CMPS - Earnings call 2 2021 | COMPASS Pathways plc

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Operator

Good day, ladies and gentlemen. Welcome to the COMPASS Pathways Second Quarter 2021 Conference Call. [Operator Instructions] As a reminder, this call is being recorded. I would now like to introduce your host for today's conference, Stephen Schultz, Senior Vice President of Investor Relations.

You may begin.

Stephen Schultz

Thank you, operator. Investor and quarter for is XXXX Senior President you, for us Steve of Pathways. Vice second COMPASS our results of all thank joining you today Schultz, Welcome at Relations call. My name And today, Chairman Executive Officer. and Officer; Financial George Morgan, Chief and our Chief Piers joined I'm by Goldsmith, will with review a of financial results. today's George update our with will call begin recent follow on business a progress, and Piers our

on recorded open of then questions. The line COMPASS and website will Relations the available hope the you've conclusion being will We had to call shortly be release press a today. for results issued the We the Investor Pathways' chance is after our earlier review call.

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

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

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

George Goldsmith

Thank you, welcome, Steve, and everyone.

trial Phase was the we objective are psychological III comparing in Phase and a trial our a a in at XX-milligram in of our XXX interactions of significant therapists. based study, the this last III goal to to planned individuals, primary Phase identify inform dose, we psilocybin design. The now we of given from therapy that with expect dose aspects to of patient specially treatment-resistant the our this is trial with a from scale prior one XX-milligram is measured fully of we report XXX. their to is development symptoms target a end milestone, participant and in This clinical or on trial depression to all trial the process on progressing psilocybin progress pleased our reduction dose of of as trials depression, milestone to important the recruited IIb in July X, the announced psilocybin of am I original as history, you On business. reached completed COMPXXX in the exceeding other X-milligram regulators. In that that program X by a make of This remind this to MADRS psilocybin lead TRD, clinical support continue requirement the year. I COMPXXX is trained step our great that quarter, the This dose want this aspects session. With primary is at endpoint and of trial data the with development our largest the the conjunction weeks.

to Phase trial plan as to program, preclinical design possible. extensive has information those effect our studies, treatment believe regulators that as will begin also of expect obtained the data, an we We of COMPXXX III at in tolerability. the rapid our as arising the addition of sustained looking and response with numerous as therapy safety well-tolerated we a have a up be will the we provide from end at potential We in The meet this well Phase which II quickly to to pivotal meeting. and to durability points weeks safety our profile. Once XX inform psilocybin we from

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We from later year. this study this expect data

We also the next of studies few indications new plan over to begin new and months. a number

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first think. listen what app. The episodes available podcast are us Do any tell you the X COMPASS or website through and

patents. Finally, a word on

to of recently patents. granted patents does to Germany nonbinding a nonbinding office, with our our an defensibility now we that, will aspects questioning and the build the just The any a opinion We some X patents. With one U.K. request claims who now came strong The to in you update the give for invalidate or of over it's opinion. claims, hand U.S., and for received U.K., and of quarter. Hong our in portfolio party, the of will strength Kong. and granted its of Piers, We in the continue U.K. in IP opinion remain IP our patent not confident financial I opinion response a a from third results that, the of a opinion from

Piers Morgan

research principally X of an increase compensation X you, clinical continues The expenses full noncash X year expenses, maintain or fees recent expenses million recap XX, development equivalents XXXX. I of from months June $X.X and million at second $X.X included preclinical ended loss million in the the million underwriting related to expenses prior psilocybin the and additional from shoe. with the operations with prior of with the period $X.X to ended million investigational months and studies in XX, The results year for the XX, for second expected expenses, for therapy position This of $X.X $XXX.X additional development prior cash Thank is of and our of includes with an expense of million amounted raise quarter ADSs financial the million June XXXX now George. for This June which compared $X.X with fund to adoption compensation our in noncash financial XXXX. from compared underwriter first, to cash the a $X.X COMPXXX $XXX.X includes primarily loss compared development an of June green XX, This $XX.X million company months the period. Research and amounted increase share-based increase will million $XX.X XXXX, increase an million million, to: $XX.X The quarter exercise proceeds strong December XXXX, which X was of with attributable XX, into development. to share-based XXXX. increase compared operations compared in operations trial before and at to purchase is XXXX, $XXX.X the XXXX. supporting our period. million of ended in for the

