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Alexza Reports 2007 Year-End Financial Results and Updates Clinical Pipeline Status
Date:3/17/2008

for the treatment of breakthrough pain in cancer and non-cancer patients. In December 2007, Alexza entered into an agreement with Endo Pharmaceuticals to jointly develop AZ-003. Endo is responsible for regulatory, pre-clinical and clinical development, and for commercializing the product in North America. Alexza is responsible for the development of the Staccato Electric Multiple Dose device and has the exclusive right to manufacture the product for clinical development and commercial supply.

-- AZ-007 (Staccato zaleplon) is being developed for the treatment of insomnia in patients who have difficulty falling asleep, including patients who awake in the middle of the night and have difficulty falling back asleep. Alexza filed an Investigational New Drug application in December 2007. In March 2008, the Company completed enrollment in a Phase 1 clinical trial that enrolled 40 healthy volunteers at a single site. The purpose of this trial was to assess the safety, tolerability and pharmacokinetic parameters of a single dose of AZ-007. Using a double-blind, randomized trial design, four doses of AZ-007 (ranging from 0.5 to 4 mg) were compared to placebo. The Company expects to report initial results of this trial in the Q2 2008.

Financial Results -- Three and Twelve Months Ended December 31, 2007 and 2006

The net loss for the years ended December 31, 2007 and 2006, as reported in accordance with accounting principles generally accepted in the United States (GAAP), was $45.1 million and $41.8 million, respectively. GAAP R&D expenses were $13.7 million in the fourth quarter of 2007 and $45.6 million for the year ended December 31, 2007, as compared to $10.5 million and $36.5 million in the comparable periods in 2006. GAAP operating expenses were $17.4 million in the fourth quarter of 2007 and $60.5 million for the year ended December 31, 2007, as compared to $13.9 million and $46.5 million for the comparable periods in 2006. The increases resulted from
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SOURCE Alexza Pharmaceuticals, Inc.
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