COMPASS Pathways plc (CMPS) Earnings Call Transcript & Summary

All right. So good afternoon, everybody, and thanks for attending Citi's 16th Annual Biopharma Conference. I'm Neena Bitritto-Garg, one of the biotech analysts here at Citi. For our next session, I'm really happy to be joined by the CEOs of 2 companies addressing mental health conditions through studying psychedelic drugs, including George Goldsmith from COMPASS Pathways and Florian Brand from Atai Life Sciences. So over the next 45 minutes or so, we're going to talk about the potential for psychedelic medicines and mental health conditions as well as some specifics of each company's programs. But before we do get into the discussion, if anybody listening has questions that you want me to ask, feel free to either e-mail me directly or submit your questions through the web portal, and then I can incorporate them if there is time. So now I want to just turn it over to Florian and George to each give kind of a quick introduction. I don't know if we want to go alphabetically for anyone to go first. Then George.

Yes. Happy to -- if you want to take the lead, George.

Sure. So COMPASS Pathways is a mental health care company looking to transform the patient experience in mental health care. Our goal is to provide accelerated patient access to evidence-based innovation in mental health. We do that by really focusing on breakthrough areas of new models of care where we can integrate digital therapy and powerful medicinal catalyst. In that case, we're using psilocybin as our initial program. We'll be talking more about that. But our focus is being a mental health care company, transforming outcomes and patient experience through our research and through the tools that we create.

Great. Yes, at Atai, the 2 of our companies share some history together. So we were leading the Series A and B round of COMPASS. So we are -- I guess, know each other since quite a while on the new mile, go back some years and Atai was founded 3 years ago, actually shortly after COMPASS Pathways. With -- as we similar -- and we share kind of the very same visions that we need more efficacious therapies available for mental health patients. And once we realized that there's a lot of potential in psilocybin. We also realized that there are very interesting other psychedelic compounds such as ibogaine, ketamine where we're developing one of the nontumors as we can discuss a little bit later. So we really saw an even greater potential beyond psilocybin. And that's why we decided to start Atai as a company that is really focused to demonstrate the safety that those compounds -- initially focused on psychedelics, demonstrating that those compounds are safe and efficacious. So really a heavy R&D focus here on our side. And then mentioned out more broadly are in the meanwhile, very much agnostic when it comes to mechanism, compound classes, et cetera. So I have also a lot of non-psychedelic compounds in development that we're equally excited about in addition to some of our also digital therapeutics that we are also developing.

Perfect. So to start off, and you both actually touched on this a little bit, but I guess if you could tell us a little bit about just kind of the genesis of both of these companies and how you got kind of involved in this space, in the psychedelic kind of drug development space. And then also just like what your near-term and long-term visions are for kind of how psychedelic medicines should be incorporated in the treatment landscape for mental health conditions? I know it's a very high-level broad question, but I'd appreciate any thoughts you have. And whoever wants to go first.

I'll get started on that because sure we started on the journey a little bit before. So first of all, I think, it's important. While everyone is terribly excited about psychedelics, really the huge unmet need is in mental health care. And what we're really focused on is transforming patient experience and outcomes in mental health care. The way we got started was personal sets of experiences with our family, where our son became incredibly disabled with depression, OCD, et cetera. We looked for care at some of the leading institutions. It seemed like trial and error in medicines, and it kept getting worse. We nearly lost him. And I think that this for us was a wake-up call to the need for innovation in mental health care, my cofounder and wife life partner, is a doctor, physician. She was shocked at kind of the state of psychiatry compared to other areas of medicine. And out of that, we realized that there is a huge opportunity for innovation. And as we looked at areas of potential innovation, we saw very much the promise of psilocybin. She woke me up after reading a paper said, "Hey, you were in the 60s and 70s. What do you know about this?" And that led a journey where we became familiar with the reemergence of this research, became key donors in the area for some of the academic studies but also realized very deeply that there was no path forward from the small studies into patients. My past background prior to that was working on what is not an oxymoron for many in the audience. It's actually regulatory innovation, and really looking at how do we accelerate access to medicines. So we're bringing a lot of those concepts into how do we integrate digital, how do we integrate psychotherapy and a powerful medicine into a new model of care to create transformative outcomes. Florian?

