COMPASS Pathways Q4 2023 Earnings Call Transcript

Quartr
Provided by Quartr
February 29, 2024

There are 12 speakers on the call.

Operator

Good day, ladies and gentlemen, and welcome to the Compass Pathways 4th Quarter 2023 Conference Call. At this time, all participants are in a listen only mode. As a reminder, this call is being recorded. I would now like to introduce your host for today's call, Stephen Schultz. You may begin.

Speaker 1

Welcome all of you and thank you for joining us today for our Q4 2023 results conference call. 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 Mary Rose Hughes, our Interim Chief Financial Officer Terry Luxom, our incoming Chief Financial Officer and Doctor. Guy Goodwin, our Chief Medical Officer. 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 archived for a period of 30 days.

Speaker 1

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 ks filed with the U. S. Securities and Exchange Commission and in subsequent filings made by Compass with the SEC.

Speaker 1

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.

Speaker 2

Thank you, Steve. Good day, everyone, and thank you for joining us. Let me begin by thanking Mary Rose Hughes, our Interim Chief Financial Officer, for her tremendous support over this last quarter. And let me welcome Teri Locksmith back from climbing Mount Kilimanjaro and into the CFO role starting tomorrow, March 1. Teri brings to Compass deep, extensive strategic experience working for publicly traded companies in the pharmaceutical and biotech sectors.

Speaker 2

Her broad experience through all stages of development is precisely the expertise and leadership that Compass requires as we progress our Phase 3 program in treatment resistant depression. Many of you already know Teri and I hope that over coming months, the rest of you will have the opportunity to meet her. And in a moment, I'll ask her to provide a few thoughts on her new role at Compass. First, though, let me report that Compass continues to actively recruit both our Phase 3 COM360 trials in treatment resistant depression, with top line data expected this year and next. While our overall Phase 3 clinical program completion remains on track with top line data from the 6 study expected in the middle of 2025, we are experiencing some recruitment delays in the five trial, which extends our guidance for top line data from that trial into quarter 4 of this year.

Speaker 2

Importantly, this change in guidance does not impact expected timing regarding submission of our NDA filing. As we've consistently guided, we do expect that both trials will be required for NDA submission consistent with the FDA's draft guidance for the development of psychedelics published in June last year. We will also have all necessary preclinical and clinical pharmacology studies for a complete NDA dossier. In parallel with the Phase 3 trial program, we continue to take the steps needed to ensure a well developed delivery network for COMF360, if approved. This includes developing collaborations that will educate both COMPASS and settings of care on how COM360 may fit into treatment options for appropriate patients.

Speaker 2

A key element of these research collaborations is to explore and develop multiple potential commercial delivery templates to ensure a successful rollout of COM360 treatment subject to FDA approval in different care settings. Earlier this quarter, we announced the first two such collaborations with Greenbrook TMS and Hackensack Meridian Health, which are 2 very different but equally important collaboration partners. These collaborations will explore how to improve the patient care experience and gain a better understanding of potential commercial models for the administration of COM3 50 psilocybin treatments. We also expect to announce additional research collaborations this year. December, we announced initial safety data from our open label Phase 2 clinical trial of a single 25 milligram dose of COMF360 in 22 people living with post traumatic stress disorder or PTSD.

Speaker 2

We were also pleased to see the publication of COMF360 data from an investigator initiated study in bipolar type 2 in JAMA Psychiatry. In a moment, Guy will provide more information on both of these studies. While TRD is our lead indication for COM360, we see logical expansion of its utilization into additional indications where there are significant comorbidities and overlap, such as PTSD and bipolar 2, subject to additional financing. With that, let me now ask Teri to introduce herself and share a bit about why she came to Compass.

Speaker 3

Teri? Thanks, Kabir. Now that I'm back at C level, I'm really happy to be joining you in this experience and pioneering leadership team. Similar to many, I've sadly witnessed the impact of mental health issues on people close to me. So a big draw for me to the company was seeing Compass fully embracing its mission with a thoughtful, innovative and data driven approach to tackling significant unmet need in this area.

