Let's get started. For our next session, we're really excited to have COMPASS with us, represented by a lot of their management team, which is really exciting. We've got Lori, Teri, and Steve, and that's CFO, Chief Commercial Officer, Chief Patient Officer. Thank you all for being here. Thanks for having us. Yeah. Thanks, Leo. Yeah. Maybe just by way of a brief introduction, I guess you've shown a lot of data for COMP360 psilocybin. Can you just maybe talk about the consistent benefits you've seen, some of the data that emerged from COMP005 and, you know, eventually we'll get into all the forward-looking and more exciting well, not more exciting, but equally exciting parts of the story as well? Yeah. I guess I can kick it off. As you're talking about forward-looking, I just will remind people that we will be making forward-looking statements, so I'll point you to our risk factors on our website. Now that we've got the important stuff out of the way, we can answer the question. Just to give a little bit of a high level for those that are new to the story, COMPASS Pathways, we are developing synthetic psilocybin to treat mental health conditions. The first indication is in treatment-resistant depression. Our second indication is in PTSD. We believe it has broader applications beyond that, we're really excited to be on the path to filing our NDA, which we've said we'll be targeting for the fourth quarter of this year. We're very far along in this journey. We've got two phase III trials in treatment-resistant depression. As Leo was alluding to, we've got data for both of those trials. We've got primary endpoint data, six-week data for both those trials. Both were highly statistically significant, positive data, really strong safety profile there. Also, we have the longer term six-month data for our first phase III trial, and we're awaiting the six-month data for the second phase III trial, which we expect early Q3. We believe already that we have a really strong profile emerging for psilocybin and for COMP360, which is the, what we call our psilocybin product. Maybe I'll turn it over to Lori just to give a little bit on what we saw in the phase III data from February in terms of the profile and why we're so excited from a commercial perspective around what we're seeing with the product profile and how it compares to some of the standard of care. Thanks, Teri. We are extremely excited about the profile that's emerging for COMP360. What we saw is unlike anything that's available on the market today, either for MDD or TRD. The efficacy that we saw improved in this really difficult to treat patient population is really impressive. There's only one pharmacologic product available right now that is indicated for treatment-resistant depression, and that is SPRAVATO. SPRAVATO is treating about 100,000 patients at a $1.6 billion, $1.7 billion revenue in 2025, projected by J&J themselves to get to $3.5 billion in 2028. The reason that this growth is happening is because they are actively working to build out an infrastructure that is capable of delivering multi-hour in-office treatments like SPRAVATO, TMS, ECT. This infrastructure has been growing incredibly rapidly, that growth is really exhibited by how many sites were brought online in 2025. In 2025 alone, over 4,000 sites were added that have the capability of prescribing these multi-hour in-office treatments. That growth is really remarkable. The reason we're excited is because versus SPRAVATO, the treatment of COMP360 could show efficacy in less than 24 hours and improve durability after one or two treatments out to six months. It may be even longer. We just haven't seen data beyond six months at this point. That is truly differentiating from a patient burden and obviously efficacy standpoint. SPRAVATO, as I mentioned, the only other analog in treatment-resistant depression is treatment durability at best two weeks, but the course of treatment is typically starting twice a week for the first month, then once a week for the second month, once a week or every other week for the, in perpetuity. These are long appointments. They are heavily burdensome for the patient as well as the caregiver who has to drive the patient home. To be able to have comparable efficacy from a treatment that's only one or two treatments over six months is really truly gonna revolutionize the psychiatry industry. Yeah. That's really helpful. Maybe staying with the clinical side, just briefly, you're going to have, as you mentioned, another update of another cut of data in the third quarter. Can you help set expectations for what we should be looking for from the longer term COMP006 data? Any additional data you may share from COMP005? There's been a lot of discussion of, you know, either deepening responses or can we tell anything on durability durations. Can you just talk about those? Yeah. I can start, and Steve and Lori can chime in. The COMP006 Part B data is primarily going to help us with payer discussions and providing more clarity around the dosing regimen to give Lori and her team some information to be able to guide physicians around dosing schedule and how best to and when best to bring patients back. There's no bar that we're looking for in the COMP006 Part B data. This is really just to round out the profile and really help us understand what will the label look like as it relates to dosing, and what information will Lori have to both educate physicians in the field as well as have payer discussions. You shouldn't be looking for a particular number or a particular even efficacy measure necessarily. We did see with the six-week data that we disclosed in February. If you remember COMP005, it was a single dose