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~~February 3018, ~~2025~~2026

Avenue Therapeutics, Inc.

(Exact Name of Registrant as Specified in Charter)

Delaware
(State or Other Jurisdiction
of Incorporation)

001-38114
(Commission File Number)

47-4113275
(IRS Employer Identification No.)

1111 Kane Concourse, Suite 301

Bay Harbor Islands, FL 33154

(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:

¨	Written communications pursuant to Rule 425 under the Securities Act.

¨	Soliciting material pursuant to Rule 14a-12 under the Exchange Act.

¨	Pre-commencement communications pursuant to Rule 14d-2b under the Exchange Act.

¨	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

Securities registered pursuant to Section 12(b) of the Act:      None

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

Title of Class	Trading Symbol(s)
Common Stock	ATXI (OTC Markets Group, Inc.)

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. ¨

Item 51.0701. ~~Submission~~Entry ofinto ~~Matters~~Material toDefinitive ~~a Vote of Security Holders~~Agreement.

On ~~December 30~~February 18, ~~2025~~2026, Avenue Therapeutics, Inc. (the “Company” ~~or “Avenue”~~) entered ~~held~~into ~~its~~a ~~2025~~license ~~annual~~agreement ~~meeting of stockholders~~ (the “~~Annual~~License ~~Meeting~~Agreement”) at ~~10:00~~with ~~a.m. Eastern~~Duke ~~Time~~University by(“Duke”), ~~means~~whereby ofthe Company obtained from Duke an ~~online~~exclusive, ~~virtual~~worldwide ~~meeting~~license ~~platform.~~to Atcertain ~~the~~patents ~~2025~~and ~~Annual~~know-how ~~Meeting,~~for the ~~following~~development ~~proposals~~and ~~were~~commercialization of products, ~~approved:~~including ATX-04 (iclenbuterol) , for the ~~election~~treatment of ~~six~~lysosomal ~~directors~~storage diseases, subject to ~~hold~~customary ~~office~~retained ~~until~~rights for Duke and other non-profit or governmental institutions to use the ~~2026~~licensed ~~annual~~technology ~~meeting~~for ofnon-commercial ~~stockholders;~~research and ~~(ii)~~ educational purposes. Under the License ~~ratification~~Agreement, the Company agreed to make an upfront payment and reimburse certain patent expenses to Duke, and to make development, ofregulatory, and commercial milestone payments upon the ~~appointment~~achievement of ~~KPMG~~certain ~~LLP~~milestones. asIn addition, the Company’s ~~independent~~is ~~registered~~obligated ~~public~~to ~~accounting~~pay a ~~firm~~tiered ~~for~~low ~~the~~single-digit ~~year~~royalty ~~ending~~on ~~December 31, 2025~~future net sales of licensed products. ~~These~~The ~~proposals~~Company ~~are~~intends ~~described~~to inadvance ~~detail~~ATX-04 inthrough ~~the~~a ~~definitive~~late-stage clinical ~~proxy~~development ~~statement~~program ~~for~~leveraging ~~the~~existing ~~Annual~~human ~~Meeting~~safety ~~filed~~and efficacy data, with ~~the~~an ~~Securities~~initial ~~and~~focus ~~Exchange~~on treating Pompe disease as an ~~Commission~~adjunct onto ~~December 5,~~enzyme ~~2025~~replacement therapy (“ERT”).

AsThe ofLicense ~~the~~Agreement ~~November 25,~~includes ~~2025~~customary ~~record~~development ~~date~~and ~~for~~commercialization ~~the~~diligence ~~determination~~obligations offor the ~~stockholders~~Company, ~~entitled~~as towell ~~notice~~as ~~of,~~customary ~~and~~termination ~~to vote at~~provisions, ~~the~~including ~~2025~~for ~~Annual~~uncured ~~Meeting,~~material 3breach,~~183,426~~ ~~shares~~certain ~~of Common Stock~~insolvency-related ~~were~~events ~~outstanding~~ and ~~eligible~~specified topatent ~~vote with an aggregate of 3~~challenges,~~183,426~~ ~~votes~~ and ~~250,000~~otherwise ~~shares~~continues ofon ~~the~~a ~~Company’s~~product-by-product ~~Class A Preferred Stock were outstanding~~ and ~~eligible~~country-by-country tobasis ~~vote~~for ~~with~~so anlong ~~aggregate of 3,500,000 votes,~~ as ~~determined in accordance with Article IV, Section 2.1.2~~royalties ofare ~~the Company’s Third Amended and Restated Certificate of Incorporation, as amended~~payable.

~~Proposal~~The 1foregoing description of the License Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the License Agreement, which the Company expects to file as an exhibit to a subsequent filing with the Securities and Exchange Commission.

~~The~~Item ~~votes~~8.01 ~~with~~Other ~~respect to the election of six directors to hold office until the 2026 annual meeting of stockholders were as follows:~~Events.

Director	Votes For		Votes Withheld		Broker Non-Votes
Jay Kranzler, M.D., Ph.D.		3,861,508		106,488		0
Faith Charles		3,862,060		105,936		0
Neil Herskowitz		3,861,974		106,022		0
Alexandra MacLean, M.D.		3,861,559		106,437		0
Curtis Oltmans		3,862,009		105,987		0
Lindsay A. Rosenwald, M.D.		3,861,558		106,438		0

The Company issued a press release on February 23, 2026 announcing its entry into the License Agreement, a copy of which is attached as Exhibit 99.1 hereto.

~~Proposal~~Item 29.01 Financial Statements and Exhibits.

~~The~~(d) ~~vote on the proposal to ratify the selection of KPMG LLP as Avenue’s independent registered accounting firm for the year ending December 31, 2025 was as follows:~~Exhibits

Total Votes For			Total Votes Against			Abstentions
	3,862,335			104,651			1,010

The following exhibits are furnished herewith:

Exhibit Number		Description
99.1		Press Release, dated February 23, 2026
104		Cover Page Interactive Data File (embedded within Inline XBRL document)

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.

	AVENUE THERAPEUTICS, INC.
	(Registrant)
Date: December 31, 2025
Date: February 23, 2026
	By:	/S/ DAVID JIN
		David Jin
		Interim Principal Financial Officer and Chief Operating Officer

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