Speaker 3

Psychedelics and their potential to treat mental health conditions have received significant attention in the media, but we are still very much just at the beginning of this journey. While psychedelics could be transformative to mental health, in these early days, it is critical for companies to build and execute robust clinical trial plans to realize the long term potential. This is precisely the approach Compass has taken with its large Phase 2 and ongoing Phase 3 programs in TRD. There are a lot of important milestones over the next 12 to 18 months for the company. And with a strong balance sheet and an experienced team, we are well positioned for success.

Speaker 3

I'm really looking forward to working with the team to help shape the landscape and prepare for this potential important treatment option for patients. With that, let me hand the call back to Spiro.

Speaker 2

Many thanks, Terry. Welcome once again, and it's great to have you join our leadership team. Let me now hand the call over to Guy to update you on clinical news during the quarter. Guy? Thank you, Kabir.

Speaker 2

Looking at the COM360 pivotal program, nearly all sites have been initiated for COMF-five. For the 6 trial, we have sites initiated in the U. S, Canada, UK, Ireland, Sweden and Spain. I anticipate further progress this year. Patient demand is strong in all geographies, which as expected, reflects the degree of unmet need in this population.

Speaker 2

However, as Kavira said, we are experiencing delays in recruitment in our 5 trial. As we've said before, these trials are complex. Beyond the Schedule 1 drug authorizations and unique handling requirements and redosing protocol, we are formally confirming every patient's TRD diagnosis, an important element to the quality of this program. This has been a challenge that medical record keeping is decentralized in the U. S.

Speaker 2

And has slowed the pace of screening and enrolling. However, now that nearly all 5 sites are open and with the addition of resources, we will see an increased pace of recruitment, which should help improve enrollment. The challenges we have encountered are specific to U. S. Clinical sites.

Speaker 2

And as Kabir mentioned, we don't see the same impacts to COMP-six, a global trial, which remains on track. Separately, we're also excited by the potential for COMP-three sixty in other indications. PTSD is an additional indication of interest, which we have investigated in an exploratory Phase 2 safety study of 22 patients, all of whom were administered a single dose of 25 milligrams COMP360 sirothiban. We announced initial safety data in December, which demonstrated that COM360 was well tolerated up to 24 hours and the safety profile was as expected with no treatment emergent serious adverse events recorded. The study participants have been followed for 12 weeks, and we look forward to announcing the full PTS data set, including efficacy later this spring.

Speaker 2

In addition, as Kabir mentioned, the full results of an independent investigator led study in bipolar type 2 depression were published in JAMA Psychiatry. These data first announced in 2022 demonstrated the potential for investigational COM360 psilocybin treatment in another difficult to treat depressive disorder. The study was conducted by Scott Aronson at Sheppard Pratt in Baltimore and funded by COMPASS. It investigated the safety and efficacy of a single 25 milligram dose of COM360 silicilent treatment with psychological support. The primary endpoint was change in MADRIS total score from baseline to week 3.

Speaker 2

All 15 participants had lowered MADRIS scores with a mean change from baseline of minus 24 points at week 3. 12 participants met the criteria for response and 11 met the criteria for admission. While this is a small trial, we see the results as extremely promising. Importantly, there was no increase in the suicidality score based on MADRS and no unexpected adverse events or difficulties with the dosing sessions over the 12 weeks of the study. We did not see the onset of a manic, hypomanic or mixed state, which is a particular concern for patients with bipolar disorder.

Speaker 2

The most common adverse event was headache reported by 4 out of 15 participants on the day of dosing with symptoms resolving within 24 hours. People living with bipolar 2 depression, like those living with TRD, have limited or no options. So it's encouraging to see early signal that COM360 psilocybin may have potential to help those living with these depressive conditions. As Kabir indicated, based on this study's results, bipolar type 2 looks to be an indication of interest for the use of COM360 and additional larger studies are under consideration. This is a good fit with our mission as a company.

Speaker 2

Let me now hand the call to Mary Rose for financial overview. Mary Rose?

