COMPASS Pathways plc Price & Performance (CMPS)

Welcome, all of you, and thank you for joining us today for our fourth quarter twenty twenty four results conference call. Again, my name is Steve Schulz, Senior Vice President of Investor Relations at Compass pathways Today, I'm joined by Kibir Nath, our Chief Executive Officer and Terry Lucksom, our Chief Financial Officer. Who will have prepared remarks. In addition, Doctor. Guy Goodwin, our Chief Medical Officer Lori Engelbert, our Chief Commercial Officer and Doctor. Steve Levine, our Chief Patient Officer will be available for the Q and A. The call is being recorded and will be available on the Compass Pathways Investor Relations website Shortly after the conclusion of the call, and will be available for a period of thirty days. 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 most recent annual report on Form 10 ks filed with The U. S. Securities and Exchange Commission and in subsequent filings made by Compass with the SEC COMPASS.

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 statement, even if our estimates or assumptions change. I'll now hand the call over to Kabir Nath. Thank you, Steve.

Good day, everyone, and thank you for joining us. Let me begin by thanking our existing and new investors who participated in our financing last month. This not only positions us to complete the COMP360 program in TRD, but also importantly allows us to progress a PTSD development program. Beyond the encouraging results from our open label Phase 2a study, that we received last May. This will be an exciting couple of years for Compass COMPASS, with multiple upcoming data readouts, and the January financing positions us well for success. As we guided to on the third quarter earnings call, we eagerly await the top line results from the six week primary endpoint from the five trial in the second quarter of this year We've recruited over 90% of patients in the trial so we're within sight of the end of recruitment which we will announce once enrollment is complete. As a reminder, when the top line results become available in the second quarter, we'll be disclosing three key efficacy measures for the six week primary endpoint. The MADRIS effect difference between the arms the associated P value and confidence intervals. We believe that these data should provide investors with a clear understanding of the treatment effect and if positive, together with our Phase 2b results, provide a strong validation for the treatment potential for COMP360 in TRD.

From a safety standpoint, given that the trial is continuing blinded through twenty six weeks, we'll provide a high level assessment from the independent DSMB which reviews unblinded safety data on a regular basis. [indiscernible] which is the second Phase three trial, enrollment is going well. And a high throughput five sites will convert over to six sites upon completing enrollment in 02/2005. So we're gaining momentum and we're excited for the twenty six week results of six to read out in the second half of twenty twenty six. As mentioned earlier, given the recent financing, we're now able to resume the development of COMPASS for PTSD and we're in the process of refining our plans for a late stage clinical program. We're working through the various questions to address as well as potential clinical designs the scope of which is under discussion both internally and with external advisors. Our primary goals are to maximize the probability of success and to get COMPASS to those who suffer from PTSD as quickly as possible. We look forward to updating you on our plans as they progress. Finally, on the commercial front, our strategic collaborations with select healthcare delivery organizations including interventional psychiatry networks, are providing important insights into the various care settings insights which we're using to inform our strategy for launch and post launch scaling, Many of these organizations are delivering Spravato now, which is particularly helpful as we identify COMPASS opportunities to scale within their operating models.

While our Phase three data will give us full clarity on the COMP360 profile, based on our data to date, we believe we will have a clinically differentiated treatment that is rapid acting, with meaningful durability. [indiscernible] the financial update.

Thank you, Kibir. I'll now step through the full year financial results. Cash used in operations for the full year was $10,919,200,000.0 dollars within the guidance range that we provided last year of $114,000,000 to $120,000,000 For the year ended 12/31/2024, net loss $155,100,000 or $2.3 per share, compared with a net loss of $118,500,000 or $2.32 per share These results include non cash share based compensation of $19,500,000 in 2024 and $17,300,000 in 2023 COMPASS.

