Prepared remarks
Good day, ladies and gentlemen, and welcome to the COMPASS Pathways Second 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.
Thank you, operator. 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. 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 statements, even if our estimates or assumptions change. I'll now hand the call to Kabir Nath.
Thank you, Steve, and thank you all for joining us today. The first half of this year has been an exciting time for COMPASS. Now that we have highly statistically significant positive Phase III primary endpoint readouts, as well as demonstrated durability through 6 months from both our trials, we believe we have largely derisked the clinical and regulatory profile of COMP360. In addition to confirming its rapid onset and durability, the totality of data from the program so far shows it has a generally well tolerated and safe profile. Taken together, these data reinforce our belief the COMP360 has the potential to fundamentally change how mental health is managed. With these data sets in hand, we continue to make significant progress towards our NDA filing for the treatment of TRD. Our rolling submission and review process allows us to submit data in waves to the FDA, and they have started to review some modules that we've already submitted. We continue to expect to complete the NDA filing in the fourth quarter. With the potential for an accelerated approval following our final submission, we are advancing our commercial readiness. We've built a fantastic commercial team with incredible experience, and we're executing on all fronts to be prepared to get COMP360 to the millions of patients living with TRD who urgently need new treatment options. We're also well-positioned with our strong balance sheet, with $433 million of cash on hand as of June 30, which carries us well through launch and into 2028. Let me now hand the call to Lori to talk through in more detail how we're preparing to transform treatment options for these patients.
Thanks, Kabir. Hi, everyone. Thank you for joining. As Kabir outlined, we have achieved significant milestones in the first half of the year. Notably, we have advanced important commercial readiness initiatives across organizational capabilities, strategic collaboration, policy and payer engagement, and distribution. All are significant steps toward being launch ready. Earlier this year, we rounded out hiring of the commercial leadership team, attracting highly experienced, energized leaders who immediately started to build out their functions. My direct reports come from companies like J&J, Gilead, Otsuka, and Axsome, and between them have led over 70 product launches. The prospect of launching the first psychedelic in history with a medicine that has the potential to fundamentally change the way mental health is treated is a very powerful attractor of talent. We are bringing in outstanding professionals from across the pharma industry, and I am incredibly proud of the team we are building at COMPASS. In the first half of this year, we also announced additional strategic collaborations with Radial and Osmind, taking the total to eight, each with their own distinct capabilities. These collaborations played a critical role in helping to inform our priority focus at launch of ensuring optimal end patient experience. With the final submission of our NDA expected in the fourth quarter, our focus in the second half of this year is on operationalizing launch plans and ensuring launch readiness. This includes advancing everything from training, education, access and reimbursement, and patient support mechanisms. Importantly, we have also already initiated recruiting for the sales force. Our timelines for launch remain fluid, given the National Priority Review Voucher and executive order in April, and the need for federal DEA and state rescheduling. We remain focused on being ready to launch, which we anticipate being in the first half of 2027. At launch, we will leverage the well-established existing interventional psychiatry treatment center infrastructure. These treatment sites are specifically designed to support in-office treatments for products that require multi-hour monitoring, such as Spravato, TMS, and ECT. The established infrastructure has existing capacity, and importantly, is already equipped with the staff and operational know-how needed to support additional multi-hour treatments like COMP360. Seven years ago, when Spravato launched, this infrastructure did not exist. Today, there are more than 8,000 established sites across the U.S., and this continues to grow rapidly. COMP360 is poised to lead a profound shift in mental health care, moving beyond daily or frequent dosing toward an option potentially involving just a few treatments a year, which could be life-changing for patients. Across two highly statistically significant and positive Phase III trials, COMP360 demonstrated extremely rapid onset of action with deep and clinically meaningful reduction in depressive symptoms as quickly as one day, unprecedented durability sustained through at least six months, and notably, reproducibility of effect in a chronic treatment-resistant patient population, one of the most difficult psychiatric conditions in which to demonstrate efficacy. The data are strong, and both patients and prescribers are excited about the potential for a new treatment option. In recent prescriber-focused market research, approximately 90% of interventional psychiatrists stated that they would prescribe COMP360 within the first year it is available. In my experience, this is the highest willingness-to-prescribe percentage I have ever seen in prelaunch market research. With the COMP360 emerging profile and continued interest and excitement around the class, we are eager to bring a new treatment option to the approximately 4 million patients living with TRD today who have limited treatment options. We are confident in the blockbuster opportunity. COMP360 has the potential to fundamentally change the way that patients living with depression are cared for, and COMPASS is committed to helping as many patients as possible. We are making significant progress towards being launch ready, and I look forward to discussing more with you throughout the rest of this very exciting year. Thank you, and let me hand the call back to Kabir.
