Image source: The Motley Fool.
DATE
Tuesday, Nov. 3, 2026
CALL PARTICIPANTS
- Senior Vice President of Investor Relations - Stephen Schultz
- Chief Executive Officer - Kabir Nath
- Chief Commercial Officer - Lori Englebert
- Chief Patient Officer - Steve Levine
- Chief Financial Officer - Teri Loxam
TAKEAWAYS
- Cash and Cash Equivalents -- $444 million as of Sept. 30, 2026, representing an increase from $149.6 million at the end of 2025.
- Research and Development Expenses -- $23.5 million for the third quarter, decreasing from $27.3 million in the prior year period due to reduced clinical trial costs.
- Selling, General and Administrative Expenses -- $33.0 million for the quarter, increasing from $13.2 million in 2025 reflecting investments in commercial infrastructure and market access capabilities.
- Net Loss -- $9.8 million for the third quarter, or $0.07 per basic share, compared with $137.7 million in the same period of 2025.
- Warrant Liability Adjustments -- A $40.8 million gain was recorded for the third quarter due to non-cash fair value adjustments, compared to a $101.3 million loss in 2025.
- Total Debt -- $51.0 million as of Sept. 30, 2026, compared with $31.6 million as of Dec. 31, 2025.
- Cash Runway -- Management expects current funds to be sufficient to support operating expenses and capital expenditure requirements into 2028.
- NDA Submission Timeline -- The final rolling submission for the treatment-resistant depression indication is scheduled for completion within the next two weeks.
- FDA Review Target -- The company is utilizing a National Priority Voucher that encourages a review target of one to two months for the submitted application.
- Expected Launch Date -- Management targeted the first half of 2027 for the potential commercial launch of COMP360 in the U.S.
- Patient Population TRD -- Approximately 4 million individuals in the U.S. live with treatment-resistant depression, a market currently served by only one approved drug.
- Market Penetration -- Less than 3% of TRD patients in the U.S. currently utilize the only approved treatment, largely due to the burden of frequent dosing requirements.
- Treatment Center Infrastructure -- More than 8,500 interventional psychiatry centers are currently established in the U.S. and equipped for multihour treatments.
- Prescriber Interest -- 90% of interventional psychiatrists surveyed in prelaunch market research indicated they would prescribe COMP360 within its first year of availability.
- Onset of Action -- Clinical data for COMP360 demonstrated symptom relief within 24 hours of administration for patients in a difficult-to-treat population.
- Durability of Effect -- 52-week open label data from the COMP005 trial showed that an additional 25 mg dose of COMP360 could extend clinical benefits out to one year.
- PTSD Opportunity -- An estimated 13 million adults in the U.S. are affected by post-traumatic stress disorder, representing a primary label expansion target for the company.
- State Rescheduling Progress -- Over 93% of the U.S. population lives in states that intend to reschedule within 30 days of federal action by the Drug Enforcement Administration.
- CPT Code Transition -- Management anticipates that the transition of CPT Category III codes to Category I codes will take 12 to 18 months post-launch.
- Commercial Staffing -- All planned nonfield-based commercial roles are currently filled as the company focuses recruitment efforts on its world-class field force.
- Patient Experience Research -- 95% of surveyed TRD patients described themselves as constantly struggling or barely able to get by day-to-day.
- Caregiver Impact -- 70% of surveyed caregivers stated that TRD affects the family social, physical, and mental health.
- Distribution Models -- The company plans to make COMP360 available through both specialty pharmacy and buy-and-bill models, with reimbursement through pharmacy benefits.
- Patent Lifecycle -- The polymorph patent family for COMP360 extends to 2038, with potential restoration extending protection to 2040 or 2041.
Need a quote from a Motley Fool analyst? Email pr@fool.com
RISKS
- Lori Englebert warned that "after federal DEA reschedules, the states also need to reschedule," which must occur before the product can be prescribed and administered.
- CFO Loxam noted that "as the fair value of the warrants fluctuates with our share price, this adjustment can result in significant variability in our reported net income or net loss."
- Lori Englebert stated that "patients either have a large financial burden or can't access the product, or sites don't get reimbursed for their time spent monitoring the patient," indicating factors that could deter a successful launch.
