COMPASS Pathways (CMPS) 6 Nov 222022 Q3 Earnings call transcript

Company Profile

Participants

Steven Schultz	SVP, IR
George Goldsmith	Co-Founder and Executive Chairman
Kabir Nath	CEO
Guy Goodwin	Chief Medical Officer
Mike Falvey	CFO
Charles Duncan	Cantor Fitzgerald
Neena Bitritto-Garg	Citi
Ritu Baral	Cowen
Patrick Trucchio	H.C. Wainwright & Company
François Brisebois	Oppenheimer
Bert Hazlett	BTIG
Esther Hong	Loop Capital
Sumant Kulkarni	Canaccord Genuity
Michael Okunewitch	Maxim Group

Call transcript

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Operator

Good day, ladies and gentlemen, and welcome to the COMPASS conference Third Quarter Call. [Operator Instructions] As a reminder, this call is being recorded. And I would now like to introduce your host for today's conference, Steven Schultz. Sir, you may begin.

Steven Schultz

Welcome all of you, and thank you for joining us today for our third quarter 2022 results conference call. the a earlier review this depression today, announcing publication had releases two quarter in you've Phase the issued our Journal we summarizing of The hope New chance for of the to press and Xb England We trial of Medicine. treatment-resistant results our accomplishments COMPASS name is Vice Again, Schultz, my President of Pathways. Senior Steven Investor Relations at Chairman; George our joined today, by Goldsmith, Dr. our and Nath; I'm Executive Chief Executive Officer, Kabir And Co-Founder Mike Falvey, and Chief Goodwin, Financial Officer; Guy Chief our Officer. Medical The being the and the be COMPASS will Pathways the after of call shortly recorded is available Investor on Relations conclusion call. website

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

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

Goldsmith. subsequent that, Additionally, forward-looking any assumptions over I'll or any be date. today our if revise We relied obligation With these George forward-looking disclaim update views views even the not or of statements specifically now of and call our upon our change. should represent only as to as as to statements, representing hand estimates any

George Goldsmith

smooth has Guy my will future I comments, quarterly Kabir, open and Chairman excitement as am report will Board to to on end will the as of COMPASS we and business candidate who pathways We be Chairman drug will this will insurance. through to to this the financial developed ensure prepared psilocybin progress, into results It's people's to call reimbursed I mental leader therapy continue call Thank investigational you, a where call and comments, COMPXXX We're need an regulatory enormous in that indications new a opportunity And psychological have that created and been health better for tools. developing with exploring exists. researchers patient drug innovative we so patients, we're therapies, joining candidate, already sadness some will that with I a promising care difference new then cover the in treatment-resistant COMPASS. to lives. a Steve, therapy that provide year with trials, can can a and clear After on governments, serve of support baton the clinical transition combined thereafter. Executive mental serve avenues update, for by many rely my made we and everyone. and Mike and open the I groundbreaking a have journey create We're together. final as that combining and health to make our patients investigational powerful our delivering results we've forge an digital our care. therapy, of strong psychological running providers, depression, support, health progress to provide the to pleased questions. together, hand approved could forces After review. welcome,

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Kabir Nath

here experience. as Thank our and been level over Phase my COMPASS accomplishment tools, took and you to the investment during COMPASS through it already program, Even the their already and you three support only it's work the It's prior exhilarating are XX day very Series several archive now of activity certainly high, design, commercialization. Capital Day. digital important if to found including my our advanced covered since in the In over round much, been Otsuka, to so. George, but Markets program, not everyone. clinical of Pathways, CEO on to successful done finalized X that psychological the view at particularly X we we work, exposure also I I including aspects and the of work doing to ensure urge B that good program you as you've extraordinarily just and an presented October XXXX, months I of well our as learning our to in as not Phase of we approach other with design

in presentation One all Markets for to team preparing brings Day. for striking These presentation leadership here their at Capital to executive passion breadth qualities, that the was things experience depth of the that our mission. vision team's COMPASS and the the in COMPASS understand commitment and to most their on were of evident me the of

with successfully our reimbursement forward to start As be of depression, my processes. priority X main therapy and the trial, will the program suffering Phase treatment-resistant this COMPXXX to year for move psilocybin look clinical patients regulatory we through

the and also areas this digital led products We COMPASS success. of well pleased both will health psychological long-term and bringing report significant and pharmaceutical to focused I'm addressing happy I together clinical you moment. the integrating commercialization share with development need gained of also that team ensure ensure preparations during in support. products Otsuka, really into also report right continued very digital Phase our delivered adding and the and support very with and executing complex urgently make outcome active Guy and very new completed also patients needs systems therapists, cohort At Phase In with and to COMPASS with care online it's I'm in analysis will the we in pharmaceutical of that experience who on underway. training to a quarter, it. that Xb the had our area, We've is health this recruitment digital mental complex which so progress steady quarter, towards study, to trained program. been to you to to our X for experienced sites solutions

our X his mortality study. With disorder, long-term Beyond also by Phase to X turn our post-traumatic patient have of Guy no will now existing area Guy? in Phase trials thoughts very medicines to provide the nervosa Phase stress ongoing on let this. also is X COMPXXX of that, program anorexia Anorexia It program in steps date, highest we the nervosa disorder outcome PTSD. the and discuss need. and planned and to high have in next are large PTSD and TRD, treatment represent any me TRD treat options. an Phase or two underserved been has that who approved rate populations psychiatric unmet Xb

