Achieve Life Sciences, Inc. (NASDAQ:ACHV) Q3 2018 Earnings Conference Call Transcript

Nov 07, 2018 • 04:30 pm ET

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Achieve Life Sciences, Inc. (NASDAQ:ACHV) Q3 2018 Earnings Conference Call Transcript

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Presentation
Operator
Operator

Good day, ladies and gentlemen, and welcome to the Achieve Life Sciences Third Quarter 2018 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. (Operator Instructions) As a reminder, this conference call is being recorded.

I would now like to introduce your host for today's conference, Ms. Jaime Welch, Executive Vice President of Commercial at Achieve. Ma'am, you may begin.

Executive
Jaime Welch

Thank you, Shanelle, and thanks everyone for joining us. With me today from Achieve are Rick Stewart, Chief Executive Officer; Dr. Anthony Clarke, Chief Scientific Officer; Dr. Cindy Jacobs, Chief Medical Officer; and John Bencich, Chief Financial and Operating Officer.

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 documents filed with the SEC concerning factors that could affect the company, copies of which are available on the website.

I'll now turn the call over to Rick.

Executive
Richard Stewart

Thank you, Jaime. On today's call, we will provide an update on the tremendous progress we continue to make on the cytisinicline development program. We will also discuss the near-term milestones that we believe have the potential to create significant value for the company over the next 12 months. Following our development program update, John will discuss our recent financing and third quarter 2018 financial results.

To begin, as you have may noticed, a new generic name for cytisine has been adopted by the United States Adopted Names Council or USAN. USAN is responsible for selecting simple, informative and unique generic drug names. They establish logical nomenclature classifications based on pharmacological and/or chemical relationships. Our new name cytisinicline went into effect in the third quarter and will be used in future.

Moving on to our clinical development program, as discussed last quarter, consistent with the FDA's suggestion to consider evaluation of alternative dosing strategies for cytisinicline, we've initiated a Phase 2b optimization trial in approximately 250 smokers in the U.S. This trial known as ORCA-1 will evaluate both 1.5 milligram and 3 milligram doses of cytisinicline on a declining titration schedule over 25 days as well as three times daily dosing. This trial is randomized and blinded to compare the effectiveness of the cytisinicline doses and schedules to respective placebo groups. The primary efficacy endpoint is reduction in the number of cigarettes smoked during treatment with secondary analysis conducted on smoking cessation rates, safety and compliance.

We were excited to announce last week that the ORCA-1 trial has been initiated. Clinical trial sites have been instructed to limit patients enrollment due to the upcoming holiday season. Accelerated recruitment will start in the New Year. ORCA-1 is being conducted at eight trial locations across the U.S. and data results are expected in mid-2019. We believe the results of this trial will help us better define key elements of our