Compass Pathways PLC
NASDAQ:CMPS
Earnings Call Analysis
Q4-2023 Analysis
Compass Pathways PLC
Upon analyzing the earnings call, the narrative unfolding for COMPASS Pathways depicts a strategic movement towards the potential milestone achievement of its COMP360 psilocybin therapy. The company's fiscal fortitude is highlighted by an operating cash usage of $97.4 million for the full year 2023, aligning with prior guidance and accompanied by an anticipated R&D tax credit, expected to bolster the first quarter of the upcoming year. Despite a net loss, the organization's careful cash management indicates a robust financial health, with cash reserves increasing from $143.2 million to $220.2 million, a strong indication of fiscal responsibility and forward planning.
The company's clinical voyage with COMP360 reveals promising progression, underscored by regulatory movements favoring psychedelics and the successful sales of esketamine, suggesting a welcoming market for COMPASS's treatments. Setbacks, such as slight enrollment delays resulting in a Q4 2024 projection for pivotal trial data, have not deterred the course, as financial guidance remains firm, with operation cash usage forecasted between $110 million and $130 million for the forthcoming year.
COMPASS's tactical alliances, particularly with Greenbrook and Hackensack, are part of a deliberate effort to crystallize service delivery models and reimbursement approaches. These collaborative ventures each hold a mirror to distinct healthcare settings, equipping the company with varied templates that will be emblematic for wider, prelaunch operational strategies.
COMPASS casts its focus on post-traumatic stress disorder and depression in bipolar disorder type II, while conscientiously embracing the intertwined nature of depression and anxiety. Although not immediately pursued, the company keenly observes comorbid instances and competitor dynamics, signaling a discreet yet responsive approach towards potential expansions of COMP360's therapeutic applications.
As COMPASS Pathways aspires to transform the treatment landscape for psychiatric conditions, it balances the dynamics of rigorous clinical development with financial prudence and collaborative ingenuity. The year ahead promises to be one of significant strides and potential triumphs, all while remaining intently attuned to shareholder value.
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Good day, ladies and gentlemen, and welcome to the COMPASS Pathways Fourth Quarter 2023 Conference Call. [Operator Instructions] As a reminder, this call is being recorded.
I would now like to introduce your host for today's call, Stephen Schultz. You may begin.
Welcome all of you, and thank you for joining us today for our fourth quarter 2023 results conference call. Again, my name is Steve Schultz, 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; Teri Loxam, our incoming Chief Financial Officer; and Dr. Guy Goodwin, our Chief Medical Officer.
The call is being recorded and will be available on the COMPASS Pathways' Investor Relations website shortly after the conclusion of the call and will be archived for a period of 30 days.
Before we begin, let me remind everyone that during the call today, the team will be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as amended. You should not place undue reliance on these forward-looking statements. Actual events or results could differ materially from those expressed or implied by any forward-looking statements as a result of various risks, uncertainties and other factors, including those risks and uncertainties described under the heading Risk Factors in our annual report on Form 10-K 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.
Thank you, Steve. Good day, everyone, and thank you for joining us.
Let me begin by thanking Mary-Rose Hughes, our Interim Chief Financial Officer, for her tremendous support over this last quarter. And let me welcome Teri Loxam, back from climbing Mount Kilimanjaro and into the CFO role starting tomorrow, March 1. Teri brings to COMPASS deep, extensive strategic experience, working for publicly traded companies in the pharmaceutical and biotech sectors. Her broad experience through all stages of development is precisely the expertise and leadership that COMPASS required as we progress our Phase III program in treatment-resistant depression. Many of you already know Teri, and I hope that over the coming months, the rest of you will have the opportunity to meet her. And in a moment, I'll ask her to provide a few thoughts on her new role at COMPASS.
