COMPASS Pathways (CMPS) 31 Oct 242024 Q3 Earnings call transcript

And today, I'm joined by Kabir Nath, our Chief Executive Officer; Lori Engelbert, our Chief Commercial Officer; and Teri Loxam, our Chief Financial Officer, who will be giving prepared remarks as well as Dr. Guy Goodwin, our Chief Medical Officer; and Dr. Michael Gold, our Chief R&D Officer, who will join us for Q&A.

The call is being recorded and will be available on the Compass Pathways Investor Relations website shortly after the conclusion of the call and will be available for a period of 30 days.

Before we begin, let me remind everyone that during the call today, the team will be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as amended.

undue these place statements. not should reliance forward-looking on You risks, from could or with as Actual under other the various our uncertainties results filed Factors recent risks materially including a and those those factors, of heading statements events or XX-Q described forward-looking quarterly differ report expressed the and Form and U.S. any implied result in Risk uncertainties most by on the and Commission subsequent made SEC. in with Securities and Exchange by filings Compass

views any only revise be any our of We these today representing our not represent Additionally, update any forward-looking disclaim should as relied if even our estimates and statements or specifically statements to obligation views subsequent or as forward-looking upon assumptions as of date. change.

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

Good you thank Steve. you, for and everyone, day, us. joining Thank

begin quarterly to by Lori with Compass. welcoming me her call Let first

August and to as round company said we're Axon. strategic deep we executive I has XXX, such As will the of our and she recently most prepare That the COMP out call, joined our joining thrilled experience we're exceptional commercialization valuable and Ovelity be launched an commercial that having on us. at experience, brings leader Lori for pleased have team.

as commercial update. ask Teri update financial Lori And a we In I'll will moment, our a you landscape on provide with commercial are of usual, to for major investors. focus our the areas and you know which preparation, interest and

early COMP earnings back COMP X-week we to year. the anticipated address XXX trials. pushed I want the the August year of disclosure this to date our First, around call, for trial disclosure or end XXX though, next anticipated of On our questions pivotal the

updating to data now us to be our more recruitment the guidance that X-week the assurance. data of the therefore quarter, to date, to second in X-week our disclose unlikely XXX XXXX and will looks we're quarter give first on for Based it we the able

doing of and completing on drug which as everything and our into Gold, and possible integrity that came is Mike time Phase we can sites, trial. helped III as us in priority significant spending new has ensure the on we're quality sites recruit has our the trials, much in of his to given ground the us quickly top is board the development who Our maintaining the challenges with plans. insights May of refine some to and while neuroscience experience

did Phase We're on. prior company lines we assumptions conduct not such our of trials, base first the the III large comparable to benefit psychodetic and time have to

did the and enrollment IIb III the our along on were have trials new into there the III the curve learning Phase projections that of while complexity enrollment we're some to Phase aspects now based trials of number the items projections, related a Our we factor way. of been in Phase

with simpler additional to for sites become resulted The where has patient COMP schedule Phase weeks. and sites other experienced arms, in complexities active as to in patients trial These XX given, for patients blinded managing all first just themselves. and clinical the and trial be a hand, protocol a as for have specific proficient. but increases as significantly the complexity flow setting, carefully therapists they which logistical well are XXX multiple the can a IIb XX-week single for is weeks doses parts dose was XX the blinded on more

is we'll working continuing needs attention each as at the of matter and the possible. the patients funnel, sites top as and focus demand process get Mike and providing and to his hands-on to through successfully on significant dedicate continues all a approach basis. a the team are it's helping support resources to tackling are completing these to our be paying be trials. case-by-case blocking This the site and quickly to close necessary them patients of There and of from

and Beyond XXX the remember X data be the disclosing timing what with endpoint asked to so remains we frequently is be we're trial integrity will Please blinded we're Therefore, what much at we trial, that readout. X as at blinding maintain can XX weeks, we also release while in going X-week that through of data as limited the for weeks. weeks the possible. ongoing the primary

data validation X p-value The endpoint. the between of and key and arms, We confidence X-week effect, that will investors disclose IIb intervals. a the positive Phase the believe treatment clear with the if effect result. provide treatment understanding an efficacy these difference important for should MADRS provide We of measures positive,

which we'll for for to risks patients inherent high-level standpoint, safety on in an data unblinded a is provide looks assessment expected a a ideation Suicidality of trial. monitor TRD the in is suicidal safety DSMB, From at basis the this and independent feature population. regular

suicidal unblinding. of at provide part data comment any in be time the As DSMB of the not further endpoints ideation. as in-depth on will we X-week this would will able safety seeing At that the assessment endpoint, imbalance or readout, whether they're to require secondary they also tables