SUMMARY
COMPASS Pathways plc (NASDAQ:CMPS) reported a cash position of $444 million as of Sept. 30, 2026, to fund the commercial launch of its investigational COMP360 psilocybin therapy. Management confirmed that the rolling New Drug Application submission for treatment-resistant depression is scheduled for completion in Nov. 2026, with a target launch in the first half of 2027. The company is seeking accelerated regulatory review and Drug Enforcement Administration rescheduling through a National Priority Voucher and federal executive orders. Operational preparations include engaging with a network of 8,500 existing interventional psychiatry treatment centers and hiring a specialized medical and sales field force.
- CEO Nath stated, "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."
- Chief Commercial Officer Englebert indicated that the 90% willingness to prescribe figure from psychiatrists was the highest she had seen in prelaunch market research.
- The company is actively enrolling patients in a registrational trial for post-traumatic stress disorder, an indication affecting 13 million U.S. adults.
- Chief Patient Officer Levine noted that healthcare provider training requirements within the Risk Evaluation and Mitigation Strategy are expected to take one to two hours to review.
- Management stated that current interventional psychiatry sites possess the staffing and operational knowledge required to support multihour treatments like COMP360.
- The company plans to provide patient support services and reimbursement specialists to clinics to facilitate logistics and minimize affordability barriers during the initial launch phase.
INDUSTRY GLOSSARY
- TRD: Treatment-resistant depression, defined as an inadequate response to two or more courses of antidepressants.
- NDA: New Drug Application, the formal proposal to the FDA to approve a new pharmaceutical for sale and marketing.
- REMS: Risk Evaluation and Mitigation Strategy, a safety program the FDA requires for certain medications with serious safety concerns.
- CPT Category III: Temporary codes for emerging technologies and procedures used for tracking and data collection.
- NPV: National Priority Voucher, a credit that allows for a shortened review timeline for future drug applications.
- Psilocybin: A psychedelic compound being developed as a synthetic treatment for mental health conditions.
- PTSD: Post-traumatic stress disorder, a condition triggered by exposure to traumatic events.
- Buy-and-Bill: A reimbursement process where a provider purchases a drug, administers it to a patient, and then bills the payer.
Full Conference Call Transcript
Operator: Good day, ladies and gentlemen, and welcome to the Compass Pathways Q3 2026 conference call. At this time, all participants are in a listen-only mode. As a reminder, this call is being recorded. I would now like to introduce your host for today's call, Stephen Schultz. You may begin.
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. Today, I am 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 toward 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 is generally well tolerated.
We're 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 two weeks. We have ensured that the filing is the highest quality, with two highly statistically significant phase III studies, together with a positive phase II-B 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 one-to-two-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 two 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 30th, 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 two weeks, and we are encouraged by the ongoing and productive FDA interactions. We remain optimistic for approval in a timeframe 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 one 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, Otsuka, Axsome, and Intra-Cellular.
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 at Compass. At this time, all planned non-field-based commercial roles are filled, and we are now shifting focus to hiring a world-class field 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 surveyed 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 offered little relief, and more than two-thirds 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 who support them. Surveyed patients reported missing family events, reduced work hours, and even resigning from jobs because of their depression. More than half of surveyed 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 psychiatry 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 once 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 one of the most difficult psychiatric conditions in which to demonstrate efficacy. As such, the economic burden to the healthcare 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 benefit. Prescribers are also aware of the significant burden of TRD on patients.
In recent prescriber-focused market research, approximately 90% of interventional psychiatrists 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 pre-launch 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 are proud to be leading this emerging field that 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 two 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 timelines. 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 are aware of the recent speculation regarding another potential filing. There has 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. At this time, we will be conducting a live Q&A session. To our covering analysts, please use the raise hand feature to be added to the queue. Each analyst is limited to one question. Please hold for a brief moment. Our first question comes from Frank Brisebois from LifeSci Capital. Please go ahead, Frank.
Frank Brisebois: All right, thank you for taking the question, and congrats on the updates. 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 to just help us understand what are the steps and what happened.
There is 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 one-to two-month review or different scenarios that could happen in terms of timing here with the filing update for the next couple weeks here. Thank you.
Kabir Nath: Right. Thanks very much, Frank. I will address the regulatory piece and then hand to Lori to talk about rescheduling, because these are the two primary components. Yes, as we are all aware, the National Priority Voucher does encourage the FDA to complete the review within one to two months. When you look back at the limited number of precedents, they are 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 are prepared for the potential that we might actually get a complete approval within that 30-60-day timeline.
