COMPASS Pathways Q1 2024 Earnings Call Transcript

Quartr
Provided by Quartr
May 8, 2024

There are 9 speakers on the call.

Operator

Thank you for standing by, and welcome to the Compass Pathways First Quarter 2024 Earnings Investor Call. At this time, all participants are in a listen only mode. After this presentation, there will be a question and answer As a reminder, today's program is being recorded. And now I'd like to introduce your host for today's program, Mr. Stephen Schultz, Senior Vice President, Investor Relations.

Operator

Please go ahead, sir.

Speaker 1

Welcome all of you and thank you for joining us today for our Q1 2024 results conference

Speaker 2

call.

Speaker 1

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 Doctor. Guy Goodwin, our Chief Medical Officer and Terry Luxum, our Chief Financial Officer. The call is being recorded and will be available on the Compass 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.

Speaker 1

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. Additionally, these forward looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date.

Speaker 1

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 Gebirnat.

Speaker 2

Thanks, Steve. Good day, everyone, and thank you for joining us. First, that we report that COMPASS continues to execute on both of the Phase 3 COMF360 trials in treatment resistant depression. We're on track to deliver top line data for the COMF-five single dose placebo controlled study in the Q4 of this year and for the COMF-six fixed repeat dose trial in mid-twenty 25. We're also actively working on completing all necessary preclinical and clinical pharmacology studies required for a COM360 NDA dossier.

Speaker 2

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 COMF360 siliciden treatment if approved for treatment resistant depression. The most recent announcements of the Journey Clinical and Mindful Health Solutions collaborations add to those we already have in place with Reliance Medical Group, part of OptumCare, Greenbrook TMS and Hackensack Meridian Health. Each of these partners represents very different, equally important commercial models and settings of care for patients. These collaborations are focused on investigating challenges with the current patient care experience. They will Compass and these leading mental health care providers to better understand how COM360 may best fit into diverse care settings and also enable Compass to develop commercial delivery templates in these different care settings.

Speaker 2

These collaborations plus the CPT-three 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 Doctor. Guy Goodwin for a clinical update. Guy? Thank you, Kabir.

Speaker 2

It's a pleasure to speak to everyone today and review the positive data generated from the COM360 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 3 clinical sites in the U. S. And U.

Speaker 2

K, the Icahn School of Medicine at Mount Sinai in New York, Sunstone Therapies in Rockville, Maryland and the Institute of Psychiatry, Psychology and Neuroscience at 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 COM360 psilocybin treatment in 22 patients with PTSD resulting from trauma in adulthood. Participants received a single 25 milligram dose along with psychological support. Psychological support was provided by a licensed medical professional to ensure patient safety by preparing participants for the treatment session, observing and being present with patients during the session and supporting them after the session.

Speaker 2

The majority of patients entered the study with symptoms of PTSD categorized as severe with a mean CAAT5 total score at baseline of 47.5. The CAAT5 assessment involves a structured interview that provides a PTSD diagnosis aligned with DSM-five and measure the average severity of 20 symptoms. The average age of participants at the time of screening was 39 and 4 participants had prior lifetime experience with psilocybin. Veteran status and combat exposure were evaluated as were measures of the dissociative PTSD subtype. Patients diagnosed with complex PTSD were excluded from study eligibility.

Speaker 2

The effects of the COM360 treatment on the CAHPS V score were assessed at week 4 and again at week 12 to affect durability of effect. Study observations also included improvement from baseline in mean FDF score, a measure of functional impairment in daily life. Safety over 12 weeks was the primary endpoint of this study and administration of COM360 in this patient group was well tolerated with no serious adverse events observed. We're also pleased to report impressive and sustained rates of response and remission at both week 4 week 12. The key findings include administration of COP360 was well tolerated.

Speaker 2

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 2 events of suicidal ideation that resolved to join the study. The first was a moderate and transient event on administration day in a patient who went on to be a responder. The second event was mild and occurred at week 7 in a non responder.

Speaker 2

As a reminder, suicidal ideation is a common feature of PTSD as it is in TRD. We observed an early and durable improvement in symptoms from baseline following a single administration. Improvement in mean CAHPS V total score from the baseline of 47.5 was observed with a 29.9 point reduction at week 4 and 29.5 reduction at week 12. We observed increasing improvement from disability over the 12 weeks From a mean FDS total score of 22.7 at baseline, there was an 11.7 point reduction at week 4 and a 14.4. Reduction at week 12.

