Q1 2025 COMPASS Pathways PLC Earnings Call
Speaker Change: Ladies and gentlemen, thank you for standing by, and welcome to the COMPASS Pathways' first quarter 2025 earnings call. Please note that this call is being recorded. After the speakers prepared good marks, there will be a question and answer session. If you'd like to ask a question during that time, please...
Speaker Change: Press star followed by one on your telephone keypad. Thank you. I'd now like to hand the call over to Steve Schultz, Senior Vice President of his investor relations. You may now begin, sir.
Speaker Change: Welcome all of you and thank you for joining us today for our first quarter, 2025 Results Conference
Speaker Change: Again, my name is Steve Schultz, Senior Vice President of Investor Relations at COMPASS Pathways. Today I'm joined by Kabir Nath, our Chief Executive Officer, and Teri Loxam, our Chief Financial Officer, who will have prepared remarks.
Speaker Change: In addition, Dr. Guy Goodwin, our Chief Medical Officer, and Dr. Steve Labin, our Chief Patients Officer, will be available for the Q&A.
Speaker Change: The call is be 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 30 days.
Speaker Change: Before we begin, you remind everyone that during the call today, the team will be making forward-looking statements within the meeting 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.
Speaker Change: or implied by any forward licking statements as a result of various risks.
Speaker Change: Uncertainties, and other factors, including those risks and uncertainties described under the heading risk factors in our most recent quarterly report on Form 10Q.
Speaker Change: File with the US, Securities and Exchange Commission, and in subsequent filing made by Compass with the SEC.
Speaker Change: 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.
Speaker Change: We specifically display many obligations to update or revise any forward-looking statements, even how far estimates or assumptions change. I will now hand the call over to Kabir Nath. Thank you, Steve. Good day, everyone, and thank you for joining us.
recently.
Kabir Nath: We announced the completion of dosing of all participants in part A of our 005 trial, the first of two pivotal phase three trials, which marks an important milestone in our mission to address the pressing on met need, in treatment, resistant depression or TRD.
Speaker Change: We look forward to sharing the six week top line results in late two.
Speaker Change: As we've guided before, these results will include three efficacy measures for the six-week primary endpoint.
Speaker Change: The difference between the treatment arm and the placebo arm in change from baseline on Madras, the Associated P-Value, and Confidence Interval.
Speaker Change: A positive treatment effect of six weeks, based on a single dose of COMP-360, would represent a meaningful improvement in durability compared with the very limited options available to TRD patients today.
Speaker Change: From a safety standpoint, the Independent DSMBE reviews unblinded safety data on a regular basis and has been doing so since the trial started.
Speaker Change: Since the trial remains blinded through 26 weeks, we have requested the DSMB to provide a comment on suicideality.
Speaker Change: We believe that these data, if positive, should provide investors with further clinical validation of com-free-sixies treatment potential in TRD.
Speaker Change: The second Phase 3 trial, CO-006, which has three active arms, could further define the COM-360 profile with data on a second initial treatment, which we believe could potentially extend your ability or deepen response.
Speaker Change: Enrollment is going well in06, and I'll remind you that is a global trial, and we're on track for the 26 week results in the second half of 2026.
Speaker Change: Also during this quarter, 52-week safety and efficacy data from the COMP-OHO IV study was published in the Journal of Clinical Psychology.
Speaker Change: This was an observational 52-week follow-up from the Phase 2B-01 and OOTB trials of COMP-360 psilocybin treatment in 252 patients with TRD.
Speaker Change: This study showed that, for the full patient population, a single 25-mg COMP-360-silocybin dose offered long-term benefits, with an average time to depressive event of over 12 weeks.
Speaker Change: A post-hoc analysis of the subset of 58 participants that continued in the long-term follow-up study, shown time to depressive event for those patients treated with 25 milligrams was substantially longer at 189 days.
