CMPS - Earnings call transcript Q1 2024

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Operator

Thank you for standing by, and welcome to the COMPASS Pathways' First Quarter 2024 Earning Investor Call. [Operator instructions]As a reminder, today's program is being recorded. And now I'd like to introduce your host for today's program, Mr. Stephen Schultz, Senior Vice President, Investor Relations. Please go ahead, sir.

Stephen Schultz

and quarter for to. XXXX you, for us of first our results all thank joining you today Welcome, conference call my Schultz, Relations Steve name President Again, Investor of Senior at Vice Pathways. COMPASS is joined I'm Officer; today, our Chief by And Executive Dr. Nath, Kabir Chief Pathways' our Teri and a shortly of the Investor call Relations Officer; Financial be available the Loxam, and conclusion will for being website period recorded Medical days. will Chief be call on Officer.The Goodwin, Guy our is XX the archived and COMPASS of after

Factors Report on subsequent filed as of and upon the call disclaim over subsequent as Exchange COMPASS relied revise assumptions now Securities hand views even Before we or Litigation views the the will forward-looking XX-K begin, in forward-looking XXXX undue let everyone Securities that change.I'll represent as on our U.S. should with our within Act Reform me be call representing during obligation should Commission remind in by if amended.You made our meaning today statements Private place as could results differ statements filings forward-looking team today, described only and Annual to We statements be SEC.Additionally, Nath. the of and or events under of the materially with specifically not making by to those forward-looking and date. these other risks heading and or any various of Actual statements. as factors, Risk the forward-looking statements the any not any risks, expressed any or uncertainties update the result implied our a of Form uncertainties those from including these estimates reliance Kabir

Kabir Nath

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

necessary into templates the market me preparing for Guy? Guy effect care are setting settings.These COMPXXX clinical over steps develop care enable went code XXX COMPXXX also the pharmacology and if leading providers, on call for psilocybin and the year. placebo-controlled quarter COMPXXX also now mental in option, for to COMPASS COMP collaborations hand for this to in those in announcements delivery trial collaborations, CPT delivery these Reliant tracking execute the COMP in that for quarter, COMPASS if care Health. scalable of single-dose Greenbrook patient track health COMPXXX current care with these psilocybin providers may Medical fixed of how Mindful and They of and Meridian XXX patients.These the focused models for models commercial COMPASS TMS, fit recent the mid-XXXX.We're treatment-resistant clinical best and are report these better Phase all a deliver study We're leading collaborations care setting on and depression. continues studies And dossier.Also treatment, designed Solutions different, Group, required partners for to of fourth into treatment-resistant depression.The to actively equally on with towards of commercial and diverse update. Health and in to Goodwin to we me to part investigating COMPXXX approved.Let OptumCare, Dr. plus development collaborations cost-effective additional a represent already this announced treatment experience. line we inform will but the challenges of repeat very top with for Journey understand trial dose health add Hackensack assist place that preclinical working NDA commercial care let III have data important in III the the most Clinical different in Each both completing of on First, the January important metal approved, a

Guy Goodwin

The the resulting opportunity PTSD. everyone sites the included to data and patients a Phase generated entered being XX.X. to have the assess a dissociative CAPS-X clinical of as effect. had positive evaluated functional from patients effects of impairment from XX Icahn at study observed. PTSD symptoms average included the press included of the and by impressive at X at rates both majority serious a daily open-label in in status participants response and the an psilocybin.Veteran study X let for lifetime a in also weeks and score was was review along the Patients of screening session on severe COMPXXX observing with sustained with with participants The received symptoms. Maryland, primary events XX.The present licensed after Neuroscience the We're at and clinical pleasure of involves a SDS in group life.Safety the today of participants in structured the adverse of Medicine mean also single me durability during key the results with It's complex from study day DSM-X adulthood.Participants Kabir. COMPXXX to in exposure the were Psychological study emergent King's measure tolerated prior PTSD improvement events this again this and events X was administration administration of session.The study of were Psychology as College treatment diagnosis and remission adverse go saw of in II of measure drug results.This this week of and with & Psychiatry, COMPXXX U.S. over safety report subtype. were an ideation age exploratory provided tolerated. mean ensure psilocybin II experience at observations with The some of categorized morning professional the patient events. crying aligned to treatment of support. diagnosed There COMPXXX administration.There Rockville, them measures eligibility. in CAPS-X excluded Phase the week baseline adverse in summarizing School hope of assessment the the the PTSD Treatment the were the you, COMPXXX by the The medical Mount average score, score during severity time were fatigue, treatment combat study Sunstone and speak study. Study week of X serious XX, session, XX with XX XX that Thank with to endpoint U.K., of and XX% a headache, patients well at psychological Sinai assessed Institute preparing on with Therapies total of patient review a New of and evaluating XX-milligram include release multicenter treatment and in and from dose that suicidal was PTSD you We PTSD from PTSD study. was over nausea, to with London.Now baseline provides CAPS-X we X the week this trauma findings predominantly well resolved pleased no York, through support was no study specific the and supporting interview were emergent

