Aquestive Therapeutics Inc 2024年度报告

FORM 10-K (Mark One) ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____to _____ Commission File Number: 001-38599 Aquestive Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware82-3827296(State or Other Jurisdiction of Incorporation or Organization)(I.R.S. Employer Identification Number) Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.…Yes 6No Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.…Yes 6No Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities ExchangeAct of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has beensubject to such filing requirements for the past 90 days.6Yes…No Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant toRule 405 of Regulation S-T (Section 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrantwas required to submit such files).6Yes…No Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reportingcompany or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company”and “emerging growth company” in Rule 12b-2 of the Securities Exchange Act of 1934. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complyingwith any new or revised financial accounting standards provided to Section 13(a) of the Securities Act.տ Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of itsinternal control over financial reporting under Section 404(b) of Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accountingfirm that prepared or issued its audit report.տ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrantincluded in the filing reflect the correction of an error to previously issued financial statements.տ Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-basedcompensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to Section 240.10D-1(b).տ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).տYes 6No As of June 28, 2024, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market value of thecommon stock held by non-affiliates of the registrant was approximately $207.3 million based on the closing price of the registrant’s commonstock on such date. The number of outstanding shares of the registrant’s par value $0.001 common stock as of the close of business on March 3, 2025 was98,871,369. The registrant intends to file a definitive proxy statement pursuant to Regulation 14A in connection with its 2025 Annual Meeting ofShareholders within 120 days of the end of its fiscal year ended December 31, 2024. Portions of such definitive proxy statement areincorporated by reference into Part III of this Annual Report on Form 10-K. Glossary of Terms, Abbreviations and Acronyms PART I Forward-Looking Statements This Annual Report on Form 10-K and certain other communications made by us include forward-looking statementswithin 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 identifyforward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the advancement and relatedtiming of our product candidate Anaphylm™ (epinephrine) Sublingual Film through clinical development and approval by theFDA, including the timing of submission of supporting and pediatric clinical studies, and filing of the NDA for Anaphylm withthe FDA, and the following launch of Anaphylm, if approved by the FDA; the results of the Company’s clinical studies forAnaphylm and the ability of such results to support submission of the NDA for approval of Anaphylm to the FDA; Anaphylm'spotential to be the first and only oral administration of epinephrine and to be accepted