Guy Goodwin

you, Thank good and all. Kabir, day,

our available Let program Day on Capital our by presentation, our Investors pivotal of begin is Markets details reviewing X we which me Phase section. the website which the design, communicated during in

set, data overview, an a cornerstone will As application the we new FDA. high-level drug are on overall our the which focused of with form building

evidence looking support reimbursements at we believe generating scale. for to approval the as We are well this novel also will by beyond launch that the treatment

Our X clinical to trials two answer pivotal are Phase important questions. designed

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confidence with sites Phase that the robustness that patients countries a out the deliver seven and XXX can point XX provides trial, me X Phase languages, us Let Xb in XX we results. successful in of

MADRS the population will the definition signal-generating scope criteria, been core as trial exclusion patient inclusion of beyond That traditionally also essentially of trial. the Xb studies. Xb and Phase which consistent Phase change studies baseline to X depression. aids endpoint The in our pivotal in six at our previous size of powering. endpoint of trial primary week in and a total is the same our Our Phase depression be Phase is extrapolation treatment-resistant have have what went the from from Xb trial X. same same X trials and week with The in score far Phase Both our smaller,

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this We expect available end XXXX. the that data top line will by from of be trial

dose the and milligram. The day and of at COMP X. arms fixed doses the monotherapy week XX, trial COMPXXX three second will receive XX trial one comparing Patients pivotal is with at same XXX repeat-dose one

XXX three line the determined of have arms available X:X:X data trial the mid-XXXX. to dosing With be a in size randomization, expected is Top and patients. we

for study XX-milligram new small for to arms demand that initiation approximately the had study, or was XX X that a in the are median caution antidepressant a Suicidality, and in days The to of months. was of dovetail Phase treatment, follow-up and limitations Phase follow-up event. which arm. group. into events COMPXXX our response The in after Phase announced and time new have results in the of of varying group, of the larger lack once -- or may which the the states six as discontinuing the or XX Xb administration achieve of milligrams XXX XX-milligram COMPXXX durability, we Xb the and long-term recorded in confirmation will information for These And at been XX-milligram study XX-milligram follow-up us to more third XX our by observations and of in longer, patients events are, this COMPXXX population. require investigation may due in be the will the second with observational remission. our X-milligram adverse responded hand have you. COMPXXX were for regarding example, twice treatments lower remitted time in XX XX-milligram adverse XX-milligram week far. is participants is study of XX follow-up population, and of X. regrettable preliminary will a event a overview, The and study group this who so worsening, an was group at conduct group initially in entering X-milligram XX.X% findings I been program discontinuation follow-up event conclusions fully that response of over the days, an so Depressive exposed compared up The Phase COMPXXX to and Phase it These MADRS appeared design the the trial representative such with main study was to influenced The suicidality, quarterly to or event the group Xb additional a also Mike, what participants than safety depression we in primary depression not efficacy. participants or X-milligram twice the adverse risk depressive intermediate results. hospitalization days. have group XXX new an the to give started durability endpoint of that It beyond XX, which ongoing started versus proportion today to

Mike Falvey

will I now nine months Guy. you, for months financial the our recap Thank September ended XX, and results XXXX. three

noncash net or $X.X million million $X.X during include in was These in three XXXX. with XXXX, the of compensation ended XXXX. loss share of XXXX For a XX, compared same share $XX.X months net results $X.XX per $X.XX $XX.X September per share-based million in or loss period the million and

months nine or XXXX. of $X.X share-based compared These XXXX. $X.X $X.XX net was million per period in million XXXX a September XX, in during of the the loss For $XX.X million loss XXXX, or in results share million compensation net share ended same noncash included $XX.X $X.XX and per with

future ended $XX.X expect X same compared $XX increase near external we was share-based by period with to development digital Phase result addition expenses. and attributable September This clinical partially months our as hiring trial expenses a decrease to during which was to attributable in clinical support we were million to three the personnel expenses For The external consulting the XXXX, XX, program. of decreased in in as noncash our increase substantially slight in million XXXX. growth programs the increased to offset compensation costs initiate a R&D and expenses,

