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Citi's 17th Annual BioPharma Conference

Sep 7, 2022

Speaker 1

I'm one of the biotech analysts here at Citi, and I'm very pleased to be joined for our next company panel, where we're going to be focusing on mental health and new kinds of innovative options for mental health conditions. I've got with me the new CEO of Compass Pathways, Kabir Nath, the Chief Medical Officer of Pear Therapeutics, Yuri Maricich, and Florian Brand, the CEO of atai Life Sciences. Before we get into Q&A, I want to pass it to each of you to make some opening remarks. Maybe we'll start with Florian.

Florian Brand
CEO, atai Life Sciences

Sure. Yeah, happy to be here. Thanks for hosting us. I think it's a very interesting panel as it combines a range of modalities that we are all working on, especially with the digital component. We are as atai, a biotech or biopharmaceutical company in the clinical stage, and also heavily believe in the potential of digital therapeutics. By combining, especially our psychedelic agents with digital therapeutics, we believe we can actually achieve greater outcomes for patients and also address some of the scalability topics that are discussed in that context. We are very excited to be here today. I have currently, or soon have, eight programs in the clinic. Currently, I have seven in the clinic. I guess our most, from an investor perspective, also most awaited readout is the PCN- 101, our ketamine data towards the end of this year.

Yuri Maricich
CMO, Pear Therapeutics

Great. I'm representing Pear Therapeutics, and Pear Therapeutics has been really the leader in developing what we call prescription digital therapeutics, which is software that works either alone or in conjunction with standard of care pharmacotherapy to treat disease. We have three therapeutics on the market: one for substance use disorder, another that works with a medication called buprenorphine to treat opioid use disorder, and a third to treat chronic insomnia. My background is really blending the kind of traditional biotech as well as now digital to actually improve new treatment options. We are very much focused in mental and psychiatric health.

Kabir Nath
CEO, Compass Pathways

Great. Thanks. Thanks, Nina. Thanks. It's great to be here. As you said, I am the newly appointed CEO of Compass Pathways. I joined last month really as part of an expansion of the management team. George Goldsmith, our co-founder, remains executive chairman, and together we will take the company forward. Compass is a company whose vision is to provide novel models of care for people living with serious mental illness. Our most advanced program is COMP 360, our proprietary form of psilocybin. COMP 360, which is therapy combined with psychological support and digital tools, will be entering Phase III for treatment-resistant depression by the end of this year. We completed our Phase 2b last year. Those data have been released and will be published in due course in a peer-reviewed journal.

Based on that very compelling data, we are taking it forward into Phase III in TRD. We also have announced a Phase II program in anorexia nervosa.

Perfect. Just kind of a question, I guess, to kick everything off. We talked a little bit about how each of you is working in the mental health space. I think there's a lot of current gaps with therapies available for patients with mental health conditions that have really driven over the last few years this new wave of innovation with digital therapeutics and psychedelic medicines and some other novel agents kind of coming to the forefront. I guess maybe if you can each talk a little bit about some of those gaps and how you see your programs and how your kind of business model may be uniquely suited to fit some of those gaps. Whoever wants to start.

Yuri Maricich
CMO, Pear Therapeutics

Sure. I'm happy to go first. I mean, also, I think both speaking as a physician myself, but also what we see in the market is we have a massive shortage of treatments for mental and behavioral health. Many of the treatments that we do have cause significant side effects. We also don't have the ability to target those to the right population. I think we're, frankly, sadly, decades behind where oncology is. That is what we should focus on, where eventually we have the equivalent of NCCN guidelines that can help guide where different patients go. The challenge is the brain is very complicated, and it's very difficult to drug.

That's actually where I think digital treatments or digital combined with pharmacotherapy can really step in because we now have the ability to start with targeting a particular population, take evidence-based approaches, and then, based on the science, guide whether or not we bring those drugs together. A byproduct of that has been we've actually been able to help to solve some of the delivery challenges of mental and behavioral health. I think that's something else that's both a challenge, but also a real opportunity here, where now we have treatments where we can have a patient have a telemedicine appointment and then all of a sudden get on with the clinician and get their script filled for digital treatment in seconds to minutes, rather than days to weeks.

