Welcome, everyone. My name is Poorna Kannan, and I'm part of the biotech team here at Needham. It's my pleasure here to be kicking off the day two of the conference with the team from Compass Pathways. Compass Pathways is a biotechnology company which is dedicated to accelerating patient access to evidence-based innovation in mental health. We have with us here Kabir Nath, the CEO of Compass Pathways, Dr. Guy Goodwin, the CMO of Compass Pathways, and Teri Loxam, the CFO. I'd like to turn it over to the team to give us an overview of the company, which will then be followed by a Q&A. Just as a reminder, please send in any questions that you may have for the team in the dashboard.
Thank you very much, Poorna. Good morning, everyone. I'm Kabir Nath, the CEO of Compass. I'll make a brief presentation here about the company, and then look forward to Q&A. Just to note that we will be making forward-looking statements during today's presentation, so please do refer to our SEC filings for the risk factors associated with any investment in Compass Pathways. Compass Pathways is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our lead product is COMP360, our proprietary synthetic formulation of psilocybin, and our lead program is COMP360 psilocybin treatment in treatment-resistant depression. We conducted a large and robust phase IIb program. The results were announced in October 2021 and published in the New England Journal in November 2022. Right now, we have a phase III program ongoing, two pivotal trials.
Top-line data from the first is expected before the end of this year, and from the second, middle of next year. In a moment, I will go on to describe some of the IIb results and also the design of the phase III program. We also have a phase II study in PTSD, with top-line data expected in the spring of this year, and we've conducted a number of investigator-initiated studies that have generated signals in different areas of interest, different potential indications. Next, please. Beyond the clinical pipeline, as I say, for TRD and PTSD, we do also have a phase II study underway for anorexia nervosa. We're continuing to develop a balanced and differentiated pipeline.
In the preclinical space, we have prodrugs for psilocybin, prodrug development underway, and we also have a number of programs in terms of both novel psychedelic and non-psychedelic NCEs, all directed again towards areas, different areas of serious mental illness. Our phase IIb study was a very large, robust study for a phase II study. 233 patients across 10 countries and 22 sites. The design was three arms, 1 milligram, 10 milligram, and 25 milligrams of COMP360, delivered to an overwhelmingly psychedelic-naive population. Only 6% of the patients in this population had prior experience with psychedelics. Let me remind you of the challenges of treating treatment-resistant depression.
This, from a regulatory definition, means that patients have failed at least two treatments in their current episode of disease, and failed, truly failed, in the sense of actually having taken those antidepressants for long enough at a high enough dosage to determine failure. It's a population, while the definition is in the current episode, in practice, that's really a proxy for patients with chronic refractory depression. Most of the patients in our trials have had depression for years and have had numerous episodes. In practice, they have very, very few options. In fact, until the approval of esketamine, they had no drug options at all that were indicated for TRD, and even today, there are very few options for these patients, and they have, by definition, ceased responding to SSRIs or other standards of care in depression.
So this is a very hard-to-treat patient population, and what we demonstrated in this phase IIb trial was some remarkable results. The primary endpoint was difference in MADRS at three weeks, and you will see here that there was a difference between 25 milligrams and 1 milligram that was clearly statistically significant, with a P value less than 0.001, but also clinically highly meaningful, with a significant difference in MADRS scores. That difference was sustained at week six at statistical significance, and what we also saw was, in terms of percent of those who responded, 37% responded to the 25 milligram arm and were able... Around 25% of them were able to maintain that response, that remission, to 12 weeks after just one dose of COMP360, one dose of 25 milligrams.
So really very compelling results, with a rapid onset of action, with the effect occurring the day after administration, and durability. Moving to the safety profile, we did see some very mild, moderate TEAEs emerging really transitory around the day of dosing. So you can see that more than 90% were of mild or moderate severity, headache, nausea, insomnia, or anxiety, and the vast majority resolved on the day of dosing itself. There were no concerns around vital signs or ECG or labs in any of the treatment groups, and we did, as expected, see some hallucinations and illusions, all of which resolved on the day of administration. While the adverse events of suicidal ideation behavior were uncommon, they did occur unevenly across the groups in non-responders specifically.
