Page 1

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 , 2020 Or TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 ( d ) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 033-80623 Achieve Life Sciences , Inc. ( Exact name of the registrant as specified in its charter ) Delaware ( State or other jurisdiction of incorporation or organization ) 1040 West Georgia Street , Suite 1030 , Vancouver , B.C. V6E 4H1 ( Address of principal executive offices , including zip code ) ( 604 ) 210-2217 ( Registrant's telephone number , including area code ) Securities registered pursuant to Section 12 ( b ) of the Act : 95-4343413 ( I.R.S. Employer Identification No. ) Title of Each Class Common Stock , par value $ 0.001 per share Trading Symbol ( s ) . ACHV Securities registered pursuant to Section 12 ( g ) of the Act : None Yes Indicate by check mark if the registrant is a well - known seasoned issuer , as defined in Rule 405 of the Securities Act . Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15 ( d ) of the Act . Yes No Indicate by check mark whether the registrant : ( 1 ) has filed all reports required to be filed by Section 13 or 15 ( d ) of the Securities Exchange Act of 1934 during the preceding 12 months ( or for such shorter period that the registrant was required to file such reports ) , and ( 2 ) has been subject to such filing requirements for the past 90 days . Yes No Name of Exchange on Which Registered The NASDAQ Capital Market No X Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S T ( § 232.405 of this chapter ) during the preceding 12 months ( or for such shorter period that the registrant was required to submit such files ) . Yes No 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 . Large accelerated filer Non - accelerated filer Accelerated filer Smaller reporting company 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 . ■ Portions of the Registrant's Definitive Proxy Statement for its 2021 Annual Meeting of Stockholders ( " Proxy Statement ” ) , to be filed within 120 days of the Registrant's fiscal year ended December 31 , 2020 , is incorporated by reference into Part III of this Annual Report on Form 10 - K . ■ Indicate by check mark whether the registrant has filed a report on and attestation to its management's assessment of the effectiveness of its internal control over financial reporting under Section 404 ( b ) of the Sarbanes Oxley Act ( 15 U.S.C. 7262 ( b ) ) by the registered public accounting firm that prepared or issued its audit report . Indicate by check mark whether the registrant is a shell company ( as defined in Rule 12b - 2 of the Exchange Act . ) . Yes No As of June 30 , 2020 , the aggregate market value of the registrant's Common Stock held by non - affiliates of the registrant was $ 15,388,916 , computed with reference to the price at which the Common Stock was last sold on June 30 , 2020. As of March 11 , 2021 , 6,149,917 shares of the registrant's Common Stock were outstanding . DOCUMENTS INCORPORATED BY REFERENCE