Speaker Change: While there may be some responder bias associated with this subgroup, this is impressive data in a difficult to treat and highly refractory patient population. And we believe shows the potential of Compre 60 to be a clinically differentiated treatment that is both rapid acting and with meaningful durability.
Speaker Change: The Phase 3 program is designed to confirm the durability and safety profile, which, if successful and approved, could be a groundbreaking option for individuals who suffer from TRD.
Speaker Change: In addition, as we plan for the commercialization of Comp-360, we'd be working to ensure that we understand the commercial opportunity. Initially, by focusing on how Comp-360 will be delivered in a broad spectrum of settings of care.
Speaker Change: One way we are achieving this is through developing relationships with various provider types through our strategic collaborations which we previously discussed.
Speaker Change: In line with this, we announced an additional strategic collaboration this quarter with Hope Thought.
Speaker Change: Howard Boards is a community health centre that serves low-income individuals and is focused on providing broad and equitable access to innovative mental health treatments which could potentially include COMPF-360, if approved by the FDA.
Speaker Change: Health Thought is our first collaboration that is focused on community-based delivery to under-served patient populations.
Speaker Change: Beyond this, our efforts with our existing collaborations are generating considerable value.
Speaker Change: We have gained deep insights into the patient experience and care pathways for those living with TRD within high-volume interventional psychiatry practices, hospital systems and integrated delivery networks.
Speaker Change: We've strengthened our understanding of the clinical operational economic and administrative considerations of implementing and scaling analogous interventional psychiatry treatments such as privato.
Speaker Change: This enables us to understand and prepare for the launch and adoption of COMP360, if approved.
Speaker Change: And we're building a strong appreciation of how training and continue education is being delivered and how best to integrate COMP-360 in the post-approval setting.
Speaker Change: These are just a few of the many examples of meaningful insights that we are using to inform our strategy for alone and post-launch scale aim.
Now, let me turn the call to test.
Thank you Kabir.
Teri Loxam: After our January financing, we are in a very strong financial position.
Teri Loxam: At the end of March, we had cash and cash equivalence of $260 million, which we expect to fund our operations at least through the plan 26-week data readout from our second phase 3 trial, COM-006.
Teri Loxam: which is expected in the second half of 2026. This compares with $165 million at the end of 2024. Dead under the Hercules loan facility was $30.5 million at the end of the first quarter.
Teri Loxam: Cashews and Operations for the first quarter was $45.7 million, and we expect net cashews and operations for the full year 2025 to be within the range of $120 to $145 million.
Teri Loxam: Again, as Kabir said earlier, we eagerly await the results of our first phase three data, as we know you're waiting for it as well. As a reminder, this is the first of three expected data readouts from this program over the next 18 months.
Teri Loxam: Based on our data to date, including the recent 52 we follow-up data from our phase to B trial, we believe COMP360 could represent a clinically differentiated treatment option that is rapid acting with the potential for paradigm changing durability.
Teri Loxam: We also continue to work toward a final design for our late-stage clinical program in PTSD and look forward to updating investors when that design is finalized.
Teri Loxam: Given the high unmet need and limited current treatment options, we see a significant commercial opportunity in PTSD.
Teri Loxam: With that, we're going to move to Q&A, and as a reminder, Dr. Died Goodwin and Dr. Steve Levine are also with us today for the Q&A portion. And with that, let me turn it back over to the operator.
Speaker Change: We are now opening the floor for question and answer session. If you'd like to ask a question, please press star followed by one on your telephone keypad. Your first question comes from Delilah, Leonid Timashev, of RBC Capital Markets. Your line is now open.
Speaker Change: Hi, this is Kevin Onfer, Leonid. Thank you for taking our questions. So you recently, as you mentioned, published longer-term follow-up data from the phase two. Maybe you can just highlight the key takeaways in your view on durability, as well as what you may have learned about which dose is most appropriate. Thank you very much.
Kabir Nath: Thanks Kevin, this is the beer, just checking that you can hear us clearly.
Yes, I can.
Kabir Nath: I'll hand actually to Guy to take the lead on that then please.
