COMPASS Pathways plc (CMPS) Earnings Call Transcript & Summary

Good day, ladies and gentlemen, and welcome to the Compass Pathways Update webinar. As a reminder, this call is being recorded. I would now like to introduce your host for today's call, Teri Loxam, Chief Financial Officer at Compass Pathways. You may begin.

Thanks. Welcome, and thank you for joining us today for this webcast. Before we begin, let me remind everyone that during the call today, we will be making statements about our future plans and prospects that constitute forward-looking statements. Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement, including those risks and uncertainties described under the heading Risk Factors in our most recent filings with the U.S. Securities and Exchange Commission. These forward-looking statements represent our views only as of today, and we specifically disclaim any obligation to update or revise any forward-looking statements even if our estimates or assumptions change. The call is being recorded and will be available on the Compass Pathways Investor Relations website for a period of 30 days following the conclusion of the call. With that, I will turn the call over to Kabir Nath, who I'm joined with, as well as -- who's Compass Chief Executive Officer; Dr. Guy Goodwin, Chief Medical Officer; and Lori Englebert, Chief Commercial Officer. Myself and Steve Levine, Chief Patient Officer, will also be available for Q&A portion of the call. I'll now hand the call over to Kabir.

Thank you, Teri, and thank you all for joining us. Compass Pathways is at the forefront of one of the most promising innovations in mental health in decades, and we are proud to be leading the way to unlocking the potential of psychedelics. With significant unmet need in both treatment-resistant depression and PTSD, we believe COMP360 has the potential to transform outcomes for patients who have not benefited from existing treatment options. And while we advance COMP360 towards an anticipated launch in TRD, we're also progressing our late-stage trial in PTSD, where there's an even larger population of about 13 million patients in the U.S. who urgently need new treatment options. Given our Phase II data in PTSD and the overlap in patient populations and prescribers with TRD, we're well positioned with COMP360 to address both these large underserved markets. With today's data announcement from the 26-week Part B of the COMP006 trial, I am thrilled to confirm that Compass continues to make significant progress towards the potential approval of COMP360 in TRD with launch anticipated in the first half of 2027, a much needed and welcomed highly differentiated treatment option for patients living with TRD. The data further validate the previously reported COMP360 durability profile. These 006 results are remarkably consistent with what we previously shared from the 005 trial in February. We've now demonstrated that COMP360 can be both a very rapid-acting and a durable treatment for individuals who suffer from depression. SPRAVATO is the only marketed drug product approved today in TRD and it takes 10 administrations to achieve an equivalent treatment effect at Week 6, compared with 1 or 2 administrations with COMP360. Similar to the previously announced 005 data, Part B data from 006 demonstrates durability out to at least 6 months for those participants who had a clinically meaningful reduction in MADRS. The safety data for COMP360 is also encouraging with a generally well-tolerated and safe profile. The majority of adverse events are transient and predominantly occur on the day of dosing. We're convinced COMP360 will lead to a profound shift in mental health care, moving beyond daily or frequent administration towards an option potentially involving just a few treatments in a year that could be life-changing for patients. And we are accelerating our momentum to drive this change. We have demonstrated consistent and robust data across 3 positive late-stage trials in over 1,000 participants. We have differentiated the COMP360 profile with ultra-rapid onset of clinical effect and durability data out to 26 weeks from our Phase III trials. We have a clear and accelerated regulatory path with rolling to mission and initial review underway, where our active interactions with the FDA are collaborative and positive. We have a multi-blockbuster opportunity with programs in 2 very large underserved patient populations, TRD and PTSD, where there's an urgent need for new and effective options. And we have a commercial team that's made up of the best in the business, who will be ready to launch when COMP360 is approved and rescheduled. These achievements, along with our first-to-market positioning, reinforce our leadership in the field of psychiatry. We can't wait to provide COMP360 as an important option for patients. Let me now hand the call to Guy.

