Earnings Call Transcript
COMPASS Pathways plc (CMPS)
Earnings Call Transcript - CMPS Q4 2023
Operator, Operator
Good day, ladies and gentlemen, and welcome to the COMPASS Pathways Fourth 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, Senior Vice President of Investor Relations
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 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.
Kabir Nath, CEO
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 1st. 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 requires 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 trials in treatment-resistant depression with top-line data expected this year and next. While our overall Phase III clinical program completion remains on track with top-line data from the 006 study expected in the middle of 2025, we are experiencing some recruitment delays in the 005 trial, which extends our guidance for top-line data from that trial into Q4 of this year. Importantly, this change in guidance does not impact expected timing regarding submission of our NDA filing. As we've consistently guided, we do expect that both trials will be required for NDA submission consistent with the FDA's draft guidance for the development of psychedelics published in June last year. We will also have all necessary preclinical and clinical pharmacology studies for a complete NDA dossier. In parallel with the Phase 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 templates to ensure a successful rollout of COMP360 treatment subject to FDA approval in different care settings. Earlier this quarter, we announced the first two such collaborations with Greenbrook TMS and Hackensack Meridian Health, which are two very different but equally important collaboration partners. These collaborations will explore how to improve the patient care experience and gain a better understanding of potential commercial models for the administration of COMP360 psilocybin treatments. 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 II subjects to additional financing. With that, let me now ask Teri to introduce herself and share a bit about why she came to COMPASS.
Teri Loxam, Incoming CFO
Thanks, Kabir. Now that I'm back at sea level, I'm really happy to be joining you in this experience and pioneering leadership team. Similar to many, I 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 needs 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.
Kabir Nath, CEO
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?
Dr. Guy Goodwin, Chief Medical Officer
Thank you, Kabir. Looking at the COMP360 pivotal program, nearly all sites have been initiated for COMP005. For the 006 trial, we have sites initiated in the U.S., Canada, UK, Ireland, Sweden, and Spain. I anticipate further progress this year. Patient demand is strong in all geographies, which as expected, reflects the degree of unmet need in this population. However, as 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 organizations and unique handling requirements and redosing protocol, we are formally confirming every patient's TRD diagnosis, an important element to the quality of this program. This has been a challenge that medical record keeping is decentralized in the 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 COMP006, a global trial that remains on track. Separately, we're also excited by the potential for COMP360 in other indications. PTSD is an additional indication of interest which we have investigated in an exploratory Phase II safety study of 22 patients, all of whom were administered a single dose of 25 milligram 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 recorded. The study participants have been followed for 12 weeks and we look forward to announcing the full PTSD 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 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 three. All 15 participants had lowered MADRS scores with a mean change from baseline of minus 24 points at week three. Twelve participants met the criteria for response and 11 met the criteria for admission. While this is a small trial, we see the results as extremely promising. Importantly, there was no increase in the suicidality score based on 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, hypomanic, 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 financial overview. Mary-Rose?
Mary-Rose Hughes, Interim CFO
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 R&D tax credits. The timing of receipt of the credit is uncertain, but I'm pleased to confirm that HMRC has since approved our claim in full and we now anticipate receiving the tax credits 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 non-cash share-based compensation of $17.3 million in 2023 and $13.1 million in 2022. R&D expenses were $87.5 million in 2023 compared with $65.1 million in the prior year and G&A expenses were $49.4 million in 2023 compared 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 operation to be between $17 million and $23 million which assumes that we received R&D tax credit in the first quarter. However, as I 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.
Kabir Nath, CEO
Thank you, Mary Rose. I'm pleased that we're seeing continued enthusiasm and meaningful momentum building for both COMPASS and its 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. In a 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 bode well for the potential of COMP360 if approved. We also welcome the news of FDA acceptance of Lykos therapeutics NDA submission for MDMA-assisted therapy for PTSD. We're seeing increasing interest from clinicians who plan to incorporate psilocybin treatments into their mental health offerings. Our collaborations are indications of this interest, and we'll continue to develop commercial models that enable rapid, scalable, broad, and equitable access to COMP360 if approved. In closing, with our strong balance sheet, we are focused on execution of our Phase 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 in today's call. And we'll now turn to Q&A. So I will hand the call back to the operator. Thanks.