R and D expenses were $119,000,000 in 2024. Compared with $87,500,000 in the prior year. G and A expenses were $59,200,000 in twenty twenty twenty four compared with $49,400,000 in the prior year. Debt under the Hercules loan facility was $30,200,000 at the end of the fourth quarter. At 12/31/2024, we had cash and cash equivalents of $165,100,000 As Kambir mentioned, in January of this year, we completed a finance saying resulted in net proceeds of approximately $140,000,000 which together with the $165,000,000 of cash that we had at the end of the year provides us runway to fund our operations at least through the planned twenty six week data readout from our COMP-six study, which is expected in the second half of twenty twenty six. Regarding 2025 financial guidance, we expect net cash used in operations for the full year of 2025 to be within the range of 121 hundred and $45,000,000 Thank you. And I'll now turn the call back over to Kambir COMPASS. Thank you, Terry.

We have an exciting couple of years ahead with multiple data readouts from our pivotal Phase three program. [indiscernible] we expect to report the top line six week primary endpoint data towards the end of next quarter and then the twenty six week data once all six participants have completed Part A of that trial. For that six trial, we expect to disclose the twenty six week results in the second half of twenty twenty six. In parallel, we're continuing to prepare for the launch of this potentially paradigm changing treatment Given the high unmet need and limited current treatment options, we see significant commercial opportunities in TRD and PTSD. As mentioned at the beginning of the call, Doctor. Guy Goodwin, Laurie Engelbert and Doctor. Steve Levine will also be available for Q and A. Thank you. And I will now turn the call back to the operator for Your first question is from the line of Gavin Clark Gartner with Evercore ISI. Hey guys, thanks for taking the question.

So I believe the six week MADRIS delta in the Phase 2b was a bit above five points.

Think that should be a reasonable bar for the five initial top line?

Hi, Gavin. It's Gabir. And just to check, you can hear us clearly?

Yes.

Great. Thank you. Yes, so as we I think, consistently said, we have used the Phase 2b and that's six week data for the Phase 2b as the benchmark for how we plan the powering for the Phase three studies. So I think what you said is reasonable. Again, a reminder that clinically meaningful is a significantly lower number in terms of effect size, But yes, that is the guide that we have used in planning the Phase three.

Okay, great.

And just on the PTX B side, maybe you could just frame for the upcoming advisory committee meeting, if there's anything you're looking to learn that will inform your development? Thank you.

Thanks. So the upcoming BREXADCOM meeting you mean, yes?

Yes, correct. Yes.

Got it. Well, we'll be interested in basically how they view the patient population that's something that requires a certain amount of thought with PTSD because of the the spread of different kinds of trauma that result in PTSD. And also the complexity of some of the lives, the early lives of patients who develop PTSD. So I think that's one of the key things. Obviously, will be interested in how they view the issue of the actual difference in the scores, the caps five, which is still a relatively new endpoint for use both clinically and in research and indeed in regulatory trials. So how they interpret changes in that in terms of remission, response, I think that will be informative for us and will guide us in how we think about our studies. I don't think beyond that given the fact that the placebo arm here will be daily placebo, it doesn't really offer us a great deal of guidance as to what our placebo response might look like. So there are limitations, but we'll of course be we'll be tuning in.

Great. Thank you. Thanks, Kevin.

Your next question is from the line of Paul Matties with Stifel.

Hey there. This is Julian on for Paul. A lot for taking our question. I guess, can you just talk a little bit about what's actually going to be disclosed in the top line for the upcoming COMP five readout. I know you talked about some high level safety as well as potential commentary from a DSMB on suicidal ideation. So just any commentary on that would be helpful. And then also just any color on enrollment Are these studies still enrolling? And are you on track No, thanks. Happy to take both of those. So in terms of what we will be disclosing, as we've said consistently from an efficacy perspective, with the six week data, it is going to be the MADRIS effect size the difference between the arms, the p value and confidence interval that's associated with that effect size difference. From a safety perspective, as you've said, it will be a statement from the DSMB including specifically to whether they see anything clinically concerning in terms of imbalance on suicidal ideation. And just a reminder, the DSMB is seeing unblinded safety data on a regular basis. Most recently this month in fact and have just proceeded us to direct without change, without amendment.

And in terms of recruitment, as I said on the call, for five, we are now over 90% recruited for that trial. So we're very much within sight at the end of that. Six is continuing to recruit well. One of the factors there is, as we've said, high performing OIL-five sites will roll over. Into six and that's a process that again we now can start planning with exquisite detail And so we continue to be on track now for twenty six week data for six in the second half of twenty twenty six.