There were three treatment-emergent serious AEs of suicidal behavior in non-responders 30 days post-administration, which is just a reminder that we need to be vigilant to this in our, in a TRD population, and that that clearly will be an event that we will study very closely in phase III. Just as a reminder, this is inevitable in this patient population. Fully 67% of the patients in our IIb trial had a lifetime history of either suicidal ideation or behavior, and since we clearly rule out acute suicidality at the start of the trial, at baseline, to some extent, it's inevitable that you will see some worsening of response on that over the course of the trial. Next, please, Steve. With those phase IIb results in hand, we then designed the phase III program.
The first trial essentially replicates a single dose of COMP360 25 milligrams, but this time compared to placebo, so that we get a true safety profile for COMP360. The second study repeats the same three arms from the phase IIb, 1, 10, and 25, but here we've added a second fixed dose at three weeks. In both cases, now the primary endpoint is at six weeks. The hypothesis we're testing with the second dose, particularly the 25 milligrams, which we saw was the active dose, is that we may actually see a heightened response in terms of number of responders, number who go into remission, or indeed, durability. And there are some small n's from other studies that suggest that the second dose may indeed do that.
Important in the footnote here, there is no change in patient population from phase IIb to phase III. So we are, as far as possible, replicating exactly the same population, same inclusion, exclusion criteria. The first study, the placebo-controlled study, is U.S. only, and as I said, we'll read out before the end of this year from a top-line perspective. The second study is, again, an international one, including Canada, multiple sites in Europe. That is 568 patients, and we expect the top line again in the middle of 2025. Turning to the next slide, you'll also see something very innovative here, which is that in both trials, we've actually integrated a significant follow-up.
So first, both run, as I say, the primary endpoint is at six weeks, but then from week six to 26, in both trials, patients remain in their original randomized, blinded assignment with the option for a retreatment at the same dose as they received in part A. And then after 26 weeks, from 26 to 52, an open label portion in which all patients are eligible, potentially for a COMP360 25 milligram dose, which was really our incentive to keep those on non-active arms in the program all the way through as far as possible. Next, please, Steve. Alongside the work we're doing on executing on the clinical trials, and clearly that's our core focus at the moment, execution around the phase III studies for treatment-resistant depression, we're also starting to build what is necessary for a potential successful commercialization, if approved.
We, Compass Pathways, will deliver COMP360 as the medicine to treatment centers, likely through SPs, through specialty pharmacy channels, and that will be reimbursed by payers. So our revenue will arrive from selling the drug. It's clearly essential that the treatment centers that are providing the psychological support on the day of dosing for patients are reimbursed as well. And that's where we did a lot of work starting several years ago, which was successful last year, in getting a new specific reimbursement code for psychedelic therapies approved and released by the AMA. So there is a new CPT tracking code already in place, which can cover the provision of services during psychedelic therapy. And that was critical because that was something that did not exist before.
It did not exist, actually, at the time of approval of esketamine, and we saw that as a clear gap in the market. In addition, we've started to build relationships with a number of these potential treatment centers. We have already announced this year two collaborations, one with Hackensack Meridian Health, the other with Greenbrook TMS. So two very different settings of care, one, a large regional health system, the other, a for-profit interventional psychiatry network of centers. And the purpose of those is really to understand how COMP360 psilocybin treatment, if approved, can integrate with the workflows, with the existing protocols for those different settings of care, and how we can ensure that together, we can optimize the patient experience there, as well as ensure access to reimbursement, both for the drug and for the psychological support delivered by the treatment center.
As I say, we already have announced two of those. We will announce some more, and what we will do with those is really build those lessons and then have templates, if you like, that we can apply to other similar settings of care as we approach a pre-launch time. Next, please, Steve. From a cash perspective, we have runway into late 2025. At the end of last year, we had cash and cash equivalents of $220 million, and we did, in fact, raise a further $31 million in the first quarter through the first two months. Our guidance for the year is given here. First quarter, around $17 million-$23 million. Full year, $110 million-$130 million of cash used, and that's the guidance we gave on the Quarter Four earnings call at the end of February.
