COMPASS Pathways Q1 2023 Earnings Call Transcript

Quartr
Provided by Quartr
May 11, 2023

There are 13 speakers on the call.

Operator

Good day and thank you for standing by. Welcome to the Compass Pathways First Quarter 2023 Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. You will then hear an automated message advising your hand is raised.

Operator

Please be advised that today's conference is being recorded. Would now like to hand the conference over to your speaker today, Stephen Schultz. Please go ahead.

Speaker 1

Welcome all of you and thank you for joining us today for our Q1 2023 results conference call. Again, my name is Steve Schultz. I'm the Senior Vice President of Investor Relations at Compass Pathways. Today, I'm joined by Kabir Nath, our Chief Executive Officer Doctor. Guy Goodwin, our Chief Medical Officer and Mike Falvey, our Chief Financial Officer.

Speaker 1

The call is being recorded and will be available on the Compass Pathways Investor Relations website shortly after the conclusion of the call. Before we begin, Let me remind everyone that during the call today, the team will be making forward looking statements within the meaning of the Private Securities Litigation Reform Act 1995 as amended. You should not place undue reliance on these forward looking statements. Actual events or results This 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 quarterly report on Form 10 Q filed with the U. S.

Speaker 1

Securities and Exchange Commission and in subsequent filings made by Compass with the SEC. Additionally, these forward looking statements represent our views only as of today and should not be relied upon as representing our views We specifically disclaim any obligation to update or revise any forward looking statements even if our estimates or assumptions change. And with that, I will now hand the call over to Kabir Nas.

Speaker 2

Thank you, Steve. Good day, everyone, and thank you for joining us. During this past quarter, COMPASS Pathways has continued to make excellent progress With our COMF360 Phase 3 pivotal program in treatment resistant depression or TRD You may recall that on our Q4 conference call, We said that we expected the FDA to come back to us with comments on pivotal trial design amendments by March 20. We've now received comments for both the 5 and 6 trial designs. While I won't go into the details of our interactions with the FDA, I will say that the comments reflected an active and thoughtful dialogue.

Speaker 2

As you would expect, With a drug development program that has breakthrough designation, we will have ongoing engagement with the FDA more broadly over the whole course of the development program. The upshot is that we are continuing to execute both the 5 and 6 trials As described in our February conference call and importantly, with no changes to the trial design. We also continue to expect top line results for the 6 week primary endpoint for 5 in summer of 2024 And for 6 in mid-twenty 25. On the reimbursement front, The American Medical Association has accepted a current procedural terminology or CPT-three code for psychedelic therapies. This was a very welcome development and the result of a collaboration between Compass Pathways and MAPS Public Benefit Corporation.

Speaker 2

Once effective, the CPT code will provide physicians and other qualified healthcare professionals with a means to track the work involved and ultimately seek reimbursement for delivering psychedelic therapies. Existing codes can provide coverage for the preparation and integration sessions, but the new code We'll fill a gap and cover psychological support during administration. The full details of the code are expected to be released by the AMA in July this year and the code will go into effect when it's published on January 1, 2024. Currently, Clinicians are forced to use various different codes cobbled together to gain reimbursement for approved medicines that require observation or support during administration. This tracking code is a crucial step toward a single code that covers psychological support for therapies like COM360, subject to FDA approval, and it's a critical step towards obtaining reimbursement.

Speaker 2

This helps enable broad and equitable access and made available to the people who need them. Finally, we've continued our active engagement with biotech specialist investors. We've continued to communicate the depth and the progress of our programs and the strength of our value creation proposition In an area of significant unmet medical need, since the beginning of this year, we've raised roughly $28,000,000 from sales under our ATM facility, including a large block trade in April. With that, let me now hand the call over to Doctor. Guy Goodwin to provide further clinical updates.

Speaker 3

Thank you, Kabir, and good day all. Let me begin with a review of our COMPASS sponsored clinical program. In TRD, as you heard from Kabir, the Phase 3 program is progressing as planned and we are actively treating patients in both trials. We are pleased with the rate of opening of clinical sites. This is a significant achievement as it's a complicated process to ensure that clinical Slides are cleared to handle a Schedule 1 compound, are appropriately trained and can recruit suitable patients.