Your next question comes from the line of Charles Duncan with Cantor.

Charles, your line is open. There's no response from Mr. Duncan's line. We'll go to the next question. Your next question is from the line of Ritu Baral with TD Cowen. Kabir, what else will we get with with top line as far as additional analysis? Will we still get remissions responses? And how will that play? Do you think the relative importance will play both to regulators and clinicians in relation to sort of the top line MADRIS means? And will we be getting any secondary scales as well?

Thanks, Richard. So no, to be clear with the six week data, we are not going to be getting any secondaries, we're not actually going to be getting remission or anything else. It is literally just going to be the effect size difference on MADRESS with the six week data.

Got it. And then as you are at ninety percent enrolled, how has the patient disposition and demographic shaped up to your expectations Can you talk about what percentage has finally come in on background SSRIs and and how that may or may not impact the final efficacy and tolerability data that comes out.

Thanks. We aren't seeing that broken down in detail as it goes. My impression is just from the numbers of patients in washout, that we're seeing a similar kind of number to what we saw in the Phase two but I can't give you the precise statistic on that. In other respects, we aren't looking again as we go at details of the for example, comorbidities, the the drugs actually use the numbers of exposures, we're just not looking at that as we go, that's not been part of our protocol.

Got it. And will you release with top line what the powering of the study was designed to be.

Yes. I guess if you're interested, we'd be happy to share that, yes.

Once we have the data, [indiscernible] Thank you. Thanks for taking the questions. Thanks, Ritu. Your next question is from the line of Charles Duncan with Cantor. Hi.

Hopefully, you can hear me. Kabi, your team, thanks for taking the question. Congrats on the progress. Appreciate the added Added color. Wanted to follow-up on a previous question with regard to Topline four zero five.

And the recent DSMB meeting. I guess I'm wondering if you could provide a little bit of color on what you would anticipate in terms of suicidal ideation. We've talked about that in the past. I know it happens in this patient population, but provide a little more information on what you would have expected out of this patient population? Hi, Charles, Guy here. I mean, we do expect to see suicidal ideation And as you know, we're collecting it on a systematic basis using the Columbia rating scale. In due course, we'll be able to summarize for the whole population the extent to which we saw suicideality using that scale. Obviously, the serious adverse events that we collect have to be contextualized. And that is what the DSMB is able to do because it's unblinded. We can't do that from our own perspective, so we rely on their clinical judgment to decide that there is no clear reason to think that what is happening in the trial represents a signal of danger. So that essentially we rely on their clinical judgment to look at all of the information and we have to trust what they feedback to us.

And Guy, it's probably worth you adding that the reason we might see suicidal ideation is because of the patient population. So you may want expand on that and it's not necessarily part of our No, I mean, I was sort of taking that as read, but perhaps that needs to be restated depression as inherently carries with it suicidality and suicidality carries with it the risk of attempted or completed suicide. So any study that enrolls a large number of patients with treatment resistant depression in particular is running that risk Obviously, we are trying to ensure that that risk is minimal for the individuals who enter the study but there is no doubt that the condition carries the risk. That Yes, that makes sense. I get that. But with regard to the DSMB review, they have been looking at if there are any any events and tracking that. And you would know that if if there were. Correct.

We would know if they were concerned about the events that have occurred and they have full information about. Yes.

Okay.

Very good. Thanks for taking the question.

Your next question is from the line of Leonor Timoschitz with RBC. Hey guys. Thanks for taking my question. I just want to talk a little bit about the durability aspect again. Can you remind us as first of all how you're measuring durability if patients start other medication after receiving their COMPASS sixty dose? And then I guess maybe the second part is on the more practical and real world side, is it still a win if a patient starts like an SSRI or something after receiving their dose? I mean, how does the FDA think about that? And I guess, how are you guys thinking in the future if someone chooses retain their response rather than coming back to get another dose of Thanks.

Okay.

