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Corcept Therapeutics Announces Second Quarter 2005 Results

Corcept Therapeutics Incorporated (NASDAQ: CORT) today reported financial results for the second quarter ended June 30, 2005.

For the second quarter of 2005, Corcept reported a net loss of $4.1 million, or $0.18 per share, compared to a net loss of $3.6 million, or $0.18 per share, for the second quarter of 2004.

Total operating expenses were $4.4 million for the second quarter of 2005 compared to $3.7 million in the same period in 2004. In the second quarter of 2005, research and development expenses increased to $3.3 million from $2.6 million in the second quarter of 2004. This increase in research and development expenses over the prior year period was primarily related to increased activity in the clinical development of CORLUX® for the treatment of the psychotic features of psychotic major depression, or PMD.

General and administrative expenses were $1.1 million for the three months ended June 30, 2005, unchanged from $1.1 million for the three months ended June 30, 2004. There was a $100,000 increase in expenses attributable to staffing and professional fees that was offset by a decrease in non-cash stock-based compensation.

As of June 30, 2005, Corcept had cash, cash equivalents and marketable securities of $36.7 million. The total cash used in the company's operating activities for the first six months of 2005 was $10.1 million.

Updating progress in the PMD clinical program, Joseph K. Belanoff, M.D., Chief Executive Officer of Corcept said, "In May, we initiated our third Phase III clinical trial evaluating CORLUX for the treatment of the psychotic features of PMD. We anticipate having initial results from this study, which is being conducted in Europe, available by the end of 2006. While enrollment in our U.S. based Phase III trials has been slower than anticipated, we are implementing steps to increase the pace of enrollment and continue to expect to report results by the end of the first half of 2006."

Dr. Belanoff added, "We also announced the results of completed preclinical studies showing that CORLUX has the potential to both reduce the weight gain caused by olanzapine (the active ingredient in the antipsychotic medication Zyprexa®) and to prevent the weight gain caused by the initiation of treatment with olanzapine. Enrollment continues in our phase II clinical trial in Alzheimer's disease; we expect to report results on this trial in the first half of 2006."

Commenting on Corcept's financial guidance for the remainder of 2005, Fred Kurland, Corcept's Chief Financial Officer, stated, "We now expect that net cash used in 2005 will be between $20 million and $25 million. This differs from the guidance of $25 million to $30 million we provided last quarter.

Dr. Belanoff further stated, "We believe that our cash and marketable securities will enable us to complete, as currently planned, the clinical development of our lead product candidate, CORLUX, for 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 candidate, CORLUX, is currently in Phase III 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. 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 our clinical and preclinical development programs, the expected timing of results of our clinical trials, our spending pace, and our expected financial results. 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 assurances with respect to the regulatory process or regulatory approvals; there can be no assurances with respect to whether our issued patents will be successfully challenged, there can be no assurances with respect to commercial success; and financial projections may not be accurate. 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
CONDENSED BALANCE SHEETS
(in thousands)

 

June 30,

December 31,

 

          2005     

          2004     

 

(Unaudited)

(Note)

ASSETS:

   

Current assets:

   
 

Cash, cash equivalents and short-term investments

   $     32,338

    $    37,401

 

Other current assets

           1,317

              838

   

Total current assets

             33,655

             38,239

       
 

Long-term investments

                4,347

               9,486

 

Other assets

                133

                47

   

Total assets

    $     38,135

    $     47,772

       

LIABILITIES AND STOCKHOLDER'S EQUITY:

   

Current liabilities:

   
 

Accounts payable

    $        125

    $         550

 

Other current liabilities

           1,378

         1,274

   

Total current liabilities

               1,503

              1,824

Capital lease obligation, long-term portion:

                  10

                      

Total liabilities:

               1,513

               1,824

       

Total stockholders' equity

            36,622

            45,948

       
   

Total liabilities and stockholders' equity

    $     38,135

    $    47,772


CORCEPT THERAPEUTICS INCORPORATED
CONSOLIDATED STATEMENT OF OPERATIONS
(Unaudited)

 
 

For the Three Months Ended

For the Six Months Ended

 
 

June 30,

June 30,

 
 

2005

2004

2005

2004

 

OPERATING EXENSES:

     
 

Research and development*

$       3,325

$     2,569

$      8,038

$         4,146

 
 

General and administrative*

        1,061

        1,125

        2,134

        2,118

 
 
 

Total operating expenses

        4,386

           3,694

      10,172

        6,264

 
 

Interest and other income, net

           282

              117

           564

           142

 
 

Interest expense

              (7)

            (7)

            (15)

            (13)

 
   

Net loss

$    (4,111)

$   (3,584)

$           (9,623)

$        (6,135)

 
             
             
 

Basic and diluted net loss per share

$ (0.18)

$    (0.18)

$      (0.43)

$       (0.43)

 
 

Shares used in computing basic and diluted net loss per share

      22,594

      19,778

      22,585

      14,291

 
             

*Includes non-cash stock-based compensation of the following:

         
 

Research and development

$      (194)

$     117

$      (120)

$       258

 
 

General and administrative

         213

          440

           465

         830

 
   

Total non-cash stock-based compensation

$          19

$        557

$         345

$      1,088


CONTACT:
Fred Kurland
Chief Financial Officer
Corcept Therapeutics
650-327-3270
ir@corcept.com
www.corcept.com

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