Compass Pathways PLC

NASDAQ:CMPS

Earnings Call Analysis

COMPASS Q3 Earnings: Stable Progress and Strong Finances

COMPASS Pathways remains steadfast in its Phase III trials with key readouts expected in summer 2024 and mid-2025, advancing the treatment-resistant depression (TRD) pipeline amidst strong patient demand. The growing market success of Spravato, with $183 million in sales this quarter, evidences the vast unmet need in TRD and underscores the potential for COMPASS's COM360 treatment. Financial stability is bolstered by a recent financing providing $125 million upfront with a potential additional $160 million from warrant exercises, extending the cash runway to late 2025. Q3 posted a net loss of $33.4 million ($0.67 per share) compared to $18.4 million the previous year, reflective of ongoing R&D efforts and preparation for commercialization.

Management Transition and Ongoing Clinical Trials

The recent earnings call started with the announcement of Mary-Rose Hughes as the new Interim Chief Financial Officer at COMPASS, emphasizing her substantial experience and previous contributions including leading the finance team through significant financings such as an IPO and subsequent equity and debt offerings. The company is in the process of finding a permanent CFO. Prudent emphasis was also placed on COMP005 and COMP006, their Phase III trials for treatment-resistant depression, signaling confidence with expected primary endpoint readouts in summer 2024 and mid-2025, respectively.

Market Presence and Infrastructure Development

COMPASS takes an optimistic view of the market, especially with the strong sales trajectory of Spravato, an antidepressant, which is forecasted to exceed $600 million in 2023. The growth of this drug is perceived as positive for the infrastructure development of interventional psychiatry facilities, which would potentially be key for administering COMPASS's own COM360 treatment if approved. Additionally, new board member Daphne Karydas brings her expertise to further bolster the board's strength.

Financial Strength and Capital Allocation

The company has effectively secured its financial stability through a substantial private placement financing that resulted in $125 million of immediate cash and a potential additional $160 million subject to warrant exercises. This strategic move endeavors to extend the company's cash runway until late 2025, highlighting a careful balance between attracting investment and maintaining financial health.

Clinical Sites and Patient Recruitment

COMPASS reported robust patient demand and active site initiation for their clinical trials. They have initiated three-quarters of the COMP005 sites and are approved for sites across various countries for COMP006. The company acknowledged challenges in site initiation and recruitment rates but is implementing measures to address these and took pride in their competitive advantages in conducting global psychedelic trials.

Research and Development in Anorexia Nervosa

Anorexia nervosa, a condition with a high mortality rate and no FDA-approved treatments, is a part of COMPASS's research agenda. The company is exploring different methods to reduce patient burden and improve trial participation, including protocol amendments and adding new clinical sites to address this challenging area with significant unmet medical needs.

Financial Performance and Operational Expenses

COMPASS reported a net loss of $33.4 million or $0.67 per share for the quarter, and a cash usage rate in operations of $17.1 million for that same period. This represented an increase in loss from the past year, but was accompanied by successful financing efforts resulting in a strong cash position of $248 million as of September 30, 2023, up from $143.2 million at the end of 2022.

Guidance on Cash Use and Tax Credit

The company narrowed its full-year guidance for net cash used in operating activities, estimating it to be between $79 million and $85 million. Furthermore, they anticipate receiving an estimated $14 million R&D tax credit in the fourth quarter, although the precise timing is uncertain. This guidance signals careful financial management and a strategic approach to sustaining operational momentum.

Earnings Call Transcript 2023-Q3

[Operator]

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.

[Stephen Schultz, executive]

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 statements even if our estimates or assumptions change.I'll now hand the call over to Kabir Nath.

[Kabir Nath, executive]

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 3 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 Fabi 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 III trial in treatment-resistant depression, or TRD, remain on track, and we continue to expect primary endpoint readout 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 Spravato 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 centres that we expect will be capable of delivering COM360 treatment, if approved. We find this continued development, very encouraging. This quarter, we also welcomed Daphne Karydas 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. A 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 upfront 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 exercised 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 a 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 COMP 360 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?

[Guy Goodwin, executive]

Thank you, Kabir. As you've heard, both of our Phase III trials in TRD continue to advance with active recruitment. At this time, 3/4 of the COMP005 sites have been initiated. And 006, we now have approval for sites in the U.S., Canada, U.K. 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 1 and meeting the clinical and patient management requirements for robust global trials of psychedelics represents a competitive advantage. Beyond treatment-resistant depression, our open-label Phase II study in post-traumatic stress disorder, evaluating safety and tolerability is fully recruited. We expect the top line readout this year and presentation of 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 conditions, 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 2 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.

