UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 8-K
Current Report
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 24, 2008
Corcept Therapeutics Incorporated
(Exact name of registrant as specified in its charter)
000-50679
(Commission File Number)
| Delaware | 77-0487658 | |
| (State or other jurisdiction of incorporation) | (I.R.S. Employer Identification No.) |
149 Commonwealth Drive
Menlo Park, CA 94025
(Address of principal executive offices, with zip code)
(650) 327-3270
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 2.02 | Results of Operations and Financial Condition |
On March 27, 2008 Corcept Therapeutics Incorporated issued a press release announcing its financial results for the quarter and the full year ended December 31, 2007. The press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
This information and the information contained in the press release attached as Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. This information and the information contained in the press release attached as Exhibit 99.1 is not incorporated by reference into any filings of the Corcept Therapeutics Incorporated made under the Securities Act of 1933, as amended, whether made before or after the date of this Current Report, regardless of any general incorporation language in the filing unless specifically stated so therein.
| Item 8.01. | Other Events |
On March 24, 2008 Corcept Therapeutics Incorporated issued a press release announcing the commencement of its fourth Phase 3 trial evaluating CORLUX for the treatment of the psychotic features of psychotic depression. The press release is attached hereto as Exhibit 99.2 and incorporated herein by reference.
| Item 9.01. | Financial Statements and Exhibits |
(a) Financial statements:
None
(b) Pro forma financial information:
None
(c) Shell company transactions:
None
(d) Exhibits
| 99.1 | Press Release of Corcept Therapeutics Incorporated dated March 27, 2008 | |
| 99.2 | Press Release of Corcept Therapeutics Incorporated dated March 24, 2008 | |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| CORCEPT THERAPEUTICS INCORPORATED | ||||||||
| Date: March 28, 2008 | By: | /s/ Joesph K. Belanoff | ||||||
| Name: Joesph K. Belanoff Title: Chief Executive Officer | ||||||||
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Exhibit Index
| Exhibit No. |
Description | |
| 99.1 | Press Release of Corcept Therapeutics Incorporated dated March 27, 2008 | |
| 99.2 | Press Release of Corcept Therapeutics Incorporated dated March 24, 2008 | |
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Exhibit 99.1
| CONTACT: | ||
| Joseph Belanoff | ||
| Chief Executive Officer | ||
| Corcept Therapeutics | ||
| 650-327-3270 | ||
| IR@corcept.com www.corcept.com |
CORCEPT THERAPEUTICS ANNOUNCES FOURTH QUARTER 2007 RESULTS
MENLO PARK, Calif., (March 27, 2008) — Corcept Therapeutics Incorporated (NASDAQ: CORT) today reported financial results for the fourth quarter and for the full year ended December 31, 2007.
For the fourth quarter of 2007, Corcept reported a net loss of $4.2 million, or $0.11 per share, compared to a net loss of $3.9 million, or $0.17 per share, for the fourth quarter of 2006. For the full year 2007, the company reported a net loss of $11.6 million, or $0.34 per share. This result compares to a net loss of $24.9 million, or $1.09 per share, for the full year 2006.
Clinical development activities during the fourth quarter of 2007 and early 2008 included the following:
| • |
Commencement in December 2007 of the pivotal Phase 3 clinical trial of CORLUX®, our lead product candidate, for the treatment of endogenous Cushing’s Syndrome. This is an open label study which will enroll 50 patients at approximately 25 sites in the United States. The Company received Orphan Drug Designation for CORLUX for this indication in July 2007 and the Investigational New Drug application was opened in September 2007. |
| • | Commencement in March 2008 of the fourth Phase 3 clinical trial evaluating CORLUX for the treatment of the psychotic features of psychotic depression. This is a randomized, double-blind, placebo-controlled study which will enroll up to 450 patients at approximately 25 sites in the United States. |
| • | Preparations for clinical trials to further evaluate the mitigation of weight gain induced by atypical antipsychotic medications. These trials will evaluate the effectiveness of CORLUX in preventing weight gain associated with risperidone and quetiapine. |
| • | Continued development of our selective, proprietary GR-II antagonists. In November 2007, we commenced the clinical portion of our human microdosing study using Xceleron’s Accelerator Mass Spectrometry technology. The clinical portion of this study was completed in March 2008, and results are expected to be available in April 2008. |
As of December 31, 2007, Corcept had cash, cash equivalents and marketable securities of $17.4 million. The total cash used in the company’s operating activities for the full year 2007 was $11.0 million.
Total operating expenses increased to $4.4 million for the fourth quarter of 2007, from $4.1 million for the same period in 2006. In the fourth quarter of 2007, research and development expenses decreased to $2.7 million from $2.9 million in the fourth quarter of 2006. This decrease in research and development expenses was due to changes in the clinical development program for CORLUX as the costs associated with the Company’s earlier Phase 3 trials for the treatment of the psychotic features of psychotic depression were only partially offset by the costs for the preparations for the new Phase 3 trial in this indication and for the Company’s new clinical trial to evaluate CORLUX for Cushing’s Syndrome.