Secondly, of an activities. digital expenses, mainly clinical in increase personnel million and $X.X in

were expenses share-based compared firstly, $X.X related which and expenses, initiatives, million decrease in Thirdly, the The other million primarily to decrease is of compliance support our $X.X in period compared year prior general period million our and expenses. General $X.X $XX attributable and commercial fourthly, compensation. of administrative consulting million XXXX was additional of with in a of personnel in increase growth administrative noncash XXXX. and an $X.X increases same increase public to for $X.X And company. a of primarily expenses million to an costs, to in administrative quarter second regulatory in million in in personnel primarily the functions transition to: general including the

of a Secondly, noncash million share-based decrease in $X.X compensation.

XXXX increase a $X.X as depreciation a $X.X foreign in XXXX. of second compared primarily including Increase million professional in fourthly, and income fees, $X.X with million expenses, minus facilities was movement to year rent, a of in to: to income prior of operating million to other million $X an loss And with foreign of compared the XXXX. $X million foreign million and and the period million attributable in on income exchange compared second of public firstly, exchange the for other with second in XXXX of of exchange company. $X.X with quarter of a amounting in from insurance. Other expenses $X primarily the arising legal a corresponding quarter million quarter in $X.X decrease for net Thirdly, the other on associated amounted related gain of

share XXXX, of with XXXX. The $X.XX from R&D of which of to $X.X in the for the $X.XX value plus income primarily second to $XX.X a rose loss income period the credits, in million loss of loss $XX.X in the to that, months thirdly, share-based net compared $X.X reflecting per XXXX. with was $X.X $XX.X of $X June loss of $X.X period. The XXXX. And increase the loss quarter compared or during compensation operations share X per And compared or in which net you. of XX, included for the expenses, June X operations net noncash June in prior during loss $X $XX.X second XX, months share-based the the movement from in the the the XXXX, million Secondly, million XXXX loss increase XXXX. The for an amount million George. ended Thank XXXX, $XX.X million loss noncash months with of of $X.XX on ended period. and compared an million with of of loss an year other net a in a the in period prior with you compared same XX, from loss of for net for million convertible million second months X June The in million XXXX, period amounted fair to the compared with related per per tax ended I X million $XX.X was notes, compensation $X.XX corresponding $X.X million or share XX, expense loss was a XXXX $XX.X share of back corresponding ended quarter million with million quarter hand or the

George Goldsmith

Piers. you, Thank

delivering happier make steady takes progress mental the this in advancing the achieve your you trials, on a in this of live and favorable innovation goal access landscape, team and patient the accelerating time us, and capabilities, patient and your developing and all, outcomes. Thank above pipeline, To continue to to the mission partnering bold enable improving people care health digital today interest better our building best experience for commercial evidence-based with to and lives. executing ensuring to healthier We means best patient leadership, toward to COMPASS. people, clinical

questions. for We will line now the Operator? open

Operator

from first line Fitzgerald. Charles the Our Cantor comes Instructions] Duncan [Operator of question from

Charles Duncan

interpret this question, is IIb of of George standard in a percentage care? Phase and and would such results? the of it standard and kind you on durability a statistical of had Or paradigm, of that different I'm team, a to I would on care? relatively to enrollment great win? compare what weeks? for response be compelled mean And you X congratulations by color a update. since the Is guess, to on perhaps patients maybe I progress of at little quarter a large how a though, how wondering be MADRS changes would rates significance relative

George Goldsmith

much Charles, as thanks a question for so great usual.