COMP-XXX me second which Let the our to trial, is turn now trial. Phase III

at gets the weeks, weeks reminder, weeks In X arms XX and each of XXX a of C X XX through an the dose X start XXX milligrams of has the milligram, XX at doses X-part open-label trial. apart weeks. Part the end A B XXX, the of XX blinded the with and COMPXXX fully with X a at participant trial, As through part primary structure same Part milligrams, active endpoint three

on drugs. the key The this recent Licos letter received fact new FDA's class a insights and that faced they into the of AdCom by the provided challenges thinking of some response complete

FDA is was the their studies. program, and a regarding assisted were and degree concerns unblinding to Lycos MDNA of therapy ADCOM scrutiny there very most our specific to While of high relevant which

they drug COMPXXX. patients XX% as While on receive XXX to trial active a XX- of which the doses for psychedelic responses be XX trial. will know difficult will is dose to saw recruitment XX the particularly participants Phase XXX what dose risk are blinded psychodelic-naive in experience, its we of participants both to designed XX-milligram of X arms overlapping weeks, prior which and the cap it determine with IIb XXX XX and between trials the overwhelmingly with between a milligrams is and the they minimize received, unblinding with With our the

we the We insights trial. has believe that that all commercial been the strategy XXX given maintain blinding to this and we redosing data the patients. blinding of trial blinded time to the XXX reached the regulatory preserve that and further through protect gain is valuable Compass an We, ensure the decision effective to trial the and XX-week importance durability, to want around point therefore, for the of only portion release after difficult of very made and for

sites been XXXX. have XXX. projected. to expect so far are and XXX also consideration on disclosure for taken from going sites of disclose time U.S. taking shift half rollover running, for has than in recruitment While Europe, up of relying for some to at data still longer number working the now as we're in of point to in XX-week Therefore, to XXX second recruitment, that XXX initiations well the the potential well the And we into unpredictability as site which through XXX a some the we're of

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

Kabir. you, Thank

Let the me Pathways be begin team. saying Compass privilege to it by of a part what is

advancing an treatment have patients area and connection potential with for providers. or extremely Our options personal difficult-to-treat I patients depression, conditions, a health and I their patients TRD, deliver focus helping about with treatment-resistant solutions is especially on passionate for am mental to for

potential limited. opportunity. change to a And If are And an remission patients has patient population, and commitment given we the who Innovation way see this in need unmet of disorder major About depression depressive to safe need. patients for patient treatment X/X definition, pharmacologic commercial develop treatment-resistant high been after area currently, the high treatments X FDA-approved there population COMPXXX achieve depression therapies are products is effective resistant. only of are considered significant unmet from this approved, has extremely By to and fail treated treatment-resistant and suffering TRD therefore, managed. the with X are in indication.

important been facets As areas to work are research billing for success. our prepare I future are for forward I of the at include preparing interactions These with economics have underway, rescheduling, align ensuring states launch in many Compass, for been have all in by steps commercial established preparing discussions. administration diving health DEA appropriate that impressed model, investing payer to and in codes KOL already

interventional learnings additional various collaborations settings insights One with the and to the centers. have in is Through through these our important learn strategic psychiatry care bidirectional opportunity work we from select collaborations, within providers of delivery area gain networks.

the have support COMPXXX key identify the to models, [indiscernible], learnings opportunities scale operating adapted sites they working the Some of operating include and with current understanding how to to model.

and we we to for our today's at current options. sure launch will COMPXXX what centers treatment beyond make into treatment that expect are and current operating learnings be use novel delivery collaborations to Ultimately, to significant new prepared support their demand want fit a from the infrastructure can