We need to work then with the provider system and, very importantly, with the reimbursement system to make sure then that all that infrastructure is there. That's been one of the areas that we've been very much focused on.

Kabir Nath
CEO, Compass Pathways

I think just building on what Yuri said, I mean, there is a chronic problem of unmet needs. I think even just today or yesterday, CDC released another report. More than 20% of people in America sought treatment for mental illness in 2021. That's by no means everyone. We also know that there is drugs today provide some limited outcomes for some limited number of patients with, as you say, no predictive power whatsoever. In particular, in the area of depression, MDD, or let alone TRD, there is nothing rapid-acting. Everything takes a long time to act and so on. I think driven very clearly by the need for new pharmacology is one element, but also it's much more than that. It's around access to care. It's around models of care. It's around the fact that traditionally, psychiatry, to your point, remains very traditional.

It's about a pill that's delivered via a pharmacy. Whether the patient takes it or not, whether the patient's family, the caregivers are involved, nobody knows. I think what Compass saw was this huge gap here in terms of, I say, innovating novel models of care. What we also saw was some really amazing data historically from psilocybin and other psychedelics and bringing those two together to create a new form of mental health care company.

Florian Brand
CEO, atai Life Sciences

Yeah. I think a lot, so we very much align with kind of everything that was said. I think when we started Atai, already 1 billion people globally were suffering from mental health disorders and through COVID that only got worse. Kabir just mentioned statistics that relate to that phenomenon. At the same time, we have the gap to basically have access to sufficient therapists. We have the fact that the brain is complicated. There is not this one-size-fits-all solution. We have low response rates to existing treatments, high relapse rates. All that together, we try to address at atai through a very diverse pipeline. We are not focused on one mechanism. We are quite agnostic. We have, again, eight compounds in the clinic, all with very unique mechanisms and ways how they work and hopefully benefit patients.

Those compounds have in common they induce strong behavioral plasticity, as we like to say, strong neuroplastic psychoplastic effects. We try to then harness those through digital therapeutics to basically through ongoing psychotherapeutic support to help to achieve clinically meaningful and durable effects so that we do not have a short-term rapid-acting effect, but that we also help patients to change their behaviors to have really durable change. Ultimately, I think that is also everything that we are interested in, want to use, I guess, also digital phenotyping to then get more targeted, given the very heterogeneous patient populations, to identify when is it a good time to re-dose, what is the patient population that is right for this treatment, and what time. That is something that we are also working on.

Absolutely. Kind of to that point, I mean, all three companies are working on digital solutions, whether they're directly to treat the disease or to identify the right patients or the right time for re-dosing. I guess maybe if we can talk just a little bit more about what specific efforts each of you has ongoing kind of in the digital space. In particular, to the kind of idea of combining drugs with digital solutions, how do you actually think about incorporating digital technologies into clinical studies? Then Yuri, you can talk also about your clinical studies that you've actually run with some of your digital therapeutics.

Yuri Maricich
CMO, Pear Therapeutics

I'm happy to go again for us, seems like the cycle we're doing. Maybe just as a little bit of a primer for those who may not be familiar. We have three therapeutics on the market, but they actually all represent, I think, different models around your question, Nina. First is Reset for substance- use disorder. Here we have actually no pharmacotherapy that's FDA-approved for patients with cocaine, cannabis, or stimulant use disorder. Here we have an example of software that can slot in and fill a very clear unmet need. Our second therapeutic is called reSET- O, and it is for patients with opioid- use disorder. There we have pharmacotherapy, and the clinical guidelines clearly state that when we combine pharmacotherapy alongside a behavioral treatment, patients get outcomes better than either alone.

My colleagues here, I think, will also speak to that in other disease areas, for example, in depression. There we have an example of a drug plus a digital treatment actually enhancing efficacy together, where the sum is more than individual parts. The third is in chronic insomnia. We have a product called Somryst. Somryst actually delivers the guideline-recommended care cognitive behavioral therapy for insomnia that is in advance of drugs. Most patients can't get it because there's a shortage of providers. It's hard to get standardized treatment. There we have a third example of how it can fit in and actually in a step therapy approach, be first line.