Operator, Operator
Thank you. Our first question comes from Patrick Trucchio with H.C. Wainright. Your line is open.
Patrick Trucchio, Analyst
Thanks. Good morning. Just a couple of follow-up questions on the enrollment delays. So, the first is just regarding the TRD diagnosis being necessary for enrollment in the program. Can you remind us how you're defining TRD and confirming this diagnosis in patients who are enrolling the program? And secondly, can you tell us what proportion of patients are expected to have experience with psychedelics?
Kabir Nath, CEO
Thanks, Patrick. Just checking if you can hear us and I'll hand it to Guy.
Patrick Trucchio, Analyst
Yes. I can hear you.
Dr. Guy Goodwin, Chief Medical Officer
Our criteria focus on treatment-resistant depression, which requires patients to have failed at least two treatments that are adequate in dosage and duration. The delay you mentioned is due to our rigorous approach to establishing this, primarily through health records, which has proven to be a challenge in the U.S. However, we are successfully navigating this process with the patients we are recruiting. There is no shortage of patients, but verification issues have posed real challenges. We've increased the proportion of patients with prior psychedelic experience from 10% in Phase II to 15% in Phase III. It's crucial to note that individuals seeking treatment might be looking for psychedelics, which is one reason we insist on thoroughly verifying medical records.
Patrick Trucchio, Analyst
If I could just ask another follow-up. I'm curious whether the adjustment of the top-line data for the COMP005 trial will affect the timeline for filing an NDA for TRD, or if the timing will remain the same regardless of the top-line data from the 006 trial. Additionally, could you explain what data is expected to be included in the NDA? Specifically, will there be a certain amount of long-term follow-up efficacy or safety data from these trials before the NDA is submitted? Thank you.
Kabir Nath, CEO
Thanks, Patrick. I'll address your question in reverse. We haven't provided clear guidance on what will be included in the initial submission, as that will involve discussions with the agency. However, with breakthrough designation, rolling submissions are a possibility. Regarding the first part of your question, as mentioned in my prepared remarks, this does not change the expected timing of a filing. COMP006 is still on track for mid-2025, and we have consistently indicated that we believe both trials will be necessary for the submission. Therefore, we do not expect any change in the timing for the potential submission.
Operator, Operator
Our next question comes from Charles Duncan with Cantor. Your line is open.
Charles Duncan, Analyst
Good morning, Kabir and team. Thanks for taking the question. I wanted to follow up to those last questions with regard to the 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? Thanks.
Kabir Nath, CEO
I believe the challenge in the U.S. stems from the decentralized nature of the health care system. This sharply contrasts with European systems, where health care records are much easier to access. For instance, in the UK, most patients have a primary care physician, and obtaining health records is simply a matter of reaching out to the physician with the necessary consent. This creates a significant difference compared to our situation. Regarding your second question about the number of patients, we believe that with the systems we've established to streamline data access, we will be prepared. Since 006 is being implemented at most centers after 005, we expect everything to function optimally by the time many U.S. sites transition to 006. Patients enrolled outside the U.S. won't face these issues. We anticipate the patient distribution to be around fifty-fifty, and our modeling indicates that we are on track for 006. The challenges with 005 primarily relate to its initial launch in the U.S.
Charles Duncan, Analyst
That makes sense. If I could ask one follow-up, and that is, can you help us understand the screen failure rate if you're tracking that at all? But then also, are you having any challenges with washing patients out before of standard of care, albeit ineffective, antidepressants before they enter 005?
