Earnings Call Transcript - CMPS Q1 2022

Operator, Operator

Good morning, and welcome to COMPASS Pathway’s First Quarter ‘22 Earnings Call. During the presentation, all participants will be in a listen-only mode. Afterwards, we will conduct a question-and-answer session. As a reminder, today's conference is being recorded. I would like to turn the conference over to Steven Schultz, VP, Investor Relations. Please go ahead, sir.

Steven Schultz, VP, Investor Relations

Welcome all of you and thank you for joining us today for our first quarter 2022 results conference call. We hope you've had a chance to review the press release issued earlier today, covering these results. Again, my name is Steve Schultz, Senior Vice President of Investor Relations at COMPASS Pathways. Today, I'm joined by George Goldsmith, Chairman and Chief Executive Officer; Dr. Guy Goodwin, Chief Medical Officer; and Mike Falvey, our Chief Financial Officer. The call is being recorded and it will be available on the COMPASS Pathways' investor relations website shortly after the conclusion of the call. Before we begin, let me remind everyone that during the call today, the team will be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as amended. You should not place undue reliance on these forward-looking statements. Actual events or results could differ materially from those expressed or implied by any forward-looking statements as a result of various risks, uncertainties and other factors, including those risks and uncertainties described under the heading Risk Factors in our quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission and in subsequent filings made by COMPASS with the SEC. Additionally, these forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements. With that, I'll now hand the call over to our Chairman and CEO, George Goldsmith.

George Goldsmith, CEO

Thank you, Steve and welcome, everyone. I will begin today's call with an update on our business progress. I will then ask Guy to provide some high-level comments on the recently completed end of Phase II meeting with the FDA. And then, Mike will provide a financial review. After our prepared comments, we will open the call to questions. I'm pleased to report to you that in this first quarter COMPASS continues to make significant progress toward our goal of transforming mental health care. Too many individuals who suffer from mental health conditions are not properly served by the current standard of care. COMPASS is addressing this through innovations and novel medicines, evidence-based therapeutic protocols and digital tools that support patients and therapists to dramatically improve the way we care for these patients. The increasing number of people with significant mental health challenges is a global crisis and one that carries with it a large and growing cost burden to patients and healthcare systems. In the face of this growing crisis, COMPASS continues to advance our development programs in both treatment-resistant depression (TRD) and in post-traumatic stress disorder (PTSD) to substantially underserved patient populations. Our strong cash position and experienced team of experts across key disciplines continues to differentiate COMPASS in this area of science, and also keeps us on track to bring our therapy safely to patients as quickly as possible. Our innovative clinical care pathways integrate psychedelic medicine, digital platforms, data science, and psychological support to help people get well and stay well. Our novel and valuable propositions for patients, health care providers, and payers. This integrated approach is unique both in psychedelic research and in the treatment of mental health challenges overall. Our strategy of innovation is one that we believe will propel COMPASS to a much broader leadership role in developing personalized, predictive, and preventative approaches in mental health care. We know that psychiatrists and therapists caring for patients with these severe mental health conditions are eager for new treatment options. This was reflected in a survey conducted late last year in which doctors surveyed believed psilocybin therapy has potential benefits for patients with TRD. In this survey, half would prescribe psilocybin therapy if it were approved. We are also aware of the desire of individuals with these conditions to have access to new non-invasive ways of addressing their depression. They see this as a move from drugs that may only partially alleviate symptoms of depression to a treatment that provides the opportunity for a breakthrough in emotional understanding, a life-changing experience. Based on our clinical results to date, we believe this better outcome is within reach for a significant number of these individuals. With that, let me now turn to Guy, who will provide his thoughts on the next steps in our planned Phase III program.

