Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical
company advancing medicines to solve patients’ problems with
current standards of care and provide transformative products to
improve their lives, announced today that Keith Kendall,
President and Chief Executive Officer and member of the Board of
Directors of the Company, is leaving the Company. The Board of
Directors has appointed Daniel Barber, the current Chief Operating
Officer and long-tenured executive of the Company, to succeed Mr.
Kendall as the President and Chief Executive Officer of Aquestive
and member of its Board of Directors, effective immediately. The
Company and Mr. Kendall entered into a consulting agreement
effective upon his departure. Under the terms of the consulting
agreement, Mr. Kendall will assist in the transition of the role of
CEO and the execution of the Company’s business strategy and
operations until the end of the year.
Mr. Kendall joined the Company soon after its
formation as the Chief Financial Officer. In June 2011, he was
promoted to Co-President and Chief Operating Officer, and then to
Chief Executive Officer in November 2014, at which time he was
appointed as a member of the Board of Directors. Mr. Kendall led
Aquestive through significant growth under his leadership,
including a successful public market debut in 2018, approval of 6
drug products by the U.S. Food and Drug Administration with more
than 10 years of product sales, launch of its first proprietary
drug product Sympazan® in 2018, strengthening the management team,
issuance of over 200 patents worldwide, and advancement of a
late-stage proprietary product pipeline focused on treating
diseases of the central nervous system and an earlier stage
pipeline for the treatment of severe allergies, including
anaphylaxis.
Santo Costa, Chairman of the Board of Directors,
commented, "On behalf of the Board of Directors and Aquestive's
colleagues, I would like to thank Keith for the vision and
leadership he provided to the Company for the past 16 years and his
many contributions to the Board in executing its oversight and
governing responsibilities. He guided Aquestive through
extraordinary growth and built a corporate culture which will serve
as a platform for continued future success of the Company. We are
pleased that Mr. Kendall will continue as an advisor to the Company
and the senior management team through the end of the year. We wish
him great success in his future endeavors."
Mr. Barber commented, “I look forward to joining
our Board of Directors and helping to steer our business, and to
continuing to work closely with our executive team and all of our
colleagues to achieve our strategic goals. Since joining the
Company in 2007, I have been involved in many different facets of
the business and, in my new role, will remain keenly focused on
advancing the two most important value drivers for Aquestive,
product candidates Libervant and AQST-109, while carefully managing
costs.”
Mr. Costa stated, “The Board is excited to have
Dan join the board and expand his responsibilities at Aquestive.
Dan has played a major role in the Company’s success and is ideally
suited to assume these added responsibilities because of his
integral knowledge of all aspects of the business and his strong
relationships throughout the industry. I have confidence that,
under Dan’s strong leadership and commitment to the continued
success of our business, with the contribution of our talented and
capable management team, we will continue to execute our strategy
as we evolve our business.”
Mr. Kendall’s departure is unrelated to the
Company’s strategy, operations, financial condition, reported
financial results, internal controls or disclosure controls and
procedures.
About Aquestive
TherapeuticsAquestive Therapeutics, Inc. (NASDAQ: AQST) is
a pharmaceutical company advancing medicines to solve patients’
problems with current standards of care and provide transformative
products to improve their lives. We are developing orally
administered products to deliver complex molecules, providing novel
alternatives to invasive and inconvenient standard of care
therapies. Aquestive has five commercialized products on the U.S.
market, five licensed products and one stand-alone proprietary
product to date, Sympazan® (clobazam) oral film for the treatment
of seizures associated with Lennox-Gastaut syndrome. Our licensees
market their products in the U.S. and around the world. The Company
also collaborates with pharmaceutical companies to bring new
molecules to market using proprietary, best-in-class technologies,
like PharmFilm®, and has proven drug development and
commercialization capabilities. Aquestive is advancing a late-stage
proprietary product pipeline focused on treating diseases of the
central nervous system, or CNS, and an earlier stage pipeline for
the treatment of severe allergic reactions, including anaphylaxis.
For more information, visit Aquestive.com and follow us on
LinkedIn.
Forward-Looking
StatementCertain statements in this press release are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. Words such as “believe,”
“anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,”
“will,” or the negative of those terms, and similar expressions,
are intended to identify forward-looking statements. These
forward-looking statements include, but are not limited to,
statements regarding the effects of the changes to our management
described herein; our ability to retain key personnel; the 2021
financial outlook; and business strategies, market opportunities,
and other statements that are not historical facts. These
forward-looking statements are subject to the uncertain impact of
the COVID-19 global pandemic on our business including with respect
to our clinical trials including site initiation, patient
enrollment and timing and adequacy of clinical trials; on
regulatory submissions and regulatory reviews and approvals of our
product candidates; pharmaceutical ingredient and other raw
materials supply chain, manufacture, and distribution; sale of and
demand for our products; our liquidity and availability of capital
resources; customer demand for our products and services;
customers’ ability to pay for goods and services; and ongoing
availability of an appropriate labor force and skilled
professionals. Given these uncertainties, the Company is unable to
provide assurance that operations can be maintained as planned
prior to the COVID-19 pandemic.
