COMPASS Pathways Plc

Good day, ladies and gentlemen, and welcome to the Compass Pathways third quarter 2023 conference call. At this time, all participants are in a 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 third quarter 2023 results conference call. Again, my name is Steve Schultz, Senior Vice President of Investor Relations at Compass Pathways. Today, I'm joined by Kabir Nath, our Chief Executive Officer, Mary Rose Hughes, our Interim 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 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 risks uncertainties, and other factors, including those risks and uncertainties described under the heading Risk Factors in our quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission and in subsequent filings made by Compass with the SEC. Additionally, these forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statement, even if our estimates or assumptions change. I'll now hand the call over to Kabir Nath.

Thank you, Steve. Good day, everyone, and thank you for joining us. Let me begin by welcoming Mary Rose Hughes to our call as Interim Chief Financial Officer. Mary Rose has been with Compass since May 2020 when she joined as our second finance team member. She's been instrumental in laying the foundation for our finance organization and led the finance team through our NASDAQ IPO and three subsequent equity and debt financings. Mary Rose leads and manages all aspects of our finance operation, with the exception of investor relations, where she's begun to partner more extensively with Steve. I want to thank Mike Falvey for his service and contributions as CFO, and in particular for the significant financing we executed in August. We've now initiated an active search for a new CFO, and you should expect a smooth transition as we're in discussions with several strong candidates. After some introductory remarks about the business in the third quarter, I will hand the call over to Guy to provide clinical and regulatory updates. and then to Mary Rose for the financial update. COMP005 and COMP006, our phase three trials in treatment-resistant depression, or TRD, remain on track, and we continue to expect primary endpoint readouts in summer 2024 and mid-2025, respectively. Guy will provide more detail on our TRD trials and our other clinical programs in a moment. Looking at the external environment, we also continue to see strong esketamine sales sold under the brand name Spravato, which achieved global sales of $183 million this quarter, an increase of 82% compared to the third quarter of last year. This puts Bravato on a run rate of well over $600 million for 2023, continuing to demonstrate the unmet need in TRD. We believe this growth continues to be an important driver for the infrastructure of interventional psychiatry facilities and other treatment centers that we expect will be capable of delivering Comp360 treatment if approved. We find this continued development very encouraging. This quarter, we also welcomed Daphne Caridas to the Compass Board of Directors. Currently President and Chief Financial Officer at Flare Therapeutics, Daphne is a terrific addition to our board, as her biotech experience includes corporate financial management, investment management, and investment banking. Her deep biopharma industry experience and her understanding of investor priorities will help ensure that Compass remains on firm financial and strategic ground. Finally, in August, we completed an up to $285 million private placement financing, with $125 million in gross proceeds up front and up to an additional approximately $160 million in proceeds if the warrants are fully exercised. The financing structure was dictated by the investors involved and was very attractive for Compass, with the upfront investment accompanied by a warrant at a 30% premium to the last sale price. This effectively functions as an additional financing vehicle if and when the investors exercise their warrants. This financing, supported by a group of premier specialist biotech investors, extends our cash runway to late 2025 through multiple planned pivotal readouts. This strong financial foundation permits Compass to move forward confidently with our clinical programs, as well as all supporting studies for potential new drug application filing with the FDA. We also continue to invest in our pre-commercial work to ensure we're prepared for a successful Comp360 launch if approved, all with the aim of providing broad and equitable access to patients in need of better treatments. With that, let me now hand the call to Guy to update you on regulatory and clinical news during the quarter. Guy? Thank you, Kabir.

As you've heard, both of our phase three trials in TRD continue to advance with active recruitment. At this time, three quarters of the COMP005 sites have been initiated. And for COMP006, we now have approvals for sites in the US, Canada, UK, and a number of EU countries. Patient demand is strong, given the degree of unmet need in this population. As I have said before, the process of getting clinical sites up and running is a complex one, especially navigating the additional administrative details of working through the DEA licensing and Schedule I requirements. Screening and scheduling visits is also demanding for new sites. These complexities can impact the rates of early recruitment. So, as you would expect, we are paying very close attention to these factors and implementing all steps to ensure we remain on track. Patient demand is strong, however, and is the key to maximizing eventual rates of accrual at each site. Looking across our area of science, the expertise we have developed in managing the complexity of the schedule one and meeting the clinical and patient management requirements for robust global trials of psychedelics represent a competitive advantage. Beyond treatment-resistant depression, our open-label phase two study in post-traumatic stress disorder, evaluating safety and tolerability, is fully recruited. We expect the top-line readout this year and presentation of the full data set to follow next year. As we've said before, anorexia nervosa is challenging. Patients do not necessarily recognize their need for treatment. This is one reason why it is so difficult to address and why it is so important that we work to find a solution. Anorexia nervosa carries with it the highest mortality rate of any mental health condition, and there are no FDA-approved treatments available today. We are not yet ready to update the guidance on completion of this study, but we have taken some steps, including adding two additional clinical sites in Ireland and Texas, phone-based screening reduced numbers of in-person visits, and other protocol amendments to reduce the burden on the patient. I will now hand the call to Mary Rose for the financial overview.