versus placebo. With COMP006, it was two fixed doses three weeks apart versus an active comparator. We did see a deepening of response in the COMP006 data with two doses. With the COMP005 data, we were showing roughly 25% of participants reached a clinically meaningful response that was durable through six months. We noticed that the 25% increased almost 40% in COMP006 with the two doses up front. We already know that there's an impact, a positive impact of that second dose. What we really need to see is those patients now have the potential to get a third dose in Part B. Being able to see what does it look like with one or two doses in COMP005 versus potentially three doses in the first six months of COMP006, what does that look like? What does that profile, what do the trends look like, and how might that inform both label and payers? There's not a distinct data set that you should be looking for. It's really the overall trend and profile that we'll be gathering. We are, as we've mentioned on our earnings call last week, I guess it was, we have already started submitting data to the FDA as part of our rolling submission and review process. As it relates to longer-term COMP005 data, we do have the 52-week follow-up for both trials. The COMP005 52-week data we'll be getting during this review process, and we still need to kind of work through exactly those timelines of what we're submitting when to the FDA, whether that data will be something that we disclose alongside the Part B data. That's still a little bit up in the air right now as we're trying to optimize and accelerate the filing and the submission with the FDA. That will drive some of the timeline of what will get disclosed when. Wow. Just staying with the regulatory theme for a second. You guys mentioned you guys have a rolling review, a number of other designations as well. I guess, how are you thinking about this regulatory process? There's obviously been a fair amount of turmoil at the FDA as well. You guys have potential to use a Commissioner's Priority Review Voucher. There's no commissioner. I guess, can you just put that all together in one clear picture of what the regulatory path looks like, your ongoing interactions to the extent that you can talk about them? Yeah, I think we can all Yeah. chime in here. While there's a lot of noise around the FDA right now, luckily for us, it has been very stable in our discussions with the FDA. We have a very strong collaborative relationship with the psychiatric division of the FDA. The leadership there has been stable throughout our entire tenure developing this product. That has not changed. We continue to deal with the same team, and we've seen tremendous support across the various levels of the FDA, and as noted by the executive order several weeks ago, all the way up through the various different branches of the administration. We feel really good about the support that we're seeing for psilocybin in particular, as noted with the CNPV that we received. Psilocybin was called out specifically for us for treatment-resistant depression, that's just a, you know, another level of support that we're seeing. From a timelines perspective, it's really interesting because we had been talking to the FDA about a potential rolling submission and review, even as early as last September following the first set of data that we put out last year. We had been talking about how collaborative those discussions had been, that we had been aligned on a rolling submission and review upon the data that we put out in February, that rolling submission and review was finalized and officially granted by the FDA. That all happened outside of the CNPV process. We had been talking about acceleration of our timeline since last fall because of this discussion that we've been having with the FDA and their encouragement to us to accelerate. Lori and her team had been planning on being launch-ready by the end of this year as a result of those conversations. That has all been very stable for us, and we've been planning all along for this kind of accelerated path because the FDA and the psychiatric division was going to do this rolling submission and review. The CNPV just potentially accelerates the back end a little bit further. It takes what could have been like a six-month review time, given we have Breakthrough Therapy designation, to a target of one to two months. With the executive order, they also were directing a little bit more efficiency with the DEA and rescheduling. That may also be able to pull that back-end timeline forward. Overall, we feel really good about both the stability, the consistency, and quite honestly, the collaboration and encouragement that we're seeing with the FDA around COMP360 and us getting this to patients as quickly as possible. We have a very robust data set. They've been able to do all of this because we've upheld the highest standards in our trials, in the size of our trials, in, you know, creating just a surround sound of safety data, efficacy data. We have everything that the FDA could ever want for an application. That's what's allowed them to move us quickly forward, is we're ready to be moved forward. We've got a lot of strong data to support a very robust application. Commercially, the general rule of thumb is that if even if there's only a 1% probability of getting approved, you have to be ready because you would never want an approval drop in your lap and then, you know, commercial not be ready. As Teri mentioned, we from Q3, Q4 of last year, we've been planning just in case, not only not for CNPV, but the fact that the rolling review was happening, you have to assume that the FDA could shorten their review timelines, because