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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): August 10, 2026
Aquestive Therapeutics, Inc.
(Exact name of Registrant as specified in its charter)
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| Delaware | 001-38599 | 82-3827296 |
| (State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
30 Technology Drive
Warren, NJ 07059
(908) 941-1900
(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)
Not Applicable
(Former name or former address, if changed since last report)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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| Title of each class | Trading Symbol(s) | Name of each exchange on which
registered |
| Common Stock, par value $0.001 per share | AQST | Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
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| Item 7.01 | Regulation FD Disclosure. |
On August 10, 2026, Aquestive Therapeutics, Inc. (the “Company”) is furnishing information, in the form of an investor presentation, to be given at meetings with institutional investors, analysts and others. A copy of the Company’s investor presentation is attached hereto as Exhibit 99.2 to this Current Report on Form 8-K. This information may be amended or updated at any time and from time to time through another Current Report on Form 8-K, a later Company filing or other means. The investor presentation is available on the Events and Presentations page of the Investors section of the Company’s website located at www.aquestive.com, although the Company reserves the right to discontinue that availability at any time. The information on, or accessible through, the Company’s website is not incorporated by reference into this Current Report on Form 8-K.
The information in this Item 7.01, including Exhibit 99.2, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in such filing. The furnishing of the information in this Item 7.01 shall not be deemed an admission as to the materiality of any information required to be disclosed solely to satisfy the requirements of Regulation FD.
On August 10, 2026, Aquestive Therapeutics, Inc. (the “Company”) issued a press release announcing the results from its human factors validation study and pharmacokinetic study for Anaphylm™ (dibutepinephrine) sublingual film, conducted in support of the Company’s planned resubmission of its New Drug Application to the U.S. Food and Drug Administration for the treatment of Type 1 allergic reactions, including anaphylaxis. A copy of the Company’s press release is attached hereto as Exhibit 99.1 and is incorporated into this Item 8.01 by reference.
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Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
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| Exhibit Number | | Description |
| | Aquestive Therapeutics, Inc. Press Release, dated August 10, 2026 |
| | Aquestive Therapeutics, Inc. Investor Presentation, dated August 10, 2026 |
| 104 | | Cover Page Interaction Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Dated: August 10, 2026 | Aquestive Therapeutics, Inc. |
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| By: | /s/ A. Ernest Toth, Jr |
| | Name: A. Ernest Toth, Jr. |
| | Title: Chief Financial Officer |