Thank you, Kabir. I'm very pleased to present these important results from the COMP360 Phase III 006 pivotal trial in more detail. Before I do, let me take a moment to describe how I feel personally about the successful delivery of these trials. I was a psychiatrist in practice for nearly 40 years. I mostly treated patients with mood disorders and I knew how to do that. However, 6 of these patients I knew well died by suicide. A beloved aunt of mine killed herself too. Many more patients I saw lived with depressive symptoms of very chronic and unremitting despite me knowing what to do as there just weren't effective options available. Compass has made a real advance for exactly these people. Our trials promise something that can transform lives. They deserve it, and I count myself fortunately beyond words to have been able to contribute to making it happen. Let me begin by reminding you of the design of our Phase III program, which consists of 2 trials: COMP005 with a single administration of either inert placebo or 25 milligrams COMP360 psilocybin in Part A and COMP005 with 3 active arms of 2 fixed doses 3 weeks apart of 1, 10 and 25-milligram on 360 psilocybin in its part A. Both trials had a Part B, which was blinded through 26 weeks and where there was a readministration option of a single additional dose based on specified criteria. Both trials also have a Part C from 26 weeks to 52 weeks where a single 25-milligram dose of COMP360 is available for all participants openly. Today we are presenting initial 26-week Part B data from COMP006. This data is remarkably consistent with the equivalent 26-week data from 005 that we showed in February. But of course, 006 is in a much larger patient sample, and with the intermediate dose, was better blinded to the treatment allocation. It confirms the validity, consistency and durability of the efficacy signal evident over the full 26 weeks of follow-up. Therefore, if we look at results for the 25-milligram and 1 milligram arms of COMP006 out to 26 weeks, overlaid with the 005 trial in the accompanying slide, we notice 3 things. First, there is convincing separation between the 25-milligram arms and the control conditions maintained over the whole double-blind follow-up in both studies. Second, the durability of effect is confirmed as a feature of treatment with COMP360. Finally, we can see the benefit of a second dose whether as a fixed dose after 3 weeks as in the 006 trial or later in the 10 to 14-week time frame as in 005. These extraordinarily consistent and meaningful trial results make the emerging profile of COMP360 a clear option, if FDA approved, for the tremendous unmet need in treatment-resistant depression. We will go more into the results in a moment, but first, let me further highlight the difference between MDD and TRD patients and just how difficult to treat the patient population in our trials have been. As we've discussed before, we set a high bar for inclusion in both of our Phase III studies relating to prior treatment. While to mandate at least 2 treatment phases in the current episodes is conventional, we also required the duration of these prior treatments to be properly documented, to have lasted at least 8 weeks at adequate dose and with proven medical record. In ordinary practice, it is common for treatment trials to be shorter and, therefore, not often to meet this criteria. Therefore, we selected for persistence with treatment as well as treatment failure. Moreover, as shown in the top part of the table on the left of the slide, almost 40% of the participants in the 25-milligram arm of 006 had failed 3 or more such treatments in the current episode. Participants were on the highly severe and chronic end of the depressed population who are very difficult to treat. In fact, as the table on the right shows, the length of the current depressive episode was on average more than 3 years and with an average of more than 6 lifetime episodes. This is truly representative of very chronic, late-stage treatment-resistant depression. As you can see from the publication on this slide, in multiple real-world cohorts of depressed patients, the length of episode, chronicity, is the strongest single predictor of subsequent nonresponse to antidepressant treatment, as shown in the accompanying figure. It is because TRD is too often a chronic condition that individuals with TRD are impacted disproportionately compared to those with MDD, including both longer depressive episodes and more significant impact on quality of life, work performance and the risk of suicide. Together with significant medical comorbidities, these features of TRD cause much greater financial stress in health care systems and constitute a very different patient population from those treated successfully early in a depressive episode. Baseline demographics are shown in this table. Baseline severity estimated with the MADRS in the 006 trial averaged about 32 across all arms and over 60% of the participants met criteria for a severe level of depressive symptoms. Only 6% to 7% of participants had prior experience with any psychedelic and 3% to 4% had prior experience with psilocybin specifically. This was largely a naive patient population, which will have helped with the blinding of the study. Turning to the 26-week efficacy data from 006, which includes Parts A and B, we see a rapid effect from COMP360 25 milligrams evident from the day after drug administration, which is apparent after both the first and second fixed doses in Part A. We can also see that compared with the 25-milligram arm, the 10-milligram arm shows numerically reduced effects at all time points from soon after the second administration of drug. This consistent efficacy, dose response and durability support the validity of our trial design and our recommendation of the 25-milligram dose as the basis for approval. It is remarkable to see the persistence of the treatment effect of 25 milligrams COMP360 over the full 26 weeks of a double-blinded study in treatment-resistant depression. I have seen nothing comparable before in my psychiatric career. Recall that after Part A of the trial, eligible participants had the option for a third administration of COMP360. Just under 60% of the participants in the 25-milligram arm received a retreatment in Part B. Most of these treatments occurred between weeks 9 and 14. This data gives us further confidence in the profile of COMP360 that the 25-milligram dose is effective quickly and is remarkably durable. If we dive further into the 25-milligram arm as we did in February for the 005 trial and look at the patterns across remitters, responders and nonresponders, we get some further insight. This chart shows a breakdown of the patients receiving 25-milligram COMP360 into 3 groups, defined by MADRS change from baseline at Week 6. Remitters, shown in green, showed a very rapid reduction of symptoms to level below 12 on the MADRS. Responders and partial responses, shown in blue, achieved a MADRS reduction of at least 25%, but excludes the remitters. We regard this group along remitters has demonstrated a clinically meaningful response. The nonresponders are shown by the gray line. An independent peer-reviewed [Udelphi ] study published in Molecular Psychiatry recommended a less than 25% change in MADRS to define nonresponse in TRD. As we discussed in February, even modest reductions in depressive symptoms over 25% can provide significant benefit to TRD patients and lessen the risks associated with being chronically depressed. This is why we are including all participants who achieved a reduction in MADRS of 25% or more in the group having a clinically meaningful response. It is notable that a second fixed dose in Part A drove a higher proportion of patients into response by 6 weeks. In the 005 trial where there was a single dose in Part A, we had 25% of participants achieve a clinically meaningful response. In 006, this jumped to about 40% with the addition of a second fixed dose in Part A. Remember that this chronic patient population who on average had not been responding to treatment for over 3 years, having roughly 40% with a meaningful response and durable benefit from COMP360 is very gratifying. Additionally, we saw that almost 30% of those who had a clinically meaningful response but were not remitters at Week 6, became remitters after the Part B redosing, a similar finding to what we saw in 005. These data across both Phase III trials while showing important consistency also demonstrate patient-level heterogeneity. Some patients may benefit from a single dose while others may benefit from 2 to 4 doses. We will be diving into this in more detail when patient-level data becomes available and as we work through final labeling with the FDA. But what it is starting to look like is 1 or 2 doses initially, a minimum 3 weeks apart with additional doses and physician discretion based on responder status. Overall, to see patients respond so quickly and have responses that are so durable is extraordinary in this very chronic TRD patient population and bodes well for when COMP360 could be used, if approved, in the broader 4 million TRD patients. Moving on to safety. The data in 006 through 26 weeks further shows COMP360 as having a generally well-tolerated profile. Regarding specific treatment adverse events, we saw the usual: headache, nausea, hallucination, et cetera, most of which were transient, occurred on the dosing. Differences in incidences of events between 25 milligrams and 10-milligram arms were limited. The 1-milligram dose was associated with fewer reports of nausea, hallucinations, illusion, dizziness and tearfulness, as would be expected. Looking at the top serious adverse events, shown as percentages in brackets, you can see the relatively low number of events. Importantly, we are not seeing any imbalance in suicidal ideation and no other drug-related events that concern have emerged. There is 1 suspected suicide in the 25-milligram arm, which has been determined by the investigator based on the specific circumstances and timing as not related to the treatment as well as an event of suicidal behavior and 1 suicide attempt in the 1-milligram arm. Overall, we see a low number of suicidality events that are generally evenly distributed across the treatment arms. In summary, we're pleased to see the emerging safety profile of COMP360 from over 1,000 patients to be generally benign and well tolerated. Given this and the ultra-rapid and observably durable efficacy profile, I believe COMP360, if approved, will be a logical option to prescribe to depressed patients I struggle to treat as a prescribing psychiatrist, and its approval will be a landmark in medical science. Thank you. And let me hand the call to Lori.

