SAN FRANCISCO, May 1 /PRNewswire-FirstCall/ -- Medivation, Inc. (Nasdaq: MDVN) today reported on its corporate progress and financial results for the quarter ended March 31, 2008.
"We are dedicated to developing product candidates as rapidly, efficiently and cost-effectively as possible, as patients are in desperate need of novel, more effective treatment options. We have executed against this vision and made significant progress with each of our product candidates in the first quarter of 2008," said David T. Hung, M.D., president and chief executive officer of Medivation. "Our confirmatory pivotal Phase 3 trial of Dimebon in Alzheimer's disease is on track to begin this quarter. We also have completed patient enrollment in our ongoing Phase 2 trial of Dimebon in Huntington's disease and anticipate completing dosing in the second quarter and reporting top-line data shortly thereafter. In addition, we continued to advance our ongoing Phase 1-2 clinical trial of MDV3100 in castration-resistant prostate cancer and expect to present additional results at an upcoming medical conference."
First Quarter 2008 Financial Results
Medivation reported a net loss for the quarter ended March 31, 2008 of $15.5 million, or $0.54 per share, compared to a net loss of $5.6 million, or $0.20 per share, for the same period in 2007.
Total operating expenses for the three months ended March 31, 2008 were $15.9 million, compared to $6.2 million for the same period in 2007. These figures include non-cash stock-based compensation expense of $2.1 million in the first quarter of 2008 and $1.2 million in the prior year period. The increase in operating expenses for the first quarter of 2008 compared to the same period in 2007 is primarily due to increased development costs associated with the Company's lead investigational products, Dimebon and MDV3100, currently in clinical trials. Medivation expects that total operating expenses in 2008 will be in the range of $55 - $65 million, excluding stock-based compensation expense.
Cash and cash equivalents at March 31, 2008 totaled $32.9 million, compared to $43.3 million at the end of the fourth quarter 2007. At March 31, 2008 the remaining capacity under Medivation's committed equity line of credit with Azimuth Opportunity, Ltd. (Azimuth) was $78.8 million. The Company may draw on that remaining capacity at its discretion during the term of the facility, which expires on April 1, 2009.
Conference Call Information
To participate in today's live call by telephone, please dial 888-442-4145 from the U.S. or +1-719-785-1766 for international callers. In addition, the live conference call is being webcast and can be accessed on the "Events and Presentations" page of the "Investor Relations" section of the Company's website at http://www.medivation.com. A replay also will be available for 30 days following the live call.
Medivation, Inc. is a biopharmaceutical company focused on the rapid development and commercialization of innovative, life-changing therapeutics that effectively treat serious diseases with critical unmet medical needs, including diseases of the central nervous system and certain types of cancer. We aim to revolutionize treatment for deadly diseases that are not adequately addressed by currently available medicines in order to bring relief and renewed hope to seriously ill patients and their caregivers. Our current clinical development program includes a second, confirmatory pivotal Phase 3 trial of Dimebon(TM) in Alzheimer's disease, a Phase 2 clinical trial of Dimebon in patients with mild-to-moderate Huntington's disease, and a Phase 1-2 clinical trial of MDV3100 in patients with hormone-refractory (also known as castration-resistant) prostate cancer. For more information, please visit us at http://www.medivation.com.
This press release contains forward-looking statements, including statements regarding estimated 2008 operating expense levels and anticipated clinical and regulatory milestones, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve risks and uncertainties that could cause actual results to differ significantly from those projected. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. None of the Company's product candidates has been approved for sale, significant additional animal and human testing is required in order to seek marketing approval for any of its product candidates, and Medivation cannot assure you that marketing approval can be obtained for any of its product candidates. Furthermore, as is typically the case at this stage of the regulatory review process, the FDA has not yet performed an in-depth review of Medivation's preclinical and clinical data, so its views remain subject to change. Medivation's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-KSB for the year ended December 31, 2007, include information about additional factors that could affect the Company's financial and operating results.
SOURCE Medivation, Inc.