COMPASS Pathways plc (CMPS) Q4 2021 Earnings Call Transcript

COMPASS Pathways plc (CMPS -1.29%)
Q4 2021 Earnings Call
Feb 24, 2022, 8:00 a.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good day, ladies and gentlemen, and welcome to the COMPASS conference call. [Operator instructions] As a reminder, this conference call is being recorded. I would now like to introduce your host for today's conference call, Stephen Schultz. You may begin.

Stephen Schultz -- Senior Vice President, Investor Relations

For joining us today for our fourth quarter and full year 2021 results conference call. We hope you've had a chance to review the press release issued earlier today covering our results. Again, my name is Steve Schultz, senior vice president of investor relations of 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 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 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. 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 statement.

I'll now hand the call over to our chairman and CEO, George Goldsmith.

George Goldsmith -- Chairman and Chief Executive Officer

Thank you, Steve, and welcome, everyone. Let me begin by welcoming Mike Falvey to his first conference 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.

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. 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 of 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 confidence with a target dose for our planned Phase 3 program and a wealth of information to guide us in finalizing our trial design, which will be reviewed with the FDA in our upcoming end of Phase 2 meeting, which has been scheduled for late April. 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 their SSRI antidepressants, unlike those in our Phase 2b trial, in which patients were withdrawn from their antidepressants.

The study results demonstrated that 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 would consider this therapy option. 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. Beyond TRD, we commenced a 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.

We continue to expand our leadership in preclinical research, 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. With that, let me now hand over to Guy.

Guy Goodwin -- Chief Medical Officer

Thank you, George, and good day all. Late last year, we presented the top-line results from the COMP360 TRD study. Since then, we have generated additional analyses of primary and secondary endpoints that validated the top-line findings. I will talk briefly through these today.

We will be submitting our trial data for publication in a peer-reviewed journal this year. In our analysis of exploratory measures, we observed consistent improvement 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. 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 antidepressant medication.

This finding is unprecedented for this patient population. Furthermore, a post-hoc analysis of sustained responders showed clinically meaningful improvements in measures, such as the QIDS self-report scale and quality of life, which underline that patients return to levels typical of the healthy population and remain there for the length of the trial. Additionally, on the positive and negative affect schedule, or PANAS scale, on the day after COMP360 administration and at 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. 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 signs, 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. Suicidal ideation, suicidal behavior and intentional self-injury are always of concern in patients with clinical depression. Their occurrence in our Phase 2 trial was determined that each time the patient was 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.

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 at 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. Unfortunately, these events occur unpredictably and are to be expected in this patient population. The timing and circumstance of other adverse events in the trial demonstrated that COMP360 psilocybin therapy was generally well tolerated.

As George noted, we also announced in December the results from our exploratory study of COMP360 psilocybin therapy in conjunction with SSRI use. This was a single-arm open-label study of 19 patients, who received a single dose of 25-milligram COMP360 psilocybin with psychological support. They showed comparable average treatment outcomes to patients in our Phase 2b trial, where patients were withdrawn from their SSRI prior to COMP360 psilocybin in therapy. These results challenged the widely held belief that the use of SSRI medication could interfere with psilocybin's therapeutic effect.

For some patients with treatment-resistant depression, withdrawal from SSRIs is a difficult step, even though by definition, treatment resistance means that those antidepressants are not working. These findings and placebo-controlled results from a healthy volunteer study published by others last year, provide the basis for our belief that COMP360 psilocybin therapy could be an adjunctive treatment to SSRI antidepressants as well as a monotherapy. 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. Let me now hand over to Mike for the financial review. Mike?

Mike Falvey -- Chief Financial Officer

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. 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. 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.

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 its COMP360 psilocybin therapy in TRD and continues to explore additional indications and therapeutic approaches. 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 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. G&A expenses were $39.1 million in the full year 2021 compared with $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. For the three months ended December 31, 2021, and 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, $0.5 million, $1 million and $4 million in personnel expenses, non-cash share-based compensation, legal and professional fees and facilities and other expenses, respectively. The sequential increases in our operating expenses over the last few quarters reflects 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.

Thank you, and I'll now turn the call back to George.

George Goldsmith -- Chairman and Chief Executive Officer

Thank you, Mike. Again, we are very pleased with our progress over 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.

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 had a number of medical meetings. We expect to generate innovation around our COMP360 therapy and build our IP portfolio with additional patent grants.

We will continue to advance COMP360 payer partnerships in anticipation of commercial launch, and we expect to forge 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. Overall, the Phase 2b data package or 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 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 healthcare. We believe this 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?

Questions & Answers:

Operator

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

Ritu Baral -- Cowen and Company -- Analyst

Good morning, guys. Thanks for taking the question. I wanted to ask about basically the proposed Phase 3 design that, George, you mentioned you're going to sit with FDA in late April. It sounds like you probably have the briefing book together and at least a proposed design.