In summary then, 2024 is a very exciting, a pivotal year for Compass Pathways. We have PTSD phase II top-line data expected in the spring. We expect the top-line data for our first pivotal trial of COMP360 in treatment-resistant depression before the end of the year. As I've just mentioned, we will continue to see ongoing collaboration announcements to develop some of these commercial templates for different settings of care. We have a number of investigator-initiated studies underway. Some have already read out. There are others that we are expecting to see additional data. And we had a strong financial position with runway into late 2025, with $220 million of cash at the end of last year. So thank you for the opportunity to give this brief overview, and now myself, Guy, Teri, are happy to take questions, first from Poorna, and then from the audience.
Thank you.
Thank you so much, Kabir. We can get started with some of the questions that I have over here, and then, as a reminder, if anyone has any questions, please send them through the dashboard. Just to get started, what does the psychedelic market look like right now in terms of the product being approved, and how do you see that dynamic developing when more products get approved in the future?
Thank you. So no true classic psychedelic is yet approved. Esketamine from Johnson & Johnson, sold as Spravato, though is typically kind of categorized as something aligned to psychedelics, it does have some dissociative properties. That was launched in 2019, and what we've seen since J&J started to release sales numbers last year, is that that's on a pretty strong trajectory, doing around $600 million in the US last year and growing strongly. The next potential psychedelic to be approved, true psychedelic... Well, again, not necessarily a true psychedelic, but one that is clearly generally categorized as psychedelic, is MDMA for PTSD. And Lykos, formerly known as MAPS Public Benefit Corporation, had that filing accepted a couple of months ago with a PDUFA date of August. I think it's important to stress that that's a very different model and modality from what we are offering.
That really requires intensive therapy. COMP360 psilocybin treatment requires psychological support rather than therapy, and I think Guy, I'm sure, later will be happy to dig into that a little more, because it's an important distinction. We then potentially would be the next to file if we're successful in our trials. I think what you're seeing, though, is a couple of things. Today, there is not yet an established market. It's all to come. What you are seeing, though, is the regulators being very aware that this is coming. The regulators, the FDA, in June last year, put out draft guidance for the first time for the development of psychedelic therapies, and the European authorities have also acknowledged that they're gonna be reviewing a lot of these filings. You're seeing regulatory movement towards it and alignment.
You're seeing, I think, a growing acceptance among psychiatrists that these drugs could, provided there is sufficient, robust evidence generated, be an interesting new treatment option for patients with serious mental illnesses. But we're still, to be clear, very much at the start, at the very birth of this whole sector, and it is not an established sector yet.
Okay, that's really helpful. You mentioned that the new CPT III codes, which have been established for psychedelic therapies, which should help physicians get reimbursed in the near term. So just curious, for the long term, how do you envision that this payer coverage and reimbursement would work if it gets approved?
I think what's interesting is, you know, as I mentioned, we, Compass, are gonna be obtaining reimbursement for the drug, and clearly, that will depend on the profile that we actually deliver in phase III, what that profile looks like in terms of clinical meaningfulness relative to the other options for patients with TRD, which, as I mentioned, are actually few and far between. It's also critical, though, as I said, that the treatment centers providing the psychological support are also able to obtain reimbursement. In a sense, this is in no way a new paradigm. This is a drug with an associated service, and that's ultimately not that different from chemotherapy or dialysis, but clearly, it's new in psychiatry.
So it's gonna take time to establish this as a way of working in psychiatry, but I think the groundwork, what we have done, building also on some of the tailwinds from Spravato's growing success, I think we are confident that we will be able to make that happen. But it is gonna require close coordination, and in particular, it's gonna require us to be very thoughtful about how we engage patients and ensure that they can navigate, and, you know, assure access to care across both of those, the drug and the treatment center.
Okay, and how about the rescheduling expectations for COMP360? What do you think it could be once it's approved?
We choose not to speculate in public on that.
Yeah.
