Earnings call transcript Q4 2022

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Operator

Good day, ladies and gentlemen, and welcome to the COMPASS Pathways 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 results and you, for us conference of fourth our year all thank joining you today call. Welcome end XXXX name my is Schultz. Again, Steven Investor I’m at the President of Senior COMPASS Vice Pathways. Relations Mike by joined our Officer Financial I'm today, Falvey, Kabir Chief And our Chief Nath, Executive and Officer. Dr. us development. our Chief join is will Kabir unable Officer Goodwin, so be Guy to Medical today, covering clinical Investor conclusion and is be available call. Pathways being of COMPASS the after recorded will Relations call shortly The the website the on

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

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

as relied these of today be assumptions any revise only if forward-looking estimates views representing even We our upon disclaim subsequent any as or as change. to statements our not should Additionally, update or date. and represent views specifically of obligation our any forward-looking statements,

now I'll that, hand With to the over Nath. call Kabir

Kabir Nath

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

as across continue aspects all have business. bit We with make to of quite a progress strong share we to our you,

first TRD, program pivotal a started trial of or psilocybin. past depression quarter, ever we in III III this Phase During Phase COMPXXX unique achievement, the treatment-resistant our

our the important last significant the III of an field program described this this paradigm at fall, potential the we Today, with of health we're shift. XXX update potential be thrilled advances trial. know, Phase COMP to is mental that announcing holds you starting and conditions we're As forefront in to treatment a for the

a dose XX-milligram this placebo. true trial, As a COMXXX comparing single is a the reminder, monotherapy to dose of

of analysis placebo-controlled for arm, reduce specific has number further led data-driven to had a XXX trial experience, the to in major trial size the from This well to XXX the data of a recent of with Zurich, a from at completed This the XXX Phase achieve University us X-milligram a sample psychedelic expected a the re-estimation the as participants disorder of XXX, revision placebo. objectives. minimal and the a while study to our response as data the who depressive IIb or to analysis analysis using in patients on the We've COMPXXX focus of in original lower true maintaining to COMP allows required our power MDD.

complete the of reduction end XXXX component trial, the this primary to now in XXXX of as the endpoint the guided. expect six-week previously we With than by the of we summer patients, number pivotal rather

clinicians. integrate the the believe implementation which Additionally, COMP to bias the the patients we pivotal a off trial study, the follow-up X our plans from more Building for will and into long-term the selection lessons Phase Phase reduce our strategy trials, Xb follow-up follow-up for enable XXX streamlined we burden long-term program. design, and the finalized on is two

arms, repeat day dose and and receive of XX milligrams XX at to with now and Again, remind two XXX, three described which COMP you trial COMP same milligram where comparing just dose the monotherapy three. the doses one I COMPXXX week trials fixed patients are pivotal XXX, X a will milligrams,

assessment A. follow which analysis weeks The for Part each at of calling In will the primary same to each Part we're of each the both follow up follows we trial. on trials, endpoint weeks, will XX trial XX design patients principles B pivotal six building trial to weeks. from six-week the

meet their XX option the arms both according allocation to who a receive studies, retreatment in in further weeks. to criteria treatment between have randomized Patients original to comparison will B thus Part for preserving the

will as Part an XX run to of the trial. XX component weeks from open-label weeks C

in entire Importantly, open will who criteria This patients have dose XX-milligram expected a is the patient to option all meet of trials. engagement support receive for option of Part throughout retreatment C single COMPXXX the label. to the duration

MADRS will primary questions from It's line of results important value design no confident from trial to durability is that retreatment. change change there key announce which six intention is provide that nor of top primary the effect the trial, endpoint to this to weeks, to endpoint our We're baseline the the of of on at trial to time. emphasize insights that at either each in and

value COMPXXX. often condition. and with generate a behaves that in believe patients have these disorder randomization XX our potential and to regulators potential continuing is of weeks, amendments chronic evidence trials, for longer TRD payers. enhances the help will retreatment and that X By Moreover, Phase program much to other further data depressive durability enhance we clinicians, to generate like patients, following We unique conventional which the could major benefit than the

