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 the appointments of Timothy E.
Morris to the Company’s Board of Directors, effective August 5,
2022, and Kenneth Truitt, M.D., as Chief Medical Officer effective
September 6, 2022. Aquestive’s Board of Directors will
now be comprised of seven Directors, six of whom are independent
directors. Mr. Morris has been appointed to the Audit
Committee of the Board of Directors.
“I am very pleased to welcome Ken to the
Aquestive team. His extensive clinical development experience will
play an instrumental role in progressing the Company, especially
our epinephrine delivery platform and other significant
advancements to come within the allergy space,” said Dan Barber,
President and Chief Executive Officer of Aquestive. “Ken will help
ensure that AQST-109 remains on track as we continue to plan to
engage the FDA later this year in an End-of-Phase 2 meeting. I also
look forward to working with Ken as we continue to advance and
expand our product development pipeline into 2022 and beyond.”
Dr. Truitt commented, “With years of experience
in biotechnology, I recognize the potential for AQST-109 to
transform that standard-of-care for the emergency treatment of
allergic reactions. I look forward to joining the
Aquestive team as it is poised to commence its pivotal program for
AQST-109 in the U.S. next year.”
“We are delighted to welcome Tim Morris to the
Board of Directors,” said Santo J. Costa, Chairman of the Board at
Aquestive. “Tim is a highly skilled and seasoned executive who will
significantly contribute to the Board of Directors carrying out its
mandate.”
Mr. Morris commented, “These are exciting times
at Aquestive and I am pleased to be joining the Board of Directors.
I look forward to working closely with the other board members as
the Company focuses on advancing its existing pipeline while also
building its financial strength.”
About Timothy MorrisMr. Morris
presently serves as the Chief Operating Officer and Chief Financial
Officer of Humanigen, Inc. (Nasdaq: HGEN), where he focuses his
attention on manufacturing, supply chain, corporate development,
human resources, finance, investor relations, and public relations.
Previously he served as the Chief Financial Officer of Iovance
Biotherapeutics, Inc. from 2017 to 2020, AcelRx Pharmaceuticals,
Inc. from 2014 to 2017, and Vivus Inc. from 2004 to 2013. Mr.
Morris has extensive Board experience, currently serving as a board
member of DBV Technologies (Euronext: DBV, Nasdaq: DBVT), where he
is a members of the audit and pricing committees, Univercells S.A.,
where he is a member of the audit and strategic committees,
Humanetics Corporation, where he serves as the chair of the audit
committee and a member of the compensation committee, and Humanigen
Australia PTY Ltd, Humanigen Ltd., and Humanigen EU Ltd. Mr. Morris
previously served on the boards of directors of Humanigen, Inc.
from 2016 to 2020, and PAION, Inc., a U.S. subsidiary of PAION AG.
Mr. Morris earned a BS in Business, with an emphasis in Accounting,
from California State University and is a Certified Public
Accountant. Upon joining the Audit Committee, the
Company’s Chairman of the Board, Mr. Santo J. Costa, will be
stepping down as a member of the Audit Committee.
About Kenneth Truitt, M.D.Dr.
Truitt previously served as Chief Medical Officer at Venthera Inc.
and ImmusanT Inc. Dr. Truitt has garnered experience in clinical
development, spanning pre-IND through registration across multiple
therapeutic areas and has extensive experience with autoimmunity
and inflammation, CNS and sensory, pain/analgesia, pulmonary, and
rare diseases. He received his post-graduate medical training in
internal medicine and rheumatology from the University of
California at San Francisco.
Inducement Grant under Nasdaq Listing
Rule 5635(c)(4)Under the Company’s 2022 Equity Inducement
Plan, Dr. Truitt will receive on the first date of his employment
an equity award of 100,000 shares of non-qualified common stock
options (collectively, the “Inducement Options”) at an exercise
price per share equal to the closing price of Aquestive’s common
stock on the Nasdaq Global Market on September 6, 2022, the grant
date of the award (the “Grant Date”). These Inducement Options will
have a three year term and vest annually 25% on the first and
second anniversaries of the Grant Date and 50% on the third
anniversary of the Grant Date, subject to continued employment
through the applicable vesting date. These Inducement Options are
granted in reliance on the employment inducement exemption provided
under Nasdaq Listing Rule 5635(c)(4). The award of these Inducement
Options was approved by the independent Compensation Committee of
the Board of Directors and was a material inducement for Dr. Truitt
to accept employment with Aquestive Therapeutics. The
Inducement Options were granted outside of the Company’s 2018
Equity Incentive Plan.
“This is an important day for Aquestive, “Mr.
Barber continued. “Tim and Ken provide significant strength to our
Board and management team, respectively. I would also like to thank
Gary Slatko, who has served as the Company’s Chief Medical Officer
for the past several years. Dr. Slatko will remain on the Aquestive
team and will support Dr. Truitt on advancing our pipeline
programs.”
About AquestiveAquestive
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, four 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 Statement
Certain statements in this press release include
“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 advancement and related timing of AQST-109
through the regulatory and development pipeline and clinical 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 based on
our current expectations and beliefs and are subject to a 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 for AQST-109 and our
other product candidates; risk of delays in FDA approval of
Libervant® (diazepam) Buccal Film, AQST-109, and our other drug
candidates or failure to receive FDA approval; ability to address
the concerns identified in the FDA’s Complete Response Letter dated
September 25, 2020 regarding the New Drug Application for
Libervant; risk of our ability to demonstrate to the FDA “clinical
superiority” within the meaning of the FDA regulations of Libervant
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 we will be successful; risk that
a competitor obtains FDA orphan drug exclusivity for a product with
the same active moiety as any of our other drug products 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 in obtaining
market access 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
sufficient capital and cash resources, including access to
available debt and equity financing and revenues from operations,
to satisfy all of our short-term and longer term liquidity and cash
requirements and other cash needs, at the times and in the amounts
needed; 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; risk of
loss of significant customers; risks related to legal proceedings
and associated costs, including patent infringement, 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.
Investor Inquiries:ICR Westwicke Stephanie
Carrington stephanie.carrington@westwicke.com 646-277-1282
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