Good morning, ladies and gentlemen, and thank you for standing by. My name is Kelvin, and I will be your conference operator today. At this time, I would like to welcome everyone to the COMPASS Pathways Third Quarter 2025 Earnings Call. [Operator Instructions] I would now like to turn the call over to Stephen Schultz, COMPASS Pathways' Senior Vice President of Investor Relations. Please go ahead.

Welcome, all of you, and thank you for joining us today for this quarterly conference call. My name is Steve Schultz, Senior Vice President of Investor Relations at COMPASS Pathways. And today, I'm joined by Kabir Nath, our Chief Executive Officer, and Teri Loxam, our Chief Financial Officer. Lori Englebert, our Chief Commercial Officer, and Dr. Steve Levine, our Chief Patient Officer, will be available for the Q&A. The call is being recorded and will be available on the COMPASS Pathways' Investor Relations website shortly after the conclusion of the call and will be available for a period of 30 days. Before we begin, let me remind everyone that during the call today, the team will be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as amended. You should not place undue reliance on these forward-looking statements. Actual events or results could differ materially from those expressed or implied by any forward-looking statements as a result of various risks, uncertainties and other factors, including those risks and uncertainties described under the heading Risk Factors in our most recent quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission and in subsequent filings made by COMPASS with the SEC. Additionally, these forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements even if our estimates or assumptions change. I will now hand the call to Kabir Nath.

Thank you, Steve, and thank you all for joining us for today's call. We are very excited that COMPASS continues to make excellent progress on all fronts, in particular, the potential 9- to 12-month acceleration of our launch plans that we announced today. Our first Phase III trial, COMP005, demonstrated a highly statistically significant result for the primary endpoint in June, which was an important derisking event for the company. It was also a clinically and commercially meaningful result which points to the potentially differentiated profile that is emerging for COMP360. We're looking forward to the remaining data from our ongoing Phase III trials, especially from the second Phase III COMP006 trial with its 2 fixed doses, which will be important to help inform dosing for labeling. Enrollment for the 006 trial continued to accelerate throughout the summer. And today, we're pleased to announce the completion of enrollment. This is great news, since it clarifies timing for the remaining Phase III data disclosures and gives us line of sight to our potential filing time line. Following the data readout in June, we had a positive and collaborative interaction with the FDA on our filing strategy for COMP360 in TRD. We're encouraged by their support for acceleration of the planned NDA filing, including the potential for a rolling submission. To enable this, we now plan to unblind 9-week data from Part A of the 006 trial and disclose it concurrently with 26-week data from the 005 trial in Q1, which is likely to be in the later part of the quarter. The 26-week data from COMP006 is now expected in early Q3 next year, which we anticipate will be the last gating item to complete our NDA submission. Given the accelerated time lines, we are also pulling forward our launch readiness,…

Thank you, Kabir. At the end of September, we had cash and cash equivalents of $186 million compared with $222 million at the end of the second quarter. We have continued to be disciplined in our spending, which has allowed us to maintain our cash runway into 2027. Debt under the Hercules loan facility was $31.3 million at the end of the third quarter. Cash used in operations for the third quarter was $35 million, and we expect net cash used in operations for the full year 2025 to be between $120 million and $145 million. This range includes the amount receivable in respect to the R&D tax credit in the U.K., the timing for which is uncertain. As Kabir mentioned, our entire team is focused on strong execution, completing both of our Phase III trials, preparing for our NDA submission and continuing our commercial preparations. We have added resources to our regulatory team to ensure we're moving our NDA filing activities forward as quickly as possible, and we have also pulled forward select commercial activities to meet our new accelerated time lines. We are confident in the emerging profile for COMP360 and its potential to transform the landscape for those living with TRD and PTSD through a potentially rapid and durable treatment option, reinforcing our leadership in the field of psychedelics. As mentioned at the beginning of the call, Lori Englebert and Dr. Steve Levine will also be available for the Q&A. Thank you, and I'll now turn the call back to the operator for Q&A.

