CMPS

Image source: The Motley Fool. Wednesday, Aug. 5, 2026 at 8:00 a.m. ET Senior Vice President of Investor Relations - Stephen Schultz Chief Executive Officer - Kabir Nath Chief Commercial Officer - Lori Englebert Chief Financial Officer - Teri Loxam Operator: Good day, ladies and gentlemen, and welcome to the COMPASS Pathways Second Quarter 2026 Conference Call. [Operator Instructions] As a reminder, this call is being recorded. I would now like to introduce your host for today's call, Stephen Schultz. You may begin. Stephen Schultz: Thank you, operator. Welcome all of you, and thank you for joining us today for this conference call. Again, my name is Steve Schultz, Senior Vice President of Investor Relations at COMPASS Pathways. And today, I'm joined by Kabir Nath, our Chief Executive Officer, and Lori Englebert, our Chief Commercial Officer. Teri Loxam, our Chief Financial Officer, will also be available for the Q&A. The call is being recorded and will be available on the COMPASS Pathways Investor Relations website shortly after the conclusion of the call and will be available for a period of 30 days. Before we begin, let me remind everyone that during the call today, we will be making statements about our future plans and prospects that constitute forward-looking statements. Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement, including those risks and uncertainties described under the heading Risk Factors in our most recent filings with the U.S. Securities and Exchange Commission. These forward-looking statements represent our views only as of today, and we specifically disclaim any obligation to update or revise any forward-looking statements, even if our estimates or assumptions change. I'll now hand the call to Kabir Nath. Kabir Nath: Thank you, Steve, and thank you all for joining us today. The first half of this year has been an exciting time for COMPASS. Now that we have highly statistically significant positive Phase III primary endpoint readouts, as well as demonstrated durability through 6 months from both our trials. We believe we have largely derisked the clinical and regulatory profile of COMP360. In addition to confirming its rapid onset and durability, the totality of data from the program so far shows it has a generally well tolerated and safe profile. Taken together, these data reinforce our belief the COMP360 has the potential to fundamentally change how mental health is managed. With these data sets in hand, we continue to make significant progress towards our NDA filing for the treatment of TRD. Our rolling submission and review process allows us to submit data in waves to the FDA, and they have started to review some modules that we've already submitted. We continue to expect to complete the NDA filing in the fourth quarter. With the potential for an accelerated approval following our final submission, we are advancing our commercial readiness. We've built a fantastic commercial team with incredible experience, and we're executing on all fronts to be prepared to get COMP360 to the millions of patients living with TRD who urgently need new treatment options. We're also well-positioned with our strong balance sheet, with $433 million of cash on hand as of June 30, which carries us well through launch and into 2028. Let me now hand the call to Lori to talk through in more detail how we're preparing to transform treatment options for these patients. Lori Englebert: Thanks, Kabir. Hi, everyone. Thank you for joining. As Kabir outlined, we have achieved significant milestones in the first half of the year. Notably, advanced important commercial readiness initiatives across organizational capabilities, strategic collaboration, policy and payer engagement, and distribution. All significant steps towards being launch ready. Earlier this year, we rounded out hiring of the commercial leadership team, attracting highly experienced, energized leaders who immediately started to build out their functions. My direct reports come from companies like J&J, Gilead, Otsuka, and Axsome, and between them have led over 70 product launches. The prospect of launching the first psychedelic in history with a medicine that has the potential to fundamentally change the way mental health is treated is a very powerful attractor of talent. And we are bringing in outstanding professionals from across the pharma industry. I am incredibly proud of the team we are building at COMPASS. In the first half of this year, we also announced additional strategic collaborations with Radial and Osmind, taking the total to 8, each with their own distinct capabilities. These collaborations played a critical role in helping to inform our priority focus at launch of ensuring optimal end patient experience. With the final submission of our NDA expected in the fourth quarter, our focus in the second half of this year is on operationalizing launch plans and ensuring launch readiness. This includes advancing everything from training, education, access and reimbursement, and patient support mechanisms. Importantly, we have also already initiated recruiting for the sales force. Our time lines for launch remain fluid, given the National Priority Review Voucher and executive order in April, and the need for DEA -- federal DEA and state rescheduling. We remain focused on being ready to launch, which we anticipate being in the first half of 2027. At launch, we will leverage the well-established existing interventional psychiatry treatment center infrastructure. These treatment sites are specifically designed to support in-office treatments for products that require multi-hour monitoring, such as Spravato, TMS, and ECT. The established infrastructure has existing capacity, and importantly, is already equipped with the staff and operational know-how needed to support additional multi-hour treatments like COMP360. 7 years ago, when Spravato launched, this infrastructure did not exist. Today, there are more than 8,000 established sites across the U.S., and this continues to grow rapidly. COMP360 is poised to lead a profound shift in mental health care, moving beyond daily or frequent dosing toward an option potentially involving just a few treatments a year, which could be life-changing for patients. Across 2 highly statistically significant and positive Phase III trials, COMP360 demonstrated extremely rapid onset of action with deep and clinically meaningful reduction in depressive symptoms as quickly as 1 day, unprecedented durability sustained through at least 6 months, and notably, reproducibility of effect in a chronic treatment resistant patient population, one of the most difficult psychiatric conditions in which to demonstrate efficacy. The data are strong, and both patients and prescribers are excited about the potential for a new treatment option. In recent prescriber focused market research, approximately 90% of interventional psychiatrists stated that they would prescribe COMP360 within the first year being available. In my experience, this is the highest willingness to prescribe percentage I have ever seen in prelaunch market research. With the COMP360 emerging profile and continued interest and excitement around the class, we are eager to bring a new treatment option to the 4 million patients living with TRD today who have limited treatment options. And we are confident in the blockbuster opportunity. COMP360 has the potential to fundamentally change the way that patients living with depression are care for and COMPASS is committed to helping as many patients as possible. We are making significant progress towards being launch ready, and I look forward to discussing more with you throughout the rest of this very exciting year. Thank you, and let me hand the call back to Kabir. Kabir Nath: Thank you, Lori. Our progress in the first half of the year has meaningfully derisked the path towards potential approval and launch and reinforces our confidence in the strength, consistency, and robustness of the COMP360 data package that we are submitting to the FDA. With the regulatory process underway, our focus is on disciplined execution, completing our filing activities and preparing for a first pass approval and ensuring we are poised to deliver COMP360 to patients with TRD as quickly as possible following approval. And as you just heard from Lori, we will be ready. With that, let me pass the call to the operator for Q&A. Thank you. Operator: [Operator Instructions] Your first question is from the line of Paul Matteis with Stifel. Paul Matteis: Specifically, I was wondering if the team could offer some perspective on the recently issued FDA guidelines around psychedelics. And more specifically, how did you interpret the discussion of those guidelines as it relates to 12-month blinded durability? What do you think that really means or what the FDA is asking for? And how do we think about that in the context of the COMP360 program? Kabir Nath: Thanks, Paul. I'm just checking, you can hear me clearly, yes. Paul Matteis: Yes. Kabir Nath: All right. Thanks. Yes. So look, I think as you're aware, this is a finalization of a set of draft guidelines. And the original draft, in fact, came out even after we had fully designed our Phase III, aligned with the agency on that and so on. So our perspective is we have had very robust continuing dialogue with the agency throughout this program. And while the guidance is certainly interesting and we do have those on the 12 months blinded and that would seem like a pretty tall order for any psychiatry drug. We actually don't think it's going to impact the process of our regulatory approval at this stage. I think the other parts of that, that I draw your attention to is the design of Phase III studies in a complementary pair continues to be effectively exactly in line with the design of our studies. So while I think the guidance is interesting and obviously in terms of future endeavors, we will be carefully looking at that. We honestly do not think that these guidelines are going to impact the regulatory process that's already underway for us. Operator: Your next question is from the line of François Brisebois with LifeSci Capital. François Brisebois: I was just wondering, in terms of launch, can you help us understand, this always happens, but especially in your situation, just the reimbursement challenges, what are we going to have to go through just to get a better feel for the cadence here with the launch expected next year? Lori Englebert: Hi, Frank. Thanks for thequestion. As you mentioned, launches are traditionally hard coming out of the gate with the reimbursement just because you need time. What we are doing now is our market access team is already engaging with payers, and they have been now for some time. We are getting very positive feedback from the payers, especially in this TRD patient population, where proving efficacy has almost been impossible to do in the past. So it is playing very well with a key stakeholder who really, truly understands the economic burden that patients with TRD can have on a payer system. So at launch, what we expect is we are intending to have a field reimbursement team fully deployed at the time of launch. Who will be out helping these sites ensure that they can code and get the reimbursement that they need to code for and making sure that they are well educated in the process. In terms of the drug reimbursement and the conversations we are having with payers right now, we are working through that. We are still ingesting the data that we just got and released a couple of weeks ago into the value proposition that COMP360 can bring, and then we'll make decisions as we get closer to launch on what that might look like in terms of rebating and payer negotiations for formulary access. Operator: Your next question is from the line of Gavin Clark-Gartner with Evercore. Gavin Clark-Gartner: Maybe you could just characterize how any ongoing regulatory discussions are progressing? And separately, what are your expectations for DEA scheduling timelines at this point? Kabir Nath: Thanks, Gavin. So on the first part, I would just say they're going well. I mean the rolling submission is well underway. As I noted in the remarks, some of what has been sent is under review. We're getting questions on it. Clearly, given the acceleration, given the NPRV, the onus is also on us to respond very quickly, and we're doing that. So the team is doing an amazing job of being responsive to that. So nothing out of the ordinary that I would say we remain on track. And as you know, it's only when kind of in the later stages that things like label and REMS really come into play. Those are typically negotiated fairly late in the day. So nothing -- really nothing untoward to report, except we're very happy with progress. On rescheduling. I'll hand to Lori. Lori Englebert: Yes. Hi, Gavin. We are accelerating our 8-factor analysis, getting that to the CSS, FDA's Division of Controlled Substance, as quickly as possible. And in hopes of that enabling a faster FDA and DEA coordination along the way. We are also heavily engaging with the DEA or attempting to engage with the DEA to help see if we can get any further clarity on what that looks like. As I've mentioned in the past, the DEA is pretty consistent in hitting their 90 days, so we feel very confident that they will reschedule within the 90 days, but it's still a little bit fluid in terms of when that actually will happen. But given the executive order in April, we are confident in the ability to potentially pull that forward. Operator: Your next question is from the line of Ritu Baral with Cowen. Please go ahead. Ritu Baral: Another question for you, Lori. Specifically around the term training that you used in the prepared remarks, it sounds like in response to some of the prior questions, some of that training for the interventional psychiatry sites will revolve around coding. But I wanted to ask, what other aspects of training does the team plan on offering interventional psychiatry sites. Especially given that you have a good -- a very solid precedent REMS, to sort of train against and anticipate? How do you anticipate offering sort of readiness services to those sites? And how does that impact, I think, how all of us may model 2027 rollout? We've -- here at TD Cowen, we've had experience with sponsors really wanting to manage the early experience with a drug at sites and with clinicians on early rollout. So anything you can tell us about sort of the general shape of 2027 as you see it now with the training offered. Lori Englebert: Yes. Hi, Ritu. Thanks for the question. I'm going to try and collect it all into one cohesive thought. So the way I think about training. Ritu Baral: It's like one question. Lori Englebert: You're brilliant at this, you know? I -- we think about training in 2 parts. So there's going to be training, and there's going to be education. So I will address both. But in terms of training and specifically training, we announced a little while ago that we are participating in grants for third-party companies to help with the training of the site. Both on psychedelics and as soon as COMP360 gets a final label on anything that's required for the monitoring time that the patient will be in the room. We want to make sure that, that patient experience is a very good one. And so we will -- we're still doing that. So the sites will need to be trained because in the REMS, they will need to attest to being trained and part of that will be based on the training that these third-party providers are enabling. Already, there are well over 1,000 people who are already trained on the psychedelic portion of that training. And so there's a broad group of people already ready to go with that training. The other training, again, the COMP360 piece of that particular training on how to best support a patient and help enable a very good patient experience, that will come after we see the final label, and we get that finalized. We are also -- we will need to do training on REMS to make sure that they are compliant with REMS certification and all the things that they need to do with REMS. So in terms of rollout, in some cases, the fact that there will likely be a little bit of time between when we get approval and when the DEA will reschedule and then the states will reschedule. Obviously, we're trying to do this as fast as possible. We are going to leverage that time to the best of our ability. And so we will have teams out immediately upon approval, helping these sites to make sure that they know the requirements that will be under the REMS. And as we learn a little bit more and get closer, we'll be able to start communicating what we expect in terms of site readiness. This will be obviously a key KPI that we will want to communicate on. And then obviously, when it comes time to prescribing. As we are thinking through this, obviously, and you mentioned it before, which means you've listened to me in the past, and the importance of making sure that the sites and the patients have a very good experience. We are very acutely aware that we are leading the way here, and it is important for us to maintain that leadership. And so the other piece that I do want to just quickly touch on is there will also be patients. This is our field force educating the prescribers, the referring physicians. This is our medical science liaisons who have been out in the field for 2.5 years now, continuing to educate there. And we're going to continue to do additional support things like peer-to-peer education, and enabling that in an outsized way, just to make sure that we are covering all the bases and everyone is very much aware of the potential of COMP360. Operator: Your next question is from the line of Andrew Tsai with Jefferies. Lin Tsai: Thanks for the update. So I think you guys are in a very unique position to be the leader in the psychedelic space. So to maintain that leadership over the next year, what is your appetite like to do even more studies with COMP360 outside of PTSD and so forth? And any new indications or other new psychedelics we can hear about? Or is the expectation for us to be focused on the launch itself? Kabir Nath: Thank you for the question, Andrew. So yes, the expectation should be to be focused on the launch, at least for now. Clearly, as a new company with our first asset, we have a team that's working incredibly hard on the submission. But more than that, as I said in the prepared remarks, on a first pass approval because submitting is something, but this needs to be a really robust dossier. We are the leaders, you can imagine, from a quality perspective, from inspections and so on. All of this is brand new to the agency. So we really are very, very focused on not only a real robust submission, but also doing our best to get that first pass approval. You've heard a lot from Lori, and we'll continue to hear a lot more about the preparations and so on that side. the PTSD study is now underway. I think the way we think about this is as we move through what we hope is an expected approval and launch, absolutely, we will continue to look at other opportunities for COMP360. There are clearly some very interesting areas. There is a lot of interest, obviously, in substance use disorder with AUD in particular, at the forefront of that, given the size of that as a public health issue. And potentially more broadly, what other assets there may be out there as well. But in the short term, you should take us to be very, very focused on this submission, approval, and launch process for TRD. Lori Englebert: And Andrew, if you don't mind, I'll just add a couple of things there to help add a little more color. So consistent with what Kabir mentioned, we have supplied study drugs to an enormous amount of IIS studies. And so we will be looking through those to understand where the potentials may lie if that becomes an option for us with COMP360. And at the same time, we're also going to be collecting a lot of real-world evidence to really understand more about patient populations that may be responding well to COMP360. We will be attacking this on all fronts in terms of understanding what would be the next viable indication. Kabir Nath: Actually, yes, just, sorry, I should have said that, Lori, to build on that. We had taken a pause for a couple of years on our IIS. As we've said, we have supplied a lot of drug for a number of indications. We are now ramping that up again. So we actually have a number of IIS starting in areas such as OCD, which I think is potentially very interesting area. So that now, as we're getting closer to the regulatory finish line for TRD, we're actually restarting our IIS programs. Operator: Your next question is from the line of Madison El-Saadi with B. Riley. Madison Wynne El-Saadi: Maybe I'll ask on REMS certification. If you could just kind of help us understand that process, if this is something that's molecule-specific. And can sites proactively progress that process before DEA rescheduling takes place? Or is that something that happens sequentially? And then secondly, if I may, are you continuing to collect safety data or safety follow-up data? Or has the full safety data package been submitted? Kabir Nath: So I'll take the second part first and hand back to Lori. So both studies run to 52 weeks. So we will ultimately be providing the full 52-week safety data to the agency. Right now, obviously, with the 26-week data from 006 in hand, our core focus now in terms of preparing the submission is really integrating the safety from the 26 weeks blinded of both studies into an integrated summary, and that's clearly a key area of focus for us. But ultimately, the agency in the process of review will see the 52 weeks of data as well. Lori Englebert: Yes. Hi, Madison, I'll take your first question around REMS. So as you know, the REMS will not be finalized until we receive approval. And so -- because of that, we will only be able to go out and start ensuring that sites are aware of any REMS requirements, and going through the process for certification once we receive the approval. And as I mentioned earlier, as it stands now, we're going to do everything we possibly can in between the time of approval and DEA rescheduling to make sure that these sites are well prepared to administer the product when it becomes available. Operator: Your next question is from the line of Judah Frommer with MS. Judah Frommer: Just wanted to ask on the post hoc analysis you mentioned in the release on the 80% of administration sessions for the Phase IIb and PTSD being in silence. Any thoughts on how that could impact monitoring, whether it's for TRD or PTSD, and potentially staffing requirements going forward? Kabir Nath: Yes, let me start and then Lori will build on that. So Yes. I mean I think to us, it's very interesting data and really very much validates the point we've been making for a fair amount of time now that a psilocybin experience specifically truly is an inner directed one where the patient is largely leading the experience. And the role of anyone who is sitting with a patient is just for monitoring and for safety in case of need. And we see that very clearly revealed, as we said, with 80% of that being silent. And yes, to your point, that clearly, to our mind, does introduce a broader range of possibilities for who could sit in the room. If indeed, ultimately you need somebody in the room at all. Lori Englebert: Agree. And hi, Judah. The only thing I'll add there is in the near term, in terms of when we receive the REMS, there will be a requirement for a minimum of 6 hours. That is consistent with our clinical trial. And the label or the REMS requirement for who sits in the room will and should be -- or we expect to be fairly broad in terms of a health care provider. And that is consistent with what Spravato is now. And as you probably already know, Spravato has found ways to become very efficient with their rooms and how they monitor. Of course, our most important requirement is going to be safety for the patient during this experience. And so we will not lose sight of that. But sites, after getting