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شايب 2000

عضو نشط
التسجيل
6 يوليو 2005
المشاركات
210
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شايب 2000

عضو نشط
التسجيل
6 يوليو 2005
المشاركات
210
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Corcept Therapeutics Announces Second Quarter 2005 Results
MENLO PARK, Calif., Aug. 9 /PRNewswire-FirstCall/ -- 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(R) 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(R)) 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, CORLUX, is currently in Phase III clinical trials for the treatment of the psychotic features of psychotic major depression. 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. Corcept is also conducting a clinical trial to evaluate the safety and efficacy of our product in improving cognition in patients with mild to moderate Alzheimer's disease. 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

Note: Derived from audited consolidated financial statements at
that date.


CORCEPT THERAPEUTICS INCORPORATED
CONSOLIDATED STATEMENT OF OPERATIONS
(Unaudited)
For the Three Months For the Six Months
Ended 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


SOURCE Corcept Therapeutics Incorporated​
 
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