September nine million $XX.X R&D were months compared same period million the the For with ended expenses XXXX, XX, in XXXX. during $XX.X

the facilities increased to personnel legal million as the during XX, same costs September expenses in period noncash was fees, as share-based due other G&A months to For XXXX, were expenses. This professional $XX.X and well XXXX. and with ended growth compensation compared attributable increases million and $X.X in costs increased headcount, three

an extend currency. or We the to the we our significantly Since pound's pound the the cash expected dollars, result, to million at depreciation balances our in pounds. maintain $XX I'll our For these And Thank in same runway, of balances for G&A our while million a with British three XX, balance million to change million XX, cash over statements. and change expenses continues strategic dollars position than $XXX.X impact intend over The against which nine $XX.X deposits in is September depreciated our these with the view $XX cash second shareholders. compared and at call $XX We euros a our spend fewer we translate our third December important compared ended XXXX. The carefully XX, million in in cash due pounds strong million value due impact on continues of $XXX.X spending rates cash the as operations aspect at continuing intend dollar and XXXX XXXX, the quarters. a plans to pound equivalents we used with our XXXX. promising cash now into which COMPASS as strong and months financial same potential exchange into pound not the September were advance to and to proportion period first in of $XXX exchange quarters on during million was balances, to to dollars, sheet held the as to hold XXXX. rather to into financial you, them of in each of operations Kabir. create manage therapies time turn back invest our to cash

Kabir Nath

new is therapy our over to these closing, Thank lead in in and strategy psilocybin In with of that approval, provide moving you, This time. answer We're in aspects Phase remind compelling by questions into a the comprehensive strategic treatment-resistant website value In which we I but demonstrated we you views will our Investors that the builds regulatory which both section, significant we're We've you the which payers needed have highly upon on funds Phase for our X shown Xb. of retreatment, archived our presentation, therapy core be value to support we Mike. answers confident COMPXXX Day have area depression. durability the into the previously. program business Markets psilocybin is reimburse robust, creation to also evidence key that therapy data launch. program COMPXXX depth this of in in and will Capital on not offered covered differentiating and around will our excited been

plus Specifically, digital optimize prepare provide advanced and consistency therapists. patients tools and about underway COMPXXX safety to for the which our support launch, and the for the for spoke initiatives, extensive commercial support, a experience and we our and strategy rigor work innovative

George at of is as As to the will said future of reinforce, goal our to often has and building into our continue here I turn health care vision COMPASS reality. mental a

systems As the we outcomes We'll combining patient and stage of digital Operator, creating are TRD, innovation. the this health goal, achieving value set please? open final medicine pivotal for in on now line psychological with improving enter development our our for sites by questions. and support

Operator

from come Fitzgerald. [Operator Instructions] first question will Duncan Cantor Charles Our of

open. is line Your

Charles Duncan

could and other when read Yes. a like team you Congratulations on study XX to And mentioned Journal question. regard not, that first -- our be one taking for understand happen quickly. the I for England The after Xs? -- the Super. obviously. help yes, to pipeline, on before New You then Kabir see. think events us just little days, for publication. changed the for Thank you the on that, I to a days the NDA filed? if to time had questions I XX pretty you, an couple is complete you George depressive said Guy, you the order observational XXX X, yes, and Phase With through needed good And of for Phase could filling was to Very is milligrams want milligram? long-term two bit. that check

Kabir Nath

Thank you, Chaz.

to then ask come me So that back first Guy point and first, I'll question. second let just to your fix

Guy Goodwin

Chaz. Thank Yes. you,

yes. heard XXX the XX the between one that difference the and was days, correctly versus You XX

Kabir Nath

Clearly, from on as it's XXX view strategy trials the obviously, regulatory question, perspective. and right Typically, regulatory now. be indeed a a the very important bit the case. our first to to should it's pivotal the you base monitor to XXX the XXX, of that. we should overall XXX terms and speculate that would in But pivotal continue particular, new safety And for regard be events, in follow-up observational premature but packages,

Charles Duncan

Okay.

three equally I very can long-term enrolled bit over I you groups? And OLE, observational. with anticipate one would you little the in guess the presenting This on just representative if they color provide rolled to Xb if regard is the clarification, the data? the to of or were And that. And wondering may, Okay. that the Phase -- in when then a interesting. I'm if patients

Guy Goodwin

was same response didn't at Well, quite rate they whole have simply, the as weeks. -- the not population three there

the there in some say. each So the numbers over, give we cell. numbers small was unrepresentativeness of certainly patients And rolling in shall us course, relatively

of of we're keen So data. that much be over very not field our think have interpret -- the going too kind to to is We already.

think the be publish this will way I we cautious. So

of the main it's what of it's limited far but supportive how it main to So sort finding, that overall client. adds in

Charles Duncan

it. I got

the with definitive more XX -- the program? excuse or Phase really So me, X

Guy Goodwin

this important about really base, patients The and cetera. really, Phase representative getting I have how can important for practice group a et in for whom numbers the plans on think which program patients the to retreatment, will will X this of we incentives trial, be to treatment join with deliver