You know, as you know, if the FDA approves COMP360, the DEA is required to do a federal level rescheduling within 90 days. What I will say is we are, as you would expect, already in dialogue with controlled substance staff and so on, so we have our plan towards that. You know, we will see where it lands, and then I think as people are aware, ketamine is now free. There were other things like Epidiolex ultimately were ended up not scheduled at all, and so on. So we will have to see.
Okay. Okay, that makes sense. So I guess just more in terms of some clinical questions over here. I was wondering, what is the benchmark for the primary endpoint from both the studies that are currently in phase III?
I'll hand to Guy for these. You're on mute, Guy.
My apologies. I mean, we're obviously using our experience in phase II to guide the design in phase III, and some of the assumptions that we make in calculating the power of those studies are derived from that data. What we saw at week three, as you just alluded to, was a large effect that's six points on the MADRS scale. We have obviously looked carefully at what the later time points told us in that study, and we've used that data to extrapolate. We think that our phase II, which had 22 sites, remember, is a little more representative of what to expect in phase III than perhaps other development programs would allow one to expect. But that essentially is has guided us in the way we thought about it.
We also may expect, or we're going to see whether two treatments is more effective than one. And I think clinically, the benchmark is really going to be the remission rates, which are very remarkable and very complete effects, things that patients will, and clinicians will clearly value in terms of an outcome. And those numbers will be extremely important as well.
Okay. But I guess from a regulatory point of view, you'd still need to demonstrate the effect on the primary endpoint. So I guess what is... what, what in your mind is the benchmark for the primary endpoint? Would it still be what you saw in Phase II or?
Well, I mean, we, you know, frankly, we will accept a difference from a statistically significant difference, and we'll see what that is, but we clearly use the phase II data, and particularly the sixweek figures to predict what we will see. Obviously, we're using placebo this time, that we have other placebo studies to guide our expectations for that arm of the study. But if anything, that should be in favor of a larger difference between the comparator and the active treatment in 005. 006, as I say, we will—that's somewhat more exploratory simply because we have two treatments, but of course, the endpoint is only three weeks after the second treatment. So that obviously we would expect to map a little more precisely to the phase II study, which was a three week outcome.
I guess a follow-up for the 006 study. What are you anticipating to see from this additional dose?
A greater efficacy. We don't know that to be certain. We know that it's acceptable from the experience of the Imperial group, who did a double treatment in a study that was published in the New England Journal in comparison with escitalopram. So we know that it's a feasible thing to do. There was very few dropouts from that, and we have seen very few dropouts in our current ongoing study. We expect from the feedback we got from both clinicians and patients in phase II that this will be welcomed by many patients, the opportunity to have a second treatment, and therefore, we are hoping that we will also see an improved outcome. And we await the results with great anticipation.
Okay, but how about, like, the safety profile? Like, what kind of impact would it have on the current safety profile with an additional dose?
Well, clearly, there'll be the burden of a second visit and the side effects that the effects that Kabir has already explained, that the effects that the drug produces are a mixture of things, and they include very abnormal experiences, which for some patients may be anxiety-provoking. So we will increase, in all probability, that particular burden. But it has to be said that those effects are the direct effects of the drug on the day of administration, are confined to that day, largely, and maybe a little bit of a hangover effect the next day, and they are not, for the most part, severe. So yes, they will have a second administration, so a second set of those kinds of adverse events.
We will be very eager to see what happens to the longer-term effects, the most concerning of which is suicidality in patients who don't respond to treatment. So obviously, that's something the study is designed to establish. We can't really predict it in advance.
That makes sense. So I guess I was curious, is do you see the treatment-resistant depression patient population to be segmented, if there are patients who would require one additional dose versus patients who might benefit from just one dose?
We would love to offer patients precision psychiatry. In other words, to predict how they're going to respond and to design the treatments appropriately. That, I have to say, remains a beautiful hypothesis, a nice idea that tends to be spoiled by the truth of what we find, which is that it's very hard to predict outcomes. So in the first place, we expect that patients will be scheduled to receive one or two treatments, and I think in clinical practice, whether people proceed to have one, two, or three treatments will depend on their response and the intensity of their experience during the drug administration.
