COMPASS Pathways plc (CMPS) Earnings Call Transcript & Summary

All right. Good morning, everyone. Welcome to the session of the Morgan Stanley Global Healthcare Conference. I'm Judah Frommer, one of the SMID biotech analysts here. I'm just going to start off with a quick disclosure statement for important disclosures. Please see the Morgan Stanley research disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. With that out of the way, I'm excited to welcome the COMPASS Pathways' team. We've got Kabir, Teri, Steve and Guy representing. So we should be able to have a fulsome discussion up here. Maybe Kabir for those who are newer to the COMPASS story, could we start with maybe some company background and a brief overview of the COMP360 program?

Sure. Thanks, Judah. And just a reminder, we will be making forward-looking statements. So I'd just refer you to our risk factors in our many filings to the SEC. So COMPASS is a company that's dedicated to transforming the paradigm for the treatment of serious mental illnesses. Our lead product, COMP360 is a synthetic proprietary form of psilocybin, and we are currently in Phase III for treatment-resistant depression. And we'll go on to talk more about the size of that opportunity, about the lack of currently available treatment options. There's really only 1 that's currently marketed today. And with that Phase III program, we've had the primary endpoint readout of our first Phase III study. That was the 6-week primary endpoint that came out in June of this year. With that, we are 2 for 2 in terms of highly statistically significant, clinically relevant studies in treatment-resistant depression, building on a very robust Phase IIb that came out now some 4 years ago. We will see longer-term data from our first Phase III study in due course, and we can come back to talk more around that timing. Our second Phase III study is recruiting extremely well. Actually, the positive data from the first one has accelerated our ability to recruit in that. So our second study, and these are not very creatively called 005 and 006, but our second study 006 is recruiting very well, and we are confirming guidance for the full 26-week data set for the second half of next year. Our base case has been that, that data set, the 26-week data from that second 006 trial, is the gating item for a potential NDA preparation. However, we have met with the agency in the last week under a Type B meeting. And given a lot of what we're hearing from FDA, HHS, around the potential for psychedelics and the potential for acceleration. We are engaged with the psychiatry division and a discussion around potential regulatory acceleration. That's where we are.

Great. So maybe just a more point to follow-up on that last statement. What is your sense of FDA's current stance on psychedelic therapies. It seems like it has changed with the current administration, but you're talking to them fairly routinely. So how would you kind of assess their stance?

So I would say we've obviously been working with them now for 7, 8 years on this program. We have breakthrough designation for TRD. It's been highly engaged. We've essentially been solving problems together. I think what's very interesting is just last week, the CRL for Lykos was published. First, there were no surprises in that, but that also showed us the FDA's thinking. They weren't worried about functional unblinding. They were worried about issues very specific to Lykos. So I would say they are engaged. They see the potential. They clearly see the new -- for new innovative treatments. And I think also some of what we're hearing from the HHS Secretary, VA Secretary, others is clearly filtering down and is giving an impetus and a sense of urgency to move these forward. So the final thing I would say is within the psych division itself, there's actually been no changes since January. It's the same people, very engaged, very committed, and we're actually excited about the ability to collaborate and try and move with greater speed.

Okay. Great. Moving into the clinical data, you mentioned the 6-week COMP005 data. How would you say that compared versus the Phase IIb, I guess, specifically on MADRS and safety, but I think those are the 2 areas we get the most questions on. And kind of a sub-question, how has KOL versus investor reaction differed? The stock is basically back where it was prior, but maybe you can walk us through the reaction.

Yes. I think it's worth remembering that our Phase II study was quite a large study, over 20 sites, over 200 patients. So it was a little unusual for Phase II. So you might have hoped that it would be pretty predictive of what happened in Phase III. That is not always the case, of course. And it turned out it really was in this case. In that, we saw a difference up to 6 weeks in the Phase II study of 4.2 in our MADRS data in the Phase II. And we saw -- and we, therefore -- we -- in discussing our expected effect sizes, we emphasized that over 3 would be regarded as good by the field, by KOLs generally, and we came in at 3.6. Now 3.6, 4.2, given the confidence intervals around those numbers are highly comparable. And the statistical significance in both those studies was 0.001. So we have highly statistically significant effects in both those studies that are greater than the 3 points that is usually regarded as the level of clinical significance. So we felt we've done a really nice replication. Remember that the 005 that we've announced the data on was against inert placebo. That was something that the FDA had requested to give a fair safety baseline. And therefore, the second big message really from the readout that we -- the limited readout that we had was that there was no imbalance in suicidality in either the 005 at that point or indeed 006, and that came from the DSMB together with the -- time together with the readout. So those are the 2 ways in which they're complementary to the Phase II. So we have a comparable efficacy, and we have a confirmation with greater safety perhaps than people had thought we had in the Phase II with larger numbers.

