ATXI / Avenue Therapeutics, Inc. - Документы SEC, Годовой отчет, Доверенное заявление

Авеню Терапевтикс, Инк.
US ˙ OTCPK

Основная статистика
LEI 549300IN52C2XAYTBO53
CIK 1644963
SEC Filings
All companies that sell securities in the United States must register with the Securities and Exchange Commission (SEC) and file reports on a regular basis. These reports include company annual reports (10K, 10Q), news updates (8K), investor presentations (found in 8Ks), insider trades (form 4), ownership reports (13D, and 13G), and reports related to the specific securities sold, such as registration statements and prospectus. This page shows recent SEC filings related to Avenue Therapeutics, Inc.
SEC Filings (Chronological Order)
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August 14, 2025 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 ☐ TRANSITION REPORT PURSUANT TO S

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 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 001-38114 AVEN

May 15, 2025 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 ☐ TRANSITION REPORT PURSUANT TO

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 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 001-38114 AVE

April 30, 2025 EX-10.1

AnnJi License Termination and Program Transfer Agreement by and between the Company and AnnJi Pharmaceutical Co., Ltd., dated April 24, 2025.*

Exhibit 10.1 Execution Copy CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) THE TYPE OF INFORMATION THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. License Termination and Program Transfer Agreement by and between AnnJi Pharmaceutical Co., Ltd. and Avenue Therapeutics, Inc. dated April 24, 2025 Table

April 30, 2025 8-K

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): April 24, 2025 Avenue Therapeutic

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): April 24, 2025 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number)

March 31, 2025 EX-21.1

Subsidiaries of Avenue Therapeutics, Inc.*

Exhibit 21.1 AVENUE THERAPEUTICS, INC. Subsidiaries of Avenue Therapeutics, Inc. at December 31, 2024, with jurisdiction of incorporation or formation: ● Baergic Bio, Inc. (Delaware)

March 31, 2025 EX-19.1

Insider Trading Policy*

Exhibit 19.1 Avenue Therapeutics, Inc. is subject to the following Insider Trading Policy of Fortress Biotech, Inc. (“Fortress”), which is applicable to all Fortress subsidiaries. FORTRESS BIOTECH, INC. AND SUBSIDIARIES INSIDER TRADING POLICY January 22, 2024 PERSONS COVERED This Insider Trading Policy applies to Fortress Biotech, Inc. (“Fortress”) and each of its publicly traded and private subsi

March 31, 2025 10-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ 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 001-38114 AVENUE

March 31, 2025 EX-4.3

DESCRIPTION OF THE REGISTRANT'S SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934 DESCRIPTION OF CAPITAL STOCK

Exhibit 4.3 DESCRIPTION OF THE REGISTRANT'S SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934 DESCRIPTION OF CAPITAL STOCK Avenue Therapeutics, Inc. (the “Company”) has one class of securities registered under Section 12 of the Securities Exchange Act of 1934, as amended: our common stock, with $0.0001 par value (“Common Stock”). The following descriptions of our

March 17, 2025 8-K

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): March 17, 2025 Avenue Therapeutic

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): March 17, 2025 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number)

March 7, 2025 8-K

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): March 7, 2025 Avenue Therapeutics

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): March 7, 2025 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number) 4

February 14, 2025 EX-99.1

JOINT FILING AGREEMENT February 14, 2025

EXHIBIT 99.1 JOINT FILING AGREEMENT February 14, 2025 Pursuant to and in accordance with the Securities Exchange Act of 1934, as amended (the “Act”), and the rules and regulations thereunder, each party hereto hereby agrees to the joint filing, on behalf of each of them, of any filing required by such party under Section 13 or Section 16 of the Act or any rule or regulation thereunder (including a

December 4, 2024 EX-4.10

Form of Indenture, between the Registrant and one or more trustees to be named.

Exhibit 4.10 AVENUE THERAPEUTICS, INC. and Trustee INDENTURE Dated as of DEBT SECURITIES CROSS-REFERENCE TABLE(1) Section of Trust Indenture Act of 1939, as amended Section of Indenture 310(a) 6.09 310(b) 6.08 6.10 310(c) Inapplicable 311(a) 6.13 311(b) 6.13 311(c) Inapplicable 312(a) 4.01 4.04 312(b) 4.04(c) 312(c) 4.04(c) 313(a) 4.03 313(b) 4.03 313(c) 4.03 313(d) 4.03 314(a) 3.05 and 4.02 314(b

December 4, 2024 EX-FILING FEES

Filing Fees Exhibit.

Exhibit 107 Calculation of Filing Fee Tables Form S-3 (Form Type) Avenue Therapeutics, Inc.

December 4, 2024 S-3

As filed with the Securities and Exchange Commission on December 4, 2024

As filed with the Securities and Exchange Commission on December 4, 2024 Registration No.

November 29, 2024 8-K

Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing

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): November 26, 2024 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Numbe

November 15, 2024 SC 13D/A

ATXI / Avenue Therapeutics, Inc. / Fortress Biotech, Inc. - SC 13D/A Activist Investment

SC 13D/A 1 tm2428627d1sc13da.htm SC 13D/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D (Amendment No. 5) Under the Securities Exchange Act of 1934 AVENUE THERAPEUTICS, INC. (Name of Issuer) Common Stock, $0.0001 Par Value (Title of Class of Securities) 05360L403 (CUSIP Number) Fortress Biotech, Inc. c/o Lindsay A. Rosenwald, M.D. 1111 Kane Concourse, Suite 3

November 14, 2024 SC 13G

ATXI / Avenue Therapeutics, Inc. / ARMISTICE CAPITAL, LLC Passive Investment

SC 13G 1 armistice-atxi093024.htm UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* AVENUE THERAPEUTICS, INC. (Name of Issuer) Common Stock (Title of Class of Securities) 05360L403 (CUSIP Number) September 30, 2024 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designa

November 14, 2024 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 ☐ TRANSITION REPORT PURSUANT

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 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 001-38114

November 14, 2024 8-K

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): November 14, 2024 Avenue Therapeu

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): November 14, 2024 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Numbe

November 14, 2024 EX-99.1

Avenue Therapeutics Reports Third Quarter 2024 Financial Results and Recent Corporate Highlights - Topline data in Phase 1b/2a clinical trial of AJ201 for spinal and bulbar muscular atrophy anticipated around year-end 2024

Exhibit 99.1 Avenue Therapeutics Reports Third Quarter 2024 Financial Results and Recent Corporate Highlights - Topline data in Phase 1b/2a clinical trial of AJ201 for spinal and bulbar muscular atrophy anticipated around year-end 2024 Miami, FL – November 14, 2024 – Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development

September 27, 2024 8-K

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers, Financial Statements and Exhibits

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): September 23, 2024 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Numb

September 27, 2024 EX-10.1

Form of Restricted Stock Unit Agreement.

Exhibit 10.1 [FORM OF] AVENUE THERAPEUTICS, INC. 2015 INCENTIVE PLAN RESTRICTED STOCK UNIT AWARD AGREEMENT This Restricted Stock Unit Award Agreement (this “Agreement”) is made and entered into between Avenue Therapeutics, Inc. (the “Company”) and [●] (“Grantee”), effective as of [●] (such date the “Date of Grant”). This Agreement sets forth the terms and conditions associated with the Company’s a

August 9, 2024 8-K

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): August 9, 2024 Avenue Therapeutic

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): August 9, 2024 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number)

August 9, 2024 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 ☐ TRANSITION REPORT PURSUANT TO S

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 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 001-38114 AVEN

August 9, 2024 EX-99.1

Avenue Therapeutics Reports Second Quarter 2024 Financial Results and Recent Corporate Highlights - Last patient visit complete in Phase 1b/2a clinical trial of AJ201 for spinal and bulbar muscular atrophy; topline data anticipated in second half of

Exhibit 99.1 Avenue Therapeutics Reports Second Quarter 2024 Financial Results and Recent Corporate Highlights - Last patient visit complete in Phase 1b/2a clinical trial of AJ201 for spinal and bulbar muscular atrophy; topline data anticipated in second half of 2024 – - Raised $4.4 million in gross proceeds from a May 2024 warrant exercise transaction - Miami, FL – August 9, 2024 – Avenue Therape

July 12, 2024 S-8

As filed with the Securities and Exchange Commission on July 12, 2024

As filed with the Securities and Exchange Commission on July 12, 2024 Registration No.

July 12, 2024 EX-FILING FEES

Filing Fee Table

Exhibit FILING FEES. Calculation of Filing Fee Tables Form S-8 (Form Type) Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered Securities Security Type Security Class Title Fee Calculation Rule(1) Amount Registered(2) Proposed Maximum Offering Price Per Unit(1) Maximum Aggregate Offering Price(1) Fee Rate Amount of Registration Fee Equity Comm

June 26, 2024 8-K

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers, Financial Statements and Exhibits, Submission of Matters to a Vote of Security Holders

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): June 24, 2024 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number) 4

June 26, 2024 EX-10.1

Amendment to the Avenue Therapeutics, Inc. 2015 Incentive Plan.

Exhibit 10.1 AMENDMENT TO THE AVENUE THERAPEUTICS, INC. 2015 STOCK PLAN This Amendment to the Avenue Therapeutics, Inc. 2015 Stock Plan (the “Plan”), has been adopted by the Board of Directors (the “Board”) and approved by the stockholders of Avenue Therapeutics, Inc. (the “Company”), to be effective as of June 24, 2024. WITNESSETH: WHEREAS, the Company adopted the Plan for the purposes set forth

May 23, 2024 8-K

Other Events

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): May 21, 2024 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number) 47

May 15, 2024 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 ☐ TRANSITION REPORT PURSUANT TO

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 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 001-38114 AVE

May 15, 2024 8-K

Financial Statements and Exhibits, Results of Operations and Financial Condition

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): May 15, 2024 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number) 47

May 15, 2024 EX-99.1

Avenue Therapeutics Reports First Quarter 2024 Financial Results and Recent Corporate Highlights - Raised a total of $9.4 million in gross proceeds from warrant exercise transactions since January 2024 –

Exhibit 99.1 Avenue Therapeutics Reports First Quarter 2024 Financial Results and Recent Corporate Highlights - Raised a total of $9.4 million in gross proceeds from warrant exercise transactions since January 2024 – Miami, FL – May 15, 2024 – Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of

May 13, 2024 EX-1.1

At the Market Offering Agreement, dated May 10, 2024, by and between Avenue Therapeutics, Inc. and H.C. Wainwright & Co., LLC

Exhibit 1.1 AT THE MARKET OFFERING AGREEMENT May 10, 2024 H.C. Wainwright & Co., LLC 430 Park Avenue New York, New York 10022 Ladies and Gentlemen: Avenue Therapeutics, Inc., a corporation organized under the laws of Delaware (the “Company”), confirms its agreement (this “Agreement”) with H.C. Wainwright & Co., LLC (the “Manager”) as follows: 1. Definitions. The terms that follow, when used in thi

May 13, 2024 8-K

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): May 10, 2024 Avenue Therapeutics,

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): May 10, 2024 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number) 47

May 10, 2024 424B5

Up to $3,850,000 Common Stock

PROSPECTUS SUPPLEMENT (To Prospectus Dated December 10, 2021) Up to $3,850,000 Common Stock We have entered into a sales agreement (the “sales agreement”) dated May 10, 2024, with H.

