COMPASS Pathways plc (CMPS) Q4 2021 Earnings Report, Transcript and Summary

00:04 Good day, ladies and gentlemen, and welcome to the COMPASS Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] As a reminder, this conference call is being recorded. 00:23 I would now like to introduce your host for today's conference call, Steven Schultz. You may begin.

00:39 [Starts Abruptly] For joining us today for our fourth quarter and full year 2021 results conference call. We hope you've had a chance to view the press releases issued earlier today covering our 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, 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. 1:17 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 annual report on Form 10-K filed with the U.S. Securities and Exchange Commission and in subsequent filings made by COMPASS with the SEC. 02:04 Additionally, these forward-looking statements represent our views only as of today and should not be relied upon as representing our views at any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements. 02:23 I'll now hand the call over to our Chairman and CEO, George Goldsmith.

02:28 Thank you, Steve and welcome everyone. Let me begin by welcoming Mike Falvey to his first COMPASS quarterly results call. Mike joined our team in December and has a track record in building strong financial teams and valuable experience in launching and commercializing products. This experience will be important as we work to bring our COMP360 psilocybin therapy through clinical trials, regulatory approval and ultimately to patient access as a reimbursed therapy. 02:57 I will begin today's call with a business update on our recent progress. Guy, will talk about additional data from the Phase 2b study and our open label study with SSRIs, and Mike will provide a financial review. We will then open the call to questions. 3:14 In the fourth quarter of 2021, COMPASS Pathways made significant progress toward our goal of accelerating patient access to evidence-based innovation in mental health, with the successful completion of our Phase 2b trial with COMP360 psilocybin therapy in treatment-resistant depression or TRD. This trial is the largest randomized controlled psilocybin therapy study ever completed and it showed rapid and sustained response after just a single 25-milligram dose of COMP360 psilocybin with psychological support. The trial provided COMPASS with the target dose for our planned Phase III program and a wealth of information to guide us in finalizing our trial design which will be reviewed with the FDA and our upcoming end of Phase II meeting, which has been scheduled for late April. 04:05 In the trial, in addition to looking at the safety and efficacy of COMP360 psilocybin therapy we examined a number of exploratory measures recognized as being important to recovery for patients with TRD and we're pleased to see positive data. In December, we also announced results from our open label study of COMP360 psilocybin therapy in TRD patients who remained on our SSRI antidepressants, unlike those in our Phase 2b trial in which patients were withdrawn from their anti-depressants. The study results demonstrated the COMP360 has potential as an adjunctive therapy as well as a monotherapy providing greater flexibility to patients. We believe this increase in patient choice could increase the number of prescribers and patients who we consider this therapy option. 04:58 The number of patients who participated in either the Phase 2b or the open label study entered a 12-month long-term follow-up study. We will be reporting the results of this study later in the year and expect additional insight on the durability of a single COMP360 psilocybin dose with psychological support. Guy will walk through these data in more detail in a moment. 05:22 Beyond TRD, we commenced the COMPASS sponsored Phase 2 study of COMP360 psilocybin therapy for the treatment of post-traumatic stress disorder or PTSD, another indication with significant unmet need and representing an urgent problem with few current therapeutic options. We expect to expand into a further indication over the course of this year. These COMPASS sponsored programs are in addition to the ongoing investigator-initiated studies in a variety of therapeutic areas, including anorexia nervosa, bipolar depression and severely resistant TRD. 06:01 We continue to expand our leadership in preclinical research and exploring new psychedelic compounds through our discovery center and through our recently acquired intellectual property portfolio covering a variety of psychedelic and in pathogenic substances. This IP was developed together with inventor, Dr. Matthias Grill, who will be working with COMPASS on an exclusive research project to advance new product candidates. 06:27 With that, let me now hand over to Guy.