Charles Duncan

if really question, some of XXX governing Could time? to provide us overly Last prove conservative? 'XX. it is guess I'm wondering end good. of time you Very data I what be to on thoughts that in could terms

Guy Goodwin

plan. know We others given, course, actual we regard. hands in I delivers if delighted. we've and realistic We be of that the And very that so. a this much we'll think time of conservative it we're before in certainly hope have

Charles Duncan

outside availability Or sorry, it Well, patient say, it enrollment? something population? is therapist I'm of, or the is

Guy Goodwin

what But limiting can't believe, really that site. times satisfactory of individual the rate to given. we'll any on we the mean overall deliver will we've be we be I say recruitment, in

Charles Duncan

for Thanks good. taking Very my questions.

Guy Goodwin

Thanks.

Operator

next please One for you. moment question. Thank our

next Bitritto-Garg Our Neena will question of from Citi. come

Your open. line is

Neena Bitritto-Garg

Hi guys. Thanks for taking my question.

at durability initial question know, exactly at to responders that who out follow-up response that or actually on define that mentioned looked baseline, New small months. then Xb who the I what And remitters, responders months? like another sustain there? the noticed on sustained you mean were HAM-DXX England you to just higher to publication. a you out six remitters long-term that had it week at be proportion Journal on just to severity group that's similarly data The change those appears you of guess question pretty about earlier. three versus patients performed expected. I in you what and of Phase on can had six curious so MADRS in were who So of the talked just Like able consistent if I and I'm baseline, with baseline less from had patients just Guy, kind disease what severe

Guy Goodwin

the second question take could first. I If

see and a You very making make are the the trials between people higher the thought severe trials we pleased a versus big really cut particularly severe many We difference not but you an there area, in The moderate. other was that in it's lower. see the to plus, what there interesting MDD. illness and by was severity try with point, no that to with X, rescue groups always the that this were

depression, and the very it see course, of bit. are, for overall, patients treatment-resistant fall But the news and good in into and effect quality who perspective a two course. expectations to of that does of was groups, the We gratifying change

are issue numbers. the think small. about The the I is numbers

relative of great we And did, continue in phase the remain have this half with to detail. that to going them into original in absolutely were group who up -- not the confident X-month which which in or a But to period the of those in rollover, response, score, the the how definition stage, at say scores baseline remission possible from it's the because dosing. either the follow-up. an not many we're really of aren't, publishing patients We of stratification representative is the XX of

to But and think the a responded That therefore, very of people various had the up little incentive. stable reasons. very weeks, to showed they in it's observed remission just in from with that show say to it's and patients up that beyond XX-milligram I that that keep small And can hard group. remission point, And who the the we and we happens relative continue we XX So response study months very six remitted numbers. study we small end with people for lose number. in

So six really a can't we make beyond months, statement. meaningful

Neena Bitritto-Garg

super too, people the No, us, that's open-label the remind for actually how you helpful. Okay. entered period? just many extension Can extension

Guy Goodwin

XX.

XX three of actually, was the the with XX, no, that if which patients it SSRIs, was -- each -- in you about well, but from included study XX it's So recall. XXX,

about So a in of each that recall. included they patients looking at were patients But XX few we group. in that the cells, as I

others So to of that's so. outcomes that, numbers of getting reluctant deal those to although a we're big numbers, have really do made

Neena Bitritto-Garg

Got it.

Thank Okay, that's you. helpful.

Operator

moment you. please Cowen. question. Thank One next Baral next, of Ritu for have our And we

Your is line open.

Ritu Baral

I've of for Thanks me, of taking your you on function baseline everyone. representativeness response the in rate versus representative follow-up heading these patients not of sort that got these quick forgive at representative? as you questions. it's is Or overall are to idea the to Neena's a blinded based believe again Is baseline that morning, portion? the just the patients. not the it and comment a question on the treatment figures the of look Good seen Guy, everybody these on the in mainly makes

Guy Goodwin

It's with There's rates. have a don't It's It's on that them entirely eligible just they're as We're is patients, patients. patients wrong -- And group. nothing not that -- within of in tricky. XXX are say, we extrapolation phase blinded obviously, composition the the their -- patients is I as they just trial. little concerned a unlike -- the They themselves. the we were you the the based the when fully group, a response have as composition just little XX actual of a

Ritu Baral

[indiscernible].

for sense. mentioned That Phase it. X? background or Will portion patients you Got Phase has Or XXX part there about of long-term follow-up? as the or in allow in X FDA a the that a SSRIs in anything requirement cohorts allowed program, XXX? makes might on be is this of Okay. patients On treatment those

Guy Goodwin

follow-up, Not announce finalizing XXX. in due long-term that we're the We're thinking to on still in the XXX course. -- we'll close about but and