was event on first day on a transient responder. moderate a went The administration and in a to patient be who

a at The second week and non-responder. X was event in mild occurred

the XX.We score Improvement a No remission and point withdrew XX.Remission with X week increasing on by XX observed week to during XX.X% of high in there from trial. and relative weeks. equal mean XX.X% reduction ideation CAPS-X CAPS-X TRD.We onset point of mean improvement and less XX. at XX, at XX.X XX.X% reduction reduction score symptoms over From returned week or reduction total XX.We SDS XX.X XX.X week week at was improvement XX.X at from XX.X and XX Response, X disability week baseline, as of study score to X baseline an of in experience, as and a a observed total As is to at antidepressant in week administration. baseline equal or greater saw in point none at score was response was defined reminder, PTSD and XX.X% of improvement a at than early the medications the early CAPS-X a is with it single at suicidal at durable and week defined rates from of an are patients X symptom feature by improvement. total point was patients as baseline observed the following common a a XX.X also sustained

small quarter design, fourth Kabir submitting track a PTSD. provide a our this early and and the X-week next exceeded believe advanced application potential with forward results for patients of TRD of this for in COMP We onset the function of of during to XXX COMPXXX are improve with endpoint understanding to will primary expectations for of mentioned, the program.In and consider impressed COMPXXX We our by improvement. in and could publication year. full the we Although trial were particularly clinically and study look quality open-label addition, benefit life durability the substantially daily PTSD.We steps in on the as results meaningful that of

seeing improvements the in are to created medical the facilitate the we retreatment We from records, took year. earlier bottleneck which a of actions

mid year also COMPXXX results and PTSD review. III benefit for call excited and broader to by and for X-week potential across hand year forward year.We financial We progress XXX now COMPXXX our next program.Let Teri me for endpoint that's the TRD next track for profile prior remain emerging are on and the COMP both the We to patients. continuing this for later to a look Phase the the

Teri Loxam

first financial of R&D QX quarter used $XX $XX that in million cash $XX.X XXXX $XX now in and we would pleased to expect million, between claim guidance I'll the we in assumes guidance, quarter. within in which in million step Guy. to operations used that results. second million range was our $XX the I'm quarter.Regarding received tax Thanks, $XX HMRC credit provided be operations net full approximately the the and financial the Cash million be to million. XXXX of through paid first in confirm quarter first XXXX

position December the XX, from ATM at to in Hercules $XXX.X end facility our cash financial operations August equivalents quarter expect quarter. through $XXX year full to loan XXXX first million.COMPASS XX, to with $XX.X guidance, we XXXX.This of $XXX with continues of to million a compares the is XXXX.The received the maintain million financial debt at exercise million million first increase between under warrants and pipe. and cash due Turning cash in at be Long-term proceeds the was of and in March strong $XXX.X cash used

quarter, runway the cash expect in fund increase our first cash the to XXXX. we operations With into now

continue Kabir. manage to will program will you, believe and continue that to the our back carefully for call shareholders.Thank our milestones value achieve to we create turn our important to advancing pivotal and now We cash I'll

