Q3 2024 COMPASS Pathways PLC Earnings Call
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.
Kabir Nath: Thank you, Steve. Good day everyone and thank you for joining us.
Kabir Nath: 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.
Kabir Nath: Laurie brings deep strategic and commercial experience, having most recently launched ovelity at Axo. That experience will be valuable as we prepare for the commercialization of come 360 and we're thrilled that she has joined us.
Kabir Nath: 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 Teri will provide you with a financial update.
Kabir Nath: First though, I want to address questions around the anticipated disclosure of our pivotal company 60 trials.
Kabir Nath: On our August earnings call, we pushed the anticipated six-week disclosure date for the Comp005 trial back to the end of this year or early next year.
Kabir Nath: Based on our recruitment to date, in now looks unlikely that we will be able to disclose the six-week data in the first quarter and we're therefore updating our guidance for the six-week zero zero five data to the second quarter of 2025 to give us more assurance.
Kabir Nath: Our top priority is completing our phase three 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.
Kabir Nath: 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.
Kabir Nath: We're the first company to conduct such large psychedelic trials.
Kabir Nath: And we did not have the benefit of prior comparable phase three timelines to base our assumptions on.
Kabir Nath: Our phase 3 enrollment projections were based on the phase 2B in Roman curve, and while we did factor in some new aspects of the phase 3 trials into our projections, there have been a number of items related to the complexity of the trials that we are now learning along the way.
Kabir Nath: The Phase 2B was a simpler protocol with all active arms, a single dose and blinded for just 12 weeks.
Kabir Nath: Com0005 on the other hand is a 52-week trial, blinded for the first 26 weeks and has multiple parts where additional doses can be given.
Kabir Nath: which significant be increases the logistical complexity for sites to schedule patients and therapists as well as for patients themselves.
Kabir Nath: These complexities are specific to the clinical trial setting, but have resulted in inexperienced sites carefully managing patient flow as they become more proficient.
Speaker Change: Mike and his team are paying close attention to the needs of each side and are providing the necessary resources to support them on a case-by-case basis.
Speaker Change: This hands-on approach is working and we'll be continuing to dedicate all our focus to successfully completing these trials.
Speaker Change: They continue 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.
Speaker Change: Beyond timing for the trial, we're also frequently asked what data we will be disclosing with the 0.05-6-week
Speaker Change: Please remember the while the primary endpoint is at six weeks. The trial remains on going and blinded through 26 weeks.
Speaker Change: Therefore we're going to be limited in what we can release at six weeks so that we maintain the integrity of blinding as much as possible.
Speaker Change: We will disclose three T-Effacacy measures for the six-week end point. The mattress affects the difference between the arms, p-value and confidence intervals.
Speaker Change: 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 to be treatment result.
Speaker Change: From a safety standpoint, we'll provide a high level assessment for the independent DSNB, which looks at unblinded data on a regular basis, to monitor safety risks for patients in the trial.
Speaker Change: Suicideality is an inherent feature of TRD and suicidal ideation is expected in this population.
Speaker Change: As part of the DSNB assessment at the time of the day to read out, they will also comment on whether they're seeing any imbalance in suicidal ideation.
Speaker Change: At this six weekend point, we will not be able to provide secondary endpoints or in-depth safety tables as that would require further unblinding.
Speaker Change: Let me now turn to the comp 006 trial, which is our second phase III trial.
Speaker Change: As a reminder, 006 has three active dosons of 1mg, 10mg and 25mg with the same 3-part structure of 0.05.
Speaker Change: With the primary end point at the end of part A at six weeks, a fully blinded part B through 26 weeks, and an open label part 3 through 52 weeks.
Speaker Change: In the 006 trial, each participant gets two doses of Com 360, three weeks apart at the start of the trial.
Speaker Change: The recent Lycos 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 Change: While most of the FDA and adcom concerns were specific to like us in their MDNA Assistant Therapy Program, there was a high degree of scrutiny regarding unblinding, which is very relevant to our studies.