Guy Goodwin, Chief Medical Officer

Thank you, George and good day, all. Indeed, we had our meeting with the FDA and we were pleased with how the discussion developed. We have the opportunity to share our thoughts on the Phase II results, which showed that COMP 360 psilocybin therapy was acceptable to patients, rapid-acting and durable for an important fraction of a patient population that does not respond to current antidepressant standard of care. Individuals in the 25-milligram COMP360 arm compared to a 1-milligram control arm showed immediate benefits. At the Week 3 time point, the primary endpoint had a reduction in their MADRS depression score of 6.6 points with a p-value of less than 0.001 and a response rate of 37% compared to 18% in both the 10-milligram and 1-milligram arms. The clear separation between doses is compelling evidence for true drug efficacy. At the 12-week time point, the full length of the trial, 20% to 25% of those in the 25-milligram arm continue to show a sustained response from that treatment-resistant depression. Moreover, these were patients who did not return to any antidepressant use over the duration of the trial. This is very striking because it contrasts with both lower rates of response and higher rates of relapse in comparable patients treated in the control trial. The number of patients who participated in either the Phase IIb monotherapy trial or the SSRI adjunct study chose to enter a 12-month long-term follow-up study. We look forward to reporting results of this study later in the year and gaining additional insight into the durability of a single COMP360 psilocybin dose with psychological support. Critically for clinical use and measurements of quality of life, self-reported mood, and positive thinking, the individuals who responded showed similar levels to those in the healthy population. We believe this could prove to be an important differentiating feature of COMP360 therapy that will be valued by patients and clinicians alike. So these are the key points we shared with the agency and we look forward to receiving official meeting follow-up and finalizing the pivotal program design and moving forward. The informal feedback from the network of investigators who participated in Phase IIb has been strongly positive. There is palpable enthusiasm from them to participate in the next phase of the trial program. We are also looking forward to sharing more details of the Phase IIb study results in this year through publication in peer-reviewed journals and various medical meetings. Beyond the TRD program, we are also moving forward with a Phase II program in PTSD. Like TRD, we believe the clinical potential of COMP360 therapy is high and the patient need is great. The symptoms of PTSD are often severe and long-lasting, and current treatment approaches are ineffective for many patients. First-line treatment includes psychological interventions such as trauma-focused cognitive-behavioral therapy followed by pharmacological approaches such as SSRIs. Unfortunately, about 40% of those with PTSD will not improve with this treatment. The PTSD Psychopharmacology Working Group recently described current treatment outcomes as a crisis and called for novel effective and efficient trauma-focused interventions to be developed. The PTSD study is an open-label study and will enroll 20 participants. It is designed to evaluate the safety and tolerability of COMP360 psilocybin therapy in people who suffer with PTSD resulting from trauma experienced as adults. The Institute of Psychiatry, Psychology & Neuroscience at King’s College London is the first of multiple expected sites. Participants will receive a single 25-milligram dose of COMP360 psilocybin, given in conjunction with psychological support in line with the COMP360 psilocybin therapy protocol, and will be followed up to 12 weeks. The primary objective of the study is to assess the safety of COMP360 psilocybin therapy. It will also measure whether the treatment appears to improve PTSD symptoms, functionality, and quality of life. Such a study is necessary for designing and powering definitive studies of efficacy. We also continue to see encouraging findings from COMP360 independent investigator-led studies. Just last week, two posters were presented at the Society of Biological Psychiatry Annual Meeting in the USA, showing positive early signals in exploratory open-label studies for anorexia nervosa and more severe treatment-resistant depression. We will be evaluating the implications of these studies for our R&D plans. Also, you will see an announcement earlier this week on an additional IIS that has started in autism. Autism fits well with COMPASS’ focus on areas of unmet medical need and support for those who are suffering and have run out of options. The study is co-sponsored by King’s College London and South London and Maudsley NHS Foundation Trust. Let me now turn the call over to Mike for financial review.

Mike Falvey, CFO

Thanks, Guy. I will now recap our financial results for the three months ended March 31, 2022. The net loss for the three months ended March 31, 2022, was $21.2 million or $0.50 per share compared with a net loss of $12.7 million or $0.35 per share during the same period in 2021. These results include non-cash share-based compensation of $3.1 million in 2022 and $1.7 million in 2021. R&D expenses were $15.4 million for the three months ended March 31, 2022, compared with $6.9 million during the same period in 2021. The increase was attributable to an increase of $5.1 million in external development expenses, $2.6 million in personnel expenses, and $1 million in non-cash share-based compensation. This was partially offset by a reduction of $0.2 million in other expenses. The increases in the quarter were primarily due to preparation for the expected launch of our Phase III trial in TRD scheduled for the second half of this year. G&A expenses were $10.1 million for the three months ended March 31, 2022, compared with $6.7 million during the same period in 2021. This increase was attributable to an increase of $1 million in personnel expenses, $0.5 million in non-cash share-based compensation, $1.4 million in legal and professional fees, and $0.4 million in facilities and other expenses. The increases this quarter were primarily in support of our growing R&D organization and operations to support operations as a public company. COMPASS continues to maintain a strong financial position with cash and cash equivalents of $243.7 million at March 31, 2022, compared with $273.2 million at December 31, 2021. With these resources, we expect to be able to fund our operations into 2024. We view our strong balance sheet as an important strategic asset, which we will continue to manage carefully as we invest to advance these promising potential therapies while creating value for our shareholders. Thank you. And I'll turn the call back to George.

