UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 14, 2009
ALEXZA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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| Delaware | | 000-51820 | | 77-0567768 |
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| (State or other jurisdiction | | (Commission | | (IRS Employer |
| of incorporation) | | File Number) | | Identification No.) |
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| Alexza Pharmaceuticals, Inc. | | |
| 2091 Stierlin Court | | |
| Mountain View, California | | 94043 |
| | | |
| (Address of principal executive offices) | | (Zip Code) |
Registrant’s telephone number, including area code:(650) 944-7000
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| o | | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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| o | | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| o | | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| o | | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 7.01. Regulation FD Disclosure.
On September 14, 2009, Alexza Pharmaceuticals, Inc. (“Alexza”) announced preliminary results from its 366 patient Phase 2b clinical trial of AZ-104 (Staccato® loxapine) in patients with migraine headache. Both AZ-104 dose groups trended towards statistical significance, but the study did not meet its primary endpoint, which was defined as pain-relief at the 2-hour time point, compared to placebo. The press release announcing the results of the clinical trial is furnished as Exhibit 99.1 hereto, the contents of which are incorporated herein by reference.
The information presented under this Item 7.01 and attached as Exhibit 99.1 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
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| Exhibit Number | | Description |
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| 99.1 | | Press Release titled “Alexza Announces Preliminary Results from its AZ-104 (Staccato® Loxapine) Phase 2b Trial in Patients with Migraine Headache,” dated September 14, 2009. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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| | Alexza Pharmaceuticals, Inc.
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| Date: September 14, 2009 | | |
| | By: | /s/ Thomas B. King | |
| | | Thomas B. King | |
| | | President and Chief Executive Officer | |
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INDEX TO EXHIBITS
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| Exhibit Number | | Description |
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| 99.1 | | Press Release titled “Alexza Announces Preliminary Results from its AZ-104 (Staccato® Loxapine) Phase 2b Trial in Patients with Migraine Headache,” dated September 14, 2009. |