Well, I guess the most obvious way in which we see durability is that we know that we see a very early response and that we see in many cases that that in the Phase two study that that response was maintained as a change in the MADRIS from baseline. Over many weeks up to twelve weeks as you know we followed patients. There is another sense of course in which one can look durability and you've implied it the time to an intervention for a new treatment and we will be capturing that and indeed we captured that in our Phase two and that data will soon be publicly available in a publication. But that is one of the ways we will also be capturing the time to new treatment. That new treatment in our study doesn't affect the conduct of the study. The patients remain with us and have followed up within our fifty two week protocol. What the FDA's attitude to that is not obviously something I can comment on. We will deliver the data to them and they'll reach [indiscernible] But I think I can speak from a clinical perspective that I wouldn't be surprised if patients who make a good symptomatic response may actually want to go on to maintenance antidepressants.

I think that would be very unsurprising if that happened. And therefore, it may very well be that that is one of the ways in which durability [indiscernible] Your next question is from the line of Francois Boyse with Oppenheimer. There is no response from Francois's line. We'll go to the next [indiscernible] Thanks. Good morning. COMPASS of follow-up questions from me. I guess the first one would just be on the comp-five readout, what would be considered a clinically meaningful improvement in the MADRIS total score at six weeks And how should we contextualize the results in relation to prior trials with psilocybin and other TRD treatments And secondly, I was just wondering if you could provide some details on the psychological support model the implementation and how this sort of is different from what we saw with the Lycos experience and just in terms of how we should think about the psychological support model from a regulatory perspective but then also in terms of a scale up and commercialization perspective?

Thanks, Patrick. So a couple of questions in there and I'll hand to Guy. But just before that, just a reminder, you're not going to see the MADRIS effect difference on the ACTIVRIS. We're going to see the difference between the arms, just to be clear on that. So again, just a reminder that. But then let me pass to Guy to comment on that and initially on the psychological support side and then to Laurie to talk about that from a scaling perspective.

Yes. I mean, I can't really add much more to what Kavira said on the difference because we don't really reporting that. As you've seen in our Phase two study, the immediate change was of the order of 13 points on the madras. And of course, we'd be very happy if we saw that again. I think on the psychological support model, I I think what it's important to understand is that what we're trying to do is to make it easy for the FDA to understand the drug's effects in isolation from any potential efficacy from psychotherapy. And so for that reason, we have simplified the support we offer to patients so that essentially gives them the information they need for the experience, it supports them on the day, and it gives a chance for them to talk about it afterwards. We are systematizing our approach to a considerable degree and we're monitoring all of the sessions so that we will be able to ensure that the people sitting with the patients do follow exactly what we have trained them to do And what we have trained them to do is essentially to follow a protocol that is really unlike clinical practice it's very much more about following a trial protocol.

And that has required a certain amount of retraining frankly for patients who come in with more assumptions about psychotherapy. So that's our approach to the trials. I'll pass to to Laurie who may want to comment on the implications for Clinique. [indiscernible] what Guy said in terms of the purpose of the support model, is that we are making sure that patients have support through drug administration as well as prior to drug administration and after drug administration. And at launch, hopefully to end up to scale up as well, we don't expect that to be very different than what the REMS requirement are for SPRAVATO right now and that will only be limited to a licensed healthcare provider. And we will not be constrained to to therapists at the time. And just one thing to add, this is Steve Levine.

It's also worth saying that to be trained in a new treatment or a new protocol is common across medicine, not just in psychiatry, And so this is also one of the areas where we're able to focus in learning from our strategic collaboration partners which COMPASS a handful of organizations that hundreds of sites to understand who is being trained within the organization right now, how they're being trained, how they allocate budgets for that training, we'll be very informed in terms of real world training as we think about this moves into real world care settings.

Your next question is from the line of Frank Bisbois Oppenheimer.

Can you guys hear me now? We can, Frank, yes.

Okay. Wow. Okay. Sorry, I've had some IT issues. And sorry if this was mentioned as well. But was just wondering if you can with Steve making a comment this role of Chief Patient Officer and what led to that and what exactly that [indiscernible] Thank you for asking that question. I'm very happy to answer that. As a psychiatrist by background, really happy to see that Compass has placed such an emphasis on ensuring that both the patient, particularly the patient, but both the patient and healthcare providers for [indiscernible] are incorporated into everything that we think about in plan, whether it's the design of our trials, thinking ahead to a post approval environment where this actually is delivered to patients by licensed healthcare providers. And so, that's really broadly where I'm focused is involved widely across the organization and ensuring that those voices are reflected and that there's a realistic perspective on what may be needed outside of the relatively verified environment of clinical trials as this moves into real world patient settings and actually gets to patients.