An past COMPXXX is question with as be have network capable whether over One for ready sufficient been managing at providers consistent the and interventional centers will the enthusiasm there is it. the have potential for want HCPs time of the out key delivery is just for to area is in as and required. psychiatry which COMPXXX feedback discussions we year handle of demand how how well, monitoring how scale investors much much of

adapted awareness of these mentioned a well above, these occupy terms of have ongoing our needing As to also and for Spravato this but is change suggest patients Certainly, would once an Spravato came demand. are growth along and requirements. with that it centers it area and planning, growing and focus centers with worth market, to patient collaboration I was monitoring in strategic partners is as noting, rooms

to date. I've established, As impressed to approach work great mentioned with been has been look our forward foundation commercialization. before, I the advancing to A and

ready. to opportunity, to get can tirelessly and patients, we will commercial committed work have working do to but are we if exactly and to optimize market the I my be approved, COMPXXX, team to ensure the We determine is how ensuring will

of many learn and providing with meeting we more. as to insights you in progress forward and the look I future additional

me call Let hand for Teri now the to financial overview. the

used which not you, now tax in quarter quarter been the third the in received but Lori. $XX.X in was credit as step our uncertain. million XXXX $XX.X had I'll Thank full includes related third third quarter results. through to in the timing R&D in we financial Cash our cash that was operations the included million, QX originally guidance

$XX.X Excluding been which range guidance have $XX this million we provided credit, tax of for the midpoint at million. cash $XX that used to . is the operations of would in million,

million, $XXX year XXXX prior received midpoint guidance, and increase put full year near $XX full guidance. $XX operations been Regarding in to cash we and expect we which original used R&D the includes $XXX contemplated and used of fourth quarter had million XXXX would for credit the cash and that this million tax in the guidance financial XXXX our quarter in which between the operations million, between to net

$XX.X September $XXX the we cash June facility cash At million end quarter. XX, loan XXXX, equivalents million $XXX.X the XXXX. and the XX, Hercules Debt third of was compares at of This with had at million. under

our COMPXXX well the Given successfully preserve the externalization to actions Phase as made possible. strategic III focus tools. our quickly taking including on of workforce, we completing our the readout, III Therefore, as as trials we preclinical efforts cash reducing entire timing to non-COMPXXX be stopping the is changes will of as and are Phase our digital ensure potential

evidence-based methods last the test several mental to assessing years, have Over developed health treatments. tools we digital for and technology

of a our that externalizing for evidence-based intellectual for established approach employees company potentially We are benefit mental an patients. could to now and delivering associated health developing property exploring anyone these by technologies, support co-founders treatments the and new

We and a the QX are decision this externalization by details final through still on XXXX. working to look

in Collectively, the these downsizing organization actions XX%. will result by a of approximately

operations we cash, now the Kabir. back impact to to on While least we at cash full fund are runway the I'll still details working you. And expect into and our Thank through call turn XXXX.

the applying trials the review Lori. continue regulatory Thank And accelerate and quickly to you, Teri commercial possible as to and done resources best we as other get positioned for and to these success. COMPXXX XXX necessary trial. actively ways all We're

understand As directing earlier, has been I fully traveling may resources to where Mike them. and to assistance mentioned clinical be sites needed to

challenges, those overall we them program. As encounter rapidly pivotal addressing applying we're learnings the to and

I I team, that. have the on a committed will supporting know they As employees transition. and as their that saying the workforce management implications that, we're lives Teri loved organization reducing further cut costs, actions cash. through our that focus mentioned, a ones. we're impact cash. also and many in deep In preserving to to this of to taking I preserve bigger them regret And our want acknowledge today had much action

We're III trials worth of from well IIb for of our filing. we're now call well with that operator turn the large robust Phase than full as positioned clear we'll With this And Q&A. confident team X,XXX our plan to well-controlled patients' on you. a a the data deliver for and as Thank trial, I'll package a supporting and more plan. studies X Phase a committed trials success to have for

[Operator Ritu Cowen. of comes first Baral TD Instructions] the question with line Your from

[indiscernible]. top operations or Athena you face-to-face And to Was your to move . on any [indiscernible] foresee additional made is FDA for trial meeting? after conduct line decision changes This do other and [indiscernible] a readout

[indiscernible]. Thanks,

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

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

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

[indiscernible]. Just demand trying is to understand how much of this also versus really just logistical

