Q1 2026 COMPASS Pathways PLC Earnings Call

May 13, 2026

Speaker #1: Good day, ladies and gentlemen, and welcome to the COMPASS Pathways first quarter results conference call. At this time, all participants are in a listen-only mode.

Operator: Good day, ladies and gentlemen, welcome to the COMPASS Pathways Q1 results 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 to you your host for today's call, Stephen Schultz. You may begin.

Speaker #1: As a reminder, this call is being recorded. I would now like to turn and introduce to you your host for today's call, Stephen Schultz. You may begin.

Speaker #2: Welcome, all of you, and thank you for joining us today for this conference call. I'm Steve Schultz, Senior Vice President, Investor Relations at COMPASS Pathways.

Stephen Schultz: Welcome all of you. Thank you for joining us today for this conference call. I'm Stephen Schultz, Senior Vice President, 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, and Dr. Steve Levine, our Chief Patient Officer, will be available for the Q&A. The call is being recorded and will be available on the COMPASS Pathways Investor Relations website shortly after the conclusion of the call and will be available for a period of 30 days. Before we begin, let me remind everyone that during the call today, we will be making statements about our future plans and prospects that constitute forward-looking statements.

Stephen Schultz: Welcome all of you. Thank you for joining us today for this conference call. I'm Steve Schultz, Senior Vice President, 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, and Dr. Steve Levine, our Chief Patient Officer, will be available for the Q&A. The call is being recorded and will be available on the COMPASS Pathways Investor Relations website shortly after the conclusion of the call and will be available for a period of 30 days. Before we begin, let me remind everyone that during the call today, we will be making statements about our future plans and prospects that constitute forward-looking statements.

Speaker #2: And today, I'm joined by Kabir Nath, our Chief Executive Officer, and Lori Engelberg, our Chief Commercial Officer. Teri Loxam, our Chief Financial Officer, and Dr. Steve Levine, our Chief Patient Officer, will be available for the Q&A.

Speaker #2: 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.

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.

Speaker #2: 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.

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, and we specifically disclaim any obligation to update or revise any forward-looking statement, even if our estimates or assumptions change. I will now hand the call to Kabir Nath.

Speaker #2: 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. 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.

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 COMP005 and COMP006 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.

Speaker #3: With our 005 and 006 data announcement in February, we have delivered positive data from both our Phase 3 studies. COMP 360 has therefore demonstrated what no approved drug for TRD offers, clinically meaningful efficacy with both rapid onset and extended durability.

Speaker #3: In fact, these extraordinary results redefine rapidity and durability for TRD patients. With only one drug approved and actually used for TRD today, we are confident that COMP 360, 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.

Kabir Nath: 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 COMP006, which we continue to expect in early Q3, will be the final data set to complete the submission.

Speaker #3: After we announced results of our first positive Phase 3 trial last year, and based on discussions with the FDA, we began preparing for a potential accelerated launch.

Speaker #3: 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 COMP 360 NDA.

Speaker #3: 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 dataset to complete the submission.

Speaker #3: 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.

Kabir Nath: Given the award of the CMPV, we are already working closely with the FDA to enable as much efficiency and acceleration as possible. Based on the executive order, we are accelerating our engagement with the DEA since there is the potential for federal rescheduling to be completed sooner than the current statutory 90 days post FDA approval. Our two large phase III trials, blinded to an unprecedented 26 weeks for psychiatry trials, supported by our large phase II-B trial, has resulted in over 1,000 patients in the program. With comprehensive and strong preclinical toxicology, safety, and CMC data, we are confident that we will have a robust NDA submission that supports a COMP360 approval. We've also continued to make great progress in our commercial preparedness, which Lori will cover in detail.

Speaker #3: Our two large Phase 3 trials, blinded to an unprecedented 26-weeks for psychiatry trials, supported by our large Phase 2B trial, has resulted in over 1,000 patients in the program.

Speaker #3: 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.

Speaker #3: 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.

Kabir Nath: Our strategic collaborations across diverse settings of care, including the interventional psychiatry infrastructure, have provided significant learnings. Together with our foresight in establishing CPT III codes specifically for providers to get fully reimbursed for psychedelic monitoring, this has set us up well for a potential near-term launch. We are ramping up rapidly, building out the commercial team with outstanding, highly motivated talent and initiating all activities in anticipation of approval. In addition to TRD, we are also progressing our program in PTSD, which affects 13 million Americans. PTSD is another significant area of unmet need and an opportunity to expand COMP360 to individuals that have few medical options. We believe COMP360 can be an important new treatment for PTSD, and it is a very logical next target indication for COMPASS.

Speaker #3: Together with our foresight in establishing CPT-3 codes specifically for providers to get fully reimbursed for psychedelic monitoring, this has set us up well for a potential near-term launch.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: Our work with the CRO and sites for our late-stage PTSD trial is underway, and we look forward to updating you as it progresses. With both the successful financing and warrant exercises in the first quarter, we have a strong balance sheet with cash that carries us well beyond launch and into 2028.

Kabir Nath: Our work with the CRO and sites for our late-stage PTSD trial is underway, and we look forward to updating you as it progresses. With both the successful financing and warrant exercises in Q1, 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.

Speaker #3: Let me now hand the call to Lori for more on our commercial preparations.

Speaker #2: 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.

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 National Priority Review Voucher. One benefit of being selected for the voucher includes the potential for an ultra-accelerated review timeline 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.

Speaker #2: We believe that if approved, COMP 360 will reach blockbuster potential by offering a transformative new treatment for the millions of patients who deserve more options.

Speaker #2: As Kabir noted, we are pleased to have been selected for the Commissioner's Priority Review Voucher. One benefit of being selected for the voucher includes the potential for an ultra-accelerated review timeline of 1 to 2 months after final NDA submission.

Speaker #2: This provides helpful clarity on timing expectations and allows for more thoughtful and focused planning efforts. Based on the current timelines for data and submission, we remain focused on being launch-ready by the end of the year.

Lori Englebert: Based on the current timelines for data and submission, we remain focused on being launch-ready by the end of the year. Last month, the White House also issued an executive order recognizing the profound urgency of the mental health crisis facing millions of Americans and the potential impact FDA-approved psychedelics could have. In that executive order, timely rescheduling of approved treatments was stated as a priority. As a Schedule I product, COMP360 will need to be rescheduled at both the federal and state level after approval in order to be prescribed. We are accelerating work with the DEA to ensure rescheduling at the federal level goes as rapidly and 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.

Speaker #2: 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.

Speaker #2: In that executive order, timely rescheduling of approved treatments was stated as a priority. As a Schedule I product, COMP 360 will need to be rescheduled at both the federal and state level after approval in order to be prescribed.

Speaker #2: We are accelerating work with the DEA to ensure rescheduling at the federal level goes as rapidly and smoothly as possible. We have also been working at the state level for the past two years to ensure that the states follow the federal rescheduling decision in a timely manner.

Speaker #2: Over the past two years, we have made significant progress, and today, almost 90% of the U.S. population live in a state that intends to reschedule COMP360 within 30 days after FDA approval and DEA rescheduling.

Lori Englebert: Over the past 2 years, we have made significant progress, and today, almost 90% of the US population live in a state that intends to reschedule COMP360 within 30 days after FDA approval and DEA rescheduling. Through this work, we have markedly reduced the timeline to launch and for patients to access COMP360 after approval. Enabling broad and equitable access includes ensuring that both COMP360 and provider monitoring time are adequately reimbursed. Kabir mentioned earlier the work we did a few years ago on securing psychedelic specific CPT III codes, which will ensure that sites are reimbursed fully for the time required for psychedelic treatment monitoring. These codes are billable by the hour and were designed to cover clinical work and practice expenses incurred with multi-hour psychedelic treatments. We are also accelerating reimbursement and formulary discussions for COMP360 with payers.

Speaker #2: Through this work, we have markedly reduced the timeline to launch and for patients to access COMP 360 after approval. Enabling broad and equitable access includes ensuring that both COMP 360 and provider monitoring time are adequately reimbursed.

Speaker #2: Kabir mentioned earlier the work we did a few years ago on securing psychedelic-specific CPT-3 codes which will ensure that sites are reimbursed fully for the time required for psychedelic treatment monitoring.

Speaker #2: 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 COMP 360 with payers.

Speaker #2: TRD has a significantly greater impact on individuals' lives and accounts for a disproportionate share of healthcare costs versus MDD. TRD patients accrue 62% more mental healthcare costs and experience 41% higher work-related costs than MDD patients.

Lori Englebert: TRD has a significantly greater impact on individuals' lives and accounts for a disproportionate share of healthcare costs versus MDD. TRD patients accrue 62% more mental health care costs and experience 41% higher work-related costs than MDD patients. COMP360 has consistently demonstrated through three late-stage trials, clinical effects in a well-tolerated safety profile in a TRD patient population, and we expect payers to respond favorably to the emerging clinical profile and potential value that COMP360 can bring to the healthcare system. Along with enabling access to COMP360, we want to ensure that the clinical experience for the patient and the site of care is positive. This requires thoughtful consideration of how we deploy the field force and how we educate, train, and prepare patients and the sites that will be administering COMP360.

