Earnings Call Transcript - CMPS Q1 2026

Operator, Operator

Good day, ladies and gentlemen, and welcome to the COMPASS Pathways First Quarter Results Conference Call. The call is being recorded. I would now like to introduce your host for today's call, Stephen Schultz. You may begin.

Stephen Schultz, Senior Vice President, Investor Relations

Welcome all of you, and thank you for joining us today for this conference call. I'm Stephen Schultz, Senior Vice President, 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; and Dr. Steve Levine, our Chief Patient Officer, will 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, Chief Executive Officer

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 treatment-resistant depression (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 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 major depressive disorder. 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 two 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 COMP360 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 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 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 Lori for more on our commercial preparations.

Lori Englebert, Chief Commercial Officer

Thank you, Kabir. Hi, everyone, and thank you for joining. Today, there are 4 million patients with major depressive disorder 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 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 I 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 as smoothly as possible. We have also been working at the state level for 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 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 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 accrued 62% more mental health care costs and experienced 41% higher work-related 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 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 field force and how we educate, train and prepare patients and the sites that will be administering COMP360. Through the insights generated by 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 launch 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 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.

Kabir Nath, Chief Executive Officer

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 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 III trials. I do want to underscore the difficulty of establishing efficacy in 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&A.

Operator, Operator

Your first question comes from the line of Andrew Tsai of Jefferies.

Andrew Tsai, Analyst, Jefferies

Congrats on the great progress and great news. I had two questions. The first one is based on your ongoing FDA discussions — has the FDA given you any inclination whether there will be an Advisory Committee or not for COMP360? Because on one hand, the review timelines could be really accelerated and FDA does seem to be moving away from advisory committees. And I can't help but think that given recent developments, an advisory committee might be considered, and maybe it would be prudent for the FDA to hold one. So I'd be curious to know where you guys lean here?

Kabir Nath, Chief Executive Officer

Thank you, Andrew. It's Kabir, just checking that you can hear us clearly.

Andrew Tsai, Analyst, Jefferies

I can hear you. Yes.

Kabir Nath, Chief Executive Officer

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.

Andrew Tsai, Analyst, Jefferies

Got it. And then secondly, when you share the 26-week Part B data from COMP006 study, 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 topline 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, Chief Executive Officer

So thanks, Andrew. Yes. So from a timing perspective, you're right that the 52 weeks of follow-up 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 in due course.

Operator, Operator

Your next question comes from the line of Francois Brisebois of LifeSci Capital LLC.

Francois Brisebois, Analyst

So just quickly here, in terms of the third quarter data implications, can you just help us understand maybe what the expectations are? And is it still a gating factor to complete the filing based on the developments that have happened recently? I just want to better understand what that data is and how important it is for the launch here.

Kabir Nath, Chief Executive Officer

Francois, may I call you Frank, please?

Francois Brisebois, Analyst

Frank is totally fine.

Kabir Nath, Chief Executive Officer

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 CNPV. 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 CNPV 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 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.

Francois Brisebois, Analyst

Okay. Great. And then can you give us a little more color on reimbursement and maybe the CPT codes—where maybe the evolution of it is. 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 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, Chief Executive Officer

I'll hand that question to Steve.

Dr. Steve Levine, Chief Patient Officer

Thanks, Kabir. On the CPT portion of the question, in terms of the work remaining for the CPT Category III codes: they are currently Category III codes, 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 are reported, that will enable the American Medical Association's RUC—the Relative Value Update Committee—with representation from the specialty societies 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 Category I value form. Ahead of that, there will be the opportunities for negotiations directly with payers by providers for reimbursement for treatment. On the staffing-related question—how patients will be prepared and what delivery will look like in terms of 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, and the language that will ultimately end up in our REMS will be a result of discussion with the 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 has prepared in briefing materials for similar drugs, which use language to the effect of a prescriber available, a licensed health care provider on site. These, of course, are the important elements in terms of having sufficient experience and training of providers necessary to ensure safeguarding the patients.

Operator, Operator

Your next question comes from the line of François Brisebois of Stifel.

