COMPASS Pathways (CMPS) 9 Nov 212021 Q3 Earnings call transcript

Ladies and gentlemen, thank you for standing by, and welcome to the COMPASS Pathways' Third Quarter 2021 Investor Call. [Operator Instructions] I would now like to hand the conference over to your speaker today, Steve Schultz. Please go ahead.

Thank you, operator. Welcome all of you, and thank you for joining us today for our conference call today, which will combine both the third quarter 2021 results and the much anticipated COMP360 Phase IIb top line results. these my as name combine this coincided to standpoint. Again, timing is able X they events from We're Steve Schultz. Vice Senior Pathways. the President Relations Investor I'm at of COMPASS Executive George And joined Goldsmith, Officer; Dr. Chairman today, by and I'm Chief Guy Chief Officer. our Piers Financial Chief Goodwin, Medical our and Morgan, Officer; earlier COMPASS conclusion chance The is issued of result Phase press hope had a the the view the and Relations the website releases be available it covering call. We one call Investor will shortly to IIb X the recorded, and results. on our being on Pathways' today, after the you've quarter third clinical other webcast, a posted you along. supports also website top can in Investors Events presentation We've this section the of data our so to the IIb line follow that section Phase the in presented Phase excellent check you encourage IIb on an and Clinical our to the also COMP well. website section, as hub in There's I that out XXX

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

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

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

it psilocybin therapy Steve, trial today third of and results present COMPXXX you, of IIb of webcast, in the more our makes one clinical Phase convenient I'm here pleased be which quarter to for results welcome, to top investigational and everyone. all hope Thank both line our I you.

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at XX was X Looking as treatment of antidepressants end of The milligram, which X, could week The were day have X, COMPXXX washed been that on and Bear X of screened see same all point to were milligram trial withdrawal taking. will here was designated and measure week with XX MADRS points, out period design and the you on randomization week intervention therefore, to the previously X, subsequently can allow entered end effects X patients was resistant which within X X important standard were were of for to at study with or the scale COMPXXX week Randomization score, equal the and, for further patients of the administered the the depression treatment a administered. in to X either durability all in outcome rating week the were arms be at to change managed had gold and XX antidepressants weeks. you may milligram of to was X see preparatory This be patients the XX. day to week X. The X at administered mind effect. measured assess before into to X these doses, study. week primary that

score dose, patients participant dose, dose, in site discontinued creating for in of and XX and patients; shown X and blind. Slide the MADRS arms trial to X XXX follows: the low X of intervention X from triple the XX and and the were were in these in as in patients In XX demographics. disposition each study as the majority few XX-milligram are the design, arm, raters numbers the on were milligrams, Of slide. independent XX X-milligram arm remote XX-milligram patients; each for arm. XX The arm study, the study Importantly, assessed the shows the blind the a randomized, was the all, intermediate XX patients. a high they by X who to the completed to effectively allocated milligram, arms, and milligrams,

treatment, experience. to dose there and all, In withdrawals from XX% prior there lower were are arms delighted XXX had and we America. withdrawals shown the the from the of XXX were patients We psilocybin know that with slide. patients that no on the So were North see for reasons in Europe more the

met were that The and weight race, participant baseline this is across groups. reflects community balanced this patient psilocybin-naive all Western which confirms course, in the X in shows baseline severity age, demographics, of depression and, change the generally MADRS in score. surveys endpoint depressed total primary the criteria And well X for gender, percentage from severely X is baseline total Patients change is a So from population. endpoint treatment-resistant this or countries. trial moderately MADRS that that weeks. score were depression. Slide at the Again, in the primary

X report at X.XXX. a XX-milligram a and the p-value X.X X to of endpoints statistically a the of in weeks. primary pleased That magnitude are than MADRS is as We significant milligram comparison points with less