Thank you, Guy. I'll now cover the highlights of our third quarter financial results. Comparing this year to last, for the third quarter 2023, net loss was $33.4 million, or 67 cents per share, including non-cash share-based compensation of $4.4 million, compared to a net loss of $18.4 million, or 43 cents per share, including non-cash share-based compensation of $3.5 million per third quarter 2022. I will now turn to analysis of our current third quarter results compared to the prior second quarter results. Our current quarter financial results reflect our continued success in advancing our Phase 3 trials in treatment-resistant depression and encouraging progress in extending our cash runway with the proceeds from the August financing. Cash yields and operations in the third quarter were $17.1 million, towards the higher end of the guidance range we provided last quarter due to the R&D tax credit not yet being received. We now anticipate receiving the credit in the fourth quarter. In this quarter, net loss was $33.4 million, or 67 cents per share, compared with a net loss of $28.3 million, or 62 cents per share, for the prior quarter. These results include non-cash share-based compensation of $4.4 million in this quarter and $4.6 million in the prior quarter. R&D expenses were $21.5 million in this quarter compared with $19.8 million in the prior quarter. The increase was mainly due to external development expenses related to progression of our phase three program. G&A expenses were broadly consistent in both quarters at $12.5 million in this quarter and $12.8 million in the prior quarter. Turning to our balance sheet, Cash increased by $99.9 million in the third quarter of 2023. In August, we entered into a securities purchase agreement and received net proceeds of $116.9 million upon closing. And if investors exercise their warrants, we will receive up to an additional approximately $160 million in cash proceeds. Long-term debt under our Hercules loan facility was $28.4 million at the end of the third quarter. Regarding fourth quarter financial guidance, we expect net cash used in operating activities to be between $9 million and $15 million. We are now expecting to receive our estimated $14 million R&D tax credit in the fourth quarter. However, the timing of this is uncertain. Turning to full-year financial guidance, we are narrowing the range for cash use and operations to between $79 million and $85 million. We have narrowed our full year range as we approach the end of the year and are able to forecast remaining spend in 2023 with greater accuracy. Compass continues to maintain a strong financial position with cash and cash equivalents of $248 million at September 30th, 2023. compared with $143.2 million at December 31st, 2022. The August financing has extended our runway into late 2025, which we will continue to manage carefully in order to continue advancing our pivotal programs and achieve important milestones that we believe will create value for our shareholders. Thank you. I'll now turn the call back to Kabir.

Thank you, Mary Rose. Let me say again that we are pleased with our ongoing progress. Phase three clinical site initiations continue to grow in both trials and in numerous countries. We're less than a year from our initial phase three top line data. So 2024 should be an exciting year for Compass, and we look forward to updating you further as we approach this milestone. We're also encouraged that interventional psychiatry treatment infrastructure continues to evolve and expand. The growth of esketamine is evidence that people living with TRD need novel, rapid-acting treatments. We believe Comp360 will be an important option for these patients. From January 2024, The new CPT-3 tracking code for the provision of services associated with psychedelic medications, which we've discussed extensively in previous calls, will also be effective. This may well contribute to the development of both awareness and infrastructure ahead of any potential launch of COM360, if approved, and it's an important component of ensuring broad and equitable access to treatment for patients. In closing, with our strong balance sheet, we can navigate these challenging market conditions. We will invest the funds raised in our financing wisely. Our phase three program in treatment-resistant depression and our follow-on indications are our clear focus. On behalf of the entire Compass team, I want to thank those investors who participated in the August financing. Thank you again for your participation in today's call. We will now turn to Q&A, so I'll hand the call back to the operator.

Thank you. At this time, we'll conduct the question and answer session. As a reminder to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again.