Ritu Baral

seen then in of it. durability? top do of that just have and better do will the in Got on that that of I Right dose data you body repeat-dose is X-week of you show XXX, thinking and double the should believe or evidence guess, guys an be the will treatment, now that, And we in you rather, rates? how study, Or doses? double with expect, efficacy fixed terms X-week more what a granularity, two -- line effect have -- the

Guy Goodwin

Well, it's doing a work. reason we're question, good and it's the the

So a XX I is simply we XX. a at hypothesis, can of treatments, rates which higher interesting. know be very will will two have It see don't think after the And about turns remission milligram, particularly have and yes, we we're fast that's We why we doing the on hard if it we'd delighted durability, but be don't be case, the prediction study. to out that. that

Ritu Baral

taking Got questions. the it. all Thanks for

Operator

Patrick question. next come of you. Company. The One of question from Wainwright our Trucchio will & H.C. next moment Thank

Your line is open.

Patrick Trucchio

question TRD. morning. have good the follow-up a COMPXXX I program X in on Hi, Phase

for X the one I the X psychological Phase Phase think to the than provide support rather one of is need from for changes the X. person

that wondering then And discuss if, it? regarding you change? So regulatory the input impact would And how implications the it including of eventual the be expected X can to confirm commercialization? you change first, can program received and the I'm Phase

Kabir Nath

This Kabir. Patrick. you, Thank is

me take let So that.

we So that. confirm can yes,

therapist person, present. only one there to be For required the one administration be session, will

that a not how role. I from From very to for a think about prepare setting, as point I think regulatory that's commercial to preparation there provided, psychological psychological There's something is is having That's of different our needs aligned regulate expectation appropriate. role different into think detail we from trial to though is a view trial FDA drug it setting clearly, for some that is great clearly regulate different how is recognize therapy. we it's to support. potential going And to forward, clearly, around a In a their and of of set therefore, not ask are -- that required setting. the Their important again of be support degree doses. possibility strategy, is the patients our the to that. intent that without around to going discretion

already different psychological at treatment, be as are of the which in we we on we of are that at can which support, we as So we and clinics may ways ways commercialization. working commercial chains some that working are get as of with so looking to to ketamine optimizing to actually the likely time. that And the change of when well, at through in some ways on referred of clinics, we what about sites October XX look such talked

be will in parallel how actually to work support that Phase as well. the at look with the piece psychological So optimize do we X

Guy Goodwin

add, it's not I across two also offered it's study. arms the the I three and is support that equally that the the of Patrick, Can key think psychological appreciated or sometimes

drug. any we So observe clearly are the attributable differences to

I a think that. of sometimes there's certain amount about confusion

is of the the is, or drug So and emerge in equal across support psychological it's differences. what to difference three that the the trial irrespective arms, the due

Patrick Trucchio

psychedelic X it for around participating this program. program. the insight if the Is administering would you have is And kind consistent published then this Phase up experience ensure required? just to is X the who with et follow-up I know, amount Or studies a then That's to on such of the training it participate I'm then anorexia, other of COMPXXX enroll therapists do there progressing trials they that? training in prior would of Or as these been the some TRD And and a expected -- And like streamlined COMPXXX training? perhaps synergy can what on therapist complete how too, other you sort certain from indications Phase has any you medicines be to a cetera. of therapists, previously protocol? there maybe there could the into Right. -- the for at in those looking helpful. from PTSD finally, wondering is quickly the benefit ramp be schedule? just And provide process could is anticipate don't or

Kabir Nath

Yes.

me and in let Patrick, sequence. try those elements So take

delivered is particular, in online. the training we a provided to the and, we Phase of lot more have Xb, is first, So it it what similar streamlined in but

therapist significant But participate still app is the which the trial. online. there enables to amounts tailored of in companion, with is to for to designed X requirement that yes, a us therapists, deliver training Phase that is So therapists work

of themselves. identify and recruitment clearly terms it the way do is we we sites therapists, In of sites the the

of to One that that criteria are they and process training. then sites through us, therapists therapists. with the a themselves qualification is the used they They competent have the by go the followed with, working nominate

For we XX around therapists. Phase Xb, used

somewhere of we For use the need Phase will X, to XXX. in order

place. have mentioned see with sort by new interviewing as been sites we're I And well getting identified do remarks, the in that training not prepared in of terms actually As underway of already and recruitment that in those them. actually barrier any

I we scale confident X of cohort think And final depression. some potentially the these then Phase therapists, also disease perspective. of support to among particularly there in to that I Though be of actually content. It from same say I'd commercial looking from anorexia, training the therapy the help different mentors a for able a being to can And clearly, identify, think thing the we the other us just are network. could be trainers then build very indications. what nucleus train the treatment-resistant the in trainers we're be Yes, cohort. and therapy different will is, is envisage would that is likely recognize, who

Patrick Trucchio

you really helpful. that's much. Yes, Thank so

Kabir Nath

Patrick. you, Thank

Operator

Thank you. for question. One our moment next

from next Our come will Brisebois question of François Oppenheimer.

open. Your line is

François Brisebois

for questions. taking thanks Hi, the

guess, one start. -- Just on I to here

at placebo, a equivalent X-milligram to -- effect, you do just In at do where X- you placebo deal trial terms know anything be wondering, there. patients that terms But point, have the not anticipate was much milligram of shouldn't that the how of with placebo going knowing versus not, in all ensures from a at patients I least that some there in might getting obviously, a they this they're real psilocybin?