Speaker 4

Thank you, Guy. I'll now step through the full year financial results. Cash used in operations in the full year 2023 was $97,400,000 within the guidance range we provided for the full year last quarter of $94,000,000 to $100,000,000 excluding the R and D tax credit. The timing of receipt of the credit is uncertain, but I'm pleased to confirm that HMRC have since approved our claim in full and we now anticipate receiving the tax credits in the first quarter of this year. For the year ended December 31, 2023, net loss was $118,500,000 or $2.32 per share compared with a net loss of $91,500,000 or $2.16 per share during the same period in 2022.

Speaker 4

These results include non cash share based compensation of $17,300,000 in 2023 $13,100,000 in 20.22. R and D expenses were $87,500,000 in 2023 compared with $65,100,000 in the prior year, and G and A expenses were $49,400,000 in 2023 compared to $45,400,000 in the prior year. Long term debt under our Hercules loan facility was $28,800,000 at the end of the 4th quarter. Regarding Q1 financial guidance, we expect net cash used in operations to be between $17,000,000 $23,000,000 which assumes that we received R and D tax credit in the Q1. However, as I've mentioned already, the timing is uncertain.

Speaker 4

Turning to full year financial guidance. We expect cash used in operations to be between $110,000,000 $130,000,000 We expect to narrow this range as the year progresses. Compass continues to maintain a strong financial position with cash and cash equivalents of $220,200,000 at December 31, 2023, compared with $143,200,000 at December 31, 2022. We will continue to manage our cash carefully to continue advancing our pivotal programs and to achieve important milestones that we believe will create value for our shareholders. Thank you.

Speaker 4

And I'll now turn the call back to Kabir.

Speaker 2

Thank you, Mary Rose. I'm pleased that we're seeing continued enthusiasm and meaningful momentum building for both COMPASS and this area of science. Our COM360 Phase 3 program remains on track with the first trial expected to read out this year, not only a key milestone for COMPASS, but also a major event in the development of psychedelic medicines. The FDA's draft guidance for clinical studies of psychedelic drugs, along with the European Medicines Agency's plans to establish regulatory guidelines for the development and therapeutic use of psychedelic substances in Europe are important signs that regulators are preparing for the potential use of psychedelics as treatment. In a sign of the continuing unmet need in TRD, esketamine sold under the brand name Spravato achieved global sales of almost $700,000,000 in 2023, which demonstrates the continued growth of interventional psychiatry and the infrastructure to deliver it, which bode well for the potential of COM360 if approved.

Speaker 2

We also welcome the news of FDA acceptance of LICOT's therapeutics NDA submission for MDMA assisted therapy for PTSD. We're seeing increasing interest from clinicians who plan to incorporate psilocybin treatments into their mental health offerings. Our collaborations are indications of this interest and we'll continue to develop commercial models that enable rapid, scalable, broad and equitable access to COM360, if approved. In closing, with our strong balance sheet, we are focused on execution of our Phase 3 program in treatment resistant depression. This will be an exciting year for Compass Pathways, and we look forward to updating you on our progress over the coming year.

Speaker 2

Thank you again for your participation on today's call. And we'll now turn to Q and A. So I will hand the call back to the operator. Thanks.

Operator

Thank you. Our first question comes from Patrick Trucchio with H. C. Wainwright. Your line is open.

Speaker 5

Thanks. Good morning. Just a couple of follow-up questions enrollment delays. So the first is just regarding the TRD diagnosis being necessary for enrollment in the program. Can you remind us how you're defining TRD and confirming this diagnosis in patients who are enrolling the program?

Speaker 5

And secondly, can you tell us what proportion of patients are expected to have experience with psychedelics?

Speaker 2

Thanks, Patrick. Just checking if you can hear us and I'll hand it to Guy.

Speaker 5

Yes. I can

Speaker 6

hear you.