Yes. Thank you. I think nothing more to add there, essentially, because I think we very much share a similar background in the sense of why we got involved. So as many know, Lars was a cofounder of myself in a different context. So when we started the company in a different field. And then joined COMPASS Pathways after he found help and healing in psilocybin-assisted therapy in a jurisdiction where it's legal. So I'm kind of seeing him going through this very, very troublesome phase and finding ultimately heal in alternative approaches that he kind of then tried based on the, yes, clinical data that was produced in the economic studies was really encouraging to double down and then get involved to -- similar to what George has to really make a difference in a truly for patients that haven't really seen any true innovation since 25 years. So that's really kind of the main driver for all of us at Atai. And I think that's what we definitely share with the COMPASS team.

Two mission-driven companies are really looking at how do we change outcomes in mental health, and we certainly need to do that. I mean it's bigger than all of us.

Absolutely. Absolutely. So just kind of regarding -- because there's a lot of questions that I get kind of from investors around the use psychedelics and kind of the history of psychedelic drugs. And obviously, one of the things that both of your companies have talked a lot about is, the importance of co-administration of psychedelic drugs with extensive kind of psychotherapy. And I guess if -- can you each you kind of give me some of your thoughts on just kind of the whole process, right, that a patient goes through as it relates to taking a psychedelic drug kind of for a medical use? And what part of kind of that process of the -- perhaps the dosing and the integration, do you think is really the most critical to ensure that the patient has a positive experience and that the benefit is durable?

I'll go with that, just because we're doing -- just finished our Phase IIb trial where all these things had to come together. So it's not extensive psychotherapy, to be very clear. It's actually a very focused process. The way to best think about this is a protocol in which a powerful medicine is delivered under support regulators, the model that really work for regulators just thinking of almost like chemotherapy, where there's a protocol and a powerful substance and a follow-up treatment plan. For us, what we do is we have to take people off of their existing SSRIs, if they're on them because that has a dampening effect on the effect of psilocybin. That washout was done over a couple of week period with support, some patients need more or less, but that doesn't seem to be a problem in our study or in other studies that have used a washout period. Then they have 2 preparation sessions basically to help them understand what the experience could be like for them to understand some of their issues with the therapist. That therapist really is providing psychological support rather than psychotherapy. That psychological support then is used in the actual session. So there is a 2 preparatory sessions accounting roughly an hour each. They then have a powerful high-dose psilocybin experience in the high-dose condition or a medium dose or a very low dose in our Phase IIb trial. But there is a 6- to 8-hour dosing period with a patient and the therapist. That's given with eyeshades, soundtrack. It's a deep inward experience with the support of therapists there. Should there be any kind of encountering of challenging material or a need to share insights, the following day, those insights are processed with that therapist. And then there may be additional integration where people think about how to create an action plan for their life. If you think about depression and many mood disorders as actually a story and narrative that deeply grips people, it's lots of rumination, lots of negative valance to it. Psilocybin and our work in this substance seems to reset that. And therefore, there's also indications of a period of neuroplasticity, which could be used to accelerate learning in a new way of seeing the world. A new narrative can emerge and the integrations about that, it's really impossible to say which part is most important. No one could ethically do a study where we don't prepare people and see how that compares to people who are prepared. So this is really a protocol that's been developed. It's been really modernized from the work that was done many, many years ago. Sorry, I went into so much detail, but it is a novel approach. And that's done as an episodic monotherapy, really important. No other medicines on board, no other augmentation. This is a single experience with a durable effect. That's what's erratically different about it. And the durability since it is different in different patients, that gives us an opportunity to use digital phenotyping to really understand how do we get to the holy grail of psychiatric care, which is being precision, predictive and preventative. And that's really our focus in this work [ and we're supported ] by this unique substance.

