Achieve Life Sciences, Inc. (NASDAQ:ACHV) Q1 2024 Earnings Conference Call May 9, 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
Michael Higgins - Ladenburg Thalmann
John Vandermosten - Zacks
Ilya Zubkov - Freedom Broker

Operator

Greetings. Welcome to Achieve Life Sciences’ First Quarter 2024 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.

Before we begin, 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’s 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. Today, we will review our first quarter 2024 financial performance and discuss key highlights, including reaching agreement with the FDA on the long-term cytisinicline exposure data necessary for our NDA filing.

Critically for the timing of the NDA submission, we agreed on the number of subjects required with six months exposure to enable the NDA filing. Cindy will provide an update on the ORCA-OL study and discuss the status of initiation in just a moment.

Concurrently with the FDA decision, we successfully secured financing of up to $124 million enabling Achieve to execute the ORCA-OL trial and provide cash runway through the NDA submission, NDA approval and beyond. The financing included participation from new fundamental healthcare investors, including our manufacturing partner Sopharma.

The investor demand for the financing demonstrates the importance of cytisinicline in battling nicotine dependence and a growing confidence in cytisinicline’s market opportunity. The visibility of cytisinicline as a drug for nicotine dependence has been raised markedly during the quarter. And, as many of you will have read, the results from the Phase 2 ORCA-V1 trial of cytisinicline for vaping cessation were published in JAMA Internal Medicine earlier this week.