Really, across all these, kind of one of the things we're focused on is both, A, continuing to make the software products better, which I think is one of the key aspects that's exciting. It doesn't mean we have to go back to non-clinical work. We can keep actually making the product better as we go over time, but also integrating it into the clinical workflow and delivery models to make the delivery of the treatment something that is as seamless as any other product out there. That also includes around clinical decision support. We fit into, for example, electronic health records like Epic, like Cerner, and we can help support them in making sure that then patients are getting evidence-based care because we can fit into order sets very conveniently.

There is all the backend data that we can maybe talk about a little bit later that we're able to collect, both patient-reported outcomes, lab outcomes that come from the clinical care team and the electronic health record, but then also matching that with claims so that we can more rapidly get to questions of not just clinical benefit and safety, but also value.

Kabir Nath
CEO, Compass Pathways

I think, yeah. For us, first, I mean, Compass was founded in 2016. If we're successful, we come to market in the next few years. First, it's unthinkable that we would not be employing digital tools and technologies in whatever we bring to market, given that, as I say, it combines COMP 360 with psychological support. Three areas where, in the immediate term, we're focusing on digital applications. One is in terms of my pathfinder, which connects the patients with their therapy. Because clearly, for something like psilocybin therapy, that is a profound experience. It's important that the patient is appropriately prepared. The focus there is around really safeguarding and ensuring the safety of the patient. Second is with therapists, therapist companion.

That is also critical because clearly ensuring that psychological support is delivered appropriately, that we have consistency around the training, around the delivery, is fundamental to achieving outcomes as well. The third area, we were required to record all our sessions. We have a very powerful engine that is actually going through that and will, over time, build not only a very significant body of data around that, but already we are doing work to see how we can make some of those connections between, for instance, the preparation session and outcomes. My view is, over time, and this builds on the points we have already made about the lack of good quality data in psychiatry and the inability to lay out specific pathways for different patients, this tool will enable us to do that. It is clearly drug-agnostic.

Today, we're working with COMP 360, but that can be applied to other drugs as well. That for us is also a key area.

Florian Brand
CEO, atai Life Sciences

Yeah. I mean, to add to this again, a lot of similarities, I believe. I think for us, we are currently, so we see potential for the entire pipeline. And we have non-psychedelics and psychedelics in development. Right now, we are focused on the psychedelic-assisted psychotherapies. There we have this, I guess we're facing an already shortage of therapists, right, in the mental health care. We aim to address that through optimizing the therapist time during those guided sessions that need to take place with psychedelic agents.

Here we believe that in the preparatory phase, as well as in the integration phase of the therapy, the psychedelic-assisted therapy, digital therapeutics can play a very, very significant role to not necessarily eliminate the therapist, yet optimize really the therapist time so that he or she can focus on what is or where their time is really, really most effectively deployed. Again, along those ways, we mentioned digital phenotyping in the beginning. I think also Kabir alluded to some elements of that, identify the right digital biomarkers that can be voice, that can be typing behavior, it can be facial recognition, so there are many elements that we are exploring to move more to this targeted precision psychiatry approach through the support of digital in mental health care.

Kabir Nath
CEO, Compass Pathways

I could just pick up on something Florian said because I guess this is an emerging field, so definitions matter. I think at Compass, we're clear. We are not offering psychotherapy. We are offering drug therapy with psychological support. I think that distinction is important because absolutely preparation is key, administration, integration may or may not be key, and we need to do the work to really understand that. Again, what we are asking the FDA to approve is a drug.

Yeah. Absolutely. No, that makes sense. I guess maybe a question for Yuri just around, you've obviously gone through an entire regulatory pathway with your digital therapeutics. You've done clinical trials. I guess how do you see that as kind of separating your products from apps that are available in the app store for free? How do you kind of, how do you really clarify that with physicians and with patients and make it clear that these are different products?