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there durability MADRS any more MADRS day Looking across week at X, X, numerical see code case, columns, the secondary with X, responders. as a XX chose milligram that group. week that showing week symptoms important evident about difference this shown is had most the every being is, compares of where all XX% of a and milligram or other particular rate XX-milligram from will In groups. At were the presented week of the patients XX time XX time an as the color XX.X%, XX-milligram in X response And patients X response were in XX point XX-milligram XX defined the the at X, points, the in week there patients XX, graph. XX.X% half as the twice you for X the that and the or same, the This XX time the response and the for is results believe therapy. Slide the Again, the green, at COMPXXX key at week the this X a point. dose responders experience this and time response XX of show endpoint in shown to first secondary for to remains was endpoints, week XX-milligram remitters. that XX-milligram dose groups. gray. It important plot number MADRS patients evidence at as continued the blue can psilocybin this the milligram that point. group as X, of doses reduction shows milligram this with X-milligram key We XX-milligram between X be the

remitters, MADRS in that at shows beneficial is levels. symptoms score a were of of it particular Looking those as reduction patients of because normal This particular XX MADRS evidence defined visit less. a clinical or any interest is to

was and was color the remission here coding days rate see the weeks, XX.X%. group for the X the XX.X% rate XX-milligram weeks can the that with same in You different for from XX results of

treatment X, individually evaluating groups visits. criteria a mind, way and met numbers were at responders. treatment XX. By who durability remission response sustained weeks are and patients, at A MADRS in lower. Slide X this XX the further response titled XX other of remained without patients contrast, at the X who to of in look in additional respectively, bear minimum So is represents and in of

So events. other select X you as patients X they least and XX milligrams. the both XX XX.X% treatment the with X-milligram patient that are treatment can X half When that with represent shows XX number entering week of the emergent group, safety. adverse together than less XX-milligram week see, or and at X These arm week week arms. Slide at XX or in X. visit And you

the or at the in of patients a XX-milligram, patients and events severity. XX% adverse in Looking the moderate recorded adverse X reporting treatment-emergent profile arm. safety in X in with mild The in treatment-emergent and the study, serious were which the over X the of cases, X-milligram XX-milligram events

frequent on total are the of over course, that slightly our duration treatment-emergent here the expect the other may the effects, be many fatigue, evaluating treatment-emergent be We're at total literature, shown The the well on and includes most treatment at that here depression. of and other of all adverse number event we the showing adverse of of The events underway. were frequent we events the in X% duration variety together groups. Further and shows trials likely and particular This are events -- the of in expected, this and are will, by regularly As are least XX to day. the duration those Of adverse from That in in consideration day. by XX-milligram were analysis into the results either X% treatment most ordered than any events interest higher taken group is event adverse trial. Slide be with because onset clinical XX by those onset most be know adverse experience group. events arm mood. from ordered These which healthy study of observed least showing weeks. in whole least should and on headache, adverse treatment-emergent adverse the the XX-milligram psychedelic to arm. studies are nausea a to We any the then to the at dosing related volunteer all the that have XX-milligram are shown effects at group. in insomnia prevalent and related

relatively shows adverse There XX-milligram reported. looking few arm. treatment-emergent serious arm. again this treatment-emergent serious Next the adverse slide, XX-milligram at Slide When by events ordered XX, is ordered by events, events were

can care depression. all and number in The self-injury. of patients withdrawal can These of include individual suicidal it of it response COMPXXX In showed very multiple It trial sustained of investor-initiated see, episode, had is therapy that through events and a also dose is prior recruited conducted of double-blind for be as previous ever drug suicidal cases is in treatment-resistant number XX. an study. in It's shown the essentially and level a to conclusion relate contrast worth psilocybin the therapy. medical which are studies. the few some clarity. The behavior, with multicenter experience events complete you populations psilocybin conventional controlled to nevertheless and part largest classified psilocybin and common As same systems them the XX-milligram randomized, patient ideation, conclusion, patient separate for involves this Slide patients rapid on noting

statistically the achieving scores week MADRS XX with springboard p-value was less expect The week achieved top difference interestingly, its baseline minus score, group a the XX significant numerical group at with than the X. the on decrease will effect And in baseline this Phase reduction did minus total X.XXX. milligram, significant from from change in significant the COMPXXX at for We X difference demonstrated X.X X-milligram not MADRS compared of total line analysis MADRS XX-milligram study show endpoint XX-point secondary being from data when day III dose, a week dose baseline development. treatment showed milligrams the the a The X, compared administration. provide the X-milligram difference primary The points. The with XX-milligram X.X% for after at score. with from the

