Achieve Life Sciences, Inc. (NASDAQ:ACHV ) Q4 2024 Earnings Conference Call March 11, 2025 8:30 AM ET Company Participants Nicole Jones - IR Richard Stewart - Chief Executive Officer Cindy Jacobs - President and Chief Medical Officer Jaime Xinos - Chief Commercial Officer Mark Oki - Chief Financial Officer Conference Call Participants Gary Nachman - Raymond James Thomas Flaten - Lake Street Capital Markets Francois Brisebois - Oppenheimer and Company Justin Walsh - Jones Trading Brandon Folkes - Rodman & Renshaw John Vandermosten - Zacks SCR Boris Tolkachev - Freedom Broker Operator Greetings, and welcome to the Achieve Life Sciences Fourth Quarter and Year-End 2024 Earnings Call and Webcast. At this time all participants are in a listen-only mode.
Reiterates Planned Cytisinicline NDA Submission Expected at the End of Q2 2025 Company to Host Conference Call at 8:30 AM EDT Today, Tuesday, March 11, 2025 SEATTLE and VANCOUVER, British Columbia, March 11, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence for smoking cessation, today announced its financial results for the fourth quarter and year-end 2024 and reiterated its plans to submit its new drug application (NDA) for cytisinicline at the end of the second quarter of 2025. Recent Highlights Reached key milestones in the ORCA-OL long-term exposure trial, including completion of enrollment and meeting the requirement of 300 participants receiving six months of cumulative cytisinicline treatment, as required for the submission of the NDA Announced positive outcomes from two data safety monitoring committee (DSMC) reviews with no safety concerns in the ORCA-OL clinical trial Appointed Dr. Kristen Slaoui and Nancy Phelan to the Board of Directors, bringing extensive leadership experience in corporate strategy and commercialization Appointed Mark Oki as Chief Financial Officer to oversee the company's financial strategy and operational initiatives Announced the successful outcome of the End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for defining cytisinicline development as a treatment for vaping cessation “We are thrilled with our progress to date and excited to have the NDA submission on track for the end of next quarter, furthering our mission to bring cytisinicline to market as the first new FDA-approved nicotine dependence treatment in nearly 20 years,” said Rick Stewart, Achieve's Chief Executive Officer.
SEATTLE and VANCOUVER, British Columbia, March 06, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence for smoking cessation, today announced it will report its fourth quarter and year-end 2024 financial results and provide an update on the cytisinicline development program on Tuesday, March 11, 2025, at 8:30 AM EDT.
New Directors Bring Extensive Leadership Experience in Corporate Strategy and Commercialization New Directors Bring Extensive Leadership Experience in Corporate Strategy and Commercialization
Over 300 Participants Have Completed Cumulative Six Months of Cytisinicline Treatment in the ORCA-OL Trial, Completing the Long-Term Exposure Requirement for NDA Submission
SEATTLE and VANCOUVER, British Columbia, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company dedicated to the global development and commercialization of cytisinicline for the treatment of nicotine dependence, today announced that Mark Oki has joined the company as its Chief Financial Officer, effective December 5, 2024. Mr. Oki will oversee the company's financial strategy and operations, including accounting, investor relations, information technology, legal and other key administrative functions, ensuring effective planning and execution to support organizational objectives.
Milestone Reinforces the Potential for Cytisinicline as a First-in-Class Treatment for Vaping Cessation Milestone Reinforces the Potential for Cytisinicline as a First-in-Class Treatment for Vaping Cessation
SEATTLE and VANCOUVER, British Columbia, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company dedicated to the global development and commercialization of cytisinicline for the treatment of nicotine dependence, today announced that Rick Stewart, CEO of Achieve Life Sciences, and management will be participating at two upcoming investor conferences.
Achieve Life Sciences, Inc. (NASDAQ:ACHV ) Q3 2024 Earnings Conference Call November 7, 2024 4:30 PM ET Company Participants Nicole Jones - IR Richard Stewart - Chief Executive Officer Cindy Jacobs - President and Chief Medical Officer Jerry Wan - Principal Accounting Officer Jaime Xinos - Chief Commercial Officer Conference Call Participants Thomas Flaten - Lake Street Capital Justin Walsh - JonesTrading John Vandermosten - Zacks Small-Cap Research Gary Nachman - Raymond James Boris Tolkachev - Freedom Broker Operator Greetings, and welcome to the Achieve Life Sciences Third Quarter 2024 Earnings Conference Call and Webcast. [Operator Instructions] And as a reminder, this conference is being recorded.
SEATTLE and VANCOUVER, British Columbia, Oct. 23, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company dedicated to the global development and commercialization of cytisinicline for the treatment of nicotine dependence, announced that Dr. Cindy Jacobs, Achieve's President and Chief Medical Officer, presented at the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) Joint Public Meeting on “Advancing Smoking Cessation: FDA and NIH Priorities” held on October 21, 2024.