Achieve Life Sciences, Inc. (NASDAQ:ACHV) Q2 2023 Earnings Conference Call August 15, 2023 8:30 AM ET

Company Participants

Nicole Jones - Investor Relations

John Bencich - Chief Executive Officer

Jerry Wan - Principal Accounting Officer

Conference Call Participants

Thomas Flaten - Lake Street Capital

Francois Brisebois - Oppenheimer

Farhana Sakloth - Ladenburg Thalmann

Laura Suriel - Alliance Resource Partners

John Vandermosten - Zacks Research

Operator

Greetings. Welcome to the Achieve Life Sciences Second Quarter 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. [Operator Instructions] As a reminder, this conference is being recorded.

At this time, I would like to hand the call over to Nicole Jones, Investor Relations. Thank you. You may 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 to everyone who has joined us this morning. The first-half of 2023 has seen the culmination of our ambitions to bring the first smoking cessation products to market in nearly 20-years take a meaningful step forward. Several milestones were met in close proximity, all of which contributed substantial value to the cytisinicline program and to shareholders.

Firstly, the ORCA-3 Phase 3 trial results in May, validated and closely replicated those of the ORCA-2 trial and demonstrated significant efficacy with a benign side effect profile. Secondly, just prior to the excellent ORCA-3 results, Achieve announced positive results from the ORCA-V1 Phase 2 clinical trial in 160 e-cigarette users. Thirdly, Achieve renegotiated the terms of our convertible loan agreement extending the maturity date. Fourthly, the Journal of American Medical Association or JAMA published our groundbreaking ORCA-2 study. And finally, we raised additional capital providing cash runway well into 2024.

Overall, significant progress was made on many fronts. We look forward to continuing the campaign to highlight the value of cytisinicline and the underlying public health important, so cytisinicline in the U.S. and globally. With both Phase 3 smoking cessation clinical trials completed in over 1,500 subjects, the combined results confirmed the compelling efficacy and safety evidence of cytisinicline necessary to pursue FDA approval for smoking cessation. We are aiming to make an NDA submission in the first-half of 2024 and if approved, cytisinicline could be the first new prescription treatment made available to the roughly 28 million smokers in the U.S. in nearly two decades.