Unknown Analyst (Julian on for Paul), Analyst

This is Julian on for Paul. Congrats on all the great progress. Just two from us. I guess what are your expectations for second doses versus one 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 academic centers versus private interventional psychiatry clinics? I'm curious how that may or may not influence your commercial strategy?

Kabir Nath, Chief Executive Officer

Thanks, Julian. So on the first question: as you know from what we've already shown, we saw that there was a clinically meaningful response rate from a single administration—about 25% in 005—and we saw about 40% in 006 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 is for those who haven't responded 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 label, Lori or Steve may want to add here. We are seeking a label that essentially provides for one or two doses and then with further episodic dosing at provider discretion. That gives clinical 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-term period. But equally, we clearly saw so far that there are patients who do benefit from having that second dose at three weeks. And then I'll hand to Lori and Steve to comment on the academic versus interventional clinic breakdown.

Lori Englebert, Chief Commercial Officer

Yes. I agree with Kabir's assessment on what we're seeking for the label. The 26-week data combined with the 005 data is really going to be used to help guide clinical decision-making by the sales force as we're out educating providers. In terms of the Spravato patients being treated in academic centers versus interventional psychiatry treatment centers: academic centers are treating a very small portion. It is, I think, less than 5% of patients who are actually being treated at academic centers. So the primary focus at launch will be on the interventional psychiatry treatment centers that are currently prescribing Spravato, which is about 7,500 clinics already.

Dr. Steve Levine, Chief Patient Officer

I'll just add that we do engage with many academic centers and hear a lot of excitement from them about the potential of implementing COMP360. We do expect academic sites to deliver COMP360, but 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 interventional clinics have. So they will deliver the treatment, but reflective of the breakdown that we see with Spravato prescriptions, we expect that distribution to be similar with those interventional centers having a higher capacity to treat patients.

Operator, Operator

Your next question comes from the line of Joshua Schimmer of Cantor.

Joshua Schimmer, Analyst, Cantor

How are you thinking about the incremental capacity for COMP360 administration at those roughly 7,500 interventional clinics? Is there any way to quantify that? And then what percent of the centers do you expect will be adopting the buy-and-bill model for COMP360 early on? And how do you expect that to evolve over time?

Kabir Nath, Chief Executive Officer

Thanks, Joshua. I'll hand those to Steve.

Dr. Steve Levine, Chief Patient Officer

Josh, good to hear from you. Thanks for the question. On capacity, we know these centers have existing capacity today and that is an important consideration when we get questions about how these sites will make decisions about which treatment to deliver and whether they're making trade-offs based upon reimbursement. First, these sites know 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 decide which treatment to deliver. Given that a Spravato room and the Spravato staffing model are the same as what we anticipate will be required to deliver COMP360, they don't need to make adjustments in their centers today in order to have capacity to deliver the new treatment; they'll be able to use rooms interchangeably. It is likely that within the same day they may treat a patient with COMP360 and one with Spravato, or over the course of the week these rooms may be used for either treatment. So there's plenty of existing capacity that will first be filled prior to adding additional sites. Should they have the good problem from their perspective of treating lots of patients and running out of capacity, the economics are favorable for them to add space or new locations. On buy-and-bill versus specialty pharmacy: what we've seen with Spravato is that penetration of buy-and-bill relative to specialty pharmacy reimbursement has increased over time. We believe it's somewhere between 35% to 45% buy-and-bill at this point. This is something the psychiatry model was not used to prior to Spravato, but providers are beginning to recognize the economic value. We would expect that in the earliest days of launch, more sites may initially work with specialty pharmacy channels, but we would expect them to adopt buy-and-bill over time and for that to increase.

Lori Englebert, Chief Commercial Officer

Yes. The only thing I'll add, Josh, is that we will enable both channels at launch. That is an important nuance: both specialty pharmacy and buy-and-bill will be supported. For a realistic expectation, we do expect a ramp to heavier buy-and-bill over time.

Operator, Operator

Your next question comes from the line of Judah Frommer of Morgan Stanley.

