COMPASS Pathways Plc

Good day, ladies and gentlemen, and welcome to the Compass Pathways fourth quarter 2023 conference call. At this time, all participants are in listen-only mode. As a reminder, this call is being recorded. I would now like to introduce your host for today's call, Stephen Schultz. You may begin.

Welcome, all of you, and thank you for joining us today for our fourth quarter 2023 results conference call. Again, my name is Steve Schultz. Today, I'm joined by Kabir Nath, our Chief Executive Officer, Mary Rose Hughes, our Interim Chief Financial Officer, Terry Luxem, our incoming Chief Financial Officer, and Dr. Guy Goodwin, our Chief Medical Officer. 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 archived 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 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 statement, even if our estimates or assumptions change. I will now hand the call over to Kabir Nath.

Thank you, Steve. Good day, everyone, and thank you for joining us. Let me begin by thanking Mary Rose Hughes, our Interim Chief Financial Officer, for her tremendous support over this last quarter. And let me welcome Terry Lockson back from climbing Mount Kilimanjaro and into the CFO role starting tomorrow, March the 1st. Terry brings to Compass deep, extensive strategic experience working for publicly traded companies in the pharmaceutical and biotech sectors. Her broad experience through all stages of development is precisely the expertise and leadership that Compass requires as we progress our phase three program in treatment-resistant depression. Many of you already know Terri, and I hope that over the coming months, the rest of you will have the opportunity to meet her. And in a moment, I'll ask her to provide a few thoughts on her new role at Compass. First, though, let me report that Compass continues to actively recruit both our Phase III Comp360 trials in treatment-resistant depression, with top-line data expected this year and next. While our overall Phase III clinical program completion remains on track with top-line data from the 006 study expected in the middle of 2025, we are experiencing some recruitment delays in the 005 trial, which extends our guidance for top-line data from that trial into quarter four of this year. Importantly, this change in guidance does not impact expected timing regarding submission of our NDA filing. As we've consistently guided, we do expect that both trials will be required for NDA submission, consistent with the FDA's draft guidance for the development of psychedelics published in June last year. We will also have all necessary preclinical and clinical pharmacology studies for a complete NDA dossier. In parallel with the Phase 3 trial program, we continue to take the steps needed to ensure a well-developed delivery network for Comp360, if approved. This includes developing collaborations that will educate both Compass and Settings of Care on how Comp360 may fit into treatment options for appropriate patients. A key element of these research collaborations is to explore and develop multiple potential commercial delivery templates to ensure a successful rollout of Comp360 treatment subject to FDA approval in different care settings. Earlier this quarter, we announced the first two such collaborations with Greenbrook TMS and Hackensack Meridian Health, which are two very different but equally important collaboration partners. These collaborations will explore how to improve the patient care experience and gain a better understanding of potential commercial models for the administration of COM360 psilocybin treatments. We also expect to announce additional research collaborations this year. In December, we announced initial safety data from our open-label phase two clinical trial of a single 25 milligram dose of Comp360 in 22 people living with post-traumatic stress disorder, or PTSD. We were also pleased to see the publication of Comp360 data from an investigator-initiated study in bipolar type 2 in JAMA psychiatry. In a moment, Guy will provide more information on both of these studies. While TRD is our lead indication for Comp360, we see logical expansion of its utilization into additional indications where there are significant co-morbidities and overlaps, such as PTSD and Bipolar II, subject to additional financing. With that, let me now ask Teri to introduce herself and share a bit about why she came to Compass. Teri.

Thanks, Kabir. Now that I'm back at sea level, I'm really happy to be joining you in this experience in pioneering leadership team. Similar to many, I've sadly witnessed the impact of mental health issues on people close to me. So a big draw for me to the company was seeing Compass fully embracing its mission with a thoughtful, innovative, and data-driven approach to tackling significant unmet need in this area. Psychedelics and their potential to treat mental health conditions have received significant attention in the media, but we are still very much just at the beginning of this journey. While psychedelics could be transformative to mental health, in these early days it is critical for companies to build and execute robust clinical trial plans to realize the long-term potential. This is precisely the approach Compass has taken with its large Phase II and ongoing Phase III programs in TRD. There are a lot of important milestones over the next 12 to 18 months for the company, and with a strong balance sheet and an experienced team, we are well positioned for success. I'm really looking forward to working with the team to help shape the landscape and prepare for this potential important treatment option for patients. With that, let me hand the call back to Kabir.