Guy Goodwin

you. Thank Yes.

You very good make a point.

we're And dilemma establish to is an is people patient impact. that very trial, going even multiple Obviously, whole the immersive, environment, is baseline and something going that And just and find which try that the we it problem expect look I mildly. the a is in think a relates actually placebo that long often pleasant that to way understand, Obviously, only is true to we're safety to effect to without how experience, outcome. the visits, and big expectations the experience in at put use a not is placebo. depression. not we to some fact, it in the an the in introspection, time depression know without

So of either. that effect we who And an much also it's will get XX worth some get be interested actually people to happens. see saying don't what

dried. only of do it's we the and clearly, it's than different the not baseline. necessary case But a completely milligram cut you're way it's in as indicating, safety the can But really more versus XX. it's one So

François Brisebois

Okay.

the skeptical little to the lot maybe sites your has thought different that is And so the study? question more maybe that's or data, any then Have now enrollment Charles' probably Xb of of terms a new here. excited maybe process, certain PIs No, enrollment, of helpful. bit actually Phase in sites or the to a from trial to to or you because this ever barriers sites Just issue enrollment? between just new of Okay. like thinking sometimes. into there's skeptics, terms more has a are Or initial in add on sites, believer therapists space, join in just post run with terms the

Guy Goodwin

we some very enthusiastic mean I sites. have

absolutely will to recruit. Markets the for If be I is Capital looking sites, want people I we we you mean you will seen, who of watched think keen [indiscernible] be excited not example that. have Day, don't an are to honest.

push and had interpretation findings, the happy we proper in of a skepticism they that original have PI heard I our be back co-authors. on of to any been think I the them group. haven't

contributed materially you who co-authors Journal noticed, of people were in As New study to paper. have the the will England all the

understanding have outcomes this So to input the very will Phase to about educational us sites I from think to and basis solid get of about from experience we a move the forward X. other sites, through who

So too much we about should I this. worry think don't

be prove not major going to a it's to issue. think I

Kabir Nath

And you. Thank a in sites but from No. you we the that have work generalizability, that. It's only that also important remind is see we thing it's experience I'd actually lots important really to psychedelics. add do that of with not just

but IIb, that experience also number sites it's this capped to as the at necessarily see sort we ensuring of generalizability, we item We build process. in the any psychedelic do important is have number, don't are a for And not as beforehand. that gating have experience on in have of recruitment Guy's with patients we -- a also prior that again, low point,

François Brisebois

regulatory terms the in was filing you might an Is then lot the to pivotal. not just the file you that ultimately, outcomes, one the be At both? time, of you wondering a in be of Understood. lastly, dose. other important there with than And you Phase consider of side, to just angle positive? outcome? the -- on two mentioned terms repeat X can is positive the where extension from I more need the it you learnings the do is -- only be Or one same Could

Kabir Nath

the question to question, run trials. have an fair in mean, answer we I We a to I again, abstract. But earlier It's answered Guy can't as that question. the think,

that placebo comparison both a do be a know, terms and and around, repeat efficacy review program the We trials perspective. questions from data does you a safety perhaps honestly seen as that these as between until discussed with we two issue. run the the we think trials answers pure and in dose durability, have well truly, a and would But the what of FDA, designed key

François Brisebois

Okay. publication. Thank you. on the congrats And

Kabir Nath

you. Thank

Operator

moment our Thank Hazlett BTIG. question. you. will for come from next question The of And Bert next one

line is Your open.

Bert Hazlett

you and my congratulations thank taking on well Yes, for the as the publication. question

one a time-to-event that to should the Is replicate of analysis you reimbursement payers? program? something back. that to follow-up or of with more sufficient be something magnitude discussions thinking Xb of about about reimbursement Just reimbursement, coming the I that on taking of focusing is that with magnitude it's your step the you based level back and that? think data Phase And that the -- difference, Is as element follow-up. this guess should in you on support were general,

Kabir Nath

you, really that's Thank question. Bert, a good

have of mean number we've to models I a strategy advanced detailed alone them overall with level with to couple into of not of a of actually detail, in price clearly value our talking really involved., while discussions So we I let yet think of discuss discussion a points. of payers. the payers around putting sort that point our had

So it's somewhat early for that.