Guy Goodwin: Yeah, I mean, I mean, this state is not as complete as we would like it to have been, so I'd like to start with that disclaimer really, it's not a definitive study.
A defensive follow-up study by any means, so various reasons.
Guy Goodwin: But what it does show is a difference between the durability of the three doses.
Guy Goodwin: This is most clearly seen in the subgroup who completed the study.
and they, as we mentioned earlier, [inaudible]
Guy Goodwin: Are a little unrepresentative, but nevertheless, they do demonstrate some patients who receive 25 milligrams.
Can last as long as six months, following treatment. [inaudible]
Guy Goodwin: and that is much less likely in people who've received lower doses. So I think it reiterates our conclusion from the phase two study that 25 milligrams is.
Guy Goodwin: for the time being that the preferred dose that we think should carry forward and will be the one that we obviously used in the Phase Truth Program.
Thank you.
Speaker Change: Next question comes from the line of Paul Meadows of Stiffle, Your Line of Snowball.
Paul Nettles: Hey, good morning, next you're taking my question, I appreciate it. I mean, obviously with the top line disclosure and your guys conservatism around trying to not bias.
Speaker Change: You know, a six trial, it's going to be difficult to compare across studies, which is totally reasonable. But just as it relates to thinking about the actual efficacy delta on Madras
Speaker Change: You know, one challenge in the psychedelic space is just a high degree of variability and placebo effect across trials.
Speaker Change: What is your base case? Again, the study is blinded, but what was your base case and what the placebo effect might be in this study? And how might that kind of inform the way we contextualize this effect size versus what others have observed? Thank you.
Speaker Change: Yeah, thank you for that question. I mean, our estimate, our guesstimate, I think you'd have to call it, was really based on what we saw in a previous study at NDD, from Switzerland, which was with Com360, and looking at our own data. Our own data obviously was from an arm, which received one milligram. [inaudible]
Speaker Change: So we considered whether or not patients in that population had a psychedelic experience or not or anything approaching a psychedelic experience.
Speaker Change: So we took account of the subgroup who seemed to us to have the lowest experience and looked at their responses in estimating what the placebo was likely to be. I think in this field, we generally expect to see in well-conducted trial a placebo response.
Speaker Change: The placebo arm does not receive nothing. They receive a great deal of attention and have frequent hospital visits. It's construed in a very positive way by patients and so you would expect a placebo response. You would expect also regressions of the mean.
Speaker Change: So the normal expectation is for there to be a placebo response and obviously the difference you see between placebo and the active arm can be attributed to the effect of the drug which is the key thing that we're wanting to prove.
Speaker Change: And as we've indicated, we would be very pleased to see effects of over three on the matter scale, we think that is a clinically significant, anything above that is a bonus.
Speaker Change: Okay, great. And if I can ask one follow-up question, just on the DSMB commentary on the presence or lack of a suicide-ality signal.
Ultimately, I guess...
Speaker Change: Where do you think you guys or the DSMB might draw the line between an actual signal and noise, right? Like I would imagine...
Speaker Change: Two events, first one event, could be kind of codified as noise. But is there any, I guess to the outside looking at it seems like there's an art to this, there's an element of subjectivity. How should we interpret that?
Speaker Change: Yeah, I mean, that is a practice of medicine question, really, because what we're asking the DSMB to do is to take a judgment that is based not just on the occurrence of events and the relative frequencies, but also the severity, the timing, the way in which the event evolves and may in fact, resolve.
Speaker Change: And all of those factors, I think, way, and if I were doing the job and I have in the past for a company, that would weigh in how I reported the likely probability that there was an imbalance in the two arms, which is what we're asking the DSNB to do.
Speaker Change: So it's a nuanced judgment, it cannot be done on the base of the scale, it can't be done on the base of numbers, it has to be done on the basis of a complete assessment of the picture for each of the individual instances.
Fair enough, thank you very much.