Let me hand to Lori to talk about the EO on federal rescheduling and where we see that currently.
Lori Englebert: Yeah, thanks, Kabir, and hi, Frank. Frank, as you mentioned, there is lots of confusion on all the various timeline acceleration opportunities here. As Kabir mentioned, the National Priority Voucher is the one that really talks about the FDA time period. The executive order was really focused on DEA rescheduling and how to expedite that beyond or faster than the 90-day statutory timeline that the DEA has. 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.
I am sure you have heard me say this several times now, but we have done a lot of work to make sure that states that had uncertain timelines in terms of how quickly they would reschedule after federal DEA, we now have over 93% of the U.S. population living in 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 and administered.
Frank Brisebois: Great. Thank you very much.
Operator: Thank you. Our next question comes from Paul Matteis at Stifel. Please go ahead, Paul.
Paul Matteis: Hey. Good morning. Thanks for taking my question. I understand you do not want to comment on Usona directly, so maybe I will try to ask something about competitive dynamics indirectly. Let us say this is a two-player market with multiple psilocybins. 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? Thank you.
Kabir Nath: Thanks, Paul. I mean, just a reminder, and I will hand to Lori, our indication is TRD, and that is fundamental to the value both to patients, providers, and the company. Lori?
Lori Englebert: Yeah. Thanks, Paul. This one I feel very, very confident about. If you take a look at the dynamics of pricing and how that works, it is not necessarily the pricing, a premium that is applied, it is the value that these products are bringing to the healthcare system. If you take a look at SPRAVATO, which is the only product available right now that has proven efficacy in clinical trials in a TRD patient population, TRD patients bring an enormously disproportionate burden to the healthcare system. 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, five 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. I feel very confident that the clinical trials, especially the fact that we have not only two phase III trials, but also a very robust phase II-B that showed remarkable consistency, and across all three trials in terms of how fast the product works from rapid onset. Remember, I just want to remind everyone of the gravity of this patient population. Our clinical trials patients were in their current depressive episode on average three to four years.
That means they hadn't had any relief in three to four years, and some patients saw relief within 24 hours after being dosed. That is something that I think many of us, it's hard to imagine. Payers understand the results there, and the durability obviously is a bonus as well.
Operator: Thank you. Our next question comes from Andrew Tsai at Jefferies. Please go ahead, Andrew.
Andrew Tsai: Thanks. Good morning. Thank you. Hypothetically, let's just say COMP360 was approved, everything was DEA scheduled, you're ready to go. How many months do you think it would take for the CPT Category III codes to be fully negotiated? As that's going on, can you just remind us if patients would be getting access possibly with other existing codes or would the initial launch phase mostly be cash pay? Thank you.
Kabir Nath: Andrew, that's a question for Steve.
Steve Levine: Yeah. Good morning, Andrew. Thanks for that question. Yes. First, the elements that are required to transition the code from CPT Category III to Category I primarily sit with the reporting of those codes, the generation of demand, the pinging of payers. 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 CPT Category III 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 I. Ultimately, we anticipate that taking 12-18 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.
Lori Englebert: Yeah. Andrew, if I might add here, it doesn't take anyone with any 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, or sites don't get reimbursed for their time spent monitoring the patient. That will deter a 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 is not a prohibiting factor at launch.
Andrew Tsai: Thanks so much.
Operator: Thank you, Andrew. Our next question comes from Josh Schimmer at Cantor. Please go ahead, Josh. Josh, you may be on mute. All right. Looks like Josh is having some technical difficulties, so we will take the next question from Gavin Clark-Gartner with Evercore. Please go ahead, Gavin.
Gavin Clark-Gartner: Hey, guys. 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 across psilocybin. Thank you.
Kabir Nath: Yeah. Thank you, Gavin. We are very confident in the strength of our polymorph patent. As you know, it is directed to claims covering actually a number of polymorphs, and specifically the XRPD across those, and we are very confident that will withstand scrutiny from any other oral form of psilocybin. As a reminder, when the patents were first published, they were in fact challenged, and those challenges were completely rejected, including the appeals against them. So we remain very confident in that family. That extends to 2038 before patent term restoration, so we anticipate sort of 40, 41-ish probably.