First, though, let me report that COMPASS continues to actively recruit both our Phase III COMP360 trial in treatment-resistant depression, with top line data expected this year and next. While our overall Phase III clinical program completion remains on track with top line data from the 006 study expected in the middle of 2025, we are experiencing some recruitment delays in the 005 trial, which extends our guidance for top line data from that trial into quarter 4 of this year. Importantly, this change in guidance does not impact expected timing regarding the submission of our NDA filing. As we've consistently guided, we do expect that both trials will be required for NDA submission, consistent with the FDA's draft guidance for the development of psychedelics published in June last year. We will also have all necessary preclinical and clinical pharmacology studies for a complete NDA dossier.
In parallel with the Phase III trial program, we continue to take the steps needed to ensure a well-developed delivery network for COMP360, if approved. This includes developing collaborations that will educate both COMPASS and settings of care on how COMP360 may fit into treatment options for appropriate patients. A key element of these research collaborations is to explore and develop multiple potential commercial delivery campaigns to ensure a successful rollout of COMP360 treatment subject to FDA approval in different care settings.
Earlier this quarter, we announced the first 2 such collaborations with Greenbrook TMS and Hackensack Meridian Health, which are 2 very different but equally important collaboration partners. These collaborations will explore how to improve the patient care experience and gain us better understanding the potential commercial models for the administration of COMP360 psilocybin treatment. We also expect to announce additional research collaborations this year.
In December, we announced initial safety data from our open-label Phase II clinical trial of a single 25-milligram dose of COMP360 in 22 people living with post-traumatic stress disorder, or PTSD. We were also pleased to see the publication of COMP360 data from an investigator-initiated study in bipolar type II in JAMA Psychiatry. In a moment, Guy will provide more information on both of these studies.
While TRD is our lead indication for COMP360, we see logical expansion of its utilization into additional indications where there are significant comorbidities and overlap, such as PTSD and bipolar 2, subject to additional financing.
With that, let me ask Teri to introduce herself and share a bit about why she came to COMPASS. Teri?
Thanks, Kabir. Now that I'm back at sea level, I'm really happy to be joining you in this experience in pioneering leadership team.
Similar to many, I've sadly witnessed the impact of mental health issues on people close to me. So a big draw for me to the company was seeing COMPASS fully embracing its mission with a thoughtful, innovative and data-driven approach to tackling significant unmet need in this area. Psychedelics and their potential to treat mental health conditions have received significant attention in the media, but we are still very much just at the beginning of this journey. While psychedelics could be transformative to mental health, in these early days, it is critical for companies to build and execute robust clinical trial plans to realize the long-term potential. This is precisely the approach COMPASS has taken with its large Phase II and ongoing Phase III programs in TRD.
There are a lot of important milestones over the next 12 to 18 months for the company. And with a strong balance sheet and an experienced team, we are well positioned for success. I'm really looking forward to working with the team to help shape the landscape and prepare for this potential important treatment option for patients.
With that, let me hand the call back to Kabir.
Many thanks, Teri. Welcome once again, and it's great to have you join our leadership team.
Let me now hand the call over to Guy to update you on clinical news during the quarter. Guy?
Thank you, Kabir. Looking at the COMP360 pivotal program, nearly all sites have been initiated for COMP 005. For the 006 trial, we have clients initiated in the U.S., Canada, U.K., Ireland, Sweden and Spain. I anticipate further progress this year.
Patient demand is strong in all geographies, which, as expected, reflects the degree of unmet need in this population. However, as Kabir has said, we are experiencing delays in recruitment in our 005 trial. As we've said before, these trials are complex. Beyond the Schedule I drug authorization and unique handling requirements and redosing protocols, we are formally confirming every patient's TRD diagnosis, an important element to the quality of this program. This has been a challenge because medical recordkeeping is decentralized in the U.S. and has slowed the pace of screening and enrolling. However, now that nearly all 005 sites are open and with the addition of resources, we will see an increased pace of recruitment, which should help improve enrollment. The challenges we have encountered are specific to U.S. clinical sites. And as Kabir mentioned, we don't see the same impacts to COMP 006, a global trial, which remains on track.
