Q2 2026 COMPASS Pathways PLC Earnings Call

August 5, 2026

Operator: Welcome to the COMPASS Pathways Q2 2026 conference call. At this time, all participants are in listen-only mode. As a reminder, this call is being recorded. I would now like to introduce your host for today's call, Stephen Schultz. You may begin.

Operator: Welcome to the COMPASS Pathways Q2 2026 Conference Call. At this time, all participants are in listen-only mode. As a reminder, this call is being recorded. I would now like to introduce your host for today's call, Stephen Schultz. You may begin.

Speaker #1: Welcome to the COMPASS Pathways Q2 2026 conference call. At this time, all participants are in listen-only mode. As a reminder, this call is being recorded.

Speaker #1: I would now like to introduce your host for today's call, Stephen Schultz. You may begin.

Stephen Schultz: Thank you, operator. Welcome all of you, and thank you for joining us today for this conference call. Again, my name's Steve Schultz, Senior Vice President of Investor Relations at COMPASS Pathways. Today I'm joined by Kabir Nath, our Chief Executive Officer, and Lori Englebert, our Chief Commercial Officer. Teri Loxam, our Chief Financial Officer, will also be available for the Q&A. The call is being recorded and will be available on the COMPASS Pathways Investor Relations website shortly after the conclusion of the call and will be available for a period of 30 days. Before we begin, let me remind everyone that during the call today, we will be making statements about our future plans and prospects that constitute forward-looking statements.

Steve Schultz: Thank you, operator. Welcome all of you, and thank you for joining us today for this conference call. Again, my name's Steve Schultz, Senior Vice President of Investor Relations at COMPASS Pathways. Today I'm joined by Kabir Nath, our Chief Executive Officer, and Lori Englebert, our Chief Commercial Officer. Teri Loxam, our Chief Financial Officer, will also be available for the Q&A. The call is being recorded and will be available on the COMPASS Pathways Investor Relations website shortly after the conclusion of the call and will be available for a period of 30 days. Before we begin, let me remind everyone that during the call today, we will be making statements about our future plans and prospects that constitute forward-looking statements.

Speaker #2: Relations at COMPASS Pathways. Thank you. I'm joined today by Kabir Nath, our Chief Executive Officer, and Lori Engelbert, our Chief Commercial Officer. Teri Loxam, our Chief Financial Officer, will also be available. The recording 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.

Speaker #2: 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.

Stephen Schultz: 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. 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.

Steve Schultz: 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 US Securities and Exchange Commission. These forward-looking statements represent our views only as of today. 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.

Speaker #2: is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement.

Speaker #2: Including those risks and uncertainties described under the heading Risk Factors, in our most recent filings with the U.S. Securities and Exchange Commission. These forward-looking statements represent our views only as of today, and we specifically disclaim any obligation to update or revise any forward-looking statement, even if our estimates or assumptions change.

Speaker #2: I'll now hand the call to Kabir Nath.

Speaker #3: Thank you, Steve. And thank you all for joining us today. The first half of this year has been an exciting time for COMPASS. Now that we have highly statistically primary endpoint readouts, as well as demonstrated durability through 6 months from both our trials, we believe we have largely de-risked the clinical and regulatory profile of COMP360.

Kabir Nath: Thank you, Steve. Thank you all for joining us today. The H1 of this year has been an exciting time for Compass. Now that we have highly statistically significant positive phase III primary endpoint readouts, as well as demonstrated durability through 6 months from both our trials, we believe we have largely de-risked the clinical and regulatory profile of COMP360. In addition to confirming its rapid onset and durability, the totality of data from the program so far shows it has a generally well-tolerated and safe profile. Taken together, these data reinforce our belief that COMP360 has the potential to fundamentally change how mental health is managed. With these datasets in hand, we continue to make significant progress towards our NDA filing for the treatment of TRD.

Speaker #3: In addition to confirming its rapid onset and durability, the totality of data from the program so far shows it is significant and positive. Phase 3 has a generally well-tolerated and safe profile.

Speaker #3: Taken together, these data reinforce our belief that COMP360 has the potential to fundamentally change how mental health is managed. With these datasets in hand, we continue to make significant progress toward our NDA filing for the treatment of TRD.

Speaker #3: Our rolling submission and review process allows us to submit data in waves to the FDA, and they have started to review some modules that we've already submitted.

Kabir Nath: Our rolling submission and review process allows us to submit data in waves to the FDA, and they have started to review some modules that we have already submitted. We continue to expect to complete the NDA filing in Q4. With the potential for an accelerated approval following our final submission, we are advancing our commercial readiness. We have built a fantastic commercial team with incredible experience, and we are executing on all fronts to be prepared to get COMP360 to the millions of patients living with TRD who urgently need new treatment options. We are also well positioned with our strong balance sheet, with $433 million of cash on hand as of 30 June 2024, which carries us well through launch and into 2028. Let me now hand the call to Lori to talk through in more detail how we are preparing to transform treatment options for these patients.

Speaker #3: We continue to expect to complete the NDA filing in the fourth quarter. With the potential for an accelerated approval following our final submission, we are advancing our commercial readiness.

Speaker #3: We have built a fantastic commercial team with incredible experience, and we're executing on all fronts to ensure we are prepared to get COMP360 to the millions of patients living with TRD who urgently need new treatment options.

Speaker #3: We're also well-positioned with our strong balance sheet, with $433 million of cash on hand as of June 30, which carries us well through launch and into 2028.

Speaker #3: Let me now hand the call to Lori, to talk through in more detail how we're preparing to transform treatment options for these patients.

Speaker #4: Thanks, Kabir. Hi, everyone. Thank you for joining. As Kabir outlined, we have achieved significant milestones in the first half of the year. Notably, we have advanced important commercial readiness initiatives across organizational capabilities, strategic collaborations, policy and payer engagement, and distribution.

Lori Englebert: Thanks, Kabir. Hi everyone. Thank you for joining. As Kabir outlined, we have achieved significant milestones in H1. Notably, advanced important commercial readiness initiatives across organizational capability, strategic collaboration, policy and payer engagement, and distribution. All significant steps towards being launch ready. Earlier this year, we rounded out hiring of the commercial leadership team, attracting highly experienced, energized leaders who immediately started to build out their functions. My direct reports come from companies like J&J, Gilead, Otsuka, and Axsome, and between them have led over 70 product launches. The prospect of launching the first psychedelic in history with a medicine that has the potential to fundamentally change the way mental health is treated is a very powerful attractor of talent, and we are bringing in outstanding professionals from across the pharma industry. I am incredibly proud of the team we are building at COMPASS.

Speaker #4: All significant steps toward being launch-ready. Earlier this year, we rounded out hiring of the commercial leadership team, attracting highly experienced, energized leaders who immediately started to build out their functions.

Speaker #4: My direct reports come from companies like J&J, Gilead, Oatzka, and Axum, and between them have led over 70 product launches. The prospect of launching the first psychedelic in history with a medicine that has the potential to fundamentally change the way mental health is treated is a very powerful attractor of talent.

Speaker #4: And we are bringing in outstanding professionals from across the pharma industry. I am incredibly proud of the team we are building at COMPASS. In the first half of this year, we also announced additional strategic collaborations with radial and Osmind, taking the total to 8.

Lori Englebert: In H1, we also announced additional strategic collaborations with Radial and Osmind, taking the total to eight, each with their own distinct capabilities. These collaborations played a critical role in helping to inform our priority focus at launch of ensuring optimal site and patient experience. With the final submission of our NDA expected in Q4, our focus in H2 is on operationalizing launch plans and ensuring launch readiness. This includes advancing everything from training, education, access and reimbursement, and patient support mechanisms. Importantly, we have also already initiated recruiting for the field force. Our timeline for launch remains fluid given the Commissioner's National Priority Voucher and executive order in April, and the need for DEA, federal DEA, and state rescheduling. We remain focused on being ready to launch, which we anticipate being in H1 2027.