Okay. And then just maybe on kind of KOL or clinician reaction versus investors?

KOL, I mean, the evidence that the KOL reaction, our KOLs are mainly PIs and the PIs in general, regarded this as a very strikingly positive finding and the sort of proof of their conviction, we've had an acceleration in our recruitment into 006. So we've seen people actually behaving as well as saying that they think they're impressed by this.

Okay. And you touched on it, maybe just can you further emphasize the trial design differences between 005 and 006?

Of course, yes. So 005 was a single administration, 25 milligrams psilocybin COMP360 versus inert placebo and 006 is 3 doses, that is, 3 doses, 25 milligrams, 10 milligrams or 1-milligram. The 10-milligram really ensuring that the study is as blinded as is possible to what the true dose being received is. And that is administered twice, once at baseline, once at 3 weeks, again, with a readout, the primary outcome of 6 weeks. And this gives us additional confidence given the size of the study. It's powered to detect pretty small effect actually. We think the effect, in fact, will be bigger because we've seen that in other people's data and indeed in data generated with COMP360. So we anticipate a larger effect in 006 and a more sustained effect. Obviously, time will tell whether we're correct in that.

Okay. Great. And I think one thing we bump up against is this perception that the 26-week data from the second Phase III trial, 006 in the back half of 2026 is the next material catalyst for the company. But there is more happening near term. Maybe would you be able to walk us through the catalyst path over the next 12 months, what we could learn from the next 005 update that could inform the 006 data?

Yes. I mean I'll just put the timing there and then turn back to Guy. So the 26 weeks of 005, I mean, clearly, people -- given that we declare the 6 weeks, people to work out mathematically, that data should be in hand roughly in first quarter. However, we have said we're going to gate that on every patient being through Part A of 006, just the first 9 weeks, so that there's no suggestion of influence. But Guy, in terms of what we can expect to see potentially in Part B of 005.

Yes. I mean one of the things that we will get is the effects of retreatment because we designed the study to allow retreatment with the original dose of the drug that patients have received. And that, of course, is going to allow us to make some predictions about the way in which the drug is likely to be used in clinical practice. So we're going to see people who've not responded particularly well to a single dose get retreated. We're going to see whether that essentially compensates for a single administration. We're going to look at durability in that phase. This will all be blinded and that gives it an additional value, of course.

Okay. And we will have a full safety data set. So that will also help, I think we will have the full safety profile.

Okay. Got it. Another area we get questions on is kind of background SSRIs. So how do you anticipate communicating exploratory data from patients who elect for SSRI treatment during 006, and could this support future combination therapy positioning?

Well, we'll have data because in the Part C of the -- both studies, patients will be eligible for an open-label administration 25 milligrams, and a number of them will have gone on to SSRIs because that's one of the options in Part B. So we will have quite a lot of experience of the safety and indeed the apparent efficacy unblinded of that treatment.

In a moment, I'll pass to Lori and Steve to talk about that what that is in the real world. But just from a regulatory perspective, though the studies are indeed monotherapy, typically, precedent would suggest the label will be broad. If you study only adjunct, you will likely get only an adjunct label. But by studying monotherapy and having SSRIs added on during the course of the study, you are likely to get a broad label on that.

Yes. And I agree, it will be very important data for us to generate because that will be real-world practice, and physicians will need that guidance as they decide when to administer COMP360.

Okay. Another kind of development of the company relatively recently that ties into the regulatory environment is your decision to participate in the Commissioner's National Priority Voucher, the CNPV program for COMP360. So -- can you just walk us through the rationale for doing that? And do you have any sense on time lines, or what you could potentially hear around that?

