10) |
(52) |
|||
| Net loss |
$ (3,876) |
$ (5,247) |
$ (24,873) |
$ (20,093) |
|||
| Basic and diluted net loss per share |
$ (0.16) |
$ (0.23) |
$ (1.09) |
$ (0.89) |
|||
| Shares used in computing basic and diluted net loss per share |
23,283 |
22,640 |
22,841 |
22,608 |
|||
| *Includes non-cash stock-based compensation of the following: |
|||||||
| Research and development |
$ 80 |
$ 41 |
$ 535 |
$ (26) |
|||
| General and administrative |
210 |
153 |
1,013 |
799 |
|||
| Total non-cash stock-based compensation |
$ 290 |
$ 194 |
$ 1,548 |
$ 773 |
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