Speaker Change: Next question comes from the line of Charles Duncan of Cantor. Your line is in a little
Charles Duncan: Hey, good morning, Kabir in team. Congrats on the progress. Thanks for taking the question. I wanted to ask another question about suicidality, and I'm kind of wondering if...
Back when you were designing this study.
Speaker Change: or thoughts about that from the broader color, investment community, and what is the background rate that you were considering when conducting the study given this TRD population? Thanks.
Speaker Change: Hi Charles, thank you. The issue of suicide dancing was not addressed directly or brought up by the agency in our discussions with them. Suicide dancing is a core feature of depression.
Charles Duncan: All trials with either MDD or TRD have to include patients with some degree either a history
Charles Duncan: To exclude it as a factor entirely is simply to distort the population in the way that it ceases to be representative of the target population. So, suicide out is a fact that everybody has to contend with in designing and executing these studies.
It erodes as an issue, as you may remember, [inaudible]
After we release the data from 0-0-1.
Charles Duncan: and the fact that we had an imbalance in the number of behavioral actions related to suicidality.
All of them somewhat delay from the actual treatment.
Charles Duncan: That and the accompaniment 25 milligram arm, that produced a good deal of commentary and scenes never to have left us. So we live with this.
Continuous
Charles Duncan: And that is obviously something we remain seriously concerned about. We wish to monitor carefully in the phase three and to generate the numbers that will give us confidence about the actual potential for differences between the three arms. Our expectation is that there will not be important differences between the three arms.
Charles Duncan: Just to build on both guys' points together, Charles, even in the light of the 2D day, so the FDA was still not concerned about the likelihood of suicide in our phase 3. They fully understand that this is a core feature of the disease.
Charles Duncan: Makes sense, looking forward to that data. Quick question for Steve on Healthport in terms of that recent collaboration. I'm I guess I'm wondering if you could characterize in any way.
Charles Duncan: The current delivery of escadamine or spravato that health port is involved in, if you can quantify that in any way so we get a sense of how involved they are in the field. Thanks.
Steve: Hi, Charles. Thanks for that question. Suppose just as a reminder, you know, part of the the efforts with creating this network of collaborations is for them to reflect the broad array spectrum of where I meant to help terrorists deliver it in this country.
Charles Duncan: Within the existing collaborations, we did not feel there was adequate representation of sites that served underserved populations.
Charles Duncan: and Healthport is a very high quality example of a certified community-behaved health clinic that specifically addresses the unmet needs in marginalized and underserved populations.
Charles Duncan: There are some assumptions that I think are common that community basements of health clinics are not able to deliver newer or more innovative treatments.
Charles Duncan: And it is the fact that Health Board has been able to deliver Spravado to patients as a ketamine.
Charles Duncan: And are highly motivated to make sure that there is not a widening of existing healthcare disparities and a lack of access for their population if new treatment options are approved.
Charles Duncan: and so they have some experience already with interventional treatments and are excited about and motivated to the operationally ready to deliver new treatments if approved.
Charles Duncan: And important also to note that inherent within the CCBHC model certified community behavioral health
Charles Duncan: is the sharing nationally across that system of best practices and learning and health court is also the story we didn't leader there, particularly with disseminating the social determinants of health model.
Got it. Thank you, Steve.
Speaker Change: Thank you. Your next question comes from the line of free-to-girls of T.D. Cohen, your line is now open.
Speaker Change: Hi guys, this is Athena Ahn for Retuber All. Thanks for taking the question. Given the potential former tariffs, can you provide additional color on your manufacturing supply chain and whether there has been any FDA inspection of your manufacturing center? Thank you.
Speaker Change: Thanks Athena, so yes currently product is manufactured in the UK. We have always planned and are working on plans to add an additional manufacturing capability in the US for commercial supply. So those plans were already underway and we are moving on those.
Speaker Change: These are sites that have extensive experience of manufacturing, not just for us, but are very well-established CDMOs for a wide range of pharmaceutical manufacturers, so have had multiple inspections over the years.
