Q3 2025 COMPASS Pathways PLC Earnings Call
Speaker #1: Good morning, ladies and gentlemen, and thank you for standing by. My name is Kelvin, and I will be your conference operator today. At this time, I would like to welcome everyone to the COMPASS Pathways third quarter 2025 earnings call.
Speaker #1: All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad.
Speaker #1: If you would like to withdraw your question, please press star one again. Thank you. I would now like to turn the call over to Stephen Schultz, COMPASS Pathways Senior Vice President of Investor Relations.
Speaker #1: Please go ahead.
Speaker #2: Welcome, all of you, and thank you for joining us today for this quarterly conference call. My name is Steve Schultz, Senior Vice President of Investor Relations at COMPASS Pathways.
Speaker #2: And today I'm joined by Kabir Nath, our Chief Executive Officer, and Teri Loxam, our Chief Financial Officer. Lori Engelbert, our Chief Commercial Officer, and Dr. Steve Levine, our Chief Patient Officer, will be available for the Q&A.
Speaker #2: 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 30 days.
Speaker #2: 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.
Given the accelerated timelines, we are also pulling forward our launch readiness, building on the significant progress we've already made over the last couple of years.
With our strategic collaborations across a variety of care settings and our Medical Science liaison interactions with kols. We've been very active in developing an extensive understanding of the commercial landscape and of Provider sentiment and Dynamics.
We've generated valuable learnings that we're incorporating into our launch plans, including insights into patient preference, patient flows and provider economics, which have helped us understand how concrete 60 will be differentiated from current and future treatment options if approved.
The learnings we've gained through our commercial work strengthen our confidence that 360, if approved, can be effectively integrated into the growing interventional psychiatry infrastructure and offer a differentiated and compelling treatment option for patients and providers.
With significant learnings already Incorporated. We are confident that we will be ready to launch on an accelerated time frame, which is great news for the estimated 3 million individuals in the US living with TRD.
Beyond TRD, we're also finalizing the design for a late stage PTSD trial following constructive interaction with the FDA.
We look forward to updating you further on that program in the near future.
As you can see, these are exciting times for Compass and we are focused on translating our progress into real world. Patient impact as quickly as possible as the need remains urgent.
With that, let me turn it over to Terry.
Thank you Kabir. At the end of September, we had cash and cash equivalents of 186 million compared with 222 million. At the end of the second quarter.
We have continued to be disciplined in our spending, which is allowed us to maintain our cash Runway into 2027.
Debt under the Hercules loan facility was $31.3 million at the end of the third quarter.
Cash used in operations for the third quarter was $35 million, and we expect net cash used in operations for the full year 2025 to be between $120 million and $145 million.
This range includes the amount receivable with respect to the R&D tax credit in the UK, the timing for which is uncertain.
As Kabir mentioned, our entire team is focused on strong execution, completing both of our phase 3 trials, preparing for our NDA submission and continuing our commercial preparation.
We have added resources to our regulatory team to ensure we're moving our NDA filing activities forward as quickly as possible. And we have also pulled forward, select commercial activities to meet our new accelerated timelines.
We are confident in the emerging profile for CAM-360 and its potential to transform the landscape for those living with PRD and PTSD through a potentially rapid and durable treatment option, reinforcing our leadership in the field of psychedelics.
As mentioned at the beginning of the call Lori Engelbert and Dr. Steve LaVine will also be available for the Q&A.
Thank you. And I'll now turn the call back to the operator for Q&A.
Ladies and gentlemen, we will now begin the question and answer session. I would like to remind everyone to ask a question, please press the star button, followed by the number 1 on your telephone keypad,
If you would like to withdraw your question, please press star 1. Again 1 moment, please for your first question.
Your first question comes from the line of Josh Shimmer of cancer. Please go ahead.
