Aquestive Therapeutics to Present Positive Data from Pharmacokinetic Studies for AQST-109 (epinephrine sublingual film) at American Academy of Allergy, Asthma, and Immunology (ACAAI) Annual Scientific Meeting

WARREN, N.J., Nov. 09, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing current standards of care to solve patients’ problems through simplifying complex delivery methods, will present three abstracts recapping positive data from its completed pharmacokinetic studies of AQST-109 (epinephrine sublingual film) at the American College of Allergy Asthma and Immunology (ACAAI) Annual Scientific Meeting, which will be held from November 10-14, in Louisville, Kentucky.

“Not only are we excited to share the positive results from our two completed AQST-109 pharmacokinetic studies, but we are also honored to have results selected for presentation as a Distinguished Industry Oral Abstract, with the opportunity to highlight the formulation and dosage from the podium,” said Ken Truitt, M.D., Aquestive’s Chief Medical Officer. “We look forward to connecting with leaders in the allergy community and providing insight on how our research has the potential to provide an important advance in the treatment of acute allergic reactions.”

Poster Details:

Abstract Title: Pharmacokinetics Study of Epinephrine Sublingual Film: Results from The Formulation and Dosage Selection
Presentation ID: D001
Session: Distinguished Industry Oral Abstracts- Session B
Podium Presentation Time: Saturday, November 12, 4:53 - 5:03 PM ET
Location: Room M104-M107
Presenting Author: Dr. John Oppenheimer, MD (UMDNJ Rutgers University School of Medicine)

Abstract Title: Minimal Impact of Food, Drink, Or Temperature on The Pharmacokinetics of a Sublingual Film Using a Novel Prodrug of Epinephrine (DESF)
Presentation ID: ID: P022
Category: Adverse Drug Reactions, Insect Reactions, Anaphylaxis
Presentation Time: Sunday, November 13, 12:35 PM ET
Location: Exhibit Hall (Upper Concourse), Monitor 9
Presenting Author: Holly Ponichtera, PhD (Aquestive Therapeutics)

Abstract Title: Results of a Repeat Dose Study on The Pharmacokinetics of a Sublingual Film using a Novel Prodrug of Epinephrine (DESF)
Presentation ID: ID: P021
Category: Adverse Drug Reactions, Insect Reactions, Anaphylaxis
Presentation Time: Sunday, November 13, 12:20 PM ET
Location: Exhibit Hall (Upper Concourse), Monitor 9
Presenting Author: Holly Ponichtera, PhD (Aquestive Therapeutics)

About Anaphylaxis
Anaphylaxis 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-109
AQST-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 Therapeutics
Aquestive Therapeutics, Inc. (NASDAQ: AQST) is a pharmaceutical company advancing current standards of care to solve patients’ problems by simplifying complex delivery methods. Aquestive is developing pharmaceutical products to deliver complex molecules through alternative administrations to invasive and inconvenient standard of care therapies. Aquestive has five licensed commercialized products which are marketed by our licensees in the U.S. and around the world. The Company is the exclusive manufacturer of these licensed products. 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. The Company is advancing an early stage product pipeline for the treatment of severe allergic reactions, including anaphylaxis. The Company has also developed a product pipeline focused on treating diseases of the central nervous system, or CNS. The Company's production facilities are located in Portage, Indiana, and our corporate headquarters, sales and commercialization operations and primary research laboratory facilities are based in Warren, New Jersey. 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 by the United States Food and Drug Administration (FDA) in approving Libervant® (diazepam) Buccal Film for U.S. market; risk of our ability to demonstrate to the FDA “clinical superiority” of Libervant within the meaning of the FDA regulations relative to the FDA-approved diazepam nasal spray product of an unrelated company competitor in the U.S., including by establishing a major contribution to patient care within the meaning of FDA regulations relative to the approved product, 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, and there can be no assurance that we will be successful; risk of delays in FDA approval of AQST-109 and our other drug candidates, or failure to receive FDA approval at all; 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, securities, business torts, 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.

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