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Alexza Reports 2011 Third Quarter Financial Results and Provides Business Update
Date:11/7/2011

MOUNTAIN VIEW, Calif., Nov. 7, 2011 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today reported financial results for the fiscal quarter ended September 30, 2011 and provided a business update.  The net losses for the quarters ended September 30, 2011 and 2010, as reported in accordance with accounting principles generally accepted in the United States (GAAP), were $13.4 million and $0.6 million, respectively.  The net losses for the nine-month periods ended September 30, 2011 and 2010, were $30.8 million and $26.9 million, respectively.  At September 30, 2011, Alexza had consolidated cash, cash equivalents and marketable securities of $28.3 million.

"Since the acceptance of the resubmission of our ADSUVE NDA in August, we have made additional progress toward our corporate goals for 2011." said Thomas B. King, President and CEO of Alexza.  "We confirmed the FDA advisory committee meeting date on December 12, 2011 to discuss the ADASUVE NDA and we continue to look toward our PDUFA goal date of February 4, 2012."

King continued, "At the same time, we have also made great strides internationally. In addition to submitting the Marketing Authorization Application to the EMA, we announced a partnership with Grupo Ferrer to commercialize ADASUVE in Europe, Latin America, Russia, and the Commonwealth of Independent States (CIS) countries.  We believe we are poised to enter 2012 with momentum as we continue developing ADASUVE."

Alexza Business Update

The following key events, listed in chronological order, occurred since the beginning of the third quarter of 2011:

  • Alexza conducted a face-to-face meeting with the European Medicines Agency (EMA) assigned Co-Rapporteur and his review team in July 2011.
  • In August 2011, the U.S. Food and Drug Administration (FDA) accepted Alexza's resubmission of the Adasuve͐
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  • SOURCE Alexza Pharmaceuticals, Inc.
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