Achieve Life Sciences, Inc. (NASDAQ:ACHV) Q4 2023 Earnings Conference Call March 28, 2024 4:30 PM ET

Company Participants

Nicole Jones – Investor Relations
John Bencich – Chief Executive Officer
Cindy Jacobs – President and Chief Medical Officer
Jerry Wan – Principal Accounting Officer

Conference Call Participants

Thomas Flaten – Lake Street Capital
Francois Brisebois – Oppenheimer and Company
Michael Higgins – Ladenburg Thalmann
John Vandermosten – Zacks
Ilya Zubkov – Freedom Broker

Operator

Greetings. Welcome to the Achieve Life Sciences Fourth Quarter and Year-End 2023 Earnings Conference Call and Webcast. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded.

I would like to hand the call over to Nicole Jones, Investor Relations. Thank you. You may begin.

Nicole Jones

Thank you, operator. Good afternoon, everyone, and thank you for joining us today. From Achieve Life Sciences, we are joined by John Bencich, Chief Executive Officer; Dr. Cindy Jacobs, President and Chief Medical Officer; and Jerry Wan, Principal Accounting Officer. Management will be available for a Q&A session following today’s prepared remarks.

I’d like to remind everyone that today’s conference call contains forward-looking statements based on current expectations. These statements are only predictions and actual results may vary materially from those projected. Please refer to Achieve documents available on our website and filed with the SEC concerning factors that may affect the company.

At this time, I’ll turn the call over to John.

John Bencich

Thank you, Nicole, and thank you for joining us. As we discuss Achieve’s financial results for the fourth quarter and year ended 2023, along with providing key updates on the cytisinicline development program. 2023 was a transformative year for Achieve, marked by significant clinical, regulatory, and financial milestones. Our commitment to developing cytisinicline for smoking cessation and nicotine dependence has yielded remarkable progress and we’re excited for the year ahead.

During 2023, we completed and announced results from the Phase 3 ORCA-3 and Phase 2 ORCA-V1 trials, which have been instrumental in demonstrating cytisinicline’s potential for treating nicotine dependence. The ORCA-3 trial again confirmed the promise of cytisinicline for smoking cessation, with significant efficacy and tolerability benefits observed in treated patients.

Furthermore, the ORCA-V1 trial highlighted cytisinicline’s effectiveness in treating nicotine dependence for vaping cessation, marking a pioneering step in helping to address this emerging public health challenge in which currently over 11 million adults and an additional 2.1 million youth have reported vaping in the United States alone.