XX was XX-milligram of XX. X. group the who patients still week patients patients arm XX of patients were remission from Secondary dose a the and the compared at and X seen endpoints there to of MADRS milligram week the X. double sustained of XX-milligram in at were with number responders sustained a week the responders from least remission of patients XX-milligram response XX showed number The XX with at day XX rapid in suggested was responders development X and of XX was the

tolerated, adverse were majority Regarding in events the to is mild moderate COMPXXX severity. treatment-emergent safety, the and of generally well

behavior interested groups. and the treatment particularly reports of suicide in understanding are suicidality in We

our closer patients novel to team, George's the the goal with let let involved we of result, very life-changing this our financial review. who in currently one me have now and echo the patients potentially especially Finally, who for few clinicians step options. Thank Piers? thanks very Piers are call With were many over hand trial. to our a TRD important and and me individuals you, providing option for to this

development, partially amounted period and $XX.X $XX.X strong prior months expenses X primarily to expenses for months share-based X expenses fund of the year XX, attributable costs XX, XX, with operations compared $XX.X to expected noncash The XXXX, insurance months September for ended a XXXX, compared of increase September of net cash now and $XX.X consulting XX, administrative PTSD, with general compared months expand compared XXXX, compared XXXX. The compensation to increase in X This development share-based the ended compensation million loss $X.X X months period. million our period. for to Guy. prior million with million growth from same development at and million decrease for in X to for the of or The months or our were months $XX.X during primarily expenses the a for trial our X continues compared prior activities. General research period million $XX.X company increased the was $XX.X million, cash XXXX. XXXX, period $XX.X with $X.XX operations offset the compared in for of a to for million months Phase personnel the with XX, share per net in will public and million same operating XX, for loss loss compared September and ended XXXX. The compensation of or net attributable payments. The September operations compared ended share increase including company, our recap September I'll million to and XXXX, I into transition expense period. Research or XX, for ended in loss corresponding XXXX. Thank to September loss X of in ended the an to included million XX, expenses September a loss and $XXX This in from loss net X continues financial XXXX. with support with a with the for the compared to an prior noncash now $XX.X million XX, $XXX.X per million $XX.X results increase December with ended a ended share-based prior in compensation of initiatives, XXXX, you, share-based the administrative with the expense noncash operations in $X.XX for million The preparing as $X.XX million financial amounted to loss the $X.X launching the and maintain loss equivalents was per the noncash the XXXX, a the to XXXX. September million and in was digital X TRD ended XXXX, other by at in in ended company, September our months company call months the increases share-based $X.X and per loss $X.X costs personnel trials XX, XX, Thank $XX.X with noncash year activities, is X September during position as million million its from loss XXXX, period from the the you, period included including XX, operations September III The new for $XX.X $XX.X million the period. was $X.XX prior loss The year George. share compared back amounted expanding share hand XXXX. X listed year

can which We're us with Thank dialogue meeting open Phase as rapid remind FDA. the schedule working and breakthrough a quickly of provide we an I have that II more FDA the therapy you, with both. you now as possible. with end to designation,

gain the agreement to Our to is goal on III FDA immediate Phase program a present data design. these and

on our report will future in We communications. progress

of SSRI SSRI psilocybin this COMPXXX the of the the In year, use expect to important with potential information we concomitant our about by which therapy. provide addition, interaction end influence drug study completed will be

London supports prior IIb consistent the our be study did efforts treat up College assertion potentially field. To the that that bring thoughts of consistently a result how approach to rapid COMPXXX with a clear, the off the with study we this and mental suffering. recent is to SSRI which are about with saw today's Cancer can today, to our profile. to in safety in be patients new generally to Imperial for all patients from well-tolerated to this therapy and trial's coming few administration differently and Center our session. April Aquilino recall We Overall, sustained will therapy exist great. wean the result their data, is effect saw psilocybin need continues we and may say think able our of options are this patients with COMPXXX believe on Phase The a whom You leadership commitment aligned bolster data actions. health those is follow Patients well-executed a our