Speaker 2

Thanks. Hi, Patrick. Yes, I mean, our criteria are those of treatment resistant depression, as you know, and that means that patients are required to have failed at least 2 treatments. These treatments have to meet the criteria for adequate dose and adequate duration. And the delay that you referred to is caused by the fact that we are being very rigorous in establishing this, that this has occurred through health records.

Speaker 2

And that in the U. S. Has proved to be difficult but not impossible, and we're proceeding successfully to do that in the patients we are recruiting. I should say there's no shortage of patients, but the issues around verification have been real and those are what have caused the problem. But the same of patients who may have been previously taken psychedelics, we were we've taken that number up from 10% in the Phase II to 15% in the Phase III.

Speaker 2

And just to emphasize, one of the issues that we face is that patients conceivably or patients people seeking treatment may be seeking psychedelics. And that's one of the reasons why we're particularly rigorous insisting on the medical records being proven and verifiable. Thanks very much.

Speaker 5

Got it. If I could, just another follow-up. I'm just I'm wondering if this just moving this top line data back for COMF-five trial, is that would that have any impact on the potential filing of an NDA for TRD or is the timing kind of going to be unchanged based on the top line data for the 6 trial? And separately, I guess maybe if you could just talk us through what data would be anticipated in the NDA? Specifically, would you have any certain amount of longer term follow-up efficacy or safety data from these trials before that NDA is submitted?

Speaker 5

Thanks so much.

Speaker 2

Thanks, Patrick. So I'll work backwards from that question. We have not clearly guided on what we are going to expect to include in initial submissions. That will be a valid discussion with the agency. But as a reminder, with breakthrough designation, you can clearly envisage things like rolling submissions as well.

Speaker 2

To the first part of the question, Noah, as I said in my prepared remarks, this does not alter the potential timing of a filing. 6 remains on track for mid-twenty 5, and we have always consistently guided that we do expect both trials to be needed to form an adequate or acceptable bronchitis. So no, we are not anticipating any change in the timing of the dental submission.

Speaker 5

That's helpful. Thank you so much.

Speaker 2

Thanks, Patrick.

Operator

Thank you. Our next question comes from Charles Duncan with Cantor. Your line is open.

Speaker 7

Good morning, Kavir and team. Thanks for taking the question. I wanted to follow-up to those last questions with regard to diagnosis of TRD. Can you help us understand how it's different in the United States versus elsewhere? And what percentage of patients are you anticipating in 6?

Speaker 7

And why will the problem be fixed in that trial? Thanks.

Speaker 2

I mean, I think that the problem in the U. S. Is simply the nature of the health care system is being simply more decentralized. This is in great contrast really to particularly European health care systems where usually healthcare records are extremely straightforward to access. For example, most patients in the UK have a primary care physician.

Speaker 2

To get health records, it's simply a matter of contacting the physician with appropriate consent getting the record. So there's a great that's a tremendous difference from what we have to say for each day. I think in terms of your second issue is about what was the second issue? So in terms of the number of patients Oh, 6. Yes.

Speaker 2

I mean that issue relates I mean, we think that we will be in a position having set up the systems that we now have to facilitate getting the data that the fact that 6 is taking place subsequent in most centers to 5 means that everything will really be running optimally by the time many of the U. S. Sites switch to 6. The patients entered on in ex U. S, of course, are not subject to the problems anyway.

Speaker 2

And we think the proportion, I think you also requested, will be about fifty-fifty. And we can when we model it, we think that this is we're on track, as we said, for 6. And the problems with 5 are really harder to do with the fact we started 5 first in U. S.

Speaker 7

That That makes sense. If I could ask one follow-up and that is, can you help us understand the screen failure rate if you're tracking that at all? But then also are you having any challenges with washing patients out before of standard of care, albeit ineffective, antidepressants before they enter 5?

Speaker 2

I mean, there are that represents the washout represents a challenge, but the most of the problem has been with the verification of the diagnosis. So that having 1, our Phase II trial, about onethree of the patients in that study were already off antidepressants, so twothree required washing out and the majority, great majority were able to do so once they had been enrolled in the study. But it's enrollment that has been the issue in 5.

