Achieve Life Sciences Q2 loss widens, boosts cash

Achieve Life Sciences, Inc. reported second quarter 2026 results and major financing and regulatory developments around cytisinicline.

Rhea-AI Filing Summary

Achieve Life Sciences, Inc. reported second quarter 2026 results and major financing and regulatory developments around cytisinicline. The company closed a private placement of up to $354 million, including $180 million upfront and up to $174 million from milestone-based warrants exercisable around potential FDA approval. Cash, cash equivalents, and marketable securities were $187.3 million as of June 30, 2026, supporting the ORCA‑V2 Phase 3 trial, commercialization activities, and general corporate purposes.

On June 20, 2026, Achieve received an FDA Complete Response Letter on its cytisinicline NDA related to cGMP observations at a prior manufacturer and incomplete labeling, with no deficiencies identified for efficacy or clinical safety. The company is transitioning finished product manufacturing to Adare Pharma Solutions, plans to resubmit the NDA in the fourth quarter of 2026, and anticipates potential FDA approval in the first half of 2027 followed by U.S. launch. Net loss for the quarter was $74.8 million, including a non‑cash $48.7 million charge from changes in warrant liabilities, and stockholders’ equity was $(14.7) million.

Positive

• Closed up to $354 million financing, with $180 million upfront and up to $174 million from milestone-based warrants to fund Phase 3, commercialization, and corporate needs.
• Cash and investments reached $187.3 million at June 30, 2026, providing a significantly larger liquidity position to support clinical, regulatory, and launch activities.
• FDA CRL cited no efficacy or safety deficiencies for cytisinicline, focusing instead on manufacturing and labeling issues, which may be more addressable than clinical concerns.
• Planned NDA resubmission in Q4 2026 with anticipated potential FDA approval in the first half of 2027 and a subsequent U.S. commercial launch framework.
• 52‑week ORCA‑OL safety data in 475 participants showed no new safety signals, completing the clinical safety package for the cytisinicline NDA.

Negative

• Received an FDA Complete Response Letter on the cytisinicline NDA, delaying potential approval and requiring resolution of manufacturing and labeling issues.
• Q2 2026 net loss was $74.8 million, much higher than $12.7 million a year earlier, driven partly by a large non‑cash warrant liability revaluation.
• Recorded a $48.7 million non‑cash charge from changes in warrant liabilities, adding significant volatility to reported earnings.
• Stockholders’ equity turned negative to $(14.7) million at June 30, 2026, compared with positive $21.5 million at December 31, 2025.
• General and administrative expenses more than doubled year over year in Q2 2026 to $14.6 million, reflecting increasing commercialization and corporate spending.

Filing Explained

As of June 30, 2026, Achieve Life Sciences reported 183,379 for its warrant and pre-funded warrant liability and (14,676) for stockholders’ equity, with both amounts presented in the table’s stated units; the financing is therefore reflected not only as potential funding but also as a balance-sheet liability.

8-K Event Classification

2 items: 2.02, 9.01

2 items

Item 2.02 Results of Operations and Financial Condition Financial

Disclosure of earnings results, typically an earnings press release or preliminary financials.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

Key Figures

Private placement size: $354 million Upfront financing proceeds: $180 million Potential warrant proceeds: $174 million +5 more

8 metrics

Private placement size $354 million Total potential proceeds from private placement including milestone-based warrants

Upfront financing proceeds $180 million Upfront cash from private placement

Potential warrant proceeds $174 million From warrants exercisable prior to and up to 20 trading days after FDA approval

Cash and investments $187.3 million Cash, cash equivalents, and marketable securities as of June 30, 2026

Net loss Q2 2026 $74.8 million Three months ended June 30, 2026

Non-cash warrant liability charge $48.7 million Included in Q2 2026 net loss due to change in fair value

Warrant and pre-funded warrant liability $183.4 million Balance sheet liability as of June 30, 2026

Stockholders’ equity $(14.7) million Stockholders’ equity at June 30, 2026

Key Terms

Complete Response Letter, current Good Manufacturing Practice, Official Action Indicated, Breakthrough Therapy designation, +2 more

6 terms

Complete Response Letter regulatory

"On June 20, 2026, Achieve received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration"

A complete response letter is an official communication from a drug or medical-device regulator, such as the U.S. Food and Drug Administration (FDA), telling a company that a marketing application cannot be approved in its current form and listing the specific deficiencies to be fixed. For investors it matters because it pauses or delays a product’s path to market—like a building inspector issuing a list of repairs before a certificate of occupancy—affecting revenue timing, costs and stock value.

current Good Manufacturing Practice regulatory

"The CRL relates to outstanding current Good Manufacturing Practice (cGMP) observations"

Current good manufacturing practice (cGMP) are the up-to-date, enforced rules and standards that factories follow to make medicines, medical devices, and related products reliably safe and consistent. Think of it as a detailed recipe and factory checklist that covers cleanliness, equipment, staff training and record-keeping; meeting cGMP reduces the risk of recalls, regulatory shutdowns or lawsuits and thus protects product supply, company reputation and investor value.