In fact, the design of the study allows some retreatment in what we're calling the phase B of the study, and so we will actually get some sense of whether that kind of optionality in treatment is valuable in terms of increasing numbers of patients who respond. But that is how we imagine it will be used, yeah. Prediction, not-
... Okay. I think I was just more curious in terms of the patient population, if there would be, like, a more severe segment which might benefit more from an additional treatment. Like, is how would you divide that patient population?
Well, at the moment, we really don't have a-- I mean, we-
Okay
...recruited moderate and severe patients in terms of symptom severity. And if we split them by duration of illness, if we split them by gender, if we split them by intensity of illness, we don't really see any of those baseline characteristics as predictive of outcome. So, you know, as I say, this is a challenge for the psychiatry in general, to be more precise about how we pick patients and subdivide them. At the moment, they are a large, heterogeneous group, but we don't really know how to divide them into more understandable components, I'm afraid.
Okay. That, that makes sense. Yeah. Thank you. So I guess the current remission rates in treatment-resistant patients is approximately 13%-14%. And for psilocybin, which is in phase IIb, demonstrated around 30%, and 20% had a sustained response at week 12. So I guess I'm just curious, what do you think that the 20% response at week 12 is improvement enough?
Yes, I do, in the sense that I think those people show a sustained remission, which is durable, and indeed, we will evidence just how durable in the phase III program. But from the relatively small number of patients we could follow up, there were quite a number of patients who were going beyond 12 weeks, as well as getting to 12 weeks. We can't be definitive about that, but we certainly saw good examples of that. I mean, that is extremely encouraging because the relapse rate in, for example, STAR*D, which I'm afraid everyone has to rely on for a systematic description of what happens at later stages of treatment in major depression. They showed that not only were there low relapse, pardon me, response and remission rates, but there were also high relapse rates.
So I think when you look simply at remission or relapse, you have to and response or remission, you have to also factor in relapse, and we seem to get the better the response, then the longer our patients seem to remain well. So that seems to me potential, a benefit that we will obviously have to substantiate, but that's certainly the way we expect to see things pan out.
Okay. Okay, that's helpful to know. I guess you mentioned about durability. What are you interested in seeing in terms of durability of effect? Do you think a three-month response would be acceptable, or do you anticipate having multiple administrations per year?
Yeah, it's a great question. I mean, we simply don't know, of course, so we're trying to establish a guide for that, for clinicians, by doing the phase three program in the way that we've chosen to do it. Our sense is that the ideal would be one or two treatments and something like an annual retreatment at the moment. That would be very good. It remains to be seen whether how many patients that will work for.
You know, the only thing I would add to that is I still believe if it turned out, shall we say, that it was, in general, four treatments, so three months was typical, I think that's still commercially a pretty viable value proposition.
I guess thinking in terms of commercially, how I know it's a little early right now, but how are you thinking about pricing? Would it be more about per administration, or would it be some sort of an annual pricing that you are looking at?
You're right. It's, it's a little-
Yeah
... premature to be speculating about pricing specifically, but I think obviously the phase III is designed to give us some information on the number of administrations and so on. But it is ultimately a clinical trial and not a fully representative population. So our guidance has been so far that it's likely to be per dose. We're unlikely to have sufficiently robust data to be looking at annual costs or capping costs or whatever. It is likely to be a per-dose pricing, but again, that will depend on the data we generate in phase III.
Okay, that makes sense. I guess, how do you anticipate the administration of COMP360 to compare to the burden that's associated with Spravato?
So that's a very good question. I think, you know, when you actually look at the label for Spravato, it does actually require eigth administrations in the first month, four in the second, and maintenance thereafter, which is clearly, to a degree, a patient and physician discretion, but is typically every couple of weeks for a sustained period. So that's a significant burden in terms of number of visits. Each of those visits is effectively half a day as well, because there's a two hour monitoring period after checking in, after self-administering the drug, and so on. And again, you cannot drive after that, so you need to have a family member or caregiver with you. So it's a pretty significant burden in terms of maintaining durability.