clinical experience, will learn how and who to put into the room to help these patients. Operator: Your next question is from the line of Patrick Trucchio with H.C. Wainwright. Arabella Caroline Ng: It's Arabella on for Patrick. I guess, for the PTSD trial, do you have any updates on site activation, enrollment cadence, target size, expected readout timing, or VA involvement that you can share? Kabir Nath: So other than the trial is underway, nothing in terms of enrollment and so on. The trial is 300 patients in total across 3 arms. There are going to be a number of VA sites enrolled in that. I can't give the specifics on that. What we are doing, though, is in line with the overall percentage of PTSD patients within the population where, shall we say VA or military related are not more than 15%. We're capping patient numbers at that out of the 300. But yes, it is underway. And yes, it's a 300-patient trial. Operator: Your next question is from the line of Leonid Timashev with RBC CM. Unknown Analyst: Josh on for Leo here. So with the physician discretion coming after the 1 to 2 recommended doses for COMP360. Given that you've been doing these surveys of psychiatrists, what kind of feedback might you have been hearing from docs on expected dosing schedules? And how widely might that feedback have varied? Lori Englebert: Yes. Hi, Josh. Thanks for the question. The surveys that we're doing are based on a product profile of COMP360 and what we've seen through our Phase III clinical trials. Then, as I mentioned in my remarks, what we're seeing is an overwhelming response to willingness to prescribe. And not only am I seeing numbers I've never seen before in my career. But even the facilitators of the market research are saying the exact same thing. They've never seen numbers that high in terms of willingness to prescribe. These -- the reason that this is so exciting for physicians right now is truly because of the TRD patient population. TRD patient population, again, has 1 product or 1 drug product available to patients right now. And that drug product, although it does work for some patients, can be highly burdensome for patients. And so the dosing frequency becomes a real driver for these physicians and why they're so excited about it. What we -- we have not heard any hesitancy around that. And to be honest with you, it's going to be incumbent upon the sales team and our field teams to really help educate based on all the additional data that we will have available on what that frequency of dosing may look like. Operator: Your next question is from the line of Sumant Kulkarni with Canaccord Genuity. Sumant Kulkarni: It's a 2-parter from a value proposition perspective, what's the best way one could place COMP360's time in clinic in context versus products that might promise a 2-hour or less duration in the clinic? And from a competitive perspective, what are your assumptions on whether there might be another FDA approved psilocybin molecule within the first year of approval of COMP360? Kabir Nath: Thanks for the question, Sumant. So I think as we have often said, duration in clinic is only one element of a product profile, yes. And I think from the perspective of the patient and the provider experience, it's not necessarily going to be the primary driver. Clearly, there's an efficacy and safety bar that's got to be cleared for any asset. But we actually do believe that the nature of the psilocybin experience is something that is inherently attractive to patients and providers. Also, as we've discussed in the past, even on an economic basis as long as there remains capacity in the system, there is actually not a good economic argument for why shorter is better in terms of the ability to generate revenue per room, so and such. Operator: Your next question is from the line of Rudy Li with Wolfe Research. Guofang Li: Just a quick follow-up to the market dynamic. So apparently, there are a lot of discussion on short duration versus long duration psychedelics following the Lilly deal. So maybe in 5 years, we have a couple of options, different compounds, different duration, maybe different indications. So a very exciting time, but maybe talk about your understanding of the market dynamic with multiple psychedelic options and the positioning of COMP360 in the broader psychiatry space, depression, anxiety. Lori Englebert: Yes. Hi, Rudy. So the good news is that psychedelics continue to produce very robust, very exciting data. And part of the reason why you were seeing these clinics, these Spravato certified clinics, who are enabled to support these multi-hour treatments, is because the -- this is a very exciting time for the field of mental health. And so they are growing very fast, and they're growing in anticipation of additional options being available. These products don't work for everyone. And there are 4 million -- at least 4 million patients who are underserved today, and not being treated with an interventional treatment like a Spravato or an ECT or a TMS that is indicated and has shown and proven efficacy in this patient population. And so these centers, regardless of duration. And because we have repeatedly talked about the economics not being a driver, it is really going to come down to patient preference in terms of what a patient starts, provider experience in terms of what that patient has to go through or what that site has to deal with when a patient is having their experience. And let's not forget that we're going to be on market potentially be on market first, and so we will have continued time to establish the leadership position that we are in, and we'll get some proven clinical efficacy while we're out there. In terms of economics for the sites, and I'll just double down on what Kabir said earlier, we have -- with our strategic collaboration partners, as well as outside of that through our medical science liaisons. We are not finding anyone bringing up the fact that this is a longer treatment than the shorter acting as being a prohibiting factor to prescribing. Kabir Nath: For those of you wondering, we have allowed him to go on vacation. Lori Englebert: Steve is on vacation. Missed very much. Operator: Next question is from the line of Jay Olson with Oppenheimer. Jay Olson: Congrats on all progress. Maybe a big picture question, recognizing that the company is acutely focused in the near term on the approval and successful launch of COMP360. Looking ahead to after you've accomplished that objective in the next year or 2, what will become the next major strategic priority for the company? Kabir Nath: Thank you. So PTSD clearly is a strategic priority for us. So that study is underway, and we see that as a very important second indication. As we mentioned to earlier answers, we will -- we clearly have very interesting signals in a wide range of psychiatric conditions, and we will prioritize some of those to move forward. We will, at some point, we have always been clear, from an ex U.S. perspective, we will probably likely need to partner. But that's something that we will address once we have U.S. approval in hand. And then I think more broadly, this is a space where you continue to see a lot of innovation now with psychedelic assets and so on. We would see ourselves as a leader with hopefully a successful launch under our belt, potentially being in a position to play a role in that and seeing what other assets may be available. Operator: Your next question is from the line of Ben Burnett with Wells Fargo. Benjamin Burnett: I also want to ask about your efforts just to prepare and to train sites ahead of commercial adoption. Specifically, can you talk about what are your target sites? It's our understanding that the interventional psychiatry footprint sort of offerings for Spravato today is pretty expansive with some sites associated with the university hospitals, others may be more suburban. So I guess, can you just talk to your strategy here and which centers do you plan to target initially and offer training to initially? Lori Englebert: Ben, thanks for that question. So as I mentioned in the remarks, and it's pretty widely known, there are about 8,000 sites right now. This number has grown dramatically quarter-over-quarter, where it looks about adding about 500 per quarter at least. And again, that goes to just the excitement of potential additional options coming to market. The easiest way to answer you is we are going to have a field team that is out calling on all of these sites. They will be making sure that they cover all 8,000 sites to make sure that these sites, if they have a willingness to prescribe COMP360, that they are well educated and well trained, and prepared to prescribe this product. We are also going to call on physicians that may be in the system with a high number of TRD patients who are serving as referrers to these sites that can administer these products as well. So our target list will be quite extensive at launch, and comprehensive. The other thing I think we're finding as we do some of our work is that the dosing profile of COMP360 and the potential dosing profile of COMP360 lends itself to a wider radius. So to your point earlier, if some of these are quite suburban, coming in for a once a week or every other week treatment, like those that are currently available, becomes quite difficult for someone within a certain radius of a treatment center. Even though these centers are growing very rapidly, there are still some patients who need to drive quite a way to access one of these treatment centers. With an infrequent dosing like COMP360 proposes, this does open up that ability quite a bit. Operator: We have reached the end of the Q&A session. I will now turn the call back to management for closing remarks. Please go ahead. Kabir Nath: Thank you very much all for attending. As you've heard, the first 6 months, or I guess the first 6 months and 1 week of this year, have been a very exciting and very productive time for COMPASS. With the Phase III data now, both the primary endpoints, very statistically significant positive primary endpoints from both studies, and now the 26-week data from both studies confirming the profile of COMP360 as a compelling, differentiated profile that truly can serve to meet huge unmet needs in treatment-resistant depression. So we're focused on execution. We're very happy with the process of the rolling review. As I said, we're preparing not just to finalize that, to fulfill that with that expected to complete in the fourth quarter. But really ensuring it's a really high-quality dossier so we get a first-pass approval. And as you've heard from Lori, there's activity across an extraordinary range of fronts on the commercial side to be ready for launch. So we look forward to keeping you updated on our progress on both of these major work streams through the end of this year. So thank you again. It is a very exciting time for patients with TRD. Thank you. Operator: This concludes today's call. Thank you for attending. You may now disconnect. Before you buy stock in Compass Pathways, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Compass Pathways wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $403,337!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,334,946!* That performance is why people listen. With a track record of beating the S&P 500 by 4x, Stock Advisor offers a distinct advantage. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built for the long haul. See the 10 stocks » *Stock Advisor returns as of August 12, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. COMPASS Pathways (CMPS) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

This article first appeared on GuruFocus. Cash Position: $433 million in cash on hand as of June 30, 2026, expected to fund operations through launch and into 2028. Regulatory Milestone: Rolling NDA submission for COMP360 in treatment-resistant depression (TRD) underway; completion expected in the fourth quarter of 2026. Commercial Readiness: Commercial leadership team fully hired, with direct reports from companies like J&J, Gilead, and others, collectively leading over 70 product launches. Strategic Collaborations: Total of eight strategic collaborations announced, including new partnerships with Radial and Ozmind in the first half of 2026. Market Opportunity: Targeting approximately 4 million patients living with TRD in the U.S. Prescriber Demand: Approximately 90% of interventional psychiatrists indicated willingness to prescribe COMP360 within the first year of availability. Launch Timeline: Anticipated launch in the first half of 2027, subject to FDA approval, DEA rescheduling, and other regulatory factors. Warning! GuruFocus has detected 1 Warning Sign with CMPS. Is CMPS fairly valued? Test your thesis with our free DCF calculator. Release Date: August 05, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Compass Pathways PLC (NASDAQ:CMPS) reported highly statistically significant positive Phase 3 primary endpoint readouts and demonstrated durability through six months in both trials, largely de-risking the clinical and regulatory profile of COMP360. The company is making significant progress toward its NDA filing for treatment-resistant depression (TRD), with a rolling submission underway and an expected completion in the fourth quarter, potentially leading to accelerated approval. Compass Pathways PLC (NASDAQ:CMPS) has a strong balance sheet with $433 million in cash as of June 30, 2026, which is expected to carry the company through launch and into 2028. The commercial team is highly experienced, with direct reports from companies like J&J, Gilead, and Otsuka, collectively having led over 70 product launches, and market research shows approximately 90% of interventional psychiatrists would prescribe COMP360 within the first year of availability. The company is leveraging an established infrastructure of over 8,000 interventional psychiatry treatment centers in the US, which are already equipped for multi-hour treatments, potentially facilitating a smoother and faster launch compared to previous products like Spravato. Compass Pathways PLC (NASDAQ:CMPS) is advancing strategic collaborations (now totaling eight) and has initiated recruiting for the field force, demonstrating proactive steps toward launch readiness and operationalizing launch plans. The launch timeline for COMP360 remains fluid due to the National Priority Review Voucher, Executive Order, and the need for federal DEA and state rescheduling, with an anticipated launch in the first half of 2027, creating potential delays. The FDA's finalized psychedelic guidelines, which discuss 12-month blinded durability, could pose a challenge for future programs, although management believes it won't impact the current regulatory process for TRD. Reimbursement challenges are expected at launch, as is typical for new drugs, and the company is still working through payer negotiations and value proposition data, which could affect early adoption and revenue. The REMS (Risk Evaluation and Mitigation Strategy) requirements will not be finalized until approval, and site certification for REMS can only begin after approval, potentially limiting the time available to prepare sites before the product becomes available. The company is currently focused on the TRD launch and has not yet prioritized other indications, with the PTSD study still in early stages and no clear timeline for enrollment or readout, limiting near-term pipeline diversification. There is potential competitive pressure from other psychedelic products with shorter in-clinic durations, which could impact patient and provider preferences, although management argues that duration is not the primary driver of choice. Q: Could you offer perspective on the recently issued FDA guidelines around psychedelics, specifically regarding the discussion of 12-month blinded durability and how that relates to the COMP360 program? A: Kabir Nath (CEO): The guidance is a finalization of draft guidelines that came out after we had fully designed our Phase III trials in alignment with the agency. While the 12-month blinded durability requirement would be a tall order for any psychiatry drug, we don't think it will impact our current regulatory approval process. The guidance's design for Phase III studies and complementary pairs is effectively in line with our study designs. We will carefully consider the guidance for future endeavors, but do not expect it to impact the regulatory process already underway. Q: Can you help us understand the reimbursement challenges and what we will have to go through to get a better feel for the launch cadence expected next year? A: Lori Englebert (Chief Commercial Officer): Our market access team is already engaging with payers and receiving very positive feedback, especially given the TRD patient population where proving efficacy has historically been difficult. Payers understand the economic burden of TRD. At launch, we intend to have a field reimbursement team fully deployed to help sites with coding and reimbursement education. We are still incorporating the recent Phase 3 data into our value proposition and will make decisions on rebating and payer negotiations for formulary access closer to launch. Q: How are ongoing regulatory discussions progressing, and what are your expectations for DEA scheduling timelines? A: Kabir Nath (CEO) & Lori Englebert (CCO): The rolling submission is well underway, with some modules already under FDA review. We are responding quickly to questions and remain on track to complete the NDA filing in Q4. Regarding rescheduling, we are accelerating our eight-factor analysis to the FDA and DEA. The DEA has historically been consistent in hitting their 90-day timeline, and given the April Executive Order, we are confident in the ability to potentially pull that timeline forward. Q: What aspects of training does the team plan to offer interventional psychiatry sites, and how does that impact the 2027 rollout? A: Lori Englebert (CCO): Training is divided into two parts. We are participating in grants for third-party companies to train sites on psychedelics, with over 1,000 people already trained. The COMP360-specific training on patient support will come after the final label is determined. We will also train on REMS compliance. We will leverage the time between approval and DEA rescheduling to have teams help sites understand REMS requirements. Site readiness will be a key KPI we communicate on, and we are focused on ensuring a very good patient experience to maintain our leadership position. Q: What is your appetite to do more studies with COMP360 outside of PTSD, and what other new indications or psychedelics can we expect? A: Kabir Nath (CEO) & Lori Englebert (CCO): The expectation should be to focus on the launch for now. The PTSD study is underway, and we will continue to look at other opportunities for COMP360, including substance use disorder with AUD at the forefront. We have supplied study drugs to many investigator-initiated studies (IISs) and are ramping that program back up, with new IISs starting in areas such as OCD. We will also collect real-world evidence to understand which patient populations respond well to COMP360. Q: Can you help us understand the REMS certification processis it molecule-specific, and can sites proactively progress before DEA rescheduling? Also, are you continuing to collect safety data? A: Kabir Nath (CEO) & Lori Englebert (CCO): The REMS will not be finalized until approval, so sites can only begin certification after that. We will do everything possible between approval and DEA rescheduling to prepare sites. Both Phase 3 studies run to 52 weeks, so we will provide full 52-week safety data to the agency. Our current focus is integrating the 26-week blinded safety data from both studies into an integrated summary for submission. Q: Regarding the post-hoc analysis showing 80% of administration sessions in silence, how could that impact monitoring and staffing requirements? A: Kabir Nath (CEO) & Lori Englebert (CCO): The data validates that a psilocybin experience is inner-directed, with the patient largely leading the experience and the sitter's role being for monitoring and safety. This introduces a broader range of possibilities for who could sit in the room. In the near term, the REMS will require a minimum of six hours of monitoring, consistent with our clinical trials. We expect the requirement for who sits in the room to be fairly broad in terms of healthcare providers, similar to Spravato, while maintaining patient safety as the top priority. Q: Do you have any updates on the PTSD trial regarding site activation, enrollment cadence, target size, expected readout timing, or VA involvement? A: Kabir Nath (CEO): The trial is underway with 300 patients across three arms. There will be a number of VA sites enrolled, but we cannot provide specifics. We are capping VA or military-related patients at no more than 15% of the 300, in line with the overall PTSD population. Q: With physician discretion coming after the one to two recommended doses for COMP360, what feedback have you heard from doctors on expected dosing schedules? A: Lori Englebert (CCO): Surveys based on the COMP360 product profile show an overwhelming willingness to prescribe, with numbers higher than any of us have seen in our careers. The excitement is driven by the TRD patient population, which has limited options and finds current treatments burdensome. Dosing frequency is a real driver for physicians, and we have not heard any hesitancy around it. Our sales and field teams will educate on the frequency of dosing based on additional data. Q: From a value proposition perspective, how should we place COMP360's time in clinic versus products with shorter durations, and what are your assumptions on another FDA-approved psilocybin molecule within the first year? A: Kabir Nath (CEO): Duration in clinic is only one element of a product profile and is not necessarily the primary driver for patients and providers. The nature of the psilocybin experience is inherently attractive. Even on an economic basis, as long as there is capacity in the system, there is no good economic argument for why shorter is better in terms of revenue per room. We believe being first to market will allow us to establish a leadership position with proven clinical efficacy. Q For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in Compass Pathways PLC Sponsored ADR? Here are five stocks we like better. Compass Pathways remains on track to file for FDA approval of COMP360 for treatment-resistant depression in Q4 2026, using a rolling NDA submission after positive Phase III results and six-month durability data. The company is targeting a potential commercial launch in the first half of 2027, contingent on FDA approval and federal and state DEA rescheduling. Commercial preparations include hiring sales leadership, recruiting a field force, expanding partnerships and engaging payers. Compass reported $433 million in cash as of June 30, which management expects to fund operations through launch and into 2028, while its Phase III PTSD trial and additional investigator-initiated studies continue. These 3 Psychedelic Stocks Activated After Trump's Executive Order Compass Pathways (NASDAQ:CMPS) said it remains on track to complete its new drug application, or NDA, filing for COMP360 in treatment-resistant depression in the fourth quarter of 2026, following positive Phase III results and six-month durability data from two trials. Chief Executive Officer Kabir Nath said the company believes the clinical and regulatory profile of COMP360 has been “largely de-risked” after the studies met their primary endpoints with high statistical significance. He said the program has shown rapid onset, durability through six months and what the company characterized as a generally well-tolerated safety profile. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control This 4/20, Wall Street Is Betting on More Than Marijuana COMPASS is using a rolling NDA submission process, under which the Food and Drug Administration has begun reviewing modules already submitted, Nath said. The company is seeking approval for COMP360 in treatment-resistant depression, or TRD, and continues to expect its final filing in the fourth quarter. Management said it does not expect recently finalized FDA guidance on psychedelic drug development to affect the ongoing review of COMP360. Responding to a question about the guidance’s discussion of 12-month blinded durability data, Nath said COMPASS had maintained dialogue with the FDA throughout the program and that the complementary design of its two Phase III studies aligns with the guidance. → 3 Drone Stocks That Should Soar After the Summer Slump Magic Mushrooms, Hard Cash: Compass Pathways’ Trial Win, Fast Raise “We honestly do not think that these guidelines are going to impact the regulatory process that’s already underway for us,” Nath said. The company said it is working toward potential accelerated approval and is preparing for a first-pass approval. Nath said the company has received questions on submitted portions of the NDA and is responding quickly, adding that discussions on labeling and a Risk Evaluation and Mitigation Strategy, or REMS, typically occur later in the review process. → The Bitcoin Comeback May Already Be Underway—2 ETFs for Exposure Chief Commercial Officer Lori Englebert said COMPASS is accelerating its eight-factor analysis for submission to the FDA’s controlled-substances division and is seeking additional clarity from the Drug Enforcement Administration on rescheduling. She said the company expects the DEA to reschedule within its customary 90-day period, though the exact timing remains fluid. COMPASS expects a potential launch in the first half of 2027, although management said the timing will depend on FDA review, federal DEA rescheduling and state-level rescheduling actions. Englebert said COMPASS has completed hiring its commercial leadership team and has begun recruiting for a sales force. She said her direct reports include executives from companies including Johnson & Johnson, Gilead, Otsuka and Axsome, and collectively have led more than 70 product launches. The company has also expanded strategic collaborations with Radial and Osmind, bringing its total number of collaborations to eight. Englebert said the partnerships are intended to support site and patient experience as COMPASS prepares for commercialization. COMPASS plans to use existing interventional psychiatry treatment centers, which support in-office treatments requiring multi-hour monitoring. Englebert said there are more than 8,000 such sites in the United States, including centers that provide treatments such as Spravato, transcranial magnetic stimulation and electroconvulsive therapy. The company plans to deploy a field team across those sites and also target referring physicians who treat large numbers of patients with TRD. Management said COMP360’s proposed infrequent dosing could potentially expand access for patients who live farther from treatment centers. On reimbursement, Englebert said the company’s market-access team has been engaging with payers and has received positive feedback regarding the burden associated with treatment-resistant depression. At launch, COMPASS intends to have a field reimbursement team in place to help treatment sites navigate coding and reimbursement processes. Management said it will determine potential rebate arrangements and payer negotiations closer to launch as it incorporates recently released data into COMP360’s value proposition. Englebert said COMPASS views site preparation as consisting of both training and education. The company is participating in grants to third-party organizations that train sites in psychedelic treatments, and said more than 1,000 people have already received psychedelic-focused training. Training specific to COMP360 and the final monitoring requirements will follow final labeling, she said. Sites will also require REMS-related training and certification once the FDA approves the product and finalizes the REMS program. Management said it expects to use any period between FDA approval and DEA rescheduling to help sites prepare for product administration. Englebert said the company expects a minimum six-hour monitoring requirement based on the clinical trial protocol and anticipates that the individual monitoring patients could be broadly defined as a healthcare provider, subject to the final REMS. Nath also discussed a post-hoc analysis showing that 80% of administration sessions in the company’s Phase IIb and PTSD work were conducted in silence. He said the finding supports the company’s view that psilocybin is an “inner-directed” experience and could broaden the range of personnel who may be able to monitor patients in the future. While the company’s near-term priority is completing the TRD submission, securing approval and launching COMP360, Nath said COMPASS is continuing its Phase III PTSD study. The trial is underway and is designed to enroll 300 patients across three arms, including a number of Veterans Affairs sites. Management said military- or VA-related participants will be capped at no more than 15% of the study population. COMPASS also said it is restarting its investigator-initiated study program, with studies beginning in areas including obsessive-compulsive disorder. Nath cited alcohol use disorder and other psychiatric conditions as potential future opportunities but said the company remains focused on the TRD launch process in the near term. The company reported $433 million in cash as of June 30, which Nath said is expected to fund operations through launch and into 2028. Compass Pathways (NASDAQ: CMPS) is a clinical-stage biotechnology company focused on the development and commercialization of psilocybin therapy for mental health disorders. Founded in 2016 and headquartered in London with additional offices in the United States, Compass Pathways is pioneering the use of synthetic psilocybin combined with psychotherapy to address treatment-resistant depression. The company’s flagship program is a Phase IIb clinical trial evaluating COMP360, its proprietary psilocybin formulation, which has received Breakthrough Therapy designation from the U.S. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Compass Pathways Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Data from two positive Phase 3 trials demonstrated rapid onset of effect and durable benefit through at least 6 months, further validating COMP360’s potential to establish a new standard of care in TRD COMP360 has a highly differentiated clinical profile and is expected to be a blockbuster opportunity, if approved Rolling NDA submission and initial review underway and final submission expected to be completed in Q4 Commercial launch expected in first half of 2027 COMP360 expected to fit seamlessly into current treatment infrastructure Late-stage PTSD trial underway Strong cash position of $433 million at the end of second quarter, providing cash well beyond launch and into 2028 Compass management will host a conference call on August 5 at 8:00 am ET LONDON & NEW YORK, August 05, 2026--(BUSINESS WIRE)--Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care, today reported the second quarter and first half 2026 financial results and business highlights. "The first half of 2026 marked a defining period for Compass as we continued to build momentum across clinical, regulatory and commercial fronts in preparation for the potential approval and launch of COMP360," said Kabir Nath, Chief Executive Officer of Compass Pathways. "Over the past six months, we have strengthened – and further validated – the consistent evidence supporting COMP360’s transformative potential, expanded our commercial readiness capabilities, deepened engagement across the treatment ecosystem, and advanced our rolling submission in support of a regulatory filing in Q4. Our focus now is on disciplined execution - completing our filing activities and ensuring we are ready to deliver COMP360 to patients with TRD as quickly as possible, if approved. Our conviction in the potential of COMP360 has never been stronger. We are well positioned, confident in our ability to execute, and committed to bringing this transformative new treatment option to patients." Business Highlights COMP360’s Highly Differentiated Profile as Demonstrated in First Half 2026 Rapid onset, sustained durability and infrequent dosing: COMP360 is leading a profound shift in the development of new treatment options in mental health care – moving beyond daily or frequent administration toward an option that could potentially provide strong efficacy with just a few treatments a year that could be life changing for patients Across two highly statistically significant positive Phase 3 trials, COMP360 is the first classic psychedelic1 to consistently demonstrate rapid onset, sustained durability and reproducibility of effect in TRD, one of the most difficult psychiatric conditions in which to demonstrate efficacy Generally well tolerated and safe profile: COMP360 demonstrated a generally well-tolerated and safe profile, with the vast majority of treatment-emergent adverse events (TEAEs) being transient and predominantly occurring on day of dosing Serious adverse events (SAEs) were low overall across both trials A blockbuster opportunity: Robust data from late-stage trials involving more than 1,000 participants living with TRD supports COMP360’s potential to establish a new standard of care in TRD Approximately 4 million individuals in the US live with TRD4, with only one marketed medicine that has captured <3% market share COMP360 offers a highly differentiated clinical profile and is expected to be a blockbuster opportunity New evidence distinguishes COMP360 monitoring & support from psychotherapy: Peer-reviewed post-hoc analysis published in the Journal of Psychopharmacology, demonstrates that monitoring and support in COMP360 Phase 2b PTSD treatment sessions were minimal and non-directive with almost 80% of the administration session spent in silence, providing evidence that clinical outcomes are attributable to the COMP360 psilocybin treatment experience These findings are consistent with the standardized monitoring-and-support approach used across the COMP360 clinical development program, including the TRD trials Regulatory Path Towards Approval Final New Drug Application (NDA) submission on track for Q4: In April, the U.S. Food and Drug Administration (FDA) granted Compass NDA rolling submission and review request, based on strength of positive Phase 3 data Rolling submission and initial review are underway, with some modules of the NDA submitted and on track to complete all modules in Q4 Support and momentum: National Priority Voucher (NPV) awarded for COMP360, Compass’ proprietary formulation of synthetic psilocybin for TRD, which has the potential to accelerate filing review time to be completed within 1-2 months White House Executive Order on psychedelics treatments directs the Drug Enforcement Administration (DEA) to initiate and complete review of psychedelic treatment that has successfully completed Phase 3 trials so that rescheduling may proceed as quickly as possible Progressing Toward Potential Commercial Launch in First Half 2027 During the first half of 2026, Compass advanced key commercial readiness initiatives across organizational capabilities, strategic collaborations, policy engagement and infrastructure, positioning Compass for successful launch execution. Second half 2026 efforts are centered on operationalizing launch plans and ensuring launch readiness, with commercial launch expected in first half of 2027, subject to FDA approval and following Drug Enforcement Administration (DEA) rescheduling. Advanced launch readiness efforts: Highly experienced leadership team in place Continued proactive engagement with state-level stakeholders to facilitate timely post-approval rescheduling; currently, approximately 90% of the U.S. patient population live in states that intend to reschedule within 30 days after Federal DEA Expanded strategic collaborations, with the addition of Radial and Osmind in the first half of 2026. Compass’ collaboration portfolio continues to inform key elements of the COMP360 treatment ecosystem including patient care pathways, patient and provider experience, support staff training, site economics, real-world initiatives and treatment model optimization Delivery infrastructure readiness: COMP360 is expected to fit seamlessly across diverse healthcare settings within current infrastructure of more than 8,000 centers3 offering multi-hour treatments Treatment centers are growing rapidly, and existing centers are already scaling in anticipation of a COMP360 launch and additional multi-hour psychedelic treatments coming to market At approval, focus will be on site preparedness – including training, education, REMS certification, assistance with reimbursement and patient support COMP360 PTSD Program Compass continues to progress PTSD program, with late-stage trial underway. Affecting 13 million people in the U.S. each year, PTSD remains an underserved condition and underscores the urgent need to advance care for patients experiencing this debilitating condition. Financial highlights Research and development expenses were $29.2 million and $55.7 million for the three and six months ended June 30, 2026, respectively, compared with $30.3 million and $61.2 million during the same periods in 2025, respectively. The decrease was primarily driven by lower development expenses, reflecting reduced clinical trial costs as our Phase 3 program for COMP360 psilocybin therapy in TRD progresses toward completion, as well as reduced discovery program expenses following the termination of certain programs in connection with the reorganization that took place in the fourth quarter of 2024 and the related contract terminations in 2025. This decrease was partially offset by an increase in facilities and other expenses primarily due to an increase in external consulting fees and contractors. General and administrative expenses were $23.2 million and $39.6 million for the three and six months ended June 30, 2026, respectively, compared with $12.6 million and $31.3 million during the same periods in 2025, respectively. The increase was primarily due to increased costs to support our commercial preparedness activities. Net loss was $253.8 million, or $1.88 net loss per share, and $162.6 million, or $1.33 net loss per share, for the three and six months ended June 30, 2026, respectively, compared with of $38.4 million, or $0.41 net loss per share, and $56.3 million, or $0.62 net loss per share, during the same periods in 2025, respectively. The increase in net loss was primarily driven by non-cash fair value adjustments related to our warrants. The change in fair value was $205.6 million loss and $74.7 million loss, for the three and six months ended June 30, 2026, respectively, compared with $2.5 million loss and $16.9 million gain for the same periods in 2025, respectively. As the fair value of the warrants fluctuates with our share price, this adjustment can result in significant variability in our reported net income or net loss. Cash and cash equivalents were $433.3 million as of June 30, 2026, compared with $149.6 million as of December 31, 2025. Debt was $50.7 million as of June 30, 2026, compared with $31.6 million as of December 31, 2025. Financial Guidance The current cash position is expected to be sufficient to fund operating expenses and capital expenditure requirements into 2028. Conference Call The management team will host a conference call at 8:00 am ET (1:00 pm UK) on August 5, 2026. A live webcast of the call will be available on the Compass Pathways website at: https://events.q4inc.com/attendee/246696001 About Compass Pathways We believe mental health patients deserve the possibility of a better future. Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care. Our initial focus is developing COMP360 psilocybin, a proprietary, investigational, synthetic psilocybin treatment under evaluation for treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). COMP360 is a potentially first-in-class treatment and has Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA), as well as Innovative Licensing and Access Pathway (ILAP) designation in the UK for TRD. We are leading the world’s largest classic psychedelic clinical program in TRD, and building upon that robust foundation, we are executing a late-stage trial evaluating COMP360 for PTSD, another condition with high unmet need. Our goal is to advance treatments that move the field of psychiatry towards treatment options that offer rapid onset and sustained durability with infrequent dosing. Compass is headquartered in London, UK, with a U.S. office in New Jersey. We are driven by our purpose of unlocking pathways to be – opening futures filled with possibility. Together, we are on an ambitious journey toward enabling people living with mental health conditions to find clarity through self-discovery, because every journey needs a Compass. Forward-looking statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as "may", "might", "will", "could", "would", "should", "expect", "intend", "plan", "objective", "anticipate", "believe", "contemplate", "estimate", "predict", "potential", "continue" and "ongoing," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, statements regarding our expectations regarding our financial guidance; our business strategy and goals; our expectations and projections about the company’s future cash needs and financial results; our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment of TRD or PTSD; our plans and expectations regarding our clinical trials, including our phase 3 trials in TRD and our phase 2b/3 trial in PTSD; any implication that preliminary results will be predictive of full safety and efficacy data from our phase 3 program; our expectations regarding the timing of our rolling submission of a new drug application, or NDA, for COMP360 psilocybin treatment in TRD and the timing of the review by the Food and Drug Administration, or FDA, of such NDA, including potential acceleration due to the grant of rolling review and award of a National Priority Voucher for COMP360 psilocybin treatment in TRD; the potential for the pivotal phase 3 program in TRD to support regulatory filings and approvals on an accelerated basis or at all; our expected timing of our commercial launch for COMP360 psilocybin treatment in TRD, if approved by the FDA, including the timing and substance of decisions by the U.S. Drug Enforcement Administration, or the DEA, and states to reschedule COMP360 psilocybin treatment, if approved by FDA, which contains Schedule I controlled substances and must be rescheduled before commercializing COMP360 psilocybin in the U.S,; our efforts and our ability to obtain regulatory approval and adequate coverage and reimbursement; our ability to grow our organization and transition from a clinical-stage to a commercial-stage organization and effectively launch a commercial product, if regulatory approval is obtained; our expectations regarding market adoption and commercial potential for COMP360; and our expectations regarding the benefits of our investigational COMP360 psilocybin treatment, including as a treatment of TRD or PTSD. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Compass’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: uncertainties associated with risks related to clinical development which is a lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; the full results and safety data from our Phase 3 clinical trials in TRD may not be consistent with the preliminary results to date; our need for additional funding to achieve our business goals and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our clinical trials; that the rolling review process and/or the National Priority Voucher pilot program may not actually lead to a faster FDA review or approval process; our efforts to obtain FDA approval, or approval from regulatory authorities in other jurisdictions for our investigational COMP360 psilocybin treatment on an accelerated basis, or at all, may be unsuccessful; the timing and substance of decisions by the Drug Enforcement Administration and states to reschedule COMP360 psilocybin treatment, if approved by FDA, which contains Schedule I controlled substances and must be rescheduled before commercializing COMP360 psilocybin in the U.S.; our efforts to commercialize and obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; the risk that, if approved, our COMP360 psilocybin treatment may not achieve an adequate level of acceptance by payors, health technology assessment bodies, healthcare professionals, patients and the medical community at large and market adoption may be limited; the risk that our strategic collaborations will not continue or will not be successful; and our ability to retain key personnel; and those risks and uncertainties described under the heading "Risk Factors" in Compass’s most recent annual report on Form 10-K or quarterly report on Form 10-Q, and in other reports we have filed with the U.S. Securities and Exchange Commission ("SEC"), which are available on the SEC’s website at www.sec.gov. Except as required by law, Compass disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Compass’s current expectations and speak only as of the date hereof. References For the definition of classic psychedelic, see Vollenweider, F.X. and Smallridge, J.W., 2022. Classic psychedelic drugs: update on biological mechanisms. Pharmacopsychiatry, 55(03), pp.121-138 Montgomery-Åsberg Depression Rating Scale www.spravatohcp.com/find-treatment-center – data pulled 07/31/2026 Wing V, et al. Poster S97 Contemporary Estimate of the National Prevalence of Treatment-Resistant Depression in the United States. Presented at ADAA 2026 Enquiries Media: Dana Sultan-Rothman, [email protected] Investors: Stephen Schultz, [email protected], +1 401 290 7324 View source version on businesswire.com: https://www.businesswire.com/news/home/20260805927238/en/ Contacts Enquiries Media: Dana Sultan-Rothman, [email protected] Investors: Stephen Schultz, [email protected], +1 401 290 7324

