MOUNTAIN VIEW, Calif.,
Feb. 17, 2012 /PRNewswire/ -- Alexza
Pharmaceuticals, Inc. (Nasdaq: ALXA), or the Company, today
announced that it has priced its previously announced underwritten
public offering of 44,000,000 shares of common stock and warrants
to purchase 44,000,000 shares of common stock. The common
stock and warrants will be issued separately, but will be sold in
combination in the offering, with a warrant to purchase one share
of common stock for each share of common stock sold. The
price to the public for each share and related warrant is
$0.50, for an aggregate offering
amount of approximately $22
million. The net proceeds to Alexza, after
underwriting discounts and commissions and other offering expenses,
and assuming the warrants are not exercised, are expected to be
approximately $20.4 million.
Alexza plans to use the net proceeds from the sale of securities
primarily for general corporate purposes, including regulatory,
clinical trial, research and development, general and
administrative and manufacturing expenses.
The warrants are exercisable at an exercise price of
$0.50 per share beginning one year
and one day from the date of issuance and will expire on the fifth
anniversary of the date of issuance. The offering is expected
to close on or about February 23,
2012, subject to customary closing conditions.
JMP Securities LLC is acting as the sole book-running manager in
the offering.
The common stock and warrants described above are being offered
pursuant to a shelf registration statement on Form S-3 previously
declared effective by the Securities and Exchange Commission, or
the SEC, on May 20, 2010.
A preliminary prospectus supplement related to the offering was
filed with the SEC on February 16,
2012 and is available on the SEC's website located at
http://www.sec.gov. A final prospectus supplement related to
the offering will be filed with the SEC today. When available,
copies of the final prospectus supplement relating to the offering
and the accompanying base prospectus may be obtained by contacting
JMP Securities LLC, 600 Montgomery Street, 10th Floor, San Francisco, California 94111, Attention:
Prospectus Department, (415) 835-8985. A copy of the final
prospectus supplement relating to the offering and the accompanying
base prospectus may also be accessed on the SEC website,
http://www.sec.gov. Before you invest, you should read the
final prospectus supplement and the accompanying base prospectus
and other documents Alexza has filed or will file with the SEC for
more complete information about Alexza and the offering.
This press release shall not constitute an offer to sell or the
solicitation of an offer to buy any securities of Alexza nor shall
there be any sale of such securities in any state or jurisdiction
in which such offer, solicitation or sale would be unlawful prior
to registration or qualification under the securities laws of any
such state or jurisdiction.
About Alexza Pharmaceuticals, Inc.
Alexza is a pharmaceutical company focused on the research,
development and commercialization of novel, proprietary products
for the acute treatment of central nervous system conditions.
Alexza's technology, the Staccato® system, vaporizes unformulated
drug to form a condensation aerosol that, when inhaled, allows for
rapid systemic drug delivery through deep lung inhalation.
The drug is quickly absorbed through the lungs into the
bloodstream, providing speed of therapeutic onset that is
comparable to intravenous administration, but with greater ease,
patient comfort and convenience. (Click here to see an animation of
how the Staccato system works.)
ADASUVE(TM) (Staccato loxapine) is Alexza's lead program,
which is being developed for the acute treatment of agitation in
adults with schizophrenia or bipolar disorder. Alexza
completed and announced positive results from both of its Phase 3
clinical trials and initially submitted the ADASUVE NDA in December
2009. In October 2010, the
Company received a Complete Response Letter from the FDA regarding
the application. The Company completed an end-of-review
meeting with the FDA in December 2010
and a Risk Evaluation and Mitigation Strategy (REMS) guidance
meeting with the FDA in April 2011. The ADASUVE NDA was
resubmitted in August 2011, completed
an advisory committee meeting in December
2011, received a notice of extension of the Prescription
Drug User Fee Act (PDUFA) goal date in January 2012, and has a new PDUFA goal date of
May 4, 2012.
In October 2011, the Company
established a commercial partnership for ADASUVE with Grupo Ferrer Internacional, S.A.
Grupo Ferrer is a leading
pharmaceutical company in Europe
with extensive operations in the Americas, and is Alexza's partner
in the commercialization of ADASUVE in Europe, Latin
America, Russia and the
Commonwealth of Independent States countries. Alexza filed
its ADASUVE Marketing Authorization Application (MAA) with the
European Medicines Agency (EMA) in October 2011.
For more information about Alexza, the Staccato system
technology or the Company's development programs, please visit
www.alexza.com.
Safe Harbor Statement
This press release contains forward-looking statements that
involve significant risks and uncertainties. Any statement
describing the Company's expectations or beliefs is a
forward-looking statement, as defined in the Private Securities
Litigation Reform Act of 1995, and should be considered
an at-risk statement. Such statements are subject to certain risks
and uncertainties, particularly those inherent in the process of
developing and commercializing drugs, including the adequacy of the
Company's capital to support the Company's operations, the
Company's ability to raise additional funds and the potential terms
of such potential financings, the potential of the Company's
ADASUVE NDA resubmission to adequately address the issues in the
Complete Response Letter, the timing of the FDA's review of the
NDA, the eventual prospects that ADASUVE will be approved for
marketing in the U.S., and the timing and prospects for regulatory
approval to market ADASUVE in Europe, Latin
America, Russia and the
Commonwealth of Independent States countries. The Company's
forward-looking statements also involve assumptions that, if they
prove incorrect, would cause its results to differ materially from
those expressed or implied by such forward-looking
statements. These and other risks concerning Alexza's
business are described in additional detail in the Company's Annual
Report on Form 10-K for the year ended December 31, 2010, and the Company's other
Periodic and Current Reports filed with the Securities and Exchange
Commission. Forward-looking statements contained in this
announcement are made as of this date, and the Company undertakes
no obligation to publicly update any forward-looking statement,
whether as a result of new information, future events or
otherwise.
SOURCE Alexza Pharmaceuticals, Inc.