Speaker 3

This level of infrastructure is unprecedented and one that we believe represents a significant competitive advantage for Compass both in this and future programs. Once sites are past this stage, they are better able to concentrate on recruitment and patient management. I would therefore expect to see continued progress and acceleration on those fronts. Beyond treatment resistant depression, our Phase 2 studies in PTSD and anorexia nervosa Continue to progress well and are on track. In the anorexia nervosa study, we told you on our last call that we had encountered some challenges In getting patients into and through the screening process, I'm pleased to report that we are now making excellent progress After amending and adjusting our procedures to enable recruitment more in line with our expectations, We look forward to updating you on future calls regarding expected timing.

Speaker 3

Looking beyond our sponsored trials For investigator led studies, we continue to see encouraging data coming from these programs. In March, Data on the use of COM360 with psychological support in 12 patients with treatment resistant body dysmorphic disorder or BDD Were published in the Journal of Psychiatric Research. Individuals with BDD are preoccupied by aspects of their appearance They misperceive as defective or ugly. In this study of a single 25 milligram dose of COM360, Primary treatment effect was measured with the BDD Y Box score, which improved significantly over the 12 weeks of follow-up With a large effect size and significant changes from baseline seen at week 1 and persisting through week 12 for the duration of the study. At week 12, 7 participants or 58% were considered responders.

Speaker 3

Secondary measures of PDG symptom severity, Conviction of beliefs, depression, negative affect, psychological insight and disability all similarly showed significant improvement. Tolerability and safety were evidenced by completion of all study visits by all participants and that no Serious adverse events or occurrences of suicidal ideation were reported. The signals we see in this BDD study Aligned with the hypothesis that difficult to treat disorders with preoccupying thoughts or fears represent potential target indications for COM360 psilocybin therapy. This comes on the heel of another IIS we told you about in February We've evaluated a single 25 milligram dose of COM360 psilocybin therapy in 14 patients with Type 2 bipolar depression, another condition for which treatment options are limited. This study produced very compelling data With 12 of 14 patients or 86% achieving remission at 12 weeks after administration without a resumption of antidepressant medication.

Speaker 3

It is this kind of information that these studies were designed to generate. Understanding the potential of COM360 in other indications with significant unmet need. These data sets also reinforce our confidence in our Phase 3 program. I would expect to see additional interesting data from such studies as we move through this year. I will now hand the call to Mike for the financial overview.

Speaker 4

Thank you, Guy. I'll now recap our Q1 financial results. For the 3 months ended March 31, 2023, net loss was $24,200,000 or $0.57 per share, including non cash share based compensation of $4,100,000 compared to net loss of $21,200,000 or $0.50 per share, including non cash share based compensation of $3,100,000 for the 3 months ended March 31, 2022. I will now turn to the analysis of the 3 months ended March 31, 2023 compared to the prior quarter ended December 31, 2022. For the 3 months ended March 31, 2023, net loss was $24,200,000 or $0.57 per share compared with a net loss of $30,900,000 or $0.73 per share for the 3 months ended December 31, 2022.

Speaker 4

These results include non cash share based compensation of $4,100,000 for the Q1 of 2023 $3,300,000 in the Q4 of 2022. Our Q1 financial results reflect our continued success in progressing our Phase 3 trial in treatment resistant depression. In line with our expectations, cash used in operations was $27,700,000 in the middle of the guidance range we provided last quarter. R and D expenses were $19,000,000 in the 3 months ended March 31, 2023, compared with $19,800,000 in the 3 months ended December 31, 2022. The slight decrease was mainly caused by lower external development expenses due to the change in our Phase 3 design.

Speaker 4

This decrease was partially offset by increased personnel costs. G and A expenses were $12,800,000 in the 3 months ended March 31, 2023, compared with $12,400,000 in the 3 months ended December 31, 2022. This increase was due to increased personnel and legal costs, partially offset by decreased facilities and other expenses. Our cash balance decreased by $26,000,000 in the Q1 of 2023 Due to using $27,700,000 in operating cash, partially offset by $1,100,000 provided by financing activities due primarily to the sale of shares under our ATM facility and a change of $700,000 due to exchange rate impacts. The movement in operating cash is primarily driven by our net loss, partially reduced by non cash charges.