Separately, we are also excited by the potential for COMP360 in other indications. PTSD is an additional indication of interest, which we have investigated in an exploratory Phase II safety study of 22 patients, all of whom were administered a single dose of 25 milligrams COMP360 psilocybin. We announced initial safety data in December, which demonstrated that COMP360 was well tolerated up to 24 hours, and the safety profile was, as expected, with no treatment-emergent serious adverse events reported. The study participants have been followed for 12 weeks, and we look forward to announcing the full [ PTS ] data set, including efficacy, later this spring.
In addition, as Kabir mentioned, the full results of an independent investigator-led study in bipolar type II depression were published in JAMA Psychiatry. These data first announced in 2022 demonstrated the potential for investigational COMP360 psilocybin treatment in another difficult-to-treat depressive disorder.
The study was conducted by Scott Aaronson at Sheppard Pratt in Baltimore and funded by COMPASS. It investigated the safety and efficacy of a single 25-milligram dose of COMP360 psilocybin treatment with psychological support. The primary endpoint was change in MADRS total score from baseline to week 3. All 15 participants had lowered MADRS scores with a mean change from baseline of minus 24 points at week 3. 12 participants met the criteria for response, and 11 met the criteria for remission. While this is a small trial, we see the results as extremely promising.
Importantly, there was no increase in the suicidality score based on MADRS and no unexpected adverse events or difficulties with the dosing sessions over the 12 weeks of the study. We did not see the onset of a manic, hypermanic or mixed state, which is a particular concern for patients with bipolar disorder. The most common adverse event was headache reported by 4 out of 15 participants on the day of dosing, with symptoms resolving within 24 hours. People living with bipolar II depression, like those living with TRD, have limited or no options. So it's encouraging to see early signals that COMP360 psilocybin may have potential to help those living with these depressive conditions.
As Kabir indicated, based on this study's results, bipolar type II looks to be an indication of interest for the use of COMP360, and additional larger studies are under consideration. This is a good fit with our mission for the company.
Let me now hand the call to Mary-Rose for a financial overview. Mary-Rose?
Thank you, Guy. I'll now step through the full year financial results.
Cash used in operations in the full year 2023 was $97.4 million, within the guidance range we provided for the full year last quarter of $94 million to $100 million, excluding the R&D tax credit. The timing of receipt of the credits is uncertain, but I'm pleased to confirm that HMRC has since approved our claim in full, and we now anticipate receiving the tax credit in the first quarter of this year.
For the year ended December 31, 2023, net loss was $118.5 million or $2.32 per share compared with a net loss of $91.5 million or $2.16 per share during the same period in 2022. These results include noncash share-based compensation of $17.3 million in 2023 and $13.1 million in 2022.
R&D expenses were $87.5 million in 2023 compared with $65.1 million in the prior year. And G&A expenses were $49.4 million in 2023 compared to $45.4 million in the prior year.
Long-term debt under our Hercules loan facility was $28.8 million at the end of the fourth quarter.
Regarding first quarter financial guidance, we expect net cash used in operations to be between $17 million and $23 million, which assumes that we receive R&D tax credit in the first quarter. However, as I've mentioned already, the timing is uncertain.
Turning to full year financial guidance. We expect cash used in operations to be between $110 million and $130 million. We expect to narrow this range as the year progresses.
COMPASS continues to maintain a strong financial position, with cash and cash equivalents of $220.2 million at December 31, 2023, compared with $143.2 million at December 31, 2022. We will continue to manage our cash carefully to continue advancing our pivotal programs and to achieve important milestones that we believe will create value for our shareholders.
Thank you. And I'll now turn the call back to Kabir.
Thank you, Mary-Rose. I'm pleased that we're seeing continued enthusiasm and meaningful momentum building for both COMPASS and this area of science.
Our COMP360 Phase III program remains on track, with the first trial expected to read out this year, not only a key milestone for COMPASS but also a major event in the development of psychedelic medicines. The FDA draft guidance for clinical studies of psychedelic drugs along with the European Medicines Agency's plans to establish regulatory guidelines for the development and therapeutic use of psychedelic substances in Europe are important signs that regulators are preparing for the potential use of psychedelics as treatment.