[Operator Instructions] Your first question comes from the line of Josh Schimmer of Cantor.

Congrats on the update and time lines. Quick question about selection of specialty pharma partner you may use to kind of support patient access. Have you identified any that you would anticipate to move forward with? And would there need to be any unique capabilities that they have in terms of offering those patient support services to psychiatrists who would be interested in prescribing psilocybin?

Thanks, Josh. It's Kabir. Just checking that you can hear us.

Yes, loud and clear.

Let me pass that to Lori.

Josh, it's Lori. Thanks for the question. We have not made a selection yet. It's a little bit too early to do that. But as Kabir mentioned in the opening remarks, we have done quite a considerable amount of work already in terms of understanding what the distribution pathway might look like to these treatment centers and how that might flow. And now that we're starting to accelerate some of those activities, you can expect that we will start narrowing down what that looks like in the coming months. With regards to your question about any special requirements, again, we're looking through what that might require in terms of how we will support patients once they get -- once we get to market. But there should be nothing unique that's psychiatrists will -- are not -- are unfamiliar with.

Okay. Got it. And then if I may ask one other quick question. You mentioned that sites that are able to administer SPRAVATO currently should be able to administer COMP360. Does that apply to every single site? Or what incremental changes to the office or practice might be needed to incorporate COMP360 into the 6,000 or so sites capable of delivering SPRAVATO currently?

Josh, thanks for that question. It's Steve Levine. The short answer is that we would expect that any site that is delivering SPRAVATO today would be capable of delivering COMP360, if approved. That doesn't mean that it's necessarily one for one in the implementation, but it's exactly why we're doing the work we are with the collaboration sites or strategic collaborations to understand what any incremental changes might be needed. But in terms of the physical infrastructure, the staffing, the capabilities, those all port over directly from their current experience with SPRAVATO.

Your next question comes from the line of Paul Matteis of Stifel.

So as it relates to this FDA meeting, I think you said previously that the thought was you were only going to be sharing with the agency the same level of granularity on the 005 data that we've seen, and I think you've still -- since just seen as well. To that point, do you feel like there's the need to have another FDA engagement after you release this much more detailed data early next year? And then I guess as a second question related to that, can you help set up what your expectation is when we see 26-week data? And what do you think would be a positive outcome on either the frequency of retreatment or response rates for retreatment that would align with your target product profile as it relates to how -- what you're looking for durability and just kind of the commercial sort of viability and scalability?

Thanks, Paul. So yes, on the first one, you're right. From a data perspective, we have no more data in hand. But clearly, we were able to share with the agency, some of what we've announced today in terms of time lines, where we were with 006 and so on. So there was information that we were able to share at that point with them. To your point, absolutely, we would expect with the significant data readouts in quarter 1, that would indeed be the point for another meeting with the agency really to align fully on the plan going forward in terms of rolling submission, what's going to be reviewed when and so on. So yes, that is absolutely the case. For the profile, I'll actually hand to Lori to talk a little bit about that. And again, though, I'd just remind you, contextualize, we are now going to be announcing 26 weeks from 005 together with the 9-week data from 006.

Yes. Paul, thanks for the question. So what we expect to see, and let me just remind you, in order to achieve equivocal efficacy to SPRAVATO, SPRAVATO patients need to receive 8 to 10 treatments to our one that was already demonstrated at the 6-week time line. So already, we are quite differentiated from what's available to TRD patients right now. Everything we see in the 26-week data will only help accentuate what the clinical profile of the product is going to be. And I do want to just caveat that the 005 26-week data that we will release in quarter 1 is after one administration. The 2 administration that we will see with 006, we will also really be looking forward to what that profile looks like at the 26-week data for 006. In terms of commercial liability, as I mentioned, we're already highly differentiated with the one administration getting such profound efficacy in a TRD indicated population. So anything on top of that in terms of durability will help accentuate that product profile.