XXX protocol We've they further comments earlier to if their feedback they and retreatment March us to have FDA, durability by submitted come XX principles. these amendments indicated the following had design will who back on on any

it's this with especially designation. trials, Phase therapy and underway will, that do to our with that of as comments, we course, routine receive conduct X ongoing FDA program the I that the we If is breakthrough an already consider have we further you dialogue feedback. remind

bipolar COMPXXX. by is evidence with patients. In program of dosing exploratory enrolled of American we're broader PTSD in Neuropsychopharmacology. COMPXXX the progressing presented an December, Let investigator Meeting data from open-label depression College of investigator-led The initiative now Annual me to developing for at of X were the the turn X Phase type body the

signals of safety the for XX response at psilocybin MADRS efficacy early remission a positive therapy. XX-milligram therapy after with single the COMPXXX of meeting investigated and XX in of XX results study the scale The of This patients. criteria and showed weeks dose psilocybin XX efficacy patients COMPXXX

data We that believe these a in no these you, symptoms I of psilocybin study small are depression. hypomanic remind was now further and larger Notably, in need be though an ideation. manic to studies. subject remarkable difficult-to-treat and had evidence potential this that or or the findings for support validated therapy COMPXXX provide suicidal to increase

COMPXXX December, the as see comparing further true compelling mental COMPXXX in no and I Also earlier, serious efficacy of published. evidence which referenced with patients, placebo enrolled dose for help XX of living patients the with randomized in blinded illness. weight-based to demonstrated this signal. Zurich study study variable MDD, We results This a safety new to was potential

trial mental nervosa. FDA-approved anorexia We're pioneering unmet pharmaceutical This to and there need to are mortality that of build Phase of so an for the is Turning critical robust a available the area experience a any X remind to on on we remains serious with you significant rate generated body product committed evidence illness. no highest this curve. steep of already investigator-initiated studies. no in I indication, learning

We've of we need to make to this that the better patient learned amendments population. needs vulnerable to our highly protocol meet

physicians TRD centers see no program. Phase from the protocol by specialized this in is patient unlikely it's impact on a result, XXXX. TRD we very population As will and different Please a to has different that X need at that top our data treated amend note line patients, that largely this

In the strong quarter extraordinary quarter year COMPASS a XXXX closing, progress, reiterate Pathways. a we last progress believe capping that of let of was me for of

results bring Our Phase to to COMPXXX regulatory and psilocybin ever study underway, psychological patients, and continue study the with excited most journey X we're the to support study, largest robust is in to approval. psilocybin subject therapy

I'll financial call the overview. now to for Mike hand the

Mike Falvey

Thank in then more the you, the full detail. of quarter results start will summary Kabir. brief with I results fourth year and review a

results non-cash same share-based million and million per period ended $XX.X the in For with share $XX.X net $XX.X compared was the loss share December XX, year, include with $X.X or or XXXX in in per $X.XX million These $XX during expenses $XX.X the during compensation same million of net period of in R&D a XXXX. million, loss XXXX, were XXXX. XXXX. million compared $X.XX

G&A with during XXXX. $XX.X same in million the $XX.X compared And were expenses million period

Our places. in number Phase fourth commencement reflect a X trial quarter of our the of results in TRD

million, ended the XX, XXXX. a For per ended loss $X.XX September million, the include of or net million three third $XX.X December and results in fourth three XX, was per quarter. in or $X.X with compensation $X.XX share-based compared XXXX, share, $X.X $XX.X loss These net months share months million non-cash the for the of quarter

million the This The with expenses and in quarter, Phase facility outside fourth $XX to offset were with due increase legal fees. in due the million personnel the G&A in and in trial. compared X X R&D start. the increased third were the decreased personnel $XX.X our quarter. spending development Phase R&D fourth $XX.X quarter in costs compared expenses to million growth due expenses million third to and quarter, by partially professional $XX.X was were

We million million $XXX.X XX, December equivalents COMPASS strong at position and maintain September at compared and with $XXX.X to believe XXXX. at that cash financial of continues cash XX, with December a XXXX, XXXX, $XXX.X million XX,

million by of cash our by balance cash using impact pounds. balances exchange to due in in on decreased cash Our a of $XX.X offset in quarter partially operating held the change XXXX million million $XX.X of British due to fourth $XX.X rates the

quarter tax This the $X.X of non-cash driven partially received also by used The charges our CRO, this quarters by R&D loss as from increases cash next expenses progresses. offset credit. number will for expenses largely was is prepaid Phase cash support to program R&D movement X in XXXX be operating our UK million few by our we partially our to which over net a and reduced usage

two increase appreciated rates Our British cash on to the fourth exchange cash balance dollar consecutive versus also in the our currency impact quarters an pound the the of quarter. balance. record of After reflects declines,

pounds proportion our cash exchange As each we in our XX exchange them, intend for than hold these spend fluctuations are in in rather not our months. fund to currency. balances and the a our least reminder, which dollars, runway, plans euros significantly rates to next impact at spending foreign Since balances continues we operations in expected cash to to

