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Alexza Reports 2009 First Quarter Financial Results and Updates Clinical Pipeline Status
Date:5/7/2009

oximately $11.1 million for fiscal year 2010, compared to fiscal year 2009.

The Company now anticipates that with current cash, cash equivalents and marketable securities along with interest earned thereon, expected payments from Symphony Allegro, the proceeds from option exercises, and purchases of common stock pursuant to its Employee Stock Purchase Plan, the Company will be able to maintain its currently planned operations through the first quarter of 2010. Changing circumstances may cause the Company to consume capital significantly faster or slower than currently anticipated.

Alexza's Consolidated Statements of Operations include the operations of Symphony Allegro, Inc., its variable interest entity. In January 2009, the Company adopted the provisions of Statement of Financial Accounting Standards, No. 160. Under SFAS 160, the Company no longer reverses from our net loss from operations the "Loss attributed to noncontrolling interest in Symphony Allegro, Inc." This is now reported as a line item below the net loss calculation. Net loss attributable to noncontrolling interests in Symphony Allegro was $5.2 million and $3.8 million in the three months ended March 31, 2009 and 2008, respectively.

Product Candidates Development Update

- AZ-004 (Staccato loxapine). Alexza is developing AZ-004 for the acute treatment of agitation in patients with schizophrenia or bipolar disorder. The Company projects an NDA submission for AZ-004 in the first quarter of 2010.

During 2008, Alexza successfully initiated, enrolled and completed its two pivotal Phase 3 clinical trials, announcing positive results from both studies. During 2009, Alexza has five non-pivotal safety and NDA-supporting studies to conduct, which are intended to complete the Company's NDA clinical work. During the first quarter, Alexza completed a Phase 1 placebo-controlled study in 30 healthy subjects to assess
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SOURCE Alexza Pharmaceuticals, Inc.
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Related medicine technology :

1. Endo Pharmaceuticals and Alexza Pharmaceuticals Conclude Research Collaboration
2. Alexza Initiates AZ-104 (Staccato(R) Loxapine) Phase 2b Clinical Trial in Patients With Migraine Headaches
3. Alexzas AZ-004 (Staccato(R) Loxapine) Meets Primary Endpoint of Treating Acute Agitation in Patients with Bipolar Disorder in Phase 3 Trial
4. Alexzas AZ-004 (Staccato(R) Loxapine) Phase 3 Trial Meets Primary Endpoint of Treating Acute Agitation in Schizophrenic Patients
5. Alexza Reports 2008 Second Quarter Financial Results and Updates Development of Product Candidates
6. Alexza Initiates Second Phase 3 Clinical Trial for AZ-004 (Staccato(R) Loxapine)
7. Alexza Pharmaceuticals to Present AZ-104 Phase 2a Clinical Data at the American Headache Society Annual Scientific Meeting
8. Alexza Completes Enrollment in Phase 3 Clinical Trial with AZ-004 (Staccato(R) Loxapine) for Acute Agitation
9. Alexza Announces Preliminary Results From its AZ-002 (Staccato(R) Alprazolam) Phase 2a Proof-of-Concept Trial in Patients With Panic Disorder
10. Alexza Pharmaceuticals to Present AZ-004 Phase 2a Clinical Data at the American Psychiatric Association Annual Meeting
11. Alexza Completes Enrollment in Phase 2a Clinical Trial With AZ-002 (Staccato(R) Alprazolam) in Panic Disorder Patients
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