Speaker 7

Got it. Thanks for the added color.

Operator

Thank you. Our next question comes from Francois Bridgewis with Oppenheimer. Your line is open.

Speaker 8

Hi. Just a couple here. Just sorry to ask again about the enrollment. But is the 4th quarter guidance just a very conservative? Or how do we feel comfortable that 4th quarter will be correct for 52?

Speaker 2

Thanks, Brad. We are very comfortable with that. As you would expect, we've done a number of projections, looked at different scenarios, and we are very comfortable with the Q4 guidance.

Speaker 8

Okay. And then on the commercial side, the SPRAVATO infrastructure obviously had some read through here. Can you just remind maybe us, the listeners that how SPRAVATO works? How many times people come in? And are there any efficiencies maybe for these centers that would put you in a situation that might be superior to SPRAVATO?

Speaker 8

Just any learnings there? How has that evolved as you guys look into the commercial opportunity?

Speaker 2

It's a great question. So yes, clearly, the protocol for SPRAVATO is very different from what we envisage to be a final protocol SPRAVATO. So as a reminder, the SPRAVATO label actually requires 8 administrations in the 1st month, 4 in the 2nd month and maintenance thereafter patients and physician discretion, but typically every couple of weeks. So you can imagine, therefore, over the course of the 1st 3 months that something like 12 to 15 sessions, Each of those requires the patients in the clinic for a minimum of really 3 to 4 hours given the intranasal administration and the 2 hours of monitoring. And by the way, they can't drive at home afterwards, so it actually requires a caregiver for each of those as well.

Speaker 2

In contrast, obviously, we don't yet know what the durability will be for, shall we say, a typical patient with COM360 and the Phase III is designed ready to address that. But as we've said before, based on what we know, it perhaps might be 2 to 4 administrations a year for a patient. So you can see that from a patient perspective, that's a very, very different. From the room center, it's the difference between using one room for a day, once every perhaps 3, 4 months and actually having multiple uses of rooms during the course of time for Xfinity. So we believe and we are a big part of the reason we've signed these collaborations with entities such as Greenberg and Hackensack and we'll do more is exactly to understand how we are going to integrate psilocybin differentially from SPRAVATO into those workflows and see how they address reimbursement.

Speaker 8

Great. Thank you very much. Congrats on the progress, sir.

Speaker 2

Thanks,

Operator

Frank. Thank you. Our next question comes from Neena Petrido Garg with Deutsche Bank. Your line is open.

Speaker 4

Hey guys, thanks for taking my question. So I just wanted to ask about the enrollment again. And I just wanted to confirm what kind of if there are any actions that you can take to really maybe accelerate the reviews that you're doing to confirm diagnosis? Is there anything that you've actually been able to do that you found has been helpful in accelerating that process in the U. S?

Speaker 4

Thanks.

Speaker 2

Yes. In a word, that have and we have taken those mitigating actions. So we have added specific vendors who are able with patient consent to work directly with patients and to obtain the medical record. So what we have seen is that, that does enable us, certainly in some circumstances, to obtain those records much more quickly than going just through the motions ourselves or with our CRM. So yes, we have added specific paid for vendors, a couple of different ones in fact to enable that at the majority of sites.

Speaker 4

Okay, got it. Thank you. That's helpful.

Operator

Thank you. Our next question comes from Ritu Baral with TD Cowen. Your line is open.

Speaker 9

Good morning, guys. Thanks for taking the question. Kabir, are you anticipating that this delay and this sort of going back and reconfirming TRD is going to change the patient demographic in any way shape or form? Is that sort of coming out different and how might that affect the potential powering or potential perceived expected placebo effect in the study? And the follow-up to that is, have you determined what you are going to release with top line data at the end of the year, specifically longer term follow-up and durability?

Speaker 9

And then I just got a follow-up on the centers.

Speaker 2

So let me start, but I'll also ask Guy to weigh in on the 3rd part of the question. So to be clear, this does not in any way represent a change to the inclusion criteria, nor in fact is this a change from what we needed to do in Phase IIb. But a couple of things to point out. First, obviously, the Phase 2b was only partly in the U. S.

