Great. Thanks very much. It's my pleasure to be moderating this fireside chat with the COMPASS Pathways team. Super topical time for the company after some great data recently for COMP360. I think we'll do this chat with Kabir, the CEO, and Lori Englebert, the Chief Commercial Officer. Steve, head of IR, wanted to make some brief comments just to start, and then we'll get right into it. Sound good?
Yeah, thanks, Paul, and thanks for having us. We appreciate it. Just, you know, formally, we will be making forward-looking statements today, and so I wanna refer all of you to the risk factors in our SEC filings. Thank you.
Yeah. Wonderful.
All right.
Well, yeah, thank you again. Kabir, Lori, Steve, it's awesome to see you guys. Maybe Kabir, maybe you could just kind of kick things off, set the stage for 2026. You just had some key readouts working on the COMP360 filing, more data later this year. How should we be thinking about this year just more broadly as a build year for COMPASS? I'll let you-
Yeah.
Take it away, and then I have some more specific questions.
No, thanks, Paul, and thanks for the invitation. Yeah, we put out some great data three weeks ago, and I'm sure we're gonna talk more about that. We really, I think, are showing with COMP360 that we have a profile that can redefine durability and rapidity in treatment-resistant depression. That data set was sent down to the agency. We now have a meeting scheduled with them, and the real intent of that meeting is to align on what we'd already been discussing with them, the potential for a rolling submission and rolling review.
We'll be presenting them with our potential sequence of putting in modules, you know, CMC, pre-clin, all that, but also align them that they will start to work on the clinical data they already have, and then the COMP006 26-week data becomes the final piece of data that gets slotted in, integrated into the ISS and so on. That we're on track to have early Q3, so that's the one other big data release for this year. That then once we've integrated in, that will be the final piece to get slotted into a full filing. We would anticipate completing that NDA submission in the back part of this year.
We have breakthrough, which largely tends to mean priority review, and so at that time we would see, you know, hopefully with an accepted filing and a PDUFA date that puts us kind of sometime end of the year into next year. We're not getting exact regulatory guidance yet because obviously until we've met and we've really aligned on that timetable, we can't. Lori is gonna be ready to launch by the end of the year if that's where we get to. A very exciting year for COMPASS.
Awesome. Okay. Sounds good. You do have some more data from COMP006 later this year from the long-term study. How important are these data from a regulatory perspective?
I think, you know, we already clearly have the long-term data from the first study, and what the FDA clearly wants to see is a couple of things. They do want to see, yeah, how long do one or two doses last? I don't think there's a bar on that, but clearly that will be a topic of discussion. They want to see that there's no safety issue, new safety issue, no waning effect. So far what we have from COMP005 suggests that none of those issues are real, but we obviously need to see that from COMP006 as well. From a regulatory perspective, that part is supportive. It's really important though from a labeling perspective, and I'm sure we're gonna get into this, is it one or two doses? What's that gonna look like?
That piece more from a labeling as opposed to is this approvable from a regulatory perspective is what's really important.
Yeah. Yeah. Okay. Makes sense. Lori, maybe we can talk a little about the commercial piece. Like, now that you've got a lot of data in hand, like what do you see as the biggest commercial challenges ahead of you? And what are you working on right now in March of 2026?
Well, since my boss said I need to be launch-ready by the end of the year, a whole lot of things. You know, from a you know, what we're focused on and what we see as the biggest hurdles, I wanna take a step back and just kind of set the stage because that will help, you know, kind of present what these challenges are. We are very specifically talking about the treatment-resistant depression population. This is very different than broad-based MDD. MDD is 23 million patients. About 13 million of them are actually treated with the 50+ odd MDD indicated, and FDA-approved products out there.