George Goldsmith, CEO

Thank you, Mike. As you heard from Guy, our FDA meeting went well. I know that you are all highly interested to know more about this program design. We respect the FDA's process and we'll share the Phase III program with our investors when it is finalized. Our goal is to host robust R&D data after that, where we will explain our TRD program in detail and review the progress we are making in our programs addressing additional indications, including PTSD, and share more information on our work on digitally enabled clinical care innovation. In the meantime, we are actively preparing to be Phase III ready ahead of the final design confirmation. This includes recruiting and onboarding clinical sites, further scaling and enhancement of our therapist training platform to support the significant global expansion of treatment sites that will participate in the Phase III trial program, fine-tuning training materials, supporting therapist training and certification, and expanding our suite of digital tools. Let me also highlight an important long-term public-private partnership that we launched this past quarter with King’s College London and the South London and Maudsley NHS Foundation Trust to establish The Centre for Mental Health Research and Innovation. This partnership designed to accelerate psychedelic research and develop new models of care for mental health in the UK demonstrates the direct support for the significant unmet need in mental health and a confirmation that the health system is committed to supporting new therapeutic models. We believe this partnership is a forerunner to health system and payer backing on a broader scale as we progress with COMP360 therapy development. We are also pleased to announce that COMPASS has been awarded an Innovation Passport, which is an innovative Medicines designation and marks entry into the UK's innovative licensing and access pathway, designed to accelerate the time-to-market and facilitate patient access to innovative therapies. 2022 will be another active year of milestones in which we expect the launch of an additional COMP360 clinical development program beyond the ongoing TRD and PTSD programs, publication of our Phase II COMP360 clinical data in a major peer-reviewed medical journal and at a number of medical meetings, the results of our 12-month follow-up outcome study in TRD, clinical results from one or more independent investigator-led studies, further expansion of our IP portfolio, further strengthening our focus on innovation and continuing progress in advancing COMP360 payer partnerships. Our operational leadership and strong cash position are key differentiators and enable us to continue at pace toward our goal of building a personalized, predictive, and preventative model for transforming the treatment of mental health, which has the potential to change people's lives for the better for generations to come. Thank you for your time today. We will now open the line for questions. Operator?

Operator, Operator

Thank you very much. We'll go to our first question on the line from Josh Schimmer with Evercore. Please go ahead.

Josh Schimmer, Analyst

Great. Thanks for taking the questions. First, can you please explain the rationale for exploring the use of psilocybin for treatment of autism? And then, can you also please discuss the outcome measures that are typically used in PTSD? And what type of signal are you looking for in the Phase II study to advance to a registrational enabling trial? Thank you.

George Goldsmith, CEO

Hi, Josh. Thank you so much. Guy will respond to this question, but I really appreciate those questions.

Guy Goodwin, Chief Medical Officer

Yeah. So just starting with autism, Josh. This is an experimental medicine study, designed to look at measures that tap into the assumed function of serotonin. The details are fairly technical, so I'm not sure we want to go into at this point, but they are really designed to establish whether we can see a convincing effect of different doses of psilocybin on those pathways within the brain, and of course, because people are very interested in the underlying mechanisms in autism rather than the symptoms per se or the problems that people have, we will get insight at the fundamental level. So it's essentially looking at a series of preclinical questions. Your second question was about PTSD; I mean, it's conventional to look at change in or at least in change in a single or the main traumatic symptom. We will also be looking at quality of life and general response, general well-being. But of course, the purpose of this study is essentially to establish safety and to look at the methodology around preparing patients for the experience from a different clinical group. And that I think is where we would mainly expect to see learning. So essentially this is a feasibility study. And obviously, we will get a sense of what outcome measures are relevant and sensitive to the treatments. And the point of course is then to get a really good power calculation to take this into a randomized controlled study at some point.

