Compass Pathways PLC (CMPS) 2024 Q1 法說會逐字稿

So thank you for standing by, and welcome to the Compass Pathways first quarter 2024 earning investor call. (Operator Instructions) As a reminder, today's program is being recorded. And now I'd like to introduce your host for today's program, Mr. Stephen Schulz, Senior Vice President, Investor Relations. Please go ahead, sir.

Welcome all of you, and thank you for joining us today for our first quarter 2024 results conference call. Again, my name is Steve Schultz, Senior Vice President of Investor Relations at Compass Pathways. And today I'm joined by Kabir Nath, our Chief Executive Officer, Dr. Guy Goodwin, our Chief Medical Officer, and Teri Loxam, our Chief Financial 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.

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-K filed with the US 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 as of any subsequent date. We specifically disclaim any obligation to update or revise any forward looking statements even if our estimates or assumptions change.

I'll now hand the call over to Kabir Nath.

Thanks, Steve. Good day, everyone, and thank you for joining us. First, let me report that Compass continues to execute on both of the Phase 3 concrete 60 trial in treatment resistant depression. We are on track to deliver top line data for the COMP 005 single dose placebo-controlled study in the fourth quarter of this year and for the COMP 006, fixed (inaudible) trial in mid-2025.

We are also actively working on completing all necessary preclinical and clinical pharmacology studies required for a COMP360 (inaudible)

Also in this quarter, we announced additional commercial collaborations with leading mental health care providers, designed to inform the development of scalable and cost-effective delivery models for COMP360 psilocybin treatment if approved for treatment resistant depression.

The most recent announcements have been with early clinical and mindful health solutions collaborations that add to those we already have in place with Reliance Medical Group, part of Optum Care, Greenbrook TMS and Hackensack Meridian Health, each of these partners represent very different equally important commercial models and setting the path for patients.

These collaborations have focused on investigating challenges with the current patient care experience. It will assist us in these leading mental health care providers to better understand how COMP360 made that fit into diverse care setting and also enable companies to develop commercial delivery contracts in these different care settings.

These collaborations plus the CPT III tracking code that went into effect in January are important steps towards preparing the market for a COMP360 psilocybin treatment option if approved.

Let me now hand the call over to Dr. Guy Goodwin for clinical updates. Guy.

Thank you, Kabir. It's a pleasure to speak to everyone today and review the positive data generated from the COMP360 Phase 2 clinical study in PTSD. We hope you have the opportunity to review the press release from this morning summarizing the results.

This study included three clinical sites in the US and the UK. The Icahn School of Medicine at Mount Sinai in New York, Sunstone therapies in Rockville, Maryland and the Institute of the country psychology and neuroscience that King's College in London.

Now let me go through some of the specific results we saw with this PTSD study. The study was an open-label multicenter Phase 2 exploratory study evaluating COMP360 still receiving treatment in 22 patients with PTSD resulting from trauma in adulthood.

Participants receive the single 25 milligram dose along with psychological support. Psychological support was provided by a licensed medical professionals to ensure patient safety by preparing participants with a treatment session of serving and being present with patients during the session and supporting them after the session.

The majority of patients entered the study with symptoms of PTSD categorized as severe with a mean CAPS-5 total score at baseline of 47.5. The CAPS-5 assessment involved with structured his view that provides a PTSD diagnosis aligned with the (inaudible) and measure the average severity of $0.2.

The average age of participants at the time of screening was 39 and 4 participants at prior lifetime experience with psilocybin, fashion status and combat exposure re-evaluated as when I (inaudible) associated PTSD subtype. Patients diagnosed with complex PTSD were excluded from study eligibility.

The effects of the COMP360 treatment on the CAPS-5 score were assessed at week 4 and again at week 12 to assess durability of effect.

Study observation also included improvement from baseline in the SDS score, a measure of functional impairment in day one. Safety over 12 weeks with the primary endpoint of this study and administration of Comp360 in this patient group was well tolerated with no serious adverse events of those.

We're also pleased to report impressive and sustained rates of response and remission that's both week 4 and week 12. The key findings include, administration COMP360 was well tolerated. There were no treatment emergent serious adverse events, treatment emergent adverse events over 10% included Headache, nausea, crying and fatigue.

Predominantly on the day of drug administration. There were two events of suicidal ideation that result joined the study, the first with a moderate and transient events for administration day in the patients who went on to be a responder.