Thanks so much for, um, taking the question and congrats on the the update and timelines. Um, quick question about the selection of specialty Pharma partner, you may use to um, kind of support patient access, uh, have you identified any that you had anticipated to move forward with and would there need to be any unique capabilities that they have in terms of um, offering those patient Support Services to psychiatrists to be interested in prescribing solo 7. Thank you.
Thanks Josh, it's good to be here. Just checking that you can hear us.
Yes, slide on clear. Hey Josh, it's Lori. Thanks, thanks for the question. Um, we have not made a selection, yet it's a little bit too early, uh, to to do that. But as Kabir mentioned in, in the opening remarks, we have, you know, done quite a considerable amount of work already in terms of understanding, what the distribution pathway might look like to these treatment centers and how that might flow. And now that we're starting to accelerate some of those activities, he can expect that we will start narrowing down what that looks like um, in the coming months.
Regards to your question about any, you know?
Special requirements. Again, we're we're looking through what, what, that might require in terms of how we will support patients. Um, once they get, you know, once we get to Market, uh, but there should be nothing unique that's psychiatrist. Well, are not are, are familiar unfamiliar with
Cam 360 into into the 6000 or so sites capable of delivering provider currently. Thank you.
Hi Josh. Thanks for that question. It's Steve Levine. Uh, you know, the short answer is that we would expect that any site that is delivering spread out. Today would be capable of delivering comp 360. If approved, that doesn't mean that it's necessarily 1 for 1 in the implementation, but it's exactly why we're doing the work. We are with the, uh, the collaboration sites. Our strategic collaborations to understand what any incremental changes might be needed. But in terms of the physical infrastructure, the Staffing, the capabilities, those all Port over directly from their current experiences.
Okay, thank you so much.
Your next question comes from the line of Paul Mates at Stifel. Please go ahead.
Uh, great! Thanks so much for taking a couple of our questions; we appreciate it. So, as it relates to this FDA meeting, I think you said previously that the thought was you were only going to be sharing with the agency the same level of granularity on the 05 data that we've seen, and I think you still maintain that as well. To that point, do you feel like there's the need to have another FDA engagement after you release this much more detailed data early next year? And then, I guess as a second question related to that, can you help set up what your expectation is when we see the 26-week data? And what do you think would be a positive outcome?
Um on either the frequency of retreatment or response rates for retreatment that would align with your target product profile as it relates to how what you're looking for for durability and just kind of the commercial sort of viability and scalability. Thank you.
Thanks Paul. So yes on the first when you're right from a data perspective, um we have no more data in hand but clearly we were able to share with the agency some of what we've announced today in terms of timelines where we were with those 6 and so on. So there was there was information that we were able to share at that point with them um to your point. Absolutely. We would expect with the the significant data readouts in quarter 1 that would indeed be the point for another meeting with the agency. Really to
align fully on the plan going forward, in terms of rolling submissions, what's going to be reviewed when and so on? So yes, that is absolutely the case.
For the profile. I actually hand to Lori to talk a little bit about that and again, though, I just remind you contextualized. We are now going to be announcing 26 weeks from over 5 together with the 9 week data from all those.
Yeah. Hi Paul. Thanks for the question. So what we expect to see, and let me just remind you
In order to achieve you know equivocal um efficacy to spread patients need to receive 8 to 10 treatments to our 1. That was already a demonstrated at the 6 week time plan.
So already we are quite differentiated from what's available to prb patient.
Right now.
Everything we see in the 26 week data, um, will only, uh, you know, help accentuate what the clinical profile of the product is going to be and I do want to just caveat that the 0526 week data that we will release in quarter. 1 is after 1 Administration, we 2 Administration that we will see with 06. We will also really um be looking forward to what that profile looks like at the 26th week data for 06.
In terms of commercial viability, you know as I mentioned we're already highly differentiated with 1, you know 1 Administration getting such um you know profound efficacy in a TRD indicated population.
Um, so anything on top of that September durability will will always help potentially like that product profile.
Your next question comes from the line of food from Morgan's family. Please go ahead.
