COMPASS Pathways (CMPS) 4 Aug 222022 Q2 Earnings call transcript

Company Profile

Participants

Steven Schultz	Senior Vice President, Investor Relations
George Goldsmith	Co-Founder and CEO
Dr. Guy Goodwin	Chief Medical Officer
Mike Falvey	Chief Financial Officer
Kabir Nath	New Chief Executive Officer
Ritu Baral	Cowen
Neena Bitritto-Garg	Citi
Patrick Trucchio	H.C. Wainwright
Charles Duncan	Cantor Fitzgerald
Sumant Kulkarni	Canaccord Genuity
Francois Brisebois	Oppenheimer
Elemer Piros	ROTH
Bert Hazlett	BTIG
Michael Okunewitch	Maxim Group

Call transcript

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Operator

Good day, ladies and gentlemen, and welcome to COMPASS Conference Call. At this time, all participants are in a listen-only mode.

As a reminder this call is being recorded. I would now like to introduce your host for today’s conference Steven Schultz.

You may begin.

Steven Schultz

and Quarter for XXXX you for us of Second our Results all thank joining you today Welcome Conference Call. had today you’ve release hope a review to We the issued earlier summarizing accomplishments. our chance press is name COMPASS our at Co-Founder today Investor and Chief Executive my Vice Officer; President Steve Again, Pathways George by of joined I’m and Relations Senior Goldsmith, Schultz, Dr. Medical our Chief Guy Falvey, Financial Mike Goodwin, Officer; our and Chief Officer. introduce our new Executive also am Nath. pleased to I Officer, Chief Kabir the and call. recorded Investor will being COMPASS is on the the Pathways’ website available of call after shortly The Relations be conclusion

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

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

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

George Goldsmith

his call. new and introducing to CEO, Nath, Thank first begin to welcome, you, today’s our excited results I’m quarterly COMPASS by Steve, Kabir everyone. call

I comments, to review. but ask will August won’t him the will provide financial we As will then press he the a update, COMPASS. clinical with his and to Guy into our and cover him heavy background open I After instead, business service, progress, call Xst, questions. some to prepared on our Mike thoughts just continue move on officially we’ll will provide started

to welcome even explain institutions what’s help six fail here. many health based Let me accelerate so patient psychiatrists was years, evidence how why mental why laser and told to this the need. CEO innovation Malievskaia it in next this for firsthand in so best mission our I Co-Founder, created past could focused about Pathways. when and has times, Pathways people to as I’m Kabir experienced I COMPASS the and COMPASS for to I’ve story COMPASS and right time repeat the my wife Ekaterina is say Except on won’t been excited access care. to

of the that’s first is and a are to the diverse The easy not what possible, leadership XXX. evolve for of does almost founding, our Since more to COMPASS. expanded people dreams. we’ve as grown chapter and steps they talent. but and nothing articulate our without yet role concrete With from become start two but capability next part. vision CEO and exist. Visions companies is the grow founder to talent more the When the successful, achieve joining for every clearer. became collective is addition, Kabir new require employee vision Surprisingly,

phase this COMPASS someone embark is experience led that development, has who important journey. we company this of on our with As part it’s next by of next

a Xst, This end Instead, the of ensure our our Kabir. thereafter. will Kabir. only designing leader and an forward. I’ll reporting year and my I and to not have elements the and I needed by Chairman program, attention better. as to be next serve wonderful but time words. On the as Katya Kabir? began to that mission. us say had opportunities have shifting serve values, to inspirational our It team became found me. Executive mean to completed. smooth know him a talent in of and get as ask many right and the August I to through we more believed to experiences we Chairman executive adding our achieve in we continue leadership business. transition This building to continue to III vision capabilities carry and a been as prepare Co-Founders our be what contribution Phase devoting help few commercial place the who area our find for to that Co-Founder As regulatory is is I doesn’t grow. leader to now efforts nurture of for will to my to Over is We mean we role Kabir you It clear the