Speaker #4: Each with their own distinct capabilities, these collaborations played a critical role in helping to inform our priority focus at launch of ensuring optimal site and patient experience.

Speaker #4: With the final submission of our NDA expected in the fourth quarter, our focus in the second half of this year is on operationalizing launch plans and ensuring launch readiness.

Speaker #4: This includes advancing everything from training, education, access, and reimbursement, and patient support mechanisms. Importantly, we have also already initiated recruiting for the field force.

Speaker #4: Our timelines for launch remain fluid, given the National Priority Review Voucher and the Executive Order in April, as well as the need for DEA, federal DEA, and state rescheduling.

Speaker #4: We remain focused on being ready to launch, which we anticipate will be in the first half of 2027. At launch, we will leverage the well-established existing interventional psychiatry treatment center infrastructure.

Lori Englebert: At launch, we will leverage the well-established existing interventional psychiatry treatment center infrastructure. These treatment sites are specifically designed to support in-office treatment for products that require multi-hour monitoring, such as SPRAVATO, TMS, and ECT. The established infrastructure has existing capacity, and importantly, is already equipped with the staff and operational know-how needed to support additional multi-hour treatments like COMP360. Seven years ago, when SPRAVATO launched, this infrastructure did not exist. Today, there are more than 8,000 established sites across the US, and this continues to grow rapidly. COMP360 is poised to lead a profound shift in mental health care, moving beyond daily or frequent dosing toward an option potentially involving just a few treatments a year, which could be life-changing for patients.

Speaker #4: These treatment sites are specifically designed to support in-office treatment for products that require multi-hour monitoring, such as Spravato, TMS, and ECT. The established infrastructure has existing capacity and, importantly, has already equipped with the staff and operational know-how needed to support additional multi-hour treatments like COMP360.

Speaker #4: Seven years ago, when Spravato launched, this infrastructure did not exist. Today, there are more than 8,000 established sites across the U.S., and this continues to grow rapidly.

Speaker #4: COMP360 is poised to lead a profound shift in mental health care, moving beyond daily or frequent dosing toward an option potentially involving just a few treatments a year, which could be life-changing for patients.

Speaker #4: Across two highly statistically significant and positive Phase 3 trials, COMP360 demonstrated an extremely rapid onset of action, with deep and clinically meaningful reduction in depressive symptoms as quickly as one day, unprecedented durability sustained through at least six months, and notably, reproducibility of effect in a chronic, treatment-resistant patient population.

Lori Englebert: Across two highly statistically significant and positive phase III trials, COMP360 demonstrated extremely rapid onset of action with deep and clinically meaningful reduction in depressive symptoms as quickly as one day, unprecedented durability sustained through at least six months, and notably, reproducibility of effect in a chronic treatment-resistant patient population, one of the most difficult psychiatric conditions in which to demonstrate efficacy. The data are strong, and both patients and prescribers are excited about the potential for a new treatment option. In recent prescriber-focused market research, approximately 90% of interventional psychiatrists stated that they would prescribe COMP360 within the first year of being available. In my experience, this is the highest willingness to prescribe percentage I have ever seen in pre-launch market research.

Speaker #4: One of the most difficult psychiatric conditions in which to demonstrate efficacy. The data are strong, and both patients and prescribers are excited about the potential for a new treatment option.

Speaker #4: In recent prescriber-focused market research, approximately 90% of interventional psychiatrists stated that they would prescribe COMP360 within the first year of it being available. In my experience, this is the highest willingness-to-prescribe percentage I have ever seen in pre-launch market research.

Speaker #4: With the COMP360 emerging profile and continued interest and excitement around the clock, we are eager to bring a new treatment option to the 4 million patients living with TRD today who have limited treatment options and we are confident in the blockbuster opportunity.

Lori Englebert: With the COMP360 emerging profile and continued interest and excitement around the class, we are eager to bring a new treatment option to the 4 million patients living with TRD today who have limited treatment options. We are confident in the blockbuster opportunity. COMP360 has the potential to fundamentally change the way that patients living with depression are cared for. COMPASS is committed to helping as many patients as possible. We are making significant progress towards being launch-ready. I look forward to discussing more with you throughout the rest of this very exciting year. Thank you. Let me hand the call back to Kabir.

Speaker #4: COMP360 has the potential to fundamentally change the way that patients living with depression are cared for, encompass its committed to helping as many patients as possible.

Speaker #4: We are making significant progress toward being launch-ready, and I look forward to discussing more with you throughout the rest of this very exciting year.

Speaker #4: Thank you, and let me hand the call back to Kabir.

Speaker #3: Thank you, Lori. Our progress in the first half of the year has meaningfully de-risked the path toward potential approval and launch, and reinforces our confidence in the strength, consistency, and robustness of the COMP360 data package that we are submitting to the FDA.

Kabir Nath: Thank you, Lori. Our progress in H1 of the year has meaningfully de-risked the path towards potential approval and launch and reinforces our confidence in the strength, consistency, and robustness of the COMP360 data package that we are submitting to the FDA. With the regulatory process underway, our focus is on disciplined execution, completing our filing activities and preparing for a first-pass approval, and ensuring we are poised to deliver COMP360 to patients with TRD as quickly as possible following approval. As you just heard from Lori, we will be ready. With that, let me pass the call to the operator for Q&A. Thank you.

Speaker #3: With the regulatory process underway, our focus is on disciplined execution. Completing our filing activities, and preparing for a first-pass approval, and ensuring we are poised to deliver COMP360 to patients with TRD as quickly as possible following approval.

Speaker #3: And as you just heard from Lori, we will be ready. With that, let me pass the call to the operator for Q&A. Thank you.

Speaker #1: We will now begin the question and answer session. Please limit yourself to one question. If you would like to ask a question, please press star 1 to raise your hand.

Operator: We will now begin the question and answer session. Please limit yourself to one question. If you would like to ask a question, please press star one to raise your hand. To withdraw your question, press star one again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. Please stand by while we compile the Q&A roster. Your first question is from the line of Paul Matteis with Stifel. Your line is open. Please go ahead.

Speaker #1: To withdraw your question, press star 1 again. We ask that you pick up your handset when asking a question to allow for optimum sound quality.

Speaker #1: If you are muted locally, please remember to unmute your device. Please stand by while we compile the Q&A roster. Your first question is from the line of Paul, Matisse, with Cycle.

Speaker #1: Your line is open. Please go ahead.

Speaker #5: Hey, good morning. Thanks so much for taking my question. Specifically, I was wondering if the team could offer some perspective on the recently issued FDA guidelines around psychedelics and more specifically how did you interpret the discussion of those guidelines as it relates to 12-month blinded durability?

Paul Matteis: Hey, good morning. Thanks so much for taking my question. Specifically, I was wondering if the team could offer some perspective on the recently issued FDA guidelines around psychedelics, and more specifically, how did you interpret the discussion of those guidelines as it relates to 12-month blinded durability? What do you think that really means or what the FDA is asking for, and how do we think about that in the context of the COMP360 program? Thanks so much.

Speaker #5: What do you think that really means, or what is the FDA asking for? And how should we think about that in the context of the COMP360 program?

Speaker #5: Thanks so much.

Speaker #3: Thanks, Paul. I'm just checking you can hear me clearly, yes?

Kabir Nath: Thanks, Paul, just checking you can hear me clearly, yeah?

Speaker #5: Yes, thank you.

Paul Matteis: Yes. Thank you.

