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 25, 2021

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:

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 May 25, 2021, Achieve Life Sciences, Inc. (“Achieve”) entered into an underwriting agreement (the “Underwriting Agreement”) with Oppenheimer & Co., Inc., as representative of the underwriters named therein (the “Underwriters”), pursuant to which Achieve agreed to issue and sell an aggregate of 2,857,143 shares of its common stock (the “Shares”) to the Underwriters (the “Offering”). The Shares will be sold at the public offering price of $7.00 per share, less underwriting discounts and commissions. Pursuant to the Underwriting Agreement, Achieve has also granted the Underwriters a 30-day option to purchase up to an additional 428,571 shares of its common stock at the same public offering price, less underwriting discounts and commissions.

The Underwriting Agreement contains customary representations, warranties and covenants, conditions to closing, termination provisions and indemnification obligations, including for liabilities under the Securities Act of 1933, as amended.

The Offering is being made pursuant to the shelf registration statement on Form S-3 (File No. 333-229019) that was filed by Achieve with the Securities and Exchange Commission (“SEC”) on December 26, 2018, and declared effective by the SEC on February 11, 2019, and a related prospectus supplement.

Achieve estimates that net proceeds from the Offering will be approximately $18.5 million, after deducting underwriting discounts and commissions and estimated Offering expenses, and assuming no exercise of the Underwriters’ option to purchase additional shares. Achieve intends to use the net proceeds from the Offering, together with its existing cash, cash equivalents and marketable securities, to fund ongoing cytisinicline development, other clinical research and development and for working capital and general corporate purposes. Achieve expects the Offering to close on May 27, 2021, subject to the satisfaction of customary closing conditions.

The Underwriting Agreement is filed as Exhibit 1.1 to this report and the foregoing description of the terms of the Underwriting Agreement is qualified in its entirety by reference to such exhibit. A copy of the opinion of Fenwick & West LLP, relating to the validity of the Shares, is filed with this Current Report on Form 8-K as Exhibit 5.1.

Item 8.01 Other Events

On May 24, 2021, the Company issued a press release announcing that it had commenced the Offering. On May 25, 2021, the Company issued a press release announcing that it had priced the Offering. Copies of these press releases are attached as Exhibits 99.1 and 99.2 hereto, respectively, and the information contained therein is incorporated herein by reference.

Item 9.01.  Financial Statements and Exhibits.

(d) Exhibits

Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein that do not describe historical facts, including, but not limited to, statements regarding the expected net proceeds of the Offering and the anticipated use of proceeds of the Offering, are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include, among others, the risks identified in Achieve’s filings with the SEC, including its Quarterly Report on Form 10-Q for the three months ended March 31, 2021, filed with the SEC on May 13, 2021, the prospectus supplement related to the Offering, and subsequent filings with the SEC. Any of these risks and uncertainties could materially and adversely affect Achieve’s results of operations, which would, in turn, have a significant and adverse impact on Achieve’s stock price. Achieve cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Achieve undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made or to reflect the occurrence of unanticipated events.

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.