Corcept Therapeutics Announces Third Quarter 2004 Results
2004-10-28 16:17 (New York)
MENLO PARK, Calif., Oct. 28 /PRNewswire-FirstCall/ -- Corcept Therapeutics
Incorporated (Nasdaq: CORT) today reported financial results for the third
quarter and nine months ended September 30, 2004.
For the third quarter of 2004, Corcept reported a net loss of
$4.1 million, or $0.18 per share compared to a net loss of $2.1 million, or
$0.26 per share for the third quarter of 2003. For the first nine months of
2004, the company reported a net loss of $10.2 million, or $0.60 per share.
This compares to a net loss of $7.8 million or $0.99 per share for the first
nine months of 2003.
As of September 30, 2004, Corcept had cash, cash equivalents and
marketable securities of $51.8 million. The total cash used in the company's
operating activities for the third quarter and first nine months of 2004 was
$3.4 million and $8.8 million, respectively.
Total operating expenses were $4.3 million for the third quarter of 2004,
which included $3.1 million of research and development expenses. This
compares to total operating expenses of $2.2 million in the third quarter of
2003, which included $1.5 million of research and development expenses. This
increase in research and development expenses over the prior year period was
primarily related to progress in the clinical development of CORLUX(TM) for
the treatment of the psychotic features of psychotic major depression, or PMD.
General and administrative expenses increased to $1.2 million in the third
quarter of 2004 from $614,000 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, as well as staffing and
insurance costs.
During the third quarter of 2004, Corcept reached agreement with the Food
and Drug Administration (FDA) on Special Protocol Assessments (SPA's) for the
design of two pivotal Phase III clinical trials evaluating CORLUX for the
treatment of the psychotic features of PMD. The Company initiated the first
of these trials in September and the second one in October.
"We have accomplished a great deal recently" said Joseph K. Belanoff,
M.D., Corcept's Chief Executive Officer. "As discussed above, we initiated our
pivotal clinical trials shortly after reaching the SPA agreements with the
FDA. We anticipate reporting initial results from both trials in the first
half of 2006." Due to the serious nature of PMD and the lack of approved drugs
for the disorder, the FDA has granted Fast Track designation for CORLUX for
the treatment of the psychotic features of PMD.
Commenting on Corcept's financial guidance for the remainder of 2004, Fred
Kurland, Corcept's Chief Financial Officer, stated, "Now that we have started
our pivotal clinical trials, we anticipate an increase in the pace of our
spending. Through the end of the third quarter, our net cash used was just
under $9 million for 2004. We currently expect the net cash used to be between
$15 million and $17 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, 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. |