Speaker #3: All right, thanks. Yeah, so look, I think as you're aware, this is a finalization of a set of draft guidelines. And the original draft, in fact, came out even after we had fully designed our Phase 3, aligned with the agency on that, and so on.

Kabir Nath: All right. Thanks. Look, I think as you're aware, this is a finalization of a set of draft guidelines, and the original draft, in fact, came out even after we had fully designed our phase III, aligned with the agency on that, and so on. Our perspective is we have had very robust continuing dialogue with the agency throughout this program. While the guidance is certainly interesting, and we do have thoughts on the 12 months blinded, and that would seem like a pretty tall order in any psychiatry drug. We actually don't think it's going to impact the process of our regulatory approval at this stage. I think the other parts of that I draw your attention to is the design of phase III studies in a complementary pair continues to be effectively exactly in line with the design of our studies.

Speaker #3: So our perspective is we have had very robust continuing dialogue with the agency throughout this program. And while the guidance is certainly interesting and we do have thoughts on the 12-month blinded and that would seem like a pretty tall order for any psychiatry drug, we actually don't think it's going to impact the process of our regulatory approval at this stage.

Speaker #3: I think the other parts of that that I drew your attention to is the design of phase 3 studies and a complementary pair continues to be effectively exactly in line with the design of our studies.

Speaker #3: So while I think the guidance is interesting and obviously in terms of looking at that. We honestly do not think that these guidelines are going to impact the us.

Kabir Nath: While I think the guidance is interesting and obviously in terms of future endeavors, we will be carefully looking at that. We honestly do not think that these guidelines are going to impact the regulatory process that's already underway for us.

Speaker #5: Great. Thanks so much.

Paul Matteis: Great. Thanks so much.

Speaker #1: Your next question is from the line of Francois Brisbois, with Life, Psi Capital. Your line is open. Please go ahead.

Operator: Your next question is from the line of Francois Brisebois with LifeSci Capital. Your line is open. Please go ahead.

Speaker #6: Hi, thanks for the question here. I was just wondering, in terms of launch—can you help us understand, this always happens, but especially in your situation—just the reimbursement challenges? What are we going to have to go through, just to get a better feel for the cadence here with the launch expected next year?

Francois Brisebois: Hi. Thanks for the question here. I was just wondering, in terms of launch, can you help us understand, this always happens, but especially in your situation, just the reimbursement challenges? What are we going to have to go through just to get a better feel for the cadence here with the launch expected next year?

Speaker #4: A great question. As you mentioned, launches are traditionally hard coming out of the gate with reimbursement just because you need time. What we are doing now is our market access team is already engaging with payers.

Lori Englebert: Hey, Frank. Thanks for the question. As you mentioned, launches are traditionally hard coming out of the gate with reimbursement, just because you need time. What we are doing now is our market access team is already engaging with payers, and they have been now for some time. We're getting very positive feedback from the payers, especially in this TRD patient population, where proving efficacy is almost been impossible to do in the past. It is playing very well with a key stakeholder who really, truly understands the economic burden that patients with TRD can have on a payer system.

Speaker #4: And they have been now for some time. We're getting very positive feedback from the payers, especially in this TRD patient population, where proving efficacy has been almost impossible to do in the past.

Speaker #4: So it is playing very well with a key stakeholder who really, truly understands the economic burden that patients with TRD can have on a payer system.

Speaker #4: So at launch, what we expect is we are intending to have a field reimbursement team fully deployed at the time of launch, who will be out helping these sites ensure that they can code and get the reimbursement that they that they need to code for, and making sure that they're well educated in the process.

Lori Englebert: At launch, what we expect is, we are intending to have a field reimbursement team fully deployed at the time of launch who will be out helping these sites ensure that they can code and get the reimbursement that they need to code for and making sure that they're well educated in the process. In terms of the drug reimbursement and the conversations we're having with payers right now, we are working through that. We are still ingesting the data that we just got and released a couple weeks ago into the value proposition that COMP360 can bring. We'll make decisions as we get closer to launch on what that might look like in terms of rebating and payer negotiations for formulary access.

Speaker #4: In terms of the drug reimbursement and the conversations we're having with payers right now, we are working through that. We are still ingesting the data that we just got and released a couple of weeks ago.

Speaker #4: Into the value proposition that COMP360 can bring. Then, as we get closer to launch, we'll make decisions on what that might look like in terms of rebating and payer negotiations for formulary access.

Speaker #1: Your next question is from the line of Gavin Clark from Evercore. Your line is now open. Please go ahead.

Operator: Your next question is from the line of Gavin Clark-Gardner with Evercore. Your line is now open. Please go ahead.

Speaker #7: Hey, guys. Congrats on the progress. Thanks for taking the question. Maybe you could just characterize how any ongoing regulatory discussions are progressing, and separately, what are your expectations for DEA scheduling timelines at this point?

Gavin Clark-Gardner: Hey, guys. Congrats on the progress. Thanks for taking the question. Maybe you could just characterize how any ongoing regulatory discussions are progressing? Separately, what are your expectations for DEA scheduling timelines at this point? Thank you.

Gavin Clark-Gartner: Hey, guys. Congrats on the progress. Thanks for taking the question. Maybe you could just characterize how any ongoing regulatory discussions are progressing? Separately, what are your expectations for DEA scheduling timelines at this point? Thank you.

Speaker #7: Thank you.

Speaker #3: Thanks, Gavin. So on the first part, I would just say they're going well. I mean, the rolling submission is well underway. As I noted in the remarks, some of what has been sent is under review.

Kabir Nath: Thanks, Gavin. On the first part, I would just say they're going well. The rolling submission is well underway. As I noted in the remarks, some of what has been sent is under review. We're getting questions on it. Clearly, given the acceleration, given the NPV, the onus is also on us to respond very quickly, and we're doing that. The team is doing an amazing job of being responsive to that. Nothing out of the ordinary that I would say. We remain on track, and as you know, it's only in the later stages that things like label and REMS really come into play. Those are typically negotiated fairly late in the day. Really nothing untoward to report, except we're very happy with progress. On rescheduling, I'll hand to Lori.

Speaker #3: We're getting questions on it. Clearly, given the acceleration, given the NPV, the onus is also on us to respond very quickly. amazing job of being responsive to that.

Speaker #3: So nothing out of the ordinary that I would say. We remain on track. And as you know, it's only kind of in the later stages that things like label and REMS really come into play.

Speaker #3: Those are typically negotiated fairly late in the day, so nothing really—nothing untoward to report—except we're very happy with progress. On rescheduling, I'll hand to Laurie.

Speaker #4: Yeah, hi, Gavin. We are accelerating our eight-factor analysis, getting that to the CSF FDA Division of Controlled Substance as quickly as possible, in hopes of that enabling a faster FDA and DEA coordination along the way.

Lori Englebert: Yeah. Hi, Gavin. We are accelerating our eight-factor analysis, getting that to the CSS, FDA's Division of Controlled Substance, as quickly as possible, and in hopes of that enabling a faster FDA and DEA coordination along the way. We are also heavily engaging with the DEA, or attempting to engage with the DEA, to help see if we can get any further clarity on what that looks like. As I've mentioned in the past, the DEA is pretty consistent in hitting their 90 days. We feel very confident that they will reschedule within the 90 days, but it's still a little bit fluid in terms of when that actually will happen. Given the executive order in April, we are confident in the ability to potentially pull that forward.

Speaker #4: We are also heavily engaging with the DEA, or attempting to engage with the DEA, to help see if we can get any further clarity on what that looks like.

Speaker #4: As I've mentioned in the past, the DEA is pretty consistent in hitting their 90 days so we feel very confident that they will reschedule within the 90 days.