Thank you, Lori. Our progress in the first half of the year has meaningfully derisked the path towards potential approval and launch and reinforces our confidence in the strength, consistency, and robustness of the COMP360 data package that we are submitting to the FDA. With the regulatory process underway, our focus is on disciplined execution, completing our filing activities and preparing for a first pass approval and ensuring we are poised to deliver COMP360 to patients with TRD as quickly as possible following approval. And as you just heard from Lori, we will be ready. With that, let me pass the call to the operator for Q&A. Thank you.
Questions and answers
Your first question is from the line of Paul Matteis with Stifel.
Specifically, I was wondering if the team could offer some perspective on the recently issued FDA guidelines around psychedelics. And more specifically, how did you interpret the discussion of those guidelines as it relates to 12-month blinded durability? What do you think that really means or what the FDA is asking for? And how do we think about that in the context of the COMP360 program?
Thanks, Paul. I'm just checking, can you hear me clearly?
Yes.
So look, I think as you're aware, this is a finalization of a set of draft guidelines. The original draft, in fact, came out even after we had fully designed our Phase III, aligned with the agency on that and so on. Our perspective is we have had very robust continuing dialogue with the agency throughout this program. While the guidance is certainly interesting and we do have those comments on the 12 months blinded and that would seem like a pretty tall order for any psychiatry drug, we actually don't think it's going to impact the process of our regulatory approval at this stage. The other parts that I draw your attention to are the design of Phase III studies in a complementary pair continues to be effectively exactly in line with the design of our studies. So while I think the guidance is interesting and obviously for future endeavors we will be carefully looking at that, we do not think these guidelines are going to impact the regulatory process that's already underway for us.
Your next question is from the line of François Brisebois with LifeSci Capital.
I was just wondering, in terms of launch, can you help us understand—this always happens, but especially in your situation—just the reimbursement challenges, what are we going to have to go through just to get a better feel for the cadence here with the launch expected next year?
Hi, Frank. Thanks for the question. As you mentioned, launches are traditionally hard coming out of the gate with reimbursement just because you need time. What we are doing now is our market access team is already engaging with payers, and they have been for some time. We are getting very positive feedback from the payers, especially in this TRD patient population, where proving efficacy has almost been impossible to do in the past. That is resonating well with a key stakeholder who truly understands the economic burden that patients with TRD can have on a payer system. At launch, we intend to have a field reimbursement team fully deployed at the time of launch who will be out helping these sites ensure that they can code and get the reimbursement that they need and making sure that they are well educated in the process. In terms of drug reimbursement and the conversations we are having with payers right now, we are working through that. We are still ingesting the data that we just got and released a couple of weeks ago into the value proposition that COMP360 can bring, and then we'll make decisions as we get closer to launch on what that might look like in terms of rebating and payer negotiations for formulary access.
Your next question is from the line of Gavin Clark-Gartner with Evercore.
Maybe you could just characterize how any ongoing regulatory discussions are progressing? And separately, what are your expectations for DEA scheduling timelines at this point?
Thanks, Gavin. On the first part, they're going well. The rolling submission is well underway. As I noted in the remarks, some of what has been sent is under review. We're getting questions on it. Given the acceleration and the NPRV, the onus is also on us to respond very quickly, and we're doing that. The team is doing an excellent job being responsive. So nothing out of the ordinary; we remain on track. As you know, it's only when you get into the later stages that things like label and REMS really come into play. Those are typically negotiated fairly late in the process. So nothing untoward to report; we're very happy with progress. On rescheduling, I'll hand to Lori.