And as sign of the continuing unmet need in TRD, esketamine, sold under the brand name Spravato, achieved global sales of almost $700 million in 2023, which demonstrates the continued growth of interventional psychiatry and the infrastructure to deliver it, which bodes well for the potential of COMP360, if approved. We also welcome the news of FDA acceptance of Lykos Therapeutics' NDA submission for MDNA-assisted therapy for PTSD.
We're seeing increasing interest from clinicians who plan to incorporate psilocybin treatments into their mental health offerings. Our collaborations are indications of this interest, and we'll continue to develop commercial models that enable rapid, scalable, broad and equitable access to COMP360, if approved.
In closing, with our strong balance sheet, we are focused on execution of our Phase III program in treatment-resistant depression. This will be an exciting year for COMPASS Pathways, and we look forward to updating you on our progress over the coming year.
Thank you again for your participation on today's call. I will now turn to Q&A. So I will hand the call back to the operator. Thanks.
[Operator Instructions] Our first question comes from Patrick Trucchio with H.C. Wainwright.
Just a couple of follow-up questions on the enrollment delays. So the first is just regarding the TRD diagnosis being necessary for enrollment in the program, can you remind us how you're defining TRD and confirming this diagnosis in patients who are enrolling in the program? And secondly, can you tell us what proportion of patients are expected to have experience with psychedelics?
Thanks, Patrick. I'm just checking that you can hear us, and I'll hand it to Guy.
Patrick, yes, I mean, our criteria are those with treatment-resistant depression, as you know. And that means that patients are required to have failed at least 2 treatments. These treatments have to meet the criteria for adequate dose and adequate duration. And the delay that you referred to is caused by the fact that we are being very rigorous in establishing this -- that this has occurred through health records. And that, in the U.S., has proved to be difficult but not impossible, and we're proceeding successfully to do that in the patients we are recruiting.
I should say there's no shortage of patients, but the issues around verification have been real, and those are what have caused the problem. The percent of patients who may have been -- previously taken psychedelics, we were -- we've taken that number up from 10% in the Phase II to 15% in the Phase III. And just to emphasize, one of the issues that we face is that patients conceivably -- or [ patients, people ] seeking treatment may be seeking psychedelics, and that's one of the reasons why we're particularly rigorous insisting on the medical records being proven and verifiable. Thanks very much.
Got it. If I could, just another follow-up. I'm just -- I'm wondering if this -- just moving this top line data back for COMP 005 trial, is that -- would that have any impact on the potential filing of an NDA for TRD? Or is the timing kind of going to be unchanged based on the top line data for the 006 trial?
And separately, I guess maybe if you could just talk us through what data would be anticipated in the NDA. Specifically, would you have any certain amount of longer-term follow-up efficacy or safety data from these trials before that NDA is submitted?
Thanks, Patrick. So I'll work backwards from that question. We have not clearly guided on what we are going to be -- expect to include in the initial submission. That will be a matter for discussion with the agency. But as a reminder, with breakthrough designation, you can clearly envisage things like rolling submissions as well.
So the first part of the question, no. As I said in my prepared remarks, this does not alter the potential timing of a filing. 006 remains on track for mid-'25, and we have always consistently guided that we do expect both trials to be needed to form an adequate [ or sensible dosing ]. So no, we are not anticipating any change in the timing of potential submission.
Our next question comes from Charles Duncan with Cantor.
I wanted to follow up to those last questions with regard to diagnosis of TRD. Can you help us understand how it's different in the United States versus elsewhere? And what percentage of patients are you anticipating in 006? And why will the problem be fixed in that trial?
I mean I think that the problem in the U.S. is simply the nature of the health care system is being simply more decentralized. This is in great contrast really to particularly European health care systems, where usually health care records are extremely straightforward to access. For example, most patients in the U.K. have a primary care position to get health records. It's simply a matter of contacting the physician with appropriate consent getting the record. So there's a great -- that's a tremendous difference from what we have to say in the U.K.