06:29 Thank you, George and good day all. Late last year, we presented the topline results from the COMP360 TRD study. Since then, we have generated additional analysis, the primary and secondary endpoints, but validated the topline findings. I will talk briefly through these today. We will be submitting our trial data for publication in a peer-reviewed journal this year. 06:59 In our analysis of exploratory measures we observe consistent improvements in measures of anxiety, positive and negative affect, quality of life, daily functioning, cognition and self-reported depression. We believe such improvements underline the comprehensive nature of the response to COMP360 psilocybin therapy. 07:22 Remember, a quarter of the patients in the 25 milligram group maintained their symptomatic response at 12 weeks after a single administration with no other anti-depressant medication. This finding is unprecedented for this patient population. Furthermore, a post talk analysis of sustained respondents showed clinically meaningful improvements in measures such as [indiscernible] self-report scale and quality of life, which underline that patients returned to levels typical of the healthy population and remain there for the length of the trial. 08:01 Additionally, on the positive and negative affect schedule or PANAS scale on the day after COMP360 administration and the questionnaires final administration at week 3. Patients in the 25 milligram group had a higher increase in positive affect, including feeling interested, excited and strong. These improvements in positive mood could provide important differentiation for COMP360 when eventually compared directly with other available treatments. These findings are very encouraging and will be included in the end of Phase 2 meeting with the FDA in April. 08:42 Additional safety data were also generated. As noted in the top line data, COMP360 psilocybin was generally well tolerated. Further analysis showed that there were no concerns with vital sign, ECG or clinical laboratory data in any of the treatment groups. The majority of treatment-emergent adverse events occurring on the day of COMP360 administration resolved on the same day or the day after. 09:14 Suicidal ideation, suicidal behavior and intentional self-injury are always a concern in patients with clinical depression. Their occurrence in our Phase II trial was determined that each time the patient we’ve seen with the Columbia-Suicide Severity Rating Scale. Suicidal ideation was observed in all treatment groups within a range of 5% to 7%, which is comparable with other studies of treatment-resistant patients. 09:45 Independently repeated remote rating by a blinded rater showed that levels of suicidality on item 10 of the MADRS scale were lower during the study than baseline with no differences between treatment groups. We do not believe that there is a causal relationship between the serious adverse events of suicidal ideation, suicidal behavior and self-injury, and administration of COMP360 psilocybin therapy. 10:14 Unfortunately these events occur unpredictably and are to be expected in this patient population. The timing and circumstances of other adverse events in the trial demonstrated the COMP360 psilocybin therapy was generally well tolerated. As George noted, we also announced in December, the results from our exploratory study a COMP360 psilocybin therapy in conjunction with SSRI use. This was a single-arm open label study of 19 patients who received the single dose of 25 milligram COMP360 psilocybin with psychological support. 10:57 They show comparable average treatment outcomes to patients in our Phase 2b trial where patients were withdrawn from their SSRI prior to COMP360 psilocybin therapy. These results challenge the widely-held belief that the use of SSRI medication could interfere with psilocybin therapeutic effect. For some patients with treatment resistant depression withdrawal from SSRIs is a difficult step even though by definition treatment resistant means that those anti-depressant are not working. These findings and placebo controlled results from a healthy volunteer study published by others last year, provides the basis for our belief that COMP360 psilocybin therapy could be an adjunctive treatment to SSRI anti-depressants, as well as a monotherapy. 11:53 This will have the effect of increasing the number of patients potentially eligible for treatment with COMP360 and will offer patients greater choice in how they access treatment with COMP360. We are now looking forward to meeting with the FDA to review these data and to finalize our plans for the Phase 3 program, which we expect to commence in the second half of this year. We will be discussing this with the FDA in our upcoming meeting. 12:23 Let me now hand over to Mike for the financial review. Mike?