Kabir Nath

you, Teri. Thank

PTSD FDA potential schedule a the strong these data, we're and steps. working meeting with mix align on With now to

line top is milestone and patient also key a commercial providers interventional psilocybin of Phase significant COMPASS COMPXXX the event our given the synergy.We're continue field approved. who our PTSD, later indication will data the health expansion with into year. forward III make our for leadership if in This progress TRD logical a we for to science.We potential for similarities this network see given care treatment, program and administer lead centers great to While be looking for mental COMPXXX, and profiles can psychiatry of the disclosing our

again including in Our new rapid, more indications neurological other of enable drug other TRD XX. explore neuroscience, to with that in we'll and for years of Trevor several in to Guy Chief from the pipeline opportunities.I to expertise Mike, you endeavors.This on Mill, and and I'll additional will exciting forward on him over of want it our to Officer, we the your and will of team continue Officer, and to and develop updating and COMPASS progress. models Development today's for development COMPXXX access aspects all back to a period COMPASS and and is brings current pipeline depression.Mike an year in Pathways, so years May early than exploring expanding potential our to experience transition providers, guiding his opportunities. effective Chief look Trevor interest COMPXXX indications the and program disorders, extensive Gold best experience with wish XX dedication to development operator. Development Q&A, all future as in psychiatric for thank continued advance the collaboration continue welcome turn to participation with call.We'll across therapeutic also our Dr. Mike to COMPASS' equitable after and scalable, want work now are the hand leave Mike to broad Research his COMPXXX.I past develop Thank commercial you we

Operator

And line from from our Vikram Purohit of first the question Stanley. Morgan comes

Vikram Purohit

So we had XX PTSD.

to the FDA MDMA how that scores benefits frame this for and recently could Ad an SDS that terms received first, also us going notice of in meeting that So those review the June benefit, Comm their morning, the be CAPS-X and what just you then early space of scheduling real-world assisted for the to is contextualize for in reported you to patients terms experience real-world application therapy their observe.And may company for another PTSD. in

Just in the on your there thoughts implications space more your potential broadly? wanted were what to see program for

Kabir Nath

Stephen. Vikram. Thanks, It's

As we you start, sure to us clearly. just want I can make hear

Vikram Purohit

Yes.

Kabir Nath

Great. Okay.

to I that second maybe as one to Guy question add and the So I'll hand on the take well. might Guy? first

Guy Goodwin

Yes.

So a terribly the significant rating are scales about the I reflect I think study. in is of they for near think patients return to results these way real these number not to that normality the familiar. mean,

not remission think reflect think as a is would essentially draw disability score minimum go we that they along. a that all measure think, also reflect recovery.The across attention But the we a is scores. that we're that's range emphasize, scores trials. defined basically, And of outcomes, of see, your the also are that of rates SDS of They there's I average, used lowest they're these important understand I by So as high. high course, that sustained.I to very we complete but getting reflect them to we

at conditions the again patients, show function potentially as return the treatments as other And PTSD. reflects well is important a reflect substantial symptoms course. numbers we as so in that that look That allows of you of reduction which to impact of other as for of in

second Lykos. The question about

Kabir Nath

first, that. no X/X let one. than PTSD century, is, This of I think Yes, take more mean, number I said, submission I in as surprise. me first the for mean a

currently they're is it drug. Second, a I Schedule

Comm. many pauses closely key will FDA just say very the that observing of questions wish I that application. Ad a is the sense, that people And in So like no other there surprise we, to going we well. would And an them be around how be number obviously,

Operator

our Baral TD from Ritu question And line next of comes from Cowen. the

Ritu Baral

potential on of sort Guy, the provided nature sort which positioning and compound Quick support and through Lykos. you is Was us could Kabir thing versus basis exposure of provide? from there for of aspect support assisted the therapy, psychotherapy. by my any Lykos understanding you the walk MDA the psychological the of that psychological

If talk you could And follow-up. the then the amount and I nature. like then to have a

Kabir Nath

headline, different in But, down a I we're I'll moment. the doing no what it please? Thanks. is But hand TRD. it Guy, mean, Ritu, from in

Guy Goodwin

Thanks, Ritu. Yes.

