COMPASS Pathways Q3 2024 Earnings Call Transcript

Quartr
Provided by Quartr
October 31, 2024

There are 16 speakers on the call.

Operator

Thank you for standing by. My name is Louella, and I will be your conference operator today. At this time, I would like to welcome everyone to the Compass Pathways Third Quarter 2024 Investor Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session.

Operator

Thank you. I would now like to turn the call over to Steve Schultz, Senior Vice President of Investor Relations. Please go ahead.

Speaker 1

Welcome all of you, and thank you for joining us today for our Q3 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 Laurie Engelbert, our Chief Commercial Officer and Terry Luxom, our Chief Financial Officer, who will be giving prepared remarks, as well as Doctor. Guy Goodwin, our Chief Medical Officer and Doctor. Michael Gold, our Chief R and D Officer, who will join us for Q and A.

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 and will be available 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 most recent 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 as of any subsequent date. We specifically disclaim any obligation to update or revise any forward looking statement, even if our estimates or assumptions change. I'll now hand the call over to Kabir Nath.

Speaker 2

Thank you, Steve. Good day, everyone, and thank you for joining us. Let me begin by welcoming Laurie to her first quarterly call with Compass. As I said on our August call, we're pleased to have such an exceptional leader join the company and round out our executive team. Laurie brings deep strategic and commercial experience, having most recently launched Orvelity at Axsome.

Speaker 2

That experience will be valuable as we prepare for the commercialization of COM360, and we're thrilled that she has joined us. In a moment, I'll ask Laurie to update you on the commercial landscape and our commercial preparation, which we know are areas of major interest and focus for our investors. And as usual, Terry will provide you with a financial update. First, though, I want to address questions around the anticipated disclosure of our pivotal COP360 trials. On our August earnings call, we pushed the anticipated 6 week disclosure date for the COM005 trial back to the end of this year or early next year.

Speaker 2

Based on our recruitment to date, it now looks unlikely that we will be able to disclose the 6 week data in the Q1, and we are therefore updating our guidance for the 6 week 5 data to the Q2 of 2025 to give us more assurance. Our top priority is completing our Phase III trials, and we're doing everything we can to ensure that sites recruit as quickly as possible while maintaining the integrity and quality of the trial. Mike Gold, who came on board in May, has significant drug development experience in neuroscience and is spending much of his time on the ground with the sites, which has given us new insights into some of the challenges and helped us to refine our plans. We're the 1st company to conduct such large psychedelic trials, and we did not have the benefit of prior comparable Phase III timelines to base our assumptions on. Our Phase III enrollment projections were based on the Phase IIb enrollment curve.

Speaker 2

And while we did factor in some new aspects of the Phase III trials into our projections, there have been a number of items related to the complexity of the trials that we're now learning along the way. The Phase 2b was a simpler protocol with all active arms, a single dose and blinded for just 12 weeks. COM005 on the other hand is a 52 week trial, blinded for the 1st 26 weeks and has multiple parts where additional doses can be given, which significantly increases the logistical complexity for sites to schedule patients and therapists as well as for patients themselves. These complexities are specific to the clinical trial setting, but have resulted in inexperienced sites carefully managing patient flow as they become more proficient. Mike and his team are paying close attention to the needs of each site and are providing the necessary resources to support them on a case by case basis.

Speaker 2

This hands on approach is working, and we'll be continuing to dedicate all our focus to successfully completing these trials. There continues to be significant demand from patients at the top of the funnel, and it's a matter of blocking and tackling and helping sites get patients through the process as quickly as possible. Beyond timing for the trial, we are also frequently asked what data we will be disclosing with the 5, 6 week data readout. Please remember that while the primary endpoint is at 6 weeks, the trial remains ongoing and blinded through 26 weeks. Therefore, we are going to be limited in what we can release at 6 weeks so that we maintain the integrity of blinding as much as possible.

Speaker 2

We will disclose 3 key efficacy measures for the 6 week endpoint: the MADRS effect difference between the arms, p value and confidence intervals. We believe that these data should provide investors with a clear understanding of the treatment effect and if positive, provide an important validation of the positive Phase IIb treatment result. From a safety standpoint, we'll provide a high level assessment for the independent DSMB, which looks at unblinded data on a regular basis to monitor safety risks for patients in the trial. Suicidality is an inherent feature of TRD and suicidal ideation is expected in this population. As part of the DSMB assessment at the time of the data readout, they will also comment on whether they're seeing any imbalance in suicidal ideation.