Find winning stocks in any market cycle. Join 7 million investors using Simply Wall St's investing ideas for FREE. Recent attention on COMPASS Pathways (CMPS) centers on its first quarter 2026 earnings and a series of key regulatory steps for COMP360 in treatment resistant depression, including a rolling FDA New Drug Application and priority review voucher. See our latest analysis for COMPASS Pathways. The recent regulatory milestones and stronger than expected Q1 2026 earnings have arrived alongside sharp share price swings, with a 30 day share price return of 84.7% and a 1 year total shareholder return of 168.86% contrasting with weaker 5 year total shareholder returns. This suggests that momentum has recently picked up from a low base. If you are interested in how other healthcare focused AI opportunities are trading around key data or regulatory events, now could be a good time to scan the market using the 34 healthcare AI stocks. With the stock up sharply over the past year, a market cap of about US$1.48b, and analysts publishing much higher price targets, the real question now is whether COMPASS Pathways still trades at a discount or if expectations already reflect future growth. The most followed narrative pegs COMPASS Pathways' fair value at $21.92 per share compared to the last close at $10.62, framing the recent rally as only a partial catch up to that view. Read the complete narrative. Want to see what sits behind that revenue ramp and margin lift, and how it links to a rich future earnings multiple? The narrative sets out a detailed earnings path, share count assumptions and a specific discount rate to bridge today’s price to that fair value. Result: Fair Value of $21.92 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, this hinges on COMP360 clearing Phase III and securing FDA approval on current timelines, and on COMPASS avoiding heavier-than-expected dilution to fund operations. Find out about the key risks to this COMPASS Pathways narrative. The narrative leans on future earnings and a rich P/E multiple to argue COMPASS Pathways is 52% undervalued. However, today the stock trades on a P/B of 4.4x versus 2.4x for the wider US Biotechs industry and roughly in line with a 4.4x peer average. That suggests the market already prices in a lot of optimism. Is the gap to the fair value story a margin of safety or a valuation risk? To see how this price level stacks up against what the numbers imply over time, take a closer look at the valuation breakdown in the See what the numbers say about this price — find out in our valuation breakdown.. With the story mixing optimism and concern, this is a moment to move quickly, review the full picture, and weigh both sides for yourself using the 2 key rewards and 3 important warning signs. Do not stop with a single stock. Broaden your watchlist now or you may miss opportunities that better fit your goals and risk comfort. Spot potential value opportunities early by scanning 48 high quality undervalued stocks that balance quality fundamentals with attractive pricing signals. Strengthen your core holdings by reviewing the solid balance sheet and fundamentals stocks screener (45 results) focused on companies with resilient finances and dependable foundations. Hunt for tomorrow's potential standouts with the screener containing 22 high quality undiscovered gems that highlight quality stocks still flying under most investors' radar. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include CMPS. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Image source: The Motley Fool. Wednesday, May 13, 2026 at 8 a.m. ET Chief Executive Officer — Kabir Nath Chief Commercial Officer — Lori Englebert Senior Vice President, Patient Access & Medical Affairs — Steve Levine Senior Vice President, Commercial Operations — Stephen Schultz Need a quote from a Motley Fool analyst? Email [email protected] Kabir Nath: Thank you, Steve, and thank you all for joining us today. It has been a very exciting and productive quarter for COMPASS. The company continues to lead the way in psychedelic science, validated by the confirmation of a rolling NDA submission and review and the award of a Commissioner's National Priority Voucher, or CNPV. With our 005 and 006 data announcement in February, we have delivered positive data from both our Phase III studies. COMP360 has therefore demonstrated what no approved drug for TRD offers, clinically meaningful efficacy with both rapid onset and extended durability. In fact, these extraordinary results redefine rapidity and durability for TRD patients. With only 1 drug approved and actually used for TRD today, we are confident that COMP360 with its differentiated and compelling profile will be an important option for the millions of patients that have been failed by the many approved treatments for MDD. After we announced results of our first positive Phase III trial last year, and based on discussions with the FDA, we began preparing for a potential accelerated launch. As we've said before, we will be launch ready by the end of this year. We've aligned with the FDA on our rolling submission and review plan and have begun submitting modules for the COMP360 NDA. We will continue to submit additional modules on a rolling basis over the coming months. Part B data from 006, which we continue to expect in early Q3, will be the final data set to complete the submission. Given the award of the CNPV, we are already working closely with the FDA to enable as much efficiency and acceleration as possible. In addition, based on the executive order, we are accelerating our engagement with the DEA since there is the potential for federal rescheduling to be completed sooner than the current statutory 90 days post FDA approval. Our 2 large Phase III trials blinded to an unprecedented 26 weeks for psychiatry trials, supported by our large Phase IIb trial, has resulted in over 1,000 patients in the program. With comprehensive and strong preclinical toxicology, safety and CMC data, we are confident that we will have a robust NDA submission that supports a COMP 360 approval. We've also continued to make great progress in our commercial preparedness, which Lori will cover in detail. Our strategic collaborations across diverse settings of care including the interventional psychiatry infrastructure have provided significant learnings. Together with our foresight in establishing CPT3 code, specifically for providers to get fully reimbursed for psychedelic monitoring, this has set us up well for a potential near-term launch. We are ramping up rapidly building out the commercial team with outstanding, highly motivated talent and initiating all activities in anticipation of approval. In addition to TRD, we are also progressing our program in PTSD, which affects 13 million Americans. PTSD is another significant area of unmet need and an opportunity to expand COMP360 to individuals that have few medical options. We believe COMP360 can be an important new treatment for PTSD and it is a very logical next target indication for COMPASS. Our work with the CRO at sites for our late-stage PTSD trial is underway, and we look forward to updating you as it progresses. With both the successful financing and warrant exercises in the first quarter, we have a strong balance sheet with cash that carries us well beyond launch and into 2028. Let me now hand the call to Lori for more on our commercial preparations. Lori Englebert: Thank you, Kabir. Hi, everyone, and thank you for joining. Today, there are 4 million patients with MDD who are considered treatment resistant. Spravato, the only drug indicated and used for TRD, is expected to reach $3 billion in revenue by 2027, and as of 2025 was treating less than 2% of the TRD patient population. We believe that if approved, COMP360 will reach blockbuster potential by offering a transformative new treatment for the millions of patients who deserve more options. As Kabir noted, we are pleased to have been selected for the Commissioner's Prior Review Voucher. One benefit of bad selected for the voucher includes the potential for an ultra accelerated review time line of 1 to 2 months after final NDA submission. This provides helpful clarity on timing expectations and allows for more thoughtful and focused planning efforts. Based on the current time lines for data and submission, we remain focused on being launch ready by the end of the year. Last month, the White House also issued an executive order, recognizing the profound urgency of the mental health crisis facing millions of Americans and the potential impact FDA approved psychedelics could have. In that executive order, timely rescheduling of approved treatments was stated as a priority. As a Schedule 1 product, COMP360 will need to be rescheduled at both the federal and state level after approval in order to be prescribed. We are accelerating work with the DEA to ensure rescheduling at the federal level goes as rapidly as smoothly as possible. We have also been working at the state level for the past 2 years to ensure that the states follow the federal rescheduling decision in a timely manner. Over the past 2 years, we have made significant progress. And today, almost 90% of the U.S. population live in a state that intends to reschedule COMP360 within 30 days after FDA approval and DEA rescheduling. Through this work, we have markedly reduced the time line to launch and for patients to access COMP360 after approval. Enabling broad and equitable access includes ensuring that both COMP360 and provider monitoring time are adequately reimbursed. Kabir mentioned earlier, the work we did a few years ago on securing psychodelic-specific CPT3 codes, which will ensure that sites are reimbursed fully for the time required for psychodelic treatment monitoring. These codes are billable by the hour and were designed to cover clinical work and practice expenses incurred with multi-hour psychedelic treatments. We are also accelerating reimbursement and formulary discussions for COMP360 60 with payers. TRD has a significantly greater impact on individuals' lives and accounts for a disproportionate share of health care costs versus MDD. TRD patients accrued 62% more mental health care costs and experienced 41% higher work-related costs than MDD patients. COMP360 has consistently demonstrated through 3 late-stage trials, clinical effects and a well-tolerated safety profile in a TRD patient population, and we expect payers to respond favorably to the emerging clinical profile and potential value that COMP360 can bring to the health care system. Along with enabling access to COMP360, we want to ensure that the clinical experience for the patient and the site of care is positive. This requires thoughtful consideration of how we deploy a file force and how we educate train and prepare patients in the sites that will be administering COMP360. Through the insights generated through our growing medical science liaison team through market research and through continued close work with our strategic collaborations, we have a deep understanding of what is required to enable a well-prepared and well-supported COMP360 experience. Lastly, but notably, we have been rapidly building the commercial organization in preparation for launch. This includes bringing an extremely experienced commercial leadership team that has collectively launched over 50 products. This level of experience is remarkable, and we are privileged to have such an impressive team leading loss preparation for COMP360. COMP360 has the potential to fundamentally change the way that patients living with depression are cared for, and COMPASS is committed to helping as many patients as possible. With COMP360 expected to be first to market in a highly anticipated new class for mental health, COMPASS is at the forefront of shaping a feature of psychiatric patient care. We are strongly positioned to successfully launch COMP360 and I look forward to updating you more on our progress. Thank you. And let me hand the call back to Kabir for closing remarks. Kabir Nath: Thank you, Lori. This is an incredibly exciting and defining time for patients and COMPASS. We are confident in the rigor and robustness of our development program to demonstrate the benefit of COMP360. We have conducted our program to the highest standards, which we believe must be paramount in this new field of psychodelic science. We now have data from 3 robust well-controlled clinical trials that enrolled over 1,000 participants, including over 800 from 2 successful pivotal Phase III trials. I do want to underscore the difficulty of establishing efficacy in TRD with only 2 medicines ever having been approved despite multiple efforts, that COMP360 has consistently demonstrated a clinically meaningful, rapid and durable effect and a generally safe and well-tolerated profile is a remarkable achievement and one that promises to be a transformative new offering for those living with TRD. I want to sincerely thank our investigators, trial site teams, and most importantly, the participants whose commitment and trust has made this progress possible. Thank you. And let me now pass the call to the operator for Q&A. Operator: [Operator Instructions] Your first comes from the line of Andrew Tsai of Jefferies. Unknown Analyst: Congrats on the great progress and great news. I had 2 questions. The first 1 is based on your guys' ongoing FDA discussions -- has the FDA given you any inclination whether there will be an AdCom or not for Cop360? Because on 1 hand, the review time lines could be really accelerated and FDA does -- but then FDA does seem to be doing away ADCOMS. And then I can't help but think that [indiscernible] got on and maybe it would be prudent for the FDA to hold on. So I'd be curious to know what you guys -- where are you guys lean here? Kabir Nath: Thank you, Andrew. It's Cabin just checking that you can hear us clearly. Unknown Analyst: I can hear you. Yes. Kabir Nath: Great. So thank you, yes. So it is the FDA's decision and the FDA's only decision around whether or not to hold an advisory committee. They will only make that determination once they see the totality of the data we've submitted. We will be prepared for one, and that is in our planning, if necessary. But at the moment, we do not have an indication of whether or not that's likely to happen. Unknown Analyst: Got it. And then secondly, when you share the 26-week Part B data from COMP006 study, the second 1 in early Q3, would you consider sharing a cut of the additional 26-week long Part C portion of the 005 study, your first study in conjunction with that top line release? If not in early Q3, then can we expect maybe a cut before you're possibly approved. I figure it's open label and then sharing additional long-term data could be helpful or important for pricing or labeling discussions? Kabir Nath: So thanks, Andrew. Yes. So I mean, from a timing perspective, you're right that the 52 weeks of [indiscernible] clearly run in parallel with that. We haven't made a final determination of what we'll share at what point, but I hear you loud and clear in terms of the value potentially for payers and for commercial purposes. So that's a decision that will come to in due course. Operator: Your next question comes from the line of Francois Brisebois of LifeSci Capital LLC. François Brisebois: So just quickly here, in terms of the third quarter data for implications, can you just help us understand maybe what the expectations are? And why -- is it still a gating factor to complete the filing based on the developments that have happened recently? I just want to kind of better understand what that data is and how important it is for the launch here? Kabir Nath: Francois, may I call you, Frank, please? François Brisebois: Frank is totally fine. Kabir Nath: Thanks for the question, Frank. So yes, clearly, and just for complete clarity, we had already aligned on our rolling submission plan with the FDA before the executive order and the award of the same [indiscernible]. So we had already fully aligned with the psychiatry division on what we were going to do and the time frame in which we're going to do it. That hasn't changed. And I think it's really important to note that the CMPV potentially accelerates the end part of this process, the final review, but it's been very clear in our discussions with the agency that in no way does it change the evidentiary basis that's needed for an approval. So from our perspective, we remain on track with the filing strategy we've been laid out with a rolling submission, and that does indeed include the 26 weeks of 006, which we see as significant in terms of really finalizing the profile and again for commercial focuses. François Brisebois: Okay. Great. And then can you give us a little more color on the reimbursement and maybe the CPT codes where maybe the evolution of it. Is there anything else that we need from the CPT angle between now and approval and after? And then just a little more color on -- there's a lot of discussions about the support, the psychological support and kind of the prep and then maybe the amount of people that you would expect to be in a room and their qualifications just on the commercial side, thoughts around those ideas. Kabir Nath: I'll hand that question to Steve. Steve Levine: Thanks, Kabir, on the CPT portion of the question, in terms of the work remaining for the CPT 3 codes. They are in a category 3 form at the moment, which is their tracking form as those codes are reported more, and they have started to be reported in a limited number of cases. it really will require our approval and launch for them to be recorded in greater quantity. But as they reported, that will enable the American Medical Association with their rough committee, which is an acronym for the RVU update committee with representation from APA to do their work to understand the work involved in delivering treatment and the practice expenses in order for them to make a recommendation to CMS on a valuation for the code. This is not entirely a black box. It's formulaic. There are analogous treatments to look at in terms of having some expectations coming in for where this valuation may land. But again, ultimately, the codes will need to be reported so the codes can be progressed to the Category 1 value form. Ahead of that, there will be the opportunities for negotiations directly with payers by providers for reimbursement and treatment. On the staffing-related question with how patients will be prepared and what delivery will look like as far as treatment models, ultimately, those treatment models will be up to sites of care as part of the practice of medicine. Staffing ratios, descriptions of the roles of people involved, the language that will ultimately end up in our REMS will be a result of discussion with FDA in due course during the review period. We have been guided to expect to this point that the REMS will be consistent with the one that exists for Spravato today as well as what FDA have prepared in the briefing materials for ligases.com which use language to the effect of a prescriber available, a licensed often provider on site. And these, of course, are the important elements in terms of having the sufficient experience in training of providers necessary to ensure safeguarding the patients. Operator: Your next question comes from the line of François Brisebois of Stifel. Unknown Analyst: This is Julian on for Paul. Congrats on all the great progress. Just 2 from us. I guess what are your expectations for [indiscernible] doses versus 1 initial dose thinking about the 006, 26-week data coming out? And how do you think that will be assessed by FDA with respect to implications for labeling? And then our second question is, from your commercial work, have you been able to identify what proportion of patients being prescribed Spravato are at large [indiscernible] centers versus private practice clinics? I'm curious how that may or may not influence your commercial strategy? Kabir Nath: Thanks, Julian. So yes, on the first question, as you know from what we've already shown, we saw that there was a 25% of patients had a clinically meaningful response in 005 from that single administration of COMP360, and we saw that, that was 40% in 006 with the addition of the second fixed up. So clearly, we are expecting that higher level of response to be sustained through 26 weeks, but we really do need to see the data to understand what the potential impact of a third dose for those who haven't maybe and indeed what the second dose after week 3 does for sustained response without necessarily a third dose. So turning to what that means on our start, but Lori or Steve may want to drop on here. I mean, we are seeking a label that essentially says from 1 or 2 doses and then with further episodic dosing at provider discretion. So that gives discretion because clearly, if somebody responds very well to a first dose, there may not be a need for something within 3 weeks or a short-term period. But equally, we clearly saw so far that there are patients who do benefit from having that second dose 3. So that's how we're thinking about those things. And then I'll hand to Lori and Steve to about [indiscernible] and then the [indiscernible] patients. Lori Englebert: Yes. I agree with Kabir's assessment on what we're seeking for the label, the 26-week data that we're getting from combined with the 005 data is really going to be used to help guide clinical decision-making from the sales force as we're out educating providers. So Steve, anything you want to add on that? In terms of the Spravato patients being treated in academic centers versus the more what everyone call the interventional psychiatry treatment centers, the academic centers are treating very, very small portion. It is, I think, less than 5% of patients are actually being treated at academic centers. And so the primary focus of ours will be at launch on the interventional psychiatric treatment centers that are currently prescribing Spravato, which is at about 7,500 already. Steve Levine: And I'll just add to that we do engage with many academic centers. We hear a lot of excitement for them about the potential of implementing COMP360. So we do expect academic sites to deliver COMP360. The nuance is that they are typically not built to have high-volume operations. They tend not to treat high volumes of patients. They don't have the kind of throughput that the interventional clinics have. So they will deliver the treatment, but the -- reflective of the breakdown that we see with Spravato prescriptions, we expect that to be similar with those centers having a higher capacity to treat patients. Operator: Your next question comes from the line of Joshua Schimmer of Cantor. Joshua Schimmer: How are you thinking about the incremental capacity for COMP360 administration at those 7,300 or so interventional pathways? And is there any way to quantify that? And then what percent of the centers do you expect we'll be adopting the [indiscernible] model for COMP360 early on? And how do you expect that to evolve over time? Kabir Nath: Thanks, Joshua. [indiscernible] those to Steve. Steve Levine: Josh, good to hear from you. Thanks for the question. So on the capacity side, we know that these centers have existing capacity today. And it's an important consideration when we often get questions about how these sites will make decisions about which treatment to deliver and whether they're making trade-offs that's based upon reimbursement that they may receive for delivering various treatments. First of all, these sites know that there are huge unmet needs for the treatment-resistant depression population. They are excited to have more tools available and to have the opportunity to make decisions at which treatment to deliver. But in the meantime, given especially that a Spravato room and the Spravato staffing model are the same as what we anticipate to be required to deliver COMP360, they don't need to make any adjustments in their centers today in order to have capacity to deliver the new treatment. They'll be able to use the rooms interchangeably. It is likely that within the same day, they may treat a patient with COMP360 and one with Spravato in the day or that over the course of the week, these rooms may be used for either treatment. So there's plenty of existing capacity that they will first fill prior to adding additional states. Should they have the good problem from their perspective of treating lots of patients and running out of capacity the economics are very favorable for them to add space or add new locations. On the buy and bill part of the question, what we've seen with Spravato is that the penetration of buy and bill relative to specialty pharmacy reimbursement has increased over time. We don't know the exact numbers. We believe it's somewhere between 35% to 45% of provider prescriptions at this point or buy and bill. This is something that the psychiatry model has not been used to prior to the advent of Spravato, but they are beginning to recognize the economic value of processing claims in this way. So we would hand to Lori to augment this. But I think we would expect that in the earliest days of launch, more sites may, as they get used to delivering our treatment, initially work with the specialty pharmacy channels, but we would quickly expect them to adopt buy and bill in for that to increase over time. Lori Englebert: Yes. The only thing I'll add that, Josh, is that we will enable both at launch. And so that is just an important nuance to add is that it will be enabled, but we do for a realistic expectation standpoint, expect there to be a little bit of a ramp to heavier buy and bill. Operator: Your next question comes from the line of Judah Frommer of MS. Judah Frommer: Congrats on all the progress. Maybe just a follow-up on kind of how providers are thinking about potential administration. I think there's a little bit of discussion about whether psychodelic treatment should fit into that Spravato dosing window versus maybe something