May 10, 2024 424B3

1,420,741 Shares of Common Stock underlying certain Common Warrants and Placement Agent Warrants

Filed Pursuant to Rule 424(b)(3) Registration Statement No. 333-279125 Prospectus 1,420,741 Shares of Common Stock underlying certain Common Warrants and Placement Agent Warrants This prospectus relates to the resale by the selling stockholders (the “Selling Stockholders”) identified in this prospectus under the section “The Selling Stockholders,” or their pledgees, donees, transferees or other su

May 8, 2024 CORRESP

Avenue Therapeutics, Inc. 1111 Kane Concourse, Suite 301 Bay Harbor Islands, Florida 33154

Correspondence. Avenue Therapeutics, Inc. 1111 Kane Concourse, Suite 301 Bay Harbor Islands, Florida 33154 VIA EDGAR May 8, 2024 Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Chris Edwards Re: Avenue Therapeutics, Inc. Registration Statement on Form S-3 (Reg. No. 333-279125) Request for Acceleration of Eff

May 6, 2024 EX-FILING FEES

Filing Fee Table

Exhibit 107.1 Calculation of Filing Fee Tables Form S-3 (Form Type) Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered Securities Security Type Security Class Title Fee Calculation Rule(1) Amount Registered(2) Proposed Maximum Offering Price Per Unit(1) Maximum Aggregate Offering Price(1) Fee Rate Amount of Registration Fee Equity Common Stoc

May 6, 2024 S-3

As filed with the Securities and Exchange Commission on May 3, 2024

As filed with the Securities and Exchange Commission on May 3, 2024 Registration No.

May 6, 2024 DEF 14A

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ____)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant. ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitt

May 6, 2024 DEFA14A

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ____)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant. ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitt

May 2, 2024 SC 13G/A

ATXI / Avenue Therapeutics, Inc. / Davidow Robert L - SCHEDULE 13G/A Passive Investment

SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G (Amendment No. 2) Under the Securities Exchange Act of 1934 Avenue Therapeutics, Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 05360L403 (CUSIP Number) May 2, 2024 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuant to

May 1, 2024 EX-99.1

Avenue Therapeutics Announces Exercise of Warrants for $4.4 Million in Gross Proceeds

Exhibit 99.1 Avenue Therapeutics Announces Exercise of Warrants for $4.4 Million in Gross Proceeds MIAMI, April 29, 2024 (GLOBE NEWSWIRE) - Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced the entry into definitive agreement

May 1, 2024 EX-10.1

Form of Investor Inducement Letter.

Exhibit 10.1 AVENUE THERAPEUTICS, INC. April 28, 2024 Holder of Common Stock Purchase Warrants Re: Inducement Offer to Exercise Common Stock Purchase Warrants Dear Holder: Avenue Therapeutics, Inc. (the “Company”) is pleased to offer to you the opportunity to exercise the warrants to purchase shares of the Company’s common stock, par value $0.0001 per share (the “Common Stock”), set forth on Exhib

May 1, 2024 EX-4.3

Form of Placement Agent Warrant (May 2024).

Exhibit 4.3 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTR

May 1, 2024 EX-4.1

Form of New Series C Warrant (May 2024).

Exhibit 4.1 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTR

May 1, 2024 8-K

Entry into a Material Definitive Agreement, Material Modification to Rights of Security Holders, Unregistered Sales of Equity Securities, Financial Statements and Exhibits, Other Events

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): May 1, 2024 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 Em

May 1, 2024 EX-4.2

Form of New Series D Warrant (May 2024).

Exhibit 4.2 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTR

April 26, 2024 EX-99.1

Avenue Therapeutics Announces Reverse Stock Split

EXHIBIT 99.1 Avenue Therapeutics Announces Reverse Stock Split Miami, FL – April 24, 2024 – Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that it will effect a 1-for-75 reverse split of its issued and outstanding common s

April 26, 2024 8-K

Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year, Material Modification to Rights of Security Holders, Financial Statements and Exhibits, Other Events

-12-31 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): April 25, 2024 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File N

April 26, 2024 EX-3.1

Certificate of Amendment to the Third Amended and Restated Certificate of Incorporation of Avenue Therapeutics, Inc.

EXHIBIT 3.1 CERTIFICATE OF AMENDMENT TO THE THIRD AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF AVENUE THERAPEUTICS, INC. Avenue Therapeutics, Inc. (the “Corporation”), a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware (the “DGCL”), does hereby certify: FIRST. The Certificate of Incorporation of the Corporation is hereby amended

April 17, 2024 SC 13D/A

ATXI / Avenue Therapeutics, Inc. / Fortress Biotech, Inc. - SC 13D/A Activist Investment

SC 13D/A 1 tm2412005d2sc13da.htm SC 13D/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D (Amendment No. 4) Under the Securities Exchange Act of 1934 AVENUE THERAPEUTICS, INC. (Name of Issuer) Common Stock, $0.0001 Par Value (Title of Class of Securities) 05360L304 (CUSIP Number) Fortress Biotech, Inc. c/o Lindsay A. Rosenwald, M.D. 1111 Kane Concourse, Suite 3

March 29, 2024 8-K

Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing

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): March 26, 2024 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number)

March 18, 2024 8-K

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): March 18, 2024 Avenue Therapeutic

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): March 18, 2024 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number)

March 18, 2024 10-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2023 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 001-38114 AVENUE

March 18, 2024 EX-10.19

Consulting Agreement with Dr. Jay Kranzler, dated December 1, 2020.*

Exhibit 10.19 CONSULTING AGREEMENT THIS CONSULTING AGREEMENT (this “Agreement”), effective as of this 1st day of December 2020 (the “Effective Date”) is by and between Jay Kranzler, M.D., Ph.D., having an address set forth below (hereinafter referred to as “Consultant”) and Baergic Bio, Inc., a Delaware corporation, having offices at 2 Gansevoort, 9th Floor, New York, NY 10014 (“Baergic”). W I T N

March 18, 2024 DEF 14C

SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 14C INFORMATION INFORMATION STATEMENT PURSUANT TO SECTION 14(C) OF THE SECURITIES EXCHANGE ACT OF 1934

SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 14C INFORMATION INFORMATION STATEMENT PURSUANT TO SECTION 14(C) OF THE SECURITIES EXCHANGE ACT OF 1934 Check the appropriate box: ¨ Preliminary Information Statement ¨ Confidential, for Use of the Commission Only (as permitted by Rule 14c-5(d)(2)) x Definitive Information Statement AVENUE THERAPEUTICS, INC. (Name of Registrant as S

March 18, 2024 EX-4.3

Description of Securities of Avenue Therapeutics, Inc.*

Exhibit 4.3 DESCRIPTION OF THE REGISTRANT’S SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934 DESCRIPTION OF CAPITAL STOCK Avenue Therapeutics, Inc. (the “Company”) has one class of securities registered under Section 12 of the Securities Exchange Act of 1934, as amended: our common stock, with $0.0001 par value (“Common Stock”). The following descriptions of our

March 18, 2024 EX-21.1

Subsidiaries of Avenue Therapeutics, Inc.*

Exhibit 21.1 AVENUE THERAPEUTICS, INC. Subsidiaries of Avenue Therapeutics, Inc. at December 31, 2023, with jurisdiction of incorporation or formation: ● Baergic Bio, Inc. (Delaware)

March 18, 2024 EX-97.1

Clawback Policy

Exhibit 97.1 AVENUE THERAPEUTICS, INC. Clawback Policy Effective as of October 2, 2023 The Board of Directors (“Board”) of Avenue Therapeutics, Inc. (“Company”) believes that it is in the best interests of the Company and its shareholders to adopt this Clawback Policy (“Policy”) which provides for the recoupment of certain executive compensation in the event of an Accounting Restatement (as define

March 18, 2024 EX-99.1

Avenue Therapeutics Reports Full Year 2023 Financial Results and Recent Corporate Highlights - Enrollment completed in Phase 1b/2a clinical trial of AJ201 for spinal and bulbar muscular atrophy; topline data expected in second quarter of 2024 - - Pre

Exhibit 99.1 Avenue Therapeutics Reports Full Year 2023 Financial Results and Recent Corporate Highlights - Enrollment completed in Phase 1b/2a clinical trial of AJ201 for spinal and bulbar muscular atrophy; topline data expected in second quarter of 2024 - - Presented positive BAER-101 preclinical data at American Epilepsy Society (AES) and American Society for Experimental Neurotherapeutics (ASE

March 15, 2024 8-K

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): March 11, 2024 Avenue Therapeutic

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): March 11, 2024 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number)

March 8, 2024 8-K

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): March 6, 2024 Avenue Therapeutics

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): March 6, 2024 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number) 4

March 8, 2024 PRE 14C

SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 14C INFORMATION INFORMATION STATEMENT PURSUANT TO SECTION 14(C) OF THE SECURITIES EXCHANGE ACT OF 1934

SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 14C INFORMATION INFORMATION STATEMENT PURSUANT TO SECTION 14(C) OF THE SECURITIES EXCHANGE ACT OF 1934 Check the appropriate box: x Preliminary Information Statement ¨ Confidential, for Use of the Commission Only (as permitted by Rule 14c-5(d)(2)) ¨ Definitive Information Statement AVENUE THERAPEUTICS, INC. (Name of Registrant as S

February 23, 2024 8-K

Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year, Financial Statements and Exhibits

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): February 20, 2024 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Numbe

February 23, 2024 EX-3.1

Certificate of Amendment of the Third Amended and Restated Certificate of Incorporation of Avenue Therapeutics, Inc., filed as Exhibit 3.1 to Form 8-K filed on February 23, 2024 (File No. 001-38114) and incorporated herein by reference.