Yuri Maricich
CMO, Pear Therapeutics

Yeah. It's an interesting question because this is an emerging field where there aren't kind of the standard clear guidelines where you might have between a nutraceutical and a pharmaceutical, but we do actually think of them the same, right? There are hundreds of thousands of apps in the app store. It's easy to understand how some might be confused. We really see the value proposition around the fact that not only is the software treatment or the software plus drug giving evidence-based treatment, but then do we hold the intervention to all the same standards that we would any other treatment that also all the key stakeholders expect? That starts with, one, what is the scientific basis of the treatment? Two is then their clinical evidence around safety and effectiveness.

Three is then, as Nina you were just saying, then taking it to FDA where you have a third-party independent body that is recognized as having the authority to then provide that evaluation. If they agree, that market authorization also with a label. This feeds very much into both how providers start to recognize, how am I supposed to use this? What is the value from a clinical perspective? Very importantly, payers as well. Payers are very, I think, and rightly so, concerned. Like, am I going to be asked to evaluate the hundreds of thousands of apps in the app store? Many of them have already publicly said, we're setting the floor at FDA. You don't have FDA, don't come talk to us. We need to make sure that there's that third-party imprimatur that has set those standards.

We can continue to work with those groups to help them better understand. Nina, I mean, it is a point where there was very early on a lot of education required. I'm not going to say there isn't still more education being required. As more evidence and more products come on the market, I think we're going to also see these start to show up in clinical guidelines. We're starting to see these show up in continuing medical education. This is something where it's not like in five years, but now we're starting to see clinicians using this at scale.

Absolutely. No, that makes sense. A question for Florian and Kabir just around, I know you're both working in the psychedelic medicine space. A question I get frequently from investors is just around what's prompted kind of this renaissance recently in the study of psychedelic drugs. I guess what do you see as kind of the, maybe not challenges, but as kind of the key questions that we still need to answer about psychedelic medicines in terms of the types of patients that they should be dosed to? Kind of to Kabir, to your point, the importance of integration versus whether or not integration is necessary, the kind of interplay between duration of the psychedelic experience and kind of efficacy and whether you can get a similar effect with a shorter-acting psychedelic versus a longer-acting. Yeah. Love to hear your thoughts.

Florian Brand
CEO, atai Life Sciences

Sure. Yeah. I mean, the reason why we started atai was really to bridge that gap that we identified, right, from the standard of care and what's not working. We had a high relapse rate, low response rates. We've come to traditional approaches. There was really over decades, no true innovation, like a true leap forward for patients. I think that contributed to the, I guess, openness to also research formally stigmatized substances like psychedelics. I think we have now produced a lot of data that leads to this being taken seriously from a lot of key opinion leaders. I think over time, actually quicker than I anticipated, there was a general shift in perception around those compounds. I think it's really important that we followed the data, and we have to follow the data.

I think that's ultimately also what convinced all those stakeholders in this field to take this serious. The data was primarily initially coming out of academia, very, very compelling. That led to companies like us and Compass to be able also to raise significant funds to then thoroughly research those compounds further in more advanced clinical trials. These are maybe my two cents.

Kabir Nath
CEO, Compass Pathways

I think a whole set, I guess, of social, practical, cultural considerations came together to create this moment in time, including the endocannabinoid story in PW and what's happening with medical marijuana, but also, I think, just a recognition where we all started, this huge unmet need here. There was very interesting historic data and more recent data in small ends around what some of these substances could do for patients with serious mental illness. That said, I think my answer to your question of what else do we need to demonstrate is most of it. To be clear, my view is that we are at the starting point of this revolution. Our study that we did with 233 patients in the Phase 2b is still the biggest study done yet.

I think what was really critical about that also was that it was overwhelmingly both naive patients and sites that were naive to psychedelics because it was really important to George and Katya and the other founders and other folks at Compass that we demonstrate something that was generalizable. That said, there is still a long way to go. The questions you asked have still got to be answered to the degree possible. What we also need to understand, and this is part of Florian and my challenge, is we cannot wait for all those questions to be answered before pursuing regulatory and commercial launches. For all of us, it is up to devise appropriate evidence-based clinical studies that start to answer those while also building the body of evidence with payers that will convince them.