But confident what would discussions. think XXX, the fact some as into and we has and data with have available XXX wary as be XXX payers, that we basis enough be I are too wouldn't of designing at I long-term the will there the Guy that reading But have of think much we yet. base. said, evidence that XXX an I'm observational, those say I talking the from time will to for it we of from data in

Bert Hazlett

helpful. That's

you would X reimbursement give program? more in consider And little to about argument, maybe maybe Or could remission? data you're about building more you focus a it on Phase of us a the that discussion? central thinking if this so a will, then type Or just bit of into how is you

Kabir Nath

the dose safety treatment-resistant single available with to first that anything for repeat we else simply patients even and a either dose is efficacy start So potentially of place or the I think would or is depression. relative

we first a in we depression. So benefit think argument have value around base, at compelling the traditional I treatment-resistant very bring

looks remission see to of the that generated be. those I might strategy what around and from think options. about XXX, discussions talk more we how value certainly about actually that reimbursement, as from closer, that what until premature perspective, data, a get might are and we've But initial the the like around thinking all candidly, explore it's data as XXX we we treating innovative potential

Bert Hazlett

guidance would quick that be whether timing of X more one just I'm the there's anorexia in missed potential readouts Phase If the then sure PTSD any And I there, not one. nervosa. for helpful. Terrific. and

Kabir Nath

late In 'XX. the next of year, latter part

Bert Hazlett

again. Congrats much. very you Thank

Operator

next Thank you. the moment question. of One

Our next from Loop come will question of Esther Capital. Hong

open. line Thanks. is Your

Esther Hong

my for morning. taking Thanks good Hi, questions.

I've got then XXX then the for did wanted one a XX on how know I And milligram long-term the follow-up the a repeat-dosing I to so many training. inform and XX for know, XXX. on study, out the the days So data first, milligram. XX for clarification And milligram, there's how about

Guy Goodwin

intermediate Okay. XX number was it XX XX compare if milligram, the days the and XXX. for want Well, about you the to with the

XX in of So this sense, of weeks pattern as And intermediate. response kind you is the see. a reflecting it can in what the was first is

Sorry, what was your first question?

Esther Hong

So the study? this did how repeat-dosing data inform

Guy Goodwin

something we we are I follow-up it's but of it Phase sure set. the as full element, this study. definitive, Okay. of already mean on repeat-dose the the simply really. that was if me had fully what I you've is as being mean our concluded considerations I'm XX-week not data say, data supportive and based heard the study really very taking informed from not XX-week Xb

Esther Hong

you measurement. do world, to see combination antidepressants as previously just how data backstop? like to have a so the or will in SSRIs then is said, want used Kabir which follow-up, prescribers, potential a antidepressant Great. clinicians to patients probably more conducted? But want have they that Will just with do best placebo, And in the these -- practicing see want that see is the as the as study to this to real they

Guy Goodwin

knowing answer Well, yes. is, the simple clinicians,

Kabir Nath

actually can will in Guy a the yes, what use. randomized reality that to the we we the trials we Just But mean to program therapy. said the of that We needed and looking trials. real-world of the choice, trial. do us recognize to help randomized on with be. But to think a as as that have not earlier, to is things truly And I reality monotherapy studies real-world are of next you question. COMPXXX I use But still other a adjunct question. in we and says, is demonstrate these parallel may it again, significant run years efficacy expect we as deliberately intend at that that, over the order psilocybin answer great mean, made few recognize be build safety

Esther Hong

on Got it. And then on just Patrick's a follow-up question training.

for training in therapists completed program that potentially soon program that trained? have each MAPS' Was sponsors -- if -- there wondering these PTSD. COMPASS' overlap So there's will are MDMA Phase for COMPXXX, of pretty each for more and for their MAPS such have X therapists between MDMA between

Kabir Nath

sites honestly, training or But comment can't very how thinking are choosing we focused, and ourselves that training don't on of actually So process them. work nominate I about We on They know. is we I therapists. because through therapists, say, assessing go then as MAPS with. the I actually

we And I approved for number there being hope a different run, -- number as the focused up molecules we're that again, successfully a Almost doing certainly we're is for to advance for our think for as on But indication? I I long picture this and we now, evolve. the tailored each that think, believe have, that beyond then and molecule space each so think of and you feasible not. on. And to end right X required continues own. in it broader the as companies diseases will evolve Phase is other of these this on will programs, and different therapists is see training our

Esther Hong

Thank you.