Okay. Great. Florian, I guess, do you have any thoughts?

Yes. I mean, for us, it really depends kind of as we have a very broad pipeline, right, a very broad portfolio of 11 drug development programs. Half of them, again, psychedelic in nature. And for those compounds, it really depends, again, on the compounds, how we structure that preparatory dosing itself, also the time window barriers, the durability of effect varies on a compound basis. But we are equally convinced about the potential of digital therapeutics to increase efficacy and safety of the therapy as well as, in our case, also ability to block as we're often working on naturally occurring substances which have quite some history as well as ensuring scalability. So basically, how can we optimize the therapist time to really deploy their time where it matters the most, and we believe that digital therapeutics can be a key ingredient to ensure that scalability going forward.

Absolutely. No, that makes sense. That was actually going to be my next question. So I guess, George, any additional thoughts kind of on your end in terms of the potential for digital therapeutics and scalability kind of the commercial model?

Well, I think, yes, absolutely everything that Florian said, obviously, looking at digital phenotyping this idea of how we can anticipate and predict and prevent any relapse in what are typically chronic relapsing conditions because it's a huge value proposition for payers and for patients. On the therapy side, what's interesting is not only using these different tools, but the data derived from those tools, how do we improve the delivery of therapists? How do we improve therapy itself? So I think one of the real powers of work in this area is that the medicine, the actual drug product is almost like hardware. It constrains, it is something that will have a longer life. But all of the learning and digital tools will advance and be based on the learning in the real world. So this gives us an opportunity to optimize therapy models, optimize outcomes through the data derived using everything from natural language processing, machine learning applied to the actual content. What we really need to do is to look at how do we create a deeper understanding, not of mechanism of action alone, but mechanism of change. What changes and how do we accelerate and broaden those changes in patients' lives.

Got it. That makes sense. So I guess, just thinking kind of about the commercial model, right? Like one of the questions that I've gotten from investors is around Spravato and kind of the pace of that launch and what's working well and what isn't in that launch. And I guess, how do both of you think about that kind of the precedent that this Spravato launch has set for psychedelic or psychedelic-like drugs? And how do you think your kind of model can improve upon what we've seen so far with Spravato?

George, do you want to take this or...

Yes. I just feel like I've been talking a lot. So if you want to start, Florian.

Sure. Yes, I think -- in this case, it actually is helpful not to be the first mover. I think both of our companies were very early in the space that allowed us to evaluate, in our perspective, every compound or every treatment modality and every kind of angle that makes sense in terms of radical innovation in mental health. But here, I think, it's good to actually see some lessons learned from J&J's rollout. So I think that we all, I guess, as a space, as an industry can benefit from to kind of, yes, incorporate those learnings into kind of the second or third follow-on drugs that hopefully come to market. I think there's a lot about -- a lot to be said around stakeholder education. So these therapies are very much paradigm shifting in nature. They are very much different than anything that psychiatry has had in the toolbox in the past. And here, I think, talking also, I guess, on the reimbursement side early on involving payers in the process to getting those therapies eventually reimbursed is key, talking early on with therapists. And I think luckily now the awareness around the potential of those compounds is definitely greater than 5, 6 years ago. So there's a lot of interest in the key opinion leader field that will also greatly benefit kind of the potential rollout of the compounds at COMPASS or Atai's currently developing as there's quite excitement -- quite an excitement building among practitioners at least in our perspective. So these are kind of some thoughts where we need to, I guess, starting early. A lot of the therapies that we develop actually fit right into kind of the treatment window that also Spravato is looking at. So we actually want to kind of leverage that to our window. That's kind of how we optimize our compounds in development in terms of durability effect. So that we also hear can benefit from currently being built -- currently infrastructure that is being built out. So that we need to reinvent the wheel, but kind of [indiscernible] some of our compounds are treatments into this treatment paradigm. So these are kind of some thoughts on the Spravato roll out.