George Goldsmith, CEO

I would just add, Josh, for your information, everything that we pursue is based on a very strong preclinical signal that we've achieved through the most robust program that we're aware of looking at preclinical activity across a variety of different disorders. So this is evidence-based and we're moving forward exploring these.

Josh Schimmer, Analyst

Thank you.

Operator, Operator

Thank you very much. We’ll go to our next question on the line from Charles Duncan with Cantor Fitzgerald. Go ahead.

Charles Duncan, Analyst

Good morning. Thank you for taking my question, and congratulations on the progress made over the past six months, George. I understand you can't discuss agency matters in detail at this time, but I have a question regarding the next steps for COMP360 in TRD. Could you share your perspective on whether it makes sense to pursue development in patients currently on SSRIs? Also, what would be an appropriate control arm? Should it align with your Phase IIb, or what should we expect moving forward, keeping in mind that you need those meeting minutes to provide a definitive response?

George Goldsmith, CEO

Hi, Charles. Thank you for your question, and I appreciate your creativity. Right now, we are focused on waiting for the FDA's response, which will be a key topic in our discussion today. We do not want to second guess or anticipate their feedback, as this is very important. At this stage, we will provide more information as we progress through the summer and start to receive the benefits you mentioned. Our general perspective is to follow our data closely and pursue the path with the most robust evidence, which is currently centered on monotherapy. We also have additional data for our adjunct treatment, which we will be considering.

Charles Duncan, Analyst

Okay. And maybe if I could follow, ask a follow-up question that you won't likely be able to answer, but in a different way, which is, when you've gotten feedback from thought leaders, how do they see the responses? You pointed or Guy pointed to durability of effect over a 12-month or 12 weeks, it seems like that's, that's really pretty interesting clinical response, but is that going to be sufficient to really demonstrate an effect which is clinically meaningful at 12 weeks?

Guy Goodwin, Chief Medical Officer

Maybe I should take this because I've talked to the PIs from the IIb study at some length, almost all of them now. And I think what is striking is that virtually all of them who've recruited a significant number of patients because obviously with a blinded study, but I think virtually all of them described patients then you really well. We had a fairly dramatic improvement that was durable and I think it's that group that we all kind of pretty convinced by obviously that's not the same as doing clinical trials, but it is extremely important in the impression that clinicians have of the promise of the treatment. And the way in which they can develop it in the future once, of course, they get a chance to use it in real life, so to speak. So that's what essentially encourages us from a purely clinical point of view.

George Goldsmith, CEO

And we also think that it's absolutely extraordinary that patients on no other medications after a single experience 12 weeks later have this response. So I think this is really the birth perhaps of a new paradigm and we're really examining that deeply.

Charles Duncan, Analyst

I agree with you 100%. Last quick question, hopping over to PTSD and a follow-on to Josh's question, will CAPS 5 be considered as an endpoint or at least exploratory in that study?

Guy Goodwin, Chief Medical Officer

We haven't released that information. We haven't published the protocols yet, but we will do in due course.

Charles Duncan, Analyst

Okay. Very good. Thanks for taking my questions. Look forward to the updates.

Operator, Operator

Thank you very much. We'll get to our next question on the line, it is from Neena Bitritto-Garg with Citi. Go ahead.

Neena Bitritto-Garg, Analyst

Hey, guys. Thanks for taking my question. Just following on the PTSD line of questioning, I saw on one of the posters that was presented last week. I think for the severe TRD patients, there were a few that did have PTSD who didn't necessarily respond as well as those who didn't. I guess, any thoughts on maybe why that was and how that may read through at all to the Phase II study in PTSD? Thanks.

Guy Goodwin, Chief Medical Officer

Well, I mean, it's a great question. Of course, it’s why we do research. I mean I think essentially we will find out whether there is something about how we prepare patients that experience we need the experience ourselves of running this study and working out what the limitations are in this patient group. But you're absolutely right to highlight that those there were three cases in the study from Sheppard Pratt and obviously, we've looked at that and spoken to the PI about it. At the moment, it's just destroying the win, but we're very aware that it happened, but what he says about those patients, and we take that information into the design of the study, that has started at King's College in London.

