Form 8-K

8-K — ACHIEVE LIFE SCIENCES, INC.

Accession: 0001193125-26-218175

Filed: 2026-05-12

Period: 2026-05-07

CIK: 0000949858

SIC: 2835 (IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES)

Item: Results of Operations and Financial Condition

Item: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers

Item: Financial Statements and Exhibits

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 7, 2026

ACHIEVE LIFE SCIENCES, INC.

(Exact name of Registrant as Specified in Its Charter)

Delaware

033-80623

95-4343413

(State or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

22722 29th Drive SE, Suite 100

Bothell, WA

98021

1040 West Georgia, Suite 1030

Vancouver, BC, Canada

V6E 4H1

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (604) 210-2217

N/A

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

Symbol

Name of exchange

on which registered

Common Stock, par value $0.001 per share

ACHV

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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. ☐

Item 2.02 Results of Operations and Financial Condition.

On May 12, 2026, Achieve Life Sciences, Inc. (the “Company”) issued a press release announcing its financial results for the first quarter ended March 31, 2026. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

Appointment of Board Member

In connection with the previously reported private placement (the “Private Placement”) of the Company’s securities, and pursuant to the designation right granted to Frazier Life Sciences, on May 11, 2026, the Company’s board of directors (the “Board”) appointed Christopher Martin to serve as a director of the Company, effective immediately.

Mr. Martin’s compensation will be as provided under the Company’s non-employee director compensation program (the “Non-Employee Director Compensation Program”). In connection with his appointment as a non-employee director of the Board and consistent with the Non-Employee Director Compensation Program, Mr. Martin will be entitled to receive a pro-rated $40,000 annual retainer for service as a non-employee director for the Company’s fiscal year ending December 31, 2026. In addition, consistent with the Non-Employee Director Compensation Program, Mr. Martin will receive a stock option to purchase 47,250 shares of the Company’s common stock, par value $0.001 per share (“Common Stock”), which will vest monthly over three years, subject to continued service as a director on the Board or employee or consultant of the Company.

The Company has entered into a standard form of indemnification agreement with Mr. Martin, in substantially the form that is filed as Exhibit 10.11 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2025.

Pursuant to the terms of the securities purchase agreement entered into by the Company and the investors in connection with the Private Placement, the Company has also agreed to nominate Mr. Martin for re-election to the Board at the 2026 annual meeting of stockholders and the 2027 annual meeting of stockholders, until such time as Frazier Life Sciences beneficially owns less than 5% of the outstanding Common Stock of the Company.

Except as described above, there are no arrangements or understandings between Mr. Martin and any other persons pursuant to which he was selected as a director. There are no family relationships between Mr. Martin and any director or executive officer of the Company, nor does Mr. Martin have a direct or indirect material interest in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K promulgated under the Securities Exchange Act of 1934, as amended.

Departure of Board Member

On May 7, 2026, Thomas King informed the Board that he has elected to resign from his position as a member and as chairman of the Board, effective as of June 8, 2026. Mr. King’s resignation from the Board was not the result of any disagreement with the Company on any matter relating to the Company’s operations, policies or practices. Following Mr. King’s resignation, Lucian Iancovici, MD, was appointed as Chair of the Board, effective as of June 8, 2026.

Departure of Chief Commercial Officer

Jaime Xinos, the Company’s Chief Commercial Officer, will depart the Company, effective as of May 31, 2026. In connection with her separation, Ms. Xinos will be entitled to receive the severance described in her Amended and Restated Employment Agreement dated October 16, 2024, filed as Ex. 10.14 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2025.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.

Description

99.1

Press release of Achieve Life Sciences, Inc. dated May 12, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

The information in Item 2.02 of this Form 8-K and Exhibit 99.1 attached hereto is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

ACHIEVE LIFE SCIENCES, INC.

Date: May 12, 2026

/s/ MARK OKI

Mark Oki

Chief Financial Officer (Principal Financial Officer)

EX-99.1

Filename: d854692dex991.htm · Sequence: 2

EX-99.1

Exhibit 99.1

Achieve Life Sciences Reports First Quarter 2026 Financial Results and Provides Business Updates

Closed Private Placement of Up to $354 Million, Including $180 Million Upfront and $174 Million in Milestone-Driven Warrants

Appoints New CEO and Expands Board of Directors

Advances U.S.-based Manufacturing Transition & Partnership

Conference Call Scheduled for 8:30 AM EDT Today, May 12, 2026

SEATTLE and VANCOUVER, British Columbia, May 12, 2026 (GLOBE NEWSWIRE) — Achieve Life Sciences, Inc. (Achieve or the Company)

(Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment for nicotine dependence, today announced financial results for the first quarter of 2026 and

provided corporate highlights, including the recent financing and leadership updates.

