Karuna Therapeutics, Inc. (NASDAQ:KRTX) Q2 2023 Earnings Conference Call August 3, 2023 8:00 AM ET

Company Participants

Alexis Smith - Senior Director of Investor Relations

William Meury - President and Chief Executive Officer

Troy Ignelzi - Chief Financial Officer

Andrew Miller - Founder and Chief Operating Officer

Conference Call Participants

Paul Matteis - Stifel

David Amsellem - Piper Sandler

Myles Minter - William Blair

Jason Butler - JMP Securities

Guofang Li - Leerink Partners

Jay Olson - Oppenheimer

Yatin Suneja - Guggenheim Partners

Laura Chico - Wedbush Securities

Ram Selvaraju - H.C. Wainwright

Jeff Hung - Morgan Stanley

Operator

Welcome to the Karuna Therapeutics Second Quarter 2023 Financial Results Conference Call. [Operator Instructions] Please note that this call is being recorded.

I will now turn the call over to Alexis Smith, Head of Investor Relations.

Alexis Smith

Thank you. Good morning, everyone, and thank you for joining our second quarter 2023 financial results conference call. I'm joined on the call today by Bill Meury, President and Chief Executive Officer; and Troy Ignelzi, Chief Financial Officer, who will begin our call with prepared remarks, as well as Andrew Miller, Founder and Chief Operating Officer; and Will Kane, Chief Commercial Officer, who will join Bill and Troy for the Q&A portion of our call.

Before we begin, I encourage everyone to visit the investors page of our website at investors.karunatx.com to find our press release and presentation related to today's call. Forward-looking statements related to our product development, regulatory and commercialization plans, our research activities and financial outlook may be presented during this call. Please refer to today's press release and our SEC filings for important risk factors that could cause our actual performance and results to differ materially from those expressed or implied in these forward-looking statements.

And now, I'll hand it over to Bill.

William Meury

Thanks, Alexis, and good morning, everyone. We're now midway through 2023 and have made excellent progress in terms of our NDA, advancing our development programs for new indications and the pre-commercialization work for the anticipated launch of KarXT in the second half of next year, assuming approval. First, I'll start with where we are on our NDA for schizophrenia and outline what's ahead. As we shared last quarter, we had a productive meeting with the FDA in April, where we discussed various aspects of our submission, including those related to our data package and timing. That meeting and the subsequent meeting minutes in May confirmed our key assumptions and we continue to work towards a submission in September as planned. Here's where we are. The clinical data needed for the submission is in hand. This is data that we've generated across our 3 positive efficacy and safety trials, EMERGENT-1, EMERGENT-2 and EMERGENT-3, as well as the necessary long-term safety data from EMERGENT-4 and EMERGENT-5. This is the data that will make up the bulk of our clinical module. The data has been collected, cleaned and analyzed, and now we're in the final stages of writing the ISE and ISS. Additionally, the other key technical sections of the NDA, including CMC, nonclinical pharmacology and toxicology and human pharmacokinetics and bioavailability are complete or near complete. Our NDA consists of several hundred thousand pages and the team will start assembling, formatting and publishing our submission document in the next several weeks.