Exhibit 3.1 CERTIFICATE OF AMENDMENT TO THE THIRD AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF AVENUE THERAPEUTICS, INC. Avenue Therapeutics, Inc. (the “Corporation”), a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware (the “DGCL”), does hereby certify: FIRST. The Certificate of Incorporation of the Corporation is hereby amended

February 2, 2024 424B3

33,080,598 Shares of Common Stock

Filed Pursuant to Rule 424(b)(3) Registration Statement No. 333-276671 Prospectus 33,080,598 Shares of Common Stock This prospectus relates to the resale by the selling stockholders (the “Selling Stockholders”) identified in this prospectus under the section “The Selling Stockholders,” or their pledgees, donees, transferees or other successors in interest, from time to time, of shares of our Commo

January 30, 2024 CORRESP

Avenue Therapeutics, Inc. 1111 Kane Concourse, Suite 301 Bay Harbor Islands, Florida 33154

Avenue Therapeutics, Inc. 1111 Kane Concourse, Suite 301 Bay Harbor Islands, Florida 33154 VIA EDGAR January 30, 2024 Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Tamika Sheppard Re: Avenue Therapeutics, Inc. Registration Statement on Form S-3 (Reg. No. 333-276671) Request for Acceleration of Effective Da

January 29, 2024 DEF 14C

our Definitive Information Statement on Schedule 14C, filed with the SEC on January 29, 2024

SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 14C INFORMATION INFORMATION STATEMENT PURSUANT TO SECTION 14(C) OF THE SECURITIES EXCHANGE ACT OF 1934 Check the appropriate box: ¨ Preliminary Information Statement ¨ Confidential, for Use of the Commission Only (as permitted by Rule 14c-5(d)(2)) x Definitive Information Statement Avenue Therapeutics, Inc. (Name of Registrant as S

January 24, 2024 EX-FILING FEES

Filing Fee Table

Exhibit 107.1 Calculation of Filing Fee Tables Form S-3 (Form Type) Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered Securities Security Type Security Class Title Fee Calculation Rule(1) Amount Registered(2) Proposed Maximum Offering Price Per Unit(1) Maximum Aggregate Offering Price(1) Fee Rate Amount of Registration Fee Equity Common Stoc

January 24, 2024 EX-3.1

Form of Amendment to Third Amended and Restated Certificate of Incorporation

Exhibit 3.1 CERTIFICATE OF AMENDMENT TO THE THIRD AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF AVENUE THERAPEUTICS, INC. Avenue Therapeutics, Inc. (the “Corporation”), a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware (the “DGCL”), does hereby certify: FIRST. The Certificate of Incorporation of the Corporation is hereby amended

January 24, 2024 S-3

As filed with the Securities and Exchange Commission on January 24, 2024

As filed with the Securities and Exchange Commission on January 24, 2024 Registration No.

January 17, 2024 PRE 14C

SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 14C INFORMATION INFORMATION STATEMENT PURSUANT TO SECTION 14(C) OF THE SECURITIES EXCHANGE ACT OF 1934

SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 14C INFORMATION INFORMATION STATEMENT PURSUANT TO SECTION 14(C) OF THE SECURITIES EXCHANGE ACT OF 1934 Check the appropriate box: x Preliminary Information Statement ¨ Confidential, for Use of the Commission Only (as permitted by Rule 14c-5(d)(2)) ¨ Definitive Information Statement Avenue Therapeutics, Inc. (Name of Registrant as S

January 12, 2024 8-K

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): January 9, 2024 Avenue Therapeuti

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): January 9, 2024 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number)

January 8, 2024 EX-99.1

Avenue Therapeutics Enters into Warrant Exercise Transactions for $5.0 Million in Proceeds

Exhibit 99.1 Avenue Therapeutics Enters into Warrant Exercise Transactions for $5.0 Million in Proceeds MIAMI, Jan. 5, 2024 (GLOBE NEWSWIRE) - Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced the entry into warrant exercise

January 8, 2024 EX-10.1

Form of January 2023 Investor Inducement Letter.

Exhibit 10.1 AVENUE THERAPEUTICS, INC. January 5, 2024 Holder of Common Stock Purchase Warrants Re: Inducement Offer to Exercise Common Stock Purchase Warrants Dear Holder: Avenue Therapeutics, Inc. (the “Company”) is pleased to offer to you the opportunity to exercise all of the warrants to purchase shares of the Company’s common stock, par value $0.0001 per share (the “Common Stock”), issued to

January 8, 2024 EX-10.2

Form of November 2023 Investor Inducement Letter.

Exhibit 10.2 AVENUE THERAPEUTICS, INC. January 5, 2024 Holder of Common Stock Purchase Warrants Re: Inducement Offer to Exercise Common Stock Purchase Warrants Dear Holder: Avenue Therapeutics, Inc. (the “Company”) is pleased to offer to you the opportunity to exercise all of the warrants to purchase shares of the Company’s common stock, par value $0.0001 per share (the “Common Stock”), issued to

January 8, 2024 EX-4.2

Form of New Series B Warrant (January 2024).

Exhibit 4.2 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTR

January 8, 2024 EX-4.1

Form of New Series A Warrant (January 2024).

Exhibit 4.1 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTR

January 8, 2024 8-K

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): January 5, 2024 Avenue Therapeuti

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): January 5, 2024 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number)

January 2, 2024 SC 13G/A

ATXI / Avenue Therapeutics, Inc. / SABBY MANAGEMENT, LLC - ATXI 13GA 1.02.24 Passive Investment

SC 13G/A 1 atxi0124.txt ATXI 13GA 1.02.24 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No.1)* Avenue Therapeutics, Inc. (Name of Issuer) Common Stock (Title of Class of Securities) 05360L205 (CUSIP Number) December 31, 2023 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to

December 13, 2023 SC 13G/A

US05360L3042 / Avenue Therapeutics Inc / Davidow Robert L - SC 13G/A Passive Investment

SC 13G/A 1 davidow13g.htm SC 13G/A SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G (Amendment No. 1) Under the Securities Exchange Act of 1934 Avenue Therapeutics, Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 05360L304 (CUSIP Number) December 11, 2023 (Date of Event Which Requires Filing of this Statement) Check the appropria

November 28, 2023 SC 13G

US05360L3042 / Avenue Therapeutics Inc / Davidow Robert L - SCHEDULE 13G Passive Investment

SC 13G 1 davidow13g.htm SCHEDULE 13G SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 Avenue Therapeutics, Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 05360L304 (CUSIP Number) October 31, 2023 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designa

November 24, 2023 8-K

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): November 20, 2023 Avenue Therapeu

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): November 20, 2023 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Numbe

November 13, 2023 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 ☐ TRANSITION REPORT PURSUANT

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 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 001-38114

November 13, 2023 EX-99.1

Avenue Therapeutics Reports Third Quarter 2023 Financial Results and Recent Corporate Highlights - Phase 1b/2a clinical trial of AJ201 remains on track to report topline data in second quarter of 2024 - - Positive BAER-101 preclinical data accepted f

Exhibit 99.1 Avenue Therapeutics Reports Third Quarter 2023 Financial Results and Recent Corporate Highlights - Phase 1b/2a clinical trial of AJ201 remains on track to report topline data in second quarter of 2024 - - Positive BAER-101 preclinical data accepted for presentation at American Epilepsy Society (AES) Annual Meeting - - Agreement reached with U.S. FDA on study design and analysis approa

November 13, 2023 8-K

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): November 13, 2023 Avenue Therapeu

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): November 13, 2023 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Numbe

November 2, 2023 EX-4.1

Form of Series A Warrant (November 2023).

Exhibit 4.1 SERIES A COMMON STOCK PURCHASE WARRANT AVENUE THERAPEUTICS, INC. Warrant Shares: [·] Issuance Date: November 2, 2023 Initial Exercise Date: November 2, 2023 THIS SERIES A COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that Cede & Co. or its registered assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter se

November 2, 2023 EX-10.1

Placement Agency Agreement dated October 31, 2023, by and among Avenue Therapeutics, Inc., Maxim Group LLC and Lake Street Capital Markets, LLC.

Exhibit 10.1 PLACEMENT AGENCY AGREEMENT October 31, 2023 Maxim Group LLC 300 Park Avenue, 16th Floor New York, NY 10022 and Lake Street Capital Markets, LLC 920 Second Avenue South, Suite 700 Minneapolis, Minnesota 55402 Ladies and Gentlemen: Subject to the terms and conditions herein (this “Agreement”), Avenue Therapeutics, Inc., a Delaware corporation (the “Company”), hereby agrees to sell up to

November 2, 2023 EX-4.3

Form of Pre-funded Warrant (November 2023).

Exhibit 4.3 PREFUNDED COMMON STOCK PURCHASE WARRANT AVENUE THERAPEUTICS, INC. Warrant Shares: [·] Issuance Date: November 2, 2023 Initial Exercise Date: October 31, 2023 THIS PREFUNDED COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that Cede & Co. or its registered assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter

November 2, 2023 EX-99.1

Avenue Therapeutics Announces Pricing of $5.0 Million Public Offering

EX-99.1 8 tm2329202d2ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 October 31, 2023 Avenue Therapeutics Announces Pricing of $5.0 Million Public Offering MIAMI, Oct. 31, 2023 (GLOBE NEWSWIRE) - Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today

November 2, 2023 EX-4.2

Form of Series B Warrant (November 2023).

Exhibit 4.2 SERIES B COMMON STOCK PURCHASE WARRANT AVENUE THERAPEUTICS, INC. Warrant Shares: [·] Issuance Date: November 2, 2023 Initial Exercise Date: November 2, 2023 THIS SERIES B COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that Cede & Co. or its registered assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter se

November 2, 2023 424B4

3,853,400 Units, Each Consisting of (A) One Share of Common Stock, (B) One Series A Warrant to Purchase One Share of Common Stock and (C) One Series B Warrant to Purchase One Share of Common Stock 12,780,000 Pre-Funded Units, Each Consisting of (A) O

Filed Pursuant to Rule 424(b)(4) Registration Statement No. 333-274562 Prospectus 3,853,400 Units, Each Consisting of (A) One Share of Common Stock, (B) One Series A Warrant to Purchase One Share of Common Stock and (C) One Series B Warrant to Purchase One Share of Common Stock 12,780,000 Pre-Funded Units, Each Consisting of (A) One Pre-funded Warrant to Purchase One Share of Common Stock, (B) One

November 2, 2023 EX-10.2

Form of Securities Purchase Agreement, dated October 31, 2023, by and among Avenue Therapeutics, Inc. and the investors party thereto.

