NASDAQ:CMPS COMPASS Pathways Q2 2025 Earnings Report $4.24 -0.05 (-1.17%) Closing price 04:00 PM EasternExtended Trading$4.24 0.00 (-0.12%) As of 07:57 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. ProfileEarnings HistoryForecast COMPASS Pathways EPS ResultsActual EPS-$0.38Consensus EPS -$0.37Beat/MissMissed by -$0.01One Year Ago EPSN/ACOMPASS Pathways Revenue ResultsActual RevenueN/AExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/ACOMPASS Pathways Announcement DetailsQuarterQ2 2025Date7/31/2025TimeBefore Market OpensConference Call DateThursday, July 31, 2025Conference Call Time8:00AM ETUpcoming EarningsCOMPASS Pathways' Q3 2025 earnings is scheduled for Thursday, October 30, 2025, with a conference call scheduled at 8:00 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)SEC FilingEarnings HistoryCompany ProfilePowered by COMPASS Pathways Q2 2025 Earnings Call TranscriptProvided by QuartrJuly 31, 2025 ShareLink copied to clipboard.Key Takeaways Positive Sentiment: COMPO-365 Phase III trial met its primary endpoint with a 3.6-point MADRS improvement at six weeks versus placebo, exceeding the three-point threshold for clinical and commercial relevance. Positive Sentiment: Compass delivered two positive late-stage trials in treatment-resistant depression (Phase IIb and Phase III), a rare achievement in psychiatry that de-risks its regulatory and commercial outlook. Positive Sentiment: The company has submitted for the FDA Commissioner’s Priority Review Voucher and plans meetings this quarter to explore accelerated approval pathways under its Breakthrough Therapy designation. Neutral Sentiment: As of June 30, Compass held $222 million in cash, projecting a runway into 2027, with Q2 operating cash burn of $38.7 million and 2025 guidance for $120–$145 million net cash use. Positive Sentiment: Preparations for a potential commercial launch include leveraging existing SPRAVATO infrastructure and CPT-coded reimbursement, while expanding the pipeline with a planned Phase III PTSD study and encouraging anorexia Phase II signals. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallCOMPASS Pathways Q2 202500:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:01Hello, everyone, and welcome to Compass Pathways Second Quarter twenty twenty five Earnings Conference Call. Please note that this call is being recorded. After the speakers' prepared remarks, there will be a question and answer session. Thank you. I'd now like to hand the call over to Stephen Schultz, Senior Vice President of Investor Relations. You may now go ahead, please. Steve SchultzSVP - IR at COMPASS Pathways00:00:31Welcome all of you, and thank you for joining us today for our second quarter twenty twenty five results conference call. Again, my name is Steve Scholz, Senior Vice President of Investor Relations at Compass Pathways. Today, I'm joined by Kabir Nath, our chief executive officer, and Terry Luxem, our chief financial officer, who will have prepared remarks. In addition, doctor Guy Goodwin, our chief medical officer Doctor. Steve Levine, our Chief Patient Officer and Lori Engelbert, our Chief Commercial Officer, will be available for the Q and A. Steve SchultzSVP - IR at COMPASS Pathways00:01:03The 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 thirty 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 in 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. Steve SchultzSVP - IR at COMPASS Pathways00:01:51Securities 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 will now hand the call over to Kabir Nath. Kabir NathCEO at COMPASS Pathways00:02:20Thank you, Steve. Good day, everyone, and thank you for joining us. Let me begin by welcoming Justin Gover to the Compass board of directors. Justin was the CEO and one of the founders of GW Pharmaceuticals, and we're truly excited to have access to his expertise. Under Justin's leadership, Epidiolex, the first cannabis plant derived medicine to be approved by the FDA, had a successful commercial launch. Kabir NathCEO at COMPASS Pathways00:02:48I look forward to leveraging his expertise as we embark on a similar path to gain FDA approval and launch COMT three sixty for TRD. In addition to announcing the addition of Justin to the board earlier this week, we announced that doctor Linda Mcgoldrick will be retiring from the board at the October after a transition period. I'd like to thank Linda for her service on the board over the last five years where she was instrumental in supporting the growth of the company through the IPO and subsequent developments. Turning now to our operations, this has been an exciting quarter for Compass. In late June, we announced the successful achievement of the primary endpoint of the COMT360-five trial, the first of our two pivotal Phase III trials. Kabir NathCEO at COMPASS Pathways00:03:38The positive results were highly statistically significant, demonstrating a clinically meaningful reduction in depression and no unexpected safety findings based on the latest data reviewed by the independent DSMB. This assessment included all data reviewed by the DSMB to date from both the five and six trials going beyond the six week time point for five alone. There was a 3.6 difference in change from baseline in mattress between the twenty five milligram and the placebo arms at six weeks, exceeding the three point difference that is both clinically meaningful and commercially viable. While cross trial comparisons are always challenging, this difference sustained to six weeks with a single administration of COMM three sixty is similar to the difference seen at four weeks in the pivotal trials for the blockbuster drugs, Bravato, which required eight administrations. So we believe the result that we have seen at six weeks with COMT three sixty is both clinically and commercially compelling. Kabir NathCEO at COMPASS Pathways00:04:45With this positive data, Compass has delivered two for two, announcing positive, highly statistically significant results from two robust late stage studies of over 230 patients each in a very difficult to treat patient population in depression. Given the track record of previous studies in psychiatry, particularly in severe depression, our achievement of two positive late stage studies is remarkable and provides important clinical validation for COMT three sixty's treatment potential in TRD. We plan to meet with the FDA to discuss these results and explore next steps in getting COMT three sixty to patients as rapidly as possible, patients who so desperately need new treatment options. The second pivotal phase three trial, COMP o o six, continues to recruit well, and we confirm that we're on track to disclose the 26 data in the second half of next year. As a reminder, the protocol for this trial has a second dose after three weeks with the six week primary endpoint assessment, therefore, only three weeks after the second administration. Kabir NathCEO at COMPASS Pathways00:05:57We should also get some good information on the effects of a second dose as part of the twenty six week o o five data given that subject to specific retreatment criteria, participants can get another dose in Part b, which runs from the six week time point through twenty six weeks. To prepare for a potential commercial launch, our team continues to work with a broad array of mental health care providers, both through our strategic collaborations and through our field medical team to refine our understanding of how COMT three sixty treatment will fit into existing settings of care. We're frequently asked by investors how COMT three sixty will be viewed by providers who are used to the approximately three hour SPRAVATO treatment window. Through our discussions with these providers, we know that patient preference will be a driving factor in treatment selection. As you're well aware, SPRAVATO patients need to be driven to the clinic