I would agree with everything that Florian said. They were first, they learned a lot we can benefit from that learning, are benefiting from the learning. And I think in my past life, I worked to create something called parallel scientific advice in European Medicines Agency, with the European Medicines Agency, which really brings payers and regulators together to design trials before, not after they're conducted. And we use that even before we formed the company. We've used it several times engaging payers early regulatory approval is seeing starting line. It's not crossing the finish line, and that's been embedded in our development process with health economic indicators in our Phase IIb trial as well as digital endpoints. So we're really very much focused on designing this for the 21st century.

Great. No, that makes a lot of sense. So another question that I get frequently kind of around the development of psychedelic drugs, especially naturally occurring ones, is surround IP, right? IP and exclusivity. So I guess, can you walk us through kind of at a high level your general IP strategy? I know you have different programs in the pipeline. But yes, that would be helpful if you could just kind of walk us through high-level thoughts. And then any specifics particularly kind of for George, obviously, for COMP360, specifics kind of the IP and your thoughts on -- I know there's been some questions around the recent challenge in the U.K. So if you could talk a little bit about that, too, that would be great.

Florian, why don't you start and I'll...

Yes, happy to. So we had Atai, I guess, more broadly, our focus on, I guess, mental health, again, agnostic when it comes to therapeutics hence, I guess, our approach might slightly differ from COMPASS in 1 or 2 areas. But like we have kind of everything currently from composition over use patents to formulation and then more broadly think about IP as part of our ability to block strategy, including our digital therapeutics. So basically, the combination of the compound and the app as a companion app. So it's a little bit like a drug device combination. And on the IP side are, again, exploring everything around formulation, so PK/PD parameter optimization. And we talked about durability, route of administration is a big one. So as we kind of want to get those compounds in the best, safest way to the brain. So there's a lot of innovation potential here. So really thinking along those lines around formulation, manufacturing, and use patents and composition of matter, of course, that we talked about, which is the latter, which is less relevant for the psychedelic companies that are around. But also here, looking at second and third generation molecules where we look at how we can optimize those compounds in terms of -- and George talked about neuroplasticity, downward regulation of the default mode network. So what's actually driving the efficacy. So here we are researching different areas and we'll eventually have also here a more robust IP given that these will be considered the composition of matter if we basically show what we intend to show in terms of efficacy and safety with those new leads that we have in development.

Well, just building on that, I think, much of what Florian said, certainly applies to us and we have 8 patents that have been granted right now, more announcements forthcoming. I think the -- obviously, this is an important area to continue to build upon. First and foremost, when we talk about protection [indiscernible] have to look at data exclusivity and market exclusivity afforded by regulation. Psilocybin is actually chemical entity despite its history because it's never registered before. So we have all of that, that's part of an NCE, new active substance from a regulatory sense. And then on the patented state, I think, what we discovered is that the prior art simply didn't create the scale and the purity that was needed, and we used that plus formulation difficulties to create polymorphic -- polymorph strategy, it's kind of geeky and technical, but has served other companies well in terms of NCE approach for that particular polymorphic form. We've been struck by how early some of the challenges have been both pre and post grant. That means we must be onto something somewhere because you rarely see those -- that early. There was a nonbinding opinion offered around in the U.K. That's a nonbinding opinion, has no effect on any of our file patents. So obviously, there are people who are watching and looking at this strategy, which we're quite comfortable and confident in. And as we add technology and more indications, so we're using all the tools that we can to create a robust value proposition to really look at getting the investment we need to transform mental health at scale.

Absolutely. No, that makes sense. So there's also -- I know both of you are also working on efforts to create kind of novel therapeutic -- or sorry, novel psychedelic drugs that are targeting, right, like 5-HT2A, where you can kind of tailor the properties a little bit more deliberately, right, like the duration of psychedelic experience and things like that. So I guess, can you talk a little bit about some of the efforts that each of you is kind of undertaking on kind of that front? And then what also are kind of your thoughts on, I guess, the give and take between safety and efficacy when actually shortening or prolonging the psychedelic experience?