Your next question comes from the line of Judah Frommer of Morgan Stanley.

Congrats on the progress here. Just curious if any of the interactions with the FDA included conversation around submissions for the commissioner's priority review application. I think you had said at some point, you did have interactions with the agency on that submission. And if not, has the agency pointed toward TRD versus PTSD in any way being higher areas of unmet need in their view?

Yes. So thanks, Judah. Yes, we -- as we've said before, we did apply for a CNPV but we know that hundreds, perhaps thousands of companies applied for CNPV. There was some interaction. But obviously, we've seen the first list. We're aware the commissioner said that there may be more coming. But really, I think our discussions have been with the division, and that's where we've had the very positive feedback that there is momentum there and so on. I think -- from an agency perspective, I think they see both TRD and PTSD as areas in desperate need of new options for patients. I don't know that at the agency level as opposed to shall we say at the political level, there's any distinction there. We are clearly the most advanced with our program, which is in TRD. And that's -- I think we have a very good relationship and good understanding of the urgency of trying to move that forward, subject to data.

Okay. Maybe just a quick follow-up. Any interaction or commentary from the VA within these agency conversations? Or do those kind of weigh on their decision-making there?

So I don't think we could comment on how the VA and FDA interact, but I'll turn to Steve to talk about our interactions with the VA kind of independent of that.

Thanks, Kabir. Judah, yes, we have regular engagement with the VA and have for quite some time now. About 1 year, 1.5 years ago, the VA convened an integrated project team that is specifically tasked with thinking -- early thinking and planning for the implementation of psychedelic treatments, if approved. And that includes senior VA leadership within the Office of Mental Health. We engaged with them on a regular basis. We provided many resources for them to help guide their thinking about what they will need to ensure that there is access within the VA upon approvals. And so that's been a very positive set of interactions.

Your next question comes from the line of Gavin Clark-Gartner of Evercore ISI.

Congrats on the update. So by presenting the 006 data at 9 weeks, do you risk the integrity of the study in any way? Like I know that was part of FDA discussions previously. So I'm curious what led regulators to change their stance? And also curious if by presenting this data at an earlier time point, do you lose the commercial ability to make claims around the durability of the 2-dose regimen?

No. So to be clear, Gavin, I mean, it was our choice in the past, you'll recall that we actually changed guidance from disclosing Part A of 006 to only disclosing the 26-week data in the light of, shall we say, a lot of the confusion and commentary around Lykos at the time. A few things are clearer. First, when really -- given that CRL was published, it actually does not focus on functional unblinding and expectancy as a key issue. There were a whole lot of other deficiencies as well. Second, we will actually have the vast majority of patients through Part B of 006 by the time we disclosed data from Part A. And in our perspective, that does not, in any way, compromise what we may see in Part B, which would also be integral to claims. I don't know, Lori, if you want to just build on that?

No, I agree. And just a reminder, it is double blinded through 26 weeks. So as we present that data to the agency, there should be no hesitation in terms of how we promote based on that data.

All right. Great. That is super helpful. And just a separate topic. What's your current assumption for how the label or the REMS may read on monitoring requirements? Like specifically, I'm wondering if a single versus a group room may be required and if one health care provider can monitor multiple people simultaneously and if any of this was discussed in the Type B.

Thanks, Gavin. It's Steve Levine. It's a great question. I think what you should anticipate is that the label or REMS will not necessarily get into granular detail about the practice of medicine and the delivery of treatment to patients, so much as describing how the studies were conducted. It would be expectable that at the time closest to launch, most sites would likely deliver this treatment in the most conservative way possible with one patient occupying a private room as SPRAVATO was often delivered today. But also taking lessons from SPRAVATO, it's also likely that as clinicians gain more experience and comfort with delivering COMP360, they likely will find additional efficiencies in delivering it and that could include group administration. It could include rooms with curtain bays, et cetera, ways that allow them to move patients efficiently through their centers. And this is also work that we've been exploring in some early work with our strategic collaborations.