Speaker 2

At this 6 week endpoint, we will not be able to provide secondary endpoints or in-depth safety tables as that would require further unblinding. Let me now turn to the COMP-six trial, which is our 2nd Phase 3 trial. As a reminder, 6 has 3 active dose arms of 1 milligram, 10 milligrams and 25 milligrams with the same 3 part structure as 5, with the primary endpoint at the end of Part A at 6 weeks, a fully blinded Part B through 26 weeks and an open label Part C through 52 weeks. In the 6 trial, each participant gets 2 doses of COM360 3 weeks apart at the start of the trial. The recent LICOS AdCom and the fact that they received a complete response letter provided key insights into the FDA's thinking and some of the challenges faced by this new class of drugs.

Speaker 2

While most of the FDA and ADCOM concerns were specific to Lycos and their MDMA assisted therapy program, there was a high degree of scrutiny regarding unblinding, which is very relevant to our studies. While both the five and six trials are blinded to 26 weeks, the six trial with its 3 active arms is designed to minimize the risk of unblinding as participants know they will receive a dose of COM360. With a 15% cap on recruitment of patients with prior psychedelic drug experience, it will be difficult for the overwhelmingly psychedelic naive participants to determine which dose they received, particularly between the 10 25 milligram doses, which is what we saw with the overlapping responses between 10 25 milligrams in our Phase 2b trial. We believe that this is an effective strategy to maintain blinding and given the importance of the 6 trial for COMPASS to gain valuable regulatory and commercial insights around redosing and durability, we want to ensure that we preserve that through the blinded portion of the trial. We therefore made the very difficult decision to further protect the blinding of the 6 trial and only release data after the 26 week time point has been reached for all patients.

Speaker 2

While recruitment for 6 has been going well so far at the sites that are up and running, We are still working through some site initiations in Europe, some of which have taken longer than projected. And we are also relying on a number of the U. S. Sites from 5 to roll over to 6. Therefore, taking into consideration the shift of disclosure to the 26 week time point for 6 as well as potential unpredictability in recruitment, we now expect to disclose data for 6 in the second half of twenty twenty six.

Speaker 2

While we have a better understanding of the variables impacting enrollment, we're continuing to actively consider all other opportunities to accelerate this trial. We remain fully confident in the potential impact psilocybin can have for patients. We want to do everything we can to ensure a successful development and regulatory outcome for COM360, and we believe that these steps give us the best chance. In parallel to optimizing our regulatory strategy, we're also focused on building a robust commercial strategy and adequately preparing the market for a potential paradigm changing treatment, and that's where Laurie is focused. I'll now turn it over to her to go through some of the observations since joining.

Speaker 3

Thank you, Kabir. Let me begin by saying what a privilege it is to be part of the Compass Pathways team. Our focus on advancing treatment options for patients with difficult to treat mental health conditions, especially for patients with treatment resistant depression, or TRD, is an area I have a personal connection to and I am extremely passionate about helping deliver potential solutions for patients and their providers. By definition, treatment resistant depression is an area of extremely high unmet need. About 1 third of patients treated for major depressive disorder failed to achieve remission after 2 therapies and are therefore considered treatment resistant.

Speaker 3

Innovation and commitment to develop safe and effective products in this patient population has been limited. And currently, there are only 2 FDA approved pharmacologic treatments with a TRD indication. If approved, COP360 has the potential to change the way patients who are suffering from treatment resistant depression are managed. And given the high unmet need in this patient population, we see significant commercial opportunity. As I have been diving in at Compass, I have been impressed by many facets of the commercial work that are already underway, all important steps forward in preparing for launch success.

Speaker 3

These areas include ensuring appropriate billing codes are established to align with our administration model, preparing states for DEA rescheduling, KOL interactions and investing in health economics research to prepare for future payer discussions. One additional area of important work is our bidirectional learnings through strategic collaborations with select interventional psychiatry networks. Through these collaborations, we have the opportunity to gain insights and learn from providers in various care settings within the delivery centers. Some of the key learnings include understanding current operating models, how they have adapted to support SPRAVATO and working with the sites to identify opportunities to scale the Comp360 operating model. Ultimately, we want to use the learnings from our collaborations to make sure that delivery centers can fit Comp360 into their current operating infrastructure at launch and are prepared to support what we expect will be significant demand for a new and novel treatment beyond today's current treatment options.