We're very specifically talking about treatment-resistant, which is only 4 million patients, you know, this is a large patient population, but only 200,000 or less than 200,000 are actually being treated with TRD-indicated products. Now, this is important for everyone to understand because the reason that so few patients are being treated for treatment-resistant depression with a TRD-indicated product is because they are the ones that are available. Think about SPRAVATO, and then if you wanna go a little bit broader, ECT, TMS. These are high patient burden products or you know, drugs to administer to patients. Physicians just haven't had options that actually you know, would fit very nicely into a patient's lifestyle that actually has proven efficacy in treatment-resistant depression.
The unmet need is at an extreme level here, in terms of what patients are needing right now. You know, our North Star is to enable broad and equitable access, so keeping that in mind will help kind of narrow down the focus of, you know, what I think the biggest challenge is, and that is making sure that patients can easily access COMP360 at launch. Two focus points for, you know, making sure that we enable that is one, rescheduling. Making sure that the FDA reschedules in a timely manner, keeping to their 90-day window after FDA approval, and then, the states need to reschedule after that. And so we-
How much of that, Lori, is actually in your control? Like, can you really actually influence the pace of that process?
That's a great question. No. We expect it to be about 90 days. What we can do, though.
Okay
What we can do and what we are doing is really making sure that if there are ways to make that timeline shorter, either from a, you know, really succinct and fast simultaneous review from the FDA recommendation for scheduling over to the DEA, if that can happen faster, we are working to try very hard to see if that timeline can get shorter. We don't expect it to go past the 90 days. They've never gone past the 90 days before, so that feels, you know, pretty secure. The other piece of that is the states rescheduling. The states will need to reschedule in order for us to be able to ship the product to those states, but most importantly, before a prescriber can prescribe, the product needs to be rescheduled at the state level.
Mm.
We are working to make sure, you know, our goal is that by the time we, you know, launch, we have about 90% of the patient population already rescheduled within 30 days of DEA. That is what we're working on very hard right now. We are right now currently sitting about 70%-75% of the patient population of the U.S. sits in states that will reschedule within 30 days after federal DEA. We're working to enact legislation in the other states to pull those timelines in as quick as possible. That's kind of the first order of business that we're, you know, really focused on right now.
The second is a pretty broad one, but that goes back into making sure that the sites are able to prescribe COMP360 once we launch. That will require educational efforts, scientific exchange, making sure REMS, you know, educated and trained on REMS, getting the sales force up and running, making sure reimbursement is, you know, easy for these sites. A pretty broad bucket and pretty comprehensive from a commercial effort standpoint.
Yeah. Okay. Well, maybe you'll be asked for the thousandth time this morning about time in the office, right? Eight hours versus two hours. It's like I feel like that's the obsession, right? Like, is this doable? Is this scalable? What are the economics of that piece? Like, is that the question you get from providers a lot about how to kind of make this work logistically? And sort of like regardless, like how are you thinking about that from like logistics, economics, education, like all of that that you have to kind of help the site get ready for?
Yeah. Just before Lori answers all that, I will answer the first part. No, that is not the question we're getting from providers at all. What we're getting from providers is, "When is psilocybin available? Because we can't wait to get our hands on it.
Yeah.
This other stuff that frankly we don't really like dealing with that might come in a few years' time, let's not talk about it." That's actually what we get from providers. Let me pass to Lori for the rest of the question.
I cannot-
Fair enough. Providers don't ask the same questions as hedge funds. Weird. Okay. Go on.
Yeah. My response was just gonna be like I've never heard a prescriber ever ask that question before. If there's ever an indication that psychiatry is shifting, it is the fact that we are now obsessed with this provider economic model that is going on. In 15 years of being in psychiatry and promoting to psychiatrists, I've never had a provider economic question or concern. I still don't. It is coming from people understanding the applicability of the product. You know, I am very lucky that COMPASS had the foresight to really think about enacting CPT codes that would allow for the evaluation and management of specifically related to psychedelics on an hour-by-hour basis.