Kabir Nath

mental of that with to of since other a George, I All have helped next good our patients new Katya, illnesses to of first day Today to been share COMPASS and impressed mental serious of boldness in the health story some a of XXXX. database solutions family I investment on start, the too thank and as mental this create will value honored and much passion approaches for helped to patient the depression we they health friends COMPASS’ delivery. and evidence-based mission regulatory work develop I’ve by to not are similar treatments. Otsuka’s for you current we severe the and options in met and most mental care I and believed outcomes COMPASS Executive not I that George and combining conditions. And admire get world’s and bring that mental they in as make their mission Series creating are struck systems in serious and COMPASS to interventions. psychological to those was innovative been when serious and advance to current achieving living From Chief for accessible scientific deep of I’m and by I in round by with determination Katya everyone. us care. of who experience have from by COMPASS as COMPASS chapter to and team, predictive next rigor Pathways, standard-of-care. as the Georgia health B I health helped to forward improve investment pharmacological, personal and or vision lead solutions approval and many digital commitment the personalized, share illness. suffer And very selected them embark by dedication Officer. truly preventative goal, have

for decades CEO Business. and the of myself, previously For Pharmaceutical as most America Pharmaceuticals at both tech have in serving Director Otsuka’s several and North recently in healthcare industry Managing med experience as Global Otsuka Senior and of President biopharma, I

technology and Phase time development products we embark program commercialization capabilities. mental III for the health is my lead on great also Otsuka, do resistant patients treatment as suffering the of partnerships complex solutions, with at to I addressing During depression. coordinated and especially pharmaceutical and and company’s work There Head our digital of as needs COMPASS,

One with clinical digital urgently reimbursement of and you. successfully meeting who into regulatory through I it’s processes, ensuring moving support to and therapy the needed. look with delivered my main priorities COMPXXX will endeavor to healthcare for working for that can serious trials, be and it patients psychological and forward patients COMPASS am I initiatives George. together hand psilocybin in excited of to we partnership to transformative illness. solutions realize continued vision new back Together, I enable to evidence-based this create important models mental care, believe leading critically access with I’ll George. to integrated be which systems,

George Goldsmith

III this that And Thank to during have the review Kabir, protocols we have report you, to progress again, you and Phase pleased by welcome. I’m also at submitted to to thrilled steady continued are FDA. you quarter and are make the our been helm. as under COMPASS

therapy support end guidance therapeutic looking me with steps you the Phase will populations during in to underway. All represent new announced next sharing and and We of our preparations regulatory underserved the this treatment targets year. these our reaffirm anorexia details and our commencing of progress PTSD approval new programs With we to program are program and existing Last is for XXth. Phase Day, to by the for with We for the III his TRD program Most Phase III anorexia Phase a reimbursement some on are of by add planned therapy. III the III options. let program turn Guy this now Phase Wednesday, of contribute patient who that, that and active for our evidence this pleased the with continue importantly, the COMPXXX II on believe of will the agency three program. program Investor currently the which thoughts to discussions detail more October Guy? scheduled this forward week, large psilocybin we we’re in to program provide

Dr. Guy Goodwin

Thank day and you, good all. George,

details are in limit from with and II of competence our FDA. program today’s control the I under still George’s say will I trials incorporated our submitted review, the the Since echo Let the important me What comments design Phase number lessons two III call. a during Phase pivotal protocols program. included our of on is interactions progress can my

no COMPXXX patient’s Again, developing in the Medicine digital take the Any key from is trial details represents of in impact in symptoms Medical anorexia at will Diego moved psilocybin psychiatric after COMPXXX Columbia the using Approximately of illness. the in Pratt approved will support administered the will result any all School and with acceptability This COMPXXX highest EDE to after as the extremely XX% would journey is psilocybin place participants This San an therapists also U.S., nervosa them. medical but have changes subsequent patient’s U.K. and endpoint in to therapy primary anorexia and measured psychoeducation suicide, are of result people program, pharmacological week, who to compare This of trial a we forward highest with tools disorders when week investigational eating high and The the the deaths in other be October. this Center, it of of and King’s preparation anorexia live approach Global closest at you to in X%. of people support study the current the follow the an four study complications examination, we it, the thought psilocybin does milligram suicide. disorder on XX rate from treatment Score only II to of unmet I We suicide have EDE mortality world four rate Phase London, Not in the effects milligrams of anorexia Last ahead in program element psychological nervosa. research patient highlight leading training, critical up, nervosa. therapy treatment. California look and X third institutes XX mental with across enormous therapy. changed measures. baseline the College of FDA XX% to interview nervosa psychedelic a with administration available, need, option sharing of COMPXXX with University University Sheppard to a With almost announced on