I think in terms of -- your second issue is about -- what was the second issue?
In terms of the number of patients...
006.
Yes. I mean that issue relates -- I mean we think that we will be in a position having set up the systems that we now have to facilitate getting the data. But the fact that 006 is taking place subsequent in most centers to 005 means that everything will really be running optimally by the time many of the U.S. sites switch to 006. The patients entered on -- in ex U.S., of course, are not subject to the problems anyway. And we think the proportion, I think you also requested, will be about 50-50. And we can -- when we model it, we think that this is -- we're on track, as we said, for 006. And the problems with 005 are really partly to do with the fact we started 005 first in the U.S.
That makes sense. If I could ask one follow-up, and that is, can you help us understand the screen failure rate if you're tracking that at all? But then also, are you having any challenges with washing patients out before -- of standard of care, albeit an effective antidepressant, before they enter 005?
I mean they're -- that route represents -- the washout represents a challenge, but the most of the problem has been with the verification for diagnosis. So that has been 001, our Phase II trial, about 1/3 of the patients in that study were already off antidepressant. So 2/3 acquired washing out. And the majority -- great majority were able to do so once they have been enrolled in the study, but [indiscernible] in 005.
Our next question comes from François Brisebois with Oppenheimer.
Just a couple here. Just -- sorry to ask again about the enrollment. But is the fourth quarter guidance [indiscernible] a very conservative? Or how do we feel comfortable that fourth quarter will be correct for 005?
Thanks, Frank. We are very comfortable with that. We, as you would expect, [ have ] a number of reprojections, looked at different scenarios, and we are very comfortable with the fourth quarter guidance.
Okay. And then on the commercial side, the Spravato infrastructure, obviously has some read-through here. Can you just remind maybe us, the listeners that -- how Spravato works, how many times people come in? And are there any efficiencies maybe for these centers that would put you in a situation that might be superior to Spravato? Just any learnings there. How has that evolved as you guys look into the commercial opportunity?
No, it's a great question. So yes, clearly, the protocol for Spravato is very different from what we envisaged via final protocol for COMP360. So as a reminder, the Spravato label actually requires 8 administrations in the first month or in the second month and maintenance thereafter, with patients' and physicians' discretion, but typically every couple of weeks.
So you can imagine, therefore, over the course of the first 3 months, that's something like 12 to 15 sessions. Each of those requires the patients in the clinic for a minimum of really 3 to 4 hours, given the intranasal administration and the trials [ they're ] monitoring. And by the way, they can't drive at home afterwards [indiscernible] actually requires a caregiver for each of those as well.
In contrast, obviously, we don't yet know what the durability will be for a [indiscernible] typical patient with COMP360, and the Phase III is designed really to address that. But as we've said before, based on what we know, it perhaps might be 2 to 4 administrations a year for the patient. So you can see that from a patient perspective, that's a very, very different from [indiscernible] center. It's the difference between using one room for a day, once every perhaps 3 to 4 months and actually having multiple uses of rooms during the course of time for esketamine.
So we believe a big part of the reason we've signed these collaborations with entities such as Greenbrook and Hackensack, and we'll do more, is exactly to understand how we are going to integrate psilocybin differentially from Spravato into those workflows and [indiscernible].
Great. Congrats on the progress here.
Our next question comes from Neena Bitritto-Garg with Deutsche Bank.
So I just wanted to ask about the enrollment again. And I just wanted to confirm what kind of -- if there are any actions that you can take to really maybe accelerate the review that you're doing to confirm diagnosis. Is there anything that you've actually been able to do that you found has been helpful in accelerating that process in the U.S.?
Yes. [ And the work ] that have and we have taken those mitigating actions. So we have added specific vendors who are able -- with patient concern to work directly with patients and to obtain the medical record. So what we have seen is that, that does enable us certainly, in some circumstances, to obtain those records much more quickly than going just through the motions ourselves or with our CRM. So yes, we have added specific paid-for vendors, a couple of different ones, in fact, to enable that at the majority of sites.