The good news is that many of these serious mental illnesses we're trying to treat are very expensive, and they are seen by payers as a significant burden. You're starting from that point, but we're clearly going to have to generate the evidence around durability, repeat dosing, and so on to make this a truly scalable business.

Absolutely. I guess kind of along the point of just psychedelic medicines, I mean, recently we've seen, right, a broader movement, I think, from a regulatory perspective, at least in the U.S. and in other countries as well, to kind of either decriminalize or even legalize for medical use certain psychedelic medications. I guess how does that potentially impact the business model for companies like yourselves?

Florian Brand
CEO, atai Life Sciences

You're really following the medical road, right? I think maybe GW was already mentioned. I think that's a very good example here. We're focused on running those clinical trials, seeking or wanting to generate the data. That's also what's said to actually not only convince regulators that these compounds are safe and efficacious, but also the payers. Ultimately, our ambition, and again, why we started atai, is that we improve mental health care at a large scale. That means also accessibility and reimbursement of those therapies. Decriminalization and legalization won't lead to necessarily a broader access because it won't be reimbursed by insurance. We don't have the standards in our perspective that we should comply with. It's really regulatory, up to the regulators, in my perspective, to approve medicines, not legislators. Yeah. That's my view.

Kabir Nath
CEO, Compass Pathways

I would agree. I mean, our belief is very clear that the path to legalization is through the medical model. That is the path to legalization. That's what we're doing in terms of the diseases we're studying. I think also to say that we don't see that as a threat to the business model because TRD, PTSD, anorexia nervosa are the three areas we're focused on at the moment. I believe all of those should be patients should be under the care of a psychiatrist. That should be within the clinical setting. We don't see legalization as a threat, though I agree with Florian that there are concerns about it. I think we would say, though, that decriminalization is appropriate. It is wrong that people, many of them with serious mental illness, should be locked up for having consumed some of these substances.

I don't think that's appropriate and part of our cultural trend. I don't see those as a threat to our business model.

Absolutely. No, that makes sense. I think across all three companies, right, we've talked about the importance of payers. We've also talked about kind of all of these kind of new models of care, whether they're digital or psychedelic with some support. They all kind of require a little bit of a paradigm change, right, and a change in thinking from both a psychiatrist perspective and to Yuri's point, and as Florian mentioned as well, from a payer perspective. I guess can you help us kind of understand how you do that, right? How do you actually change the treatment paradigm from a commercial perspective?

Yuri Maricich
CMO, Pear Therapeutics

Sure. I'll speak with given that we have three commercial products. I mean, first and foremost is that there is a lot of education. Thankfully, because this has now really picked up steam as a space, the clinicians, the payers, and now also regulators have seen more and more of these types of treatments. I think they're starting to become accustomed. We're starting to see more well-worn pathways across those three key stakeholders here. We're seeing the integration elements where at scale, now health systems are saying not just, "Should we do this?" They have moved to, "How are we doing this in a repetitive format?" What are the key advantages to our business? I think the kind of tailwinds of COVID has also helped because it is inevitable that we have digital assets alongside everything we do.

All the health systems are rushing, and all the payers are rushing to create digital front doors. Having a digital treatment alongside a drug, patients get it. We do not need to convince patients because patients do everything else on their phone. Why should this be any different? It is now just laying all that infrastructure and plumbing and then making sure you have the evidence to show, is there clinical benefit and is there value? I think one of the advantages actually now that we have three products out there is also the commercial model, I personally believe, becomes more efficient. I mean, the traditional detailing model that pharma has utilized for decades is dying. I mean, I was at a point where if a sales rep got into my workroom in the hospital, they got chased out. They were not allowed to talk to us.