open-label Kaye study published is Walter Society Dr. research timely at interested investigator to manner. the development Psychiatry a inform in investigator by Pathfinder, first-to-use of patients we’ll initiated excellent supporting and My a conducted developed trial. consents, Our San provides indication be therapy psilocybin positive in commercial for This principal responsiveness. this is can California will the engaging Kaye, The our collect were Professor real the generated treatment early digital on benefits University scale May, The which signals how COMPASS clinically Dr. at trials. therapy app to participant program from supported early is investigator the for an educational in deliver participation on example of studies about meaningful patients results COMPXXXs world of Biological and initiated a Annual This study II model app data Meeting. signals in Diego. in clinical Psychiatry of an with education by exploratory, Phase at the of

entire provide content, at training centralized deploying app to Therapists training to therapists. while We application with feedback designed COMPASS a continuously This the train analytics recruit, the improve a provide to same program. progress will COMPASS specific and update -- streamline are providing platform custom process and Companion, is to that training also time the developed web

automated help training to the an feature introducing be to therapists their further with feedback. will we sessions after meet translation for and review they with patient transcription and Finally,

at COMPXXX stress site our Day Yehuda, post-traumatic look will Rachel reporting expert XXth. Phase depression Sinai in demonstrate as internationally during forward these our they PTSD New Mt. disorder. King’s City, Investor recently already. these ongoing second investigator. study, progress. We study PTSD This adds tools study in The treatment Dr. on We Hospital We College resistant to II is anorexia with the in October added as recruiting programs to recognized on development to a York and principal PTSD actively

over financial to for Let me call now the Mike turn the review.

Mike Falvey

our Thanks, and XX, Guy. for I’ll the now six months the financial ended XXXX. months recap three June results

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

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

June and with were preclinical ended hires, expenses the XXXX. These development period personnel therapy increased to as as trials. COMPXXXs during due XX, R&D compensation continue investigate well same we additional million share-based to costs due other three months million, For expenses, $XX.X psilocybin clinical XXXX, were in increases increased non-cash and as compared to $XX.X in the and

R&D year. this expenses until modestly III our Phase expect We later commences program increase to

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

fees, growth $XX.X increased and XXXX. months non-cash due during as to three These expenses period well as million, and professional increased legal XX, other G&A other compensation were to personnel were a in ended attributable with million company. facilities our initiatives, expenses share-based as the and $X.X For increases the to support and XXXX, costs hiring, June including operations compared same public

XXXX, strong at equivalents with with million with June cash compared the and XXXX, $XXX.X in same the December six June XX, during $XXX.X million, at position For were million its $XX.X financial period compared maintain months ended XX, COMPASS G&A continues expenses XXXX. $XX.X million of cash XX, to XXXX.

be into carefully view an as manage now expect value to the at as With these able invest to create balance operations to time turn our these fund shareholders. we which our potential while sheet Thank for call the I’ll asset, to strategic back to resources, we strong same XXXX. we George. promising We you important our continuing advance to therapies, intend and

George Goldsmith

investigational and and with those currently closing, to his COMPXXX is Thank improving are In Kabir patient I experience forward employees not you, who Mike. treatments. our access deliver therapy look I will team psilocybin leadership leadership by available to seeing to that continue well COMPASS to to our and advance patients of that know outcomes, helped positioned our goals thrive.

to Importantly, our know a make health building of is to well leadership generations public of as mental role experience focus We private partnerships, transition because difference our central are is me come. commitment enable as and joining shares on plan, efforts, Directors Kabir we will to to successful the lives priority important shaping well people Chairman. This deep executed the for on policy patient transforming in that leading with development my every advocacy focus to of Board a Kabir company. in strong a COMPASS significant people’s succession compass and as care. growth our along

for of so your will here mental I tools, new on journey to incredible anorexia now the what perspectives of at of our better I leadership programs additional information in for to those we this addition in Thank change grateful, our join from to for this KOLs. also commercial as chapter am our time XXth, As Phase the We in exciting forward pleased of the program to and you you interactions the look TRD of treatment guy, advanced our investors Reinforced people’s look move today. though, an October our to science closer suite strategy, potential next which by III grow goal feature from sharing Day forward we CEO, together. to with area which of transforming and our us. COMPASS, the continues and for of all for health, us you who our Investor our This on digital is come. mission. having upcoming heard has support PTSD and generations our look to we forward our our time we’ve progress for are FDA lives accomplished and our team

We will now open the line Operator? for questions.

Operator

Thank you. Our Baral Instructions] ahead. from Please [Operator first of Ritu question comes go Cowen.

