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Favrille Provides Update on Timing of Analysis from Pivotal Phase 3 Clinical Trial; Reports Third Quarter 2007 Financial Results
Date:10/25/2007

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"The decision to trigger data cutoff and analysis based on trial duration relies on our level of confidence that the assumptions in the sample size calculations are appropriate; the most significant of which is the behavior of the control group. The guidance from the independent DMB combined with simulations we have performed based on the long-term follow-up from our Phase 2 trial gives us confidence that the timing of this analysis will provide adequate patient follow-up needed to retain the pre-specified statistical power of the trial. It is important to note that the DMB assessment was performed in a manner which ensured blinding and the integrity of this pivotal Phase 3 trial."

Third Quarter 2007 Financial Review

Favrille also reported its financial results for the third quarter of 2007. For the three and nine months ended September 30, 2007, the Company reported net losses of $12.3 million, or $0.37 per share, and $35.2 million, or $1.10 per share, respectively, compared to a net loss of $9.6 million, or $0.33 per share, and $30.3 million, or $1.13 per share, for the same periods in 2006.

Research and development expense was approximately $9.5 million and $27.1 million for the three and nine months ended September 30, 2007, respectively, compared to approximately $7.5 million and $23.4 million for the same periods in 2006. The increases were primarily due to additional expenses for personnel and stock-based compensation and increases in validation, rent and operating costs, supplies and depreciation related to the commercial-scale manufacturing facility expansion; offset by decreases in expenses associated with the pivotal Phase 3 clinical trial, which completed patient enrollment in January 2006. Total stock-based compensation included in research and development was approximately $670,000 and $1.7 million for the three and nine months ended September 30, 2007, respectively, compared to approximately $458,000 and $1.4 million for t
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SOURCE Favrille, Inc.
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