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COMPASS Pathways Q1 2026 Earnings Call Transcript

Date

Wednesday, May 13, 2026 at 8 a.m. ET

Call participants

• 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

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Takeaways

• Rolling NDA submission and FDA alignment -- COMPASS Pathways (NASDAQ:CMPS) began a rolling NDA submission for COMP360, with remaining modules to be submitted over the coming months and completion dependent on final 26-week Part B data from the 006 trial. The company confirmed alignment with the FDA on this process.
• Commissioner's National Priority Voucher (CNPV) -- Management stated that the CNPV could provide an "ultra accelerated review time line of 1 to 2 months after final NDA submission," contingent on submission of the last required data.
• Phase III efficacy and durability -- Both pivotal Phase III studies for COMP360 in treatment-resistant depression (TRD) delivered positive topline data, with rapid onset and durable clinical response. Over 1,000 patients were enrolled across all late-stage trials.
• Launch readiness -- The company reiterated plans to be "launch ready by the end of this year" and reported rapid expansion of the commercial team, including leadership with experience launching more than 50 products.
• CPT3 reimbursement codes -- Psychedelic-specific CPT3 codes have been secured to ensure provider reimbursement for monitoring, covering both clinical work and practice expenses for multi-hour treatments. Conversion to Category I is anticipated post-approval based on utilization.
• Site access and market penetration -- Nearly 90% of the U.S. population now live in states intending to reschedule COMP360 within 30 days after FDA and DEA approval, which could shorten the timeline to patient access following regulatory clearance.
• Spravato treatment benchmark -- The initial market focus targets the 7,500 interventional psychiatric treatment centers prescribing Spravato, with academic centers currently delivering fewer than 5% of TRD patient treatments.
• Clinical dosing findings -- In Phase III 005, 25% of patients experienced a clinically meaningful response to a single COMP360 dose, while 006 saw a 40% response rate with a second dose. Additional durability and re-dosing data will be finalized with upcoming 26-week results.
• Balance sheet strength -- Recent financings and warrant exercises have secured sufficient cash resources to support operations through 2028, according to management.
• PTSD program advancement -- The PTSD Phase II study uses CAPS-5 as the primary endpoint, with a four-week treatment interval due to the assessment window, and includes collaboration with VA sites.

Summary

COMPASS Pathways reported progress on its rolling NDA submission for COMP360, with all modules expected to be submitted after completion of the final 26-week trial data. The company may benefit from a Commissioner's National Priority Voucher, which could compress the FDA review window to as little as one to two months after final data submission. Management described ongoing commercial launch activities, including team expansion and payer engagement, aiming for U.S. launch readiness by year-end, subject to regulatory review. The company outlined progress in reimbursement infrastructure, regulatory alignment at state and federal levels, and market-access strategies targeting nearly 90% U.S. population coverage shortly after potential approval.

• Both pivotal Phase III trials for TRD enrolled over 800 patients, resulting in more than 1,000 total late-stage trial participants supporting the submission.
• 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, highlighting COMP360's market opportunity.
• Existing Spravato treatment sites are operationally prepared for COMP360 administration, with flexible capacity and no immediate requirement for facility investment.
• CPT3 codes enable hourly provider billing for psychedelic treatment monitoring, with movement to Category I and valuation assignment to follow post-launch as usage data accumulates.
• State-level legislative initiatives have accelerated the rescheduling pathway for COMP360, with nearly every major U.S. state committing to synchronize with federal policy changes within a month of approval.
• The PTSD pipeline leverages synergies from the TRD infrastructure, and the company is engaged in multiple collaborations with the VA to support future adoption upon approval.

Industry glossary

• CNPV (Commissioner’s National Priority Voucher): FDA voucher conferring ultra-accelerated NDA review, potentially compressing review period to one to two months post-submission for designated breakthrough therapies.
• CPT3 code: Temporary tracking code from the American Medical Association for emerging procedures, allowing hourly reimbursement for psychedelic drug monitoring until sufficient utilization warrants permanent Category I status.
• TRD (Treatment-resistant depression): A major depressive disorder subset where patients do not respond to at least two prior treatments, representing high unmet clinical need.
• CAPS-5 (Clinician-Administered PTSD Scale for DSM-5): A structured diagnostic tool used as the primary endpoint for assessing symptom severity and change in PTSD clinical trials.
• REMS (Risk Evaluation and Mitigation Strategies): FDA-mandated protocols to ensure safe administration and monitoring of medications with known safety risks, tailored for each approved product.

Full Conference Call Transcript

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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