Achieve Life Sciences, Inc. (NASDAQ:ACHV) Q3 2022 Earnings Conference Call November 14, 2022 4:30 PM ET

Company Participants

Nicole Jones - Investor Relations-CG Capital

John Bencich - Chief Executive Officer

Jerry Wan - Principal Accounting Officer

Cindy Jacobs - President & Chief Medical Officer

Conference Call Participants

Thomas Flaten - Lake Street Capital

François Brisebois - Oppenheimer

Michael Higgins - Ladenburg Thalmann

John Vandermosten - Zacks

Jim Molloy - Alliance Global Partners

Operator

Good day, ladies and gentlemen, and welcome to Achieve Life Sciences Third Quarter 2022 Earnings Conference Call. All lines have been placed on a listen-only mode. And the floor will be open for questions and comments following the presentation. [Operator Instructions]

At this time, it is my pleasure to turn the floor over to your host Nicole Jones, CG Capital Investor Relations. Ma'am, the floor is yours.

Nicole Jones

Thank you, operator. On today's call from Achieve we have John Bencich Chief Executive Officer; and Jerry Wan Principal Accounting Officer. Achieve 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 document 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. It was yet again a busy and exciting quarter for Achieve. As we continue to advance cytisinicline through the clinic and closer to becoming the first new prescription treatment for nicotine dependence in nearly two decades.

In September, we announced completion of target enrollment in our confirmatory Phase III ORCA-3 trial for smoking cessation. And just last week we announced the earlier-than-expected completion of enrollment in our Phase II ORCA-V1 trial for nicotine e-cigarette or vaping cessation.

As a reminder, the ORCA-3 trial is the second and final randomized Phase III trial required for FDA submission and ultimately marketing authorization in the US. The design mirrors that of the previous ORCA-2 trial that read out with overwhelmingly positive results earlier this year.

Both trials were designed to evaluate the smoking cessation efficacy, safety and tolerability of 3-milligram cytisinicline dosed three times daily over a period of either 6 weeks or 12 weeks compared to placebo. The trials also share the same primary endpoint to evaluate smoking abstinence during the last four weeks of treatment which is the FDA's approvable endpoint for smoking cessation medications.