longer that COMP360 would take. Can you just remind us from the provider's perspective, the economics of turning over a room maybe 2 or 3x for multiple Spravato applications versus maybe a single administration of COMP360 and what the economics look like relative to each other? Kabir Nath: Thanks, Judah. This is Steve's favorite question. Steve Levine: Yes. Thank you for the opportunity to talk about this, Judah. So exactly, as you said, there are inefficiencies with shorter treatment and you need to turn the room over multiple times in a day because this is, I guess, self-evident, but when you have time in between patients where you need to turn the room over to clean it, the administrative work of an additional patient, et cetera, that is a gap that is unreimbursed time. Therefore, if you are able to fill that room with 1 patient and you are reimbursed for the entire time that the patient is in that room, then that is much more efficient for these sites. To put some numbers to it, if you consider that site operating at full capacity, which as I've just said earlier, doesn't exist. These sites have plenty of capacity. But to be conservative, let's say they're at full capacity, and then let's say they're maximally efficient, which most sites also are not, that would mean they could get 3 Spravato patients in a room in a day. With average reimbursement for Spravato session, somewhere south of $300, but using round numbers, then that means they're potentially being reimbursed for the room at $900 per day. That works for these sites. That is not ideal necessarily in their minds. And so that's really kind of the target that would be the minimum that they would need if they were just purely making these trade-offs. That makes us very confident that this will make sense for them. But in addition, if we consider that the observation time for COMP360 will probably be about 6 hours, within a typical operating day for these sites, it means they could also most likely get a Spravato patient in that room, too. And since most of these sites aren't having more than one Spravato patient in that room in a day anyway, this is all upside. This is all additive for them. Operator: Your next question comes from the line of Ritu Baral of TD Cowen. Ritu Baral: Steve, you mentioned the [indiscernible] committee of the AMA. So our understanding is that this committee meets once a year and unfortunately, has only 1 psychiatry [indiscernible] and it's very sort of surgeon dominated. Is there anything that you guys can do -- first of all, do you know when this [indiscernible] committee is scheduled for the year? And second, is there anything you can do as far as prep for this committee to sort of optimally communicate the value proposition of COMP360? And then I've got a follow-up on the DEA discussions. Have you been in communication with the DEA proper? And do you have an idea at this point if communications and review of the FDA will start even before the NDA is complete? Or would you expect that this would still be sort of expedited review on the tail end of approval? And then if I can just ask a quick follow-up after that. What are your expectations for the REMS in so far as the requirements for administration as well as either preparation and consolidation afterwards? Like what will actually be required by the REMS? Because we've heard from doctors that, that will be absolutely the most important thing. Kabir Nath: Thanks, Rishi. So I'll ask Steve to comment on the [indiscernible], I'll take the DEA question with Lori, and then [indiscernible] will take the rates question. Stephen Schultz: It will be a sandwich Okay. Starting with the rock portion. You asked about the date of the next RUC meeting. I don't have the schedule on the top of my head. We can follow up on that. But to the rest of it, you're correct that historically, there has been an overrepresentation, let's say, on the RUC of surgeons and other procedurally focused committee members. That has been shifting fortunately. I don't know exactly how many psychiatrists are currently sitting on the committee, but there has been an effort to correct the historical imbalance in the representation of the committee. When we did the initial work on the Category III code a few years ago, we took advice from a number of people, including those who had served on the RUC in the past. So we were very well informed heading into the initial application for the Category III code. We will continue to work with experienced consultants as the code progresses to Category I and make sure that this goes in a direction that is very favorable to ensuring that there is adequate reimbursement to ensure patient access. I will hand over for the second part of the question and be back with you on REMS. Kabir Nath: So Ritu, on the DEA, I mean, as you know, the executive order mentions the fact that the analysis could potentially start as soon as Phase III is completed. After further conversation with those responsible for that, it's clear that the intent is that the DEA and the FDA can arrive at their conclusion simultaneously. However, it would still be a sequential process. So essentially, we will provide a factor analysis, the controlled substance staff within the FDA will then review that. Historically, they have submitted their findings at the end of the review period because that's just the way the FDA has worked. That could potentially be accelerated with the DEA then doing their sequential review, but all of this coming together in time on the same day or a day apart at the end of it. That's the intent. Where we will actually get to in practice, we will have to see. Lori Englebert: The only thing I'll add -- hi, Ritu, the only thing I'll add is that we are working with DEA consultants as well as accelerating our time lines to when you would traditionally communicate with the DEA so that we can reach a further understanding. But to -- for planning purposes, as of right now, we are not planning for -- we will be ready if there's anything that happens before, but we see no indication that these time lines have shifted forward. Steve Levine: And then back to me for REMS, Steve again. So you're referencing in our clinical trials that we had spent time preparing patients ahead of administration supported them on the day of administration and then follow them up for safety after. Within a clinical trial context, it was important that everyone had the same conditions, the same experience and everything was highly standardized. And so in that context, we specified a number of preparatory sessions, as an example as well as a standardized length of those visits. As this translates into your well care delivery and how this will be guided by the REMS, what becomes most important is not a certain number of sessions or a length of those sessions, just that patients are adequately prepared and they are properly followed up for safety. And so anything that would be in a REMS would be very typical of REMS' language and not get down to the granular level of detail of dictating the practice of medicine. The reality is that with any treatment, there is some preparation and safety seller anyway so much as any necessary language that just gives a little bit of guidance on what activities are important in terms of preparing patients. And that would include being enrolled in the REMS, having informed consent and so on. And then ensuring that patients are followed up afterwards as a safety check. Operator: Your next question comes from the line of Madison El-Saadi of B. Riley Securities. Madison Wynne El-Saadi: A couple from us. Maybe what have you learned about the CPV mechanics since receiving the award a couple of weeks ago? Should we think of this 1- to 2-month CPV review clock is not really starting until that final module is submitted? Or has it, I guess, to some degree, already started, which would imply the FDA response closer to 1 month versus the 2 months? And then afterwards, an unrelated follow-up. Kabir Nath: Yes. So thank you for the question. So our understanding is certainly that, that formal 1- to 2-month goal is following the completion of the NDA submission. However, what it also does imply clearly is an even more flexible and responsive way of working with the agency. As we've said before, we already have an excellent relationship with the psychiatry division. It's collaborative, it's constructive. It's focused on solving problems on what we've already seen in the last couple of weeks is that, that is even more so. And in particular, some of the standard time lines of 30 days to request a meeting and x days for a response and so on, those have gone away in timing. So this really is about, first, a much more flexible day-to-day interaction with the agency. But the actual formal clock of about 1 to 2 months, as we understand it, will only start with the submission. And again, to be clear, that's a goal. Yes, it's a goal that they can complete it within a couple of months. Madison Wynne El-Saadi: Understood. That's great to hear. And then secondly, so many of these sites offer TMS. Based on what we know or what we believe we know about how [indiscernible] works or how TMS works, do you think there may be an additive or even synergistic effect from combining these treatments? Kabir Nath: That's definitely a Steve question. Steve Levine: Thanks, Madison. Yes, that's an intriguing one. It's something that has been raised to date. It's really a matter of speculation. You can [indiscernible] theoretical reasons why there may be synergies. It would be good to see some data. I know that there's at least 1 small academic study already looking at the concurrent use of these 2 modalities. I'm sure that the sites that deliver those treatments, both TMS and COMP360, may be interested in that question. And if they do, I hope they track outcomes and we gather data and have some guidance on whether that may be an effective approach. Ultimately, these sites are ecosystems of care. They offer multiple treatments. They're trying to offer as many tools as possible for these patients to maximize their outcomes. Treatment resistant depression is, for any patients, a chronic condition and they will receive many treatments over a lifetime. And so whether these treatments are combined in some way or whether over time, they wind up adding multiple of them, we would expect that somebody receiving their care in 1 of these sites may have more than 1 of these treatments over the course of their car. Lori Englebert: And Madison, if you don't mind, I'll chime in as well. Part of the benefit of us producing the data in treatment resistant depression is that we believe that there's a huge unmet. Spravato is the only indicated product drug product being used right now in this patient population. And given the frequency of treatment that Spravato requires, it is often patient prohibitive. And so in order for patients who want to receive these type of treatments, it has to fit into their schedule, and we believe COMP360 brings a very complementary patient profile -- patient friendly profile to these patients. So we expect COMP360 to be earlier line than where TMS is currently being used right now, which is traditionally one of your later to last mines of treatment. Operator: Your next question comes from the line of Patrick Trucchio of HC Wainwright. Patrick Trucchio: A few questions. The first is on -- regarding the Phase III trial, the COMP006. For the Part B 26-week data that's expected in the third quarter. Can you tell us, first, just which measures will be released at that time? Is it sort of maintenance of greater than 25% [indiscernible] reduction, remission durability, time to relapse, treatment frequency, patient-reported outcomes and as well as safety? And which parts of those data matter most for the NDA as well as the label and payer discussions? Kabir Nath: Yes. So Patrick, we haven't yet determined what we would release publicly from a simple perspective, all of that data will be necessary from an NDA perspective, so clearly, everything, all those endpoints, primary, secondary, all the safety data will clearly go to the FDA. And I'll hand to Lori to talk about the commercial piece. Lori Englebert: All of that data will also be important for payer in clinical decision making, which we all have in due course to help inform all of those decisions. But in immediate discussions with payers, it will be the redosing in the durability piece that we will -- that we are really looking for so that we can inform payers on how many doses to expect per patient. And Steve? Steve Levine: And just 1 to add -- sorry, Patrick, just 1 thing to add to that, which is similar to what we guided prior to the release of Part B of 005, just to be clear, there isn't a particular bar. There isn't some number that's a measure of success there. It is important data, but it's data to really round out the profile of the drug. And as Lori said, to have discussions with payers, to guide expectations clinically with providers, so there's nothing that we're rooting for necessarily. We just need to understand the longer-term trajectories of these patients. Patrick Trucchio: Great. And then just on the commercial side, more specifically, I'm just wondering if you can talk more about just your launch readiness and being ready by the end of the year. And to what extent you've begun that process of hiring a field force and building out a REMS infrastructure and sort of discussed the sort of the structure with payers and distribution contracts. And as well, related to that, of those 7,300 centers that could offer the treatment or greater than 7,300 centers, how many have you actively engaged with? And what proportion do you think are ready or will be ready to administer COMP360 within the first 3 to 6 months after approval? Lori Englebert: So given the work of the strategic collaborations that we've been doing for several years now, which really sets us up for success and also enabled us largely to be able to be -- to say that we can be launch ready under such short time lines. I'm going to let Steve answer that last question, and I'll answer your original question at the end. Steve Levine: We're flipping it around in reverse order. Okay. Yes. So in terms of the sites that we've engaged with and we'll be ready. As Laurie said, we've been working with sites like this for quite some time now, whether it's formerly within our strategic collaborations, whether it's engagement by our field medical team as they've been out for the past couple of years, meeting with health care providers around the country or other relationships we already have with the leadership of these organizations. I think it's fair to say that we've engaged with the vast majority, and we know really quite -- many of them quite well. It is that level of engagement and knowing them that well that gives me a lot of confidence to say we don't need to encourage these sites to get ready. They're almost more excited than we are. This is really why they built the infrastructure in the first place. It wasn't to deliver one treatment. It wasn't to deliver Spravato. It was in anticipation of having more treatments, particularly ones with the profile like COMP360. The feedback we've been getting since the last data release is that they are just so excited for their patients to have a treatment that has this rapidity of effect, this durability of effect, which is on a scale far different from anything they've had available to them to this point. The ability to recruit patients from a much larger radius to the point that Lori made earlier about the burden on patients of the frequency of treatment with Spravato particularly with TMS, needing to come every day is really hyper local patient recruitment with COMP360 with just 1 or 2 treatments, they're able to have patients travel for much further area. So they are excited. They are really bombarding us every day with questions of when are you going to be approved? What do we need to know? So they will be ready. Lori Englebert: Yes. And Patrick, so will we. And so hopefully, you can hear through mine and team's excitement -- collective excitement here about this particular topic just how confident we are in the fact that we are not only building out a pretty remarkable team, this team, this leadership team, getting them on board first was fairly important so that they could start to build out their teams. And all of that is underway right now. So every single aspect in function within a commercial organization has a remarkable leader at the helm and they are currently in the process of building out and have already expanded the team. The team has already doubled in the past 2 months. And so we are well on our way of making sure that we are adequately prepared. All that -- everything you mentioned is underway. So compliant payer discussions are beginning. Right now, the negotiating piece, I just want to set expectations on the negotiating piece with payers. We won't start negotiations until we understand the clinical profile better of COMP360, as we mentioned before, but we certainly are engaging with payers to start those initial discussions right now. Train distribution is well on its way. We are working there to understand what our distribution strategy is. And again, with some really remarkable leaders and very, very experienced [indiscernible]. Operator: Your next question comes from the line of Leonid Timashev of RBC Capital Markets. Leonid Timashev: I wanted to ask on PTSD. Obviously, another part of the executive order was significant underlying excitement for treating PTSD. So I guess I'm curious how you're thinking about your program specifically, whether there's any changes you're envisioning to the trial, whether you think the evidentiary standards may be lower and you can move ahead with just 1 Phase III registrationally? And given the focus on veterans from the administration, whether there's plans to explore that subpopulation more deeply? Kabir Nath: Thanks, Leo, and I'll start on that. So first, yes, we agree. PTSD is a very significant unmet need. As we have said, we are planning that as a single late-stage trial. Obviously, we will have to see what the data says and sound because ultimately, will be a FDA decision around that. Within that trial, we will have VA sites. More broadly though, we are already heavily engaged with the VA, and I'm going to hand to Steve to talk a little bit about what that is. Just before I do, we should also note that it is now [indiscernible] available. We are supporting a study within the VA, which is a very robust clinical study, which is a TRD population with heavy PTSD commodity. So that study will also support. But I'll hand to Steve to talk more broadly about the work we [indiscernible]. Steve Levine: Thanks, Kabir. Yes, PTSD is an area where we are really excited. This is 13 million U.S. adults who currently have very few options, terribly underserved. So really excited to be moving this program forward. As a reminder, the design of this study was, from the beginning, intended to support registration with the single trial. And so that still remains the aim. As Kabir said, we already are engaged with the VA in various ways. He mentioned the study that we are supporting, we are supplying the drug as well as the training of the initial cohort of trainers for a large multisite VA study, looking at people living with both treatment-resistant depression and PTSD in addition to a second study as well within the VA. Beyond that, we have had active engagement for quite some time now with VA's integrated project team, which has been working for multiple years now on their preparations to be able to implement psychedelic treatments as they're approved. So that engagement is robust and ongoing. And it certainly is a priority for us to ensure that as we bring new treatments to market that these are available for veterans. Operator: Your next question comes from the line of Sumant Kulkarni of Canaccord Genuity. Sumant Kulkarni: I have a few here. First, how do you expect competitive and legal dynamics on Selasiben to play out given Yusona Institute also has a national priority voucher for product and could already have its Phase III data in-house for major depressive disorder? Kabir Nath: So I can only comment on the fact that we, Sumant, COMPASS have 2 very large Phase III trials, where we've already declared the primary end point, and we've agreed on a rolling submission and review plan, and that's what we're focused on right now. Sumant Kulkarni: Do you expect a label limit on the number of treatments per year for complex? And how soon after a patient needs retreatment would they be able to get it in the real world? Kabir Nath: No, but I'll hand from a kind of commercial payer perspective to the Lori or Steve. Lori? Lori Englebert: I'll speak to it from the payer standpoint, Steve can speak to it from a clinician standpoint. So agree with Kabir completely. We expect no limit in the label. We will have through negotiations be discussing with payers what that looks like. And if there would be limits from a prior authorization reapproval process. That is not only standard practice, especially with these type of treatments, but also should be expected. But it is, again, not going to be overly onerous for the sites nor again is this outside of the norm of what happens in clinical practice right now. Steve Levine: Well, just to answer the last part of your question, Sumant, about the treatment frequency or the intervals. What we've seen so far is that some patients have some benefit from a second administration, whether it's on the fixed interval 3 weeks after the first or on a more variable basis as we saw in Part B of 005 because the minimum interval we've studied is 3 weeks, I would expect that there likely would not be dosing closer than 3 weeks apart. They really clinically would likely not be a reason to. Otherwise, I think the upcoming data from Part B of the longer-term progress in 006 put together with Part B will help give some guidance to clinicians on how they would think about retreatment. And then otherwise, as Lori said, that will be further guided by payer policy. Sumant Kulkarni: Got it. And then last one on PTSD. Other than less frequent dosing, what are the key reasons that would make patients want to take COMP360 versus a [indiscernible]? Kabir Nath: So they are likely to be first. We need to see data in terms of allergic and safety on both of them, clearly. There are likely to be very different experiences from a patient perspective. These are very different medicines with different MOAs. To your point, certainly, the TRANSCEND protocol [indiscernible] has been more burdensome from a patient perspective as well. But I think we will need to see how those are fully characterized through the clinical trials, both in terms of patient experience, provider experience and in frequency of administration there's clear differentiation in treatment. Steve Levine: And to be clear, there hasn't been an approved drug in PTSD this century. There are only 2 approved options right now, both are old generic SSRIs that are only modestly efficacious, more options, more options, right? There's 13 million people with PTSD. It is not 1 or the other. There's not going to be 1 winner here. We are excited for any new option that is safe and efficacious in this population. The patients living with PTSD deserve to have more treatment options. Operator: Your next question comes from the line of Tom Shrader of BTIG. Thomas Shrader: This is Jen Kim on for Tom Shrader. Congrats on all the progress. A couple of couple of PTSD questions. What's the primary endpoint for PTSD phase to trial and has the FDA align on that endpoint in a special protocol assessment. And in the TRD program, the 2 doses of COMP006 were administered 3 weeks apart, but in COMP202 for PTSD, you landed on a 4-week interval. Could you walk us through the clinical rationale for that difference? Kabir Nath: Sure. So the primary endpoint is the CAPS-5, which is very well validated as the normal primary endpoint in PTSD. So we are using the standard