Speaker 2

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 experiencing a greater or equal 15 point improvement on CAAT V score with 81.8% at week 4 and 77.3% at week 12. Remission as defined by CASK5 total score of less than or equal to 20 was 63.6% at week 4 and 64.5 percent at week 12. No patients withdrew from the study and none returned to antidepressant medication during the trial. Although a small trial with open label design, the results exceeded our expectations and advanced our understanding of potential application of COM360 in PTSD.

Speaker 2

We were particularly impressed by the early onset and durability of improvement. We believe that COP360 could provide a clinically meaningful benefit and substantially improve 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 to TRD, as Kabir mentioned, we are on track for the primary 6 week endpoint in COM5 during the Q4 of this year. We are seeing improvements from the actions we took to facilitate the retrieval of medical records, which created a bottleneck earlier in the year.

Speaker 2

We also remain on track for COP006 for the primary 6 week endpoints mid next year. We are excited by the profile that's emerging for COM360 across both TRD and PTSD and the potential benefit for patients. We look forward to our Phase III results later this year and next year and continuing to progress the broader COMP360 program. Let me now hand the call to Terri for financial review.

Speaker 3

Thanks, Guy. I'll now step through the Q1 financial results. Cash used in operations in the Q1 was $20,800,000 within the guidance range we provided of $17,000,000 to $23,000,000 and which assumes that 2022 R and D tax credit would be received in the Q1. I'm pleased to confirm that HMRC paid our 2022 claim of approximately $15,000,000 in full in the Q1. Regarding Q2 2024 financial guidance, we expect net cash used in operations to be between $32,000,000 $38,000,000 Turning to full year financial guidance, we expect cash used in operations to be between $110,000,000 $130,000,000 Compass continues to maintain a strong financial position with cash and cash equivalents of $262,900,000 at March 31, 2024.

Speaker 3

This compares with $220,200,000 at December 31, 2023. The increase in cash in the Q1 is due to proceeds received through the ATM and exercise of warrants from our August 2023 pipe. Long term debt under Hercules loan facility was $29,100,000 at the end of the Q1. With the cash increase in the Q1, 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.

Speaker 3

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

Speaker 2

Thank you, Terry. 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 COM360, we see logical expansion into PTSD given the similarities in 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.

Speaker 2

We also continue to make great progress with the network of interventional psychiatry centers and mental health care providers who can administer COM3-sixty 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 COM360. I also want to welcome Doctor. Mike Gold to the company's 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 neurotherms with extensive therapeutic experience in neurological and psychiatric disorders, including depression.

Speaker 2

Mike will work with Guy to continue to develop COM360 in TRD and other indications and to explore and advance other potential pipeline opportunities. I want to thank Trevor Mill, Compass' current Chief Development Officer, for his dedication and expertise in guiding the development of our COM360 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.

Speaker 2

We'll now turn to Q and A. So I'll hand it back to the operator.

Operator

Certainly. One moment for our first question. And our first question comes from the line of Vikram Projit from Morgan Stanley. Your question please.

Speaker 4

Hi, good morning. Thank you for taking our questions. So we had 2 on PTSD. So first, could you just frame for us in terms of real world experience and real world benefit, what the CAHPS V and SDS scores that you reported this morning, how to contextualize those in terms of the benefits that patients may observe? And then also 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.

Speaker 4

Just wanted to see what your thoughts were there on potential implications for your program and the space more broadly? Thank you.

Speaker 2

Thanks, Vikram. It's good day. And as we start, I just want to make sure you can hear us clearly. Yes. Okay, great.

Speaker 2

So I'll hand to Guy to take the first question and maybe the second one. I might add on how it's up to Guy. Yes. So I think the way to think about these results is that they reflect a real near return to normality for a significant number of patients in the study. I mean these rating scales are not terribly familiar, so we're all getting to understand them as we go along.

Speaker 2

But basically, they reflect the lowest scores that we see reflect essentially complete recovery. The average, of course, is not that. There's a range of outcomes, but we emphasize, I think, that these very high rates of remission, as defined by a minimum score, are high. And we think that's important also that they're sustained. I think I would also draw your attention to the SBS scores.

Speaker 2

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 potentially in PTSD. That again reflects the numbers that we show, reflects substantial return of function for patients, which is as important as the reduction of symptoms, of course. The second question about glycos. Yes. I mean, let me take that.