Speaker Change: While both the 005 and 006 trials are blinded to 26 weeks, the 006 trial with its three active arms is designed to minimize the risk of unblinding as participants know they will receive a dose of
Speaker Change: With a 15% cap on recruitment of patients with prior psychedelic drug experience.
Speaker Change: It will be difficult for the overwhelmingly psychedelic naive participants to determine which dose they received.
Speaker Change: Particularly between the 10 and 25 milligrams, which is what we saw with the overlapping responses between 10 and 25 milligrams in our phase 2B trial.
Speaker Change: We believe that this is an effective strategy to maintain blinding and given the importance of the 0.0.06 trial for compass to gain valuable regulatory and commercial insights around redocing and durability.
Speaker Change: We want to ensure that we preserve that through the blinded portion of the trial.
Speaker Change: We've therefore made the very difficult decision to further protect the blinding of the 006 trial and only release data after the 26 week time point has been reached for all patients.
Speaker Change: While recruitment for 0.06 has been going well so far that the sights that are up and running.
Speaker Change: We're still working through some site initiations in Europe, some of which have taken longer than projected And we're also relying on a number of the US sites from 005 to Rollover to 006
Speaker Change: Therefore, taking into consideration the shift of disclosure to the 26-week time point for 0.06, as well as potential unpredictability and recruitment, we now expect to disclose data for 0.06 in the second half of 2026.
Speaker Change: While we have a better understanding of the variables impacting enrollment, we're continuing to actively consider all other opportunities to accelerate this trial.
Speaker Change: We remain fully confident in the potential impact cellocybin can have for patients. We want to do everything we can to ensure a successful development and regulatory outcome for come 360 and we believe that these steps give us the best chance.
Speaker Change: 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.
Speaker Change: and that's where Lory is focused. I'll now turn it over to her to go through some of the observations since joining.
Lory: Thank you, Kabir. Let me begin by saying what a privilege it is to be partly compassed pathways team.
Lory: Our focus on advancing treatment options for patients with difficult to treat mental health conditions.
Lory: Especially for patients with treatment resistant depression or TRD, it's an area I have a personal connection to and I am extremely passionate about helping deliver potential solutions for patients and their providers.
Lory: By definition, treatment resistant depression is an area of extremely high unmet need.
Lory: About one third of patients treated for major depressive disorder, failed to achieve remission after two therapies and are therefore considered treatment resistant.
Lory: Innovation and commitment to develop safe and effective products in this patient population has been limited. And currently, there are only two FDA proved pharmacologic treatments with a TRD indication.
Lory: If approved, COP 360 has the potential to change the way patients who are suffering from treatment resistant depression are managed. And given the high unmet need in dissipation population, we see significant commercial opportunity.
Lory: As I have been diving in at Compass, I have been impressed by many facets of the commercial work that are already underway.
Lory: All imported steps forward in preparing for Loxam steps.
Lory: 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.
Lory: One additional area of important work is our bi-directional learning through strategic collaborations with select interventionals psychiatry networks.
Lory: Through these collaborations, we have the opportunity to gain insight and learn from providers in various care settings within the delivery centers.
Lory: Some of the key learnings include understanding current operating models, how they have adapted to support servado, and working with the sites to identify opportunities to scale the operating model.
Lory: 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 Lunch.
Lory: and a prepared to support. What we expect will be significant demand for a new and novel treatment beyond today's current treatment options.
Lory: 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 Comfort 60 and how much providers want to be ready for it.
Lory: One key question which investors have as well.
Lory: As well as the Interventional Flight Cuyatry Network is capable of managing sufficient demand for Com360 of scale.
Lory: and how delivery centers will handle the monitoring time required.
Lory: As I mentioned above, this is an area of focus with our collaboration partners and ongoing strategic planning.
Lory: But it is also work-noting.
Lory: Wich Provado came to market, it was a change for these centers as well, in terms of patients needing to occupy rooms and monitoring requirements.
Lory: Certainly, Shravada Growth would suggest that these centers have adapted and are growing along with awareness and patient demand.