Neena Bitritto-Garg, Analyst

Got it. Thank you.

George Goldsmith, CEO

Thanks, Neena.

Operator, Operator

Thank you very much. We’ll go to our next question on the line from Ritu Baral with Cowen. Go ahead.

Ritu Baral, Analyst

Good morning, everyone. I'm going to rephrase my question regarding the FDA. George and Guy, could you share what the main discussion topics were? Specifically, while you don’t have the final feedback from the FDA, what did you propose for the psychological support during Phase III? I understand that clinicians discussed more efficient monitoring of potential group sessions and the qualifications of the caregivers providing that support. Can you walk us through what was proposed and whether it aligns with your commercial plans? I have a follow-up as well. Thank you.

George Goldsmith, CEO

Thank you, Ritu. And you're right in anticipating that we won't go into what we proposed in that meeting. I'm sorry to frustrate you, but I think this is a really important thing; the regulators exist for a purpose. And we really want them to be able to come back to us with their perspective. So we aren't going to be second guessing and as I said at the beginning. I do think that your point around the psychological support is really important. This is a critical aspect of this therapy, and we really are looking at how do we enhance that based on the data that we have. So we're doing a lot of work on our Phase IIb data and we also have something unique in this area, which are recordings video and audio of each session. And we can really start linking that through our machine learning activities or natural language processing activities to develop a better picture of what leads to improved outcomes in terms of the preparation, the support during the session, and the integration afterward. That's really unique in this whole area and we're diving deeper on that and we'll take those learnings into Phase III as you can imagine.

Ritu Baral, Analyst

Got it. My follow-up is sort of the same question but focused on PTSD, which is in Phase II. So hopefully you can you can talk about it. Guy, you mentioned that the psychological support around the PTSD is similar to the MDD program. I'm just wondering if there are any material differences to the approach knowing that sort of the psychological support offered as part of the next program, for instance, is very focused on the actual triggering trauma of PTSD. So I'm wondering, is there an element of that wrapping around your PTSD protocol? Thanks for taking the questions.

Guy Goodwin, Chief Medical Officer

The protocol is not fundamentally different from the Phase IIb program. We are particularly interested in findings from recent publications by the Imperial Group that highlight the significance of emotional breakthroughs in predicting outcomes. As George previously noted, we are examining this closely in relation to the transcripts of preparatory studies involving patients with treatment-resistant depression (TRD). Extrapolating this to post-traumatic stress disorder (PTSD) presents its own set of challenges. We believe that the core of the therapy lies in the drug’s effects, especially how these effects aid emotional learning in patients who are administered the drug. We aim to focus on ensuring patient safety, which involves being present with patients on the treatment day and creating a safe environment for their experiences. We have much to learn about the application of this in PTSD, and the best starting point is to use a protocol similar to what was effective in TRD. We also intend to adopt a similar learning methodology by recording the sessions and determining the most effective ways to assist patients.

Ritu Baral, Analyst

Got it. Thanks for taking the questions.

George Goldsmith, CEO

I might just add one quick thing here, based on what Guy pointed to, but just to bring it out. I think one of the really important things that we're doing is an empirical base of how to help therapists be better in their work and their supported patients. And to do that by applying machine learning and looking at how that links to outcomes. So this is something, it's a really important as we advance this whole field.

Operator, Operator

Thank you very much. We'll go to our next question on the line from Bert Hazlett with BTIG. Go ahead.

Bert Hazlett, Analyst

Thank you. Thank you for your comments and I won't ask about the Phase III study design, I promise.

George Goldsmith, CEO

Thank you, Bert.

Bert Hazlett, Analyst

Well, with regard to some of the other indications that you've discussed in press releases recently, in particular anorexia nervosa. The study out of UCSD, I believe discussed or commented on a 30% reduction in the eating order psychopathology at one month of 40% reduction at three months, and I’d love for you to comment on whether that rises to the level of additional investment for your COMP360 psilocybin program. And if you could, if there are additional endpoints of interest in this setting, and if you could comment on safety and tolerability in this setting, that would be interesting as well.

