Good day, ladies and gentlemen, and welcome to this COMPASS Pathways Update Webinar. At this time, all participants are in a listen-only mode. Following the formal presentations, we'll be conducting a live question- and- answer session. To our analysts joining us live, please use the raise hand feature under the reaction button at the bottom of your screen to indicate you have a question. Due to time constraints, we kindly ask you to limit your questions to one. 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. 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. We specifically disclaim any obligation to update or revise any forward-looking statement, 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, 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. Thank you all for joining us. COMPASS Pathways is at the forefront of one of the most promising innovations in mental health in decades. We're 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. 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 for 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 COMP006 results are remarkably consistent with what we previously shared from the COMP005 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 of week six, compared with one or two administrations with COMP360. Similar to the previously announced COMP005 data, part B data from COMP006 demonstrates durability out to at least six 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. We are accelerating our momentum to drive this change. We have demonstrated consistent and robust data across three 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 submission and initial review underway, where our active interactions with the FDA are collaborative and positive. We have a multi-blockbuster opportunity with programs in two very large underserved patient populations, TRD and PTSD, where there's an urgent need for new and effective options. 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 COMPASS, the COMP360 phase III COMP006 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, six 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 that were 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 fortunate 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 two trials. COMP005, with a single administration of either inert placebo or 25 mg COMP360 psilocybin in part A, and COMP006 with three active arms of two fixed doses three weeks apart of 1 mg, 10 mg, and 25 mg COMP360 psilocybin in its part A. Both trials had a part B, which was blinded through 26 weeks, and where there was a re-administration option of a single additional dose based on specified criteria. Both trials also had a part C from 26 weeks to 52 weeks, where a single 25 mg 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 COMP005 that we showed in February. Of course, COMP006 is in a much larger patient sample, and with the intermediate dose, with better blinding 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 the results for the 25 mg and 1 mg arms of COMP006 out to 26 weeks overlaid with the COMP005 trial in the accompanying slide, we notice three things. First, there is convincing separation between the 25 mg 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 three weeks, as in the COMP006 trial, or later in the 10 to 14-week timeframe, as in COMP005. These extraordinarily consistent and meaningful trial results make the emerging profile of COMP360 a clear option if FDA approves 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 treatments. While to mandate at least two treatment failures in the current episode is conventional, we also require the duration of these prior treatments to be properly documented to have lasted at least eight weeks at adequate dose and with proven medical records. In ordinary practice, it is common for treatment trials to be shorter and therefore not often to meet this criterion. We selected for persistence with treatment as well as treatment failure. As shown in the top part of the table on the left of the slide, almost 40% of the participants in the 25 mg arm of COMP006 had failed three 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 three years and with an average of more than six 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 non-response 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 healthcare systems. 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 COMP006 trial averaged about 32 across all arms, and over 60% of the participants met criteria for a severe level of depressive symptoms. Only 6%-7% of participants had prior experience with any psychedelic, and 3%-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 COMP006, which includes Parts A and B, we see a rapid effect from COMP360 25 mg 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 mg arm, the 10 mg arm shows numerically reduced effects at all time points from soon after the second administration of drug. This consistent efficacy, dose response, and durability supports the validity of our trial design and our recommendation of the 25 mg dose as the basis for approval. It is remarkable to see the persistence of the treatment effect of 25 mg 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 mg arm received a retreatment in Part B. Most of these treatments occurred between weeks nine and 14. This data gives us further confidence in the profile of COMP360 that the 25 mg dose is effective quickly and is remarkably durable. If we dive further