that, that not detailed follow-up questionnaire fact, which patients the there, is In in quite have people that about really is kind be their in due experience.And inward everyone be we do essentially and heard exposure publishing There's a little from we'll their have of the results suggests there course. has a journey really way that of same the just but to to a by And essentially what experience. memories driven seems mainly contextualize in psilocybin. bit relation change this that

course, themselves the in therapist and [ force, month interesting of contrast sustained conventional remarkable subsequent preparation, it's you've which and the ]. hours as psychotherapy who the patients is as And is in to they but exercises leading group, occur given external the would we so work. that TRD specific it's they sense with terms doing as they're in There's psychotherapy.So efficacy So interactive conventional way are own relatively the patients that of short. remark, indeed on prepare psychotherapy. they the previous same driven the prepared not heard. have a That XX contrast after would that a had by of being in a of exposure their are that, we and in are very think And an be feel no integration

Ritu Baral

it you just then suicidality? anything some patients that helpful. about X of suicidality? Very of to suicidality. criteria with of history see can the to were talk as exclusion And relates able you Was experience Did -- patients in the unique you there those did history a

Guy Goodwin

though X group is PTDS BDAP we complex first this this probably was recruit careful mean, because severe the study, [ in not group, vulnerable be with PTSD, patients even not wanted to a the ]. complex really a I Yes. this is to

So have of this XX% wish measure of also a significant have specific these single intent. is to suicidality.So But also and patients them many and be as in their expressed active dead, which them simplifies history outcome. expressed of as a lifetimes the show trauma, of with suicidal ideation XX% plans

they were there were So in this sub-threshold attempted unfortunately which not risk lifetime seeing The is events, particular at feature course, relatively this is is group where suicides, or a a of the suicide obviously and there group and stage suicidality that what were no effects.So of has therefore illness. as the suicidal, serious a were adverse recruited condition. no we're

Ritu Baral

have some And you'd the Kabir, one us by What love you you Comm it. a have that quick and the to little elaborate questions Comm. hanging hope to when key left I if Ad further Got do that that? Ad you Can just question, follow-up follow-up, said you Lykos first a addresses. could have on answered have you questions would you

Kabir Nath

and to And them thing, fact and to this ultimately, and the Lykos' it's component, is as is fact, up is so be how one But protocol that before, in clearly, will that how parses successful, on. a on something in to at your will that be they the comment and that's think that, we've probed the there again, significant itself question go. Well, therapy. that see reflected said FDA therapeutic if and understands interesting that clearly labeling how will that,

question, probably well clearly of categorized what that's for assessment overall as think benefit-risk key generally the as psychedelic. the I as a is

FDA But -- that. about I the arguments arcade into get how could think, the benefit-risk we overall again, approaches So again,

Operator

Cantor. the Duncan of Charles line from next our comes And from question

Charles Duncan

had TRD. a on PTSD progress. on and one Kabir and then I congrats team, question on the

seems robust. data PTSD the fairly On

So jumping seeing could I magnitude including it or risk of than, I change in input, gun, FDA one guess X you're know the Phase patients say, are program, capital-efficient III given that you with call at CAPS-X. imagine the the, that you maybe of relatively less both but a roughly seeking XX studies,

Kabir Nath

So, Charles, encouraged say, into you're not we Suffice by III to call. data. this me on study going trick to Phase obviously, are a this designing

As on plans. are clearly working we I plans, development said,

so to is, appropriately, robust of to agency this that trading the with will have will outline sizing We assurance the take and together of of you a evidence robust trials Both still be discussion.What is it that put data to very need off that to we number capital be be but will determined, design have in doing those we my forward. much and efficiency. whatever on, goals

Charles Duncan

it. in Confident that. Appreciate

TRD. on Moving to

Another terms to color a the and B in number ask at on open even C of you patients and question, not in be of any provide Can you're least into of Part kind Part but interested retreatment in then of anyway. or B pacing I'll probably going answering, it the blinded basis Part label? patients on

Kabir Nath

were you But a have as both trial, what we say, think which give sign. running right. to to also except anticipated in patients clearly as parts. The is going we've potentially also So we we've dropouts than significantly are importantly, the in good specific, lower no. not answer again that I is I'm have said, the said