Yes. Hi, Gavin. We are accelerating our 8-factor analysis, getting that to the Controlled Substances staff as quickly as possible in hopes of enabling faster FDA and DEA coordination along the way. We are also engaging with the DEA to seek further clarity on timing. As I've mentioned in the past, the DEA is pretty consistent in meeting their 90-day timeline for rescheduling, so we feel confident they will reschedule within that period, but the exact timing remains a bit fluid. Given the executive order in April, we are optimistic about potential acceleration.
Your next question is from the line of Ritu Baral with Cowen. Please go ahead.
Another question for you, Lori. Specifically around the term 'training' that you used in the prepared remarks, it sounds like in response to some of the prior questions, some of that training for the interventional psychiatry sites will revolve around coding. But I wanted to ask, what other aspects of training does the team plan on offering interventional psychiatry sites, especially given that you have a solid precedent REMS to train against and anticipate? How do you anticipate offering readiness services to those sites? And how does that impact how we may model 2027 rollout? We've had experience with sponsors wanting to manage the early experience with a drug at sites and with clinicians on early rollout. So anything you can tell us about the general shape of 2027 as you see it now with the training offered?
Hi, Ritu. We think about training in two parts: training and education. On training specifically, we announced that we are participating in grants for third-party companies to help with site training on psychedelics and, once COMP360 has a final label, on anything required for the monitoring time that the patient will be in the room. We want to make sure that the patient experience is a very good one, and sites will need to be trained because in the REMS they will need to attest to being trained; part of that will be based on the training these third-party providers enable. Already, there are well over 1,000 people trained on the psychedelic portion of that training, so there is a broad group ready to go. The COMP360-specific training on how to best support a patient and enable a good patient experience will come after we see the final label and get that finalized. We will also need to train sites on REMS to ensure compliance with REMS certification and all requirements. In terms of rollout, given likely time between approval and DEA and then state rescheduling, we're going to leverage that time to the best of our ability. We will have teams out immediately upon approval helping sites understand REMS requirements and preparing them to administer the product when it becomes available. Site readiness will be a key KPI we will communicate on. Regarding prescribing, our field force will educate prescribers and referring physicians, and our medical science liaisons have been out in the field for 2.5 years continuing that education. We will also support peer-to-peer education to ensure comprehensive coverage and awareness of COMP360's potential.
Your next question is from the line of Andrew Tsai with Jefferies.
Thanks for the update. You guys are in a unique position to be the leader in the psychedelic space. So to maintain that leadership over the next year, what is your appetite like to do even more studies with COMP360 outside of PTSD and so forth? Any new indications or other new psychedelics we can hear about? Or is the expectation for us to be focused on the launch itself?
Thank you for the question, Andrew. The near-term expectation should be focus on the launch. As a company with our first asset, we have a team working hard on the submission and on achieving a first pass approval because submitting is one thing, but this needs to be a robust dossier. We are the leaders from a quality perspective, including inspections, and this is new to the agency. We are very focused on a robust submission and getting that first pass approval. The PTSD study is underway. As we move through what we hope is an approval and launch, we will continue to evaluate other opportunities for COMP360. There are interesting areas such as substance use disorder, with AUD in particular given its public health impact, and other opportunities. But in the short term, be focused on submission, approval, and launch for TRD.
Andrew, to add color: consistent with Kabir's comments, we have supplied study drugs to a large number of investigator-initiated studies (IIS). We will review those to understand potential opportunities for COMP360. At the same time, we'll be collecting real-world evidence to better understand patient populations responding to COMP360. We'll pursue multiple fronts to identify the next viable indication.
To build on that, we paused some IIS for a couple of years and have supplied drug for a number of indications. We are ramping IIS up again and have a number of IIS starting in areas such as OCD, which is potentially interesting. Now that we are getting closer to the regulatory finish line for TRD, we are restarting IIS programs.
