COMPASS Pathways plc (NASDAQ:CMPS) Q4 2022 Earnings Call Transcript

Kyle Qian: Got it. Thanks, And maybe one more. In all the non-TRD studies such as in bipolar anorexia nervosa or MDD how many incidents of suicidal ideation have you observed as of to-date? And what percent of total would that be?

Kabir Nath: So, we will have to get back to you with that data. I actually don’t have this. I’m not aware of any specific finding, but I would need to come back to you with anything particularly in the MDD study from Zurich which I’ll cover. As I remember — as I mentioned in the bipolar study, we saw none. There were no examples of that among those 14 patients. And I think Steve is reminding me that some of these are in our investor presentation.

Operator: Thank you. And we have a follow-up question from Frank Brisebois with Oppenheimer. Your line is open.

François Brisebois: Hi, thank you. Just a quick one here. You mentioned March 20th maybe getting feedback from the FDA in terms of your amendments. Is this something that — on 005, is this something that you would disclose or you’ll hear the feedback and adjust accordingly, or just — I’m just trying to figure out what we should be waiting for in terms of expectations of that date.

Kabir Nath: Yes. So, as you know I mean typically we have not actually disclosed the to and fro of our correspondence with the FDA because as you would expect for any Phase III company we have a lot of to and fro including protocol amendments and so on. We recognize though that this was sufficiently significant both in terms of 005 and the integration of the long-term follow-up that we wanted to flag it. That said we believe that first in terms of the sizing and power of 005 ultimately that’s a sponsor decision based on our analysis of the data and what we believe around treatment difference. And for the long-term follow-up that’s clearly aligned with the design principles that we had worked through with the FDA. So, I think we do not see that as a particular clearing event, but we also wanted to acknowledge given the significance of the changes we’re making that there is a date in which they said they will get back to us with comments if any.

François Brisebois: Perfect. Thank you.

Operator: And I’m showing no further questions at this time. I would now like to turn the conference back to management for closing remarks.

Steven Schultz: Thank you, Amy. So, thanks everyone. Thank you very much for your participation today. Thanks for the many questions. And as always you know where to find us and we’re always happy to take more. So, thanks everyone. Have a great day.

Operator: And this concludes today’s conference call. Thank you for participating. You may now disconnect.