General and administrative expenses increased to $1.7 million for the fourth quarter of 2007, from $1.1 million for the same period in 2006, primarily attributable to increases in stock-based compensation expense and cash compensation and professional fees.
On March 25, 2008, Corcept sold approximately 8.9 million shares of its common stock and warrants to purchase approximately 4.5 million shares of its common stock in a private transaction that generated approximately $25 million in net proceeds, after deducting costs of issuance. This financing was led by a new investor, Longitude Capital. Paperboy Ventures LLC, Sutter Hill Ventures and Alta Partners, LLP, all of which are significant shareholders in Corcept, as well as various entities and individuals related to these firms and other accredited investors, including entities affiliated with members of the board of directors also invested. In connection with the financing, Patrick Enright of Longitude Capital will join the Company’s board of directors. Mr. Enright is a Managing Director and Founder of Longitude Capital, a venture capital firm, which specializes in investments in life sciences companies. Thomas Weisel Partners served as a financial advisor to the Company in this transaction.
In addition, on March 25, 2008, the Company entered into a Committed Equity Financing Facility (CEFF) with Kingsbridge Capital Limited (Kingsbridge), a private investment group. Under the terms of the agreement, Kingsbridge has committed to provide up to $60 million of capital through the purchase of newly-issued shares of the Company’s common stock during the three years after the resale registration statement related to the CEFF securities has been declared effective by the Securities and Exchange Commission. Under the terms of the agreement, the exact timing and amount of any CEFF financings will be determined solely by the Company, subject to certain conditions. Under NASDAQ rules, the Company will be able to sell up to a maximum of approximately 9.6 million shares pursuant to this agreement. The actual amount of funds that can be raised under this agreement will be dependent on the number of shares actually sold under the agreement and the market value of the Company’s stock during the pricing periods of each sale.
“These financing transactions provide the resources necessary for us to enroll patients in our Phase 3 clinical studies for our lead product, CORLUX, for the psychotic features of psychotic depression and for the treatment of Cushing’s Syndrome, to conduct our studies in the management of antipsychotic weight gain and to accelerate the development of our selective GR-II antagonists,” remarked Joseph K. Belanoff, M.D., Chief Executive Officer of the Company.
In commenting on the clinical program, Dr. Robert L. Roe, the Company’s President said, “We believe that CORLUX has the potential to provide an important therapeutic benefit for patients with psychotic depression and for patients with Cushing’s Syndrome. Our new Phase 3 clinical trial in psychotic depression has been designed to incorporate the learnings from our earlier Phase 3 trials and thereby optimize the potential for CORLUX to demonstrate a rapid and sustained reduction in psychotic symptoms. We have initiated sites and have begun to enroll patients in this study. We have also initiated sites and are screening patients for enrollment into our Phase 3 pivotal study of CORLUX for the treatment of endogenous Cushing’s Syndrome. We were pleased to have received Orphan Drug Designation for CORLUX for the treatment of Cushing’s Syndrome, a rare but severe disorder that can affect every organ system in the body and can be lethal if not treated effectively. Because this syndrome affects only an estimated 10 to 15 of every one million people, identification and enrollment of the 50 patients for the study is anticipated to be a relatively slow process.”
Commenting on Corcept’s financial guidance for 2008, Anne LeDoux, Corcept’s Vice President and Controller, stated, “Based on the currently planned timeline of our clinical development program and the recent completion of these financing transactions, we expect that net cash used in 2008 will be between $21 million and $25 million.”
About Psychotic Depression
Psychotic depression is a serious psychiatric disorder that affects approximately three million people annually in the United States. It is more prevalent than either schizophrenia or bipolar I disorder. The disorder is characterized by severe depression accompanied by delusions, hallucinations or both. People with psychotic depression 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 psychotic depression.
About Cushing’s Syndrome
Cushing’s Syndrome is caused by prolonged exposure of the body’s tissues to high levels of the hormone cortisol. Cushing’s Syndrome is relatively rare and most commonly affects adults aged 20 to 50. An estimated 10 to 15 of every one million people are affected each year. Symptoms vary, but most people have one or more of the following manifestations: high blood sugar, high blood pressure, upper body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are common. Cushing’s Syndrome can affect every organ system in the body and can be lethal if not treated effectively.
About Weight Gain associated with Antipsychotic Medications
The group of medications known as atypical antipsychotics, including olanzapine, risperidone, clozapine and quetiapine, are widely used to treat schizophrenia and bipolar disorder. All medications in this group are associated with treatment emergent weight gain of varying degrees and carry a warning label relating to treatment emergent hyperglycemia and diabetes mellitus. Weight gain and alterations in metabolic efficiency have been observed for many years in patients with abnormally high circulating cortisol.