Florian, why don't you start, and I'll dig in a little bit to what we're doing.

Sure, happy to. Yes. So indeed, I think, I mentioned it earlier, so we are also exploring how to treat those molecules in a way that they maintain the efficacy. And we shorten the duration to ensure a more scalable approach. So these are kind of the third-generation approaches that I mentioned earlier. So that's basically happening at our drug discovery engine called entheogenics where we are basically exactly doing that. I think there's also intellectually, academically, very interesting research going on, again, what's driving the efficacy, right? Is it neuroplasticity? Do we meet the psychedelic effects? So I think there's a lot of interesting angles here to be explored. It's early days. But I think what's important is that we have a scalable solution at hand. If we have a component with the psychedelic effect, how do we deploy it in the most scalable way? And here we are, again, interesting in kind of the 1 or 2 hour range. I think that there's a reason to believe that this based on prior evidence in humans, and that's kind of what we always look at when we onboard compounds and what's actually the prior evidence out there, at least anecdotally in humans that points to efficacy and molecules like DMT and others, where we believe that we can, yes, through also an appropriate route of administration, achieve a 1- or 2-hour treatment window. We believe that's good hypothesis to start that we can demonstrate efficacy in a shorter time duration. There are certainly also companies out there that maybe try that in a very, very short duration, where we are -- at least in Atai are rather skeptical. we're not necessarily testing the extreme of 12-hour trips and 5-minute trips. But I think somewhere in the middle, there's a sufficient reason to believe that this is a reasonable approach.

And as we started our plan, it's really important. [ Given ] the mission that we're on, our job was to figure out how the fastest path to helping as many patients as possible. It's why we started with psilocybin and built the organization around it. It enabled us to go quickly into a Phase IIb and then into a Phase III program. And again, that helps more patients. That's why we exist. Obviously, optimizing that through shorter acting is important. No scientists we've talked to understands whether this downregulation of default mode network is a switch or in length of an experience. So does the experience length matter? We need to look at that, and I think, Florian, this 1- to 2-, 3-hour window is interesting. All that does is leveraging the existing infrastructure for greater throughput to meet the huge unmet need. So let's get that all built with psilocybin and obviously, building on their work done in ketamine, the infrastructure for that. But our whole focus here is really around what is the nature of the experience that is usable and a basis for changing a person's narrative, a view of their life. And what we are quite skeptical, I think, with, Florian, as well these very rapid experiences where people meet aliens, they talk to entities, they come back. That's a shot from a canon and what happened to me. And with high levels of issues around reenactment or flashbacks and so forth. So I think patient safety, absolutely front and center; patient experience, shortly behind. And so we were looking at all of this. And -- but our primary focus is reaching patients as quickly as possible with the most safe and effective approach using psilocybin and then using that as a foundation for others. We have a large number of compounds going into screening, and we expect to see some of those -- some of the shorter-acting but similar durability of action over the next 18 months. So focusing on that. And obviously, the last thing I would just say is because we're so focused on building a robust infrastructure for late-stage trials, developing payer propositions as part of those late-stage trials, we're happy to partner with any organizations that have earlier-stage infrastructure, but the infrastructure that we'll have in Phase III coming out of our 10 country, 22-site Phase II program, radically expanding that, I think, is a very attractive proposition for others. So we're really focused on the late-stage path to patients.

Definitely. That makes sense. So I just want to talk a little bit about conducting studies with psychedelic drugs now. So one question from investors is around how do we think about translating data from investigator-initiated studies that are relatively small, right, single center studies typically into a larger rigorous double-blind, placebo-controlled randomized, multicenter international study, right? Like how do we think about that? Because that's, obviously -- in psychiatry, in particular, that's a -- that can be a tricky thing to kind of navigate when you go from these smaller single-center studies to a larger global study. So yes, how should we think about that both, just the general dynamics of that and then as it relates specifically to psychedelic, if there's anything to keep in mind there?