into the 25 mg arm, as we did in February for the COMP005 trial, and look at the patterns across remitters, responders, and non-responders, we get some further insight. This chart shows a breakdown of the patients receiving 25 mg COMP360 into three groups defined by MADRS change from baseline at week 6. Remitters, shown in green, showed a very rapid reduction of symptoms to levels 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 with remitters, as demonstrating a clinically meaningful response. The non-responders are shown by the gray line. An independent peer-reviewed Delphi study published in "Molecular Psychiatry" recommended a less than 25% change in MADRS to define non-response 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 six weeks. In the COMP005 trial, where there was a single dose in Part A, we had 25% of participants achieve a clinically meaningful response. In COMP006, this jumped to about 40% with the addition of a second fixed dose in Part A. For this chronic patient population, who on average had not been responding to treatment for over three 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 COMP005. 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 two to four 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. What it is starting to look like is one or two doses initially, a minimum of three weeks apart, with additional doses at 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 COMP006 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 and occurred on the day of dosing. Differences in incidences of events between 25 mg and 10 mg arms were limited. The 1 mg 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% 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 of concern have emerged. There is one suspected suicide in the 25 mg 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 one suicide attempt in the 1 mg 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 for the depressed patients I struggle to treat as a prescribing psychiatrist, and its approval will be a landmark in medical science. Thank you. Let me hand the call to Lori. Thank you, Guy. I am excited to speak to you today about the potential opportunity we see for COMP360, based on the emerging clinical profile from the datasets presented today, and update you on our commercial preparation. Data from our two 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 one-third of those patients were failed by at least two 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 five trials to achieve the two statistically significant results needed for FDA approval. COMP360 has now demonstrated clinical meaningfulness and statistical significance across three 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 COMP005 and COMP006, 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 COMP006, we saw those results improve even more after the second initial dose three 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, perhaps most significant, in both COMP005 and now with Part B of COMP006, after rapid onset, COMP360 then demonstrated unprecedented and truly remarkable durability that is sustained through at least six months with only one or two 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 six-month period. If approved, COMP360 could offer significantly reduced patient and caregiver burden without sacrificing clinical outcomes for TRD patients. Finally, 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, 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 workstreams ongoing. Timelines 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 timeline 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. We feel a responsibility to patients to enable a successful launch. Thank you, Lori. Let me first thank all the 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's data with the FDA and will 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. 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. We will keep you updated as things progress. We're confident that COMP360 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, our 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 in 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. I'll now turn the call back to Tara for Q&A. Thank you. Great. Thank you, Kabir. At this time, we'll be conducting a question- and- answer session with our speakers. To our analysts joining us live, please use the raise hand feature under the Reactions button on the bottom of your screen to indicate you have a question. As a reminder, we kindly ask that you limit your questions to one due to time constraints. Please hold for a brief moment while we poll for questions. Our first question comes from Andrew Tsai at Jefferies. Please go ahead, Andrew. Hey, thanks for sharing the detailed data, and congratulations on being close to the goal line. My question is about the commercial aspect of COMP360, actually, now that you have COMP005 and COMP006 fulsome data sets on hand. 