What that means is, right now they're sitting in the Category III form, which is, you know, really just evaluating new technology or products coming to market. Once they come to the fully recognized Category I or CPT enacted codes, what we expect to see is that because they are specific to the psychedelic experience and support that is required for the psychedelic experience, is that the entire practice economics and provider time that is required to help support the administration of these products will be accounted for. This is very different than what's happening with SPRAVATO right now. SPRAVATO is being adequately reimbursed for their time, but they are just using general evaluation and management codes. These are very, you know, very basic to the time spent by the provider and the site economics.
It's not taking into account the full picture of what psychedelics will require from a support standpoint. We feel pretty good about that piece. What I wanna talk about to help continue build upon this is because it is on an hour-by-hour basis. Right now the full six-eight hours that a room will need to be blocked for the administration of COMP360 will be fully reimbursed to the site. Right now with SPRAVATO, they don't get that full time period in a day, and they get it at presumably a much lower level of reimbursement than we anticipate.
The reason they can't get a full hour blocked is because not only would they have to schedule, you know, two-three patients in a day, there is time in between patients that they can't bill for. There is some slight advantage to a COMP360 full-day experience. Now, that shouldn't scare people too much in terms of, you know, you're blocking a room for one patient versus three. As I mentioned before, there are plenty of patients out there, and these sites are building at a rapid pace. New sites and the sites that are currently existing are adding capacity, and willing to add capacity, as psychedelics come to market. Yes, of course, for COMP360 'cause we are first to market, but as psychedelics come to market, this is kind of the shift.
This is the shift in psychiatry.
Yeah. Yeah. Okay. I think you've already established, like, a CPT code, is that right?
That's right. The CPT codes went into effect in January 2024, confirmed by AMA. They are out there and ready to be used by psychedelics. We are getting a tiny bit of use by IV ketamine with these codes. Once a psychedelic comes to market, they will start to be used. The faster we can-
Yeah
show adoption, the faster they'll get enacted into CPT Category I codes.
Yeah. Okay. Like, the first year of the SPRAVATO launch was incredibly slow, but it's hard to know if that was because of the novelty of this model and none of it's being established or COVID or, you know, something else. I guess given what we're talking about here about, like, sites, education, figuring out these logistics, figuring out reimbursement, like, does that argue for our first six months of a launch where, like, we're really not seeing the same, like, bolus that the unmet need might suggest? Like, how much time do you think in year one it's gonna take to get, like, a number of these major sites, like, pretty comfortable with this process?
Well, we do our job really well. You know, we've already started working with a lot of the sites that prescribe SPRAVATO right now, through our collaborations, our strategic collaborations that we're working on. If we do our job really well, the time that we will need from approval to launch, which it will be, of course, constrained by that DEA rescheduling time period of about three months, three-four months, if you factor in the states, then we are going to spend that time, you know, wisely, making sure that the sites that we know or anticipate will be the early adopters have all of the information that they need to get set up and ready to prescribe. That was not a luxury that SPRAVATO had when they launched.
When they launched, there were a handful of sites that actually could administer multi-hour products. You know, they had to basically build from scratch. This infrastructure is sitting there, you know, fully established with the staffing, the know-how, importantly, of how to get, you know, work with REMS, get PAs through the system. All of that is sitting there already established for us, and it's growing at a pace that is hard to keep track of.
Yeah. Yep. Okay. You know, one thing that I've really noticed with COMPASS over the years since I met with your predecessor, Kabir, it may be seven years ago to today, is kind of the evolving view on the relevance and necessity of therapy to the whole experience and, like, as a component of the product. So maybe, like, talk a little bit about how you think that piece is gonna be contemplated from a regulatory perspective or described in a REMS. I know you guys say that during the session, there really isn't any therapy, but there is, like, the integration session as a follow-up. Like, I guess bottom line, like, do you feel like there's gonna be any requirements here?
Do you think people are going to be leveraging therapy as any part of this in the real world, or is it really gonna be the same sort of any medical professional can be present?
