Hello, everyone. Welcome back to the fifth annual Ethical Affairs of Compass Pathways, who for the second year in a row will provide perspectives on commercialization of novel compounds in psychiatry. So we're going to start first with an introduction, followed by insurance coverage and reimbursement, commercialization strategies, and time permitting, maybe a discussion around Risk Evaluation and Mitigation Strategy, or REM. So maybe just starting with an introduction, what are some of the key challenges in implementing agents that require a physician administration or psychological support or full psychotherapy? You know, in other words, these treatments that have to be administered in clinical or hospital settings, and how can they be overcome? Thanks, Patrick. And before we start, just to remind people, we will be making forward-looking statements, and I'd remind you to direct you to our SEC filings in terms of the risk factors for investing in Compass Pathways. So thanks, Patrick. It's a pleasure to be here. I'll start, and between Steve and I, we will try and cover as much ground as we can over the next 30 minutes. So clearly, as you highlighted in the introduction, this is a paradigm where there is both the delivery of a drug but also psychological support required at a physical treatment center in order for the patient to have the experience, which we believe is necessary for the potential effect. So while this is, in many ways, a novel paradigm in psychiatry, particularly given the duration of the dosing episode for COMP360 psilocybin treatment, of course, this is nothing new in medicine. Chemotherapy and dialysis are, in fact, exactly the same model when you think about it. So while we clearly are extremely engaged on answering the questions specific to COMP360 and bringing this into, shall we say, the interventional psychiatry setting, it's not necessarily reinventing the wheel fully from scratch. We'll also, I'm sure, touch on Spravato and the degree to which Spravato also gives us kind of some leading indicators and so on for where we need to go. And Steve, please add, before we kind of get into any specifics. Well, just maybe to build a little bit on your last point there, I think that Spravato's current billion-dollar run rate is a demonstration that a multi-hour administration in psychiatry in a supervised medical setting is viable. We've had the opportunity to learn from some of their initial commercialization challenges as well as plan for some of the things more specific to COMP360. As Kabir said, we can dive into the details of that. Yeah, great. So maybe we'll stay on this topic just as far as, you know, what are some market access considerations for psychedelic treatments specifically and relative to COMP360 specifically? And how do you intend on addressing those considerations? Yeah, so I think the first thing to say is clearly there are two different reimbursement pathways that we require to be in place here. So Compass will be charging for the drug. And clearly, you know, during the Phase III, we will establish what we believe will be a very compelling profile in terms of both efficacy and safety for the drug. And there are known paradigms for how you price a drug in that setting, given competition, given the benefit it delivers to patients, clinicians, and so on, acknowledging that in the U.S., there's also a need to engage with the payer side around that. Clearly, though, obtaining adequate coverage for the treatment, the psychological support piece is critical as well. Let me turn to Steve to talk about some of those aspects and also some of the work we've already done, not only to identify the challenges, but start to solve them in that space. Yeah, thanks, Kabir. And so again, even though we will not derive revenue from the delivery of services, we do need to ensure that healthcare providers are adequately compensated for their services. And so to that end, that's the large part of the reason for our work with CPT codes. And as a reminder, last year, we applied along with Lykos for new CPT codes that describe the psychological support that happens on a day of administration for psychedelic treatment. And those codes were issued. They went live on January 1st. And now those are available to be used to describe and track any relevant procedures. We'll also need to address training in that psychological support. And that's something that maybe we're spending a bit of time on too if we have time. But both of these things are also reasons why we've put together this network of commercial research collaborations. We've made a number of these announcements since the beginning of the year. These are research activities with live commercial settings that are representative of the various types of sites of care where mental health care are delivered in the U.S., each representative of different phenotypes of those sites of care. They allow us to learn about the potential implementation within both their settings of care, but also because they represent a phenotype to build templates that can be used for similar types of infrastructure. Great. And then just maybe some more specifics on insurance coverage and reimbursement. How does the, maybe you can walk us through the reimbursement process. And you've already kind of touched on some of these aspects, but for in-clinic administered drugs like Spravato and how that might differ from traditional prescription medications. Yeah, Steve? Yeah, I can take that. So Spravato is another example where there are two lines of reimbursement. One is for the drug, and the other is for the administration and the in-office multi-hour observation by healthcare providers. With that product specifically, they did not obtain the Category III CPT codes prior to their approval. They took a somewhat different pathway and one that was pretty challenged, actually. They were relying upon cobbling together existing but not best fit codes in order to describe that observation. Ultimately, the reimbursement that healthcare providers see from that is, in many cases, sufficient, but it really, the codes weren't tailor-made for those services, and they're potentially not capturing all of the work involved in delivering that care and therefore all of the value. Where they've landed is to use some Evaluation and Management codes, which are general medical codes used not just in psychiatry, but in many