Speaker Change: As mentioned before, I've been impressed with the work today. A great foundation has been established and I look forward to advancing our approach to commercialization.
Speaker Change: We have worked to do to determine exactly how we will optimize the commercial opportunity, but my team and I are committed to ensuring Count 360 if approved can get to patients and we will be working tirelessly to ensure the market is ready.
Speaker Change: I look forward to meeting with many of you in the future and providing additional insights as we progress and learn more.
Speaker Change: Let me now hand the call to Terry for the financial overview.
Terry: Thank you, Laurie. I'll now step through the Q3 Financial Results.
Terry: Cash used an operations in the third quarter was $22.2 million, which includes $13.6 million related to our 2023 R&D tax credit that we received in full in the third quarter, but had not originally been included in our third quarter cash guidance as the timing was uncertain.
Terry: Excluding this tax credit, cash used in operations would have been $35.8 million, which is
Terry: Regarding 4th quarter 2024 financial guidance.
Terry: Weekspect, NetCash use an operations to increase to between $37 and $43 million.
Terry: which was put cash used in operations for the full year 2024 between $114.20 million.
Terry: Near the midpoint of our prior guidance and includes the 2023 R&D tax credit that we received this quarter and which had been contemplated in the original full year guidance.
Terry: At September 30th, 2024, we attach and cash equivalents of $207 million.
Terry: This compares with $228.6 million at June 30, 2024.
Terry: Get under the Hercules Long Facility with $29.8 million at the end of the third quarter.
Terry: Given the timing and strategic changes made to the Phase 3 read-outs, we are taking actions to preserve cash and ensure our entire focus is on successfully completing the Phase 3 Con 360 trials as quickly as possible.
Terry: Therefore, we will be reducing our workforce, including stopping our non-con 360 pre-clinical efforts, as well as the potential externalization of our digital tools.
Terry: Over the last several years, we have developed digital tools and technology to test evidence-based methods for assessing mental health treatments.
Terry: We are now exploring externalizing these technologies into electrical properties and a sub-seated 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.
Terry: We are still working through the details and look to have final decision on the sixth journalization by Q1 2025. Collectively, these actions will result in a downsizing of the organization by approximately 30%.
Terry: While we're still working through the full details and impact on cash, we expect our cash runway to fund operations at least in 2226.
Speaker Change: Thank you and I'll now turn the call back to Kabir.
Kabir Nath: Thank you Teri and Laurie.
Kabir Nath: We're applying the resources necessary to get these trials done as quickly as possible and best position come 360 for regulatory and commercial success and we continue to actively review all other ways to accelerate the 006 trial.
Kabir Nath: As I mentioned earlier, Mike has been traveling to clinical sites to fully understand where assistance may be needed and directing resources to them.
Kabir Nath: As we encounter challenges, we're addressing them rapidly and applying those learnings to the overall pivotal program.
Speaker Change: As Teri mentioned, we're also taking action to cut costs for the focus the organization and preserve cash.
Speaker Change: In saying that, I want to acknowledge that our actions today and reducing our workforce have much bigger implications preserving cash.
Speaker Change: I know that they will have a deep impact on the lives of many employees and their loved ones.
Speaker Change: I regret that.
Speaker Change: and as a management team we're committed to supporting them through this transition.
Speaker Change: With our two robust phase three trials and our large phase two B trial, we'll have more than a thousand patients worth a data from well-controlled trials, as well as a full package of supporting studies for a filing.
Speaker Change: We're confident that we're well positioned for success with a clear plan and a committed team to deliver on this plan.
Speaker Change: Thank you and I'll now turn the call to the operator for Q&A.
Speaker Change: Up this time.
Speaker Change: I would like to remind everyone in order to ask a question, press star, then the number one on your telephone keypad, we will pause for just a moment to compile the Q&A roster.
Speaker Change: Your first question comes from the line of Redu Barall, with TD Cohen, please go ahead.
Speaker Change: Hi guys, this is Lupina on for which we're taking my class stand.
Speaker Change: What's your distance with the moon now?
Speaker Change: Hop-line readout made after additional FDA court attendance or a face-to-face meeting. And do you foresee any other changes to trial operations in conduct?
