COMPASS Pathways plc (NASDAQ:CMPS) Q1 2022 Earnings Conference Call May 10, 2022 8:00 AM ET
Steven Schultz – SVP, IR
George Goldsmith – Chairman & CEO
Guy Goodwin – Chief Medical Officer
Mike Falvey – CFO
Conference Call Participants
Josh Schimmer – Evercore ISI
Charles Duncan – Cantor Fitzgerald
Neena Bitritto-Garg – Citi
Ritu Baral – Cowen
Bert Hazlett – BTIG
Francois Brisebois – Oppenheimer
Elaine Kim – Berenberg
Patrick Trucchio – HC Wainwright
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. [Operator Instructions] 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.
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.
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 continue 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 that integrates 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 carrying 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 doctor survey believe psilocybin therapy has potential benefit 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?
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 an immediate benefits. And it’s week three, the primary endpoint had a reduction in the mattress 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 a true drug efficacy.
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 contrast with both lower rates of response and higher rates of relapse in comparable patients treated in the study 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 to suicide in return to the same levels of 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 phase cognitive behavior 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 call 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 experience as adult. The Institute of Psychiatry, Psychology & Neuroscience 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 study.
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.
Thanks, Guy. I will now recap our financial results for the three months ended March 31, 2022. 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 and activities to support operation 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.
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 a 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 fore runner to health system in 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, which is designed to accelerate the time-to-market and facilitating 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?
Thank you very much. [Operator Instructions] We’ll go to our first question on the line from Josh Schimmer with Evercore. Please go ahead.
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.
Hi, Josh. Thank you so much. Guy, will respond to this question, but really appreciate those questions.
Yeah. So just starting with the autism, Josh. This is an experimental medicine study, which is really designed to look at measures which are tapping 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 or the fundamental level. So it’s essentially looking at a series of preclinical question.
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 the feasibility study. And obviously, we will get a sense of what outcome measures are relevant and sensitive to the treatments. And the points of course is then to get a really good power calculation to take this into a randomized controlled study at some point.
I would just add, Josh for your information those on the call that everything that we pursue is based on a very, very strong preclinical signals that we’ve achieved through the most robust program that we’re aware of looking at preclinical activity in across a variety of different disorders. So this is evidence based as we are and we’re moving forward exploring this.
Thank you very much. We’ll go to our next question on the line and it’s from Charles Duncan with our Cantor Fitzgerald. Go ahead.
Hey. Good morning. Thanks for taking my question and congrats on the progress in this last, call it, six months George in the recent meeting. With agency, I respect that you’re not going to be able to talk a lot about that at this point, but I did have a question on next steps regarding COMP360 in TRD. I guess, could you characterize the — maybe not the agency’s response, but your perspective on whether or not it makes sense to pursue development in patients who are taking SSRIs or not? And then, what is an appropriate control arm? Is it consistent with your Phase IIb or what could we anticipate going forward and acknowledging that you really need those meeting minutes to be able to speak definitively?
Hi, Charles. Thank you so much for recognizing what I will not be able to — just to share with you and I love the creativity of your question. So I think where we are right now is very much focusing on — waiting for the response from the FDA. This will be a theme, I’m sure of our discussion today. We don’t want to, in any way second guess or anticipate what they say to us. This is really important.
And so, at this point, we are — we will be disclosing more as we go through the summer and receive the benefits as you suggested. And I think that, the general perspective that we have is, we’re going to follow our data and really go in the kind of direction that we have the most robust data and obviously that is focused on monotherapy, and we have additional data in our adjunct which we’re obviously going to be considering.
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 12 week?
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 trial, 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.
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.
I agree with you 100%. Last quick question, hopping over to PTSD and a follow-on to Josh’s question, will CAPS 5 (ph) be considered as an endpoint or at least exploratory in that study?
We haven’t released that information. We haven’t published the protocols yet, but we will do in due course.
Okay. Very good. Thanks for taking my questions. Look forward to the updates.
Thank you very much. We’ll get to our next question on the line, is from Neena Bitritto-Garg with Citi. Go ahead.
Hey, guys. Thanks for taking my question. Just following on the PTSD line of questioning, If I on one of the posters that was presented last week. I think for the severe TRD patients that, 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.
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 to 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 is started at King’s College in London.
Got it. Thank you.
Thank you very much. We’ll go to our next question on the line from Ritu Baral with Cowen. Go ahead.
Good morning, guys. So, I guess, I’m going to ask — trying to ask the question about the FDA in different way. George and Guy, can I ask what the main discussion topics at least were and more specifically, you don’t have FDA’s final feedback, but what did you guys proposed for this psychological support around the Phase III. I know clinicians and you guys had talked about sort of more streamlining of monitoring potential sort of group sessions, group monitoring through AV and also qualifications of those patient. I’m sorry, those caregivers providing the psychological support. Can you at least walk us through what was proposed and does that align with face your commercial plans? And then I have a follow-up. Thanks.