disciplines of medicine. And so very differently, again, we've applied for very specific codes for psychedelic treatments that were worded very intentionally to ensure that we're capturing all of the work and resources, including practice expenses that will be required to be able to adequately describe what's being done and make sure all the value is captured and that healthcare providers are adequately reimbursed. And so if we look across the multiple steps of treatment, because there's one or more administration days, but there's also a bit of time before and after that to prepare patients and to follow up with them for safety, we now believe that any of the activities involved in the delivery of this treatment are described with existing codes. You've mentioned these codes, a number of codes. Can you just maybe walk us through what each of these reimbursement codes is and just sort of the status of these codes for treatments like Spravato and COMP360? Yes. So for Spravato, by and large, as I said, they're using Evaluation and Management codes, E/M codes. So the numbers associated with them are 99213 through 99215, and that depends upon the length and complexity of the visit. And then because there are multiple hours of observation after patients self-administer the Spravato, they also use typically multiple increments of add-on time codes. For us, and differently, we are looking at, on an administration day, the use of an Evaluation and Management code most likely by the prescriber to describe the medical component of the services. But additionally, the new codes that we're talking about that are currently Category III, 0820 through 0822T, which are specifically for monitoring and intervention during the administration of a psychedelic treatment. They cover the psychological support or any other model used to support patients on that administration day and cover the work done by a full staff, including a prescriber within that supervised setting. For any preparation or integration sessions, they'll be able to use existing psychotherapy codes. Now, of course, we've made the point that our model is psychological support, not psychotherapy. Nonetheless, the activities performed during prep and integration are described by the psychotherapy codes, and so those would be appropriately used for those visits. Right. Great. And how important is it to build partnerships with mental health professionals and clinics for successful commercialization of COMP360 or other treatments in that class? I think it's very important, and that's one of the reasons why we have announced the number of these research collaborations. So while what Steve has described on the psychological support and the reimbursement for that is clearly novel, we clearly mustn't lose sight of some of the more traditional questions like, what's going to be the mix of Part D and Part B? How are we going to ensure that we have appropriate flexibility both for direct delivery, essentially on a named patient basis to treatment centers, but also buy and bill where there may be networks that are actually open to that that are prepared to take that degree of risk? So what we have already announced, as Steve described earlier, is a number of these research collaborations that really allow us to dig into a great deal of detail as to how exactly COMP360 treatment may be integrated into their existing protocols, their existing physical facilities, and ultimately into their relationships with payers as well. Recognizing that we've deliberately chosen to cover a number of different phenotypes, shall we say, of potential treatment center. Obviously, it can't be comprehensive, but in the anticipation that we are successful with data and are in a position to file, we would then have that significant period between filing of approval to really ramp up and scale those phenotypes to a number of different examples of those settings of care. So yes, working to understand this at a very granular level through deep relationships with key places is key to our model. Yeah, that's helpful. Can you talk about the potential need for HEOR, Health Economics and Outcomes Research, to demonstrate longer-term cost benefits associated with these psychedelic treatments, but COMP360 in particular? I think what I would say is the best practice is absolutely that you develop appropriate models precisely for that. We're already doing that work in building the models. Obviously, they'll be informed by the data that we generate in Phase III, particularly around durability, which is a key question. Depth of response and remission with durability as well. But Steve, from a provider perspective, you may want to add. Yeah, I would just add that, so of course, there's the work that Kabir's describing in a pre-launch environment, and we'll continue to gather that data. Although we anticipate insurers of all types to cover our product if there's an approval, we're interested in broad and equitable patient access. We would like as unrestricted access as possible for appropriate patients, as demonstrated through our data. We hope over time to further demonstrate longer-term value of the delivery of our treatment that will hopefully open up broader access as we move forward. I guess the next question is just around the potential of value-based pricing models for psychedelic treatments. How could this impact market access? Is there a potential benefit to having value-based pricing models? This is a great question, Patrick, and it's one that comes up frequently. So I mean, as you're aware, I think as we're all aware, psychiatry, not least owing to the subjectivity of the endpoints and the heterogeneity of the patient populations, there really are, as far as I can think of, actually no examples really of value-based contracts that exist today in psychiatry. Look, I think we aspire to a time where, through the evidence we build, through potentially real-world experience of being able to more closely identify for which patients we're likely to see better outcomes or for which patients we might need a certain number of dosings, we could actually move towards that. Without knowing for certain today, my expectation, though, that at launch, this will be per dose pricing. I think that is the likeliest model at launch. Right. That makes sense. And then maybe we'll talk about some commercialization strategies. I guess first, just how can we