So from our perspective, that's why I said potentially something that's delivered once every three months, acknowledging it's a full day, that once every three months, we think compares very favorably from a patient perspective. It compares favorably from a throughput perspective and so on, for a treatment center. Of course, the challenge we have that we are starting to deal with is if treatment centers are offering Spravato, they're making money on every one of those visits. So it's how do we ensure that the economics work from a reimbursement perspective, and that's work that we're engaged on now. But certainly, from a patient, clinician, and throughput perspective, I think we potentially, if we can deliver the profile we've been discussing in phase three, offer something that is highly, compellingly differentiated from esketamine.
Okay. We actually... One of the questions that we have here is that, how will psychotherapy be viewed from a payer and regulatory perspective, given it's part of the regimen?
... So I'll actually turn to Guy to start on the regulatory side of that and how we actually truly view psychological support. Sorry, Guy, you're on mute again.
Sorry, I'm trying to avoid clicks and bangs from my computer. If you look at what the FDA discussed in their guidance that came out last year that Kabir alluded to, you'll see that they accept potentially a wide range, and this is from trials, a wide range of clinical backgrounds to provide psychological support. And that reflects the fact that what is being provided is something that can be essentially coached, and on the day of the administration of the drug, involves a great deal of simply passive accompaniment of the patient. It isn't an active treatment; it isn't an active psychotherapy.
So I think, I mean, Kabir may wish to go on and discuss this, but what we're looking at with providers is how most optimally we can adapt the model so that they can use existing staff, train existing staff to implement in practice what we are showing works in clinical trials.
Yeah. I mean, thank you, Guy, and, yeah, just to build on that, I mean, so we would anticipate a label that is broad in terms of, you know, COMP360 administration for treatment-resistant depression with psychological support. That to be carried through in the REMS, which we can surely expect, given that psilocybin is currently Schedule I. I think we have to assume there will be a REMS that governs the prescribing for that. And as Guy says, that then gives us the flexibility to work with providers on who are the existing people today who could potentially provide that psychological support in the room on the day of administration.
Okay, that's, that's really helpful. I guess in your, in your conversations with, with the FDA or any regulatory body, how do they think about, I guess, adding psychotherapy as part of this regimen? So, like, would it be priced as an addition, or would it be thought of as just the whole therapy itself?
So, again, for the regulators, don't really care about-
Oh, sorry, about the payers.
How much it costs?
Yeah, no, sorry. I was talking about payers. Yeah, my bad.
No, so, so look, I think, again, that's part of the purpose of the type of collaborations that we're doing today, you know, with Greenbrook TMS, with other places, and so on. We would expect there's gonna be a mixture of buy and bill and direct drug sale here. You can certainly envision some providers seeing this as a buy and bill opportunity, where they would essentially charge a single price and potentially use the profit on the drug to subsidize some of the provider side. You can see in other places, and that's why we got the CPT III code, that this is just a separate reimbursement, one for the drug and one for the provision of psychological support.
Okay. Okay, that's helpful. Thank you. I guess recently you've mentioned that there have been some delays in recruitment for the COMP005 study, which has been mainly in the US. So, just curious, is there a difference in the treatment-resistant patient population between the US and ex-US?
So I'll, I'll start on that, but I'll invite Guy to jump in as well. So no, there is no difference in the population. We're using the same criteria we used in the phase IIb. The challenge is that to actually ensure that people truly have treatment-resistant depression, as I mentioned, we need evidence of at least two courses of medication in the current episode at a specific duration and dosage. Those records are not centrally held in the U.S., so that requires prescribing records, dispensing records, and requires them to be pulled together. Typically, in Europe, they are held in one place, so the process of actually confirming that patients meet the entry criteria is much more complicated in the U.S. than it is ex-U.S. That's really the challenge for us.
Guy, I don't know if you want to add anything.