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? Maybe compare and contrast how the monitoring staffing language might read compared to Spravato's REMS. Thank you. Thanks, Andrew. It's Kabir. Just to check, you can hear us clearly? Yes. Thank you. Great. I'll hand that question to Steve, if I may. Thanks, Kabir, 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. Within those initial discussions, we've been guided to look at the existing Spravato REMS as well as what FDA prepared themselves for Lykos's ADCOM a couple of summers ago. With that, excuse me, what we would expect is fairly typical language within a REMS that specifies a prescriber on site that talks about a licensed healthcare provider being available. The main differences that we might see from Spravato to COMP360 would primarily relate to the observation time. Spravato requires two 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 six-hour observation period after a patient takes the single capsule. Thanks so much. Thank you for the questions, Andrew. Our next question comes from François Brisebois from LifeSci Capital. Please go ahead, François. Hi. Thanks for the questions and congrats 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 three years of an episode and six lifetime episodes. Is there a duration here with these episodes where 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. Thank you. Thanks, François. I'll ask Guy to take that. 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. It's certainly true that when you talk to some of the PIs who treated the patients in our studies, it's clear that patients may have spent much of their adult life depressed. We were fairly insistent that they do recruit people who have been well at some point. We're not recruiting patients who, in a sense, can never tell you they've been well. 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. Not all patients are. They have sufficient medical records to validate that they had continued in care. I think both those factors result in getting patients who are highly valid as treatment-resistant, but of course, particularly difficult to treat. I think they're well-recognized by clinicians as being a major part of the population who are described as having treatment-resistant depression. Thank you. Thanks for the question, François. Our next question comes from Paul Matteis at Stifel. Please go ahead, Paul. Hey, good morning. Congrats on all the progress, and thanks for taking a couple of questions from us. 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? Maybe just curious how proximal that event was to the actual treatment itself. 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? 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. Thank you. Thanks, Paul. I'll send to Guy for those as well. 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. I can say that it occurred over 80 days following treatment. It was not within the time frame that was related to the treatment. 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's about the use of antidepressants. There was, within the protocol, the option for patients in Part B to opt to go onto antidepressants instead of receiving a repeat treatment. This is true in both COMP005 and COMP006. 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. 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. It's a very interesting possibility that patients become more treatable with SSRIs as a result of receiving psilocybin. It'll be very interesting to see that. Finally, there is the issue of co-administration, which we think will also be an issue. We will have data on that from Part C of the study because patients who remain protocol compliant, who went onto an SSRI into Part C, were then eligible for a 25 mg dose co-administered with their ongoing SSRI treatment. 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 COMP006. Obviously, it's highly relevant to clinical practice when the drug is finally approved. Thank you. Thanks for the question, Paul. Our next question comes from Ritu Baral at TD Cowen. Please go ahead, Ritu. Good morning, guys. Thanks for taking the question, and congratulations on this data. If we are doing the math right over here, for COMP006, we're backing into about a 25% remission rate at week 26 or month six. For COMP005, 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, what sort of indication or administration language is possible as far as determining which patient should get what, is tolerability also a consideration in that final dosing recommendation that could be in the label? Thanks, Ritu. I think I'll ask Guy first just to address the kind of the remission number 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. Guy first on the remission side and the impact of the second dose. Thank you, Ritu, for the question. It's highly pertinent, obviously, to how the drug will eventually be used. I think really COMP006 is probably the most instructive because it brings the second treatment rather earlier. So the issue of whether you would get one or two is a little better addressed by the data from COMP006. You'll remember in COMP005, people had to wait for quite a long time. 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. 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. 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. We're tending to see two treatments as the likely preferred approach. Clearly, in individual cases, you'll get variability because clinical practice is inherently variable. Understood. Lori, anything you would add? No, I'll just add, hey, Ritu. I think obviously Guy said it well, 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. Right now, as it stands, as Guy alluded to, the label language that we're thinking about is one or two initial doses followed by physician discretion for redosing. 