ACHIEVE LIFE SCIENCES, INC.

ACHIEVE LIFE SCIENCES, INC. announced that its stockholders approved an amendment to the Certificate of Incorporation to increase the number of authorized shares of common stock from 150,000,000 to 300,000,000 shares. This amendment was filed on July 6, 2026, following the Annual Meeting of Stockholders held on July 2, 2026. Additionally, stockholders elected nine directors, ratified PricewaterhouseCoopers LLP as the independent auditor for 2026, and approved executive compensation in a non-binding advisory vote.

Achieve Life Sciences, Inc. announced its inclusion in the Russell 2000® Index, effective June 26, 2026. The company is also a member of the Russell 3000® Index. These indexes are widely used benchmarks for institutional investors, with approximately $12.2 trillion in assets benchmarked against them as of June 30, 2025.

Achieve Life Sciences, Inc. announced its Annual Meeting of Stockholders on July 2, 2026, where shareholders will vote on several key proposals. The most significant proposal is to amend the certificate of incorporation to increase authorized common stock from 150 million to 300 million shares. This follows a recent April 2026 private placement that raised approximately $180 million gross proceeds. The company also announced changes to its board, reducing its size from thirteen to nine members, and the appointment of Andrew D. Goldberg as CEO and Lucian Iancovici as Chairman.

Achieve Life Sciences, Inc. announced the appointment of Jeffrey Farrow and Reid Waldman, MD to its Board of Directors. These strategic additions bring significant experience in commercial launches, capital markets, and company building, as Achieve prepares for the NDA resubmission and commercial launch of cytisinicline, a treatment for nicotine dependence. The company aims to introduce the first new prescription smoking cessation medicine in nearly two decades, with cytisinicline also holding Breakthrough Therapy designation for vaping cessation.

Achieve Life Sciences announced the presentation of comprehensive long-term safety data from its ORCA-OL study for cytisinicline at the American Thoracic Society 2026 Annual Meeting. The study demonstrated a favorable safety profile over 52 weeks of continuous exposure in a diverse population, with no new safety signals identified by the independent Data Safety Monitoring Committee and a low incidence of nausea (2.5%). This final clinical dataset completes the comprehensive evidence package supporting the company's New Drug Application (NDA) for cytisinicline as a treatment for nicotine dependence, moving it closer to potential approval.

Achieve Life Sciences reported an improved net loss of $(10.2) million for Q1 2026, compared to $(12.8) million in Q1 2025, with net cash used in operating activities also decreasing to $(6.9) million. Subsequent to the quarter-end, the company significantly enhanced its liquidity by raising approximately $180.0 million in gross proceeds through a private placement. The company continues to navigate a dispute with Sopharma AD concerning manufacturing agreements for its sole product candidate, cytisinicline.

Achieve Life Sciences announced significant leadership changes, including the appointment of Andrew D. Goldberg, MD, as the new CEO, and the addition of three new board members, while Thomas King and Jaime Xinos departed. The company also closed a private placement of up to $354 million, securing $180 million upfront to fund its ORCA-V2 Phase 3 trial and commercialization efforts. For the first quarter of 2026, Achieve reported a net loss of $10.2 million and total operating expenses of $10.5 million. The company expects a Complete Response Letter from the FDA by June 20, 2026, due to prior manufacturer issues, with plans to resubmit its New Drug Application in Q4 2026 for a U.S. commercial launch in H1 2027.

Achieve Life Sciences announced three senior leadership appointments, including Christopher Martin to its Board of Directors, Mark Zappia as Senior Vice President, Commercial, and Jim Willis as Vice President of Sales and Sales Enablement. These strategic hires, who previously worked together on a successful commercial launch at Verona Pharma (acquired by Merck & Co. for $10.8 billion), are crucial as Achieve moves towards the commercialization of cytisinicline. The appointments follow a recent CEO change and a financing of up to $354 million, reflecting a deliberate build-up of leadership. Additionally, Tom King will step down from the Board in June 2026, with Dr. Lucian Iancovici assuming the role of Chairman.

Achieve Life Sciences, Inc. announced it will report its first quarter 2026 financial results and provide a corporate update on Tuesday, May 12, 2026, at 8:30 AM EDT. Investors can access the event via webcast or a live conference call. The company also highlighted that the FDA has set a Prescription Drug User Fee Act (PDUFA) date of June 20, 2026, for its New Drug Application for cytisinicline.

ACHIEVE LIFE SCIENCES, INC. announced significant leadership changes, including the appointment of Andrew D. Goldberg, M.D. as Chief Executive Officer and President, effective April 2026. The company also added Lucian Iancovici and Aaron Royston to its Board of Directors, effective April 17, 2026, following their designation by TPG Life Sciences Innovations and venBio Partners, respectively, after a recent private placement. Other key executive appointments include a new Chief Legal Officer, Chief Operations Officer, Chief Financial Officer, Chief Medical Officer, and Chief Commercial Officer.