Alexza Reports 2008 Second Quarter Financial Results and Updates Development of Product ...(y from increased spending on AZ-004 and ...),Health

Date:8/6/2008

y 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 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 $1,447,000 and $2,638,000 in the quarter and six month period ended June 30, 2008 compared to $557,000 and $1,276,000 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 six month period ended June 30, 2008 by $5.9 million and $9.6 million, and reduced net loss by $2.6 million and $4.7 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. In June 2008, the Company completed enrollment in its first Phase 3 clinical trial of 344 schizophrenic patients with acute agitation at 24 U.S. clinical centers. The trial was an in-clinic, multi-center, randomized, double-blind, placebo-controlled study and tested AZ-004 at two dose levels, 5 and 10 mg. Patients received up to three doses of study drug in a 24-hour period, depending on their clinical status. The primary endpoint for the study is the change from baseline in the PAN
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SOURCE Alexza Pharmaceuticals, Inc. Copyright©2008 PR Newswire. All rights reserved

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