Well, I think that, first of all, this is about developing this medicinal catalyst that we surround with technology and therapy towards an outcome. As such, we're not going to defy history. So my headline of how to think about that, best word for me is cautiously, that's what we've done. Obviously, there's a predominance of signals that are similar, which is what gives us such confidence in the design and development of our program. But all the concerns are right, that's why we're doing this program. There's never been any dose-finding studies that which we need to do, right? So our whole Phase II program is very much focused on identifying the most safe, tolerable and efficacious dose. So these are things that we need to look at going into long later-stage trials. Obviously, there's also a question of the population. Do we have a bunch of people who have been in earlier studies, who like psychedelics found them useful in coming to the studies and find them useful, again. How do we think about that? So we've spent a lot of time working with regulators on limiting the upper number of people who've had prior psychedelic experiences so we can look at the generalizability, which has been one of the concerns of some of the smaller studies. So you basically take that learning, do the best you can, putting it in your studies. It's what we're doing. I'm sure it's what others do. And you do the work. And that's what we're doing. We've the largest study ever done, following the second largest study in healthy volunteers ever done. We did the first largest, that's largest study volunteers, largest study in patients right now. And end of year, we'll be reporting out. So I think we'll be able to answer this question better come the beginning of next year.

Absolutely. For. And I guess, do you have any thoughts on kind of translatability?

I think completely agree with everything that George said. I mean it's key to our approach, right? We heavily rely on the prior evidence out there. And it certainly, in our perspective, are very valid approach to, in general, derisking drug development in an area that has proven to be quite tricky. So those signals are -- and I think it's also worthwhile mentioning often, even though academic studies, there are really large effect size. So even if you kind of think about that multi-center trial might kind of decrease that effect size by some degree, there is a good starting point that informal -- that makes us confident, it gives us reason to believe to explore those compounds further and generate the data that is needed, of course, then to kind of make the next decisions, right?

Absolutely. No, that makes sense. So just one more question kind of on clinical trials and running clinical trial of psychedelic medicine. So I know, George, we've talked about this a lot in the past. But just kind of the issue of expectancy bias and the potential for unblinding. So I guess, can you talk a little bit about how your -- what you've kind of done in this study, like specifically for COMP360? And how you're thinking about addressing those issues. And then Florian, you're, obviously, welcome to comment as well as it relates to how you're thinking about some of your programs.

Our whole focus is early and often engagement with regulators because it's much better to engage before than after. And so this has been a really interesting and interesting-for-regulators question. The way it's been addressed is we do the best we can on blinding. Obviously, we have to prepare people for a high dose, they may not have that high dose experience. That can lead the patient to perhaps suspecting that they received a lower dose. Therapists who support this are also blinded, obviously, the study team is blinded to this. But sometimes you could see some differences in a high dose, low dose, which led us to the final blinding, which is the blinding of the ratings. This is what really matters, right? So what we've agreed is that to be working with regulators to agree a remote, completely blind assessment of MADRS that is administered by phone. We have a lot of MADRI across the studies because we really want to understand the durability of the single dose, remember, of episodic monotherapy. And I think what we do is the best we possibly can in this and the regulators know it's difficult for expectancy, we all agreed on somewhat unusual strategy, which is let's equate expectancy by telling everybody you're getting psilocybin. And that was seen as a very -- as a best -- as an emerging best practice. It's now been supported as a best practice in these kinds of trials. Because you equate expectancy, everybody expects that they'll get it. And then the question is, do you end up in these kinds of trials where you don't have ongoing interactions, ongoing dosing? Do you end up creating what's called a nocebo effect rather than a placebo effect, where essentially people who are waiting for the full-on big experience that they're prepared for from a safety perspective, they don't receive that. And they have a narrative that says, "The world doesn't treat me well, things are not going to work out. And here I failed this trial." And so does that actually worsen the depression, which increases separation. That's a concern -- for us, it wasn't a regulatory concern. Obviously, it's a patient concern in the trials. So I think that gives you probably more than enough to think about in this area.