Exhibit 10.2 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of October 31, 2023, between Avenue Therapeutics, Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively the “Purchasers”). WHEREAS, subject to the terms and condit

November 2, 2023 EX-4.4

Warrant Agent Agreement, dated October 31, 2023 by and between Avenue Therapeutics, Inc. and VStock Transfer, LLC.

Exhibit 4.4 Warrant Agent Agreement This WARRANT AGENT AGREEMENT (this “Warrant Agreement”) dated as of October 31, 2023 is by and between Avenue Therapeutics, Inc, a Delaware corporation (the “Company”), and VStock Transfer, LLC (the “Warrant Agent”). WHEREAS, the Company is selling in a public offering up to (i) 3,853,400 units (the “Units”), with each Unit consisting of (x) one (1) share of com

November 2, 2023 8-K

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): October 31, 2023 Avenue Therapeut

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): October 31, 2023 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number

November 2, 2023 EX-99.2

Avenue Therapeutics Announces Closing of $5.0 Million Public Offering

Exhibit 99.2 Avenue Therapeutics Announces Closing of $5.0 Million Public Offering MIAMI, Nov. 2, 2023 (GLOBE NEWSWIRE) - Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced the closing of its previously announced public offeri

October 30, 2023 CORRESP

October 30, 2023

October 30, 2023 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-1004 Re: Avenue Therapeutics, Inc. Registration Statement on Form S-1, as amended File No. 333-274562 Ladies and Gentlemen: As the placement agent of the proposed offering of Avenue Therapeutics, Inc. (the “Company”), we hereby join the Company’s request for

October 30, 2023 CORRESP

Avenue Therapeutics, Inc. 1111 Kane Concourse, Suite 301 Bay Harbor Islands, Florida 33154

Avenue Therapeutics, Inc. 1111 Kane Concourse, Suite 301 Bay Harbor Islands, Florida 33154 VIA EDGAR October 30, 2023 Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Joshua Gorsky Re: Avenue Therapeutics, Inc. Registration Statement on Form S-1 (Reg. No. 333-274562) Request for Acceleration of Effective Date

October 27, 2023 CORRESP

Avenue Therapeutics, Inc. 1111 Kane Concourse, Suite 301 Bay Harbor Islands, Florida 33154

Avenue Therapeutics, Inc. 1111 Kane Concourse, Suite 301 Bay Harbor Islands, Florida 33154 VIA EDGAR October 27, 2023 Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Joshua Gorsky Re: Avenue Therapeutics, Inc. Registration Statement on Form S-1 (Reg. No. 333-274562) Request for Acceleration of Effective Date

October 27, 2023 CORRESP

October 27, 2023

October 27, 2023 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 Re: Avenue Therapeutics, Inc.

October 24, 2023 EX-10.16

Form of Placement Agency Agreement

Exhibit 10.16 PLACEMENT AGENCY AGREEMENT , 2023 Maxim Group LLC 300 Park Avenue, 16th Floor New York, NY 10022 and Lake Street Capital Markets, LLC 920 Second Avenue South, Suite 700 Minneapolis, Minnesota 55402 Ladies and Gentlemen: Subject to the terms and conditions herein (this “Agreement”), Avenue Therapeutics, Inc., a Delaware corporation (the “Company”), hereby agrees to sell up to an aggre

October 24, 2023 EX-FILING FEES

Filing Fee Table

Exhibit 107 Calculation of Filing Fee Tables Form S-1 (Form Type) Avenue Therapeutics, Inc.

October 24, 2023 S-1/A

As filed with the Securities and Exchange Commission on October 23, 2023.

As filed with the Securities and Exchange Commission on October 23, 2023. Registration Statement No. 333-274562 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 2 to Form S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Avenue Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 2834 47-4113275 (State or Other Jurisdicti

October 24, 2023 CORRESP

October 24, 2023

October 24, 2023 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-1004 Re: Avenue Therapeutics, Inc. Registration Statement on Form S-1, as amended File No. 333-274562 Ladies and Gentlemen: As the placement agent of the proposed offering of Avenue Therapeutics, Inc. (the “Company”), we hereby join the Company’s request for

October 24, 2023 EX-4.8

Form of Warrant

Exhibit 4.8 [SERIES A/SERIES B] COMMON STOCK PURCHASE WARRANT AVENUE THERAPEUTICS, INC. Warrant Shares: [•] Issuance Date: [•], 2023 Initial Exercise Date: [•], 2023 THIS [SERIES A/SERIES B] COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that Cede & Co. or its registered assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions herein

October 24, 2023 EX-10.17

Form of Securities Purchase Agreement

Exhibit 10.17 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of , 2023, between Avenue Therapeutics, Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively the “Purchasers”). WHEREAS, subject to the terms and conditions set

October 24, 2023 CORRESP

Avenue Therapeutics, Inc. 1111 Kane Concourse, Suite 301 Bay Harbor Islands, Florida 33154

Avenue Therapeutics, Inc. 1111 Kane Concourse, Suite 301 Bay Harbor Islands, Florida 33154 VIA EDGAR October 24, 2023 Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Joshua Gorsky Re: Avenue Therapeutics, Inc. Registration Statement on Form S-1 (Reg. No. 333-274562) Request for Acceleration of Effective Date

October 24, 2023 EX-4.10

Form of Warrant Agent Agreement

Exhibit 4.10 Warrant Agent Agreement This WARRANT AGENT AGREEMENT (this “Warrant Agreement”) dated as of [•], 2023 is by and between Avenue Therapeutics, Inc, a Delaware corporation (the “Company”), and VStock Transfer, LLC (the “Warrant Agent”). WHEREAS, the Company is selling in a public offering up to (i) [•] units (the “Units”), with each Unit consisting of (x) one (1) share of common stock, p

October 5, 2023 FWP

Filed Pursuant to Rule 433

Filed Pursuant to Rule 433 Issuer Free Writing Prospectus dated October 5, 2023 Relating to Preliminary Prospectus dated September 29, 2023 Registration No.

October 4, 2023 FWP

Filed Pursuant to Rule 433

Filed Pursuant to Rule 433 Issuer Free Writing Prospectus dated October 3, 2023 Relating to Preliminary Prospectus dated September 29, 2023 Registration No.

September 29, 2023 S-1/A

As filed with the Securities and Exchange Commission on September 29, 2023.

As filed with the Securities and Exchange Commission on September 29, 2023. Registration Statement No. 333-274562 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to Form S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Avenue Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 2834 47-4113275 (State or Other Jurisdic

September 29, 2023 EX-4.9

Form of Pre-funded Warrant

Exhibit 4.9 PREFUNDED COMMON STOCK PURCHASE WARRANT AVENUE THERAPEUTICS, INC. Warrant Shares: [•] Issuance Date: [·], 2023 Initial Exercise Date: [·], 2023 THIS PREFUNDED COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that Cede & Co. or its registered assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at

September 29, 2023 EX-FILING FEES

Filing Fee Table

Exhibit 107 Calculation of Filing Fee Tables Form S-1 (Form Type) Avenue Therapeutics, Inc.

September 29, 2023 EX-4.10

Form of Warrant Agent Agreement

Exhibit 4.10 Warrant Agent Agreement This WARRANT AGENT AGREEMENT (this “Warrant Agreement”) dated as of [•], 2023 is by and between Avenue Therapeutics, Inc, a Delaware corporation (the “Company”), and VStock Transfer, LLC (the “Warrant Agent”). WHEREAS, the Company is selling in a public offering up to (i) [•]units (the “Units”), with each Unit consisting of one (1) share of common stock, par va

September 28, 2023 8-K

Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing

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): September 27, 2023 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Numb

September 27, 2023 8-K

Other Events

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): September 27, 2023 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Numb

September 18, 2023 EX-FILING FEES

Filing Fee Table

Exhibit 107 Calculation of Filing Fee Tables Form S-1 (Form Type) Avenue Therapeutics, Inc.

September 18, 2023 SC 13D/A

US05360L3042 / Avenue Therapeutics Inc / Fortress Biotech, Inc. - SC 13D/A Activist Investment

SC 13D/A 1 tm2326316d1sc13da.htm SC 13D/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D (Amendment No. 3) Under the Securities Exchange Act of 1934 AVENUE THERAPEUTICS, INC. (Name of Issuer) Common Stock, $0.0001 Par Value (Title of Class of Securities) 05360L304 (CUSIP Number) Fortress Biotech, Inc. c/o Lindsay A. Rosenwald, M.D. 1111 Kane Concourse, Suite 3

September 18, 2023 S-1

As filed with the Securities and Exchange Commission on September 18, 2023.

As filed with the Securities and Exchange Commission on September 18, 2023. Registration Statement No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Avenue Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 2834 47-4113275 (State or Other Jurisdiction of Incorporation or

September 8, 2023 8-K

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): September 8, 2023 Avenue Therapeu

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): September 8, 2023 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Numbe

September 8, 2023 EX-10.1

Registration Rights Letter Agreement, dated as of September 8, 2023, by and among Avenue Therapeutics, Inc. and the purchaser parties thereto

Exhibit 10.1 1111 Kane Concourse, Suite 301, Bay Harbor Islands, FL 33154 September 8, 2023 Fortress Biotech, Inc. 1111 Kane Concourse, Suite 301 Bay Harbor Islands, FL 33154 Attention: Lindsay Rosenwald, MD, Chief Executive Officer Lindsay Rosenwald, MD c/o Fortress Biotech, Inc. 1111 Kane Concourse, Suite 301 Bay Harbor Islands, FL 33154 Re: Registration Rights Dear Mr. Rosenwald, Reference is h

August 11, 2023 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 ☐ TRANSITION REPORT PURSUANT TO S

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 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 001-38114 AVEN

August 10, 2023 8-K

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): August 10, 2023 Avenue Therapeuti

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): August 10, 2023 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number)

August 10, 2023 EX-99.1

Avenue Therapeutics Reports Second Quarter 2023 Financial Results and Recent Corporate Highlights - First patient dosed in Phase 1b/2a clinical trial of AJ201; topline data anticipated in first half of 2024 - - Positive BAER-101 preclinical data demo