Sure. So this was something that was announced, I guess, a couple of months ago, and there are essentially 5 criteria, and you had to meet at least 1 of them. We clearly meet 3 of them, which is an area of significant unmet need, lacking new treatments, a public health emergency and something that is in and of itself innovative. And indeed, the criteria call out the treatment of mental health, particularly PTSD. So the submission is actually straightforward. It's 350 words. So we assume that every biopharma company and every biotech company did indeed submit an application. I can tell you, we have had engagement, which suggests that we're not at the bottom of that list at least. So we have had engagement with the agency. There has been to and fro on that. I think just yesterday, I believe the commissioner here, we were in investor meetings, so sort of barely, he said he is -- they are planning to announce 10 to 12 pilots in a matter of weeks or whatever. I think we know there is a lot of talk about psychedelics, the desire to accelerate. Our focus as COMPASS has been, given where we are in data generation in our program, we are the closest of any psychedelic companies for a potential regulatory approval. We've also been in surround sound on the Hill to kind of make that point as well. I don't know, Lori, if you want to comment on that.

Yes, I think it's very important for us and for patients to make sure that the standards are not reduced that we are just simply talking about accelerating as fast as possible and working with the agency, and what for other divisions as normal pathways. And so on the Hill, we have been doing just that. We've been spending a lot of time there making sure that we're educating on, we're not advocating for any exceptionalism. We are advocating really to make sure that they are aware of COMPASS, aware of the clinical trials and the rigor that we are putting behind them to ensure patient safety.

Okay. That makes sense. And then maybe just a couple of comments on how you're thinking about the ex U.S. opportunity. Has there been engagement with ex U.S. regulators outlook for potential global registration pathways?

So yes, so when we designed this 005, 006 pair of Phase III studies, we took scientific advice. We've taken supplementary scientific advice from 3 countries actually a couple of years ago. But from a regulatory perspective, these 2 trials together should be sufficient to deliver a CHMP approval potentially, obviously, subject to data and so on. We have engaged with MHRA. We have the so-called ILAP, and I'm afraid you can't test me on what it actually stands for, but it is an innovative program that brings together MHRA and [indiscernible], and we've had positive discussions there. Beyond that, beyond Europe and that, we haven't actually engaged more broadly. And while we believe we have something that is certainly from a regulatory perspective, viable, the likelihood is at some point, we would seek to partner some of the ex-U.S. opportunities.

Okay. That makes sense. I think the kind of the next area of focus tends to be potential commercial launch plan. So how many treatment centers are you targeting? How equipped are they to support an accelerated approval scenario if that's the direction that it goes?

Yes, it's a really good question. I might want to just step back a moment and paint the landscape of what the addressable patient population looks like. So right now, there are 9 million MDD patients being treated with antidepressants. These are your antidepressants that you get in a retail pharmacy and patients take on a daily basis, sometimes twice a day. When Spravato launched in 2019, they were effectively the only product used for treatment-resistant depression. So of those 9 million MDD patients, there are 3 million that are classified as treatment-resistant because they have been failed by 2 prior antidepressants. There are only 2 products approved by the FDA right now to treat treatment-resistant depression. There are 50-plus approved to treat MDD. And the reason that number of 3 million is so high or 1 of the reasons that, that number is so high is that it's very hard to prove efficacy in the treatment-resistant depression population. So when Spravato launched in 2019, the infrastructure to have a different way of treating, so a therapy that -- or a treatment that requires hours of monitoring after administration, that was a very minimal infrastructure setup. Fast forward to now 2025, there are over 6,000 sites setup for multi-hour delivery of treatment in these centers. That number is growing very rapidly. They are 6 years post launch when they're supposed to technically be slowing down. They're growing 30% year-over-year. So the interest in understanding the work that J&J has done, we will be able to leverage. The infrastructure is there, 6,000 sites, about 5,000 HCPs. We know who they are. We're doing a ton of work through the strategic collaborations, and Steve can speak more to that if of interest to really understand what barriers could be in place once we get to launch, we will be first-in-class. We take that very seriously. We want to make sure that any barriers are removed and part of understanding those 6,000 treatment centers, work with the strategic collaborations will help us achieve that.

Okay. Maybe you can talk about whether your initial patients need to be Spravato switches necessarily and maybe some of the dynamics at these treatment centers in terms of whether a Spravato room would have to be converted to a COMP360 room. I think there's some perception that these 6,000 centers are kind of peak potential and that the number of rooms available are currently being filled. But can you help us with some of the dynamics there? Do you need to necessarily take share from Spravato, it sounds like not.

