Aquestive Therapeutics, Inc. provided an update on the development timeline and pathway for its oral epinephrine product candidate, Anaphylm??. As previously disclosed, Aquestive submitted its revised protocol for the proposed pivotal PK clinical trial to the Food and Drug Administration (FDA) in August 2023. The Company intends to commence the pivotal trial in the fourth quarter 2023, following alignment with the FDA.

In the most recent pilot PK study (AQ109103 or the "103" study) completed in July 2023, Anaphylm, using the proposed final dosing administration instructions, was shown to deliver epinephrine systemically as effectively as either commercially available autoinjectors or the manual intramuscular (IM) injection. The Anaphylm 12mg data met all of the critical parameters, including maximum concentration (Cmax) and partial area under the curve (pAUCs), during the critical early time periods by falling between the levels demonstrated for comparator products (bracketing) that the Company anticipates measuring in the pivotal PK clinical trial. The name for AQST-109 "Anaphylm" has been conditionally approved by the FDA.

Final approval of the Anaphylm?? proprietary name is conditioned on FDA approval of the product candidate. These forward-looking statements include, but are not limited to, statements regarding the advancement and related timing of product candidate Anaphylm??

(epinephrine) Sublingual Film through clinical development and approval by the FDA, including the filing of a pivotal clinical trial for Anaphylm, the potential benefits Anaphylm could bring to patients, 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 the Company's business including with respect to its clinical trials including site initiation, enrollment and timing and adequacy of clinical trials; on regulatory submissions and regulatory reviews and approval of Anaphylm; pharmaceutical ingredient and other raw materials supply chain, manufacture, and distribution; and ongoing availability of an appropriate labor force and skilled professionals. 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 its product development activities and clinical trials for Anaphylm and other product candidates; risk of the Company's failure to generate sufficient data in its PK/PD comparability submission for FDA approval of Anaphylm, including the risk of the FDA End-of-Phase 2 meeting for Anaphylm, includingthe risk that the FDA may require additional clinical studies for FDA approval of Anaphyrm; risk of delays in or the failure to receive FDA approval of AnaphylM and other product candidates, and there can be no assurance that the Company will be successful in obtaining FDA approval; risk of insufficient capital and cash resources, including insufficient access to available debt and equity financing and revenues from operations, to satisfy all of the Company's short-term and longer term liquidity and cash requirements and other cash needs, at the times and in the amounts needed, including to fund future clinical development activities for Anaphylm and Other product candidates; risk of the rate and degree of market acceptance of its product candidates including Anaphylm; risk of the product candidates including AnaphylM; risk of the success of any competing products; uncertainties related to general economic, political, business, industry, regulatory, financial and market conditions and other unusual items; and other unusual items; and Other unusual items; and other risks and uncertainties affecting the Company described in the "We are advancing the development of Anaphylm, the first and only non-invasive, orally delivered epinephrine product candidate to demonstrate clinical results comparable to autoinjectors (such as EpiPen®?

and Auvi-Q®?) for the emergency treatment of severe allergic reactions, including anaphylaxis. The company intends to commence the pivotal study in a highly portable package with the durability to withstand many of daily life and potentially combines the convenience with enhanced portability with positive clinical outcomes". In the convenience with positive clinical outcomes.

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