frequently, which is a burden to the patient and caregiver, and, generally, they're not able to return to work that day. Kabir NathCEO at COMPASS Pathways00:07:05In addition, we believe that the added administrative burden and the work required to turn a room potentially multiple times may actually favor COM three sixty from a practice standpoint. Finally, the CPT three codes specific to psychedelics that were put in place back in early twenty twenty four provide for hourly reimbursement. So regardless of the length of the administration for COM three sixty, the provider will be covered. Steve and Laurie can go into much more detail on all of this. Beyond TRD, we're also excited about the potential for COM three sixty in PTSD. Kabir NathCEO at COMPASS Pathways00:07:44We're in the final steps of designing a late stage clinical program in PTSD, and we look forward to updating you when that design is finalized and once we've reviewed it with the FDA. Given the high unmet need and limited current treatment options, we see a significant commercial opportunity in PTSD. In addition, as you know, we have been running a small phase two study in anorexia. This was a double blind, randomized controlled phase two clinical trial investigating the safety and efficacy of COMT three sixty psilocybin treatment in participants with anorexia nervosa. It was a multicenter study which enrolled 32 participants. Kabir NathCEO at COMPASS Pathways00:08:26The study has now completed, and we recently received the data. From an efficacy standpoint, there was an encouraging positive signal in the reduction of eating disorder and depressive symptoms in the twenty five milligram arm, which was sustained through twelve weeks. However, the low overall numbers of participants and the high number of dropouts in the control arm limited statistical power. The safety profile was aligned with the high risk patient population in anorexia, and no unexpected safety signals were reported. As we've discussed before, this is a difficult condition to study. Kabir NathCEO at COMPASS Pathways00:09:03We're proud of the data that we've been able to generate, and we'll publish or present the full dataset in future. With that, let me now hand the call to Teri to go through some financial updates before we move on to q and a. Teri LoxamCFO at COMPASS Pathways00:09:17Thank you, Kabir. At the June, we had cash and cash equivalents of $222,000,000 which we expect to fund our operations into 2027. This compares with $260,000,000 that we had at the end of the first quarter. Debt under the Hercules loan facility was $30,900,000 at the end of the second quarter. Cash used in operations for the second quarter was $38,700,000 and we expect net cash used in operations for the full year 2025 to be within the range of 120,000,000 to 145,000,000 We're energized by the positive five primary result, which we believe has de risked the company from a regulatory and commercial perspective. Teri LoxamCFO at COMPASS Pathways00:10:08And we look forward to the upcoming twenty six week data from both phase three trials. We are finalizing a PTSD study and look forward to updating you soon on that design and timeline. 2025 has already been an important year for the company, and the remainder of this year and two thousand twenty six is shaping up to be even more exciting. We are heads down focused on continuing to execute on our pivotal program while exploring all opportunities to get COMM three sixty to patients suffering from hard to treat depression and PTSD as quickly as possible. As mentioned in the beginning of the call, Doctor. Teri LoxamCFO at COMPASS Pathways00:10:48Guy Goodwin, Doctor. Steve Levine, and Lori Engelbert will also be available for Q and A. Teri LoxamCFO at COMPASS Pathways00:10:55Thank you, and I'll now turn the call over to the operator for Q and A. Operator00:11:16Your first question comes from the line of Paul line is now open. Paul MatteisMD & Head - Therapeutics Research at Stifel Financial Corp00:11:24Good morning. Paul Matteis from of Stifel here. Thanks for taking my question. I was curious if you could expand upon the engagement you've had with the FDA since the data. What do you think the scenarios are here where you could have an accelerated path for a filing? Paul MatteisMD & Head - Therapeutics Research at Stifel Financial Corp00:11:39And with any scenarios, I guess, do you think you actually could move quickly enough where the second Phase III study wouldn't read out before you submit or during a review? I guess, like, there a real way to actually move ahead of that data? Are we gonna ultimately, of course, get that data before there's any sort of regulatory decision in any scenario? Thank you. Kabir NathCEO at COMPASS Pathways00:11:59Thanks very much, Paul. It's Kabir. I'm just checking. You can hear me clearly? Paul MatteisMD & Head - Therapeutics Research at Stifel Financial Corp00:12:05Yes. Thank you. Kabir NathCEO at COMPASS Pathways00:12:06Thanks, Paul. So thank thank you for the question. So as we've said, we have requested and we will be meeting with the FDA in this quarter. As we said on the call, we are two for two now in treatment resistant depression. So the phase two b with over two hundred and thirty patients, this phase three with the primary endpoint data, two hundred and fifty patients, and importantly, consistent data across the trials. Kabir NathCEO at COMPASS Pathways00:12:35While the two b, of course, the primary endpoint was at three weeks, as you know, at six weeks, we did see a statistically significant difference. And, actually, it's a pretty similar difference to what we've seen here in the phase three. So we are two for two, we believe, in a very hard to treat patient population and one in urgent need of new interventions. So to your point, it clearly is the right thing to ask what accelerated pathways may be available, and that's exactly what we are planning to do. I'm not at this stage gonna handicap the chances, and, obviously, we need to have that meeting with the agency in quarter three, see what their view is. Kabir NathCEO at COMPASS Pathways00:13:13We're obviously encouraged by the fact that there are other leaders within the administration more broadly who seem to share our view in the potential and share our view that there are grounds to move this more quickly. But in terms of specifically which elements of o o five or whether part of o o six will be needed, that really depends on our discussions with the agency. Paul MatteisMD & Head - Therapeutics Research at Stifel Financial Corp00:13:38Kabir, just on your last comment there, understanding your request to meeting and meet the folks with the psychiatry division, are there plans or expectations you'd be engaging with others that are more senior at the FDA or within HHS as well? Kabir NathCEO at COMPASS Pathways00:13:53Yes. But I'm not gonna go into details of those, but, absolutely. We recognize that this needs to be a, you know, a a a concerted approach using whatever levers we can. But I might just ask Laurie to comment on some of the work we have been doing around the broader engagement of stakeholders, not just in the administration, but actually in the political environment as well because we recognize that's also a critical part of this. Lori EnglebertChief Commercial Officer at COMPASS Pathways00:14:18Yeah. Thanks, Kabir, and and hi, Paul. So, obviously, we are very encouraged by statements that have been made by by secretary Kennedy as well as the commissioner. They as Kabir stated, they are very clearly, you know, viewing psychedelics as a potential to treat these patients, who have otherwise, limited option. You know, we've seen that through, you know, examples of them appointing, Matt Zorn, Mike Davis. Lori EnglebertChief Commercial Officer at COMPASS Pathways00:14:44This seems all very positive for, you know, for the industry, in