Company Overview

Alexza Pharmaceuticals is a rapidly emerging pharmaceutical company focused on the development and commercialization of novel products for the treatment of acute and intermittent conditions. Our proprietary Staccato^® system vaporizes excipient-free drugs to form condensation aerosols that deliver pure drug to deep lung tissues through one simple breath — providing uniquely fast and convenient therapeutic effect. The company currently has six products in development targeting five central nervous system or psychiatry indications: acute agitation, panic attacks, migraine headaches, breakthrough pain, and insomnia.

Since early 2007:

• We have completed enrollment of a Phase 3 study of AZ-004 (Staccato loxapine) for acute agitation in schizophrenic patients with a goal of submitting our first NDA in the first half of 2010.


• We completed our Phase 2b study With AZ-001 (Staccato prochlorperazine) for migraine. We also completed a thorough QT study in subjects and are conducting a 28-day animal inhalation toxicology study, in preparation for an end-of-Phase 2 meeting with the FDA.


• We completed a Phase 2a study of AZ-104 (Staccato loxapine) for migraine. This new product program – a lower dose version of our agitation product – strengthens our portfolio of potential migraine therapies.


• We established a partnership with Endo Pharmaceuticals to develop AZ-003 (Staccato fentanyl, now EN 3294) for breakthrough pain in North America. This partnership will also fund further development of a multi-dose version of our Staccato system.


• We began and completed enrollment of a Phase 1 trial of our newest product, AZ-007 (Staccato zaleplon) for insomnia.


• We opened our new 11,000 square foot manufacturing facility at our new company headquarters.


• We entered into a commercial supply agreement with Autoliv ASP, Inc. for the chemical heat packages in our Staccato devices


• We formed Alexza Singapore Pte. Ltd. to oversee the commercial manufacturing of the lower housing assembly for our Staccato devices.


• We completed a successful follow-on offering of 6.9 million shares of common stock, raising net proceeds of $66 million to fund our continued clinical and precommercial development activities, and we entered into two new financing agreements to facilitate our growth: a $10 million equity investment from Bio*One Capital, made in connection with our decision to initiate device component manufacturing operations in Singapore, and a $50 million equity line of credit with Azimuth Opportunity Ltd.

We are particularly pleased to note that these many accomplishments reflect progress in both the product development and pre-commercialization sides of our business. Our clinical development has been especially rapid, and in anticipation of a potential first product approval, we have actively been building the infrastructure for the manufacturing, market launch and ongoing sales and marketing support.

We believe we are pioneering a genuinely revolutionary technology that can greatly improve the treatment of many patients suffering with acute and intermittent conditions. Our overriding goals are to bring the company’s first product, AZ-004, through Phase 3 clinical trials and regulatory approval, while continuing to develop our other product candidates.

Alexza Common Stock is traded on the Nasdaq Stock Market under the symbol ALXA.

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