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 RVU use? Steve? Thanks, Ritu. Always appreciate a good CPT question. As a reminder, the CPT codes are still currently in their Category 3 form, which is prior to receiving evaluation through the RUC process and getting the 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 know how to code for delivering COMP360 when approved to ensure that we can progress that process moving from Category 3 to 1 as quickly as possible. Thanks, all. Thanks for the question, Ritu. Our next question comes from Judah Frommer at Morgan Stanley. Please go ahead, Judah. Hi. Good morning, guys. Thanks for taking the question, for the update here, and congrats on the progress. I guess just within the regulatory and commercial timelines that you've cited, any new insights into how quickly COMP360 could be rescheduled post-approval? Just, I guess more high level, maybe just given prior experience in this space, can you qualify interactions with the agency given the priority voucher granting and how those interactions have maybe been more responsive this time? Thanks. Yeah. Thanks, Judah. I'll start and then see if Lori wants to add on the rest of it. As you know, the executive order did include the suggestion that the FDA and DEA work, shall we say, more closely, and that there'd be a way to accelerate federal DEA rescheduling post the potential approval. We are still kind of working to learn the mechanics of that and how likely that is. 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 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. Again, we're cognizant of that and the potential for them 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'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? Yeah, I'll just add quickly on rescheduling, and hi, Judah. There's a reason why we continue to say we'll be launch-ready by the end of the year. The reason we continue to say we'll 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. That includes rescheduling in a very timely fashion. 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 two years, where we have been educating on the importance of making sure that rescheduling happens in a timely fashion. The executive order only adds credence to the work that we've been doing to try and expedite that. Like I said, and as we've all said, if it happens sooner, we will be ready to launch. Great. Thank you for the question, Judah. Our next question comes from Madison El-Saadi at B. Riley. Please go ahead, Madison. Hi, everyone. Thank you for taking our question. Curious, what was the longest time remission lasted? Just curious how this may inform the dosing interval range in the real world. Secondly, if I may, does anything in this readout refine the language you're seeking in the label? Have you had a chance to collect any unblinding data? Thanks. Yeah. Thank you very much for the question about durability. We certainly had patients in COMP005 who remitted to the single treatment and remained remitted throughout the 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. We have certainly seen patients who have received a single treatment and gone the full 26 weeks. That will be something that clinicians will see in real life, so to speak. Obviously in COMP006, we had more patients, but they had two treatments, and a significant fraction of them in the group who are illustrated in green in our study went through in remission through to 26 weeks as well. It's certainly a clear-cut phenomenon that occurs. Its frequency will depend upon how you select your populations for treatment. Yeah. Lori, anything you want to say? The second part, I think we already addressed that in talking really about how we're thinking about dosing and labeling at the moment. Clearly that is informed by this covered data. Lori, anything you want to add on that? Hi, Madison, and thanks, Kabir. I'll just add a couple more comments. At the risk of restating earlier comments, the way we're thinking about the label right now based on this data, which reconfirms a lot of what we saw in the COMP005 26-week data, is one or two initial doses, minimum of three weeks apart. That was obviously informed by the COMP006 data. Then redosing upon clinician discretion, obviously informed by the 26-week COMP006 data. What we expect to see or what we expect to happen in the real world, more specifically to answer your question, is probably on average a two to four per year per patient, somewhere around there. 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 potentially based on patient response level. Thank you for the questions, Madison. Our next question comes from Leo Timashev at RBC Capital Markets. Please go ahead, Leo. Hey, guys. Thanks for taking my question. I know when you guys were discussing TRD, you mentioned that there's a high level of comorbidities. You mentioned pain, anxiety, migraines. I guess if you look at your data, does anything suggest that COMP360 treatment is helping lift patients out of those? I mean, even anecdotally, that you're really sort of breaking the TRD cycle on any of these other comorbidities as well? Thanks. Hi. Yeah. Not yet. We obviously got a hierarchy of data cuts, we're looking at the top line and moving down, so to speak. We'll get to addressing that kind of subgroup question in due course. At the moment, not really. In speaking to individual PIs, they have not spontaneously reported anything like, "Oh, well, yeah, the migraine cleared up as well." That would be highly anecdotal in any case, but we will get to some of this as we go through data that we've