Speaker 4

Regarding guidance, we expect the 2nd quarter net cash used in operating activities to be between $22,000,000 $30,000,000 And the full year to be between $85,000,000 $110,000,000 The size of the 2nd quarter range is due to the challenge in predicting the precise timing of cash out plays to support our Phase 3 program in its early stages. As the trial reaches steady state enrollment, We expect to offer a narrower quarterly and annual range. Compass continues to maintain a strong financial position with cash and cash equivalents of $117,100,000 at March 31, 2023, compared with $143,200,000 at December 31, 2022. In addition to our Q1 cash balance, in the Q2, we have received net proceeds of 26 $900,000 through the share of sale of shares under our ATM facility, which has further strengthened our cash position and extended our runway. We view our strong balance sheet as an important strategic asset, which we manage carefully as we invest to advance these promising potential therapies, while at the same time continuing to create value for our shareholders.

Speaker 4

Thank you. And I'll now turn the call back to Kadir.

Speaker 2

Thank you, Mike. In closing, let me say that now as a Phase 3 company, Compass Pathways leads the way in the development of psychedelic therapies. We believe these therapies represent the next generation of mental health therapeutic options. There's a significant and growing number of people across the world suffering from serious mental illness who are not helped by existing standards of care. We must act with urgency on their behalf.

Speaker 2

Most programs in this area of science today Are unproven, early stage and risky. We've established a high bar for evidence regarding safety and efficacy. Many of those early stage clinical studies will likely fail to meet their primary endpoints as we have seen with news from some other studies earlier this year. As Guy noted, we're progressing as expected in our Phase 3 program in treatment resistant depression. While we ultimately expect to leverage our extensive data set to expand the development of COM360 into a range of areas of unmet need, TRD is our first target indication and our clear focus.

Speaker 2

To this end, We continue to advance our commercial strategy on a number of fronts as we move through the Phase 3 program towards an NDA submission with the FDA. The CPT-three code, as discussed earlier, is a prime example of a successful step forward with our commercial approach and a clear indication that it can translate to significant value creation. As Mike noted, We continue to be in a solid financial position with a strong balance sheet to help us advance these promising therapies. We are making strong, meaningful progress in our work to develop and deliver new therapeutic solutions Thank you again for your participation on today's call. We'll now turn to Q and A.

Speaker 2

So I'll hand this back to the operator.

Operator

And wait for your name to be announced. One moment for our first question. Our first question comes from the line of Elmer Piros from EF Hutton. Your line is open.

Speaker 5

Yes, good morning. Congratulations on putting in the temporary CPT code, Kabir. Bob, maybe one question about That is how precedented or not, having a code established 1 to 2 years before Either MAPS or you are going to launch a psychedelic therapy. And maybe if you could contrast this to the situation with J and J's bravado, which may have J and J may have not been as prepared as you may be. And if you wouldn't mind comparing The treatment regimen with COM360, this bravado, especially considering that A patient would have to spend 8 times 2 hours in a clinic in the 1st month to receive that treatment and just your take on J and J's first Announcement of after, I think, 4 years of recording an annualized $500,000,000 or so in revenue with that drug.

Speaker 5

I was wondering if you could provide a little comparison between the 2.

Speaker 2

Thanks, Elmer, for the question. Just to check if you can hear us clearly?

Speaker 5

Yes, I can.

Speaker 2

Great. Thank you. So, no, thank you for the question. And I think, yes, you raised a couple of very important points here Around the CPT code. So I think first, let's understand that as I said, there are existing codes that can Account for preparation and integration, those fall within the normal range of psychotherapy sessions.

Speaker 2

But we recognized a long time ago But in terms of a 6 to 8 hour administration session or in the case of MAPS, multiple sessions of therapy associated with MDMA, There were not the appropriate codes to cover that, and it therefore became a priority for us working together to establish that. Recognize this is a CPT-three code, but this enables physicians and other HCPs To track the work that's involved, the activities that are required, and it's really a central precursor So converting that ultimately into a CPT-one code that can be reimbursed. And I think for Janssen, perhaps The recognition that the SPRAVATO sessions under the REMS would require this monitoring period, which was different from anything else That was available at the time was something that came a little later in the process. And again, we are grateful to have had the opportunity to learn from that. For the second part of your question, as you said, esketamine does require multiple administrations in the 1st month And thereafter at regular intervals, and that's not surprising given the relatively short duration of effect.

