Compass Pathways PLC (CMPS) 2026 Q1 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the COMPASS Pathways first-quarter results conference call. (Operator Instructions) As a reminder, this call is being recorded. I would now like to turn -- to introduce to you your host for today's call, Stephen Schultz. You may begin.

Welcome, all of you, and thank you for joining us today for this conference call. I'm Steve Schultz, Senior Vice President of Investor Relations at COMPASS Pathways. And today, I'm joined by Kabir Nath, our Chief Executive Officer; and Lori Englebert, our Chief Commercial Officer. Teri Loxam, our Chief Financial 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, we will be making statements about our future plans and prospects that constitute forward-looking statements. Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement, including those risks and uncertainties described under the heading Risk Factors in our most recent filings with the US Securities and Exchange Commission. These forward-looking statements represent our views only as of today, and we specifically disclaim any obligation to update or revise any forward-looking statement even if our estimates or assumptions change.

I'll now hand the call to Kabir Nath.

Thank you, Steve, and thank you all for joining us today. It has been a very exciting and productive quarter for COMPASS. The company continues to lead the way in psychedelic science, validated by the confirmation of a rolling NDA submission and review and the award of a Commissioner's National Priority Voucher or CNPV. With our 005 and 006 data announcement in February, we have delivered positive data from both our Phase III studies.

COMP360 has therefore demonstrated what no approved drug for TRD offers, clinically meaningful efficacy with both rapid onset and extended durability. In fact, these extraordinary results redefine rapidity and durability for TRD patients. With only one drug approved and actually used for TRD today, we are confident that COMP360 with its differentiated and compelling profile will be an important option for the millions of patients that have been failed by the many approved treatments for MDD.

After we announced results of our first positive Phase III trial last year and based on discussions with the FDA, we began preparing for a potential accelerated launch. As we've said before, we will be launch ready by the end of this year. We've aligned with the FDA on our rolling submission and review plan and have begun submitting modules for the COMP360 NDA. We will continue to submit additional modules on a rolling basis over the coming months.

Part B data from 006, which we continue to expect in early Q3, will be the final data set to complete the submission. Given the award of the CNPV, we are already working closely with the FDA to enable as much efficiency and acceleration as possible. In addition, based on the executive order, we are accelerating our engagement with the DEA since there is the potential for federal rescheduling to be completed sooner than the current statutory 90 days post FDA approval.

Our 2 large Phase III trials blinded to an unprecedented 26 weeks for psychiatry trials, supported by our large Phase IIb trial has resulted in over 1,000 patients in the program. With comprehensive and strong preclinical toxicology, safety and CMC data, we are confident that we will have a robust NDA submission that supports a COMP360 approval.

We've also continued to make great progress in our commercial preparedness, which Lori will cover in detail. Our strategic collaborations across diverse settings of care, including the interventional psychiatry infrastructure have provided significant learnings. Together with our foresight in establishing CPT III codes specifically for providers to get fully reimbursed for psychedelic monitoring, this has set us up well for a potential near-term launch. We are ramping up rapidly, building out the commercial team with outstanding, highly motivated talent and initiating all activities in anticipation of approval.

In addition to TRD, we are also progressing our program in PTSD, which affects 13 million Americans. PTSD is another significant area of unmet need and an opportunity to expand COMP360 to individuals that have few medical options.

We believe COMP360 can be an important new treatment for PTSD, and it is a very logical next target indication for COMPASS. Our work with the CRO and sites for our late-stage PTSD trial is underway, and we look forward to updating you as it progresses. With both the successful financing and warrant exercises in the first quarter, we have a strong balance sheet with cash that carries us well beyond launch and into 2028.

Let me now hand the call to Lori for more on our commercial preparations.

Thank you, Kabir. Hi, everyone, and thank you for joining. Today, there are 4 million patients with MDD who are considered treatment-resistant. Spravato, the only drug indicated and used for TRD is expected to reach $3 billion in revenue by 2027. And as of 2025, it was treating less than 2% of the TRD patient population. We believe that if approved, COMP360 will reach blockbuster potential by offering a transformative new treatment for the millions of patients who deserve more options.

As Kabir noted, we are pleased to have been selected for the Commissioner's Priority Review Voucher. One benefit of being selected for the voucher includes the potential for an ultra accelerated review timeline of 1 to 2 months after final NDA submission. This provides helpful clarity on timing expectations and allows for more thoughtful and focused planning efforts. Based on the current timelines for data and submission, we remain focused on being launch ready by the end of the year.

Last month, the White House also issued an executive order, recognizing the profound urgency of the mental health crisis facing millions of Americans and the potential impact FDA-approved psychedelics could have. In that executive order, timely rescheduling of approved treatments was stated as a priority. As a Schedule I product, COMP360 will need to be rescheduled at both the federal and state level after approval in order to be prescribed. We are accelerating work with the DEA to ensure rescheduling at the federal level goes as rapidly and smoothly as possible. We have also been working at the state level for the past 2 years to ensure that the states follow the federal rescheduling decision in a timely manner.

