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Biotech / Medical : Corcept Therapeutics Incorporated (CORT)
CORT 71.34-2.9%11:11 AM EST

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To: tuck who wrote (8)8/10/2004 1:05:47 AM
From: mopgcw   of 32
 
Corcept Therapeutics Announces Second Quarter 2004 Results

2004-08-09 16:20 (New York)

MENLO PARK, Calif., Aug. 9 /PRNewswire-FirstCall/ -- Corcept Therapeutics
Incorporated (Nasdaq: CORT) today reported financial results for the second
quarter and six months ended June 30, 2004.
For the second quarter of 2004, Corcept reported a net loss of $3.6
million, or $0.18 per share compared to a net loss of $2.9 million, or $0.37
per share for the second quarter of 2003. For the first six months of 2004,
the company reported a net loss of $6.1 million, or $0.43 per share. This
compares to a net loss of $5.7 million of $0.73 per share for the first six
months of 2003.

As of June 30, 2004, Corcept had cash, cash equivalents and marketable
securities of $55.2 million. The total cash used in the company's operating
activities for the second quarter and first six months of 2004 was $3.2
million and $5.4 million, respectively. In April 2004, Corcept completed its
initial public offering, in which the company sold 4,500,000 shares of common
stock at $12 per share. The net proceeds of this offering were $49.0 million.

Total operating expenses were $3.7 million for the second quarter of 2004
compared to total operating expenses of $2.9 million in the second quarter of
2003. In the second quarter of 2004, research and development expenses
increased to $2.6 million from $2.3 million in the second quarter of 2003.

This increase was primarily related to preparations for the commencement of
pivotal clinical trials for the treatment of the psychotic features of
psychotic major depression or PMD using CORLUX. These trials are expected to
commence during the second half of 2004. General and administrative expenses
increased to $1.1 million in the second quarter of 2004 from $615,000 for the
same period in 2003. This increase was attributable to an increase in non-cash
stock-based compensation, and increases in patent, legal and professional
fees, staffing costs and insurance costs.

Total operating expenses were $6.3 million for the six months ended June
30, 2004, compared to total operating expenses of $5.8 million in the first
six months of 2003
"We believe that the funds raised in our initial public offering will
enable us to complete the clinical development of our lead product candidate,
CORLUX(TM), for the treatment of PMD," said Dr. Joseph Belanoff, Corcept's
Chief Executive Officer. "Due to the serious nature of PMD and the lack of
approved drugs for the disorder, the FDA has granted a Fast Track designation
for CORLUX for the treatment of the psychotic features of PMD. We made good
progress in the second quarter of 2004 preparing for the commencement of
pivotal Phase III trials. The goal of our pivotal trials is to demonstrate
that CORLUX causes a rapid and sustained reduction in the psychotic symptoms
of PMD, a result that we observed in the double-blind clinical study we
completed last December. We are in active dialogue with the FDA concerning the
design of these trials."
Commenting on Corcept's financial guidance for the remainder of 2004, Fred
Kurland, Corcept's Chief Financial Officer, stated, "Our forecast for cash use
for the remainder of 2004 is unchanged from our view a quarter ago. After we
commence our pivotal clinical trials, we anticipate an increase in the pace of
spending over that experienced in the first half of 2004. We continue to
expect a net cash burn of between $15 million and $20 million for 2004."

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(TM), 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.
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