Official Action Indicated regulatory

"prior third-party manufacturing facility, which received an Official Action Indicated classification"

A preliminary determination by a regulator that a company’s product, practice, or filing likely requires formal enforcement, correction, or review. For investors it signals elevated regulatory risk—similar to a police officer saying there’s enough concern to start an investigation—because it can lead to fines, product holds, recalls, or delayed approvals that may affect revenue, costs, or market confidence.

Breakthrough Therapy designation regulatory

"has received Breakthrough Therapy designation for the vaping cessation indication"

A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.

warrant liabilities financial

"includes a non-cash charge of $48.7 million related to the change in fair value of the warrant liabilities"

Warrant liabilities are the financial obligations a company records when it grants warrants—special rights allowing someone to buy shares at a set price in the future. If the warrants are expected to be exercised, they are treated as a liability because the company might need to deliver shares or cash later. This matters to investors because it affects the company’s reported financial health and the potential dilution of existing shares.

contingent consideration financial

"Contingent consideration | | | | | | | | | | 1,372"

Contingent consideration is an additional payment agreed when one company buys another that will be paid later only if specific future targets are met, such as revenue, profit, or regulatory milestones. It matters to investors because it shifts risk between buyer and seller and affects the acquiring company's future cash flow and reported value — like promising a bonus after results are proven.

Earnings Snapshot

Net loss: $74.8 million · Guidance included

Quarter ended June 30, 2026

Net loss $74.8 million Increased from $12.7 million in the quarter ended June 30, 2025

Total operating expenses $18.4 million Increased from $12.6 million in the quarter ended June 30, 2025

Cash, cash equivalents, and marketable securities $187.3 million Increased from $36.4 million as of December 31, 2025

Guidance

The company intends to resubmit the cytisinicline NDA in the fourth quarter of 2026 and anticipates potential FDA approval in the first half of 2027, followed by a U.S. commercial launch.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What were Achieve Life Sciences (ACHV) second quarter 2026 financial results?

Achieve reported a Q2 2026 net loss of $74.8 million, or $0.80 per share, compared with a net loss of $12.7 million, or $0.37 per share, in Q2 2025. The quarter included a large non‑cash warrant liability charge.

How much cash does Achieve Life Sciences (ACHV) have after the private placement?

As of June 30, 2026, Achieve held $187.3 million in cash, cash equivalents, and marketable securities. Management expects private placement proceeds to support the ORCA‑V2 Phase 3 trial, commercialization of cytisinicline, and general corporate purposes.

What are the terms of Achieve Life Sciences’ (ACHV) recent $354 million financing?

Achieve closed a private placement of up to $354 million, including $180 million upfront and up to $174 million from milestone‑based warrants exercisable prior to and up to 20 trading days following potential FDA approval of cytisinicline.

What did the FDA Complete Response Letter mean for Achieve Life Sciences (ACHV)?

The FDA’s Complete Response Letter for the cytisinicline NDA cited cGMP issues at a prior manufacturer and incomplete labeling, with no deficiencies in efficacy or clinical safety. Achieve is addressing this by transitioning finished product manufacturing to Adare Pharma Solutions.

When does Achieve Life Sciences (ACHV) expect potential FDA approval of cytisinicline?

Achieve intends to resubmit the NDA in Q4 2026 and anticipates potential FDA approval in the first half of 2027, followed by a planned U.S. commercial launch of cytisinicline.

How did operating expenses change for Achieve Life Sciences (ACHV) in Q2 2026?

Total operating expenses for Q2 2026 were $18.4 million, up from $12.6 million in Q2 2025. The increase was driven mainly by higher general and administrative costs linked to commercial buildout and organizational expansion.

What safety data did Achieve Life Sciences (ACHV) report for cytisinicline?