primary endpoint. And because the CAPS-5 requires a 4-week look back, practically speaking, the second dose has to be in 4 weeks, it can't be in 3 weeks, and that's the reason for that. So it's tied to that input. But as I say, this is the standard end point that has been used in PTSD trials. Operator: Your next question comes from the line of Jay Olson of Oppenheimer. Jay Olson: Congrats on the progress. Maybe we'll just follow up on PTSD. Could you talk about any synergies that you expect to capture from the infrastructure that you're building for TRD? And also, what are some of the differentiating benefits to [indiscernible] versus other compounds being used or studied for PTSD? And then maybe just any other indications you're planning to pursue for [indiscernible] beyond TRD and PTSD? Kabir Nath: So we'll go backwards through these. So -- and I'll leave Steve and Lori to talk both about synergies and some of the reasons to believe. So we're clearly very focused on some of these broader neuropsychiatric conditions that do indeed share synergies in terms of patterns of prescribing, locations on treatment and so on. And while we haven't made any determination on other areas, you can imagine there are some such as [indiscernible], OCD, in all of which we have seen signals based on IAS and studies we've supported but we don't not yet inhibition lay out formally where else we might go. So let me hand to Lori to talk about kind of the commercial synergies and then maybe Steve to touch on reasons to believe [indiscernible]. Lori Englebert: Given the high overlap in comorbidities between TRD and PTSC, the infrastructure that currently treats will be the same infrastructure that treats for TRD patients. So the synergies are exceptionally high. Steve mentioned earlier, the work we're doing at the VA. Obviously, there's a large focus on PTSD patients at the VA, so we fully anticipate that the VA will be well accepted and ready to treat patients once it becomes available. And from a sales force standpoint, there would be -- it would be very minimal change to the sales force to add on PTSD. Steve Levine: And then the last part, Nice to talk to you, Jay. One of the things that we saw in our Phase II study in PTSD, one of the reasons, along with the opportunity to meet the unmet needs for these patients was the experience that our patients had in that study. We were able to do qualitative interviews with the participants, and we heard some really important feedback that seems highly differentiated from other options that are available for patients within with PTSD or are currently being investigated. And that is that one of the reasons why people often avoid PTSD care is that they're forced to confront exactly the source of their trauma, which is a very frightening prospect. It can make treatment itself very distressing. It's something that we're aware comes up with some of the pathogenic treatments like NDMA where these are very intensive sessions. It's the reason why, in many cases, these are studied with psychotherapy with trained psychotherapists actively engaging with them as traumatic material comes up. What we saw in our Phase II study, which was largely focused on safety, feasibility, acceptability was that this is a very acceptable treatment, one that was very pleasant for patients where the trauma itself didn't even necessarily come up during the experience. And that was something that surprised and was gratifying to them afterwards that despite the fact that they weren't forced to go through such a dramatic experience and getting treatment that they had profound shifts in the emotional relationship to that trauma. And so we think that bodes really well for this -- the further development of this as a potential treatment because of that really positive patient experience. Operator: With no further questions, that concludes our Q&A session. I will now turn the conference back over to management for closing remarks. Kabir Nath: Thanks, everyone, for your participation today. As you've heard, we are excited by the fact that we are aligned on a rolling submission review with the FDA. We were already aligned on that before the award of CMPV, but that clearly validates and there's a recognition of the really great work we've done, the robust data that we have generated. So as you've heard, we are working with the FDA and DEA to see if there are other further opportunities for acceleration. Most importantly though, you've heard how excited we are about the opportunity to be -- to launch a first-in-class psychedelic. As we talk to providers, patients, current employees, prospective employees, everyone truly sees this as the opportunity of a lifetime. And we are delighted to be in the forefront of theft and leading the way in establishing psychedelic as a transformative new option patients in need of new treatments. So thanks for your attention, and we look forward to updating you on our continued progress during the remainder of the year. Thank you. Operator: This concludes today's conference call. You may now disconnect. 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Compass Pathways (NASDAQ:CMPS) reported first-quarter financial results on Wednesday. The transcript from the company's first-quarter earnings call has been provided below. Benzinga APIs provide real-time access to earnings call transcripts and financial data. Visit https://www.benzinga.com/apis/ to learn more. Access the full call at https://events.q4inc.com/attendee/144892287 Compass Pathways PLC reported a productive quarter with positive data from both Phase 3 studies of COM360, which demonstrated rapid and durable efficacy for treatment-resistant depression (TRD). The company is preparing for a potential accelerated launch of COM360, with plans to be launch-ready by the end of the year, supported by strong financials that extend into 2028. Strategic initiatives include ongoing collaboration with the FDA for a rolling NDA submission and engagement with the DEA for potential rescheduling of COM360, as well as advancing trials for PTSD. Operational highlights include building out a commercial team, leveraging strategic collaborations for market readiness, and securing CPT3 codes for psychedelic treatment reimbursements. Management expressed high confidence in the regulatory process and the potential market impact of COM360, noting strong interest and readiness among treatment centers. OPERATOR Good day ladies and gentlemen and welcome to The Compass Pathways 1st Quarter Results Conference call. At this time, all participants are in listen only mode. As a reminder, this call is being recorded. Now, I'd like to introduce your host for today's call, Stephen Schultz. You may begin. Welcome all of you and thank you Stephen Schultz (Senior Vice President Investor Relations) for joining us today for this conference call. I'm Steve Schultz, Senior Vice President Investor Relations at Compass Pathways and today I'm joined by Kabir Nath, our Chief Executive Officer, and Lori Engelbert, our Chief Commercial Officer. Terry Loxam, our Chief Financial Officer and Dr. Steve Levine, our Chief Patient Officer will be available for the Q and A. The call is being recorded and will be available on the Compass Pathways investor relations website shortly after the conclusion of the call and will be available for a period of 30 days. Before we begin, let me remind everyone that during the call today, we will be making statements about our future plans and prospects that constitute forward looking statements. Each forward looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement, including those risks and uncertainties described under the heading Risk Factors in our most recent filings with the U.S. Securities and Exchange Commission. These forward looking statements represent our views only as of today and we specifically disclaim any obligation to update or revise any forward looking statement, even if our estimates or assumptions change. I'll now hand the call to Kabir Nat. Kabir Nath Thank you Steve. And thank you all for joining us today. It has been a very exciting and productive quarter for Compass. The company continues to lead the way in psychedelic science, validated by the confirmation of a rolling NDA submission and review and the award of a Commissioner's national priority voucher or CNPV. With our 005 and 006 data announcement in February, we have delivered positive data from Both our Phase 3 studies. COMP360 has therefore demonstrated what no approved drug for TRD offers. Clinically meaningful efficacy with both rapid onset and extended durability. In fact, these extraordinary results redefine rapidity and durability for TRD patients with only one drug approved and actually used for TRD today, we are confident that COMF360, with its differentiated and compelling profile, will be an important option for the millions of patients that have been failed by the many approved treatments for MDD. After we announced results of our first positive phase 3 trial last year and based on discussions with the FDA, we began preparing for a potential accelerated launch. As we've said before, we will be launch ready by the end of this year. We've aligned with the FDA on our rolling submission and review plan and have begun submitting modules for the COMP360 NDA. We will continue to submit additional modules on a rolling basis over the coming months. Part B data from 006, which we continue to expect in early Q3, will be the final data set to complete the submission. Given the award of the cmpv. We are already working closely with the FDA to enable as much efficiency and acceleration as possible. In addition, based on the Executive Order, we are accelerating our engagement with the DEA since there is the potential for federal rescheduling to be completed sooner than the current statutory 90 days post FDA approval. Our two large phase 3 trials, blinded to an unprecedented 26 weeks for psychiatry trials supported by our large phase 2b trial, has resulted in over 1000 patients in the program with comprehensive and strong preclinical toxicology, safety and CMC data. We are confident that we will have a robust NDA submission that supports a COMP360 approval. We've also continued to make great progress in our commercial preparedness which Laurie will cover in detail. Our strategic collaborations across diverse settings of care, including the interventional psychiatry infrastructure, have provided significant learnings together with our foresight in establishing CPT Category III codes specifically for providers to get fully reimbursed for psychedelic monitoring. This has set us up well for a potential near term launch. We are ramping up rapidly building out the commercial team with outstanding highly motivated talent and initiating all activities in anticipation of approval. In addition to TRD, we are also progressing our program in PTSD which affects 13 million Americans. PTSD is another significant area of unmet need and an opportunity to expand COMP360 to individuals that have few medical options. We believe COMP360 can be an important new treatment for PTSD and it is a very logical next target indication for compass. Our work with the Contract Research Organization (CRO) and sites for our late stage PTSD trial is underway and we look forward to updating you as it progresses. With both the successful financing and warrant exercises in the first quarter, we have a strong balance sheet with cash that carries us well beyond launch and into 2028. Let me now hand the call to Laurie for more on our commercial preparations. Lori Engelbert Thank you Kabir hi everyone and thank you for joining today. There are 4 million patients with MDD who are considered treatment resistant. Spravato (esketamine), the only drug indicated and used for TRD, is expected to reach 3 billion in revenue by 2027 and as of 2025 was treating less than 2% of the TRD patient population. We believe that if approved, COMP360 will reach blockbuster potential by offering a transformative new treatment for the millions of patients who deserve more options. As Kabir noted, we are pleased to have been selected for the Commissioner's Priority Review Voucher. One benefit of being selected for the voucher includes the potential for an ultra accelerated review timeline of one to two months after final NDA submission. This provides helpful clarity on timing expectations and allows for more thoughtful and focused planning efforts based on the current timelines for data and submission. We remain focused on being launch ready by the end of the year. Last month the White House also issued an Executive order recognizing the profound urgency of the mental health crisis facing millions of Americans and the potential impact FDA approved psychedelics could have. In that executive order, timely rescheduling of approved treatments was stated as a priority. As a Schedule 1 product, COMP360 will need to be rescheduled at both the federal and state level after approval in order to be prescribed. We are accelerating work with the DEA to ensure rescheduling at the federal level goes as rapidly and smoothly as possible. We have also been working at the state level with the past two years to ensure that the states follow the federal rescheduling decision in a timely manner. Over the past two years we have made significant progress and today almost 90% of the US population live in a state that intends to reschedule COMP360 within 30 days after FDA approval and DEA rescheduling. Through this work we have markedly reduced the timeline to launch and for patients to access COMP360 after approval. Enabling broad and equitable access includes ensuring that both COMP360 and provider monitoring time are adequately reimbursed. Kabir mentioned earlier the work we did a few years ago on securing psychedelic specific CPT Category III codes which will ensure that sites are reimbursed fully for the time required for psychedelic treatment monitoring. These codes are billable by the hour and were designed to cover clinical work and practice expenses incurred with multi hour psychedelic treatments. We are also accelerating reimbursement and formulary discussions for COMP360 with payers. TRD has a significantly greater impact on individuals lives and accounts for a disproportionate share of health care costs versus MDD. TRD patients accrue 62% more mental health care costs and experience 41% higher work related cost costs than MDD patients. COMP360 has consistently demonstrated through three late stage trials, clinical effects and a well tolerated safety profile in a TRD patient population and we expect payers to respond favorably to the emerging clinical profile and potential value that COMP360 can bring to the healthcare system. Along with enabling access to COMP360, we want to ensure that the clinical experience for the patient is the site of care is positive. This requires thoughtful consideration of how we deploy the field force and how we educate, train and prepare patients and the sites that will be administering COMP360. Through the insights generated through our growing Medical Science Liaison team, through market research and through continued close work with our strategic collaborations, we have a deep understanding of what is required to enable a well prepared and well supported COP360 experience. Lastly, but notably, we have been rapidly building the commercial organization in preparation for launch. This includes bringing an extremely experienced commercial leadership team that has collectively launched over 50 products. This level of experience is remarkable and we are privileged to have such an impressive team leading launch preparation for COMP360. COMP360 has the potential to fundamentally change the way that patients living with depression are cared for. A COMPASS is committed to helping as many patients as possible. With COMP360 expected to be first to market in a highly anticipated new class for mental health, COMPASS is at the forefront of shaping the future of psychiatric patient care. We are strongly positioned to successfully launch COMP360 and I look forward to updating you more on our progress. Thank you and let me hand the call back to Kabir for closing remarks. Kabir Nath Thank you Laurie. This is an incredibly exciting and defining time for patients and compass. We are confident in the rigor and robustness of our development program to demonstrate the benefit of COMP360. We have conducted our program to the highest standards which we believe must be paramount in this new field of psychedelic science. We now have data from three robust, well controlled clinical trials that enrolled over 1,000 participants, including over 800 from two successful pivotal phase three trials. I do want to underscore the difficulty of establishing efficacy in Treatment-Resistant Depression (TRD) with only two medicines ever having been approved. Despite multiple efforts that COMP360 has consistently demonstrated a clinically meaningful, rapid and durable effect and a generally safe and well tolerated profile is a remarkable achievement and one that promises to be a transformative new offering for those living with trd. I want to sincerely thank our investigators, trial site teams and most importantly the participants whose commitment and trust has made this progress possible. Thank you and let me now pass the call to the operator for Q and A. OPERATOR Thank you. The floor is now open for questions. If you have dialed in and would like to ask a question, please press star one on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star one again. If you are called upon to ask a question and are listening via a loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute when asking your question. Your first question comes from the line of Andrew Tsai of Jefferies. Your line is open. Hi, good morning. Congrats on the great progress and the great news. I had two questions. The first one is, you know, based on your guys ongoing FDA discussions, has the FDA given you any inclination whether there will be an ADCOM or not for comp360? Because on one hand the review timelines could be really accelerated and you know, FDA does, but then FDA does seem to be doing away adcoms and then I can't help but think that Lyco's got one and maybe it could be prudent for the FDA to hold one. So I'd be curious to know what you guys, where you guys lean here. Thank you. Kabir Nath Thank you. Andrew, it's Kabir. I'm just checking that you can hear us clearly. I can hear you. Yeah. Great, thanks. So, thank you. Yes. So it is the FDA's decision and the FDA's decision only around whether or not to hold an advisory committee. They will only make that determination once they see the totality of the data we've submitted. We will be prepared for one and that is in our planning if necessary. But at the moment we do not have an indication of whether or not that's likely to happen. Andrew Tsai (Equity Analyst) Got it. And then secondly, when you share the 26-week Part B data from COMP360, the second one in early Q3, would you consider sharing a cut of the additional 26 week long Part C portion of the 005 study,, your first study in conjunction with that top line release? If not in early Q3, then can we expect maybe a cut before you're possibly approved? I figure it's open label and then sharing additional long term data could be helpful or important for pricing or labeling discussions.. Kabir Nath So. Thanks Andrew. Yes. So I mean from a timing perspective you're right that the 52 weeks of 005 clearly run in parallel with that. We haven't made a final determination of what we'll share at one point, but I hear you clearly in terms of the Value potentially for payers and for commercial purposes. So that's a decision we will come to in due course. Andrew Tsai (Equity Analyst) Great, thank you. Thanks. Francois Brisebois (Equity Analyst) Your next question comes from the line of Francois Brisebois of LifeSci Capital LLC. Your line is open. Yep, thank you. Very well said on the. Francois. Yeah, that's great. So just quickly here in terms of the third-quarter data for implications, can you help us understand maybe what the expectations are and you know, why is it still a gating factor to complete the filing based on the developments that have happened recently, I just want to kind of better understand what that data is and how important it is for launch here. Kabir Nath Thanks. And Francois, may I call you Frank, please. Frank is totally fine. Thanks. Thanks for the question, Frank. So, yeah, clearly and just for complete clarity, we had already aligned on our rolling submission plan with the FDA before the executive order and the award of the cmpv. So we had already fully aligned with the psychiatry division on what we were going to do and the timeframes in which we were going to do it. That hasn't changed. And I think it's really important to note that the CMPV potentially accelerates the end part of this process, the final review. But it's been very clear in our discussions with the agency that in no way does it change the evidentiary basis needed for approval. So from our perspective, we remain on track with the filing strategy we laid out with a rolling submission, and that does Indeed include the 26 weeks of 06, which we see as significant in terms of really finalizing the profile and again for commercial purposes. Francois Brisebois (Equity Analyst) Okay, great. Thank you. And then can you give us a little more color on the reimbursement and maybe the CPT Category III codes where maybe the evolution of it. Is there anything else that we need from the CPT angle between now and approval and after. And then just a little more color on. There's a lot of discussions about the support, the psychological support, and kind of the prep. And then, you know, maybe the amount of people that you would expect to be in a room and their qualifications. Just on the commercial side, you know, thoughts around those, those ideas. Thank you. Kabir Nath I'll hand that question to Steve. Steve Levine (Chief Patient Officer) Thanks, Kabir. Hi, Frank. On the CPT portion of the question, in terms of the work remaining for the CPT Category III codes, they are in a Category 3 form at the moment, which is their tracking form. As those codes are reported more and they have started to be reported in a limited number of cases, it really will require our approval and launch for them to be reported in greater quantity. But as they're reported, that will enable the American Medical association with their RUC (Relative Value Scale Update Committee), which is an acronym for the Relative Value Unit Update Committee with representation from American Psychiatric Association (APA), to do their work to understand the work involved in delivering this treatment and the practice expenses in order for them to make a recommendation to CMS on evaluation for the code. This is not entirely a black box. It's formulaic. There are analogous treatments to look at in terms of having some expectations coming in for where this valuation may land. But again, ultimately the codes will need to be reported so the codes can be progressed to the category one value for ahead of that there will be the opportunities for negotiations directly with payers by providers for reimbursement and treatment. On the staffing related question with how patients will be prepared and what delivery will look like as far as treatment models, ultimately those treatment models will be up to sites of care as part of the practice of medicine, staffing ratios, descriptions of the roles of people involved. The language that will ultimately end up in our REMs will be a result of discussion with FDA in due course during the review period. We have been guided to expect to this point that the REMs will be consistent with the one that exists for Spravato today as well as what FDA have prepared in the briefing materials for Lycosis ADCOM which use language to the effect of a prescriber available a licensed healthcare provider on site and these of course are the important elements in terms of having the sufficient experience and training of providers