Ritu Baral

different making III, generating Good But useful very high designing morning, bit? Phase I to mentioned I’ve guys. something Phase mentioned elaborate generating if the aspects different for datasets. Thanks datasets, I question. just for going looking lot generates Can it different of taking on payers? protocols, IIIs data you’re Phase about George, got the more that very, III detail there’s note, understand coming. or wanted trial. whether plural. about thinking be the that that ask about to populations And little you then the at question you I’m a some wondering the a two anorexia on such you on a And level

George Goldsmith

Great.. the for Hi, thanks question. Ritu, and

I we’ve we aiming process far keep deeper is to share disclosed think everything we’re full not so things go to here continue details. have and sign-off we to as underway. will Again, is FDA that what the from that after do and into

we’ve since our been as we, of XXXX the on that working even and in been the U.S. life payer including measures that’s Europe XXXX side like reimbursement in study II you think I on with know, and Phase in information, quality things payers, going

studies of to able sides be -- us the to on both going including are we enable discussions reimbursement So of the all in accelerate that endpoints our Atlantic.

to until expect hold to dealt just going on is a ask of everything off more study have XXth, which terms we we’re with. October people design, time In details to

Ritu Baral

in points guidance? time are out that finding George. the Are interested Fair you than more payers further like enough, regulatory

George Goldsmith

I so that on we program. And we’ll think we in variation there again, and be depending more that XXth in that study our the we’re systems entire accommodating that the the is designs. share see report of all to on able as

Ritu Baral

-- scale, don’t then regulators endpoint? sub-scales -- import a program are the they And what key quick, EDE I SSRIs approved. on pivotal familiar on? that, not I’m is anorexia think this and with of But it. the the for any Got there approved know very I super are were not

Dr. Guy Goodwin

EDE measure is the main psychotherapy since the the can question. I a in the is been important the of has certainly which This trials. we most the great main in been been as That’s psychotherapy And regarded anorexia mean, here. Guy in is way treated that make. used has we measures that the past,

our we the We will are that to Difficulty] underlying of quality of with which and George think and be of have, patients which relate course, and key particularly all a control, anorexia of including feature other informative studies. said, life, secondaries, is obsessionality in [Technical as problems

think obviously speculate this go far think play program. I how in the other I we forward advice taking little purposes, early bodies are as we’re as will from about regulatory for But the with that. regulatory FDA a as there this future and to

Ritu Baral

Thanks taking for Great. all the questions.

George Goldsmith

Thanks, Ritu.

Operator

Thank moment. you. One

Our next Citi. Bitritto-Garg question proceed. from comes of Neena Please

Neena Bitritto-Garg

burn I’m historically on also will be before a in a planning that year great? the reporting if little for that just sorts have that, and us I question. about what give should Maybe versus that, know Investor sense study. guys. on, taking and XXth And And due and at you readout? then like that cash impact. II metrics maybe follow-up we Thanks. quarter this had I you bit adjunctive wondering talk me. SSRI to October a the timing one of the of if just be for could Day One on patients FX that you’re that Hey, out or Phase for the slightly Phase is can long-term looks some maybe my to would higher data you see expect whether IIb for Thanks just two the

Mike Falvey

cash George. Guy start the I’ll and and over Thanks, it balance Yeah. then on Neena. turn to

at notice, you cash quarter the from at as yeah, of So, million $XXX to went $XXX the our beginning end. balance the

you that’s that a $XX or flow, about $XX operations, change half million our was summary rate. is our run if look of in for normal at million. used So about of cash change about And which

dollars or week, dollars half we’ve in million our the other forecasts pound-denominated our impact into and our hold we in balances from and both came The as of noted $XX translating match spending for each balances reporting cash currency. past And pounds cash rate in purposes. exchange to the

a spend our is be most continued So into we because of going strategy. and them this dollars. pounds going impact those intend change And is this not paper forward, to $XX million loss, to

currency first So probably have any thing last we’ve I our of the we’ll continue continues And is small. currency to should future impact seen the most align runway continues the our into impacts cash half balances changes so also be to over to spending and plans, been that add, currency operating significant. XXXX. that the cash And important unusually

Historically, strengthened make impact. little all energy a take so really to for direction because operating dollar something consistently. have see natural in in impacts important don’t to going those of hedge us why, we uncertainty currency So the what is place pretty forward, put is they’ll it’s which spike and against prices know sure this very this political you’ll currencies, and

George Goldsmith

we is about know study, which the question XXX. the follow-up So

filled had XXX, years to up Just and was our take who continued which main the Phase being We are that patients basically patients is follow analyzed. the where also patients as study, data reminder, took and this the IIb now in SSRIs. was participated adjunctive a our both which study XXX, know

be Day I timely we to the on a of Investor XXth will discuss think it October. the moment present when it

be when So, get there. day I for interesting waiting think, again, that will we increasingly

Neena Bitritto-Garg

Got it. Thank you.