Speaker 2

I mean, I think first, no surprise. This is, as they've said, the first submission in PTSD for more than a quarter of a century, number 1. 2nd, it is currently a Schedule 1 drug. So in that sense, no surprise that there is going to be an outcome. And I would just say we wish them well.

Speaker 2

And obviously, we, like many other people, will be observing very closely how the FDA poses a number of the key questions around that application.

Speaker 4

Got it. Thank you.

Operator

Thank you. One moment for our next question. And our next question comes from the line of Ruth Thruberal from TD Cowen. Your question please.

Speaker 5

Quick thing on potential positioning versus the LICA compound and MDA assisted psychotherapy. Kabir and Guy, could you walk us through sort of the nature of the psychological support that you provide? Was there any aspect of exposure therapy, which from my understanding is sort of the basis for the psychological support provided by Lycos. If you could talk to like the amount and then the nature. And then I have a follow-up.

Speaker 2

Thanks. I'll hand it down in a moment. But I mean, the headline, Richard, is this is no different from what we're doing in TRD. Yes. Thanks, Richard.

Speaker 2

In fact, we have quite a detailed follow-up questionnaire, which we'll be publishing the results from in due course. And what that suggests is that essentially patients do not really 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 their memory and their experience. And that seems to be essentially driven by this inward journey that everyone has heard about in relation to psilocybin. So patients are prepared in the same way as we prepare the TRD group as you've heard.

Speaker 2

There's no specific exposure exercises as would occur with the conventional psychotherapy. And patients indeed remark who have had previous psychotherapy in contrast to that, that they feel that they are in a sense doing their own work, that they are leading themselves and they're not being driven by an external interactive force, which would be the therapist in conventional psychotherapy. So it's a very interesting contrast of 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 given that it's sustained after COVID.

Speaker 5

Very helpful. And then can you just talk about some of the exclusion criteria as it relates to suicidality? Did you were you able to exclude patients with a history of suicidality? Was there anything unique in history of those 2 patients that experienced suicidality?

Speaker 2

Yes. 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 2 vulnerable patients and the severe probably the complex PTSD group would be that. So this is a single trauma, which also simplifies the measure of outcome. But these patients also show significant history of suicidality. So 70% of them had expressed in their lifetimes the wish to be dead and as many as 30% of them have expressed active suicidal aviation with specific plans and intent.

Speaker 2

So this is a group that has lifetime suicide out as a feature of the illness. The particular group were obviously recruited at the place where they were not curitival. And therefore, we have therefore, what we're seeing is relatively sub threshold effect. There were no serious adverse events. And of course, there were no attempted suicides or suicide, which unfortunately is a risk in this condition.

Speaker 5

Got it. And if I could have just one quick follow-up, and a follow-up to the first question. Kabir, you left us hanging when you said you would have some key questions that you'd love to have answered by the Likos ADCOM. Can you elaborate a little further on that? What questions do you have that you hope the ADCOM addresses?

Speaker 2

So one and again, it's up to them to comment on how they think that will go. But clearly, and as we've said this before, the MICOS protocol is therapy. And in fact, your question itself drove a path to 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 that's successful how that will be reflected in labeling and so on. I think that's probably the key question.

Speaker 2

As well as clearly the overall assessment of benefit risk for what is generally categorized as a psychedelic. So again, we could get into our case arguments about that. But I think, again, how the FDA approaches the overall benefit risk.

Speaker 5

Great. Thank you so much.

Operator

Thank you. One moment for our next question. And our next question comes from the line of Charles Duncan from Cantor. Your question please.

Speaker 6

Hey, good morning. Congrats on the progress. I had a question on PTSD and then one on TRD. On the PTSD data, it 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 maybe including 1 or 2 studies both with less than say roughly 90 patients given the call it magnitude of change that you're seeing in Caps5?

Speaker 2

So Charles, you're not going to trick me into designing a Phase 3 study on this call. Suffice to say, obviously, we are encouraged by this data. As I said, we clearly are working on plans, on development plans. We will need to take a robust outline of that to the agency together with this data to have that discussion. What that number of trials is, the sizing and so on, it's still very much to be determined.

Speaker 2

But you have my assurance, we will be doing it appropriately trading off robust evidence and capital efficiency. Both of those will be goals and one other design we put forward.

Speaker 6

Appreciate that. Confident in it. Moving on to TRD, another question you're probably not

Speaker 2

going to

Speaker 6

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.

