UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 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 12, 2021

Avenue Therapeutics, Inc.

(Exact Name of Registrant as Specified in Charter)

1140 Avenue of the Americas, Floor 9

New York, New York 10036

(Address of Principal Executive Offices)

(781) 652-4500

(Registrant’s telephone number, including area code)

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:

Securities registered pursuant to Section 12(b) of the Act:

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).  x

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. x

On December 12, 2021, Avenue Therapeutics, Inc. (the “Company” or “Avenue”), entered into an Underwriting Agreement (the “Underwriting Agreement”) with Aegis Capital Corp., as representative of several underwriters therein (the “Underwriters”). Pursuant to the Underwriting Agreement, the Company agreed to sell in an underwritten offering (the “Offering”) an aggregate of 1,910,100 shares (the “Shares”) of the Company’s common stock, par value $0.0001 (the “Common Stock”), at an offering price of $1.07 per share, for gross proceeds of approximately $2,043,807.00 less underwriting discounts and commissions. The Shares are being offered by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-261520), initially filed with the Securities and Exchange Commission (the “Commission”) on December 7, 2021, declared effective on December 10, 2021, and supplemented by the prospectus supplement dated December 10, 2021 relating to the Offering.

The closing of the Offering is subject to satisfaction of customary closing conditions set forth in the Underwriting Agreement and is expected to occur on or about December 15, 2021.

The summary of the Underwriting Agreement set forth above does not purport to be complete and is subject to and qualified in its entirety by reference to the text of the Underwriting Agreement, a form of which is filed herewith as Exhibit 1.1. The Underwriting Agreement includes customary representations, warranties, closing conditions and covenants by the Company and the Underwriter.

Alston & Bird LLP delivered an opinion as to the validity of the Shares, a copy of which is attached hereto as Exhibit 5.1 and is incorporated by reference herein.

The following exhibits are filed as part of this report:

SIGNATURES

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.