Speaker Change: Thank you.
Speaker Change: Thanks for the feedback and I can just check you can hear us clearly.
Speaker Change: Yes, Okay, Good.
Speaker Change: So that was a compass decision. It was a compass decision that we made at a certain abundance of caution, really after observing all that happened through the Lycos process and debating internally around the need to really maintain that line through the blinded portion of 0.06.
Speaker Change: And we said on the call, we continued to look at always, we can do to accelerate the conduct of 0, 0, 6 and that will continue to be an act of effort.
Speaker Change: Thank you.
Speaker Change: Your next question comes from the line of Leynid Timashas with RBC. Please go ahead.
Speaker Change: 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 comforts six you would be used in the real world. I guess is this largely just due to limitations that, you know, staffing sites or is this something where I'm talking to therapists having those.
Speaker Change: All the appointments aligned is going to be a challenge for any initial commercial update. So there are any learnings that you go through the clinical process that might inform how you go about commercialization. Just try and understand how much of this is also.
Speaker Change: Man vs. really just logistical death.
Kabir Nath: Thanks Leo, it's a really important question, man. The fundamental answer is that a clinical trial setting is clearly very different from a commercial setting in the sense of what's needs to be communicated to patients and so on. But let me ask Laurie, I'm to apply that a little with some of the key differences and how we're thinking about the commercial site.
Laurie: Yeah, hey, Lianette, thank you for the question.
Laurie: So, you know, as you know, clinical trials are intentionally honest because they're working to fit within a regulatory construct.
Speaker Change: 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 position what we regulated based on what they are restricted by by utilization management, formulary access.
Speaker Change: and things like that. 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.
Speaker Change: And the way that I think about how we will go about optimizing the patient flow, which is...
Speaker Change: You know, 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 two ways.
Speaker Change: One, you have to make sure that the patients are adequately being referred from referring physicians to the 12 sites.
Speaker Change: 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 positions are adequately educated to make sure that they're referring to patients to the treatment centers.
Speaker Change: This requires education to require education on TRD, really helping physicians identify the appropriate patients and really making sure that they understand comfort, sanctities, clinical benefits.
Speaker Change: This will all come very naturally through a self-immarketing effort as we get close to the launch.
Speaker Change: The second piece of it, which I think is important for the underlying piece of your question, and that really is ensuring capacity of patient flow at the treatment sites.
Speaker Change: You can think about this in my mind, I think about it in two ways. You can either go abroad and really have an inefficient process, where you have a lot of treatment size and not a lot of patients flowing through.
Speaker Change: 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.
Speaker Change: Make the pageant for official app establishment sites.
Speaker Change: and those are a lot of things we're learning from our collaboration partners. We're taking a look at opportunities there.
Speaker Change: The End
Speaker Change: Your next question comes from the line of Charles Duncan with cancer. Please go ahead.
Speaker Change: Mr. Charles Duncan, please go ahead.
Speaker Change: The End.
Charles Duncan: Can you hear me? Yes, we can. Hello.
Charles Duncan: Okay, for morning, the beer and tea, and all of them on my little fist pointed on timing. I do really appreciate the focus on maintaining.
Charles Duncan: Regrets Clinical Evaluation and Ultimate Regulatory Success. I have a question about...
Speaker Change: What has changed over the course of the last six weeks? Have you discussed this with the agency in terms of oath and is it possible that your regulatory strategy in terms of oath five and oath six being necessary?
Speaker Change: Has perhaps changed or do you have any other thinking about that?
Speaker Change: 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 that a decision around what data we disclose from 0.06 when?
Speaker Change: But we would still anticipate the base case is that 0.05 and 0.06 are needed for a fighting.
Charles Duncan: 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?
Charles Duncan: Patients from anti-depressant meds that are standard of care or is that not a complexifier at all to the enrollment. How fast that's in my car? It's my goal.
Speaker Change: We are actually seeing a greater than 90% successful washout rate for our standard care coming into the trials.