Do you have a timeline on the additional U.S. site?
Not at this point.
Speaker Change: But as I say, we are working on that, that was already in the plan and in our focus for the next couple of years ahead of potential commercials. This is fun.
Speaker Change: Yeah, and Athena is probably worth mentioning that from a manufacturing perspective compared to other biotech for other pharmaceuticals, this is a pretty straightforward process and a pretty small quantity of material and so...
Speaker Change: It's not really at the top of our minds in terms of-
Speaker Change: You know, risks, we're mitigating any risks we have, but, you know, as Kabir mentioned, as we near commercialization, that is currently the plan. And clearly, you know,
Speaker Change: This is a typical small molecule, so in terms since we haven't yet established a price, if in fact there was a tariff element on any cost of goods, we would clearly be able to consider that in setting a price in due course.
For more information, visit www.fema.gov
Got it. Thank you.
Speaker Change: Your next question comes from the line of Vikram Purohit of Morgan Stanley . Your line is now open.
Speaker Change: Hi guys, thanks for seeing our question. This is Park on the victim. Tricks one question. Could you provide the current mix of color on a patient's enrolled into COMPASS? Here there applies like how similar or distinct is this patient's profile? That was enrolled on the phase 2B.
Speaker Change: Essentially, the criteria for recruitment are the same. We are not continuously monitoring the actual baseline characteristics. I mean, we're remaining blind to the data, but we know that we're recruiting patients using the same criteria, so there's really no reason why there would be any difference.
Speaker Change: It's the only thing which we have stressed repeatedly in the phase 2b, the actual percentage with prior psychedelic experience was 6% in the phase 3, it's packed at 15% and while we don't to guys point and know the exact exactly we can assume it is around that percentage in the 05 study.
Speaker Change: Okay, thank you, and then just one more quickly. What are your current thoughts on BD specifically with regards to a large pharma partnership? Is this something that you guys would be interested in, and if so, when could this make sense?
Speaker Change: Yes, so we are clear that we believe we're doing something unique and if approved what we have is paradigm-breaking transformational for the treatment of serious mental illness.
Speaker Change: And our commitment is to do that ourselves in the US if we can.
Speaker Change: and potentially some other select geographies at the moment. So, from our perspective, COMPASS is set up to commercialize COMP360, if approved, and to build from, you know, and I have no particular comment on big strategic intent of this point.
All right, thank you.
Thank you very much.
Speaker Change: Your next question comes from the line of three months, who currently can kind of occur to a genuity. Your line is that we'll pass.
Speaker Change: Hi, thanks for taking my question. Also a question on suicide-ality risk. What do you think is an optimal time to pass before suicide-ality might not be attributable to a single dose of COMP360 and how might you prepare for imbalances in non-responders to COMP360 because of the potential unblinding given the nature of the product?
Thank you very much.
That's actually quite a tough question, I-
Speaker Change: I think my answer is really that we will wait and see what the data shows us to be honest. I don't think predictions are in order here. That's rather a poor answer to your question, but I think that's the way I feel about it.
Speaker Change: Just a quick follow-up, have you seen any changes within the FDA for anyone that might be considered a champion of psychedelic therapeutic approaches in your interaction so fast?
Speaker Change: Thus far we've seen no changes in our interactions with the FDA which you know in the last couple of months have been largely routine.
around event reporting and so on.
Thank you.
Clearly we're...
Speaker Change: Tracking like everyone else, some of the changes higher up in the hierarchy, not only within the FDA, but higher up than that. As we've said before, we see that potentially, producing some favourable tailwinds for us, but at this stage nothing has changed around our day-to-day interactions with the agency.
Thank you.
Speaker Change: Your next question comes from the line of Patrick Trucchio of H.C. Wingwrest. Your line is now open.
Patrick Truccio: Thanks. Good morning. First, just regarding the COMP360 TRD program and the 52-week observational follow-up study, I'm wondering how we should interpret those data in the context of your pivotal program or in the potential commercialization.