One moment for our first question. Our first question comes from Ritu Baral with TD Cohen.

Your line is open.

Good morning, guys. Thanks for taking the question. Kabir, I wanted to ask you for a little more detail, if you have it, around this question of administration centers, potential administration centers. Do you have an idea right now as to the number of clinical centers that are giving spravato or even ketamine, and what percentage of the existing centers may be appropriate, you know, have the potential expansion capacity for Comp360. And then as a quick follow-up to that, as you open your sites and clinical sites, and congrats on getting all five open, all the 05 ones open, As you finish opening them and they start enrollment, do you feel that they have, in effect, been completely trained to act as commercial centers? Or post-approval, post-potential approval, would there have to be further training and setup before they could flip to commercial? Thanks.

Thanks, Rita. And just to check, you can hear me clearly? Yep. Great. So thank you for your question. So to the first question, we don't have exact numbers, but our belief is that there are several hundred treatment centers today that are able to offer esketamine. And that's a mix of some of these interventional psychiatry centers that we've talked about, but also the fact that it's clearly being administered within regional health systems, within some of the larger clinics. I think it's important to distinguish that from ketamine clinics. And again, we've seen clearly that those that were just offering off-label ketamine have struggled economically, and there are more of those, but we don't necessarily see those as appropriate sites for the potential delivery of COM360. But essentially, anywhere that is today offering Spravato, we certainly see as being potentially adaptable for the delivery of Comp360, and we see the numbers continuing to grow. Part of the pre-commercial work we are doing is clearly to acquaint ourselves with some of those, to start talking to regional health systems and so on around how they would see the opportunity to bring Comp360 on board. In terms of sites, and again, just to clarify, we have the majority of sites for 005 now up and running with a few more site initiations to go. So as we've said in the past, our sites are a mixture. They're a mixture of some truly academic sites that you wouldn't necessarily expect to be significant from a commercial perspective, but then a number of others that we absolutely do believe will be able to scale rapidly into commercial. In terms of the training, I'll comment, but I will also ask Guy to add his thoughts. Clearly, the training we're delivering today is intensive and designed for a clinical trial setting. And obviously, that's a unique and very different setting from what we would expect a real world commercial setting to be. By definition, the therapists there are getting very comfortable with the support of patients during the administration of psilocybin. But your specific question as to whether there may need to be some different, modest, tailored training for commercial is one we are continuing to work through. because it is clearly a different setting from a clinical trial setting. Guy, do you want to add anything there?

No, just to say that I think our training program has evolved really well in the last year, stimulus being the trial, and it will continue to evolve as we move towards commercialization. We work with providers to think about exactly how it will work in practice. So I think we're well on track to see changes, which will be beneficial in the long term.

Great. Thank you so much. One moment for our next question. Our next question comes from Charles Duncan with Kantor. Your line is open.

Yes, good morning Kabir and team. First of all, congratulations on the progress with site openings and thanks for taking our questions. I had just a couple of questions when you when you consider the rate limiting steps to progress. in 005 and 006. I'm wondering if you believe that site openings are, you know, perhaps a bigger modulator than patient demand. And for those sites that you have open for 005, are you seeing, you know, more than call it a single patient being enrolled? Thanks.

Thanks Charles. We're certainly seeing more than single patients. You know, it's still, for some of the sites, it's still quite early. The earliest sites have got going pretty well. And, you know, we will wait to see exactly how the run rate picks up over the next few weeks. As I tried to explain, it is early in the setup where there are delays and where new sites have difficulty coming to terms with things. But we're pretty confident that those who've got up earliest and who are most experienced are showing a good run rate, yeah.

Okay, that's helpful. And then moving on to the PTSD, the open-label study data yet this year, given that it's open-label, signal-seeking, what would you see as a win? Surely you're not looking for a p-value or anything like that, but I'm quite intrigued with this, so interested to know what would encourage you to call it operationalize the next step.

Well, it's a safety study, so acceptability will be the number one question, just how well it went for the patients, how well it went for the therapist. The second issue is obviously we look at effect sizes of the response in the secondary measures we're making, particularly the measures of trauma memory. And what we will do is obviously compare that with existing studies. We can look across the map study. Much as it's difficult to do that with different trials, it's too tempting, and we'll be making decisions on the basis of what we find. So we're looking forward to doing that next year.

Did you anticipate operationalizing a study next year in PTSD?