The second event was mild and occurred at week seven in our non-responder. As a reminder, suicidal ideation is a common feature of PTSD as it is in TRD. We observed an early and durable improvements in symptoms from baseline following a single administration. Improvement in mean CAPS-5 total score from baseline to 47.5 with the 29.9 reduction at week 4 and 29.5 reduction at week 12.

We observed increasing improvement disability over the 12 weeks. From a mean, SDS total score of 22.7 at baseline, there was an 11.7 reduction at week 4 and a 14.4 reduction at week 12. We also saw high and sustained rates of response and remission relative to baseline with early onset of symptom improvement.

Response as defined by patients experienced a greater or equal 15 point improvement on the CAPS-5 score was 81.8% at week 4 and 77.3% at week 12. Remission as defined by CAPS-5 total score less than or equal to 20, was 63.6% at week 4 and 54.5% at week 12.

No patients withdrew from the study have not returned to the present medication during the trial. Although a small trial with open label design, the results exceeded our expectations and advance our understanding of potential application of COMP360 in PTSD. We were particularly impressed by the early onset and durability of improvements.

We believe the COMP360 could provide a clinically meaningful benefit from substantially improved daily function and quality of life in patients with PTSD. We look forward to submitting the full results of this study for publication, and we'll consider next steps for the program. In addition, the TRD, as Kabir mentioned, we are on track for the primary 6 week endpoint in COMP 005 during the fourth quarter of this year.

We are seeing improvements from the actions we took to facilitate the retrieval of medical records, which created a bottleneck early in the year. We also remain on track for COMP 006 for the prior six week endpoint, mid next year. We are excited by the profile that's emerging for COMP360 across both TRD and PTSD and the potential benefit for patients.

We look forward to our Phase 3 results later this year and next year and continuing to progress the broader COMP360 program.

Let me now hand the call to Teri for a financial review.

Thanks, Guy. I'll now step through the Q1 financial results. Cash used in operations in the first quarter was $20.8 million within the guidance range we provided of $17 million to $23 million and which assumes that 2022 R&D tax credit would be received in the first quarter. I'm pleased to confirm that HMRC paid our 2022 claim of approximately $15 million in fall in the first quarter.

Regarding second quarter 2024 financial guidance, we expect net cash used in operations to be between $32 million and $38 million.

Turning to full year financial guidance, we expect cash used in operations to be between $110 million and $130 million. Compass continues to maintain a strong financial position with cash and cash equivalents of $262.9 million at March 31, 2024.

That compares with $220.2 million at December 31, 2023. The increase in cash in the first quarter due to proceeds received through the [ATM] and exercise of warrants from our August 2023 pipe. Long-term debt under Hercules loan facility was $29.1 million at the end of the first quarter.

With the cash increase in the first quarter, we now expect our cash runway to fund operations into 2026. We will continue to manage our cash carefully to continue advancing our pivotal program and to achieve important milestones that we believe will create value for our shareholders.

Thank you, and I'll now turn the call back to Kabir.

Thank you, Teri. With these strong PTSD data, we're now working to schedule a meeting with the FDA and align on potential next steps. While TRD is our lead indication for COMP360, we see logical expansion into PTSD given the similarities and patient profiles and the potential commercial synergies.

We're looking forward to disclosing our top-line data for our Phase 3 program later this year. This will be a key milestone for Compass and given our leadership, a significant event for the field of psychedelic science.

We also continued to make great progress with a network of interventional psychiatry centers and mental health care providers who could administer COMP360 treatment if approved, our expanding collaborations are indications of interest from providers, and we'll continue to develop commercial models that enable rapid, scalable, broad and equitable access to COMP360.

I also want to welcome Dr. Mike Gold to the Compass team as our new Chief Research and Development Officer effective May 20. Mike brings more than 25 years of experience across all aspects of drug development in neuroscience, with extensive therapeutic experience in neurological and psychiatric disorders, including depression. Mike will work with Guy to continue to develop COMP360 in TRD and other indications and to explore and advance of potential pipeline opportunity.

I want to thank Trevor Mill, Compass current Chief Development Officer for his dedication and expertise in guiding the development of our COMP360 program over the past several years and exploring additional early pipeline opportunities. Trevor will leave after a transition period with Mike, and we wish him all the best in his future endeavors.

This is an exciting year for Compass Pathways, and we look forward to updating you on our continued progress. Thank you again for your participation on today's call. I will now turn to Q&A. So I'll hand it back to the operator.

Certainly One moment for our first question.

Vikram Purohit, Morgan Stanley. Your question, please.

