MOUNTAIN VIEW, Calif.,
Dec. 22, 2015 /PRNewswire/
-- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today
that on December 17, 2015, the
Company received a letter from the Nasdaq Staff indicating that the
Company had not regained compliance with the $35 million market capitalization requirement for
continued listing on The Nasdaq Capital Market by the end of the
previously granted compliance period, which expired on December 16, 2015. As a result, the Company
would be subject to delisting unless it timely requests a hearing
before a Nasdaq Listing Qualifications Panel (the "Panel").
Based on the foregoing, the Company intends to timely request
a hearing before the Panel at which it will present its plan of
compliance and request a further extension of time. The Panel
has the discretion to grant the Company up to an additional 180
calendar days from December 17, 2015
to regain compliance. This request will automatically stay
any delisting or suspension action pending the issuance of a final
decision by the Panel and the expiration of any further extension
granted by the Panel. There can be no assurance that the
Panel will ultimately grant an extension of the compliance
period.
About Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals is focused on the research, development, and
commercialization of novel, proprietary products for the acute
treatment of central nervous system conditions. Alexza's
products and development pipeline are based on the
Staccato® system, a hand-held inhaler designed to
deliver a pure drug aerosol to the deep lung, providing rapid
systemic delivery and therapeutic onset, in a simple, non-invasive
manner. Active pipeline product candidates include AZ-002
(Staccato alprazolam) for the management of epilepsy in
patients with acute repetitive seizures and AZ-007 (Staccato
zaleplon) for the treatment of patients with middle of the night
insomnia.
ADASUVE® is Alexza's first commercial product and is
currently available in 20 countries, approved for sale by the U.S.
Food and Drug Administration, the European Commission and in
several Latin American countries. Teva Pharmaceuticals
USA, Inc., a subsidiary of Teva
Pharmaceutical Industries Ltd., is Alexza's current commercial
partner for ADASUVE in the United
States, though Alexza has announced its intention to
reacquire the United States
commercial rights from Teva with an estimated target completion
date of January 2016. Grupo Ferrer Internacional SA is
Alexza's commercial partner for ADASUVE in Europe, Latin
America, the Commonwealth of Independent States countries,
the Middle East and North Africa countries, Korea, Philippines and Thailand.
ADASUVE® and Staccato® are registered
trademarks of Alexza Pharmaceuticals, Inc. For more
information about Alexza, the Staccato system technology or
the Company's development programs, please visit
www.alexza.com.
This news 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 ability of
Alexza and Ferrer to effectively and profitably commercialize
ADASUVE, Alexza's ability to secure a new U.S. commercial partner
for ADASUVE and the terms of any such partnership, estimated
product revenues and royalties associated with the sale of ADASUVE,
the adequacy of the Company's capital to support the Company's
operations, and the Company's ability to raise additional funds and
the potential terms of such potential financings.
Additionally, there are risks and uncertainties inherent in the
process of negotiating the acquisition of the U.S. rights for
ADASUVE from Teva and restructuring the obligations under the
outstanding note from Teva. Alexza does not have a defined timeline
for this process and is not confirming that the process will result
in any specific action or transaction. 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, 2014 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.
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SOURCE Alexza Pharmaceuticals, Inc.