Thank you, Guy. I am excited speak to you today about the potential opportunity we see for COMP360 based on the emerging clinical profile from the data sets presented today and update you on our commercial preparations. Data from our 2 positive Phase III trials clearly demonstrate that COMP360, if approved, will be highly differentiated from currently available treatment options and is strongly positioned to be the leading treatment for the millions of TRD patients who are underserved today. Let me start by quickly illustrating just how many MDD patients are considered treatment resistant. In 2025, approximately 12 million diagnosed and treated MDD patients were prescribed over 50 different antidepressants. However, despite having a multitude of options, approximately 1/3 of those patients were failed by at least 2 prior antidepressants while in their current episode and are considered treatment-resistant. This equates to a patient population of approximately 4 million TRD patients in the U.S. Once an MDD patient is considered treatment-resistant, data show that the chance of achieving meaningful clinical outcomes from additional antidepressants is significantly diminished and the patient and economic burden of disease becomes dramatically higher. Proving consistent efficacy in this patient population in clinical trials has historically been almost impossible to achieve. It is so difficult that there is only one FDA-approved and marketed drug product available today for TRD, SPRAVATO. In fact, it took SPRAVATO 5 trials to achieve the 2 statistically significant results needed for FDA approval. COMP360 has now demonstrated clinical meaningfulness and statistical significance across 3 robust late-stage trials. This is why the consistency of the COMP360 results is so impressive and is bringing hope and excitement for a potential new treatment option to patients, their loved ones and their providers. Taking a holistic view of the top line data that has been presented through 26 weeks for both Phase III trials. From a commercial perspective, the most important takeaways are: first and foremost, COMP360 has demonstrated through multiple robust clinical trials and in over 1,000 participants, consistent clinically meaningful efficacy in a patient population that has historically had limited treatment options. Second, in both 005 and 006, COMP360 demonstrated extremely rapid onset of action with deep and dramatic reduction in depressive symptoms as quickly as the day following the first administration. In 006, we saw those results improve even more after the second initial dose 3 weeks later. These are impressive results, especially in this particular patient population, where other available antidepressants have provided limited to no relief. Effects that quick can be life-changing for patients, and this is highly differentiated when compared against other products that can take weeks to months to determine if the treatment is working. Third and perhaps most significant, in both 005 and now with Part B of 006, after rapid onset, COMP360 then demonstrated unprecedented and truly remarkable durability that is sustained through at least 6 months with only 1 or 2 additional doses after the first administration. This dosing profile is distinctly different from the only other TRD marketed medicine, SPRAVATO, where per label, SPRAVATO would need to be dosed 20 to 28 times over a comparable 6-month period. If approved, COMP360 could offer significantly reduced patient and caregiver burden without sacrificing clinical outcomes for TRD patients. Finally, and importantly, COMP360 demonstrated a generally well-tolerated and safe profile, potentially making it easy for patients and clinicians to try. COMP360 is redefining rapidity and durability that can be achieved in a TRD patient population and providing hope and excitement for a potential new treatment option. The data presented today only adds to the emerging clinical profile of this promising new drug. COMP360 has the potential to revolutionize how mental health conditions are treated, and we are confident that if approved, COMP360 can provide a highly differentiated and compelling treatment option for a patient population that currently has minimal options. With the rolling NDA submission and initial review underway, the commercial team is actively preparing for launch with many critical work streams ongoing. Time lines are fluid for approval and DEA rescheduling given the national priority review voucher and the executive order in April. However, we do expect the FDA review to happen in a faster time line than traditional reviews. And as such, we continue to focus on being launch-ready by the end of the year with an anticipated launch in the first half of 2027. Compass has been very active with pre-commercial work over the past several years. Now with the clinical profile of COMP360 more fully emerging, we have begun the more advanced launch preparation work. This includes detailed discussions with payers, preparing effective marketing materials, enabling product distribution, setting up patient support mechanisms and preparing for field force execution. All of this is complementary to the ongoing scientific exchange with KOLs and educational efforts with advocacy organizations, sites of care and federal and state policymakers. At launch, we will leverage the well-established existing interventional psychiatry infrastructure. These treatment sites are specifically designed to support in-office treatments for products that require multi-hour support and monitoring, such as SPRAVATO, TMS or ECT. With approximately 7,500 sites across the U.S. and growing rapidly, these centers are already equipped with the staff, operational know-how and infrastructure needed to support additional multi-hour treatments like COMP360, with many of these sites already scaling in anticipation of a COMP360 launch. At approval, our focus will be on site preparedness. This includes everything from training and educating, REMS certification, assistance with reimbursement and patient support. We are heavily focused on removing barriers to prescribing and making the patient and site experience our top priority. We anticipate that COMP360 will be the first psychedelic approved in this highly anticipated new class and we feel the responsibility to patients to enable a successful launch. As a company, the work we are doing now is leading the way for all psychedelic products coming behind us and with our firmly established leadership we intend to not only be first in class but best in class. If COMP360 is approved, it will undoubtedly bring a welcomed and meaningful new treatment option to TRD patients and their providers as effective new treatment options are desperately needed. [ COMP360 ] has the potential to fundamentally change the way that patients living with depression are cared for, and Compass is committed to helping as many patients as possible. We are making great progress towards being launch ready, and I look forward to discussing more with you throughout the rest of this very exciting year. Let me hand the call back to Kabir.

