Achieve Life Sciences Announces Changes in Executive Leadership and Board of Directors
Achieve Life Sciences, Inc. (Nasdaq: ACHV) announced significant changes in its executive leadership and Board of Directors. Richard Stewart, co-founder and current Executive Chairman, will reassume the role of Chief Executive Officer, replacing John Bencich, who served as CEO for the past four years. Thomas King, currently the lead independent director, will assume the role of Executive Chairman.
The leadership change is aimed at bringing in a CEO with substantial M&A and commercial experience to drive the company towards critical milestones, including potential licensing or strategic transactions for the commercialization of cytisinicline, their smoking cessation and nicotine dependence treatment. Achieve remains on track to meet its objectives, including completing enrollment for the ORCA-OL study, meeting with the FDA for an End-of-Phase 2 meeting for vaping cessation, and progressing towards an NDA submission expected in the first half of 2025.
Achieve Life Sciences, Inc. (Nasdaq: ACHV) ha annunciato cambiamenti significativi nella sua leadership esecutiva e nel Consiglio di Amministrazione. Richard Stewart, co-fondatore e attuale Presidente Esecutivo, riprenderà il ruolo di Amministratore Delegato, sostituendo John Bencich, che ha ricoperto il ruolo di CEO negli ultimi quattro anni. Thomas King, attualmente il direttore indipendente principale, assumerà il ruolo di Presidente Esecutivo.
Il cambiamento nella leadership è volto a portare un CEO con sostanziali esperienze in M&A e in ambito commerciale per guidare l'azienda verso traguardi critici, comprese potenziali licenze o transazioni strategiche per la commercializzazione di cytisinicline, il loro trattamento per la cessazione del fumo e la dipendenza da nicotina. Achieve rimane in carreggiata per raggiungere i suoi obiettivi, inclusa la conclusione delle iscrizioni per lo studio ORCA-OL, l'incontro con la FDA per un incontro di fine Fase 2 per la cessazione del vaping, e il progresso verso una proposta NDA prevista per la prima metà del 2025.
Achieve Life Sciences, Inc. (Nasdaq: ACHV) anunció cambios significativos en su liderazgo ejecutivo y en la Junta Directiva. Richard Stewart, cofundador y actual Presidente Ejecutivo, asumirá el cargo de Director Ejecutivo, reemplazando a John Bencich, quien se desempeñó como CEO durante los últimos cuatro años. Thomas King, actualmente el director independiente principal, asumirá el papel de Presidente Ejecutivo.
El cambio de liderazgo tiene como objetivo traer un CEO con experiencia sustancial en M&A y comercialización para impulsar a la empresa hacia hitos críticos, incluyendo posibles concesiones de licencias o transacciones estratégicas para la comercialización de cytisinicline, su tratamiento para la cesación del tabaquismo y la dependencia de nicotina. Achieve sigue en camino de alcanzar sus objetivos, incluyendo la finalización de la inscripción para el estudio ORCA-OL, la reunión con la FDA para una reunión de Fin de Fase 2 para la cesación del vaping, y avanzando hacia una presentación de NDA prevista para la primera mitad de 2025.
Achieve Life Sciences, Inc. (Nasdaq: ACHV)가 임원 리더십 및 이사회에서 중요한 변화를 발표했습니다. Richard Stewart 공동 창립자이자 현재의 이사회 의장 겸 CEO가 다시 CEO로 취임하여 지난 4년 간 CEO로 재직했던 John Bencich를 대체합니다. 현재 독립 이사인 Thomas King이 이사회 의장으로 취임합니다.
리더십 변화의 목표는 M&A와 상업 경험이 풍부한 CEO를 영입하여 cytisinicline의 상용화와 관련한 중요한 이정표를 향해 회사를 이끌기 위함입니다. Achieve는 ORCA-OL 연구 참가자 등록 완료, FDA와의 만남을 통한 2상 시험 종료 미팅, 2025년 상반기 NDA 제출 예상 등 목표를 달성하기 위해 순항하고 있습니다.
Achieve Life Sciences, Inc. (Nasdaq: ACHV) a annoncé des changements significatifs dans sa direction exécutive et son Conseil d'Administration. Richard Stewart, co-fondateur et actuel Président Exécutif, reprendra le rôle de Directeur Général, remplaçant John Bencich, qui a exercé cette fonction pendant les quatre dernières années. Thomas King, actuellement le directeur indépendant principal, assumera le rôle de Président Exécutif.
Ce changement de direction vise à apporter un Directeur Général avec une expérience significative en M&A et en commerce pour orienter l'entreprise vers des jalons critiques, y compris des concessions de licences potentielles ou des transactions stratégiques pour la commercialisation de cytisinicline, leur traitement pour l'arrêt du tabac et la dépendance à la nicotine. Achieve reste sur la bonne voie pour atteindre ses objectifs, notamment la finalisation des inscriptions pour l'étude ORCA-OL, une rencontre avec la FDA pour une réunion de fin de phase 2 concernant l'arrêt du vapotage, et le cheminement vers une soumission NDA prévue pour la première moitié de 2025.
Achieve Life Sciences, Inc. (Nasdaq: ACHV) hat bedeutende Veränderungen in der Unternehmensführung und im Vorstand bekannt gegeben. Richard Stewart, Mitbegründer und derzeitiger Vorstandsvorsitzender, wird erneut die Rolle des Chief Executive Officers übernehmen und damit John Bencich ersetzen, der in den letzten vier Jahren als CEO tätig war. Thomas King, derzeit der leitende unabhängige Direktor, wird die Rolle des Vorstandsvorsitzenden übernehmen.