About Corcept Therapeutics Incorporated
Corcept Therapeutics Incorporated is a pharmaceutical company engaged in the development of GR-II antagonist drugs for the treatment of severe psychiatric and metabolic diseases. Corcept’s lead product, CORLUX, is currently in Phase 3 clinical trials for the treatment of the psychotic features of psychotic depression and Cushing’s Syndrome. The Company is also engaged in preparation for clinical trials to evaluate CORLUX for the mitigation of weight gain induced by antipsychotic medications and continued development work on its proprietary, selective GR-II antagonists. For additional information about the company, please visit www.corcept.com.
Statements made in this news release, other than statements of historical fact, are forward-looking statements, including, for example, statements relating to Corcept’s clinical development programs, and its spending plans as well as the amount of funds that may be raised under the CEFF. Forward-looking statements are subject to a number of known and unknown risks and uncertainties that might cause actual results to differ materially from those expressed or implied by such statements. For example, there can be no assurances with respect to the pace of enrollment, cost, rate of spending, completion or success of clinical trials; financial projections may not be accurate; there can be no assurances that Corcept will pursue further activities with respect to the clinical development of CORLUX. These and other risk factors are set forth in the Company’s SEC filings, all of which are available from our website (www.corcept.com) or from the SEC’s website (www.sec.gov). We disclaim any intention or duty to update any forward-looking statement made in this news release.
CORCEPT THERAPEUTICS INCORPORATED
CONDENSED BALANCE SHEETS
(in thousands)
| December 31, 2007 |
December 31, 2006 | |||||
| (Note) | (Note) | |||||
| ASSETS: |
||||||
| Current assets: |
||||||
| Cash, cash equivalents and short-term investments |
$ | 17,366 | $ | 9,456 | ||
| Other current assets |
290 | 343 | ||||
| Total current assets |
17,656 | 9,799 | ||||
| Long-term investments |
— | — | ||||
| Other assets |
88 | 103 | ||||
| Total assets |
$ | 17,744 | $ | 9,902 | ||
| LIABILITIES AND STOCKHOLDER’S EQUITY: |
||||||
| Current liabilities: |
||||||
| Accounts payable |
$ | 1,115 | $ | 916 | ||
| Other current liabilities |
1,879 | 2,597 | ||||
| Total current liabilities |
2,994 | 3,513 | ||||
| Capital lease obligation, long-term portion |
16 | 29 | ||||
| Total stockholders’ equity |
14,734 | 6,360 | ||||
| Total liabilities and stockholders’ equity |
$ | 17,744 | $ | 9,902 | ||
| Note: | Derived from audited financial statements at that date. |
CORCEPT THERAPEUTICS INCORPORATED
STATEMENT OF OPERATIONS
(in thousands, except per share amounts)
| For the Three Months Ended December 31, |
Year Ended December 31, |
|||||||||||||||
| 2007 | 2006 | 2007 | 2006 | |||||||||||||
| (Unaudited) | (Unaudited) | (Audited) | (Audited) | |||||||||||||
| Collaboration revenue |
$ | — | $ | 73 | $ | 482 | $ | 294 | ||||||||
| Operating expenses: |
||||||||||||||||
| Research and development* |
2,672 | 2,922 | 7,860 | 20,834 | ||||||||||||
| General and administrative* |
1,746 | 1,141 | 4,867 | 5,042 | ||||||||||||
| Total operating expenses |
4,418 | 4,063 | 12,727 | 25,876 | ||||||||||||
| Loss from operations |
(4,418 | ) | (3,990 | ) | (12,245 | ) | (25,582 | ) | ||||||||
| Interest and other income, net |
235 | 110 | 688 | 719 | ||||||||||||
| Other expense, net |
(9 | ) | 4 | (16 | ) | (10 | ) | |||||||||
| Net loss |
$ | (4,192 | ) | $ | (3,876 | ) | $ | (11,573 | ) | $ | (24,873 | ) | ||||
| Basic and diluted net loss per share |
$ | (0.11 | ) | $ | (0.17 | ) | $ | (0.34 | ) | $ | (1.09 | ) | ||||
| Shares used in computing basic and diluted net loss per share |
39,548 | 23,283 | 34,251 | 22,841 | ||||||||||||
| *Includes non-cash stock-based compensation of the following: |
||||||||||||||||
| Research and development |
$ | 65 | $ | 80 | $ | 213 | $ | 535 | ||||||||
| General and administrative |
435 | 210 | 846 | 1,013 | ||||||||||||
| Total non-cash stock-based compensation |
$ | 500 | $ | 290 | $ | 1,059 | $ | 1,548 | ||||||||
Exhibit 99.2
| CONTACT: | ||
| Joseph Belanoff | ||
| Chief Executive Officer | ||
| Corcept Therapeutics | ||
| 650-327-3270 | ||
| IR@corcept.com www.corcept.com |
CORCEPT THERAPEUTICS ANNOUNCES COMMENCEMENT OF NEXT PHASE 3
STUDY WITH CORLUX® FOR THE TREATMENT OF PSYCHOTIC DEPRESSION
Agreement Signed with MedAvante, Inc.