Operator

comes line of question from Co. next the from Patrick Trucchio H.C. Wainwright our & And

Patrick Trucchio

the I'm about FDA the trial trial can the then in regarding trial development Phase pivotal any Phase wondering mid-XXXX. and data think talk for to IIb to us the fourth impact the Can with line relative I design where a III if quarter. inform trial frame as emerged how the expect outcome II relative the for outcome in about the Congrats PTSD.And well in bit expected X I'm top expected guidance to should TRD the trial as Phase on potential in line an have in learnings could of possible drug discuss wondering you study from little include Phase secondly, TRD you for data or data top psychedelic positive pivotal TRD PTSD study have the that the release? from And to in both in the that that top you this would PTSD. is line in read-through very outcome what we the

Kabir Nath

Patrick. Thanks,

open-label moment. about that thing me how this But just hand guess, the I'll to say FDA XX we II further in But around Guy first let to So anything hand inform the say, Phase an was I guidance to a patient think design. to will reminder, a study. Guy

Guy Goodwin

and Yes. I that seeing of or mean placebo FDA be active comparisons even another dose be the treatment, obviously an interest expressed placebo. active an in it or can treatment the with another can

range in tremendous III our carefully course, we've drug a So to options account of across program take differences Phase we when read anyone think database TRD into advantage space, a PTSD they've for left TRD, quite between and developing II PTSD.I seen. of shared this think how not and design for we really of from and wide about we'll don't are a that what the indeed the with But there safety indication. there's Phase PTSD

Kabir Nath

guided on to we have to not Patrick, your again, be in we'll a with position And top-line. exactly question, what release second

and aware, any terms you Guy, any that. success, you're significant have have that this to TRD. if COMPXXX that And and positive study weeks comment want I make? and so in have we're XXX, powered the be B XXX of terms evidence don't to for And going further and any result believe designed clearly, from we we Part very As be will and sensitive to XX look, to blinded, read-through of around potential of in know, for runs you

Guy Goodwin

one. of to acceptability model and And mean, we see the than I we've required XXX, perspective XXX see I being Patrick, as as essential think regulatory to number which that think are we the potentially that us to in the clinicians as well. from and simply particularly practice probably ordinary informative it rather before, to a forward, understand patients Not commercial a said going help clinical I treatments will is really.

Patrick Trucchio

the the collaborations following wondering, or another I'm the population estimate based just on expectation commercial think at for you able how be you of rollout on TRD in could, if have the TRD? preparation launch these in proportion And these do announced to -- significant for may commercial this collaborations about of an today. of an on I possible should reach time we Or the potential COMPXXX collaborations?

Kabir Nath

Thanks, Patrick. It's a great question.

models exercises. significant of rollout. is collaborations potentially are need of clear, then different care. instance to be contributor wide we examples commercial to we understanding So when for file, number providers. could enough to already settings delivery different fortunate settings scaling template, this would healthcare that are templates And understanding some say about numerically that Other, learning building of the these to different more I the at range really experience, They while pre-launch TMS, like we be will expect But other as a will settings.So areas. all is to what of apply to and a would care health deepen stage those you assuming is this of our of this imagine really we're be to our could think understanding to learning really year deepen these across potential, you them a of Greenbrook different those

Operator

BTIG. line comes next Tom Shrader from our question from And of the

Thomas Shrader

It's a remedial one on PTSD.

your So your price of what they medical like group using? some impairment a baseline as level level are patients? would they TRD what And do care same level the at support this patients with score, have, of

Guy Goodwin

for or intervention used a particularly scales are severe. the as for one is require score which that or intervention scores classified be X, They'd the of when on each people item one scale, that way would X the merit afraid. complicated I'm in the criteria of It's symptom. And it CAPS-X

they're a who are would you for group needs that a in these -- will coming of sort unpacking future. more little but be group some it need idea in are it So that a the little a experience. gives who and we treatment, not mild But the

Kabir Nath

Yes --

Thomas Shrader

hospitalized? background how on Any much they're

Guy Goodwin

is We of line. on don't the yet. top all This patients data very much these have

when able give we that the get we'll to you tables So in, color. all be

Kabir Nath

And something or antidepressant roughly SSRI half on were or an something.