Well, just to explain that the implications of that is that patients cycle through the protocol and have to drop out because we haven't been able to meet the bureaucratic requirements of actually getting the information in our hands. So that, that's why it's a problem. We don't have any shortage, really, of patients entering the study and wishing to participate. It is just this funnel that effectively restricts the numbers who can actually be enrolled in the study. So screening is not the problem; it's very much this enrollment phase. And we think that we have managed to certainly approach this realistically by hiring vendors who will actually do some of the donkey work, the legwork for us, and we expect to see the fruits of that come through in the next few weeks.
I think it's also obvious that it's not the first time that people have had this problem because these vendors exist for this very purpose, to take the burden off CROs and companies who are trying to do clinical studies in the U.S.
Okay. Yeah, that makes sense.
The only thing I'd add is just to remind you, as we said in the earnings, this does not change the overall program timing. 006 remains on track, and we have always clearly guided that our expectation is both studies are required for a filing, which is very much in line with the FDA's draft guidance.
Sorry to go back to the previous topic again, but we have another question here, which is that: Does the business model work if the payers have to reimburse psychotherapists?
So as I said, at maturity, this is no different from chemotherapy or dialysis, you know, where you have a drug company that is selling drug, and you have a service provider who has a business model around providing services and getting reimbursed for that. What's different, of course, is that psychiatry, that doesn't yet exist at scale, and this is gonna be, after Spravato, one of the first attempts to build that. But again, provided we can provide the appropriate economic incentives to each of the players, there is no reason why the business model wouldn't work.
But we acknowledge that, again, coming back to that's why we're working now with some of these different settings of care, we need to understand what the true cost then of having a piece of real estate tied up for a day, a room, and an HCP at some level with a license also in that room for a day. We need to understand the true cost of that and the true economics. Because as we've discussed extensively, we think this is likely to be quarterly or even less frequent. We actually strongly believe that you can make the business case work, but that's a lot of the work we're doing on the commercial side in the next couple of years.
Okay.
Kabir, it's probably worth also reminding people, you mentioned it earlier, but that's where the CPT code comes in, and the fact that we've established the CPT code should facilitate that reimbursement, and acknowledging that and going into our launch with that really helps people.
Agreed. Thanks, Teri.
That's really helpful. So I guess coming in terms of, like, in the last few minutes, speaking about cost, you've mentioned that you have cash funds sufficient to fund operations until late 2025. Can you elaborate on some of the activities that are covered under these operations?
Sure. So, yes, we have cash through late 2025. Currently, the phase III TRD programs are the primary costs that are incurred in that runway. We have a number of other indications that we're interested in, that we've done some earlier phase work in. We have a PTSD trial that's in phase II, that's due to read out here in the spring, so anywhere between March and June. And if positive, that is an indication that we would like to potentially do a broader, later-stage trial in. That's something that would not be currently contemplated in our cash runway. So we've currently got our initial TRD indication in there, but any additional indications for late stages, we would need to raise additional funds or change something to be able to finance those.
Okay. That's helpful. I guess just in the last minute over here, the question that I have is like, Spravato treatment for depression has yielded global sales of around $700 million in 2023. I guess, what are your expectations for COMP360 if it's approved?
So we have not given revenue guidance yet. What I would turn to and say, though, is there are, to our knowledge, at least one million patients with treatment-resistant depression in the U.S. within the system today. Probably significantly more, who are not necessarily under the care of a psychiatrist outside the system. So you don't have to imagine, you know, huge penetration numbers or peak shares to see that there's a very significant opportunity here, given that number of patients who really have, other than Spravato, TMS, or as a last resort, ECT, very, very few options today.
To build on that further, and I know we're on time here, in addition to TRD, as I just mentioned, there are other indications, and we anticipate COMP360 could be broadly applicable across a number of indications, many of which have comorbidities and co-, you know, are treated out of the same treatment center, so there could be synergies commercially. So this could be a broader opportunity than just the initial indication.
All right. Well, thank you so much. That sounds really exciting, and really looking forward to all the data updates that we have for the rest of the year and in future. And I know we are out of time, so I just wanna thank the team for taking the time today to speak with us. And thank you to our listeners.
Thank you, Poorna, and thank you to Needham for hosting us. Thank you.
Bye.
Thank you.