Thank you, Lori. Let me first thank all participants, sites, clinicians and caregivers involved in our COMP360 clinical program. With your incredible support COMP360 will potentially be the first classic psychedelic to be approved by the FDA in a condition with significant unmet need and where patients today have few options. As I said earlier, the FDA is actively engaged on our rolling submission and initial review. We've shared today data with the FDA, and we'll continue to submit each wave of data to them as they come in, facilitating as rapid a review process as possible. As Lori discussed, commercial preparations are well underway, and we will be ready to launch whenever FDA approval and DEA rescheduling are complete. Based on everything we know today, we expect to launch COMP360 in the first half of 2027, and we will keep you updated as things progress. We're confident that COM 360 can be effectively integrated into a rapidly growing infrastructure and offer a differentiated and compelling treatment option for patients and providers. We believe that COMP360 has the potential to transform the standard of care for the millions of patients living with treatment resistant depression. Importantly, the capabilities, infrastructure and expertise we're building in TRD are expected to translate directly to PTSD or potential second indication where we see significant commercial synergies. We have created tremendous momentum with a clear path forward in TRD, an exciting next chapter of PTSD, a robust commercial foundation and a world class team we're operating from a position of strength and look forward to delivering for patients and delivering the transformative potential of COMP360. Thank you again for your attention. And I'll now turn the call back to Tara for Q&A. Thank you.

