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. ( ...

Financial Performance - The company reported a net loss of $9.5 million for the six months ended June 30, 2019, compared to a net loss of $5.8 million for the same period in 2018, with an accumulated deficit of $38.8 million as of June 30, 2019[124]. - The company has not generated any revenue from product sales to date and has incurred operating losses each year since inception[124]. - The company expects to incur significant expenses and increasing operating losses for at least the next several years as it continues clinical development and seeks regulatory approval for cytisinicline[125]. - The company has incurred an accumulated deficit of $38.8 million through June 30, 2019, and expects to incur substantial additional losses in the future[142]. - The company has not generated any revenue from product sales to date and may not do so in the near future[142]. Clinical Trials and Development - The Phase 2b ORCA-1 trial demonstrated a 74-80% median reduction in the number of cigarettes smoked among subjects on cytisinicline, compared to a 62% reduction in the placebo arms[120]. - The 3.0 mg TID cytisinicline treatment arm showed a 54% continuous abstinence rate starting at week 4, compared to 16% for placebo (p < 0.0001)[121]. - The FDA agreed to the company's Initial Pediatric Study Plan, providing a full waiver for evaluating cytisinicline in a pediatric population due to low numbers of children smoking under the age of 12[115]. - The company initiated a clinical study in June 2017 to evaluate the effect of food on the bioavailability of cytisinicline, which demonstrated similar bioavailability in fed and fasted subjects[113]. - The company has met with the FDA to discuss the steps required for the approval of cytisinicline, including plans for chronic toxicology and additional human studies[113]. Financial Position and Capital Needs - The company has a cash and cash equivalents balance of $10.4 million and a positive working capital balance of $7.8 million as of June 30, 2019[124]. - The company anticipates needing to raise substantial additional capital to fund its operations and clinical development activities[126]. - The company 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[147]. - During the three and six months ended June 30, 2019, the company sold 124,000 shares of common stock for gross proceeds of approximately $0.4 million[150]. - As of August 8, 2019, shares of common stock with an aggregate value of approximately $6.9 million remained available for sale under the offering program[150]. Expenses and Cash Flow - Research and development expenses for the three months ended June 30, 2019, increased to $2.0 million from $1.0 million in 2018, representing a 94% increase[139]. - For the six months ended June 30, 2019, research and development expenses rose to $6.1 million from $2.2 million in 2018, marking a 177% increase[139]. - General and administrative expenses for the three months ended June 30, 2019, decreased to $1.6 million from $1.8 million in 2018, a decline of 7%[141]. - For the six months ended June 30, 2019, general and administrative expenses decreased to $3.5 million from $3.6 million in 2018, a reduction of 1%[141]. - For the six months ended June 30, 2019, net cash used in operating activities was $8.7 million, an increase from $4.1 million in the same period of 2018, primarily due to higher R&D expenses[162]. - Net cash provided by financing activities for the same period in 2019 was $4.6 million, down from $13.9 million in 2018, reflecting proceeds from warrant exercises[163]. - Net cash provided by investing activities for the six months ended June 30, 2019, was $5.0 million, compared to net cash used of $26,000 in 2018[164]. Shareholder Activities - The company completed a public offering on June 19, 2018, selling 710,500 Class A Units at $4.00 each and 9,158 Class B Units at $1,000 each, raising approximately $12.2 million in net proceeds[151][152]. - From June 19, 2018, to August 8, 2019, all 9,158 shares of Series A Convertible Preferred Stock were converted into 2,289,500 shares of common stock, with no shares remaining outstanding[152]. - During the same period, 1,168,000 warrants were exercised at $4.00 each, generating approximately $4.7 million, leaving 2,282,000 warrants outstanding[153]. - The October 3, 2018 registered direct offering raised total gross proceeds of $5.6 million, with net proceeds of $5.0 million after expenses[154]. - The company entered into an At The Market Offering Agreement on June 7, 2019, allowing for the sale of up to $6.0 million in common stock[155][158]. Asset Management - As of June 30, 2019, the company reported a decrease in assets compared to December 31, 2018, primarily due to reduced cash and short-term investments used for operations[168]. - The fair value of new warrants issued in connection with a Warrant Exercise Agreement was recognized as $3.9 million in accumulated deficit as of June 30, 2019[161].

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, 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. (Exact Name of Registrant as Specified in Its Charter) Delaware 95-4343413 (S ...

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, 2018 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) ...