12:29 Thanks, Guy. COMPASS continues to maintain a strong financial position with cash and cash equivalents of $273.2 million at December 31, 2021 compared with $190.3 million at December 31, 2020, with these resources, we expect to be able to fund our operations into 2024. 12:51 I will now recap our financial results for the year ended and the three months ended December 31, 2021. Net loss for the full year 2021 was $71.7 million, or $1.79 per share compared with a net loss of $60.4 million, or $3.55 per share during the same period in 2020. These results include non-cash share-based compensation of $8.6 million in 2021 and $18 million in 2020. 13:24 Net loss for the three months ended December 31, 2021 was $25.7 million, or $0.61 per share, compared with $18.8 million or $0.52 per share during the same period in 2020. These results include non-cash share-based compensation of $2.8 million in 2021 and $1.4 million in 2020. 13:47 Research and development expenses were $44 million for the full year 2021 compared with $23.4 million during the same period in 2020. The increase was due to an increase of $16.1 million, $6 million and $0.4 million in development costs, personnel expenses and other expenses, respectively. Partially offset by a reduction of $1.8 million in non-cash share-based compensation, as COMPASS progresses, it's COMP360 psilocybin therapy and TRD and continues to explore additional indications and therapeutic approaches. 14:26 For the three months ended December 31, 2021, R&D expenses were $13.6 million compared with $4.5 million during the same period in 2020. The increase was due to an increase of $7.3 million, $2.1 million and $1 million in the development costs, personnel expenses and non-cash share-based compensation, respectively, partially offset by a reduction of $1.3 million in other R&D expenses. 14:54 G&A expenses were $39.1 million in the full year 2021 compared to $28 million during the same period in 2020. The increase was due to an increase of $7.9 million, $1.8 million and $9 million in personnel expenses, legal and professional fees, and facilities and other expenses, respectively, partially offset by a reduction of $7.6 million in non-cash share-based compensation expenses. 15:23 For the three months ended December 31, 2021, G&A expenses were $14.7 million compared with $7 million during the same period in 2020. This increase was due to an increase of $2.2 million, $0.5 million, $1 million and $4 million in personnel expenses, non-cash share-based compensation, legal and professional fees, and facilities in other expenses, respectively. The sequential increases in our operating expenses over the last few quarters reflect continued support of our development programs and staffing increases to build an organization to support our growth and our operations as a public company. We expect these types of increases to continue over the next couple of quarters, as we prepare for our Phase 3 trial in TRD. When our trial design is finalized and communicated, we intend to provide more detailed financial guidance for the remainder of the year. 16:18 Thank you and I'll now turn the call back to George.

16:21 Thank you, Mike. Again, we are very pleased with our progress in the last year and even more confident in our ability to provide new options for patients to help them lead happier and healthier lives. Looking forward, this year, we are excited to add a new chapter to a record of achievement. We have an active year of milestones ahead across numerous programs beginning with the advancement into Phase 3 for COMP360 psilocybin therapy for TRD. 16:51 In addition, we expect to complete the Phase 2b long-term follow-up study around the middle of the year. We expect to launch an additional COMP360 clinical development program beyond the ongoing TRD and PTSD programs. We aim to publish a detailed Phase 2 COMP360 clinical data in a major peer-reviewed medical journal and at a number of medical meetings. We expect to generate innovation around our COMP360 therapy and build our IP portfolio with additional patent grants. 17:28 We will continue to advance COMP360 payer partnerships in anticipation of commercial launch and we expect to forward strategic relationships and collaborations, pursue our data and technology strategy and further enhance our scalable therapist training platform that can support the significant global expansion of treatment sites that will participate in the Phase 3 trial program. 17:54 Overall, the Phase 2b data package, our impending start of the Phase 3 program and the advancement of our earlier stage pipeline will strengthen the significant leadership position we have established in this area of science. With broad reimbursed patient access as our North Star (ph) and supported by a strong operational foundation and the financial resources to fuel our continued progress. We are making encouraging progress toward our goal of building a personalized, predictive and preventative model for transforming mental health care. We believe this has the potential to change people's lives for the better for generations to come. 18:33 Thank you for your time today. We will now open the line for questions. Operator?

18:41 [Operator Instructions] Our first question or comment comes from the line of Ritu Baral from Cowen. Your line is open.

19:08 Good morning, guys. Thanks for taking the question. I wanted to ask about basically the proposed Phase III design that George, you mentioned you're going to sit with FDA in late April sounds like you probably have the briefing book together and at least the proposed design. Can you -- maybe just bracket for us what we should be thinking in terms of patient numbers, thoughts about what control will be, will it still be sort of one milligram or any requirements for placebo and also the number of sites, especially given the trial prep and insight training that's important for this trial that your average run of the no entity studies, when do you consider?