on -- the extent whom. field is our a and help about focus general inform looking I II think durability us that at response, the in Phase really of for the of response

study, goal study. so this also our is but the things MADRS looking looked in And durability. understanding to such been the large have before never X-week at be at a systematic that are really in These

both core program. XX this a on So XX focus go is define a a to to our extent pivotal between into difference purpose durability real really dose of the a of and milligram. learn here and milligram whole to Remember, the is study

who responsible And also development will our focus And science question? respond, to our to so answer are Did part be. again, identify likely your that as really of where most that's process. the patients

Charles Duncan

IIb, pretty could Or that Good. you program. Yes. to is you study? studies? conduct do the planning pivotal Phase regarding fact, on me. It fast-forward Phase X -- need you given to push Phase and III future only button in plan speculate is the sense a believe X guess, to unmet having Phase is to IIb, it's I'm a But this -- pivotal here That large going in prudent TRD, imagine that III that and are ask not program, regarding on to you I makes a a

George Goldsmith

on -- different a in type spot you're is program. this terms of think I of Well,

I'm at be our and out there a might as prudent Phase of of a teed think it's patient have I deliver to to Phase coming lead that Phase whilst results pivotal to all II of series pivotal, could treat so fairly understand sure expensive sure one then this need us really And where by IIb therapists. a not from that And additional would really enough how we up have do We trained program. this perspective, a be we III make that scale.

well and of do is environment. we're think is I for So focus the our understand this that who also prepare to to that And think kind responds commercial the really program. I science, funded

in can't the the again, So of results the foresee future we of terms study.

our the However, bet. we as data to to to goal possible be quickly important proceed availability, a I is Phase as think and really III assuming that good program again stone patient into work, have stepping

Charles Duncan

good a million than positive, $XX lot think I in quarterly is you be you'll guess XXX. though. But the higher a it seems I'm set Piers, a of it. because what Yes, kind housekeeping, sure came run as to able R&D here would to wondering I which Relative work I'm question so, or at rate just a is assuming it thing data little doing like think little of you're for I Last for a expense, R&D FactSet, expense? interpret bit with

Piers Morgan

Yes.

sponsored II go XXXX. thanks, in FDA looking We IIb in it's to significant start complete Phase Obviously, Phase also, couple Phase the So we've going volatile year then up, of well to IIa particular, months. other to studies projected we the we and on to And as guide the see the X the obviously end ramp in we're that studies of as quite by one as start, things III don't expenditure. indications -- Charles. be of end a in and Phase assuming said, with our in a of going this can

be that the think I some will continue R&D volatility our quarterly expenditure. in there to -- So

Operator

comes Our from line Baral of question from the Cowen. next Ritu

Ritu Baral

milligram? And the questions. milligrams XX doses? the right frame been activity us how mentioned milligrams Like multiple now versus X-week trials primary XX-week milligram? statistical we Charles' time in you of point is novel as your because and endpoint. antidepressants, a versus us George, a the the plus there's through XX plan at should especially has it primary for help points of is XX it milligram you for as Can milligrams XX-week XX versus actually stands sort efficacy or at focus then X primary X pooled on time analysis, the and versus other earlier on XX endpoint? between lot can be efficacy weeks Or X of the case X some Just powering looking it the milligrams follow-up you talk that

George Goldsmith

Sure.

the that the should is -- statistical way I this collaboration is just this developed people TRD with the we includes STAR*D, -- largest developed note again, which the protocol trial. it So the who

So those single were XX team protocol of a the review the both across -- and XX us brought protocol this help with on and sites. countries together and the to have regulators against that we had create sides Atlantic

milligrams As versus we of us at look then part milligram. did XX choose X that, milligrams, at XX have to look to

hierarchical where antidepressant, So of different is Journal it we're X given a dosing we we saw conjunction England assessment. X the population, still by data progressive very the milligrams when separation population, coming a XX again, with New heartened leading milligram but between milligram. MDD and And in a was out, saw

this XX variability to then amount on tolerable the really milligrams smaller remember, the also weeks, excited dose. to at We've XX the see the purpose to is So a milligram durability. of And on and most point leads in is seen at safe impact if studies. in look milligram. Remember, is single looking at XX dose, this is about design we And versus durability. greatest quite what the your look we're we're X we're the the at fair and which first, versus looking a what milligrams here that X MADRS. possibility To

