Leadership Changes - Richard Stewart reassumes the role of Chief Executive Officer, replacing John Bencich who will serve as an advisor during the transition [1] - Thomas King is appointed as the Executive Chairman of the Board of Directors [1] - The leadership change is driven by the need for a CEO with substantial M&A and commercial experience to push the company towards critical milestones, including potential licensing or strategic transactions for the commercialization of cytisinicline [2] Company Objectives and Progress - The company remains on track to meet its objectives for the year, including completing enrollment for the ORCA-OL study, meeting with the FDA for the End-of-Phase 2 meeting for vaping cessation under Breakthrough Therapy designation, and progressing towards the NDA submission expected in the first half of 2025 [2] - The company aims to bring forward a potentially life-changing treatment for nicotine dependence while optimizing shareholder value [2] Industry Context and Market Opportunity - Approximately 29 million adults in the United States smoke combustible cigarettes, contributing to over eight million deaths worldwide annually, with smoking being the leading cause of preventable death [3] - Over 11 million adults in the United States use e-cigarettes, and approximately 2.1 million middle and high school students reported using e-cigarettes in 2023 [3] - There are currently no FDA-approved treatments specifically indicated for nicotine e-cigarette cessation, highlighting a significant unmet medical need [3] Product Overview - Cytisinicline is a plant-based alkaloid with high binding affinity to the nicotinic acetylcholine receptor, believed to aid in treating nicotine addiction by reducing withdrawal symptoms and the reward associated with nicotine products [4] - Cytisinicline is an investigational product candidate for nicotine addiction treatment and has not yet received FDA approval [4]

Achieve Life Sciences, Inc. (NASDAQ:ACHV) Q2 2024 Earnings Conference Call August 13, 2024 4:30 PM ET Company Participants Nicole Jones - IR John Bencich - CEO Cindy Jacobs - President and Chief Medical Officer Jerry Wan - Principal Accounting Officer Conference Call Participants Thomas Flaten - Lake Street Capital Justin Walsh - JonesTrading John Vandermosten - Zacks Ilya Zubkov - Freedom Broker Thomas Flaten - Lake Street Capital Operator Greetings, and welcome to the Achieve Life Sciences Second Quarter ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED June 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ______________ TO ____________. Commission file number 033-80623 Achieve Life Sciences, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 95-4343413 (St ...

Exhibit 99.1 Achieve Life Sciences Reports Financial Results for Second Quarter 2024 and Provides Corporate Update Company to host conference call at 4:30 PM EDT today, Tuesday, August 13, 2024 SEATTLE, Wash and VANCOUVER, British Columbia, August 13, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage pharmaceutical company dedicated to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced its financial res ...

SEATTLE and VANCOUVER, British Columbia, Aug. 13, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage pharmaceutical company dedicated to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced its financial results for the second quarter of 2024 and provided an update on its cytisinicline development program. Recent Highlights The FDA granted Breakthrough Therapy designation for cytisinicline treatment of nic ...

SEATTLE and VANCOUVER, British Columbia, July 31, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ:ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for cytisinicline for nicotine e-cigarette, or vaping, cessation. "Since there are no FDA-approved medications specifically in ...

SEATTLE and VANCOUVER, British Columbia, July 29, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that it has entered into a $20 million debt refinancing agreement with Silicon Valley Bank (SVB), a division of First-Citizens Bank. The new loan agreement refinances the existing debt facility with SVB and SVB Capital ...

SEATTLE and VANCOUVER, British Columbia, July 25, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced it will report its second quarter 2024 financial results and provide an update on the cytisinicline development program on Tuesday, August 13, 2024, at 4:30 PM EDT. To access the webcast, please use the following link: ...

SEATTLE and VANCOUVER, British Columbia, July 09, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that Achieve management will be attending the JonesHealthcare Seaside Summit 2024 being held July 14-16, 2024, in Encinitas, CA. John Bencich, CEO of Achieve, will present on Monday, July 15, 2024, at 8:45 AM PDT. Follo ...

Core Insights - Achieve Life Sciences, Inc. announced the presentation of Phase 2 ORCA-V1 trial data for cytisinicline, which showed that treatment more than doubled the likelihood of quitting vaping compared to placebo [1][2]. Company Overview - Achieve Life Sciences is focused on the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence [1][4]. - The company aims to address the smoking health crisis, with an estimated 28 million adults in the U.S. smoking combustible cigarettes and over 11 million using e-cigarettes [4]. Clinical Trial Details - The ORCA-V1 trial involved 160 daily e-cigarette users across five clinical trial locations in the U.S. Participants received 3 mg of cytisinicline three times daily or a placebo for 12 weeks, alongside standard cessation behavioral support [3]. - The trial was supported by the National Institute on Drug Abuse (NIDA) with grant funding totaling $2.8 million [3]. Product Information - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors in the brain, potentially reducing withdrawal symptoms and the satisfaction associated with nicotine products [5]. - Currently, there are no FDA-approved treatments specifically for nicotine e-cigarette cessation, highlighting a significant market opportunity for cytisinicline [4].