Yeah. Hi, good morning guys, and congrats on the progress here, I'm just curious, if, if any of the interactions with FDA, um, included conversation, around submissions for the commissioner's priority review application. I, I think you had said at some point you did have interactions um, with the agency on that submission and and if not, you know, has the agency pointed toward TRD versus PTSD PTSD, in any way, being higher areas of of unmet need in their view. Thanks.
Yes. So um, thanks, dude. Yes. We as we've said before, we did apply for a cmtv but we know that hundreds perhaps thousands of companies applied for cmtd. Um there was some interaction but obviously we've seen the first list. Um, we're aware of the commissioner has said that there may be more coming. Um, but really I think, you know, our discussions have been with the division and that's where we've had the very positive feedback that there is momentum there and so on.
Yeah from uh from an agency perspective, I think they see both TRD and PTSD as areas in desperate need of new options for patients. I don't know that, you know, at the agency level as opposed to shall we say the political level, there's any distinction there, we are. Clearly the most advanced with our program which is in TRD. And you know that's
I think we have a a very good relationship and good, understanding of the urgency of trying to move that forward subject to data.
Okay, maybe just a quick follow up any um, interaction or commentary from the VA, um, Within These agency conversations or those kind of way on on their decision-making there. Thank you.
So I I don't think we could comment on how the VA and FDA interact. But I'll turn to Steve to talk about our interactions with the VA kind of independent of that. Thanks. Yes, we have regular engagement with the VA in half for quite some time now. Uh, the better year year and a half ago, the VA can be integrated project team. That is specifically tasked with thinking early thinking and planning for the inflammation of implementation of psychedelic treatments, if approved and that includes senior VA leadership within the office of mental health we engage with them on a regular basis. Uh we uh provided many resources for them to help guide their thinking about what they will need to ensure that there is access within the VA upon approvals. Excuse me.
And so that's in a very positive set of interactions.
Your next question comes from the line of Gavin Clark Carter as every core isi. Please go ahead.
Hey guys, congrats on the update and thanks for taking the questions.
So, by presenting the o6 data at 9 weeks, do you risk the Integrity of this study in any way? Like, I know that was part of FDA discussions previously. So I'm curious what led Regulators to, um, change their stance and also curious. If I presenting this data at the earlier time point, do you lose the commercial ability to make claims around the durability of the 2 dose regimen?
No. So to be clear, Gavin. I mean it was our choice in the past you'll recall that we actually changed guidance from disclosing part A of 06 to only disclosing the 26 week data in the light of shall we say a lot of the confusion and commentary around like us at the time, a few things are clear. At first, when he was given the crl was published, it actually does not focus on functional on blinding and expectancy. As a key issue, there were a whole lot of other deficiencies as well.
Second, we will actually have the vast majority of patients through part, B of 006 by the time we disclose data from part A and in our perspective that does not in any way compromise, what we may see in Part B, which would also be integral to claims. I don't know. Laura, if you want to just build on that. No, I agree. And just a reminder, you know, it is double blinded through 26 weeks. So as we, you know, present that data to to the agency, there should be
Uh, no hesitation in terms of how we can promote.
All right. Great. That is super helpful and just a separate topic. What's your current assumption for how the label or the rims May read on monitoring requirements? We specifically, I'm wondering if, um, a single versus a group room, maybe choir required in a 1, healthcare provider can monitor multiple people simultaneously? And if any of this was discussed on the type B, thanks so much.
Thanks, Kevin. Hi, it's Steve Levine. It's a great question. Uh, I think you know what you should anticipate is that the label or rims will not necessarily get into granular, detail about the practice of medicine and the delivery of treatment to patients so much as describing how the studies were conducted.
It would be expectable that at the time closest to launched, most sites would likely deliver this treatment in the most conservative way possible. With, you know, 1 patient occupying, the private room as Privado was often delivered today but also, you know, taking lessons from. So it's also likely that as clinicians gain more experience and comfort with delivering comp 360, they likely will find additional efficiencies in, delivering it. And that could include group Administration, uh, it could include, uh, you know, rooms with curtain days, Etc. Ways that allow them to move patients, sufficiently through their centers. And this is also work that, you know, we would've been exploring in some early work with our strategic collaboration.