and of itself. We also have, been spending quite a bit of time in DC as the potential first to market, company in the psychedelic space. We do find we we do take it very seriously that we wanna make sure that everyone is, well educated, and informed. And so we've been spending quite a bit of time there, what we're finding is that, you know, members of congress are also highly receptive, not only to the BA sector, which, of course, you know, they are they care very much about and and gets a lot of commentary, but also, for the broader patient population. So we we are encouraged by the conversations that we're having and and continue wanna continue our efforts there. Kabir NathCEO at COMPASS Pathways00:15:28One thing I should have said and to add, you'll be aware that last week, the the formal application process for the commissioner's national priority review voucher, the one that promises a very accelerated timeline open. So we have submitted our application for that along, I'm sure, with many other companies, but we did do that as well. Paul MatteisMD & Head - Therapeutics Research at Stifel Financial Corp00:15:48Okay. Very good. Thanks for taking the questions. Kabir NathCEO at COMPASS Pathways00:15:51Cool. Operator00:15:55Your next question comes from the line of Patrick Trucchio of H. C. Wainwright. Your line is now open. Luis SantosSenior Equity Research Associate, Healthcare & Biotechnology at H.C. Wainwright & Co., LLC00:16:05Hello, good morning. This is Luis in for Patrick. I would like to ask a little bit on the collaboration, the strategic collaborations that you are putting in place for the interventional psychiatry treatment centers. How are they progressing? What feedback have you received about readiness for COM360 delivery if approved? Luis SantosSenior Equity Research Associate, Healthcare & Biotechnology at H.C. Wainwright & Co., LLC00:16:26And how confident that the existing network of centers that you've already engaged with will support the delivery of three sixty to approve? Thank you so much. Kabir NathCEO at COMPASS Pathways00:16:38Luis, and I'll pass to Steve to answer that. Steve LevineChief Patient Officer at COMPASS Pathways00:16:41Thanks. Hi, Luis. Thanks for the question. Yes, we have been engaged now in the work with these collaborations for the past couple of years. As a reminder, they are representative of the broad swath of sites of mental health care delivery in this country, including hospital systems, interventional psychiatry networks, community behavioral health, and others. Steve LevineChief Patient Officer at COMPASS Pathways00:17:02And what we are finding in this work, and as a reminder, some of them deliver SPRAVATO today, and those that do are highly representative of the 6,000 centers that are currently delivering SPRAVATO around the country. And, you know, one thing is abundantly clear. It's that this work is reinforcing our conviction that COMM three sixty, if approved, fits directly into the infrastructure that is delivering SPRAVATO today. If you look at a SPRAVATO room, it looks like what is necessary for comp three sixty. The staffing of these centers is what we believe will be required to deliver comp three sixty. Steve LevineChief Patient Officer at COMPASS Pathways00:17:38And so, you know, we are we are very confident that the network is ready if and when we get approval. And even if that approval is accelerated, it is weighted. Analyst00:17:52Thank you. Operator00:17:56Next question comes from the line of Gavin Clark Gartner with Evercore ISI. Your line is now open. Gavin Clark-GartnerMD - Biotechnology Equity Research at Evercore ISI00:18:05Hey guys, congrats on the progress and thanks for taking the questions. First, I was just curious if you've seen a pickup in six enrollment following the five data? And then secondly, just following off your last point on the commercial side of things, do you have an estimate for what percent of SPRAVATO use is given in single rooms versus kind of group room settings where multiple people can be monitored at the same time? Thank you. Kabir NathCEO at COMPASS Pathways00:18:31Thanks, Gavin. So I'll take the first one. So the o o five data has been viewed very positively by investigators, not only in o five and o o six. We're now in that kind of the really steepest scent point of the o six recruitment, and it's going extremely well, which is why we're able to reconfirm our guidance for data in the second half of next year. But, yes, I would say in general, the reception from investigators to the data has been very positive and has reinforced their belief in the potential of o o six and, you know, frankly, the derisking both from a clinical and regulatory perspective. And I'll pass to Steve for the second question. Steve LevineChief Patient Officer at COMPASS Pathways00:19:09Hi, Gavin. Regarding your question about whether SPRAVATO is currently delivered in individual rooms versus in group settings, It is primarily in individual rooms, and that is another reason why we believe that infrastructure is in place. You know, there is, you know, the likelihood that as these products mature in the market and they are commonly delivered, sites may look at various models to deliver them. But, again, currently, today, it's primarily individual rooms and ready to deliver comp three sixty when available. Operator00:19:46Question comes from the line of of TD Cowen. Your line is now open. Athena ChinBiotechnology Equity Research Analyst at TD Cowen00:19:54Hi, guys. Thanks for taking my question. This is Athena Chen on for Ritu Baral. Are you guys pursuing the commissioner's national priority voucher, and what is your understanding of the criteria to meet eligibility? Thank you. Kabir NathCEO at COMPASS Pathways00:20:09Hi, Athena. Yes. I did actually just confirm that in an earlier question. We did submit our application. We also do, as part of our briefing book for the meeting with the FDA, raise that question. Kabir NathCEO at COMPASS Pathways00:20:20So in terms of the criteria, I I believe there were five priorities listed, and they include significant need, public health crisis, both of which we clearly hit, innovative treatments also. There are also ones around manufacturing and global pricing, are less relevant to us, But it's clear that the criteria don't expect a company to hit all five of those, and we believe on three of them, we very clearly tick those boxes. It also requires you to be ready to start submitting elements of a filing package, and we clearly are in terms of CMC and some of our other preclinical and some. We're in very good shape with that. So we think we're a great candidate. Kabir NathCEO at COMPASS Pathways00:21:00We recognize that there are, in theory, only five pilots that we were taken forward. But we also recognize that the decisions were due to be made by the CMO, but it appears that the CMO of the FDA is currently a vacant position as of Monday night. So what the process is, we don't know. But we believe we absolutely meet the criteria, and that's why we've submitted. Athena ChinBiotechnology Equity Research Analyst at TD Cowen00:21:24Understood. Thank you. Operator00:21:29Your next question comes from the line of Judah Frommer of Morgan Stanley. Your line is now open. Judah FrommerExecutive Director - Senior Equity Research Analyst at Morgan Stanley00:21:36Yes. Paul MatteisMD & Head - Therapeutics Research at Stifel Financial Corp00:21:37Hi, thanks for taking the question. Judah FrommerExecutive Director - Senior Equity Research Analyst at Morgan Stanley00:21:39Just following up on kind of your commentary regarding interactions with the agency. It seems like there is some high level connectivity, but are you able to comment on consistency of interaction with kind of mid and lower level members at the agency? Just curious if there's been consistency within team makeup in the teams