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

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Registration No. 333-

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

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FORM S-8

REGISTRATION STATEMENT

Under

The Securities Act of 1933

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AEROVATE THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

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930 Winter Street, Suite M-500

Waltham, MA 02451

(617) 443-2400

(Address, including zip code and telephone number, including area code, of Registrant’s principal executive offices)

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Aerovate Therapeutics, Inc. 2021 Stock Option and Incentive Plan

Aerovate Therapeutics, Inc. 2021 Employee Stock Purchase Plan

(Full title of the plans)

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Timothy P. Noyes

Chief Executive Officer

Aerovate Therapeutics, Inc.

930 Winter Street, Suite M-500

Waltham, MA 02451

(617) 443-2400

(Name, address, including zip code, and telephone number, including area code, of agent for service)

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Copies to:

Edwin M. O’Connor, Esq.

Alicia M. Tschirhart, Esq.

Goodwin Procter LLP

100 Northern Avenue

Boston, Massachusetts 02210

(617) 570-1000

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Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

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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 7(a)(2)(B) of the Securities Act. ☒

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EXPLANATORY NOTE

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Pursuant to General Instruction E of Form S-8, Aerovate Therapeutics, Inc. (the “Registrant”) is filing this registration statement with the Commission to register (1) 988,918 additional shares of the Registrant’s common stock, $0.0001 par value per share (“Common Stock”) available for issuance under the Registrant’s 2021 Stock Option and Grant Plan (the “Plan”), pursuant to the evergreen provisions of the Plan, and (2) 247,229 additional shares of Common Stock available for issuance under the Registrant’s 2021 Employee Stock Purchase Plan (the “ESPP”), pursuant to the evergreen provisions of the ESPP. This Registration Statement incorporates by reference the contents of the Registrant’s Registration Statements on Form S-8 (SEC File No. 333-257579 and SEC File No. 333- 263990), filed with the Securities and Exchange Commission on June 30, 2021 (with respect to the Plan and ESPP) and March 30, 2022 (with respect to the Plan), respectively, pursuant to General Instruction E, except for “Item 8. Exhibits.”

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PART II

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INFORMATION REQUIRED IN THE REGISTRATION STATEMENT

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The exhibits to this Registration Statement are listed in the Exhibit Index attached hereto and incorporated by reference herein.

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EXHIBIT INDEX

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SIGNATURES

Pursuant to the requirements of the Securities Act of 1933, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-8 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Waltham, Commonwealth of Massachusetts, on this 29 day of March, 2023.

POWER OF ATTORNEY AND SIGNATURES

KNOW ALL BY THESE PRESENT, that each individual whose signature appears below hereby constitutes and appoints each of Timothy P. Noyes and George A. Eldridge as such person’s true and lawful attorney-in-fact and agent with full power of substitution and resubstitution, for such person in such person’s name, place and stead, in any and all capacities, to sign any and all amendments (including post-effective amendments) to this Registration Statement on Form S-8, and to file the same, with all exhibits thereto, and all documents in connection therewith, with the Securities and Exchange Commission granting unto each said attorney-in-fact and agent full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as such person might or could do in person, hereby ratifying and confirming all that any said attorney-in-fact and agent, or any substitute or substitutes of any of them, may lawfully do or cause to be done by virtue hereof.

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Pursuant to the requirements of the Securities Act of 1933, this Registration Statement has been signed by the following person in the capacities and on the date indicated.

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Exhibit 5.1

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March 29, 2023

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Aerovate Therapeutics, Inc.

930 Winter Street, Suite M-500

Waltham, MA 02451

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Re:Securities Being Registered under Registration Statement on Form S-8

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We have acted as counsel to you in connection with your filing of a Registration Statement on Form S-8 (the “Registration Statement”) pursuant to the Securities Act of 1933, as amended (the “Securities Act”), on or about the date hereof relating to an aggregate of 1,236,147 shares (the “Shares”) of Common Stock, $0.0001 par value per share (“Common Stock”), of  Aerovate Therapeutics, Inc., a Delaware corporation (the “Company”), that may be issued pursuant to the Company’s 2021 Stock Option and Incentive Plan and the Company’s 2021 Employee Stock Purchase Plan (collectively, the “Plans”).

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We have reviewed such documents and made such examination of law as we have deemed appropriate to give the opinions set forth below. We have relied, without independent verification, on certificates of public officials and, as to matters of fact material to the opinion set forth below, on certificates of officers of the Company.

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The opinion set forth below is limited to the Delaware General Corporation Law.

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For purposes of the opinion set forth below, we have assumed that no event occurs that causes the number of authorized shares of Common Stock available for issuance by the Company to be less than the number of then unissued Shares.

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Based on the foregoing, we are of the opinion that the Shares have been duly authorized and, upon issuance and delivery against payment therefor in accordance with the terms of the Plans, will be validly issued, fully paid and nonassessable.

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This opinion letter and the opinion it contains shall be interpreted in accordance with the Core Opinion Principles as published in 74 Business Lawyer 815 (Summer 2019).

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We hereby consent to the inclusion of this opinion as Exhibit 5.1 to the Registration Statement.  In giving our consent, we do not admit that we are in the category of persons whose consent is required under Section 7 of the Securities Act or the rules and regulations thereunder.

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Very truly yours,

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/s/ Goodwin Procter LLP

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GOODWIN PROCTER LLP

Exhibit 23.1

Consent of Independent Registered Public Accounting Firm

We consent to the use of our report dated March 29, 2023, with respect to the consolidated financial statements of Aerovate Therapeutics, Inc., incorporated herein by reference.

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Exhibit 107

Calculation of Filing Fee Tables

Form S-8

(Form Type)

Aerovate Therapeutics, Inc.

(Exact Name of Registrant as Specified in its Charter)

Table 1: Newly Registered Securities

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