Speaker 2

So you are right. The answer is no. I'm not going to give specifics except to say, as we said, we clearly have patients in both parts. But also importantly, as we've also said, the dropouts are running significantly lower than what we had potentially anticipated in the trial, which I think is, again, a good sign.

Speaker 6

Got it. Thanks for taking the questions.

Speaker 2

Thanks, Rob.

Operator

Thank you. One moment for our next question. And our next question comes from the line of Patrick Trucchio from H. C. Wainwright.

Operator

Your question please.

Speaker 7

Thanks. Good morning and congrats on this very positive outcome in PTSD. I'm wondering if you can talk a little bit about the trial design for the Phase 2 study in 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 in PTSD? And then secondly, I'm wondering regarding the pivotal Phase 1 trial in TRD with top line data expected in the Q4. 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 the study relative to both the Phase 2b trial in TRD as well as possible read through to the outcome from the pivotal trial 2 in TRD where the top line data is expected mid-twenty 25?

Speaker 2

Thanks, Patrick. So I'll hand to Guy in a moment, but I guess just the first thing today, arrived at this Phase 2 was an open label 22 patient study. But let me hand to Guy to say anything around the FDA guidance that would inform how we think about further design? Yes. I mean, the FDA have obviously Yes.

Speaker 2

I mean the FDA have obviously expressed an interest in seeing comparisons with another treatment, and that can be placebo or it can be another dose of the active treatment or even active placebo. So they've left 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 Phase II and indeed Phase III program for PTSD. I don't think there are tremendous differences between TRD and PTSD from what we've seen. But of course, there'll be the advantage of a shared safety database with TRD, there's no reason not to read across the PTSD indication. And on your second question, Patrick, again, we have not guided to what exactly we'll be in a position to release the top line.

Speaker 2

As you're aware, this Part B runs to 26 weeks blinded, so we're going to have to be sensitive around that in terms of that. And look, we powered and designed this study for success clearly, and we believe that any significant result will be very positive and further evidence of the potential for COM360 in TRD. And then, Guy, in terms of any read through from O5 to O6, if you have any comment you want to make? Not really. I mean, I think we see 6, I think as we said before, Patrick, we see 6 as being particularly informative from a clinical perspective rather than simply a regulatory one.

Speaker 2

And that it will help us to understand the number of treatments that are probably required in ordinary practice 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

Speaker 7

I could, just on these on the commercial collaborations following another announcement today, I'm wondering if do you have an estimate or an 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 COM360 and TRD?

Speaker 2

Thanks, Patrick. It's a great question. So to be clear, these collaborations are really learning exercises. They are examples of different settings of care. And while some like, for instance, Greenbrook TMS, we would expect potentially that numerical significant contributor to commercial rollout.

Speaker 2

Others, this is all more about building templates, understanding delivery models that we will then need to apply to a wide range of other health care settings. So what I would say at this stage is you can think of them really as this learning experience, really to deepen our understanding of the potential, to deepen our understanding of these different areas. But assuming we're fortunate enough to file, you could imagine that the year pre launch is when we will be really scaling those set base across a number of those different settings, the different health care providers.

Speaker 7

Great. Thanks so much.

Operator

Thank you. One moment for our next question. And our next question comes from the line of Tom Shrader from BTIG. Your question please. Good morning.

Operator

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?

Operator

Thanks.

Speaker 2

So it's basically classified as severe. And one of the criteria for the way in which one scores the cat slide is that it would merit intervention or require intervention when people score 2 or 3, particularly on the scales that are used for each item of symptom. It's a complicated scale, I'm afraid, so it needs a little we will be unpacking it a little more in the future. But that gives you some idea that these are a group who would need treatment. They're not a group who are sort of mild and coming into the experience.

Operator

Any background on how much they're hospitalized?

Speaker 2

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. And roughly half were on something, NSFRI or antidepressant or something. I think all have received previous treatment at some time.

Speaker 2

Sorry, that was the question. That's the answer. That included psychotherapy as well as drug treatment and about half were actively still on drugs, which we then discontinued. And Tom, 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 PTSD. So again, we couldn't genuinely 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.

Speaker 2

So honestly, premature to comment on how these would relate to each other commercially.

Operator

Perfect. Thank you. Thank you. One moment for our next question. And our next question comes from the line of Soumit Kulkarni from Canaccord Genuity.

Operator

Your question please.