Judah Frommer, Analyst, Morgan Stanley

Congrats on all the progress. Maybe just a follow-up on how providers are thinking about potential administration. There's some discussion about whether psychedelic treatment should fit into that Spravato dosing window versus something longer that COMP360 would take. Can you remind us from the provider's perspective the economics of turning over a room two or three times for multiple Spravato administrations versus maybe a single administration of COMP360 and what the economics look like relative to each other?

Kabir Nath, Chief Executive Officer

Thanks, Judah. This is Steve's favorite question.

Dr. Steve Levine, Chief Patient Officer

Thank you. Exactly, as you said, there are inefficiencies with shorter treatments where you need to turn the room over multiple times in a day. When you have time between patients where you need to clean the room and perform administrative work for an additional patient, that is unreimbursed time. Therefore, if you are able to fill that room with one patient and are reimbursed for the entire time the patient is in the room, that is much more efficient for these sites. To put some numbers to it, if you consider a site operating at full capacity—and to be conservative, let's say they are at full capacity and maximally efficient, which most sites 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, using round numbers, that means potentially being reimbursed around $900 per day for that room. That works for these sites but is not necessarily ideal. This is the minimum they'd likely need if purely making trade-offs. That makes us confident that COMP360 will make sense for them. Additionally, if we consider observation time for COMP360 will probably be about six hours within a typical operating day for these sites, it means they could also most likely get a Spravato patient in that room as well. Since most of these sites aren't having more than one Spravato patient in a room in a day anyway, this is upside and is additive for them.

Operator, Operator

Your next question comes from the line of Ritu Baral of TD Cowen.

Ritu Baral, Analyst, TD Cowen

Steve, you mentioned the RUC committee of the AMA. Our understanding is that this committee meets once a year and unfortunately has only one psychiatry representative and is very surgeon-dominated. Is there anything you guys can do—first, do you know when this RUC committee is scheduled for the year? And second, is there anything you can do as far as prep for this committee to optimally communicate the value proposition of COMP360? And then I've got a follow-up on DEA discussions. Have you been in communication with the DEA proper? Do you have an idea if communications and review with the DEA will start even before the NDA is complete? Or would you expect expedited review on the tail end of approval? And then a quick follow-up on your expectations for the REMS in terms of requirements for administration and post-treatment monitoring—what will actually be required by the REMS, because we've heard from doctors that will be the most important thing.

Stephen Schultz, Senior Vice President, Investor Relations

Starting with the RUC portion: I don't have the exact date of the next RUC meeting on the top of my head; we can follow up on that. Historically, there has been an overrepresentation on the RUC of surgeons and other procedurally focused members. That has been shifting, fortunately, and 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 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 this goes in a direction favorable to ensuring adequate reimbursement to ensure patient access. I'll hand over for the DEA and REMS parts of your question.

Kabir Nath, Chief Executive Officer

Ritu, on the DEA: as you know, the executive order mentions that DEA analysis could potentially start as soon as Phase III is completed. After further conversation with those responsible, it's clear the intent is that the DEA and the FDA can arrive at their conclusions contemporaneously; however, it would still be a sequential process. We will provide a scheduling analysis document, the controlled substances staff within the FDA will review that, and historically they have submitted their findings at the end of the review period because that's how the FDA has worked. That could potentially be accelerated with the DEA then doing their sequential review, allowing both to come together at or near the same time at the end of the process. That's the intent; where we actually get to in practice we'll have to see.

Lori Englebert, Chief Commercial Officer

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. For planning purposes, as of right now, we are ready if there's any acceleration, but we see no clear indication that these timelines have materially shifted forward beyond what we've been planning for.

Dr. Steve Levine, Chief Patient Officer

Back to REMS: in our clinical trials we prepared patients ahead of administration, supported them on the day of administration, and followed them up for safety afterwards. In a clinical trial context, it was important that everyone had the same conditions and everything was highly standardized, including preparatory sessions. As this translates into real-world care delivery and how this will be guided by the REMS, what becomes most important is not prescribing a specific number or length of sessions, but that patients are adequately prepared and properly followed up for safety. Anything that would be in a REMS would be typical REMS language and would not dictate the practice of medicine at a granular level. The REMS would emphasize informed consent, enrollment in the REMS program, and ensuring that patients are followed up afterwards as a safety check. It would provide guidance on important activities for preparing and monitoring patients rather than specifying exact session counts.