Yes. From my side, nothing further to add. So it's exactly what George said, I think, really looking at what matters for us, it's how do regulators position themselves. And so far, they don't seem to -- well, they seem to be supportive for the strategies that George laid out, and we are intending to apply the same also for our portfolio.

Okay. Great. So now over the last 10 minutes here, I want to talk a little bit more specifically about some of your individual programs. So I guess we'll start with COMP360 just because we've been talking a little bit more about that extensively. So obviously, you've got your Phase IIb study that's ongoing right now, dated by the end of the year. Can you walk us through, George, kind of how we should think about the magnitude of the treatment effect at week 3, the potential for a dose response and how we should think about durability just because that is a pretty active investor to be after? Sage had their data earlier this year in MDD. So I've been getting a lot of questions about that. And I guess what -- specifically like what would you view as a win at both kind of the 3- and the 12-week time points?

Now we have separation across doses that there are a population that we can identify who will respond and maintain that response that it will be different across this. We have a 3-week endpoint looking at a 50% reduction in symptoms, and we're interested. Can we hit that with 25? What does it look like with 10 relative to 1? So we're comparing a 25-milligram dose to 1. We're then comparing a 10-milligram dose to 1, looking for what is the safest, most tolerable dose. This is to inform our Phase III design. So the purpose for us is to create the most robust, which we have done, data set on the planet with regard to controlled studies for these medicines, both with healthy volunteers and now with patient populations TRD but other things we're working on. So our real goal is to inform our Phase III program. I'd be speculating, and I don't want to have people -- other people speculation based on my speculation of what we're going to look at. Obviously, we've seen in the smaller studies very significant differences. How that translates based on your other questions as we have to take that with a grain of salt. So I think some of this is patients, but I do want to clarify that this is not an ongoing study. We recruited 216 patients with the target 3 arms of 72. We exceeded that through the midst of COVID actually, 233 patients were participating in this study, last patient received psilocybin administration on the 8th of July. And we have a 12-week follow-up and some data analysis to do. So we're well on track for reporting later this year.

Absolutely. Okay. So I guess, just in terms of kind of going back to kind of the durability question. Is there like a specific, I guess, threshold that you're looking to meet on durability or that you've received kind of from your regulatory discussions that...

Yes. So from a regulatory perspective, remember, we're doing a single dose, a single dose of something of people who've been taken off of medication. And we're looking at will that single experience translate into 3 and then 12 weeks [indiscernible]. And if we have something that we'll actually do that in a significant -- with a significant number of responders, that's never ever been seen in the past. And what we do know from prior studies that there is heterogeneity in the durability. What we don't know is how the heterogeneity and the initial patient population led to the heterogeneity and the durability. So we spent a lot of time working on eliminating as much heterogeneity in the sample as we possibly can with referral patients who come in with validated medical records for past failures, et cetera. So I think we're going to see a lot of that. What we see in durability as a large number of patients make it 3 to 5 weeks, some decline after that. In Robin Carhart-Harris' study, which was the basis of our FDA breakthrough therapy designation. What we saw was that at even 12 months, for patients who had an average of 18.5 years of prior depressive and 4.6 prior failures, approximately 25% of those folks had no longer any pharmaco or psychotherapy at 12 months, self-reported. And that the durability for many of them went at least to 12 weeks through the study. So we're quite positive. But I think the real issue here is who has the more durable experiences and how can we predict and how can we preempt relapse, and that's really the focus so that we can help people get better and stay better.

Absolutely. No, that makes sense. Okay. I just want to save some time to ask Florian some questions, too. So...

[indiscernible]

Sure. So I guess, Florian, just obviously, you have a very large portfolio of psychedelics and non-psychedelic drugs as well. I guess just thinking broadly about the portfolio, what would you say is, in your view, the most exciting program and why?

Other than COMPASS?

I was about to say, I was about to say.

Other than COMPASS.