Your next question comes from the line of Ritu Baral of TD Cowen.

This is Athena Chin on for Ritu. Could you please review the state of your commercialization preparation for 360 and provide more color on what activities you pulled forward given the accelerated time lines? And then I have another follow-up.

Thanks, Athena. I'll hand that to Lori.

Athena, thanks for the question. So as Kabir mentioned in the prepared remarks, we have done some really incredible work over the past couple of years, specifically with our strategic collaborations as well as our MSLs and then a whole host of other critical components of a commercial preparation such as government affairs, HEOR, we've done some market access for all of that to get prepared for a real solid understanding of what strategy should be. What that actually means is that we understand the marketplace landscape, we understand where the prescribers -- who the prescribers are, where they are, how we might want to ensure that they can seamlessly integrate COMP360 into their treatment practice as it stands today. What we will pull forward and start shifting to is your more fundamental traditional commercial activities like marketing, messaging, figuring out how to structure a sales force, getting an IT infrastructure set up and prepare to ingest data as the sales reps are out in the field. And of course, a lot of that comes with also some market access and payer discussions around the potential to reimburse the product. So we are pulling those forward by several months. And obviously, a lot of that will be contingent, especially the payer discussions will be contingent upon the durability data and a complete understanding of what the 006 data looks like so that we can put together a very nice picture for what the full clinical profile of COMP360 will be to engage in the payer discussions. But a lot of that does not contingent upon doing marketing activities and sales force sizing and things like that to prepare. So we will be ready based on the fact that we have a very strong strategy in place, and we are just pulling forward some of the execution activities.

Got it. And on the filing, are there any outstanding drug liking requirements that are needed or ongoing? And when can we expect those to complete?

No. So as we said on the call, we would -- we do expect 26-week data from 006 to be the final gating items. So everything else in terms of preclinical, CMC, stability, et cetera, will be well in hand before all that. So no, there are going to be no other outstanding requirements.

Your next question comes from the line of Patrick Trucchio of H.C. Wainwright.

The first question is just on the Type B meeting with the FDA. I'm wondering if there was any change from what had been discussed previously. Or just has the agency's tone or the way that they're talking to you about COMP360, has this changed from what you've heard previously, And particularly as it relates to the potential for the rolling submission and how we should think about that? And then I have a few follow-ups.

Yes. No, thanks, Patrick. So yes, I mean, I think it's fair to -- first, as we've consistently said, we have an excellent relationship with the division. We've had breakthrough designation now for a number of years. That's allowed us to have regular dialogue. I think it's been clear for some time that the division sees the potential in psychedelics in COMP360, they see the need. But at the same time, they're going to adhere to exactly the same high standards as they always have, and we're very happy with that, and we will continue to uphold those standards. But yes, I mean, traditionally psych has perhaps not been as forward-looking in terms of rolling submissions and so on as some other divisions. And so in that sense, there was, as we've said, encouragement, a very positive spirit around the meeting. And so in that sense, something of a change in tone, but again, in the context of the relationship that's always been excellent and a very supportive division.

Right. And then as we look ahead, first, is it still the anticipation that there would be an advisory committee? And as you prepare for this anticipated outcome, what key elements of the submission or support model would address questions around safety, support, mechanism of action, any of these other questions? And maybe also as this relates to learnings from that published CRL? And then separately, just on the commercial front. I think in the past, you've said there is roughly 6,000 interventional psychiatry centers capable of administering multi-hour treatment. So I'm wondering, at the time of launch, what proportion of those would be certified and able to deliver COMP360.

