COMPASS Pathways plc (NASDAQ:CMPS) Q4 2023 Earnings Call Transcript

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Dr. Guy Goodwin: Only to say, I mean obviously aware of this. I mean it’s a relatively small study in Australia, 72 patients as I recall, but yet to acknowledge that that was published yesterday and something that we will dig into more.

Sumant Kulkarni: Correct. Do the logistical hurdles in the U.S. That are leading to the slight delay contribute to a meaningful change in the financial outlay required for 005 and 006?

Mary-Rose Hughes: That’s a great question. So no, I mean clearly we’ve made some additional investments and we think it’s important to do that. But not a material change. We still have runway into 2025.

Operator: Our next question comes from Jason McCarthy with Maxim Group. Your line is open.

Jason McCarthy: Hey, guys. This is Michael Okunewitch on the line. Thank you for taking my questions today. So I guess to start off, I’d just like to ask, are you using a more rigorous verification of the TRD diagnosis compared to the Phase IIb? And if so, what is the reason? Does this have to do with greater public awareness of psychedelics and their efficacy? Or just a factor of a larger U.S. portion for the study?

Kabir Nath: So no, we’re not it is exactly the same inclusion criteria. It is the same population. It is as I said in answer to an earlier question. I mean partly it is the fact that this is 100% U.S. and also I do think the nature of the arms of the study this being true placebo as opposed to both 001 and 006 that have three doses of active drug, I think that also is a contributing factor.

Jason McCarthy: All right. And then just one more for me. I just wanted to see how closely you would be watching the Lykos NDA process and potential subsequent approval. Is there anything in particular that you’re looking for on the commercial reimbursement side that may help to inform your strategy for COMP360?

Kabir Nath: So yes, we will clearly be observing the regulatory process for Lykos very closely. We wish them well and I think it’s clearly premature to see how they’re thinking through commercial reimbursement. But obviously, we recognize that there will be lessons from that progress both through the regulatory and commercial basis for us.

Operator: Our next question comes from Elemer Piros with Rodman & Renshaw.

Elemer Piros: I don’t have a question related to the delay, but I have a question about the anxiety indication was mentioned that you are not focusing on it necessarily. But would you be interested in licensing COMP360 to indications that are potentially of no interest to you?

Kabir Nath: That’s an interesting question. What I will say is, in general, split indications are enormously challenging in my experience. If you could particularly if you can’t clearly identify a very different dosing paradigm and so on. So that’s not something we have given any great consideration to. Clearly, if somebody comes with a very compelling proposal, we would listen to it. But it’s not in general, it’s pretty hard with a single molecule in my experience.

Operator: Thank you. There are no further questions at this time. I’d like to hand the call back over to management for any closing remarks.

A – Kabir Nath: Thanks, everyone, for joining. In conclusion, let me just say, again, our guidance for the overall timing of our Phase II program in TRD is unchanged. We are acknowledging and giving guidance around a slight delay into Q4 2024 for top line data from 005, but our overall guidance remains unchanged. We continue to be very focused on execution in TRD. And also as we said, continuing to think about which other indications of interest would be the most compelling places to take COMP360 there. So thank you very much everyone. Thank you for your time and attention today. Thank you for your participation.

Operator: This concludes your conference call for today. [Operator Closing Remarks].

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