Speaker 2

Obviously, during our Phase 3, we're going to generate evidence around durability, around the impact of retreatment, and that will give a sense also of When retreatment might be expected, but certainly we saw from the Phase 2b a lasting effect for a significant number of patients even at 12 weeks, and We have some modest data that suggests it can go longer than that. So we would expect a much less frequent administration for COM360 Then you need to see for esketamine and we believe that that will also translate into a lower burden not only for patients critically, but also for providers and treatment centers as well. And finally, yes, as you mentioned Janssen Broke out for the first time, SPRAVATO sales this year, a few years into the launch. Let's recognize that the launch did come just ahead of the pandemic, which put all sorts of challenges into pharmaceutical drug launches. But I think the fact that you saw over $100,000,000 of Sales in the U.

Speaker 2

S. In the Q1 with a strong growth trajectory is very encouraging for us in a couple of different ways. It shows first that Despite some initial skepticism about the efficacy in clinical trials, physicians have become very used to working with esketamine and are actually seeing Real world evidence of efficacy that's perhaps patient acceptance that's strong. I think critically, it speaks to the fact that the infrastructure has developed significantly since the launch, not just in terms of Interventional psychiatry centers, and we've talked in the past about some of those standalone centers, but also in the fact that other psychiatry practices, Other academic and hospital settings have become much more used to the fact that this is a treatment paradigm that's here to stay. And we would expect much of that infrastructure to be relevant to us at Compass for psilocybin as well.

Speaker 2

So overall, I think we take Strong encouragement from that and the fact that they've identified that as a growth driver.

Speaker 5

Yes. Thank you very much. And at what point I know it's too early in the lunch, but at what point would you be able to project enrollment rates? And For now, you reiterated the previous guidance for completion of both of those both of the pivotal trials. Shall we expect that towards the end of this year or when you have a little more confidence on the trajectory?

Speaker 2

Yes. It's a fair question, Omar. I would just say definitely not yet, and I don't want to give a commitment to when we would do that. I mean, as I said, We have patients dosed in both trials. As Guy mentioned, the fact that we are well on the way to building the trial Structure with more sites coming on board and so on is very encouraging.

Speaker 2

But I don't want to promise a date of which we will actually give Enrollment numbers or percentages enrolled, but for now, given where we are, we are confident as we did in reiterating those timings for the primary endpoints.

Speaker 5

Thank you so much. Good to hear.

Speaker 2

Thanks, Oha.

Operator

One moment for our next question. Our next question comes from the line of Charles Duncan from Cantor. Your line is open.

Speaker 6

Hey, good morning, Kabir and team. Thanks for taking the question and congrats on the progress. I did have a question Regarding the ongoing Phase 3s, so maybe you're not going to be able to answer them. But I'm wondering if you could provide more color on the FDA interactions. You said they're active thoughtful dialogue, but I guess I'm assuming no modification in the primary or secondary endpoints.

Speaker 6

And then perhaps if Guy could speak to The pacing of the trial, great to see that you've made some progress in terms of patient enrollment. But I'm wondering if the biggest, call it, rate limiter for this trial is site opening Or is it patient access and availability of appropriate patients? Thanks.

Speaker 2

Thanks, Chas. And I'll actually ask Guy to take both of those parts, if that's okay.

Speaker 3

Yes. We as you know, Chas, There's no change in primary outcomes. There's no fundamental change in the design of the studies as a result of our to and fro with the agency. We're well on track as far as we're concerned with recruitment at the moment. You asked an interesting question because it falls into different phases of the At the beginning, the limiting step is simply site initiation.