Your next question is from the line of Madison El-Saadi with B. Riley.
Maybe I'll ask on REMS certification. If you could help us understand that process: is this something that's molecule-specific? Can sites proactively progress that process before DEA rescheduling takes place, or is that sequential? And secondly, are you continuing to collect safety data or safety follow-up data, or has the full safety data package been submitted?
I'll take the second part first. Both studies run to 52 weeks, so we will ultimately provide the full 52-week safety data to the agency. Right now, with the 26-week data from 006 in hand, our core focus in preparing the submission is integrating the safety from the 26 weeks blinded of both studies into an integrated summary, and that's a key area of focus. Ultimately, the agency will see the 52 weeks of data as part of the review process.
Hi, Madison. Regarding REMS, the REMS will not be finalized until we receive approval. Because of that, we will only be able to start ensuring sites are aware of REMS requirements and begin the certification process once we receive approval. As mentioned earlier, we'll do everything possible in the time between approval and DEA rescheduling to make sure sites are prepared to administer the product once it becomes available.
Your next question is from the line of Judah Frommer with MS.
Just wanted to ask on the post hoc analysis you mentioned in the release about 80% of administration sessions for the Phase IIb and PTSD being in silence. Any thoughts on how that could impact monitoring, whether it's for TRD or PTSD, and potentially staffing requirements going forward?
Yes, let me start and then Lori will build on that. That is very interesting data and validates the point we've emphasized that a psilocybin experience is an inner-directed one where the patient largely leads the experience. The role of anyone sitting with a patient is primarily monitoring and safety in case of need, and that is revealed by 80% of sessions being silent. To our mind, that introduces a broader range of possibilities for who could sit in the room, if ultimately somebody needs to be in the room at all.
Hi, Judah. In the near term, when we receive the REMS, there will be a requirement for a minimum monitoring period of six hours, consistent with our clinical trial. We expect the REMS requirement for who sits in the room to be fairly broad in terms of a health care provider, which is consistent with Spravato. Spravato sites have found ways to become efficient with rooms and monitoring. Our most important requirement is patient safety during the experience, and sites will learn with clinical experience how and who to put into the room to help patients.
Your next question is from the line of Patrick Trucchio with H.C. Wainwright.
For the PTSD trial, do you have any updates on site activation, enrollment cadence, target size, expected readout timing, or VA involvement that you can share?
Other than the trial is underway, there's nothing additional on enrollment cadence to share. The trial is 300 patients in total across three arms. There will be a number of VA sites involved, but I can't provide specifics. We are capping VA or military-related patients at no more than 15% of the 300, consistent with the overall PTSD population distribution. The trial is underway and is a 300-patient trial.
Your next question is from the line of Leonid Timashev with RBC CM.
With the physician discretion coming after the 1- to 2-dose recommended schedule for COMP360, and given that you've been doing surveys of psychiatrists, what feedback have you been hearing from doctors on expected dosing schedules? How widely has that feedback varied?
Hi, Josh. The surveys we conduct are based on a product profile of COMP360 and what we've seen through our Phase III clinical trials. We're seeing an overwhelming response in willingness to prescribe. The survey numbers are the highest I've seen in my career and similarly remarked upon by the market research facilitators. The enthusiasm comes from the TRD patient population, where proving efficacy has been difficult historically and current options can be burdensome for patients. Dosing frequency is a key driver for physicians and contributes to their excitement about COMP360. We haven't heard hesitancy around dosing. It will be incumbent upon the sales team and field teams to educate based on additional data on what the frequency of dosing may look like.
Your next question is from the line of Sumant Kulkarni with Canaccord Genuity.
From a value proposition perspective, what's the best way to place COMP360's time in clinic in context versus products that might promise a two-hour or less duration in clinic? And from a competitive perspective, what are your assumptions on whether there might be another FDA-approved psilocybin molecule within the first year of COMP360's approval?