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

you question. Leonid, thank for Yes. the

we're to working key Most clinical from is which that regulatory to to we optimizing trials. collaborations construct. a in referring that lot do fit the [indiscernible] make about very think on on you restricted to clinical It lot but One, being what's is From to the ways. has our I to to we and to management, commercial they're know, operations will utilization trials, what mentioned with adequately a commercialization. very are optimizing over likely, commercial the lot regulated that are within that the from clinical be the to standpoint, flow. patient learning formulary you sure our in they're because go the are will flow, operational call. happen anticipate the that We trials also physicians going treatment by it a that. centers. We're that will do when make happening not things patients need will access, in is sites. make sure the necessarily a sure . And hard similar from will they're it really flow the we referring that about like clinical is clinical We're an to of about not adequately product approved, situation you think it patient work is -- based side. are intentionally the And as That's to positions So have what trials a trial sites. way physicians patients that analogous learning to referred how educated from in the X will have be the that learning

resins the comp education, requires requires marketing effort will making very they helping and benefit. really get through as This sure to patients naturally This identify it and TRD. really closer understand sales all clinical on education come It's launch. we physicians that appropriate

think sites. of your that for ensuring really at The piece I of capacity of is piece underlying which patient is and second it, flow question, important the treatment the

can think I X mind, my You think about this, in about ways. in it

either have lot and of you the your and opportunity can or broad can go flowing sites of lot treatment an a you you and have a You about optimize patients really concentrated And lot those to of inefficient look process at not size where you're look at might really how We're through taking collaboration things are partners. a opportunities a efficient patient real at that we're sites. optimizing full there. a our treatment at from learning opportunities make those where think effort

next with question Duncan Cantor. comes the Your Charles from line of

evaluation on really timing. regulatory Okay. on I'm do ultimate clinical appreciate disappointing the and focus a I little rigorous success. maintaining

'XX have of course any discussed And weeks. in this possible has question agency Or of? has that it the you necessary about over strategy 'XX your X other being what changed do So perhaps in and regulatory you about with thinking terms have changed? is terms of a that? the Have I the last

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

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

to I'll that Mike. pass

Charles, Michael. it's

coming actually are we hot XX% rate of greater So care standard trials. than seeing wash a successful the into form

and published just just we II think the reporting that I confirm paper that from Phase on study. out it of guy came I with

not is sort It remain a this they So not do clinicians community our point -- it's investigators and obstacle. the there logistical to a tell patients of there out. is some reluctance a education wash does of is in -- for because

But in from fact, not and we it's from trials, the observed what a problem.

not than said, XX% seen And effect from wash I complete withdrawal. ability a have trials our to [indiscernible] in like higher now. that right out We

research paper XX would site little due could We that to seems was saw seems you to like the expect helpful. be like to just Last longer appreciate year timing, bit the it I a question yet and that Journal is a than regard shift with weeks that. XX shift.

So XX is confidence a well? or enrollment in enrollment there as also of your modulation in

some is curve. say Your as the recruitment What the there is still said correct. on is, uncertainty math we call, I around would

curve. European inflection accelerate that XXX, the have experienced and the given will continue for sites in end I both think an be well guidance therefore, finishes, done that we're point, also but confident, those with we're the to can sites into in which expectation XXX doing the XX-week to point we everything that will very roll XXX as with we've on

moving well it conservatism X weeks. element So as to incorporate of you're correct, XX does an around from

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

the Yes. Charles. question, Thanks for

third mentioned, of as million into XXXX. least $XXX have we at we of quarter. had the the of gets cash So as us That end

longer as we the and along We restructuring to and are that cost as these anticipate the announced from trials are that -- more with we restructuring savings offset delays, the do they preserve so a meant cash. go

and further doing whether to potential are over detailed here some we'll is on doing we to that additional savings the We through runway, extend savings the analysis might weeks. incorporate for working and coming work be be able still that

comfortable into and to extend expenses we'll at can very If least disciplined spend that we're cash 'XX. our beyond committed the in in work So and success. we doing, COMPXXX's that, ensuring we're are our have that's we being

question of with comes Francois the line Your Brisebois from Openheimer. next

like still us help feel just understand seems touch commercial. is just a what will something good on between now difference that be to want referrals to us [indiscernible]. back answer difference. education help question, And a commercial be a the there And side year between terms a final with maybe the of time, for the and on sales was comfortable the second maybe be Can and and also can just estimate these question you you was would why brought there. I like prior about like it clinical launch? -- similar just readouts At you a understand as in what up on the potential? And data same done clearly needs

Frank. Thanks,

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

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

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

Yes.

the trial [indiscernible]. [Technical working do as that Difficulty] how question I'll is in about the first as a or collaboration the one, that main we really with clinical discussion little Again, first to with from either sites that with or we're we're more HCPs your get So around the one. or thinking working sites we're answer well that really give -- try you you I'll HCPs clarity about

my on going getting Just for the excitement here. commercial opportunity

cut we [Technical off, but exactly I'm sure So where I'll not Difficulty].