necessary to ensure safeguarding patients. Julian on behalf of Paul Great, thank you very much. Your next question comes from line of palmates of stifel. Your line is open. Hey, thanks so much. This is Julian on for Paul Matteis. Appreciate you taking our questions and congrats on all the great progress. Just two from us. What are your expectations for rate of re-treatment after 2 initial doses vs 1 initial dose? Thinking about the 006 26-week data coming out and how you think that will be assessed by FDA with respect to implications for labeling. And then our second question is from your commercial work, have you been able to identify what proportion of patients being prescribed Spravato (esketamine) are at large academic medical centers versus private practice clinics and curious how that may or may not influence your commercial strategy. Thank you. Kabir Nath Thanks Julian. So yeah, on the first question as you know from what we've already shown we saw that there was a 25% of patients had a clinically meaningful response in from that single administration of COM 360 and we saw that that was 40% in.0006 with the addition of the second fixed dose. So clearly we are expecting that higher level of response to be sustained through 26 weeks. But we really do need to see the data to understand what the potential impact of a third dose for those who had it maybe. And indeed what the second dose after week three does for sustained response without necessarily a third dose. So turning to what that means on our star, but Laurie and Steve may want to jump on here. We are seeking a label that essentially says from one or two doses and then with further episodic dosing at the provider's discretion. So that gives discretion because clearly if somebody responds very well to a first dose, there may not be a need for something within three weeks or a short time period. But equally, we clearly saw so far that there are patients who do benefit from having that second dose three weeks apart. So that's how we're thinking about label. Lori Engelbert And then I'll hand to Laurie and Steve to talk about first that and then the percentage of patients. Steve Levine (Chief Patient Officer) Yep, I agree with Kabir's. Hi Julian, by the way, this is Lori. I agree with Kabir's assessment on what we're seeking for the label. The 26 week data that we're getting from 06 combined with the 005 data is really going to be used to help guide clinical decision making from the field force as we're out educating providers. So Steve, anything you want to add on that in terms of the Spravato (esketamine) patients being treated in academic centers versus the more what everyone calls the interventional psychiatry treatment centers,, the academic centers are treating very, very small portion. It is, I think less than 5% of patients are actually being treated at academic. And so the primary focus of ours will be at launch on the interventional psychiatry treatment centers, that are currently prescribing Spravato (esketamine), which is at about 7,500 already. And I'll just add to that that we do engage with many academic centers. We hear a lot of excitement for them about the potential of implementing COMP360. So we do expect academic sites to deliver COMP360. The nuance is that they are typically not built to have high volume operations. They tend not to treat high volumes of patients. They don't have the kind of throughput that the interventional clinics have. So they will deliver the treatment. But reflective of the breakdowns that we see with Spravato (esketamine) prescriptions, we expect that to be similar with those centers having a higher capacity to treat more patients. Joshua Schimmer Super helpful. Thanks for the color. Your next question comes from the line of Joshua Schimmer of Cantor. Your line is open. Great. Thanks for taking the questions. How are you thinking about the incremental capacity for COMP360 administration at the 7,300 or so interventional psych pathways? And is there any way to quantify that? And then what percent of the centers do you expect be adopting the buy-and-bill model for comp 360 early on? And how do you expect that to evolve over time? Thank you. Kabir Nath Thanks Josh. I'll open those to Steve. Steve Levine (Chief Patient Officer) Hi Josh, good to hear from you. Thanks for the question. So on the capacity side, you know, we know that these centers have existing capacity today and it's, you know, it's an important consideration when we often get questions about how these sites will make decisions about which treatment to deliver and whether they're making trade offs based upon reimbursement that they may receive for delivering various treatments. First of all, these sites know that there are huge unmet needs for the treatment resistant depression population. They are excited to have more tools available and to have the opportunity to make decisions of which treatment to deliver. But in the meantime, given especially that a Spravato (esketamine) room and the Spravato (esketamine) staffing model are the same as what we anticipate to be required to deliver COMP360, they don't need to make any adjustments in their centers today in order to have capacity to deliver the new treatment. They'll be able to use the rooms interchangeably. It is likely that within the same day they may treat a patient with COMP360 and one with Spravato (esketamine) later in the day. Or that over the course of the week these rooms may be used for either treatment. So there's plenty of existing capacity that they will first fill prior to adding additional space should they have the good problem. From their perspective of treating lots of patients and running out of capacity, the economics are very favorable for them to add space or add new locations. On the buy and build part of the question, you know, what we've seen with Spravato (esketamine) is that the penetration of buy-and-bill relative to specialty pharmacy reimbursement has increased over time. We don't know the exact numbers. We believe it's somewhere between 35 to 45% of Spravato (esketamine) prescriptions at this point are buy in bill. This is something that the psychiatry model has not been used to prior to the advent of Spravato (esketamine). But they are beginning to recognize the economic value processing claims in this way. So we would, and I'll hand to Laurie to augment this, but I think we would expect that in the earliest days of launch, more sites may, as they get used to delivering our treatment, initially work with the specialty pharmacy channels. But we would quickly expect them to adopt buy-and-bill and for that to increase over time. Lori Engelbert Yeah. Only thing I'll add there, Josh, is that, you know, we will enable buy-and-bill both at launch. And so that is, you know, just an important nuance to add, is that it will be enabled. But we do, you know, from a realistic expectation standpoint, expect there to be a little bit of a ramp to heavier buy and bill. Judah Fromer Great. Thanks very much. Your next question comes from line of Judah Fromer of Ms. Your line is open. Yeah. Hi guys. Thanks for taking the question and congrats on all the progress. Maybe just a follow up on, you know, kind of how providers are thinking about potential administration. I think there's, you know, a little bit of discussion about whether, you know, psychedelic treatments should fit into that spravato dosing window versus maybe something longer that COMP360 would take. Can you just remind us from the provider's perspective, the economics of turning over a room maybe two or three times for multiple Spravato (esketamine) applications versus maybe a single administration of COMP360 and what the economics look like relative to each other? Thank you. Kabir Nath Thanks, Judah. This is Steve's favorite question. Steve Levine (Chief Patient Officer) Yes, thank you for the opportunity to talk about this, Judah. So exactly as you said, there are inefficiencies with shorter treatments and needing to turn a room over multiple times in a day, because this is, I guess, self evident. But when you have time in between patients where you need to turn the room over to clean it, the administrative work of an additional patient, etc. That is a gap that is unreimbursed time. Therefore, if you are able to fill that room with one patient and you are reimbursed for the entire time that the patient is in that room, then that is much more efficient for these sites. To put some numbers to it, if you consider that a site operating at full capacity, which as I just said earlier, doesn't exist, these sites have plenty of capacity. But to be conservative, let's say they're at full capacity and then let's say they're maximally efficient, which most sites also are not, that would mean they could get three spravato patients in a room in a day with average reimbursement for a spravato session somewhere south of $300. But using as round numbers, then that means they're potentially being reimbursed for the room at $900 per day that works for these sites. That is not ideal necessarily in their minds. And so that's really kind of the target that would be, you know, the minimum that they would need if they were just purely making these trade offs. That makes us very confident that this will make sense for them. But in addition, if we consider that the observation time for comp 360 will probably be about six hours within a typical operating day for these sites, it means they could also most likely get a Spravato (esketamine) (esketamine) patient in that room too. And since most of these sites aren't having more than one Spravato (esketamine) (esketamine) patient in that room in a day anyway, this is all upside. This is all additive for them. OPERATOR Your next question comes from line of ritu Barel of TD Cowan. Your line is open. Ritu Barel Thanks for squeezing me in, guys. Steve, you mentioned the RUC committee of the ama. So our understanding is that this committee meets once a year and unfortunately has only one psychiatry rep and it's very sort of surgeon dominated. Is there anything that you guys can do? Well, first of all, do you know when this rep committee is scheduled for the year? And second, is there anything you can do as far as prep for this committee to sort of optimally communicate the value proposition of comp 360? And then I've got a follow up on the DEA discussions. Have you been in communication with the DEA proper and do you have an idea at this point if communications and review of the FDA will start even before the NDA is complete? Or would you expect that this would still be sort of expedited review on the tail end of approval? And then if I can just ask a quick follow up after that, what are your expectations for the Risk Evaluation and Mitigation Strategies (REMS) insofar as the requirements for administration as well as either preparation and consolidation afterwards, like what will actually be required by the REMs? Because we've heard from doctors that that will be absolutely the most important thing. Kabir Nath Thanks, Richu. So I'll ask Steve to comment on the ruc. I'll take the DEA question with Laurie Steve Levine (Chief Patient Officer) and then Steve will take the REMS questions. It'll be a sandwich. Okay, starting with the RUC portion. You asked about the date of the next RUC meeting. I don't have the schedule on the top of my head. We can follow up on that. But to the rest of it, you're correct that historically there has been maybe overrepresentation. Let's say on the ruck of surgeons and other procedurally focused committee members that has been shifting. Fortunately, I don't know exactly how many psychiatrists are currently sitting on the committee, but there has been an effort to correct the historical imbalance and the representation on the committee. When we did the initial work on the Category three code a few years ago, we took advice from a number of people, including those who had served on the RUC in the past.. So we, you know, we were very well informed. Heading into the initial application for the category 3 code, we will continue to work with experienced consultants as the code progresses to Category one and make sure that this goes in a direction that is very favorable to ensuring that there is adequate reimbursement to ensure patient access. I will hand over for the second part of the question and be back with you on rems. Kabir Nath Yes. So Richard, on the dea, I mean, as you know, the executive order mentions the fact that the analysis could potentially start as soon as Phase three is completed. After further conversation with those responsible for that, it's clear that the intent is that the DEA and the FDA can arrive at their conclusions simultaneously. However, it would still be a sequential process. So essentially we will provide an eight factor analysis. The controlled substance staff within the FDA will then review that. Historically they have submitted their findings at the end of the review period because that's just the way the Food and Drug Administration (FDA) has worked. That could potentially be accelerated with the DEA then doing their sequential review. But all of this coming together in time, on the same day or a day apart at the end of it, that's the intent where we will actually get to in practice, we will have to see. Lori Engelbert The only thing I'll add hi Ritu, the only thing I'll add is that we are working with DEA consultants as well as accelerating our timelines to when you would traditionally communicate with the DEA so that we can reach a further understanding. But to for planning purposes, as of right now, we are not planning for. We will be ready if there's anything that happens before, but we see no indication that these timelines have shifted forward Steve Levine (Chief Patient Officer) and then back to me for REMs. Steve, again, so you're referencing in our clinical trials that we had spent time preparing patients ahead of administration, supported them on the day of administration, and then followed them up for safety after. Within a clinical trial context, it was important that everyone had the same conditions, the same experience, that everything was highly standardized. And so in that context we specified a number of preparatory sessions as an example, as well as a standardized length of those visits. As this translates into real world care delivery and how this will be guided by the rems. What becomes most important is not a certain number of sessions or a length of those sessions, just that patients are adequately prepared and they are properly followed up for safety. And so anything that would be in a Risk Evaluation and Mitigation Strategies (REMS) would be very typical of Risk Evaluation and Mitigation Strategies (REMS) language and not get down to the granular level of detail of dictating the practice of medicine. The reality is that with any treatment there is some preparation and safety follow up anyway, so much as any necessary language that just gives a little bit of guidance on what activities are important in terms of preparing patients. And that would include being enrolled in the REMs, having informed consent and so on, and then ensuring that patients are followed up afterwards as a safety check. Madison Elsadi Your next question comes from the line of Madison Elsadi of B. Riley Securities. Your line is open. Hi, thanks for taking your question. A couple from us. Maybe what have you learned about the Commissioner's National Priority Voucher (CNPV) mechanics since receiving the award a couple weeks ago? Should we think of this one to two month Commissioner's National Priority Voucher (CNPV) review clock as not really starting until that final module is submitted? Or has it, I guess to some degree already started, which would imply the FDA response closer to one month versus two months and then afterwards a unrelated follow up? Kabir Nath Yes, thank you for the question. So our understanding is certainly that that formal one to two month goal is following the completion of the NDA submission. However, what it also does imply clearly is an even more flexible and responsive way of working with the agency. As we've said before, we already have an excellent relationship with the psychiatry division. It's collaborative, it's constructive, it's focused on solving problems. And what we've already seen in the last couple of weeks is that that is even more so. And in particular, you know, some of the standard timelines of 30 days to request a meeting and X days for a response and so on, those have gone away entirely. So this really is about first, a much more flexible day to day interaction with the agency. But no, the actual formal clock of that one to two months, as we understand it, will only start with the submission. And again, to be clear, that's a goal. Yes, it's a goal that they can complete it within a couple of months. Madison Elsadi Understood. That's great to hear. And then secondly, so many of these sites offer Transcranial Magnetic Stimulation (TMS) based on what we know, or what we believe we know about how psilocybin works, about how Transcranial Magnetic Stimulation (TMS) works, do you think there may be an additive or even a synergistic effect from Combining these treatments. Thanks. Kabir Nath That's definitely a Steve question. Steve Levine (Chief Patient Officer) Thanks, Madison,. Yeah, that's an intriguing one. It's something that has been raised to date. It's really a matter of speculation. You can concoct theoretical reasons why there may be synergies. Be good to see some data. I know that there's at least one small academic study already looking at concurrent use of these two modalities. I'm sure that the sites that deliver Both treatments, both TMS and COMP360, may be interested in that question. And if they do, I hope they track outcomes and we gather data and have some guidance on, on whether that may be an effective approach. Ultimately, you know, these sites are ecosystems of care. They offer multiple treatments. They're trying to offer as many tools as possible for these patients and maximize their outcomes. Treatment resistant depression is for many patients a chronic condition and they will receive many treatments over a lifetime. And so whether these treatments are combined in some way or whether over time they wind up having multiple of them, we would expect that somebody receiving their care in one of these sites may have more than one of these treatments over the course of their care. Lori Engelbert And Madison, if you don't mind, I'll chime in as well. You know, part of the benefit of us producing the data in treatment resistant depression is that we believe that there's a huge unmet need. Svravato is the only indicated product, drug product being used right now in this patient population. And given the frequency of treatment that Spravato requires, it is often patient prohibitive. And so in order for patients to want to receive these type of treatments, it has to fit into their schedule. And we believe com360 brings a very complimentary patient profile, patient friendly profile to these patients. So we expect comp360 to be earlier line than where TMS is currently being used right now, which is traditionally one of your later to last lines of treatment. Madison Elsadi Understood. That's very helpful, thanks. Your next question comes from the line of Patrick Trucchio of HC Rin Wright. Your line is open. Thanks. Good morning. A few questions. The first is regarding the phase three trial, the comp 006 for the part B 26 week data that's expected in the third quarter. Can you tell us first just which measures will be released at that time? Is it sort of maintenance of greater than 25% Madrid reduction, remission, durability, time to relapse, treatment frequency, patient reported outcomes as well as safety, and which parts of those data matter most for the NDA as Well, as the label and payer discussions. Patrick Trucchio Yeah. So Patrick, we haven't yet determined what we would release publicly. From a simple perspective, all of that data will be necessary from an NDA perspective. So clearly everything, all those endpoints, primary, secondary, all the safety data will clearly go to the fda. And I'll hand to Laurie to talk Kabir Nath about the commercial piece. Lori Engelbert All of that data will also be important for payer and clinical decision making, which we will all have in due course to help inform all of those decisions. But in immediate discussions with payers, it will be the redosing and the durability piece that we are really looking for so that we can inform payers on how many doses to expect per patient,. Steve Levine (Chief Patient Officer) And Steve, and just one add, Sorry Patrick. Just one thing to add to that, which is similar to what we guided prior to the release of Part B of 005. Just to be clear, there isn't a particular bar, there isn't some number that's a measure of success there. It is important data, but it's data to really round out the profile of the drug and as Laurie said, to have discussions with payers to guide expectations clinically with providers. So there's nothing that we're rooting for necessarily. We just need to understand the longer term trajectories of these patients. Patrick Trucchio And then just on the commercial side, more specifically, I'm just wondering if you can talk more about just your launch readiness and being ready by the end of the year and you know, to what extent, you know, you've, you've begun that process of, you know, hiring a field force and building out a REMS infrastructure and you know, sort of discussed, you know, the sort of the structure with payers and distribution contracts and as well related to that, you know, of the 7,300 centers that you know, could offer the treatment, or greater than 7,300 centers, how many have you actively engaged with and what proportion do you think are ready or will be ready to administer Comp360 within the first three to six months after approval. Lori Engelbert So given the work of the strategic collaborations that we've been doing for several years now, which really sets us up for, for success and also enabled us, you know, largely to be able to be, to say that we would be launch ready under such short timelines. I'm going to let Steve answer that last question and then I'll answer your original question at the end. We're flipping it around in reverse order. Okay? Steve Levine (Chief Patient Officer) Yes. So in terms of the sites that we've engaged with and will be Ready. As Laurie said, we've been working with sites like this for quite some time now. Whether it's formally within our strategic collaborations, whether it's engagement by our field medical team as they've been out for the past couple of years, meeting with healthcare providers around the country, or other relationships we already have with the leadership of these organizations, I think it's fair to say that we've engaged with the vast majority and we know really many of them quite well. It is that level of engagement and knowing them that well that gives me a lot of confidence to say we don't need to encourage these sites to get ready. They're almost more excited than we are. This is really why they've built the infrastructure in the first place. It wasn't to deliver one treatment, it wasn't to deliver Spravato. It was an anticipation of having more treatments, particularly ones with a profile like confli6 to the feedback we've been getting since the last data release is that they are just so excited for their patients to have a treatment that has this rapidity of effect, this durability of effect, which is on a scale far different from anything they've had available to them to this point. The ability to recruit patients from a much larger radius, to the point that Laurie made earlier about the burden on patients of the frequency of treatment with Spravato, but particularly, particularly with TMS needing to come every day, it's really hyper local patient recruitment with COMP360, with just one or two treatments, they're able to have patients travel from much further area. So they are excited. They are really