Gavin Clark-Gartner: Perfect. Thank you.
Operator: Thank you, Gavin. Our next question comes from Ritu Baral with TD Cowen. Please go ahead, Ritu.
Ritu Baral: Good morning, guys. 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 or sponsoring for drug training, and how might that translate to other therapies that could be competitively available? Then you mentioned buy-and-bill versus the 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: Thanks, Ritu. That was definitely two questions, not one.
Ritu Baral: Sorry.
Kabir Nath: But leaving that aside, I think we'll hand the first part to Steve and then to Lori.
Steve Levine: Yeah, I'll take training. Good morning, Ritu. In turn, we'll start with what the requirements will be. Based on our interactions with the FDA as we work towards finalizing our REMS, we expect there to be training content within the REMS that will take about one to two hours to review. Again, that will represent the requirements for healthcare 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 organizations 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: Hi, Ritu. I'll answer the second question. Remember, for psychiatry, buy-and-bill is relatively new, as new as SPRAVATO has come to market. Right now, we think and believe SPRAVATO buy-and-bill volume is somewhere in the 30%-40% range of volume. In terms of preference, just using that as a proxy, we don't believe that buy-and-bill will be huge for COMP360 out of the gate, but we expect it to ramp to something very similar to SPRAVATO, potentially even surpassing it.
What we know is that some sites do prefer buy-and-bill, and we definitely want to make sure that option remains open for them, because it is obviously an additional source of revenue, and also part of the reason why interventional psychiatry 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.
Ritu Baral: Thanks.
Operator: Thank you, Ritu. Our next question comes from Madison El-Saadi from B. Riley. Please go ahead, Madison. Madison, you may be on mute.
Madison El-Saadi: Yes. Thanks for taking our question. In your phase III, over, I believe, 95% of the patients had failed two to four treatments. How does COMP360 efficacy compare in less severe versus the more refractory patients? Is this, I know you've spoken about this before, is this difference something that's fundamental to psilocybin itself? Maybe I'll just state the same question in a different way. Within COMP005, COMP006, did response and durability differ between patients with zero to one prior failure versus those that had three or four prior failures? Thanks.
Steve Levine: Good morning, Madison. First, I'll be a bit obnoxious and say I'm militant at saying that patients are failed by treatments. They haven't failed. That's a side point and not a criticism of you. 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.
Looking at the baseline characteristics in our phase III study and also in phase II-B, where the average length of the current episode is three to four years, to see the benefit that we've seen for these patients is really quite remarkable. 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. I think we can say that pretty clearly because the stream does move in one direction.
We know that for the 55+ 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 even more likely to benefit.
Lori Englebert: Madison, it might also just be worth noting that because we were studying treatment-resistant depression, we were required to study failures after two failures. We would not have any data on the zero to two failures.
Madison El-Saadi: Understood. Thank you both.
Operator: Thank you, Madison. Our next question comes from Josh Brewer with RBC. Please go ahead, Josh.
Josh Brewer: Hey, everybody. I was wondering if you could give us a little more detail on the outlines of the white glove approach you will 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. Thanks.
Steve Levine: [inaudible]
Lori Englebert: Yeah. Thanks, Josh. This is probably my favorite topic to talk about. Steve has his favorites, I have my favorites. 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, but also how Compass shows up as a company. I think it's very important to understand that physicians, when adopting something as paradigm-changing as COMP360 has the potential to do, and psychedelics 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 pharma company.
There will be some newness to this, and the newness will be what the REMS requirements will look like, and how they get reimbursed for the time spent monitoring for the six hours. All of this will need some handholding, which is the white glove 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. We are going to put forth a very robust patient support services program. We're going to make sure that sites know how to bill correctly.
We're going to make sure that they are attaching the CPT Category III codes so that we can advance them to Category I as quickly as possible. 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: Josh, it's maybe worth adding that what we've been building and what we're planning for is not only based on past experience, and certainly it's not pulled out of thin 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 receive that care today.
Josh Brewer: All right. Thanks, guys.
Operator: Thank you, Josh. Our next question comes from Pat Trucchio with H.C. Wainwright. Please go ahead, Pat.
Pat Trucchio: Hi. Good morning. My question is on repeat dosing. I am wondering what regulatory feedback you have 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. We are not going to go into great detail on the label now, given where we are in the review process. As we have said always, what we would envisage and target is after one or two initial administrations, that then there is the provision for episodic dosing per physician decision.
