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. |