[Operator Instructions] So our first question comes from Andrew Tsai at Jefferies.

Thanks for sharing the detailed data and congratulations on being close to the goal line. So my question is about the commercial aspect of COMP360 actually now that you have 005 and 006 fulsome data sets on hand. So as we think about how you will be leveraging strategically SPRAVATO's infrastructure, can you talk about what you envision the REMS requirement could look like for COMP360 and then maybe compare and contrast how the monitoring staffing language might read compared to SPRAVATO's REMS.

Thanks, Andrew. It's Kabir. Just to check, you can hear us clearly.

Yes.

Great. I'll hand that question to Steve, if I may.

Thanks, Kadir, and thanks, Andrew, for the question. With the breakthrough therapy designation that we've had since 2018, we've had ongoing robust dialogue with FDA. And certainly, more recently, with the agreement with them on a rolling submission of our NDA and their rolling review, we've had the opportunity to have some preliminary discussions about the REMS that we'll propose. Naturally, as you know, that's something that will need to be negotiated with them and will be determined later in the process. But within those initial discussions, we've been guided to look at the existing SPRAVATO REMS as well as what FDA prepared themselves for [ LCOS AdCom ]a couple of summers ago. And with that, what we would expect is fairly typical language within REMS that specifies a prescriber on site that talks about a licensed health care provider being available. The main differences that we might see from SPRAVATO to COMP360 would primarily relate to the observation time. SPRAVATO requires 2 hours of observation after it takes 20 to 30 minutes for patients to self-administer the nasal spray. Based on the design of our trials, we would anticipate a 6-hour observation period after a patient takes the single capsule.

Our next question comes from Francois Brisebois from LifeSci Capital.

On the update. I was just wondering if you could talk a little bit more about the severity of these patients. You mentioned, on average, 3 years of an episode and 6 lifetime episodes. Is there a duration here with these episodes where it's just -- it's not considered an episode anymore. Just talk a little bit more of how severe these patients and why they might have been so difficult to treat.

Thanks, Frank, and I'll ask Guy to take that.

Yes. I don't think we can say there's a threshold. There's not a sort of particular time over which people cease to be classifiable as having an episode and maybe having as it were a long-term personality problem. But it's certainly true that when you talk to some of the PIs who have treated the patients in our studies, it's clear that patients may have spent much of their adult life depressed. But we were fairly insistent that they do recruit people who have been well at some point. So we're not recruiting patients who, in a sense, can never tell you they've been well. So they have episodes. These episodes, as you can see, are very long. And the main reason they're so well represented in our studies is that our criteria clearly selected for people who have been consistent in taking medication and not all patients are, and they had sufficient medical records to validate that they have continued in care. And I think both those factors result in getting patients who are highly valid as treatment-resistant, but of course, particularly difficult to treat. And I think they're well recognized by clinicians as being a major part of the population who are described as having treatment-resistant depression.