Speaker #4: But it's still a little bit fluid in terms of when that actually will happen. But given the executive order in April, we are confident in the ability to potentially pull that forward.

Speaker #1: Your next question is from the line of Ritu Barrow, with TD Cohen. Your line is now open. Please go ahead.

Operator: Your next question is from the line of Ritu Sarawag with TD Cowen. Your line is now open. Please go ahead.

Speaker #8: Good morning, guys. Thanks for taking the question. Another question for you, Laurie. Specifically around the term training that you used in the prepared remarks, it sounds like in response to some of the prior questions, some of that training for the interventional psychiatry sites will revolve around coding.

Ritu Sarawag: Good morning, guys. Thanks for taking the question. Another question for you, Lori. Specifically around the term training that you used in the prepared remarks. It sounds like in response to some of the prior questions, some of that training for the interventional psychiatry sites will revolve around coding. I wanted to ask, what other aspects of training does the team plan on offering interventional psychiatry sites, especially given that you have a very solid precedent, REMS, to sort of train against and anticipate. How do you anticipate offering sort of readiness services to those sites, and how does that impact, I think, how all of us may model 2027 rollout? Here at TD Cowen, we've had experience with sponsors really wanting to manage the early experience with a drug at sites and with clinicians on early rollout.

Ritu Baral: Good morning, guys. Thanks for taking the question. Another question for you, Lori. Specifically around the term training that you used in the prepared remarks. It sounds like in response to some of the prior questions, some of that training for the interventional psychiatry sites will revolve around coding. I wanted to ask, what other aspects of training does the team plan on offering interventional psychiatry sites, especially given that you have a very solid precedent, REMS, to sort of train against and anticipate. How do you anticipate offering sort of readiness services to those sites, and how does that impact, I think, how all of us may model 2027 rollout? Here at TD Cowen, we've had experience with sponsors really wanting to manage the early experience with a drug at sites and with clinicians on early rollout.

Speaker #8: But I wanted to ask, what other aspects of training does the team plan on offering interventional psychiatry sites? Especially given that you have a very solid precedent REMS to sort of train against and anticipate, how do you anticipate offering sort of readiness services to those sites?

Speaker #8: And how does that impact, I think, how all of us may model the 2027 rollout? Here at TD Cowen, we've had experience with sponsors really wanting to manage the early experience with a drug at sites and with clinicians.

Speaker #8: On early rollout. So anything you can tell us about sort of the general shape of 2027 as you see it now with the training offered.

Ritu Sarawag: Anything you can tell us about sort of the general shape of 2027 as you see it now with the training offered? Thanks.

Ritu Baral: Anything you can tell us about sort of the general shape of 2027 as you see it now with the training offered? Thanks.

Speaker #8: Thanks.

Speaker #4: Yeah, hey, Ritu. Thanks for the question. I'm going to try and collect it all into one cohesive thought. So, the way I think about training is—you're brilliant at this.

Lori Englebert: Yeah. Hey, Ritu. Thanks for the question. I'm going to try and collect it all into one cohesive thought. The way I think about training is. You know? We think about training in two parts. There's going to be training, and there's going to be education. I will address both. In terms of training and specifically training, we announced a little while ago that we are participating in grants for third-party companies to help with the training of the site, both on psychedelics and as soon as COMP360 gets a final label on anything that's required for the monitoring time that the patient will be in the room. We want to make sure that that patient experience is a very good one. We're still doing that.

Speaker #4: We think about training we think about training in two parts. So there's going to be training. There's going to be education. So I will address both.

Speaker #4: But in terms of training and specifically training, we announced a little while ago that we are participating in grants for third-party companies to help with the training of the sites, both on psychedelics and as soon as COMP360 gets a final label on anything that's required for the monitoring time that the patient will be in the room.

Speaker #4: We want to make sure that the patient experience is a very good one, and so we are still doing that. The sites will need to be trained because, in the REMS, they will need to attest to being trained.

Lori Englebert: The sites will need to be trained because in the room they will need to attest to being trained, and part of that will be based on the training that these third-party providers are enabling. Already, there are well over 1,000 people who are already trained on the psychedelic portion of that training. There is a broad group of people already ready to go with that training. The other training, again, the COMP360 piece of that particular training on how to best support a patient and help enable a very good patient experience, that will come after we see the final label and we get that finalized. We also will need to do training on REMS to make sure that they are compliant with REMS certification and all the things that they need to do with REMS.

Speaker #4: And part of that will be based on the training that these third-party providers are enabling. Already, there are well over 1,000 people who are already trained on the psychedelic portion of that training.

Speaker #4: And so there's a broad group of people already ready to go with that training. The other training—again, the COMP360 piece, that particular training on how to best support a patient and help enable a very good patient experience—that will come after we see the final label and we get that finalized.

Speaker #4: We are also will need to do training on REMS to make sure that they are compliant with REMS certification and all the things that they need to do with REMS.

Speaker #4: So in terms of rollout, in some cases, the fact that there will likely be a little bit of time between when we get approval and when the DEA will reschedule, and then the states will reschedule—obviously, we're trying to do this as fast as possible.

Lori Englebert: In terms of rollout, in some cases, the fact that there will likely be a little bit of time between when we get approval and when the DEA will reschedule and then the states will reschedule. Obviously, we're trying to do this as fast as possible. We are going to leverage that time to the best of our ability. We will have teams out immediately upon approval, helping these sites make sure that they know the requirements that will be under the REMS. As we learn a little bit more and get closer, we'll be able to start communicating what we expect in terms of site readiness. This will be obviously a key KPI that we will want to communicate on. Obviously when it comes time to prescribing.

Speaker #4: We are going to leverage that time to the best of our ability. And so, we will have teams out immediately upon approval, helping these sites make sure that they know the requirements that will be under the REMS.

Speaker #4: And as we learn a little bit more and get closer, we'll be able to start communicating what we expect in terms of site readiness.

Speaker #4: This will be obviously a key KPI that we will want to communicate on. And then obviously, when it comes time to prescribing, as we are thinking through this, obviously, and you mentioned before, which means you've listened to me in the past and the importance of making sure that the sites and the patients have a very good experience.

Lori Englebert: As we are thinking through this, obviously, and you mentioned it before, which means you've listened to me in the past, and the importance of making sure that the sites and the patients have a very good experience. We are very acutely aware that we are leading the way here, and it is important for us to maintain that leadership. The other piece that I do want to just quickly touch on is there will also be patients. This is our field force educating the prescribers, the referring physicians. This is our medical science liaisons who have been out in the field for two and a half years now, continuing to educate there.

Speaker #4: We are very acutely aware that we are leading the way here. And it is important for us to maintain that leadership. And so the other piece that I do want to just quickly touch on is there will also be patients.

Speaker #4: This is our field force educating the prescribers, the referring physicians, this is our medical science liaisons who have been out in the field for two and a half years now, continuing to educate their and we're going to continue to do additional support things like peer-to-peer education, and enabling that in an outsized way.

Lori Englebert: We're going to continue to do additional support things like peer-to-peer education, and enabling that in an outsized way, just to make sure that we are covering all the bases and everyone is very much aware of the potential of COMP360.

Speaker #4: Just to make sure that we are covering all the bases and everyone is very much aware of the potential of COMP360.

Speaker #1: Your next question is from the line of Andrew Tassai, with Jefferies, your line is now open. Please go ahead.

Operator: Your next question is from the line of Andrew Tsai with Jefferies. Your line is now open. Please go ahead.

Speaker #2: Hey, good morning. Thanks for the updates. Appreciate you taking the question. So I think you guys are in a very unique position to be the leader in the psychedelic space.

