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

2; (Staccato® Loxapine) New Drug Application (NDA) as a complete, class 2 response to the FDA's Complete Response Letter, and indicated a Prescription Drug User Fee Act (PDUFA) goal date of February 4, 2012.
  • On October 5, 2011, Alexza entered into a commercial partnership for ADASUVE with Grupo Ferrer Internacional, S.A. (Grupo Ferrer) for the commercialization of ADASUVE in Europe, Latin America, Russia and the Commonwealth of Independent States countries.
  • On October 24, 2011, Alexza announced that the FDA has scheduled a meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) for December 12, 2011, at which the ADASUVE NDA will be discussed.
  • On October 26, 2011, Alexza filed a Marketing Authorization Application (MAA) for ADASUVE with the European Medicines Agency (EMA).

  • Alexza believes that, based on its cash, cash equivalents and marketable securities balance at September 30, 2011, the proceeds from the Grupo Ferrer partnership, net of the $5 million payment to the former Symphony Allegro stockholders, and the Company's current expected cash usage, it has sufficient capital resources to meet its anticipated cash needs, at its current expense levels, into the second quarter of 2012.  Changing circumstances may cause Alexza to consume capital significantly faster or slower than currently anticipated, or to alter its operations.

    Financial Results - Periods Ended September 30, 2011 and 2010

    Alexza recorded $1.3 million and $3.8 million of revenues in the three and nine months ended September 30, 2011, respectively, compared to $0.7 million in both the three and nine months ended September 30, 2010.  The revenues were related to the license agreement with Cypress Biosciences, Inc., signed in the third quarter of 2010.

    GAAP operating expenses were $11.2 million and $29.6 million in the three and nine-month periods ended September 30, 2011, respectively, compared to operating expenses o
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    SOURCE Alexza Pharmaceuticals, Inc.
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