Exhibit 99.1 Avenue Therapeutics Reports Second Quarter 2023 Financial Results and Recent Corporate Highlights - First patient dosed in Phase 1b/2a clinical trial of AJ201; topline data anticipated in first half of 2024 - - Positive BAER-101 preclinical data demonstrate excellent anti-seizure activity in translational animal model; Phase 2a trial in epilepsy planned to initiate in 2024 - - Agreeme

July 21, 2023 8-K

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): July 17, 2023 Avenue Therapeutics

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): July 17, 2023 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number) 4

July 5, 2023 8-K

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): June 29, 2023 Avenue Therapeutics

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): June 29, 2023 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number) 4

July 5, 2023 EX-10.1

Form Avenue Therapeutics, Inc. Stock Option Plan

Exhibit 10.1 AVENUE THERAPEUTICS, INC. 2015 INCENTIVE PLAN STOCK OPTION AGREEMENT Unless otherwise defined herein, the terms defined in the 2015 Incentive Plan (the “Plan”) shall have the same defined meanings in this Stock Option Agreement. I. NOTICE OF STOCK OPTION GRANT Name: Address: The undersigned Optionee has been granted an Option to purchase shares of Common Stock of the Company (“Common

June 28, 2023 424B3

1,108,270 Shares of Common Stock

Filed Pursuant to Rule 424(b)(3) Registration Statement No. 333-272730 Prospectus 1,108,270 Shares of Common Stock This prospectus relates to the resale by the selling stockholders (the “Selling Stockholders”) identified in this prospectus under the section “The Selling Stockholders,” or their pledgees, donees, transferees or other successors in interest, from time to time, of shares of our Common

June 26, 2023 8-K

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): June 22, 2023 Avenue Therapeutics

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): June 22, 2023 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number) 4

June 23, 2023 CORRESP

Avenue Therapeutics, Inc. 1111 Kane Concourse, Suite 301, Bay Harbor Islands, FL 33154

Avenue Therapeutics, Inc. 1111 Kane Concourse, Suite 301, Bay Harbor Islands, FL 33154 VIA EDGAR June 23, 2023 Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Alan Campbell Re: Avenue Therapeutics, Inc. Registration Statement on Form S-3 (File. No. 333-272730) Request for Acceleration of Effective Date Ladie

June 16, 2023 S-3

As filed with the Securities and Exchange Commission on June 16, 2023

As filed with the Securities and Exchange Commission on June 16, 2023 Registration No.

June 16, 2023 EX-FILING FEES

Filing Fee Table

Exhibit 107.1 Calculation of Filing Fee Tables Form S-3 (Form Type) Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered Securities Security Type Security Class Title Fee Calculation Rule(1) Amount Registered(2) Proposed Maximum Offering Price Per Unit(1) Maximum Aggregate Offering Price(1) Fee Rate Amount of Registration Fee Equity Common Stoc

May 22, 2023 8-K

Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing

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): May 19, 2023 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number) 47

May 12, 2023 EX-10.10

Registration Rights Agreement, dated as of February 28, 2023, by and among Avenue Therapeutics, Inc. and AnnJi Pharmaceutical Co. Ltd.

Exhibit 10.10 CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. REGISTRATION RIGHTS AGREEMENT This Registration Rights Agreement (the “Agreement”), dated as of February 28, 2023, is made by and among Avenue Therapeutics, Inc. a Delaware corporation (the “C

May 12, 2023 EX-99.1

Avenue Therapeutics Reports First Quarter 2023 Financial Results and Recent Corporate Highlights

Exhibit 99.1 Avenue Therapeutics Reports First Quarter 2023 Financial Results and Recent Corporate Highlights Miami, FL – May 12, 2023 – Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today reported financial results and recent corporate

May 12, 2023 EX-10.9

License Agreement entered into by and between AnnJi Pharmaceutical Co. Ltd. and Avenue Therapeutics, Inc., dated February 28, 2023

Exhibit 10.9 CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. License Agreement by and between Annji Pharmaceutical Co. Ltd. and Avenue Therapeutics, Inc dated February 28, 2023 Table of Contents 1. Definitions 1 2. License; Right of First Negotiation 20

May 12, 2023 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 ☐ TRANSITION REPORT PURSUANT TO

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 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 001-38114 AVE

May 12, 2023 8-K

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): May 12, 2023 Avenue Therapeutics,

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): May 12, 2023 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number) 47

May 4, 2023 424B3

1,940,299 Shares of Common Stock

Filed Pursuant to Rule 424(b)(3) Registration Statement No. 333-271208 Prospectus 1,940,299 Shares of Common Stock This prospectus relates to the resale by the selling stockholder (the “Selling Stockholder”) identified in this prospectus under the section “The Selling Stockholder,” or its pledgees, donees, transferees or other successors in interest, from time to time, of up to 1,940,299 shares of

May 1, 2023 CORRESP

Avenue Therapeutics, Inc. 1111 Kane Concourse, Suite 301, Bay Harbor Islands, FL 33154

Avenue Therapeutics, Inc. 1111 Kane Concourse, Suite 301, Bay Harbor Islands, FL 33154 VIA EDGAR May 1, 2023 Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Alan Campbell Re: Avenue Therapeutics, Inc. Registration Statement on Form S-1 (File. No. 333-271208) Request for Acceleration of Effective Date Ladies

April 28, 2023 DEF 14A

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ____)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant. x Filed by a Party other than the Registrant ¨ Check the appropriate box: ¨ Preliminary Proxy Statement ¨ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e

April 28, 2023 DEFA14A

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ____)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant. x Filed by a Party other than the Registrant ¨ Check the appropriate box: ¨ Preliminary Proxy Statement ¨ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e

April 17, 2023 EX-99.1

Avenue Therapeutics Announces Regulatory Update Based on Type C Meeting with FDA and Next Steps in the Development of IV Tramadol

Exhibit 99.1 Avenue Therapeutics Announces Regulatory Update Based on Type C Meeting with FDA and Next Steps in the Development of IV Tramadol Miami, FL – April 17, 2023 – Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of rare and neurologic diseases, today anno

April 17, 2023 8-K

Financial Statements and Exhibits, Other Events

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): April 17, 2023 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number)

April 11, 2023 EX-FILING FEES

Filing Fee Table

Exhibit 107.1 Calculation of Filing Fee Tables Form S-1 (Form Type) Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered Securities Security Type Security Class Title Fee Calculation Rule(1) Amount Registered(2) Proposed Maximum Offering Price Per Unit(1) Maximum Aggregate Offering Price(1) Fee Rate Amount of Registration Fee Equity Common Stoc

April 11, 2023 S-1

As filed with the Securities and Exchange Commission on April 10, 2023.

As filed with the Securities and Exchange Commission on April 10, 2023. Registration Statement No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Avenue Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 2834 47-4113275 (State or Other Jurisdiction of Incorporation or Orga

March 31, 2023 EX-21.1

Subsidiaries of Avenue Therapeutics, Inc.

Exhibit 21.1 AVENUE THERAPEUTICS, INC. Subsidiaries of Avenue Therapeutics, Inc. at December 31, 2022, with jurisdiction of incorporation or formation: ● Baergic Bio, Inc. (Delaware)

March 31, 2023 EX-4.3

Description of Securities of Avenue Therapeutics, Inc.

Exhibit 4.3 DESCRIPTION OF THE REGISTRANT’S SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934 DESCRIPTION OF CAPITAL STOCK Authorized Capital Stock Our authorized capital stock consists of 75,000,000 shares of common stock, with $0.0001 par value (“Common Stock”), and 2,000,000 shares of Preferred Stock, with $0.0001 par value, of which 250,000 have been designate

March 31, 2023 10-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2022 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 001-38114 AVENUE

March 30, 2023 EX-99.1

Avenue Therapeutics Reports Full Year 2022 Financial Results and Recent Corporate Highlights

Exhibit 99.1 Avenue Therapeutics Reports Full Year 2022 Financial Results and Recent Corporate Highlights Miami, FL – March 30, 2023 – Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of rare and neurologic diseases, today reported financial results and recent cor

March 30, 2023 8-K

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): March 30, 2023 Avenue Therapeutic

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): March 30, 2023 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number)

March 8, 2023 8-K

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers, Financial Statements and Exhibits, Other Events, Shareholder Director Nominations

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): March 7, 2023 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number) 4

March 8, 2023 EX-99.1

Avenue Therapeutics Provides Regulatory Update on IV Tramadol and Other Corporate Updates Company to participate in Type C meeting for IV Tramadol with FDA on March 9, 2023

Exhibit 99.1 Avenue Therapeutics Provides Regulatory Update on IV Tramadol and Other Corporate Updates Company to participate in Type C meeting for IV Tramadol with FDA on March 9, 2023 Miami, FL – March 8, 2023 – Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment o

March 2, 2023 8-K

Entry into a Material Definitive Agreement, Unregistered Sales of Equity Securities, Financial Statements and Exhibits, Other Events

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): February 28, 2023 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Numbe

March 2, 2023 EX-99.1

Avenue Therapeutics Enters into a Transformational License Agreement with AnnJi Pharmaceutical to Develop and Commercialize AJ201, a First-in-Class Clinical Asset for the Treatment of Spinal and Bulbar Muscular Atrophy AJ201 is being evaluated in a P

Exhibit 99.1 Avenue Therapeutics Enters into a Transformational License Agreement with AnnJi Pharmaceutical to Develop and Commercialize AJ201, a First-in-Class Clinical Asset for the Treatment of Spinal and Bulbar Muscular Atrophy AJ201 is being evaluated in a Phase 1b/2a clinical trial in the U.S. for the rare X-linked genetic neurodegenerative disease also known as Kennedy’s Disease which curre

February 14, 2023 SC 13G/A

US05360L3042 / Avenue Therapeutics Inc / CVI Investments, Inc. - SC 13G/A Passive Investment

SC 13G/A 1 tm235037d21sc13ga.htm SC 13G/A CUSIP No: 05360L304 SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO § 240.13d-1(b), (c) AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO § 240.13d-2. (Amendment No. 1)* Avenue Therapeutics, Inc. (Name of Issuer) Common Stock, $0.0001 par value per share (Title

February 10, 2023 EX-FILING FEES

Filing Fee Table

Exhibit 107 Calculation of Filing Fee Tables Form S-8 (Form Type) Avenue Therapeutics, Inc.