Andrew Tsai: Hey, good morning. Thanks for the updates. Appreciate you taking the question. I think you guys are in a very unique position to be the leader in the psychedelic space. To maintain that leadership over the next year, what is your appetite like to do even more studies with COMP360 outside of PTSD and so forth? Are any new indications or other new psychedelics we can hear about? Or is the expectation for us to be focused on the launch itself? Thank you.

Speaker #2: So to maintain that leadership over the next year, what is your appetite like to do even more studies with COMP360 outside of PTSD and so forth?

Speaker #2: Are there any new indications or other new psychedelics we can hear about, or is the expectation for us to be focused on the launch itself?

Speaker #2: Thank you.

Kabir Nath: Thank you for the question, Andrew. Yes, the expectation should be to be focused on the launch, at least for now. Clearly, as a new company with our first asset, we have a team that's working incredibly hard on the submission, but more than that, as I said in the prepared remarks, on a first pass approval, because submitting is something, but this needs to be a really robust dossier. We are the leaders. You can imagine from a quality perspective, from inspections and so on, all of this is brand new to the agency. We really are very focused on not only a really robust submission, but also doing our best to get that first pass approval. You've heard a lot from Lori, and we'll continue to hear a lot more about the preparations and so on that side. The PTSD study is now underway.

Speaker #5: Thank you for the question, Andrew. So yes, the expectation should be to be focused on the launch at least for now. Clearly, as a new company with our first asset, we have a team that's incredibly working incredibly hard on the submission.

Speaker #5: But more than that, as I said in the prepared remarks, on a first-pass approval—because submitting is something, but this needs to be a really robust dossier.

Speaker #5: We are the leaders. You can imagine, from a quality perspective, from inspections and so on, all of this is brand new to the agency.

Speaker #5: So we really are very, very focused on not only a really robust submission, but also doing our best to get that first-pass approval. You've heard a lot from Laurie, and we'll continue to hear a lot more about the preparations and so on on that side.

Speaker #5: The PTSD study is now underway. I think the way we think about this is, as we move through what we hope is an expected approval and launch, absolutely, we will continue to look at other opportunities for COMP360.

Kabir Nath: I think the way we think about this is, as we move through what we hope is an expected approval and launch, absolutely, we will continue to look at other opportunities for COMP360. There are clearly some very interesting areas. There is a lot of interest, obviously, in substance use disorder with AUD in particular, at the forefront of that, given the size of that as a public health issue. Potentially more broadly, what other assets there may be out there as well. In the short term, you should expect us to be very focused on this submission, approval, and launch process for TRD.

Speaker #5: There are clearly some very interesting areas. There is a lot of interest obviously in substance use disorder with AUD in particular, at the forefront of that, given the size of that as a public health issue.

Speaker #5: And potentially more broadly, what other assets there may be out there as well. But in the short term, you should expect us to be very, very focused on this submission, approval, and launch process for TRD.

Speaker #4: And Andrew, if you don't mind, I'll just add a couple of things there to help add a little more color. So, consistent with what Kabir mentioned, we have supplied study drugs to an enormous amount of IAS studies, and so we will be looking through those to understand where the potentials may lie.

Lori Englebert: Andrew, if you don't mind, I'll just add a couple things there to help add a little more color. Consistent with what Kabir mentioned, we have supplied study drugs to an enormous amount of IIS studies. We will be looking through those to understand where the potentials may lie if that becomes an option for us with COMP360. At the same time, we're also going to be collecting a lot of real-world evidence to really understand more about patient populations that may be responding well to COMP360. We will be attacking this on all fronts in terms of understanding what would be the next viable indication.

Speaker #4: If that becomes an option for us with COMP360. And at the same time, we're also going to be collecting a lot of real-world evidence to really understand more about patient populations that may be responding well to COMP360.

Speaker #4: We will be attacking this on all fronts in terms of understanding what would be the next viable indication.

Speaker #5: And actually, yeah, just so I should have said that, Laurie, to build on that, we had taken a pause for a couple of years on our IASs as we said, we have supplied a lot of drug for a number of indications.

Kabir Nath: Actually, I should have said that, Lori, to build on that. We had taken a pause for a couple of years on our IISs. As we said, we have supplied a lot of drug for a number of indications. We are now ramping that up again. We actually have a number of IISs starting in areas such as OCD, which I think is potentially very interesting, so that now as we're getting closer to the regulatory finish line for TRD, we're actually restarting our IIS programs again.

Speaker #5: We are now ramping that up again. So we actually have a number of IASs starting in areas such as OCD, which I think is potentially very interesting.

Speaker #5: So that now, as we're getting closer to the regulatory finish line for TRD, we're actually restarting our IAS programs.

Speaker #2: Great. Thank you.

Andrew Tsai: Great. Thank you.

Speaker #1: Your next question is from the line of Madison Elsad with B. Riley. Your line is now open. Please go ahead.

Operator: Your next question is from the line of Madison El-Saadi with B. Riley. Your line is now open. Please go ahead.

Speaker #6: Hi everyone. Thanks for taking our question. Maybe I'll ask on RIMS certification. Maybe just kind of help us understand that process. If this is something that's molecule-specific, and can sites proactively progress that process before DEA rescheduling takes place, or is that something that happens sequentially?

Madison El-Saadi: Hi, everyone. Thanks for taking our question. Maybe I'll ask on REMS certification. If you could just help us understand that process, if this is something that's molecule specific. Can sites proactively progress that process before DEA rescheduling takes place, or is that something that happens sequentially? Secondly, if I may, are you continuing to collect safety data or safety follow-up data, or has the full safety data package been submitted? Thanks.

Speaker #6: And then secondly, if I may, are you continuing to collect safety data or safety follow-up data? Or has the full safety data package been submitted?

Speaker #6: Thanks.

Speaker #5: So I'll take the second part first and hand back to Laurie. So both studies run to 52 weeks. So we will ultimately be providing the full 52-week safety data.

Kabir Nath: I'll take the second part first and hand back to Lori. Both studies run to 52 weeks, so we will ultimately be providing the full 52-week safety data to the agency. Right now, obviously, with the 26-week data from COMP006 in hand, our core focus now in terms of preparing for submission is really integrating the safety from the 26 weeks blinded of both studies into an integrated summary, and that's clearly a key area of focus for us. Ultimately, the agency in the process of review will see the 52 weeks of data as well.

Speaker #5: To the agency, right now, obviously, with the 26-week data from 006 in hand, our core focus in terms of preparing for submission is really integrating the safety from the 26 weeks blinded of both studies into an integrated summary.

Speaker #5: And that's clearly a key area of focus for us. But ultimately, the agency, in the process of review, will see the 52 weeks of data as well.

Speaker #4: Yeah, hi Madison. I'll take your first question around RIMS. So, as you know, the RIMS will not be finalized until we receive approval. And so, because of that, we will only be able to go out and start ensuring that sites are aware of any RIMS requirements and go through the process for certification once we receive the approval.

Lori Englebert: Yeah. Hi, Madison. I'll take your first question around REMS. As you know, the REMS will not be finalized until we receive approval. Because of that, we will only be able to go out and start ensuring that sites are aware of any REMS requirements, and going through the process for certification once we receive the approval. As I mentioned earlier, as it stands now, we're going to do everything we possibly can in between the time of approval and DEA rescheduling to make sure that these sites are well prepared to administer the product when it becomes available.

Speaker #4: And as I mentioned earlier, as it stands now, we're going to do everything we possibly can in between the time of approval and DEA rescheduling to make sure that these sites are well prepared to administer the product when it becomes available.

Speaker #6: Understood. Thanks for taking our question.

Madison El-Saadi: Understood. Thanks for taking our question.

Speaker #1: Your next question is from the line of Judah Frema, with MS, your line is now open. Please go ahead.

