Verona Pharma plc (NASDAQ:VRNA) Q4 2023 Earnings Call Transcript

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Regardless of background therapy, regardless of eosinophil counts, it allows them really found a new foundational therapy that their patients and the doctors desire to have within their practice.

Unidentified Analyst: Okay. Great. Thank you.

Operator: The next question comes from Joon Lee with Truist Securities. Please go ahead.

Joon Lee: Hi. Good day and congrats on the quarter. And thanks for taking my question. What are your expectations for this fixed-dose, nebulized ensifentrine plus LAMA in COPD space? Are there any specific populations being unlocked with this combo? Any color would be helpful. Thank you.

David Zaccardelli: Thanks so much for the question. I’ll just make a brief comment and then ask, Dr. Tara Rheault to comment as well. I think that our view is that if the natural progression with regard to products for the treatment in COPD, you may know the combination products are very commonly used in combining different Bronchodilators, anti-inflammatory together. And combining ensifentrine with a LAMA, I think makes natural sense. I think our view is that it would address a fairly broad population COPD as well as this is a typical treatment. And with that, I’ll turn it over to Tara, to make any comments.

Tara Rheault: Sure. I think one of the real important features of the fixed-dose combination that we’re preparing is that you’ve got ensifentrine with bronchodilator and anti-inflammatory pharmacology combined with another bronchodilator. So you have essentially two bronchodilator mechanisms in an anti-inflammatory mechanism that’s non-steroidal, essentially giving you the profile of a Triple in the fixed-dose combination. So we think it will be a very important alternative to Triple Therapy for quite a few patients.

Joon Lee: Thank you. And sorry, I forgot to mention this was maybe on for June. Thanks for taking our question.

David Zaccardelli: Thanks so much.

Operator: [Operator Instructions] The next question comes from Tom Shrader with BTIG. Please go ahead.

Tom Shrader: Good morning. Good luck on the PDUFA date. We’ve been waiting for this forever. I have a follow-up on the mixed product. You’re doing an awful lot of dosing when you’ve already shown it’s safe and efficacious at doses. Are you trying to — is the hope that this would really be a different product than the combination and that you would maybe get at some of the synergies that you saw in your early data?

David Zaccardelli: Thanks so much Tom for that question. Tara, if you’d like to comment on our strategy on dose selection and exploring that in these trials.

Tara Rheault: Sure. Yes. So this is a new product. It’s a new formulation. That’s the requirement in order to feasibly combine ensifentrine and a LAMA. And so — let’s see. What was the second part of your question again?

Tom Shrader: Well, there are some interesting synergies between ensifentrine and LAMA in the early preclinical data about rapidity of action. The question is, are you hoping to capture some of that?

Tara Rheault: Of course. That early data did show some synergistic effects with ensifentrine and glycopyrrolate and other muscarinic antagonist and that certainly was mirrored in the Phase III data we saw on top of long-acting muscarinic antagonist.

Tom Shrader: Okay. And if I could follow up quickly on bronchiectasis. Would you try to develop a second product? Would it look different than the COPD product because you’re kind of in an orphan indication so the price points might be very different?

David Zaccardelli: Yes. No, I think Tom, our strategy is actually to progress with the current formulation. Of course, that’s very efficient as you can imagine. And I think as an incremental indication while it’s not technically an orphan. I appreciate that if the number is closer — we’re addressing, it as just another indication which is great in helping patients. The ensifentrine in its current formulation could do.

Tom Shrader: Okay. Great. And again, good luck.

David Zaccardelli: Thanks, so much.

Operator: This concludes our question-and-answer session. I would like to turn the conference back over to David Zaccardelli for any closing remarks.

David Zaccardelli: Great. Thank you everyone for your questions today. And in addition, I’d like to thank our shareholders for their continued support and the dedicated and talented team at Verona for their work and commitment. And we look forward to updating you on our progress over the next few months. Have a great day.

Operator: The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.

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