ensure that therapists and healthcare professionals are properly trained to administer and oversee these novel treatments like COMP360? Steve? Yes. It's, of course, important to prepare patients for any treatment. This is not specific to psychedelic treatments. Whether it's Prozac or Spravato, there were always elements of preparing and supporting patients throughout treatment. It's unlikely that either in a label or in our REMS, there's going to be a tremendous amount of detail that really prescribes how this support needs to be delivered, although we certainly, as the manufacturer, will have an interest and a responsibility in good quality outcomes and patient safety. Support can be provided by a pretty broad range of licensed healthcare providers, as we're testing in our trials currently. And that combined workforce numbers in the hundreds of thousands. And I think it's important to note that thousands of therapists are already being trained in potentially related models by third-party training organizations right now. We're already looking at what the overlaps may be in the content and method that those organizations are using to train people in analogous ways. The model that we're testing to support patients within our clinical trials to better understand what may already be in place as far as training therapists and preparing them to be well-trained to deliver this treatment safely at launch. Right. No, that makes a lot of sense. I guess just a couple of other questions that come up from time to time is just the scalability of psychedelic treatments like COMP360. How do you scale up also maintaining these high standards of care? And And also kind of what safety? Would there be any additional safety measures that need to be in place? Or how do you think about these considerations? Yeah. So I think the first thing, let's acknowledge that we're dealing with a highly vulnerable patient population with chronic refractory depression, and we are putting them into a subjective state, which makes them more vulnerable. So for Compass, patient safety is paramount and at the center of everything we do. So that's the first thing to say. I think as we think about the scalability while assuring safety, one of the things, and I'll turn to Steve to talk more about this as well, is while per protocol in the trials, we are required to use licensed therapists, it's clear from our interactions and indeed, even more recently, the Lykos Advisory Committee, that the FDA are not going to be regulating the psychotherapy or psychological support component of this treatment. They are not going to be setting parameters around who is in the room, who needs to be providing that psychological support. And so that gives us the flexibility to appropriately demonstrate different models from the clinical trial setting that are potentially more scalable. Steve? Yes. And to the aspect of your question around the safety while scaling, some of the guardrails that would be in place will, number one, be a REMS, right? REMS, of course, standing for Risk Evaluation and Mitigation Strategy, which is a program that we will work on with FDA to outline various elements to assure the safe use of the delivery of our product. And so very different than perhaps off-label ketamine, which is largely an unregulated space and more similar to Spravato, which also has a REMS, there will be some parameters that help to make sure that this treatment is being delivered in a safe way. There's also the training that we were just touching upon earlier. There will be approved training programs to make sure that those, the healthcare providers, and to Kabir's point, that's more than just therapists, but likely also nurses and other licensed healthcare providers are well-prepared to support our patients safely. And then lastly, I'll say that this is yet another reason for our research collaborations. I think in a number of cases where there might be any safety concerns with the delivery of a new treatment, oftentimes it's not because of irresponsible practice or any intention to cause harm, but rather the sites themselves not being adequately educated or prepared to deliver a new treatment. By working closely with sites now within these research collaborations to understand what any of the knowledge or educational gaps may be and how to best support them in a commercial environment helps to ensure that they will be best trained and best prepared to be able to deliver the treatment safely at scale. Right. That's super helpful. We do want to ask a few questions about REMS, but before we do, maybe you can talk about the opportunities for partnerships and collaborations and commercialization of COMP360 or treatments like it. Yeah. I think, well, at the high level, we at Compass are committed to bringing this to market ourselves. We believe that we can do that, clearly, subject to data or approval and necessary financing. So I think from a sense of, do we see a broad strategic partnership as required? No. But clearly, this is going to be a collaborative model with many different players involved in making it work. The range of capabilities that we will need at Compass may be a mixture of in-house and third-party sourced, whether that's through account management, MSLs, patient navigators, patient engagement, and so on. So I think there is a range of potential partners we will be working with. Similarly, to build on Steve's point on the training side, we Compass are unlikely to be delivering training ourselves at scale. Again, I would anticipate us working with partnerships and so on to do that. Right. No, that makes a lot of sense. So now maybe just a few on REMS. Maybe just first, maybe you could just talk about what a REMS is and what is its purpose and kind of presumably we anticipate individual REMS for psychedelic compounds like COMP360, but I'm wondering, is there a possibility that we may have a shared REMS? That's an interesting question. I think the first thing to say is shared with what? In In the sense that while we are using psychedelics to describe this whole space, we don't have time to get into the fact that esketamine is very different from MDMA, is very different from psilocybin, is very different from potentially a DMT or a 5-MeO-DMT, and so on. So while conceptually, there are clearly elements that could be common against the delivery of each of those drugs, I'm not yet sure whether the