at balance to our sheet strong as our as create intend asset, value continuing therapies, view to time for while important manage to carefully, we an same the strategic which invest promising shareholders. advance potential We we

year guidance XXXX. As previously and full the quarter the providing are financial indicated, we first for

activities to first used operating be million expect full $XX quarter million in to and the to million We of net range of the be in in million. $XX range year the $XXX $XX the to cash

due quarter in first to in phase. its the the is Phase start-up range The to outlays cash precise support predicting timing of challenge X the program

reaches offer to quarters, in trial state the future range. a steady we quarterly plan As enrollment narrower

call now to the back Thank I'll turn Kabir. you and

Kabir Nath

area of our continue Mike. addressing challenges. to application. we therapy believe Phase an target lead first but leader has complex you, potential our therapeutic X, science, the in is for Thank indication psilocybin With asset in depression, broad be COMPXXX industry Treatment-resistant we that COMPXXX

We is commercial also at the important continue strategy. our launch. reimbursement have advance focused and process, participated to CPT on place this we code soon, to codes codes new final towards this we final An and in stages code. the objective, this called step precursor February, CPT in tracking In be the of hope to available meeting the the have commercial would to

successfully. Our call. strategy, approval, strategy continue for therapy by COMOXXX lead provide is creation, launch. this can needed that believe you, today's regulatory execute in reimburse as both as to we psilocybin designed to significant and participation as robust new again, the your payers to value this the once comprehensive to We therapy upon Thank evidence support well

now we'll so call hand I you. operator. to will turn back Q&A, And Thank the to the

Operator

Duncan [Operator Charles from first is Cantor And our with Instructions] Fitzgerald. question

Your line is open.

Charles Duncan

Thank that. thoughts I'm interesting. guess, questions on for effect team. on thanks and ultimately, a sample clearly, has you questions little our can could the bit downward. wondering, you on give what of size that that on out that on, Yes, also size that resulted ask and I this But that Phase in good out did you a prior you of you're morning, to whether couple update trial a color if perspective your study? us provide the was for have taking more program, or the Kabir the X you for saw changes not saw. And you, of adjustment responses X-milligram I looking some of

Kabir Nath

question the Charles. Thanks for

this control. So as something for a the Xb, recall, we able that largely X-milligram And the looks expect, naive as do conforms psychedelics, that saw as of around experience patients And given us, range the in psychedelic experience. to psychodelic naive majority further placebo but X-milligram were Phase the essentially response. no on of to we in effectively the like you'll kind analysis, was to a the you'd clustered arm, was population, a

we to with around able that between was data. that validate, that assumptions which MADRS, pure MDD, see likely difference analyze actually the were a from of around Zurich again true thinking data to a, our And our data were from outcome. that, used the were on Phase in was we Xb lower and from And then correlation to able When baseline the the that placebo arm COMP some in study arm. validate our strong able We able lack fact of in to again, in placebo internal XXX. a

assume three the something COMP uses the the As arms we can there. XXX, around of course, difference same so recall you treatment as Xb,

treatment with confident different, our We're what that actual not the a power confirm but from we are we size that the I But the the treatment and very outcome. are haven't for. comfortable are validity the true We the looking placebo disclose to affect or will disclosed difference arm. powering that the of that differences we can reduced we perspective, at is maintaining don't for are that intend integrity

Charles Duncan

sense. Makes

in just of that's patients was mentioned is in Sounds worked intrigued actually drug patients I'll with out importantly, is of being I'm that then or really bigger. some suggest follow-up back brief if from you time. B patient add wanted. to really some If thinking I that on was that through if the ask the Part what agency more that. Or I that wondering and the for I'm that over suggesting engagement you one weeks. just take result queue. investigators able may part your value terms And that you guess the like could XX feedback to with hop delta knew patients that the some

Kabir Nath

we But I a combination where study, challenge them having separate long say those for for not option randomized continued they a is actually XXX, patients. dose would a in of learning relevant option for that we'd yes, the as had No, investigators very I patients to actually thanks. as I retreatment. recognized all denied re-consent it's both to and a regulators, a potentially as But payers, of from well. single that integrating. that but all And mentioned from opposed clinicians out where terms also is plus clear from clearly a think, I it's understanding to information I time things. was mean the maintaining in for And as partly dose weeks a as believe that well durability as of XX further that course,

Charles Duncan

for taking Thanks my Okay. questions.

