COMPASS Pathways Plc American Depository Shares Deutsche Bank 2026 Healthcare Summit

You want me to start? We're going to be passing it back and forth throughout today. Thanks for having us, first of all. Really appreciate being here. We'll likely be providing some forward-looking remarks, because our lawyers are always interested, check our risk factors. We are, as David mentioned, in the lead in terms of psychedelics, potentially getting to market. We're in really, really good shape. We've completed two phase III trials, both being highly statistically significant. Really great results and a really incredible profile that Lori can talk more about as to why we feel like COMP360 is so differentiated. First indication is for treatment-resistant depression. We are also underway with a late-stage trial in PTSD, which will be a follow-on to TRD. We are in a rolling submission and review right now with the FDA for our TRD product.

We anticipate completing that submission in the fourth quarter, and we have guidance out there that we expect to launch within the first half of next year. We are really on the doorstep here of bringing our synthetic psilocybin product to market, and really excited by the progress. We have made tremendous progress, not only from a clinical development perspective, but also on the commercial side. The only product right now that's out there approved for TRD is SPRAVATO, which is a Johnson & Johnson product, and we are able to leverage a lot, if not all, of the work that they have done in launching their product, for COMP360. Both Lori and Steve can talk more about that. We're in really, really good shape. Really excited to bring this product to market.

I'll take that one. You want to take that?

Yeah. I'll take that one. We spend a lot of time together, so probably going to be figuring out who wants to answer which question each time. Right now, as we've previously stated, we intend to complete our NDA filing in Q4. Just to level set, in 2018, we received Breakthrough Therapy designation. But most recently, in April of this year, we received the commissioner's Priority Review Voucher, and we also will potentially benefit from the Executive Order on DEA. We also had an agreement with the FDA prior to receiving the voucher to undergo a rolling submission and rolling review. This is something that the psychiatry division, to our knowledge, has not done, at least in the recent history. We would have been the first product to benefit from a rolling review. Then we received a Priority Review Voucher, which did two things.

What that did is it increased the frequency of conversation with the FDA, and it also allowed the FDA to have a target review time of 1-2 months. Once we complete the NDA filing in Q4 of this year, what we anticipate is a little bit of uncertainty in terms of timing of approval, because the FDA does clearly state a target of 1-2 months. We do not know if they will take the 60 days to do an acceptance period and then the target 1-2 months. But certainly, we are prepared even if they don't. Once we receive an approval, at some point in very short proximity after filing, completing that NDA, in Q4, the DEA then needs to reschedule because this is a Schedule I product.

Right now, the DEA is, by statute, supposed to reschedule a product of an approved medical use within 90 days. The executive order back in February asked the DEA to work in a timely fashion for psychedelics, so there could be a potential to shorten that timeframe from 90 days after approval. Then the states need to reschedule, which we've done a lot of work to prepare the states to reschedule within 30 days after DEA. All of this to say is we don't have a real good answer of when a potential launch will happen, but we feel very certain that it will happen in the first half of 2027.

Steve, do you want to take that one?

Yes, I'll take that one. We expect a fairly broad label to essentially say for the treatment of treatment-resistant depression. As far as the dosing, we have studied up to four doses in a year in our COMP006 trial. They were up to three in the COMP005 trial. We looked at an initial dose in two different ways. One was a single initial administration in COMP005. That was our placebo-controlled trial. In our three-dose, low-medium-high 006 study, we looked at two initial administrations, three weeks apart. What we have seen from that study with the two initial doses three weeks apart, as well as from the part B data, the blinded part B data from the first study, where that second dose was given a bit later, typically between weeks 10 and 14, is that for many participants, there was a significant additional benefit of having a second dose.

Ultimately, we think that that will translate into a label that may talk about initiation of treatment as two doses no sooner than three weeks apart, with additional treatment at clinician discretion or as clinically indicated. That will likely be a clinical decision, truly, because this is a heterogeneous population. One thing we showed in the part B section of both studies was a breakout of cohorts by initial level of response. You can see the trajectories of those patients, where some, just 24 hours after that first administration, are in remission, then may not need another administration for quite some time. Whereas others have received up to three or four doses over the course of 52 weeks. Ultimately we would expect, in the real world, patients to have treatment on a frequency of two to four times per year.

One thing that is important to point out with that is that currently the only pharmaceutical product that is approved in this population, treatment-resistant depression, which is a very different population than MDD, for which there are 50-plus approved products, is that only approved product is SPRAVATO, which unfortunately does not have significant durability. It is administered typically on the order of 25 to 50 times per year, which places tremendous burden on both patients and their caregivers that need to drive them to this treatment. Regardless of the final nuances of that label language, it will indicate that this is a treatment administered on a scale quite different from what is currently available to these patients today.