Can you maybe just bracket for us what we should be thinking in terms of patient number, thoughts about what control will be? Will it still be sort of 1 milligram or any requirements for placebo? And also the number of sites, especially given the trial prep and site training that's important for this trial that your average run of the no entity study, wouldn't be to consider.

George Goldsmith -- Chairman and Chief Executive Officer

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. Know that because we are who we are, we are addressing all of the outstanding questions that have emerged in our designs that we'll be taking 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.

With regard to the number of sites, we will have a significant uptick in these and have been preparing all of our therapists training approaches and so forth for that Again, we view Phase 3, given our very promising results in Phase 2, as a path to bringing this to patients as quickly as possible. And therefore, we'll be working with more centers, more therapists, etc. We also are strongly developing our technology support to accelerate this process or rollout of therapy and therapist training.

Ritu Baral -- Cowen and Company -- Analyst

Got it. And then...

George Goldsmith -- Chairman and Chief Executive Officer

Sorry, I couldn't tell you more, but I will be telling you more later.

Ritu Baral -- Cowen and Company -- Analyst

Got it. Looking forward to the May update once you guys have the meeting minutes in hand. A quick follow-up just on the PTSD trial. Can you maybe guide or take us through the just high level of that trial design, even though it is in investigative 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.

George Goldsmith -- Chairman and Chief Executive Officer

Sure. Guy, I'll turn that over to you. It's a medical question. Guy, are you on mute? OK.

I will -- Guy? We've been having some technical difficulty with Guy, his connection. So what we're really looking at here with the PTSD is this is a first step to look at what psilocybin can do. We have interesting preclinical data on this, and we believe that, that gives us some reason to believe that this will be effective at 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.

In terms of -- could you remind me sorry, Ritu, it's been...

Ritu Baral -- Cowen and Company -- Analyst

Oh, sure. Just the -- compare and contrast the opportunity for psilocybin and PTSD versus MDMA?

George Goldsmith -- Chairman and Chief Executive Officer

So I think what we see with the MDMA approach is that it's very significant amounts of psychotherapy, and we're being informing our program with that. But some of the things we're looking at is whether there can be a shift in the therapy provision aspects of this using a different medicine and psilocybin as opposed to that. So we're going to be looking at understanding the therapy provision. 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. And my apologies, I've just heard that Guy is having very significant difficulty, said he will not be able to join the call.

Ritu Baral -- Cowen and Company -- Analyst

No problem, I will follow up.

George Goldsmith -- Chairman and Chief Executive Officer

Thank you very much.

Operator

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

Charles Duncan -- Cantor Fitzgerald -- Analyst

Yes, good morning. 

George Goldsmith -- Chairman and Chief Executive Officer

Hi, Charles.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Hi, George and team. Thanks for taking the question and congrats on, I thought, a very good year of progress last year. I had a couple of follow-ups to Ritu's question. I'm respectful that you won't be able to provide a lot of details, until you meet with the agency, makes a lot of sense.

But one question that I had was when you meet with the agency, will you be discussing the concomitant and antidepressant medicines? Or are you going to stick with the monotherapy versus the adjunctive therapy for the Phase 3 program?

George Goldsmith -- Chairman and Chief Executive Officer

I'm sorry, will we be sticking with the -- so we will be -- could you repeat the question? I'm sorry.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Yes, so will you stick with monotherapy paradigm?

George Goldsmith -- Chairman and Chief Executive Officer

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'll be discussing both with them, obviously. Perhaps not obviously, but we will and service the patients.

Charles Duncan -- Cantor Fitzgerald -- Analyst

OK. So the Phase 3 program is intended to be a monotherapy program or possibly a broader program to include adjunctive therapy ?

George Goldsmith -- Chairman and Chief Executive Officer

Possibly a broader program, again, to be discussed.

Charles Duncan -- Cantor Fitzgerald -- Analyst

OK. 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?

George Goldsmith -- Chairman and Chief Executive Officer

Yes, this is predominantly looking at durability, Charles, because one of the things that has just been unanswered 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 psilocybin therapy than is 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, I want to see how long did that continue for which patients. And we can sort of understanding carefully how do we figure out who the responders will be, what dosing would look like, etc.

So this is purely the long term is to follow those patients without any additional dosing and to look at how long did the single dose work for whom? And what are the characteristics of those patients that can help inform subsequent trials and commercial use.

Charles Duncan -- Cantor Fitzgerald -- Analyst

OK. Very good, George. And last question is perhaps for Mike, but you'll probably detect it's kind of a backdoor 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?

George Goldsmith -- Chairman and Chief Executive Officer

Mike, do you want to take that?