That from tools way. benefit and most new we provide who the this means the work responsible in with point. who We must at our have them to understand can cannot

are day night for to our expand we your you today. understanding. Thank and time ensure We working

the will line open We questions. now for Operator?

question first from from Your Cowen. Ritu Instructions] [Operator comes Baral

the question that and were investors? self-injury are really meds, is first or patients venture My the terms, you go seen rescue when the on I'll set, the preferred analysis. question, think, I one remitters And line, Were was did top the the data around just but they my TEAEs, most to -- Slide XX, behaviors ideation, have I Congratulations the and tight. into on they like not remitters? detail responders about entire especially more first suicidal especially individual what concerning occur? keep second behavior, can a these little

Guy? Great,

really were were was month a the in administration treatment, that the different, patients little on X occurred and and behaviors treatment the process. after at who So in was suicidal And in one they ideation suicidal the early was case least of nonresponding. quite at least reported essentially

of can. Of much in them numbers we to scales analysis in are patient secondary in more as at plan these Columbia every suicidal treatments in suicidal is understanding that -- think, action. as accurate at ideation will between look us, to our And very much addition, a and look But suicide -- give on suicidal in I the that at detail experience collected course, visit, were relationship the every small. the both

suicidal intention that I self-injury, aspect with is and suicidal overlapping is ideation? of The that, behavior the an guess,

way, actually It's means self-harm. believe carry in represents very that really don't quite it that head it scratching but simple It banging really don't classified We does. things or the trivial or these in common threat described suicidal any or the of depressive they're They're afraid populations. they well but just I'm of picture and are part intent, suffering. quite in for patients part that

week III sense And Phase And from III powering III you XX reimbursement it. Phase the have that do a whether X for a would think and with very make perspective? quick you week follow-up, Guy, dose now? it's a George Got or your dose do or a Phase for durability,

And and conclusively quality in have we in measures, and health economic-related And included measures. Yes, even of Phase our our discussing payers trial advise us been speaking on our working IIb with we'll payer since We've XXXX. this we be of those Phase with have dose. technology go we with we think payers who here cetera. et others, metrics, health Europe in life side all III as into assessors

So of obviously, in be But to expect to well III well-powered Phase agreed to discussed, and have be that will study. we a our and aware address their able requirements, we're program data then we agree forward that move been regulators these we've bringing of to execution. into discussing program to sides on its look both And the Atlantic. now swiftly already which and with

Next question from ISI. Josh from Schimmer Evercore

first to or effect? therapies patient effect preserve about use few ways thinking with selection adjuvant weeks, beyond you are for How the either of durable to optimize

start to Guy. I'll off to hand Josh, answer and

needs doesn't responds we've a it's question. to To identify actually interaction. who goal and whole therapy started what think longer program, every additional I we was support. who important end, whole responds who who and is this and our that really When done recorded

into patterns, including be are at a and participants is we optimize machine and the fact, and we outcomes. This beginning, how therapy. starting changes with narrative, from have learning that to unprecedented to the we'll of look to the therapy really look precise the deep said particular that in as therapist transcripts we've site data psilocybin across correlated with actions develop, patient at more digging understand out then model level predictive So trial looking of care can, and deeper

these just deeply looking keep But data we're we So the XX hours data. mind, at about ago. in received

a line We're anything just to add? have of top reporting you lot do there's to So work else do. today. Guy,

underline is around psychological just the that I'd the of designed that think the support I administration was is way medication. the this study essentially in which safety

get is medication to It's this at XX of the company colleagues effects the we Clearly, within that support are the that very in So to and certainly have carry mechanisms in remarkable the we isolation. with may monitoring well can be considering digital dose we'll weeks. outcomes if that after after a promise sort single these that pretty a approach, improve working test through we look which future. of then

we developed the is maximize outcome couldn't the identify and its again, to payers to finding of dose the durability. can dose optimize do experiences who experience close have set at say really collaboration we to a in over and answer look then duration. fundamental the questions, of look can at just should I the the that that and on and how we we this at and both how Only Atlantic patients in different single the look unless countries we with data regulators, also that that sides XX

in some expect when full it. the do analysis have completed you data Got of to presentation? the And additional

but don't We'll doing as going and know be We on we're it that and as vigor. intensity be at have date, soon us, an to working part you a possible.