Yes. I can speak to this from the perspective of a psychiatrist who spent 2010 to 2020 treating thousands of TRD patients through a nationwide network of interventional psychiatry practices that I had built initially delivering ketamine, but later Spravato once approved in 2019 and other interventional treatments. Lori covered the unmet need quite well just before, underscoring that there are 3 million patients living with treatment-resistant depression, only 50,000 to 60,000 of whom are currently receiving Spravato. This does today largely happen within interventional psychiatry practices. And a Spravato room is a COMP360 room. The staffing required to deliver Spravato is the staffing required to deliver COMP360. And so to your question about whether that requires then pulling from rooms that are currently delivering Spravato, it will likely be a mix. There's currently capacity in the system. So there isn't necessarily an immediate need to build additional capacity. It's there and waiting. It's likely that we will see some switching, but the reality is there are so many patients who are currently underserved that doesn't necessarily need to be. If those rooms are filled up and that would be good news for patients because it would mean that they are being better served than they are today, then these centers would likely be very happy to build additional capacity given that the economics are very favorable for them to do so.

Okay. That makes sense. And speaking of the economics, you've highlighted hourly reimbursement codes as being supportive. Can you expand on payer engagement, and how reimbursement might work in practice, what's different versus what Spravato has in place for COMP360?

Maybe Lori can cover the payer engagement piece. But just in terms of the provider perspective on the provider economics of delivering this treatment, as you mentioned, a few years ago, we did work to receive new CPT codes. We applied to the AMA. Those were granted. They went live in January of 2024. These are specific to the administration of psychedelic treatments. And as you pointed out, they're reportable on an hour-by-hour basis. So regardless of the length of that administration, providers will be fully reimbursed for that time. That relates directly to a bit of a myth that's out there that should be dispelled, which is then that shorter is better. I think because of the success of Spravato now being on a $1.7 billion run rate and that being a roughly 3-hour treatment visit, the assumption that for a psychedelic treatment to be commercially viable, it would need to fit within that time window. The reality is, though, that, again, given that the codes are reportable hourly, if you can have 1 patient in that room for the day and be fully reimbursed for that time, that's actually more desirable than having a shorter-acting treatment given that with shorter-acting treatments, you would need to turn that room over multiple times in the day to realize the same revenue. That comes with significant additional operational complexity as well as administrative work and cost. You have to clean that room, there's REMS compliance, the controlled substance storage and handling, not taking, prior authorization, a lot of work goes into the care of each of these patients. So actually, it's superior to have the longer-acting treatment.

Got it. And maybe just on the...

Yes, happy to. So just to level set, the payer engagements would be to ensure that the drug is reimbursed for the patient. And those engagements -- constructive engagements are a bit premature just by the simple fact that we only have 1 data point from a Phase III, once we fully characterize what the clinical benefit will be and the economic benefit to payers will be -- then we will have more constructive discussions. However, we are engaging with payers, mostly because, one, they -- psychedelic's will be first-in-class, and they need to make sure that they are aware and understand the rigor behind the clinical trials that are being conducted through COMPASS. And also, it should be noted, again, TRD is a high burden to the payer system from a patient standpoint, and I hate speaking about patients that way. But they understand that, and they understand that Spravato is the only one who's proven clinical efficacy in that patient population right now. And so we are hoping for a favorable outcome, especially if we can show durability beyond even the 6 weeks, which is already beneficial to patients.

Okay. And maybe just one more from the provider perspective. We got the question on patient monitoring, how patient monitoring is done within the trials versus how it could be done in the real world, and how that might compare to Spravato or any other, like you said, longer-acting treatment in one of these centers?

Yes, I can cover that. So with -- we'll start with Spravato. Most people are familiar with the 2 hours of monitoring that's required within the REMS for Spravato. There is some additional time, which is that it takes for the patient to self-administer the nasal spray, which can take up to 20 to 30 minutes. That administration needs to be directly observed by a health care provider. At that point, the 2 hours of monitoring doesn't need to be continuously eyes on. However, there's somebody coming in and out of the room to check vital signs multiple times as well as to check on the patient. So it's pretty active in terms of the level of supervision that happens with Spravato. We anticipate something very similar with COMP360. There's another misconception out there that there's some form of therapy happening with these treatments. But the reality is that with a classical psychedelic like COMP360 psilocybin, this is a quiet internal experience where patients are typically lying down, wearing an eyeshade, listening to a playlisted music, and there is an interaction with the supporting monitor. So we do expect that the staffing, the ratios, the requirements in terms of the in-office support will look pretty comparable to Spravato.

Okay. Got it. Maybe just moving to the next potential indication. PTSD, when do you anticipate finalizing the PTSD pivotal trial protocol, and what's expected time line to trial initiation there?