Our next question comes from Paul Matteis at Stifel.

Congrats on all the progress a couple of. We appreciate it. One, just on the suicide event. Can you give a little bit more context on why that was deemed to be not drug-related? And maybe just curious how proximal that event was to the actual treatment itself? And then second, I was wondering if you could clarify in the longer-term follow-up data after patients get the additional dose, were any other treatment options offered -- were patients allowed to go on to SSRIs? And maybe just like in the real world, do you think that maybe SSRIs might be used to extend the dosing interval and help maintain patients given that SSRIs are maybe not the best acute therapies, but good maintenance therapies?

Thanks, Paul, and I'll turn to Guy for those as well.

Yes. I think we won't make detailed comments about the particular circumstances of the suicide because actually, we believe they're still under some sort of legal review in Spain. But I can say that it occurred over 80 days following treatment. So it was not within the time frame that was related to the treatment. And that was the fact that the clinician was in close contact with the patient throughout follow-up gave him confidence about his conclusion. I think we can say that much. Your second question is about the use of antidepressants. There was within the protocol, the option for patients in Part B to opt to go on to antidepressants instead of receiving a repeat treatment, and this is true in both 005 and 006. And we know that a significant fraction of patients took advantage of that. In addition, there will be patients who effectively violated the protocol by going on to antidepressants. And we will obviously have data on that because we were continuing to follow those patients through the duration of the trial. I think it is quite likely that we will see in real practice, as you suggest, that patients are treated with both modalities, and it's a very interesting possibility that patients become more treatable with SSRIs as a result of receiving psilocybin. It will be very interesting to see that. And then finally, there is the issue of co-administration, which we think will also be an issue, and we will have data on that from Part C of the study because patients who remain protocol compliant, who went on to an SSRI into Part C were then eligible for a 25-milligram dose co-administered with their ongoing SSRI treatment. So I think there's several aspects of the interplay between SSRI use and psilocybin use. We'll get information on that from further analysis of patient level data in 006. But obviously, it's highly relevant to clinical practice when the drug is finally approved.

Our next question comes from Ritu Baral at Cowen.

Congratulations on this data. If we are doing the math right over here, for 006, we're backing into about a 25% remission rate at Week 26 or Month 6. And for 005 with retreatment, we're backing in for Part B into about 10%, which suggests to us that there's a pretty strong dose response here, especially on measures of remission. How do you guys see that evolving into the label? Can you guys address how this is being or will be presented as part of the rolling NDA? And then what sort of indication or administration language is possible as far as determining which patient should get what, which -- and is tolerability also a consideration in that final dosing recommendation that could be?

Thanks, Ritu. So I think I'll ask Guy first just to address the kind of the remission number, and then Lori to address the labeling side. What I will say as a preamble is clearly that is still more data that we need to actually really understand that and determine what final label we'll be putting forward. But Guy, first on the remission side and the impact of the second dose.

Yes. I think -- thank you, Ritu, for the question. I mean it's highly pertinent obviously, to how the drug will eventually be used. I think really 006 is probably the most instructive because it brings the second treatment rather earlier. And so the issue of whether you would get 1 or is a little better addressed by the data from 006. You remember in 005, people have to wait for quite a long time. I mean the way we're thinking about it is that because of this very immediate clinical response, which is detectable and obvious in those patients who remit or respond literally a day and certainly a week after the administration of the drug that we think clinicians will be able to judge dosing on the basis of clinical response. And so therefore, we think it will be boiled down to if people have a spectacular response to the first treatment, which many patients do, then that may be a reason not to give a second if they don't want it. But at the same time, if there's any question of the first treatment not having given a full effect, then it's very likely a second would be recommendable and would probably be the way the clinical treatment would evolve. So we're tending to see 2 treatments as the likely preferred approach. But clearly, in individual cases, you'll get variability because clinical practice is inherently variable. Lori, anything you want to add?

No, I'll just add, too. I think, obviously, Guy said it well, and I'll echo Kabir's comment around we need additional data to really make sure we're determining what we go in with dosing recommendation for the label. But right now, as it stands and as Guy alluded to, the label language that we're thinking about is 1 or 2 initial doses followed by physician discretion for redosing. And I know that we will use the patient level data that continues to come in to help guide the clinical decision-making and really help payers understand what to expect from payer response levels.

If I could squeeze one last question in. Any updates on the CPT codes or determination of RV use?

