Achieve Life Sciences Reports Second Quarter 2026 Financial Results and Provides Business Updates
Rhea-AI Summary
Achieve Life Sciences (Nasdaq: ACHV) reported second quarter 2026 results and business updates, highlighted by closing 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 of cytisinicline.
According to Achieve, the FDA issued a Complete Response Letter on June 20, 2026, limited to cGMP issues at a prior third-party facility and unfinished labeling, with no identified deficiencies in cytisinicline’s clinical efficacy or safety. The company is transitioning finished drug product manufacturing to Adare Pharma Solutions, has completed technology transfer and an initial engineering batch, and intends to resubmit its NDA in Q4 2026, anticipating potential FDA approval in the first half of 2027.
Achieve strengthened its leadership with a new CEO, multiple senior commercial, CMC, and quality hires, and six new directors. ORCA-OL 52‑week safety data in 475 participants showed no new safety signals, and analyses in participants with cancer history from ORCA-2/3 showed cytisinicline was well tolerated with numerically higher abstinence than placebo. Cash, cash equivalents, and marketable securities were $187.3 million at June 30, 2026; Q2 operating expenses were $18.4 million and net loss was $74.8 million, including a non‑cash $48.7 million warrant revaluation charge.
Positive
- Closed private placement of up to $354 million, including $180 million upfront
- Quarter-end cash, cash equivalents and marketable securities of $187.3 million at June 30, 2026
- FDA Complete Response Letter identified no deficiencies in cytisinicline’s clinical efficacy or safety
- ORCA-OL 52-week safety study in 475 participants reported no new safety signals
- Planned NDA resubmission in Q4 2026 with anticipated potential FDA decision in first half 2027
- Board and management expansion, including new CEO and multiple senior commercial and CMC/quality leaders
Negative
- Received FDA Complete Response Letter on cytisinicline NDA citing cGMP observations and incomplete labeling
- Q2 2026 net loss of $74.8 million versus $12.7 million in Q2 2025
- Non-cash warrant liability revaluation charge of $48.7 million in the quarter
- Warrant and pre-funded warrant liability of $183.4 million at June 30, 2026
- Stockholders’ equity negative at $(14.7) million as of June 30, 2026
- General and administrative expenses rose to $14.6 million in Q2 2026 from $5.9 million in Q2 2025
News Explained
The June 30 balance sheet carried $183,379 thousand in warrant liabilities against $187,303 thousand in cash and securities, with potential future share conversion.
Achieve Life Sciences’s closed private placement is now reflected in a
A private placement is a sale to selected investors outside a public offering, while a pre-funded warrant is sold near the full share price with a nominal exercise price and converts to shares when exercised.
The placement ceiling equals
The specific checkpoints are the warrant and pre-funded warrant liability line in the next balance sheet and exercise activity through
Sources and calculations
- Achieve Life Sciences second-quarter 2026 results and business updates (2026-08-11)
- Private placement / PIPE definition (undated)
- Pre-funded warrant definition (undated)
- Achieve Life Sciences first-quarter 2026 fundamentals (2026Q1)
- Offering gross vs quarterly operating cash outflow, in days of cash use $354,000,000 / ($6,932,000 / 90) = [object Object]
Key Figures
Previous Earnings Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 12 | Q1 earnings report | Positive | +7.2% | Reported Q1 results and private placement, with FDA response timing and cash update. |
| Mar 24 | Q4 earnings report | Positive | -28.4% | Reported year-end results, NDA progress, manufacturing partnership, and planned commercial launch. |
| Nov 06 | Q3 earnings report | Positive | -3.9% | Reported FDA NDA acceptance, voucher, long-term safety, and quarterly financial results. |
| Aug 07 | Q2 earnings report | Positive | +0.0% | Reported NDA submission, Omnicom partnership, public offering, and Phase 3 progress. |
| May 13 | Q1 earnings report | Positive | +6.8% | Reported planned NDA submission, Phase 3 publication, safety milestones, and cash position. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Earnings-tagged events averaged a -3.65% 24-hour reaction, with four of five events diverging from the announcement sentiment.
Key Terms
complete response letter regulatory
current good manufacturing practice regulatory
new drug application regulatory
private placement financial
warrants financial
phase 3 rcts medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Closed a private placement of up to
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, Aug. 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 versus15.8% 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
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 | ||||||||||||||