Speaker Change: I think we just published, and I was completely guided and just came out.
Speaker Change: of Paper Reporting on that from the Phase 2 study. So this is 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.
Speaker Change: to help patients who do wash out, but in fact, and from the observance files, it's not a problem. We have not seen an Ocebo effect from withdrawal, and like I said, higher than 90% of the release of these things that wash out in our files right now.
Speaker Change: We saw that journal site research paper was helpful. I appreciate that. Last question is, with regard to O6 timing, the ship to 26 weeks, you know, seems like a year and yet that seems like it could be a little bit longer.
Speaker Change: Then you would expect just due to the ship. So is there also a modulation of enrollment or your confidence and enrollment in those six as well?
Speaker Change: Your Maths is correct.
Speaker Change: What I would say is, as we said on the call, there is still some uncertainty around the root group when you curve. I think we're very confident there for on the guidance we've given for the 26 week end point.
Speaker Change: But we're doing everything we can to continue to accelerate both with European sites. And also with the expectation that a 0,05 finishes those experienced sites that have done well in 0,05 will roll into 0,06 which will be an inflection point in that curve.
Speaker Change: So, you're correct, it does incorporate an element of conservatism as well, around moving from 6 to 26 weeks.
Speaker Change: Super one question for Teri in terms of more math checking my math and that is...
Speaker Change: It seems like you have sufficient cash through 25, into 06 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 06?
Speaker Change: Yeah, thanks to the question Charles, so as we had mentioned, we have $27 million of cash as of the end of the third quarter that gets us at least into 2020-6.
Speaker Change: We are, we announced a restructuring along with these delays. Excuse me, as the trials do cost more as they go longer. And so the savings that we have.
Speaker Change: that we anticipate from the restructuring armants who offset that and preserve cash. We are still doing some detailed analysis on the potential for saving and working through whether we might be able to incorporate additional savings to further extend runway, and that is where it will be doing here over the coming weeks.
Speaker Change: So we're very comfortable, we'll have cash at least in the 26th if we can extend the on that. That's the work that we're doing and we are committed to being disciplined in our expenses and our spend in ensuring free sets, please.
Speaker Change: Back.
Speaker Change: Okay, appreciate all the color, thank you for taking my question.
Speaker Change: Thanks for watching.
Speaker Change: Your next question comes from the line of Francois Brisibois with Openheimer. Please go ahead.
Francois Brisibois: 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. 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.
Francois Brisibois: He's just helping us understand maybe why you still feel comfortable with it.
Speaker Change: Mary, you know, sales, potential.
Speaker Change: and also a second question, can you help us understand what needs to be done between these final data readouts now and launch and just like what would be a good estimate for a year there. Thank you.
Speaker Change: Thanks Frank. So I'm not quite sure I'd call the second part of the question and what needs to be done in welcome that. Sorry.
Speaker Change: In context of launch, you know, between the final readouts now with the timeline pushes, just try and understand what else has to be done after these readouts.
Speaker Change: to move forward to launch.
Speaker Change: Thank you. Show our positive glory, thanks.
Speaker Change: Yes, I'll answer your first one. I'm trying to give you a little more clarity around the first one. Again, you know, really thinking about the main question that we get from either HCPs that we're in discussion with.
Speaker Change: or HCPs that we're working with or the trial sites as well as the collaboration sites that we're working with.
Speaker Change: The End
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Speaker Change: We ask everyone to please stay on the line.
Speaker Change: The End.
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Speaker Change: Sorry, I think we're back, can you hear me okay?
Speaker Change: Yes, we can hear you now. You may go ahead. Let's just get going on my excitement for the commercial opportunity here. So, I'm not exactly sure where we cut off, but I'll reset.
Speaker Change: The End
Speaker Change: Once again we are asking everybody to stay on the line. Thank you.
Speaker Change: I think we're back. Can everyone hear?
Speaker Change: Yes, please go ahead.
Speaker Change: I hope everyone heard.
Speaker Change: All the points around the excitement for the commercial opportunity but what I'll shift gears to is really what needed between now and launch.