Kabir Nath

Charles. Thanks,

Operator

our with Baral One Cowen. next you. And question. question our for Thank next moment from Ritu comes

line Your open. is

Ritu Baral

B? – C some is got same Good or then And to for morning, the guess XXX? I Part guys. follow-up. different Part described taking for in is wanted for question. of C Thanks the for the a just And about I about and threshold ask more I've B Part the Part protocol XXX. details retreatment What of it

Kabir Nath

is – so do retreat people who relapse it not who after either will remit So we or remitting. what

the is original and criteria retreatment that for for the will So in it be with B. is B line Remembering assignment. our retreatment option that in there in randomized Part Part one

Part that. will it's C the what on to, thing. depending be same were open dose again retreatment randomized with the And So you label

Ritu Baral

that is MADRS clinician it particular is And or discretion? there a threshold a defined relapse

Kabir Nath

we specific disclosed is a perspective. haven't from There at the a one, moment competitive which

Ritu Baral

Fair enough.

And describe protocol the amendments. Okay. And they drove you were? essentially what nervosa anorexia them. then what Can

patient generally investors unfamiliar with relatively I this population. think are

were to us are new to considerations very likely new you So well? that as what

Kabir Nath

you. Thank question. great a It's No.

say straightforward, we're mean would So amendments I some are more that's of I those some thinking what about. is

willingness they work not be. what I is in learned already perhaps So able this vulnerable challenging. in there's population just the with clearly fact challenging to very the to would this think were we was fully an patients how aware even the that patient is highly from IIS element participate trial are that investigators of is know. a a We that And openness, where

number that. we're of been thinking of things scales have -- about kind is to some too tried much visits the and we we So over into again actually just get of

challenges I criteria around need a to first working we some sure study this that's of this move can have meets protocol think the as thing of population. of I we we and the actually that screening learn make continue that population. with But that the and say patient this expect to would around forward to

Ritu Baral

actually And haven't can talk activation -- correct? about be I going? also site XXX, you in to you just Understood. is can first you And how wanted your talk dosed patient clear, just about

Kabir Nath

Yeah.

you going activation well. are is correct. So And site

sites for We XXX. have more actually both now than XXX a dozen activated and

takes which second Just individual I long site experience, we complex the remind time. unfortunately. despite getting around the that it's It's our time these studies know activation for you, licenses quicker no a DEA all

So to that underway. of or in they're screening, from wash again, we is whatever them patients need out many but have And well SSRIs on.

So that's we guidance reiterating and we're where But timing why kind we've at guidance on first the period washout are for extended. with XXX. comfortable XXX of the the new and for given is

Ritu Baral

all questions. taking Perfect. Thanks for the

Kabir Nath

Thanks, Ritu.

Operator

you. company François from next Brisebois question the our And One is is question. for and Thank next the Oppenheimer. moment

is open. line Your

François Brisebois

was part was think add you code touched Hey, just because story guys. comments wondering color just and on here? if that wondering to can the Thanks launch Mike's for very -- important at taking I do the on CPT you it's a the of after and you I questions. touched Kabir, reimbursement. I

Kabir Nath

Happy to. Sure.

eight this recognize learning needed some the to hadn't Spravato We place. from unprecedented. six comprehensive strategy necessarily potentially from we perspective extended code a that towards around with a monitoring recognize a that in session kind is place it that And that of could administration the Janssen what we put cover the also happened fact in put hours get-go of to from launched administration. of So psilocybin essentially actually that

So both submission with had we're psychiatrists associations meeting and I the the confident that for time actually working professional psychologists now in think other team the significant has the meetings necessary will very and two We've get groups a of essentially been period latest to AMA. February both code. we APAs, a that and now tracking made

issued commercial previous say a of what a launch understand those be the to months. initially of launch that recognize have soon conduct that even Now it's confident, experience, new of the to to us trials, as was the or evidence place be said, possible. work will And as once to actually code to we're but it use reimbursable able we'll at is soon supporting that, tracking will start that couple to And code by in during learning that next into body that -- clearly, I essential from this after. code, of allocation to build turn the be whom allow But after soon I as in the administration the we as sessions. should

François Brisebois

purely is in psychological administration, code? support. Okay. you or there in that code the that related could intended And encompassed be to any mentioned – Is the that that support word

Kabir Nath

Yeah.

a which as experience, It not needs is what the the cover and there interventional. it's to code services is administration cover be existing therapy, to define the sessions by is know, really not So is in but session. the for because our to provided their patient This And we trained through it professionals metapsychology integration you not codes it's the that. view that, offer and designed is support directed, as support can are shorter. preparation we