Kabir Nath, CEO
The washout presents a challenge, but the main issue has been with the verification for diagnosis. In our Phase II trial, about a third of the patients were already off antidepressants, so two-thirds needed to wash out, and the vast majority were able to do so after being enrolled in the study. However, enrollment has been the problem in 005.
Operator, Operator
Our next question comes from François Brisebois with Oppenheimer.
François Brisebois, Analyst
Hi. Just a couple here. Just sorry to ask again about the enrollment. But, is the fourth quarter guidance just very conservative? Or how do we feel comfortable that fourth quarter will be correct for 005?
Kabir Nath, CEO
We are very comfortable with that. As you would expect, we've done a number of projections, looked at different scenarios, and we are very comfortable with the fourth quarter guidance.
François Brisebois, Analyst
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?
Kabir Nath, CEO
It's a great question. Clearly, the protocol for Spravato is quite different from what we expect the final protocol for COMP360 to be. The Spravato label requires eight administrations in the first month, four in the second month, and then maintenance at the physician's discretion, typically every couple of weeks. So, over the first three months, patients might undergo about 12 to 15 sessions, each requiring them to spend at least 3 to 4 hours in the clinic due to the intranasal administration and two hours of monitoring. Additionally, since they cannot drive home after these sessions, it necessitates having a caregiver for each visit. In contrast, we don’t yet know the durability for an average patient using COMP360, but the Phase III study is designed to explore this. Based on current knowledge, it may require only 2 to 4 administrations per year. From a patient perspective, this is significantly different; it transforms the experience from visiting a clinic perhaps every three to four months to having more frequent sessions. This is a key reason we've partnered with organizations like Greenbrook and Hackensack, to better understand how to integrate psilocybin into existing workflows and to consider reimbursement strategies.
François Brisebois, Analyst
Great. Thank you very much. Congrats on the progress, sir.
Operator, Operator
Our next question comes from Neena Bitritto-Garg with Deutsche Bank.
Neena Bitritto-Garg, Analyst
Thank you for taking my question. I wanted to ask about the enrollment process again. Can you confirm if there are any actions you can take to speed up the reviews for confirming diagnoses? Have you found anything helpful in accelerating that process in the U.S.?
Kabir Nath, CEO
Thanks. Yes. In a word, that had and we've taken those mitigating actions. So, we have added specific vendors who are able with patient consent to work directly with patients and to obtain the medical 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.
Operator, Operator
Our next question comes from Ritu Baral with TD Cowen.
Ritu Baral, Analyst
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.
Kabir Nath, CEO
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 three doses of active 110 and 25 while in 005 there is a real placebo and clearly from a patient willingness or a patient incentive to enroll, that is a significant difference between 005 and both 001 and 006. So I don't know if you want to add anything on that.
Dr. Guy Goodwin, Chief Medical Officer
I don't believe that the situation is unique to us; the vendors we've engaged have recognized this as a widespread issue. Our definitions and considerations regarding power and placebo response remain consistent. We're experiencing a delay, but we believe we've addressed some of the contributing factors. Regarding the second part of your question, as you know, this is a blinded trial through Part B for 26 weeks, so what we can announce regarding the top line results will be determined at that point.
Ritu Baral, Analyst
Got it. And then a follow-up question. You mentioned multiple delivery templates when you speak of 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 two, sort of like just large different phenotypes of delivery models that we should all be thinking about at this point?
Kabir Nath, CEO
It's a great question. And what I would say is the work we're doing is precisely to understand how many different phenotypes of delivery, shall we say, that we're going to need. And so, if we take these first two, obviously, Greenbrook and Hackensack are very different. Greenbrook is a full-profit network of interventional psychiatry centers that is essentially today offering TMS, Ketamine, Spravato, but very interested in offering psychedelics as well, but have only recently grasped into, I would 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 a very large kind of tertiary care center with 300 beds which will probably going to be at the heart of where they will treat psychedelics. So, I think the reason we are doing this and the reason you will see a couple more collaborations again in very different settings of care. It's exactly so that we learn what sort of different delivery models are required. And that would extend also to reimbursement. I mean, for instance, you can imagine some commercial centers might be very open to buy and bill. They actually fit very well with their economics and offer an attractive route. Health systems and so on, it's much more likely to be Part B rather than Part B. But these are the questions we want to answer.
