Aquestive Therapeutics, Inc. (NASDAQ: AQST) (the “Company” or
“Aquestive”), a pharmaceutical company advancing medicines to solve
patients’ problems with current standards of care and provide
transformative products to improve their lives, today provided an
update on recent business developments and outlined key 2023
objectives. In addition, Aquestive’s Chief Executive Officer,
Daniel Barber, and Chief Financial Officer, Ernie Toth, will host
investor meetings from January 9 to 11, 2023 in San Francisco,
concurrent with the 41st Annual J. P. Morgan Healthcare Conference.
“In 2023, we plan to focus our resources on the
following key initiatives: (1) advancing AQST-109 into a pivotal PK
study, (2) continuing to work with the FDA to potentially
accelerate the market access for Libervant, (3) exploring new
capabilities for our manufacturing business, (4) continuing to
expand our base of strategic collaborations with other companies,
and (5) strengthening our balance sheet,” remarked Mr. Barber. “We
are thankful for the collaborations that we have forged with a
variety of global companies, including Indivior Inc., Zambon
S.p.A., Otter Pharmaceuticals, LLC (a subsidiary of Assertio
Holdings, Inc. [“Assertio”]), Mitsubishi Tanabe Pharma America,
Inc., Atnahs Pharma UK Limited (Pharmanovia), Haisco Pharmaceutical
Group Co., Ltd., and Hypera S.A. It is worth highlighting that the
majority of these collaborations were entered into over the last 24
months. We look forward to securing possible additional
collaborations in 2023 as we continue to prioritize our alliance
strategies to bringing innovative and, in some cases, life-saving
medications to patients.”
“This is a pivotal year for Aquestive as we seek
to build upon our momentum from the second half of 2022. We have an
experienced team that has not only driven multiple FDA approvals,
but has also excelled at collaborating with leading life sciences
companies. We will be focused on realizing our potential as we
progress through the year,” concluded Mr. Barber.
AQST-109 (epinephrine sublingual
film)In late December 2022, Aquestive received the final
minutes from the End-of-Phase 2 (EOP2) meeting with the United
States Food and Drug Administration (FDA) for AQST-109 (epinephrine
sublingual film) for the treatment of severe allergic reactions
including anaphylaxis, which provided clarity as to the FDA’s
expectations regarding key program areas. Aquestive is conducting
additional analysis regarding the bracketing of PK performance of
approved epinephrine products and plans to finalize its protocol
for the pivotal PK trial in the first half of 2023. Aquestive
anticipates conducting the pivotal PK study in the second half of
2023, and continues to plan for a potential launch in 2025, if
approved by the FDA.
LibervantThe Company continues
to actively pursue U.S. market access for Libervant™ (diazepam)
Buccal Film. Libervant was tentatively approved by the FDA in
August 2022, subject to an Orphan Drug Exclusivity block until
January 2027 based on a competing product.
The Company provided the FDA with additional
clinical data in September 2022 and has been informed that the FDA
is reviewing this data. Furthermore, in October 2022, the Company
provided the FDA with a draft protocol for a head-to-head
comparative PK study of Libervant versus the competing product.
This was followed by a publication of a crossover food effect PK
study of diazepam nasal spray in the peer-reviewed scientific
journal Epilepsia in late November 2022.
Commercial Collaborations and
ManufacturingThe Company continues to anticipate strong
order demand for the manufacture of Indivior’s Suboxone® Sublingual
Film in 2023. In addition, the Company is prepared to support the
continued growth of Hypera’s Ondif (ondansetron) Oral Film in
Brazil, Zambon’s upcoming launch of riluzole oral film in Europe,
and the ongoing marketing efforts of Assertio with Sympazan®
(clobazam) Oral Film.
Furthermore, the Company is currently exploring
possible out-licensing opportunities for Libervant in several
markets, including the U.S., China, and South America. The Company
plans on exploring possible out-licensing opportunities for
AQST-109 outside of the United States in 2023.
In 2022, the Company completed work to expand
its manufacturing capabilities to include serialization and
secondary packaging. This expansion allows the Company to support
its existing and possible future business collaborations more
broadly. With over 90,000 square feet of GMP facilities in Indiana,
the Company will continue to explore possible additional
manufacturing capabilities in 2023.
About AnaphylaxisAnaphylaxis is
a serious systemic hypersensitivity reaction with rapid onset and
potentially fatal. As many as 49 million people in the United
States are at chronic risk for anaphylaxis. Lifetime prevalence is
at least 5%, or more than 16 million people in the United States.