Operator

moment. One Thank you.

Trucchio H.C. Patrick from Wainwright. comes Please of proceed. question next Our

Patrick Trucchio

morning congrats Good on the progress. all and Thanks.

these integration are of up What regarding now multiple the TRD, first indications this terms COMPXXX I’m protocols are is to anorexia. the in level is is, different and including and and therapy therapeutics PTSD if extent same well, indications, wondering as Just the program, the the differing these digital how across of the included different indications? psychological [ph], the indications on And which sessions? expected the treatment out be different at follow these building support what evaluating to in expected specifically to press or different if all, be TALK trials

George Goldsmith

that it’s to III were is certainly, that both improve also the -- way delivered in opportunity question. think look proposed that anorexia and Phase in of also The digital we certainly opportunity therapy studies thank how is it We this and in support an to some Patrick, The included you at will the an for the which study that therapy it in described call. be currently can reduced. be refined and burden the

So going not to October I’m XXth. that the therapists, with of we reducing -- I things multiple cetera. the that quality forward, see of again terms think costs improving some additional demonstrate digital a detail when be completely side the extent et the answers you that therapeutic in associated the the may we sure particularly we’ll are details the and of support as some digital question, -- your interested in from way

Patrick Trucchio

And of the three? or is just of of pretty therapy expect compared have across the as with -- terms expected it Okay. that or TRD kind is be would as we to to to are those compared the PTSD level psychological more to in psychotherapy support, similar anorexia protocols then

Dr. Guy Goodwin

they remain can similar, but are same. instance, first much exploratory the to how the little they these how think doing we’re reasons establish studies for I and because just In

we’re -- that as think objectives studies in undertaking. the is the partial the both a I that So sense objective

Patrick Trucchio

Okay.

George Goldsmith

protocol. past, patients it receive if need more these -- have they the Patrick. obviously in And hi, Patients of the as part support, they

So here. that’s patient clearly first

Patrick Trucchio

for Yeah. if the so build clinic COMPASS look looking on out guess, side, an can separately, discuss just there one XXXX? TRD? a commercialization And to perhaps, then -- COMPASS’ how preparations, ahead, the in helpful contribute help. this MDMA COMPXXX? build way Europe? could I be any, could to I’m And U.S. can are far just and commercial wondering to care of to might underway, health COMPXXX if that as out How mental of for efforts, in and -- prepare the ask I if PTSD potential just What that in initially, could we the If the you approval in be that’s then, ahead I infrastructure

George Goldsmith

take Sure. I’ll that.

think focus infrastructure of the United and example, is leverage wherever S-ketamine, for our for existing I seen delivery we’ve States. XXXX So possible to sites nearly in

quite But to our point, plus Europe, pharmacological these move you’ll MDMA working engaging We’ll make we XXth. this if launch. centers, working of with as I fully receives obviously, and those supportive on therapies into delivery that are III of approval, -- academic regulatory a we’ve III, sure you as therapies, of more that more on infrastructure. think system So Phase to clinic build all out we’re report looking will to leads know, your see Phase for we’ve that while care addition us successful to including the a more in be in October in And been that to TMS, obviously, all and been really sites sites and at. of and TMS delivery

Patrick Trucchio

you very Thank Perfect. much.

George Goldsmith

-- And key has that those reasons Kabir is focus that’s really issues. on us joined to one the of

So there are. we

Patrick Trucchio

Yeah. you. Great. Thank

Operator

moment. One you. Thank

comes Our Please Cantor Charles next Fitzgerald. proceed. Duncan from question of

Charles Duncan

Okay. Yeah.

note, I of George progress on morning, cash Is you you agency, think, if then end good So, anything II that the control to anything, the I provide? with XXXX, The or on of PTSD. have and the could with does can the couple for can wondering surprise you’re But I’m with points on I Mike provide details had I you the consider feedback paradigm think in debate agency the fully had any lot And you through sample use, Congratulations guess October it the that questions on? meeting good of et if there team. additional elements of size, dosing from I any XXth. design arm, or just then mentioned, color you of if just that elements be Phase questions and realized a that program, share this and of details be cetera? we’ll program. one that regard it on could it completion that the and a are innovative investors waiting there would waiting