Speaker 3

An area of consistent feedback as we have been out in discussions with HCPs over the past year is just how much enthusiasm there is for the potential of Comp 360 and how much providers want to be ready for it. One key question, which investors have as well, is whether the interventional psychiatry network is capable of managing sufficient demand for Comp 360 at scale and how delivery centers will handle the monitoring time required. As I mentioned above, this is an area of focus with our collaboration partners and ongoing strategic planning, but it is also worth noting when SPRAVATO came to market, it was a change for these centers as well in terms of patients needing to occupy rooms and monitoring requirements. Certainly, SPRAVATO growth would suggest that these centers have adapted and are growing along with awareness and patient demand. As mentioned before, I've been impressed with the work to date.

Speaker 3

A great foundation has been established, and I look forward to advancing our approach to commercialization. We have work to do to determine exactly how we will optimize the commercial opportunity, but my team and I are committed to ensuring Comp360, if approved, can get the patients, and we will be working tirelessly to ensure the market is ready. I look forward to meeting with many of you in the future and providing additional insights as we progress and learn more. Let me now hand the call to Teri for the financial overview.

Speaker 4

Thank you, Laurie. I'll now step through the Q3 financial results. Cash used in operations in the Q3 was $22,200,000 which includes $13,600,000 related to our 2023 R and D tax credit that we received in full in the 3rd quarter but had not originally been included in our Q3 cash guidance as the timing was uncertain. Excluding this tax credit, cash used in operations would have been $35,800,000 which is at the midpoint of the range for guidance that we provided of $32,000,000 to $38,000,000 Regarding Q4 2024 financial guidance, we expect net cash used in operations to increase to between $37,000,000 $43,000,000 which would put cash used in operations for the full year 2024 between $114,000,000 $120,000,000 near the midpoint of our prior guidance and includes the 2023 R and D tax credit that we received this quarter and which had been contemplated in the original full year guidance. At September 30, 2024, we had cash and cash equivalents of $207,000,000 This compares with $228,600,000 at June 30, 2024.

Speaker 4

Debt under the Hercules loan facility was $29,800,000 at the end of the 3rd quarter. Given the timing and strategic changes made to the Phase III readouts, we are taking actions preserve cash and ensure our entire focus is on successfully completing the Phase III COM360 trials as quickly as possible. Therefore, we will be reducing our workforce, including stopping our non COM360 preclinical efforts as well as the potential externalization of our digital tools. Over the last several years, we have developed digital tools and technology to test evidence based methods for assessing mental health treatments. We are now exploring externalizing these technologies, intellectual property, and associated employees to a new company established by our co founders that could potentially support an evidence based approach for anyone developing and delivering mental health treatments for the benefit of patients.

Speaker 4

We are still working through the details and look to a final decision on this externalization by Q1 2025. Collectively, these actions will result in a downsizing of the organization by approximately 30%. While we are still working through the full details and impact on cash, we expect our cash runway to fund operations at least into 2026. Thank you. And I'll now turn the call back to Kabir.

Speaker 2

Thank you, Teri and Laurie. We're applying the resources necessary to get these trials done as quickly as possible and best position COM360 for regulatory and commercial success, and we continue to actively review all other ways to accelerate the 6 trial. As I mentioned earlier, Mike has been traveling to clinical sites to fully understand where assistance may be needed and directing resources to them. As we encounter challenges, we're addressing them rapidly and applying those learnings to the overall pivotal program. As Terry mentioned, we're also taking action to cut costs, further focus the organization, and preserve cash.

Speaker 2

In saying that, I want to acknowledge that our actions today in reducing our workforce have much bigger implications preserving cash. I know that they will have a deep impact on the lives of many employees and their loved ones. I regret that. And as a management team, we're committed to supporting them through this transition. With our 2 robust Phase III trials and our large Phase IIb trial, we'll have more than 1,000 patients' worth of data from well controlled trials, as well as a full package of supporting studies for a filing.

Speaker 2

We're confident that we're well positioned for success with a clear plan and a committed team to deliver on this plan. Thank you. And I'll now turn the call to the operator for Q and A.

Operator

Your first question comes from the line of Ritu Baral with TD Cowen. Please go ahead.

Speaker 5

Hi, guys. This is Athena on for Richard for taking my question. Was your decision to move the OO submission to top line readout made after additional FDA correspondence or a face to face meeting? And do you foresee any other changes to trial operations and conduct? Thank you.

Speaker 6

Thanks Athena. It's Kabea. Can you just check, you can hear us clearly?

Speaker 7

Yes.