Operator: Your next question is from the line of Judah Frimer with MF. Your line is now open. Please go ahead.

Speaker #7: Yeah. Hi, guys. Thanks for taking the question. I just wanted to ask about the post-hoc analysis you mentioned in the release, regarding 80% of administration sessions for the 2b and PTSD being in silence.

Judah Frimer: Yeah. Hi, guys. Thanks for taking the question. Just wanted to ask on the post-hoc analysis you mentioned in the release on the 80% of administration sessions for the II-B and PTSD being in silence. Any thoughts on how that could impact monitoring, whether it's for TRD or PTSD and potentially staffing requirements going forward? Thanks.

Judah Frommer: Yeah. Hi, guys. Thanks for taking the question. Just wanted to ask on the post-hoc analysis you mentioned in the release on the 80% of administration sessions for the II-B and PTSD being in silence. Any thoughts on how that could impact monitoring, whether it's for TRD or PTSD and potentially staffing requirements going forward? Thanks.

Speaker #7: Any thoughts on how that could impact monitoring, whether it's for TRD or PTSD, and potentially staffing requirements going forward? Thanks.

Speaker #5: Yeah, let me start and then Laurie will build on that. So yes, I mean, I think to us, it's very interesting data and really very much validates the point we've been making for a fair amount of time now that a psilocybin experience specifically truly is an inner directed one where the patient is largely leading the experience.

Kabir Nath: Yeah, let me start, and then Lori will build on that. Yes, I mean, I think to us it's very interesting data and really very much validates the point we've been making for a fair amount of time now that a psilocybin experience specifically truly is an inner-directed one, where the patient is largely leading the experience. The role of anyone who is sitting with a patient is just for monitoring and for safety in case of need. We see that very clearly revealed, as we said, with 80% of that being silent. Yes, your point back clearly to our mind does introduce a broader range of possibilities for who could sit in the room. If indeed, ultimately you need somebody in the room at all.

Speaker #5: And the role of anyone who is sitting with the patient is just for monitoring. And for safety in case of need. And we see that very clearly revealed, as we said, with 80% of that being silent.

Speaker #5: And yes, to your point, that clearly to our mind does introduce a broader range of possibilities for who could sit in the room. If indeed ultimately you need somebody in the room at all.

Speaker #4: Agree. And hi, Judah. The only thing I'll add there is that in the near term, in terms of when we receive the RIMS, there will be a requirement for sticks out—a minimum of six hours.

Lori Englebert: Agree. Hi, Judah. The only thing I'll add there is, in the near term, in terms of when we receive the REMS, there will be a requirement for a minimum of six hours. That is consistent with our clinical trial. The label or the REMS requirement for who sits in the room will and should be, or we expect to be fairly broad in terms of a healthcare provider. That is consistent with what SPRAVATO is now. As you probably already know, SPRAVATO has found ways to become very efficient with their rooms and how they monitor. Of course, our most important requirement is going to be safety for the patient during this experience. So we will not lose sight of that. Sites, after getting clinical experience, will learn how and who to put into the room to help these patients.

Speaker #4: That is consistent with our clinical trials. And the label or the RIMS requirement for who sits in the room will and should be or we expect to be fairly broad in terms of a healthcare provider.

Speaker #4: And that is consistent with what Spravato is now. And as you probably already know, Spravato has found ways to become very efficient with their rooms and how they monitor.

Speaker #4: Of course, our most important requirement is going to be safety for the patient during this experience. And so we will not lose sight of that.

Speaker #4: But sites, after getting clinical experience, will learn how and who to put into the room to help these patients.

Speaker #1: Your next question is from the line of Patrick Truchio, with HC Wainwright, your line is now open. Please go ahead.

Operator: Your next question is from the line of Patrick Trucchio with H.C. Wainwright. Your line is now open. Please go ahead.

Speaker #8: Hi. It's Arab Alon for Patrick. Thank you so much for taking the question. I guess for the PTSD trial, do you have any updates on site activation, enrollment cadence, target size, expected readout timing, or VA involvement that you can share?

[Company Representative] (H.C. Wainwright): Hi, it's Arabella on for Patrick. Thank you so much for taking the question. I guess for the PTSD trial, do you have any updates on site activation, enrollment cadence, target size, expected readout timing, or VA involvement that you can share?

[Analyst] (H.C. Wainwright): Hi, it's Arabella on for Patrick. Thank you so much for taking the question. I guess for the PTSD trial, do you have any updates on site activation, enrollment cadence, target size, expected readout timing, or VA involvement that you can share?

Speaker #5: So other than the site is underway, nothing in terms of enrollment and so on. The trial is 300 patients in total across three arms.

Kabir Nath: Other than the site is underway, nothing in terms of enrollments and so on. The trial is 300 patients in total across three arms. There are going to be a number of VA sites enrolled in that. I can't give you specifics on that. What we are doing, though, is in line with the overall percentage of PTSD patients within the population where, shall we say VA or military related are not more than 15%. We're capping patient numbers again at that out of the 300. Yes, it is underway and it's a 300 patient trial.

Speaker #5: There are going to be a number of VA sites enrolled in that. I can't give the specifics on that. What we are doing, though, is in line with the overall percentage of PTSD patients within the population, where shall we say VA or military related are not more than 15%, we're capping patient numbers again at that out of the 300.

Speaker #5: But yes, it is underway. And yeah, it's a 300 patient trial.

Speaker #1: Your next question is from the line of Leonard Timishev with RBCCM. Your line is open. Please go ahead.

Operator: Your next question is from the line of Leonid Timashev with RBCCM. Your line is open. Please go ahead.

Speaker #6: Hi guys. Josh on for Leo here. Thanks for taking my question. So with the physician discretion coming after the one to two recommended doses for COMP 360, given that you've been doing these surveys of psychiatrists, what kind of feedback might you have been hearing from docs on expected dosing schedules?

Josh Enfolio: Hi, guys. Josh Enfolio here. Thanks for taking my question. With the physician discretion coming after the one to two recommended doses for COMP360, given that you've been doing these surveys of psychiatrists, what kind of feedback might you have been hearing from docs on expected dosing schedules, and how widely might that feedback have varied? Thanks.

[Analyst] (RBCCM): Hi, guys. Josh Enfolio here. Thanks for taking my question. With the physician discretion coming after the one to two recommended doses for COMP360, given that you've been doing these surveys of psychiatrists, what kind of feedback might you have been hearing from docs on expected dosing schedules, and how widely might that feedback have varied? Thanks.

Speaker #6: And how widely might that feedback have varied? Thanks.

Speaker #4: Yeah, hi Josh. Thanks for the question. The surveys that we're doing are based on a product profile of COMP360 and what we've seen through our Phase 3 clinical trials.

Lori Englebert: Hi, Josh. Thanks for the question. The surveys that we're doing are based on a product profile of COMP360 and what we've seen through our phase III clinical trials. As I mentioned in my remarks, what we're seeing is an overwhelming response to willingness to prescribe. Not only am I seeing numbers I've never seen before in my career, but even the facilitators of the market research are saying the exact same thing. They've never seen numbers this high in terms of willingness to prescribe. The reason that this is so exciting for physicians right now is truly because of the TRD patient population. TRD patient population, again, has one product or one drug product available to patients right now. That drug product, although it does work for some patients, can be highly burdensome for patients.

Speaker #4: And as I mentioned in my remarks, what we're seeing is an overwhelming response in willingness to prescribe. I've never seen this before in my career, and even the facilitators of the market research are saying the exact same thing.

Speaker #4: They've never seen numbers this high in terms of willingness to prescribe. These the reason that this is so exciting for physicians right now is truly because of the TRD patient population.