Speaker 8

Morning and afternoon. Thanks for taking my questions and nice to see the PTSD data. I have 2. So first on COM360, how can the company optimally mitigate the risk associated with suicidal ideation in trials given both TRD and PTSD have high background rates of this type of event in patients to start with? And second, it's very nice to see Doctor.

Speaker 8

Michael Gold on 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 COMPASS might be looking at?

Speaker 2

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

Speaker 2

But we insist that our preparation and the support during the administration optimizes the preparedness of patients. And we think for that reason, we're seeing these relatively minor changes in the rating scale. Bear in mind that we have not had no attempted suicide or suicides in any of our studies. And what we're seeing and describing here are changes on the scale, which is sub threshold for actual events that you would classify as clinically serious, particularly in this study. And to answer your question, yes.

Speaker 2

So I think first, we've always said that we use cash credibility with COM360. And I believe with our progress with TRD and what we've announced today with PTSD, we're well on the way to doing that. We do have discovery assets, some of which we could be in a position to advance into 1st in human in the relatively short timeframe. But I think having established ourselves as a credible developer, late stage developer of drugs, it absolutely is part of our thoughtful strategy to how we might expand into other assets over time. But recognizing again, that's not a given.

Speaker 2

We have to demonstrate credibility and success with our lead assets, and I think we're well on the way to doing that.

Operator

And our next question comes from the line of Elmer Prius from Rodman. Your question please. Yes, good morning. Maybe a question to Guy. Guy, I'm looking at the PTSD results with MDMA from the Phase 3 trial.

Operator

And it appears that it takes about 12 weeks to reach maximal benefit with MDMA plus therapy. How does that compare to what you observed with a single dose of COM3,060?

Speaker 2

Our CAT III, pardon me, CAT V number is taken at 4 weeks. It's the first measure we take because it's a 4 week measure. And of course, that shows the full effect at 4 weeks and it's sustained out at 12 weeks using the same measure. So that's what we appear to see. We will have an even finer grain evidence for early very speedy onset from other measures that we took from patients that we don't yet have available to show you, but we will have them in this course.

Operator

So do you believe that the results with MDMA are probably due to the second dose, the 3rd dose amplifying the effect and with the end results being about the same reduction in Caps V as what we see.

Speaker 2

Yes. That's what we all see.

Operator

Yes. Thank you. Thank you very much. Thank you. This does conclude the question and answer session of today's program.

Operator

I'd like to hand the program back to management for any further remarks.

Speaker 2

So just to say thanks all for your participation. As I say, I think as we've 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 plan program might be. We continue to execute on the time lines we established in February for COM-five and COM-six in TRD. And I think, therefore, we are looking forward to exciting news later in the year.

Speaker 2

So thanks, everyone, for your participation. Thanks for your support. I wish everyone a very good rest of the day.

Operator

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

Powered by Quartr

Key Takeaways

  • Phase 3 COMF360 Trials on Track: Compass is executing its two Phase 3 trials in treatment‐resistant depression, with top‐line data for the COMF-5 single‐dose study expected in Q4 2024 and for the COMF-6 repeat‐dose study in mid-2025, while completing preclinical and pharmacology work for an NDA dossier.
  • Commercial Collaborations Expanded: The company added partnerships with Journey Clinical and Mindful Health Solutions to existing collaborations, leveraging the new CPT-3 tracking code to develop scalable, cost-effective delivery models for COM360 psilocybin treatment across diverse mental health care settings.
  • Positive Phase 2 PTSD Results: In an open-label study of 22 adult PTSD patients, a single 25 mg psilocybin dose was well-tolerated with no serious adverse events, yielding a 29.9-point CAPS-5 reduction at week 4 (29.5 at week 12) and high response (81.8% at week 4, 77.3% at week 12) and remission rates (63.6% at week 4, 64.5% at week 12).
  • Strong Financial Position: Q1 2024 cash used in operations was $20.8 million (vs. guidance of $17–23 million), with Q2 net cash use guidance of $32–38 million and full‐year guidance of $110–130 million; cash and equivalents stood at $262.9 million as of March 31, 2024, extending runway into 2026.
  • Leadership Enhancement: Dr. Mike Gold will join as Chief Research and Development Officer, bringing over 25 years of neurotherapeutics experience to advance COM360 and explore additional pipeline opportunities.
AI Generated. May Contain Errors.
Earnings Conference Call
COMPASS Pathways Q1 2024
00:00 / 00:00