19:56 Hi, Ritu. Thank you so much for your question. I'm going to start by saying that probably across a number of these questions, I'll be responding by saying until we review the Phase 3 program with the FDA and get their guidance and support, we won't be making comments on specific aspects of it. No, that because we are who we are, we are addressing all of the outstanding questions sort of emerged in our designs, that will be taken to the FDA and work on resolving those and getting to a point where we have a well-articulated plan that we'll be sharing as soon as we complete our interactions with the FDA during the first half of this year. 20:39 With regard to the number of sites, we will have a significant uptick in these and have been preparing all of our therapist training approaches and so forth for that. Again, we view Phase 3 given our very promising results in Phase II as a path to bringing this to patients as quickly as possible and therefore, we will be working with more centers, more therapists, et cetera. We also are strongly developing our technology support to accelerate this process of rollout of therapy and the therapist training.

21:18 Got it.

21:18 I'm sorry, I couldn't tell you more, but I will be telling you more later.

21:23 Got it. Looking forward to the May update, once you guys have been meeting minutes in pan. A quick follow-up just on the PTSD trial, can you maybe guide, like, take us through the just the high level of that trial design, even though it is investigator run? And then George, how do you see the evolution of the space maybe compare and contrast the right patient that the clinical benefit versus MDMA PTSD program?

21:55 Sure. Guy, I'll turn it over to you, so medical question. Guy, are you on mute? Okay. I will -- Guy? We've been having some technical difficulty with Guy with his connection. So what we're really looking at here with the PTSD, this is a first step to look at what psilocybin can do. We have the interesting preclinical data on this and we believe that, that gives us some reason to believe that this will be effective in work. So I think this is what we're going to be pursuing in this trial. And our work and that's going to be announced further as we complete the announcement of our sites for that trial. 22:55 In terms of -- could you remind me, sorry, Ritu.

22:59 Sure. Just the -- compare and contrast the opportunity for psilocybin and PTSD versus MDMA.

23:09 So I think what we see with the MDMA approach that it's very significant amounts of psychotherapy and we're being informing our program without, but some of the things we're looking at as whether there can be a shift in the therapy provision aspects of this using a different medicine and psilocybin is opposed to that. So we're going to be looking at understanding the therapy provision and we're working with leaders in PTSD therapy. And we'll be really looking at how we might optimize this utilizing specific qualities of psilocybin in terms of its impact. So that's work underway and we'll be sharing much more about this program later on in the year.

23:58 Great. Thanks for it. Thanks for the time.

24:02 And my apologies, I've just heard that Gay is having very technical difficulty. So, he will not be able to join the call.

24:11 No problem. I'll follow up.

24:14 Thank you very much.

24:14 Thank you. Our next question or comment comes from the line of Charles Duncan from Cantor Fitzgerald. Your line is open.

24:21 Hi, Charles.

24:23 Yes. Good morning. Hi, George and team. Thanks for taking the question. Congrats and I thought a very good year progress last year. I had a couple of follow-ups to Ritu’s question. I am respectful that you won't be able to provide a lot of details, until you meet with the agency, makes lot of sense. But one question that I had was, when you meet with the agency, will you be discussing the concomitant anti-depressant medicines, or are you going to stick with the monotherapy versus the adjunctive therapy for the Phase 3 program.

25:04 I'm sorry. We will be sticking with the -- so we will be – can you repeat the question, sorry.

25:13 Yes. So [Multiple Speakers] monotherapy paradigm.

25:18 So we will certainly bring the monotherapy paradigm to them as well as the information coming from the adjunctive approach which we think is a very, very promising set of early signals. And so we will be discussing both with them obviously. Well, perhaps not obviously, but we will in service of patients.

25:42 Okay. So the Phase 3 program is intended the monotherapy program or possibly broader program to include adjunctive therapy SSRI.

25:56 Possibly a broader program again to be discussed.

26:01 Okay. Very good. And then with regard to the 12 month longer term follow up study that you mentioned. I'm not sure, if I heard this correctly. So if you could just clarify, was an additional dose available to patients if needed and will you be evaluating durability based on that one as well?

26:24 Yes. This is predominantly looking at durability trials, because one of the things, which has just been on answered since the beginning, which is why we designed the Phase 2 trial that we did, was how long does this last for whom and we don't want to be providing more suicide and therapy than as required. So we really first and foremost, want to understand durability. We saw that in 25% of our 25-milligram dose at three months and obviously, we want to see how long does that continue for which patients and we can sort of understanding carefully, how do we figure out who the responders will be, what dosing went look like et cetera. So this is purely the long-term those who follow those patients without any additional dosing and to look at how long did the single dose work for whom and one of the characteristics of those patients, we can help inform subsequent trials and commercial use.

