Achieve Life Sciences posts Q1 2026 results
Achieve Life Sciences reported first quarter 2026 results and highlighted a large financing and leadership changes as it advances cytisinicline toward potential approval.
Rhea-AI Filing Summary
Achieve Life Sciences reported first quarter 2026 results and highlighted a large financing and leadership changes as it advances cytisinicline toward potential approval. Cash, cash equivalents and marketable securities were $29.3 million as of March 31, 2026, excluding estimated net proceeds of about $168.6 million from an April 2026 private placement that totals up to $354 million, including $180 million upfront and $174 million in milestone-driven warrants.
Total operating expenses for the quarter were $10.5 million, resulting in a net loss of $10.2 million or $0.19 per share. The company’s New Drug Application for cytisinicline has a Prescription Drug User Fee Act date of June 20, 2026.
The board appointed Christopher Martin as a director, with a pro-rated $40,000 annual retainer and options for 47,250 shares vesting over three years. Chairman Thomas King will resign effective June 8, 2026, with Lucian Iancovici, MD, becoming Chair, and Chief Commercial Officer Jaime Xinos will depart effective May 31, 2026.
Positive
- Substantial financing completed: Achieve closed a private placement of up to $354 million, including $180 million upfront and $174 million in milestone-driven warrants, with estimated net proceeds of about $168.6 million, materially strengthening liquidity ahead of a potential cytisinicline launch.
Negative
- None.
Insights
Large private placement strengthens Achieve’s balance sheet ahead of the June 2026 PDUFA decision.
Achieve Life Sciences secured a private placement of up to $354 million, comprising $180 million upfront and $174 million in milestone-based warrants. As of March 31, 2026, it held $29.3 million in cash, cash equivalents and marketable securities, excluding estimated net proceeds of about $168.6 million from this financing.
This capital position supports ongoing regulatory and pre-commercialization work for cytisinicline, which has an FDA PDUFA date of June 20, 2026. Q1 2026 total operating expenses were $10.5 million, with a net loss of $10.2 million, showing the company is still pre-revenue and investment-heavy.
Leadership changes include a new director, a planned chair transition on June 8, 2026, and the departure of the Chief Commercial Officer on May 31, 2026. Subsequent filings may provide more detail on how commercial responsibilities are reallocated as the PDUFA date approaches.
8-K Event Classification
Key Figures
Key Terms
private placement financial
PDUFA date regulatory
Breakthrough Therapy designation regulatory
convertible debt financial
contingent consideration financial
right-of-use assets financial
Earnings Snapshot
FAQ
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What is the FDA PDUFA date for Achieve Life Sciences’ cytisinicline?
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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FORM
CURRENT REPORT
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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) | ||||||
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
| 1 | Agaku I. Tobacco Product Use among U.S. Adults, 2023–2024, NEJM, doi: 10.1056/EVIDpha2500339. |
| 2 | World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017. |
| 3 | U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014. |
| 4 | 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: |
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| Research and development |
3,292 | 7,097 | ||||||
| General and administrative |
7,171 | 5,797 | ||||||
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| Total operating expenses |
10,463 | 12,894 | ||||||
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| Loss from operations |
(10,463 | ) | (12,894 | ) | ||||
| Other income |
295 | 67 | ||||||
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| Net loss |
$ | (10,168 | ) | $ | (12,827 | ) | ||
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| Basic and diluted net loss per share |
$ | (0.19 | ) | $ | (0.37 | ) | ||
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| Weighted average number of basic and diluted common shares |
53,381,989 | 34,685,072 | ||||||
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Consolidated Balance Sheets
(In thousands)
| March 31, | December 31, | |||||||
| 2026 | 2025 | |||||||
| Assets: |
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| 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 | 52 | ||||||
| Right-of-use assets |
49 | 64 | ||||||
| License agreement |
696 | 751 | ||||||
| Goodwill |
1,034 | 1,034 | ||||||
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| Total assets |
$ | 33,105 | $ | 41,790 | ||||
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| Liabilities and stockholders’ equity: |
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| Accounts payable and accrued liabilities |
$ | 6,203 | $ | 3,760 | ||||
| Current portion of long-term obligations |
51 | 61 | ||||||
| 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 |
— | 5 | ||||||
| Stockholders’ equity |
10,678 | 21,518 | ||||||
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| Total liabilities and stockholders’ equity |
$ | 33,105 | $ | 41,790 | ||||
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