George Goldsmith

looking maybe have and this we the say the interactions We’ve development you a interactions happy of FDA. we’re I under new follow-on. So fact area at, the incredibly generation. question around kind at and look we’ve first-in-class in what the negative observed was been with and to our been that by is been this prior this is mind breadth that that of have and encouraged here keep when very kick with evidence nothing FDA And of has to in a would Guy what at, surprise off the the of by that, thoroughness all. whole our encouraged --

doing I do think the we at we’re as just work COMPASS.

our point details as view, of said. we October, from more can in we so, And share

been right. at I get set in want seriously that we proper sure think huge discussions we and have and we’re to ensuring productive really and make all think scale a everything it’s very evidence the forward our I to are we so of very taking move responsibility indications these

you that’s on on? all So add to want front. did say can that I about Guys,

Dr. Guy Goodwin

No. I don’t think so.

precedents study. and one pivotal the I broadcast, what has is trials based I said, mean, approval TRD on received pivotal George this just think in just we’ve single program we’ve we with said. noticed as indications no that announced to a that this consistent included on two actually reiterate we where has in

part our So an in think, thinking. of sense I that’s, a important

George Goldsmith

most always want a thinking we’re successful therapists we’ve a take the we therefore, to to that about designing you question… ready about for the as do Phase backwards and so forth fact from launch. the by complemented and successful launch, talked is III Which want Mike, have

Mike Falvey

Sure.

George Goldsmith

modeling? …on financial

Mike Falvey

Yeah.

And the runway in Phase that into for budgeted that as contemplated projected. placeholder cash if III we put to XXXX program. that affirm that continue that over Charles, So, we a to runway, plans, have we make runway coming with and sure the is in a continue anything refine we’re, area, runway, we’ve did we in so healthy on up we in the

Charles Duncan

provide enrollment Was any the to, on color I’m Got a enrollment? it. That and new you in guess, a With if program, to to trends all desire PTSD Thanks. of to and I I PTSD or broader I investigator added driven guess the patients you look new set makes regard interest sense. color the by can XXth. forward wondering clinical capture important feel the additional the guess, by, a October program. site Appreciate site

Mike Falvey

it wasn’t class world It on center, do expertise we two class -- had better world and centers class has numbers one to sure. do capitalizing than two than really with with to and for centers world

Charles Duncan

Okay. for taking my Thanks questions.

George Goldsmith

Charles. Thanks,

Operator

Thank you. moment. One

comes question Genuity. of Sumant next Please proceed. from Canaccord Our Kulkarni

Sumant Kulkarni

anorexia. to TRD questions. Good Thanks the I one morning have on taking two, afternoon and on team. for one and my

here or or sit to Phase make it strategic TRD we by with if a financial decision driven as in choose does sense trials parallel III for start considerations? both that you predominantly today, run to So staggered were

Mike Falvey

really this Sumant. we’re sorry of detail I’m at point, the not discussing level in this trials

I as we’ve an we an think with ourselves explained see process -- important the confidential in FDA.

record. the I’m guess, but you the We sorry like a broken I’m on record, broken XXth. I will the that’s I just, conclusions tell October sound a

Sumant Kulkarni

problem. No

records broken can Some good. be

to differences score you participants So on and an female in mimic clinical there based expect are the ratio do its EDE II, either any of real the Phase baseline confounding endpoint? gender anorexia the or in at world distribution at to relevance male

Mike Falvey

only actually question. mean, studies women. a most That’s include I good

So on in you like as this trial exploratory it with develops we’re and we’ll let stage know issues an of ours.

Sumant Kulkarni

Thank you.

Operator

moment. One you. Thank

Brisebois comes of question proceed. from Please Oppenheimer. Francois Next

Francois Brisebois

little questions. taking But for October forward on look details, for the I Thanks here. to XXth to different Hi. try bit side… the I’ll ask something so more a digital

George Goldsmith

Franc. Thanks,

Francois Brisebois

you of including sure wondering, just the these to and that make discussion how prep, tools some the and in call. these, bodies in us of the include this prep. validated are digital much you with to more that on kind patient are order guys was I if goes say with in order you more … gets he regulatory But teased needs

any Just discussion from would of there it be FDA, there the maybe helpful? too can is is any much body actually side, -- where there’s drug, and this, the if how we the the what’s usage digital tell regulatory discussions are it