collected, particularly on patient experience, which we're just starting to look at now, which will be relevant to the question you just posed. We don't yet have the granularity that would interest you, I think. If we're patient, we'll get there. Lori? Hi. Yes. Hi, Leo. I just want to add, I think your question is a really good one. Once we get the additional data, especially some of the secondary endpoints, we will be taking a look at things not necessarily specific to comorbidities, although we will address some of that and can address some of that through IIS studies that we are currently running. We'll use the secondary data for quality-of-life measures, which is becoming increasingly more important not only to obviously the patient and understanding how patients feel and what those improvements look like, it also is becoming a critical decision-maker for physicians and also, interestingly enough, becoming very important for payers. As we get that information and additional data, we'll be taking a look at how that increases the value proposition for the product. Thank you for the questions, Leo. Our next question comes from Sumant Kulkarni at Canaccord. Please go ahead, Sumant. Morning. Thanks for moving the product that much closer to potential use by patients and for taking our question. From a commercial targeting perspective, what did you learn about any common characteristics of patients in your trials that were responders to COMP360 versus non-responders? Do you expect a specific label limit on the number of discretionary COMP360 retreatment after the initial one or two doses per year per patient? Thanks, Sumant. I think we don't have anything that really drives us towards being able to identify a priori responders or non-responders. As we've said, the response to the first dose does clearly seem to signal the likelihood of a subsequent response. I suppose by the same token, non-response seems to predict non-response. We're going to take the data down to a finer grain level in due course just to try and answer that very question. If I could, Sumant, I'll just quickly add. You probably have often heard me reference the patient-level data that we'll use to help guide the clinical decision-making. A lot of that will come once we get the patient-level data. We'll be able to understand and be able to use through our field force execution standpoint, additional data that helps physicians understand potentially what type of patients to look for in terms of their response level and when and how to retreat. I also just want to call out that in our trials, the maximum number of doses that we have dosed in an annualized basis is four. I don't expect the label to limit the number of doses. There could be potential payer limitations. These are things that we'll have to look through, especially in the first year of launch. As we collect real-world data, we'll continue to evaluate what the appropriate dosing on an annualized basis looks like. Yeah. Specifically from a safety perspective, we did run tox studies and so on after work with the FDA that would support many more doses to Lori's point. From that perspective, it's unlikely to be a label limitation. Great. Thank you for the question, Sumant. Our next question comes from Jay Olson at Oppenheimer. Please go ahead, Jay. Oh, hey. Congrats on all the progress and appreciate all the work you're doing for patients in need. Did you observe any characteristics or particular symptoms that might help predict which patients could maintain durable remission from those who ultimately require retreatment? Did you find any learning effects with retreatment that could shorten the time to discharge for patients who received subsequent doses? Thank you. Just to take the last question first, we observed actually that the post-hoc ratings of the experience by patients were remarkably consistent from one treatment to the next, which was something that really hadn't been documented well before. It's not like you see any adaptation or a desensitization to repeated treatment. People are getting the full effect according to the dose that they're given. We have looked a little bit in our phase II data for predictors of response without success. There remain things that one can do, and we are digging into aspects of the information that we have, both around baseline symptoms and also some of the interactions that we recorded in the preparation of patients, which might answer this question. There are various, obviously, methodologies that would allow us to dig a little deeper into things. At the moment, we can't comment on what that's going to show because at the moment we're still too much into the designing the necessary studies rather than having completed them. You ask a great question, and we hope to provide better answers than we currently have. At the moment, we're still rather top line as you put. Steve, do you have a comment on discharge? Yeah. Thanks, Kabir, and good morning, Jay. Just a couple of additional words on the issue of time to discharge. Important to point out that we intentionally in our trial design did not include multiple early assessments of readiness for discharge. We weren't trying to rush participants out of these study sites. In practice, what happened in the protocol was that these first assessments of readiness was not until 6 hours post-administration. When you factor in some additional administrative work, the checking of vital signs, a couple of scales, et