Achieve presented 52‑week safety data from the ORCA‑OL study in 475 participants, with median exposure of 361 days. The independent Data Safety Monitoring Committee identified no new safety signals, completing the clinical safety package for the NDA.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Available on EDGAR 08/11/2026 - 04:05 PM Accepted by SEC EDGAR 08/11/2026 - 04:04 PM Learn about SEC filing dates

0000949858false00009498582026-08-112026-08-110000949858dei:OtherAddressMember2026-08-112026-08-11

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): August 11, 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 August 11, 2026, Achieve Life Sciences, Inc. issued a press release announcing its financial results for the second quarter ended June 30, 2026. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1 104		Press release of Achieve Life Sciences, Inc. dated August 11, 2026 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: August 11, 2026	/s/ MARK OKI
	Mark Oki Chief Financial Officer (Principal Financial Officer)

Exhibit 99.1

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

Closed a private placement of up to $354 million, with $180 million upfront and up to $174 million from warrants exercisable prior to and up to 20 trading days following FDA approval

Strengthened organization with new Chief Executive Officer, experienced commercial, CMC, and quality leaders, along with six new appointments to the Board of Directors

Anticipates potential FDA approval in the first half of 2027, followed by U.S. commercial launch

SEATTLE and VANCOUVER, British Columbia, August 11, 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 second quarter of 2026 and provided business updates.

“This quarter was about building Achieve to match the significant opportunity of cytisinicline,” said Andrew D. Goldberg, MD, Chief Executive Officer of Achieve. “We added a commercial team, senior CMC and quality leadership, six new directors, and advanced the finished drug product manufacturing transition to the United States. The Complete Response Letter raised no question about the efficacy or clinical safety of cytisinicline. With the team and financing in place, our focus turns to resubmission and commercial readiness. Behind that work are millions of adults still looking for help to quit.”

Key Highlights:

Regulatory Update

•On June 20, 2026, Achieve received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for cytisinicline, an outcome the Company disclosed it anticipated in April 2026. The CRL relates to outstanding current Good Manufacturing Practice (cGMP) observations from an inspection of the Company’s prior third-party manufacturing facility, which received an Official Action Indicated classification, and to final product labeling that was not completed by the FDA’s action date. The FDA identified no deficiencies related to the clinical efficacy or safety of cytisinicline.

•Announced the transition of finished drug product manufacturing of cytisinicline to U.S.-based Adare Pharma Solutions (Adare). The Company has completed analytical method technology transfer, manufactured its first cytisinicline engineering batch, and fully qualified testing procedures at Adare’s facility. The Company intends to resubmit its NDA naming Adare as its

finished drug product manufacturer for commercial supply in the fourth quarter of 2026 and anticipates potential FDA approval in the first half of 2027, with U.S. commercial launch to follow.

Leadership and Board Updates

•Strengthened the Board of Directors with the appointments of Lucian Iancovici, MD (Managing Director, TPG), Aaron E. Royston, MD (Managing Partner, venBio), Christopher Martin (former Chief Commercial Officer, Verona Pharma), Jeffrey Farrow (CFO and CSO, Tarsus Pharmaceuticals), and Reid Waldman, MD (Founder and CEO, Veradermics), bringing combined expertise across healthcare investing, biopharmaceutical finance, and clinical-stage leadership. Dr. Goldberg also joined the Board in connection with his appointment as Chief Executive Officer.

•Announced commercial buildout with Mark Zappia and Jim Willis joining as Senior Vice President, Commercial, and Vice President of Sales and Sales Enablement, respectively, both previously part of the commercial launch team for Ohtuvayre® (ensifentrine) at Verona Pharma.

•Continued the finished drug product manufacturing transition with the appointments of Ronald Dadino as Senior Vice President, CMC and Supply Chain, and Gloria Cosgrove as Senior Vice President, Global Quality, each bringing significant U.S.-based pharmaceutical manufacturing and quality experience.

Scientific Data Advancement

•Presented 52-week safety data from the ORCA-OL study at the American Thoracic Society (ATS) 2026 Annual Meeting, completing the anticipated clinical evidence package supporting the cytisinicline NDA. Among 475 participants dosed for up to 52 weeks (median cumulative exposure of 361 days), no new safety signals were identified by the independent Data Safety Monitoring Committee.

•Presented analysis of ORCA-2 and ORCA-3 Phase 3 RCTs evaluating cytisinicline in participants with a baseline history of cancer at the American Society of Clinical Oncology (ASCO) 2026 annual meeting. Cytisinicline was well tolerated and showed numerically higher abstinence rates than placebo in this population (24.4% with 12 weeks of cytisinicline versus 15.8% with placebo).