I in why week week, -- response. is we're at durability XX looking week, to X understand week we do what look at and X that's And X week, the to hope really X the for discussion question. So at week, the in XX, we're whom. of durability our regulators, with agreed that to with looking secondary trying answers at coming X and

Ritu Baral

mentioned you you're did the thinking And does. about about. your It that indications that to ask prepared then something in remarks, I want new

most I sort about a IT and severe addiction strategic perspective from as think bipolar TRD the perspective, had and anorexia, But company, you investigator-sponsored mentioned a does consider what studies. you perspective, think promising additional indications, the of in as indications? these funding

George Goldsmith

our are need looking exists simple. So We're what at high at simply north is, populations point, unmet by areas very effectively this that -- true being in COMPASS of treatments. patient at addressed that not addressing existing is

you II. TRD, we've bipolar doing when like look targets. We're looking so are Sheppard that PTSD, these anorexia, disclosed. And all Pratt some obviously, also, at things work at severe

think our is generate strategy I So signals. to

disclosing to and is and rationale by support And driven areas. patient unmet need And preclinical as have for be sponsored there's we'll be the work of in us we in what of to year. be We a around research simply goal part all a areas approach move huge specific that those program these areas. more our will these our are forward where scientific later

Operator

question of the comes from Evercore line next Josh Our ISI. from Schimmer

Joshua Schimmer

of support to bit -- the Maybe up the may that settings? And therapy? about be maybe development expect treatment separately, was pursue centers on would of Ritu to wait you to a you molecule little another may portfolio explore. in talk you Do in better capacity your COMPXXX? eventual efforts demand you you accommodate if to with some for expansion would suited indications there's Or see follow asking additional for that about then can psilocybin those the the question

George Goldsmith

Sure.

us first on I with again drives And to think So we're this progressing is a we to the that as possibility. regard be see need. that actually what going unmet wherever question, focus

focus. And driving what's been the so that's

question, I a you answered did go X-part I've first think sure make part, like the I'd you back because to Josh? and

Joshua Schimmer

the in compounds psychonomic of number portfolio... a have you that Knowing

George Goldsmith

Thank you. it. Got Yes.

you. thank -- So

exploring focus, improve allow can beginning can to these make is level a we'll access if that very is we do. the from be we patients. what of COMPXXX fastest different patients. to help will because So of more we optimized that And help. of it have sure Whether something will whole can need, us psilocybin unmet get to approach us our patients a that question. But to because indication And drove the I right think that's right, the we're for downstream, what lives patients, the now, here that's there's have

So But that obviously, right is starting COMPXXX the shared in things we development out have with then of discovery characteristics. one. now, we've our and with other center COMPXXX, different coming

capacity In building, straightforward. terms it's very of

As I commented as goal an our indications. building program, on exploring Phase III be through Phase capacity expanded program well our out is through III as other to

us helps sure us that that build And capability. to think as make of after It helps infrastructure but build III we share it's we Phase II So clear, therapies. of have a our meeting, more capacity. -- much will about Phase very end our II Phase ours focus become I

having you. don't we patients. improve Thank but insufficient the And of results, so end to capacity actually then up lives promising

Operator

question the Citi. of Neena Bitritto-Garg comes from next Our line from

Neena Bitritto-Garg

a And you second and around for kind share some or is around doing. is discovery as of the kind question you're their can visits the just analysis? And coming bit kind of if lost follow-up in on patients that set we up may ensure patients to I'm data at dropouts are handled that how then So can are of formulation to my who you're about work just time first -- kind well point? XX-week ensuring question anything just you of have curious be talk in robust of follow little how that a that

terms bit cetera, durability intensity in that some kind these of psychodelic experience, little molecules are of some of that the et about the of of a of would in onset you for the next-generation great. If characteristics of looking be experience, you action, key talk could

