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Alexza Reports 2008 First Quarter Financial Results and Updates Development of Product Candidates

ng 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 $1,191,000 in the first quarter of 2008 compared to $719,000 in the comparable period 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 first quarter of 2008 by $3.8 million and reduced net loss for the first quarter of 2007 by $2.1 million.

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 February 2008, Alexza initiated its first Phase 3

clinical trial, designed to enroll approximately 300 schizophrenic

patients with acute agitation at 25 U.S. clinical centers. The trial

is an in-clinic, multi-center, randomized, double-blind,

placebo-controlled study and will test AZ-004 at two dose levels, 5

and 10 mg. Patients may receive up to 3 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 PEC score,

measured at 2 hours after the first dose. Various assessments of a

patient's agitation state will be conducted at serial time points

using standard agitation scales over the first 4-hour post-dose time

period, with follow-up assessments at the end of the 24-hour study

period. Side effe

SOURCE Alexza Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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