They're literally hanging out like a linebacker trying to catch someone in the parking lot. That allows us to be much more efficient with our reps because now we're having enterprise discussions with large health systems. We're talking more directly to key decision-makers. The implementation happens across an entire enterprise rather than trying to get a couple of scripts here and a couple of scripts there. I think it's better for everyone because you have more data-driven decisions, because you lay the infrastructure that allows for scalability. From a manufacturer development perspective, it allows us to be much more efficient.

Absolutely.

Florian Brand
CEO, atai Life Sciences

Yeah. I mean, I concur. I think most important for us, especially if you look at the, again, we also have non-psychedelic, very interesting non-psychedelic compounds, but the psychedelics one, I believe that will have the most impact in terms of paradigm shift. Focusing on these, key also here is stakeholder engagement early on. I believe esketamine is an important approval and has led to more optionality for patients. Yet I think in there is a lot to be learned. It's always easy kind of to criticize the first mover. I think I applaud Janssen, what they've done. Yet I think we can learn a lot there how we can roll out paradigm-shifting therapies in the right way. That in our perspective involves very early on to be very closely involved with stakeholders, payers, psychiatrists, and so forth.

Kabir Nath
CEO, Compass Pathways

I mean, I agree with both Yuri and Florian. I guess a couple of additional points. I mean, I think first, paradigms have shifted even in psychiatry, long-acting, some of the neurostimulation, and so on. It is possible over time, but we shouldn't underestimate the complexity. The good news is where you say commercial challenge, there's always opportunity, yes. I think as Florian said, esketamine is helpful to us. We can have some learnings from that, in particular, who pays for what. Ensuring that who pays for what is clearly articulated, identified, and that we have whatever plans in place well ahead of launch to make that happen.

I think the final thing, and just to build on Yuri's point of view, full disclosure, I spent six years running Otsuka before this, which is a very successful mental health company, and was also very active in digital and indeed invested in psychedelics. Within a legacy pharma business, it's hard to get the changes of behavior on that side. Whereas at Compass, we talk about being very open to collaborating with payers to create value-based solutions, to create novel revenue models and so on. We really mean it because there's no legacy business at risk if I create a value-based model. If that's the right way to ensure better outcomes for patients and to ensure that co-creation of value, then we can do that. I think that's also a really important distinction.

Absolutely. I know we've talked a little bit about esketamine over the last couple of minutes. Florian, I know one of your portfolio companies is going to have some data from an arketamine formulation later this year. Maybe if you can talk a little bit about just what you're hoping to see there. I know the goal with that program is really to get that potentially for at-home use rather than having to go to the physician's office and get dosed and be monitored in that sort of a setting. Maybe if you could talk a little bit about, yeah, what you are hoping to see from the proof of concept data. Kibir, too, I'd be curious your thoughts on that program just because I know Otsuka did do a deal with Perception for that program, yeah.

Florian Brand
CEO, atai Life Sciences

Yeah. No, happy to. The target product profile, our ketamine is also in line with what was said earlier, a rapid acting antidepressant. Differentiated here from other available options. Indeed, our goal is to make it available for at-home use. That is certainly the goal. That is also what we want to show in the Phase II POC study looking at basically two things concurrently in terms of endpoints and address. The CADDS, that is a measure or a scale of dissociation. Anything around or below four is considered normal. Based on preclinical data, but also a small open-label study in TRD patients, we have that indicator basically that you can achieve a significant drop in the MADRS with very little movement on the CADDS led us to start this program.

We want to differentiate on the dissociation side from esketamine, meaning esketamine is around about 15 in terms of the CADDS at efficacious doses, while we believe we can be significantly below. The goal here is to be around four and, yeah, see a significant delta between placebo and the active arketamine on the mattress.

Kabir Nath
CEO, Compass Pathways

The only comments I have are clearly Otsuka saw the same potential for differentiation from esketamine. What I will say, though, is the setting for psychiatric care in Japan is fundamentally different from, I mean, it looks more like the U.S. and U.K. 50 years ago with the long-term institutionalization of patients with serious mental illness. As I recall, Otsuka is actually developing it for in-hospital administration as opposed to here. It is a very different environment.

Florian Brand
CEO, atai Life Sciences

Yeah. It is a Japan-focused deal, I think.