Guy Goodwin

Yes.

of all kind. previous I received think have some treatment

then That as treatment. half that's included which then psychotherapy about that question, on actively answer. well still Sorry, was drug we the as if the were drugs, And discontinue.

Kabir Nath

second your we of And alone question, to for do Tom, to finalize actually TRD, say to have PTSD. let lot work profile still a would the I

again, for and we comment see So see we we -- durability might a what expect many so on to PTSD, on. couldn't administrations would in subsequent genuinely how couldn't trial

honestly, comment relate premature So, other each to these would to commercially. on how

Operator

line our from Genuity. Sumant of from Canaccord And next the Kulkarni comes question

Sumant Kulkarni

data. the I X. to see Nice have PTSD

So the Gold first, risk COMPXXX, background rate optimally given the have nice can board. with?And this in on high of with both see Michael and mitigate to second, to suicidal PTSD in company start ideation Dr. how associated very type it's TRD patients event trials, of on

might Given Michael's think going extensive COMPASS looking evolve compounds how at? forward might of strategy be experience of with types multi-asset COMPASS the of that companies, do terms you in the

Guy Goodwin

Well, thanks, Sumant.

to these our we not approach. here and populations. and a what support everyone studying clinically ethical particularly Ultimately, describing studies. actual exclude a study. treatment to Otherwise, the are the impossible I actively really it's of I seem that treatment. to sample.But no that really this suicidality or changes preparation randomize is on the in existence are serious, you're sorts think seeing of we're these any seeing attempted think would suicides for of standard sub-threshold of have we optimizes as who minor the suicidal, relatively And we're in patients in them that because it answer the patients. to is completely doesn't this during that patient that we administration think classify or generalizable you no reason, in And preparedness rating takes for suicides the which changes we our mind scale. in events recruit low don't truly insist And scale, had Bear that

Kabir Nath

that with doing to today developer I need And that.We of thoughtful humans with assets I Sumant having underway given. to But advance credibility which might And ourselves in drugs, a is into discovery time we've assets, with our as actual credible stage do it announced first, TRD we're what PTSD, with and first be well COMPXXX. we've time.But over a yes, some again, I we believe your established our in have into the progress could we think, always part to said not recognizing, of relatively frame. question, to how of absolutely a expand think other strategy late position that's short in we developer,

success lead and the We we're credibility our and have to well way think assets, on to doing demonstrate that. I with

Operator

next Rodman. [Operator the comes our Elemer from from line of question Piros instructions]And

Elemer Piros

weeks Maybe plus a you the it to the takes Guy, How COMPXXX? it III a MDMA with observed what dose therapy. that XX maximum And looking at I'm PTSD of question to about that trial. compare with does to Phase results MDMA with Guy. appears benefit single from reach

Guy Goodwin

It's is weeks. number that X-week at the we full And it's And take at the out measure measure. CAPS-X it's a of XX measure. course, weeks same Our sustained the X because at first effect using taken weeks. X shows

So we to that's appear see. what

finer-grained that show measures to We will will evidence early, from patients speedy available for them course. we even other have an from you, yet have that took we due in we very don't onset have but

Elemer Piros

you with dose, in see? probably to the results believe you same results third end second with CAPS-X as being are the dose amplifying what do the that the the and due reduction So MDMA the effect about

Guy Goodwin

what that's we Yes, see, all yes.

Operator

of today's the conclude does This the program for any further you. to hand like session remarks. to program. back Thank question-and-answer management I'd

Kabir Nath

thanks all say to just So participation. your for

I I in during we've this say, robust PTSD. signal heard also As encouraged by questions, we've very seen we're think as the

year. to program news be.We and we and on COMP established TRD, execute at are for look plan for XXX later COMP continue to might in XXX and future I the working are to in therefore, exciting a looking forward timelines February what We think, the we the

for So day. I your thanks of Thanks participation. very good a rest everyone support. the everyone for wish your

Operator

in your conference. today's for the This gentlemen, and program. does ladies participation you, conclude Thank

disconnect. You day. may Good now

COMPASS Pathways (CMPS) 8 May 242024 Q1 Earnings call transcript