ACHV

EX-99.1

2 achv-ex99_1.htm

EX-99.1

EX-99.1

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 follo

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