Mike Falvey -- Chief Financial Officer

Sure. So first, thank you for walking your backdoor 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, '23 and into 2024. And in putting that together, we contemplated fully funding the Phase 3 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 2 trial and all the 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, is a real strategic asset. So we're going to continue to protect that because we think that in the end really helps patients.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Yes, absolutely. Thanks for taking the questions and...

George Goldsmith -- Chairman and Chief Executive Officer

You can see we are being resolute in our Phase 3 question.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Yeah, that's all right. Well, we want you to get the feedback from the agency, and we'll talk soon about that.

George Goldsmith -- Chairman and Chief Executive Officer

Next question.

Operator

Thank you. Our next question or comment comes from the line of Neena Bitritto-Garg from Citi. Your line is open.

Neena Bitritto-Garg -- Citi -- Analyst

Hey, guys. Thanks for taking my question. Another question on Phase 3 here. So I know you mentioned earlier that you are planning to expand to significantly more sites than 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 enrolled 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.

George Goldsmith -- Chairman and Chief Executive Officer

So I'll take your second question first. We were 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 3 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 hands of patients as a reimbursed model of care. And so when we are developing our work, we're doing a great deal of effort to make sure that our screening is appropriate, that we have the right patients, that we have as homogeneous group of patients as possible. That work has played out very successfully in our Phase 2b trial. We'll be taking that forward.

And when we expand sites, we'll be taking all of that learning into our Phase 3 program. And we have done a tremendous amount of work identifying the Phase 3 infrastructure, which will be significantly larger than our Phase 2 infrastructure was. And again, all these pieces will come together mid-year with an intention as we've disclosed to start Phase 3 in the second half of 2022.

Neena Bitritto-Garg -- Citi -- Analyst

Got it. Thank you.

Operator

Thank you. Our next question or comment comes from the line of Patrick Trucchio from H.C. Wainright. Your line is open.

Unknown speaker -- H.C. Wainwright and Company -- Analyst

Hi. Good morning.

George Goldsmith -- Chairman and Chief Executive Officer

Hi, Patrick.

Unknown speaker -- H.C. Wainwright and Company -- Analyst

Sorry, this is Jason speaking for Patrick. 

George Goldsmith -- Chairman and Chief Executive Officer

Hi, Jason.

Unknown speaker -- H.C. Wainwright and Company -- Analyst

Thank you for taking my question. Yeah. Hi. How are you doing? And so I guess just -- I have one question in terms of the Phase 3 and then kind of -- just kind of discuss a little bit more on the IP.

So can you just talk a little bit on how the potential for simultaneous treatment or group therapies could become part of the Phase 3 program? And what if any feedback has been received from regulators on this potential front and possibly also discuss on the digital therapeutic front, and how digital therapeutics could be part of the Phase 3 program.

George Goldsmith -- Chairman and Chief Executive Officer

So in terms of simultaneous administration, that's really independent of the design. So how sites will administer that is not part of the plan right now, so are not being discussed. The design will be discussed. But obviously, the FDA has enabled that in the past with our study at Aquilino Cancer Center.

So again, that will tend to be site-specific conversation. 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 focused on training and adherence and receiving therapeutic 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 the person's language, their narrative, etc.

So we're doing a tremendous amount of natural language processing, etc., on those creating a different set of exploratory end points, digital endpoints. In addition, we will be providing patient platform called myPathfinder, 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 on the therapy side and on the patient. You bet.

Unknown speaker -- H.C. Wainwright and Company -- Analyst

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

George Goldsmith -- Chairman and Chief Executive Officer

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

Unknown speaker -- H.C. Wainwright and Company -- Analyst

All right. Thank you so much and congrats on the fantastic year. And we'll speak soon. Thank you.

George Goldsmith -- Chairman and Chief Executive Officer

We really appreciate it. Thanks.

Operator

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

Josh Schimmer -- Evercore ISI -- Analyst

Thanks so much for taking the question.

George Goldsmith -- Chairman and Chief Executive Officer

Hi, Josh.

Josh Schimmer -- Evercore ISI -- Analyst

Just a question about trial protocols and maybe in the Phase 2, given the potentially severe and refractory nature of the patients being enrolled in the risk for potential suicide ideation. What are the protocols in place to detect and intervene early should a patient wind up deteriorating in the mental health status? Thank you.

George Goldsmith -- Chairman and Chief Executive Officer

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's an escalation process to us should anything happen. So I think we are putting those same processes in place. And really, to your point, this is very, very difficult population. People struggle a great deal going in as we revealed into our Phase 2b trial, nearly two-thirds of people had prior history of suicidal ideation.

Sadly, it goes with a very significant distress that people have with treatment-resistant depression. And of course, there were no suicides in Phase 2b. There was just the ideation. And some early behaviors that were not serious and quite later after the dosing.