[Mary-Rose Hughes, executive]

Thank you, Guy. I'll now cover the highlights of our third quarter financial results. Comparing this year to last, for the third quarter of 2023, net loss was $33.4 million or $0.67 per share, including noncash share-based compensation of $4.4 million. Compared to a net loss of $18.4 million or $0.43 per share, including noncash share-based compensation of $3.5 million for third quarter 2022.I will now turn to the 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 III trials in treatment-resistant depression and encouraging progress in extending our cash runway with the proceeds from the August financing. Cash used in 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 $0.67 per share compared with a net loss of $28.3 million or $0.62 per share for the prior quarter. These results include noncash 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 III 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 upon 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 in 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 30, 2023, compared with $143.2 million at December 31, 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.

[Kabir Nath, executive]

Thank you, Mary Rose. Let me say again that we are pleased with our ongoing progress. Phase III clinical site initiations continue to grow in both trials and in numerous countries. We're less than a year from our initial Phase III 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 COM360 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 COM 360, 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 III 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.

[Operator]

Thank you. At this time, we'll conduct the question-and-answer session. Our first question comes from Ritu Baral with TD Cohen.

[Ritu Baral, analyst]

Kabir, to ask you for a little more detail if you have it around this question of administration centres, potential administration centres. Do you have an idea right now as to the number of clinical centres that are giving Spravato or even esketamine. And what percentage of the existing centres may be appropriate, have the potential expansion capacity for CoMP360. And then as a quick follow-up to that, as you open your sites, clinical sites and congrats on getting all the 051 open, as you finish opening them and they start enrolment, do you feel that they have, in effect, been completely trained to act as commercial centres or a post potential approval, would there have to be further training and set up before they could flip to commercial.

[Kabir Nath, executive]

So to the first question, we don't have exact numbers, but our belief is that there are several hundred treatment centres today that are able to offer esketamine. And that's a mix of some of these interventional psychiatry centre 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 esketamine clinics. And again, we've seen clearly that those that were just offering off-label esketamine have struggled economically and there are more of those, but we don't necessarily see those as appropriate sites for the potential delivery of Com 60.But essentially anywhere that is today offering Spravato, we certainly see as being potentially adaptable for the delivery of COM 360, 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 COMP 60 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 a very different setting from what we would expect a real-world commercial setting to be. By definition, the therapies 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 set. Guy, do you want to add anything to that?

[Guy Goodwin, executive]

Just to say that I think our training program has evolved really well in the last year, the 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.

[Operator]

Our next question comes from Charles Duncan with Cantor.

[Charles Duncan, analyst]

First of all, congratulations on the progress with site openings. I had just a couple of questions. When you consider the rate limiting steps to progress in 005 and 006, I'm wondering if you believe that site openings are perhaps a bigger modulator than patient demand. And for those sites that you have opened for 005, are you seeing more than, call it, a single patient being enrolled?

[Kabir Nath, executive]

We're certainly seeing more than single patients. Some of the sites, it's still quite early. And the earliest sites have got going pretty well. And 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 is showing a good run rate.

[Charles Duncan, analyst]

That's helpful. And then moving on to the PTS, 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 and next step?

[Kabir Nath, executive]

Well, it's a safety study. So acceptability will be the number question, just how well it went for the patients, how well it went to the therapies. 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 to 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.

[Charles Duncan, analyst]

Could you anticipate operationalizing a study next year in PTSD?

[Guy Goodwin, executive]

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, we are always driven by unmet needs in the science, and we will consider a strategy for how we might take that forward. But there are no decisions at this point.

[Charles Duncan, analyst]

And the cash guide through 05 or mid -- not '05, excuse me, 25%. Does that contemplate a study Kabir, or would that be a difference of thinking?

[Mary-Rose Hughes, executive]

Yes. So that's virtually 2025, it doesn't contemplate a further study. We would consider that as [Indiscernible]. If evidence of promising, but not right now.

[Operator]

Our next question comes from François Brisebois with Oppenheimer.

[François Brisebois, analyst]

Just a couple of them. You said that you've been discussing with sites about potentially switching or also allowing COMP360 down the road at sites that currently have Spravato that delivers Spravato. How are those discussions going? What potential pushback could there be from sites?

[Kabir Nath, executive]

So as I said, I mean, in principle, the premise we're taking in is that anyone who has 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 COM360.Clearly, the economics are delivering these 2 are very different. So just as a reminder, Esketamine label and administrations in the first month for 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 part of the work we're doing is 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 CO360. And of course, it's in that context that the work we did on the CBT 3 code is so important.

[François Brisebois, analyst]

And then can you help us understand, economically for its centre 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 centre?

[Kabir Nath, executive]

So what I would say is when you've seen one sensor, you've seen one centre. 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 just on [Indiscernible], I mean we know that our job is to make sure that it is economically attractive to provide COMP60, and we had to understand how that compares to Spravato or TMS or whatever other interventions that these centres maybe deliver.

[François Brisebois, analyst]

Last one, in terms of your press release and something you had mentioned a publication recently. Can you just elaborate more on the significance of AI in this space?

[Kabir Nath, executive]

Well, is obviously the top of everyone's mind at the moment, we've looked and we use 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 thing that take place between the therapists 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 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 quite interesting.

[Operator]

Our next question comes from Patrick Trucchio with H.C. Wainright.