Dr. Guy Goodwin

it’s doesn’t I which and growing area your issues drug, obviously the efficacy think to think, the answers around I issues a the it issues George the as Well, I on clear of of the of the key new who statements and discussed the the is They a amount confound key think, want sight Obviously, know, is may for that comment. I support. haven’t program. it’s, the it’s one. safety. committed of and clear usually themselves have And the made the they’re effects have it’s far question. psychological FDA a issue, drug that interested of the of as I objective support, in necessary minimum know don’t that public digital officials usually, in whether

George Goldsmith

as we from inform just think, view these these all endpoints I data Well, subsequent of exploratory developments. addition, in to help arising

actual et So they impact deliver any on have the cetera. don’t just study, delivery,

Francois Brisebois

that space this now, Okay. some lot there’s field. at mostly potential acquisitions at guys and I of That’s are was there players, kind on in were are high consolidation at COMPXXX? wondering helpful. or focused level if on And M&A look your some focused but we was views you just biotech whatnot, you in and a right you any criteria the to And just specific of been in morning COMPXXX would any then look

George Goldsmith

never COMPXXX on here. focused but it’s just top Obviously, sole our not our focus. We’re priority,

patient we’ve you’d on COMPASS that that’s know, will obviously and and we impact we’ve based space and going assess north true to the assessing. be that’s in to imagine, terms at you patients everything -- time on in almost always outcomes scale seen As of our

patients to will makes going if see help interested. and rigorous something we’re has sense, it base, evidence be So that it a we

answer enough that I hope. the So probably to question is should

Francois Brisebois

or? Yeah. going this all or to not No. if October very you And Thank potentially much. is it you sharing in-person forward XXth. look I to are

George Goldsmith

people online, be more It’s event, viewing going be is lot to will many it it tune that able will thought a archive. to our virtual in of into be a

virtual purely alive. half we, is or would half live virtual they’re thought, Also So either be all way. virtual, as not that as good kind all the experience with our best of

So virtual right be the seems format. to

Francois Brisebois

very much. you Thank Certainly.

George Goldsmith

think, offering perspectives, the heard at be COMPASS through I And the to should the Investor us those in some will that’s it’s be hearing. opportunity, something virtual really KOL here interested up all that deliver We give of we’ve Day best that also out because would investors point also to we’re showcase going to the and format. team

Francois Brisebois

you. Thank Great.

Operator

you. One moment. Thank

proceed. comes question from next Our Piros ROTH. Elemer Please of

Elemer Piros

everyone. morning, a specifically but not incorporate level the in outcomes? that Do plan you to Phase the the I’m previously in difference subsequent almost tool the studies? of dosing have this Good just a preparedness to this asking of therapy Yes. as selection for for general III, actual alluded George, concept? had a in you made

George Goldsmith

to can learned I probably know Elemer. is -- But learned this and hi, organization that. help any can that just of to over the ethos it that anything for use. Guy well going I turn think improve we’re think, Guy? enough on specific And do to you put I that action. I outcomes we’ll us we everything thoughts to think we

Dr. Guy Goodwin

this gets opinion need the that the of I the is on what to Phase obviously, optimize think as how that preparation at will III real so future by certainly shaping I it. better. we the be in we that expert it we’ll keep we’re imply think take treatment we’ll aspect do it certainly world as better into focused looking restricted and And and way on be simple. settings you is But increasingly things the to we develop looking and

George Goldsmith

will Phase develop protocols. Phase from And into IIb we taking be III as our the and learnings we design

Elemer Piros

much. so you Thank

Operator

One Thank moment. you.

Please from Hazlett Bert proceed. BTIG. next comes Our question of

Bert Hazlett

the on the and questions. you Thank progress. you thank all Congratulations for taking

the bit Just opposed three a picture obtain, be for to one little then the further one months earlier appeared two little showed items. bigger that bit and program data that small It -- maybe guess, the study I as granularity or again one earlier nervosa month. at a and study anorexia the with strengthened -- end may more out

as and the then, going antidepressants results curious if to endpoint out? I’m that looking at those week further are trial you’re So in be Thanks. for excluded And four to secondly, patients?