Operator: Thank you, Pat. Our next question comes from Maxwell Skor with Morgan Stanley. Please go ahead, Maxwell.
Maxwell Skor: Great. Thank you very much for taking my question. I was just wondering, has the FDA given any signal on whether the first approved psilocybin 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. Thank you.
Kabir Nath: Yeah. Again, we will not go into much detail on the REMS, but what we can say is what we have said publicly in the past, that the FDA directed us to use the SPRAVATO REMS 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 should be reflected in the REMS. Steve, anything you want to add or?
Steve Levine: No, I think that-
Lori Englebert: Yeah, that's exactly how we're feeling about it, is that each molecule has different behaviors, and therefore the REMS should reflect language and restrictions around that.
Maxwell Skor: Great. Thank you.
Operator: Thank you, Maxwell. Our next question comes from Sumant Kulkarni from Canaccord. Please go ahead, Sumant.
Sumant Kulkarni: Thanks for taking our question, and unfortunately, it's a two-parter. From a payer logistics perspective, what is your view on the relative ease of successful reimbursement of a psychedelic that might be approved for TRD versus those that might be approved for MDD, perhaps at a lower price point? How important do you think is meeting the letter of the ICH guidelines for psilocybin prior to approval?
Kabir Nath: Just to clarify the second question, you mean in terms of number of patients studied?
Sumant Kulkarni: Yes, number of patients studied.
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: Yeah, but we have.
Kabir Nath: We have.
Lori Englebert: But we have.
Kabir Nath: We have.
Lori Englebert: We have-
Kabir Nath: Yes.
Lori Englebert: Yeah.
Kabir Nath: With more than 1,000 patients, and of course, also with the 52-week data from COMP005 being part of our submission. Lori?
Lori Englebert: Yeah, Sumant, thanks for the question on TRD versus MDD. This is probably my second favorite topic to discuss. As I mentioned before, the way that we see the value of TRD data playing out with payers is very positively. Again, we have generated data in over 1,000 patients, very consistent data in a patient population that has been in their current episode for three to four years. As you can imagine, and unfortunately, Steve would kick me under the table if I didn't-
Kabir Nath: I wouldn't sit in the treatment.
Lori Englebert: Because you're sitting between us, so he can't. But if I didn't share this disclaimer in that obviously, we do not enjoy speaking about patients this way. But unfortunately, when a patient is in an episode for three to four years, the economic burden that can bring to the healthcare system is quite different than a patient who is newly diagnosed with MDD. 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 three to four 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. 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: Thank you, Sumant. Our next question comes from Thomas Shrader with BTIG. Please go ahead, Thomas.
Thomas Shrader: Good morning. Thank you for taking my one, but somewhat vague question. You often make the comment that COMP360 is likely to make more sense for patients relative to ketamine, the one 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 are preaching to the converted, or is there work to be done there? Because it logically makes sense, but I am curious how much the community already feels that way. Thank you.
Steve Levine: Thanks, Tom. Yeah, unfortunately, or fortunately, I think that is 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 36-54 that are required per the label with SPRAVATO.
Thomas Shrader: Yeah.
Steve Levine: Reminder, even if there is a somewhat shorter period of time of observation with SPRAVATO versus what we expect for COMP360, for patients and their caregivers, a day is a day. So we are talking about just a few versus 36-54, and that is self-evident.
Thomas Shrader: Great. Thanks.
Lori Englebert: Thomas, if I might add just one more point that you didn't ask, but I would like to throw in there. That is, when you think about the frequency of dosing with a product like SPRAVATO 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, their caregivers who have to drive them, they also have to take time off of work.
The radius in which patients can drive to do this on a frequent basis is quite small versus one where they go in anywhere from two to four times in a year. You obviously open up that radius of patients coming into treatment centers. Not only is it very appealing to patients, but treatment centers are also getting excited about the potential to drive more patients in from further away.
Thomas Shrader: Got it. Thanks.
Operator: Thank you. Our next question comes from Devin Kaddali with Wolfe. Please go ahead, Devin.
Devin Kaddali: Hi there. Thanks for taking our question. 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.