George Goldsmith

colleague, hand off my second. for I'll take it and to the first the question Lars,

here single dose we of was actually that's being a follow-up single there and that follow-up have we a effective. With to to a again, conducted visits aspect of have unusual provided. terms In quite bit follow-up the we remotely, an provided actually has moved And quite dose compliance, patients. where been because COVID,

trial So the compliance, we world, unmet which the real issues lot think there is given the be to either important will that in anticipate need. I of in incredibly relative a or don't

we'll So that's how that. doing be

handling disclosed not aspects. some of be have We other how the we'll

of like up, we future you to in take to the do So will lost the... cetera. Lars, in follow that would terms et

Lars Wilde

on your And discovery your yes, on third -- our work. absolutely. question On

we psychedelic we're indeed, as and we and compounds, mentioned, are that. developing several psychedelic-like novel having goals So with

the think answer question. actually overarching goal is I to scientific a

LSD we know, in there's know experience of can to we effects. mescaline, over still a years and durable work such caution the you 'XXs how the a in which 'XXs XXXXs, as do field, need As psychodelic work be long-duration the past XX with compounds is Because shortest. lot not done short everyone have 'XXs, but that of enthusiasm the all and the an been lot psilocybin, while and of maintaining psilocybin antidepressant the

And let trials us lowest different up changes end significantly human benefits that entire to up way all if to an anxiolytic hours. hour don't to physiology half potentially convey see and X subjects know trials terms if infer the of X experience I mechanistic patient we at signatures different pick So experience, reduced same in might for that the think, patients. in then of have for antidepressant need will durations creating an Phase from, the benefits. Therefore, we're novel in in run we the eventually, can form we typical molecules

In based properties core XC the slight receptor. such are the of that's There anxiety can To agonism the changes. on other work we're other as, that terms receptors cause serotonin for the the tandem of properties is example, receptor. us target molecules for XA extent, and the receptor at, experience system in some in looking X-HTXA modulate

would treated. And also and one the the want microdosing. idea clinical risk There's the running trials I So of might to indication a lot modulate of, then being activity receptor that there's X-HTXB on enthusiasm depending microdosing on at binding. of with say,

say. to quite think explore agonism the would some is the where example, Therefore, exploring. And that. these binds heart is to And one in need wanted and then it's caution valve regime, need drugs goal to do most bind to to, a dosing are can used that XA improve agonism. strongly to the we're of for very the chronic the basic do over through understood work which to dosing receptor, LSD problems I lot XB quickly them well I humans for elements and of last we to eventually can XB to heart receptor fenfluramine obviously, move like lead a going I'm studies matters. that LSD terms the screening if thing mean X-HTXB the purpose. attack. toxicology lead at a because, experience preclinical in the everyone and that's to that chronic of widely thickening, cardiovascular mechanistic one then

very sufficient problems. time personal patients. clinic through is the on years these that this needs Overall, very exploring deep-rooted strong in We to actually the psychological the within follow XX psilocybin. actually of the that's therefore, work traumatizing worthwhile first We patient actually and therapeutic to ability tryptamine-like itself dissociation researching. And has elements XX we character full be molecules to thereafter. with the the X have happens with process try the doesn't then strong and the next short-acting in in molecules preserve compounds some these experience to believe that goal be might and X to issues that months, as to a of dissociation, where believe has a the to patient Some with

Operator

line the comes Our from Berenberg. next from question Hong Esther of

Esther Hong

like IIb Congratulations other And depression? them for questions. on the on to have top the indications analysis regarding something an have anxiety? couple of A social any anxiety enrolled how other may Do of will be such as treatment-resistant patients in first of study. of is symptoms symptoms there COMPXXX like comorbidity question the social improved progress. Phase My