Dr. Guy Goodwin

Yeah. in Yeah. can on, going kept for we It’s that And you the XX-week as those goes -- things keep be time intervene. most four other to Thank ways constant four component. because weeks first we’ve you. weeks, a observational and things many

then initial continuing think I an four and observe to So what optimizes see. over treatment effect it can makes XX to keeping sense weeks, weeks as we

the we strategies from will Phase of continue patients IIb there. worked the used still well In with antidepressants, since to and we in it the withdraw same terms antidepressants

Bert Hazlett

use. picture kind the should to to mentioned And formulation you some Thank just there’s with had you’ve continued Terrific. there in with visibility of maybe novel drug and elaborate the drug of questions, work press some release, maybe NCEs? candidates novel you. method of And are actually -- both a see obviously for goals you bit bigger more we then patents novel could composition regard granted discovery and the of we those whether candidates, little when what the Thanks. on efforts and should

George Goldsmith

develop we to discovery patient But enhance Before think a on be we’re do that et the there, I of start we’ve to our shine been of what cetera. I is light us clear novel can enable to always discussion the will on efforts, some again, have the looking chemical this of some that to will part experience. XXth entities

on need precious over unit now, at same to to look help acting, time. more little that, shorter of And right but we data there’s so obviously, patients

efforts property important compounds dimensions, But one of elements different these. a we our at we’ll integrate of and selection out thinking obviously, in So approaches. certainly and of to we’ll of into is design on the program, lot report discovery looking future that’s intellectual and continue have that the that,

Bert Hazlett

you much. Thank very

George Goldsmith

Thank you.

Operator

And moment. One from Group. you. of Jason question our McCarthy comes Thank Please next Maxim proceed.

Michael Okunewitch

This Jason. for Hey, taking Michael questions. on the my Okunewitch guys. you is for line Thank

strategies. you training refining So, first, therapists your guess, I mentioned

needed expect long and certified comment to for could would how actually you you a on take and training how COMPXXX? just comprehensive fully trained is it therapists So to of program

George Goldsmith

III think, I again, process the the Phase of that we’re So, finalizing in design. part as of

be that will think the that So XXth. I comprehensively shared more on

have settings, therapists with for a experience that to their supervision, as we model, training, provides them and that we training ability multi-tiered to that then in the said, is then work view Our clinical own. includes under to on move clinical

of use hence So the been it’s this our approach, optimized, approximately hours. now XX focus a has scalability on comprehensive for technology. being very It’s process. looking whole But right at

on think recorded and XXth, that is a the then most every more the improve transcripts about learning we’re element hearing mentors process and the much therapist the is building what session actually important forward. move I and doing as therapist to you’ll we of be this enable provides component where that the

the time. of how III, this do And gets or improve to we’ll the real whether through all Phase over iterations therapist therapy world in of that and training we the incorporated and of trials, be all PTSD, that or learning releasing it’s our so anorexia

really And world. important over size times our scalability. this to doing is element real the we’re and So this in continue an development people feedback providing the from to right of goal is make of just what terms

So talk are it’s more agreed. the key elements We’ll it. of about those as the program

Michael Okunewitch

right. All Thank And follow very you one up. much. just more

mentioned… You

George Goldsmith

ahead. Go

Michael Okunewitch

you in -- have coming to … think for -- the primary layering studies vector to study pipeline Should quite anorexia investigator a program in in COMPXXX expected your are any initiated to near- few the the more. and we you as anorexia expansion and readout medium-term? can of from for in label initiated other of investigator that kind this point

George Goldsmith

Sure.

these. did Obviously, a as trials. But we are positive these the investigator with that we closely at contribution something we for see development. anorexia, think those significant make need. caught have plan patient results look look initiated prioritizing to we is you’ve So, and will to would benefit, we unmet We independent yes, if our patient and ones choose use at really

are initiated these independent I mentioned, As investigator trial.

But So things year. would you report to given know when out. of news these it’s hard this are, where will more expect may be hearing for us that things I some

Michael Okunewitch

All right. much. you very Thank

George Goldsmith

Thank you.

Operator

back now conference Thank the to closing management to would remarks. you. turn I for like

George Goldsmith

the patience doing and all to to anorexia critical is been and signals Phase wanted II we’re are we in. regard only is appreciate stakeholders other we exciting the looking but done before have for that first-in-class, the not engaged in so that with need patience utmost seeing also has because incredibly we process with thank our results study, your from when with at for we’re them looking something us. early This that I are we not start care among we everyone and appreciate This the do we and we at your an time it things. their to

So we’re development, support, fast it’s in therapy technology our quickly our and an our exciting data. effectively in time, and moving

forward for So there. to need you that, look thank October your always, and excited I the to interest, subsequent I we’ll many of And Thank for think we’re and seeing as available XXth we’re questions really you support about with as want and arise. you.

Operator

concludes may for now you and Thank participating This call. disconnect. conference today’s you

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