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 ...

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, 2022 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 (I.R.S. Employer incorporation ...

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) ...

Financial Performance - The company reported a net loss of $14.7 million for the year ended December 31, 2020, with an accumulated deficit of $60.4 million[270]. - The company has not generated any revenue from product sales to date and may not do so in the near future[303]. - The company has incurred an accumulated deficit of $60.4 million through December 31, 2020, and expects to incur substantial additional losses in the future[303]. - Net cash used in operating activities for the year ended December 31, 2020 was $13.5 million, a decrease from $15.2 million in 2019, primarily due to reduced research and development expenses[320]. - Net cash provided by financing activities for the year ended December 31, 2020 was $32.7 million, significantly higher than $17.3 million in 2019, driven by multiple public offerings and warrant exercises[321]. Cash and Capital - As of December 31, 2020, the company had cash and cash equivalents of $35.9 million and positive working capital of $34.0 million[270]. - The company entered into a share and unit purchase agreement with Lincoln Park Capital Fund, allowing the sale of up to $11.0 million in shares of common stock[304]. - The company has sold an aggregate of 27,868 shares of common stock under the Purchase Agreement, resulting in gross proceeds of approximately $4.4 million[305]. - The December 2019 public offering generated total gross proceeds of $13.8 million, with net proceeds of $12.3 million after deducting $1.5 million in underwriting discounts and commissions[312]. - In April 2020, the company completed a private placement raising approximately $1.9 million from the sale of 280,782 units, each consisting of one share of common stock and a warrant[313]. - The July 2020 registered direct offering raised approximately $6.0 million, with net proceeds of approximately $5.3 million after deducting placement agent fees[315]. - The August 2020 public offering raised total gross proceeds of approximately $7.5 million, resulting in net proceeds of approximately $6.8 million after expenses[317]. - The December 2020 public offering raised total gross proceeds of approximately $17.3 million, with net proceeds of approximately $15.8 million after deducting underwriting discounts and commissions[319]. Research and Development - Research and development expenses for 2020 were $6.9 million, a decrease of 29% from $9.7 million in 2019, primarily due to the completion of the ORCA-1 trial[299]. - Research and development expenses are expected to increase as the company continues ongoing nonclinical studies and initiates new clinical trials[296]. - The company has completed two chronic toxicology studies and is in progress with one carcinogenicity study as part of its drug application process[284]. Clinical Trials and E-Cigarette Studies - In the Phase 2b ORCA-1 trial, cytisinicline treatment arms showed a 74-80% median reduction in the number of cigarettes smoked compared to a 62% reduction in placebo arms[273]. - The ORCA-1 trial demonstrated a 54% abstinence rate at week 4 for the 3 mg TID cytisinicline arm compared to 16% for placebo (p<0.0001)[275]. - The RAUORA trial indicated that cytisinicline achieved a continuous abstinence rate of 12.1% at 6 months compared to 7.9% for varenicline, with a Relative Risk of 1.55[280]. - Cytisinicline was well-tolerated with no serious adverse events reported, and significantly fewer nausea adverse events compared to varenicline (p<0.001)[279]. - The company is considering clinical studies for e-cigarette users, with nearly 14 million adult users in the U.S. reported in 2018[282]. - Approximately 73% of surveyed e-cigarette users indicated they intend to quit vaping within the next 3 to 12 months, with over half willing to try a new prescription product[282]. - The company is developing a Phase 2 clinical trial protocol, ORCA-V1, to evaluate cytisinicline for e-cigarette users and is seeking non-dilutive funding for this trial[283]. Impact of COVID-19 - The impact of the COVID-19 pandemic has caused delays in clinical trial enrollment, with expectations for completion now pushed to mid-2021[285]. Accounting and Financial Reporting - The adoption of the new lease accounting standard (Topic 842) had a material impact on the consolidated balance sheets, specifically through the recognition of right-of-use (ROU) assets and lease liabilities for operating leases[335]. - The company elected the short-term lease recognition exemption for all qualifying leases, meaning ROU assets and lease liabilities will not be recognized for those leases[333]. - The adoption of Accounting Standards Update 2018-13 on fair value measurement did not have a significant impact on the company's financial position or results of operations[335]. - The consolidated balance sheets as of December 31, 2020, and 2019, reflect the changes due to the new lease accounting standard[337]. - The consolidated statements of loss and comprehensive loss for the years ended December 31, 2020, 2019, and 2018 were not impacted by the new lease accounting standard[335]. - The company implemented internal controls to prepare financial information in accordance with the new lease accounting standard[333]. - The new lease accounting standard requires lessees to recognize leases on-balance sheet for all leases with a term longer than 12 months[332]. - The company did not provide disclosures required under the new standard for periods before January 1, 2019[333]. - The accounting for finance leases remained substantially unchanged after the adoption of the new standard[335]. - There were no applicable quantitative and qualitative disclosures about market risk provided in the report[335].