Yeah. Thanks, Paul, and it's a great question. I'll start, and then Lori can add on and so on. Yeah, we have been very clear, I think, from the start that to get FDA approval, we need to get a drug approved, and we need to get a drug approved that sits in medical practice, in clinical practice, that sits in a certain place in a patient journey, but it's not our job as a drug sponsor to dictate that medical and clinical practice. That's why we were very clear, you know, across every arm of every trial we've run, extremely standardized training delivered to the person who was in the room, standardized playlist, and so on because we really want to remove all those variables and focus on the fact that there is here a drug effect with a dose response.
The psilocybin experience itself is a largely inner-directed one, and that's why we have been very clear that during that administration session itself, there is not active therapy being delivered. We've talked about the fact that we were required to record all those. We've listened to transcripts. 80%+ is silent, and if you just isolated the therapist part of the dialogue, it would be meaningless. It does not provide any direct intervention. That's very different from saying that patients will not benefit from therapy in the course of being treated for treatment-resistant depression.
Right
We absolutely expect in the course of clinical and medical practice that many patients will indeed benefit from therapy, and there will be an ongoing process. What we expect to have, and Lori will build on this, is there clearly is always a requirement to discuss with a patient the type of experience they're gonna have. That's the case for any drug, any procedure. That's all preparation means in this case. This clearly is a very different type of experience, particularly for patients who've never had it before, and it's really important that somebody explains to them what it's gonna be, how they can think about that, how can they make sure that they feel safe in that environment, in that day of administration. We expect that the monitoring will just be by any licensed healthcare professional.
There's somebody who is trained to understand safety because that's what it's really for. In terms of integration, again, what we would expect is a follow-up, a check-in for safety again, but we do not currently expect the label or the REMS to actually talk to what surrounds the administration itself and those couple of things around it. Lori?
Yeah. If you think about the way the SPRAVATO REMS reads now, in loose guidance, you know, we have been directed to look at the SPRAVATO REMS as well as the Lykos Adcomm briefing materials that discuss what Lykos' REMS would be, as guidance for our potential REMS. It is basically exactly what Kabir just said. It is make sure the patient is educated on what to expect. As a check, make sure that the site is adequately trained. As a check, make sure a provider is on site or a prescriber is on site, you know, as a check. That you need to, you know, have a provider, a licensed healthcare provider sit in or a professional sit in a room with a patient for a time period.
With SPRAVATO, it's up to three hours. For us, we expect that to be, you know, six-eight hours.
Yeah. Okay. Makes sense. I guess maybe this is an open question, but do you launch next year or late this year, but let's say next year, you know, what do you think the first 100 early adopters look like? Do you think they're SPRAVATO experienced patients coming from somewhere else? Like, do you have good insight into that?
We have hypotheses. Obviously with the clinical profile just now starting to emerge, you know, again, going back to there are so many patients out there who are not being treated with TRD indicated products. I think it would be, you know, unfair of us to assume that SPRAVATO patients are gonna jump from SPRAVATO over to COMP360, nor would we want that, right? If they're stable on SPRAVATO, then no provider is going to suggest that they move. They may want to, and that certainly will happen. What we do expect is that there is a very large patient population sitting out there that has not been treated, so we expect plenty of those to start coming into the funnel, and into these centers.
We expect there are a lot of patients who have just stopped treatment altogether, who are sitting and waiting for, you know, a new product that could come to market that is with a patient-friendly dosing regimen that is not too disruptive to their life, but does provide efficacy. You know, we will continue to work not only at the sites who have this bolus of patients that are sitting and asking for COMP360 already. We know that again through strategic collaborations and market research. The patient interest is very high in terms of willingness to take COMP360.
We will also need to do some education to make sure that constant patient flow is coming in from physicians that are referring to sites that are set up to administer COMP360. The first, did you say 100 days or 100?
Patients. I said the first 100 patients. I don't know. First 100 patients.