Steve Levine: Yeah, thanks for the question, Devin. If you look at the now finalized guidance from FDA for the design of clinical trials in psychedelics, our design matches what they have guided, which is to have one primary monitor and to use CCTV to assist with the total monitoring by two total healthcare 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. This happens to match the current staffing models that are used in the interventional psychiatry clinics delivering SPRAVATO today.
Not only is a current SPRAVATO room today, the COMP360 room of tomorrow, once approved and rescheduled, but the staff that are currently caring for patients in these centers receiving treatments like SPRAVATO 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 receiving our product.
Devin Kaddali: Thank you.
Operator: Thank you. Our next question comes from TianQi Hang with Wells Fargo. Please go ahead, TianQi.
TianQi Hang: Hi, how is it going, team? This is TianQi calling in on behalf of Ben Burnett. We have a question on REMS. Could you please talk about how you are preparing for the REMS program and really how much resources or infrastructure you are kind of dedicating, not just setting up the REMS program, but also keep it operational kind of after it launch? We are asking this question because we really wanted to know that, is it fair to assume that a psychedelics REMS would be kind of challenging to run for some organization with very few people, like 20, 30 people with no infrastructure or commercial arm, even if they hypothetically choose to outsource some of the REMS?
Just want to have appreciation of that complexity and the resources intensive. Thank you.
Kabir Nath: I will hand, I think, first to Lori and then 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 are already doing for SPRAVATO, outside of a couple of small tweaks that would be specific to the molecule itself, like the six hours versus two hours requirement. Yes, it is something that is not only resourced from a personnel standpoint internally, but also it is very expensive to operate a REMS. Obviously, we are doing that and working very hard with REMS providers to facilitate that.
TianQi Hang: Thank you.
Operator: Thank you. Our final question comes from Chiara Montironi from Kempen. Please go ahead, Chiara.
Chiara Montironi: Hello, team. Thanks for taking my question. I was wondering, from your initial dialogue with the FDA, so much before the final FDA guidance on psychedelics, could you maybe remind us which were the sort of minimal requirements for NDA submission for psychedelics medicine in terms of number of trials, number of patients, follow-up duration for safety?
Kabir Nath: Thanks, Chiara, for the question. What I can say is, first, we had excellent engagement as we designed first the phase II-B and then the phase III program. As you say, that was 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 to a query from a journalist, that psychedelic medicines will be held to the same high standards of rigor and demonstrating evidence as anything else they look at. I think that probably from the words of the FDA is probably the best way I can answer that question.
Chiara Montironi: Clear. Thank you. Can I maybe sneak in a last question as well?
Kabir Nath: All right. Since you're last, Chiara, I will allow it.
Chiara Montironi: Great. On the other indications for expansion, could you maybe help us understand how will you go about selecting these?
Kabir Nath: Yeah. I will comment and then invite Lori and Steve to jump in as well. I mean, I think what we see clearly so far, the focus has been on, yeah, very traditional areas of neuropsychiatry. Well, I think all of us determined 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 psilocybin, to look in related areas where there has really been no traction for a 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, but we clearly see indications of interest there. There are others more closely related to TRD, such as bipolar II, where again, we have very interesting IIS. Then there are equally other areas where, again, there has been nothing approved for a very long time, such as OCD. But importantly, our very next indication is PTSD. As we have said, often PTSD, with 13 million adults in the U.S., is actually potentially an even bigger opportunity than TRD.
Chiara Montironi: Clear. Thank you very much.
Operator: Thank you for your questions, Chiara, and to all of our analysts. I will now turn it back to Kabir for closing remarks.
Kabir Nath: Thanks very much. As you've heard, we are getting ready to complete our submission in the next two weeks. We are incredibly excited as Compass, everyone at Compass is excited, not only at the prospect of completing that, but the fact with the National Priority Voucher, with the potential for 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, as I say, are confident from the regulatory perspective we have submitted. We will be completing the submission of a very high-quality dossier that we believe will absolutely meet the FDA's highest standards.
With the team that Lori has built, the work that she and Steve are leading to get us ready on the commercial side, we cannot wait to be the first out there to launch a psychedelic. Thank you. Thanks, everyone, for your attention.
This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. Parts of this article were created using Large Language Models (LLMs) based on The Motley Fool's insights and investing approach. It has been reviewed by our AI quality control systems. Since LLMs cannot (currently) own stocks, it has no positions in any of the stocks mentioned. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability.
The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.