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Verona Pharma plc (VRNA) CEO David Zaccardelli on Q1 2020 Results - Earnings Call Transcript

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Verona Pharma plc (NASDAQ:VRNA) Q1 2020 Earnings Conference Call April 30, 2020 9:00 AM ET

Company Participants

David Zaccardelli - Chief Executive Officer

Mark Hahn - Chief Financial Officer

Kathy Rickard - Chief Medical Officer

Conference Call Participants

Lucy Codrington - Jefferies

Tom Shrader - BTIG

Liana Moussatos - Wedbush

David Zaccardelli

Welcome to today’s call. With me today are Mark Hahn, our Chief Financial Officer; and Dr. Kathy Rickard, our Chief Medical Officer.

Before I review our progress during the first quarter, it goes without saying that we are living in unprecedented times as we all grapple with the impact of the COVID-19 global pandemic. We hope those joining us today are keeping safe and healthy.

At Verona Pharma, I’m pleased to report that the team is well. We have all been working remotely in the U.S. and the U.K. since government regulations were imposed and all business travel has been restricted.

Our company goals for 2020 are clear and include receiving responses from the FDA regarding our end of Phase II submission package for nebulized ensifentrine to obtain clarity on the path forward for the Phase III program, securing sufficient funding to support the Phase III program and initiating the Phase III clinical trials. I am pleased that the U.S. FDA has advised that it will provide a written response to the company’s submitted end of Phase II package rather than holding a meeting. We expect to receive this response during the second quarter. We expect to obtain feedback on the design of our planned Phase III clinical program for nebulized ensifentrine in COPD including specifics on study design, dose selection and safety exposure data.

In addition, we will obtain responses to items related to preclinical including toxicology and CMC that will be important to a potential NDA filing.

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