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 Warrant

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."

Leadership Transition

Manufacturing Partnership with Adare Pharma Solutions

Regulatory Milestone and Manufacturing Readiness

Scientific Data Advancement

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.

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.

VP, Strategic Communications and Stakeholder Relations

Consolidated Statements of Loss

(In thousands, except per share and share data)

Consolidated Balance Sheets