Trevi Therapeutics, Inc. (NASDAQ:TRVI) Q3 2023 Earnings Call Transcript

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Jennifer Good: David, why don’t you take the first one? I’ll take the second one.

David Clark: Yes. No, it’s a really important question. So cough hypersensitivity is a key driver in both IPF and refractory chronic cough, as you know. So there’s a similarity in terms of underlying what is driving both of these conditions even though the pathophysiological initiation is different in these two conditions. But it leads to the same sort of degree of cough hypersensitivity. I mean our key differentiation factor, as Jennifer talked about during her presentation that you’ve heard from us before, is the key here. So we’ve got peripheral activity, which is good. We also have the central activity, which differentiates us. And in essence, it’s that activity suppressing modulary, so brain basal cough reflex center and the cerebral, the higher level cerebral control of it.

That is the key differentiation so that, in essence, we believe that central activity and its ability to be independent of what the triggering mechanism is going to drive effects in both of these indications and other cough indications.

Jennifer Good: Thank you, Serge, for the PN partnering question. Yes, we continue to be in touch with parties interested. Our colleague Farrell was off at BIO-Europe this week, continuing those discussions. So we’re clear on where the interest lies here, who’s interested. As we’ve always said, we would like to get through the FDA meeting and be clear about the path forward and what’s left, and then we’ll make decisions at that time about whether we license the drug or not at that time. So yes good interest still.

Serge Belanger: Thank you.

Jennifer Good: Thank you.

Operator: [Operator Instructions] The next question comes from Mayank Mamtani from B. Riley Securities. Please go ahead.

Mayank Mamtani: Good afternoon, Team. Thanks for taking my questions. So I appreciate the helpful comments on the RCC landscape. I was just curious what you might be looking for at the FDA adcom coming up closer to the end of the year or one of the P2X3 inhibitors that you mentioned. And then the second question was on the IND filing, if you could sort of remind us where we are with that process.

Jennifer Good: Yes. So the adcom is a great question. And David, you should add any color. I’m going to watch the whole day. I think it will be really telling what the FDA or how they focus on with gefapixant. As you know, it was a small sort of placebo-adjusted change, but they did have statistical significance. They were required to go back and do some work. So my expectations are the drug likely gets approved. Merck is certainly putting a lot of resources behind getting ready to launch it. But I think we’ll be watching it just to learn sort of what the position is, how people view it. I don’t know, David, if you have anything else regulatory-wise you’re looking for.

David Clark: No. Similar to what you’ve said. I mean certainly, I would just add my own personal comment from listening to a lot of experts in this field. I certainly share your view. I hope they get approved because of the medical need in this field.

Jennifer Good: IND, you want to take that one? Where are we with getting an IND open?

David Clark: So the IND is progressing for the respiratory physiology study. So we would expect to make an announcement on that and timing for that in the near future. But we are on track for having that submitted in the near future.

Mayank Mamtani: Got it. And maybe just one quick runway question. If you could clarify if that assumes any incremental spend on CN or any cash inflow you may have from a prudential partnership discussion?

Lisa Delfini: No. The cash runway includes our existing cash. So no additional cash influx assumed or inflow.

Mayank Mamtani: Okay. Thanks for that clarification. Appreciate you taking my question.

Jennifer Good: Yeah. Thank you, Mayank.

Operator: I am not showing any further questions. This concludes our question-and-answer session. I would like to turn the conference back over to Jennifer Good for closing remarks.

Jennifer Good: We would like to thank everybody for participating in today’s call. We will be attending the Stifel Conference next week and we hope to see some of you there. Thank you.

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

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