Operator, Operator

Your next question comes from the line of Madison El-Saadi of B. Riley Securities.

Madison El-Saadi, Analyst, B. Riley Securities

A couple from us. Maybe what have you learned about the CNPV mechanics since receiving the award a couple of weeks ago? Should we think of this one- to two-month review clock as not really starting until that final module is submitted? Or has it, to some degree, already started, which would imply the FDA response could be closer to one month versus two months? And then afterwards, an unrelated follow-up.

Kabir Nath, Chief Executive Officer

Thank you for the question. Our understanding is that the formal one- to two-month goal begins following the completion of the NDA submission. However, what it also implies is an even more flexible and responsive way of working with the agency. We already have an excellent relationship with the psychiatry division—collaborative and constructive and focused on solving problems—and what we've seen in the last couple of weeks is that is even more so. Some of the standard timelines of 30 days to request a meeting and specific days for a response have become more flexible. This really is about much more flexible day-to-day interaction with the agency. But the actual formal clock of about one to two months, as we understand it, will only start with the completed submission. And again, to be clear, that's a goal—a goal that they can complete it within a couple of months.

Madison El-Saadi, Analyst, B. Riley Securities

Understood. And then secondly, many of these sites offer TMS. Based on what we know about how these modalities work, do you think there may be an additive or even synergistic effect from combining these treatments?

Dr. Steve Levine, Chief Patient Officer

That's an intriguing question and largely a matter of speculation at this point. There are theoretical reasons why there might be synergies, and it would be good to see some data. I know there is at least one small academic study looking at concurrent use of these two modalities. Sites that deliver both TMS and COMP360 may be interested in that question, and if they do study it, we hope they track outcomes so we can gather data and have guidance on whether that may be effective. Ultimately, these sites are ecosystems of care offering multiple treatments and tools to maximize outcomes for patients with treatment-resistant depression. Patients will receive many treatments over a lifetime, so whether these treatments are combined concurrently or used sequentially, we expect patients may receive more than one of these treatments over the course of their care.

Lori Englebert, Chief Commercial Officer

And Madison, I'll add that part of the benefit of producing data in treatment-resistant depression is that Spravato is currently the only approved product being used in this patient population, and given the frequency of treatment that Spravato requires, it is often prohibitive for patients. COMP360 brings a more patient-friendly profile, so we expect it to be complementary to other modalities and potentially used earlier in the treatment sequence than some options like TMS, which often are used later.

Operator, Operator

Your next question comes from the line of Patrick Trucchio of H.C. Wainwright.

Patrick Trucchio, Analyst, H.C. Wainwright

A few questions. First, regarding the Phase III trial COMP006: for the Part B 26-week data expected in the third quarter, can you tell us which measures will be released at that time? Will it include maintenance of greater than 25% reduction, remission durability, time to relapse, treatment frequency, patient-reported outcomes, and safety? Which parts of those data matter most for the NDA as well as the label and payer discussions?

Kabir Nath, Chief Executive Officer

Patrick, we haven't yet determined exactly what we would release publicly ahead of the full submission. From an NDA perspective, all of that data will be necessary—primary and secondary endpoints, durability measures, patient-reported outcomes, and all safety data will go to the FDA. I'll hand to Lori to talk about the commercial and payer perspective.

Lori Englebert, Chief Commercial Officer

All of that data will also be important for payer and clinical decision-making. In immediate discussions with payers, it will be the redosing and durability pieces that we are really looking for so we can inform payers on how many doses to expect per patient. That will be important for payer discussions and utilization expectations.

Dr. Steve Levine, Chief Patient Officer

Just to add, similar to what we said prior to the release of Part B of 005, there isn't a particular single numeric bar that defines success for the 26-week data. It's important data to round out the profile of the drug and to guide clinical and payer expectations. We're not rooting for a specific number; we need to understand longer-term trajectories of patients.

Patrick Trucchio, Analyst, H.C. Wainwright

Great. And then on the commercial side: can you talk more about your launch readiness and being ready by the end of the year? To what extent have you begun hiring a field force, building out a REMS infrastructure, and initiating payer and distribution discussions? And of the roughly 7,500 centers that could offer the treatment, how many have you actively engaged with and what proportion do you think will be ready to administer COMP360 within the first three to six months after approval?