27:18 Okay. Very good, George. And last question is perhaps for Mike, but you'll probably detect it's kind of a back factor a way of getting more information on the trial designs and that is regarding the cash and I think you mentioned two year or he mentioned funding through or into 2024. And I guess I'm wondering what are the assumptions behind that? Are you planning on one or two trials in the program for the Phase 3 program for COMP360 and TRD?

28:01 Mike, do you want to take that.

28:01 Sure. So first, thank you for walking your back door question through the front door. And so -- the cash position that we have at the end of 2021 was $273 million and we believe that does carry us through 2022, 2023 and into 2024. And in putting that together, we contemplated fully funding the Phase III study over that period, not knowing the exact definition of that program. We're pretty confident that whatever the final design is, we can prosecute that trial together with the Phase II trial and other activities associated with being a public company. So we're pretty confident in that runway and in this kind of a financial market that kind of financial stability, we believe it's a real strategic asset. So we're going to continue to protect that because we think that's in the end, really helps patients.

29:11 Yeah, absolutely. Yeah. Thanks for taking the question.

29:15 You can see we’ve been resolute in our Phase 3 questions.

29:20 Yeah. That's right. Well, we want you to get the feedback from the agency and we'll talk soon.

29:30 Thank you. Next question.

29:36 Our next question or comment comes from the line of Neena Bitritto-Garg from Citi. Your line is open.

29:42 Hey, guys. Thanks for taking my question. Another question on a Phase III here. So I know you mentioned earlier that you are planning to expand to significantly more sites and, in the Phase 2b and I guess maybe if you can tell us a little bit about how you're planning to ensure that you do have the right patients involved given, given the expansion in the number of sites and anything you can comment on at this point on how you plan to kind of manage the placebo response if there's anything maybe different than what you did in the Phase 3? Thanks.

30:22 So I'll take your second question first. We are very, very happy with how the Phase 2b played out and obviously, we'll be taking those results to the FDA and discussing options for the Phase 3. And so until we do that, we really will be just kind of keeping the Phase III designs to ourselves until we understand what their feedback is. The second piece that I think is important here is that everything we're doing is looking at how do we rapidly and most rapidly get this into the hands of patients as a reimbursed model of care. And so when we are developing our work, we are doing a great deal of effort to make sure that our screening is appropriate that we have the right patients that we have this homogeneous group of patients as possible that work is played out very successfully in our Phase 2b trial. We will be taking that forward and when we expand sites, we will be taking all of that learning into our Phase 3 program. And we have done a tremendous amount of work identifying the Phase III infrastructure, which will be significantly larger than our Phase II infrastructure was. And again all these pieces will come together midyear with an intention as we've disclosed to start Phase 3 in the second half of 2022.

31:48 Got it. Thank you.

31:53 Thank you. Our next question or comment comes from the line of Patrick Trucchio from HC Wainwright. Your line is open.

32:01 Hi. Good morning.

32:03 Hi, Patrick.

32:05 Sorry, this is Jason speaking for Patrick. Thanks for taking my question. Hi. How are you doing? And so I just kind of just -- I have one more question in terms of your Phase III and just kind of got a little bit more on the IP. So can you just give us a little bit on the how the potential for [indiscernible] treatments or groups therapies could become part of the Phase 3 program and what if any feedback has been received from regulators on its potential front and possibly also discuss on digital on the digital therapeutic fronts and how digital therapeutics could be part of the Phase 3 program?

32:43 So in terms of simultaneous administration that's really independent of the designs so how sites will administer that is not part of the plan right now. So or not being discussed the design will be discussed, but obviously the FDA has enabled that in the past with our study it Aquilino Cancer Center. So again, that will tend to be site-specific conversation. 33:12 Next with regard to the digital aspects both the patients and the therapists have digital platforms to support them through the trial. The therapists are focus on training and adherence and receiving shares feedback on the trials. What's important is that every single session is recorded and that provides a wealth of information as we look at understanding potential behavioral markers, changes in person language their narrative et cetera. So we're doing a tremendous amount of natural language processing et cetera, on those creating a different set of exploratory endpoints so digital endpoints. 33:56 In addition, we will be providing patient platform called My Pathfinder which will be an app that will enable patients to help navigate them through the trial, provide educational material and support material to them. So those are core parts of the Phase 3 program that's being developed, both IFRS side and on the patient. You bet.

