Business and Finance
MOUNTAIN VIEW, Calif. (Map) -
"This flexible financing facility is an important addition to our portfolio of financing options, giving us the ability to raise capital quickly and at a competitive cost, and potentially to manage dilution more effectively by issuing shares in multiple tranches at times of our choosing over the next 24 months," said August J. Moretti, Senior Vice President and Chief Financial Officer of Alexza. "We believe these advantages could benefit Alexza and our stockholders as we continue to execute our business plan. This equity line of credit, in addition to our existing capital resources, now gives us the ability to support operations through the end of the first quarter of 2010."
"In addition to starting our first Phase 3 study with AZ-004 (Staccato(R) loxapine), this transitional year in our history includes moving into the early commercial planning for the manufacturing, regulatory submissions, and potential sales and marketing of AZ-004," said Thomas B. King, President and CEO of Alexza. "We expect our first AZ-004 Phase 3 clinical trial to take approximately 12 months to enroll, so we anticipate the top line data from this study could be available in Q2 2009"
Alexza will determine, at its sole discretion, the timing, the dollar
amount and the floor price per share of each draw under this facility, subject
to certain conditions. When and if Alexza elects to use the facility, Alexza
will issue shares to Azimuth at a small discount to the volume weighted
average price of Alexza's common stock over a preceding period of trading
days. Reedland Capital Partners, an Institutional Division of Financial West
Group will act as placement agent and receive a fee for its services at the
time of any draw under the facility. Any shares sold under this facility will
be sold pursuant to a shelf registration statement declared effective by the
Securities and Exchange Commission on
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these 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 state.
About Alexza Pharmaceuticals
Alexza Pharmaceuticals is an emerging specialty pharmaceutical company focused on the development and commercialization of novel, proprietary products for the treatment of acute and intermittent conditions. The Company's technology, the Staccato system, vaporizes unformulated drug to form a condensation aerosol that allows 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.
Alexza has six product candidates in clinical development. Alexza's lead
program, AZ-004 (Staccato loxapine) for the treatment of acute agitation in
schizophrenic or bipolar disorder patients, is in Phase 3 testing. AZ-001
(Staccato prochlorperazine) for the acute treatment of migraine headaches has
completed Phase 2 testing. AZ-104 (Staccato loxapine) for the acute treatment
of migraine headaches and AZ-002 (Staccato alprazolam) for the acute treatment
of panic attacks associated with panic disorder are in Phase 2 testing.
Product candidates in Phase 1 testing include AZ-003 (Staccato fentanyl) for
the treatment of breakthrough pain, which is partnered with Endo
Pharmaceuticals in
Safe Harbor Statement
The anticipated conference call will contain 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. 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
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