George Goldsmith

thank Esther, We have been very -- you. focused

recruiting records. Quite I on clearly comorbid is using depression have over of the medical focused again, HAM-A with it all on have that, through that and only this anxiety seen And patients in improved, in our studies XX% active also been PIs think are but significantly in of comorbidity. suppression depression, often, the we other assessing in of there that any has treatment-resistant and -- patients is improved point, validated anxiety. we this at very comorbid anxiety. dose We've not impact that of terms

that most called set patients social interrogating such this out very at our be we can the specifically. future benefit we area. But it other program. what as carefully looking In the created haven't terms in will learn to we will of have things also and who largest ever anxiety, to We'll about inform data

Esther Hong

could there And from separately. if wondering just -- additional any this It's patent -- the could was so just challenge lot be set. like you follow-up Seems on U.K., details? Yes. I the data the a provide in a then regarding

George Goldsmith

dismissed the on who by was merits of barrier the to to This has to August U.S. of same So patents new the comes our the XXXX. arguments. in U.K. appears one be from repeat that it's review challenges. many been request first challenge challenge and cited group of challenge to a patent are the those the that U.S. -- prior and patent, post-grant was our and initiated office, unsuccessful considered on not found And they of And was patent patentability. the made

think, that this party, just from intellectual one this we property nonbinding to I from its of this in opinion And opinion response some confident, patent So invalidate U.K. remain patents. the in came U.K. third The a particular our environment. aspects It's U.K. on for it's nonbinding opinion, and of opinion doesn't of the just office part is a questioning again, patent. of of claims. any and the claims a it that our this was request or challenge,

aspect strength that enough, we in and And our of supported so confident others. opinion interestingly patents, this also and remain in while challenging the defensibility some

Esther Hong

my it who is? challenged third that ask the U.S.? may the the question. Got I Is That's the it. as And party group last then same in

George Goldsmith

is. it Yes,

Operator

Our from of H. from Patrick Wainwright. line comes the next Trucchio C. question

Patrick Trucchio

indication, Or III wondering the emerged is And any, to have in MDMA COMPASS its on a trials learnings, couple potential in one Phase other program? -- is in MDMA approval could and III appears that program? program if of track apply I'm questions. it to that what the Phase PTSD that clinical follow-up a just I differences for from potential XXXX. COMPXXX with delivery first in of Just mechanism, guess understanding the the TRD

George Goldsmith

ahead, that you Lars, take -- Yes. why At one? are we this point, go don't

Lars Wilde

PTSD. just results MDMA saw with with rollout We I now say, of the Maybe great of another approval it's mental approvals providers. and moving suicidal in macro closer III clinic right? Patrick, really development. ketamine And see ideation. chronic racemic Spravato the And a in in to treatment-resistant to the We Phase Yes. we're health, achievement want phenomenal level, depression on happy a

the that potential that I rates the be. outstanding what might shows And in of with a remission p-value the is think what of XX% is study therapies were north you XX,XXX. X of psychedelic in

possible of accessible study our full into from payer what to psilocybin is know, are that did I as of as requests as -- we aware one reimbursement. things the objectives is learn therapy requires one need And patients it? designs. we in absolutely of many that incorporating think make core think our you to I

efficacies we've only data both since the Europe worked required you and for developing America in make in safety, know, commercialization. the North systems and for approval, company the order but payer to not days also early we're of with As sure

we're think where on focused therapy heavy you it's our a in I that the efficacy approach. We that core MDMA, these learning something from is see study. studies, in elements that very for

and that simultaneous patients think delivered able have the scalable looking X to groups are therapists Again, really of time, the believe we the is therapist participants. in patient. we up day, dosing under that disorder a -- the a eventually X seems achieved now X per in reduced X that We our of treating patient in at merits United administration. and then We running going the data and is study model. We're safety major group X, depressive preparation, also for States great patients I required. a to also cancer well. be with were in IND of Phase number the in amount actual groups integration the per I through the reduce we session therapists to At patients involved therapists same what learned we're diagnosis. in we're of of they to with from And

that. And from so learning we're absolutely

the required XX patients for you numbers think Phase that had in astonishing this study. at look when I III results, they only

from very The then hope the we're and how large patient Obviously, to a has of think the and I similar question. data large Phase And we Phase study. lot set running your III decide number. actually has too, our second answers I analysis, a Phase are this IIb learn to going III be. a

Patrick Trucchio

you III manufacturing that's quality And helpful. Phase the Yes, in release, then compounds in hires highlighted Yes. additional and new affairs, preparation clinical and indications. in just press clinical safety, science, regulatory for

you the us that additional on underway III wondering program those hires So new on preparations these for and potential are some can Phase the additional give and on any details if indications? studies,

George Goldsmith

Sure.