34:21 Okay. Great. Thank you for the additional color. And I guess, kind of just the last question is, can you discuss on the latest on for the IP for COMP360 and kind of like the level of confidence that COMP360 therapy should have a robust long-term protection?

34:36 We are very confident in our IP position which get stronger over time. There have been a prior challenge and that was actually over turned on merit. So we're not commenting on pending legal matters, but as you asked about our confidence, it is unwavering and strong.

35:00 All right. Thank you so much and congrats on the fantastic year. Thank you.

35:07 We really appreciate it. Thanks.

35:10 Thank you. Our next question or comment comes from the line of Josh Schimmer from Evercore. Your line is open.

35:17 Hi. Thanks so much for taking the questions. Just a question about question about trial protocols and maybe in the Phase 2 given the potentially severe and refractory nature of the patients and being enrolled in the risk for potential suicide ideation. What are the protocols in place to detect and intervene relation to patient windup deteriorating in there and the mental health status? Thank you.

35:42 Thanks. This is a really important question and again, our focus on patient safety is very high. At the time of every interaction with the site in Phase 2b, as well as in the Phase 3 program, we assess suicidal ideation and any other aspects of that with the patient directly and obviously there is an escalation process to us it should anything happen. So I think we are putting those same processes in place and really, to your point, this is a very, very difficult population people struggle a great deal going into as we revealed into our Phase 2b trial nearly two-thirds of people had prior history of suicidal ideation side where it goes with very significant distress of people have with treatment since its’ depression. And of course, there were no suicides in Phase 2b there is just the ideation and some early behaviors that we're in non-serious and quite later after the dosing.

36:53 Are there specific algorithms for how to manage those patients or is it left to the discretion of the treating physician?

37:02 It's a good question and right now, what we're doing is obviously the sites are trained and how to handle that, I'm not aware of a special protocol other than their own clinical judgment. Again, we can follow up with Guy.

37:18 Thanks very much.

37:21 Thank you. Our next question or comment comes from the line of Esther Hong from Berenberg. Your line is open.

37:29 Hi. Good morning. Thanks for taking my question. So MAPS is expected to launch the first psychedelic for commercial use MDMA for PTSD. I was wondering what if anything could COMP360 leverage from that commercial launch? Thanks.

37:48 Really great question, Esther and thank you for it. I think, obviously there are similarities in the structure of the therapy around the medicines, the therapy is different because of the different nature that having sites and facilities and trained therapists makes a lot of benefit for both program. So obviously, we are working closely to make sure the trainers -- people who've been trained in MAPS therapy can also be trained in. Our therapy approach, so I think having more capability, more sites, all of that does nothing but enhance our ability to reach patients faster.

38:32 Got it. Thank you.

38:33 Thank you. Our next question or comment comes from the line of Bert Hazlett from BTIG. Your line is open.

38:42 Yes. Good morning and thank you for taking my question. Hi, George. Thank you very much. It was really intriguing to hear some of your focus on the additional characteristics of COMP360 in the TRD trial, you've mentioned these before, but obviously the durability of the single dose is important, but as you consider characteristics -- additional characteristics that you saw in the study like effects on anxiety on positive FX, quality of life in cognition and others are the things that rise to the four -- characteristics that rise to the four that you think would be important as you look forward either in Phase 3 or in your discussions with the agency? Thank you.

39:34 Absolutely. A great question and I think that what really rose that before was for us was an addition to the significant relief and symptoms for many patients at the point of our mission. There are positive affect, and most importantly their quality of life for those who responded on 25-milligram there are levels of quality of life approach weeks was equivalent to what a normal quote on quote normal person without any depression would experience. So our proposition here is a completely different model, not just of less symptoms or fewer symptoms, but actually a greater connection to one's life with a broad proposition of improving quality of life and reducing total quality -- total cost of care. So improving quality, reducing costs, critically important for this patient population for health systems and obviously a huge patient benefit. So that's the thing that's been most interesting in addition to the very, very strong signals of durability for patients on the 25-milligram dose. And obviously, we're working to increase the number of patients who do enter remission and stay on remission, and also looking at all the other aspects that we learned through the trial as we go into our Phase 3.