Speaker Change: and what I like to focus on is what we're actually doing right now, what our immediate focus is.
Speaker Change: So right now, you know, the things that we need to focus on are really increasing the awareness around TRD and educating on Compton 360 Phase 2.
Speaker Change: Data, that's what our MSLs are out in the field doing right now. So that is a very conservative effort and obviously we're learning a lot from the feedback, from KOLs around that.
Speaker Change: Another important area focused for us is really making sure that states get rescheduled in a very timely manner after DEA scheduling.
Speaker Change: That is an effort that is unique to us, given that we're currently setting at a schedule one 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.
Speaker Change: The other effort that we're really focusing on again, I've said it a couple of times, so it's really focusing on how we optimize that patient flow. And again, that's learning through our collaboration and in the partnership that we have in place, as well as anything that we learn from KOL interactions with our in the cells, and obviously come to clinical trials.
Speaker Change: And then of course we are, you know, a cutely aware of.
Speaker Change: The importance of getting good formularie 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 the players when the time comes.
Speaker Change: The End
Speaker Change: Mr. Farron Swar, you are still on the line.
Speaker Change: Yeah, I mean, maybe it's my phone, in terms of the commercial point, I didn't hear anything, but maybe others didn't, I'm not sure.
Speaker Change: We're having some technology challenges here. I'll revisit some of the reasons why I'm excited for comfort.
Speaker Change: and that's probably a better approach.
Speaker Change: I think we have a lot of learnings to do. We have a lot of challenges that will when they do overcome but we have time to figure those out. Being first to market takes time and we will be first in class, first in market.
Speaker Change: And that is a situation where you need a lot of time to think for strategy and planning.
Speaker Change: and so we have time to work through some of these complex issues that present themselves with the administration of Comfort 16 and figure out how we can optimize.
Speaker Change: and that patient flow.
Speaker Change: The reason I'm excited is you have a great analogist for Vato.
Speaker Change: Roboto again lost into these interventional psychiatry centers and they were able to adapt and we all know it's well on on path to the Abelian dollar product. They've steadily grown their sites since their launch and they're now sitting at well over 4,000 sites.
Speaker Change: 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 Change: Thanks for watching. Here's your next question. Come to the line of Vikram Purohitt with Morgan Stanley. We go ahead.
Speaker Change: I have everyone thanks for taking our questions. This is Morgan on for Bicram, so we have two on the 005 program.
Speaker Change: First, would you expect a change to the profile of patients enrolled in the trial given the delay? And second, given the delay or any of the parameters of data that you will report for this release different verses? Prior expectations. Thank you.
Speaker Change: Thanks Morgan and I'll answer both. No in both cases the focus is on recruiting exact 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 so no changes on either of those.
Speaker Change: Okay, and if I may squeeze one more question in there, how is your focus on non-terity indications including PTSD impacted by these timeline delays? I know you mentioned a deep prioritization of preclinical efforts, but what does it look like for some of the clinical indications?
Speaker Change: So as you know we have clearly said PDSD is an area of significant interest, very high on net need, we have very compelling, or the its small data set from phase two. What we've also said is why we have planned.
Speaker Change: From 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 Change: Okay, thank you.
Speaker Change: Your next question comes from the line of elementary purals with Rodman, please go ahead.
Speaker Change: Yes, good morning. What I'd like to ask is about the eligibility for recruitment.
Speaker Change: Is there any difference between the time period between week six and 26 and between 26 weeks and 52 weeks? And maybe a port B to this question is...
Speaker Change: How to be defined relapse and if someone went back onto an anti-depressant, do you want them to win them off before retweetment with country 6th day?
Speaker Change: Guy, if I may ask you to take that.
Speaker Change: The second question is quite simply that if people have gone back on to answer the questions, then they can stay on them, particularly.
Speaker Change: This would be in part C, where this will commonly occur, we think, and we'll obviously offer quite important useful information about the feasibility of administering the drivers of co-administration.
Speaker Change: The criteria for retreatments are simply a threshold on the manbrus and they're not different between the two phases B and C.