Speaker #2: COMP360 has consistently demonstrated, through three late-stage trials, clinical effects in a well-tolerated safety profile in a TRD patient population, and we expect payers to respond favorably to the emerging clinical profile and potential value that COMP360 can bring to the healthcare system.

Speaker #2: Along with enabling access to COMP360, we want to ensure that the clinical experience for the patient and the site of care is positive.

Speaker #2: This requires thoughtful consideration of how we deploy the fill force and how we educate, train, and prepare patients and the sites that will be administering COMP 360.

Speaker #2: 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.

Lori Englebert: 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 launch preparation for COMP360. COMP360 has the potential to fundamentally change the way that patients living with depression are cared for, and COMPASS is committed to helping as many patients as possible.

Speaker #2: 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.

Speaker #2: This level of experience is remarkable, and we are privileged to have such an impressive team leading launch preparation for COMP 360. COMP 360 has the potential to fundamentally change the way that patients living with depression are cared for, encompasses committed to helping as many patients as possible.

Speaker #2: With COMP 360 expected to be first to market in a highly anticipated new class for mental health, COMPASS is at the forefront of shaping the future of psychiatric patient care.

Lori Englebert: With COMP360 expected to be first to market in a highly anticipated new class for mental health, Compass is at the forefront of shaping the future of psychiatric patient care. We are strongly positioned to successfully launch COMP360, and I look forward to updating you more on our progress. Thank you, and let me hand the call back to Kabir for closing remarks.

Speaker #2: We are strongly positioned to successfully launch COMP 360, 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.

Speaker #1: 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 COMP 360.

Kabir Nath: Thank you, Laurie. This is an incredibly exciting and defining time for patients and Compass. We are confident in the rigor and robustness of our development program to demonstrate the benefit of COMP360. We have conducted our program to the highest standards, which we believe must be paramount in this new field of psychedelic science. We now have data from three robust, well-controlled clinical trials that enrolled over 1,000 participants, including over 800 from two successful pivotal phase III trials. I do want to underscore the difficulty of establishing efficacy in TRD, with only two medicines ever having been approved despite multiple efforts. That COMP360 has consistently demonstrated a clinically meaningful, rapid, and durable effect, and a generally safe and well-tolerated profile, is a remarkable achievement and one that promises to be a transformative new offering for those living with TRD.

Speaker #1: We have conducted our program to the highest standards which we believe must be paramount in this new field of psychedelic science. We now have data from three robust, well-controlled clinical trials that enrolled over 1,000 participants including over 800 from two successful pivotal phase three trials.

Speaker #1: I do want to underscore the difficulty of establishing efficacy in TRD, with only two medicines ever having been approved despite multiple efforts. That COMP360 has consistently demonstrated a clinically meaningful, rapid, and durable effect—and a generally safe and well-tolerated profile—is a remarkable achievement, and one that promises to be a transformative new offering for those living with TRD.

Speaker #1: 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.

Kabir Nath: 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. Let me now pass the call to the operator for Q&A.

Speaker #3: Thank you. The floor is now open for questions. If you have dialed in and would like to ask a question, please press star one on your telephone keypad to raise your hand and join the queue.

Operator: Thank you. The floor is now open for questions. Your first question comes from the line of Andrew Tsai of Jefferies. Your line is open.

Speaker #3: If you would like to withdraw your question, simply press star one again. If you are called upon to ask a question and are listening via loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute when asking your question.

Speaker #3: Your first question comes from the line of Andrew Tsai of Jefferies. Your line is open.

Speaker #4: Hi, good morning. Congrats on the great progress and the great news. I had two questions. The first one is, based on your guys' ongoing FDA discussions, has the FDA given you any inclination whether there will be an AdCom or not for COMP 360?

Andrew Tsai: Hi. Good morning. Congrats on the great progress and the great news. I had two questions. The first one is, you know, based on your guys' ongoing FDA discussions, has the FDA given you any inclination whether there will be an AdCom or not for COMP360? On one hand, the review timelines could be really accelerated, and, you know, FDA does seem to be doing away AdComs. I can't help but think that Lykos got one, and maybe it could be prudent for the FDA to hold one. I'd be curious to know what you guys, where you guys lean here. Thank you.

Speaker #4: Because on one hand, the review timelines 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 Lycos got one and maybe it could be prudent for the FDA to hold one.

Speaker #4: So I'd be curious to know what you guys where you guys lean here. Thank you.

Speaker #1: Thank you, Andrew. It's Kabir. I'm just checking that you can hear us clearly.

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

Speaker #4: I can hear you. Yeah.

Andrew Tsai: I can hear you, yeah.

Speaker #1: Great. Thanks. So thank you. Yeah. So it is the FDA's decision and the FDA's only decision around whether or not to hold an advisory committee.

Kabir Nath: Great. Thanks. Thank you. Yes. It is the FDA's decision and the FDA's only decision around whether or not to hold an advisory committee. You know, they will only make that determination once they see the totality of the data we've submitted. We will be prepared for one and, you know, that is in our planning if necessary. At the moment, we do not have an indication of whether or not that's likely to happen.

Speaker #1: 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.

Speaker #1: If necessary, but at the moment, we do not have an indication of whether or not that's likely to happen.

Speaker #4: Got it. And then secondly, when you share the 26-week Part B data from COMP 006 study, the second one in early Q3, would you consider sharing a cut of the additional 26-week-long Part C portion of the 005 study, your first study, in conjunction with that top line release?

Andrew Tsai: Got it. Secondly, when you share the 26-week part B data from COMP006 study, the second one in early Q3, would you consider sharing a cut of the additional 26-week long part C portion of the COMP005 study, your first study, in conjunction with that top line release? Can we expect maybe a cut before you're possibly approved? I figure it's open label, sharing additional long-term data could be helpful or important for pricing or labeling discussions. Thanks.

Speaker #4: 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.

Speaker #4: Thanks.

Speaker #1: So thanks, Andrew. Yeah. So I mean, from a timing perspective, you're right that the 52 weeks of 005 clearly run in parallel with that.

Kabir Nath: Thanks, Andrew. Yes. I mean, from a timing perspective, you're right that the 52 weeks of COMP005 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. That's a decision we will come to in due course.

Speaker #1: We haven't made a final determination of what we'll share or at what point, but I hear you loud and clear in terms of the value potentially for payers and for commercial purposes.

Speaker #1: So that's a decision we will come to in due course.

Speaker #4: Great. Thank you.

Andrew Tsai: Great. Thank you.

Speaker #1: Thanks.

Kabir Nath: Thanks.

Speaker #3: Your next question comes from the line of François Brisbois of LifePsy Capital, LLC. Your line is open.

Operator: Your next question comes from the line of Francois Brisebois of LifeSci Capital, LLC. Your line is open.

Speaker #5: Yep. Thank you. Very well said on the François. Yeah. That was great. 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?

Francois Brisebois: Yep. Thank you. Very well said on the French. Yeah, that was great. Just quickly here, in terms of the Q3 data for implications, can you just help us understand maybe what the expectations are and, you know, why? You know, is it still a gating factor to complete the filing based on the developments that have happened recently? I just wanna kinda better understand what that data is and how important it is for launch here.

François Brisebois: Yep. Thank you. Very well said on the French. Yeah, that was great. Just quickly here, in terms of the Q3 data for implications, can you just help us understand maybe what the expectations are and, you know, why? You know, is it still a gating factor to complete the filing based on the developments that have happened recently? I just wanna kinda better understand what that data is and how important it is for launch here.

Speaker #5: I just want to kind of better understand what that data is and how important it is for launch here.

Speaker #1: Thanks. And François, may I call you Frank, please?

Kabir Nath: Thanks. Francois, may I call you Frank, please?

Speaker #5: Frank is totally fine.

Francois Brisebois: Frank is totally fine.

François Brisebois: Frank is totally fine.

Kabir Nath: Oh, okay. Thanks. Thanks for the question, Frank. Yeah, clearly, and just for complete clarity, we had already aligned on our rolling submission plan with the FDA before the executive order and the award of the CNPV. We had already fully aligned with the psychiatry division on what we were gonna do and the timeframes in which we were gonna do it. That hasn't changed, and I think it's really important to note that the CNPV potentially accelerates the end part of this process, the final review. 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.

Speaker #1: Thanks for the question. Frank. So yeah, clearly, 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 CMPB.

Speaker #1: So we had already fully aligned with the psychiatry division on what we were going to do and the time frames in which we were going to do it.

Speaker #1: That hasn't changed. And I think it's really important to note that the CMPB 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.

Speaker #1: So from our perspective, we remain on track with the filing strategy we've laid out, with a rolling submission, and that does indeed include the 26 weeks of 006, which we see as significant in terms of really finalizing the profile and, again, for commercial purposes.

Kabir Nath: From our perspective, we remain on track with the filing strategy we laid out with a rolling submission, and that does indeed include the 26 weeks of COMP006, which we see as significant in terms of, you know, really finalizing the profile and again for commercial purposes.

Speaker #5: Okay. Great. Thank you. And then can you give us a little more color on the reimbursement and maybe the CPT codes where maybe the evolution of it?

Francois Brisebois: Okay, great. Thank you. Then can you give us a little more color on the reimbursement and maybe the CPT III, CPT codes, where maybe the evolution of it. Is there anything else that we need from the CPT angle, you know, between now and approval and after? Then just a little more color on, there's a lot of discussions about, the support, the psychological support and kind of the prep and then, you know, maybe the amount of people that you would expect to be in a room and their qualifications just on the commercial side. You know, thoughts around those ideas. Thank you.

François Brisebois: Okay, great. Thank you. Then can you give us a little more color on the reimbursement and maybe the CPT III, CPT codes, where maybe the evolution of it. Is there anything else that we need from the CPT angle, you know, between now and approval and after? Then just a little more color on, there's a lot of discussions about, the support, the psychological support and kind of the prep and then, you know, maybe the amount of people that you would expect to be in a room and their qualifications just on the commercial side. You know, thoughts around those ideas. Thank you.

Speaker #5: 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.

Speaker #5: Thoughts around those ideas. Thank you.

Kabir Nath: I'll hand that question to Steve.

Speaker #1: I'll hand that question to Steve. Thanks, Kabir. Hi, Frank. 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 they're tracking form.

Kabir Nath: I'll hand that question to Steve.

Steve Levine: Thanks, Kabir. Hi, Frank. On the CPT portion of the question, in terms of the work remaining for the CPT III codes, they are in a category 3 form at the moment, which is their tracking form. As those codes are reported more, and they have started to be reported in a limited number of cases, it really will require our approval and launch for them to be reported in greater quantity. As they are reported, that will enable the American Medical Association with their RUC committee, which is an acronym for the RVS Update Committee, with representation from APA to do their work to understand the work involved in delivering this treatment and the practice expenses in order for them to make a recommendation to CMS on evaluation for the codes. This is not entirely a black box. It is formulaic.

Speaker #1: As those codes are reported more and they have started to be reported in a limited number of cases, it really will require our approval and launch for them to be reported in greater quantity.

Speaker #1: But as they're reported, that will enable the American Medical Association with their RUC 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 this treatment and the practice expenses in order for them to make a recommendation to CMS on evaluation for the code.

Speaker #1: 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.

Steve Levine: There are analogous treatments to look at in terms of having some expectations coming in for where this valuation may land. Again, ultimately, the codes will need to be reported so the codes can be progressed to the category 1 valued form. Ahead of that, there will be the opportunities for negotiations directly with payers by providers for reimbursement of treatment. On the staffing-related question with how patients will be prepared and what delivery will look like as far as treatment models, you know, 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.

Speaker #1: But again, ultimately, the codes will need to be reported so the codes can be progressed to the category 1 valued form. Ahead of that, there will be the opportunities for negotiations directly with payers by providers for reimbursement of treatment.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: 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 had prepared in their briefing materials for light doses outcome, which use language to the effect of a prescriber available, a licensed healthcare provider on site.

Steve Levine: 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 their briefing materials for Lykos' MDMA, which use language to the effect of a prescriber available, a licensed healthcare provider on site. These, of course, are the important elements in terms of having the sufficient experience and training of providers necessary to ensure safeguarding patients.

Speaker #1: And these, of course, are the important elements in terms of having the sufficient experience and training of providers necessary to ensure safeguarding patients.

Speaker #5: Great. Thank you very much.

Francois Brisebois: Great. Thank you very much.

François Brisebois: Great. Thank you very much.

Speaker #3: Your next question comes from the line of Paul Matisse of Stifel. Your line is open.

Operator: Your next question comes from line of Paul Matteis of Stifel. Your line is open.

Speaker #6: Hey. Thanks so much. This is Julian on for Paul. Appreciate you taking our questions and congrats on all the great progress. Just two from us.

[Analyst] (Stifel): Hey, thanks so much. This is Julian, on for Paul Matteis. Appreciate you taking our questions and congrats on all the great progress. Just two from us. I guess what are your expectations for rate of retreatment after 2 initial doses versus 1 initial dose? Thinking about the COMP006 26-week data coming out and how you think that will be assessed by FDA with respect to implications for labeling. Our second question is, from your commercial work, have you been able to identify what proportion of patients being prescribed SPRAVATO are at large academic medical centers versus private practice clinics? I'm curious how that may or may not influence your commercial strategy. Thank you.

Julian Pino: Hey, thanks so much. This is Julian, on for Paul Matteis. Appreciate you taking our questions and congrats on all the great progress. Just two from us. I guess what are your expectations for rate of retreatment after 2 initial doses versus 1 initial dose? Thinking about the COMP006 26-week data coming out and how you think that will be assessed by FDA with respect to implications for labeling. Our second question is, from your commercial work, have you been able to identify what proportion of patients being prescribed SPRAVATO are at large academic medical centers versus private practice clinics? I'm curious how that may or may not influence your commercial strategy. Thank you.

Speaker #6: I guess, what are your expectations for rates of retreatment after two initial doses versus one initial dose? Thinking about the 006, 26-week data coming out, and how you think that will be assessed by the FDA with respect to implications for labeling?

Speaker #6: And then our second question is, from your commercial work, have you been able to identify what proportion of patients being prescribed Spravato are at large academic medical centers versus private practice clinics?

Speaker #6: And curious how that may or may not influence your commercial strategy. Thank you.

Kabir Nath: Thanks, Julian. Yeah, on the first question, as you know from what we've already shown, we saw that there was a 25% of patients had a clinically meaningful response in COMP005 from that single administration of COMP360, and we saw that that was 40% in COMP006 with the addition of the second fixed dose. Clearly, we are expecting that higher level of response to be sustained through 26 weeks, but we really do need to see the data to understand what the potential impact of a third dose for those who had it may be, and indeed, what the second dose after week 3 does for sustained response without necessarily a third dose. Turning to what that means on our starboard, Lori Englebert and Steve may want to jump on here.

Speaker #1: Thanks, Julian. So yeah, on the first question, as you know from what we've already shown, we saw that 25% of patients had a clinically meaningful response in 005 from that single administration of COMP360.

Speaker #1: And we saw that that was 40% in 006 with the addition of the second fixed dose. So clearly, we are expecting that higher level of response to be sustained through 26 weeks.

Speaker #1: But we really do need to see the data to understand what the potential impact of a third dose, for those who had it, may be.

Speaker #1: And indeed, what the second dose after week three does for sustained response. Without necessarily a third dose. So turning to what that means on our staff, but Laurie and Steve may want to jump on here.

Speaker #1: I mean, we are seeking a label that essentially says from one or two 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 three weeks or a short-term period.

Kabir Nath: I mean, we are seeking a label that essentially says from one or two doses and then with further episodic dosing at provider discretion. That gives discretion because clearly if somebody responds very well to a first dose, there may not be a need for something within three weeks or a short-term period. Equally, we clearly saw so far that there are patients who do benefit from having that second dose three weeks apart. That's how we're thinking about labeling. Then I'll hand to Lori and Steve to talk about first that and then the registration.

Speaker #1: But equally, we clearly saw so far that there are patients who do benefit from having that second dose three weeks apart. So that's how we're thinking about labeling.

Speaker #1: And then I'll hand to Laurie and Steve to talk about first that, and then the percentage of patients.

Speaker #4: Yeah. I agree with Kabir's hi, Julian, by the way. This is Laurie. I agree with Kabir's assessment on what we're seeking for the label, the 26-week data that we're getting from 006.

Lori Englebert: Yep. I agree with Kabir's. Hi, Julian, by the way. It's Lori. I agree with Kabir's assessment on what we're seeking for the label. The 26-week data that we're getting from COMP006 combined with the COMP005 data is really gonna be used to help guide clinical decision-making from the field force, as we're out educating providers. So, Steve, anything you want to add on that?

Speaker #4: Combined with the 005 data, it's really going to be used to help guide clinical decision-making from the field force as we're out educating providers.

Speaker #4: So Steve, anything you want to add on that?

Speaker #6: No, that covers it.

Steve Levine: No, that covers it.

Speaker #4: In terms of the Spravato patients being treated in academic centers versus the more what everyone calls the interventional psychiatry, treatment centers, the academic centers are treating very, very small portion.

Lori Englebert: In terms of the SPRAVATO patients being treated in academic centers versus the more, what everyone's called 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. The primary focus of ours will be at launch on the interventional psychiatry treatment centers that are currently prescribing SPRAVATO, which is at about 7,500 already.

Speaker #4: 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 psychiatry treatment centers that are currently prescribing Spravato which is at about 7,500 already.

Speaker #6: And I'll just add to that that we do engage with many academic centers. We hear a lot of excitement for them about the potential of implementing COMP 360.

Steve Levine: 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, 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. They will deliver the treatment, but the, you know, reflective of the breakdowns that we see with SPRAVATO prescriptions, we expect that to be similar with those centers having a higher capacity to treat more patients.

Speaker #6: So we do expect academic sites to deliver COMP 360. The nuance is that they are typically not built to have high-volume operations. They tend not to treat high volumes of patients.

Speaker #6: They don't have the kind of throughput that the interventional clinics have. So they will deliver the treatment. But the reflective of the breakdowns that we see with Spravato prescriptions we expect that to be similar with those centers having a higher capacity to treat more patients.

Speaker #5: Super helpful. Thanks for the color.

Stephen Schultz: Super helpful. Thanks for the color.

Julian Pino: Super helpful. Thanks for the color.

Speaker #3: Your next question comes from the line of Joshua Shimmer of Cantor. Your line is open.

Operator: Your next question comes from the line of Josh Schimmer of Cantor Fitzgerald. Your line is open.

Speaker #5: Great. Thanks for taking the questions. How are you thinking about the incremental capacity for COMP 360 administration at those 7,300 or so interventional site pathways?

Josh Schimmer: Thanks for taking the questions. How are you thinking about the incremental capacity for COMP360 administration at the 7,300 or so interventional site pathways? Is there any way to quantify that? What % of the centers do you expect will be adopting the bind bill model for COMP360 early on? How do you expect that to evolve over time? Thank you.

Speaker #5: And is there any way to quantify that? And then what percent of the centers do you expect will be adopting the BIMDOL model for COMP360 early on?

Speaker #5: And how do you expect that to evolve over time? Thank you.

Speaker #1: Thanks, Joshua. Thanks to Steve.

Kabir Nath: Thanks, Josh. I'll pass it over to Stephen.

Speaker #6: Hi, Josh. Good to hear from you. Thanks for the question. So on the capacity side, we know that these centers have existing capacity today.

Steve Levine: Hi, Josh. good to hear from you. Thanks for the question. On the capacity side, you know, we know that these centers have existing capacity today. It's, you know, it's an important consideration when we often get questions about how these sites will make decisions about which treatment to deliver and whether they're making trade-offs based upon reimbursement that they may receive for delivering various treatments. First of all, these sites know that there are huge unmet needs for the treatment-resistant depression population. They are excited to have more tools available and to have the opportunity to make decisions of which treatment to deliver.

Speaker #6: 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 based upon reimbursement that they may receive for delivering various treatments.

Speaker #6: First of all, these sites know that there are huge unmet needs for the treatment-resistant depression population. They are excited to have more tools available and to have the opportunity to make decisions of which treatment to deliver.

Speaker #6: 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.

Steve Levine: 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 later in the day, or that over the course of the week, these rooms may be used for either treatment. There's plenty of existing capacity that they will first fill prior to adding additional space.

Speaker #6: 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 later in the day.

Speaker #6: Or that over the course of the week, these rooms may be used for either treatment. So there's plenty of existing capacity that they will first fill prior to adding additional space.

Speaker #6: 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.

Steve Levine: 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, you know, 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 SPRAVATO prescriptions at this point are 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.

Speaker #6: On the BIMDOL part of the question, what we've seen with Spravato is that the penetration of BIMDOL relative to specialty pharmacy reimbursement has increased over time.

Speaker #6: We don't know the exact numbers. We believe it's somewhere between 35 to 45 percent of Spravato prescriptions at this point are BIMDOL. This is something that the psychiatry model has not been used to prior to the advent of Spravato.

Speaker #6: But they are beginning to recognize the economic value of processing claims in this way. So we would, and I'll hand to Laurie to augment this.

Steve Levine: We would, you know, 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 and for that to increase over time.

Speaker #6: 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.

Speaker #6: But we would quickly expect them to adopt BIMDOL. And for that to increase over time.

Speaker #4: Yeah. I only think I'll add there, 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.

Lori Englebert: Yeah. Only thing I'll add there, Josh, is that, you know, we will enable both at launch. That is, you know, just an important nuance to add is that it will be enabled, but we do, you know, from a realistic expectation standpoint, expect there to be a little bit of a ramp to heavier buy and bill.

Speaker #4: But we do, from a realistic expectation standpoint, expect there to be a little bit of a ramp to heavier BIMDOL.

Speaker #5: Great. Thanks very much.

Josh Schimmer: Great. Thanks very much.

Speaker #3: Your next question comes from the line of Judah Fromer of MS. Your line is open.

Operator: Your next question comes from line of Judah Frommer of MS. Your line is open.

Speaker #5: Yeah. Hi, guys. Thanks for taking the question and congrats on all the progress. Maybe just a follow-up on kind of how providers are thinking about potential administration.

Judah Frommer: Yeah. Hi, guys. Thanks for taking the question and congrats on all the progress. Maybe just a follow-up on, you know, kind of how providers are thinking about potential administration. I think there's, you know, a little bit of discussion about whether, you know, psychedelic treatments should fit into that SPRAVATO dosing window versus maybe something longer that COMP360 would take. Can you just remind us from the provider's perspective, the economics of turning over a room maybe two or three times for multiple SPRAVATO applications versus, you know, maybe a single administration of COMP360 and what the economics look like relative to each other? Thank you.

Speaker #5: I think there's a little bit of discussion about whether psychedelic treatments should fit into that Spravato dosing window versus maybe something longer that COMP 360 would take.

Speaker #5: Can you just remind us from the provider's perspective the economics of turning over a room maybe two or three times for multiple Spravato applications versus maybe a single administration of COMP 360 and what the economics look like relative to each other?

Speaker #5: Thank you.

Speaker #1: Thanks, Judah. This is Steve's favorite question.

Kabir Nath: Thanks, Judah. This is Steve's favorite question.

Speaker #6: Yes, thank you for the opportunity, Judah. So yeah, exactly as you said, there are inefficiencies with shorter treatments and needing to turn a room over multiple times in a day, because this is, I guess, self-evident.

Steve Levine: Yes. Thank you for the opportunity to talk about this, Judah. Yeah, exactly as you said, there are inefficiencies with shorter treatments and needing to turn a room over multiple times in a day because this is, I guess, self-evident. 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. If you are able to fill that room with one patient and you are reimbursed for the entire time that the patient is in that room, that is much more efficient for these sites. To put some numbers to it, if you consider that a site operating at full capacity, which as I've just said earlier, doesn't exist. These sites have plenty of capacity.

Speaker #6: But when you have time in between patients where you need to turn the room over to clean it, and the administrative work of an additional patient, etc., that is a gap that is unreimbursed time.

Speaker #6: Therefore, if you are able to fill that room with one patient, and you are reimbursed for the entire time that the patient is in that room, then that is much more efficient for these sites.

Speaker #6: To put some numbers to it, if you consider that a site operating at full capacity, which, as I've just said earlier, doesn't exist, these sites have plenty of capacity.

Speaker #6: But to be conservative, let's say they're at full capacity. And then let's say their maximally efficient, which most sites also are not, that would mean they could get three Spravato patients in a room in a day.

Steve Levine: 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 a Spravato session somewhere south of $300, but using $600 as round numbers. 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. That's really kind of the target that would be, you know, the minimum that they would need if they were just purely making these trade-offs. That makes us very confident that this will make sense for them.

Speaker #6: With average reimbursement for Spravato sessions, somewhere south of $300. But using $300 is round numbers. Then that means their potentially being reimbursed for the room at $900 per day.

Speaker #6: 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.

Speaker #6: That makes us very confident that this will make sense for them. But in addition, if we consider that the observation time for COMP 360 will probably be about six hours, within a typical operating day, for these sites, it means they could also most likely get a Spravato patient in that room too.

Steve Levine: 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. Since most of these sites aren't having more than 1 SPRAVATO patient in that room in a day anyway, this is all upside. This is all additive for them.

Speaker #6: 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.

Speaker #3: Your next question comes from the line of Ritu Baral of TD Cowan. Your line is open.

Operator: Your next question comes from line of Ritu Baral of TD Cowen. Your line is open.

Speaker #7: Thanks for squeezing me in, guys. Steve, you mentioned the rough committee of the AMA. So our understanding is that this committee meets once a year.

Ritu Baral: Thanks for squeezing me in, guys. Steve, you mentioned the RUC committee of the AMA. Our understanding is that this committee meets once a year and unfortunately has only one psychiatry rep and is very sort of surgeon-dominated. Is there anything that you guys can do? First of all, do you know when this RUC committee is scheduled for the year? Second, is there anything you can do as far as prep for this committee to sort of optimally communicate the value proposition of COMP360? I've got a follow-up on the DEA discussions. Have you been in communication with the DEA proper? Do you have an idea at this point if communications and review of the FDA will start even before the NDA is complete?

Speaker #7: And unfortunately, has only one psychiatry rep. And it's very sort of surgeon-dominated. Is there anything that you guys can do well, first of all, do you know when this rough committee is scheduled for the year?

Speaker #7: And second, is there anything you can do as far as prep for this committee to sort of optimally communicate the value proposition of COMP 360?

Speaker #7: 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?

Speaker #7: 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.

Ritu Baral: Would you expect that this would still be sort of expedited review on the tail end of approval? If I can just ask a quick follow-up after that. What are your expectations for the REMS, insofar as the requirements for administration, as well as either, preparation and consolidation afterwards? Like, what will actually be required by the REMS? 'Cause we've heard from doctors that that will be absolutely the most important thing.

Speaker #7: What are your expectations for the REMS insofar as the requirements for administration as well as either preparation and consolidation afterwards? What will actually be required by the REMS?

Speaker #7: Because we've heard from doctors that that will be absolutely the most important thing.

Speaker #1: Thanks, Ritu. So I'll ask Steve to comment on the ROC. I'll take the DEA question with Laurie. And then Steve will take the REMS question.

Kabir Nath: Thanks, Ritu. I'll ask Steve to comment on the RUC. I'll take the DEA question with Laurie, and then Steve will take the REMS question.

Speaker #6: It'll be a sandwich. Okay, starting with the ROC portion. You asked about the date of the next ROC meeting. I don't have the schedule on the top of my head.

Steve Levine: It'll be a sandwich. Okay. Starting with the RUC portion. You asked about the date of the next RUC meeting. I don't have the schedule on the top of my head. We can follow up on that. To the rest of it, you're correct that historically there has been the 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 on the committee. When we did the initial work on the category 3 code a few years ago, we took advice from a number of people, including those who had served on the RUC in the past.

Speaker #6: We can follow up on that. But to the rest of it, you're correct that historically, there has been maybe overrepresentation, let's say, on the ROC of surgeons and other procedurally focused committee members.

Speaker #6: 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 on the committee.

Speaker #6: When we did the initial work on the Category 3 code a few years ago, we took advice from a number of people, including those who had served on the ROC in the past.

Speaker #6: So we were very well-informed heading into the initial application for the Category 3 code. We will continue to work with experienced consultants as the code progresses to Category 1 and make sure that this goes in a direction that is very favorable to ensuring that there is adequate reimbursement to ensure patient access.

Steve Levine: We, you know, we were very well informed heading into the initial application for the category 3 code. We will continue to work with experienced consultants as the code progresses to category 1 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.

Speaker #6: I will hand over for the second part of the question and be back with you on REMS.

Speaker #1: Yeah. 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 3 is completed.

Kabir Nath: Yeah. Ritu Baral, 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, you know, 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. Essentially, we will provide an eight-factor analysis. The controlled substance staff within the FDA will then review that. Historically, they have submitted their findings at the end of the review period because that's just been the way the FDA has worked. That could potentially be accelerated with the DEA then doing their sequential review, all of this coming together in time, you know, on the same day or a day apart at the end of it.

Speaker #1: After further conversation, with those responsible for that, it's clear that the intent is that the DEA and the FDA can arrive at that conclusion simultaneously.

Speaker #1: However, it would still be a sequential process. So essentially, we will provide an eight-factor analysis. The controlled substance staff within the FDA will then review that.

Speaker #1: Historically, they have submitted their findings at the end of the review period because that's just been the way the FDA has worked. That could potentially be accelerated with the DEA then doing their sequential review.

Speaker #1: 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.

Kabir Nath: That's the intent. Where we will actually get to in practice, we will have to see.

Speaker #5: Now, the only thing I'll add, hi, Ritu. The only thing I'll add is that we are working with DEA consultants as well as accelerating our timelines to when you would traditionally communicate with the DEA.

Lori Englebert: The only thing I'll add. Hi, Ritu. The only thing I'll add is that, you know, we are working with DEA consultants as well as, you know, accelerating our, our timelines to when you would traditionally communicate with the DEA, so that we can reach a further understanding. To, you know, for planning purposes, as of right now, we are not planning for, you know, we will be ready if there's anything that happens before, but we see no indication that these timelines have shifted forward.

Speaker #5: 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.

Speaker #5: But we see no indication that these timelines have shifted forward.

Speaker #6: And then back to me for REMS. Steve again. So you're referencing in our clinical trials that we had spent time preparing patients ahead of administration, supported them on the day of administration, and then followed them up for safety after.

Steve Levine: Back to me for REMS. Steve again. You're referencing in our clinical trials that we had spent time preparing patients ahead of administration, supported them on the day of administration, and then followed them up for safety after. Within a clinical trial context, it was important that everyone had the same condition, same experience, that everything was highly standardized. In that context, we specified a number of preparatory sessions as an example, as well as a standardized length of those visits. As this translates into real-world care delivery and how this will be guided by the REMS, what becomes most important is not a certain number of sessions or a length of those sessions, just that patients are adequately prepared, and they are properly followed up for safety.

Speaker #6: Within a clinical trial context, it was important that everyone had the same conditions, the same experience, that everything was highly standardized. And so in that context, we specified a number of preparatory sessions as an example, as well as a standardized length of those visits.

Speaker #6: As this translates into real-world care delivery and how this will be guided by the REMS, what becomes most important is not a certain number of sessions or a length of those sessions, just that patients are adequately prepared and they are properly followed up for safety.

Speaker #6: 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.

Steve Levine: 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 follow-up anyway. So much as any necessary language that just gives, you know, 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.

Speaker #6: The reality is that with any treatment, there is some preparation and safety follow-up anyway. So much as any necessary language that just gives a little bit of guidance on what activities are important in terms of preparing patients.

Speaker #6: 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.

Speaker #4: Your next question comes from Line of Medicine, El Saadi of B Riley Securities. Your line is open.

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

Speaker #7: Hi. Thanks for taking your question. A couple from us. Maybe what have you learned about the CMPV mechanics since receiving the award a couple of weeks ago?

Madison El-Saadi: Hi. Thanks for taking our question. A couple from us. Maybe what have you learned about the CNPV mechanics since receiving the award a couple weeks ago? Should we think of this 1 to 2-month CNPV review clock as not really starting until that final module is submitted, or has it, I guess, to some degree already started, which would imply the FDA response closer to 1 month versus 2 months? Afterwards, an unrelated follow-up.

Speaker #7: Should we think of this one- to two-month CMPV review clock as not really starting until that final module is submitted? Or has it, I guess, to some degree, already started?

Speaker #7: Which would imply the FDA response closer to one month versus two months. And then afterwards, an unrelated follow-up.

Speaker #6: Yeah. So no, thank you for the question. So our understanding is certainly that that formal one to two-month goal is following the completion of the NDA submission.

Kabir Nath: Yes. No, thank you for the question. 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. What we've already seen in the last couple of weeks is that that is even more so. In particular, you know, some of the standard timelines of 30 days to request a meeting and X days for a response and so on, those have gone away entirely. This really is about, first, a much more flexible day-to-day interaction with the agency.

Speaker #6: 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.

Speaker #6: It's collaborative. It's constructive. It's focused on solving problems. And what we've already seen in the last couple of weeks is that that is even more so.

Speaker #6: And in particular, some of the standard timelines of 30 days to request a meeting and X days for a response and so on, those have gone away entirely.

Speaker #6: So this really is about, first, a much more flexible day-to-day interaction with the agency. But no, the actual formal clock of that one to two months, as we understand it, will only start with the submission.

Kabir Nath: The actual formal clock of that 1 to 2 months, as we understand it, will only start with the submission. To be clear, that's a goal. It's a goal that they can complete it within 2 months.

Speaker #6: And again, to be clear, that's a goal. Yes, it's a goal that they can complete it within a couple of months.

Speaker #7: 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 psilocybin works, about how TMS works, do you think there may be an additive or even a synergistic effect from combining these treatments?

Madison El-Saadi: Understood. That's great to hear. Secondly, many of these sites offer TMS. Based on what we know or what we believe we know about how psilocybin works, about how TMS works, do you think there may be an additive or even a synergistic effect from combining these treatments? Thanks.

Speaker #7: Thanks.

Speaker #6: That's definitely a Steve question. Psychiatrist on the call.

Kabir Nath: That's definitely a Steve question. Any psychiatrist on the call?

Steve Levine: Thanks. Thanks, Madison. Yeah, that's an intriguing one. It's something that has been raised. To date, it's really a matter of speculation. You can concoct, you know, theoretical reasons why there may be synergies. It'd be good to see some data. I know that there's at least one small academic study already looking at concurrent use of these two modalities. I'm sure that the sites that deliver both treatments, both TMS and COMP360, may be interested in that question. If they do, I hope they track outcomes, and we gather data and, you know, have some guidance on whether that may be an effective approach. Ultimately, you know, these sites are ecosystems of care. They offer multiple treatments. They're trying to offer as many tools as possible for these patients to maximize their outcomes.

Speaker #7: Thanks, Madison. Yeah, that's an intriguing one. It's something that has been raised to date. It's really a matter of speculation, using concoct theoretical reasons why there may be synergies.

Speaker #7: It'd be good to see some data. I know that there's at least one small academic study already looking at the concurrent use of these two modalities.

Speaker #7: I'm sure that the sites that deliver both treatments, both TMS and COMP360, may be interested in that question. And if they do, I hope they track outcomes and we gather data and have some guidance on whether that may be an effective approach.

Speaker #7: 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.

Speaker #7: Treatment-resistant depression is, for many patients that chronic condition, they will receive many treatments over a lifetime. And so whether these treatments are combined in some way or whether over time they wind up having multiple of them, we would expect that somebody receiving their care in one of these sites may have more than one of these treatments over the course of their care.

Steve Levine: Treatment-resistant depression is, for many patients, a chronic condition. They will receive many treatments over a lifetime. Whether these treatments are combined in some way or whether over time they wind up having multiple of them, we would expect that somebody receiving their care in one of these sites may have more than one of these treatments over the course of their care.

Speaker #8: And Madison, if you don't mind, I'll chime in as well. Part of the benefit of us producing the data and treatment-resistant depression is that we believe that there's a huge unmet need for VADO as the only indicated product drug product being used right now in this patient population.

Lori Englebert: Madison, if you don't mind, I'll chime in as well. You know, part of, you know, the benefit of us producing the data in treatment-resistant depression is that we believe that there's a huge unmet need. SPRAVATO is the only indicated product, drug product being used right now in this patient population. Given the frequency of treatment that SPRAVATO requires, it is often patient prohibitive. In order for, you know, patients to want to receive these type of treatments, it has to fit into their schedule. We believe COMP360 brings a very complimentary patient profile, patient-friendly profile to these patients.

Speaker #8: And given the frequency of treatment that's provided required, it is often patient prohibitive. And so in order for patients to want to receive these types of treatments, it has to fit into their schedule.

Speaker #8: 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 lines of treatment.

Lori Englebert: We expect COMP360 to be earlier line than where TMS is currently being used right now, which is traditionally one of the later to last lines of treatment.

Speaker #7: Understood. That's very helpful. Thanks.

Madison El-Saadi: Understood. That's very helpful. Thanks.

Speaker #4: Your next question comes from Line of Patrick Truchio of HC Wrenwright. Your line is open.

Operator: Your next question comes from the line of Patrick Trucchio of H.C. Wainwright. Your line is open.

Speaker #6: Thanks. Good morning. I'm a few questions. The first is regarding the phase three trial, the COMP006. For the Part B 26-week data, that's expected in the third quarter.

Patrick Trucchio: Thanks. Good morning. 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 Q3, can you tell us first just which measures will be released at that time? Is it sort of maintenance of greater than 25% MADRS reduction, remission durability, time to relapse, treatment frequency, patient-reported outcomes, and as well as safety? Which parts of those data matter most for the NDA as well as the label and payer discussions?

Speaker #6: Can you tell us, first, just which measures will be released at that time? Is it sort of maintenance of greater than 25% Madras reduction?

Speaker #6: Remission durability, y, 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?

Speaker #6: Yeah. So, Patrick, we haven't yet determined what we would release publicly. From a simple perspective, all of that data will be necessary from an NDA perspective.

Steve Levine: Yeah. Patrick, we haven't yet determined what we would release publicly. From a, you know, a simple perspective, all of that data will be necessary from an NDA perspective. Clearly everything, all those endpoints, primary, secondary, all the safety data will clearly go to the FDA. I'll hand to Lori to talk about the commercial piece.

Kabir Nath: Yeah. Patrick, we haven't yet determined what we would release publicly. From a, you know, a simple perspective, all of that data will be necessary from an NDA perspective. Clearly everything, all those endpoints, primary, secondary, all the safety data will clearly go to the FDA. I'll hand to Lori to talk about the commercial piece.

Speaker #6: So clearly, everything all those endpoints, primary, secondary, all the safety data will clearly go to the FDA. And I'll hand to Laurie to talk about the commercial piece.

Speaker #8: All of that data will also be important for payer and clinical decision-making, which we will all have in due course. To help inform all of those decisions.

Lori Englebert: All that data will also be important for payer and clinical decisions making, which we will all have in due course, to help, you know, inform all of those decisions. In immediate discussions with payers, it will be the redosing and the durability piece that we are really looking for so that we can inform payers on how many doses to expect per patient. Steve?

Speaker #8: But immediate discussions with payers, it will be the redosing and 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.

Speaker #8: And Steve?

Speaker #7: And just one—sorry, Patrick—just one thing to add to that, which is similar to what we guided prior to the release of Part B of 005. Just to be clear, there isn't a particular bar.

Steve Levine: Sorry, Patrick, just one thing to add to that.

Patrick Trucchio: Yeah

Steve Levine: which is, you know, similar to what we guided prior to the release of part B of COMP005, Just to be clear, there isn't a particular bar. There isn't, you know, 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. There's nothing that we're rooting for necessarily. We just need to understand the longer term trajectories of these patients.

Speaker #7: 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.

Speaker #7: And as Laurie said, to have discussions with payers to guide expectations clinically with providers. So there's nothing that we're rooting for necessarily. We just need to understand the longer-term trajectories of these patients.

Speaker #7: 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.

Patrick Trucchio: Great. Just on the commercial side, more specifically, I am just wondering if you can talk more about just your launch readiness and being ready by the end of the year and, you know, to what extent, you know, you've begun that process of, you know, hiring a field force and building out a REMS infrastructure and, you know, sort of discussed, you know, the sort of the structure with payers and distribution contracts. Related to that, you know, of the 7,300 centers that, you know, could offer the treatment or greater than 7,300 centers, how many have you actively engaged with and what proportion do you think are ready or will be ready to administer COMP360 within the first 3 to 6 months after approval?

Speaker #7: 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.

Speaker #7: And as well, related to that, of the 7,300 centers that could offer the treatment or greater than 7,300 centers, how many have you actively engaged with?

Speaker #7: And what proportion do you think are ready or will be ready to administer COMP360 within the first three to six months after approval?

Speaker #8: So given the work with 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 say that we would be launch ready under such short timeline, I'm going to let Steve answer that last question, and then I'll answer your original question at the end.

Lori Englebert: 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, you know, largely to be able to say that we would be launch ready under such short timelines. I'm gonna let Steve answer that last question, and then I'll answer your original question at the end.

Speaker #6: We're flipping it around on here. We're in reverse order. Okay. Yes. So in terms of the sites that we've engaged with and will be ready, as Laurie said, we've been working with sites like this for quite some time now, whether it's formally within our strategic collaborations, whether it's engagement by our field medical team as they've been out for the past couple of years meeting with healthcare providers around the country.

Steve Levine: Oh, we're flipping it around on you. We go in reverse order. Okay. Yes, in terms of the sites that we've engaged with and will be ready, as Lori said, we've been working with sites like this for quite some time now. Whether it's formally within our strategic collaborations, whether it's engagement by our field medical team as they've been out for the past couple of years meeting with healthcare providers around the country, or other relationships we already have with the leadership of these organizations, I think it's fair to say that we've engaged with the vast majority, and we know, you know, really many of them quite well.

Speaker #6: 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.

Steve Levine: It is that level of engagement and knowing them that well that gives me a lot of confidence to say, you know, 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. You know, the feedback we've been getting since the last data release is that, you know, 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.

Speaker #6: 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.

Speaker #6: They're almost more excited than we are. This is really why they've built the infrastructure in the first place. It wasn't to deliver one treatment.

Speaker #6: It wasn't to deliver Spravato. It was in anticipation of having more treatments, particularly ones with a 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.

Speaker #6: The ability to recruit patients from a much larger radius to the point that Laurie made earlier about the burden on patients of the frequency of treatment with Spravato, but particularly with TMS, needing to come every day is really hyper-local patient recruitment with COMP360, with just one or two treatments.

Steve Levine: 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, but particularly with TMS needing to come every day, it's really hyper-local patient recruitment. With COMP360, with just 1 or 2 treatments, they're able to have patients travel from much further area. They are excited. They are really bombarding us every day with questions of, you know, When are you gonna be approved? You know, What do we need to know? They will be ready.

Speaker #6: They're able to have patients travel from much further area. So they are excited. They are really bombarding us every day with questions of when are you going to be approved?

Speaker #6: What do we need to know? So they will be ready.

Speaker #8: Yeah. And Patrick, so will we. And so hopefully, you can hear through mine and Steve'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 very important.

Lori Englebert: Yes. Patrick, so will we. Hopefully you can hear through mine and Steve'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 really important so that they could start to build out their teams. All of that is underway right now. Every single aspect of and 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. We are well on our way of making sure that we are adequately prepared.

Speaker #8: So that they could start to build out their teams and all of that is underway right now. So every single aspect of and 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.

Speaker #8: The team has already doubled in the past two months, and so we are well on our way to making sure that we are adequately prepared. All that—everything you mentioned—is underway.

Lori Englebert: All that, everything you mentioned is underway. You know, compliance, payer discussions are beginning right now. The negotiating piece, I just wanna 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. We certainly are engaging with payers to start those initial discussions right now. Training 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 at the helm.

Speaker #8: So compliance, 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.

Speaker #8: But we certainly are engaging with payers to start those initial discussions. Right now, training distribution is well on its way. We are working there to understand what our distribution strategy is.

Speaker #8: And again, with some really remarkable leaders and very, very experienced at the helm.

Speaker #7: Terrific. Thanks so much.

Patrick Trucchio: Terrific. Thanks so much.

Speaker #6: Thanks, Patrick.

Steve Levine: Thanks, Patrick.

Kabir Nath: Thanks, Patrick.

Speaker #1: Your next question comes from Linda Leonid Timishev of RBC Capital Markets. Your line is open.

Operator: Your next question comes from the line of Leonid Timashev of RBC Capital Markets. Your line is open.

Speaker #9: Hey, guys. Thanks for taking my question. I wanted to ask Gon, PTSD, obviously, another part of the executive order was significant underlying excitement for treating PTSD.

Leonid Timashev: Hey, guys. Thanks for taking my question. I wanted to ask on PTSD. Obviously, another part of the executive order was significant underlying excitement for treating PTSD. I guess I'm curious how you're thinking about your program specifically, whether there's any changes you're envisioning to the trial, whether you think the evidentiary standards may be lower, and you can move ahead with just one phase III registrationally. You know, given the focus on veterans from the administration, whether there's plans to, you know, explore that subpopulation more deeply. Thanks.

Speaker #9: So I guess I'm curious how you're thinking about your program specifically, whether there's any changes you're envisioning to the trial, whether you think the evidentiary standards may be lower and you can move ahead with just one phase three registrationally and given the focus on veterans from the administration, whether there's plans to explore that subpopulation more deeply.

Speaker #9: Thanks.

Speaker #6: Thanks, Leo. And I'll start on that. So first, yeah, we agree PTSD is a very significant unmet need. As we have said, we are planning that as a single late-stage trial.

Kabir Nath: Thanks, Leonid, I'll start on that. First, we agree PTSD is a very significant unmet need. As we have said, we are planning that as a single late-stage trial. Obviously, we will have to see what the data says and so on because ultimately it will be a FDA decision around that. Within that trial, we will have VA sites. More broadly, though, we are already heavily engaged with the VA, and I'm gonna hand to Steve Levine to talk a little bit about what that is. Just before I do, we should also note that it is now publicly available. We are supporting a study within the VA, which is a very robust clinical study, which is a TRD population with heavy PTSD comorbidities. That study we're also supporting.

Speaker #6: Obviously, we will have to see what the data says and so on because ultimately, it will be a FDA decision around that. Within that trial, we will have VA sites more broadly, though we 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.

Speaker #6: We should also note that it is now publicly available. We are supporting a study within the VA, which is a very robust clinical study which is a TRD population with heavy PTSD comorbidity.

Speaker #6: So that study will also support. I'll hand to Steve to talk more broadly about the work we're doing with the VA.

Kabir Nath: I'll hand to Steve to talk more broadly about the work we're doing with the VA.

Speaker #10: Thanks, Kabir. Yeah, PTSD is an area where we are really excited. This is 13 million U.S. adults who currently have very few options—terribly underserved.

Steve Levine: Thanks, Kabir. Yeah, PTSD is an area where we are really excited. This is 13 million US adults who currently have very few options, terribly underserved. Really excited to be moving this program forward. As a reminder, the design of this study was from the beginning intended to support registration with a single trial. That still remains the aim. As Kabir said, we already are engaged with the VA in various ways. He mentioned the study that we are supporting. We are supplying the drug as well as the training of the initial cohort of trainers for a large multi-site VA study looking at people living with both treatment-resistant depression and PTSD, in addition to a second study as well within the VA.

Speaker #10: So really excited to be moving this program forward. As a reminder, the design of this study was from the beginning intended to support registration with a single trial.

Speaker #10: 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.

Speaker #10: We are supplying the drug as well as the training of the initial cohort of trainers for a large multi-site VA study. Looking at people living with both treatment-resistant depression and PTSD.

Speaker #10: 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.

Steve Levine: 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 are approved. That engagement is robust and ongoing, and it certainly is a priority for us to ensure that as we bring new treatments to market, that these are available for our veterans.

Speaker #10: So that engagement is robust and ongoing. And it certainly is a priority for us to ensure that as we bring new treatments to market, that these are available for our veterans.

Speaker #1: Your next question comes from Linda Sumant Kulkarni of Canaccord Genuity. Your line is open.

Operator: Your next question comes from line of Sumant Kulkarni of Canaccord Genuity. Your line is open.

Speaker #11: Hi, team. Thanks for taking up questions. I have a few here. First, how do you expect competitive and legal dynamics on psilocybin to play out given Usona Institute also has a national priority voucher for its product and could already have its phase three data in-house for major depressive disorder?

Sumant Kulkarni: Hi, team. Thanks for taking our questions. I have a few here. First, how do you expect competitive and legal dynamics on psilocybin to play out given Usona Institute also has a national priority voucher for its product and could already have its phase III data in-house for major depressive disorder?

Speaker #6: So I can only comment on the fact that we Sumant Compass have two very large phase three trials where we've already declared the primary endpoint.

Kabir Nath: I can only comment on the fact that we, Sumant, COMPASS have two very large phase III trials where we've already declared the primary endpoint, and we've agreed on a rolling submission and review plan, and that's what we're focused on right now.

Speaker #6: And we've agreed on a rolling submission and review plan. And that's what we're focused on right now.

Speaker #11: Thank you. And do you expect a label limit on the number of treatments per year for COMP360? And how soon after a patient needs retreatment would they be able to get it in the real world?

Sumant Kulkarni: Thank you. Do you expect a label limit on the number of treatments per year for COMP360? How soon after a patient needs retreatment would they be able to get it in the real world?

Speaker #6: So no, but I'll hand from a kind of commercial payer perspective to either Lori or Steve. Lori?

Kabir Nath: No, but I'll hand from a kind of commercial payer perspective to either Lori or Steve. Lori.

Lori Englebert: I'll speak to it from a payer standpoint. Steve Levine can speak to it from a clinician standpoint. 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, you know, not only standard practice, especially with these type of treatments, but also, you know, should be expected. It is, again, not going to be overly onerous for the sites, nor, again, is it outside of the norm of what happens in clinical practice right now.

Speaker #3: payer standpoint. Steve can speak to it from a clinician standpoint. So agreed with Kabir completely. We expect no limit in the label. We will through negotiations be discussing with payers what that looks like.

Speaker #3: And if there would be limits from a prior authorization reapproval process, that is not only standard practice especially with these types of treatments, but also should be expected.

Speaker #3: 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.

Speaker #11: Got it. And sorry, go ahead.

Sumant Kulkarni: Got it. Next one on.

Sumant Kulkarni: Got it.

Steve Levine: Next one on.

Steve Levine: And I-

Sumant Kulkarni: Sorry, go ahead.

Speaker #10: Well, 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, three weeks after the first, or on a more variable basis as we saw in part B of 005.

Steve Levine: Well, just to answer the last part of your question, Sumant, about the treatment frequency or the intervals. You know, what we've seen so far is that some patients have some benefit from a second administration, whether it's on the 6th interval, 3 weeks after the 1st or on a more variable basis as we saw in part B of COMP005. Because the minimum interval we studied is 3 weeks, I would expect that there likely would not be dosing closer than 3 weeks apart. There really clinically would likely not be a reason to. Otherwise, you know, I think the upcoming data from part B of the longer term progress in COMP006 put together with part B of COMP005 will help give some guidance to clinicians on how they would think about retreatment.

Speaker #10: Because the minimum interval we've studied is three weeks, I would expect that there likely would not be dosing closer than three weeks apart. There really clinically would likely not be a reason to.

Speaker #10: Otherwise, I think the upcoming data from Part B of the longer-term progress in 006, put together with Part B of 005, will help give some guidance to clinicians on how they would think about retreatments. And then otherwise, as Lori said, that would be further guided by payer policy.

Steve Levine: Otherwise, as Lori said, that would be further guided by payer policy.

Speaker #11: Got it. And then the last one on PTSD. Other than less frequent dosing, what are the key reasons that would make patients want to take COMP360 versus Azuca, Transcend, TSND 201, or methadone?

Sumant Kulkarni: Got it. Last one on PTSD. Other than less frequent dosing, what are the key reasons that would make patients want to take COMP360 versus Otsuka Transcend's TSND-201 or methylone?

Speaker #10: So they are likely to be first. We need to see data in terms of efficacy and safety on both of them, clearly. They are likely to be very different experiences from a patient perspective.

Kabir Nath: They are likely to be First, you know, we need to see data in terms of efficacy and safety on both of them, clearly. They are likely to be very different experiences from a patient perspective. These are very different medicines with different MOAs. To your point, certainly the Transcend protocol hitherto has been more burdensome from a patient perspective as well. I think, you know, we will need to see how those are fully characterized through the clinical trials. We believe both in terms of patient experience, provider experience, and in frequency of administration, there's clear differentiation between them.

Speaker #10: These are very different medicines with different MOAs. To your point, the certainly the Transcend protocol hitherto has been more burdensome from a patient perspective as well.

Speaker #10: But I think we will need to see how there's a fully characterized through the clinical trial. Both in terms of patient experience, provider experience, and in frequency of administration.

Speaker #10: There's clear differentiation between them.

Speaker #11: Yeah. And to be clear, there hasn't been an approved drug in PTSD this century? There were only two approved options right now. Both are old generic SSRIs that are only modestly efficacious.

Steve Levine: To be clear, there hasn't been an approved drug in PTSD this century. There are only two 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 one or the other. You know, there's not gonna be one winner here. We are excited for any new option that is safe and efficacious in this population. You know, the patients living with PTSD deserve to have more treatment options.

Speaker #11: More options, more options, right? There are 13 million people with PTSD. It is not one or the other. There's not going to be one winner here.

Speaker #11: We are excited for any new option that is safe and efficacious in this population that patients living with PTSD deserve to have more treatment options.

Speaker #11: Thanks.

Kabir Nath: Thanks.

Speaker #1: Your next question comes from Linda of Tom Schrader of BTIG. Your line is open.

Operator: Your next question comes from the line of Thomas Shrader of BTIG. Your line is open.

Speaker #12: Good morning. This is Jenny Kim on for Tom Schrader. Thank you for taking our questions. And congrats on all the progress. A couple of PTSD questions.

Jenny Kim: Good morning. This is Jenny Kim on for Thomas Shrader. Thank you for taking our questions, and congrats on all the progress. A couple of PTSD questions. What's the primary endpoint for the PTSD phase II-B/III trial, and has the FDA aligned on that endpoint in a special protocol assessment? In the TRD program, the 2 doses of COMP006 were administered 3 weeks apart. In COMP002 for PTSD, you've landed on a 4-week interval. Could you walk us through the clinical rationale for that difference? Thank you.

Speaker #12: What's the primary endpoint for the PTSD phase two B three trial? And has the FDA aligned on that endpoint in a special protocol assessment?

Speaker #12: And in the TRD program, the two doses of COMP 006 were administered three weeks apart, but in COMP 202 for PTSD, you've landed on a four-week interval.

Speaker #12: Could you walk us through your clinical rationale for that difference?

Kabir Nath: Sure. The primary endpoint is the CAPS-5, which is very well validated as the normal primary endpoint in PTSD. We are using the standard primary endpoint. Because the CAPS-5 requires a 4-week look back, practically speaking, the second dose has to be at 4 weeks. It can't be at 3 weeks. That's the reason for that. It's tied to that endpoint. As I say, this is the standard endpoint that has been used in PTSD trials. Yeah. No, there is no SPA on this. There doesn't need to be.

Speaker #6: 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.

Speaker #6: And because the CAPS-5 requires a four-week lookback, practically speaking, the second dose has to be at four weeks. It can't be at three weeks.

Speaker #6: So that's the reason for that. So it's tied to that endpoint. But as I say, this is the standard endpoint that has been used in PTSD trials and no, there is no FDA on this.

Speaker #6: There doesn't need to be.

Speaker #12: Okay. Thank you.

Jenny Kim: Okay. Thank you.

Speaker #1: Your next question comes from Linda of Jay Olson of Oppenheimer. Your line is open.

Operator: Your next question comes from the line of Jay Olson of Oppenheimer. Your line is open.

Speaker #13: Well, hey, congrats on the progress and thanks for taking our questions. Maybe we'll just follow up on PTSD. Could you talk about any synergies that you expect to capture from the infrastructure that you're building for TRD?

Jay Olson: Oh, hey, congrats on the progress, and thanks for taking our questions. Maybe we'll just follow up on PTSD. Could you talk about any synergies that you expect to capture from the infrastructure that you're building for TRD? Also, what are some of the differentiating benefits to psilocybin versus other compounds being used or studied for PTSD? Then maybe just any other indications you're planning to pursue for psilocybin beyond TRD and PTSD. Thank you.

Speaker #13: And also, what are some of the differentiating benefits to psilocybin versus other compounds being used or studied for PTSD? And then maybe just any other indications you're planning to pursue for psilocybin beyond TRD and PTSD.

Speaker #13: Thank you.

Speaker #10: Yeah. So we'll go backwards through these. So on all these, Steve and Lori could talk both about synergies and some of the reasons to believe.

Kabir Nath: Yeah. We'll go backwards through these. You know, and I'll leave Steve and Lori to talk both about synergies and some of the reasons to believe. We're clearly very focused on some of these broader neuropsychiatric conditions that do indeed share synergies in terms of patterns of prescribing, locations of treatment, and so on. While we haven't made any determination on other areas, you can imagine there are some, such as bipolar II, OCD, in all of which we have seen signals based on IISs and studies we've supported. We are not yet in a position to lay out formally where else we might go. Let me hand to Lori to talk about kind of the commercial synergies and then maybe Steve to touch on reasons to believe in psilocybin.

Speaker #10: So we're clearly very focused on some of these broader neuropsychiatric conditions that do indeed share synergies in terms of patterns of prescribing, locations of treatment, and so on.

Speaker #10: And while we haven't made any determination on other areas, you can imagine there are some such as bipolar II, OCD, in order of which we have seen signals based on IISs and studies we've addition to lay out formally where else we might go.

Speaker #10: So let me hand to Lori to talk about kind of the commercial synergies and then maybe Steve to touch on reasons to believe and so on.

Speaker #3: Yeah. Given the high overlap in comorbidities between TRD and PTSD, the infrastructure that currently treats will be the same infrastructure that treats for TRD patients.

Lori Englebert: Yeah. Given the high overlap in comorbidities with between TRD and PTSD, you know, the infrastructure that currently treats will be the same infrastructure that treats for TRD patients. 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 equipped and ready to treat patients once it becomes available. From a sales force standpoint, it would be very minimal, you know, change to the sales force to add on PTSD.

Speaker #3: 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.

Speaker #3: So we fully anticipate that the VA will be well-equipped and ready to treat patients once it becomes available. And from a Salesforce standpoint, there would be very minimal change to the Salesforce to add on PTSD.

Speaker #10: And then the last part, nice to talk to you, Jay. One of the things that we saw in our phase two study in PTSD, one of the reasons along with the opportunity to meet the unmet needs for these patients was the experience that our patients had in that study.

Steve Levine: 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 living with PTSD or are currently being investigated. 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.

Speaker #10: We were able to do qualitative interviews with the participants, and we heard some really important feedback that seems highly differentiated from other options that are available for patients living with PTSD or are currently being investigated.

Speaker #10: 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.

Speaker #10: Which is a very frightening prospect. It can make treatment itself very distressing. It's something that we're aware comes up with some of the pathogenic treatments, like MDMA, where these are very intense sessions.

Steve Levine: It's something that we're aware comes up with some of the empathogenic treatments like MDMA, where these are very intense sessions. It's the reason why, you know, 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. That was something that surprised and was gratifying to them afterwards that, you know, despite the fact that they weren't forced to go through such a traumatic experience in getting treatment, that they had profound shifts in the emotional relationship to that trauma.

Speaker #10: It's the reason why many cases these are studied with psychotherapy, with trained psychotherapists, actively engaging with them as traumatic material comes up. What we saw in our phase two study, which was largely focused on safety, feasibility, acceptability, was that this was a very acceptable treatment, one that was very pleasant for patients where the trauma itself didn't even necessarily come up during the experience.

Speaker #10: 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 traumatic experience in getting treatment, they had profound shifts in the emotional relationship to that trauma.

Speaker #10: And so we think that those really well for this, the further development of this as a potential treatment because of that really positive patient experience.

Steve Levine: We think that bodes really well for the development of this as a potential treatment because of that really positive patient experience.

Speaker #1: Super helpful. Thank you. With no further questions, that concludes our Q&A session. I'm going to attend the conference back over to management for closing

Jay Olson: Super helpful. Thank you.

Operator: With no further questions, that concludes our Q&A session. I'll now turn the conference back over to management for closing remarks.

Speaker #6: 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.

Kabir Nath: Thanks everyone for your participation today. As you've heard, we are excited by the fact that we are aligned on a rolling submission review with the FDA. We were already aligned on that before the award of the CNPV, that clearly validates and is a recognition of the really great work we've done, the robust data that we have generated. 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 launch a first in class psychedelic.

Speaker #6: We were already aligned on that before the award of the CMPV. But that clearly validates and is a recognition of the really great work we've done, the robust data that we have generated.

Speaker #6: 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.

Speaker #6: As we talk to providers, patients, current employees, prospective employees, everyone truly sees this as the opportunity of a lifetime. And we are delighted to be in the forefront of that and leading the way in establishing psychedelics as a transformative new option for patients in need of new treatments.

Kabir Nath: As we talk to providers, patients, current employees, prospective employees, everyone truly sees this as the opportunity of a lifetime, and we are delighted to be in the forefront of that and leading the way in establishing psychedelics as a transformative new option for patients in need of new treatments. Thanks for your attention, and we look forward to updating you on our continued progress during the remainder of the year. Thank you.

Speaker #6: 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.