Speaker 3

That takes time. It takes things Just happened, which are quite beyond anyone's control well, beyond the control of us and of the investigators, which are things like EMA licenses. We we are obviously plotting and we have modeled the rate at which patients will be recruited. And I would simply say that as far as our simulations of the future go and as far as we can be confident in the way we've achieved openings so far, We're looking very good. Obviously, we expect that once all the sites are open, then there will be different considerations around what limits recruitment, but we anticipate the demand for entry into the studies to be unusually positive For most compared to most depression studies, and we know from feedback we have had from the sites, that's certainly true in some centers.

Speaker 3

So we look forward to seeing the results of that. We'll be tracking it very carefully. And of course, it's the key metric for us Over the next 12 months to see that rise in recruitment curve, and we're happy that we will be able to do that and give you some indication of our happiness with it. But We're going to be careful about numbers because they can be misleading and they can be misunderstood.

Speaker 6

Yes, absolutely fair on that and appreciate it. Regarding anorexia nervosa, quite intrigued with that. Happy to hear that it's Kind of back on track. Can you provide any additional information on the actual amended procedures or how they were amended Or what is perhaps changed the vector on that trial versus last quarter?

Speaker 3

There were quite minor amendments to the protocol. I mean, unfortunately, that takes time. They were really to do with The visit burden on patients and just the preparedness of patients to participate in the study, you'll appreciate that randomized clinical Trials are not like ordinary practice. They place unusual demands on the subjects who participate. And I think that the need for in person visits, In particular, it was something that was too demanding in the initial stages, and we felt no reason for I'm not changing because it didn't materially affect how the study would run or the results.

Speaker 3

So it's been a simplification of the trial design, if not A fundamental change in the actual objectives or the questions that it will answer.

Speaker 6

Okay. That's helpful. Last question for Mike, Quickly, on the ATM that was noted a large block trade, you may not be able to Fully answer this, but I'm wondering if you could characterize the investor, obviously not a certain Identity, but maybe an investing type or whether or not they had previously held a position, any additional information and that you could provide that. Thanks.

Speaker 7

So because the investment came in through

Speaker 4

the ATM, I am a little bit limited on the information that I can provide. I would point out that if you go back and look at trading volumes earlier in the quarter, it's pretty clear When that happens and the size of it. And I can characterize the investor, we've spoken on prior calls that We've been working pretty intensively to bring biotech specialists sophisticated investors into the register, Not only to support us with our current financing needs, but investors who are going to understand the fact that we're going to be coming back Additionally, in the future, as we get closer to commercialization and as we build for a successful launch, so Those conversations continue and we continue to make progress. And I'd say that this investor would fall into that Realm of the investing universe that we've been working closely with.

Speaker 6

It makes sense. Sequentially funding the company I've seen with other neuro innovators, so should work here too. Thanks for taking my questions.

Speaker 5

Sure. Thanks,

Operator

One moment for our next question. Our next question comes from the line of Frank Brisebois from Oppenheimer. Your line is open.

Speaker 7

Hi, thanks for taking the question. Just in terms

Speaker 2

of the

Speaker 7

reimbursement, can you just we in a prior question, SPRAVATO was brought up quite a bit. And I'm just wondering SPRAVATO, just for those that might not be aware, what coding do they use? Is it and this G code, is that like how different is that from a CPT-one? And just maybe understanding for investors here, the difference here between the GEICO, CPT-one and CPT-three? And then maybe what Kind of additional color could we be expecting in July here?

Speaker 7

Thank you.

Speaker 2

Yes. Thank you, Frank. It's a great question. So the first thing I will say is, since These codes are only going to be published in July. We're actually not going to talk in very much detail about what we expect to see in them or what they will actually cover until after that because The AMA would not like us to do so.

Speaker 2

I think what I would focus on is what we have done here, which is Acknowledging that facilitated specifically this 6 to 8 hour administration is a unique model of psychological support For which nothing existed and the idea of stringing together multiple codes to do that would clearly be Unappealing to providers, not necessarily feasible, but also would not give any consistency. That's the reason that we actually focus therefore on obtaining this I think what Janssen is doing is using a variety of different codes. It is a different model of support. As you're aware, it is Post administration monitoring as opposed to support during administration, and they have been able to use a number of different codes. I think more we would like to hold till after the summer when we can talk more about the CPT code And then get into some of the different mechanisms for payment because obviously there are some areas where we're seeing bundled payment across drug And provision of services, some areas where we're seeing that separating.