40:55 Thank you. We look forward to the additional data and the long-term follow-up data as well. Thank you.

41:02 Super.

41:03 Thank you. Our next question or comment comes from the line of Francois Brisebois from Oppenheimer. Your line is open.

41:10 All right. Thanks for taking the questions. Obviously, a lot's been kind of asked and you guys have discussed what you're going to talk about on the Phase 3 details, but I was just wondering in the Phase 2b, can you just remind us how standardize the psychological support was in terms of preparing the patients? And then maybe the integration part as well was this kind of the same amount of sessions for each patient or any color on that would be helpful?

41:40 Sure. So there was a great deal -- obviously, we focused a great deal on the uniformity of this across the trial, but above everything it's patient safety and a focus on patient experience. So occasionally, there may have been a bit more support for patients provided again at -- with patient safety and focus first and foremost. However, everything that we're doing is really looking at providing a very consistent form of support for patients. So patients can rely on a model that can be delivered, whether it is in the Netherlands or anywhere in Europe, the U.S. et cetera. It will be a consistent level of support that they perceive. So the methods are the same and obviously clinical judgment is used, but we saw a tremendous similarity across the trial and we are looking obviously at the adherence to the model as part of our work in preparing for Phase III in the next level of training but we are high and what we saw.

42:44 Great. If I could just quickly follow up, this is not, not too much backdoor. But just kind of a follow-up on Charles's question about when you see monotherapy, and then potentially combo. And the answer was, there is a possibility, is there also a possibility for repeat dosing or that we just don't touch on at all?

43:08 Obviously, we're looking at all different aspects to enable people to get well and stay well and obviously, looking at redosing is one of those dimensions, and we'll be reporting out on the final design when it's agreed.

43:22 Okay, great. And then just, sorry, lastly, in terms of the conferences where you might present this data that you mentioned, any specific conferences that you would like to highlight?

43:34 The APA, A&CP towards the end of the year and I think those are the two, there will be some others, but those are the two that are top of mind right now.

43:45 Great. Thank you so much.

43:49 Thank you. Just to add, we are – obviously, the results will be published in a leading Journal this year as well from our Phase 2b study.

44:00 Thank you. Our next question or comment comes from the line of Kyle Kim from Canaccord Genuity. Your line is open.

44:08 Kyle speaking for Sumant. What is your conceptual -- Hello, what is your conceptual take on some of the psilocybin (ph) in the comparative pipelines? And comparatively, what is your advantage, what your advantage mainly be around your potential to be a first mover or what would it be something entirely?

44:30 So a few things, one is, so we chose psilocybin because of our focus on patients and you're getting things to patients as quickly as possible. In this program enabled us to do just that. At the same time, innovation never stops here at COMPASS. We have our work with our discovery center, our relationship with Dr. Guy, we announced and are looking at a very robust program at shorter acting substances, substances that have different receptor occupancy, et cetera. The short answer is we really don't know if shorter acting actually will produce the level of benefit that we've demonstrated in Phase 2b. So I think this is really important that we need to generate the data we realize there's a lot of enthusiasm about shorter acting but the enthusiasm is greatly outpacing the evidence available. So we're going into this area as we do, and we do that with a great deal of focus on developing robust evidence that we can then move forward into clinical programs, and we have a very robust pipeline looking at shorter acting and other ways of designing these to produce perhaps less anxiety et cetera then existing. So we're very focused on meeting the preclinical and discovery work in this area as well as being the leader in our clinical development.

45:59 Thank you.

46:01 Thank you. I'm showing no additional questions in the queue at this time. I'd like to turn the call back over to management for any closing remarks.

46:10 We greatly appreciate all of your support and interest. Obviously, all eyes are focused on our Phase 3 program which as is our history, we will develop in a robust way reflecting our values to be compassionate, bold, rigorous and inclusive in the design of our trials that work. So we're looking forward to that. And we also will be sharing increased progress on other areas of our business, as we progress this year and it will be an exciting milestone filled year for COMPASS once again. Thank you.

46:45 Ladies and gentlemen, thank you for participating in today's conference. This concludes the program. You may now disconnect. Everyone have a wonderful day.