Guy Goodwin, Chief Medical Officer

So this was obviously an independent study, which we were very interested to receive the results from, as I'm sure you were. The impression of Walt Kay, who is an extremely experienced and internationally renowned researcher, was that he thought the results for several of the patients were really extremely impressive. Now this is the kind of story we've had in other indications. So we're encouraged by that. But we obviously have a lot to do before we think about the commitment to further investments in this area. And since I have not really my role I should defer to George or Mike in that regard.

George Goldsmith, CEO

Yeah. And I think that we're obviously looking at anything that could benefit patients with high unmet need. This is certainly one of those populations. And we're looking at that as we dig into the data and look at what might be possible.

Bert Hazlett, Analyst

Any brief comments on safety or tolerability of COMP360 psilocybin in the study results?

Guy Goodwin, Chief Medical Officer

There were really no concerns identified in that study. The investigators were very careful at first due to the patients' metabolic conditions, so there was significant interest in determining that this was well tolerated with acceptable safety. This is encouraging at this point, even with a small number of patients. However, that is how the process begins.

Bert Hazlett, Analyst

Great. Thank you. We look forward to further updates. Thank you very much.

Operator, Operator

Thank you. We'll go to our next question on the line from Francois Brisebois with Oppenheimer. Go ahead.

Francois Brisebois, Analyst

Hi. Thanks for taking the question. So I was just wondering, you mentioned the survey late last year and based on the data of Phase 2b about 50% of physicians would prescribe or want to use the COMP360. I was just wondering, just to play devil's advocate here, was there a stratification or any information on why a physician might not want to use it?

Guy Goodwin, Chief Medical Officer

No, I don't think so. We were primarily focused on the individuals who showed interest in using it. However, you're correct that we should also consider those who are not interested, which we believe is largely due to a lack of knowledge. In other surveys, it appears that patients, as well as clinicians and the general public, often express disinterest mainly because they aren't well-informed about it.

George Goldsmith, CEO

And I think this is simply our first foray into this area to understand the baseline, and our focus is really to do much more comprehensive medical education and so forth, and you'll be hearing more about that as we move forward, but it's a key part to help educate prescribers and other key stakeholders, and you'll see more from us in the coming year.

Francois Brisebois, Analyst

Okay. No, that's helpful. And then I was just wondering in terms of the therapy, the psychotherapy, there's just been a lot of discussion around it. And I was wondering your thoughts more at a high level about the psychotherapy process just being standardized and obviously, maybe some variation between disease status between patients, but any thoughts on the standardization of the process?

George Goldsmith, CEO

Yeah. I'll turn it over to Guy in a moment, but just the high-level view is that one of the key issues confronting payers and providers is really about how to deliver and ensure a linkage between psychotherapy and outcomes. And I think our focus is really to start providing a greater connection based on evidence and training and we're aiming to do that in all of our work so that we can deliver a more standardized approach that actually links to the data to improve outcomes. So that's our goal and ambition. Guy, if you want to build on that at all.

Guy Goodwin, Chief Medical Officer

Yeah. I think we can certainly standardize the psychoeducational component of the preparation. One can do that with a really effective teaching platform. One can use the methods used widely in education to check with people; people's training has been successful. I don't see any reason why we shouldn't apply that in the preparation of patients for this experience, and indeed that's what our digital team is working on at the moment.

Francois Brisebois, Analyst

Okay. Great. And just lastly here, you mentioned more medical meetings throughout the year in recent medical meetings. Nice to see that a lot of these are in person again. I'm just wondering if there's any specific meetings that you want to highlight that could be interesting?

Guy Goodwin, Chief Medical Officer

Yeah. I mean, the American Psychiatric Association Meeting is obviously the biggest meeting in the U.S. and we should be there for that and presenting a poster. ASCP, which is the Clinical Pharmacology Meeting, probably the most influential in the U.S., we should be presenting new data there. And then finally, in Europe, the ACNP in October. And very, very much finally, in December, nearly at the end of the year, the ACNP meeting where we expect again to present new data on mechanisms.

Francois Brisebois, Analyst

Great. Thank you very much.

Operator, Operator

Thank you. We got next question on the line, it is from Esther Hong with Berenberg. Go ahead.

Elaine Kim, Analyst

Hi. Thanks for taking our questions. This is Elaine Kim on for Esther. Our first question is, how similar is anorexia nervosa in terms of patients responding to treatment, for example in concerns versus depressive symptoms? And we have a follow-up question.