Over the past 2 years, we have made significant progress. And today, almost 90% of the U.S. population live in a state that intends to reschedule COMP360 within 30 days after FDA approval and DEA rescheduling. Through this work, we have markedly reduced the time line to launch and for patients to access COMP360 after approval. Enabling broad and equitable access includes ensuring that both COMP360 and provider monitoring time are adequately reimbursed.

Kabir mentioned earlier the work we did a few years ago on securing psychedelic-specific CPT III codes, which will ensure that sites are reimbursed fully for the time required for psychedelic treatment monitoring. These codes are billable by the hour and were designed to cover clinical work and practice expenses incurred with multi-hour psychedelic treatment.

We are also accelerating reimbursement and formulary discussions for COMP360 with payers. TRD has a significantly greater impact on individual's lives and accounts for a disproportionate share of healthcare costs versus MDD. TRD patients accrue 62% more mental health care costs and experienced 41% higher work-related costs than MDD patients.

COMP360 has consistently demonstrated through 3 late-stage trials, clinical effects and a well-tolerated safety profile in a TRD patient population, and we expect payers to respond favorably to the emerging clinical profile and potential value that COMP360 can bring to the health care system. Along with enabling access to COMP360, we want to ensure that the clinical experience for the patient and the site of care is positive. This requires thoughtful consideration of how we deploy the field force and how we educate, train and prepare patients and the sites that will be administering COMP360. Through the insights generated through our growing medical science liaison team, through market research and through continued close work with our strategic collaborations, we have a deep understanding of what is required to enable a well-prepared and well-supported COMP360 experience.

Lastly, but notably, we have been rapidly building the commercial organization in preparation for launch. This includes bringing in an extremely experienced commercial leadership team that has collectively launched over 50 products. This level of experience is remarkable, and we are privileged to have such an impressive team leading launch preparation for COMP360.

COMP360 has the potential to fundamentally change the way that patients living with depression are cared for, and COMPASS is committed to helping as many patients as possible. With COMP360 expected to be first to market in a highly anticipated new class for mental health, COMPASS is at the forefront of shaping the future of psychiatric patient care. We are strongly positioned to successfully launch COMP360, and I look forward to updating you more on our progress.

Thank you. And let me hand the call back to Kabir for closing remarks.

Thank you, Lori. This is an incredibly exciting and defining time for patients and COMPASS. We are confident in the rigor and robustness of our development program to demonstrate the benefit of COMP360. We have conducted our program to the highest standards, which we believe must be paramount in this new field of psychedelic science. We now have data from 3 robust, well-controlled clinical trials that enrolled over 1,000 participants, including over 800 from 2 successful pivotal Phase III trials.

I do want to underscore the difficulty of establishing efficacy in TRD with only 2 medicines ever having been approved despite multiple efforts that COMP360 has consistently demonstrated a clinically meaningful, rapid and durable effect and a generally safe and well-tolerated profile is a remarkable achievement and one that promises to be a transformative new offering for those living with TRD. I want to sincerely thank our investigators, trial site teams and most importantly, the participants whose commitment and trust has made this progress possible. Thank you. And let me now pass the call to the operator for Q&A.

(Operator Instructions) Andrew Tsai, Jefferies.

Congrats on the great progress and the great news. I had two questions. The first one is based on your guys' ongoing FDA discussions, has the FDA given you any inclination whether there will be an AdCom or not for COMP360 because on one hand, the review time lines could be really accelerated and FDA does -- but then FDA does seem to be doing away AdComs. And then I can't help but think that Lykos got one and maybe it could be prudent for the FDA to hold one. So I'd be curious to know what you guys -- where you guys lean here.

Thank you, Andrew. It's Kabir. I'm just checking that you can hear us clearly?

I can hear you, yes.

Great. So thank you. Yes. So it is the FDA's decision and the FDA's only decision around whether or not to hold an Advisory Committee. They will only make that determination once they see the totality of the data we've submitted. We will be prepared for one, and that is in our planning, if necessary. But at the moment, we do not have an indication of whether or not that's likely to happen.

Got it. And then secondly, when you share the 26-week Part B data from COMP006 study, the second one in early Q3, would you consider sharing a cut of the additional 26-week long Part C portion of the 005 study, your first study in conjunction with that top line release? If not in early Q3, then can we expect maybe a cut before you're possibly approved? I figure it's open label and then sharing additional long-term data could be helpful or important for pricing or labeling discussions.

Yes. So I mean, from a timing perspective, you're right that the 52 weeks of 005 clearly run in parallel with that. We haven't made a final determination of what we'll share at what point, but I hear you loud and clear in terms of the value potentially for payers and for commercial purposes. So that's a decision we will come to in due course.

Francois Brisebois, LifeSci Capital LLC.