February 10, 2023 8-K

Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year, Financial Statements and Exhibits

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): February 9, 2023 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number

February 10, 2023 EX-3.1

Second Amended and Restated Bylaws of Avenue Therapeutics, Inc., filed as Exhibit 3.1 to Form 8-K filed on February 10, 2023 (File No. 000-38114) and incorporated herein by reference.

Exhibit 3.1 SECOND AMENDED AND RESTATED BYLAWS OF AVENUE THERAPEUTICS, INC. Adopted February 9, 2023 I. CORPORATE OFFICES 1.1 Registered Office The registered office of the corporation shall be in the City of Dover County of Kent, State of Delaware. The name of the registered agent of the corporation at such location is Incorporating Services, Ltd. 1.2 Other Offices The board of directors may at a

February 10, 2023 S-8

As filed with the Securities and Exchange Commission on February 10, 2023

As filed with the Securities and Exchange Commission on February 10, 2023 Registration No.

February 3, 2023 EX-10.1

Amendment to the Avenue Therapeutics, Inc. 2015 Incentive Plan.

Exhibit 10.1 AMENDMENT TO THE AVENUE THERAPEUTICS, INC 2015 INCENTIVE PLAN This Amendment to the Avenue Therapeutics, Inc. 2015 Incentive Plan (the “Plan”), has been adopted by the Board of Directors (the “Board”) and approved by the stockholders of Avenue Therapeutics, Inc. (the “Company”), to be effective as of January 30, 2023. 1. The Plan is hereby amended by deleting Section 5.1 of the Plan i

February 3, 2023 8-K

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): January 30, 2023 Avenue Therapeut

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): January 30, 2023 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number

February 3, 2023 EX-3.1

Certificate of Amendment of the Third Amended and Restated Certificate of Incorporation of Avenue Therapeutics, Inc., filed as Exhibit 3.1 to Form 8-K filed on February 3, 2023 (File No. 001-38114) and incorporated herein by reference.

Exhibit 3.1 CERTIFICATE OF AMENDMENT TO THE THIRD AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF AVENUE THERAPEUTICS, INC. Avenue Therapeutics, Inc. (the “Corporation”), a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware (the “DGCL”), does hereby certify: FIRST. The Certificate of Incorporation of the Corporation is hereby amended

February 1, 2023 8-K

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): January 27, 2023 Avenue Therapeut

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): January 27, 2023 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number

February 1, 2023 EX-10.3

Form of Pre-funded Warrant (Registered Offering) (January 2023)

Exhibit 10.3   PRE-FUNDED WARRANT TO PURCHASE COMMON STOCK   AVENUE THERAPEUTICS, INC.   Warrant Shares: [●] Initial Exercise Date: January 27, 2023    Issue Date: January 31, 2023   THIS PRE-FUNDED WARRANT TO PURCHASE COMMON STOCK (the “Warrant”) certifies that, for value received, [●] or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the con

February 1, 2023 EX-10.4

Form of PIPE Warrant (PIPE)

Exhibit 10.4   NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGI

February 1, 2023 EX-99.1

Avenue Therapeutics Announces $3.25 Million Registered Direct and Private Placement Priced at the Market Under Nasdaq Rules

Exhibit 99.1 Avenue Therapeutics Announces $3.25 Million Registered Direct and Private Placement Priced at the Market Under Nasdaq Rules Miami, FL, January 27, 2023 - Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of central nervous system diseases, today announ

February 1, 2023 EX-10.2

Form of Securities Purchase Agreement (PIPE), dated January 27, 2023, by and among Avenue Therapeutics, Inc. and the purchaser party thereto

Exhibit 10.2   PIPE SECURITIES PURCHASE AGREEMENT   This PIPE Securities Purchase Agreement (this “Agreement”) is dated as of January 27, 2023, between Avenue Therapeutics, Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (including their respective successors and assigns, each a “Purchaser” and collectively, the “Purchasers”).   WHEREAS, su

February 1, 2023 EX-10.1

Form of Securities Purchase Agreement (Registered Offering), dated January 27, 2023, by and among Avenue Therapeutics, Inc. and the purchaser party thereto

Exhibit 10.1   RD SECURITIES PURCHASE AGREEMENT   This RD Securities Purchase Agreement (this “Agreement”) is dated as of January 27, 2023, between Avenue Therapeutics, Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (including their respective successors and assigns, each a “Purchaser” and collectively, the “Purchasers”).   WHEREAS, subjec

February 1, 2023 EX-99.2

Avenue Therapeutics Announces Closing of $3.25 Million Registered Direct and Private Placement

Exhibit 99.2 Avenue Therapeutics Announces Closing of $3.25 Million Registered Direct and Private Placement MIAMI, Jan. 31, 2023 (GLOBE NEWSWIRE) - Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of central nervous system diseases, today announced the closing of

February 1, 2023 EX-10.7

Placement Agent Agreement entered into by and between Avenue Therapeutics, Inc. and Aegis Capital Corp., dated January 27, 2023

Exhibit 10.7   AEGIS CAPITAL CORP.   January 27, 2023   PERSONAL AND CONFIDENTIAL   Dr. Alexandra MacLean Avenue Therapeutics, Inc. 1140 Avenue of the Americas, Floor 9   New York, NY 10036   Re: ATXI Shelf Takedown   Dear Dr. MacLean:   The purpose of this Placement Agent Agreement (this “Agreement”) is to outline our agreement pursuant to which Aegis Capital Corp. (“Aegis” or the “Placement Agen

February 1, 2023 EX-10.6

Form of Lockup Agreement

Exhibit 10.6 Avenue Therapeutics, Inc. - Lock-up Agreement January 27, 2023 Avenue Therapeutics, Inc. 1111 Kane Concourse, Suite 301 Bay Harbor Islands, FL 33154 Ladies and Gentlemen: The undersigned understands that Avenue Therapeutics, Inc., a Delaware corporation (the “Company”), entered into Securities Purchase Agreements (the “SPAs”) on January 27, 2023 with each purchaser (each, an “Investor

February 1, 2023 EX-10.5

Form of Registration Rights Agreement, dated January 27, 2023, by and among Avenue Therapeutics, Inc. and the purchaser party thereto

Exhibit 10.5   REGISTRATION RIGHTS AGREEMENT   This Registration Rights Agreement (this “Agreement”) is made and entered into as of January 27, 2023, between Avenue Therapeutics, Inc., a Delaware corporation (the “Company”), and each of the several purchasers signatory hereto (each such purchaser, a “Purchaser” and, collectively, the “Purchasers”).   This Agreement is made pursuant to the Securiti

January 31, 2023 424B5

448,000 Shares of Common Stock Pre-Funded Warrants to purchase up to 1,492,299 Shares of Common Stock

Filed Pursuant to Rule 424(b)(5) Registration No. 333-261520 PROSPECTUS SUPPLEMENT To the Prospectus dated December 10, 2021 448,000 Shares of Common Stock Pre-Funded Warrants to purchase up to 1,492,299 Shares of Common Stock We are offering 448,000 shares of our common stock, par value $0.0001 per share (“Common Stock”), and pre-funded warrants (“Pre-funded Warrants”) to purchase up to 1,492,299

January 25, 2023 EX-16.1

Letter from BDO USA, LLP

Exhibit 16.1 Tel: 212-371-4446 Fax: 212-371-9374 www.bdo.com 622 Third Ave, Suite 3100 New York, NY 10017 January 25, 2023 Securities and Exchange Commission 100 F Street N.E. Washington, D.C. 20549 We have been furnished with a copy of the response to Item 4.01 of Form 8-K for the event that occurred on January 21, 2023, to be filed by our former client, Avenue Therapeutics, Inc. We agree with th

January 25, 2023 8-K

Financial Statements and Exhibits, Changes in Registrant's Certifying Accountant

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): January 21, 2023 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number

January 17, 2023 DEFA14A

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. )

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant. x Filed by a Party other than the Registrant ¨ Check the appropriate box: ¨ Preliminary Proxy Statement ¨ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e

January 6, 2023 SC 13D/A

ATXI / Avenue Therapeutics Inc / Fortress Biotech, Inc. - SC 13D/A Activist Investment

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D (Amendment No. 2) Under the Securities Exchange Act of 1934 AVENUE THERAPEUTICS, INC. (Name of Issuer) Common Stock, $0.0001 Par Value (Title of Class of Securities) 05360L205 (CUSIP Number) Fortress Biotech, Inc. c/o Lindsay A. Rosenwald, M.D. 1111 Kane Concourse, Suite 301 Bay Harbor Islands, FL 33154 (781) 652-

January 4, 2023 DEFA14A

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. )

DEFA14A 1 tm231610d1defa14a.htm DEFA14A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant. x Filed by a Party other than the Registrant ¨ Check the appropriate box: ¨ Preliminary Proxy Statement ¨ Confidential, for Use of the Commi

December 14, 2022 SC 13G/A

ATXI / Avenue Therapeutics Inc / Nantahala Capital Management, LLC - SC 13G/A Passive Investment

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1)* Avenue Therapeutics, Inc. (Name of Issuer) Common Stock, $0.0001 par value (Title of Class of Securities) 05360L205 (CUSIP Number) December 14, 2022 (Date of Event which Requires Filing of this Statement) Check the appropriate box to designate the rule p

November 18, 2022 DEFA14A

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. )

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant. x Filed by a Party other than the Registrant ? Check the appropriate box: ? Preliminary Proxy Statement ? Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e

November 18, 2022 DEF 14A

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. )

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant. x Filed by a Party other than the Registrant ¨ Check the appropriate box: ¨ Preliminary Proxy Statement ¨ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e

November 10, 2022 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q

Table of Contents ? ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.

