UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ______________ TO ____________. Commission file number 033-80623 Achieve Life Sciences, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 95-4343413 (S ...

Achieve Life Sciences, Inc. (NASDAQ:ACHV) Q4 2022 Earnings Conference Call March 16, 2023 4:30 PM ET Company Participants Nicole Jones - Investor Relations John Bencich - Chief Executive Officer Cindy Jacobs - President and Chief Medical Officer Jerry Wan - Principal Accounting Officer Jaime Xinos - Executive Vice President, Commercial Conference Call Participants Thomas Flaten - Lake Street Capital Michael Higgins - Ladenburg Thalmann Francois Brisebois - Oppenheimer Operator Hello and welcome to the Achie ...

Financial Performance - The net loss for the year ended December 31, 2022, was $42.4 million, with an accumulated deficit of $135.9 million as of the same date [330]. - Cash and cash equivalents stood at $24.8 million, with a positive working capital balance of $5.7 million as of December 31, 2022 [330]. - Research and development expenses for 2022 were $30.1 million, an increase from $24.0 million in 2021, primarily due to the initiation of Phase 3 trials [344]. - General and administrative expenses rose to $10.7 million in 2022 from $9.1 million in 2021, driven by higher employee expenses and legal fees [345]. - Other expenses increased to $1.6 million in 2022 from $0.1 million in 2021, mainly due to interest expense on convertible debt [347]. - The company has not generated any revenue from product sales to date and may not do so in the near future [348]. - The company expects to incur significant expenses and increasing operating losses for several years as it continues clinical development of cytisinicline [331]. Going Concern and Financing - Substantial doubt exists regarding the company's ability to continue as a going concern without additional financing [331]. - The company will need to raise substantial additional capital to fund ongoing operations and clinical development activities [350]. - The financial results have been prepared assuming the company will continue to operate as a going concern, which may require adjustments if this assumption is not met [334]. Capital Raising Activities - The company completed a public offering on May 27, 2021, selling 3,285,714 shares at $7.00 per share, raising approximately $23.0 million in gross proceeds and net proceeds of about $21.3 million after expenses [352]. - The company entered into a $25.0 million contingent convertible debt agreement on December 22, 2021, with $15.0 million funded as convertible debt at closing [354]. - The convertible debt matures on December 22, 2023, with a conversion price of $9.34 per share, and mandatory conversion occurs if the stock price exceeds $24.00 for thirty consecutive trading days [356]. - For the year ended December 31, 2022, net cash used in operating activities was $37.5 million, an increase from $29.4 million in 2021, primarily due to the initiation of clinical trials [364]. - Net cash provided by financing activities for the year ended December 31, 2022, was $19.3 million, down from $36.6 million in 2021, reflecting proceeds from the November 2022 private placement and other stock sales [365]. - The company sold 200,000 shares under an At-the-Market Offering Sales Agreement in 2022, generating gross proceeds of $1.5 million, with approximately $23.5 million remaining available for sale under the agreement [360]. - In November 2022, the company sold approximately 4,093,141 units in a private placement at $4.625 per unit, resulting in net proceeds of approximately $17.9 million after expenses [363]. - The company must maintain a minimum liquidity ratio of at least 1.25 to 1.00 under the Loan Agreement, with a minimum market capitalization of at least $250 million if certain conditions are met [358]. Accounting and Reporting - The company has no investing activities reported for the years 2022 or 2021 [365]. - The company accounts for government grants by recognizing benefits as qualifying expenditures are incurred, which reduces related research and development expenses [371]. - The adoption of ASU 2020-06 allowed the company to account for convertible instruments and their conversion features as a single unit of debt, eliminating the need for separate recording [381]. - The company recognized ROU assets and lease liabilities of $0.5 million each for operating leases due to the new accounting standard, impacting the consolidated balance sheets [379]. - The adoption of the Accounting Standards Update 2018-13 did not significantly impact the company's financial position or results of operations [379]. - The new standard ASU 2020-06 is effective for fiscal years beginning after December 15, 2021, with early adoption permitted [380]. - The company elected to early adopt ASU 2020-06 effective in 2021, with no impact on prior period financial statements [380].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 Title of each class Trading Symbol Name of exchange on which registered FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED September 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ______________ TO ____________. Commission file number 033-80623 Achieve Life Sciences, Inc. ( ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 Title of each class Trading Symbol Name of exchange on which registered FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED June 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ______________ TO ____________. Commission file number 033-80623 Achieve Life Sciences, Inc. (Exact ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 Title of each class Trading Symbol Name of exchange on which registered FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED March 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ______________ TO ____________. Commission file number 033-80623 Achieve Life Sciences, Inc. (Exac ...

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, 2021 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 95-4343413 (State or other jurisdiction of incorporation or organization) ...