Kabir Nath
CEO, Compass Pathways

It is a Japan-only deal.

Florian Brand
CEO, atai Life Sciences

It's a caveat. While we maintain the rights for all other areas of the world, I think especially interesting, again, coming to scalability, I think here we would have an option next to the in-clinic treatments that we develop to reach patients at home. I believe that will be important going forward, always having in mind that you need multiple options available for patients in that perspective.

Absolutely. Maybe a question for Yuri just around, I know recently you did kind of announce some strategic updates. With that, I think there was a little bit of a culling of the pipeline, but just kind of curious to hear your thoughts on some of the pipeline programs that Paired does have and how those could potentially be used in some of the conditions that we've talked about, like depression or anxiety. I know you were working on the schizophrenia program as well. Yeah. How you see digital therapeutics kind of treating and fitting into those models.

Yuri Maricich
CMO, Pear Therapeutics

Sure. I mean, and we remained very bullish on the pipeline, I think, in general. It was clear to us that the macro environment is quite volatile. We want to be focused on making sure we demonstrate to the world that I really believe each of these digital therapeutic products, again, whether they're a combination or not, have incredible economic potential as is. The more that we all show that, then the more value will continue to be ascribed to the pipeline. Our average selling price, it's not $4.99 in the app store, right? It's based on the health economic value of these products. We need to continue to scale revenue there. I think what's exciting to me about the pipeline is one, as we just said, I mean, it is a greenfield out there for psychiatry and other mental health.

Two is that there are many drugs that could be made better that are already on the market. That allows us to basically get treatments to patients to do our R&D faster and have a more immediate impact and thus also revenue generation. Also, the scalability of development is so much faster because of the fact that we can take digital components. Almost if you think of like a molecule, you could take a benzene ring and a hydroxyl group and then reassemble them. Rather than having to go back and start again in non-clinical, you can just run a couple of additional clinical studies and you have a new product on the market that either can work alone or in conjunction with drug.

Lastly, there is a platform effect here, which we do not typically see in biotech, but we do see in tech, which is customers, particularly health systems, do not want to integrate with 50 different prescription digital therapeutic companies. They want to integrate with one platform. I think we are going to see consolidation ultimately around different platforms that are going to then have all that infrastructure and platform integration.

Absolutely. No, that makes sense. Kibir, I know we're going to see in October, we're going to get the details of the Phase III program. We're going to see maybe some long-term follow-up data from the Phase 2b study in TRD. I guess maybe more of a general question, can you walk us through what really the purpose of the Phase 2b study was versus the purpose of the Phase III? I think that's where a lot of investors, I'm getting a lot of questions about how the Phase III could be designed. I think really the question is, how is it being designed to kind of answer a slightly different question, right, to prepare the market for COMP3 60?

Kabir Nath
CEO, Compass Pathways

It's a very fair question. Again, Phase 2b was a classic proof of concept dose-finding study. As I said earlier, I think one of the most important things about it was that it was done in overwhelmingly psychedelic naive patients and sites because clearly first there was a need to generate the efficacy and safety data, but also to show that it was generalizable. The 2b did that. It showed rapid reductions in depressive symptoms for a third of patients, sustained remission of 12 weeks for a quarter of patients. In terms of the Phase III, we have disclosed it is pivotal trials in the plural. I'm not going to tell you any more than that before October the 12th.

In that sense, it's clearly designed to build on the evidence we showed in Phase 2b around dose, around potentially duration, potentially the need for repeat. It will be a very robust program that we believe answers the questions that we debated with the FDA. The reason that we have been so clear about not going out there is the FDA does not like setting precedents. Whatever they agree to here is a pretty significant precedent in psychedelics as a large, well-powered Phase III program. We don't want to be seen to be putting pressure on them in terms of what we say. I guess from an investor perspective, I would say, while we're clearly doing something very different in terms of psychological support in the digital apps, this is the paradigm for the development of novel neuropsychiatric drugs.