Yeah. And I think, Frank, I mean, I think it's self evident that a psilocybin experience is a very different we talk about a paradigm changing approach and it absolutely is a paradigm changing approach, specifically from the point of view of the patient and that we're supporting some pretty vulnerable patient populations. Through what can be a challenging experience. So having somebody of Steve's caliber and experience really advocate for that and stand for that within the company, we felt was really important. And who better to have than Steve to do it?

Okay, great. And then just on the five, in terms of timing of twenty six week data, can you just help us Just remind us what you're sharing here about Part A and enrollment and when twenty twenty six week comes out? Just how should we best guess twenty six week data?

For timing? Thank you.

So [indiscernible] As you know for six, we we've given a fairly wide range for guidance for the twenty six weeks for now and the second half of twenty twenty six, but obviously as we get clearer on six enrollment and timelines, we are in position to give more specific guidance also around the twenty six weeks of Ophi. But for now, we're not giving specific timing guidance around that. Okay. I'll keep you at things. Thank you. Vikram, your line is open. There's no response. We'll go to the next question. We'll go to the next question. Sumat Kukarni, with Canaccord Genuity. Hi, thanks for taking my questions. I actually have three So there was an earlier question on point separation on the Mater scale.

But do you think that COM360 might need to hit some higher bar relative to what is considered conventionally clinically relevant and made us to be successful in the real world? Or would the non chronic dosing paradigm more than outweigh that scenario?

So I'll hand the guy, but just as a reminder, I mean, this is TRD, Sumant, not MDD. And there's precisely two approved drugs in TRD. I mean, this is the guy. Well, I think that's the honest answer actually that the yardstick doesn't really exist to anything like the extent that it exists in MDD. Is there anything else we should say on that? I mean, No, so it's a lower bar.

Yes. If anything, it will be a lower bar for TRD versus MDD.

Understood. So now with the [indiscernible] How is your thinking evolved on how the product might be able to compete with other compounds that require shorter times in the clinic given that we've seen some Phase two data from five year DMT, for example? Hi, this is Steve. I'll take that one. Thank you. I think in terms of considering what drives decision making from healthcare providers, amongst many considerations, key amongst them are the economics, whether this is an economically viable and hopefully attractive crop for them. And so with that, it really highlights the work that we did on procuring new Category three CPT codes.

Which are specific for the administration day and the support provided on that day. And as a reminder, those codes can be used across a range of psychedelic treatments if approved. And they're reported on an hour by hour basis. And so regardless of the length of the treatment, we anticipate that healthcare providers will be reimbursed for the services provided.

I also just want to add, if you don't mind, Samant, that we need to think about the indications that some of these will be approved for. Our indication will be the only TRD on the product for quite some time. [indiscernible] Got it. And my last question, there seems to be some enthusiasm around support for psychedelic medicines at very high levels in the current political environment. How would you say that any changes either in terms of personal personnel or morality FDA have affected the tone of your recent interactions with the agency if any? Any predictions you might have there on what that might mean as you head into a potential regulatory process here?

Thank you, Samantha. It is a great question. And I mean, the straight answer is we don't yet know to be clear. But obviously, we are tracking things very closely. I think our overall perspective is at worst some of these changes are neutral. And potentially there's some positive tailwinds in this. And if you think about an area we haven't really focused on, for instance, PTSD, the combination of that the influence of veterans organizations and so on, you can see that clearly in that space, could be a tailwind. So far in terms of FDA interaction, there is no change for us to comment on.

Your next question is from the line of Jason McCarthy with Maxim Group.

Hey, guys. This is Michael Ovchinovich on the line. Thank you much for taking my questions today.

I guess just to start off, at least see if you could talk a little bit more about your pipeline plans. You did mention you're designing a late stage study in PTSD. Can you talk about some of the other indications that you're working on? I know anorexia has been a target for a while.