Thanks guys. Congrats again.
Your next question comes from the line of V2. Burrell of TD Cohen, please go ahead.
Thanks for taking the question. Could you please review the state of your commercialization preparation for 360 and provide more color on what activities you pulled forward, given the accelerated timelines? And then, I have another follow-up.
Thanks Sabina. I'll hand that to Lori. Hey uh, thanks for the question. So as Kabir mentioned, in the prepared remarks, we have done some really incredible work over the past couple of years, specifically with our strategic collaborations, um, as well as our msl's and then a whole host of other, you know, critical components um of a of a commercial preparation, such as Government Affairs, h, o r. We've done some Market access work, all of that to get prepared for a real solid understanding of what the strategy should be. What that actually means is that we understand, you know, the marketplace landscape. We understand what the prescribers who the prescribers are, where they are, how we might want to uh, ensure that they can seamlessly integrate comprehensively into uh, into their treatment practice as it stands today.
What we will pull forward and start shifting to is your more fundamental, traditional commercial activities like marketing messaging figuring out how to structure a sales force. Uh getting an IT infrastructure set up and and prepared to ingest data um as the sales reps are out in in the field and of course a lot of that comes with also some Market access and and pay your discussions um around the potential to reimburse the product.
Um so we are pulling those forward by several months and obviously a lot of that will will be contingent specially. The payer discussions will be contingent upon um the durability data and a complete understanding of what Co 6 data looks like. So that we can put together a very nice picture for what the full clinical profile of conversation will be to engage in the paired discussions. But a lot of that does not contingent upon doing marketing activities and Salesforce sizing and things like that to to prepare.
So we will be ready based on the fact that we have a very strong strategy in place. Um and we are just going forward some of these, the execution activities.
Got it. Um, and on the filing, are there any outstanding drug? Like drug lighting requirements that are needed or ongoing? Um, and when can we expect those to complete?
No. So, um, as we've said on the call, we would we do expect 26 week data from 006 to be the final gating items. So everything else in terms of pre-clinical CMC, stability, Etc, will be well in hand before all that. So know if there are going to be no other art schedule works,
Got it. Thank you.
Your next question comes from the line of Patrick Trio of HC Wainwright. Please go ahead.
Thanks, good morning. Um the first question is just on the type B meeting with the FDA I'm wondering if there was any change from, you know, um what had been discussed previously or just has the you know, agency's tone or the way that they're talking to you about comp 360. Has this changed from what you've heard previously and particularly as it relates to the potential for the rolling submission, and how we should think about that. And then I have a few follow-ups.
Yeah, no, thanks Patrick. So, yes, I mean, I think it said first, as we consistently said, we have an excellent relationship with division. We've had breakthrough designation now for a number of years, that's allowed us to have regular dialogue. I think it's been clear for some time, so, the division sees the potential in psychedelics in cam 360, they see the need but at the same time, they're going to adhere to exactly the same high standards and they always have and we're very happy with that. And we will continue to uphold those standards.
but yes, I mean traditionally psyche has perhaps not been
As forward-looking in terms of rolling submissions and so on as some other divisions. And so in that sense, there was, you know, as we said encouragement, a very positive spirit around the meeting and so in that sense something of a change in tone. But again in the context of the relationship that's always been excellent and a very supportive division
What proportion of those would be certified and able to deliver comp 360.
Okay. So that last 1, I will have Stephen a moment, um, but the question around, so obviously it's the fda's determination as to whether or not they want an advisory committee and that will depend on when they actually receive data.
Reviewed package. All I can tell you is we will be ready. Um we are anticipating that that may happen and we will be ready for that.
