Aquestive Therapeutics Negotiates Six Month Extension to June 30, 2022 for Additional Libervant™ Related Capital Under Current Debt Agreement
August 09 2021 - 8:00AM
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 has reached an agreement with its
lenders to amend the base indenture providing an extension of the
term by six months to June 30, 2022 to provide additional debt in
the aggregate of up to $30.0 million. In line with the extension to
June 30, 2022, Aquestive is entitled, at its option, to draw up to
$10 million following FDA approval for Libervant, the first orally
delivered diazepam product for the management of seizure clusters,
and up to an additional $20 million following the FDA grant of U.S.
market access for Libervant.
“We continue to believe that our non-invasive
and innovative product for refractory epilepsy represents a
meaningful improvement in the treatment options available to this
patient population and a significant commercial opportunity. We
appreciate the continued support from our lenders and their
flexibility given the current PDUFA date for Libervant. With this
six month extension, we maintain the capital optionality and may
access to up to $30 million under our existing debt facility that
we can potentially utilize to fund the launch of Libervant, if
approved for market access,” said Keith Kendall, Chief Executive
Officer of Aquestive.
The FDA has accepted for filing the resubmission
of the New Drug Application (NDA) for Libervant™ (diazepam) Buccal
Film for the management of seizure clusters. The FDA has assigned a
Prescription Drug User Fee Act (“PDUFA”) target goal date of
December 23, 2021. Aquestive received a Complete Response Letter
(CRL) from the FDA in September 2020, completed a Type A meeting
with the FDA in November 2020 and received further guidance from
the FDA in February 2021. Based upon the Agency’s guidance, the
submission included additional statistical modeling and supporting
analyses of the existing clinical data. The Company continues to
believe that no additional clinical studies will be required for
FDA approval of Libervant for U.S. market access.
About Aquestive
TherapeuticsAquestive 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 StatementThis
press release includes “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995.
For this purpose, 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™, including our belief that the
resubmitted NDA addresses all of the issues raised in the CRL,
through the regulatory and development pipeline 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; risk of delays in FDA
approval of Libervant 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
in obtaining such approval; 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 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 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; 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,
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.
Investor InquiriesWestwicke, an ICR
CompanyStephanie
Carringtonstephanie.carrington@westwicke.com646-277-1282
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