Lori Englebert, Chief Commercial Officer

Given the work of our strategic collaborations over several years, which set us up for success, and having built relationships across the treatment ecosystem, we are well positioned to be launch ready in a compressed timeline. We are building out the commercial organization now, have brought in experienced leaders to build their teams, and have already expanded the commercial team significantly in the past two months. All functional areas within the commercial organization have leaders in place and are in the process of hiring. Payer engagement is underway for initial discussions, though formal negotiations will intensify as we clarify the clinical profile. Distribution strategy planning and training efforts are well underway. We are confident that we will be ready operationally and commercially to support a launch by the end of the year.

Dr. Steve Levine, Chief Patient Officer

Regarding site engagement: we've engaged with the vast majority of key centers through our strategic collaborations, field medical outreach over the past couple years, and existing relationships. Many centers know us well and are enthusiastic; they built infrastructure to deliver multiple treatments, not just one. Since the last data release, feedback has been very enthusiastic—sites are eager and many are prepared. The capacity exists and the sites are asking operational and clinical questions daily. This extensive engagement is why we are confident sites will be ready quickly after approval.

Operator, Operator

Your next question comes from the line of Leonid Timashev of RBC Capital Markets.

Leonid Timashev, Analyst, RBC Capital Markets

I wanted to ask on PTSD. Obviously, another part of the executive order was significant focus on treating PTSD. How are you thinking about your program specifically—whether there's any changes you're envisioning to the trial, whether you think the evidentiary standards may be different and whether a single Phase III could support registration? And given the focus on veterans from the administration, are there plans to explore the veteran subpopulation more deeply?

Kabir Nath, Chief Executive Officer

Thanks, Leonid. First, we agree PTSD is a significant unmet need. We are planning a single late-stage registrational trial for PTSD. Ultimately that will be an FDA decision, but the trial has been designed with registration in mind. The trial will include VA sites, and more broadly we are heavily engaged with the VA. We are also supporting a VA study that is a robust clinical study in a TRD population with high PTSD comorbidity, which will provide additional supportive data.

Dr. Steve Levine, Chief Patient Officer

PTSD is an area we're excited about—13 million U.S. adults with few options. The design of our PTSD study was, from the beginning, intended to support registration with a single trial, and that remains the aim. We are engaged with the VA in multiple ways: we are supplying drug and training 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 VA study. We also have active engagement with the VA's integrated project team, which has been preparing to implement psychedelic treatments as they are approved. That engagement is robust and ongoing and it's a priority for us to ensure veterans have access as treatments are approved.

Operator, Operator

Your next question comes from the line of Sumant Kulkarni of Canaccord Genuity.

Sumant Kulkarni, Analyst, Canaccord Genuity

I have a few here. First, how do you expect competitive and legal dynamics on other psilocybin development programs to play out given other organizations may also have priority review vouchers and Phase III data? Second, 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? Third, on PTSD, other than less frequent dosing, what are key reasons patients would prefer COMP360 versus other compounds?

Kabir Nath, Chief Executive Officer

On the competitive landscape, our focus is on our own program. COMPASS has two very large Phase III trials where we've declared the primary endpoint and agreed on a rolling submission and review plan with FDA, which is what we're focused on right now. On the label and retreatment frequency, we do not expect to have a specific limit in the label on the number of treatments per year. Lori and Steve can speak to payer and clinical perspectives, but from a label perspective we are not planning a numeric limit. Payer policies and prior authorization processes are likely to define more detailed utilization management expectations, which would be typical.

Lori Englebert, Chief Commercial Officer

From a payer standpoint, we expect there will be discussions about utilization management like prior authorizations, which is standard practice. Those discussions are normal and should be expected, but they are not going to be unusually onerous for sites and are within the normal scope of clinical practice today.