Many thanks, Teri. Welcome once again, and it's great to have you join our leadership team. Let me now hand the call over to Guy to update you on clinical news during the quarter. Guy? Thank you, Kabir. Looking at the Comp360 pivotal program, nearly all sites have been initiated for Comp005. For the 006 trial, we have sites initiated in the US, Canada, UK, Ireland, Sweden, and Spain. I anticipate further progress this year. Patient demand is strong in all geographies, which, as expected, reflects the degree of unmet need in this population. However, as Kathira said, we are experiencing delays in recruitment in our 005 trial. As we've said before, these trials are complex. Beyond the schedule one drug authorizations and unique handling requirements and redosing protocols, we are formally confirming every patient's TRD diagnosis, an important element to the quality of this program. This has been a challenge that medical record keeping is decentralized in the US and has slowed the pace of screening and enrolling. However, now that nearly all 005 sites are open and with the addition of resources, we will see an increased pace of recruitment, which should help improve enrollment. The challenges we have encountered are specific to U.S. clinical sites, and as could be mentioned, we don't see the same impacts to COMP006, a global trial which remains on track. Separately, we're also excited by the potential for COMP360 in other indications. PTSD is an additional indication of interest, which we have investigated in an exploratory phase 2 safety study of 22 patients, all of whom were administered a single dose of 25 mg COMP360 psilocybin. We announced initial safety data in December, which demonstrated that Comp360 was well tolerated after 24 hours, and the safety profile was as expected, with no treatment emergent serious adverse events recorded. The study participants have been followed for 12 weeks, and we look forward to announcing the full PTS data set, including efficacy, later this spring. In addition, as Kabir mentioned, the full results of an independent investigator-led study in bipolar type 2 depression were published in JAMA Psychiatry. These data, first announced in 2022, demonstrated the potential for investigational Comp360 psilocybin treatment in another difficult-to-treat depressive disorder. The study was conducted by Scott Aronson at Shepherd Pratt in Baltimore and funded by Compass. It investigated the safety and efficacy of a single 25 milligram dose of Comp360 psilocybin treatment with psychological support. The primary endpoint was change in MADRS total score from baseline to week three. All 15 participants had lowered MADRS scores with a mean change from baseline of minus 24 points at week three. 12 participants met the criteria for response and 11 met the criteria for admission. While this is a small trial, we see the results as extremely promising. Importantly, there was no increase in the suicidality score based on madras, and no unexpected adverse events or difficulties with the dosing sessions over the 12 weeks of the study. We did not see the onset of a manic, hypomanic, or mixed state, which is a particular concern for patients with bipolar disorder. The most common adverse event was headache, reported by four out of 15 participants on the day of dosing, with symptoms resolving within 24 hours. People living with bipolar II depression, like those living with TRD, have limited or no options, so it's encouraging to see early signals that COM360 psilocybin may have potential to help those living with these depressive conditions. As Kabir indicated, based on this study's results, bipolar type 2 looks to be an indication of interest for the use of Comp360 and additional larger studies are under consideration. This is a good fit with our mission as a company. Let me now hand the call to Mary Rose for financial overview. Mary Rose.

Thank you, Guy. I'll now step through the full year financial results. Cash used in operations in the full year 2023 was $97.4 million. Within the guidance range, we provided for the full year last quarter of $94 to $100 million, excluding the R&D tax credit. The timing of receipt of the credit is uncertain, but I'm pleased to confirm the HMRC have since approved our claim in full, and we now anticipate receiving the tax credit in the first quarter of this year. For the year ended December 31st, 2023, net loss was $118.5 million, or $2.32 per share, compared with a net loss of $91.5 million, or $2.16 per share, during the same period in 2022. These results include non-cash share-based compensation of $17.3 million in 2023 and $13.1 million in 2022. R&D expenses were $87.5 million in 2023, compared with $65.1 million in the prior year. And G&A expenses were $49.4 million in 2023, compared with $45.4 million in the prior year. Long-term debt under our Hercules loan facility was $28.8 million at the end of the fourth quarter. Regarding first quarter financial guidance, We expect net cash used in operations to be between $17 and $23 million, which assumes that we received R&D tax credit in the first quarter. However, as I've mentioned already, the timing is uncertain. Turning to full-year financial guidance, we expect cash used in operations to be between $110 and $130 million. We expect to narrow this range as the year progresses. Compass continues to maintain a strong financial position with cash and cash equivalents of $220.2 million at December 31st, 2023, compared with $143.2 million at December 31st, 2022. We will continue to manage our cash carefully to continue advancing our pivotal programs and to achieve important milestones that we believe will create value for our shareholders. Thank you, and I'll now turn the call back to Kabir.