bombarding us every day with questions of, you know, when are you going to be approved? You know, what do we need to know? So they will be ready? Yeah. Lori Engelbert And Patrick, so will we. And so hopefully you can hear through mine and Steve's excitement, collective excitement here about this, this particular topic, just how confident we are in the fact that we are not only building out a pretty remarkable team. This team, this leadership team, getting them on board first was very important so that they could start to build out their teams. And all of that is underway right now. So every single aspect of infun within a commercial organization has a remarkable leader at the helm. And they are, they are currently in the process of building out and have already expanded the team. The team has already doubled in the past two months. And so we are well on our way of making sure that we are adequately prepared. All that. Everything you mentioned is underway. So, you know, compliance, payer Discussions are beginning right now. The negotiating piece. I just want to set expectations on the negotiating piece with the payers. We won't start negotiations until we understand the clinical profile better of comp360, as we mentioned before. But we certainly are engaging with payers to start those initial discussions. Right now. Trade and distribution is well on its way. We are working there to understand what our distribution strategy is. And again with some really, really remarkable leaders and very, very experienced activities. Patrick Trucchio Terrific. Thanks so much. Thanks, Patrick. Leonid Timoshev Your next question comes from the line of Leonid Timoshev of RBC Capital Markets. Your line is open. Hey guys, thanks for taking my question. I wanted to ask on ptsd, obviously another part of the executive order was significant underlying excitement for treating ptsd. So I guess I'm curious how you're thinking about your program specifically, whether there's any changes you're envisioning to the trial, whether you think the evidentiary standards may be lower and you can move ahead with just one phase three registrationally and given the focus on veterans from the administration, whether there's plans to explore that subpopulation more deeply. Thanks. Kabir Nath Thanks Leo and I'll start on that. So first, yeah, we agree PTSD is a very significant unmet need. As we have said, we are planning that as a single late stage trial. Obviously we will have to see what the data says and so on because ultimately it will be a FDA decision around that. Within that trial we will have VA sites. More broadly though we are already heavily engaged with the va and I'm going to hand to Steve to talk a little bit about what that is. Just before I do, we should also note that it is now publicly available. We are supporting a study within the VA which is a very robust clinical study which is a TRD population with heavy Post-Traumatic Stress Disorder (PTSD) comorbidities. So that study we're also supporting. But I'll hand to Steve to talk Steve Levine (Chief Patient Officer) more broadly about the work we're doing for the VA. So thanks Kabir. Yeah, PTSD is an area where we are really excited. This is 13 million US adults who currently have very few options, terribly underserved. So really excited to be moving this program forward. As a reminder, the design of this study was from the beginning intended to support registration with a single trial. And so that still remains the aim. As Kabir said, we already are engaged with the VA in VArious ways. He mentioned the study that we are supporting. We are supplying the drug as well as the training of the initial cohort of trainers for a large multi site VA study looking at people living with both treatment resistant depression and PTSD in addition to a second study as well within the VA. Beyond that, we have had active engagement for quite some time now with VA's Integrated Project Team, which has been working for multiple years now on their preparations to be able to implement psychedelic treatments as they're approved. So that engagement is robust and ongoing and it certainly is a priority for us to ensure that as we bring new treatments to market that these are aVAilable for our veterans. Sument Kukarni Your next question comes from Land of Sument Kukarni of Canaccourt Genuity. Your line is open. Hi team, thanks for taking our questions. I have a few here. First, how do you expect competitive and legal dynamics on COMP360 to play out given Usona Institute also has a national priority voucher for its product and could already have its phase three data in house for major depressive disorder. Kabir Nath So I can only comment on the fact that we Sumant at Compass Pathways Compass have two very large Phase three trials where we we've already declared the primary endpoint and we've agreed on a rolling submission and review plan and that's what we're focused on right now. Sument Kukarni Thank you. And do you expect a label limit on the number of treatments per year for COMP360 and how soon after a patient needs retreatment would they be able to get it in the real world? Kabir Nath No, but I'll hand from a kind of commercial payer perspective to Lori Engelbert I'll speak to it from the payer standpoint. Steve can speak to it from a clinician standpoint. So agree with CAVIR completely. We expect no limit in the label. We will through negotiations be discussing with payers what that looks like and if there would be limits from a prior authorization reapproval process that is, you know, not only standard practice, especially with these type of treatments, but also should be expected. But it is again not going to be overly onerous for the sites. Nor again is this outside of the norm of what happens in clinical practice right now. Steve Levine (Chief Patient Officer) Well, just to answer the last part of your question, Samantha, about the treatment frequency or the intervals, what we've seen so far is that some patients have some benefit from a second administration, whether it's on the fixed interval three weeks after the first, or on a more variable basis as we saw in part B of 005, because the minimum interval we studied is three weeks, I would expect that there likely would not be dosing closer than three weeks apart,, though really clinically would likely not be a reason to otherwise. You know, I think the upcoming data from part B of the longer term progress in 006 but together with part B of 005 will help give some guidance to clinicians on how they would think about retreatment and then otherwise. As Laurie said, that would be further guided by payer policy. Sument Kukarni Got it. And then last one on ptsd, other than less frequent dosing, what are the key reasons that would make patients want to take com360 versus Asuka transcends TSMD201 noribogaine normethalone. Kabir Nath So they are likely to be first, we need to see data in terms of efficacy and safety on both of them. Clearly they are likely to be very different experiences from a patient perspective. These are very different medicines with different mechanisms of action (MOAs). To your point, certainly the Transcend protocol hitherto has been more burdensome from a patient perspective as well. But I think we will need to see how those are fully characterized through the clinical trials, both in terms of patient experience, provider experience and infrequency of administration. There's clear differentiation between them. And to be clear, there hasn't been an approved drug in PTSD this century. There are only two approved options right now. Both are all generic Selective Serotonin Reuptake Inhibitors (SSRIs)s that are only modestly efficacious. More options. More options. Right. There's 13 million people with PTSD. It is not one or the other. There's not going to be one winner here. We are excited for any new option that is safe and efficacious in this population. The patients living with PTSD deserve to have more treatment options. Jenny Kim Thanks. Your next question comes from the line of Tom Schrader of btig. Your line is open. Good morning, this is Jenny Kim on for Tom Schrader. Thank you for taking your questions and congrats on all the progress. A couple of PTSD questions. What's the primary endpoint for the PTSD Phase 2b3 trial? And has the FDA aligned on that endpoint in a special place protocol assessment? And in the TRD program, the two doses of COM006 were administered three weeks apart. But in COMP0COMP202 for PTSD, you've landed on a four week interval. Could you walk us through the clinical rationale for that difference? Kabir Nath Sure. So the primary endpoint is the CAHPS 5, which is very well validated as the normal primary endpoint in ptsd. So we are using the standard primary endpoint. And because the CAHPS 5 requires a four week look back, practically speaking, the second dose has to be at four weeks. It can't be at three weeks. That's the reason for that. So it's tied to that endpoint. But as I say, this is the standard endpoint that has been used in PTSD trials. And no, there is no spa on this. There doesn't need to be. Jenny Kim Okay, thank you. Jay Olsen Your next question comes from the line of Jay Olsen of Oppenheimer. Your line is open. Well, hey, congrats on the progress and thanks for taking our questions. Maybe we'll just follow up on ptsd. Could you talk about any synergies that you expect to capture from the infrastructure that you're building for trd? And also what are some of the differentiating benefits to psilocybin versus other compounds being used or studied for ptsd? And then maybe just any other indications you're planning to pursue for psilocybin beyond Treatment-Resistant Depression (TRD) and ptsd. Thank you. Kabir Nath So we'll go backwards through these. So, you know, and I'll leave Steve and Laurie to talk both about synergies and some of the reasons to believe. So we're clearly very focused on some of these broader neuropsychiatric conditions that do indeed share synergies in terms of patterns of prescribing, locations of treatment, and so on. While we haven't made any determination on other areas, you can imagine there are some, such as bipolar 2, Obsessive-Compulsive Disorder (OCD), in all of which we have seen signals based on IISS and studies we've supported, but we don't, not yet in a position layout formally where else we might go? So let me hand to Laurie to talk about kind of the commercial synergies and then maybe Steve to touch on reasons to believe suicide. Lori Engelbert Yeah. Given the high overlapping comorbidities with between Treatment-Resistant Depression (TRD) and ptsd, you know, the infrastructure that currently treats will be the same infrastructure that treats for Treatment-Resistant Depression (TRD) patients. So the synergies are exceptionally high. Steve mentioned earlier the work we're doing at the va. Obviously, there's a large focus on PTSD patients at the va. So we fully anticipate that the VA will be. Will be well equipped and ready to treat patients once it becomes available. And from a salesforce standpoint, there would be very minimal change to the salesforce to add on ptsd. Steve Levine (Chief Patient Officer) And then the last part. Nice to talk to you, Jay. One of the things that we saw in our phase two study in ptsd, one of the reasons, along with the opportunity to meet the unmet needs for these patients, was the experience that our patients had in that study. We were able to do qualitative interviews with the participants and we heard some really Important feedback that seems highly differentiated from other options that are available for patients living with PTSD or are currently being investigated. And that is that one of the reasons why people often avoid PTSD care is that they're forced to confront exactly the source of their trauma, which is a very frightening prospect. It can make treatment itself very distressing. It's something that we're aware comes up with some of the pathogenic treatments like mdma, where these are very intensive sessions. It's the reason why many cases, these are studied with psychotherapy, with trained psychotherapists actively engaging with them as traumatic material, comes up. What we saw in our phase 2 study, which was largely focused on safety, feasibility, acceptability, was that this is a very acceptable treatment, one that was very pleasant for patients where the trauma itself didn't even necessarily come up during the experience. And that was something that surprised and was gratifying to them afterwards that, you know, despite the fact that they weren't forced to go through such a traumatic experience in getting treatment, that they had profound shifts in the emotional response relationship to that trauma. And so we think that bodes really well for this, the further development of this as a potential treatment because of that really positive patient experience. OPERATOR Super helpful. Thank you. With no further questions, that concludes our Q and A session. I will now turn the conference back over to management for closing remarks. Kabir Nath Thanks everyone for your participation today. As you've heard, we are excited by the fact that we are aligned on a rolling submission review with the fda. We were already aligned on that before the award of the cnpv, but that clearly validates and is a recognition of the really great work we've done, the robust data that we have generated. So as you heard, we are working with the FDA and DEA to see if there are other further opportunities for acceleration. Most importantly though, you've heard how excited we are about the opportunity to launch a first in class psychedelic. As we talk to providers, patients, current employees, prospective employees, everyone truly sees this as the opportunity of a lifetime and we are delighted to be in the forefront of that and leading the way in establishing psychedelics as a transformative new option for patients in need of new treatments. So thanks for your attention and we look forward to updating you on our continued progress during the remainder of the year. Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice. UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. This article Transcript: Compass Pathways Q1 2026 Earnings Conference Call originally appeared on Benzinga.com ﾩ 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Compass Pathways (NASDAQ:CMPS) shares rose 14% after it reported first quarter results that topped expectations and showed continued regulatory progress for its lead therapy COMP360 in treatment-resistant depression. For the quarter, Compass reported an adjusted loss of $0.30 per share, coming in ahead of analyst expectations of a loss per share of $0.43. The result reflected lower-than-expected operating costs alongside ongoing progress in its late-stage clinical programs. Operating expenses declined year over year, with both research and development and general and administrative costs moving lower. R&D spending decreased as the company’s Phase 3 COMP360 program advanced toward completion, reducing clinical trial activity and related development expenses. Compass ended the quarter with $466 million in cash and cash equivalents, supported by financing and warrant exercises, providing runway into 2028. The company also said the FDA has granted a rolling New Drug Application (NDA) submission and review for COMP360, with portions of the filing already submitted. Compass also received a Commissioner’s National Priority Voucher (CNPV), which could materially shorten review timelines once the application is complete. The company reiterated plans to finalize its NDA submission in the fourth quarter of 2026, with additional Phase 3 durability data expected in early Q3. “With regulatory acceleration unfolding, we are working diligently towards our goal of completing the filing of a robust clinical package by Q4 and securing COMP360 approval,” Compass Pathways CEO Kabir Nath said in a statement. “COMP360 represents a fundamentally different approach for patients with treatment resistant depression, unlike any other treatment approved today.” Jefferies analysts said they see a high likelihood of FDA approval for COMP360 around year-end 2026, followed by DEA rescheduling and a potential commercial launch in early 2027. They highlighted the upcoming 26-week Phase 3 data readout as a key step enabling the rolling NDA completion and noted the CNPV could support a rapid one- to two-month review process. The analysts described COMP360 as a potentially large commercial opportunity in treatment-resistant depression, comparing its infrastructure needs to existing esketamine-based therapies such as Spravato, and suggesting the treatment could be integrated into many of the more than 7,000 US treatment centers already operating in the space. Jefferies said its base case assumes a launch in early 2027 with meaningful uptake supported by existing clinic infrastructure and reimbursement pathways, and sees long-term peak sales potential in the multi-billion-dollar range if adoption trends prove favorable.

This article first appeared on GuruFocus. Release Date: May 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Compass Pathways PLC (NASDAQ:CMPS) has demonstrated positive data from both Phase III studies, showing clinically meaningful efficacy for COMP360 in treatment-resistant depression (TRD). The company has received a Commissioner's National Priority Voucher, which could accelerate the review timeline for COMP360's NDA submission. Compass Pathways PLC (NASDAQ:CMPS) is preparing for a potential accelerated launch of COMP360 by the end of the year, with strategic collaborations and commercial preparations underway. The company has a strong balance sheet, with cash reserves expected to last beyond the launch and into 2028. There is significant excitement and engagement from treatment centers and the VA for the potential of COMP360, indicating strong market interest and readiness for adoption. The FDA's decision on whether to hold an advisory committee meeting for COMP360 is still uncertain, which could impact the review process. There is no final determination on the release of long-term data from the 52-week study, which could be important for pricing and labeling discussions. The reimbursement process for COMP360, including the transition from CPT-3 to CPT-1 codes, is still in progress and may affect provider adoption. The DEA's rescheduling process for COMP360 remains sequential and could delay the timeline for federal approval and market entry. The competitive landscape for psilocybin treatments is evolving, with other companies like Usona Institute also pursuing similar indications, which could impact market share. Warning! GuruFocus has detected 2 Warning Sign with CMPS. Is CMPS fairly valued? Test your thesis with our free DCF calculator. Q: Based on your ongoing FDA discussions, has the FDA given any indication whether there will be an ADCOM for COM360? A: Kabir Nat, CEO: The FDA will decide on holding an advisory committee once they see the totality of the data submitted. We are prepared for one if necessary, but currently, we have no indication of whether it will happen. Q: When you share the 26-week Part B data from the COMP006 study, would you consider sharing additional long-term data from the 005 study? A: Kabir Nat, CEO: We haven't made a final decision on what we'll share, but we recognize the potential value for payers and commercial purposes. We will decide in due course. Q: Can you explain the importance of the third quarter data for implications and why it's still a gating factor to complete the filing? A: Kabir Nat, CEO: We had already aligned on our rolling submission plan with the FDA before recent developments. The CMPV potentially accelerates the final review, but it doesn't change the evidentiary basis needed for approval. The 26 weeks of '06 data is significant for finalizing the profile and commercial purposes. Q: Can you give more details on reimbursement and the CPT codes? A: Steve Levine, Chief Patient Officer: The CPT-3 codes are in a tracking form and will progress to a valued form as they are reported more. This will enable the AMA's RUC committee to make a recommendation to CMS on valuation. Negotiations with payers for reimbursement will occur ahead of that. Q: What are your expectations for treatment after two initial doses versus one initial dose, and how will the FDA assess this for labeling? A: Kabir Nat, CEO: We expect a higher level of response with two doses to be sustained through 26 weeks. We are seeking a label that allows for one or two doses with further episodic dosing at provider discretion. Q: How are you thinking about the incremental capacity for COMP360 administration at interventional sites, and what percent of centers will adopt the buy-and-bill model? A: Steve Levine, Chief Patient Officer: These centers have existing capacity and can use rooms interchangeably for COMP360 and Spravato. We expect buy-and-bill penetration to increase over time, similar to Spravato. Q: What are your expectations for the REMS requirements for administration and preparation? A: Steve Levine, Chief Patient Officer: The REMS will likely be consistent with existing ones for similar treatments, focusing on ensuring patients are adequately prepared and followed up for safety, without dictating the practice of medicine. Q: Can you discuss the synergies you expect to capture from the infrastructure built for TRD when addressing PTSD? A: Laurie Engelbert, Chief Commercial Officer: The infrastructure for TRD will also treat PTSD patients, with minimal changes needed. The VA is well-equipped to treat PTSD, and the salesforce will require minimal adjustments. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Shares of Compass Pathways (NASDAQ:CMPS) climbed nearly 8% in premarket trading on Wednesday after the company reported first-quarter results that exceeded analyst expectations and highlighted important regulatory advances for its COMP360 psilocybin-based treatment. Compass Pathways posted adjusted earnings per share of -$0.30 for the quarter, beating analyst forecasts of -$0.43 per share. The company continues progressing toward regulatory approval for COMP360, its investigational treatment for treatment-resistant depression. Compass said the U.S. Food and Drug Administration granted the company permission for a rolling New Drug Application submission and review process following positive Phase 3 trial data. The company also received a Commissioner’s National Priority Review Voucher, which could shorten the FDA review timeline to approximately one to two months after filing. Research and development expenses fell to $26.5 million during the three months ended March 31, 2026, compared with $30.9 million in the same period a year earlier. Compass said the reduction reflected lower clinical trial costs as its Phase 3 programme approaches completion. General and administrative expenses also declined to $16.4 million from $18.7 million last year, primarily because of reduced legal and professional service expenses. The company reported net income of $91.2 million, equivalent to $0.71 per basic share and -$0.30 per diluted share. In the same period last year, Compass reported a net loss of $17.9 million. The improvement was mainly driven by a non-cash fair value adjustment gain of $130.9 million related to warrants. “COMP360 represents a fundamentally different approach for patients with treatment resistant depression, unlike any other treatment approved today,” said Kabir Nath, chief executive officer of Compass Pathways. Cash and cash equivalents totaled $466.0 million as of March 31, 2026, compared with $149.6 million at the end of 2025. The increase followed successful financing transactions and warrant exercises completed by the company. Compass said its current cash position is expected to support operations into 2028, extending well beyond the company’s anticipated commercial launch timeline. The company remains on schedule to complete its final NDA submission during the fourth quarter of 2026 and expects to be commercially launch-ready before year-end. Compass Pathways stock price