Speaker #4: TRD patient population again has one product or one drug product available to patients right now. And that drug product, although it does work for some patients, can be highly burdensome for patients.

Speaker #4: And so the dosing frequency becomes a real driver for these physicians and why they're so excited about it. What we have not heard any hesitancy around that.

Lori Englebert: The dosing frequency becomes a real driver for these physicians and why they're so excited about it. We have not heard any hesitancy around that, and to be honest with you, it's going to be incumbent upon the sales team and our field teams to really help educate based on all the additional data that we will have available on what that frequency of dosing may look like.

Speaker #4: And to be honest with you, it's going to be incumbent upon the sales team and our field teams to really help educate based on all the additional data that we will have available on what that frequency of dosing may look like.

Speaker #1: Your next question is from the line of Sunnet Kulkarni with Canaccord Generalty, your line is open. Please go ahead.

Operator: Your next question is from the line of Sumant Kulkarni with Canaccord Genuity. Your line is open. Please go ahead.

Speaker #5: Good morning, and thanks for taking a question. It's a two-part question. From a value proposition perspective, what's the best way one could place COMP360's time in clinic in context versus products that might promise a two-hour or less duration in the clinic?

Sumant Kulkarni: Good morning, and thanks for taking our question. It's a two-parter. From a value proposition perspective, what's the best way one could place COMP360's time in clinic in context versus products that might promise a 2-hour or less duration in the clinic? From a competitive perspective, what are your assumptions on whether there might be another FDA-approved psilocybin molecule within the first year of approval of COMP360?

Speaker #5: And from a competitive perspective, what are your assumptions on whether there might be another FDA-approved psilocybin molecule within the first year of approval of COMP 360?

Speaker #5: So thanks for the question, Sunnet. So I think as we have often said, duration in clinic is only one element of a product profile, yes?

Kabir Nath: Thanks for the question, Sumant. I think as we have often said, duration in clinic is only one element of a product profile, yes? I think, from the perspective of the patients and the provider experience, it's not necessarily going to be the primary driver. Clearly, there's an efficacy and safety bar that's got to be cleared for any asset, but we actually do believe that the nature of the psilocybin experience is something that is inherently attractive to patients and providers. Also, as we've discussed in the past, even on an economic basis, as long as there remains capacity in the system, there is actually not a good economic argument for why shorter is better in terms of the ability to generate revenue per room size.

Speaker #5: And I think from the perspective of the patient and the provider experience, it's not necessarily going to be the primary driver. Clearly, there's an efficacy and safety bar that's got to be cleared for any asset.

Speaker #5: But we actually do believe that the nature of the psilocybin experience is something that is inherently attractive to patients and providers. Also, as we've discussed in the past, even on an economic basis, as long as there remains capacity in the system, there is actually not a good economic argument for why shorter is better.

Speaker #5: In terms of the ability to generate revenue per room per site.

Speaker #1: Your next question is from the line of Rudy Lee with Wolf Research, your line is now open. Please go ahead.

Operator: Your next question is from the line of Rudy Lee with Wolfe Research. Your line is now open. Please go ahead.

Speaker #6: Hey, thanks for taking my question. Just a quick follow-up to the market dynamics. So, apparently, there are a lot of discussions on short-duration versus long-duration psychedelics following the leading deal.

Rudy Lee: Hey, thanks for taking my question. Just a quick follow-up to the market dynamic. Apparently, there are a lot of discussions on short duration versus long duration psychedelics following the Lilly deal. Maybe in 5 years, we have a couple options, different compounds, different duration, maybe different indications. Very exciting time, but maybe talk about your understanding of the market dynamic with multiple psychedelic options and the positioning of COMP360 in the broader psychiatry space, depression, anxiety. Thanks.

Rudy Li: Hey, thanks for taking my question. Just a quick follow-up to the market dynamic. Apparently, there are a lot of discussions on short duration versus long duration psychedelics following the Lilly deal. Maybe in 5 years, we have a couple options, different compounds, different duration, maybe different indications. Very exciting time, but maybe talk about your understanding of the market dynamic with multiple psychedelic options and the positioning of COMP360 in the broader psychiatry space, depression, anxiety. Thanks.

Speaker #6: So maybe in five years, we have a couple of options—different compounds, different durations, maybe different indications. So, very exciting time. But maybe talk about your understanding of the market dynamics with multiple psychedelic options.

Speaker #6: And the positioning of COMP 360 in the broader psychiatry space, depression, anxiety, thanks.

Speaker #4: Yeah, hi Rudy. So the good news is that psychedelics continue to produce very robust, very exciting data. And part of the reason why you are seeing these clinics—these Spravato-certified clinics, who are enabled to support these multi-hour treatments—is because this is a very exciting time for the field of mental health.

Lori Englebert: Yeah. Hi, Rudy. The good news is that psychedelics continue to produce very robust, very exciting data. Part of the reason why you are seeing these clinics, these SPRAVATO-certified clinics, who are enabled to support these multi-hour treatments is because this is a very exciting time for the field of mental health. They are growing very fast, and they're growing in anticipation of additional options being available. These products don't work for everyone. There are, in TRD, at least 4 million patients who are underserved today, and not being treated with an interventional treatment like a SPRAVATO or an ECT or a TMS that is indicated and has shown and proven efficacy in this patient population.

Speaker #4: And so, they are growing very fast, and they're growing in anticipation of additional options being available. These products don't work for everyone, and there are at least four million patients with TRD who are underserved today.

Speaker #4: And not being treated with an interventional treatment like Spravato, or an ACT, or TMS, that is indicated and has shown and proven efficacy in this patient population.

Speaker #4: And so these centers regardless of duration and because we have repeatedly talked about the economics not being a driver, it is really going to come down to patient preference in terms of which patient what a patient starts provider experience in terms of what that patient has to go through or what that site has to deal with when a patient is having their experience.

Lori Englebert: These centers, regardless of duration, and because we have repeatedly talked about the economics not being a driver, it is really going to come down to patient preference in terms of what a patient starts, provider experience in terms of what that patient has to go through or what that site has to deal with when a patient is having their experience. Let's not forget that we're going to potentially be on market first, and we will have continued time to establish the leadership position that we are in, and we'll get some proven clinical efficacy while we're out there. In terms of economics for the sites, and I'll just double down on what Kabir said earlier.

Speaker #4: And let's not forget that we're going to be on market potentially be on market first. And so we will have continued time to establish the leadership position that we are in.

Speaker #4: And we'll get some proven clinical efficacy while we're out there. In terms of economics for the sites, and I'll just double down on what Kabir said.

Speaker #4: Earlier, we have time with our strategic collaboration, partners as well as outside of that through our medical science liaisons. We are not finding anyone bringing up the fact that this is a longer treatment than the shorter acting as being a prohibiting factor to prescribing.

Lori Englebert: With our strategic collaboration partners as well as outside of that through our medical science liaisons, we are not finding anyone bringing up the fact that this is a longer treatment than the shorter acting as being a prohibiting factor to prescribing.

Speaker #6: Thanks for the comment.

Rudy Lee: Thanks. Hood Connor.

Rudy Li: Thanks. Hood Connor.

Kabir Nath: For those of you wondering what traveling our inner Steve. We've allowed him to go on vacation.

Speaker #5: And you wonder when. Traveling NSD. We've allowed him to go on vacation.

Speaker #4: NSD was on vacation. Missed very much.

Lori Englebert: Steve is on vacation, missed very much.

Operator: Your next question is from the line of Jay Olson with Oppenheimer. Your line is now open. Please go ahead.

Speaker #1: Your next question is from the line of Jay Olson with Oppenheimer your line is now open. Please go ahead.