that you're talking to. Thank you. Kabir NathCEO at COMPASS Pathways00:22:03Thanks, Judah. Nice to meet you. And the answer is absolutely. So as a reminder, we have breakthrough designation. And as we've always said, we have consistently had excellent engagement with the psychiatry division. Kabir NathCEO at COMPASS Pathways00:22:14Currently, we've seen no change to either the staffing, the level of engagement, the responsiveness, and so on. So at the day to day level with the FDA, we remain, you know, very tightly aligned with a good relationship, so no changes. Judah FrommerExecutive Director - Senior Equity Research Analyst at Morgan Stanley00:22:30Thanks. Operator00:22:35Change comes from the line of Leonid Imashev of RBC Capital Markets. Your line is now open. Leonid TimashevBiotechnology Analyst at RBC Capital Markets00:22:43Hey guys, thanks for taking my question. I had one on safety, especially as it relates to redosing. So I guess, how are you guys thinking about the risk of suicidality or any elevations in suicidal ideation? Anything that's after that correct after every dose of COMM-three sixty or potentially every dose of placebo? Or is it just something that occurs after the first dose on the study? Leonid TimashevBiotechnology Analyst at RBC Capital Markets00:23:06I guess, do have any data, that you can speak to with respect to that? And then relatedly, I know in the anorexia study, you said there were no unexpected safety signals. I wonder if you could just talk a little bit more about what you saw in terms of safety from the anorexia study, especially on on suicidality. Thanks. Kabir NathCEO at COMPASS Pathways00:23:22Thanks, Leo. And I'll pass to Guy in a moment. But first, just as we've always said, the the statement we made last month from the DSMB did refer to all data they were seeing today from both o o five and o o six, so including the study that that has the second dose in. But let me hand to Guy for a more you know, a broader discussion about Guy, please. Guy GoodwinChief Medical Officer at COMPASS Pathways00:23:45Yes. I think I think we have to be a bit we we we don't have, detail on the time course of, the suicidality that is being seen in zero zero five and zero zero six. All we know is that there's no imbalance between the arms. So I can't really comment directly to your question except to sort of be reassuring about the fact that there isn't a clear effect of the drug. There's much more likely to be an effect of the illness and that will depend obviously on how people have responded and how the response is maintained. Guy GoodwinChief Medical Officer at COMPASS Pathways00:24:17We will certainly have all that information in due course but not at the moment. It's a good question about, the anorexia group. This was a small study remember but it was clear that we saw higher rates of suicidality, than we are used to seeing just measured as events in that group. That was true in both the arm receiving one milligram and the arm receiving twenty five milligrams. So again we had no imbalance between the arms but higher overall rates reflecting the fact that it's a more dangerous condition from the point of view of mortality. Guy GoodwinChief Medical Officer at COMPASS Pathways00:24:55It has the highest mortality of any psychiatric disorder And suicide is one of the leading causes along with the physical problems that patients also encounter. So the relative safety of our treatment in this high risk group is again a reassuring thing really for the whole programme. Operator00:25:20Next question comes from the line of Sumant Kulkarni of Canaccord Genuity LLC. Your line is now open. Sumant KulkarniManaging Director at Canaccord Genuity Inc00:25:29Thanks for taking my questions. What is the earliest that you could file a new drug application for COM360? And how should we think about when you might announce a timeline for reporting Part B from the COMPO-five trial? And then I have a follow-up. Kabir NathCEO at COMPASS Pathways00:25:43Thanks, Sumant. So, again, I'll I'll refer you to use my earlier answer until we've met with the agency. It's premature to speculate on exactly what that could be because we really need to reach alignment on what data they would like to see and and the process for that. As we have said before, we will, in due course, announce the full enrollment of o o six. As and when we do, that will be the point at which we can all look at our calendars and project forward. Kabir NathCEO at COMPASS Pathways00:26:12Because as a reminder, we have said twenty six weeks of o zero five, part b of o zero five, we will only release once all patients are through part a of o zero six in order to avoid any potential suggestion that there's a confound between those two sets of data. Sumant KulkarniManaging Director at Canaccord Genuity Inc00:26:30Got it. And how onerous is the process to submit an application to the commissioner's priority review program in terms of any trial data necessary? And is there any phase three related efficacy or durability data in that application or your briefing book that investors have not seen yet? Kabir NathCEO at COMPASS Pathways00:26:46So in terms of what was required to submit for it, it's a 350 word abstract. So I could safely say that there was no data included in that. And, again, I think as we're all aware, it's unclear what the selection criteria are actually gonna be for the pilots. And, no, to confirm, I mean, we have no more phase three data than you is out in the public domain and that we have already released. Operator00:27:13Thanks. I'd now like to hand back the call over to the management for final remarks. Kabir NathCEO at COMPASS Pathways00:27:22Thank you very much. So thanks, everyone, for your attention this morning. We're excited about the progress that we have made and the progress we're continuing to make. We've delivered two positive late stage studies in treatment resistant depression, which is remarkable and likely a unique achievement. With that, we're also very encouraged by the signals we're hearing from within the administration and more broadly about them sharing our belief in the potential for these transformative treatments for patients who have so few options, and we're committed to working with the appropriate regulatory and administration authorities to see what we can do to advance COM three sixty for treatment resistant depression. Kabir NathCEO at COMPASS Pathways00:28:06In addition, we will be in due course announcing the design of a PTSD study. I think particularly with recent events again at the agency, it's very clear that there is an urgent need for new treatments for PTSD, and we're excited to move COM three sixty forward in that as well. So thanks again for your attention this morning. I wish everyone a good day. Operator00:28:30This concludes today's call. You may now disconnect. Goodbye.Read moreParticipantsExecutivesSteve SchultzSVP - IRKabir NathCEOTeri LoxamCFOLori EnglebertChief Commercial OfficerSteve LevineChief Patient OfficerGuy GoodwinChief Medical OfficerAnalystsPaul MatteisMD & Head - Therapeutics Research at Stifel Financial CorpLuis SantosSenior Equity Research Associate, Healthcare & Biotechnology at H.C. Wainwright & Co., LLCAnalystGavin Clark-GartnerMD - Biotechnology Equity Research at Evercore ISIAthena ChinBiotechnology Equity Research Analyst at TD CowenJudah FrommerExecutive Director - Senior Equity Research Analyst at Morgan StanleyLeonid TimashevBiotechnology Analyst at RBC Capital MarketsSumant KulkarniManaging Director at Canaccord Genuity IncPowered by Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) COMPASS Pathways Earnings HeadlinesHC Wainwright Brokers Reduce Earnings Estimates for CMPSAugust 9, 2025 | americanbankingnews.comAnalysts Set COMPASS Pathways PLC Sponsored ADR (NASDAQ:CMPS) Price Target at $17.00August 7, 2025 | americanbankingnews.comIs Elon's