Dr. Steve Levine, Chief Patient Officer

On retreatment timing clinically: some patients benefit from a second administration either at a fixed interval three weeks after the first or at a more variable interval as observed in Part B of 005. The minimum interval we've studied is three weeks, so I would expect dosing closer than three weeks would be unlikely. Upcoming Part B longer-term data from 006 combined with 005 Part B will help give guidance to clinicians on retreatment approaches; payer policy will further influence how retreatment is managed.

Kabir Nath, Chief Executive Officer

On PTSD and other compounds: these are different medicines with different mechanisms of action and likely different patient experiences. Some protocols for other compounds have been more burdensome from a patient perspective. We will need to see the full characterization through clinical trials for safety, patient experience, and dosing frequency. We believe COMP360 may offer differentiating characteristics such as a favorable patient experience and a dosing profile that could be more patient-friendly, but we'll learn more as data emerges.

Dr. Steve Levine, Chief Patient Officer

To be clear, PTSD has very limited treatment options—there have been no newly approved drugs this century specifically for PTSD, only older generic SSRIs with modest efficacy. More safe and effective options are needed. We are excited for any new option that is safe and efficacious for this population; patients with PTSD deserve more treatment options.

Operator, Operator

Your next question comes from the line of Tom Shrader of BTIG.

Tom Shrader (Jen Kim on for Tom), Analyst, BTIG

This is Jen Kim on for Tom Shrader. Congrats on all the progress. A couple of PTSD questions. What's the primary endpoint for the PTSD Phase II/III trial and has the FDA aligned on that endpoint in a Special Protocol Assessment? And in the TRD program, the two doses of COMP360 were administered three weeks apart, but in COMP202 for PTSD you landed on a four-week interval. Could you walk us through the clinical rationale for that difference?

Kabir Nath, Chief Executive Officer

Sure. The primary endpoint for the PTSD study is the CAPS-5, which is well validated and the standard primary endpoint in PTSD trials. Because the CAPS-5 requires a four-week look-back for symptom assessment, practically speaking the second dose in that protocol is scheduled at four weeks rather than three weeks; the timing is tied to that assessment requirement. This is the typical approach used in PTSD trials.

Operator, Operator

Your next question comes from the line of Jay Olson of Oppenheimer.

Jay Olson, Analyst, Oppenheimer

Congrats on the progress. On PTSD, could you talk about synergies you expect to capture from the infrastructure you're building for TRD? Also, what are some differentiating benefits to COMP360 versus other compounds being studied for PTSD? And are there any other indications you're planning to pursue beyond TRD and PTSD?

Kabir Nath, Chief Executive Officer

We'll go through these. We are clearly focused on broader neuropsychiatric conditions that share synergies in prescribing patterns and settings of care. While we haven't made determinations on other indications, potential areas could include other disorders where we've seen signals in research—however, we have not formally outlined additional indications at this time. I'll hand to Lori on commercial synergies and to Steve on clinical differentiators.

Lori Englebert, Chief Commercial Officer

Given the high overlap in comorbidities between TRD and PTSD, the infrastructure that currently treats TRD patients will be the same infrastructure that can treat PTSD patients. So the commercial synergies are very high. The VA focus on PTSD also increases synergies, and we fully anticipate the VA to be prepared to treat once available. From a sales force standpoint, adding PTSD would require minimal change.

Dr. Steve Levine, Chief Patient Officer

From a clinical perspective, in our Phase II study in PTSD we conducted qualitative interviews with participants. We heard important feedback that differentiates COMP360 from some other approaches: many patients avoid PTSD care because they fear being forced to confront traumatic memories directly, which can make treatment distressing. Some other protocols explicitly involve confronting traumatic material, often with intensive psychotherapy. In our Phase II, many participants reported COMP360 to be an acceptable and even pleasant experience where trauma itself did not necessarily come up during the session, yet they still experienced profound shifts in their emotional relationship to trauma afterwards. That experience—less emphasis on forced re-exposure and a tolerable, acceptable patient experience—could be an advantage for broader uptake. We think these patient experience factors bode well for further development.

Operator, Operator

Your next question comes from the line of Sumant Kulkarni of Canaccord Genuity (additional follow-up).

Sumant Kulkarni, Analyst, Canaccord Genuity

I have a quick follow-up: will there be any difference in REMS or REMS-like requirements between TRD and PTSD usage, or do you expect a consistent REMS approach across indications?