normal applications would go in, and then they start the clock of review, and start reviewing. So, we were already planning for some shorten timeline anyway. The CNPV is only helping us firm up timelines. It's not actually adding any more stress to the system of being prepared. Got it. You alluded to another regulatory step, which is DEA rescheduling. Can you talk about the expectations, the timelines there sort of as mentioned, having the commercial team in place, but, you know, there might be some staggering of where and how you can launch? How does that all fit into what we should expect for the first, you know, few months, you know, first year of what a launch could look like? Yeah, it's a great question, and one we're working through because the executive order that came out really did, you know, state an intent to have that timeline shrink. Right now, as it stands, the FDA will give an approval, and the DEA starts their review for scheduling, and that they have 90 days statutorily to hit that. On average, the DEA does hit about 90- 95 days. They hold their timelines pretty firm. Right now, the EO and we still need to figure out what the EO actually means in terms of shortening that timeline. Again, we will be ready even if there is some pull in of that timeline from DEA rescheduling. The DEA rescheduling at a federal level is only the first step, though. You can imagine that the DEA will reschedule based on the new EO somewhere between the day after approval and 90 days. Again, we will work over the course of, you know, the next several months to try and see if we can get any clarity in what that might look like, and obviously we'll be facilitating any, you know, acceleration of that as possible. Once that happens, the states need to reschedule in order for us to distribute the product and physicians to be able to prescribe in each of the states. We have been doing a lot of work over the past two and a half years to work with states that do not follow the federal DEA immediately. We've been doing work in the states that have some uncertain timelines of when they will actually reschedule. I just want to be clear, it's not that they won't reschedule or follow, you know, federal, it's just that they don't have timelines dictated by their laws or their legislation to actually do it in a timeframe. What we've been doing is trying to work with these states to make sure that they are educated on the unmet need in each of the states and the importance of being able to get, you know, these novel products to patients as soon as possible once they become available. For the most part, right now, we are looking at close to 90% of the U.S. population lives in a state that intends to reschedule within 30 days of federal. That's truly remarkable. Two years ago, that number was about 45% of the population. We've done a lot of work to really make sure that we can distribute and physicians can prescribe, as soon as possible after federal DEA rescheduling. What you can expect is, you know, an approval, DEA, hopefully approval, DEA rescheduling within a certain time frame, and then the states need to reschedule before we can actually start the launch, so to speak. It's important to note in where you were going with your question is, we are going to utilize that time. You know, we're going to maximize the time in between approval and when we actually launch the product. You know, we're going to be making sure sites are trained, we're going to get a sales force on board, we're going to make sure they're trained and can go out and promote compliantly. All of that will happen in that timeframe, in between. Got it. Another aspect that might maybe modulate launch and uptake is any potential REMS. You guys have talked that you expect something broadly consistent of what we've seen with SPRAVATO. Can you maybe lay that out a little more? I guess, how do you envision sort of what the parameters might be around how this drug can actually, you know, be in the hands of physicians and ultimately be in the hands of patients? Sure, I can take that one. I mean, first, to look at the SPRAVATO REMS as the best analog right now, it's important to recognize that that has not been a particular barrier for adoption by sites. The REMS itself is not particularly onerous. What has been a bit more of a differentiator for the sites that deliver SPRAVATO is more of the administrative capabilities, having the teams in place to deliver an in-office treatment. And to that extent, those requirements mirror what we expect to be necessary for COMP360. Diving into the details of an expected REMS, and of course, this is with the caveat that this remains to be discussed with FDA, but it's reasonable to assume that similar to SPRAVATO, there'll be language around the requirements for a prescriber available for a licensed healthcare provider on site, and to otherwise describe what amounts to the safe use of the product. REMS tend to be very focused on elements that need to be tracked over time to be monitored for safety. That's enrolling patients in a REMS, which is essentially a registry, for the sites to be authorized to be certified as centers by establishing policies and procedures in caring for patients, monitoring of identified elements over time during the administration sessions. What you don't typically see would be anything related to the practice of medicine. Exactly, you know, how the treatment is delivered, how medical decisions are made, et cetera. We would similarly expect that according to precedent and what is the purview of FDA, that this will focus on the safe use of the product, not the practice of medicine, and therefore, again, will be more restricted to what are