Thanks, Sumant. Duration in clinic is only one element of a product profile. From the perspective of patient and provider experience, it's not necessarily the primary driver. There's an efficacy and safety bar any asset must clear. We believe the nature of the psilocybin experience is inherently attractive to patients and providers. Also, as we've discussed, from an economic perspective, as long as there remains capacity in the system, there is not a clear economic argument that shorter is always better in terms of revenue per room. So duration alone won't determine adoption.
Your next question is from the line of Rudy Li with Wolfe Research.
There is a lot of discussion about short-duration versus long-duration psychedelics following the Lilly announcement. In five years, we may have multiple options with different compounds, durations, and indications. Could you talk about your understanding of the market dynamic with multiple psychedelic options and the positioning of COMP360 in the broader psychiatry space, including depression and anxiety?
Hi, Rudy. The good news is psychedelics continue to produce robust and exciting data. Clinics that are Spravato-certified, which can support multi-hour treatments, are growing rapidly in anticipation of additional options coming to market. These products won't work for everyone; there are at least four million underserved patients today who are not being treated with interventional treatments like Spravato, ECT, or TMS that have proven efficacy for this population. These centers will exist regardless of treatment duration. Because economics is not necessarily the main driver, adoption will come down to patient preference and provider experience. We will potentially be on market first, which gives us time to establish leadership and demonstrate proven clinical efficacy. In terms of site economics and conversations with partners and MSLs, we are not finding anyone who considers longer treatments to be a prohibiting factor to prescribing.
For those wondering about internal staffing on this call, we have allowed Steve to go on vacation; he is missed.
Next question is from the line of Jay Olson with Oppenheimer.
Congrats on all the progress. A big-picture question: recognizing the company's near-term focus on approval and launch of COMP360, looking ahead after you accomplish that objective in the next year or two, what will become the next major strategic priority for the company?
Thank you. PTSD is clearly a strategic priority; that study is underway and is an important second indication. We have interesting signals across a wide range of psychiatric conditions and will prioritize which to move forward with. From an ex-U.S. perspective, we will likely need to partner, which we'll address after U.S. approval. More broadly, the space continues to see a lot of innovation with psychedelic assets. We see ourselves as a leader, and with a successful launch, we may be in a position to play a role in further innovation and consider other assets.
Your next question is from the line of Ben Burnett with Wells Fargo.
I also want to ask about your efforts to prepare and train sites ahead of commercial adoption. Specifically, what are your target sites? My understanding is the interventional psychiatry footprint for Spravato today is extensive with sites associated with university hospitals and suburban clinics. Can you talk to your strategy and which centers you plan to target initially and offer training to?
Ben, thanks for the question. There are about 8,000 sites right now, and that number has grown dramatically quarter-over-quarter, roughly adding about 500 sites per quarter. Our field team will be calling on all of these sites to ensure that if they are willing to prescribe COMP360, they are well educated, well trained, and prepared to prescribe. We will also call on physicians who serve as referrers with high numbers of TRD patients. Our target list at launch will be extensive and comprehensive. Additionally, COMP360's potential infrequent dosing profile broadens the radius of viable sites for some patients, because infrequent dosing can make travel to treatment centers more feasible for suburban patients who might currently have to drive far for weekly or biweekly treatments.
We have reached the end of the Q&A session. I will now turn the call back to management for closing remarks. Please go ahead.
Thank you very much all for attending. The first six months of this year have been a very exciting and productive time for COMPASS. With the Phase III data now—statistically significant positive primary endpoints from both studies—and the 26-week data from both studies confirming the profile of COMP360 as a compelling, differentiated profile that can meet huge unmet needs in treatment-resistant depression, we're focused on execution. We're happy with the rolling review progress and are preparing to complete the filing expected in the fourth quarter. We want to ensure a high-quality dossier to achieve first-pass approval. As Lori described, there's substantial commercial activity across many fronts to be ready for launch. We look forward to keeping you updated on progress on these work streams through the end of this year. It is a very exciting time for patients with TRD. Thank you.
This concludes today's call. Thank you for attending. You may now disconnect.