Sure. So the anorexia study, we have completed that closed enrollment and we will expect to see data sometime in 2025 on that. We have a number of IISs that we've conducted in the past that have given us interest [indiscernible] But right now from a full steam development ahead, our focus is on TRD and PTSD.

All right. Thank you. And then just I wanted to see if you could comment on just given the recent rise we've seen in adoption on Stravato, it did more than $1,000,000,000 this year. Do you think that having another interventional psychiatric therapeutic in TRD could help prepare the market for something like COMP360?

We absolutely do. So J and J has done a great job of really preparing and educating HCPs on what TRD actually is. As a reminder, TRD is broadly referred to as the failure of two prior antidepressants And what we are seeing and what we're thinking about with Sprabato is if you think about the addressable patient population, which is probably around about three million, MDD patients right now, SPRAVATO has less than two percent of patients in that TRD patient population. So any additional success on the SPRAVATO side only bodes well for us coming to market.

All right. Thank you very much for taking my questions and congrats on the progress. Thanks, Mike.

Your next question is from the line of Vikram Prahit with Morgan Stanley. Hi, everyone. Can you hear me? Yes. Great. This is Morgan on for Vikram. So two from us for PPSC. One, could you walk us through how you prioritize PTSD over the other indications like bipolar disorder that you're exploring in different IISs? And then on the path to filing for PTSD, what do you imagine that looking like in terms of studies patients, number of patients and what level of follow-up data do you think is needed? Thank you.

Yes. Thanks, Morgan. So I mean, I think PTSD, as you'll be aware, nothing has been approved more than twenty years in PTSD. So in terms of true unmet need, the scale of the problem, and kind of the intensity that focus around the problem it was clear to us that particularly having seen the signal, in our Phase 2a, this was an area that both from a medical and therefore from a commercial perspective rose absolutely to the top of the priority list. So that's hence the focus on PTSD ahead of any other indication I'll hand the guide to talk a little bit more around the development regulatory side.

Yes. I mean, we are obviously in the process of thinking carefully about that. I can't say that we're yet fixed on one way to go.

I mean, we expect to have a meeting with the FDA two thrash that out at some point. And we've obviously developed a number of scenarios with the way we could could actually develop the the treatment in PTSD. I mean the patient population we're also going to have a little bit of guidance from the FDA's attitude from the ADCOM that's going to take place for brexpiprazole which will obviously be following and that will maybe give us some insight into the way the patient population in particular is is observed. So we're looking forward to an exciting year with this. I mean the other indications that you mentioned, for example, bipolar two disorder, a little more difficult simply because co medication and the complexity of the condition. PTSD as Kabeer has indicated has this massive unmet need. There are very little very little available and we have this really very encouraging data that showed durability after a single administration. So I think that's clearly the first place to go.

Yes, Morgan, hey, it's Laurie. If you don't mind, I'll just add a little bit of additional color. It is a very highly prevalent population as well. They're about thirteen million patients. Out there. And as Guy mentioned, very limited options. There are actually only two FDA approved products for PTSD right now. And as Kabeer mentioned, it's been a very long time since innovation has happened in the market.

Thank you. Your next question is from the line of Frank Rispoyce Oppenheimer? Hey, sorry. Just an extra one here. On the DSMB side, the comment you made that you just had recently, can you remind us what exactly you said of how recent that interaction was? And being 90% enrolled, is it fair to assume that there are no more DSMB looks at this until readout or could there be one more? So as in recent, it's this month as it was in February.

So that's how recent the loss is. I guess, as to the kind of the quarterly cadence versus when we have have top line in hand that we will see what happens in the course of next quarter. But I mean the regular cadence is quarterly.

At this time, there are no further questions. I will now hand the call back over management for closing remarks.

Thanks very much. So thanks everyone for your time and attention today. As we said, we're at the start of a very exciting couple of years for Compass with multiple data readouts between now and the latter part of 2026 and in particular we're excited about the five top line that we expect to see towards the end of next quarter. So thanks everyone. Thanks for your time.

This concludes today's call. Thank you for joining. You may now disconnect your lines.