“Achieve is a mission-driven company. Nicotine dependence is

one of the largest preventable public health hazards we know, and smoking remains the leading cause of preventable death,” said Andrew D. Goldberg, MD, Chief Executive Officer of Achieve. “If approved, cytisinicline would be the first

new FDA-approved smoking cessation therapy in more than two decades, and could also be the first ever for vaping cessation. My job is to ensure we have the team, the capital, and the strategy to bring

cytisinicline to patients.”

Dr. Goldberg continued, “This quarter reflects deliberate work to build the company for the launch ahead. We

closed a transformational financing, strengthened our Board, and advanced our transition to U.S. manufacturing. The Company will provide additional commercial leadership updates today. We are building the foundation to execute fully, and that is

what we intend to do.”

Key Highlights:

Capital Raise

•

Closed a private placement of up to $354 million, including $180 million upfront and up to

$174 million from milestone-based warrants that may be exercised at any time prior to, and up to 20 trading days following, FDA approval of cytisinicline. Backed by leading healthcare investors, the proceeds will be used to fund the ORCA-V2 Phase 3 trial for cytisinicline for e-cigarette cessation, the commercialization of cytisinicline, and for working capital and general corporate purposes.

Leadership Transition

•

Appointed Andrew D. Goldberg, MD as Chief Executive Officer and a Board member. New directors Christopher

Martin, Lucian Iancovici, MD, and Aaron E. Royston, MD, add expertise in commercialization, company building, and corporate governance. Tom King has decided to step down from the Board, with his last day of service on June 8, 2026.

Dr. Iancovici will assume the role of Chairman of the Board. Jaime Xinos will also transition from the role of Chief Commercial Officer, effective May 31, 2026, after nearly 9 years of dedicated service to Achieve. The Company expresses

its gratitude for her contributions to advancing cytisinicline through clinical development. In connection with this transition, the Company has reorganized its commercial leadership for the launch ahead, which will be detailed in a separate

announcement today.

Manufacturing Partnership with Adare Pharma Solutions

•

Announced Achieve partnered with U.S.-based Adare Pharma Solutions (Adare) to support its commercial

manufacturing. Achieve also completed an analytical method technology transfer to the site, successfully manufactured its first cytisinicline engineering batch, and fully qualified all testing procedures at the facility.

Regulatory Milestone and Manufacturing Readiness

•

Announced Achieve’s prior third-party manufacturer facility received an Official Action Indicated

classification by the U.S. Food and Drug Administration (FDA) related to general current Good Manufacturing Practice matters, with observations not specific to cytisinicline. As a result, Achieve expects to receive a Complete Response Letter from

the FDA on or before June 20, 2026, the Prescription Drug User Fee Act goal date. The Company intends to resubmit its New Drug Application in the fourth quarter of 2026, naming Adare as its new and primary manufacturing partner for commercial

supply. The Company’s stated expectation is for U.S. commercial launch in the first half of 2027.

Scientific Data Advancement

•

Published in Nicotine & Tobacco Research, which provided evidence that cytisinicline

selectively interacts with the α4ß2 nicotinic receptor while exhibiting minimal interaction with the 5-HT3 receptor, a key mechanism potentially underlying its gastrointestinal tolerability. These

findings help explain the low nausea rates observed in clinical trials and support cytisinicline as a promising alternative for smoking cessation, particularly in individuals sensitive to medication-related side effects.

•

Presented data at the Society for Research on Nicotine and Tobacco (SRNT) 2026 Annual Meeting from a

pooled analysis of over 1,600 participants in the Phase 3 ORCA-2 and ORCA-3 trials. Cytisinicline for 12 weeks significantly increased continuous abstinence versus

placebo in patients with prior varenicline and bupropion use (32.4% vs. 6.0%; OR 7.5), supporting its potential for patients who have failed existing therapies.

•

Presented late-breaking ORCA-OL post-trial survey data at SRNT, which

followed participants for up to 52 weeks of cytisinicline treatment. Among survey respondents, 98% reported they would recommend cytisinicline to others, 88% reported fewer cravings compared to prior quit attempts, and 76% reported physical health

improvement compared to before the study.