cetera, what we saw was that most patients were ready to leave at that point. Post-approval in a real world environment, what we would expect is because of our trial design, that our REMS would state a minimum of six hours of observation. We think that given the typically three to four hours, that is the more typical duration of this experience, that sites may leverage common areas, lounge spaces, et cetera, within their sites for the efficient movement of patients through. That with the gathering of some real world data, there may be an opportunity over time to reduce the observation time. Great. Thanks for the question, Jay. Our next question comes from Tom Shrader at BTIG. Please go ahead, Tom. Good morning. Congratulations. Thanks for taking the question. This was asked, but I don't think you got to it. Is there an update on how much blinding you think you're really getting from the 1 mg dose? Are you collecting any data? Do you consider the 10 mg to 25 mg, would you consider that fully blinded? I know it's an old question, but I think it'll be discussed. Just any updated thoughts you have. Thank you. Tom, yeah, we are collecting the data, but we're not yet in a position to share that. Guy, I don't know if you just want to comment on design overall. Yes. If you look at other people's published data, it's fairly clear that disguising a non-event, if it were, is really very difficult. People tend to pick the 1 mg or lower doses. They're much less confident about picking intermediate and higher doses, and that was why we chose the design we chose. Our prediction was and remains that the 10 mg and 25 mg will be very confusable. We think overall, the different expectations that surround three options rather than the very binary, inert versus active will be resolved. I think what will be more interesting is to subdivide patients on the basis of their certainty about what they receive and to see if that actually affects the treatment response. Because much of this criticism is around whether or not there is unblinding on the assumption it makes a difference. It remains to be proved that it really does. In the little data that we have, for example, in TRD from the EPIsoDE trial published by a German group earlier this year, it's pretty clear in table they published that actually, whether or not people knew that they were on the high dose actually didn't seem to make a difference to whether they responded or not. I would predict that that's what we will also find, but we haven't yet got that data in a form that we can share with you in a meaningful way. Great question, great problem to have, and one I think we can solve. Just to reiterate, so you've agreed with the FDA how you're going to ask people what they think they got? Yes. We indeed did. Yeah. We asked them exactly what the FDA asked us to ask them. Yeah. Perfect. Great. Thank you very much. Thanks for the questions, Tom. Our next question comes from Rudy Li at Wolfe Research. Please go ahead, Rudy. Hey, congrats on the progress, and thanks for taking my question. As you highlight the difference of TRD versus MDD, now you have data in the most difficult to treat patients. How do you plan to use the data for payer discussion and physician education, especially given the competition from other psychedelic program for MDD? Thanks. Thank you. Lori? Yeah, I'm happy to take that. Hi, Rudy. Yeah. I'll start with payers first, and as I mentioned in the call, there is only one product right now that is indicated for and marketed for TRD, and that is Spravato. Payers, because of the strength of the data, and in that particular patient population, payers understand the economic burden that come with treatment-resistant patients. They see it in their claims database. They see the impact, they feel the impact of all the comorbidities of TRD patients. They cover Spravato pretty broadly, PA to label. That is very encouraging, from a TRD negotiating standpoint for COMP360. MDD, with payers, as I mentioned, there are over 50 indicated MDD products right now being used on an annual basis. Payers routinely will require new MDD products to step through several products before they can actually move to an expensive new innovative product. That is because the MDD trials, by nature, MDD is less difficult to prove efficacy in. The fact that we are coming in with very strong three consistent trials that prove very strong efficacy in this patient population, I feel very good about our opportunity with payer negotiations, and where we'll end up from a formulary access standpoint and potential gross to net. Very helpful. Thanks. Thank you for the questions, Rudy. Our next question comes from Chiara Montironi at Van Lanschot Kempen. Please go ahead, Chiara. Hi, guys. Thank you for taking my question. I think my question was already partly addressed. I was wondering if you could provide a bit more color on the DEA descheduling. How does the process look like? Which are the expected timelines? Any nuggets will be helpful. Thank you. Thanks, Chiara. I'll ask Lori to take that. Sure, absolutely. Hi, Chiara. The DEA rescheduling process right now as it stands is when an FDA product becomes approved and it is currently Schedule I, which means there's no medical use approved for it. Once it becomes approved, it then automatically becomes approved for medical use. The DEA then needs to reschedule it at a federal level. Right now, by statute, they have 90 days to do that. Historically, over the past 10 years, they