Our next question comes from Ritu Baral with TD Cowen.
Kabir, are you anticipating that this delay and this sort of going back and reconfirming TRD is going to change the patient demographic in any way, shape or form? Is that sort of coming out different? And how might that affect the potential powering or potential perceived expected placebo effect in the study?
And the follow-up to that is, have you determined what you are going to release with top line data at the end of the year, specifically longer-term follow-up and durability? And then I just got a follow-up on the centers.
So let me start, but I'll also ask Guy to weigh in on the third part of the question.
So to be clear, this does not, in any way, represent a change to the inclusion criteria, nor in fact is this a change from what we needed to do in Phase IIb. But a couple of things to point out. First, obviously, the Phase IIb was only partly in the U.S. It was ultimately a global study. Second, I think we do think it's relevant that Phase IIb 001 and 006 have 3 doses of active [ 1, 10 and 25 ], whereas in other sites, there is a real placebo and clearly, from a patient willingness or a patient incentive, to enroll. That is a significant difference between 005 and both 001 and 006.
Guy, I don't know if you want to add anything on that?
Yes. I don't think that -- I mean as you heard, the vendors that we've hired are there because this is a general problem. It wasn't just a problem. Our definition hasn't changed. And so our considerations around power and placebo response are unchanged as well. So it's just a delay, and we think we've overcome some of the factors that contributed to it now.
And for the second part of the question, Ritu, is that, as you are very well aware, this is a blinded trial through Part B through the 26 weeks and, therefore, determining what we will be able to announce with top line is something that will be a matter of a review at that time.
Got it. And then a follow-up question. You mentioned multiple delivery templates when you speak with your collaborations with Greenbrook and Hackensack. And you mentioned that you're working through options. Are there any sort of buckets of different templates or particular aspects of delivery that you are, I guess, building out and investigating with those 2 sort of like just large phenotype -- or different phenotypes of delivery models that we should all be thinking about at this point?
It is a great question. And what I would say is the work we're doing is precisely to understand how many different phenotypes of delivery shall we say that we're going to need. And so if we take the first 2, obviously, Greenbrook and Hackensack are very different. Greenbrook is a for-profit network of interventional psychiatry centers that is essentially [indiscernible] today offering TMS, ketamine, Spravato. They're very interested in offering psychedelics as well but have only kind of recently branched into, so to say, more traditional psychiatric treatment.
And therefore, how this will fit, they already have physical infrastructure for the delivery of these things. So working out what works for them in that context may be very different from someone like Hackensack, which is an integrated regional health system with multiple sites that currently have different specialisms but also [indiscernible] large kind of tertiary care center with 300 beds, which will probably going to be at the heart of where they will treat the [ psychedelics ].
So I think the reason we are doing this and the reason we -- you will see a couple of more collaborations, again, in very different settings of care is exactly so that we learn what sort of different delivery models are required. And that would extend also to reimbursements. I mean, for instance, you can imagine some commercial centers might be very open to buy-and-bill. That may actually fit very well with their economics and offer an attractive route. But health systems and so on, it's much more likely to be [ Part D ] rather than [ Part B ]. But these are the questions we want to answer.
Got it. So each collaboration is going to represent a type of setting that is -- that has significant use in the U.S. or EU? Is that the way to think about each of these individual collaborations?
The way to think about it is they are deliberate. Obviously, there's a limit to the number we can do in the very precommercial setting. And yes, they are designed to be sufficiently different that they can, as we say, allow us to develop templates but then in kind of where we get to formal prelaunch activity that we're lucky enough to get there, but we can then take those templates to other examples of the similar setting. And that's the way it plans [indiscernible].
Our next question comes from Sumant Kulkarni with Canaccord Genuity.
I'll add my welcome to Teri. It's great to work with you again. The question is actually on additional indications for COMP360. You have mentioned PTSD and depression in type II bipolar disorder. But is there a reason why you've not specifically mentioned anxiety, especially given comorbidity with depression? And are you collecting any anxiety-related measures in your Phase III program? And just a bit of a follow-on to that, how closely are you watching a potential competitor, Incannex's program, with psilocybin and GAD that reported Phase II data yesterday?