Very well said on the Francois. Yes, that's great. So just quickly here, in terms of the third quarter data for implications, can you just help us understand maybe what the expectations are? And why -- is it still a gating factor to complete the filing based on the developments that have happened recently? I just want to kind of better understand what that data is and how important it is for launch here?

Thanks. And Francois, may I call you, Frank, please?

Frank is totally fine.

Thanks for the question, Frank. So yes, clearly, and just for complete clarity, we had already aligned on our rolling submission plan with the FDA before the executive order and the award of the CNPV. So we had already fully aligned with the psychiatry division on what we were going to do and the time frames in which we were going to do it. That hasn't changed.

And I think it's really important to note that the CNPV potentially accelerates the end part of this process, the final review, but it's been very clear in our discussions with the agency that in no way does it change the evidentiary basis that's needed for an approval. So from our perspective, we remain on track with the filing strategy we've laid out with a rolling submission, and that does indeed include the 26 weeks of 006, which we see as significant in terms of really finalizing the profile, and again, for commercial purposes.

Okay. Great. And then can you give us a little more color on the reimbursement and maybe the CPT code where maybe the evolution of it? Is there anything else that we need from the CPT angle between now and approval and after? And then just a little more color on -- there's a lot of discussions about the support, the psychological support and kind of the prep and then maybe the amount of people that you would expect to be in a room and their qualifications just on the commercial side, thoughts around those ideas.

I'll hand that question to Steve.

Thanks, Kabir. Frank, on the CPT portion of the question, in terms of the work remaining for the CPT III codes, they are in a Category III form at the moment, which is their tracking form as those codes are reported more and they have started to be reported in a limited number of cases. It really will require our approval and launch for them to be reported in greater quantity. But as they reported, that will enable the American Medical Association with their RUC Committee, which is an acronym for the RVU Update Committee, with representation from APA to do their work to understand the work involved in delivering this treatment in the practice expenses in order for them to make a recommendation to CMS on the valuation for the code.

This is not entirely a black box. It's formulaic. There are analogous treatments to look at in terms of having some expectations coming in for where this valuation may land. But again, ultimately, the codes will need to be reported so the codes can be progressed to the Category I valued form. Ahead of that, there will be the opportunities for negotiations directly with payers by providers for reimbursement of treatment.

On the staffing-related question with how patients will be prepared and what delivery will look like as far as treatment models. Ultimately, those treatment models will be up to sites of care as part of the practice of medicine. Staffing ratios, descriptions of the roles of people involved, the language that will ultimately end up in our REMS will be a result of discussion with FDA in due course during the review period.

We have been guided to expect to this point that the REMS will be consistent with the one that exists for Spravato today as well as what FDA have prepared in the briefing materials for Lykos' AdCom with use language to the effect of a prescriber available, a licensed health care provider on site. And these, of course, are the important elements in terms of having the sufficient experience and training of providers necessary to ensure safeguarding patients.

Paul Matteis, Stifel.

This is Julian on for Paul. Congrats on all the great progress. Just two from us. I guess what are your expectations for retreatment after 2 initial doses versus 1 initial dose, thinking about the 006 26-week data coming out and how you think that will be assessed by FDA with respect to implications for labeling? And then our second question is, from your commercial work, have you been able to identify what proportion of patients being prescribed for Spravato are at large academic medical centers versus private practice clinics? I'm curious how that may or may not influence your commercial strategy.

Thanks, Julian. So yes, on the first question, as you know, from what we've already shown, we saw that there was a 25% of patients had a clinically meaningful response in 005 from that single administration of COMP360, and we saw that that was 40% in 006 with the addition of the second fixed dose. So clearly, we are expecting that higher level of response to be sustained through 26 weeks, but we really do need to see the data to understand what the potential impact of a third dose for those who had it may be and indeed what the second dose after week 3 does for sustained response without necessarily a third dose.

So turning to what that means, and I'll start, but Lori and Steve may want to jump on here. I mean, we are seeking a label that essentially says from 1 or 2 doses and then with further episodic dosing at provider discretion. So that gives discretion because clearly, if somebody responds very well to a first dose, there may not be a need for something within 3 weeks or a short-term period. But equally, we clearly saw so far that there are patients who do benefit from having that second dose 3 weeks apart. So that's how we're thinking about label.

And then I'll hand to Lori and Steve to talk about first that and then the percentage of patients.

I agree with Kabir. Julian, by the way, this is Lori. I agree with Kabir's assessment on what we're seeking for the label, the 26-week data that we're getting from 006, combined with the 005 data is really going to be used to help guide clinical decision-making from the field force as we're out educating providers. So Steve, anything you want to add on that?

No, that covers...

In terms of the Spravato patients being treated in academic centers versus the more -- what everyone calls the interventional psychiatry treatment centers, the academic centers are treating a very, very small portion. It is, I think, less than 5% of patients are actually being treated at academic centers. And so the primary focus of ours will be at launch on the interventional psychiatry treatment centers that are currently prescribing Spravato, which is at about 7,500 already.