and what the opportunity. on I'll And focus what's immediate gears between focus But what is now excitement we're needed shift really everyone is heard launch. our like all around to the to hope doing now, the for right what actually commercial I'd what I points is.

focus the we MSLs our So on out doing right really the are right II educating on and data. COMPXXX to TRD what are things awareness need field in the increasing Phase now, That's around now. that

very we're And effort. lot from the obviously, feedback So learning concerted KOLs that. a a from that is around

Another important area us in us, really that of timely states scheduling. very That we're an after a is X rescheduled is get Schedule is unique given focus currently that for product. manner effort DEA that to sure making sitting a at

to need prescribe, distribute in we can those timely get product in rescheduled states So physicians a for we the be able to manner order and states. to the to

effort was we obviously, clinical through that's trials. that said times, focusing have learnings place that with and couple as collaborations from the the again, we how patient that as we optimize other And our MSOs it KOL a really again, from well focusing that in on, on learned of and our interactions The flow. I've really partnerships we're anything

importance of of good we access. aware then, And course, formulary the are getting acutely of

so we And right armed good present payers now, when is a information that so working [indiscernible] team build with the diligently to can to be time data comes. set to robust our

it's phone. my maybe mean I

I of sure. the did, others anything, not maybe hear terms didn't point, In I'm commercial but

here. having some we're Yes, technology challenges

for reasons a I'm COMPXXX some So of I'll why excited and better just I'll approach. probably revisit that's the --

we learnings of I lot a to have think do.

market are And and where be planning. time, but to of will have a situation we out. those overcome, we We time of think you is that to we -- we'll and first need figure first time a first-in-class a have to lot takes that market. lot to need Being strategy to through challenges

sites administration to that have some we flow. out into . The Spravato, and psychiatry so patient complex great adapt, launch, They've know were they're is now their and can obviously. in $X It TRD themselves natural again, have a we the that there, to able is and at it's well sites. COMPXXX There of issues Spravato. you on product. interventional our with steadily with out how they be X,XXX present the these well and excited these natural grown to we will a time centers, only figure sitting overlaps. the I'm analog and their through optimize over billion And launched path prescribers overlap product work since marketed is all prescribers, of reason

question Our with line Vikram the comes of from next Stanley. Purohit Morgan

Morgan on for This Vikram. is

the So X we have on XXX program.

change the the to delay profile or trial expect the you this versus would you'll in expectations? parameters patients the And any enrolled for of delay? release given given second, to different that First, the of report data prior

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

changes of on either no So those.

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

So an unmet you said need. very high interest, as is know, clearly a area PDSD have of we significant

from we our -- ahead set moving have is while is said current very We that also planned that What in not data compelling, Phase albeit we've have runway. for small II.

has not So changed. that situation

execute in to We a not have in time. on plans at hand, them but position we're this

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

want What I'd and XX to between and there on retreatment. And be period is the XX between week part in a eligibility the retreatment X like difference between and Is for back antidepressant do about weeks. to to XX maybe ask went question time you with B any them them how define do COMPXXX? someone an if we And to before is, weeks relapse. off this

Guy, you may if that. I ask take to

antidepressants, as useful the information have C. people we particularly. threshold commonly drug and administering about quite if they're that then and X B for obviously they retreatment in C, stay question and Part quite of on phases occur, we'll simply MADRS, a are different co-administration. the The criteria offer between important feasibility not where the a on on simply them, is would the The second gone this will back to be This think can

recovered So or either not meet to then relapse patients have criteria . patients same have have who recovered the who essentially. and

Your the Clark ISI. of comes next Evercore Kevin question from line Gartner with

Gavin. [indiscernible] for is This on

For do us, imbalance table, a update for you'll And imbalances. defined? safety what be won't that We you the potential just of what suicidal you will wondering XXX were DSMB you Just how essential? detailed look the be is considering ideation providing like? noted but comments that kind on under rate providing

mean So I the is I'll start. DSMB independent.

know, all? up So imbalance. they that add DSMB to don't an the us consider tell at to I Mike, to it's But if what like to you'd

don't think in I we're quantitative So give where a you can I place criteria.

think depends the or of on ideation of but severity cases it the of the nature degree cetera. I et imbalance, and that the planning, on also

is point, -- this a an them -- of a gives a as latitude be space. So have independent the that charter in DSMB to lot it's and we in place where

park to the I'm of a number see. have going so -- So interpretation to give really you. don't response cases the clinical their It they depends there. on I that

