Core Insights - Achieve Life Sciences has promoted Ms. Jaime Xinos to Chief Commercial Officer to lead the commercial operations and strategic preparations for the anticipated U.S. launch of cytisinicline, a treatment for nicotine dependence [1][2][3] Company Overview - Achieve Life Sciences is focused on the global development and commercialization of cytisinicline, targeting the nicotine addiction epidemic, with approximately 29 million adults in the U.S. smoking combustible cigarettes [4] - The company aims to address the health impacts of tobacco use, which is responsible for over eight million deaths worldwide annually, including nearly half a million in the U.S. [4] Product Information - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors in the brain, potentially aiding in smoking and e-cigarette cessation by reducing cravings and the satisfaction associated with nicotine [5] - Currently, there are no FDA-approved treatments specifically for e-cigarette cessation, highlighting a significant market opportunity for cytisinicline [4][5] Leadership and Strategy - Ms. Xinos brings nearly 25 years of experience in the biotechnology and pharmaceutical industries, having held leadership roles at major companies such as Pfizer and Novartis [3] - The company plans to forge strategic partnerships with commercialization experts to navigate the challenges faced by small biotech firms launching their first product [2][3]

SEATTLE and VANCOUVER, British Columbia, Oct. 01, 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, is pleased to announce the appointment of Dr. Mark L. Rubinstein as its new Head of Medical Affairs. Dr. Rubinstein brings more than two decades of experience in clinical medicine, scientific research, and medical affairs leadership, w ...

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 ...

Company Overview - Achieve Life Sciences, Inc. is a late-stage pharmaceutical company focused on the development and commercialization of cytisinicline for smoking cessation and nicotine dependence [1][2] - The company will report its second quarter 2024 financial results and provide an update on the cytisinicline development program on August 13, 2024 [1] Industry Context - There are approximately 28 million adults in the United States who smoke combustible cigarettes, with tobacco use being the leading cause of preventable death, resulting in over 8 million deaths globally and nearly 500,000 deaths annually in the U.S. [2] - Smoking and exposure to secondhand smoke are responsible for more than 87% of lung cancer deaths, 61% of pulmonary disease deaths, and 32% of deaths from coronary heart disease [2] - Over 11 million adults in the U.S. use e-cigarettes, with 2.1 million middle and high school students reporting e-cigarette use in 2023 [2] Product Information - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors in the brain, aimed at treating nicotine addiction for both smoking and e-cigarette cessation [3] - The product is still investigational and has not received FDA approval for any indication in the United States [3]