# EDGAR Filing Document

**Accession Number:** 0001644963
**File Stem:** 0001104659-23-006536
**Filing Date:** 2023-1
**Character Count:** 8183
**Document Hash:** 53310e4db9b0acda96beee1bbc916154
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-23-006536.hdr.sgml**: 20230125

**ACCESSION NUMBER**: 0001104659-23-006536

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 16

**CONFORMED PERIOD OF REPORT**: 20230121

**ITEM INFORMATION**: Changes in Registrant's Certifying Accountant

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230125

**DATE AS OF CHANGE**: 20230125

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** AVENUE THERAPEUTICS, INC.
- **CENTRAL INDEX KEY:** 0001644963
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 474113275
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38114
- **FILM NUMBER:** 23552590

**BUSINESS ADDRESS:**
- **STREET 1:** 1111 KANE CONCOURSE
- **STREET 2:** SUITE 301
- **CITY:** BAY HARBOR ISLANDS
- **STATE:** FL
- **ZIP:** 33154
- **BUSINESS PHONE:** 781-652-4500

**MAIL ADDRESS:**
- **STREET 1:** 1111 KANE CONCOURSE
- **STREET 2:** SUITE 301
- **CITY:** BAY HARBOR ISLANDS
- **STATE:** FL
- **ZIP:** 33154

?xml version="1.0" encoding="utf-8"?

**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**<br> (State or Other Jurisdiction<br> of Incorporation) | **001-38114** <br> (Commission File Number) | **47-4113275**<br> (IRS Employer Identification No.) |

---

**1111 Kane Concourse, Suite 301**

**Bay Harbor Islands, Florida 33154**

(Address of Principal Executive Offices)

**<u>(781) 652-4500</u>**

(Registrant's telephone number, including area code)

**2 Gansevoort Street, 9th Floor**

**New York, New York 10014**

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

---

| |
|:---|
| Written communications pursuant to Rule 425 under the Securities Act. |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act. |
| Pre-commencement communications pursuant to Rule 14d-2b under the Exchange Act. |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act. |

---

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

---

| | | |
|:---|:---|:---|
| &nbsp;&nbsp;**Title of Class** | &nbsp;&nbsp;**Trading Symbol(s)** | &nbsp;&nbsp;**Exchange Name** |
| &nbsp;&nbsp;Common Stock | &nbsp;&nbsp;ATXI | &nbsp;&nbsp;Nasdaq Capital Market |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; ◻

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ◻

---

| | |
|:---|:---|
| **Item 4.01** | **Changes in Registrant's Certifying Accountant** |

---

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a)** **Dismissal of Independent Registered Public Accounting Firm** 

On January 21, 2023, the Audit Committee (the "Audit Committee") of the Board of Directors of Avenue Therapeutics, Inc. (the "Company") dismissed BDO USA, LLP ("BDO") as the Company's independent registered public accounting firm, effective immediately.

BDO's report on the Company's financial statements as of and for the fiscal years ended December 31, 2021 and 2020 did not contain an adverse opinion or disclaimer of opinion, nor was it qualified or modified as to uncertainty, audit scope, or accounting principles, except that the report contained an explanatory paragraph regarding the Company's ability to continue as a going concern. During the fiscal years ended December 31, 2021 and 2020, and the subsequent interim periods through January 21, 2023, there were: (i) no disagreements within the meaning of Item 304(a)(1)(iv) of Regulation S-K and the related instructions between the Company and BDO on any matters of accounting principles or practices, financial statement disclosure, or auditing scope or procedure which, if not resolved to BDO's satisfaction, would have caused BDO to make reference thereto in their reports; and (ii) no "reportable events" within the meaning of Item 304(a)(1)(v) of Regulation S-K.

The Company has requested that BDO furnish a letter addressed to the Securities and Exchange Commission stating whether or not it agrees with the statements in the immediately preceding paragraph. A copy of BDO's letter, dated January 25, 2023, is filed as Exhibit 16.1 to this Form 8-K.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b)** **Engagement of New Independent Registered Public Accounting Firm** 

Effective as of January 23, 2023, the Audit Committee engaged KPMG LLP ("KPMG") as the Company's independent registered public accounting firm for the fiscal year ended December 31, 2022. During the fiscal years ended December 31, 2021 and 2020 and the subsequent interim periods through January 23, 2023, neither the Company nor anyone on its behalf has consulted with KPMG regarding: (i) the application of accounting principles to a specific transaction, either completed or proposed, or the type of audit opinion that might be rendered on the Company's financial statements, and neither a written report nor oral advice was provided to the Company that KPMG concluded was an important factor considered by the Company in reaching a decision as to any accounting, auditing, or financial reporting issue; (ii) any matter that was the subject of a disagreement within the meaning of Item 304(a)(1)(iv) of Regulation S-K and the related instructions; or (iii) any reportable event within the meaning of Item 304(a)(1)(v) of Regulation S-K.

---

| | |
|:---|:---|
| **Item 9.01** | **Financial Statements and Exhibits.** |

---

*(d) Exhibits*

The following exhibits are furnished herewith:

---

| | |
|:---|:---|
| **Exhibit<br> Number** | **Description** |
| [16.1](tm234276d1_ex16-1.htm) | [Letter from BDO USA, LLP](tm234276d1_ex16-1.htm) |
| 104 | Cover Page Interactive Data File (embedded within Inline XBRL document) |

---

**SIGNATURES**

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

---

| | | |
|:---|:---|:---|
|  | **AVENUE THERAPEUTICS, INC.** | **AVENUE THERAPEUTICS, INC.** |
|  | (Registrant) | (Registrant) |
| Date: January 25, 2023  |  |  |
|  | By: | /s/ David Jin |
|  |  | David Jin |
|  |  | Interim Principal Financial Officer and Chief Operating Officer |

---

## Exhibit 16.1

**Exhibit 16.1**

---

| | | |
|:---|:---|:---|
| ![](tm234276d1_ex16-1img001.jpg) | Tel: 212-371-4446<br> Fax: 212-371-9374<br> **www.bdo.com** | 622 Third Ave, Suite 3100<br> 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 the statements made in response to that Item insofar as they relate to our Firm.

Very truly yours,

BDO USA, LLP, a Delaware limited liability partnership, is the U.S. member of BDO International Limited, a UK company limited by guarantee, and forms part of the international BDO network of independent member firms.

BDO is the brand name for the BDO network and for each of the BDO Member Firms.