Financial Results

As of March 31, 2026, the Company’s cash, cash equivalents, and marketable securities were $29.3 million, not including estimated net proceeds

of approximately $168.6 million from the private placement, after deducting estimated agent fees and other expenses. Total operating expenses and net loss for the three months ended March 31, 2026 were $10.5 million and

$10.2 million, respectively

Conference Call Details

Achieve will host a conference call at 8:30 AM EDT today, Tuesday, May 12, 2026. To access the webcast, please use the following link: 1Q26 Earnings

Webcast. Alternatively, you may join the live conference call by dialing 877-269-7756 (U.S. & Canada) or 201-689-7817 (International) and referencing conference ID 13759781. A webcast replay will be available approximately three hours after the call and archived on the website for 90 days.

About Achieve Life Sciences, Inc.

Achieve Life Sciences, Inc. is a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a

treatment of nicotine dependence. In September 2025, the company announced that its New Drug Application, submitted to the U.S. Food and Drug Administration (FDA) in June 2025, had been accepted for review. The FDA has assigned a Prescription Drug

User Fee Act (PDUFA) date of June 20, 2026. The NDA is for cytisinicline to be used as a treatment of nicotine dependence for smoking cessation in adults, based on two successfully completed Phase 3 studies and its open-label safety study.

Additionally, the company has completed a Phase 2 study with cytisinicline in vaping cessation and conducted a successful end-of-Phase 2 meeting with the FDA for a

future vaping indication.

About Cytisinicline

There

are approximately 25 million adults in the United States who smoke combustible cigarettes.1 Tobacco use is currently the leading cause of preventable death that is responsible

for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.2,3

In addition, there are nearly 18 million adults in the United States who use e-cigarettes, also known as vaping.1 In 2024, approximately 1.6 million middle and high school students in the United States reported using e-cigarettes.4 There are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. The FDA

has awarded the Commissioner’s National Priority Voucher for e-cigarette or vaping cessation and granted Breakthrough Therapy designation to address this critical need.

Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine

receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of nicotine craving symptoms, and

reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed as a treatment of nicotine dependence for smoking cessation and has not been approved by the FDA for any

indication in the United States.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation

Reform Act of 1995, including, but not limited to, statements Achieve makes regarding the timing, nature and outcome of cytisinicline clinical development and regulatory review and approval, data results, the timing, nature and success of

Achieve’s commercialization activities, the potential market size for cytisinicline, the potential benefits, efficacy, safety and tolerability of cytisinicline, the development and effectiveness of new treatments, the performance of

Achieve’s third-party manufacturing partners, the successful launch and commercialization of cytisinicline, the use of proceeds from the private placement of our securities in April 2026, and statements concerning Achieve Life Sciences’

future plans and prospects. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at

all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks,

uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including Achieve’s Annual Reports on Form 10-K and Quarterly

Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be

required by applicable law.

Achieve Contact

Nicole

Jones

VP, Strategic Communications and Stakeholder Relations

ir@achievelifesciences.com

425-686-1510

References

Agaku I. Tobacco Product Use among U.S. Adults, 2023–2024, NEJM, doi: 10.1056/EVIDpha2500339.

World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization,

2017.

U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress.

A Report of the Surgeon General, 2014.

Jamal A, Park-Lee E, Birdsey J, et al. Tobacco Product Use Among Middle

and High School Students — National Youth Tobacco Survey, United States, 2024. MMWR Morb Mortal Wkly Rep 2024;73:917–924.

Consolidated Statements of Loss

(In thousands, except per share and share data)

Three months ended March 31,

2026

2025

Operating expenses:

Research and development

3,292

7,097

General and administrative

7,171

5,797

Total operating expenses

10,463

12,894

Loss from operations

(10,463

)

(12,894

)

Other income

295

Net loss

(10,168

)

(12,827

)

Basic and diluted net loss per share

(0.19

)

(0.37

)

Weighted average number of basic and diluted common shares

53,381,989

34,685,072

Consolidated Balance Sheets

(In thousands)

March 31,

December 31,

2026

2025

Assets:

Cash, cash equivalents and marketable securities

29,269

36,404

Prepaid expenses and other current assets

1,792

3,485

Other assets and restricted cash

265

Right-of-use

assets

License agreement

696

751

Goodwill

1,034

Total assets

33,105

41,790

Liabilities and stockholders’ equity:

Accounts payable and accrued liabilities

6,203

3,760

Current portion of long-term obligations

Current portion of convertible debt

5,579

3,704

Contingent consideration

1,272

1,557

Non-current portion of convertible debt

9,322

11,185

Other long-term obligations

—

Stockholders’ equity

10,678

21,518

Total liabilities and stockholders’ equity

33,105

41,790

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dei_

Data Type:

dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Details

Name:

dei_EntityAddressesAddressTypeAxis=dei_OtherAddressMember

Namespace Prefix:

Data Type:

Balance Type:

Period Type: