Conferencia de resultados del T3 de 2026 de COMPASS Pathways (CMPS): NDA de COMP360 y lanzamiento en 2027

La teleconferencia de resultados del tercer trimestre de 2026 de COMPASS Pathways (NASDAQ: CMPS) se centró en la vía regulatoria y los preparativos comerciales para COMP360 en la depresión resistente al tratamiento (TRD), en lugar de los resultados operativos trimestrales.

Conclusiones clave

• COMPASS prevé completar la presentación por entregas periódicas de la solicitud de nuevo fármaco (NDA) para COMP360 en un plazo de dos semanas. El expediente incluye dos estudios de Fase III estadísticamente significativos y un estudio positivo de Fase IIb, con más de 1.000 pacientes inscritos en todo el programa.
• El voucher de prioridad nacional establece un período objetivo de revisión por parte de la FDA de uno a dos meses. La dirección afirmó que la aprobación podría producirse potencialmente en un plazo de 30 a 60 días, aunque los plazos siguen sujetos a la revisión de la FDA.
• La empresa se prepara para lanzar COMP360 para la TRD en la primera mitad de 2027, supeditado a la aprobación de la FDA y a la reclasificación de sustancias controladas a nivel federal y estatal.
• El efectivo totalizaba 444 millones de dólares al 30 de septiembre de 2026. La dirección prevé que el balance financie holgadamente las operaciones durante el lanzamiento planificado y hasta 2028.
• COMPASS estima que aproximadamente 4 millones de personas en Estados Unidos padecen TRD, mientras que menos del 3% recibe actualmente el único tratamiento aprobado y comercializado para esta indicación.
• La dirección caracterizó el perfil de COMP360 como capaz de ofrecer efectos en 24 horas y una durabilidad potencial de hasta 12 meses con solo unos pocos tratamientos.

Datos financieros clave

Rendimiento empresarial y operativo

Avance regulatorio de COMP360

COMPASS señaló que la presentación por entregas periódicas de su NDA sigue en marcha para completarse en un plazo de dos semanas. La solicitud está respaldada por dos estudios de Fase III y un estudio de Fase IIb con más de 1.000 pacientes en total, así como por datos de 52 semanas incluidos en el expediente.

La dirección calificó de productiva la interacción con la FDA. El voucher de prioridad nacional apunta a una revisión de uno a dos meses, aunque la dirección reconoció que los precedentes son limitados y los plazos de revisión han variado.

La reclasificación de sustancias controladas a nivel federal y estatal también afectará al calendario de lanzamiento. La empresa indicó que ya ha facilitado a la FDA la documentación necesaria para el proceso de reclasificación federal. Según la dirección, más del 93% de la población de Estados Unidos vive en estados que han indicado su intención de reclasificar en los 30 días posteriores a la acción federal.

Preparativos para el lanzamiento comercial

Se han cubierto todos los puestos comerciales previstos fuera del terreno y COMPASS está reclutando ahora a su equipo de ventas sobre el terreno. Los enlaces de enlace científico médico están informando a los clínicos sobre la TRD y COMP360, mientras que el equipo de acceso a pagadores está entablando conversaciones con planes a nivel nacional, regional y estatal.

La empresa planea utilizar la infraestructura existente de psiquiatría intervencionista en Estados Unidos. La dirección citó más de 8.500 centros de tratamiento dotados de personal, capacidad de monitorización y flujos de trabajo operativos que podrían dar soporte a sesiones de COMP360 de varias horas de duración.

COMPASS prevé ofrecer vías de acceso tanto por farmacia especializada como por la modalidad buy-and-bill. La dirección estimó que la modalidad buy-and-bill representa actualmente entre el 30% y el 40% del volumen en entornos comparables de psiquiatría intervencionista y prevé que su adopción aumente con el tiempo.

En una investigación de mercado patrocinada por la empresa, aproximadamente el 90% de los psiquiatras intervencionistas encuestados afirmó que prescribiría COMP360 en su primer año de disponibilidad. Esto refleja una intención manifestada y no el comportamiento real de prescripción.

Posicionamiento en el mercado

La dirección destacó el esquema de administración poco frecuente de COMP360 en comparación con los tratamientos que requieren visitas clínicas recurrentes. La empresa considera que un menor número de sesiones de tratamiento al año podría reducir la carga para los pacientes y los cuidadores, al tiempo que amplía el radio geográfico atendido por los centros de tratamiento.

COMPASS también puso de relieve la carga económica asociada a la TRD. En su estudio con pacientes, el 95% de los encuestados afirmó sentirse en lucha constante o saliendo adelante a duras penas, mientras que aproximadamente el 75% refirió agotamiento emocional tras probar múltiples tratamientos sin una mejora significativa.

Ampliación de la cartera de productos

El estudio potencialmente de registro de la empresa para el trastorno de estrés postraumático (PTSD) se encuentra en fase activa de inscripción de pacientes. COMPASS estima que más de 13 millones de adultos en Estados Unidos se ven afectados por el PTSD y considera que esta indicación representa una oportunidad significativa de ampliación de etiqueta.

La dirección también identificó los trastornos por uso de sustancias, el trastorno bipolar II y el trastorno obsesivo-compulsivo como posibles áreas de desarrollo futuro. No se facilitaron plazos de desarrollo para estas indicaciones.

Orientaciones de la dirección

• COMPASS prevé completar la presentación de la NDA para COMP360 en un plazo de dos semanas.
• La empresa se está preparando para un potencial lanzamiento en Estados Unidos en la primera mitad de 2027, sujeto a la aprobación regulatoria y a la reclasificación de sustancias controladas.
• La dirección prevé que el saldo de efectivo de 444 millones de dólares respalde las operaciones holgadamente durante el lanzamiento y hasta 2028.
• Tras un eventual lanzamiento, la empresa prevé informar sobre métricas que incluyen certificaciones REMS, prescripciones, prescriptores y acceso a pagadores.
• El esquema de administración repetida preferido por la dirección implicaría una o dos administraciones iniciales seguidas de dosis episódicas a discreción del médico. La redacción final de la etiqueta sigue bajo revisión de la FDA.

Riesgos y aspectos a vigilar

• El período de revisión de la FDA de uno a dos meses es un objetivo asociado al voucher de prioridad nacional, no un plazo de aprobación garantizado.
• La disponibilidad comercial requiere la reclasificación por parte de la DEA a nivel federal, seguida de la correspondiente medida a nivel estatal.
• Los requisitos finales de la estrategia REMS continúan en discusión con la FDA. La dirección describió la aplicación como compleja, intensiva en recursos y costosa.
• El reembolso tanto de COMP360 como del período de monitorización clínica será clave para su adopción. La empresa prevé que la transición de los códigos CPT de Categoría III a la Categoría I lleve entre 12 y 18 meses.
• COMPASS aún no ha analizado las tasas de respuesta o remisión según el número de fracasos terapéuticos previos. Sus estudios en TRD tampoco aportan datos para pacientes con menos de dos fracasos terapéuticos previos.
• El acceso inicial podría verse afectado si los pacientes se enfrentan a costes desembolsados sustanciales o si los centros de tratamiento no reciben un reembolso adecuado por el tiempo de monitorización. La empresa planea programas de apoyo a pacientes y profesionales sanitarios para abordar estas barreras.

Aspectos destacados del turno de preguntas y respuestas con analistas

Plazos de la FDA y de la reclasificación: La dirección señaló que el voucher de prioridad abre la posibilidad de un proceso con la FDA de 30 a 60 días, pero reconoció una amplia variedad de precedentes. La reclasificación federal y estatal también debe producirse antes de que COMP360 pueda prescribirse y administrarse.

Reembolso y codificación: COMPASS prevé que los códigos CPT de Categoría III respalden el lanzamiento inicial. Se espera que la transición a los códigos de Categoría I lleve de 12 a 18 meses, y está previsto apoyo sobre el terreno para ayudar a los centros de tratamiento a documentar y facturar correctamente.

REMS y monitorización: Basándose en las pautas de los ensayos clínicos, el modelo de la empresa utiliza un monitor principal, asistencia por CCTV y dos profesionales sanitarios en total. La dirección prevé que los requisitos comerciales finales no sean más estrictos que los utilizados en los ensayos, aunque la estrategia REMS sigue en revisión por parte de la FDA.

Propiedad intelectual: La dirección expresó su confianza en la familia de patentes del polimorfo de COMP360, que se extiende hasta 2038. La empresa prevé que una eventual restauración del plazo de la patente podría ampliar la protección aproximadamente hasta 2040 o 2041.

Capacitación y apoyo a los centros: Se prevé que la revisión del contenido del curso de capacitación sobre la REMS lleve a los profesionales sanitarios entre una y dos horas aproximadamente. COMPASS también está respaldando una formación y capacitación más amplias orientadas a preparar a los centros de tratamiento para la atención asistida con psicodélicos.

Transcripción completa de la teleconferencia de resultados

Transcripción completa de la conferencia de resultados

Comentarios de la dirección

Operator

Good day, ladies and gentlemen, and welcome to the COMPASS Pathways Third Quarter 2026 Conference Call. As a reminder, this call is being recorded. I would now like to introduce your host for today's call, Stephen Schultz. You may begin

Stephen Schultz

Welcome all of you, and thank you for joining us today for this conference call. Again, my name is Steve Schultz, Senior Vice President of Investor Relations at COMPASS Pathways. And today, I'm joined by Kabir Nath, our Chief Executive Officer; and Lori Englebert, our Chief Commercial Officer. Dr. Steve Levine, our Chief Patient Officer; and Teri Loxam, our Chief Financial Officer, will also be available for the Q&A. The call is being recorded and will be available on the COMPASS Pathways Investor Relations website shortly after the conclusion of the call and will be available for a period of 30 days.

Before we begin, let me remind everyone that during the call today, we will be making statements about our future plans and prospects that constitute forward-looking statements. Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement, including those risks and uncertainties described under the heading Risk Factors in our most recent filings with the U.S. Securities and Exchange Commission. These forward-looking statements represent our views only as of today, and we specifically disclaim any obligation to update or revise any forward-looking statement even if our estimates or assumptions change. I will now hand the call to Kabir Nath.

Kabir Nath

Thank you, Steve, and thank you all for joining us today. COMPASS continues to make excellent progress towards the potential FDA approval of our psychedelic treatment, which will fundamentally change how mental health is managed. Today, for the estimated 4 million individuals in the U.S. who are impacted by treatment-resistant depression, there is only one approved and marketed drug with that indication and fewer than 3% of those patients are actually being treated with it. COMP360's profile is unique and compellingly differentiated in delivering both a rapid onset with effects seen within 24 hours and durability potentially out to 12 months with just a few treatments.

The data also show a safety profile that's generally well tolerated. We are confident that COMP360's efficacy in this difficult-to-treat patient population, along with a much less frequent administration schedule will be highly attractive to patients and prescribers, a confidence that's been well supported by the recent market research that we've been conducting. We will complete our rolling NDA submission in the next 2 weeks.

We have ensured that the filing is the highest quality with 2 highly statistically significant Phase III studies together with a positive Phase IIb study that together enrolled over 1,000 patients. This will enable the agency to review it with its usual scientific rigor. Given that this has been a rolling submission and because we've been granted a national priority voucher, the ongoing interactions with the FDA remain productive with a high level of constructive engagement between our respective teams.

The voucher sets a 1- to 2-month review target for the FDA, so there's the potential for a very rapid approval. Our commercial preparations are moving forward with tremendous momentum. Lori has assembled an all-star team that has the expertise and experience to introduce COMP360 and deliver a successful launch following the potential approval of the TRD indication.

Our late-stage trial for post-traumatic stress disorder or PTSD, which is designed to be registrational, is actively enrolling. PTSD represents an important label expansion opportunity for COMP360. Over 13 million adults in the U.S. are affected by PTSD and the only approved medicines are 2 drugs that were approved over 25 years ago, which offer limited effectiveness. Given our robust and strong patent portfolio for COMP360, we're also exploring several other opportunities to expand the label. With our demonstrated success in clinical development for this class of medicines and the ability to leverage the commercial infrastructure we're building, we envisage multiple potential future indications.

This could drive tremendous long-term revenue and earnings growth for the company well beyond TRD and PTSD. For now, our priority remains completely focused on maximizing the 2027 launch of COMP360 in TRD. We expect our strong balance sheet with $444 million of cash on hand as of September 30 to carry us well through the launch and into 2028. Let me now hand the call to Lori to provide more detail on our commercial strategy and set the stage for some of the key parameters we will be using to evaluate the launch as it progresses through the course of 2027. Lori?

Lori Englebert

Thanks, Kabir. We continue to rapidly advance commercial launch preparations, and we will be ready for the earliest possible approval date. As Kabir noted, the NDA submission is well on track to be completed in the next 2 weeks and we are encouraged by the ongoing and productive FDA interactions. We remain optimistic for approval in a time frame that reflects the spirit of the national priority voucher. The emerging product profile of COMP360 offers both rapid onset of action seen within 24 hours and remarkable durability not previously available in depression treatments.

Combined with a generally well-tolerated and safe profile, COMP360 is highly differentiated, and we are confident that clinicians will adopt COMP360 as the treatment of choice for patients with TRD. COMPASS is well positioned to establish this emerging field of psychedelic medicine, not only by bringing an innovative and important new product to market with COMP360, but also the manner in which we do it. As the leader, we have a responsibility to patients and providers to set the gold standard for commercial execution. The commercial leadership team is 1 of the most highly experienced that I have ever worked with.

Collectively, we have led over 65 product launches at companies like J&J, Gilead, Osaka, Axon and intracellular. The level of passion and expertise that this team brings is remarkable. Over the past several quarters, the commercial leaders have been building each of their respective functional teams, and the level of talent that we have been able to attract speaks volumes about the opportunity these individuals see COMPASS. At this time, all planned nonfield-based commercial roles are filled -- and we are now shifting focus to hiring a world-class sales force.

The recruiting for the field-based roles is going remarkably well with an incredibly high level of interest. In addition -- over the past quarter, our newly expanded team of medical science liaisons have continued to educate clinicians on TRD and COMP360. And our payer access team has been actively engaging with payers across regional and national accounts as well as state level plans. The marketing and launch strategy work remains on track, and we are confident that we will be launch ready at the earliest possible time point.

One key initiative of our commercial preparations has been extensive market research to fully understand the human impact of TRD. COMPASS has completed multiple research projects that have involved patients caregivers, prescribers and providers. One of the most impactful and consistent findings from this research is the significant burden of TRD. For example -- when asked about their day-to-day experience, nearly all, 95% of survey patients describe themselves as constantly struggling and barely able to get by on a day-to-day basis. For the many people with TRD, the path to relief can mean years of trial and error through the many treatments approved for MDD, which have not demonstrated efficacy in TRD and the continual therapy switching is a burden of its own.

After having tried multiple treatments without meaningful symptom improvement, approximately 75% of TRD patients felt emotionally exhausted from the false hope of trying treatments that ultimately offer little relief and more than 2/3 of patients state that living with TRD has made them feel hopeless about their future. The impact of TRD extends beyond depressive symptoms, robbing patients of special moments and opportunities as well as profoundly affecting the families and caregivers to support them. Survey patients reported missing family events, reduced work hours and even resigning from jobs because of their depression.

More than half of survey caregivers feel emotionally exhausted by the cyclic nature of searching for effective treatments for their loved ones and approximately 70% say TRD affects the whole family's social, physical and/or mental health. These insights provide an important perspective on the real-world impact of TRD and underscore the urgent need for new TRD treatments like COMP360. This unmet need highlights the significant market opportunity for COMPASS, potentially reaching the estimated 4 million patients in the U.S. Today, less than 3% of these patients are accessing the only marketed and approved TRD treatment, Spravato due largely to the burden associated with the required frequency of dosing. One of the biggest advantages of COMP360 is its durability with infrequent dosing. This is why we are confident in its potential. At launch, we will leverage the well-established interventional psychiatry treatment center infrastructure. These treatment sites are specifically designed to support in-office treatments for products that require multi-hour support and monitoring.

This established infrastructure has existing capacity and importantly, is already equipped with the staff and operational know-how needed to support additional multi-hour treatments like COMP360. Seven years ago, when Spravato launched, this infrastructure did not exist. Today, there are more than 8,500 interventional [indiscernible] treatment centers in place across the U.S. and it continues to grow rapidly.

We are working closely with these providers to ensure a smooth integration in which COMP360 is available, and we believe the physical and operational capabilities are in place to support scaling to meet patient demand. We will also have a dedicated team of specialists working directly with clinics to facilitate the logistics associated with reimbursement for both the drug and the monitoring time for COMP360 administration. TRD is 1 of the most difficult psychiatric conditions in which to demonstrate efficacy. As such, the economic burden to the health care system is significant, much higher compared with MDD -- and payers are acutely aware of this. Our payer discussions are active and going well. COMP360 will be available through both specialty pharmacy and buy-and-bill with drug reimbursed through pharmacy benefits.

Prescribers are also aware of the significant burden of TRD on patients. In recent prescriber focused market research, approximately 90% of interventional psychiatrist stated that they would prescribe COMP360 within the first year of being available. This is the highest willingness to prescribe percentage I have ever seen in prelaunch market research. We are confident that prescribing, dosing and reimbursement will easily integrate within current clinical practice. As we look ahead to our launch -- we anticipate sharing certain key performance measures that reflect the launch progress throughout 2027. These will include items such as REMS certifications, prescriptions, prescribers and payer access and I look forward to being able to update you on these key launch metrics. COMP360 is poised to lead a profound shift in mental health care. Moving beyond the daily antidepressants or frequent dosing required with Spravato toward an option involving just a few treatments a year, fundamentally changing the way that patients living with depression are cared for. As you have heard -- we are making excellent commercial progress, and I look forward to discussing more with you as we near the launch of COMP360 Thank you. Let me hand the call back to Kabir.

Kabir Nath

Thank you, Lori. COMPASS is excited to be at the forefront of this new era. We're proud to be leading this emerging field but has the potential to set new standards of care and completely change the treatment paradigm in mental health. We will complete the filing of the NDA submission in the next 2 weeks. And with the national priority voucher and the executive order on DEA rescheduling, there are several areas of potential acceleration. We look forward to providing further guidance regarding time lines.

Everyone at COMPASS is highly focused on execution, advancing with speed, discipline and purpose across the organization to deliver COMP360 to patients with TRD as quickly as possible following approval. Before we turn to Q&A, let me acknowledge that we're aware of the recent speculation regarding another potential filing. There's been no official statement, and we will not be providing any comments on this matter. With that, let me pass the call to the operator for Q&A.

Operator

Thank you, Kabir. [Operator Instructions] So our first question comes from Franc Brisebois from LifeSci Capital.

Preguntas y respuestas

François Brisebois

All right. And congrats on the update. I did hear the last part, so I will not ask about it. I was just wondering, in terms of timing, I think there will be -- you mentioned some more color coming up. But I was just wondering if you can kind of go through the scenarios. So just help us understand what are the steps and what happened? There's a lot of noise and a lot of information with all the executive orders. And so we just wanted to get a better feel of the likeliness of kind of a 1- to 2-month review or different scenarios that could happen in terms of timing here. with the filing update for the next couple of weeks here.

Kabir Nath

Thanks very much, Frank. So I'll address the regulatory piece and then hand to Lori to rescheduling of this. These are the 2 primary components. So yes, as we are all aware -- the national priority voucher does encourage the FDA to complete the review within 1 to 2 months. And when you look back at the limited number of precedents, they're all very different -- but that sometimes encompasses both an acceptance and a review period, but there is a reasonably wide distribution around a median of around 60 days. But obviously, as we said, we're prepared for the potential that we might actually get a complete approval within that 30- to 60-day time line. Let me hand to Lori to talk about the EO on federal rescheduling and where we see that currently.

Lori Englebert

Yes, Franc, as you mentioned, there's lots of confusion on all the various time line acceleration opportunities here. And as Kabir mentioned, the national priority voucher is the 1 that really talks about the FDA time period -- the executive order was really focused on DEA rescheduling and how to expedite that -- faster than the 90-day statutory time line that the DEA has -- and so we are working to get insight into that.

What that actually means is that the DEA is encouraged to reschedule in a more timely manner. What I can tell you is that we have provided every documentation possible to the FDA already, and we did that some time ago. So the ball is in their court and they have everything they need to be able to do this in a faster time period. Unfortunately, we likely will have a little -- not much insight into what that timing looks like. But I also want to just add in terms of timing, we also need to make sure we understand that after federal DEA reschedules, the states also need to reschedule. And I'm sure you've heard me say this several times now, but -- we have done a lot of work to make sure that states that had uncertain time lines in terms of how quickly they would reschedule after federal EA.

We now have over 93% of the U.S. population living states that have stated that they intend to reschedule within 30 days. after federal DEA. So that timing also needs to happen before a product can actually be prescribed in a minister.

Operator

Our next question comes from Paul Matteis at Stifel.

Paul Matteis

I understand you want to comment on Soda directly. So maybe I'll try to ask something about competitive dynamics indirectly. Let's say, this is a 2-player market with multiple sales items. What would be the pitch on why COMP360 should be the go-to product, one; and two, could still garner premium pricing, if that were what the market looks like. .

Kabir Nath

So yes, I mean just a reminder, and I'll handle Lori. Our indication is TRD and that is fundamental to the value both to patients, providers and the companies. Lori?

Lori Englebert

Yes. Thanks, Paul. This 1 I feel very, very confident about. If you take a look at the dynamics of pricing and how that works, not necessarily the pricing premium that is applied. It's the value that these products are bringing to the health care system. And if you take a look at SPRAVATO, which is the only product available right now that has proven efficacy in clinic trials in a TRD patient population, TRD patients bring an enormously disproportionate burden to the health care system. And so payers respond very well to a product that has proven efficacy in that patient population compared to the 55 MDD products that are currently available of which are branded products that are all fighting and having to discount quite deeply to get into a favorable position on a formulary for payers.

So I feel very confident that the clinical trials, especially the fact that we have not only 2 Phase IIIs, but also a very robust Phase IIb that showed remarkable consistency and across all 3 trials in terms of how fast the product works from rapid onset Remember, and I just want to just remind everyone of the gravity of this patient population. Our clinical trials, patients were in their current depressive episode on average 3 to 4 years.

That means they hadn't had any relief in 3 to 4 years, and they -- some patients saw relief within 24 hours after being dosed. That is something that I think many of us is hard to imagine. So payers understand the results there and the durability obviously is a bonus as well.

Operator

Our next question comes from Andrew Tsai at Jefferies.

Lin Tsai

Hypothetically, let's just say COMP360 was approved. Everything was DEA schedule, you're ready to go. How many months do you think it would take for the CPT 3 codes to be fully negotiated. And as that's going on, can you just remind us if patients would be getting access possibly with other existing codes or with the initial launch phase, mostly be cash paying

Kabir Nath

Andrew, that's a question for Steve.

Steve Levine

Andrew, thanks for that question. Yes. So first, the elements that are required to transition the code from Category 3 to Category 1, primarily it with the reporting of those codes, the generation of demand, the pinging of payers. And so we will have support out in the field, ensuring that sites have appropriate guidance on the codes that they can use to make sure that the Category 3 codes are being reported. There is also the consideration of the editorial calendar for the AMA, which is the process that these codes will need to go through in order to transition to category 1.

Ultimately, we anticipate that taking 12 to 18 months. But in the interim, as I said, sites will be supported to understand how they can code in the short term. And we will have patient support programs in place to ensure that affordability is not a barrier to access in the early days of the launch.

Unknown Executive

Yes. And Andrew, if I might add here, it doesn't take anyone with an experience to understand what would prohibit a very successful launch. And that is patients either have a large financial burden or can't access the product. our sites don't get reimbursed for their time spent monitoring the patients. That will ever launch pretty quickly. We have and will be taking extraordinary measures to make sure that we have, as Steve mentioned, patient support services out available for patients and sites to make sure that, that is not a prohibiting factor at launch.

Operator

Thank you, Andrew. Our next question comes from Josh Schimmer at Cantor. Josh, you may be you are on mute. All right. It looks like Josh is having some technical difficulties. So we'll take the next question from Gavin Clark-Gartner with Evercore.

Gavin Clark-Gartner

Great to see all the progress. Maybe you could just comment on your confidence in the strength of the polymorph IP and how broadly that extends kind of across psilocybin?

Kabir Nath

Yes. Thank you, Gavin. So we are very confident in the strength of our polymorph patent. As you know, it's directed to claims covering actually a number of polymers and specifically the PD across those. And we are very confident that, that would stand extremely from any other oral form osilocibin. As a reminder, when the patents were first published, they were, in fact, challenged and those challenges were complete rejected, including the appeals against them. So we remain very confident in that family that extends to 2038 with 4 patent term restoration so we anticipate sort of 4041-ish probably.

Operator

In. Our next question comes from Ritu Baral with Cowen.

Ritu Baral

Another question on competitive positioning, especially as it relates to site support. Lori, you mentioned that the team that you have will help with drug sourcing and monitoring. What about training that has come up with a lot of the interventional sites that we have spoken to. What sort of programs are you guys developing our sponsoring for drug trading? And how might that translate to other therapies that could be competitively available? And then you mentioned buy-and-bill versus a pharmacy benefit that could be used for reimbursement.

Do you guys have any idea right now what the preference for buy-and-bill versus pharmacy benefit is in the interventional sites that you guys are working with?

Kabir Nath

That was definitely 2 questions. [indiscernible]In the first start to Steve, and then to Lori.

Steve Levine

Yes, I'll take training, we'll start with what the requirements will be. based on our interactions with the FDA as we work towards finalizing our rents, we expect there to be training content within the REMS that will take about 1 to 2 hours to review -- and again, that will represent the requirements for health care providers. Beyond that, there's an opportunity here. because we anticipate the approval of our product to be the beginning really of a shift and an evolution in how mental health care is delivered.

We will also support and we have begun to support the enablement of other forms of training and education. We will develop our own resources, but we've also enabled this through the grants that we've provided to training organization and to other forms of education and training that we will enable to really solidify our leadership in the space of preparing the workforce for this paradigm shift in how people living with severe mental health care conditions receive their care.

Lori Englebert

And Ritu, I'll answer the second question. So remember for psychiatry, buy and bill is relatively new, as new as [indiscernible] has come to market. So -- right now, we think and believe buy-and-bill volume is somewhere in the 30% to 40% range of volume. And in terms of preference, just using that as a proxy, we don't believe that buy and build will be huge for COMP360 out of the gate, but we expect it to ramp to something very similar to [indiscernible] potentially even surpassing it. .

What we know is that some sites do prefer buy and bill, and we definitely want to make sure that, that option remains open for them because it is obviously an additional source of revenue. And also part of the reason why interventional psychiatric treatment centers are starting to grow so rapidly. There is obviously appeal in the fact that there are additional sources of revenue for these sites beyond just the billing for monitoring time.

Operator

Our next question comes from Madison El-Saadi Saudi from B. Riley.

Madison Wynne El-Saadi

Yes. for taking our question. In your Phase III, over, I believe, 95% of the patients had failed 2 to 4 treatments. How does COMP360 efficacy compare in less severe versus the more refractory patients? And is this -- I know you've spoken about this before -- is this different something that's fundamental to psilocybin itself? And maybe I'll just take the same question in a different way. Within [indiscernible] did response and durability different between patients with 0 to 1 prior failure versus those that had 3 or 4 prior failures. .

Steve Levine

Maison. First, there'll be a bit of noxious and say I'm militant at saying that patients are failed by treatments. They haven't failed. But that's a side point and not a criticism of view. We haven't yet done an analysis of the response or remission rates or other outcome measures based upon the number of lines of treatment that have failed these patients within our studies. That said, it's well established that the longer someone goes untreated, the more lines of treatment that have failed these patients, the more refractory they are, the less likely it is that they'll benefit from further treatment.

And looking at the baseline characteristics in our Phase III study and also in Phase IIb, where the average length of the current episode is 3 to 4 years to see the benefit that we've seen for these patients is really quite remarkable -- and it's very reasonable to assume that those who have a shorter time course of treatment or who have had fewer treatments within this episode would actually be more likely to benefit or might have a deeper response.

And I think we can say that pretty clearly because the stream does move in 1 direction. We know that for the 55 plus MDD labeled antidepressants that exist today -- many of them have tried to demonstrate efficacy in TRD and failed to do so. However, if you are starting with the most difficult-to-treat patients, and showing the efficacy we've shown with the rapid onset and the durability that's on the scale unlike anything we've ever seen, it is very reasonable to assume that those who have had a less refractory course would be more -- even more likely to benefit.

Lori Englebert

And Madison it might also just worth noting that because we were study treatment-resistant depression we were required to study failures after 2 failures. So we would not have any data on the 0 to 2 failures.

Operator

You -- our next question comes from Josh Brewer with RBC.

Unknown Analyst

Hi, everybody. I was wondering if you could give us a little more detail on sort of the outlines of the glove approach you'll be taking in the initial phases of the launch and whether or not you expect white glove service to have the biggest impact on adoption enthusiasm among private academic, community or government sites.

Lori Englebert

Yes. Thanks, Josh. It's probably my favorite topic to talk about. Steve has his favorites. I have my favorites. So the white glove approach that I like to talk about is all encompassing about the way that we will show up. not only the way that our field force shows up in offices, also how Compass shows up as a company. I think it's very important to understand that physicians when adopting something as paradigm changing at COMP360 has the potential to do and psychedelic in general coming to market. .

There will be some hesitancy or uncertainty. There will be some -- this is not the typical oral antidepressant that's rolling out from a former company there will be some newness to this. And the news will be what the REMS requirements will look like and what -- how they get reimbursed for the time spent monitoring for the 6 hours. All of this will need some handholding, which is the white blob that I'm referring to. We also recognize, as I mentioned earlier, in comments that we want to make sure that we're showing up and making sure that patients are not prohibited from receiving treatment due to financial concerns.

And so we are going to put forth a very robust patient support services program. We're going to make sure that sites know how to build correctly. We're going to make sure that they are attaching the CPT 3 code so that we can advance them to category 1 as quickly as possible. So all of this requires a somewhat different approach and level of attention to the sites and to patients that is not usual in pharma companies.

Steve Levine

And Josh, it's maybe worth adding that what we have been building and what we're planning for is not only based on past experience. And certainly, it's not pulled out as an air. Much of this has been -- the foundations have been laid with the work we've been doing over the past few years with a wide variety of settings of care, many of which you named within your question, to really understand any of the potential barriers to implementation and delivery, not just in the most obvious settings like the interventional psychiatry clinics, of which there's more than 8,500 at this point for whom this will be very easy -- but also all the other settings of care where people living with TRD received that care today. .

Operator

Our next question comes from Pat Trucchio with H.C. Wainright.

Patrick Trucchio

My question is on repeat dosing. I'm wondering what regulatory feedback you've received on physician-directed retreatment versus minimum interval or defined symptom threshold? And what would be the ideal language in an upcoming potential label? .

Kabir Nath

Thank you, Patrick. So we're not going to go into great detail on the label now given where we are in the review process. But as we've said always, what we would envisage and target is after 1 or 2 initial administrations then there is the provision to episodic dosing per physician decision.

Operator

Thank you, Pat. Our next question comes from Maxwell Skor with Morgan Stanley.

Maxwell Skor

I was just wondering, has the FDA given any signal on whether the first approved silicibin REMS will become, let's say, a template for later entrants -- or will each product get its own REMS? Any color or commentary on this would be very helpful.

Kabir Nath

Yes. Again, we will not go into much detail on the rent for what we can say is what we have said publicly in the past that the FDA directed us to use a probate runs as a template and that would be where we see the direction going. I obviously can't comment on how they're thinking about the class more generally. But I would stress that there are clearly key differences between, let's say, psilocybin and MDMA -- and we clearly see that, that should be reflected in a REMS. Steve, anything you want to add .

Unknown Executive

No.

Lori Englebert

T Yes. That's exactly how we're feeling about it is that a molecule has different behaviors, and therefore, the rent should reflect language and restrictions around that. well.

Operator

Our next question comes from Sumant Kulkarni from Canaccord.

Sumant Kulkarni

Unfortunately, it's a 2-parter. So from a payer logistics perspective, -- what is your view on the relative ease of successful reimbursement of a economic that might be approved for TRD versus those that might be approved for MDD perhaps at a lower price point? And how important do you think is meeting the letter of the ICH guidelines for psilocybin prior to approval? .

Kabir Nath

So just to clarify the second question you mean in terms of number of patient studies. .

Sumant Kulkarni

Yes, number of patients in [indiscernible]

Kabir Nath

That would be a question for the FDA. I don't know how they think about it. But the first question --

Lori Englebert

We have. We have -- but we have .

Kabir Nath

With more than 1,000 patients and of course, also with the 52-week data from OFI being part of our submission. Laurie?

Lori Englebert

On TRD versus MDD, this is probably my second favorite topic to discuss. So as I mentioned before, the way that we see the value of TRD data playing out with payers is very possibly. Again, we are we have generated data in over 1,000 patients, very consistent data in a patient population that has been in their current episode for 3 to 4 years. As you can imagine, and unfortunately, Steve would kick me under the table if I didn't.

[indiscernible]-- but if I didn't show this disclaimer or disclaimer in that, obviously, we do not enjoy speaking about patients this way. But unfortunately, when a patient is in an episode for 3 to 4 years, the economic burden that, that can bring to the health care system is quite different than a patient who is newly diagnosed with -- and so payers react very strongly and have reacted through our payer discussions already to the fact that we are generating such remarkably consistent and powerful data 24 hours after being in a depressive episode for 3 to 4 years is extremely powerful for payers.

Most importantly, it's powerful for patients and the caregivers. -- that they live with as well as for prescribers who are able to see these results. So we feel very confident and very good about the TRD data versus an MDD more generalized population and where that may land on formulary access, most importantly, in terms of rebating and formulary position.

Operator

Our next question comes from Thomas Shrader with BTIG.

Thomas Shrader

Somewhat vague question. You often make the comment that COMP360 is likely to make more sense for patients relative to ketamine, the on treatment versus potentially months. As you approach the market, how often do you find that mirrored in your prescriber base? Is that something that you're talking -- preaching to the converted -- or is there work to be done there? Because it logically makes sense, but I'm curious how much the community already feels that way.

Unknown Executive

Thanks, Tom. Yes. I mean, unfortunately, I think that's not something we really need to convince prescribers of when they see this emerging profile of the rapid onset that Lori was just describing of being able to see these results within 24 hours, but then being able to maintain durability out to 12 months with just a few treatments versus the 36 to 54 that are required for the label with [indiscernible] -- reminder, even if there is a somewhat shorter period of time of observation with [indiscernible] versus what we expect for for patients and their caregivers a day is a day.

So we're talking about just a few versus 36 to 54, and that is self-evident.

Lori Englebert

I might add 1 more point that you didn't ask, but I would like to throw in there. And that is when you think about the frequency of dosing with a product like at and the treatment centers that are currently available to prescribe them, the radius in which a patient is willing to drive that often -- and as Steve said, it's a day is a day. I mean these are days off of work that patients have to take. Not only that, they're caregivers who have to drive them, they also have to take time off of [indiscernible]. The radius in which patients can drive to do this on a frequent basis. is quite small versus 1 where they go in anywhere from 2 to 4x in a year, you obviously open up that radius of patients coming into treatment centers. So not only is it a very appealing to patients, both treatment centers are also getting excited about the potential to do a from further away.

Operator

Our next question comes from Devin Kodali with Wolfe.

Unknown Analyst

I was wondering if you could provide some additional color on the current monitoring requirements during the treatment session and how they could evolve in the coming years, pending approval and rollout.

Kabir Nath

Yes. Thanks for the question, Devin. If you look at the now finalized guidance from FDA for the design of clinical trials in code our design matches what they have guided, which is to have 1 primary monitor and to use CCTV to assist with the total monitoring by 2 total health care providers. We are, as I mentioned earlier, still finalizing the REMS in discussion with FDA, but we would certainly anticipate that the final requirements will be no more stringent than what has been required so far in clinical trials. And this happens to match the current staffing models that are used in the interventional psychiatry clinics delivering [indiscernible] today. And so not only is a current [indiscernible] today, [indiscernible] room of tomorrow once proved and we scheduled, but the staff that are currently caring for patients in these centers receiving treatments like [indiscernible] and TMS and the staffing ratios and the workflows, et cetera, will be mirrored in what is needed to support patients in the real world receive them on product.

Operator

Our next question comes from Tian Chiang with Wells Fargo.

Unknown Analyst

On team. This is [indiscernible] on behalf of [indiscernible] -- so we have a question on ramps. Could you please talk about how you are preparing for the rent program? How much -- really how much resources infrastructure you're kind of indicating not just setting up the REMS program, but also keep it operational kind of after launch. We're asking this question because we really wanted to know that is it fair to assume that a psychedelics brand will be kind of challenging to run for some organization with like very few people like 20, 30 people with no infrastructure or commercial arm even if they have to have issues to outsource some of the REMS. Just want to have appreciation of that complexity in the resources intensive.

Kabir Nath

Yes, I will hand. I think, first Lori and Steve. But in a word, it is resource-intensive and complex.

Lori Englebert

It is extremely resource intensive and complex, and we have an entire group at COMPASS who will help facilitate all of this. It is resource intensive and complex from a manufacturer side, from a site side, this will be very consistent with what they're already doing for Spread outside of a couple of small tweaks that would be specific to the molecule itself-- like the 6 hours versus 2 hours requirement. And so yes, it is something that is not only resourced from a personnel standpoint in terms internally but also it is very expensive to operate [indiscernible] -- and obviously, we are doing that and working very hard with brands providers to facilitate that.

Operator

Our final question comes from Kara Montrone from Kempen.

Unknown Analyst

So I was wondering from your initial dialogue with the FDA, so much before the final FDA guidance on code -- could you maybe remind us which were the sort of minimal requirements for NDA submission for psychedelic medicine in terms of number of trials, number of patients, follow-up duration for safety.

Kabir Nath

Thanks, Kara, for the question. So -- what I can say is, I mean, first, we had excellent engagement as we design first the Phase IIb and then the Phase III program. And you said that it's a number of years ago before even the draft guidance came out. What I can point you to is the FDA continues to say publicly, including as recently as last week in response query from a journalist that psychotropic medicines will be held to the same high standards of rigor and demonstrating evidence of anything else they have. So I think that probably from the words of the FDA is probably the best way I can answer that question. .

Unknown Analyst

Clear. And can I maybe sneak in a last question as well? On the other indications for expansion, could you maybe help us understand how will you go about selecting these.

Kabir Nath

Yes. So I'll comment and then invite Lori and Steve to jump in as well. So I mean, I think what we see clearly so far, the focus has been on very traditional areas of neuropsychiatry. Well, I think all of us determined that, that was the first place to start in our case, TRD and others MDD and GAD and so on. But I think there is real opportunity given what we see happens with patients treated with last -- look in related areas where there has really been no traction for very long time.

Substance use disorder is an obvious one. And obviously, there are many subsets of that. alcohol use is probably the most prevalent and the biggest public health burden. We clearly see indications of interest there. There are others more closely related to TRD such as bipolar 2, where again, we had very interesting I -- and then there are equally other areas where, again, there has been nothing approved for a very long time, such as OCD.

But importantly, of next -- very next indication is PTSD. And as we've said often PTSD, with 13 million adults in the U.S. is actually potentially an even bigger opportunity than TRD.

Operator

Thank you for your questions, Kara, to all of our analysts. I will now turn it back to Kabir for closing remarks.

Kabir Nath

Thanks very much. So as you've heard, we are getting ready to complete our submission in the next 2 weeks. We are incredibly excited as COMPASS -- everyone COMPASS is excited, not only at the prospect of completing that. But the fact with the national priority voucher with the potential for a faster FDA rescheduling that we will, as we said, be preparing to launch in the first half of 2027. The team is ready for that. We are, as I say, are confident from the regulatory perspective we have submitted. We'll be completing the submission of a very high-quality dossier that we believe will absolutely meet the FDA's higher standards -- and with the team that Lori has built the work that she and Steve are leading to get us ready on the commercial side, we can't wait to be the first out there to launch a psychedelic. Thank you. Thanks, everyone, for your attention.