Speaker 2

And I think we're very happy to get into more discussion around that once the details of the code are out and published. Thank you.

Operator

One moment for our next question. Our next question comes from the line of Joshua Schimmer from Evercore ISI. Your line is open.

Speaker 8

Hey, sir. I'm taking the question. Before just coming back to the CPT codes, they go into effect January 1, that means that is when the resource Consumption analysis will begin and over what time does that occur and when do final codes and reimbursement likely go into place? And then If it's going to be done for both Maps and Compass, how do the codes reconcile differences between the resource consumption that They exist between the two products. Thank you.

Speaker 2

Thanks, Josh, for the question. So on the latter part, once we see details of the code, I think that will make it Some of the answers to the second part of the question. For the first part, there is no fixed timeline from which a CPT-three code Grows up, shall we say, to become a CPT-one code. What happens is that from January 1, it will be available to be used for tracking activities. What's important is that there is adoption, that there is good experience, but also the data that we continue to generate Through the trials, the data that maps may start to generate in the real world supports strong evidence of efficacy and so on.

Speaker 2

And again, there is a process Building that body of evidence, as you say, starting to actually construct the value elements of it, but there is no fixed timeframe But it's becoming reimbursable. Obviously, by doing this well in advance of what we may be able to launch, it is our expectation that we will be able to have something that is reimbursable at or very close to launch, but that's going to depend on continuing efforts by us, By MAPS and potentially others from January of next year.

Operator

Okay, got it.

Speaker 8

And then now that you've seen an uptick in enrollment in the anorexia When do you expect to be in a position to report data?

Speaker 3

I think, to be honest, that we based this on a recruitment Curve, we're still at the stage of developing that curve to see where it will saturate, where we'll get to the required numbers. So it would be premature to give a date Just at this minute. But we're confident that we're on track to complete the study and the exact timing we will release when we're more confident about it.

Speaker 8

Okay. Thank you.

Speaker 2

Thanks, Rob.

Operator

One moment for our next question. Our next question comes from the line of Patrick Trucchio from H. C. Wainwright. Your line is open.

Speaker 9

Thanks. Good morning. Just a quick follow-up on the potential commercialization as we look ahead To the potential commercialization of COM360, I'm wondering if you can frame for us what a potential REMS program could entail and If it would be similar to SPRAVATO's or would there be some important differences we should be aware of? And how could this in some way help streamline the launch

Speaker 2

COM360. Thanks, Patrick. I mean, I guess, It's a little premature to speculate on the shape of the REMS, Yes. But it's also to a large extent that will follow the label and what's in the label in terms of what's in the REMS. But yes, I think we need to be clear that we do expect to REMS with I also expect the key element being via Tassu, the elements to assure safe use.

Speaker 2

Those are clearly going to require, I would expect, essentially distribution through specialist pharmacies to treatment centers For a given patient with the indication and so on, Claire, it will require physician certification, patient certification and so Beyond that, in terms of the scope and what we may end up negotiating with the FDA around the actual elements, Honestly, I think it's premature.

Speaker 9

Yes. That's really helpful. And then, I'm just wondering if you can talk about the level of interest or acceptance in Psychodynamic therapy, specifically among the neuropsych key opinion leaders and clinical trial investigators, how have these views changed, particularly as we had more data published including from the COM360 Phase 2b trial. And how do you view this evolution as progressing as we approach The Phase 3 readout next year for COM360?

Speaker 3

Thanks, Bhashti. I think it's within the academic Sites, there's a certain there's a mixture. Some people still think that the commercialization will be difficult. But in a sense, it's not university sites' Opinion that's really going to matter in that. It's really to do with the kind of relationships we build with more commercial providers.