Hi, good morning. Thank you for taking our questions. So we had two on PTSD. So first, could you just frame for us in terms of real-world experience and real-world benefit, what the CAPS-5 and SDS scores that you reported this morning. How to contextualize those in terms of the benefits to patients may observe and then also some of another company in the space recently received notice that the FDA is going to be scheduling an AdCom meeting for early June to review their application for their MDMA assisted therapy for PTSD. Just wanted to see what your thoughts were there on potential implications for your program and the space more broadly.

Thank you. (inaudible) as we stop just to make sure you can hear us clearly.

Yeah.

Okay. Great. So I'll hand the Guy to take the first question and maybe the second one I might add on as of (inaudible)

So I think the way to think about these results because they reflect a real near return to normalcy for a significant number of patients in this study. With this rating scale, but not terribly familiar. So we're all getting to understand them as we go along. But basically, they reflected the lowest growth that we see reflect essentially a complete recovery.

And the average, of course, is not that the range of outcomes. But we emphasize, I think the very high rates of remission as defined by a minimum score thoughts on that and we think that's important also that space and I think I would also draw your attention to the SDS score from they reflect a measure of disability that is used across trial and so that allows you to look at the impact of other treatments in other conditions as well as in potential PTSD.

That again reflects the numbers that we show reflects substantial return function for patients, which is an important reduction symptom control.

The second question about life Lykos.

Yeah, let me take that. And certainly, I think first, no surprise. This is the extent of first the submission in PTSD for more than a quarter of the country number one. Second, it is currently a Schedule one drug, that sense, no surprise that there is going to be an AdCom. And I will just say we wish them well and obviously, we like many other people will be observing very closely while the FDA poses a number of the key questions around that application.

Got it. Thank you.

Ritu Baral, TD Cowen. Your question, please.

Good morning, guys. Thanks for taking the question. Quick thing on how potential positioning versus like us compound an MDA assisted psychotherapy. Kabir and Guy, could you walk us through sort of the nature of the psychological support and that you provide on was there any aspect of exposure therapy, which from my understanding, is sort of a basis for the psychological support provider like us, if you could talk to like the amount of the nature and I have a follow-up.

Thank you, (inaudible) headline, Ritu, is this is no different from what we're doing in TRD, Guy please.

Yes, thanks. In fact we have (inaudible) on what that suggests is that essentially patients will have the same kind of exposure experience. There's a little bit of that. But mainly there is really just a change in the way people contextualize to a memory and their experience.

And that seems to be essentially driven by this in with journey with everyone has heard about in relation to the site. And so patients are prepared in the same way as the capacity of the Group, as you know, exposed explicit exposure exercises that would occur with a conventional psychotherapy and physicians in the remark who have had previous psychotherapy in contrast to that, but I feel that they are in a sense doing their own work, but they are leaving themselves and then not being written by an external interactive force, which would be the therapist and conventional psychotherapy.

So it's a very interesting contrast for the preparation, of course, in terms of hours and so on and subsequent integration is relatively short. And we think that the efficacy is remarkable and everybody's sustained up.

Very helpful. And then can you just talk about some of the exclusion criteria as it relates to suicidality this year? Were you able to exclude patients with a history of suicidality was there anything unique in history of sufficient to carry suicidality?

Yeah. I mean, this is a group even though this was not complex PTSD because this was really a first study. We wanted to be careful not to recruit to vulnerable patients than they -- so they're probably the complex PTSD group would be that.

So this is a state of trauma, which also simplifies the measure of outcome for these patients also showed significant history of suicidality. So 70% of the express edit tracked and life sciences, which the stat plan as many as 30% of the express active suicidal ideation with specific plans and intent since it is a group that had lifetime suicidality is a feature of the illness. The particular group along with the recruiting of the transplant and were not (inaudible)

And therefore, we are therefore, what we're seeing is relatively soft threshold, which as serious adverse events were unforeseen, (inaudible) suicide, which unfortunately is a risk in this business.

Got it. And if I could have just one quick follow-up. And a follow-up to the first question could be, are you left us hanging when you said you would have some key questions that you'd love to have answered by the lack of AdCom. Can you elaborate a little further on that? What questions do you have that you hope the oncology office?

So there is also events are going to have a no-go clearly, and we've said this before the Michael's protocol, is that the back to your question, it's a program that was the fact that there is a significant therapeutic component and that clearly is something that will be interesting to see how the FDA understands that pauses that and ultimately, if successful, how that will be reflected in labeling and so I think that's probably the key costs. As well as the overall assessment of benefit risk for what is you generally categorize the psychedelic, but again, because the offtake agreements and have that, but I think, again how the FDA approach here will that the risk.