And I'll just add to that, that we do engage with many academic centers. We hear a lot of excitement for them about the potential of implementing COMP360. So we do expect academic sites to deliver COMP360. The nuance is that they are typically not built to have high-volume operations. They tend not to treat high volumes of patients. They don't have the kind of throughput that the interventional clinics have. So they will deliver the treatment, but the -- reflective of the breakdowns that we see with Spravato prescriptions, we expect that to be similar with those centers having a higher capacity to treat more patients.

Joshua Schimmer, Cantor.

How are you thinking about the incremental capacity for COMP360 administration at the 7,300 or so interventional pathways? And is there any way to quantify that? And then what percent of the centers do you expect will be adopting the buy-and-bill model for COMP360 early on? And how do you expect that to evolve over time?

Thanks, Josh. I'll pass both of those to Steve.

Josh, good to hear from you. Thanks for the question. So on the capacity side, we know that these centers have existing capacity today. And it's an important consideration when we often get questions about how these sites will make decisions about which treatment to deliver and whether they're making trade-offs based upon reimbursement that they may receive for delivering various treatments.

First of all, these sites know that there are huge unmet needs for the treatment-resistant depression population. They are excited to have more tools available and to have the opportunity to make decisions of which treatment to deliver. But in the meantime, given especially that a Spravato room and the Spravato staffing model are the same as what we anticipate to be required to deliver COMP360, they don't need to make any adjustments in their centers today in order to have capacity to deliver the new treatment. They'll be able to use the rooms interchangeably.

It is likely that within the same day, they may treat a patient with COMP360 and one with Spravato later in the day or that over the course of the week, these rooms may be used for either treatment. So there's plenty of existing capacity that they will first fill prior to adding additional space, should they have the good problem from their perspective of treating lots of patients and running out of capacity, the economics are very favorable for them to add space or add new locations.

On the buy-and-bill part of the question, what we've seen with Spravato is that the penetration of buy-and-bill relative to specialty pharmacy reimbursement has increased over time. We don't know the exact numbers. We believe it's somewhere between 35% to 45% of Spravato prescriptions at this point are buy-and-bill. This is something that the psychiatry model has not been used to prior to the advent of Spravato, but they are beginning to recognize the economic value of processing claims in this way. So we would -- and I'll hand to Lori to augment this, but I think we would expect that in the earliest days of launch, more sites may as they get used to delivering our treatment, initially work with the specialty pharmacy channels, but we would quickly expect them to adopt buy-and-bill and for that to increase over time.

The only thing I'll add there, Josh, is that we will enable both at launch. And so that is just an important nuance to add is that it will be enabled, but we do, from a realistic expectation standpoint, expect there to be a little bit of a ramp to heavier buy-and-bill.

Judah Frommer, MS.

Congrats on all the progress. Maybe just a follow-up on kind of how providers are thinking about potential administration. I think there's a little bit of discussion about whether psychedelic treatments should fit into that Spravato dosing window versus maybe something longer that COMP360 would take. Can you just remind us from the provider's perspective, the economics of turning over a room maybe 2x or 3x for multiple Spravato applications versus maybe a single administration of COMP360 and what the economics look like relative to each other?

Thanks, Judah. This is Steve's favorite question.

Thank you for the opportunity to talk about this, Judah. So yes, exactly as you said, there are inefficiencies with shorter treatments and needing to turn a room over multiple times in a day because this is, I guess, self-evident, but when you have time in between patients where you need to turn the room over to clean it, the administrative work of an additional patient, et cetera, that is a gap that is unreimbursed time. Therefore, if you are able to fill that room with one patient and you are reimbursed for the entire time that the patient is in that room, then that is much more efficient for these sites.

To put some numbers to it, if you consider that a site operating at full capacity, which, as I've just said earlier, doesn't exist, these sites have plenty of capacity. But to be conservative, let's say they're at full capacity. And then let's say they're maximally efficient, which most sites also are not. That would mean they could get 3 Spravato patients in a room in a day.

With average reimbursement for Spravato session somewhere south of $300, but using $300 as round numbers, then that means they're potentially being reimbursed for the room at $900 per day. That works for these sites. That is not ideal necessarily in their minds. And so that's really kind of the target that would be the minimum that they would need if they were just purely making these trade-offs. That makes us very confident that this will make sense for them.

But in addition, if we consider that the observation time for COMP360 will probably be about 6 hours within a typical operating day for these sites, it means they could also most likely get a Spravato patient in that room, too. And since most of these sites aren't having more than one Spravato patient in that room in a day anyway, this is all upside. This is all additive for them.

Ritu Baral, TD Cowen.

Steve, you mentioned the RUC Committee of the AMA. So our understanding is that this committee meets once a year and unfortunately, has only one psychiatry rep and it's very sort of surgeon dominated. Is there anything that you guys can do -- first of all, do you know when this RUC Committee is scheduled for the year? And second, is there anything you can do as far as prep for this committee to sort of optimally communicate the value proposition of COMP360?