Thank you, Mary Rose. I'm pleased that we're seeing continued enthusiasm and meaningful momentum building for both Compass and this area of science. Our COMP360 Phase P program remains on track, with the first trial expected to read out this year. Not only a key milestone for Compass, but also a major event in the development of psychedelic medicine. The FDA's draft guidance for clinical studies of psychedelic drugs, along with the European Medicine Agency's plans to establish regulatory guidelines for the development and therapeutic use of psychedelic substances in Europe, are important signs that regulators are preparing for the potential use of psychedelics as treatments. In a sign of the continuing unmet need in TRD, Eskenamine, sold under the brand name Spravato, achieved global sales of almost $700 million in 2023, which demonstrates the continued growth of interventional psychiatry and the infrastructure to deliver it, which bode well for the potential of Comp360 if approved. We also welcome the news of FDA acceptance of Lycos Therapeutics' MDA submission for MDMA-assisted therapy for PTSD. We're seeing increasing interest from clinicians who plan to incorporate psilocybin treatments into their mental health offerings. Our collaborations are indications of this interest, and we'll continue to develop commercial models that enable rapid, scalable, broad, and equitable access to Comp360 if approved. In closing, with our strong balance sheet, we are focused on execution of our Phase 3 program in treatment-resistant depression. This will be an exciting year for Compass Pathways, and we look forward to updating you on our progress over the coming year. Thank you again for your participation on today's call, and we'll now turn to Q&A, so I will hand the call back to the operator. Thanks.

Thank you. If you'd like to ask a question, please press star 1-1. If your question has been answered and you'd like to move yourself in the queue, please press star 11 again. Our first question comes from Patrick Truccio with HC Wainwright. Your line is open.

Thanks. Good morning. Just a couple of follow-up questions on the enrollment delays. So the first is just regarding the TRD diagnosis being necessary for enrollment in the program. Can you remind us how you're defining TRD and confirming this diagnosis in patients who are enrolling in the program? And secondly, can you tell us what proportion of patients are expected to have experience with psychedelics?

Thanks, Patrick. I'm just checking that you can hear us, and I'll hand it to Guy. Yep. Hi, Patrick. Yes, I mean, our criteria are those of treatment-resistant depression, as you know, and that means that patients are required to have failed at least two treatments. These treatments have to meet the criteria for adequate dose and adequate duration. And the delay that you referred to is caused by the fact that we are being very rigorous in establishing this, that this has occurred through health records. And that in the US has proved to be difficult, but not impossible. And we're proceeding successfully to do that in the patients we are recruiting. I should say there's no shortage of patients, but the issues around verification have been real, and those are what have caused the problem. But the same for patients who may have been previously taken psychedelics, we've taken that number up from 10% in the phase two to 15% in the phase three. And just to emphasize, one of the issues that we face is that patients conceivably, or people seeking treatment, may be seeking psychedelics, and that's one of the reasons why we're particularly rigorous in insisting on the medical record being proven and verifiable. Thanks very much.

Got it. If I could, just another follow-up. I'm just wondering if this, just moving this top-line data back for Comp 05 trial, is that, would that have any impact on the potential filing of an NDA for TRD, or, you know, is the timing kind of going to be unchanged based on the top-line data for the 06 trial? And separately, I guess maybe if you could just talk us through what data would be anticipated in the NDA. You know, specifically, would you have any, you know, certain amount of longer-term follow-up efficacy or safety data from these trials before that NDA is submitted? Thanks so much.

Thanks, Patrick. So I'll work backwards from that question. We have not clearly guided on what we are going to expect to include in the initial submission. That will be a matter for discussion with the agency. But as a reminder, with breakthrough designation, you can clearly envisage things like rolling submissions as well. To the first part of the question, no. As I said in my prepared remarks, this does not alter the potential timing of a filing. 006 remains on track for mid-25, and we have always consistently guided that we do expect both trials to be needed to form an adequate or acceptable dossier. So, no, we are not anticipating any change in the timing of a potential submission.