Great. Thank you so much.

Charles Duncan, Cantor. Your question, please.

Hey, good morning, Kabir and team. Congrats on the progress. I had a question on PTSD and then one on TRD on the PPSD data, seems fairly robust. So I guess at the risk of jumping the gun, I know that you are seeking FDA input but could you imagine a relatively capital-efficient Phase 3 program may be including one or two studies, both with less than say, roughly 90 patients, given the I'll call it a magnitude of change that you're seeing in CAPS-5?

The chart you're not going to correct me come. I'm designing a Phase 3 study on the call. So if I have to say, obviously here. We are encouraged by this data. As I said, we clearly are working on plans or development plans. We will need to take a robust pipeline of that to the agency together with the state to have that discussion, whilst that number of trials is the signing and so on, it's still very much to be determined how my insurance we will be doing it appropriately trading off robust evidence and capital efficiency.

Both of those will be (inaudible)

Appreciate that confidence in it. Moving on to TRD another question. You're probably not going to be interested in answering, but I'll ask it anyway. Can you provide any color on the number of patients or at least the kind of pacing of patients into Part B and even Part C in terms of retreatment on a blinded basis in Part B and then open-label. Thanks.

You are right of the answer is no, I'm not going to give specifics, except to say, as we've said, we clearly have patients in both up, but also importantly, as we've also said, the dropout rate significantly lower than what we had potentially anticipated in the trial with (inaudible) this again, a good sign.

Got it. Thanks for taking the questions.

Patrick Trucchio, H.C. Wainwright. Your question, please.

Thanks. Good morning and congrats on this very positive outcome in TPSD. I'm wondering if you can talk a little bit about the trial design for the Phase 2 study and PTSD relative to the FDA guidance for psychedelic drug development and discuss any of the learnings that have emerged that could have an impact or inform the potential Phase 3 trial on PTSD?

And then secondly, I'm wondering regarding the pivotal Phase one trial in TRD with top line data expected in the fourth quarter, can you frame for us what data you would expect to include in that top line release and how we should think about the outcome from this study relative to both the Phase 2b trial in TRD as well as possible read through to the outcome from the pivotal trial two and TRD., where the top line data is expected mid-2025.

And Patrick, so I'll hand to Guy, in a moment. Just the first thing to say, as a reminder, this Phase 2 is an open-label 22 patient study. But let me hand the Guy to say anything around the FDA guidance that will inform how we think about some of the design.

Yeah. You have obviously expressed an interest in seeing comparisons with another treatment that can be placebo or it can be another dose of the active treatment or even an active placebo. So they collect really quite a wide range of options for anyone developing a drug in this space, and we'll take that into account when we think carefully about how we design our fair share in the Phase 3 program for PTSD, but then they try tremendous differences between CRP and PTSD from what we've seen, but of course, (inaudible) big advantages for a shared safety database with CRP, no reason not to read across to PTSD indication.

And on your second question, Patrick. Again, we have not guided. So what exactly will be in a position to release with top line. As you're aware, we are this Part B runs to 26 weeks blinded. So they're going to have to be sensitive around that in terms of that.

And look, we haven't designed the study for success clearly have we believe that any significant result will be very positive and further evidence of the potential for COMP360, TRD. And then a Guy in terms of (inaudible) any comment you want to make?

Not really. That we see OpEx. I think as we said before, Patrick, we see or expect to see particularly informative from a clinical perspective rather than simply a regulatory one. (inaudible) help us to understand the number of treatments that are probably require in ordinary refractories potentially going forward, which is essential to the commercial model and to the acceptability to clinicians and patients as well.

Right. That's helpful. And if I could just on these on the commercial collaborations following another announced today. I'm wondering if do you have an estimate or expectation for the proportion of the TRD population you may be able to reach at the time of the potential launch based on these commercial collaborations? Or how significant should we think about these collaborations in preparation for possible rollout of COMP360 and TRD.?

Thanks Patrick, it's a great question. So to be clear, these collaborations are already learning exercise as they are examples of different settings of care. And well, some like, for instance, Greenberg TMS, we would expect potentially that be numerically a significant contributor.

So commercial rollout, although this is all more about building campaign understanding to the remodel that we will then need to apply to a wide range of other health care settings.

So what I would say at this stage, as you can think of them really is this learning experience really to deepen our understanding of the potential to deepen our understanding the different there. But assuming we're fortunate enough to find you could imagine that media prelaunch is when we will be ready scaling those 10 states across a number of different things, different health care providers.

