Aquestive Therapeutics, Inc. released positive topline pharmacokinetic (PK) data from the temperature /pH study of its product candidate Anaphylm (epinephrine) Sublingual Film. The table below indicates the remaining clinical studies anticipated before submission of the New Drug Application (NDA) for Anaphylm. Anticipated Timing: Pivotal PK Studies FDA Meetings /Actions: Completed in 2024 Phase 3 PK Study (including repeat dose) Temperature/pH PK Study Type C Meeting; Currently Underway Self-administration PK Study; Oral allergy syndrome (OAS) Challenge Study; Remaining in 2024 Pediatric Study Pre-NDA Meeting.

Timeline does not include chemistry, manufacturing, and controls (CMC), preclinical and human factors activities. The company plan on requesting a pre-NDA meeting with the FDA upon receipt of topline data. The company continue to anticipate conducting pediatric study for Anaphylm in the fourth quarter 2024, if agreed upon with the FDA, and filing shortly thereafter.

Anaphylm ("Anaphylm") Sublingual Film has the potential to be the first and only non-invasive, orally delivered epinephrine for the treatment of severe life-threatening allergic reactions, including anaphylaxis, if approved by the United States Food and Drug Administration (FDA). The tradename "Anaphylm" for AQST-109 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 the Company's product candidate Anaphylm®? (epinephrine)Sublingual Film through clinical development and approval by the FDA, including expected clinical studies and clinical study dates including the pediatric study for Anaphyl m, the necessary studies to address the FDA's comments on the Company's pivotal PK study protocol and other concerns identified in the FDA Type C meeting minutes for Anaphylm, the timing of the pre-NDA meeting and Aquestive's goal of filing an NDA for Anaphylm before the end of 2024, and the potential benefits Anaphylm could bring to patients. Such risks and uncertainties include, but are not limited To, risk 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; risk of the Company's ability to generate sufficient data in its PK/PD comparability submission for FDA approval of Anaphylm; risk the Company's ability to generate enough data in its PK/PD comparisonability submission for FDA approval of anaphylm; risk of The Company's ability to address the FDA's comments On the Company's pivotal PK study protocols and other concerns identified in the company's pivotal PK study protocol and others identified in the FDA Type C Meeting minutes for Anaphylm.