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"The first four months of 2008 have been very productive for Alexza, as wehave continued to make progress on all of our product candidates.Importantly, we initiated our first pivotal Phase 3 trial with AZ-004(Staccato(R) loxapine)," said Thomas B King, President and CEO of Alexza. "Wehave a comprehensive plan in place to collect the data and other supportinginformation we will need to submit an NDA for AZ-004. We plan to initiate oursecond AZ-004 Phase 3 clinical trial in the third quarter of 2008."
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Financial Results -- Three Months Ended March 31, 2008 and 2007
GAAP operating expenses were $19.2 million in the first quarter of 2008,compared to $13.8 million for the comparable period in 2007. The firstquarter increase resulted from increased spending on AZ-004 and AZ-104 as theCompany continued development of these product candidates under the SymphonyAllegro agreement, increased spending on AZ-003 with continued development ofthis product candidate under the development agreement with EndoPharmaceuticals, increased spending for device development and manufacturingprocess scale-up efforts, increased personnel related costs to support theseefforts, and increased share-based compensation costs.
On January 1, 2006, Alexza adopted FAS 123R and reports employeeshare-based compensation expense based on the fair value of the award.Share-based compensation was $1,191,000 in the first quarter of 2008 comparedto $719,000 in the comparable period in 2007.
Alexza's Consolidated Statements of Operations include the operations ofSymphony Allegro, Inc., its variable interest entity. As the Company has nodirect ownership in Allegro, it reduces its net loss by the losses incurred byAllegro. "Loss attributed to noncontrolling interest in Symphony Allegro,Inc." reduced net loss for the first quarter of 2008 by $3.8 million andreduced net loss for the first quarter of 2007 by $2.1 million.
In April 2008, Alexza announced positive initial results from the Phase 1study. AZ-007 delivered an IV-like pharmacokinetic profile with a median timeto peak venous concentration (Tmax) of 1.6 minutes. Zaleplon exposure wasdose proportional across the 4 doses studied, as calculated by power analysis.Pharmacodynamics, measured as sedation self-assessed on a 100 mm visual-analogscale, showed onset of effect as early as 2 minutes after dosing with AZ-007.There were no serious adverse events. The most frequently reported adverseevents in subjects receiving AZ-007 were dizziness and somnolence. These dataindicate a rapid onset of effect, apparently directly related to the IV-likepharmacokinetics, and showed that AZ-007 was generally safe and well toleratedin this population of healthy volunteers.
Conference Call Information
Alexza will host a conference call today at 4:30 p.m. Eastern Time. Areplay of the call will be available for two weeks following the event. Theconference call, replay and webcast are open to all interested parties.
To access the conference call via the Internet, go tohttp://www.alexza.com, under the "Investor Relations" link. Please join thecall at least 15 minutes prior to the start of the call to ensure time for anysoftware downloads that may be required. Interested parties may alsopre
