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].

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, 2020 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, 2020 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 ...

Smoking Cessation Treatment - Cytisinicline is an established smoking cessation treatment with over 20 million users globally, including over 2,000 patients in Phase 3 clinical trials[99] - In the Phase 2b ORCA-1 trial, subjects on cytisinicline experienced a 74-80% median reduction in the number of cigarettes smoked compared to a 62% reduction in placebo arms[110] - The 3 mg TID dosing schedule for cytisinicline demonstrated a 54% abstinence rate at week 4, compared to 16% for placebo (p<0.0001)[111] - The FDA agreed on the 3 mg TID dosing schedule for Phase 3 development following the ORCA-1 trial results[114] - The planned Phase 3 trial will assess smoking abstinence over 6-week and 12-week treatment periods, with secondary endpoints extending to 24 weeks[115] - Cytisinicline has shown no clinically significant drug interactions, allowing for co-administration with other medications[103] - The Phase 1 clinical study indicated that cytisinicline was well tolerated, with no severe adverse events reported[112] - The company aims to address the global smoking and nicotine addiction epidemic, which causes over 8 million deaths annually[98] Financial Performance - The company reported a net loss of $3.3 million for the three months ended March 31, 2020, with an accumulated deficit of $49.0 million[118] - Cash and cash equivalents as of March 31, 2020, were $12.2 million, with a positive working capital balance of $11.4 million[118] - Research and development expenses decreased to $1.5 million for the three months ended March 31, 2020, down from $4.1 million in the same period of 2019[132] - General and administrative expenses for the three months ended March 31, 2020, were $1.8 million, compared to $1.9 million for the same period in 2019[133] - The company has no products approved for commercial sale and has not generated any revenue from product sales to date[118] - The company expects to incur significant expenses and increasing operating losses for at least the next several years as it continues clinical development of cytisinicline[119] - The company is uncertain about its ability to continue as a going concern without obtaining additional financing[119] - The company anticipates that its operating losses will fluctuate significantly from quarter to quarter and year to year due to the timing of clinical development programs[119] Financing Activities - The company has entered into a Purchase Agreement with Lincoln Park Capital Fund, LLC, allowing it to sell up to $11.0 million in shares of common stock[139] - The company has engaged FreeMind Group to assist in securing non-dilutive funding for evaluating cytisinicline in reducing or ceasing vaping[117] - The company extended the term of the Purchase Agreement with LPC from 30 months to 54 months and increased the number of shares for Regular Purchases from 80,000 to 150,000[142] - From September 14, 2017, to May 14, 2020, the company sold a total of 557,378 shares, generating gross proceeds of approximately $4.4 million with offering expenses of $0.5 million[143] - The public offering completed on December 17, 2019, raised total gross proceeds of $13.8 million, with net proceeds of $12.3 million after deducting $1.5 million in underwriting discounts and commissions[156] - The company entered into a private placement on April 27-28, 2020, issuing approximately 5,615,653 units for aggregate gross proceeds of approximately $1.9 million[158] - The company did not offer any shares for sale under the At The Market Offering Agreement from June 7, 2019, to May 14, 2020, with approximately $6.0 million remaining available for sale[148] - The Warrant Exercise Agreement with Armistice resulted in aggregate exercise proceeds of approximately $4.2 million from the exercise of warrants for 1,107,813 shares[149] Asset and Liability Management - As of March 31, 2020, total assets decreased to $16.6 million from $21.1 million as of December 31, 2019, primarily due to cash and short-term investments used for operations[166] - Total liabilities decreased to $1.7 million as of March 31, 2020, from $3.0 million as of December 31, 2019, mainly due to lower employee bonus accruals and trade payables[166] - For the three months ended March 31, 2020, net cash used in operating activities was $4.5 million, a decrease from $4.9 million for the same period in 2019, attributed to reduced research and development expenses[160] - The company had no off-balance sheet financing arrangements as of March 31, 2020[163]

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, 2019 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) ...

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, 2019 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. ( ...