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Alexza Reports 2012 Second Quarter Financial Results and Provides Business Update
Date:8/8/2012

MOUNTAIN VIEW, Calif., Aug. 8, 2012 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today reported financial results for the fiscal quarter ended June 30, 2012 and provided a business update.  The net loss for the quarters ended June 30, 2012 and 2011, as reported in accordance with accounting principles generally accepted in the United States (GAAP), were $7.0 million and $9.0 million, respectively.  The net loss for the six-month periods ended June 30, 2012 and 2011 were $10.8 million and $17.4 million, respectively.  At June 30, 2012, Alexza had consolidated cash, cash equivalents, marketable securities and restricted cash of $26.4 million.

"Since our last quarterly update in May, we have made strong progress with both of our ADASUVE™ marketing applications, resulting in the resubmission of our ADASUVE NDA and the Day 120 Response for our ADASUVE MAA," said Thomas B. King, President and CEO of Alexza.  "We also completed the EU Pre-Approval Inspection of our Mountain View facility.  We now have our NDA PDUFA date in December 2012 and also project our Day 210 opinion from the CHMP for our MAA in December of this year.

King continued, "We have also established a committed equity financing facility with Azimuth Opportunity, L.P., replacing a similar facility that expired in June.  This new financing facility provides Alexza additional financing flexibility by giving us the potential ability to raise capital efficiently."

Alexza Business Update

The following key events, in chronological order, occurred since the beginning of the second quarter of 2012:

  • In May, Alexza received a second Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its ADASUVE New Drug Application (NDA).  In June, Alexza resubmitted its ADASUVE NDA to the FDA in response
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  • SOURCE Alexza Pharmaceuticals, Inc.
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