Aquestive Therapeutics Presented Positive Early Phase 1 Results for Oral Epinephrine Film AQST-109 at the American Academy of Allergy, Asthma, and Immunology (AAAAI) Annual Meeting


Aquestive Therapeutics, Inc.

WARREN, NJ, Feb. 28 10, 2022 (GLOBE NEWSWIRE) — Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to solve patient problems with current standards of care and provide transformative products to improve their lives, presented a late-breaking poster summarizing positive key data from a Phase 1 pharmacokinetic study of oral epinephrine film AQST-109 at the American Academy of Allergy, Asthma, and Immunology (AAAAI) annual meeting, which was held February 25-28 in Phoenix, Arizona.

Poster title: A Phase 1 Randomized Study Assessing the Tolerance, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Safety of Increasing Single Doses of Sublingual Film of the Prodrug 109 Epinephrine (AQST-109) in Healthy Male Volunteers
Poster number: L37
Presentation time: February 28, 2022 at 9:45 a.m. MST

Main author: John Oppenheimer, MD, FAAAAI, Clinical Professor of Medicine at UMDNJ Rutgers, Pulmonary and Allergy Associates NJ

This poster presentation provides an opportunity to share our first human data on AQST-109 with the international allergy community,” said John Oppenheimer, MD, FAAAAI, Clinical Professor of Medicine at UMDNJ Rutgers, Pulmonary and Allergy Associates NJ. “Dosing with AQST-109 resulted in PK and PD responses that were within the expected therapeutic range. This is the first time that epinephrine has been shown to achieve therapeutic blood concentrations after sublingual administration. AQST-109 shows promise as a viable alternative to injection for the management of anaphylaxis, and I look forward to further evaluation of this investigational drug.

The webcast of Dr. Oppenheimer’s presentation can be viewed by registered participants in the AAAAI meeting library.

About the AQST-109
AQST-109 is a polymer matrix-based epinephrine prodrug delivered 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 AQST-109’s packaging is thinner and smaller than an average credit card, can be carried in a pocket, and is designed to be weather resistant such as exposure to rain and/or sun. The Investigational New Drug Application (IND) was opened by the FDA on February 24, 2022. In addition, Health Canada has granted authorization to continue our adaptive design crossover study. The Company plans to continue manufacturing registration batches and conduct pivotal studies for AQST-109 in 2022.

About Aqueous Therapeutics
Aquestive Therapeutics is a pharmaceutical company that advances medicines to solve patient problems with today’s standards of care and deliver transformative products to improve their lives. The Company has four approved and licensed products and currently markets an exclusive product developed internally, the oral film Sympazan® (clobazam). The Company also has a portfolio of proprietary commercial products focused on treating diseases of the central nervous system, or CNS, and other unmet needs, and is developing complex orally administered molecules to provide alternatives to standard of care therapies. administered invasively. The Company also collaborates with other pharmaceutical companies to bring new molecules to market using advanced proprietary technologies, such as PharmFilm®, and has proven capabilities for drug development and commercialization.

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 form of these 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 associated timing of our product candidate AQST-109 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 global COVID-19 pandemic on our business, including with respect to our clinical trials, including site initiation, patient recruitment and timing and adequacy of clinical trials; on regulatory submissions and regulatory reviews and approvals of our product candidates; supply chain, manufacturing and distribution of pharmaceutical ingredients and other raw materials; sale and demand for our products; our liquidity and availability of capital resources; customer demand for our products and services; the ability of customers to pay for goods and services; and the continued availability of a suitable workforce and skilled professionals. Given these uncertainties, the Company is not able to guarantee that operations can be maintained as planned before 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. These risks and uncertainties include, but are not limited to, risks associated with the Company’s development work, including any delays or changes in the timing, cost and success of our product development activities and clinical trials for AQST-109 and our other product candidates; the risk of delays or lack of approval of AQST-109, Libervant™ (diazepam) Buccal Film and our other drug candidates by the United States Food and Drug Administration (FDA); ability to address concerns identified in the FDA’s comprehensive 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 Libervant’s FDA regulations over FDA-approved diazepam rectal gels and nasal sprays including establishing a major contribution to patient care within the meaning of the FDA regulations relating to approved products as well as the risks associated with other potential avenues or positions that 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 product nasal spray from a competitor in the United States and there can be no assurance that we will be successful; risk that a competitor will obtain orphan drug exclusivity from the FDA for a product with the same active moiety as any of our other drug products for which we are seeking FDA approval and that competing orphan drug previously approved blocks these other product candidates in the United States for seven years for the same indication; risk of obtaining market access for other reasons; the risk inherent in bringing a new product to market (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); risk of developing our sales and marketing capabilities; the risk of sufficient capital and liquidity resources, including access to available debt and equity financing and operating income, to meet all of our short-term and long-term cash and other cash requirements, at the times and in the amounts needed; risk of non-compliance with all financial and other restrictive covenants and of any default; short-term and long-term liquidity and liquidity needs, cash funding and cash consumption; the risk of government claims against Indivior for which we license, manufacture and sell Suboxone® and which represents the substantial portion of our current operating revenues; risks related to the outsourcing of certain marketing functions and other operational and personnel management functions to third parties; risk relating to the rate and degree of market acceptance of our products and product candidates; the success of any competing product, including generics; the risk related to 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 regulations on product exclusivity; legislation or regulatory actions affecting pricing, reimbursement or access to pharmaceutical products; claims and risks that may arise regarding the safety or effectiveness of the Company’s products and product candidates; risk of losing significant customers; risks related to legal proceedings and associated costs, including patent infringement cases challenging the generic sale of our proprietary products to at-risk third parties, and other antitrust investigation and litigation cases; changes in governmental laws and regulations; risk of product recalls and withdrawals; uncertainties relating 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 10K, our quarterly reports on Form 10-Q and our current reports on Form 8- K filed with the Securities Exchange Commission (SEC). Given these 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 anyone acting on our behalf are expressly qualified in their entirety by this cautionary statement. The Company undertakes no obligation to update any forward-looking statements, outlook or guidance after the date of this press release, whether as a result of new information, future events or otherwise, except as required by law. applicable so requires.

PharmFilm®, Sympazan® and the Aquestive logo are trademarks of Aquestive Therapeutics, Inc. All other trademarks referenced herein are the property of their respective owners.

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