Direct costs of anaphylaxis have been estimated at $1.2 billion per
year, with direct expenditures of $294 million for epinephrine, and
indirect costs of $609 million. The frequency of hospital
admissions for anaphylaxis has increased 500–700% in the last 10–15
years. 52% of patients, who previously experienced anaphylaxis, had
never received an epinephrine autoinjector prescription, and 60%
did not have an autoinjector currently available. The most common
causes of anaphylaxis are foods (such as peanuts), venom from
insect stings, and medications. Epinephrine injection is the
current standard of treatment intended to reverse the severe
manifestation of anaphylaxis, which may include skin rash, throat
swelling, respiratory problems, gastrointestinal distress, and loss
of consciousness.
About AQST-109AQST-109 is a
polymer matrix-based epinephrine prodrug administered as a
sublingual film that is applied under the tongue for the rapid
delivery of epinephrine. The product is similar in size to a
postage stamp, weighs less than an ounce, and begins to dissolve on
contact. No water or swallowing is required for administration. The
packaging for AQST-109 is thinner and smaller than an average
credit card, can be carried in a pocket, and is designed to
withstand weather excursions such as exposure to rain and/or
sunlight.
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 marketed by
our licensees 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 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
StatementsCertain 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 our
product candidate AQST-109 through clinical development and FDA
approval, including the Company’s ability to provide sufficient
data in its NDA submission to address the FDA’s concerns and the
potential benefits AQST-109 could bring to patients, as well as the
timing of a possible launch of AQST-109, if approved by the FDA;
statements regarding the approval of Libervant by the FDA for U.S.
market access and overcoming Orphan Drug Exclusivity of a competing
product before January 2027; statements regarding the demand for
the manufacture of Suboxone Sublingual Film; statements regarding
the potential and related timing for expanding the Company’s
manufacturing capabilities and supporting the growth of demand for
other existing and potential future licensed products in the U.S.
and other countries; statements regarding potential outlicensing of
AQST-109 outside of the U.S. and of Libervant in the U.S. and other
countries; statements regarding entering into commercial
transactions with other companies and the ability to provide
innovative and life-saving medications to patients; statements
regarding the Company’s ability to strengthen its balance sheet and
available cash and cash equivalents; 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 the
Company’s business including with respect to its clinical trials
including site initiation, enrollment and timing and adequacy of
clinical trials; on regulatory submissions and regulatory reviews
and approval of AQST-109; pharmaceutical ingredient and other raw
materials supply chain, manufacture, and distribution; and ongoing
availability of an appropriate labor force and skilled
professionals.
These forward-looking statements are based on
the Company’s 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
the Company’s product development activities and clinical trials
for AQST-109; risk of the Company’s failure to generate sufficient
data in its PK and pharmacodynamics (PD) comparability submission
for FDA approval of AQST-109; risk of the Company’s failure to
address the concerns identified in the FDA EOP2 meeting for
AQST-109; risk of delays in or the failure to receive FDA approval
of AQST-109, including the risk that the FDA may require additional
clinical studies for FDA approval of AQST-109; risks that the FDA
will not approve Libervant for U.S. market access by overcoming the
seven year Orphan Drug Exclusivity of a competing product, and
there can be no assurance that the Company will be successful in
obtaining such approval; risk inherent in commercializing a new
product (including technology risks, financial risks, market risks
and implementation risks and regulatory limitations); risk of our
ability to out-license our proprietary products; risk of
insufficient capital and cash resources, including insufficient
access to available debt and equity financing and revenues from
operations, to satisfy all of the Company’s short-term and longer
term liquidity and cash requirements and other cash needs, at the
times and in the amounts needed; 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 that we are unable to refinance our current
corporate debt on terms and conditions satisfactory to the Company,
or not at all; risk of eroding market share for Suboxone and risk
of a sunsetting product, which accounts for the substantial part of
our current operating revenue; risk of the rate and degree of
market acceptance of our licensed 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; uncertainties
related to general economic, political, business, industry,
regulatory and market conditions and other unusual items; and other
risks and uncertainties affecting the Company described in the
“Risk Factors” section and in other sections included in its Annual
Report on Form 10-K, in its Quarterly Reports on Form 10-Q, and in
its Current Reports on Form 8-K filed with the Securities and
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 the Company or any person acting on its
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.
Investor Inquiries:ICR
WestwickeStephanie
Carringtonstephanie.carrington@westwicke.com646-277-1282
Aquestive Therapeutics (NASDAQ:AQST)
Historical Stock Chart
From Feb 2024 to Mar 2024
Aquestive Therapeutics (NASDAQ:AQST)
Historical Stock Chart
From Mar 2023 to Mar 2024