Speaker 6

Okay, great. So that was a compass decision. It was a compass decision that we made out of an abundance of caution really after observing all that happened through the LICOS process and debating internally around the need to really maintain that blind through the blinded portion of 6. And we said on the call, we continue to look at all ways we can do to accelerate the conduct of 6 and that will continue to be an active effort.

Speaker 5

Understood. Thank you.

Operator

Your next question comes from the line of Leonid Timashev with RBC. Please go ahead.

Speaker 8

Hi guys. Thanks for taking my question. I guess I'm trying to understand how the potential complexities in the trial recruitment may or may not have any impact on how COM360 would be used in the real world. I guess is this largely just due to limitations that staffing sites or is this something where booking the therapist having all the appointments aligned is going to be a challenge for any initial commercial uptake here? So are there any learnings as you go through the clinical process that might inform how you go about commercialization?

Speaker 8

Just trying to understand how much of this is also demand versus really just logistical steps. Thanks.

Speaker 6

No. Thanks, Leo. It's a really important question. And the fundamental answer is that a clinical trial setting is clearly very different from a commercial setting in the sense of what needs to be communicated to patients and so on. But let me ask Laurie to amplify that a little with some of the key differences and how we're thinking about the commercial side.

Speaker 3

Yeah. Hayley and Ed, thank you for the question. So, as you know, clinical trials are intentionally onerous because they're working to fit within a regulatory construct. We do not anticipate that it will flow over to the commercial side. Most likely what will happen in commercial operations when the product is approved is that it will physicians will be regulated based on what they're restricted by utilization management, formulary access, and things like that.

Speaker 3

From an operational standpoint, we are learning a lot from our clinical sites. We're also learning a lot from our key collaborations that we mentioned on the call. And a lot of that has to do with really optimizing the patient flow. And the way that I think about how we will go about optimizing the patient flow which is we're learning from the clinical trials but is not necessarily analogous to the clinical trials is that you have to think about it in 2 ways. 1, you have to make sure that the patients are adequately being referred from referring physicians to the trial sites.

Speaker 3

That's what's happening in the clinical trials. It will be a very similar situation in commercialization. We're going to need to work very hard to make sure that physicians are adequately educated to make sure that they're referring patients to the treatment centers. This requires education. This requires education on TRD.

Speaker 3

It's really helping physicians identify the appropriate patients and really making sure that they understand CompFresenexy's clinical benefit. This will all come very naturally through, you know, a sales and marketing effort as we get closer to launch. The second piece of it, which I think is important for for the underlying piece of your question and that really is ensuring capacity, of patient flow at the treatment sites. You can think about this in my mind I think about it in 2 ways. You can either go broad and really have an inefficient process where you have a lot of treatment sites and not a lot of patients flowing through or you can think about how you might optimize the opportunity at your sites and really look at a real concentrated effort where you're optimizing opportunities to make that patient feel efficient at those treatment sites.

Speaker 3

And those are a lot of things we're learning from our collaboration partners. We're taking a look at opportunities there.

Operator

Your next question comes from the line of Charles Duncan with Cantor. Please go ahead. Mr. Charles Duncan, please go ahead.

Speaker 9

Yes. Can you hear me? Yes. We can. Hello?

Speaker 9

Okay. Good morning, Haber and team. Although I'm a little disappointed on timing, I do really appreciate the focus on maintaining rigorous clinical evaluation and ultimate regulatory success. So I have a question about what has changed over the course of the last 6 weeks? Have you discussed this with the agency in terms of and is it possible that your regulatory strategy in terms of 'five and 'six being necessary has perhaps changed?

Speaker 9

Or do you have any other thinking about that?

Speaker 6

Thanks for the question, Charles. And the short answer is no, nothing about our regulatory strategy has changed at this point. What has changed clearly is a decision around what data we disclosed from 6 when, but we would still anticipate the base cases that 5 and 6 are needed for a filing.

Speaker 9

Okay. And if you could provide a little bit of color on the enrollment patterns, are you still feeling good about the ability to wash out patients from antidepressant meds that are standard of care or is that not a complexifier at all to the enrollment?

Speaker 2

I'll pass that to Mike.

Speaker 10

Hey, Charles, it's Mike Holdach. So we are actually seeing a greater than 90% successful washout rate from standard of care coming into the trials. I think we just published and I was going to confirm with Guy that it just came out, a paper reporting on that from the Phase 2 study. So this is not, it's not a logistical obstacle. It does remain a point of education for our investigators and clinicians in the community because there is some there is a reluctance to sort of tell patients they do washout.