November 10, 2022 8-K

Financial Statements and Exhibits, Results of Operations and Financial Condition

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): November 10, 2022 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Numbe

November 10, 2022 EX-99.1

Avenue Therapeutics Reports Third Quarter 2022 Financial Results and Recent Corporate Highlights

Exhibit 99.1 Avenue Therapeutics Reports Third Quarter 2022 Financial Results and Recent Corporate Highlights New York, NY ? November 10, 2022 ? Avenue Therapeutics, Inc. (Nasdaq: ATXI) (?Avenue? or the ?Company?), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of central nervous system diseases (?CNS?), today reported financial r

November 8, 2022 8-K

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): November 8, 2022 Avenue Therapeut

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): November 8, 2022 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number

November 8, 2022 PRE 14A

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. )

PRE 14A 1 tm2229862d1pre14a.htm PRE 14A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant. x Filed by a Party other than the Registrant ¨ Check the appropriate box: x Preliminary Proxy Statement ¨ Confidential, for Use of the Commi

November 8, 2022 EX-99.1

Avenue Therapeutics Completes the Acquisition of Baergic Bio and its Selective GABA-A α2/3 Receptor Positive Allosteric Modulator for the Treatment of Central Nervous System Disorders

Exhibit 99.1 Avenue Therapeutics Completes the Acquisition of Baergic Bio and its Selective GABA-A α2/3 Receptor Positive Allosteric Modulator for the Treatment of Central Nervous System Disorders New York, NY – November 8, 2022 – Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies fo

November 4, 2022 8-K

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): October 31, 2022 Avenue Therapeut

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): October 31, 2022 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number

October 19, 2022 SC 13D/A

ATXI / Avenue Therapeutics Inc / Invagen Pharmaceuticals, Inc. - SC 13D/A Activist Investment

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 3)* AVENUE THERAPEUTICS, INC. (Name of Issuer) Common Stock, $0.0001 Par Value (Title of Class of Securities) 05360L205 (CUSIP Number) A.S. Kumar General Counsel, Cipla Limited c/o InvaGen Pharmaceuticals Inc. Site B, 7 Oser Ave. Hauppauge, New York 11788 Te

October 18, 2022 8-K

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): October 18, 2022 Avenue Therapeut

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): October 18, 2022 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number

October 17, 2022 EX-99.1

JOINT FILING AGREEMENT

Exhibit 1 JOINT FILING AGREEMENT The undersigned acknowledge and agree that the foregoing statement on Schedule 13G is filed on behalf of each of the undersigned and that all subsequent amendments to this statement on Schedule 13G may be filed on behalf of each of the undersigned without the necessity of filing additional joint filing agreements.

October 17, 2022 SC 13G

ATXI / Avenue Therapeutics Inc / INTRACOASTAL CAPITAL, LLC - SCHEDULE 13G Passive Investment

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* Avenue Therapeutics, Inc. (Name of Issuer) Common Stock, $0.0001 par value per share (Title of Class of Securities) 05360L205 (CUSIP Number) October 11, 2022 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate th

October 17, 2022 EX-99.2

Joint Filing Agreement

CUSIP No:   05360L304 EXHIBIT II JOINT FILING AGREEMENT This will confirm the agreement by and among the undersigned that the Schedule 13G filed with the Securities and Exchange Commission on or about the date hereof with respect to the beneficial ownership by the undersigned of the shares of common stock of Avenue Therapeutics, Inc.

October 17, 2022 SC 13G

ATXI / Avenue Therapeutics Inc / CVI Investments, Inc. - SC 13G Passive Investment

CUSIP No:    05360L304 SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO § 240.13d-1(b), (c) AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO § 240.13d-2. (Amendment No. )* Avenue Therapeutics, Inc. (Name of Issuer) Common Stock, $0.0001 par value per share (Title of Class of Securities) 05360L304 (CUSIP

October 17, 2022 EX-99.1

LIMITED POWER OF ATTORNEY

CUSIP No:   05360L304 Exhibit I LIMITED POWER OF ATTORNEY THIS LIMITED POWER OF ATTORNEY given on the 16th day of July, 2015 by CVI Investments, Inc.

October 12, 2022 EX-99.1

Avenue Therapeutics Announces Pricing of $12 Million Underwritten Public Offering

Exhibit 99.1 Avenue Therapeutics Announces Pricing of $12 Million Underwritten Public Offering NEW YORK, Oct. 06, 2022 (GLOBE NEWSWIRE) - Avenue Therapeutics, Inc. (Nasdaq: ATXI) (?Avenue? or the ?Company?), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of central nervous system diseases, today announced the pricing of its underw

October 12, 2022 8-K

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): October 6, 2022 Avenue Therapeuti

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): October 6, 2022 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number)

October 12, 2022 EX-4.2

Form of Pre-funded Warrant (October 2022)

Exhibit 4.2 PRE-FUNDED COMMON STOCK PURCHASE WARRANT AvENUE THERAPEUTICS, INC. Warrant Shares: [?] Issuance Date: October 11, 2022 Initial Exercise Date: October 11, 2022 THIS PRE-FUNDED COMMON STOCK PURCHASE WARRANT (the ?Warrant?) certifies that, for value received, Cede & Co., or its registered assigns (the ?Holder?) is entitled, upon the terms and subject to the limitations on exercise and the

October 12, 2022 EX-1.1

Underwriting Agreement, dated October 6, 2022, by and between Avenue Therapeutics, Inc. and Aegis Capital Corp.

Exhibit 1.1 Underwriting Agreement October 6, 2022 Aegis Capital Corp. 1345 Avenue of the Americas, 27th Floor New York, NY 10105 Ladies and Gentlemen: Avenue Therapeutics, Inc., a Delaware corporation (the ?Company?), agrees, subject to the terms and conditions in this agreement (this ?Agreement?), to issue and sell to Aegis Capital Corp. (the ?Underwriter?) an aggregate of 3,636,365 units, with

October 12, 2022 EX-99.2

Avenue Therapeutics Announces Closing of $12 Million Underwritten Public Offering

Exhibit 99.2 Avenue Therapeutics Announces Closing of $12 Million Underwritten Public Offering NEW YORK, Oct. 11, 2022 (GLOBE NEWSWIRE) - Avenue Therapeutics, Inc. (Nasdaq: ATXI) (?Avenue? or the ?Company?), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of central nervous system diseases, today announced the closing of its previo

October 12, 2022 EX-4.3

Warrant Agent Agreement, dated October 6, 2022, by and between Avenue Therapeutics, Inc. and VStock Transfer, LLC

Exhibit 4.3 Warrant Agent Agreement This WARRANT AGENT AGREEMENT (this ?Warrant Agreement?) dated as of October 6, 2022 (the ?Issuance Date?) is by and between Avenue Therapeutics, Inc, a Delaware corporation (the ?Company?), and VStock Transfer, LLC (the ?Warrant Agent?). WHEREAS, pursuant to the terms of that certain Underwriting Agreement (?Underwriting Agreement?), dated October 6, 2022, by an

October 12, 2022 EX-4.1

Form of Warrant, filed as Exhibit 4.1 to Form 8-K filed on October 12, 2022 (File No. 001-38114) and incorporated herein by reference.

Exhibit 4.1 COMMON STOCK PURCHASE WARRANT AVENUE THERAPEUTICS, INC. Warrant Shares: [?] Issuance Date: October 11, 2022 Initial Exercise Date: October 11, 2022 THIS COMMON STOCK PURCHASE WARRANT (the ?Warrant?) certifies that Cede & Co. or its registered assigns (the ?Holder?) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any ti

October 11, 2022 424B4

2,652,065 Units, each consisting of one Share of Common Stock and one Warrant to purchase Shares of Common Stock 984,300 Pre-Funded Units, each consisting of one Pre-funded Warrant to purchase Shares of Common Stock and one Warrant to purchase Shares

Filed Pursuant to Rule 424(b)(4) Registration No. 333-267206 Prospectus 2,652,065 Units, each consisting of one Share of Common Stock and one Warrant to purchase Shares of Common Stock and 984,300 Pre-Funded Units, each consisting of one Pre-funded Warrant to purchase Shares of Common Stock and one Warrant to purchase Shares of Common Stock We are offering 2,652,065 units, each consisting of one s

October 6, 2022 FWP

AVENUE THERAPEUTICS, INC. ⎸ NASDAQ: ATXI ⎸ OCTOBER 2022 Corporate Overview Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration Statement No. 333 - 267206 (Preliminary Prospectus dated October 6, 2022)

FWP 1 tm2227654d1fwp.htm FREE WRITING PROSPECTUS AVENUE THERAPEUTICS, INC. ⎸ NASDAQ: ATXI ⎸ OCTOBER 2022 Corporate Overview Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration Statement No. 333 - 267206 (Preliminary Prospectus dated October 6, 2022) 2 Notice & Disclaimers Free Writing Prospectus This free writing prospectus relates to the proposed public offering of securities o

October 6, 2022 EX-FILING FEES

Filing Fee Table

Exhibit 107 Calculation of Filing Fee Tables Form S-1/A (Form Type) Avenue Therapeutics, Inc.

October 6, 2022 S-1/A

Baergic unaudited balance sheet as of June 30, 2022 and December 31, 2021, the related statements of operations and stockholders’ equity for each of the three and six months ended June 30, 2022 and 2021, and statements of cash flows for the six months ended June 30, 2022 and 2021, and the related notes, incorporated by reference to the Registration Statement on Form S-1 (Reg. 333-267206), filed by the registrant with the SEC on October 6, 2022

As filed with the Securities and Exchange Commission on October 6, 2022. Registration Statement No. 333-267206 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form S-1 (Amendment No. 2) REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Avenue Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 2834 47-4113275 (State or Other Jurisdiction

October 5, 2022 EX-1.1

Form of Underwriting Agreement

Exhibit 1.1 Underwriting Agreement [?], 2022 Aegis Capital Corp. 1345 Avenue of the Americas, 27th Floor New York, NY 10105 Ladies and Gentlemen: Avenue Therapeutics, Inc., a Delaware corporation (the ?Company?), agrees, subject to the terms and conditions in this agreement (this ?Agreement?), to issue and sell to Aegis Capital Corp. (the ?Underwriter?) an aggregate of [?] units, with each such un

October 5, 2022 CORRESP

October 5, 2022

CORRESP 1 filename1.htm October 5, 2022 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 RE: Avenue Therapeutics, Inc. (CIK: 0001644963) Registration Statement on Form S-1 (the “Registration Statement”) Reg. No. 333-267206 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations of the U.S. Securities and Ex

October 5, 2022 EX-FILING FEES

Filing Fee Table

Exhibit 107 Calculation of Filing Fee Tables Form S-1/A (Form Type) Avenue Therapeutics, Inc.