So, as we've said, we are very focused on our TRD program, but also completing PTSD and anorexia. But clearly, if we see a strong signal, you know, we're always driven by unmet need and the science, and we will consider a strategy for how we might take that forward. But there are no decisions at this point.

Okay. And the cash guide through 05, or mid, not 05, excuse me, 25, does that contemplate a study, Kabir, or would that be a different set of thinking?

Yeah, so that's through to late 2025. So it doesn't contemplate a further study. We would consider that as a buy-up, as Kabir said, if the evidence is promising, but not right now.

Okay, very good. Thanks for taking the questions.

Thank you.

Thank you, Charles.

One moment for our next question. Our next question comes from Francois Brisbois with Oppenheimer. Your line is open.

Sorry, thanks for taking the questions. Just a couple here. So can you, you said that you've been discussing with sites about potentially switching or also allowing Comp360 down the road at sites that currently have to deliver Spravato. How are those discussions going? Is there any, you know, what potential pushback could there be from sites? Thank you.

So, yeah, I mean, thank you, Frank, for the question. I mean, as I said, I mean, in principle, the premise we're taking in is that anyone who is delayed today delivering Spravato for patients with treatment-resistant depression should first be very interested in potentially delivering Comp 360 for the same population, but also have clearly taken steps around establishing physical settings that could be appropriate for Comp 360. Clearly, the economics of delivering these two are very different, so just as a reminder, Escanamine per label is eight administrations in the first month, four in the second, and that after required fairly frequent administrations, but it's a shorter duration of time in the clinic with the monitoring period. With COM360, we're obviously looking at something that is a longer session on the day of dosing, but much less frequent. So, you know, part of the work we're doing as we engage with these is to really get a deep understanding of the practice economics and ensure that the appropriate incentives are in place to make it feasible for these places, not only to treat with Spravato, but also with Comp360. And of course, it's in that context that the work we did on the CPT-3 code is so important.

Great. And then, can you help us understand, economically, Forest Center, and maybe that's evolving, but is it more practical or profitable to have multiple sessions, but then maybe have some holes between sessions or to have a longer session with one patient? What makes more sense economically for the center?

So what I would say is when you've seen one center, you've seen one center. So that's part of the answer to that. And that's one of the reasons why this is a lot of work as we build this. But I guess to turn it around, Frank, I mean, we know that our job is to make sure that it is economically attractive to provide Comp360, and we have to understand how that compares to Spravato or TMS or whatever other interventions that these centers may be delivering.

Okay, and just quickly, our last one, in terms of the press release and something you had mentioned, a publication recently, can you just elaborate more on the significance of AI in this space?

Well, AI is obviously the top of everyone's mind at the moment. I mean, we've looked and we've used machine learning and we're using large language models to try and understand the processes that go on both in preparing patients and also in integrating their experience after treatment. Our initial efforts of this suggests that certainly the session after treatment, we can look at the actual utterances that take place between the therapist and the patient and make a pretty good estimate of whether people are going to be responders or non-responders subsequently. I mean, that's something that is essentially confirming what our other measures tell us. So it's not actually predictive in the sense that it precedes treatment. But we are looking in some detail at whether it's possible to do that and whether there are ways of really understanding patient experience, patient presentation using the kind of measures that emerge from these very complex models that can now be constructed. I think there are other ways in which AI might contribute to training, and we're also exploring those. And at some point next year, we'll probably tell you a bit more about that because it's

Thank you. Thanks, Frank.

One moment for our next question. Our next question comes from Patrick Truscio with HC Wainwright. Your line is open.

Thanks. Good morning. I have a question about some of the dynamics that we're seeing in the field. So, as we begin to see these additional psychedelic compounds generate clinical data in depression, anxiety, I'm wondering if you could provide some perspective on Comp360 relative to these compounds and what you see as advantages of your approach to Comp360 treatment as compared to others in the field.

So, let me start, and I'm sure Guy will add as well. So, I mean, I think first, we are focused on generating and delivering the evidence for Comp360. And just as a reminder, the Phase IIb we conducted remains by a significant way the largest and most robust study yet done with any psychedelic compound, you know, with the potential exception of esketamine if you regard that study group as psychedelic. So, you know, I think our view is others have got to generate data on the same sort of scale and with the same sort of robustness. before we can really start comparing across molecules or approaches. Again, as you know, our phase three is designed not only to replicate but potentially enhance the benefits of Comp360 with the repeat dose administration and also generate much more robust data around durability. So very candidly, Patrick, I don't think we're at the stage of making comparisons across assets and so on. But if there's a specific that you want to ask us to address, I'm sure Guy or I could take that.