Steve?

Ritu, I always appreciate a good CPT question. So as a reminder, the CPT codes are still currently in their Category 3 form, which is prior to receiving evaluation through the rev process and giving a recommendation to CMS. The criterion primarily for progressing that to Category 1 would be the reporting of the code with the use of services that apply to the code. The bulk of that will likely happen post approval, once COMP360 is being prescribed. We will have a team. We've already started building a team that will focus specifically on billing and reimbursements and ensuring that sites appropriately now had a code for delivering COMP360 when approved to ensure that we can progress that process moving from Category 3 to 1 as quickly as possible.

Our next question comes from Judah Frommer at Morgan Stanley.

Thanks for the updates here and congrats on the progress. I guess just within the regulatory and commercial time lines that you've cited, any new insights into how quickly COMP360 could be rescheduled post approval? And then just, I guess, more high level, maybe just given prior experience in the space, can you qualify interactions with the agency given the priority voucher granting and how those interactions have maybe been more [indiscernible]?

So I'll start and then see if Lori wants to add on. So as you know, the executive order did include the suggestion that the that the FDA and DEA work, shall we say, more closely and that there'll be a way to accelerate federal DEA rescheduling post a potential approval. We are still kind of working to learn the mechanics of that and how likely that is. So right now, the base case continues to be that they have 90 days, but there is some optimism that it could happen quicker, but we can't give you a definite guidance on that. In terms of interactions, yes, I mean, I think with the priority voucher, important to say that the FDA's target is to complete a review in 60 days. It's not actually a commitment. So again, we're cognizant of that and the potential still to need to accept the filing. What I would say from an interaction perspective is absolutely there is a, shall we say, a fluidity and a to-and-fro that you would not normally get through this and that, that's actually been very positive. Now it goes both ways. We also need to address questions quickly and so on, and we're committed to that side of it from our perspective. Lori, anything to add on rescheduling?

I'll just add quickly on rescheduling, Judah. The reason why we continue to say we'll be launch-ready by the end of the year, and the reason we continue to say will be launch-ready by the end of the year is because if everything works the way that, in the most optimal fashion, we need to be launch-ready by the end of the year. And that includes rescheduling in a very timely fashion. And as you've heard me speak about before, we've had a very strong government affairs approach and presence on the Hill over the past 2 years where we have been educating on the importance of making sure that rescheduling happens in a timely fashion. So the executive order only adds credence to the work that we've been doing to try and expedite that. And like I said, and as we've all said, if it happens sooner, we will be ready to launch.

Our next question comes from Madison El-Saadi at B. Riley.

Curious, what was the longest time remission lasted? Just curious how this may inform the dosing interval range in the real world. And then secondly, if I may, is there anything in this readout refine the language you're seeking in the label? And then have you had a chance to collect any kind of unblinding or -- unblinding data?

Yes. Thank you very much for the question about durability. We certainly had patients in 005 who remitted to the single treatment and remained remitted throughout 26-week follow-up. Obviously, the numbers that we will see in any subsequent or real world population is going to depend upon individual resistance to treatment, which I think will turn out to be a continuum. But we have certainly seen patients who have received a single treatment and gone the full 26 weeks. So that will be something that clinicians will see in real life, so to speak. Obviously, in 006, we have more patients, but they had 2 treatments, and a significant fraction of them in the group who illustrated in green in our study went through in remission through to 26 weeks as well. So it's certainly a clear cut phenomenon that occurs. Its frequency will depend upon how you select your population for treatment.

Yes. Lori, I don't know if you want to take the second part. I mean, I think we already addressed that in talking really about how we're thinking about dosing and labeling [indiscernible]. And clearly, that is informed by this covered data. Lori, anything you want to add on that?

I'll just add a couple of more comments. So at the risk of restating earlier comments, the way we're thinking about the label right now based on this data, which reconfirmed a lot of what we saw in the 005 26-week data, is 1 or 2 initial dosing -- doses minimum of 3 weeks apart. And that is obviously informed by the 006 data. And then redosing upon clinician discretion obviously informed by the 26-week 006 data. What we expect to see or what we expect to happen in the real world, and more specifically to answer your question, is probably on average a 2 to 4 per year per patient, somewhere around there. And we will continue to look at the patient level data to help inform clinicians and again, payers as well, what the expectations for that might look like based on -- potentially based on patient response level.

Our next question comes from Leo Timashev at RBC.