October 5, 2022 EX-4.5

Form of Pre-funded Warrant

Exhibit 4.5 PRE-FUNDED COMMON STOCK PURCHASE WARRANT AvENUE THERAPEUTICS, INC. Warrant Shares: [?] Issuance Date: [?], 2022 Initial Exercise Date: [?], 2022 THIS PRE-FUNDED COMMON STOCK PURCHASE WARRANT (the ?Warrant?) certifies that, for value received, Cede & Co., or its registered assigns (the ?Holder?) is entitled, upon the terms and subject to the limitations on exercise and the conditions he

October 5, 2022 CORRESP

Avenue Therapeutics, Inc. 2 Gansevoort St., 9th Floor New York, NY 10014

CORRESP 1 filename1.htm Avenue Therapeutics, Inc. 2 Gansevoort St., 9th Floor New York, NY 10014 VIA EDGAR October 5, 2022 Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Jason Drory Re: Avenue Therapeutics, Inc. Registration Statement on Form S-1 (Reg. No. 333-267206) Request for Acceleration of Effective D

October 5, 2022 EX-4.4

Form of Warrant

Exhibit 4.4 COMMON STOCK PURCHASE WARRANT AVENUE THERAPEUTICS, INC. Warrant Shares: [?] Issuance Date: [?], 2022 Initial Exercise Date: [?], 2022 THIS COMMON STOCK PURCHASE WARRANT (the ?Warrant?) certifies that [?] or its registered assigns (the ?Holder?) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the da

October 5, 2022 EX-4.6

Form of Warrant Agent Agreement

Exhibit 4.6 Warrant Agent Agreement This WARRANT AGENT AGREEMENT (this ?Warrant Agreement?) dated as of [?], 2022 (the ?Issuance Date?) is by and between Avenue Therapeutics, Inc, a Delaware corporation (the ?Company?), and VStock Transfer, LLC (the ?Warrant Agent?). WHEREAS, pursuant to the terms of that certain Underwriting Agreement (?Underwriting Agreement?), dated [], 2022, by and between the

October 5, 2022 S-1/A

As filed with the Securities and Exchange Commission on October 4, 2022.

As filed with the Securities and Exchange Commission on October 4, 2022. Registration Statement No. 333-267206 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form S-1 (Amendment No. 1) REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Avenue Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 2834 47-4113275 (State or Other Jurisdiction

September 30, 2022 8-K

Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing

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): September 29, 2022 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Numb

September 22, 2022 EX-3.1

Certificate of Amendment of the Third Amended and Restated Certificate of Incorporation of Avenue Therapeutics, Inc., filed as Exhibit 3.1 to Form 8-K filed on September 22, 2022 (File No. 001-38114) and incorporated herein by reference.

Exhibit 3.1 CERTIFICATE OF AMENDMENT TO THE THIRD AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF AVENUE THERAPEUTICS, INC. Avenue Therapeutics, Inc. (the ?Corporation?), a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware (the ?DGCL?), does hereby certify: FIRST. The Certificate of Incorporation of the Corporation is hereby amended

September 22, 2022 8-K

Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year, Material Modification to Rights of Security Holders, Financial Statements and Exhibits, Other Events

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): September 22, 2022 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Numb

September 22, 2022 EX-99.1

Avenue Therapeutics Announces Reverse Stock Split and Provides Regulatory Update for IV Tramadol Including Receipt of Type A Meeting Minutes from the FDA

Exhibit 99.1 Avenue Therapeutics Announces Reverse Stock Split and Provides Regulatory Update for IV Tramadol Including Receipt of Type A Meeting Minutes from the FDA New York, NY ? September 22, 2022 ? Avenue Therapeutics, Inc. (Nasdaq: ATXI) (?Avenue? or the ?Company?), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of central n

August 31, 2022 8-K

Other Events

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): August 31, 2022 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number)

August 31, 2022 EX-FILING FEES

Filing Fee Table

Exhibit 107 Calculation of Filing Fee Tables Form S-1 (Form Type) Avenue Therapeutics, Inc.

August 31, 2022 S-1

As filed with the Securities and Exchange Commission on August 31, 2022.

As filed with the Securities and Exchange Commission on August 31, 2022. Registration Statement No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Avenue Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 2834 47-4113275 (State or Other Jurisdiction of Incorporation or Org

August 22, 2022 DEF 14C

SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 14C INFORMATION INFORMATION STATEMENT PURSUANT TO SECTION 14(C) OF THE SECURITIES EXCHANGE ACT OF 1934

SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 14C INFORMATION INFORMATION STATEMENT PURSUANT TO SECTION 14(C) OF THE SECURITIES EXCHANGE ACT OF 1934 Check the appropriate box: ¨ Preliminary Information Statement ¨ Confidential, for Use of the Commission Only (as permitted by Rule 14c-5(d)(2)) x Definitive Information Statement Avenue Therapeutics, Inc. (Name of Registrant as S

August 15, 2022 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q

Table of Contents ? ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.

August 15, 2022 EX-10.1

Stock Contribution Agreement between Avenue Therapeutics, Inc. and Fortress Biotech, Inc., dated May 11, 2022

? Exhibit 10.1 ? STOCK CONTRIBUTION AGREEMENT THIS STOCK CONTRIBUTION AGREEMENT (this ?Agreement?) is made and entered into as of May 11, 2022 (the ?Effective Date?), by and between Avenue Therapeutics, Inc., a Delaware corporation (?Acquirer?) and Fortress Biotech, Inc., a Delaware corporation (?Contributor?). RECITALS A.Contributor is the owner and shareholder of record of 250,000 shares of Clas

August 12, 2022 8-K

Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing

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): August 9, 2022 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number)

August 10, 2022 PRE 14C

SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 14C INFORMATION INFORMATION STATEMENT PURSUANT TO SECTION 14(C) OF THE SECURITIES EXCHANGE ACT OF 1934

SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 14C INFORMATION INFORMATION STATEMENT PURSUANT TO SECTION 14(C) OF THE SECURITIES EXCHANGE ACT OF 1934 Check the appropriate box: x Preliminary Information Statement ¨ Confidential, for Use of the Commission Only (as permitted by Rule 14c-5(d)(2)) ¨ Definitive Information Statement Avenue Therapeutics, Inc. (Name of Registrant as S

August 3, 2022 8-K

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

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): August 1, 2022 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number)

July 29, 2022 8-K

Submission of Matters to a Vote of Security Holders

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): July 25, 2022 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number) 4

July 28, 2022 EX-99.F

SHARE REPURCHASE AGREEMENT

Exhibit F SHARE REPURCHASE AGREEMENT THIS SHARE REPURCHASE AGREEMENT (this ?Agreement?) is made and entered into as of this 25th day of July, 2022 (the ?Execution Date?), by and among InvaGen Pharmaceuticals Inc.

July 28, 2022 SC 13D/A

ATXI / Avenue Therapeutics Inc / Invagen Pharmaceuticals, Inc. - SC 13D/A Activist Investment

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 2)* AVENUE THERAPEUTICS, INC. (Name of Issuer) Common Stock, $0.0001 Par Value (Title of Class of Securities) 05360L205 (CUSIP Number) A.S. Kumar General Counsel, Cipla Limited c/o InvaGen Pharmaceuticals Inc. Site B, 7 Oser Ave. Hauppauge, New York 11788 Te

May 25, 2022 8-K

Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing

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): May 24, 2022 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number) 47

May 16, 2022 8-K

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers, Entry into a Material Definitive Agreement, Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing

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): May 11, 2022 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number) 47

May 16, 2022 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q

Table of Contents ? ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.

May 13, 2022 8-K

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

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): May 11, 2022 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number) 47

April 5, 2022 8-K

Other Events

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): April 1, 2022 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number) 4

March 30, 2022 8-K

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

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): March 28, 2022 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number)

March 25, 2022 EX-21.1

Subsidiaries of Avenue Therapeutics, Inc.

Exhibit 21.1 AVENUE THERAPEUTICS INC. List of Subsidiaries Avenue Therapeutics, Inc. does not have any subsidiaries.

March 25, 2022 10-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K

Table of Contents ? ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.

March 25, 2022 EX-4.3

Description of Securities of Avenue Therapeutics, Inc.

Exhibit 4.3 ? DESCRIPTION OF THE REGISTRANT?S SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934 DESCRIPTION OF CAPITAL STOCK ? Authorized Capital Stock ? Our authorized capital stock consists of 50,000,000 shares of common stock, with $0.0001 par value, and 2,000,000 shares of Preferred Stock, with $0.0001 par value, of which 250,000 have been designated as Class

March 21, 2022 8-K

Other Events

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): March 18, 2022 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number)

March 8, 2022 8-K

Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing, Other Events

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): March 2, 2022 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number) 4

February 16, 2022 EX-99.1

Avenue Therapeutics Announces Outcome of FDA Advisory Committee Meeting on IV Tramadol

Exhibit 99.1 Avenue Therapeutics Announces Outcome of FDA Advisory Committee Meeting on IV Tramadol New York, NY ? Feb. 15, 2022 ? Avenue Therapeutics, Inc. (NASDAQ: ATXI) (?Avenue?), a company focused on the development of intravenous (?IV?) tramadol for the U.S. market, today announced the outcome of the U.S. Food and Drug Administration (?FDA?) joint meeting of the Anesthetic and Analgesic Drug

February 16, 2022 8-K

Financial Statements and Exhibits, Other Events

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): February 15, 2022 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Numbe

February 14, 2022 SC 13G

ATXI / Avenue Therapeutics Inc / Nantahala Capital Management, LLC - SC 13G Passive Investment

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* Avenue Therapeutics, Inc. (Name of Issuer) Common Stock, $0.0001 par value (Title of Class of Securities) 05360L205 (CUSIP Number) December 31, 2021 (Date of Event which Requires Filing of this Statement) Check the appropriate box to designate the rule pu

February 11, 2022 8-K

Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing

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): February 8, 2022 Avenue Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware (State or Other Jurisdiction of Incorporation) 001-38114 (Commission File Number

February 9, 2022 SC 13G/A

ATXI / Avenue Therapeutics Inc / VANGUARD INDEX FUNDS - SCHEDULE 13G/A Passive Investment

SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Schedule 13G Under the Securities Exchange Act of 1934 (Amendment No.: 1)* Name of issuer: Avenue Therapeutics Inc. Title of Class of Securities: Common Stock CUSIP Number: 05360L205 Date of Event Which Requires Filing of this Statement: December 31, 2021 Check the appropriate box to designate the rule pursuant to which this Schedule is fil

February 9, 2022 SC 13G/A

ATXI / Avenue Therapeutics Inc / VANGUARD GROUP INC - SCHEDULE 13G/A Passive Investment

SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Schedule 13G Under the Securities Exchange Act of 1934 (Amendment No.: 1)* Name of issuer: Avenue Therapeutics Inc. Title of Class of Securities: Common Stock CUSIP Number: 05360L205 Date of Event Which Requires Filing of this Statement: December 31, 2021 Check the appropriate box to designate the rule pursuant to which this Schedule is fil

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