And then I've got a follow-up on the DEA discussions. Have you been in communication with the DEA proper? And do you have an idea at this point if communications and review of the FDA will start even before the NDA is complete? Or would you expect that this would still be sort of expedited review on the tail end of approval?

And then if I can just ask a quick follow-up after that. What are your expectations for the REMS insofar as the requirements for administration as well as either preparation and consolidation afterwards? Like what will actually be required by the REMS because we've heard from doctors that that will be absolutely the most important thing.

Thanks, Ritu. So I'll ask Steve to comment on the RUC. I'll take the DEA question with Lori, and then Steve will take the REMS question.

It will be a sandwich. Okay. So starting with the RUC portion. You asked about the date of the next RUC meeting. I don't have the schedule on the top of my head. We can follow up on that. But to the rest of it, you're correct that historically, there has been the overrepresentation, let's say, on the RUC of surgeons and other procedurally focused committee members. That has been shifting, fortunately. I don't know exactly how many psychiatrists are currently sitting on the committee, but there has been an effort to correct the historical imbalance in the representation on the committee.

When we did the initial work on the Category III code a few years ago, we took advice from a number of people, including those who had served on the RUC in the past. So we were very well informed heading into the initial application for the Category III code. We will continue to work with experienced consultants as the code progresses to Category I and make sure that this goes in a direction that is very favorable to ensuring that there is adequate reimbursement to ensure patient access. I will hand over for the second part of the question and be back with you on REMS.

So Ritu, on the DEA, I mean, as you know, the executive order mentions the fact that the analysis could potentially start as soon as Phase III is completed. After further conversation with those who are responsible for that, it's clear that the intent is that the DEA and the FDA can arrive at their conclusion simultaneously. However, it would still be a sequential process. So essentially, we will provide an 8-factor analysis. The controlled substance staff within the FDA will then review that.

Historically, they have submitted their findings at the end of the review period because that's just the way the FDA has worked. That could potentially be accelerated with the DEA then doing their sequential review, with all of this coming together in time on the same day or a day apart at the end of it. That's the intent. Where we will actually get to in practice, we will have to see.

The only thing I'll add is that we are working with DEA consultants as well as accelerating our time lines to what you would traditionally communicate with the DEA so that we can reach a further understanding. But to -- for planning purposes, as of right now, we are not planning for -- we will be ready if there's anything that happens before, but we see no indication that these time lines have shifted forward.

And then back to me for REMS, Steve again. So you're referencing in our clinical trials that we had spent time preparing patients ahead of administration, supported them on the day of administration and then followed them up for safety after. Within a clinical trial context, it was important that everyone had the same conditions, the same experience that everything was highly standardized. And so in that context, we specified a number of preparatory sessions as an example, as well as a standardized length of those visits.

As this translates into real-world care delivery and how this will be guided by the REMS, what becomes most important is not a certain number of sessions or a length of those sessions, just that patients are adequately prepared and they are properly followed up for safety. And so anything that would be in a REMS would be very typical of REMS language and not get down to the granular level of detail of dictating the practice of medicine.

The reality is that with any treatment, there is some preparation and safety follow-up anyway, so much as any necessary language that just gives a little bit of guidance on what activities are important in terms of preparing patients. And that would include being enrolled in the REMS, having informed consent and so on and then ensuring that patients are followed up afterwards as a safety check.

Madison El-SaadI, B. Riley Securities.

A couple from us. Maybe what have you learned about the CNPV mechanics since receiving the award a couple of weeks ago? Should we think of this 1- to 2-month CNPV review clock as not really starting until that final module is submitted? Or has it, I guess, to some degree, already started, which would imply the FDA response closer to 1 month versus 2 months? And then afterwards, an unrelated follow-up.

Yes. So thank you for the question. So our understanding is certainly that, that formal 1- to 2-month goal is following the completion of the NDA submission. However, what it also does imply clearly is an even more flexible and responsive way of working with the agency.

As we've said before, we already have an excellent relationship with the psychiatry division. It's collaborative. It's constructive. It's focused on solving problems. And what we've already seen in the last couple of weeks is that that is even more so. And in particular, some of the standard time lines of 30 days to request a meeting and x days for a response and so on, those have gone away entirely. So this really is about, first, a much more flexible day-to-day interaction with the agency. But no, the actual formal clock about 1 to 2 months as we understand it, will only start with the submission. And again, to be clear, that's a goal. Yes, it's a goal that they can complete it within a couple of months.

Understood. That's great to hear. And then secondly, so many of these sites offer TMS. Based on what we know or what we believe we know about how psilocybin works, how TMS works, do you think there may be an additive or even a synergistic effect from combining these treatments?

That's definitely a Steve question (inaudible) on the call.