Guy Goodwin, Chief Medical Officer

I think we don't really see them as tapping into the same functional domains. TRD and anorexia nervosa really do look very different. I mean, the key issue being the preoccupation in anorexia with weight and shape. There are some potential similarities in the sense that these both patient groups have very persistent troubling preoccupations, and we think we understand part of the neurobiology of that is lying in the so-called default mode network, which is kind of the introspective side of human experience and that seems to be particularly rigid in both conditions. So, there is that sense that there may be a mechanistic similarity which is not necessarily at the symptom level but at the functional level, and of course, we believe that the way in which we're one of the ways in which psilocybin works is actually to break up the rigidity of those connections and to offer greater connectedness to different parts of the brain. So we think there is a kind of link at the mechanistic level, but symptom-wise in terms of presentation clinical difficulties, they're expressed, of course, in a very different way.

Elaine Kim, Analyst

Thank you. That makes a lot of sense. Our follow-up question is, in the same anorexia study, there were statistically significant reductions in concerns at month three. So although the study is small, does this add support to psilocybin durability of effect?

Guy Goodwin, Chief Medical Officer

I think we need to be cautious because this is an uncontrolled study, it's open label, and there is no control comparison group. Skeptics may have their doubts, but we are interested due to the severe nature of what has traditionally been considered an intractable condition. We're keen on those numbers, as well as the insights from experienced clinicians like Walt Kay, who noted significant changes in patients. This feedback is crucial for our planning.

Elaine Kim, Analyst

Okay. Thank you very much.

Operator, Operator

Thank you. We’ll go to our next question on the line, it's from Patrick Trucchio with H.C. Wainwright. Go ahead.

Patrick Trucchio, Analyst

Thanks. Good morning and good afternoon. Just the first question is just around as we are looking at the expansion of the COMP360 program. We have TRD then now expanding into areas of PTSD, autism, potentially anorexia. How should we think about how broad this program can become? How many indications can you realistically explore, and how do we view it just in the context of the discovery efforts at COMPASS and just in terms of next-generation compounds and how those would then factor into kind of your development plans?

George Goldsmith, CEO

Hi, Patrick. Thanks so much for the question. I'll start off and Guy will probably add some color commentary additionally. So I think what's really important is that our North Star, our True North at COMPASS is simply how do we find ways to help people in areas of large unmet need, who are failed by current treatments. And so that's what we focus on. And we started with TRD based on our conversations with payers, regulators, and providers if that was the place to start. Obviously, we will be using a similar methodology to go next and that's how we came up with PTSD as our second area of focus, and we'll be continuing to apply that. And we're going to focus on as many of these programs as we find that there is actually a rationale to approach and that there is a strong investor proposition as well. These are huge areas of unmet need and I think we are really looking at how we address those. So that's the overarching perspective. Now on the other side, we want to make sure that we get this to patients as quickly as possible. That means, we're really focusing on our TRD program first and foremost, that's where we're furthest ahead, not only in our development process but for the entire field and the entire transformation of mental health. So that's where our priorities are. And as we look at these other areas, we will be following the data, which is what we do.

Patrick Trucchio, Analyst

Yeah. That's really helpful. And just one clarification on the PTSD program. So following this Phase II trial with the intention to move directly into a pivotal Phase III program, or would you need to run another Phase II?

Guy Goodwin, Chief Medical Officer

I think it's a little early to say frankly, Patrick. I think we will wait and see what we find. I mean this is still early days with PTSD. We are obviously interested in it, we're committed to finding out more, but I mean the first study will be informative in ways that we don't yet understand and we wait that understanding before we say more.

Patrick Trucchio, Analyst

Got it. Yeah. Okay. That's helpful. Thank you so much.

George Goldsmith, CEO

Thank you. Look forward to seeing you soon at this conference.

Operator, Operator

Thank you very much. And there are no further questions at this time. I now turn the call back to management for any closing remarks.

George Goldsmith, CEO

We really appreciate your support and interest today. We continue down our path of executing as we do at pace. We are excited about the next steps we will be evolving this year. We are making a lot of progress on many different dimensions and we'll look forward to sharing that as we move forward through the year again. Thank you.

Operator, Operator

Thank you very much and thank you everyone. That does conclude the conference call for today. We thank you for your participation. Please disconnect your lines. Have a good day everyone.