Cara Therapeutics, Inc. (NASDAQ:CARA) Q4 2023 Earnings Call Transcript

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So that’s where that comment came from. And then regarding your second question, regarding quality of life and impact on quality of life, this is — KOMFORT is the first time we — anyone had conducted a robust randomized study, and we’re still trying to understand what quality of life endpoints are most appropriate for the NP patient population. And so that we still navigate that — we’re still navigating through that and understanding what that is. The tools that are used for other dermatological conditions, not necessarily — are not necessarily relevant to NP. And that’s what we understood from our Phase 2 data, and that’s what we continue to work through as we move forward to our pivotal program.

Dennis Ding: Thank you.

Operator: Thank you. Stand by for our next question. Our next question comes from the line of [Kyle Klein] (ph) of Canaccord Genuity. Please go ahead, Kyle.

Unidentified Analyst: This is Kyle speaking for Sumant. Two questions related. The first is regarding the readout happening in [3Q] (ph). Are you guys planning on disclosing granular details on the safety of the different doses? And then second question is on the highest dose, what are the safety expectations you’re expecting? And what are potential limitations as well? Thanks.

Chris Posner: Thanks, Kyle. Well, the first one, yeah, we’re going to disclose top line efficacy and safety results in Q3, that will be with the Part A readout. So the first answer to your question is yes, we will be disclosing top line efficacy and safety. And the second part, Joe, I’ll turn it to you.

Joana Goncalves: Yeah. And just to add with the top line safety what we typically present. So your adverse bands, most common discontinuation. So just a typical safety data. And then your second question regarding the highest dose and expectations. It was the highest dose of the 2 milligram twice daily, which was used in our KOMFORT study. And so we would anticipate a similar readout of the safety as we saw there. And in fact, that remains very consistent with what we’ve seen throughout all our programs with AD and with NP, so we feel very comfortable with that profile. And it’s a very acceptable one. Of course, we’ve got two lower doses. And so the expectation is that the tolerability may be base with the lower doses. But I want to reiterate that the highest dose was a very good profile. And so if we see the same, we’ll be very pleased with that.

Operator: Our next question comes from the line of David Amsellem of Piper Sandler. Your question please, David?

David Amsellem: Hey, thanks. So kind of wanted to switch gears and dig into your comments about being a core development company. I guess with that in mind, just looking away from NP — do you have any thoughts on other potential settings for oral DSK, I guess, in a perfect world where resources weren’t an issue? And then secondly, with the cash runway being what it is to ’26 ,- is there anything early stage out there that you might be looking at that you might be mining the world for, so to speak, in terms of bringing anything in just to think of the business beyond oral DSK? And just how are you thinking about business just in general? Thank you.

Chris Posner: Yeah. Thanks, David. Great hearing from you. So the first part of your question around are we looking at other things. I mean, our goal with our prioritization in January was to focus our cash and our resources on neuropathic pruritus, i.e., notalgia paresthetica. We want to be really disciplined there. And what we’re able to do now is fund that program through a succession of key milestones, which is great. So we’re — that’s our sole focus right now. You asked the question of biz dev, I mean certainly, we do look at assets. And our focused strategy gives us options to potentially leverage the value inflection points in the NP program to add more value to the company in due course, right? So right now, again, we have our streamlined organization aligned to the strategy of preserving our cash to make sure we could execute the NP program with the cash we have. That’s our focus.

David Amsellem: That’s helpful. Thanks.

Chris Posner: Thanks, David.

Operator: Thank you. I would now like to turn the conference back to Chris Posner for closing remarks. Sir?

Chris Posner: Yeah. Thank you very much, and thanks again, everyone, for joining us today, and I wish everyone a great afternoon. And with that, I’ll close the call.

Operator: This concludes today’s conference call. Thank you for participating, and you may now disconnect.

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