Thanks, Madison. Yes, that's an intriguing one. It's something that has been raised to date. It's really a matter of speculation. You can concoct theoretical reasons why there may be synergies.

It would be good to see some data. I know that there's at least one small academic study already looking at the concurrent use of these 2 modalities. I'm sure that the sites that deliver both treatments, both CMS and COMP360 may be interested in that question. And if they do, I hope they track outcomes and we gather data and have some guidance on whether that may be an effective approach.

Ultimately, these sites are ecosystems of care. They offer multiple treatments. They're trying to offer as many tools as possible for these patients to maximize their outcomes. Treatment-resistant depression is, for many patients, a chronic condition, and they will receive many treatments over a lifetime. And so whether these treatments are combined in some way or whether over time, they wind up having multiple of them, we would expect that somebody receiving their care in one of these sites may have more than one of these treatments over the course of their care.

And Madison, if you don't mind, I'll chime in as well. Part of the benefit of us producing the data in treatment-resistant depression is that we believe that there's a huge unmet need. Spravato is the only indicated product -- drug product being used right now in this patient population. And given the frequency of treatment that Spravato requires, it is often patient prohibitive. And so in order for patients to want to receive these type of treatments, it has to fit into their schedule.

And we believe COMP360 brings a very complementary patient profile -- patient-friendly profile to these patients. So we expect COMP360 to be earlier line than where TMS is currently being used right now, which is traditionally one of your later to last lines of treatment.

Patrick Trucchio, H.C. Wainwright.

A few questions. The first is regarding the Phase III trial, the COMP006 for the Part B 26-week data that's expected in the third quarter. Can you tell us, first, just which measures will be released at that time? Is it sort of maintenance of greater than 25% MADRS reduction, remission durability, time to relapse, treatment frequency, patient-reported outcomes and as well as safety? And which parts of those data matter most for the NDA as well as the label and payer discussions?

So Patrick, we haven't yet determined what we would release publicly. From a simple perspective, all of that data will be necessary from an NDA perspective. So clearly, everything, all those endpoints, primary, secondary, all the safety data will clearly go to the FDA. And I'll hand to Lori to talk about the commercial piece.

All of that data will also be important for payer and clinical decision-making, which we will all have in due course to help inform all of those decisions. But in immediate discussions with payers, it will be the redosing and the durability piece that we will -- that we are really looking for so that we can inform payers on how many doses to expect per patient. And Steve?

And just one -- sorry, Patrick, just one thing to add to that, which is similar to what we guided prior to the release of Part B of 005, just to be clear, there isn't a particular bar. There isn't some number that's a measure of success there. It is important data, but it's data to really round out the profile of the drug. And as Lori said, to have discussions with payers to guide expectations clinically with providers. So there's nothing that we're rooting for necessarily. We just need to understand the longer-term trajectories of these patients.

Great. And then just on the commercial side, more specifically, I'm just wondering if you can talk more about just your launch readiness and being ready by the end of the year. And to what extent you've begun that process of hiring a field force and building out a REMS infrastructure and sort of discussed the sort of the structure with payers and distribution contracts and as well related to that, of the 7,300 centers that could offer the treatment or greater than 7,300 centers, how many have you actively engaged with? And what proportion do you think are ready or will be ready to administer COMP360 within the first 3 to 6 months after approval?

So given the work of the strategic collaborations that we've been doing for several years now, which really sets us up for success and also enable us largely to be able to be -- to say that we will be launch ready under such short timelines. I'm going to let Steve answer that last question, and then I'll answer your original question at the end.

We're flipping it around in reverse order. Okay. Yes. So in terms of the sites that we've engaged with and we'll be ready, as Lori said, we've been working with sites like this for quite some time now, whether it's formally within our strategic collaborations, whether it's engagement by our field medical team as they've been out for the past couple of years, meeting with healthcare providers around the country or other relationships we already have with the leadership of these organizations, I think it's fair to say that we've engaged with the vast majority, and we know really quite -- many of them quite well.

It is that level of engagement and knowing them that well that gives me a lot of confidence to say we don't need to encourage these sites to get ready. They're almost more excited than we are. This is really why they've built the infrastructure in the first place. It wasn't to deliver one treatment. It wasn't to deliver Spravato. It was in anticipation of having more treatments, particularly ones with the profile like COMP360.

The feedback we've been getting since the last data release is that they are just so excited for their patients to have a treatment that has this rapidity of effect, this durability of effect, which is on a scale far different from anything they've had available to them to this point. The ability to recruit patients from a much larger radius to the point that Lori made earlier about the burden on patients of the frequency of treatment with Spravato, but particularly with TMS needing to come every day. It's really hyperlocal patient recruitment with COMP360 with just 1 or 2 treatments, they're able to have patients travel for much further area. So they are excited. They are really bombarding us every day with questions of when are you going to be approved? What do we need to know? So they will be ready.

