Alexza to Initiate the First Phase 3 Trial for AZ-004 (Staccato(R) Loxapine) in La... (headaches AZ-002 (Staccato alprazolam) f...)

Alexza to Initiate the First Phase 3 Trial for AZ-004 (Staccato(R) Loxapine) in Late Q1 2008

Date:9/18/2007

headaches, AZ-002 (Staccato alprazolam) for the acute treatment of panic attacks associated with panic disorder, AZ-104 (Staccato loxapine) for the acute treatment of migraine headaches, AZ-003 (Staccato fentanyl) for the treatment of patients with acute pain and AZ-007 (Staccato zaleplon) for the treatment of sleep disorder in patients who have difficulty falling asleep.

Safe Harbor Statement This press release includes forward-looking statements regarding the development, therapeutic potential and safety of AZ-004 and the Company's other product candidates. Any statement describing the Company's expectations or beliefs is a forward-looking statement, as defined in the Private Securities Litigation Reform Act of 1995, and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of developing and commercializing drugs. The Company's forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. Earlier stage clinical trial results are not necessarily predictive of later stage clinical trial results. These and other risks concerning Alexza's business are described in additional detail in the Company's Annual Report on Form 10- K/A for the year ended December 31, 2006, and the Company's other Periodic and Current Reports filed with the Securities and Exchange Commission, including the risks under the headings "We have a history of net losses. We expect to continue to incur substantial and increasing net losses for the foreseeable future, and we may never achieve or maintain profitability." "We will need substantial additional capital in the future. If additional capital is not available, we will have to delay, reduce or cease operations." "Failure or delay in commencing or completing clinical trials for our product candidates could harm our
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SOURCE Alexza Pharmaceuticals, Inc.
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