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 that is 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 afterwards. 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.
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, I guess the psychological support around the PTSD is similar to the entity (ph) 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.
The protocol is not radically different from the Phase IIb program. What we are very interested in and this comes from the General Literature in particularly the publications recently from the Imperial Group is the importance of emotional breakthrough in predicting outcomes. And we are certainly looking at that in detail as George explained from the transcripts of the preparatory studies for patients with TRD. How we extrapolate that to PTSD, it’s obviously a challenge.
We think that the essence of the therapy lies in the drug effect as you know, and the way in which the drug effects facilitates emotional learning in patients who received the drug. And essentially, we will be endeavoring again to ensure that our preparation is essentially for safeguarding patients so being with the patients on the day and also allowing the patient to have a safe experience. And I think we have a lot to learn about how that works in PTSD and the safest way to start is with essentially a very similar protocols what worked in TRD. But we plan to obviously to adopt same learning approach in terms of recording the sessions and looking at kind of what is clearly the best way to do that for patients.
Got it. Thanks for taking the questions.
I might just that 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.
Thank you very much. We’ll go to our next question on the line from the line of Bert Hazlett with BTIG. Go ahead.
Thank you. Thank you for your comments and I won’t ask about the Phase III study design, I promise.
Thank you, Bert.
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 [indiscernible] order of psychopathology at one month of 40% reduction at three months and I’d love for you to comment is to 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. Thank you.
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 Kaye (ph), who is an extremely experienced an internationally renowned researcher was it, he thought the results for several of the patients was 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.
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.
Any brief comments on safety or tolerability of COMP360 psilocybin in the study results.
There were really no red flags detected in that study. And of course, the investigators were extremely cautious initially because of the metabolic state of the patients potentially and therefore there’s quite a lot of interest in finding that this was really — as far as we can tell was well tolerated with acceptable and that’s as encouraging at this point, as you can be on a handful of patients. But nevertheless, that’s the way it start.
Great. Thank you. We look forward to further updates. Thank you very much.
Thank you. We’ll go to our next question on the line from Francois Brisebois with Oppenheimer. Go ahead.
Hi. Thanks for taking the question. So I was just wondering, you mentioned the survey late last year and 50 based on the data to be 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?
No. Frank, hi. Guy, here. I don’t believe so. I mean we were essentially interested in the people who did want to use it I guess, but you’re right that we should certainly attend to that the group who don’t, but we kind of attributed that to lack of knowledge and another surveys that’s often seem to be the case that patients — the rather the clinicians and indeed the general public when they say they are not interested usually because they don’t really know very much about it.
And I think this is our 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 this coming year.
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, may be some variation between disease status between patients, but any thoughts on the standardization of the process?
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.
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 and 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 with this experience and indeed that’s what our digital team is working on at the moment.
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 it could be interesting?
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, very much finally, in December, nearly the end of the year, the ACNP meeting where we expect again to present new data on mechanism.
Great. Thank you very much.
Thank you. We got next question on the line, it is from Esther Hong with Berenberg. Go ahead h
Hi. Thanks for taking our questions. This is Elaine Kim on for Esther. Our first question is, how similar is anorexia security in terms of patients responding to treatment? For example even concerns versus depressive symptoms and we have a follow-up question.
I think we don’t really see them as really tapping 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 introspected (ph) 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 the symptom level but 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 a 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 there expressed, of course, in very different way.
Thank you. That makes a lot sound. Our follow-up question is, in the same [indiscernible] study, there were statistically significant reductions in any concerns at month three. So although the study is small, does this add support to psilocybin durability of effect?
It may do, I think, we obviously are cautious that this is an uncontrolled study it’s open label, and there is no control comparison group. So the skeptic and be skeptical, but we are interested because of the in-tractability of the traditionally regarded as an intractable condition. We’re obviously very interested in those numbers, but also in the impression of the experienced clinician like Walt Kaye (ph) who actually describe the patients in — he was very struck by the changes. So that kind of thing is important to our planning as well.
Okay. Thank you very much.
Thank you. We’ll go to our next question on the line, is from Patrick Trucchio with HC Wainwright. Go ahead.
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 [indiscernible] of PTSD, autism potentially anorexia. How should we think about how broad this program can become? How many indications can you realistically explore it and how do we view it, just in the context of the discovery efforts at COMPASS and just in terms of kind of next-generation compounds and how those would then factor into kind of your development plans?
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 are 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 our — what we focus on. And we started with TRD based on our conversations with payers and 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 kind of 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.
Yeah. That’s really helpful. And just one clarification on the PTSD program. So following this Phase II trial with the intention be to move directly into a pivotal Phase III program or would you need to run another Phase II?
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. 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.
Got it. Yeah. Okay. That’s helpful. Thank you so much.
Thank you. Look forward to seeing you soon this conference.
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.
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.
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.