I think clearly, um,
Who has access to the Leos cro, which is helpful, but as we've always said, we have done a comprehensive job of collecting side effects. Including positive. Shall we say side effects Euphoria and so on. So, I think we have the data to characterize the risk, benefit of calm free 60 in the way, you would expect of any drug.
In addition, as we've said, the person in the room is there for safety. It's uh, it's not a, they're not there to direct therapy or to intervene they are there for safety. We have had that them trained to a very standardized protocol consistent across every arm of each study. And as we've talked about before as well, we are doing some sampling of that to ensure that that's in line with the education, we've given them and so on. So I think you know, obviously As Time evolves we will look at our strategy, look at everything. We're preparing in in relation to the specific concerns that were raised by the agency either in
The case of loss and other ones, but we will be ready for an advisory committee. Whatever happens.
You see? Yeah, this is Steve Levine. And as far as the second part of your question, about the Readiness of these bravado, Interventional infrastructure to deliver comp 360 at launch we see in our strategic collaboration. So already is a high representation of this concentrated delivery Network that delivers from Auto today.
Uh but Additionally, you know the bidirectional information exchange that happened within these collaborations helps us to not only understand how to best support these sites and patients that these sites so that they can be activated to deliver our treatment.
But because they share characteristics with other Interventional, Psychiatry practices. Uh, it allows us to build templates to also be ready to support them. But you'll also note that this network of collaboration isn't exclusively Interventional. Psychiatry it, really reflects the diversity of sites of care where patients, living with treatment, resistant, depression receive their care today and although we would expect that some of the earliest adopters would be the Interventional Psychiatry sites. We are committed to Broad and Equitable access and that means enabling access in a in a broader array of treatment sites.
Great. Thanks so much.
Your next question comes from the line of sumo carne of caner genuity LLC. Please go ahead.
Good morning. Nice to see all the progress, and thanks for taking your questions. I have a couple as a point of clarification. What is the key variable that has allowed you to bring forward? Your timeline for commercialization by 9 to 12 months? Is that related primarily to an ability to submit an NDA for comp 360 for treatment resistant, depression ahead of your original plans, or is it something else? And second is it fair to assume that you would need to have the party from comp 00006 and Part B from comp 0005 in hand to initiate a rolling NDA submission.
Thanks so much. So, um, a couple of things. First, clearly the completion of 006 enrollment that has come ahead of expectation. So you you'll know that we were guiding until now for second half of 26 for the 26th week data from OSX. So we've now tightened that to early Q3. So we've gained a number of months there from there and you know, clearly
06 has gone extremely well particularly over the course of this summer with European sites in particular for performing very strongly. So a big chunk of the acceleration comes from our execution, on 06 part of it, then does come from the potential to have the agency. Start reviewing of some modules in line with
A typical rolling submission. Whereas you know you can submit preclin and CNC and so on ahead of the full package of clinical data. So there were clarifications around that if needed
But yes to your points. You know, as and the earlier question, we would expect another meeting with the agency in quarter 1. With the data, the 26 week data from 05, and the 9 week data from 06 in hand.
That we would expect to be another meeting, which would actually kind of formalize, the plan.
For closing remarks, please go ahead.
Thanks everyone for participating. Today as you've heard, we are extremely excited about this potential acceleration of 9 to 12 months really based both on our execution around 06 also the a good positive dialogue. We've had with the agency as well as the decisions we've made about unblinding 06 data in the first quarter of next year.
I I remind you again that we will be talking about PTSD and due course we're excited about that. We have actually now finalized the protocol on that we have selected a cro they the protocol is with them for costing and so on and so we look forward to announcing that and in getting on with that with the potential to have first patients and that in first quarter of next year as well.
So, very exciting times for Compass. We're thrilled with where we're at. We are ready to move on. That accelerated timeline as you've heard from Lori and Steve as well. Today, a lot of activity on the commercial front building on the learnings we already have. So, we're looking forward to a very engaged and active next 12 to 15 months, thanks everyone for taking part today.
Ladies and gentlemen, this concludes today's call we thank you for participating. You may now. Disconnect