MENLO PARK, Calif., (March 24, 2008) — Corcept Therapeutics (NASDAQ: CORT) today announced the commencement of its fourth Phase 3 trial, Study 14, evaluating CORLUX for the treatment of the psychotic features of psychotic depression. This trial is a randomized, double-blinded, placebo-controlled study which will enroll up to 450 patients at approximately 25 sites in the United States. In connection with this study Corcept also announced the signing of an agreement with MedAvante, Inc., a provider of centralized clinical rating services.
The Study 14 protocol incorporates learnings from the three most recently completed Phase 3 trials. Based on confirmation of a correlation between the amount of drug in a patient’s blood and the likelihood that the patient will respond to treatment, this study will use a CORLUX dose of 1200 mg once per day for seven days. The study’s primary endpoint will be a comparison of the number of patients who meet response criteria at both days 7 and 56, as has been used in Corcept’s previous studies of psychotic depression. MedAvante’s centralized rating services are expected to increase the accuracy, reliability, and quality of the psychiatric assessments. A review of past studies has also led to refinement of clinical site selection.
MedAvante will provide centralized psychometric assessments via high resolution video-conferencing. Robert L. Roe, MD, Corcept’s President commented, “We are very excited about MedAvante providing the expert centralized rating services. Reducing inter-rater variability will increase our study’s power to detect a difference between CORLUX and placebo.”
Joseph K. Belanoff, M.D., Chief Executive Officer of Corcept said, “We look forward to working with MedAvante in our new study. We are hopeful that the combination of an increased dose and the use of centralized ratings will allow us to definitively determine the efficacy of CORLUX in the treatment of the psychotic features of psychotic depression.”
Given the serious nature of psychotic depression the United States Food and Drug Administration, or FDA, has granted a fast-track designation for CORLUX for the treatment of the psychotic features of psychotic depression. In addition, the FDA has indicated that CORLUX will receive a priority review if no other treatment is approved for psychotic depression at the time Corcept submits its New Drug Application.
About Psychotic Depression
Psychotic depression 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 psychotic depression 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 psychotic depression.
About Corcept Therapeutics Incorporated
Corcept Therapeutics Incorporated is a pharmaceutical company engaged in the development of GR-II antagonist drugs for the treatment of severe psychiatric and metabolic diseases. Corcept’s lead product, CORLUX, is currently in Phase 3 clinical trials for the treatment of the psychotic features of psychotic depression and Cushing’s Syndrome. The Company is also engaged in preparation for clinical trials to evaluate CORLUX for the management of weight gain induced by antipsychotic medications and continued development work on its proprietary, selective GR-II antagonists. For additional information about the company, please visit www.corcept.com.
About MedAvante
MedAvante has pioneered and commercialized a solution that addresses one of the global pharmaceutical industry’s most intractable problems: the high rate of uninformative or failed studies. MedAvante provides centralized expert psychological rater services to the pharmaceutical industry using unique methods to systematically remove potential sources of bias and variability from the assessment process. By centralizing assessments with expert, standardized, objective, blinded clinical interviewers over MedAvante’s 2 way real-time high quality video-conferencing, MedAvante’s Expert Centralized Ratings makes subjective measures of determining drug efficacy increasingly objective. As a result, pharmaceutical sponsors can increase study power, reduce trial failure rates, and get better CNS drugs to market sooner in the patent protected period. In the last three years MedAvante has administered 10,000 remote expert assessments to over 200 research sites for Phase 2 and Phase 3 large Pharma CNS studies. For additional information, please visit www.MedAvante.net.
Statements made in this news release, other than statements of historical fact, are forward-looking statements, including, for example, statements relating to Corcept’s clinical development programs, and its spending plans, and the ability of MedAvante’s services to increase the accuracy, reliability, and quality of the psychiatric assessments in the new Phase 3 trial. Forward-looking statements are subject to a number of known and unknown risks and uncertainties that might cause actual results to differ materially from those expressed or implied by such
statements. For example, there can be no assurances with respect to the completion or success of clinical trials; and there can be no assurances that Corcept will pursue further activities with respect to the clinical development of CORLUX. These and other risk factors are set forth in the Company’s SEC filings, all of which are available from our website (www.corcept.com) or from the SEC’s website (www.sec.gov). We disclaim any intention or duty to update any forward-looking statement made in this news release.