Achieve Life Sciences, Inc. (NASDAQ:ACHV) Q2 2024 Earnings Conference Call August 13, 2024 4:30 PM ET

Company Participants

Nicole Jones - IR
John Bencich - CEO
Cindy Jacobs - President and Chief Medical Officer
Jerry Wan - Principal Accounting Officer

Conference Call Participants

Thomas Flaten - Lake Street Capital
Justin Walsh - JonesTrading
John Vandermosten - Zacks
Ilya Zubkov - Freedom Broker
Thomas Flaten - Lake Street Capital

Operator

Greetings, and welcome to the Achieve Life Sciences Second Quarter 2024 Earnings Conference Call and Webcast. [Operator Instructions] As a reminder, this conference is being recorded.

I would now like to turn the call over to Nicole Jones with Investor Relations. Thank you, Nicole. 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.

We are excited to provide an update today on the tremendous progress we have made on the Cytisinicline Development Program from both the clinical and regulatory fronts. In recent weeks, several key accomplishments have provided excellent momentum for furthering our mission of bringing cytisinicline to the millions of people who are battling nicotine dependence.

Furthermore, we are pleased with the recent refinancing, which will propel us towards our first NDA submission for smoking cessation, which remains on track for filing in the first half of 2025.

We'll go through each of our achievements in more detail, but briefly, in the last few months, we have received FDA breakthrough therapy designation for cytisinicline for treating e-cigarette or vaping nicotine dependence. We initiated and gained significant traction on the ORCA-OL trial evaluating the long-term safety effects of cytisinicline.

We were added to the U.S. Russell 3000 and Russell Microcap Indexes, and we refinanced our outstanding debt agreement with SVB. We are very pleased with this progress, and the support we are receiving from the scientific, regulatory and financial communities, that are setting up cytisinicline for great success.