Speaker Change: So, either patients who have not recovered or patients who have recovered and then relapse have to meet the same criteria, essentially.
Speaker Change: Same to Guy, Teri Loxam, thank you very much Guy
Speaker Change: Oh, you're done
Speaker Change: Your next question comes from the line of Kevin Clark Gardner with Evercore I.S.I. Please go ahead.
Speaker Change: Hi, this is Yasha on for a gathering thing for taking our question. For us, you noticed for 0.05 that you won't be providing the detailed safety table, but you'll be providing comments on potential suicidal ideation and balances. We're just wondering what great DU and or the DSMB, considering imbalance and such and such and such, how is that defined and what will that update kind of look like? Thank you.
Speaker Change: So I'll start, the DSNB is independent, so it's up to the DSNB to tell us what they consider on imbalance, but I don't like if you like to add a little. So I think we're going to play something to give you quantitative criteria to defend on the degree of imbalance.
Speaker Change: and the major in the cases and severity of the ideation or planning etc. This is a place where we have, you know, to be appointed to be independent DS and being in the charter gives them a lot of attitude and that's why so.
Speaker Change: I'm going to park the response area. I don't have a number to give you. It really depends on your clinical interpretation of the cases that they see.
Speaker Change: Thank you.
Gawai: Gawai Next question comes from the line of Patrick Churchill with HPC Wayne Wright and Co. Please go ahead.
Patrick Churchill: Outric True Trail
Patrick Churchill: Hello, good morning. For either few questions, the first is the expectation that you will continue to need data from both Comp 05.
Patrick Churchill: 10.506, the CSTM at the NDA for Com360 and TRD.
Patrick Churchill: and secondly, can you tell us if the expectation is that there will be an advisory committee to assess the potential of Comprehcy in TRD?
Patrick Churchill: and then can you talk more about how the data that's generated from these trials, the 0506 trials, with these updated timelines discussed earlier, should put you in a better position to address the potential questions during a potential advisory committee.
Speaker Change: Thanks very much Patrick. So I'll answer very quickly. Yes. And yes, the questions one and two. We continue to guide.
Speaker Change: We'll need data from both. We absolutely expect an adcom based on the fact this is a schedule one brought up and the precedent is always there will be and for the third part I'll pass to Mike from our third part again which is do the changes help us we believe.
Speaker Change: Put us in a strong position to address issues that might come up at an outcome.
Speaker Change: Well, I think to the extent that we preserve the integrity of those six study and reducing bias in terms of unblinding the other health systems.
Speaker Change: Fairly New New York City.
Speaker Change: Well, we are just one spouse to do whatever they can to minimize.
Speaker Change: to the functional and lining, I was just gonna have to be your comment.
Speaker Change: We're going to be probably first in class and generally speaking for first in class, the agency general calls for ad comes even in areas of mundane as in antibiotics.
Speaker Change: That's helpful and then can you frame for us more broadly as we think about you know
Speaker Change: Com-Pounce that have been approved recently trials that are underway. What would be considered a positive outcome in terms of improvement on the mattress scale in a phase 3 TRD trial?
Speaker Change: Both in terms of reduction from baseline and active treating relative to both fibo.
Speaker Change: and then separately I'm wondering as we are going to see the top line data from the
Speaker Change: O5 trial, how do you envision that that data will read through to the O6 trial just given the differences in the way these studies have been designed.
Speaker Change: So, I would say, 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.
Speaker Change: What we are examining the amount of data that we are releasing from O5.
Speaker Change: because we're going to be releasing Tena while a 6th still in sort of part some part a and some basically in Part B.
Speaker Change: So we want to be really
Speaker Change: Through me to about how much we put out there.
Speaker Change: We're also the sites that are running over five in overseas 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 they're nothing other than the US, your different jar is well so we're doing everything that we can.
Speaker Change: to minimize or move on any sort of reach from all the five toes. So obviously we're hoping.
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Speaker Change: and the other one is the one that's going on.
Speaker Change: High Sanjus.
Speaker Change: with that kind of thing.