Yeah, I was just, you know, just curious as, you know, there's some of these, you know, second generation compounds that have, you know, started to generate data. So with DMT or, you know, even with CYB3 as we look ahead to you know, perhaps larger studies with those compounds. How do you think about those relative to Comp360?

Well, I think it would be good to see them, Patrick. It would be good to see a proper study, really. And we await those with great interest.

Fair enough. So then, I guess just a follow-up question on the digital strategy. How do you envision digital being part of the go-to-market strategy with Comp360? in depression and is there an opportunity perhaps to partner with some of the emerging digital therapeutics companies in mental health care?

So I think we've always been clear to say that we regard digital at the time of launch as tools that potentially are a benefit to both patients and therapists. While we're doing some very interesting work around understanding some of the markers, understanding as Guy described just now, how we can actually link what happens in sessions between the therapist and the patient to outcomes. Our expectation is not that that will be in place for launch. We clearly need to do a lot more work about building robust data sets and validating those. So what we're looking at at launch is digital tools, if you like, an app, my Pathfinder, Therapist Companion as well. I think you know clearly digital therapeutics per se has been a pretty challenging field in mental health, we haven't really seen anyone establish scale there yet but. You know, our ambition is to help get patients with serious mental illness to better outcomes. And yes, I can see down the road there could be the potential for synergies or working with some of these other companies that have made progress in that. But right now, that's not a core focus or a core priority for us.

Yeah, that's helpful. And then just one last one. You know, there's a number of these investor-initiated studies, investigator-initiated studies. that are ongoing across several indications. I'm wondering if you can give us an idea of which of these studies might complete this year or next, and which do you think could provide, you know, helpful insight to current or future programs?

Yes, I'll take that, Patrick. I mean, we have one which is, I think, will be published next year, which was in TRD in patients primarily drawn from the VA system who have a lot of pre-occurring trauma. an interesting study. We also have another one which looks at suicidality rather specifically. And I think that will probably have some preliminary data, certainly in 2024. I think in addition, we've already made you aware of the anorexia study at Imperial. But that will probably be fully published later in 2024. So I think those three examples are probably the best. And, I mean, we can't entirely predict some of the others that are, you know, as you know, we can't predict any of them properly because they're not our studies. But, you know, we know that the three I've mentioned will be reporting in some detail in 2024. And, of course, they're rather relevant, particularly the TRD and the suicidality studies, they're rather relevant to our core focus. So we'll be very interested in those.

Right. Terrific. Okay. Thank you so much.

One moment for our next question. Our next question. One moment for our next question. Our next question comes from Jason McCarthy with Maxim Group. Your line is open.

Hey, guys. This is Michael Okunowich on the line. I guess to kick off, I'd just like to see if you could expand a little bit on Francois' question regarding the AI model. Given that this is something of an early response analysis rather than a predictive marker, would you look at whether this could be part of the decision process or whether a patient would go into, you know, only needing one dose or potentially repeat dose like you're evaluating in the 006 study?

I think that's a very interesting question.

At the moment, we don't know how... I mean, at the moment, we're thinking of it as more in relation to the quality of the therapy inputs and how we can feed back to therapists how they're doing. There is this predictive component very early on, but we're not clear that that is more predictive than the very early change in symptoms that we also see. That's why I wanted to be clear that it's not fully predictive in the sense that we don't know that patients are responding by other measures. So I think the question is how far it can be automated, how far it's acceptable to actually record patients and therapists outside an experimental setting. So I think we're cautious about how it's likely to be practical to apply it. But we do think that it can improve our understanding. It supports our clinical measures because it's clearly not administered by someone. It purely arises from natural, ecologically sound interactions. And it also, as I say, may help us in the way in which we refine the therapist training, which will be very key to how we launch SCOMP360. All right.

Yeah, thank you for that. And then just one more for me, and I'll hop back in the queue. I'd just like to see if you could comment on if there's anything that you're specifically looking at or evaluating from the MAPS regulatory process and launch prep to possibly help inform your strategic direction for Comp 360.

So all I would say on that is obviously we don't have any specific insights into either of those, either that regulatory process or what they're doing for launch prep. But yes, we will clearly... be watching that. We will be watching the process of the application, assuming it's successful, assuming that there's an outcome and so on, and indeed, how they prepare for launch. And obviously, we do talk to many of the same sites and many of the same physicians.