These forward-looking statements are also based
on our current expectations and beliefs and are subject to a due
number of risks and uncertainties that could cause actual results
to differ materially from those described in the forward-looking
statements. Such risks and uncertainties include, but are not
limited to, risks associated with the Company's development work,
including any delays or changes to the timing, cost and success of
our product development activities and clinical trials and plans
for AQST-109, AQST-108 and our other drug candidates; risk of
delays in regulatory advancement through the FDA of Libervant,
AQST-109, AQST-108, and our other drug candidates or failure to
receive approval; the ability to address the concerns identified in
the FDA’s Complete Response Letter dated September 25, 2020
regarding the NDA for Libervant, including the risk that the FDA
may require additional clinical studies for FDA approval of
Libervant for U.S. market access; risk of our ability to
demonstrate to the FDA the “clinical superiority” of Libervant
within the meaning of the FDA regulations relative to FDA-approved
diazepam rectal gel and nasal spray products including by
establishing a major contribution to patient care within the
meaning of FDA regulations relative to the approved products, as
well as risks related to other potential pathways or positions
which are or may in the future be advanced to the FDA to overcome
the seven year orphan drug exclusivity granted by the FDA for the
approved nasal spray product of a competitor in the U.S., and there
can be no assurance that the Company will be successful; the timing
of the PDUFA target goal date for Libervant; the potential for
AQST-109 as the first orally administered epinephrine product
candidate for the treatment of anaphylaxis; the focus on growing
the Company’s commercial sales of Sympazan®; risk that a competitor
obtains FDA orphan drug exclusivity for a product with the same
active moiety as any of our other drug product candidates for which
we are seeking FDA approval and that such earlier approved
competitor orphan drug blocks such other product candidates in the
U.S. for seven years for the same indication; risk that a
competitor will obtain other market exclusivity with respect to our
product candidates; risk in obtaining market access for our product
candidates for other reasons; risk inherent in commercializing a
new product (including technology risks, financial risks, market
risks and implementation risks and regulatory limitations); risk of
development of our sales and marketing capabilities; risk of legal
costs associated with and the outcome of our patent litigation
challenging third party at risk generic sale of our proprietary
products; risk of sufficient capital and cash resources, including
access to available debt and equity financing, including under the
Company's At-The-Market facility and the Lincoln Park Purchase
Agreement, and revenues from operations, to satisfy all of our
short-term and longer term cash requirements and other cash needs,
at the times and in the amounts needed, or at all; risks and
uncertainties concerning the royalty and other revenue stream of
the KYNMOBI® monetization transaction, achievement of royalty
targets worldwide or in any jurisdiction and certain other
commercial targets required for contingent payments under the
monetization transaction; risk of our ability to collect the
upfront cash payment under the Company's license agreement with
Haisco Pharmaceutical Group Co., Ltd.; risk of failure to satisfy
all financial and other debt covenants and of any default;
short-term and long-term liquidity and cash requirements, cash
funding and cash burn; risk related to government claims against
Indivior for which we license, manufacture and sell Suboxone® and
which accounts for the substantial part of our current operating
revenues; risk of eroding market share for Suboxone and risk of a
sunsetting product; risks related to the outsourcing of certain
marketing and other operational and staff functions to third
parties; risk of the rate and degree of market acceptance of our
product and product candidates; the success of any competing
products, including generics; risk of the size and growth of our
product markets; risks of compliance with all FDA and other
governmental and customer requirements for our manufacturing
facilities; risks associated with intellectual property rights and
infringement claims relating to the Company's products; risk of
unexpected patent developments; the impact of existing and future
legislation and regulatory provisions on product exclusivity;
legislation or regulatory actions affecting pharmaceutical product
pricing, reimbursement or access; claims and risks that may arise
regarding the safety or efficacy of the Company's products and
product candidates; including anticipated sales of Sympazan®; risk
of loss of significant customers; risks related to legal
proceedings, including patent infringement, securities,
investigative and antitrust litigation matters; changes in
government laws and regulations; risk of product recalls and
withdrawals; uncertainties related to general economic, political,
business, industry, regulatory and market conditions and other
unusual items; and other uncertainties affecting the Company
described in the “Risk Factors” section and in other sections
included in our Annual Report on Form 10-K, in our Quarterly
Reports on Form 10-Q, and in our Current Reports on Form 8-K filed
with the Securities Exchange Commission. Given those uncertainties,
you should not place undue reliance on these forward-looking
statements, which speak only as of the date made. All subsequent
forward-looking statements attributable to us or any person acting
on our behalf are expressly qualified in their entirety by this
cautionary statement. The Company assumes no obligation to update
forward-looking statements or outlook or guidance after the date of
this press release whether as a result of new information, future
events or otherwise, except as may be required by applicable
law.
___________________________________________________________________________________________________________________PharmFilm®,
Sympazan® and the Aquestive logo are registered trademarks of
Aquestive Therapeutics, Inc. All other registered trademarks
referenced herein are the property of their respective owners.
Aquestive Contact: Stephanie CarringtonICR
WestwickeStephanie.carrington@westwicke.com646-277-1282
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