Speaker Change: [inaudible]
Speaker Change: Please go ahead.
Speaker Change: So, bye to you.
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Speaker Change: Oh, Mac.
Speaker Change: Goodwin.
Speaker Change: Hello, we are in private mode again, all right?
Speaker Change: Cheers!
Speaker Change: Alright, all good for now. Can you try to speak a couple of sentences just in the picture? Can you hear me now? Are we okay?
Speaker Change: Auburnie, we are going back in private mode, 3, 2.
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Speaker Change: You may resume the conference.
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Speaker Change: We'll get it.
Speaker Change: Yes, you are now back online.
Speaker Change: Okay.
Speaker Change: and so again our apologies for the tax furnishes we're going to know what's going on but we'll work with them.
Speaker Change: Let me just finish the last part of this and then that promise I will thank you back to the memories. For us, it's such that the detecting is clinically relevant and different.
Speaker Change: and TRB that Farrey is made a little bit lower in terms of the text rustling here in the entity, just because of the difficulty of the punctualization. So I'm going to defer to actually give you a number on exactly what that effect looks like in points on.
Speaker Change: Mantersword, we have active power for plenty of big roll of new differences in our studies.
Speaker Change: God, it's thanks for my support to the show you are still on the line.
Speaker Change: Yep, that's helpful. Thank you very much. My pleasure, my apologies for the error.
Speaker Change: Your next question comes from the line of Tom Schrader with BTIG. Please go ahead.
Tom Schrader: Thanks for taking the question. I'll be quick to give a big situation. Give in the comment about complexity and all that. Are your dropout rates tracking as expected and you haven't said you're adding patients. Are you? Thank you.
Speaker Change: Mike Kabir, so the intuition rate is actually running a little bit below our plans, so subjects are staying in the study. So we are not experiencing a higher than planned at Christian.
Speaker Change: We are not changing the sample size. We are not even adjusting the sample size in the study. We are emphasizing in per eye-opreadance and are very clear how to accelerate recruitment that can be used as quickly as possible and how to enhance retention so that we minimize our missing data problem.
Speaker Change: For the moment, the Christian is well within fighting for hammers.
Speaker Change: Your next question comes from the line of Sumantre Kukarni with Kenakor Genuity LLC. Please go ahead.
Sumantre Kukarni: Hi, thanks for taking my questions. I have two, for 0.05 roughly what percentage of the trial participants do you expect would have completed the 26 weeks at the time you announced the six week data and what prompted the decision to announce top line at six weeks for 0.05 versus waiting for the full 26 weeks.
Sumantre Kukarni: which might give us more insight into durability of treatment as well and I will follow up after that.
Speaker Change: Yes, so, I can't give you an answer to the first part, but just to be clear on the second week, have always guided.
Speaker Change: for releasing six-week data of 005.
Speaker Change: I think as you're very well aware the design is very different in 006 that is a design that the agency themselves recognizes the best possible to preserve the landing and that's why I'll focus on preserving the landing in 006.
Speaker Change: So our decision on 0.05 is never changed from what we've guided in the past.
Speaker Change: Garret and then a commercial question for Laurie, do you think the current phase reprogram gives you enough commercial firepower to address what tree treatments schedule might be needed in the real world as has potential implications for pricing.
Speaker Change: Yeah, I'm sorry, could you, would you mind repeating the question? Does it give us enough data for a load of things scheduled?
Speaker Change #100: So I'm therefore to address price for the three countries. Oh, we believe 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 Change #101: Thanks for watching!
Speaker Change #101: Thanks for watching.
Speaker Change #102: 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 Change #103: Thanks for what I'm first of all again, our apologies for the quality of this call. We will clearly be taking action from that in advance of our next call. So I'm sorry about the interruptions and thank you to your patients.
Speaker Change #103: 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 concrete six-cytotations in need.
Speaker Change #103: Our confidence in Comfort 360 remains steadfast and we are excited by what's ahead.
Speaker Change #103: Thank you again for joining the call today and we look forward to further conversations with all of you. Thank you.
Speaker Change #104: Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.