Our Please next with Patrick Wainwright the ahead. Co. & HC of question comes from Trucchio go line

few a questions. have I

more trials, address potential discussed position us And will should better COMPXXX committee about advisory TRD? with is talk you you need XXX that's updated assess is potential committee? these XXX expectation put the data XXX is, and that of will data if you can in NDA And these during trials and earlier potential questions COMPXXX from from continue the can the time you that to a there submit to secondly, be lines and to expectation an then how tell first a COMPXXX to advisory the and TRD. The generated both for the

very much, Patrick. Thanks

expect We always we a to both. the we need based I'll part, X precedent an on to very questions X, will absolutely AdCom is that yes So Mike. quickly. the this And be. fact answer data I'll Yes guide the Schedule to from for pass product, and and and continue will X that is it third

third the me party again. Remind

us a do to address issues AdCom. is we might us, believe, changes up position Which these stronger help at put that come in

just of want speaking, probably sponsors agency antibiotics. the we of going terms generally mean, preserve I to aware ask yes, we're in XXX reduce the clearly, to because beer's it, Adcom comment, [indiscernible] bias and of to do first-in-class. can binding any calls to they going us I integrity areas in for And whatever that be study agency think Well, to the first-in-class, functional and as minimize while just the the underlying, of it for generally helps extent the

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

size. effect about question processing So your

of of second can I patients limiting we're is say, your one the if releasing Part first amount why I of let so reasons from data sort XXX is still releasing So in sort because in be of XXX we while would part of are and some are -- me some to that the data impact both we -- sense B. going the well, in of answer this one see

really want how to much we about So put we there. be out prudent

the We're XXX sites are at point -- are and this running also none. that XXX

time. the studies at have both sites don't we any So are running that same

sites. So geographies the different And overlapping as they're not U.S., well. through than the other

can of dose. read-through doing any are from everything that sort block XXX we we minimize to or So

we're obviously, hoping. Now

[Technical Difficulty]

what's them. again, know but work our on, we'll we apologies through going platform Okay. don't for Once issues,

to just the this [indiscernible]. last me it of will take back I finish part [indiscernible]. Let

For us, in difficulty terms success because of NTD is of difference of just that clinically detecting varies relevant compared TRV a bit to lower maybe the protects little population. the a in

the give that going number effect we have power I'm matter. to you So relevant points in studies. We're on looks to just a -- our clinically adequate end deferred actually exactly for differences in on like what

line the of from comes Shrader BTIG. question with next Your Tom

the I'll given be quick situation.

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

a bit is attrition plan. actually the our running little below So rate

study. staying in subjects So are the

experiencing are not we So attrition. higher-than-planned a

We are not size. the sample changing

the adjustments sample study. any to not size are the We doing in

recruitment the clear parameters. and emphasizing quickly missing are planning to data retention We reasons as accelerate possible so I for hope attrition minimize are we enhance to complete studies to moment, how that well as our and the very [indiscernible] that how problem. within But is

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

X do X-week announced XXX, time might insight well? the at the us And line waiting completed versus would of the roughly, a weeks you which what weeks, per trial have XXX XX after XX have for decision expect I into you treatment at for full durability participants top And percentage as follow-up of data. that. X the announce weeks to give the what have the prompted more I

Yes.

give part, we can't X-week I have the be guided releasing but on you of Sumant, clear to So always an for just second, the XXX. to first answer data

is designs that very very you're the the well agency blending. our themselves preserving in why a as that's possible think design focus blinding recognize And to are is I XXX, aware, the XXX. different on preserve best that in

our XXX past. on changed in we've guided from the So decision what never has

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

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

schedule enough . to data in [indiscernible]. -- us give it and address therefore, price Does

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

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

again, all, call, first of will And taking advance for quality around apologies be the of in [indiscernible]. clearly that call. of action this our we Thanks, our next

So continuing need. commitment highest and thanks bring are an execution to urgency quality on we for pivotal as I'm the completely COMPXXX maintain at of a COMPASS while sorry interruptions about focused patience. our to the with said, We trials, in the and your to patients

COMPXXX ahead. we in by confidence Our are steadfast, what's and remains excited

again for you. you. look joining of all Thank with and we today, to further forward you call the Thank conversations

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

disconnect. now may You