Verona Pharma plc (NASDAQ:VRNA) Q1 2023 Earnings Conference Call May 9, 2023 9:00 AM ET

Company Participants

David Zaccardelli - President and Chief Executive Officer

Mark Hahn - Chief Financial Officer

Kathleen Rickard - Chief Medical Officer

Christopher Martin - Senior Vice President Commercial

Conference Call Participants

Andreas Argyrides - Wedbush

David Risinger - SVB Securities

Thomas Shrader - BTIG

Boobalan Pachaiyappan - H.C. Wainwright

Joon Lee - Truist Securities

Operator

Good morning. Welcome to Verona Pharma's First Quarter 2023 Financial Results and Operating Highlights Conference Call. At this time, all participants are in a mode. Earlier this morning, Verona Pharma issued a press release announcing its financial results for the 3 months ended March 31, 2023. A copy can be found in the Investor Relations tab on the corporate website, www.veronapharma.com. Before we begin, I'd like to remind you that during today's call, statements about the company's future expectations, plans and prospects are forward-looking statements. These forward-looking statements are based on management's current expectations.

These statements are neither promises nor guarantees and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements. Any such forward-looking statements represent management's estimates of the -- as of the date of this conference call. While the company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. As a reminder, this call is being recorded and will remain available for 90 days. I'd now like to turn the call over to Dr. David Zaccardelli, Chief Executive Officer. Please go ahead.

David Zaccardelli

Thank you, and welcome, everyone, to today's call. With me today are Mark Hahn, our Chief Financial Officer; Dr. Kathy Rickard, our Chief Medical Officer; and Chris Martin, our Senior Vice President of Commercial. During the first quarter, we continued to make substantial progress towards the planned submission of our NDA for nebulized ensifentrine for the maintenance treatment of COPD in the United States. We recently had a pre-NDA meeting with the FDA and believe that we are aligned on the content of the regulatory package. The NDA will comprise data from the successful Phase III ENHANCE program and other ensifentrine clinical studies including safety data from approximately 3,000 subjects. We remain on schedule to submit the NDA in the second quarter and look forward to providing an update later this quarter.