Speaker 10

But in fact, and from what we observed from the trials, it's not a problem. We have not seen a placebo effect from withdrawal. And like I said, higher than 90% ability to complete that washout in our trials right now.

Speaker 9

Yeah. We saw that journal site research paper was helpful. I appreciate that. Last question is, with regard to 2006 timing, the shift to 26 weeks seems like a year and yet that seems like it could be a little bit longer than you would expect just due to the shift. So is there also a modulation of enrollment or your confidence in enrollment in 'six as well?

Speaker 6

Your maths is correct. What I would say is, as we said on the call, there is still some uncertainty around the recruitment curve. I think we're very confident, therefore, on the guidance we've given for the 26 week endpoint. But we're doing everything we can to continue to accelerate both with European sites and also with the expectation that as 5 finishes, those experienced sites that have done well in 5 will roll into 6, which will be an inflection point in that curve. So you're correct.

Speaker 6

It does incorporate an element of conservatism as well around moving from 6 to 26 weeks.

Speaker 9

Super. One question for Terry in terms of more math, checking my math, and that is, it seems like you have sufficient cash through 2025 into 2006 seems a little bit more of a stretch to me. Could you anticipate having sufficient cash through the read given the current view on timing for 2006?

Speaker 4

Yes. Thanks for the question, Charles. So as we had mentioned, we have $207,000,000 of cash as of the end of the Q3. That gets us at least into 2026. We are we announced a restructuring along with these delays, excuse me, as the trials do cost more as they go longer.

Speaker 4

And so the savings that we have that we anticipate from the restructuring are meant to offset that and preserve cash. We are still doing some detailed analysis on the potential for savings and working through whether we might be able to incorporate additional savings to further extend runway. And that is work that we'll be doing here over the coming weeks. So we're very comfortable. We'll have cash at least into 26.

Speaker 4

If we can extend beyond that, that's the work that we're doing, and we are committed to being disciplined in our expenses and our spend and ensuring Comp360's success.

Speaker 9

Okay. Appreciate all the color. Thanks for taking my questions.

Speaker 6

Thanks, Charles.

Operator

Your next question comes from the line of Francois Brisebois with Oppenheimer. Please go ahead.

Speaker 7

Hi. Thanks for the question. I just want to touch back on something that was brought up on a prior question about the difference between clinical and commercial. And it seemed like the answer was there is clearly a difference. At the same time, the education will be similar in terms of referrals on the commercial side, Kiki.

Speaker 7

Just help us understand maybe why you still feel comfortable with maybe sales potential? And also as a second question, can you help us understand what needs to be done between these final like data readouts now and launch? And just like what would be a good estimate for a year there? Thank you.

Speaker 6

Thanks, Frank. So I'm not quite sure I caught the second part of the question. What needs to be done in what context, sorry?

Speaker 7

In context of launch, between the final readouts now with the time line pushes, just trying to understand if what else has to be done after these readouts to move forward to launch? Thank you.

Speaker 6

Sure. I'll pass that to Laurie. Thanks.

Speaker 3

Yes. So I'll answer your first one or try to give you a little more clarity around the first one. Again, really thinking about the main question that we get from either HCPs that we're in discussion with or HCPs that we're working with or the clinical or the trial sites as well as the collaboration sites that we're working with, really is about how do you opt Sorry, I think we're back. Can you hear me okay?

Operator

Yes, we can hear you now. You may go

Speaker 3

ahead. I was just getting going on my excitement for, for the commercial opportunity here. So not exactly sure where we cut off, but I'll I'll I'll

Speaker 5

I think we're back.

Speaker 3

Can everyone hear?

Operator

Yes. Please go ahead.

Speaker 3

I hope everyone heard all the points around the excitement for for the commercial opportunity, but what I'll what I'll shift gears to is is really what's needed between now and launch. And what I like to focus on is is what we're actually doing right now, what our immediate focus is. So right now, you know, the things that we need to focus on are really increasing the awareness around TRD and educating on COM 3 60 phase 2 data. That's what our MSLs are out in the field doing right now. So that is a very concerted effort and obviously we're learning a lot from the feedback from KOLs around that.

Speaker 3

Another important area of focus for us is really making sure that states get rescheduled in a very timely manner after DEA scheduling. That is, you know, an effort that is unique to us given that, we're currently setting sitting at a Schedule 1 product. So we need to be able to get the states rescheduled in a timely manner in order for physicians to prescribe, and we can distribute the product to those states. The other effort that we're really focusing on, again, I've said it a couple of times, was really focusing on how we optimize that patient flow. And again, that's learnings through our collaborations and in the partnerships that we have in place as well as anything that we learn from KOL interactions with our MSLs and obviously from the clinical trials.