Okay. So that last one, I will hand to Steve in a moment. But the question around -- so obviously, it's the FDA's determination as to whether or not they want an advisory committee, and that will depend on when they actually receive data in the review package. All I can tell you is we will be ready. We are anticipating that, that may happen, and we will be ready for that. I think clearly, obviously, we do -- everyone now has access to the Lykos CRL which is helpful. But as we've always said, we have done a comprehensive job of collecting side effects, including positive, shall we say, side effects, euphoria and so on. So I think we have the data to characterize the risk benefit of COMP360 in the way you would expect of any drug. In addition, as we've said, the person in the room is there for safety. It's not a -- they're not there to direct therapy or to intervene, they are there for safety. We have had that then trained to a very standardized protocol consistent across every arm of each study. And as we've talked about before as well, we are doing some sampling of that to ensure that that's in line with the education we've given. So I think, obviously, as time evolves, we will look at our strategy, look at everything we're preparing in relation to the specific concerns that were raised by the agency either in the case of Lykos and other ones, but we will be ready for an advisory committee whatever happens. Steve?

Yes, this is Steve Levine. And as far as the second part of your question about the readiness of these SPRAVATO interventional infrastructure to deliver COMP360 at launch, within our strategic collaborations, there already is a high representation of this concentrated delivery network that delivers SPRAVATO today. But additionally, the bidirectional information exchange that happens within these collaborations helps us to not only understand how to best support these sites and patients at these sites so that they can be activated to deliver our treatment. But because they share characteristics with other interventional psychiatry practices, it allows us to build templates to also be ready to support them. But you'll also note that this network of collaborations isn't exclusively interventional psychiatry. It really reflects the diversity of sites of care where patients living with treatment-resistant depression receive their care today. And although we would expect that some of the earliest adopters would be the interventional psychiatry sites, we are committed to broaden equitable access and that means enabling access in a broader array of treatment sites.

Your next question comes from the line of Sumant Kulkarni of Canaccord Genuity LLC.

Nice to see all the progress. I have a couple. As a point of clarification, what is the key variable that has allowed you to bring forward your time line for commercialization by 9 to 12 months? Is that related primarily to an ability to submit an NDA for COMP360 for treatment-resistant depression ahead of your original plans? Or is it something else? And second, is it fair to assume that you would need to have the Part A from COMP006 and Part B from COMP005 in hand to initiate a rolling NDA submission?

Thanks, Sumant. So a couple of things. First, clearly, the completion of 006 enrollment that has come ahead of expectations. So you'll know that we were guiding until now for second half of '26 for the 26-week data from 006, so we've now tightened that to early Q3. So we've gained a number of months there from there. And clearly, 006 has gone extremely well, particularly over the course of the summer with European sites in particular performing very strongly. So a big chunk of the acceleration comes from our execution on 006. Part of it then does come from the potential to have the agency start reviewing of some modules in line with a typical rolling submission, where, as you know, you can submit preclin and CMC and so on ahead of the full package of clinical data. So there were clarifications around that in the meeting. But yes, to your point, as -- and the earlier question, we would expect another meeting with the agency in quarter 1 with the data, the 26-week data from 005 and the 9-week data from 006 in hand. And that we would expect to be another meeting which would -- actually can formalize the plan going forward.

There are no further questions at this time. And with that, I will turn the call back to the management for closing remarks. Please go ahead.

Thanks, everyone, for participating today. As you've heard, we are extremely excited about this potential acceleration of 9 to 12 months, really based both on our execution around 006, also a good positive dialogue we've had with the agency as well as the decisions we've made about unblinding 006 data in the first quarter of next year. I'd remind you again that we will be talking about PTSD in due course. We're excited about that. We have actually now finalized the protocol on that. We have selected a CRO, the protocol is with them for costing and so on. And so we look forward to announcing that and getting on with that with the potential to have first patient in that in the first quarter of next year as well. So very exciting times for COMPASS. We're thrilled with where we're at. We are ready to move on that accelerated time line. As you've heard from Lori and Steve as well today, a lot of activity on the commercial front, building on the learnings we already have. So we're looking forward to a very engaged and active next 12 to 15 months. Thanks, everyone, for taking part today.

Ladies and gentlemen, this concludes today's call. We thank you for participating. You may now disconnect.