have routinely taken about 90 days to reschedule the product. After the federal DEA reschedules, then the states need to reschedule so that physicians and prescribers in those states can prescribe the product legally within their state. We have been doing a lot of work, again, with the government affairs team to make sure that that is done in a timely manner on a state-by-state basis. Right now we're sitting with approximately 90% of the U.S. population living in a state that will intend to reschedule within 30 days after the federal DEA. The timelines from a federal DEA standpoint, as we mentioned earlier in the call, could be shorter than the 90 days based on the executive order. Once it gets federally rescheduled, then the states will reschedule, and the majority of them will do so within 30 days after that. Thank you. Thanks for the question, Chiara. Our final question comes from Michael Okunewitch at Maxim. Please go ahead, Michael. All right. Thank you so much for taking my questions today and for answering the data. I just want to hear something, I guess, a little bit more broadly about the market and how it's evolved. In particular, there have been a lot of headlines around psychedelic medicine. There's been a lot of new high-quality data coming out. Have you seen any increased acceptance towards this particular modality at the patient and the provider level? Thanks, Michael. The easy answer is yes. I'll turn to Lori and Steve to provide some bulk color behind that. You want to start by what you're hearing from the provider level, I can add in some patient, I think it's also probably important to add in some payer receptivity as well. Yeah, thanks. Good morning, Michael. As Lori said, we can divide these stakeholder groups that you talked about, patients, providers, payers. Certainly at the provider level from multiple sources, including the ongoing work that we've been doing over several years with our network of strategic collaborations, which are sites that are today caring for patients living with TRD, in many cases delivering the most analogous treatment, Spravato. In all cases, very much looking for additional tools to be able to bring to bear to this very difficult to treat condition. They've been excited. I think that excitement has only grown as they've seen high quality data as they see that we are really on the cusp of a potential approval them really having this option in their hands. That's also been supplemented by the work we've been doing with our medical science liaisons, who've been out in the field now for multiple years engaging with healthcare providers. Similarly, as data has been released both on COMP360 as well as for other development programs, healthcare providers only continue to have more excitement, they really do see the potential for this to shift the paradigm of how these patients receive their care. At the patient level, we've been working for many years with advocacy organizations, they've been entirely supportive. They increasingly are putting out educational content to their membership to prepare them for the potential approval of psychedelic treatments. To further build on that point as well as to talk about payers, I'll hand to Lori. Yeah. Thanks, Steve. Hi, Michael. This is a great question to be our last question of the day, because I can say with a lot of certainty what we're seeing hearing, not only from, as Steve mentioned, through the strategic collaborations the work with advocacy organizations, but through market research, through conversations that we're having with the market, both payers, providers, patients, is unlike anything I've seen in my 25 plus year career. Even the market research companies that we are working with sometimes say that they've never seen such receptivity or interest in a product in all the market research that they have done. Payers will come to us versus us proactively going to them to seek out information. There is truly an excitement an interest level that I don't think psychiatry's felt in many, many years. We're obviously extremely excited about the opportunity. We're doing everything we possibly can to make sure that this launch is successful. I mean what I said in the prepared remarks, and that is we will be potentially first in class, but we fully intend on being best in class, and that's because we're going to maintain this leadership that we have established and worked very hard to establish over the past several years. All right. Thank you very much. Great. Thank you for the question, Michael. This concludes our Q&A session for today. I will now turn the call back over to COMPASS Pathways management for closing remarks. Thank you very much, Tara. Again, thank you all for your participation on the call. As you've heard, we're very excited by the way that today's data really confirms, in a remarkably consistent way, the extraordinary, compelling, differentiated profile for COMP360 in its unique combination of extremely rapid onset and durability out to six months from just a handful of doses. With this data in hand, we're reconfirming our intention to complete our submission in Q4 of this year. We will be launch-ready. We have very good dialogue with the FDA. We're excited about the path forward, and we're looking forward to bringing COMP360 to the four million TRD patients in need as soon as we can. Thank you again, and we will keep you updated on our progress towards that over the remainder of this very exciting year. Thank you.