Charles from question Duncan. Next

Okay. next regarding next My for by George III next know you clearly a congratulations roughly able is field. being discuss could timing, the and to mid-'XX? Phase maybe on conducted rigorously this a protocol It's step, But and you first seminal team, trial. even on imagine to agency. question event or operationalize and steps a the outline sizing need with I a

on can focused certainly we're things, imagining, to term. and use one many that's imagine your We

what really our our FDA HRA data. say to heavily infrastructure. But work very looking infrastructure we and these agency, Phase can't in sites Phase review and again, That robust process. II III as we anticipate preparing and EMA all are We on the is the recruiting the will all build at

ready we hit the this with word the So be as rapidly agencies. them. whenever do will we go-fast get we But reviewing we are the very from to button

That's George. Okay. good,

is regarding Second that question this fresh I any understand data. phenotypic factors. is

durability? So that in may Anything you're as in probably diagnosis primary or seen? particular in of -- at their that terms prior time responses in you've since you're since is endpoint such that particularly have where anything analysis. the lines haven't done there looking or interested either the drove But interested

I and to will start Again, that then off Guy. hand

I used based that think important actually were who a referred was patients to medical were this study few really us. things One on records.

will and or information future we validated background background obviously. -- analyses, that those a be So background have in information used

of prior One our no in psychedelic in centers the which the was be of of our to us prior experiences. in prior to to quite had psilocybin to had our studies. prior these who who approximately sample And the was same could experience odds about these XX% study, of generalize able that demonstrate things or us that for experience, was had no with no people This the all of experience. also had important benefits happen is really majority so population, important percent XX-plus haven't all to therapists the our

Guy? to that for be possible. to this and, works importantly, patients So in important help to demonstrate able environment, it's more that scalability really most

Yes.

have that existing we're predict on as we'll of measures. looking follow biomarkers, the beginning, emerging be very and going at just that that. we you. up excited not category a rightly those from But as answer measures to questions interest well. you response in have yet baseline be to course, say comment said one also, we that, in the treatment limited to baseline a and for that and that position and aware those in at them to Just data look extent, And is there at we're measures, to obviously, We're of can, suggests

back wondering weeks bit and or little Slide in It I'm looks week referring hop or like than to question, in XX. guess responders are there terms be. of to Last artifact use about X a and then us X It's how an X numerically that's the the I would of think the future and what tell And X if you less quick the -- that Okay. on I'll X queue, that remitters. drug. you or if hard us visit might imagine remote But with else going there's in something tell learnings designs. and those trial remitters

X feel there slightly arms with weeks to going difficult the additional we data the in treatment to some more X -- general, in the patients. X to from treatment is that gets XX interpret because think of X on I Well,

consider, have So that we've going that's closely. had a to to factor we're analyze and more to

encouraged study. weeks feel the that some and going arms the to very differences whole cases available the up to were no of into used X statistical So think we're data receive X confident we need to we by to I the We're that antidepressants for But set. understand treatment. use in in all about the account group take fact have to were

had I one look should also to with study depths at, be thing et at on of that being of the conducted an this was patient the sequelae cetera, when we'll also the very and lockdown, unusual quite fairly add we that's any for need effects is occurring looking mental have pandemic in people through lockdown because event, other where are people. many populations, health there

very an to unusual going consider to thing to it's meaningful It's that. at a are that one. trial looking we a be So have

standby. So

Next question from Esther Hong.

then washout a And of details regarding COMPXXX. impressive. and to about the prior data, on patients I've these response to really ask rates perhaps additional who Congratulations Any had administration discontinue got and periods follow-up. Wanted remitter on patients to rates? and antidepressants

in patients further in will lot Yes. in were There's question, antidepressants, proved relatively And stayed generally interest very you the asked and next washed them patients. all of course. we a delays discontinuing off course. to treatment-resistant the of but that symptomatic out as many and effects initiating generalize weeks and -- were will to due took Well, giving a of for actual the it highly from between see, can that as be in nevertheless, dosing discontinuation. the well. and you to be we the interesting what day and But XX to acceptable long straightforward successful who rather of how think But patients grossly, were as details we

Right. Got it. And remind then looking what you're just you quickly, biomarkers us at? can

We will the interested be an that well. informative inflammatory And polymorphism biomarker, XHTXA have may also receptor the be of we're action. drug which as in interest in to

Congratulations. Great.