empire crumbling?The Tesla Shock Nobody Sees Coming While headlines scream "Tesla is doomed"... Jeff Brown has uncovered a revolutionary AI breakthrough buried inside Tesla's labs. One that is helping AI escape from our computer screens and manifest itself here in the real world all while creating a 25,000% growth market explosion starting as early as October 23rd.August 14 at 2:00 AM | Brownstone Research (Ad)HC Wainwright Cuts COMPASS Pathways (NASDAQ:CMPS) Price Target to $40.00August 7, 2025 | americanbankingnews.comCompass Pathways price target lowered to $40 from $45 at H.C. WainwrightAugust 6, 2025 | finance.yahoo.comCOMPASS Pathways' (CMPS) Buy Rating Reaffirmed at Canaccord Genuity GroupAugust 4, 2025 | americanbankingnews.comSee More COMPASS Pathways Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like COMPASS Pathways? Sign up for Earnings360's daily newsletter to receive timely earnings updates on COMPASS Pathways and other key companies, straight to your email. Email Address About COMPASS PathwaysCOMPASS Pathways (NASDAQ:CMPS) plc operates as a mental health care company in the United Kingdom and the United States. It develops COMP360, a psilocybin therapy that is in Phase III clinical trials for the treatment of treatment-resistant depression; and is in Phase II clinical trials for the treatment of post-traumatic stress disorder and anorexia nervosa. The company was formerly known as COMPASS Rx Limited and changed its name to COMPASS Pathways plc in August 2020. COMPASS Pathways plc was incorporated in 2020 and is headquartered in London, the United Kingdom.View COMPASS Pathways ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Brinker Serves Up Earnings Beat, Sidesteps Cost PressuresWhy BigBear.ai Stock's Dip on Earnings Can Be an Opportunity CrowdStrike Faces Valuation Test Before Key Earnings ReportPost-Earnings, How Does D-Wave Stack Up Against Quantum Rivals?Why SoundHound AI's Earnings Show the Stock Can Move HigherAirbnb Beats Earnings, But the Growth Story Is Losing AltitudeDutch Bros Just Flipped the Script With a Massive Earnings Beat Upcoming Earnings Palo Alto Networks (8/18/2025)Home Depot (8/19/2025)Medtronic (8/19/2025)Analog Devices (8/20/2025)Synopsys (8/20/2025)Lowe's Companies (8/20/2025)TJX Companies (8/20/2025)Intuit (8/21/2025)Workday (8/21/2025)Alibaba Group (8/21/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. Start Your 30-Day Trial MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
PresentationSkip to Participants Operator00:00:01Hello, everyone, and welcome to Compass Pathways Second Quarter twenty twenty five Earnings Conference Call. Please note that this call is being recorded. After the speakers' prepared remarks, there will be a question and answer session. Thank you. I'd now like to hand the call over to Stephen Schultz, Senior Vice President of Investor Relations. You may now go ahead, please. Steve SchultzSVP - IR at COMPASS Pathways00:00:31Welcome all of you, and thank you for joining us today for our second quarter twenty twenty five results conference call. Again, my name is Steve Scholz, Senior Vice President of Investor Relations at Compass Pathways. Today, I'm joined by Kabir Nath, our chief executive officer, and Terry Luxem, our chief financial officer, who will have prepared remarks. In addition, doctor Guy Goodwin, our chief medical officer Doctor. Steve Levine, our Chief Patient Officer and Lori Engelbert, our Chief Commercial Officer, will be available for the Q and A. Steve SchultzSVP - IR at COMPASS Pathways00:01:03The 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 thirty 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 in 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. Steve SchultzSVP - IR at COMPASS Pathways00:01:51Securities 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 will now hand the call over to Kabir Nath. Kabir NathCEO at COMPASS Pathways00:02:20Thank you, Steve. Good day, everyone, and thank you for joining us. Let me begin by welcoming Justin Gover to the Compass board of directors. Justin was the CEO and one of the founders of GW Pharmaceuticals, and we're truly excited to have access to his expertise. Under Justin's leadership, Epidiolex, the first cannabis plant derived medicine to be approved by the FDA, had a successful commercial launch. Kabir NathCEO at COMPASS Pathways00:02:48I look forward to leveraging his expertise as we embark on a similar path to gain FDA approval and launch COMT three sixty for TRD. In addition to announcing the addition of Justin to the board earlier this week, we announced that doctor Linda Mcgoldrick will be retiring from the board at the October after a transition period. I'd like to thank Linda for her service on the board over the last five years where she was instrumental in supporting the growth of the company through the IPO and subsequent developments. Turning now to our operations, this has been an exciting quarter for Compass. In late June, we announced the successful achievement of the primary endpoint of the COMT360-five trial, the first of our two pivotal Phase III trials. Kabir NathCEO at COMPASS Pathways00:03:38The positive results were highly statistically significant, demonstrating a clinically meaningful reduction in depression and no unexpected safety findings based on the latest data reviewed by the independent DSMB. This assessment included all data reviewed by the DSMB to date from both the five and six trials going beyond the six week time point for five alone. There was a 3.6 difference in change from baseline in mattress between the twenty five milligram and the placebo arms at six weeks, exceeding the three point difference that is both clinically meaningful and commercially viable. While cross trial comparisons are always challenging, this difference sustained to six weeks with a single administration of COMM three sixty is similar to the difference seen at four weeks in the pivotal trials for the blockbuster drugs, Bravato, which required eight administrations. So we believe the result that we have seen at six weeks with COMT three sixty is both clinically and commercially compelling. Kabir NathCEO at COMPASS Pathways00:04:45With this positive data, Compass has delivered two for two, announcing positive, highly statistically significant results from two robust late stage studies of over 230 patients each in a very difficult to treat patient population in depression. Given the track record of previous studies in psychiatry, particularly in severe depression, our achievement of two positive late stage studies is remarkable and provides important clinical validation for COMT three sixty's treatment potential in TRD. We plan to meet with the FDA to discuss these results and explore next steps in getting COMT three sixty to patients as rapidly as possible, patients who so desperately need new treatment options. The second pivotal phase three trial, COMP o o six, continues to recruit well, and we confirm that we're on track to disclose the 26 data in the second half of next year. As a reminder, the protocol for this trial has a second dose after three weeks with the six week primary endpoint assessment, therefore, only three weeks after the second administration. Kabir NathCEO at COMPASS Pathways00:05:57We should also get some good information on the effects of a second dose as part of the twenty six week o o five data given that subject to specific retreatment criteria, participants can get another dose in Part b, which runs from the six week time point through twenty six weeks. To prepare for a potential commercial launch, our team continues to work with a broad array of mental health care providers, both through our strategic collaborations and through our field medical team to refine our understanding of how COMT three sixty treatment will fit into existing settings of care. We're frequently asked by investors