Speaker 3

So I think that the impressions I get certainly are there's great enthusiasm for the idea and there's really very little push Back on our interpretation of the data, the enthusiasts for this area think it's going to be great and are really positive about it. But we have to recognize that many of the sites who are doing the trials are not necessarily all going to be commercially active. But I think overall, the feeling is that there's a lot of enthusiasm within the profession for this approach and there's a lot of acceptance that There needs to be changes to allow it to happen and I think that's very important. I think the final thing is that this is going to be an opportunity for patients who have not currently receiving adequate treatment actually to get it because I think there's going to be a move to not leave people In primary care, inadequately treated, not receiving the kind of additional treatments that sometimes work. And this will provide an attraction, I think, for getting those sort of patients who are currently not being treated into treatment.

Speaker 3

And I think a lot of psychiatrists recognize that and we'll certainly be as we go forward, we'll be driving along with the Key opinion leaders be that particular message that this is an area that is not only failure of treatment, but really not offering adequate treatment to people.

Speaker 2

Yes. And I would just add, we're starting to engage with regional health systems, not necessarily household names, not the big ones you've heard of, Regional health systems that are seeing significant numbers of patients that are already offering TMS, SPRAVATO, in some cases, ECT, And the level of excitement there and interest is extremely high. They are very interested to see how they can add this as another option for certain patients, both existing patients We're not benefiting from current treatments, but also as Guy said, extending it to other patients. So again, early days, obviously, we don't want to go too fast with that. But we are, as I say, starting to engage with a number of those and getting a lot of very positive feedback.

Speaker 9

Terrific. Thank you so much.

Operator

One moment for next question. Next question comes from the line of Ritu Baral from Cowen. Your line is open.

Speaker 10

Good morning. Thanks for taking the question. I apologize for my voice this morning. About the CPT code, can you clarify when The information gathering for resource utilization exactly begins. Okay.

Speaker 10

I think you and I have talked about this. I believe it covers the administration session, but I'm wondering Is there possibility that it might capture the prep session? Would you want to create A different CPT code for that prep session or do you think and the consolidation session, or do you think that existing codes would cover prep and consolidation. I'm going to have a follow-up. Thank you.

Speaker 2

Thanks, Ritu. So yes, our belief is that existing codes Can follow, can support preparation and integration and the need, the gap was Code or codes that could cover the administration. I think it's also important to acknowledge, obviously, in a trial setting, It is the same therapist for preparation and administration and integration. In a real world commercial setting, You can well see that a patient may have an existing relationship with a therapist who would actually be involved in the preparation and integration sessions And the support required during the administration would come from a different provider. And that's a model that we may well see emerge.

Speaker 2

So in that context as well, our focus really was on the novel piece, the gap that existed for this extended administration.

Speaker 10

So it's just this CPT code will just be the administration session from the start?

Speaker 2

Again, let's wait for July and see the details of it. It's actually 3 codes, not just one. We can't go into any more detail now, but let's wait for that to see it. And in terms of when it can start, as we said, it's the 1st January 24. So So that's the point for which people can start to use this code to track activities to track what's actually happening during these sessions.

Speaker 10

Understood. And then just moving to anorexia, you mentioned changes in total enrollment, because of challenges And patients through screening, can you describe some of those changes to the protocol? And do you believe that Excuse me. Do you believe these changes will result in any maturity changes And the patient population will be of ignoring projected? Thanks for taking the question.

Speaker 3

Thanks, Ritu. I don't think it will change in patient population. This is a fairly defined condition, as I'm sure you know. I mean, the issues really were around patient burden and participation in the study. And I guess we had assumed that the patients will be more tolerant of that, leading from our experience with TRD.

Speaker 3

And I think quite simply, many of the patients with anorexia nervosa are more ambivalent about treatment. And so that additional burden, I think, may have served as a barrier. By burden, I simply mean having to turn up for multiple visits in person, which were not strictly necessary, but in a sense were simply put down because that is the way we had previously done studies and there is a tendency to trust In face to face assessments more than remote ones. There's no real reason to do that when someone's not dealing with the primary outcomes. And therefore, we modified the protocol to allow more remote assessment.

Speaker 3

We don't think that reduces the quality The information we will get materially, it doesn't change the outcomes and the key measurements of outcome will remain In person, and therefore, will be the same as originally planned. So the changes are relatively modest, but they may make a surprising difference, and we will Obviously, hope that they do and keep you updated on when they do.

Speaker 10

Thanks for taking the question. Pleasure.

