Achieve Life Sciences, Inc. (NASDAQ:ACHV) Q3 2023 Earnings Conference Call November 9, 2023 4:30 PM ET

Company Participants

Nicole Jones - IR

John Bencich - CEO

Jerry Wan - Principal Accounting Officer

Cindy Jacobs - President and CMO

Conference Call Participants

Thomas Flaten - Lake Street

Michael Higgins - Ladenburg Thalmann

John Vandermosten - Saks

Operator

Greetings. Welcome to Achieve Life Sciences Third Quarter Earnings Conference Call and Webcast. [Operator Instructions] Please note this conference is being recorded.

At this time, I'll turn the conference over to Nicole Jones with Investor Relations. Nicole, you may now begin.

Nicole Jones

Thank you, operator, and thank you to everyone for joining the call today. Today from Achieve, we have John Bencich, Chief Executive Officer; Dr. Cindy Jacobs, President and Chief Medical Officer; and Jerry Wan, Principal Accounting Officer. Achieve's management will be available for Q&A after the 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 could affect the company.

I'll now turn the call over to John.

John Bencich

Thank you, Nicole and thanks, everyone, for joining us today to review our third quarter highlights and the overall status of the cytisinicline program.

Over the last quarter as well as throughout the entire year, significant progress has been made in establishing the foundation for the first novel nicotine dependence treatment in almost two decades.

So far this year, with a small and efficient team of only 22 full-time employees, Achieve accomplished many significant milestones including the announcement of positive results from our second Phase 3 cytisinicline trial for smoking cessation and published results from our first Phase 3 trial in JAMA. Reported a statistically significant efficacy benefit in the Phase 2 ORCA-V1 trial, the first ever randomized controlled trial for e-cigarettes cessation.

We've completed three additional clinical studies of over 100 subjects required for NDA submission, made significant progress on the compilation of the NDA, held numerous interactions and conducted three formal meetings with the agency to prepare for filing and approval in the U.S., including most recently a pre-NDA discussion that occurred at the end of October and increased outreach and further discussions with potential commercial organizations on the cytisinicline U.S. and global marketing opportunity.