That's helpful. Thank you so much. Thanks, Patrick.

Thank you. Our next question comes from Charles Duncan with Cantor. Your line is open.

Good morning, Kabir and team. Thanks for taking the question. I wanted to follow up to those last questions with regard to diagnosis of TRD. Can you help us understand how it's different in the United States versus elsewhere And, you know, what percentage of patients are you anticipating in 006, and why will the problem be fixed in that trial?

Thanks. I mean, I think that the problem in the U.S. is simply the nature of the healthcare system is being simply more decentralized. This is in great contrast really to particularly European health care systems where usually health care records are extremely straightforward to access. For example, most patients in the UK have a primary care physician. To get health records, it's simply a matter of contacting the physician with appropriate consent, getting the records. So there's a great, that's a tremendous difference from what we have to say today. I think in terms of your second issues about in terms of the number of patients. I mean, that issue relates, I mean, we think that we will be in a position having set up the systems that we now have to facilitate getting the data, that the fact that O06 is taking place subsequent in most centers to 005 means that everything will really be running optimally by the time many of the US sites switch to 006. The patients entered in ex-US, of course, are not subject to the problems anyway. And we think the proportion, which I think you also requested, will be about 50-50. And when we model it, we think that we're on track, as we said, for 0-0-6. And the problems of 0-0-5 are really partly to do with the fact we started 0-0-5 first in the US. That makes sense.

That makes sense. If I could ask one follow-up, and that is, can you help us understand the screen failure rate if you're tracking that at all? But then also, are you having any challenges with washing patients out before of standard of care, albeit ineffective, antidepressants before they enter O5?

I mean, the washout represents a challenge, but most of the problem has been with the verification of the diagnosis. So having 001, our phase 2 trial, about a third of the patients in that study were already off antidepressants, so two-thirds required washing out, and the majority, great majority, were able to do so once they had been enrolled in the study. But it's enrollment that has been the issue in 005.

Got it. Thanks for the added comment.

Thank you. Our next question comes from Francois Britois with Oppenheimer. Your line is open.

Hi. Just a couple here. Sorry to ask again about the enrollment, but is the fourth quarter guidance just a very conservative, or how do we feel comfortable that fourth quarter will be correct for O5-3?

Thanks, Frank. We are very comfortable with that. We, as you would expect, have done a number of reprojections, looked at different scenarios, and we are very comfortable with the full code of guidance.

Okay. And then on the commercial side, this bravado infrastructure obviously has some read-through here. Can you just remind, you know, maybe us, the listeners, that how bravado works, how many times people come in, and are there any efficiencies maybe for these centers that would put you in a situation that might be superior to Spravato? Just any learnings there? How has that evolved as you guys look into the commercial opportunity?

It's a great question. So, yes, clearly the protocol for Spravato is very different from what we envisage to be a final protocol for competition safety. So as a reminder, the Spravato label actually requires eight administrations in the first month, four in the second month, and maintenance thereafter, you know, half. patient and physician discretion, but typically every couple of weeks. So you can imagine, therefore, over the course of the first three months, that something like 12 to 15 sessions, each of those requires the patient in the clinic for a minimum of really three to four hours, given the intranasal administration and the two hours of monitoring. And by the way, they can't drive home afterwards either, so it actually requires a caregiver for each of those as well. In contrast, obviously, we don't yet know what the durability will be for, shall we say, a typical patient with COMP360, and the phase three is designed ready to address that. But as we've said before, based on what we know, it perhaps might be two to four administrations a year for a patient. So you can see that from a patient perspective, that's a very, very different But from the learning center, it's the difference between using one room for a day, once every perhaps three to four months, and actually having multiple uses of rooms during the course of time for aesthetics. So we believe, and a big part of the reason we signed these collaborations with entities such as Greenberg and Hackensack, and we'll do more, is exactly to understand how we are going to integrate psilocybin differentially from Sravato into those workflows and think of how they're directly involved.

Great. Thank you very much. Congrats on the progress, sir. Thanks, Frank.

Thank you. Our next question comes from Nina Petrito-Garg with Deutsche Bank. Your line is open.