Operator

One moment for our next question. Our next question will come from the line of Nina Bittredogarg from Citi.

Speaker 11

I remember last time on the last earnings call, you mentioned addition of Part B and Part C to both Phase 3 TRD studies. And I was just wondering if you could share at this point what the retreatment criteria are in those two parts. I know Part B, I think has optional retreatment and then Part 3, I believe is based on a relapse. So can you just provide us with the actual criteria for both of those?

Speaker 2

That would be great. Yes, I

Speaker 3

mean the criteria for retreatment are essentially that patients have a MADRS above a certain threshold And that threshold will be a threshold of 20 on the total score.

Speaker 11

Okay. And it's the same in both Part B and Part C?

Speaker 3

It's the same in both parts, yes.

Speaker 10

Okay. That's helpful. Awesome. Thank you.

Operator

One moment for our next question. Our next question comes from the line of Sumant Kulkarni from Canaccord. Your line is open.

Speaker 12

Good Morning or afternoon for some of you. Thanks for taking my questions. So in the past, you've said that there would be no interim analysis for COMF-five. Is that still the case? And if there is no interim analysis, do you plan to provide any efficacy updates on a blinded basis?

Speaker 12

And when could one expect those relative to the top line data in summer of 2024?

Speaker 2

Yes. So Sumit, I think your question was, do we plan an interim analysis? And the answer remains no. And no, we should not expect to know anything before summer of 2024.

Speaker 12

Got it. And then could you specifically compare the in person Support services during psychedelic therapy that may be needed for COM360 versus MAT, which is specifically characterized as MDMA assisted therapies. Obviously, these are different treatments and indications, but I'm trying to get a relative sense of the reimbursement burden.

Speaker 2

So let me start and Guy may jump in. I mean, so a psilocybin Session, as we know, consists of for a patient, there is preparation. There is the actual administration session itself, which is 6 to 8 hours and there is integration. As you know, in Phase 2b, we studied 1 dose. In the Phase 3, we have both the 2 dose study in the core part of the protocol as well as the single dose.

Speaker 2

But as just reference, we do have an option for retreatment on relapse or failure to remit In Part B and then again in Part C. So that is kind of the burden for us from a sinexplatin perspective. The MDMA protocol from recollection is at 12 therapy sessions, including 3 doses of MDMA, I think. That's correct.

Speaker 3

And I think it's the interactions that take place on the therapy days with the drug Are quite intense. The drug is sometimes described as producing greater empathy and therefore more communication between people. That contrast with psilocybin where on the day of administration at the doses we are using 25 milligrams, The patients are essentially inwardly guided. They're not interacting with the therapist. And in fact, the therapists are instructed not to interact with the patients Other than to help them to, in a sense, remain focused on their internal journey is the word that they usually use.

Speaker 3

There's a great difference in the way we should be thinking about the role of psychotherapy. Psychotherapy is a key part of the MDMA treatment. It is not a key part of the psilocybin treatment and that's why we have used the term psychological support where the emphasis is really on Safety and safeguarding, and it is not on essentially a treatment of a psychotherapeutic kind.

Speaker 12

Understood. And once the CPT-three code goes live in 2024, is there any potential for approved but off label products' ability to utilize this code for therapy sessions?

Speaker 2

It's a good question. I guess at the discretion of The provider, yes, but I'm actually not entirely sure.

Speaker 4

Thank you.

Operator

Thank you. And with no further questions in the queue, I'd like to turn the call back over to management for any closing remarks.

Speaker 2

Thank you very much. So once again, thank you everyone for your participation and thank you for the questions as well. Just a reminder, we are making excellent progress On our Phase III trials for treatment resistant depression as well as continuing to build the body of evidence for COMF360 more generally, We're excited obviously about the CPT-three code. We're excited about the validation externality you see from SPRAVATO as well in terms of momentum. And we believe we're also making strong strides towards demonstrating a commercial value proposition for COM360.

Speaker 2

So thanks everyone. Have a good rest of the day.

Operator

This concludes today's conference call. Thank you for participating. You may now disconnect. Everyone, have a good day.

Powered by Quartr
Earnings Conference Call
COMPASS Pathways Q1 2023
00:00 / 00:00