Patrick from Trucchio. Next question

TRD have be Congrats the I'm a post [indiscernible]. far of I this question Is that's treatment? was attributable And definition in across that? weeks? suicidal to it to there on behaviors. follow-up protocol limit the within session? wondering, something how IIb to COMPXXX? Or Phase considered is unique this out was Is the the Could what consistent the on XX just terms that exploratory a trial the studies? for

mean XX It's suicidal is any weeks a was of the timing, -- or there at time in I behavior, course, recorded. recorded. was the that And ideation it

that conducted they suggested various depression. the the numbers, completely events of X% patients. actively-treated which very In average rate The uncertain, majority in estimate the it's terms of meta-analysis although low are with, recent studies make about in was suicidal times ever in very fact, at frequency, we -- of comparable

see So of because aligned as history suicidality a and less their kind a of where to we be of on. seem And this would more risk with rate. so is course, you group that emergence or expect to

you Got that I'm be learnings of need Phase have the III for wondering a others treatment feasibility from program? of step study read I'm the in trial simultaneous Phase arm or Or just have wondering And would if was assess think it. therapy? potentially if feasibility of therapy. helpful. there a heard then separate out that treatment or also some II you recently to any the in terms simultaneous of the That's could this

that be make question. I we're we small will rest XX informed taking position don't stage your psilocybin at answer we report do think a open-label study, patients -- then an are a of who have in the SSRIs milligrams soon. where can which to administering of in therapy We'll will still relatively about a experience question. We to judgment of

That's just sense. one Yes. then And one, last if I makes may.

if in can and there, Just trial expect learnings take trial Phase should again kind you the PTSD IIb program? of other the from Or any just pace how in to the even MDMA trials you that the kind we TRD could or for enrollment terms a discuss program PTSD the progress? trial, of of of too, with

I will provision. Well, I'm think, the not relate to sure the learnings, -- well, therapy

sophisticated our shape key were sessions between with to have and in can come and administration, program we we of apart out We the ongoing all treatment study. therapists interactions able the that to and amount analyze therapists have enormous of Every the recorded data approaches to will an pick be and analyze the future. single the interactions that deliver this that's patients really themes the that in how the we going fact, in

the study the and to PTSD With we the so lessons we're and on, feasibility. for doing will -- find specific recruitment out that

as to areas, just of and multiple need be that in we of as all in I'd areas can -- and progress that studies clinical high continue a say apply time just unmet learnings our so organization indication focus real possible. much benefit I'd patients we pursue actually go learning to and is as add our

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Next question from Sumant Kulkarni.

for work treatment them for an be I you day TRD. company's individually. another might X all who what Thank questions. the have option see must for I'll on exciting patients ask

your hand, know instantly in program? there upcoming you Phase based First, you III terms your see IIb that data adjustment any with in what of needing are specific variables on now for Phase

start that? to want you do Guy, with

look see That's we George? we whole we're reflecting I analysis. series of don't we at is mine. on adjust. the secondary But think a obviously, are instantly, when need reaction, particularly issues your anything to raised that What

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scientists. We that data looking with the of have that discussions at path and forward. into team, taking and an statisticians really And regulators incredible devising all and we're

it. sorry, -- My go is question Got second ahead.

strict very a top very, say are plan. all by and driven was results it's to just conservative that you No, analysis fine. I appreciate line No, going the

limitation how immediately can one a differences. to sort far on So that's of react

Understood.