Yes. So we're in the process of financing. We got some agency feedback, but we are right now in that process. And we would have hoped to start a trial early next year.

Okay. Great. And can you give us any sense for, I guess, addressable market for PTSD versus TRD kind of how should investors be thinking about that?

Yes. There are 2 -- well, there's lots of components to think about, but there are several areas to think about from a commercial synergy standpoint. So these will high overlap TRD patients, very similar to PTSD patients treated in the same types of centers. So the synergistic approach from what we're rolling out, and we'll roll out for TRD will apply here. So it's about 13 million patients right now that are experiencing PTSD, may be surprising to some, but veterans is not the highest percentage of population. That population is typically around 10% to 15% of PTSD patients. Women are actually the larger component here. And so that's important to understand. The other thing that's important to understand is there's been a tremendous lack of innovation in this space. It's been 20 to 25 years since the last product was approved, and there are only 2 FDA-approved to treat PTSD.

Okay. Great. Maybe I should have asked this question earlier. But it seems there is some level of interest in non-hallucinogenic psychedelic agents. So can you help us with the therapeutic case for retaining the hallucinogenic experience in COMP360? And I guess, how do you think about kind of that comparison more generally?

Guy?

Well, I'll start, but Steve can obviously chime in as well. I mean, pragmatically, what we find is that the intensity of the most characteristic psychedelic experience is predictive of outcome in all our trials. So on the face of it, it looks pretty important. Clearly, there is associated that experience a change in brain, and it's possible that the 2 are somehow dissociable. But Occam's razor suggests you should look for one hypothesis and my hypothesis would be that the 2 are related. And therefore, I'm personally skeptic, but I'd be convinced by different data.

Yes. Guy covered that well. The only thing I'll add is that we don't think of treatment-resistant depression as a winner takes all environment. The size of the unmet need is too large. We hope, there are multiple new treatments available for these patients. Right now, the data is very early on non-hallucinogenic, so we'll see. But again, hopefully, we will, over time, see multiple approvals for this population.

Okay. And then maybe just 1 from the patient perspective on longer acting psychedelics versus shorter duration, whether they're psychedelic or not. I guess is there this recognition from patients that whichever therapy works regardless of how long it takes is the right way to go? Or does it seem like there's a patient preference to get in and out of the clinic. I think there's some misperception about how quickly you're back on your feet post-Spravato. So maybe just help us from a patient perspective there.

Yes. Again, both speaking from the perspective of experience as well as a lot of work that we do already with patient advocacy groups, the idea that somebody is going back to work after having Spravato or potentially one of the other shorter-acting psychedelic treatments in development, very unlikely. So for a patient, the day is a day. And there's also the consideration of their caregiver given that they need to drive patients to each of these treatments. And so going back to where we started with our top line data from 005, the effect that we saw at week 6 after a single administration versus Spravato, where in their pivotal studies in the first 4 weeks, there were 8 administrations to get to their primary endpoint, which was comparable or 10 in the first 6 weeks. It really can't be overstated the difference in the level of burden to patients and their caregivers as well as to clinics, by the way, because that frequency of treatment can be challenging for capacity. So yes, I think for patients, a day into a day, and they tend to find the day in our trials to be an immersive, relaxing and often meaningful experience.

Okay.

And I think it's important to stress that not all psychedelics are created equal. So the patient experience between ketamine, MDMA, psilocybin, 5-MeO-DMT are radically different. And ultimately, there will be a significant degree of both patient and clinician preference also that actually drives this marketplace.

Okay. Great. And maybe just 1 follow-up there. We do get a question, I guess, if you had to look into your crystal ball, what could, I guess, annual dosing look like? What's the range that you're thinking about?

At the moment, we're seeing 3 to 5 annually. But again, the Phase III will clearly inform that. And just as a reminder, with 006, we obviously have the 2 as it were initial doses. So depending if that hypothesis does play out, if we see better efficacy and so on, it will be probably 1 or 2 initial doses followed by up to 3 or 4 in the remainder of the year. But again, we need to see the data. And there will be a wide distribution. Everyone's not [indiscernible]

And it's highly likely that the label will not dictate what that looks like.

Got it.

And I mean, we don't know. So I should heavily caveat that. We don't know. But it is likely that it will not mostly because of the variation that we will likely see. So it will be -- the burden is on us to generate enough data to make sure that we can inform clinical decision-making along the way.