I talent, think that focus that and here whole our continues. world-class is on

have the our we a comes background background So in cetera. FDA, strong drug very Very, new -- with from psychiatrists, Safety Safety development. Head et of Clinical

leading Quality, organization. quality of the Our someone into how who's the Head functioning of to been again, terms design in entire of

think Chairman someone former go hired rigor with at our as depression, people really studies. in these and and at And come speaks do we and ability rapidly we academic or about Oxford to is to respected area I as to of the coming the of of So the Goodwin CMO have cetera, think deeply, into how VP Guy focus execute look strengthen we all our level on above. in us. I et ability bipolar, to this When our work Guy we have Danielle, that in deeply

important. Danielle Google And to and Remember, of how that focused about and the we these development. medicinal together, need talent in I think do the digital, us of the think therapeutic. the it's whole every we're world-class we focus brings kind area, to critically and on. which pulling pieces we're of all Verily therapy

these looking who really focused care patients pathways is are served So new that's how not by at clinical team we what the ones, define do for existing on.

full-time it's a else's we're and you little the detail, of gratifying us be And that now really team one So I I background, more XXX think think, bit sharing hopefully, it. been employees. on everyone and people, we'll to no see bit and as capability but that build. will like it's of There been more over really little the a in is breadth terms give

Patrick Trucchio

and you from you your end or -- the And just And I'm quick just Yes. TRD. IIb on II top after would then just the could how be expect perspective that one data Phase line the wondering COMPXXX from outcome soon Phase meeting? of follow-up would ideal what meeting?

George Goldsmith

only bear to meeting Phase so been FDA. all the we've reviewing And scenarios program the a III regulators II with on the the is in and goal -- data studies III additional our to our to We've different the data, based all of not but year for done now. safety bring it over bring Phase to Phase the all bear

we're us, As know all to you've execution. gotten about

So that to but possible, do not as faster. goal is our as quickly

II again. We've a prepared patient-oriented the well to are goal we for is our of any Phase for CRO, our and Phase our infrastructure time minimize the So and start of between III like developing And with company III. the at also that. worked end Phase we're

dates build in doing meeting we'd the go next with year, about depending we Again, to Phase That's expect why why on all upon we're we're data. study. the be evidence-based quickly as what it's that's may early in So the the going learn possible. to first These company. data. as the an change That's we're which following III and the certainly, where quarter, to FDA, get to

Operator

comes BTIG. question Bert next Our from from line Hazlett of the

Robert Hazlett

the progress. forward IIb to Congratulations Look upcoming. the data on

then you potentially sessions? Just discussion the you anorexia, preparation, with pending similarly to afterwards? little you're additional indications? And mentioning, in regard being the others as regard any you managed applications? earlier, do but road, be -- having, might effect opinion, on integration changes regard this to TRD this and consider with just that Or administration PTSD envision any spoke with there down can Would You as and the the support then to to that indications a you therapist the additional changes integration -- the patent. potential any were that one it have group the follow-up bit patients to with nonbinding

George Goldsmith

Okay.

IP I first issue I'll certainly, start with can the after in question, on weigh well So that. think Lars and as the

take that's we to look calibrated. need PTSD broadly. We anorexia that be have Danielle dosing sponsor And really absolutely at be So the and patients on integration. need the administration the opposed It's as psilocybin we're to through people support is will session patient to doing. therapy as will it in what really starting absolutely what the doing the to We'll What with populations, prepare. different with part smaller we're IIS these investigators, of study. the population the learn in suffering how independent question, obviously responsibility smaller subject first customize patient leaders we're our the of opinion in reason structure and already to for matter broad the key with starting as specifically the have and areas experts, working closely happened about and studies these with sites will we'll

So patients clearly we of that that part through working will those optimized that for hope answers the we as with a I based then on program what learned question, all experts be Bert. this core is have external along.