That is really what we're doing. I mean, the paradigm for any major company that has brought through a new drug, and whether that's intracellular or any of these other companies or even Karuna's latest data or whatever, that is the paradigm. Psychiatry is a relatively conservative division. Much as I would wish them to behave like an oncology that doesn't believe in Phase I, II, and III anymore, that's not the case.

Absolutely. In the last five minutes or so here, I do want to ask each of you just one more quick question. I guess maybe Florian, I know you have a very broad pipeline, so just curious if you can maybe pick one of your favorite programs that you feel like is underappreciated just to highlight.

Florian Brand
CEO, atai Life Sciences

I guess we'll never stop that by trying to get me to agree on one of those programs. I mean, ultimately, we recently had our earnings call. I think what's exciting for investors about it is that we structured our pipeline now in a way and also extended our runway in 2025 that allows us to deliver really on those eight clinical programs that we will soon have, eight programs that we will have soon in the clinic. Right now, it's seven. On those programs, we will see over the next two years POC or POC-like data. Efficacy data that is meaningful to investors in my perspective. I think we're having a very diverse approach that also considers, I guess, some of the risk associated with drug development, especially in psychiatry.

Multiple shots on goal, not relying on one specific mechanism, but having a very broad array of pharmacological agents and a great potential to combine them with our digital efforts. I think that is really exciting for investors. In terms of what I would highlight, I would not pick out one specific program, but as we are a platform company with a diverse pipeline, I would like to emphasize that as a unique selling point. Sorry, it is disappointing.

No, totally fair. I guess, Kabir, maybe we can talk a little bit about some of the other indications that you're working on for COMP 360. PTSD or anorexia?

Kabir Nath
CEO, Compass Pathways

Absolutely. I think PTSD, we already have the Phase II program underway. Again, clearly significant unmet need, very little approved. I think anorexia nervosa is very interesting because that was really a demonstration of the success of our IIS program. We had provided drug to Dr. Kate at UCSD, small study in anorexia nervosa, but some very strong signals in a handful of those patients. That enabled us immediately to scale up to a Compass-sponsored Phase II, which we announced, which will be 60 patients across four sites. Again, just a reminder, anorexia, there has never been any drug approved. It is the disease with the highest mortality rate of any serious mental illness. We are very excited about that, keen to push that forward.

There are a range of other IISs as well, and you'll hear more about those on October the 12th. Again, with the same principle that if we see a strong signal, we're able to move quickly to potentially scale up to a real proof of concept.

Absolutely. And then just final question for Yuri. I know we talked a little bit about the kind of strategic update recently, but maybe if you could talk a little bit specifically on the impact that may have on kind of the script trajectory of the launch of your three commercial products.

Yuri Maricich
CMO, Pear Therapeutics

Yeah. I mean, I think one of the things we just highlighted there is kind of before the volatility of the markets as we went into the beginning of the year, right? Many companies were focused almost exclusively on revenue. I think now there's kind of been a reminder of the importance of discipline about revenue and costs. We have just decided that we are going to focus on paid scripts. That is going to mean that we are instead focusing not on any scripts, but on the scripts that are going to generate revenue. Because of that, we wanted to say, look, that means we are going to be far more selective around where we make investments because of that changing macro environment.

I think overall, we still remain very excited about the progress we see around script growth, adoption, use, particularly on the enterprise scale, and also around continued reimbursement there. I think the thing to watch again is the average selling price and the unit economics is really, really attractive. I mean, there's not many software businesses, if you think about it from that way, let alone biotech businesses where you have that kind of strong unit economics. The important thing is it's backed up by data, and it's data that payers can now use. Frankly, also we're seeing providers because most psychiatry and behavioral health delivery organizations don't have the ability to show their value. We're seeing even payers say, this helps us to see how are we doing in tackling that.

Kabir Nath
CEO, Compass Pathways

That gives them more assurance on continuing to support coverage and pricing power for us.

Absolutely. Fantastic. I think with that, we actually are out of time. I appreciate all three of you joining me. It's been great. Thank you, everybody, for listening.

Florian Brand
CEO, atai Life Sciences

Thank you.

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