Great. Thanks much.

Thom Shrader, BTIG. Your question, please.

Good morning. Thanks for taking the question. It's a remedial one on PTSD. So patients with your baseline score, what level of impairment, do they have what level of medical care are they using? And would a group like this at some level support the same price as your TRD patients? Thanks.

As they classified as severe, and it's one criteria fully the way in which one score the CAPS-5 is that it would narrow intervention or require intervention when people score two or three particularly on the scale that we use for each item of symptom is accommodated scale, it needs a little we will be unpacking it a little more in the future.

But that gives you some idea of that age group who would need treatment, but they're not a group who are sort of mild and coming in for the experience.

Any background on how much they're hospitalized?

We don't have all of the data on these patients yet this is very much top line. So when we get all the tables in, we'll be able to give you that color.

On roughly half quarter of something an SSRI or (multiple speakers)

Yeah, I think all have received previous treatment at some time. Sorry, final question. That's beyond that, the answer. That Included psychotherapy as well as drug treatment. And about half were actively (inaudible) drugs, which we then discontinued.

And so to your second question, I would say we still have a lot of work to do to actually finalize the profile for TRD, let alone the GSP. So again, we couldn't genuinely, we couldn't comment on how many administrations we would see for PTSD, what durability we might expect to see in a subsequent trial and so on. So honestly, premature to comment on how these would relate to each other commercial.

Perfect. Thank you.

Sumant Kulkarni, Canaccord Genuity.

Thanks for taking my questions and nice to see the PTSD data. I have to -- so first on COMP360, how can the company optimally mitigate the risk associated with suicidal ideation in trials, given both TRD and PTSD and high background rate of this type of event in patients to start with. And second, it's very nice to see Dr. Michael Gold and board.

Given Michael's extensive experience with multi-asset companies, how do you think the strategy of Compass might evolve going forward in terms of the types of compounds that companies might be looking at?

Well, I think the standard answer this is really we don't recruit patients who were actively suicidal because it really doesn't seem ethical to randomize them to no treatment or low treatment. I think everyone takes that approach. Ultimately, it's impossible to completely exclude the existence of suicidality and these sorts of patient populations. Otherwise in offsetting a truly generalizable sample.

But we insist that our preparation and the support during the administration optimizes the preparedness of patients, and we think for that reason, we are seeing these relatively minor changes in ratings scale, (inaudible) in mind that we have not had no attempted suicide or suicide in any of our studies and what we're seeing and describing here are changes on scale, which is the threshold for action events that you would classify clinically serious, particularly in this study.

Thanks for asking the question. First, we've always said should we get back to credibility with COMP360. And I really with our premise with TRD and what we've announced today with PTSD, we're well on our way to doing that. We do have discovery assets, some of which we could be in a position to advance into first in human in a relatively short timeframe.

But I think having established ourselves as a credible developer here of late stage of over of drug, it absolutely is part of our four pronged strategy to how we might expand into other assets over time. But recognizing again that's not a given, we have to demonstrate credibility and success with our lead asset. And I think, well, let's do that.

Got it. Thanks.

Thank you. (Operator Instructions)

Elemer Piros, Rodman.

Yes, good morning. Maybe a question to Guy. A Guy on looking at the PTSD results with MDMA from the Phase three trial and it appears that it takes about 12 weeks to reach maximum benefit with MDMA plus therapy. How does that compare to what you observed with single dose of COMP360?

Our COMP360, that's probably CAPS-5 numbers is taken at four weeks. The first measure we take because it's a four-week measure. And of course, that shows the full effect at full week and it's sustained at 12 weeks using the same measure. So that's what we did said. We will have an even finer grain evidence, but early very speedy onset from other measures that we took in patients but we don't yet have decided to show you (inaudible)

So do you believe that the results with MDMA are probably due to second dose, the third dose amplifying the effect and with the end results being about the same reduction in CAPS-5. (multiple speakers)

So that's what we all see.

Yeah. Thank you. Thank you very much.

Thank you. This call conclude the question-and-answer session of today's program. I'd like to hand the program back to management for any further remarks.

So just to say thank you all for your participation. And as I say, I think as we heard also during the questions, we are very encouraged by this robust signal we've seen in PTSD. We are working to look at what our future plans for the program might be.

We continue to execute on the timelines we established in February for COMP 005 and COMP 006 in TRD and I think therefore, we are looking forward to exciting news later than it. So thanks everyone, for your participation, and thanks for your support and wish everyone a very good rest of the day.

Thank you, ladies, and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.