Speaker 3

And then of course we are acutely aware of the importance of getting good formulary access. And so right now, our HUR team is working diligently to build a robust information set so that we can be armed with good data to present to payers when the time comes.

Operator

Mr. Francois, you are still on the line.

Speaker 7

Yes. I mean, maybe it's my phone. In terms of the commercial point, I I didn't hear anything, but, maybe others did. I'm not sure.

Speaker 3

Yeah. We're we're we're having some technology challenges, here. So I'll I'll just I'll I'll I'll revisit some of the the reasons why I'm excited for for Comp 360 and that that's probably a better approach. I think we have a lot of learnings to do. We have a lot of of challenges that we'll need to overcome, but we have time to figure those out.

Speaker 3

Being first to market takes time and we are we will be 1st in class, 1st to market and that is is is a situation where you need a lot of time to think through strategy and planning. And so we have time to work through some of these complex issues that present themselves with the administration of COM360 and figure out how we can optimize that patient flow. The reason I'm excited is you have a great analog in SPRAVATO. SPRAVATO again launched into these interventional psychiatry centers and they were able to adapt and we all know it's well on path to be a $1,000,000,000 product. They've steadily grown their sites since their launch and they're now sitting at well over 4,000 sites.

Speaker 3

There is a natural overlap with prescribers obviously. It is the only marketed TRD product out there and our prescribers will be natural overlaps.

Speaker 6

Thanks Frank.

Operator

Our next Our next question comes from the line of Vikram Parujit with Morgan Stanley. Please go ahead.

Speaker 11

Hi, everyone. Thanks for taking our questions. This is Morgan on for Vikram. So we have 2 on the 5 program. 1st, would you expect a change to the profile of patients enrolled in the trial given the delay?

Speaker 11

And second, given the delay, are any of the parameters of data that you'll report for this release different versus prior expectations? Thank you.

Speaker 6

Thanks, Morgan. And I'll answer both. No in both cases. So the focus is on recruiting exactly the same patients consistent throughout the trial. And in terms of guidance about what we released today was clarifying what we had always expected to say.

Speaker 6

So no changes on either of those.

Speaker 11

Okay. And if I may squeeze one more question in there, how is your focus on non TRD indications, including PTSD, impacted by these timeline delays? I know you mentioned deprioritization of preclinical efforts, but what does it look like for some of the clinical indications?

Speaker 6

So as you know, we have clearly said, PTSD is an area of significant interest, very high unmet need. We have very compelling, albeit small data set from Phase 2. What we've also said is while we have planned for moving that ahead, that is not in our current runway. So that situation has not changed. We have plans in hand, but we're not in a position to execute on them at this time.

Speaker 6

Okay. And then, execute on them at

Speaker 7

this time.

Speaker 11

Okay. Thank you.

Operator

Your next question comes from the line of Elemer Piros with Rodman. Please go ahead.

Speaker 12

Yes, good morning. What I'd like to ask is about the eligibility for retreatment. Is there any difference between the time period between week 626 and between 26 weeks 52 weeks? And maybe a Part B to this question is how do we define relapse? And if someone went back onto an antidepressant, do you want them to wean them off before retreatment with COM360?

Speaker 6

Guy, if I may ask you to take that?

Speaker 13

Hi, Omer. The second question is quite simply that if people have gone back on to antidepressants, then they can stay on them, particularly this would be in Part C, wherever this will commonly occur, we think, and will obviously offer quite important useful information about the feasibility of administering the drivers of coadministration. The criteria for retreatment are simply a threshold on the MADRS and they're not different between the 2 phases B and C. So either patients who have not recovered or patients who have recovered and then relapse have to meet the same criteria essentially.

Speaker 12

Same criteria. Thank you very much, Guy.

Speaker 13

Pleasure.

Operator

Your next question comes from the line of Gavin Clark Gardner with Evercore ISI. Please go ahead.

Speaker 5

Hi, this is Yasha on for Gavin. Thanks for taking our question. For us, you noted for 5 that you won't be providing a detailed safety table, but you'll be providing comments on potential suicidal ideation imbalances. We were just wondering what rate do you and or the DSMB consider an imbalance essentially? Just how is that defined?

Speaker 5

And what will the update kind of look like?