And Patrick, so will we. And so hopefully, you can hear through my and Steve's excitement -- collective excitement here about this particular topic, just how confident we are in the fact that we are not only building out a pretty remarkable team, this team, this leadership team, getting them on board first was very important so that they could start to build out their teams. And all of that is underway right now. So every single aspect and function within a commercial organization has a remarkable leader at the helm, and they are currently in the process of building out and have already expanded the team.

The team has already doubled in the past 2 months. And so we are well on our way of making sure that we are adequately prepared. All that -- everything you mentioned is underway. So compliant payer discussions are beginning right now. The negotiating piece, I just want to set expectations on the negotiating piece with payers. We won't start negotiations until we understand the clinical profile better of COMP360, as we mentioned before, but we certainly are engaging with payers to start those initial discussions right now. Trade distribution is well on its way. We are working there to understand what our distribution strategy is. And again, with some really remarkable leaders and very, very experienced at the helm.

Leonid Timashev, RBC Capital Markets.

I wanted to ask on PTSD. Obviously, another part of the executive order was significant underlying excitement for treating PTSD. So I guess I'm curious how you're thinking about your program specifically, whether there's any changes you're envisioning to the trial, whether you think the evidentiary standards may be lower and you can move ahead with just one Phase III registrationally, and given the focus on veterans from the administration, whether there's plans to explore that subpopulation more deeply?

Thanks, Leo, and I'll start on that. So first, yes, we agree PTSD is a very significant unmet need. As we have said, we are planning that as a single late-stage trial. Obviously, we will have to see what the data says and so on because ultimately, it will be an FDA decision around that. Within that trial, we will have VA sites. More broadly, though, we are already heavily engaged with the VA, and I'm going to hand to Steve to talk a little bit about what that is.

Just before I do, we should also note that it is now, but we are supporting a study within the VA, which is a very robust clinical study, which is a TRD population with heavy PTSD comorbidity. So that study, we're also supporting. But I'll hand to Steve to talk more broadly about the work we're doing with the VA.

Thanks, Kabir. Yes, PTSD is an area where we are really excited. This is 13 million US adults who currently have very few options, terribly underserved. So really excited to be moving this program forward. As a reminder, the design of this study was from the beginning, intended to support registration with a single trial. And so that still remains the aim.

As Kabir said, we already are engaged with the VA in various ways. He mentioned the study that we are supporting. We are supplying the drug as well as the training of the initial cohort of trainers for a large multisite VA study, looking at people living with both treatment-resistant depression and PTSD in addition to a second study as well within the VA.

Beyond that, we have had active engagement for quite some time now with VA's integrated project team, which has been working for multiple years now on their preparations to be able to implement psychedelic treatments as they're approved. So that engagement is robust and ongoing, and it certainly is a priority for us to ensure that as we bring new treatments to market that these are available for veterans.

Sumant Kulkarni, Canaccord Genuity.

I have a few here. First, how do you expect competitive and legal dynamics on psilocybin to play out given the Usona Institute also has a national priority voucher for its product and could already have its Phase III data in-house for major depressive disorder?

So I can only comment on the fact that we, Sumant, at COMPASS have 2 very large Phase III trials where we've already declared the primary endpoint, and we've agreed on a rolling submission and review plan, and that's what we're focused on right now.

And do you expect a label limit on the number of treatments per year for COMP360? And how soon after a patient needs retreatment would they be able to get it in the real world?

So no, but I'll hand from a kind of commercial payer perspective to either Lori or Steve. Lori?

I'll speak to it from a payer standpoint. Steve can speak to it from a clinician standpoint. So I agree with Kabir completely, we expect no limit in the label. We will through negotiations, be discussing with payers what that looks like and if there would be limits from a prior authorization pre-approval process that is not only standard practice, especially with these type of treatments, but also should be expected. But it is, again, not going to be overly onerous for the sites nor again, is outside of the norm of what happens in clinical practice right now.

Well, to answer the last part of your question, Sumant, about the treatment frequency or the intervals. What we've seen so far is that some patients have some benefit from a second administration, whether it's on the fixed interval 3 weeks after the first or on a more variable basis as we saw in Part B of 005. Because the minimum interval we studied is 3 weeks, I would expect that there likely would not be dosing closer than 3 weeks apart. There really clinically would likely not be a reason to. Otherwise, I think the upcoming data from Part B of the longer-term progress in 006 put together with Part B of 005 will help give some guidance to clinicians on how they would think about retreatment. And then otherwise, as Lori said, that will be further guided by payer policy.

Got it. And then last one on PTSD. Other than less frequent dosing, what are the key reasons that would make patients want to take COMP360 versus Otsuka, Transcend's TSND-201, or methylone?

So they are likely to be first. We need to see data in terms of efficacy and safety on both of them, clearly. They are likely to be very different experiences from a patient perspective. These are very different medicines with different MOAs. To your point, certainly, the Transcend protocol hitherto has been more burdensome from a patient perspective as well. But I think we will need to see how those are fully characterized through the clinical trials, we believe, both in terms of patient experience, provider experience and infrequency of administration, there's clear differentiation between them.