Robert Hazlett

and it the patents application? And have does. just this any pending effect whether Yes, on regarding might

George Goldsmith

question? Again, Lars, Lars. And if it's to -- I turn will over it to that want answer you

Lars Wilde

on detail. comment I ongoing prosecution understand do in Bert, that you absolutely. hope Yes, we not patent

are Of strategy. very our in confident course, we

We any current have X patent challenge. the major impact don't grants pending. from nonbinding expect still We

Operator

of comes Jason from line question from McCarthy Maxim the next Our Group.

Jason Mccarthy

asked them to questions something, want it talk back role the bring in sees terms under Can but Or about COMPASS capacity. about on it will to way out of up clinics infrastructure you any COMPASS third-party will of if go and think, to that? Josh's purely there be your them be building was rolling I acquiring answered, or I question A for umbrella? the lot own,

George Goldsmith

clearly, work do partners to to group deployment. of vigorous -- to not Hence, deliver a certainly very given the any with don't plan our care. mission, want We of we to kind a we a we want to just delivery closely have to bottleneck be So want be partners.

can through our goal is actually ongoing understanding we work the of progressing make and so to that care data. better Our partners that's how those with our

that's to with is working be of other this for it's models partners. whether for think to administered need It's critical it ketamine, -- strategy. the clinical psychiatry. so to whether this in care points MDMA, new ecosystem, I paradigm vibrant our a group a And broad for the I think care that for

we're on beyond to and sure expect we our partners. And of we terms commercial of future vigorously effectively a work So with cannot comment never in making that bottleneck. whole group a that plans,

Operator

Our comes Elemer from of next from Capital question ROTH Piros Partners. line the

Elemer Piros

have if would of duration is, I you you regulatory to the George, of sort spend What sort -- regulatory sort of this may part was you explored you benchmark trial. observation framework? in And investigator-initiated the And to for of could study, What B cancer on minutes see, have of the the from perspective? question wondering a treatment you to would end couple here? invest or to what usable points have just be the have for program?

George Goldsmith

Yes.

very Obviously, other these many And who their these we're difficult issues. about are on we with how regulators hear. So right, focused are in obviously, as anxiety think given to very suffering new patients to treat, patients working areas. physical comorbid about MDD, ways, these with are with often

simultaneously, fact, So but integration. I a administration impact goal first X think is we a rooms, the delivery study that could actually therapy see preparation, in with did in a this to in different people patient our if, and simultaneous make of among separate model. And psilocybin was durable this in study

terribly a and this not of different So delivery that is actually pretty models forms is cancer care from model support other distinct groups. in

the at Cancer patients in data. Again, Again, of changes measures. to but we're qualitative start boring, discussions scale. MADRS bringing think want set about think with small patient at And step And have X-week that at is And all in those we Aquilino a program And an seeing help is inform be interesting data following looking I based What conversation point. the studies we this we're do later. regulators here. are looking Oncology/Hematology the I of experience ongoing first group and there be and the about a be in been model with working an doing on also we will what to going so, study traditional to Center. There's to movement will this to sorry all We for Maryland is X-week closely at a measure the that evidence. have endpoint.

Operator

no showing would back to I'm for time, I like closing over to call this At turn management the remarks. further questions.

George Goldsmith

like questions, our appreciative a and investors making for this in the support appreciate and your much very We're thank the greatly very all on I'd to focused difference support questions lives. and of the much thoughtful today. very patients'

my So with and at that, thank COMPASS you. I colleagues

Operator

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

You may now disconnect.

COMPASS Pathways (CMPS) 11 Aug 212021 Q2 Earnings call transcript