MENLO PARK, CA -- (Marketwire) -- 03/30/09 -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a pharmaceutical company engaged in the development of drugs for the
treatment of severe psychiatric and metabolic disorders, today updated its
corporate progress, reported financial results for the fourth quarter and
the full year ended December 31, 2008, and outlined its corporate outlook
for 2009.
"The past year has been one of significant progress across all of our
development programs. We initiated Phase 3 trials of CORLUX® in
psychotic depression and in Cushing's Syndrome -- indications for which
there is significant unmet medical need. We also continued to advance our
next-generation selective GR-II antagonists, generating important proof of
concept data supporting their use for the mitigation of antipsychotic
induced weight gain. We now have a large and growing body of data
supporting the broad potential of GR-II antagonism in many important
diseases," said Joseph Belanoff, M.D., Chief Executive Officer of Corcept.
"We believe that each of these three programs has the potential to create
significant value for our shareholders, and that it is advantageous to
advance our Cushing's Syndrome and selective GR-II antagonist programs in
order to assure that these programs reach key milestones even in the
absence of additional financing. Consequently, we have decided to reduce
the level of activity and extend the timeline for our Phase 3 psychotic
depression study."
Fourth Quarter and Recent Development Highlights
-- Enrolled patients in our 50-patient open-label Phase 3 trial of CORLUX
in patients with Cushing's Syndrome.
-- Enrolled patients in our 450-patient double-blind placebo controlled
Phase 3 trial of CORLUX in patients with psychotic depression. We believe
that the addition of a third party centralized rating service to
independently evaluate patients for entry into the study has improved the
consistency of rating across clinical trial sites and will reduce the
background noise that was experienced in earlier studies and is endemic to
many psychopharmacologic studies; however, it has also caused enrollment of
this trial to ramp up more slowly than previously projected.
-- Announced positive results from two preclinical studies of one of our
next-generation selective GR-II antagonists, CORT 108297, demonstrating the
potential to both reduce weight gain caused by olanzapine and to prevent
weight gain caused by initiation of treatment with olanzapine. Olanzapine
is the active ingredient in Lilly's Zyprexa®, which is indicated for the
treatment of schizophrenia and bipolar disorder.
-- Announced positive results from a clinical study that tested whether
CORLUX mitigates the weight gain associated with Risperdal®. The data
demonstrated that adding CORLUX to Risperdal treatment in healthy subjects
resulted in a statistically significant reduction in weight gain compared
to that seen in subjects receiving Risperdal alone. Risperdal, a leading
antipsychotic for the treatment of schizophrenia and bipolar disorder, is
marketed by Johnson & Johnson.
-- Announced additional positive results from the CORLUX/Risperdal
clinical study that demonstrate that the addition of CORLUX to Risperdal
also results in less abdominal fat, lower fasting insulin levels and lower
triglyceride levels than with Risperdal alone.
"We are pleased to have shown that CORLUX appears to mitigate the weight
gain associated with Risperdal, just as CORLUX mitigated the weight gain
associated with Zyprexa. This study provides evidence that the benefits of
GR-II antagonism are not limited to concurrent use with Zyprexa and may, in
fact, be applicable to the broad class of antipsychotics," said Dr. Robert
L. Roe, M.D., President of Corcept. "We are also encouraged by the
positive results of our pre-clinical studies of CORT 108297 when taken in
combination with olanzapine, the active ingredient in Zyprexa. The use of
GR-II antagonists to prevent weight gain commonly associated with the use
of many antipsychotic drugs could provide a significant health and quality
of life benefit to the millions of people currently taking these
medications, and may have benefit for the treatment of other metabolic
problems as well."
Fourth Quarter and 2008 Financial Results
For the fourth quarter of 2008, Corcept reported a net loss of $6.2
million, or $0.13 per share, compared to a net loss of $4.2 million, or
$0.11 per share, for the fourth quarter of 2007. For the full year 2008,
the company reported a net loss of $20.1 million, or $0.43 per share. This
result compares to a net loss of $11.6 million, or $0.34 per share, for the
full year 2007.
As of December 31, 2008, Corcept had cash, cash equivalents and marketable
securities of $18.3 million. Our year-end cash balance did not include the
proceeds of a note receivable of $6.0 million plus accrued interest which
was collected in January 2009. The total cash used in the company's
operating activities for the full year 2008 was $18.4 million.
Total operating expenses increased to $6.2 million for the fourth quarter
of 2008, from $4.4 million for the same period in 2007. In the fourth
quarter of 2008, research and development expenses increased to $4.7
million from $2.7 million in the fourth quarter of 2007.