Yes. Thanks, Sumant. Great question. I mean there's a tremendous -- I mean there's shared genetic origins for depression and anxiety, and so they're closely related, and most patients with depression have anxiety levels, at least, to some degree. We are, as you asked, including anxiety measures, specifically the GAD-7, in our trials, and we did in the 001, and we published data on that already.
So we certainly see an antianxiety and anxiolytic potential with COMP360. But in many ways, the presentation of anxiety is usually in primary care, and we can't really see how COMP360 would be kind of the [indiscernible] treatment of choice under those circumstances. And for that reason, we have not gone for that in the first instance. But clearly, patients who have both depression and anxiety are probably the commonest phenotype around. And we think that there will be an advantage in treating that population on the basis of the [indiscernible], but it's eventually treating their anxiety.
I don't know whether you want to comment on the competitive difference.
The only thing to say to that, I mean, obviously aware of this. I mean it's a relatively small study in Australia, 72 patients as I recall. But yes, so acknowledge that, that was published yesterday and suddenly that we will be [ into it more ].
All right. Do the logistical hurdles in the U.S. that are leading to the slight delay contribute to a meaningful change in the financial outlay required for 005 and 006?
It doesn't. [ Sumant, it's a great question ]. So no, I mean, clearly, we've made some additional investments and put [indiscernible] important to do that. But it's not a material change. We still have runway [ into ] 2025.
Our next question comes from Jason McCarthy with Maxim Group.
This is Michael Okunewitch on the line. So I guess to start off, I just like to ask, are you using a more rigorous verification of the TRD diagnosis compared to the Phase IIb? And if so, what is the reason? Does this have to do with greater public awareness of psychedelics and their efficacy or just a factor of a larger U.S. portion for the study?
So no, we're not. It is exactly the same inclusion criteria. It's the same population. It is, as I said, in answer to an earlier question, I think partly it is the fact that this is 100% U.S. And also, I do think the nature of the arms of the study is being through placebo as opposed to both 001 and 006 that have 3 doses of active drug. I think that also is a contributing factor.
All right. And then just one more for me. I just want to see how closely you would be watching the Lykos NDA process and potential subsequent approval. Is there anything in particular that you're looking for on the commercial reimbursement side that may help to inform your strategy for COMP360?
So yes, we will clearly be observing the regulatory process for Lykos very closely. We wish them well, and I think it's clearly premature to the CEO how they're thinking through commercial and reimbursement. But obviously, we recognize that there will be lessons from their progress, both to the regulatory and commercial basis for us.
Our next question comes from Elemer Piros with Rodman & Renshaw.
I don't have a question related to the delay. But I have a question about the anxiety indication was mentioned, that you are not focusing on it necessarily. But would you be interested in licensing COMP360 to indications that are potentially of no interest to you?
Thank you, Elemer. And congratulations on the new gig. That's an interesting question. What I will say is, in general, split indications are enormously challenging in my experience if you can't particularly -- if you can't clearly identify a very different dosing paradigm and so on. So that's not something we have given any great consideration to. Clearly, if somebody comes with a very compelling proposal, we would listen to it, but it's not -- in general, it's pretty hard with the several [indiscernible].
There are no further questions at this time. I'd like to hand the call back over to management for any closing remarks.
Thanks, everyone, for joining. In conclusion, let me just say, again, our guidance for the overall timing of our Phase III program in TRD is unchanged. We are acknowledging and giving guidance around a slight delay into quarter 4 '24 for top line data from 005, but our overall guidance remains unchanged. We continue to be very focused on execution in TRD and also, as we said, continuing to think about which other indications of interest would be the most compelling basis to take on 360 now.
So thanks very much, everyone. Thank you for your time and attention today.
Thank you for your participation. This does conclude the program. You may all disconnect. Everyone, have a great day.