Aquestive Therapeutics to Host Investor & Analyst Virtual Epinephrine Drug Delivery R&D Event on March 25 at 9:00 a.m. ET
March 05 2021 - 6:00AM
Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical
company focused on developing and commercializing differentiated
products that address patients’ unmet needs and solve therapeutic
problems, announced today that it will host a virtual investor and
analyst epinephrine drug delivery research and development event on
Thursday, March 25, 2021 at 9:00 am ET.
The event will feature a review of the
epinephrine drug delivery program, inclusive of the data from the
two Phase 1 PK trials and clinical development strategy, and a
Q&A discussion. Presentations will be delivered by members of
Aquestive’s senior management team and by two prominent Key Opinion
Leaders in the field of allergy disorders:
- David Fleischer, M.D., Section
Head, Pediatric Allergy and Immunology at Children’s Hospital
Colorado, Professor of Pediatrics at University of Colorado School
of Medicine
- John Oppenheimer, M.D., Clinical
Professor of Medicine at UMDNJ Rutgers, Pulmonary and Allergy
Associates NJ
A webcast of the virtual R&D event and
accompanying slides will be available under “Events and
Presentations” in the Investors section of the Company’s website at
https://investors.aquestive.com/events-and-presentations. In
addition, the R&D event can be accessed by dialing (833)
640-1722 from the U.S. and (602) 585-9829 internationally, followed
by the conference ID: 3598556. The event webcast will be archived
for 30 days.
About Aquestive Therapeutics
Aquestive Therapeutics is a pharmaceutical
company that applies innovative technology to solve therapeutic
problems and improve medicines for patients. The Company has
commercialized one internally-developed proprietary product to
date, Sympazan® (clobazam) oral film, has a commercial proprietary
product pipeline focused on the treatment of diseases of the
central nervous system, or CNS, and other unmet needs, and is
developing orally administered complex molecules to provide
alternatives to invasively administered standard of care therapies.
The Company also collaborates with other pharmaceutical companies
to bring new molecules to market using proprietary, best-in-class
technologies, like PharmFilm®, and has proven capabilities for drug
development and commercialization.
Forward-Looking Statement
This press release includes 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 of Libervant™ and other product candidates through the
regulatory and development pipeline and business strategies, market
opportunities, and other statements that are not historical facts.
These forward-looking statements are also 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 and plans for AQST-108
and our other drug candidates; risk of delays in regulatory
advancement through the FDA of our drug candidate Libervant and
AQST-108 and our other drug candidates or failure to receive
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 that a competitor will obtain other market
exclusivity with respect to our products; risk inherent in
commercializing a new product (including technology risks,
financial risks, market risks and implementation risks and
regulatory limitations); 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
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 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; risk of failure to satisfy all financial and other debt
covenants and of any default; our and our competitors’ orphan drug
approval and resulting drug exclusivity for our products or
products of our competitors; 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 associated
with Indivior’s cessation of production of its authorized generic
buprenorphine naloxone film product, including the impact from loss
of orders for the authorized generic product and risk of eroding
market share for Suboxone and risk of 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; 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
(SEC). 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.
Investor inquiries:Westwicke, an ICR CompanyStephanie
Carringtonstephanie.carrington@westwicke.com646-277-1282
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