Washington Editor

Corcept Therapeutics Inc. filed a registration statement with the SEC for a proposed initial public offering estimated at $80 million.

The price range or number of shares have not yet been set. Two years ago when the company made its initial attempt at going public, it set a price range of $14 to $16 and its number of shares at 4.5 million. At that range, it would have pulled in $63 million to $72 million. (See BioWorld Today, Dec. 28, 2001.)

Corcept withdrew that first IPO filing in October 2002 due to "changed circumstances in the securities market," it said.

Corcept is seeking a listing on the Nasdaq National Market under the ticker symbol "CORT."

The company is in a quiet period and could not comment.

The firm's preliminary prospectus described Menlo Park, Calif.-based Corcept as a development-stage company founded in 1998. It has accumulated a deficit of about $37.8 million, with much of those funds having gone to support development of its lead drug, Corlux, a Phase III product being developed in psychotic features of psychotic major depression (PMD). Corlux also is being evaluated as a possible Alzheimer's disease treatment, in which it would be used to improve cognition in individuals with mild to moderate disease.

Licensed from Stanford University, Corlux exerts its effects by blocking the action of cortisol at one of its two receptors known as the GR-II receptor.

As of Dec. 31, the company had cash, cash equivalents and short-term investment balances of $11.6 million, compared to $21.5 million at Dec. 31, 2002, and $23 million as of Dec. 31, 2001. Net cash used in operating activities for years 2001, 2002 and 2003, was $5.4 million, $13.2 million and $10 million, respectively, according to the prospectus.

For the time being, Corcept's future hinges on the success of its GR-II antagonist Corlux, as it is the company's only advanced product.

In PMD patients, Corlux would be administered orally once daily. Thus far, the company has conducted four trials in PMD patients and expects to initiate two pivotal trials in the U.S. by the end of the year.

Pivotal trials will be randomized, double-blind, placebo-controlled studies, similar to an earlier trial referred to as study '03. Data from '03 demonstrated with statistical significance that patients who received Corlux were more likely than patients who received placebo to achieve a rapid and sustained reduction in psychosis.

Another study, referred to as '02 indicated that Corlux was well tolerated.

Corcept said its two pivotal studies are expected to be complete by early 2006. As a PMD treatment, Corlux has been granted FDA fast-track status because there are no FDA-approved treatments. Usually, psychiatrists treat those patients with electroconvulsive therapy and combination drug therapy.

In Alzheimer's disease, the company has initiated a proof-of-concept study.

The company's largest institutional stockholders are Sutter Hill Ventures, of Palo Alto, Calif., which owns about 22.3 percent; entities affiliated with Maverick Capital Investment Partnership, of New York, with 11.7 percent; and entities affiliated with Alta Partners LLP, of San Francisco, with 9.4 percent.

The offering will be managed by Thomas Weisel Partners LLC, of San Francisco; U.S. Bancorp Piper Jaffray, of Minneapolis; and Legg Mason Wood Walker Inc., of Baltimore.