Current Report Filing (8-k)

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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): December 13, 2021

Aquestive Therapeutics, Inc.

(Exact name of Registrant as specified in its charter)

Delaware			001-38599			82-3827296
(State or Other Jurisdiction of Incorporation or Organization)			(Commission File Number)			(I.R.S. Employer Identification No.)

30 Technology Drive

Warren, NJ 07059

[phone]

(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)

________________________________________________________________________________________________________________________

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:

☐			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐			Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐			Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐			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:

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).

Emerging growth company ☒

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 8.01			Other Events.

On December 13, 2021, the Company issued a press release announcing its receipt of a written response from the U.S. Food and Drug Administration with respect to the Company's pre-investigational new drug (pre-IND) submission for the Company's drug candidate, AQST-109 (epinephrine prodrug sublingual film) and the commencement of its Pharmacokinetic and Safety Trial for AQST-109. A copy of the Company’s press release is attached hereto as Exhibit 99.1 and incorporated into this Item 8.01 by reference.

Item 9.01			Financial Statements and Exhibits.

(d)Exhibits.

Exhibit Number						Description
99.1						Press Release dated December 13, 2021 announcing receipt of FDA response regarding Pre-IND submission and commencement of PK and Safety Trial for AQST-109 (epinephrine prodrug sublingual film).

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.

Dated: December 16, 2021			Aquestive Therapeutics, Inc.
			By:			/s/ A. Ernest Toth, Jr
						Name: A. Ernest Toth, Jr.
						Title: Chief Financial Officer
						(Principal Financial Officer)