how COMT three sixty will be viewed by providers who are used to the approximately three hour SPRAVATO treatment window. Through our discussions with these providers, we know that patient preference will be a driving factor in treatment selection. As you're well aware, SPRAVATO patients need to be driven to the clinic frequently, which is a burden to the patient and caregiver, and, generally, they're not able to return to work that day. Kabir NathCEO at COMPASS Pathways00:07:05In addition, we believe that the added administrative burden and the work required to turn a room potentially multiple times may actually favor COM three sixty from a practice standpoint. Finally, the CPT three codes specific to psychedelics that were put in place back in early twenty twenty four provide for hourly reimbursement. So regardless of the length of the administration for COM three sixty, the provider will be covered. Steve and Laurie can go into much more detail on all of this. Beyond TRD, we're also excited about the potential for COM three sixty in PTSD. Kabir NathCEO at COMPASS Pathways00:07:44We're in the final steps of designing a late stage clinical program in PTSD, and we look forward to updating you when that design is finalized and once we've reviewed it with the FDA. Given the high unmet need and limited current treatment options, we see a significant commercial opportunity in PTSD. In addition, as you know, we have been running a small phase two study in anorexia. This was a double blind, randomized controlled phase two clinical trial investigating the safety and efficacy of COMT three sixty psilocybin treatment in participants with anorexia nervosa. It was a multicenter study which enrolled 32 participants. Kabir NathCEO at COMPASS Pathways00:08:26The study has now completed, and we recently received the data. From an efficacy standpoint, there was an encouraging positive signal in the reduction of eating disorder and depressive symptoms in the twenty five milligram arm, which was sustained through twelve weeks. However, the low overall numbers of participants and the high number of dropouts in the control arm limited statistical power. The safety profile was aligned with the high risk patient population in anorexia, and no unexpected safety signals were reported. As we've discussed before, this is a difficult condition to study. Kabir NathCEO at COMPASS Pathways00:09:03We're proud of the data that we've been able to generate, and we'll publish or present the full dataset in future. With that, let me now hand the call to Teri to go through some financial updates before we move on to q and a. Teri LoxamCFO at COMPASS Pathways00:09:17Thank you, Kabir. At the June, we had cash and cash equivalents of $222,000,000 which we expect to fund our operations into 2027. This compares with $260,000,000 that we had at the end of the first quarter. Debt under the Hercules loan facility was $30,900,000 at the end of the second quarter. Cash used in operations for the second quarter was $38,700,000 and we expect net cash used in operations for the full year 2025 to be within the range of 120,000,000 to 145,000,000 We're energized by the positive five primary result, which we believe has de risked the company from a regulatory and commercial perspective. Teri LoxamCFO at COMPASS Pathways00:10:08And we look forward to the upcoming twenty six week data from both phase three trials. We are finalizing a PTSD study and look forward to updating you soon on that design and timeline. 2025 has already been an important year for the company, and the remainder of this year and two thousand twenty six is shaping up to be even more exciting. We are heads down focused on continuing to execute on our pivotal program while exploring all opportunities to get COMM three sixty to patients suffering from hard to treat depression and PTSD as quickly as possible. As mentioned in the beginning of the call, Doctor. Teri LoxamCFO at COMPASS Pathways00:10:48Guy Goodwin, Doctor. Steve Levine, and Lori Engelbert will also be available for Q and A. Teri LoxamCFO at COMPASS Pathways00:10:55Thank you, and I'll now turn the call over to the operator for Q and A. Operator00:11:16Your first question comes from the line of Paul line is now open. Paul MatteisMD & Head - Therapeutics Research at Stifel Financial Corp00:11:24Good morning. Paul Matteis from of Stifel here. Thanks for taking my question. I was curious if you could expand upon the engagement you've had with the FDA since the data. What do you think the scenarios are here where you could have an accelerated path for a filing? Paul MatteisMD & Head - Therapeutics Research at Stifel Financial Corp00:11:39And with any scenarios, I guess, do you think you actually could move quickly enough where the second Phase III study wouldn't read out before you submit or during a review? I guess, like, there a real way to actually move ahead of that data? Are we gonna ultimately, of course, get that data before there's any sort of regulatory decision in any scenario? Thank you. Kabir NathCEO at COMPASS Pathways00:11:59Thanks very much, Paul. It's Kabir. I'm just checking. You can hear me clearly? Paul MatteisMD & Head - Therapeutics Research at Stifel Financial Corp00:12:05Yes. Thank you. Kabir NathCEO at COMPASS Pathways00:12:06Thanks, Paul. So thank thank you for the question. So as we've said, we have requested and we will be meeting with the FDA in this quarter. As we said on the call, we are two for two now in treatment resistant depression. So the phase two b with over two hundred and thirty patients, this phase three with the primary endpoint data, two hundred and fifty patients, and importantly, consistent data across the trials. Kabir NathCEO at COMPASS Pathways00:12:35While the two b, of course, the primary endpoint was at three weeks, as you know, at six weeks, we did see a statistically significant difference. And, actually, it's a pretty similar difference to what we've seen here in the phase three. So we are two for two, we believe, in a very hard to treat patient population and one in urgent need of new interventions. So to your point, it clearly is the right thing to ask what accelerated pathways may be available, and that's exactly what we are planning to do. I'm not at this stage gonna handicap the chances, and, obviously, we need to have that meeting with the agency in quarter three, see what their view is. Kabir NathCEO at COMPASS Pathways00:13:13We're obviously encouraged by the fact that there are other leaders within the administration more broadly who seem to share our view in the potential and share our view that there are grounds to move this more quickly. But in terms of specifically which elements of o o five or whether part of o o six will be needed, that really depends on our discussions with the agency. Paul MatteisMD & Head - Therapeutics Research at Stifel Financial Corp00:13:38Kabir, just on your last comment there, understanding your request to meeting and meet the folks with the psychiatry division, are there plans or expectations you'd be engaging with others that are more senior at the FDA or within HHS as well? Kabir NathCEO at COMPASS Pathways00:13:53Yes. But I'm not gonna go into details of those, but, absolutely. We recognize that this needs to be a, you know, a a a concerted approach using whatever levers we can. But I might just ask Laurie to comment on some of the work we have been doing around the broader engagement of stakeholders, not just in the administration, but actually in the political environment as well because we recognize that's also a critical part of this. Lori EnglebertChief Commercial Officer at COMPASS Pathways00:14:18Yeah. Thanks, Kabir, and and hi, Paul. So, obviously, we are very encouraged by statements that have been made by by secretary Kennedy as well as the commissioner. They as Kabir stated, they are very clearly, you know, viewing