framework to talk about a common REMS across them makes sense. But before I kind of get there, maybe pass back to Steve just to give a bit more of a primer on the REMS itself. Yes. So again, the acronym of REMS stands for Risk Evaluation and Mitigation Strategy. These are often put in place when the agency has some additional areas of interest with safety that they want to track over a longer period of time. And so the goals of our REMS will be defined essentially by what we see in our Phase III program, if there are any safety issues in particular that we want to be looking at in more detail over a period of time. But based on those goals of the REMS, there is some detail within the REMS of the elements to assure safe use. These are the requirements for sites to be certified to deliver the treatment, for how the healthcare providers involved in delivering that treatment need to be trained and otherwise educated, the policies and procedures they need to put in place, how patients are enrolled, including things like informed consent, and then how they're monitored with each treatment over time. These are fairly common both within psychiatry and outside of psychiatry. In our early planning now for what a REMS may look like, we have the opportunity to look at many existing analogies, as well as with the recent Lykos outcome, to see the agency's thinking on their thoughts for a REMS for Lykos, which, while a very different product that includes psychotherapy and not psychological support and so forth, looking at what they propose that is very aligned with our early thinking as well. Right. That makes a lot of sense. So maybe how do we think about the balance between managing risks and safety for patients while not stifling access when we're talking about this potential for a REMS for COMP360? Yeah. So I think, I mean, my perspective, having worked with REMS in the past, and as Steve says, these are not uncommon, not just in psychiatry, but broadly across therapeutic areas, is a well-designed and put into practice REMS is not per se a barrier to access. It is, in fact, if designed and appropriately executed, it's doing what it's meant to do, which is assuring safety and dealing with any lingering or long-term safety questions. So one can't deny there is an administrative burden to REMS. That clearly is the case. This is an area, again, where you would typically work through vendors, through SPs and others to put that into place. But it does put the onus, as I say, on having this well-designed, well-executed. But per se, I do not see it as a barrier to access. Steve? Yeah. I think just one last point to add to that is that even within the regulation of what a REMS can and should be, it is explicitly stated that that structure of the REMS should not place undue burden on healthcare providers or patients. And so we will certainly aim to adhere to that. And as Kabir said, like the other existing REMS, we don't anticipate that to be a barrier to access. Right. So maybe just one last question. What are some additional commercial considerations that we've not covered in this discussion so far that you think are important for investors to understand? So I think we touched on kind of the broader view of distribution and pricing and so on. Clearly, we are going down a medical model of attempting to obtain FDA approval if we get successful data. This is an antidepressant, so that's one of the six protected classes. That doesn't mean there won't be active negotiation with CMS. Clearly, we haven't really touched on commercial payers, but I think it's important to note that clearly, beyond label and REMS, there is another potential winnowing of the funnel, which is PAs and so on. So appropriate engagement with payers at the right time with data in hand is also going to be a critical part of our strategy. There are, because this is a scheduled product, we haven't touched on rescheduling, but obviously, that's also an important component of our work, both federal level, which is a relatively straightforward process in the sense if we are lucky enough to obtain approval, the DEA is required to reschedule at federal level, and we already are engaged with the Controlled Substance Staff around that. State level is a completely different order of magnitude and challenge, and that's work we're already engaged on. Clearly, we can't predict for certain what schedule we may land on, but obviously, it will be rescheduled from Schedule I, which is no medical purpose. So there are some other elements here that we're also engaged on. Steve, what else have I missed? I would just say just high level. And Kabir, you touched on this earlier, but just to underscore it and boldface type and highlight it in some ways, we tend with psychedelic treatments, whether it's COMP360 or others, to really focus on what a different paradigm of treatment this may be. And certainly, we do have hopes that this will be differentiated from current options, provide new options for patients, and really have meaningful efficacy and safety outcomes. But I think it's important also to recognize that as much as we talk about what may be different about psychedelic treatments is that almost all of the elements of delivering treatment like this exist already within psychiatry or, as Kabir said, across other therapeutic areas. While I think we recognize that internally, there's still some work to do with educating key opinion leaders and others in the field about that, many of whom don't have a lot of experience necessarily with the implementation of new treatments within psychiatry. But I think we will have the opportunity to demonstrate how we're not necessarily going to be asking people to learn or do new things, but that this treatment can fit very nicely into existing workforces. Operationalize new things, it is hopefully just going to be an additional tool for them that fits in with the services they already offer. Yeah. Terrific. Okay. That does bring us to the end of the session. So thanks again to Kabir and Steve for this really insightful review of the commercialization around COMP360 and psychedelics and for Compass Pathways for attending our conference and as well the important work you're conducting in this area of mental health care. So the next session focused on cognitive impairment associated with schizophrenia begins in two minutes at 12:30 P.M. We'll see you then. Thank you, Patrick.