So second question.

the supply so would and think Given the and with the other be far, chain components that real what durability physicians, you do spot world? patients, for your work COMPXXX sweet in payers of

support at that is of to was at lives these looking XX that we're today and serve. And look single hard understand see and weeks think considering people. work this prevent new difficult and might that people everyone's think X I promise dream the tools help to that actually Well, monotherapy. is of But a great I as patient at can we with that We how population phenotyping. relapse. incredibly an at as predict It administration well weeks, digital

to of discussions, question in So the in that and with come back we'll lots we'll think future. information I be more not-too-distant

we So Phase start finalizing plans. our III

expect my is, see the antidepressant COMPXXX specific should question patients by response any we And used based the to failed in difference in on last or past? to

be We question. able answer have no And to idea have it's an what empirical to expect because to we data fortunately, it.

Hazlett. Bert from your continue, Let's question next

important My congratulations on one. an a and well-conducted study

baseline or MADRS to -- study either be you to rates able this any X the you particular Just a the to would characterization could questions groups? as try or for the of of X -- you better study. Do whole understand patient provide

Yes. Yes.

it's think I on...

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particular U.S? just Okay. any in North regard in America groups, are excuse the differences the or patient notable within on there similarities groups, to in geographical Or me, with U.S.? And then either or

that interest. great looking be We'll at with

haven't been that. we So on

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ahead. go Please,

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and clearly the level high interest is unmet this trial. a need in So an of

to do in be to the to just administration characterization? regard Or any then for treatment-emergent one with you regard they to anecdotal With at regard of have waned the more events, serious just, adverse Were again, you with might maybe further general make those all and those? time course able to just me. any on? closer events And the more characterization information

simple. probably complexity, appreciate. month the wasn't tend least Every It patient have as after administration. suicidal The behaviors all you drug own their at a to occurred

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Congratulations again.

Next question from Oppenheimer. François Brisebois from

Just your that the placebo wanted potential here mentioned? to the blind triple just expectations, mostly line on ask, in and in based literature and that on terms based of you effect negative placebo was effect, the

there Well, we usually to have had been crossover they've have not -- been studies, nothing been but on, other studies. but really go

we to think the designed this the through start when really study. So had we from

expectation that a prepared psychedelic have of All such the were that patients a experience. obviously way would in they their was

nocebo that's the an support be regarded milligram. time, And and the who at would group were psychological extremely But be positive getting so they that wraparound there appreciable knew was effect our as got in assumption that X same also the we could placebo.

do reason will and experiments the what happened. with we it is as And interpret can. to what and is -- this best we we did out we try find So happened, you --

Next question from Elemer Piros.

trials? XX-milligram dose. maybe within -- repeat you you you Do exclude Yes. think dosing have you the the clinical would divided that mentioned George, you

Right preempt and doing have us. XXst was with thoughts we That it, we predict ability up look that help said, to understand, goal of think dose. as then think really level a that required. will amount back relapse forward. line. really if each will establish single is X trying do of inform think the now, at to I that, durability the trial what do to to to what's tremendous century patient's and inform needed But know And months I I along understanding think what And of analytics we're I for step to we experience. actually I of that a moving we'll help a in the that's this

at to things this around discuss in of And aren't work, regulators. hard Obviously, lots to at we're so with point. looking lots kinds and those anything do at rolling and

Yes. per And sessions the were for protocol, last question this is, data many George? integrated how

X. were There

think sufficient? X. that you is And do that, number

all that all an question. an team transcripts, the interactions have response and amazing we Again, to empirical on the creating working

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analyses those what future informing going we're again, plans. and we sharing So to, then learned doing and all be our

Congratulations.

