Achieve Life Sciences, Inc. (NASDAQ:ACHV) Q1 2022 Earnings Conference Call May 12, 2022 4:30 PM ET

Company Participants

John Bencich - CEO & Director

Cindy Jacobs - President, Chief Medical Officer & Director

Jerry Wan - Principal Accounting Officer

Conference Call Participants

Thomas Flaten - Lake Street Capital Markets

Michael Higgins - Ladenburg Thalmann & Co.

John Vandermosten - Zacks Small-Cap Research

Operator

Good day, and thank you for standing by. Welcome to the Achieve Life Sciences First Quarter 2022 Earnings Conference Call. [Operator Instructions].

I would now like to hand the conference over to your first speaker today, to Nicole Jones. Please go ahead.

Unidentified Company Representative

Thank you, operator, and thanks, everyone, for joining us. On the call 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 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 filed with the SEC concerning factors that could affect the company, copies of which are available on our website. I'll now turn the call over to John.

John Bencich

Thank you, Nicole, and thank you, everyone, for joining us today. As you've probably heard, last month, we reported a highly successful outcome of the ORCA-2 Phase III clinical trial of cytisinicline for smoking cessation. Cytisinicline demonstrated impressive efficacy across the primary and secondary endpoints for both the 6- and 12-week cytisinicline treatment arms.

The safety and tolerability profile remains best-in-class with single-digit rates of adverse events reported. We could not be more excited that cytisinicline succeeded in the challenge of helping many long-term heavy smokers in whom previous treatments have failed, successfully kicked the habit.

And the timing could not be better to bring a new cessation option forward. For the first time in over 20 years, cigarette sales increased during the COVID-19 pandemic, while calls to quit lines dropped by nearly 30%.

There is still more than 30 million smokers in the U.S. alone and over $1 billion globally who have not been offered a new regulatory approved treatment in nearly 2 decades. Smoking kills more people every year than alcohol, AIDS, car accidents, illegal drugs and murders combined.