Josh Schimmer -- Evercore ISI -- Analyst

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

George Goldsmith -- Chairman and Chief Executive Officer

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.

Josh Schimmer -- Evercore ISI -- Analyst

Thanks very much.

Operator

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

Esther Hong -- Berenberg Bank -- Analyst

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.

George Goldsmith -- Chairman and Chief Executive Officer

Really great question, Esther, and thank you for it. I think, obviously, there are similarities in the structure of the therapy around the medicine. The therapy is different because of the different nature, but having sites and facilities and trained therapists makes a lot of benefit for both programs. So obviously, we are working closely to make sure the trainer, the people who have 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.

Esther Hong -- Berenberg Bank -- Analyst

Got it. Thank you.

Operator

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

Bert Hazlett -- BTIG -- Analyst

Yes, good morning and thank you for taking my question. 

George Goldsmith -- Chairman and Chief Executive Officer

Hi, Bert.

Bert Hazlett -- BTIG -- Analyst

Hi, George. Thank you very much. I was really intrigued 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 affect, quality of life and cognition and others. Are there things that rise to the four -- characteristics arise to the four that you think would be important as you look forward to either in Phase 3 or in your discussions with the agency? Thank you.

George Goldsmith -- Chairman and Chief Executive Officer

Absolutely, a great question. And I think that what really rose to the four was -- for us was in addition to the significant relief in symptoms for many patients at the point of remission. They're a positive effect. And most importantly, their quality of life for those who responded on 25-milligram, their levels of quality of life for 12 weeks was equivalent to what a "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 and total cost of care. So improving quality, reducing costs critically important for this patient population for health systems and obviously, 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 in remission and also looking at all the other aspects that we learned through the trial as we go into our Phase 3.

Bert Hazlett -- BTIG -- Analyst

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

George Goldsmith -- Chairman and Chief Executive Officer

Super. 

Operator

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

Francois Brisebois -- Oppenheimer and Company -- Analyst

Thanks for taking the questions. Obviously, a lot has 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 standardized 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.

George Goldsmith -- Chairman and Chief Executive Officer

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., etc., will be a consistent level of support that they've received. 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 3 and the next level of training. But we're very happy with what we saw.

Francois Brisebois -- Oppenheimer and Company -- Analyst

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

George Goldsmith -- Chairman and Chief Executive Officer

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.

Francois Brisebois -- Oppenheimer and Company -- Analyst

OK. 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?

George Goldsmith -- Chairman and Chief Executive Officer

The APA, ANCP toward 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.

Francois Brisebois -- Oppenheimer and Company -- Analyst

Great. Thank you so much.

George Goldsmith -- Chairman and Chief Executive Officer

Thank you. And just to add, we are -- obviously, the results will be published in a leading journal this year as well from our Phase 2b study.

Operator

Thank you. Our next question or comment comes from the line of Kyle Qian from Canaccord Genuity. Your line is open.

Kyle Qian -- Canaccord Genuity -- Analyst

Kyle speaking for Sumant. 

George Goldsmith -- Chairman and Chief Executive Officer

Hi. 

Kyle Qian -- Canaccord Genuity -- Analyst

Hello. What is your conceptual take on some of the shorter-acting psychedelics in the competitive 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?

George Goldsmith -- Chairman and Chief Executive Officer

So a few things. One is -- so we chose psilocybin because of our focus on patients and getting things to patients as quickly as possible, and 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.

Grill that we announced and are looking at a very robust program and shorter-acting substances, substances that have different receptor occupancy, etc. 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 needs to produce perhaps less anxiety, etc., than an existing psychedelic. So we're very focused on meeting the preclinical and discovery work in this area as well as being a leader in our clinical development.

Kyle Qian -- Canaccord Genuity -- Analyst

OK, thank you.

Operator

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.

George Goldsmith -- Chairman and Chief Executive Officer

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 of being compassionate, bold, rigorous and inclusive in the design of our trials at 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 field year for COMPASS once again. Thank you.

Operator

[Operator signoff]

Duration: 47 minutes

Call participants:

Stephen Schultz -- Senior Vice President, Investor Relations

George Goldsmith -- Chairman and Chief Executive Officer

Guy Goodwin -- Chief Medical Officer

Mike Falvey -- Chief Financial Officer

Ritu Baral -- Cowen and Company -- Analyst

Charles Duncan -- Cantor Fitzgerald -- Analyst

Neena Bitritto-Garg -- Citi -- Analyst

Unknown speaker -- H.C. Wainwright and Company -- Analyst

Josh Schimmer -- Evercore ISI -- Analyst

Esther Hong -- Berenberg Bank -- Analyst

Bert Hazlett -- BTIG -- Analyst

Francois Brisebois -- Oppenheimer and Company -- Analyst

Kyle Qian -- Canaccord Genuity -- Analyst

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