And to be clear, there hasn't been an approved drug in PTSD this century. There are only 2 approved options right now. Both are all generic SSRIs that are only modestly efficacious, more options, more options, right? There's 13 million people with PTSD. It is not one or the other. There's not going to be one winner here. We are excited for any new option that is safe and efficacious in this population. The patients living with PTSD deserve to have more treatment options.

Tom Shrader, BTIG.

This is Jinnie Kim on for Tom Shrader. Congrats on all the progress. A couple of PTSD questions. What's the primary endpoint for the PTSD Phase IIb/III trial? And has the FDA aligned on that endpoint in a special protocol assessment? And in the TRD program, the 2 doses of COMP006 were administered 3 weeks apart, but in COMP202 for PTSD, you landed on a 4-week interval. Could you walk us through the clinical rationale for that difference?

Sure. So the primary endpoint is the CAPS-5, which is very well validated as the normal primary endpoint in PTSD. So we are using the standard primary endpoint. And because the CAPS-5 requires a 4-week look back, practically speaking, the second dose has to be at 4 weeks. It can't be at 3 weeks, and that's the reason for that. So it's tied to that endpoint. But as I say, this is the standard endpoint that has been used in PTSD trials. And no, there is no SPA on this. That doesn't need to be.

Jay Olson, Oppenheimer.

Congrats on the progress. Maybe we'll just follow up on PTSD. Could you talk about any synergies that you expect to capture from the infrastructure that you're building for TRD? And also, what are some of the differentiating benefits to psilocybin versus other compounds being used or studied for PTSD? And then maybe just any other indications you're planning to pursue for psilocybin beyond TRD and PTSD.

So we'll go backwards through these. So -- and I'll leave Steve and Lori to talk both about synergies and some of the reasons to believe. So we're clearly very focused on some of these broader neuropsychiatric conditions that do indeed share synergies in terms of patterns of prescribing, locations of treatment and so on. And while we haven't made any determination on other areas, you can imagine there are some such as bipolar II, OCD, in all of which we have seen signals based on IISs and studies we've supported, but we don't -- not yet in a position to lay out formally where else we might go. So let me hand to Lori to talk about kind of the commercial synergies and then maybe Steve to touch on reasons to believe.

Given the high overlap in comorbidities between TRD and PTSD, the infrastructure that currently treats will be the same infrastructure that treats for TRD patients. So the synergies are exceptionally high. Steve mentioned earlier the work we're doing at the VA. Obviously, there's a large focus on PTSD patients at the VA. So we fully anticipate that the VA will be well equipped and ready to treat patients once it becomes available. And from a sales force standpoint, there would be very minimal change to the sales force to add on PTSD.

And then the last part -- nice to talk to you, Jay. One of the things that we saw in our Phase II study in PTSD, one of the reasons along with the opportunity to meet the unmet needs for these patients was the experience that our patients had in that study. We were able to do qualitative interviews with the participants. And we heard some really important feedback that seems highly differentiated from other options that are available for patients living with PTSD or are currently being investigated.

And that is that one of the reasons why people often avoid PTSD care is that they're forced to confront exactly the source of their trauma, which is a very frightening prospect. It can make treatment itself very distressing. It's something that we're aware comes up with some of the empathogenic treatments like MDMA, where these are very intensive sessions. It's the reason why in many cases, these are studied with psychotherapy with trained psychotherapists actively engaging with them as traumatic material comes up.

What we saw in our Phase II study, which was largely focused on safety, feasibility, acceptability was that this was a very acceptable treatment, one that was very pleasant for patients, where the trauma itself didn't even necessarily come up during the experience. And that was something that surprised and was gratifying to them afterwards that despite the fact that they weren't forced to go through such a traumatic experience in getting treatment that they had profound shifts in the emotional relationship to that trauma. And so we think that bodes really well for this -- the further development of this as a potential treatment because of that really positive patient experience.

With no further questions, that concludes our Q&A session. I will now turn the conference back over to management for closing remarks.

Thanks, everyone, for your participation today. As you've heard, we are excited by the fact that we are aligned on a rolling submission and review with the FDA. We were already aligned on that before the award of the CNPV, but that clearly validates and is a recognition of the really great work we've done, the robust data that we have generated. So as you've heard, we are working with the FDA and DEA to see if there are other further opportunities for acceleration.

Most importantly, though, you've heard how excited we are about the opportunity to be to launch a first-in-class psychedelic. As we talk to providers, patients, current employees, prospective employees, everyone truly sees this as the opportunity of a lifetime, and we are delighted to be in the forefront of that and leading the way in establishing psychedelics as a transformative new option for patients in need of new treatments. So thanks for your attention, and we look forward to updating you on our continued progress during the remainder of the year. Thank you.

This concludes today's conference call. You may now disconnect.