Hey, guys. Thanks for taking my question. So I just wanted to ask about the enrollment again, and I just wanted to confirm, you know, what kind of – if there are any actions that you can take to really maybe accelerate the, you know, the reviews that you're doing to confirm diagnosis. Is there anything that you've actually been able to do that you found has been helpful in accelerating that process in the U.S.? Thanks.

Yes, in a word that have and we have taken those mitigating actions. So we have added specific vendors who are able with patient consent to work directly with patients and to obtain the medical records. So what we have seen is that that does enable us certainly in some circumstances to obtain those records much more quickly than you know going just through the the motions ourselves or with our CRM. So, yes, we have added specific pay-for vendors, a couple of different ones, in fact, to enable that at the majority of sites.

Okay, got it. Thank you. That's helpful.

Thank you. Our next question comes from Ritu Baral with TD Cowan. Your line is open.

Good morning, guys. Thanks for taking the question. Kabir, are you anticipating that this delay and this sort of going back and reconfirming TRD is going to change the patient demographic in any way, shape, or form? Is that sort of coming out different, and how might that affect the potential powering or potential perceived expected placebo effect in the study? And the follow-up to that is, have you determined what you are going to release with top-line data at the end of the year, specifically longer-term follow-up and durability? And then I've just got a follow-up on those centers.

So let me start, but I'll also ask Guy to weigh in on the third part of the question. So to be clear, this does not in any way represent a change to the inclusion criteria, nor in fact is this a change from what we needed to do in Phase 2b. But a couple of things to point out. First, obviously, the phase 2B was only partly in the US. It was ultimately a global study. Second, I think we do think it's relevant that phase 2B, 001 and 006, have three doses of active, 1, 10, and 25, whereas in 005, there is a real placebo. And clearly, from a patient willingness or a patient incentive to enroll, that is a significant difference between 005 and both 001 and 006. So I don't know if you want to add anything on that. Yeah, I don't think that the trial, I mean, as you heard, the vendors that we've hired are there because this is a general problem. It isn't just our problem. Our definition hasn't changed and so our considerations around power and placebo response are unchanged as well. So it's just a delay and we think we've overcome some of the factors that contributed to it now. And for the second part of the question, Ritu, as you are very well aware, this is a blindage trial through Part B, through 26 weeks, and therefore determining what we will be able to announce with top line is something that will be a matter of review at that time.

Got it. And then a follow-up question, you mentioned multiple delivery templates when you speak of your collaborations with Greenberg and Hackensack. You mentioned that you're working through options. Are there any sort of buckets of different templates or particular aspects of delivery that you are, I guess, building out and investigating with those two? Sort of like just large... phenotypes of delivery models that we should all be thinking about at this point?

It's a great question and what I would say is the work we're doing is precisely to understand how many different phenotypes of delivery, shall we say, that we're going to need. And so if we take these first two, obviously Greenbrook and Hackensack are very different. Greenbrook is a for-profit network of interventional psychiatry centers that is essentially today offering TMS, ketamine, Spravato, are very interested in offering psychedelics as well, but have only kind of recently branched into more traditional psychiatric treatments. And therefore, how this will fit, they already have physical infrastructure for the delivery of these things. So working out what works for them in that context may be very different from somewhere like Hackensack, which is an integrated regional health system with multiple sites that currently have different specialisms, but also a very large kind of tertiary care center with 300 beds, which is probably going to be at the heart of where they will treat psychedelics. So I think the reason we are doing this and the reason you will see a couple more collaborations again in very different settings of care is exactly so that we learn what sort of different delivery models are required. And that would extend also to reimbursement. For instance, you can imagine some commercial vendors might be very open to buy and build. They actually fit very well with their economics and offer an attractive route. health systems and so on, it's much more likely to be Part B rather than Part B. But these are the questions we want to answer.

Got it. So each collaboration is going to represent a type of setting that has significant use in the U.S. or EU. Is that the way to think about each of these individual collaborations? The way to think about it is they are deliberate.

Obviously, there's a limit to the number we can do in the particular very pre-commercial setting. And yes, they are designed to be sufficiently different that they can, as we say, allow us to develop templates, but then when we get to formal pre-launch activities, if we're lucky enough to get that, that we can then take those templates to other examples of the similar settings. And that's the way it plans to be built.