psychedelics as a potential to treat these patients, who have otherwise, limited option. You know, we've seen that through, you know, examples of them appointing, Matt Zorn, Mike Davis. Lori EnglebertChief Commercial Officer at COMPASS Pathways00:14:44This seems all very positive for, you know, for the industry, in and of itself. We also have, been spending quite a bit of time in DC as the potential first to market, company in the psychedelic space. We do find we we do take it very seriously that we wanna make sure that everyone is, well educated, and informed. And so we've been spending quite a bit of time there, what we're finding is that, you know, members of congress are also highly receptive, not only to the BA sector, which, of course, you know, they are they care very much about and and gets a lot of commentary, but also, for the broader patient population. So we we are encouraged by the conversations that we're having and and continue wanna continue our efforts there. Kabir NathCEO at COMPASS Pathways00:15:28One thing I should have said and to add, you'll be aware that last week, the the formal application process for the commissioner's national priority review voucher, the one that promises a very accelerated timeline open. So we have submitted our application for that along, I'm sure, with many other companies, but we did do that as well. Paul MatteisMD & Head - Therapeutics Research at Stifel Financial Corp00:15:48Okay. Very good. Thanks for taking the questions. Kabir NathCEO at COMPASS Pathways00:15:51Cool. Operator00:15:55Your next question comes from the line of Patrick Trucchio of H. C. Wainwright. Your line is now open. Luis SantosSenior Equity Research Associate, Healthcare & Biotechnology at H.C. Wainwright & Co., LLC00:16:05Hello, good morning. This is Luis in for Patrick. I would like to ask a little bit on the collaboration, the strategic collaborations that you are putting in place for the interventional psychiatry treatment centers. How are they progressing? What feedback have you received about readiness for COM360 delivery if approved? Luis SantosSenior Equity Research Associate, Healthcare & Biotechnology at H.C. Wainwright & Co., LLC00:16:26And how confident that the existing network of centers that you've already engaged with will support the delivery of three sixty to approve? Thank you so much. Kabir NathCEO at COMPASS Pathways00:16:38Luis, and I'll pass to Steve to answer that. Steve LevineChief Patient Officer at COMPASS Pathways00:16:41Thanks. Hi, Luis. Thanks for the question. Yes, we have been engaged now in the work with these collaborations for the past couple of years. As a reminder, they are representative of the broad swath of sites of mental health care delivery in this country, including hospital systems, interventional psychiatry networks, community behavioral health, and others. Steve LevineChief Patient Officer at COMPASS Pathways00:17:02And what we are finding in this work, and as a reminder, some of them deliver SPRAVATO today, and those that do are highly representative of the 6,000 centers that are currently delivering SPRAVATO around the country. And, you know, one thing is abundantly clear. It's that this work is reinforcing our conviction that COMM three sixty, if approved, fits directly into the infrastructure that is delivering SPRAVATO today. If you look at a SPRAVATO room, it looks like what is necessary for comp three sixty. The staffing of these centers is what we believe will be required to deliver comp three sixty. Steve LevineChief Patient Officer at COMPASS Pathways00:17:38And so, you know, we are we are very confident that the network is ready if and when we get approval. And even if that approval is accelerated, it is weighted. Analyst00:17:52Thank you. Operator00:17:56Next question comes from the line of Gavin Clark Gartner with Evercore ISI. Your line is now open. Gavin Clark-GartnerMD - Biotechnology Equity Research at Evercore ISI00:18:05Hey guys, congrats on the progress and thanks for taking the questions. First, I was just curious if you've seen a pickup in six enrollment following the five data? And then secondly, just following off your last point on the commercial side of things, do you have an estimate for what percent of SPRAVATO use is given in single rooms versus kind of group room settings where multiple people can be monitored at the same time? Thank you. Kabir NathCEO at COMPASS Pathways00:18:31Thanks, Gavin. So I'll take the first one. So the o o five data has been viewed very positively by investigators, not only in o five and o o six. We're now in that kind of the really steepest scent point of the o six recruitment, and it's going extremely well, which is why we're able to reconfirm our guidance for data in the second half of next year. But, yes, I would say in general, the reception from investigators to the data has been very positive and has reinforced their belief in the potential of o o six and, you know, frankly, the derisking both from a clinical and regulatory perspective. And I'll pass to Steve for the second question. Steve LevineChief Patient Officer at COMPASS Pathways00:19:09Hi, Gavin. Regarding your question about whether SPRAVATO is currently delivered in individual rooms versus in group settings, It is primarily in individual rooms, and that is another reason why we believe that infrastructure is in place. You know, there is, you know, the likelihood that as these products mature in the market and they are commonly delivered, sites may look at various models to deliver them. But, again, currently, today, it's primarily individual rooms and ready to deliver comp three sixty when available. Operator00:19:46Question comes from the line of of TD Cowen. Your line is now open. Athena ChinBiotechnology Equity Research Analyst at TD Cowen00:19:54Hi, guys. Thanks for taking my question. This is Athena Chen on for Ritu Baral. Are you guys pursuing the commissioner's national priority voucher, and what is your understanding of the criteria to meet eligibility? Thank you. Kabir NathCEO at COMPASS Pathways00:20:09Hi, Athena. Yes. I did actually just confirm that in an earlier question. We did submit our application. We also do, as part of our briefing book for the meeting with the FDA, raise that question. Kabir NathCEO at COMPASS Pathways00:20:20So in terms of the criteria, I I believe there were five priorities listed, and they include significant need, public health crisis, both of which we clearly hit, innovative treatments also. There are also ones around manufacturing and global pricing, are less relevant to us, But it's clear that the criteria don't expect a company to hit all five of those, and we believe on three of them, we very clearly tick those boxes. It also requires you to be ready to start submitting elements of a filing package, and we clearly are in terms of CMC and some of our other preclinical and some. We're in very good shape with that. So we think we're a great candidate. Kabir NathCEO at COMPASS Pathways00:21:00We recognize that there are, in theory, only five pilots that we were taken forward. But we also recognize that the decisions were due to be made by the CMO, but it appears that the CMO of the FDA is currently a vacant position as of Monday night. So what the process is, we don't know. But we believe we absolutely meet the criteria, and that's why we've submitted. Athena ChinBiotechnology Equity Research Analyst at TD Cowen00:21:24Understood. Thank you. Operator00:21:29Your next question comes from the line of Judah Frommer of Morgan Stanley. Your line is now open. Judah FrommerExecutive Director - Senior Equity Research Analyst at Morgan Stanley00:21:36Yes. Paul MatteisMD & Head - Therapeutics Research at Stifel Financial Corp00:21:37Hi, thanks for taking the question. Judah FrommerExecutive Director - Senior Equity Research Analyst at Morgan Stanley00:21:39Just