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Alexza Reports 2008 Third Quarter Financial Results and Updates Development of Product Candidates
Date:11/6/2008

es resulted primarily from increased spending on AZ-004 and AZ-104 as the Company continued development of these product candidates under the Symphony Allegro agreement, increased spending on AZ-003 with continued development of this product candidate under the development agreement with Endo Pharmaceuticals, increased spending for commercial device development and manufacturing process scale-up efforts, increased personnel-related costs to support these efforts, and increased share-based compensation costs.

On January 1, 2006, Alexza adopted FAS 123R and reports employee share-based compensation expense based on the fair value of the award. Share-based compensation was $1,183,000 and $3,821,000 in the quarter and nine month period ended September 30, 2008 compared to $762,000 and $2,038,000 in the comparable periods in 2007. Alexza's Consolidated Statements of Operations include the operations of Symphony Allegro, Inc., its variable interest entity. As the Company has no direct ownership in Allegro, it reduces its net loss by the losses incurred by Allegro. "Loss attributed to noncontrolling interest in Symphony Allegro, Inc." reduced net loss for the quarter and nine month period ended September 30, 2008 by $6.1 million and $15.7 million, and reduced net loss by $3.0 million and $7.7 million in the comparable periods in 2007.

Product Candidates Development Update

-- AZ-004 (Staccato loxapine). Alexza is developing AZ-004 for the treatment of acute agitation in patients with schizophrenia or bipolar disorder. AZ-004 is currently in Phase 3 clinical testing and, if the data from the second Phase 3 trial is positive, the Company projects an NDA filing in early 2010.

In October 2008, the Company completed enrollment in the second of its two Phase 3 clinical trials. Alexza expects to release initial results from this trial by the end of 2008. This trial enrolled 314 bipolar disorder patients with acute agitation at 17 U.S. clinical centers.
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SOURCE Alexza Pharmaceuticals, Inc.
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