Ritu Baral, Analyst
Got it. So, each collaboration is going to represent a type of setting that has significant use in the U.S. or EU. Is that the way to think about each of these individual collaborations?
Kabir Nath, CEO
The way to think about it is they are deliberate. You know, obviously, there's a limit to the number we can do in this very pre-commercial setting. And yes, they are designed to be sufficiently different that they can, as we say, allow us to develop a template for them in when we get to formal pre-launch activities that we're lucky enough to get there, that we can then take those templates to other examples of the similar settings. And that's the way the plan has been built.
Operator, Operator
Our next question comes from Sumant Kulkarni with Canaccord Genuity.
Sumant Kulkarni, Analyst
Good morning and afternoon to the team. I'll add my welcome to Teri. It's great to work with you again. Thanks for taking my questions. The question is actually about additional indications for COMP360. You've 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 II program? And just a bit of a follow-up to that, how closely are you watching a potential competitor Incannex’s program with psilocybin and GAD that reported Phase II data yesterday?
Kabir Nath, CEO
Thanks for the question. There is a significant shared genetic background for depression and anxiety, making them closely related, and most patients with depression also experience some level of anxiety. As you inquired, we are including anxiety measures, specifically the GAD7, in our trials and have already published data on that. We do see potential for COMP360 to address anxiety, but typically, anxiety is presented more in primary care settings, and we don't envision COMP360 being the first-line treatment in those cases. Therefore, we haven't pursued that angle at this time. However, patients experiencing both depression and anxiety represent a common profile, and we believe treating their depressive symptoms will also address their anxiety incidentally. Would you like to add anything regarding the competitive landscape?
Dr. Guy Goodwin, Chief Medical Officer
Only to say, I mean obviously aware of this. I mean it's a relatively small study in Australia, 72 patients as I recall, but yet to acknowledge that that was published yesterday and something that we will dig into more.
Jason McCarthy, Analyst
Hey, guys. This is Michael Okunewitch on the line. Thank you for taking my questions today. So I guess to start off, I'd 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?
Kabir Nath, CEO
So no, we're not it is exactly the same inclusion criteria. It is the same population. It is as I said in answer to an earlier question. I mean partly it is the fact that this is 100% U.S. and also I do think the nature of the arms of the study this being true placebo as opposed to both 001 and 006 that have three doses of active drug, I think that also is a contributing factor.
Jason McCarthy, Analyst
All right. And then just one more for me. I just wanted 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?
Kabir Nath, CEO
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 see how they're thinking through commercial reimbursement. But obviously, we recognize that there will be lessons from that progress both through the regulatory and commercial basis for us.
Operator, Operator
Our next question comes from Elemer Piros with Rodman & Renshaw.
Elemer Piros, Analyst
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?
Kabir Nath, CEO
That's an interesting question. What I will say is, in general, split indications are enormously challenging in my experience. If you could 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 a single molecule in my experience.
Operator, Operator
Thank you. There are no further questions at this time. I'd like to hand the call back over to management for any closing remarks.
Kabir Nath, CEO
Thanks, everyone, for joining. In conclusion, let me just say, again, our guidance for the overall timing of our Phase II program in TRD is unchanged. We are acknowledging and giving guidance around a slight delay into Q4 2024 for top-line data from 005, but our overall guidance remains unchanged. We continue to be very focused on execution in TRD. Also, as we said, continuing to think about which other indications of interest would be the most compelling places to take COMP360 there. So thank you very much everyone. Thank you for your time and attention today. Thank you for your participation.
Operator, Operator
This concludes your conference call for today.