All right. Thank you very much for taking my questions today. Thank you.

One moment for our next question. Our next question comes from Sumant Kulkarni with Canaccord Genuity. Your line is open.

Good afternoon and morning, Tex. Thanks for taking my question. It's been some time since the Phase 2B trial has ended, but are you still following some patients that were enrolled in that? Do you have any additional anecdotes on how patients might be doing now, and are there any more data we could expect on that?

Yeah, hi, Simone. Well, we have got, of course, the follow-up data that we're in the process of writing up in full. So that's not people we're still following, but it's data that we haven't fully digested. We will be showing that, I suspect, in 2024. There are individual PIs who have a lot of interest in their patients, as you might imagine, and we know that they are conducting quite long-term follow-ups in the Netherlands, for example. These are not studies that we are sponsoring, so they're really, they're not ones we have a great deal of detail about, but we know that they're going on. And we'll be obviously very interested in what those conclusions look like from those studies.

And then a follow-up. On your Phase 3 COMP005 program, or even 006, how closely will you be monitoring blinded data, if at all?

We won't be monitoring any blind, we don't monitor blinded data. The data is by definition doesn't come to us. It comes to the third party. Thanks.

One moment for our next question. Our next question comes from Gavin Clark-Gartner with Evercore ISI. Your line is open.

Hey, I'm just wondering what screen fail rate you're seeing thus far and how this compares to your assumptions when you design the trial. Thanks.

We're not really giving out that kind of data, I'm afraid.

One moment for our next question.

As a reminder, to ask a question, you'll need to press star 11 on your telephone and wait for your name to be announced. Our next question comes from Tom Schroeder with PTIG. Your line is open.

Good morning. We're all asking kind of similar questions, but I'm curious if in the site recruitment process you're getting a sense of the final commercial footprint. Are you having your pick of sites, which is to say many places want to get involved and then you decide? or is it kind of the expected power sites? And I'm really wondering if you're getting a sense of whether this will look a little bit like the CAR-T world, where everybody sees this, they're excited about it, but the actual physical footprint is much smaller. Thank you.

Yeah, I mean, let me start on that and see if Guy wants to contribute. I mean, I think two things to say. One, we are being very careful about site selection. I mean, I think, you know, everyone knows that large trials in psychiatry are complicated and there are plenty of anecdotes about where poor site selection has contributed to poor results. So we are... very much in control of that process. We're careful. Obviously we have the nucleus of sites that were successful in phase two B or the core of the phase three program, but in going beyond that, um, you know, it's picking that right mix of academic sites, one that can scale to commercial and so on. So, you know, I think the second thing I would say clearly though is from a patient demand, as Guy said, there is very significant patient demand and interest in that. So, you know, Obviously, not every psychiatrist in a single practice will be in a position to offer Comp360 therapy. But I think as our trials evolve, as others do, and so on, as bravado continues to scale, you're seeing an ever-increasing number of potential sites that could deliver this commercially.

If I could just add, I think the analogy with CAR-T isn't quite right. I mean, our trials are more difficult to do than clinical practice. And that really makes a difference. If you talk to people who are providers of clinical services, they really don't have experience or appetite to do clinical trials. But they do have an appetite to provide a good service to an ill-served patient population. So we have literally had conversations with providers who were very keen to think about how we could look at implementing treatment in their centers, but really wouldn't dream of offering to do a clinical trial because it's just a different kind of activity. You know, bear in mind, when you give a clinical trial, you're offering people quite a high chance of failure because of the control arm. And that has to be something that, you know, the investigator understands and can live with. And for many clinicians, it's really against their human spirit. They really don't like that. So people who do trials are unusual. And getting those centers is tough. Getting people to deliver the same treatment in real life, I think, will be different and easier compared to clinical trials.

Great. Thank you for the detail.

Thank you. That concludes the question and answer session. At this time, I would like to turn the call back to management for closing remarks.

Thanks very much. So once again, thank you everyone for participating on today's call. And as we said, with the private placement financing that we raised in August, that significant financing, which has the potential for a further financial vehicle as well, we're in a position of strength to continue to execute confidently on our phase three program in TRD. We look forward to updating you with PTSD data at the end of this year, and as we've always said, with further milestones in next year. Again, thank you very much all for your attention today.

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.