Understood. Thanks for taking your questions.

Thanks.

Thank you. Our next question comes from Sumat Kulkarni with Canaccord Genuity. Your line is open.

Good morning and afternoon to the team. My welcome to Terry. It's great to work with you again. Thanks for taking my questions. The question is actually an additional indication for Comp 360. You've mentioned PTSD and depression in type 2 bipolar disorder, but is there a reason why you've not specifically mentioned anxiety, especially given comorbidity, depression? And are you collecting any anxiety-related measures in your phase 3 program? And just a bit of a follow-on to that, how closely are you watching a potential competitor in CanXS program with psilocybin and GAD that reported phase 2 data yesterday?

Yeah, thanks. Great question. I mean, there's a tremendous, I mean, there's a shared genetic origins for depression and anxiety, and so they're closely related, and most patients with depression have anxiety levels, at least to some degree. We are, as you asked, including anxiety measures, specifically the GAD-7, in our trial as we did in the 001 and we published data on that already. So we certainly see an anti-anxiety and anxiolytic potential with Comp360 but in many ways the presentation of anxiety is usually in primary care and we can't really see how Comp360 would be kind of the treatment of choice under those circumstances and for that reason we have not gone for that in the first instance. But clearly patients who have both depression and anxiety are probably the commonest phenotype around and we think that there will be an advantage in treating that population on the basis of their depressive symptoms but incidentally treating their anxiety. I don't know whether you want to comment on the competitive difference. Do the logistical hurdles in the U.S. that are leading to the slight delay contribute to a meaningful change in the financial outlay required for 005 and 006?

It definitely is a great question as well. So, no, I mean, clearly we've made some additional investment because we think it's important to do that, but not a material change. We still have runway until late 2025. Thank you.

Our next question comes from Jason McCarthy with Maxim Group. Your line is open.

Hey, guys. This is Michael Okunowich on the line. Thank you for taking my questions today. So, I guess to start off, I just I'd like to ask, are you using a more rigorous verification of the TRD diagnosis compared to the Phase IIb? And if so, what is the reason? Does this have to do with greater public awareness of psychedelics and their efficacy or just a factor of the larger U.S. portion for the study?

So, no, we're not. It is exactly the same inclusion criteria. It is the same population. It is, as I said in answer to an earlier question, I mean, partly it is the fact that this is 100% US. And also, I do think the nature of the arms of the study, this being true placebo as opposed to both O1 and O6 that have three doses of active drug, I think that also is a contributing factor.

All right, thank you. And then just one more for me. I just want to see how closely you would be watching the LICOS NDA process and potential subsequent approval. Is there anything in particular that you're looking for on the commercial reimbursement side that may help to inform your strategy for Comp 360?

So, yes, we will clearly be observing the regulatory process for LICOS very closely. We wish them well, and I think it's clearly premature to see how they're thinking through commercial reimbursement, but obviously we recognize that there will be lessons from their progress both through the regulatory and commercial phases for us. All right.

Thank you very much.

Thank you. Our next question comes from Elmer Puros with Robin and Renshaw. Your line is open.

Yes. Good morning. I don't have a question related to the delay, but I have a question about the anxiety indication was mentioned that you are not focusing on it necessarily. But would you be interested in... licensing Comp 360 to indications that are potentially of no interest to you?

Thank you, Elmer, and congratulations on the new gig. That's an interesting question. What I will say is in general, split indications are enormously challenging in my experience. particularly if you can't clearly identify a very different boasting paradigm and so on. So that's not something we have given any great consideration to. Clearly, if somebody comes with a very compelling proposal, we would listen to it. But in general, it's pretty hard with a single market, in my experience.

Thank you. Thank you very much, Kabir.

Thank you. There are no further questions at this time. I'd like to hand the call back over to management for any closing remarks.

Thanks, everyone, for joining. In conclusion, let me just say, again, our guidance for the overall timing of our Phase II program in TRD is unchanged. We are acknowledging and giving guidance around a slight delay into quarter 424 for top-line data from 005, but our overall guidance remains unchanged. We continue to be very focused on execution in TRD, and also, as we said, continuing to think about which other indications of interest would be the most compelling places to take concrete seats in there. So thanks very much, everyone. Thank you for your time and attention today.

Thank you for your participation. This does include the program. You may all disconnect. Everyone, have a great day.