Speaker #6: Oh, hey, congrats on all the progress and thanks for taking our question. Maybe a big picture question. Recognizing that the company is acutely focused in the near term on the approval and successful launch of COMP 360, looking ahead to after you've accomplished that objective in the next year or two, what will become the next major strategic priority for the company?

Jay Olson: Oh, hey. Congrats on all the progress, and thanks for taking our question. Maybe a big picture question, recognizing that the company is acutely focused in the near term on the approval and successful launch of COMP360. Looking ahead to after you've accomplished that objective in the next year or two, what will become the next major strategic priority for the company? Thank you.

Speaker #6: Thank you.

Speaker #5: Thank you. So PTSD clearly is a strategic priority for us. So that study is underway and we see that as a very important second indication as we mentioned, to earlier answers, we will we clearly have very interesting signals in a wide range of psychiatric conditions.

Kabir Nath: Thank you. PTSD clearly is a strategic priority for us. That study's underway, and we see that as a very important second indication. As we mentioned to earlier answers, we clearly have very interesting signals in a wide range of psychiatric conditions, and we will prioritize some of those to move forward. We will at some point, we have always been clear, from an ex-US perspective, we will probably likely need to partner, but that's something that we will address once we have US approval in mind. I think more broadly, this is a space where you continue to see a lot of innovation now with psychedelic assets and so on. We would see ourselves as a leader with hopefully a successful launch under our belt, potentially being in a position to play a role in that and seeing what other assets may be available.

Speaker #5: And we will prioritize some of those to move forward. We will at some point we have always been clear that from an XUS perspective, we will probably likely need to partner, but that's something that we will address once we have US approval in mind.

Speaker #5: And then I think more broadly, this is a space where you continue to see a lot of innovation now with psychedelic assets and so on.

Speaker #5: We would see ourselves as a leader with hopefully a successful launch under our belt, potentially being in a position to play a role in that and seeing what other assets may be available.

Speaker #6: Thank you.

Jay Olson: Thank you.

Speaker #1: Your next question is from the line of Ben Burnett with Wells Fargo your line is now open. Please go ahead.

Operator: Your next question is from the line of Ben Burnett with Wells Fargo. Your line is now open. Please go ahead.

Speaker #6: Hi, thank you. I also want to ask about your efforts just to prepare and to train sites ahead of commercial adoption. Specifically, can you talk about what are your target sites?

Ben Burnett: Hi. Thank you. I also want to ask about your efforts just to prepare and to train sites ahead of commercial adoption. Specifically, can you talk about what are your target sites? It's our understanding that the interventional psychiatry footprint offerings for SPRAVATO today is pretty expansive with some sites associated with university hospitals, others may be more suburban. I guess, can you just talk to your strategy here and which centers do you plan to target initially and to offer training to initially? Thank you.

Speaker #6: It's our understanding that the interventional psychiatry footprint sort of offerings Spravato today is pretty expansive with some sites associated with the university hospitals, others maybe more suburban.

Speaker #6: So I guess—can you just talk through your strategy here, and which centers you plan to target initially, and to offer training to initially?

Speaker #6: Thank you.

Speaker #4: Hi Ben. And thanks for that question. So as I mentioned in the remarks, and as a pretty widely known, there are about 8,000 sites right now.

Lori Englebert: Hi, Ben, and thanks for that question. As I mentioned in the remarks, as it's pretty widely known, there are about 8,000 sites right now. This number has grown dramatically quarter-over-quarter, where it looks about adding about 500 per quarter, at least. Again, that goes to just the excitement of potential additional options coming to market. The easiest way to answer you is we are going to have a field team that is out calling on all of these sites. They will be in making sure that they cover all 8,000 sites to make sure that these sites, if they have a willingness to prescribe COMP360, that they are well-educated and well-trained, and prepared to prescribe this product.

Speaker #4: This number has grown dramatically quarter over quarter, where it looks like it's adding about 500 per quarter, at least. And again, that goes to just the excitement of potential additional options coming to market.

Speaker #4: The easiest way to answer you is we are going to have a field team that is out calling on all of these sites. They will be making sure that they cover all 8,000 sites to make sure that these sites if they have a willingness to prescribe COMP 360, that they are well educated and well trained and prepared to prescribe this product.

Speaker #4: We are also going to call on physicians that may be in the system with a high number of TRD patients who are serving as referers to these sites that can administer these products as well.

Lori Englebert: We are also going to call on physicians that may be in the system with a high number of TRD patients who are serving as referrers to these sites that can administer these products as well. Our target list will be quite extensive at launch, and comprehensive. The other thing I think we're finding as we do some of our work is that the dosing profile of COMP360 and the potential dosing profile of COMP360 lends itself to a wider radius. To your point earlier, if some of these are quite suburban, coming in for a once a week or every other week treatment, like those that are currently available, becomes quite difficult for someone within a certain radius of a treatment center.

Speaker #4: So our target list will be quite extensive at launch. And comprehensive the other thing I think we're finding as we do some of our work is that the dosing profile of COMP 360 and the potential dosing profile of COMP 360 lends itself to a wider radius.

Speaker #4: So to your point earlier, if some of these are quite suburban, coming in for a once a week or every other week treatment, like those that are currently available, becomes quite difficult for someone within a certain radius of a treatment center.

Speaker #4: Even though these centers are growing very rapidly, there are still some patients who need to drive quite a ways to access one of these treatment centers.

Lori Englebert: Even though these centers are growing very rapidly, there are still some patients who need to drive quite a way to access one of these treatment centers. With an infrequent dosing like COMP360 proposes, this does open up that ability quite a bit.

Speaker #4: With an infrequent dosing like COMP 360 proposes this does open up that ability quite a bit.

Speaker #1: We have reached the end of the Q&A session. I will now turn the call back to management for closing remarks. Please go ahead.

Operator: We have reached the end of the Q&A session. I will now turn the call back to management for closing remarks. Please go ahead.

Speaker #7: Thank you very much all for attending. As you've heard, the first six months or I guess the first six months and one week of this year have been a very exciting and very productive time for COMPASS.

Kabir Nath: Thank you very much all for attending. As you've heard, the first six months, or I guess the first six months and one week of this year, have been a very exciting and very productive time for COMPASS. With the phase III data now, both the primary endpoints, very statistically significant positive primary endpoints from both studies, and now the 26-week data from both studies confirming the profile of COMP360 as a compelling, differentiated profile that truly can serve to meet huge unmet needs in treatment-resistant depression. We're focused on execution. We're very happy with the process of the rolling review. As I said, we're preparing not just to finalize that, to fulfill that with that expected to complete in Q4, but really ensuring it's a really high-quality dossier so we get a first-pass approval.

Speaker #7: With the phase three data now, both the primary endpoints very sufficiently significant positive primary endpoints from both studies and now the 26-week data from both studies confirming the profile of COMP 360 as a compelling differentiated profile that truly can serve to meet huge unmet needs in treatment resistant depression.

Speaker #7: So we're focused on execution. We're very happy with the process of the rolling review. As I said, we're preparing not just to finalize that to fulfill that with that expected to complete in fourth quarter, but really ensuring it's a really high-quality dossier so we get a first pass approval.

Speaker #7: And as you've heard from Lori, there's activity across an extraordinary range of fronts on the commercial side. To be ready for launch. So we look forward to keeping you updated on our progress on both of these major workstreams through the end of this year.

Kabir Nath: As you've heard from Lori, there's activity across an extraordinary range of fronts on the commercial side to be ready for launch. We look forward to keeping you updated on our progress on both of these major work streams through the end of this year. Thank you again. It is a very exciting time for patients with TRD. Thank you.

Speaker #7: So thank you again. It is a very exciting time for patients with TRD. Thank you.

Operator: This concludes today's call. Thank you for attending. You may now disconnect.

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