Speaker 2

It was ultimately a global study. 2nd, I think we do think it's relevant that Phase IIb, 1 and 6 have 3 doses of active, 11025, whereas in 5, there is a real placebo. And clearly, from a patient willingness or a patient incentive to enroll, that is a significant difference between 5 and both 1 and 6. Go ahead. I don't know if you want to add anything on that.

Speaker 2

Yes. I don't think that the track I mean, as you heard, the vendors that we hired are there because this is a general problem. It isn't just our problem. Our definition hasn't changed. And so our considerations around power and placebo response are unchanged as well.

Speaker 2

So it's just a delay, and we think we've overcome some of the factors that contributed to it now. And for the second part of the question, Ritu, as you are very well aware, this is a blinded trial through Part B through 26 weeks And therefore, determining what we will be able to announce with top line is something that will be a matter of review at that time.

Speaker 9

Got it. And then a follow-up question. You mentioned multiple delivery templates when you speak of your collaborations with Greenbrook and Hackensack, and you mentioned that you're working through options. Are there any sort of buckets of different templates or particular aspects of delivery that you are, I guess, building out and investigating with those 2, sort of like just large phenotype different phenotypes of delivery models that we should all be thinking about at this point?

Speaker 2

It's a great question. And what I would say is the work we're doing is precisely to understand how many different phenotypes of delivery, shall we say, that we're going to need. And so if we take these first two, obviously, Greenbrook and Hackensack are very different. Greenbrook is a for profit network of interventional psychiatry centers that is essentially today offering TMS, Ketamine, SPRAVATO, but very interested in offering psychedelics as well, but have only kind of recently branched into, I would say, more traditional psychiatric treatments. And therefore, how this will fit, they already have physical infrastructure for the delivery of these things.

Speaker 2

So working out what works for them in that context may be very different from someone like Hackensack, which is an integrated regional health system with multiple sites that currently have different specialisms, but also basically a very large kind of tertiary care center with 300 beds, which is probably going to be at the heart of where they will treat secondary. So I think the reason we are doing this and the reason we you will see a couple more collaborations again in very different settings of care is exactly so that we learn what sort of different delivery models are required. And that would extend also to reimbursements. I think for instance, you can imagine some commercial centers might be very open to buy and bill. They actually fit very well with their economics and offer an attractive route.

Speaker 2

Health systems and so on, it's much more likely to be Part B rather than Part B. But these are the questions we want to answer.

Speaker 9

Got it. So each collaboration is going to represent a type of setting that is that has significant use in the U. S. Or EU. Is that the way to think about each of these individual collaboration?

Speaker 2

The way to think about it is they are deliberate. Obviously, there's a limit to the number we can do in the very pre commercial setting. And yes, they are designed to be sufficiently different that they can, as we say, allow us to develop 10 pay. But then in when we get to formal pre launch activities, if we're lucky enough to get there, that we can then take those templates to other examples of the similar settings. And that's the way the plan has been built.

Speaker 9

Understood. Thanks for taking the questions.

Operator

Thank you. Our next question comes from Sumant Kulkarni with Canaccord Genuity. Your line is open.

Speaker 10

Good morning and afternoon to the team. My welcome to Terry. It's great to work with you again. Thanks for taking my questions. The question is actually an additional indications for COM360.

Speaker 10

You've mentioned PTSD and depression in Type 2 bipolar disorder, but is there a reason why you've not specifically mentioned anxiety, especially given comorbidity depression? And are you collecting any anxiety related measures in your Phase 3 program? And just a bit of a follow on to that, how closely are you watching a potential competitor in Canexis program with psilocybin and GAD that reported Phase 2 data yesterday?

Speaker 2

Yes. Thanks, Amit. Great question. I mean, there's a tremendous I mean, there's a shared genetic origins for depression and anxiety, and so they're closely related. And most patients with depression have anxiety levels at least to some degree.

