Elemer Piros: So it’s not really those who went into remission and fell out of remission.
Kabir Nath: Correct.
Elemer Piros: And is this a single retreatment, Kabir?
Kabir Nath: Yes, yes.
Elemer Piros: Okay. I think I got that. And in your effort to establish a code, are you working together with MAPS in their endeavor to potentially harmonize the activities?
Kabir Nath: Yes, we are. As we’ve said before, yes we are working with MAPS.
Elemer Piros: Okay. And one last question please. When would you be able to provide an update on your internal R&D programs into other psychoactive agents?
Kabir Nath: That’s a very good question. I don’t know. We actually haven’t landed on that but we’ll — as you mentioned we did say at Capital Markets Day, we would do that in due course. We’ll take that internally and come back to you.
Elemer Piros: Okay. Thank you so much for the update.
Kabir Nath: Thank you, Elemer.
Operator: Thank you. One moment for our next question. And our next question is from Neena Bitritto-Garg with Citi. Your line is open.
Neena Bitritto-Garg: Hi guys. Thanks for taking my questions. So, I just have two. So first one just going back to the retreatment in Part B and Part C in the 005 and 006 studies. Can you just clarify is it only at the six-month time point so week 26 and then week 52 in Part C that patients can go through this second, or possibly third dosing session, or could a patient be retreated earlier during Part B and Part C? And then my second question is just on cash and the balance sheet. It looks like you’re going to end this year with maybe a couple of quarters of cash. So, just curious how you’re planning on dealing with the cash runway? Thanks.
Kabir Nath: Thanks Neena. So yes, sorry, and I know doing this all verbally is hard. So to be clear in Part B, the option for retreatment would be between week six and 26 depending on relapse or failure to respond. And then in Part C, we would expect that to be pretty early in Part C for those patients who are eligible and chose to have a COMP360 dose. So that would be soon after the start of the final 26-week open-label section.
Mike Falvey: And then on the runway, yeah, so we’re looking at it from a couple of perspectives, the financing front and also operating moves that we could make to lengthen our runway. On the financing front, it remains a difficult market environment for financing biotech. But having said that, we have had a lot of interest from investors really since we announced the Phase 3 at our Capital Markets Day last fall. And it’s a very serious attention from sophisticated biotech investors. So as I mentioned it’s a challenging environment but there’s still an opportunity that under the right circumstances, we could do an equity offering with those interested investors. Secondly, we do have an ATM in place. So if a new investor were to want to take up a position that’s potentially a way for us to issue equity and raise cash.
And then lastly there’s, I think there’s an opportunity with debt. Now in the past, we’ve stated that we think we’re a little bit early stage to be considering forms of debt, but I think in these kinds of market environments we do have to be flexible. So under the right circumstances, that would be another way to continue to lengthen the runway of the financing. And then lastly, on the operating side, we’ve been very disciplined in the way that we’ve grown the company really since we announced the Phase 2 results at the end of 2021 and really have just focused on making sure we prepare and start to execute on the Phase 3 as well as our two advanced Phase 2 programs and really have dated all further investments on being able to continue to have a strong balance sheet and the long runway.
And so those efforts will continue. And we’ve always said, we view our strong balance sheet as an important strategic asset and while we want to pursue these breakthrough potential therapies, we want to do it in a way that’s going to create value for our shareholders. And to-date I think we’ve done that pretty successfully. And that’s going to be a key for us going forward.
Neena Bitritto-Garg: Got it. Thank you. It’s helpful.
Operator: Thank you. One moment for our next question. And we have our next question from Bert Hazlett with BTIG. Your line is open.
Bert Hazlett: Thank you. Thank you for taking my question. You covered a lot of ground on this call. And I’ll just ask I think on intellectual property, if I might on COMP360. You’ve talked about your protection that and patents that expire to 2038. There were a number of pending applications. Has there been any evolution with regard to IP for COMP360 or other elements that are of material importance? Thanks.
Kabir Nath: Thanks Bert. So, no, nothing new to disclose here, except one note, you’ll recall that three of our patents were challenged by another organization. That challenge was rejected. They appealed. And that appeal was also rejected in February. So that’s actually the only update. We continue to be confident that we have a robust state of protection out to 2038.
Bert Hazlett: Thank you. Thank you for the additional clarity on the retreatment, very helpful. Thanks.
Kabir Nath: Thanks Bert.
Operator: Thank you. One moment for our next question. And our next question is from Kyle Qian with CGS. Your line is open.
Kyle Qian: Hello. This is Kyle speaking for Sumant Kulkarni. Maybe a few from us, on the open-label retreatment, in the development process for that reaching an paradigm has the company thought of doing retreatment on an as-needed basis for maybe a longer — to a longer-term duration? And I’m curious, why that has not been implemented. Thanks.
Kabir Nath: No. Thank you, Kyle. And when you say on an, as-needed just to clarify you’re proposing multiple retreatments, yes.
Kyle Qian: Yeah. For example, over like a year duration and potentially more than one retreatment?
Kabir Nath: No. It’s a fair question. And yes, is the answer we considered a variety of designs in terms of how we extend this out. And I think, the reality is we know that our Phase 3 program however, we design it, it is not going to answer all those questions to the satisfaction of all of regulators, payers, clinicians and so on as well. Ultimately, the trade-off we arrived at was that in terms of getting clarity on durability of a single dose or potentially two doses in 006 and what happens with one retreatment recognizing also that per protocol as you’d expect as we did in IIb at some point, you have to allow patients to go back on to antidepressants or something because ethically you cannot expect to sustain on without that.
So, ultimately, the interpretability of multiple doses if they’re actually already on background SSRI is going to be challenging. I think in this case with the single re-dose in the open label that is again interesting data from the perspective of clinicians and so on as to the impact of that on a background about the therapy. But no, it’s — I acknowledge there are different designs we could have gone for we think in terms of interpretability and also balancing the needs of the different stakeholders. This was the right choice.