I wanna talk about the first 100 days, Paul, because that's what's gonna be really exciting is we're gonna watch what the success of this launch looks like. Yeah, the first 100 patients will likely come from the high prescribing SPRAVATO sites that are already set up and have a bolus of patients sitting and waiting.
Yeah. Okay. Makes sense. Kabir, anything to add there?
No. I think that's exactly right. Well, the only thing I was gonna add is let's remember the profile of the typical patient here. I mean, the regulatory definition was being failed by two or more antidepressants, or two or more treatments in the current episode. Typically, these patients have had depression for years, multiple episodes. Often the current episode has lasted three to four years, as we saw in our trials. Lifetime exposure to medicines that have failed them is typically double digits. There is that core cohort of patients, and every treating psychiatrist knows among their patients who those patients are, and that's where I'd expect the initial patients to come.
Paul, I would just add that there's no shortage of awareness and interest. As we get closer to, you know, an approval, there's gonna be more and more written about COMPASS and about, COMP360. Again, no shortage of awareness there.
Yeah. Okay, great. Well, maybe to finish things off, do you wanna just briefly talk about PTSD? Like you have some early data where the signal looks promising, but, you know, there's always the question in psychiatry about how well a signal like that might hold up in a larger study. So maybe just talk a little bit about what you saw there, your confidence that it's de-risked, and maybe just the timelines of when we're gonna get more data.
Yeah. No. You're right. Our study was relatively small. It was 22 patients open label, but we really did see a very, very strong response in terms of both response and in fact remission. What I would say is there are enough other centers now studying psilocybin and PTSD that while again, a lot of these are either open label or relatively small, there's clear evidence building that this can be effective. In particular also, we actually have a deep understanding of the patient narratives from that particular cohort of patients, and we have a deep understanding of the experience and the fact that for, of the patients who did in fact achieve remission, less than half actually had any experience of the initial traumatic event.
In fact, what we saw was that it enables people in the same way that psilocybin works in TRD to actually work through some fixed patterns of thinking without necessarily needing to re-experience what was happening before. Of course, we didn't see any unexpected safety signal, nothing triggering, which was originally the design of that study. I think taken with what we've seen, those patient narratives and what we've seen from another academic study centers and so on, we're actually very confident that it can be effective for PTSD, that COMP360 can be effective for PTSD. As you know, we've designed the study with two fixed doses.
We felt ultimately that was the best way really to make sure that we did get that impact, and we'll still need to understand COMP006 a bit better, but we're clearly seeing that second dose in TRD does in fact, you know, produce additional effect.
Yeah.
Final thing I'd say is we know that there's significant overlap in these patient populations. Yes, there is a lot of comorbidity and so on. Where are we? CRO selected, site selection underway, initiating that study relatively soon. It is a relatively large study. Historically, PTSD studies have recruited slowly. We're confident, though, that with something that we think actually works, unlike most other things that have been studied in PTSD, that we actually will be able to kind of break that paradigm of recruitment and so on. Until we're into it, I don't want to give specific guidance on when we'll see data, but I do think unlike for TRD, we will actually be a little more accommodating about telling you how we're doing on that study.
Yeah. Okay. Okay, great. I think we're at time. Anything else to add here? I guess a lot on your plate. Maybe talk a little bit about the balance sheet and how much runway you have to support everything you wanna do.
Sure. With the data last three weeks ago, we were able to pull in fresh findings, $150 million. We also called the warrants from the January 2025 financing of $200 million. That gives us runway into 2028. That gives us runway well beyond our anticipated launch, probably six-nine months beyond that. Yeah, Paul, I mean, we are heads down, focused on executing. We are focused on the competition at launch, which is SPRAVATO.
Yeah.
We're not focused on the theoretical yet to be proven vague and not very tolerable competition that might be coming behind. You know, we're focused on executing, and Lori and her team. Lori has started to build out a fantastic team, and we're excited about what's to come.
Okay. All right, great. Best of luck. Look forward to connecting with you soon. Thank you.
Thanks, Paul.
Thanks, Paul.