Dr. Steve Levine, Chief Patient Officer

While specifics will be finalized in discussion with the FDA during review, generally REMS language focuses on ensuring patient safety through preparation, monitoring, and follow-up. We would expect similar REMS elements across indications—ensuring informed consent, provider training or certification, and patient monitoring procedures—though operational details may vary by indication and setting of care. The REMS is typically not prescriptive about clinical practice details but ensures safeguards are in place.

Operator, Operator

Your next question comes from the line of Leonid Timashev of RBC Capital Markets (additional follow-up).

Leonid Timashev, Analyst, RBC Capital Markets

Thanks. One more on PTSD: are you planning any subpopulation analyses for veterans specifically, and will VA data be submitted as part of the NDA or as supportive data later?

Kabir Nath, Chief Executive Officer

We will include all relevant and high-quality supportive data in our regulatory submissions. The VA-supported studies and any well-conducted VA data will be part of the evidence base and supportive analyses; specific subpopulation analyses, including veterans, will be planned as part of trial design and statistical analysis plans so we can assess efficacy in key subgroups.

Operator, Operator

Your next question comes from the line of Tom Shrader of BTIG (follow-up).

Tom Shrader (Jen Kim on for Tom), Analyst, BTIG

Thanks for the answers. Quick clarification: do you anticipate submission of the PTSD protocol or SPA discussions with FDA before or after the TRD submission is complete?

Kabir Nath, Chief Executive Officer

We are preparing the PTSD program in parallel and will engage with the FDA as appropriate. The timing of SPA discussions is something we will coordinate with the agency and will be driven by trial readiness and our development timeline; we will update as those discussions progress.

Operator, Operator

Your next question comes from the line of Madison El-Saadi of B. Riley Securities (additional follow-up).

Madison El-Saadi, Analyst, B. Riley Securities

Quick follow-up on the CNPV mechanics: is it accurate to expect the one- to two-month review goal only once the final module is submitted and that the agency could already be informally reviewing submitted modules, meaning the overall timeline may be closer to one month rather than two?

Kabir Nath, Chief Executive Officer

Yes, the formal one- to two-month review goal is tied to completion of the NDA submission, but the award of the CNPV enables much more flexible and continuous interaction with the agency. In practice, because we are submitting modules on a rolling basis and have an active relationship with the psychiatry division, some of the review work and back-and-forth can occur earlier, which may enable a more compressed final review period. However, the formal clock starts at completed submission.

Operator, Operator

Your next question comes from the line of Patrick Trucchio of H.C. Wainwright (follow-up).

Patrick Trucchio, Analyst, H.C. Wainwright

Thanks. On launch readiness one more time: can you quantify how many hires you've made to date for commercial and how quickly you expect to scale to a full field force?

Lori Englebert, Chief Commercial Officer

We have significantly increased hiring activity; the team has already doubled in the past two months and we are actively recruiting across all functional areas. Our leaders are in place and building their teams now. We expect to scale quickly in the coming months to be ready for a potential late-year launch; we will provide further details on specific headcount and timing in future updates.

Operator, Operator

Your next question comes from the line of Jay Olson of Oppenheimer (follow-up).

Jay Olson, Analyst, Oppenheimer

Thanks for the color. One last quick question: do you expect to have any promotional materials or medical education in place prior to approval, or will that wait until after final labeling?

Lori Englebert, Chief Commercial Officer

We are preparing medical education and training materials in advance and will have compliant, non-promotional medical education ready to support clinicians. Any promotional materials will be developed in close alignment with labeling and regulatory requirements and will be deployed following approval and final labeling.

Operator, 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, Chief Executive Officer

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 recognizes the robust data that we have generated. As you've heard, we are working with the FDA and DEA to see if there are 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, and prospective employees, everyone truly sees this as the opportunity of a lifetime. We are delighted to be at the forefront and to lead the way in establishing psychedelics as a transformative new option for patients in need of new treatments. We look forward to updating you on our continued progress during the remainder of the year. Thank you.

Operator, Operator

This concludes today's conference call. You may now disconnect.