[Patrick Trucchio, analyst]

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 and depression anxiety. I'm wondering if you could provide some perspective on COMP 360 relative to these compounds? And what you see as advantages of your approach to COMP 360 treatment compared to others in the field?

[Kabir Nath, executive]

So let me start, and I'm sure Guy will add as well. So first we are focused on generating and delivering the evidence for COMP 360. 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 psychonomic compound with the potential exception of esketamine if you regard that study group is psychodetic. So 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 III is designed not only to replicate but potentially enhance the benefits of COM360 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.

[Patrick Trucchio, analyst]

I was just curious as there's some of these second-generation compounds that have started to generate data. So with TMT or even with CYB 3 as we look ahead to perhaps larger studies with those compounds? How do you think about those relative to Comp360?

[Kabir Nath, executive]

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.

[Patrick Trucchio, analyst]

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 COM360 in depression? And is there an opportunity perhaps to partner with some of the emerging digital therapeutics companies in mental health care?

[Kabir Nath, executive]

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 markets understanding as Guy described just now, how we can actually link what happened in sessions between the therapists and the patients 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 a launch is digital tools, if you like, and at my pathfinder, therapist companion as well. I think, clearly, digital therapeutics per se has been a pretty challenging field in mental health, and we haven't really seen any one established scale there yet. But our ambition is to help get patients with serious mental illness to better outcomes. And yes, I can see down the road that 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.

[Patrick Trucchio, analyst]

There's a number of these 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 helpful insights occur in our future programs?

[Guy Goodwin, executive]

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 to have a lot of prehearing trauma and an interesting study. We also have another one which looks at utility rather specifically. And I think that will probably have some preliminary data certainly in 2024. I think in addition, we've already -- I think you made you aware of the anorexia study in Imperial, but that will probably be fully published later in 2024. So I think those 3 examples are probably the best.And I mean we can't be entirely predict some of the others that are -- as you know, we can't predict any of them properly because they're not our studies. But we know that the three I have mentioned will be reporting in some detail. And of course, they're rather relevant, particularly the TRD and the finality studies that they're rather relevant to our core focus. So we'll be very interested in those.

[Operator]

Our next question comes from Jason McCarthy with Maxim Group.

[Michael Okunewitch, analyst]

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, Will you look at whether this could be part of the decision process or whether a patient would go into only needing one dose or potentially a repeat dose like you're evaluating in the 006 study?

[Kabir Nath, executive]

At the moment, we're thinking of it more in relation to the quality of the therapy input 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 want 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 the COM 360.

[Michael Okunewitch, analyst]

And 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 COM360?

[Kabir Nath, executive]

So all I would say, that is, obviously, we don't have any specific insights into either of those, either the 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 application, assuming it's successful, assuming that there's an outcome and so on and indeed, how they prepare to launch. And obviously, we do talk to many of the same sites and many of the same physicians.

[Operator]

Our next question comes from Sumant Kulkarni with Canaccord Genuity.

[Sumant Kulkarni, analyst]

It's been some time since the Phase IIb 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?

[Kabir Nath, executive]

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 are 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 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.

[Sumant Kulkarni, analyst]

And then a follow-up on your Phase III 005 program or even 006, how closely will you be monitoring blinded data, if at all?

[Kabir Nath, executive]

We don't monitor blinded data. The data is, by definition, doesn't come to us. It comes to a third party.

[Operator]

Our next question comes from Gavin Clark-Gartner with Evercore ISI.

[Gavin Clark-Gartner, analyst]

I'm just wondering what Greenfield rate you're seeing thus far and how this compares to your assumptions, when you design the trial?

[Kabir Nath, executive]

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

[Operator]

[Operator Instructions] Our next question comes from Thomas Shrader with BTIG.

[Thomas Shrader, analyst]

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.

[Kabir Nath, executive]

Yes. I mean let me start on that and see a guide on it. I think 2 things to say. One, we are being very careful about site selection. I mean, I think everyone knows that large trials in psychiatry are complicated, and there are plenty of anecdotes about where core site selection has contributed to poor results. And we are very much in control of that process. We're careful. Obviously, we have the nucleus of sites that were successful in Phase IIb for the core of the Phase III program. But then going beyond that, it's picking that right next of academic sites, one that can scale to commercial and so on.So 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 obviously, not every psychiatrist in a single practice will be in a position to offer COM60 therapy. But I think as our trials evolve with others do and so on as Spravato continues to scale, you're seeing an ever-increasing number of potential sites that could deliver this commercially.

[Guy Goodwin, executive]

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 [Indiscernible] patient population. So we have literally had conversations with providers who are very keen to think about how we could look at implementing treatment in their centre, but really wouldn't dream of offering to do a clinical trial because it's just a different kind of activity. And 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 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 centres is tough. Getting people to deliver the same treatment in real life, I think, will be different and easier compared to clinic trial.

[Operator]

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

[Stephen Schultz, executive]

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's 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 III 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.

[Operator]

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