the types of profiles that need to be available to appropriately care for patients. Got it. You mentioned the sites, that's another topic of discussion that comes up quite frequently. I think there's over 7,000 SPRAVATO sites. I don't have the latest number in front of me. You guys probably have it. If you look at it day to day, you'll be out of date because Yeah. it's changing that quickly. Exactly. I guess what's the level of, first of all, enthusiasm among these sites for onboarding a new product, and then what's their actual capacity, you know, separate from their enthusiasm to actually, you know, be able to on your ideal launch timelines, be able to administer this to patients? Why don't I start, Lori, you may want to add? Enthusiasm and capacity. On the enthusiasm side, this is why they built these centers in the first place. Yeah. They didn't build interventional psychiatry clinics just for SPRAVATO or just for TMS. Frankly, you know, the data initially for SPRAVATO's approval was not something that was particularly exciting to these prescribers. It was having an option for a group of people who have been underserved and who have been failed by multiple treatments. Here was an approved option that, you know, also fit into the sites where they were currently delivering TMS. It was a lot of work for these sites initially to ramp up to be able to deliver SPRAVATO, work that they don't need to do now in order to deliver COMP360. They were really doing the upfront work in anticipation of there being further approvals with products like COMP360, which as Lori was saying earlier, potentially has a very differentiated and compelling profile relative to the very burdensome and non-durable treatment that is SPRAVATO. Excuse me. Again, they built these centers in the first place anticipating the approval of COMP360, it's not as if they are newly getting motivated or excited to deliver COMP360. It's the data that's emerging is reinforcing why they built these centers in the first place. They're built to be platforms, to be ecosystems that deliver a range of treatments that serve the same population. Frankly, the approval of COMP360 is healthy for the sites. It's healthy for continued prescription of SPRAVATO, just as additional approvals of psychedelic treatments behind us will likely be wins for everyone. A rising tide here will raise all ships. Partly in anticipation of the other approved treatments, these centers have significant capacity today. They are not running at 100% capacity. Far from it. There are some that are very high volume prescribers of SPRAVATO that still do have additional capacity. There are others that are writing a relatively small number of prescriptions and have many rooms just sitting there available. In that way, they're not even going to be making trade-off decisions between using a room for COMP360 or SPRAVATO. They have room for all of these. The economics also favor the building of additional capacity, whether it's expanding the footprint of existing sites or building new centers should they have the good problem of filling the existing capacity. Got it. Oh, sorry. Go ahead. I was just gonna add one quick thing. You know, I mentioned earlier that over 4,000 of these sites came online. They're not building because SPRAVATO is the drug of choice. They are building because SPRAVATO is one of the many things that they're seeing happening in psychiatry. If you look at what's being built in psychiatry right now, it's predominantly psychedelics or these multi-hour treatments that require in-office visits. They are anticipating the growth that's gonna come with these multiple new treatment options. Yeah. We have just 90 seconds left. I wanted to touch on another program, PTSD. I guess, you know, there's been a lot of enthusiasm from the EO on PTSD as well. You know, with the drug is potentially potent as psilocybin, there's a lot of places you could have gone. I guess what made PTSD the right, you know, next step for COMPASS? You want to take it, Steve? Yeah, I'll take this one. I mean, first, another tremendous unmet need. Huge population. There are 4 million U.S. adults living with TRD, 13 million with PTSD, with very few options today. There hasn't been an approval in more than 25 years. There are only two approved products in PTSD, which are two old generic SSRIs with modest efficacy. With what we saw in our phase II-A study that we published last year, primarily a safety and feasibility study, but with an efficacy endpoint that showed over 80% of participants in remission after a single treatment. We are really excited about this. There are tremendous synergies with TRD. These patients are treated in the same locations. The conditions are often comorbid. Although veterans actually make up a small proportion of those living with PTSD, they are quite visible and we are committed to supporting our veterans, and to that end, we've been working closely with the VA for quite some time now, both in terms of supporting investigator-initiated studies, including one that is a very large five-site study with people with TRD who also have comorbid PTSD. Additionally, we've worked very closely with their integrated project team. We meet with them on a regular cadence, and that's the group made up of VA leadership that are responsible for implementation of psychedelics once approved within the VA system. We've had the opportunity to be very supportive to them to ensure their readiness. Got it. Unfortunately, that's all the time we had, but thank you all so much for being here and, we look forward to hearing more from the story. Yeah, thanks for having us. Thank you. We're excited for this year and for COMP360. So- Thanks, Leo.