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, 2024

ACHIEVE LIFE SCIENCES, INC.

(Exact name of Registrant as Specified in Its Charter)

Registrant’s Telephone Number, Including Area Code: (604) 210-2217

N/A

(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 (see General Instruction A.2. below):

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

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

Emerging growth company ☐

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 1.01 Entry Into a Material Definitive Agreement.

On September 27, 2024, Achieve Life Sciences, Inc. (the “Company”) entered into an Open Market Sale AgreementSM (the “Sale Agreement”) with Jefferies LLC (“Jefferies”) as part of routine financial management, under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, par value $0.001 per share (“Common Stock”), having an aggregate offering price of up to $50,000,000 (the “ATM Shares”), through Jefferies as sales agent pursuant to an at-the-market offering program (the “ATM Program”). The ATM Shares offered and sold under the ATM Program will be issued pursuant to the Company’s Registration Statement on Form S-3 filed with the U.S. Securities and Exchange Commission on June 28, 2024 (the “Registration Statement”), the prospectus supplement relating to the ATM Program filed on September 27, 2024, and any applicable additional prospectus supplement related to the ATM Program that forms a part of the Registration Statement.

Pursuant to the Sale Agreement, Jefferies may sell the ATM Shares by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended. Jefferies will use its commercially reasonable efforts to place the ATM Shares from time to time, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Sale Agreement provides that Jefferies will be entitled to compensation of up to 3.0% of the gross proceeds of the ATM Shares sold through Jefferies. The Company will also reimburse Jefferies for certain expenses incurred in connection with the Sale Agreement, and also has provided Jefferies with customary indemnification rights. The Company has no obligation to sell any of the ATM Shares under the Sale Agreement and may at any time suspend solicitation and offers under the Sale Agreement. The ATM Program will terminate upon the earlier of (i) the sale of the Maximum Program Amount (as defined in the Sale Agreement) or (ii) the termination of the Sale Agreement according to its terms by either the Company or Jefferies. The Sale Agreement contains representations for the benefit of the Company and Jefferies and other terms customary for similar agreements.

The Company currently intends to use the net proceeds from the ATM Program to fund clinical development of cytisinicline, to fund other cytisinicline related research and clinical development activities and for working capital and general corporate purposes.

The foregoing description of the Sale Agreement is not complete and is qualified in its entirety by reference to the full text of the Sale Agreement, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

The following exhibits are filed herewith:

SIGNATURES

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