Speaker 6

So I'll start. I mean, the DSMB is independent, so it's up to the DSMB to tell us what they consider an imbalance. But I don't know, Mike, if you'd like to amplify that

Speaker 2

at all.

Speaker 10

So so, I don't think we're in a place where I can give you quantitative criteria. I think that it depends on the degree of imbalance, but also on the nature of the cases and severity of the ideation or planning, etcetera. So this is a place where we have, as Kabir pointed, it's an independent DSMB and in the charter, it gives them a lot of latitude in that space. So I'm going to park the response there. I don't have a number to give you.

Speaker 10

It really depends on your clinical interpretation of the cases that they see.

Speaker 5

Thank you.

Operator

Your next question comes from the line of Patrick Trucchio with H. C. Wainwright and Co. Please go ahead. Patrick Trucchio, you are now on the line.

Speaker 14

Hello. Good morning. I have a few questions. The first is, is the expectation that you will continue to need data from both COM-five and 6 to submit the NDA for COM-three sixty and TRD? And secondly, can you tell us if the expectation is that there will be an advisory committee to assess potential of COM360 and TRD?

Speaker 14

And then can you talk more about how the data that's generated from these trials, the 5 and 6 trials with these updated timelines discussed earlier should put you in a better position to address potential questions during a potential advisory committee?

Speaker 6

Thanks very much, Patrick. So I'll answer very quickly. Yes and yes to questions 12. We continue to guide that we'll need data from both. We absolutely expect an AdCom based on the fact this is a Schedule 1 product and the precedent is always there will be.

Speaker 6

And for the 3rd part, I'll pass to Mike.

Speaker 10

Remind me the 3rd part again.

Speaker 6

Which is, do these changes help us,

Operator

we

Speaker 6

believe, put us in a stronger position to address issues that might come up at an outcome?

Speaker 10

Well, I mean, I think to the extent that we preserve the integrity of the 'six study and reduce any bias in terms of unblinding, yes, it helps us because clearly the agency, while aware of it, just wants sponsors to do whatever they can to minimize the functional unblinding. I was just going to add to Kabir's comment. We're going to be probably 1st in class. And generally speaking, for 1st in class, the agency generally calls, you know, for adcoms even in areas of mundane as antibiotics.

Speaker 14

That's helpful. And then just can you frame for us more broadly as we think about compounds that have been approved recently, trials that are underway, what would be considered a positive outcome in terms of improvement on the MADRS scale in a Phase 3 TRD trial, both in terms of reduction from baseline and active treatment relative to placebo? And then separately, I'm wondering as we are going to see this the top line data from the COMP-five trial, how do you envision that that data will read through to the 6 trial just given the differences in the way these studies have been designed?

Speaker 10

So processing your question here about effect size. So I would say what we're let me see if I can sort of answer your second one first in the sense of the impact of so this is one of the reasons why we are limiting the amount of data that we are releasing from 5 because we're going to be releasing data while 6 is still in sort of both some Part A and some patients in Part B. So we want to be really prudent about how much we put out there. We're also the sites that are running 2005 and 2006 at this point are non so we don't have any sites that are running both studies at the same time. So they're non overlapping sites and other than the US, they're different geographies as well.

Speaker 10

So we're doing everything that we can to minimize or blunt any sort of read through from 5 to 6. Now obviously, we're hoping

Operator

Ladies and gentlemen, this is the operator. I apologize, but there will be a slight delay in today's conference. Please hold and the call will resume momentarily. Thank you for your patience.

Speaker 14

Okay.

Speaker 10

All right. So let me just finish the last one. So what are the other ways

Operator

Hold on.

Speaker 10

Okay. Go ahead.

Operator

Hold on. We are in a private mode. I am going to turn us back to the public mode now.

Speaker 14

Okay.

Operator

Please go ahead.

Speaker 10

So I just

Operator

Hello. We are in private mode again. Alright.

Speaker 4

Yes. Alright.

Operator

All good for now. Can you try to speak a couple of sentences just to make sure?

Speaker 10

Can you hear me now? Are we okay to proceed?

Operator

All right. We are going back in private mode. 3, 2. You may resume the conference. Yes, you are now back online.

Speaker 10

Okay. Once again, our apologies for platform issues. We don't know what's going on, but we'll work through them. Let me just finish the last part of this and then I promise I will hand it back to the conference. For us, success is a detecting a clinically relevant difference.

Speaker 10

And in TRD, that varies maybe a little bit lower in terms of protects us compared to NTD just because of the difficulty of of of the population. So I'm gonna I'm gonna defer to actually give you a number, on on exactly what that affects looks like in in points on the vagaries. We're we're just we have adequate power for clinically relevant differences in our studies.