following up on kind of your commentary regarding interactions with the agency. It seems like there is some high level connectivity, but are you able to comment on consistency of interaction with kind of mid and lower level members at the agency? Just curious if there's been consistency within team makeup in the teams that you're talking to. Thank you. Kabir NathCEO at COMPASS Pathways00:22:03Thanks, Judah. Nice to meet you. And the answer is absolutely. So as a reminder, we have breakthrough designation. And as we've always said, we have consistently had excellent engagement with the psychiatry division. Kabir NathCEO at COMPASS Pathways00:22:14Currently, we've seen no change to either the staffing, the level of engagement, the responsiveness, and so on. So at the day to day level with the FDA, we remain, you know, very tightly aligned with a good relationship, so no changes. Judah FrommerExecutive Director - Senior Equity Research Analyst at Morgan Stanley00:22:30Thanks. Operator00:22:35Change comes from the line of Leonid Imashev of RBC Capital Markets. Your line is now open. Leonid TimashevBiotechnology Analyst at RBC Capital Markets00:22:43Hey guys, thanks for taking my question. I had one on safety, especially as it relates to redosing. So I guess, how are you guys thinking about the risk of suicidality or any elevations in suicidal ideation? Anything that's after that correct after every dose of COMM-three sixty or potentially every dose of placebo? Or is it just something that occurs after the first dose on the study? Leonid TimashevBiotechnology Analyst at RBC Capital Markets00:23:06I guess, do have any data, that you can speak to with respect to that? And then relatedly, I know in the anorexia study, you said there were no unexpected safety signals. I wonder if you could just talk a little bit more about what you saw in terms of safety from the anorexia study, especially on on suicidality. Thanks. Kabir NathCEO at COMPASS Pathways00:23:22Thanks, Leo. And I'll pass to Guy in a moment. But first, just as we've always said, the the statement we made last month from the DSMB did refer to all data they were seeing today from both o o five and o o six, so including the study that that has the second dose in. But let me hand to Guy for a more you know, a broader discussion about Guy, please. Guy GoodwinChief Medical Officer at COMPASS Pathways00:23:45Yes. I think I think we have to be a bit we we we don't have, detail on the time course of, the suicidality that is being seen in zero zero five and zero zero six. All we know is that there's no imbalance between the arms. So I can't really comment directly to your question except to sort of be reassuring about the fact that there isn't a clear effect of the drug. There's much more likely to be an effect of the illness and that will depend obviously on how people have responded and how the response is maintained. Guy GoodwinChief Medical Officer at COMPASS Pathways00:24:17We will certainly have all that information in due course but not at the moment. It's a good question about, the anorexia group. This was a small study remember but it was clear that we saw higher rates of suicidality, than we are used to seeing just measured as events in that group. That was true in both the arm receiving one milligram and the arm receiving twenty five milligrams. So again we had no imbalance between the arms but higher overall rates reflecting the fact that it's a more dangerous condition from the point of view of mortality. Guy GoodwinChief Medical Officer at COMPASS Pathways00:24:55It has the highest mortality of any psychiatric disorder And suicide is one of the leading causes along with the physical problems that patients also encounter. So the relative safety of our treatment in this high risk group is again a reassuring thing really for the whole programme. Operator00:25:20Next question comes from the line of Sumant Kulkarni of Canaccord Genuity LLC. Your line is now open. Sumant KulkarniManaging Director at Canaccord Genuity Inc00:25:29Thanks for taking my questions. What is the earliest that you could file a new drug application for COM360? And how should we think about when you might announce a timeline for reporting Part B from the COMPO-five trial? And then I have a follow-up. Kabir NathCEO at COMPASS Pathways00:25:43Thanks, Sumant. So, again, I'll I'll refer you to use my earlier answer until we've met with the agency. It's premature to speculate on exactly what that could be because we really need to reach alignment on what data they would like to see and and the process for that. As we have said before, we will, in due course, announce the full enrollment of o o six. As and when we do, that will be the point at which we can all look at our calendars and project forward. Kabir NathCEO at COMPASS Pathways00:26:12Because as a reminder, we have said twenty six weeks of o zero five, part b of o zero five, we will only release once all patients are through part a of o zero six in order to avoid any potential suggestion that there's a confound between those two sets of data. Sumant KulkarniManaging Director at Canaccord Genuity Inc00:26:30Got it. And how onerous is the process to submit an application to the commissioner's priority review program in terms of any trial data necessary? And is there any phase three related efficacy or durability data in that application or your briefing book that investors have not seen yet? Kabir NathCEO at COMPASS Pathways00:26:46So in terms of what was required to submit for it, it's a 350 word abstract. So I could safely say that there was no data included in that. And, again, I think as we're all aware, it's unclear what the selection criteria are actually gonna be for the pilots. And, no, to confirm, I mean, we have no more phase three data than you is out in the public domain and that we have already released. Operator00:27:13Thanks. I'd now like to hand back the call over to the management for final remarks. Kabir NathCEO at COMPASS Pathways00:27:22Thank you very much. So thanks, everyone, for your attention this morning. We're excited about the progress that we have made and the progress we're continuing to make. We've delivered two positive late stage studies in treatment resistant depression, which is remarkable and likely a unique achievement. With that, we're also very encouraged by the signals we're hearing from within the administration and more broadly about them sharing our belief in the potential for these transformative treatments for patients who have so few options, and we're committed to working with the appropriate regulatory and administration authorities to see what we can do to advance COM three sixty for treatment resistant depression. Kabir NathCEO at COMPASS Pathways00:28:06In addition, we will be in due course announcing the design of a PTSD study. I think particularly with recent events again at the agency, it's very clear that there is an urgent need for new treatments for PTSD, and we're excited to move COM three sixty forward in that as well. So thanks again for your attention this morning. I wish everyone a good day. Operator00:28:30This concludes today's call. You may now disconnect. Goodbye.Read moreParticipantsExecutivesSteve SchultzSVP - IRKabir NathCEOTeri LoxamCFOLori EnglebertChief Commercial OfficerSteve LevineChief Patient OfficerGuy GoodwinChief Medical OfficerAnalystsPaul MatteisMD & Head - Therapeutics Research at Stifel Financial CorpLuis SantosSenior Equity Research Associate, Healthcare & Biotechnology at H.C. Wainwright & Co., LLCAnalystGavin Clark-GartnerMD - Biotechnology Equity Research at Evercore ISIAthena ChinBiotechnology Equity Research Analyst at TD CowenJudah FrommerExecutive Director - Senior Equity Research Analyst at Morgan StanleyLeonid TimashevBiotechnology Analyst at RBC Capital MarketsSumant KulkarniManaging Director at Canaccord Genuity IncPowered by