Capital Raise

•Closed a private placement of up to $354 million ($180 million upfront; up to $174 million from milestone-based warrants exercisable prior to, and up to 20 trading days following, FDA approval of cytisinicline). Proceeds are expected to fund the ORCA-V2 Phase 3 trial, the commercialization of cytisinicline, and working capital and general corporate purposes.

Financial Results
As of June 30, 2026, the Company’s cash, cash equivalents, and marketable securities were $187.3 million. Total operating expenses for the three and six months ended June 30, 2026, were $18.4 million and $28.9 million, respectively. Total net loss for the three and six months ended June 30,

2026, was $74.8 million and $84.9 million, respectively. Net loss for the quarter includes a non-cash charge of $48.7 million related to the change in fair value of the warrant liabilities issued in connection with the Company’s private placement.

Investor Communications

Achieve will host conference calls in connection with significant clinical, regulatory, and commercial milestones, including the planned resubmission of the NDA for cytisinicline. Management will continue to participate in investor meetings and industry conferences.

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 for nicotine dependence. Achieve’s New Drug Application (NDA) for cytisinicline for smoking cessation in adults is supported by two successfully completed Phase 3 studies and an open-label long-term safety study. Achieve has also completed a Phase 2 study of cytisinicline in nicotine e-cigarette cessation, conducted an end-of-Phase 2 meeting with the FDA, and has received Breakthrough Therapy designation for the vaping cessation indication.

About Cytisinicline There are approximately 25 million adults in the United States who smoke combustible cigarettes, and tobacco use is currently the leading cause of preventable death.¹,²

In addition, there are nearly 18 million adults in the United States who use e-cigarettes, also known as vaping.1 In 2025, approximately 1.4 million middle and high school students in the United States reported using e-cigarettes.3 There are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. 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.

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 Achieve’s private placement, 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 those described in 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
¹Agaku I. Tobacco Product Use among U.S. Adults, 2023–2024, NEJM Evidence, doi: 10.1056/EVIDpha2500339.
²World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2019.
3Eunice Park-Lee, Lauren M Dutra, Hannah Cowan, et al. Tobacco Product Use Among Middle and High School Students in the United States: National Youth Tobacco Survey, 2025, Nicotine & Tobacco Research, 2026; ntag116, doi.org/10.1093/ntr/ntag116.

Consolidated Statements of Loss
(In thousands, except per share and share data)
			Three months ended June 30,								Six months ended June 30,
			2026				2025				2026				2025
Operating expenses:
Research and development				3,808				6,707				7,100				13,804
General and administrative				14,584				5,856				21,755				11,653
Total operating expenses				18,392				12,563				28,855				25,457
Loss from operations				(18,392	)			(12,563	)			(28,855	)			(25,457	)
Other income				(56,377	)			(155	)			(56,082	)			(88	)
Net loss			$	(74,769	)		$	(12,718	)		$	(84,937	)		$	(25,545	)
Basic and diluted net loss per share			$	(0.80	)		$	(0.37	)		$	(1.15	)		$	(0.74	)
Weighted average number of basic and diluted common shares				93,510,544				34,685,072				73,557,119				34,685,072
Consolidated Balance Sheets
(In thousands)
											June 30				December 31,
											2026				2025
Assets:
Cash, cash equivalents and marketable securities											$	187,303			$	36,404
Prepaid expenses and other current assets												991				3,485
Other assets and restricted cash												268				52
Right-of-use assets												34				64
Other intangible assets												169				—
License agreement												640				751
Goodwill												1,034				1,034
Total assets											$	190,439			$	41,790
Liabilities and stockholders' equity:
Accounts payable and accrued liabilities											$	5,416			$	3,760
Current portion of long-term obligations												36				61
Current portion of convertible debt												7,454				3,704
Contingent consideration												1,372				1,557
Warrant and pre-funded warrant liability												183,379				—
Non-current portion of convertible debt												7,458				11,185
Other long-term obligations												—				5
Stockholders' equity												(14,676	)			21,518
Total liabilities and stockholders' equity											$	190,439			$	41,790

Filing Exhibits & Attachments

2 documents

Press Releases

• EX-99.1 EX-99.1 295.7 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA WITH EMBEDDED LINKBASES DOCUMENT 50.2 KB