Speaker 14

Got it. Thanks so much.

Operator

Sir, Patrick Mitchell, you are still on the line.

Speaker 14

Yes, that's helpful. Thank you very much.

Speaker 10

My pleasure and I apologize for the interruption.

Speaker 7

Thank you.

Operator

Your next question comes from the line of Tom Schroeder with BTIG. Please go ahead.

Speaker 15

Thanks for taking the question. I'll be quick given

Speaker 8

the situation. Given the comments about complexity and all that, are your dropout rates tracking as expected? And you haven't said you're adding patients, are you? Thanks.

Speaker 10

Mike? Yes. So the attrition rate is We are not doing an adjustment to

Operator

the sample size in the study. We are not changing

Speaker 10

the sample size. We are not doing an adjustment to the sample size in the study. We are emphasizing and for high level reasons that are very clear, how to accelerate recruitment to complete the studies as quickly as possible and how to enhance retention so that we minimize our missing data problem. But for the moment, attrition is well within planning parameters.

Speaker 15

Perfect. Thank you.

Operator

Your next question comes from the line of Sumant Kulkarni with Canaccord Genuity LLC. Please go ahead.

Speaker 15

Hi. Thanks for taking my questions. I have 2. For 5, roughly what percentage of the trial participants do you expect would have completed the 26 weeks at the time you announced the 6 week data? And what prompted the decision to announce top line at 6 weeks for 5 versus waiting for the full 26 weeks, which might give us more insight into durability of treatment as well?

Speaker 15

And I have a follow-up after that.

Speaker 6

Yes. So, Sumant, I can't give

Speaker 2

you an answer to the first part. But just

Speaker 6

to be clear on the second, we have always guided for releasing 6 week data of 5. I think, as you're very well aware, the designs are very different in 6. That is a design that the agency themselves recognizes the best possible to preserve blinding. And that's why our focus on preserving blinding in 6. So our decision on 5 has never changed from what we've guided in the past.

Speaker 15

Got it. And then a commercial question for Laurie. Do you think the current Phase 3 program gives you enough commercial firepower to address what pretreatment schedule might be needed in the real world as that has potential implications for pricing?

Speaker 3

Yes, I'm sorry. Could you would you mind repeating the question?

Speaker 6

Does it give us enough data?

Speaker 8

Sure.

Speaker 2

We believe

Speaker 3

it does, And we think that it will be a very important piece of information and relevant to payers to see what that looks like.

Speaker 15

Thanks, Matt.

Speaker 6

Thanks, Matt.

Operator

Stuart. Seeing as we do not have any more questions at this time, I will now turn the call back over to the management for closing remarks.

Speaker 6

Thanks, Stuart. And first of all, again, our apologies for the quality of this call. We will clearly be taking action around that in advance of our next call. So I'm sorry about the interruptions and thank you for your patience. We at Compass are completely focused on the execution of our pivotal trials, while, as we said, continuing to maintain the highest quality with an urgency and a commitment to bring COM360 to patients in need.

Speaker 6

Our confidence in COM360 remains steadfast, and we are excited by what's ahead. Thank you again for joining the call today, and we look forward to further conversations with all of you. Thank you.

Operator

Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

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Key Takeaways

  • Q3 update on Phase 3 readout timing: Top-line data for COM005 (6-week primary endpoint) now expected in Q2 2025, with efficacy (MADRS, p-value, CIs) and high-level DSMB safety comments to preserve 26-week blinding.
  • COM006 delayed to H2 2026: Study 6’s three-arm, 26-week blinded design and site initiation challenges pushed data disclosure to late 2026, though efforts to accelerate enrollment continue.
  • Cost‐cutting measures underway: Compass will downsize ~30%, halt non‐COM360 preclinical work and explore spinning out digital tools to preserve a cash runway into 2026 with ~$207M on hand.
  • Commercial preparedness ramp-up: New CCO Laurie Engelbert focuses on DEA rescheduling, billing codes, KOL engagement and partnerships with interventional psychiatry networks to optimize site capacity and patient flow ahead of launch.
  • COM360’s potential in TRD: Despite delays, Compass remains confident in psilocybin’s ability to address the high unmet need in treatment-resistant depression and plans to file based on two pivotal trials, anticipating an FDA Advisory Committee.
AI Generated. May Contain Errors.
Earnings Conference Call
COMPASS Pathways Q3 2024
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