Okay. And maybe just last company specific one. Anything that we didn't discuss here maybe you could throw in cash runway and then what that's funding, but anything you'd highlight that we didn't touch on yet.

Yes. So let me just cover cash runway. We are -- we have runway into 2027. That contemplates the completion of the 2 Phase III trials, but also setting up this late-stage trial in PTSD. So I think clearly, while interest in psychedelics is increasing, I think there's an increasing understanding of the regulatory risk being discharged. We talked a little bit about that regulatory interaction. We're confident in the results of 006. So from a development perspective, we think we're in a very good place. Clearly, the fact that we will be the first psychedelic to come to market, both first and psychedelic are carrying a fairly significant discount in some investors' eyes. And I think there, people truly understanding that the Spravato infrastructure, just how much of a leg up that actually gives to us from a point of commercial launch planning, but also the work that Lori and Steve have talked about in terms of what we're doing across strategic collaborations, the work we're doing with KOLs and so on. So I think people perhaps don't fully perceive how these 3 legs are coming together now and putting us in a really strong position. I think the other thing to say is psychedelic drug development is hard, and you're seeing some other companies have some delays. So actually, the gap from us to others potentially coming behind, whether in TRD or MDD is actually getting bigger.

Got it. Okay. I'm going to move into kind of a mini survey that we're asking all the management teams. If there are any questions in the room, feel free to raise your hand. There are some mics if there are audience questions. The first amount of question, I might alter it a little bit for you guys. So the first theme is Chinese biotech. So maybe you are, maybe you're not. Like it does -- the rise of Chinese biotech impact your business decisions day-to-day. But maybe I'll layer on top of that, I think kind of the 1 of the underlying premises of that question is an IP question. So maybe it's worth highlighting the IP for COMP360?

Yes. That's right. And yes, we are not focused on China. I'm not sure that anyone is going to be looking at mind altering something in China too soon. Yes. So our IP is around psilocybin is clearly a known entity. We actually -- when the company was founded, the first work was to establish a novel polymorph that is stable and scalable. So we have a series of claims around actually 3 different polymorphs. Those patents as soon as they were published were actually challenged for a PGR here on the basis of obviousness, all those challenges were beaten back. So those patents stat. So our core is polymorph patents that last to 2038 before patent and extension. We then have formulation methods, indications behind that, but that's at the core of our strategy. We will also get NTE exclusivity presumably because we are -- if this will be the first time that psilocybin has been filed, and it is an NTE therefore.

Okay. Great. Second theme is AI. Is there a way that COMPASS is leveraging AI or thinking about potential for AI to disrupt the space in any way?

So I mean, we -- like anyone, we're using it as a productivity tool. That's kind of not interesting. I mean we have done work, and we actually have digital tools in terms of both an app and some technologies behind that. We are required to record all interactions. And so we have the transcripts of that and have done some very interesting work around that and actually seeing whether from what you see in sessions and so on, you can actually get to any sort of predictive power. Now in psychiatry, that's the holy grail for everyone to get to kind of predictive power or whatever. So we're doing the same as others in that space. I don't know any other AI comments anyone has.

The only thing I'd add is from a commercialization standpoint, AI could potentially help from more streamlined targeting and messaging rollout. So we will obviously be exploring that once we get closer to commercialization.

Okay. Great. And last, most relevant to you, and you certainly touched on it throughout the session. On the regulatory side of things, changes at FDA pricing, tariffs, any regulatory topics that are kind of top of mind, I would imagine FDA, but...

Yes. So I mean, obviously, as a pre-commercial biotech, neither tariffs nor MFN or pricing right now are kind of things that we're focused on back to your earlier question, as you think about a global strategy, clearly, how you think about pricing will come into that. The big one for us is regulatory. And as I said, from a day-to-day FDA perspective, there have been no changes in the psych division. They remain engaged. It's the same people we're dealing with. But clearly, there are a number of voices talking about the potential for psychedelics. There have been public comments about the need to accelerate psychedelics. We have applied like everyone else for one of these Commissioners' National Priority Vouchers. I would say we are clearly seeing regulatory flexibility that is positive and a sense of urgency that's very refreshing. But to build on a point Lori said earlier, we are not asking for psychedelic exceptionalism. These need to be held to the same standard as anyone else. We are conducting 2 very large, very robust Phase III trials, and that will continue to be the standard in psychiatry.

Okay. Great. If there's nothing from the audience, we are out of time. So thanks again.

Thanks very much, Judah.

Thank you.

Thank you.