Patrick Truccio: of COMP360 and TRD, and then also in the pivotal TRD program, is there tracking or use of antidepressants or others like atrophic medications, post-dosing in the trials, and how might that inform your durability or safety analyses?
Patrick Truccio: And then separately, I'm wondering regarding PTSD, have you initiated regulatory interactions around PTSD program design, and if so, what feedback have you received?
Thank you very much for your time.
Speaker Change: Steve, do you want to comment first on the durability and how that feeds into how we think about commercialization?
Steve: Yeah, I'll start there. Guy may want to jump in with the other part of the question that related to the starting of other treatments and the interpretability of the data as we get further into the study, but specifically on durability and to your question about what we learned from that long term extension that we called 004 and how we will look at durability within the phase 3 program. .
as was mentioned during the opening remarks.
Steve: There were some limitations as far as the interpretability of the long-term study, just because...
Steve: It wasn't the full patient population that continued. However, when looking at all 233 patients from that study included in the primary analysis that did give a very strong signal of durability at least two, 12 weeks.
Steve: And then for those who did continue into the long term extension study and were followed out to 52 weeks response up to six months now in phase three course will be reporting initially the six week data and frankly.
Steve: Durability, even to week six in the population, given the limited options available today, is already a shift in the paradigm. That already would be of tremendous value to patients, to help your providers, psychiatrists and others.
Steve: We will be looking at durability, of course, the ob-six weeks, blinded out to week 26 and then we'll have continued opportunity to look at durability in the open label portion, from probably 26 to week 52.
Steve: And so we'll have to see what we see there. But again, even with the initiative we have durability of six weeks would be really groundbreaking in this area.
Speaker Change: You know, to be impacted by any presence and use of added presence on the implementation of the work. Yeah, I think the
Speaker Change: The key thing in practice will be the antidepressants are going to be part of the picture for the treatment of these patients.
Speaker Change: I'm not sure that really the key for the patients is to remain well. We're going to see the addition of antidepressant treatments. We can look at that post-hoc within the trials, but I think in ordinary practice we'll expect to see a lot of co-administration.
Speaker Change: We wait, obviously, crop a data on this, but I think you have to anticipate that they will pay a part of long-term treatments in this session.
Speaker Change: And maybe we're saying that it does land a real world element to the letter portions of these studies because that is quite common in clinical practice for patients to be on multiple treatments simultaneously, often to continue in antidepressant in the back or in leather trying other options.
Speaker Change: In most cases, the reason why they're trying new treatments is because of the background tree. It's had not been particularly effective. And in some cases it's just the comfort of being on something.
Guy Goodwin: So, as Guy said, the trial is designed for us to particularly in the beginning of the study differentiate and fully characterize the profile of our drug effect.
Guy Goodwin: But it is a likelihood that patients will resume some treatments and that will give us an opportunity to better understand what real-world practice may look like.
Patrick Truccio: And on PTSD Patrick, we will be reviewing and discussing those plans for the agency, but as you'll recall, we choose not to give specific feedback on what our discussions are with the agency.
Thank you so much.
Thank you.
Speaker Change: That includes our Q&A session. I'd now like to hand back the call to the management.
Patrick Truccio: Thank you very much. So thanks everyone for your time and attention this morning.
Patrick Truccio: I think, you know, to state the obvious, we are very eagerly awaiting data. Next month, we know that you are as well, but we remain confident in that data, in that first six-week primary end-point readout of 005.
Patrick Truccio: And we continue to make very good progress on recruiting in 006 as well and reconfirmed the timelines for that, the data in the second half of 2026.
Patrick Truccio: So with that, thank you and we look forward to pressing on and executing and potentially bringing forward a paradigm changing treatment for TRD. Thanks everyone and have a good day.
Fred, I think today's call, you may now disconnect. Goodbye.
Patrick Truccio: Thank you very much. Thanks, everyone. Thank you. Thank you. Thank you.