Speaker 2

We are, as you've asked, including anxiety measures, specifically the GAD 7 in our trials, and we did in the 1, and we published data on that already. So we certainly see antianxiety and anxiolytic potential with COM360. But in many ways, the presentation of anglage is usually in primary care. And we can't really see how COM360 would be kind of the stroke to treatment of choice under those circumstances. And for that reason, we have not gone for that in the first instance.

Speaker 2

But clearly, patients who have both depression and anxiety are probably the commonest phenotype around, and we think that there will be an advantage in treating that population on the basis of their depressive symptoms, but it's potentially treating their anxiety. I don't know whether you want to comment on the competitive difference. Only to say to Maggie, I mean, obviously, you're aware of this. I mean, it's a relatively small study in Australia, 10 to 2 patients, as I recall. But yes, acknowledge that, that was published yesterday and something that we will dig into more.

Speaker 10

Got it. Do the logistical hurdles in the U. S. That are leading to the slight delay contribute to a meaningful change in the financial outlay required for 5 and 6?

Speaker 4

It doesn't, Sumant. That's a great question as well. So, no, I mean, clearly, we've made some additional investments and we think it's important to

Speaker 8

do that, but not a

Speaker 4

material change. We still have runway until 2025.

Speaker 10

Thank you.

Operator

Our next question comes from Jason McCarthy with Maxim Group. Your line is open.

Speaker 6

Hey guys, this is Michael Okunovich on the line. Thank you for taking my questions today. So I guess to start off, I'd like to ask, are you using a more rigorous verification of the TRD diagnosis compared to the Phase 2b? And if so, what is the reason? Does this have to do with greater public awareness of psychedelics and their efficacy or just a factor of the larger U.

Speaker 6

S. Portion for the study?

Speaker 2

So no, we're not it is exactly the same inclusion criteria. It is the same population. It is, as I said in answer to an earlier question, I mean, partly it is the fact that this is 100% U. S. And also, I do think the nature of the arms of the study, this being true placebo as opposed to both 1 and 6 that have 3 doses of active drug, I think that also is a contributing factor.

Speaker 6

All right. And then just one more for me. I just wanted to see how closely you would be watching the Likos NDA process and potential subsequent approval. Is there anything in particular that you're looking for on the commercial reimbursement side that may help to inform your strategy for COM360?

Speaker 2

So yes, we will clearly be observing the regulatory process for Likos very closely. We wish them well and I think it's clearly premature to see how they're thinking through commercial reimbursement. But obviously, we recognize that there will be lessons from that progress both through the regulatory and commercial basis for us.

Speaker 6

All right. Thank you very much.

Operator

Thank you. Our next question comes from Elmer Piros with Robin and Renshaw. Your line is open.

Speaker 11

Yes. Good morning. I don't have a question related to the delay, but I have a question about the anxiety indication was mentioned that you are not focusing on it necessarily. But would you be interested in licensing COM360 to indications that are potentially of no interest to you?

Speaker 2

Thank you, Elmer, and congratulations on the new gig. That's an interesting question. What I will say is, in general, split indications are enormously challenging in my experience, particularly if you can't clearly identify a very different dosing paradigm and so on. So that's not something we have given any great consideration to. Clearly, if somebody comes with a very compelling proposal, we would listen to it.

Speaker 2

But it's not in general, it's pretty hard with a single molecule in my experience.

Speaker 11

Thank you. Thank you very much, Kabir.

Operator

Thank you. There are no further questions at this time. I'd like to hand the call back over to management for any closing remarks.

Speaker 2

Thanks, everyone, for joining. In conclusion, let me just say, again, our guidance for the overall timing of our Phase 3 program in TRD is unchanged. We are acknowledging and giving guidance around a slight delay into quarter 4, 2024 for top line data from 5, but our overall guidance remains unchanged. We continue to be very focused on execution in TRD and also, as we said, continuing to think about which other indications of interest would be the most compelling places to take COM3 16 there. So thanks very much, everyone.

Speaker 2

Thank you for your time and attention today.

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