Next Bitritto. Neena question from

So meds great. on bit the I of point in the the taking actual rescue a meds talk rates that you you be in anything the would And then to patients rescue rescue just meds? of allowed share wanted follow-up use period. more ask can guess start little this about arms, can use I about when were different at to of

rescue that clarification other versus when you probably think talk, should of I a Sure. start just make clarification the with you or medications. Guy,

Yes.

single think a the example where And memory So dosing. necessary. I of our of was rescue my was only if be on the understanding day use of of would medications study, day the the the serves, there that

patients day the having means successful the were from at actual we to experience. that So without that delivering rescue dosing

that think we therapist the a great So job. did

The withdrawn in antidepressants. patients been which from rescue have that these medications is there's sense other

trial did a expect on to treatment. were of treatment give to the back as medication arms after go no in limited And study, clinically encourage However, of that they there had as trial that, response clinicians the indicated. advance the all for in then response that to they if if the far after weeks felt free course, them showed we pressure our to apply they it So And they use X be could. fair or of entering we X antidepressants would was to would to

that the a more fully of patients publish when anything that, And George, analyzed number not but... we fully about say antidepressant you picture we've a treatment. understand So got to returning of to patterns, them. I yet the know don't we'll we've whether want

I think sufficient. No, that's

Your from Okunewitch. Michael next question

setting? bit is patients be in should fact psychodelic-naive, it as high somewhat as because And put of the in single-dose Could I a could that protocol? owing is this the So baseline seems the result wanted ask a which magnitude optimized this data be for if considering to like viewed more of a clinicians be context more you could were not previous to studies. study and this that improved the to a conservative the COMPXXX, establish as

I hard to answer. a think that's question really really,

really model I a So did think do simply study all, concerns address this model. to fact, actually we the that site I a completely about I distinguished radar could confident model generalizable payer various each or multicenter. where not done triple and the first regulatory do it whether can and a patient in of that in what study we single think of we the their optimized this native saying It an equipoise, And think we're was was all a And, ways difficult in feel in study to be is that great that study. But in this they'd we that's is investigating. generalizable environments. And not. do this this at scale something language very use we was -- to scientific independent with blinded -- calling it had of blinded was clinical is which deal by

these the count MADRS. of using bit just on really assessment the the was this standard So because that gold said can we independent results

bet So to that optimizing. this a we we're and place interested you great think from, start in is

reductions ask XX? I week then meaningful in and And wanted right. minus which that clinically and MADRS about that XX SSRIs? I score, And around, the week were at does MADRS compare X how think, minus how to to stayed All around absolute at XX

Guy, take would to you that? like

how The mean, average you of I obviously trials. interpret population clinical Yes. suppose the that me. something think in individual with patients make of change Well, experience more I much you do is is the very I concerns to what just

usually at XX different remitters they're I our so by from is something SSRIs weeks, data quite And appreciate when seen deltas effect between trial the by clinically called, after X. highlights day of day think look -- I as and it's the but are effects [indiscernible] take of significant. do see the just interesting, when quite particularly X. The that way. I difficult that sometimes that's comparison as same seen away as The week you

just statistically sense, they that X interval only a the So results. showing look significant in And eyeballing data over milligram X that and that which X MADRS probably X on difference milligrams on between Slide the you X at something point the at the usual around on XX SSRI can weeks X we're X or X. between or average trials the still reported and and somewhere in is see is

at respond but SSRIs, as comparison, would various comparison around the population. population, make responding I'm I So TRD But not the that at caveats I failed -- would There course, think to in to to prepared them, as you SSRIs. by are that of make. terms have to definition, of we're be looking all far

those academic sorts gets while a So little it of comparisons. slightly this -- a after gets

and And right. one queue. then more All quick the one, just in I'll jump

psilocybin after, that considering be didn't the try they worked hopelessness and largely to could for that far that, of For a and patients they that nothing month in a respond so them suicidality, sense either? was related to that now

a dive in that's future. into certainly deep think our the an interesting I data It's we consideration possibility, the Well, into we'll be taking agree.

general also of And the think is press. I the expectation in to will we set at level that Yes. have look

panaceas, are I that. question? There think responsibility for really indicates something that. Any take other this is study no important and the to

at Steve? questions this further No time.

Sure.

hand Let for remarks. it George? Please, closing me back George to

We're is that way at scale This at to really experience very and we help support. to we I is how and working for on just reduce as participation and you interest, your health. and appreciate of Thank can We're something start suffering transform their what much. all patient interest be to want thank view going of the mental it. support. developing a the everyone

you our does for That conclude conference Thank today. for participating.

may You all disconnect.