Der Führungswechsel zielt darauf ab, einen CEO mit umfangreicher Erfahrung in M&A und im Commercial Bereich zu gewinnen, um das Unternehmen auf kritische Meilensteine zuzuführen, einschließlich möglicher Lizenz- oder strategischer Transaktionen zur Kommerzialisierung von cytisinicline, deren Behandlung gegen Tabakabhängigkeit und Nikotin. Achieve bleibt auf Kurs, um seine Ziele zu erreichen, einschließlich des Abschlusses der Patienteneinschreibung für die ORCA-OL-Studie, eines Treffens mit der FDA zur End-of-Phase-2-Besprechung zur Beendigung des Dampfens und dem Fortschritt in Richtung einer NDA-Einreichung, die für die erste Hälfte des Jahres 2025 erwartet wird.
- Richard Stewart, with substantial M&A and commercial experience, reassumes CEO role
- Company remains on track to meet key objectives for cytisinicline development
- Enrollment completion for ORCA-OL study expected
- FDA End-of-Phase 2 meeting for vaping cessation under Breakthrough Therapy designation planned
- NDA submission for cytisinicline expected in first half of 2025
- Departure of John Bencich as CEO after four years may cause temporary leadership transition challenges
Richard Stewart reassumes role of Chief Executive Officer
Thomas King appointed Executive Chairman of the Board of Directors
SEATTLE and VANCOUVER, British Columbia, Aug. 26, 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 that Mr. Richard (Rick) Stewart, Achieve’s co-founder and current Executive Chairman, will reassume the role of Chief Executive Officer. John Bencich, who served as the Company’s Chief Executive Officer for the past four years, will serve as an advisor during the transition. Additionally, the Company announced that Mr. Thomas (Tom) King, currently the lead independent director of the Board of Directors, will assume the role of Executive Chairman.
“The change in leadership is driven by the need to have a CEO with substantial M&A and commercial experience pushing the company forward to future critical milestones, whether that be a potential licensing transaction or strategic transaction for the commercialization of cytisinicline,” commented Tom King, Executive Chairman of Achieve’s Board of Directors. “On behalf of Achieve, we thank John for his tenure with the Company and appreciate his assistance during this transition.”
“It’s been an incredible journey helping Achieve grow over the past seven years and I wish the new leadership team continued success as they drive the cytisinicline program forward to patients,” commented John Bencich. “I am thankful for the time I had at Achieve and all we accomplished, and am looking forward to pursuing my next opportunity.”
Rick Stewart, Achieve Chief Executive Officer, added, “We remain on track to meet our objectives for this year, including the completion of enrollment of the ORCA-OL study, meeting with the FDA for our End-of-Phase 2 meeting for vaping cessation under Breakthrough Therapy designation, and furthering our progress on the NDA submission, that we expect to file in the first-half of 2025. I look forward to my new role and leading our excellent team to bring forward a potentially life-changing treatment for millions of people who battle nicotine dependence, while at the same time aiming to optimize shareholder value.”
About Achieve and Cytisinicline
Achieve’s focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline. There are approximately 29 million adults in the United States alone 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 More than
In addition, there are over 11 million adults in the United States who use e-cigarettes, also known as vaping.4 In 2023, approximately 2.1 million middle and high school students in the United States reported using e-cigarettes.5 Currently, there are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation.
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 withdrawal symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for the treatment of nicotine addiction and has not been approved by the Food and Drug Administration for any indication in the United States. For more information on cytisinicline and Achieve visit www.achievelifesciences.com.
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 regarding the timing and nature of cytisinicline clinical development and regulatory review and approval, data results and commercialization activities, the entry into any licensing or other strategic transactions, the potential market size for cytisinicline, the potential benefits, efficacy, safety and tolerability of cytisinicline, the ability to discover and develop new uses for cytisinicline, including but not limited to as an e-cigarette cessation product, the development and effectiveness of new treatments, and the ability to drive shareholder value. 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, among others, the risk that cytisinicline may not demonstrate the hypothesized or expected benefits; the risk that Achieve may not be able to obtain additional financing to fund the development of cytisinicline; the risk that cytisinicline will not receive regulatory approval or be successfully commercialized; the risk that new developments in the smoking cessation landscape require changes in business strategy or clinical development plans; the risk that Achieve’s intellectual property may not be adequately protected; general business and economic conditions; risks related to the impact on our business of macroeconomic and geopolitical conditions, including inflation, rising interest rates, increased volatility in the debt and equity markets, actual or perceived instability in the global banking system, global health crises and pandemics and geopolitical conflict and the other factors described in the risk factors set forth in Achieve’s filings with the Securities and Exchange Commission from time to time, 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.
Investor Relations Contact
Rich Cockrell
achv@cg.capital
(404) 736-3838
Media Contact
Glenn Silver
Glenn.Silver@Finnpartners.com
(646) 871-8485
References
1VanFrank B, Malarcher A, Cornelius ME, Schecter A, Jamal A, Tynan M. Adult Smoking Cessation — United States, 2022. MMWR Morb Mortal Wkly Rep 2024;73:633–641.
2World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.
3U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014.
4Cornelius ME, Loretan CG, Jamal A, et al. Tobacco Product Use Among Adults – United States, 2021. MMWR Morb Mortal Wkly Rep 2023;72:475–483.
5Birdsey J, Cornelius M, Jamal A, et al. Tobacco Product Use Among U.S. Middle and High School Students — National Youth Tobacco Survey, 2023. MMWR Morb Mortal Wkly Rep 2023;72:1173–1182.
FAQ
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