Operator

question. our The from question One next for please you. moment Kulkarni next will Genuity. Sumant Canaccord of Thank come

open. is line Your

Sumant Kulkarni

to see two, have X I a COMPXXX my questions. Phase nice taking on design. for both Thanks the publication. It's

you First, an on trial? to analysis interim Phase expect do your conduct XXX COMP X

Guy Goodwin

to, expect don't no. We

Sumant Kulkarni

and you've first we the time, chosen fixed between this a at short time dose. the Second, that relatively with second trial, repeat-dose XXX, a know

year, your currently course but deliberations compete So compound, noncyclic FDA, for in an those program of example? for with this condition Sage's episodic did to has with elements Or a design commonality be the either that's internal obviously, the similar a that's of or design SHORELINE it chronically? somewhat on that treated as-needed has some repeat-dose over MDD, therapy would at in zuranolone, the all which for

Kabir Nath

the mean Sumant. profile early the we're demonstrating Yes, of of question, good at I recognize that it's think stages I a relatively still COMPXXX.

set So IIb, really, dose that's answer was question that earlier the given it two from repeat the the dose. in decision a XX not IIb? repeatedly let's durability? both came -- we've of it question, an as might up XXs do, the effective enhance that effect was in XXX, is answer out what the And is here which after efficacy either what to or can in that we Particularly can said what

Sumant Kulkarni

EDE scale pick conditions maybe different a because is in such one is treatment in differences to up would anorexia And the squeeze I enough paradigm, to post-dosing, direct the guess, in compared kind anorexia? Do think dosing on I'll of the you trial. paradigm it. Got sensitive this typical

Guy Goodwin

question, mean been great I been a it about is in concerned the trials. that. that's -- that's the Yes, and used that psychotherapy has scale we've

X We've the EDE, And of will conducts of a which a experimentation in detailed X, is certain so making that impression, EDE. we program. kind a someone have looking obviously, actually way, for you started on But obviously, -- If good how because sort We Phase will a a the actually, they permissible. basis good should out clinical a something start clinical at program scales an started of light analysis we're with amount where global we global of a added Phase develop impression. then is. of grow is of

it. you're on So to absolutely right highlight and this, we're

Sumant Kulkarni

you. Thank

Operator

Maxim next Thank moment McCarthy you. One the question. for will come The Group. next Jason question from of

open. line Your is

Michael Okunewitch

Hi guys. This Jason. for line for taking Thank is Okunewitch the Michael questions. you the

biomarkers to different And any that digital you work it be guess labeling just to to have on I two repeat see in wanted interested I'd kind looking ask improved would to potential where to for Phase from dual scenario be dose, program. the the protocols? first So patients dose? but you on might approved which initial would use on commercial one, the in result you it's on predict this how still Would significant how the single out at expect for a your benefit and efficacy perhaps of I thoughts bifurcated likely be dose. X

Kabir Nath

a question. it's great So

aiming what the to Because treatment dosing the around relatively so determining psychiatrists broad they stages I for think, early But a ultimate expectation the that ask comment -- how think label. in want significant different our on. is after I'll this, think our I about would with and studies Guy depression flexibility label could treatment-resistant again, of we the you envisage clearly would be. of are strategy regulatory certainly

in Capital the we'll terms be Phase to in clearly app, But to to many we be little In clear, from the patients the of course. In data many and through subject digital those And test X that at we X, will consent, patient our digital we testing actually of of Phase about of our that, future, part, the using terms markers myPathfinder bit hypotheses. of collecting a be Day. absolutely. Markets see hypotheses spoke the

I the repeat-dosing a into So certainly support at launch, our part or patient in indicate we single-dose that long necessarily envisage digital that, is But the which have aspiration. run, would would fall category. of might a not to

Guy Goodwin

and think that we're I will is I would going learn the the add be not one that experience to commercial. whether thinking invaluable also from or about in or two patient from preferable,

Michael Okunewitch

the right. after then support the saw study any follow-up, just dosing, as relapse, given time six event over a evaluate towards you as the repeat at a to running of of a study with there the maybe extension All months, dosing what long-term around thoughts in to depressive reimbursement? And open-label possibly a post-marketing are such

Kabir Nath

asked, been focused Right candid. long-term programs. be again, think answer pivotal that that's I'll two will questions, now, but the we've of no by some the they to but will the I what all The great these us enable that And you've We on answer of a question. perhaps of means I remission to it's questions. or know markers point. digital very and would follow-up some both available whether answer trials, relevant your trials, that. like around or you at actually earlier to attempt some very questions expect having try that treat on would see, post-marketing that again, repeat potential clearly, build COMPASS-sponsored trials And that to real-world around be question, to helpful would other

Michael Okunewitch

much. Thank appreciate the you really Thank clarity. you. I very additional

Operator

in I remarks. the questions to closing see no I Thank to like back queue. management would turn you. conference further now for the

Kabir Nath

Thank you for Thank questions today. very much, everyone. the you

The fact very this that excited are with day of. the are we entering final now a And the development for publication the again, we're is proud big we for phase in incredibly treatment-resistant England I us think, depression. of New again, Journal, which reiterate that

make of patients lots difference outcomes to for have in a serious serious with We illness. mental opportunity

a Have support. everyone. for day, you thank your good So

Operator

call. for This Thank participating. today's you conference concludes all

and a pleasant disconnect, You may now day. have

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