Aquestive Therapeutics, Inc. provided an update on recent business developments and outlined key 2023 objectives. In 2023, the company plan to focus 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 manufacturing business, (4) continuing to expand base of strategic collaborations with other companies, and (5) strengthening balance sheet. This is a pivotal year for Aquestive as the company seek to build upon momentum from the second half of 2022.

The company has an experienced team that has not only driven multiple FDA approvals, but has also excelled at collaborating with leading life sciences companies. The company will be focused on realizing potential as the company progress through the year. 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. Libervant: The 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 Manufacturing: The 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 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.