Sorry, I was on mute, I was about to say. Yes, no. Of course, I mean, with COMPASS and it's also the most imminent one, of course. So this year, which will have -- and I think George mentioned that or you mentioned that before, it will really have a great impact on the mental health industry, I would say, with large, right? So this is going to be very informative for all of us, and we're looking towards those results and this data read out with great excitement. Next to COMPASS, we have -- it's always difficult to pick your favorite chart, but given that we have 11 programs. But ultimately, I think, we are well diversified and we're having quite advanced program for each anxiety addiction and depression. And with R-ketamine, where we developed a program for -- as a rapid-acting antidepressant for at-home use. And I think that's key here because it could circumvent kind of the scalability question that often arises in psychedelic-assisted therapies. So we would have here something that is rapid acting and potentially deployable at homes, and we now have to generate the data to actually prove that is true. We believe on the preclinical data as well as clinical data that given the lower association that you see in R-ketamine versus S-ketamine that we have a good therapeutic index, where we believe -- where we have reason to believe, again, based on all the data that we can develop this, the target product profile is suitable for at-home use. So very excited about this program. In addition, in the anxiety space, developing with GABA Therapeutics, the deuterated version of etifoxine. Etifoxine, again, there's also a lot of prior evidence that shows that we can potentially develop a safer benzodiazepine. I think we believe still that many of those available therapies also for anxiety, so benzos have clear drawbacks with the safety profile, addictive properties. So if we could make a leap forward here for patients by offering them a safer version of benzodiazepine, I think that is very exciting. And in addition to that, in the addiction space with DemeRx-developing ibogaine therapy, we would have another shot at a disease -- potentially disease-modifying compound that also -- and we mentioned durability of effect has a very, very durable effect when it comes to addiction patients. So very excited about those ones. Not meaning that we are less excited about the other ones, but these are just the more advanced ones in our pipeline that are closest to be in Phase II or beyond -- or yes, about to be in Phase II or in Phase III.

Got it. So I guess just a general question then on your portfolio strategy. I know you do have also -- in addition to the COMPASS readout, right, there's also a Phase II readout for RL-007 later this year. And I guess, can you just walk us through how you're thinking about the go, no-go decisions kind of within the broader portfolio, not necessarily related to RL-007 specifically, but just the broader portfolio and then, I guess, also related to RL-007?

Yes. I mean the common denominator of our approach to derisk kind of the programs is on an asset level, look at prior evidence in humans. And here, in the case of RL-007 and that's very consistent with all the other compounds. We have a good understanding of the safety profile of the compound. It has been in humans. It has been in Phase I studies and we have also here strong signals on efficacy. So not only anecdotal evidence, we have -- actually have biomarker data that points to procognitive effects of this compound. And that's what we're basically now trying to replicate those procognitive effects based on biomarkers EEG, for instance, to then show that in the patient population of schizophrenics, we can or -- replicate that. So basically to address the cognitive impairment in schizophrenia. And that approach deploying biomarkers as part of the clinical development plan to -- like to have, I would say, kind of micro milestones on the way to proof of concept is our approach then to not only just say here, you have 20 $30 million, $25 million that get us a POC, but in a very tranche, milestone-based way, deploy the capital and get it to work in those programs. So that's kind of generally how we think about structuring trials and deploying capital to -- yes, to derisk and also enable us to -- you mentioned, go, no-go decisions, to be really truth-seeking versus success-seeking. I think that's also a benefit from this portfolio approach. So we are able to say if we don't see the signals, then to reallocate funds that we earmarked for that program to other funds where we believe based on data that they're -- they have a better ROI and a better likelihood for patients to get improved medicines to the market.

Absolutely. No, that makes sense. Awesome. Well, I think, we're actually out of time. So I just wanted to thank you both for taking the time to chat with me today. It's been very insightful. It's been great having you and definitely look forward to staying in touch as especially ahead of the COMPASS data or the COMP360 data later this year.

Great. Thanks so much, Neena.

Thank you, Neena.

Thanks, guys.