François Brisebois

there's lastly that, new here. it's unknowns lot and just And Great. a because of a Okay. on field

past in support of in you of psychotherapy? just about evolved talk your to years learning's difference the And of can that and clear, Just psychological at terms how maybe looking year, be of thinking two the this in the the between approach? has terms

Kabir Nath

topic, a much we could which is into longer. this and dive – So

critical. we seen particularly expectations setting preparation, Clearly, treatments perspective have think our of things it's acknowledging from ensuring right are for the a possible think are trial as There be and we're on. clinical we perspective, the are there I the may so support. absolutely patient, psychological right start, critical, from where the this that a COMPASS in from variety

that, around But across very from administration we rather is. and very mind the support been the I there wide always have that, always a think this view during been psychological is of But is I'm COMPASS opinions than our psilocybin itself, therapy the is where of clear range word conscious we've opposed the therapy. directed as clear to support, psychedelic-assisted community. of use to fact that

François Brisebois

you see guys you quarter. and Great. Thank next

Kabir Nath

Thanks, François.

Operator

Trucchio One Patrick for question Wainwright. next Thank moment H.C. our next And you. with from question. our is

is open. line Your

Patrick Trucchio

Thanks. Good morning.

the an top readouts Just the if component a XXX you do long-term changes on you would the I'm outcomes also TRD, following TRD protocol to clarification able line NDA Phase be need program. to for from to the and X that would wondering, or trials? XXX submit the

Kabir Nath

I We It's we X, question. more a be. endpoint a primary it's get that, clearly exactly strategy the start a and hand, entirety XXX, endpoints course, our dialogue will as think, would we full for by regulatory to think that on I as the the that XX out than time is premature weeks. to will it's XXX six And the point data-driven. know of But of we would of it's at would what pretty a the see primary little And the be. Phase perspective. weeks And XXX What actually I in what dataset that, agency we XXX. to still speculate see great from the premature have robust with regulatory clearly,

Patrick Trucchio

in trial wondering, follow-up a I'm And And in you ahead have helpful. That's move then a can to intend I Phase on that. if with whether depression. COMXXX bipolar you discuss Yeah. X would

Kabir Nath

Thank you.

amazing, the but site. XX like XX out single So open-label mean, – are it XX results we just patients is I I of and said, are

to. So we we'd recognize validate in that order have to that really

and what right for thinking arm relatively sort but you that early would what what of around a need control sort it's bipolar of now design is thinking would are like stages. We size, look

Patrick Trucchio

Got it.

maybe a guess, helpful. I That's And Okay. then, separate question. just

short-acting mechanism of Just with around multiple clinical There's the development. course, with short-acting compounds action advancing of -- that longer-acting also of some advancing there's agents. programs, or are psychedelic

And wondering, COMXXX X-MeO-DMT. the including trials approaches of some compared advantages advantages as other how out to of discuss to if of and like demonstrated now you underway. compounds how so in are the of or builds would And Phase you I'm DMT other can be expect -- X the kind of that space those these these program some COMPXXX

Kabir Nath

question. my a It's data And good agents fundamental I think without will response so where on. those mean determine -- best what and so are is used I is

So some other Phase like some in shorter-acting, particular too by mechanisms of and emerging X in by are around that validated larger it's will out. it's molecules, until the of everyone, intrigued that's we're questions in attempting of shake studies much we're answer data answered durability from field to the been say to kind these other how but early

from say obviously say experiences is of is patient very thought into has also are route by -- shorter-acting a school different think we'd definition easier we what while shall perspective. they a an I But says And a there commercialization. that

before I have and understand experience is alone whether of so think duration that to key differentiation. fact to data know before in it's way a kind seen patients the we premature we've

that space forward I'm other continue to watch and pleased agents data. with obviously moving good the we are So

way perspective. long that's results competitive perspective a a the patient looks from we're But for set fantastic think from think what for and the field determining I like and ultimately a patients. I

Patrick Trucchio

helpful. Thank very you That’s Okay. much.

Steven Schultz

Thanks, Patrick.

Operator

And One you. Elemer our is Thank question Piros with question. for our moment next next EF Group. Hutton from

Your line is open.

Elemer Piros

B if be and please retreatment there paradigm for you question, would Thank XXX the in What clarify my could taking XXX the morning. I'd Good to Yes. a you Kabir. Port that in -- like trials? both

Kabir Nath

Yes.

So Clearly, who the those is their in original as it for not for retreatment choice do remembering option earlier after remission patient's that B. it's in we will be relapse treatment. Part said the respond assigned there who

Elemer Piros

So it is true.

will occur even retreatment trial? XXX in So the

Kabir Nath

either patient yes. or choice retreatment at So placebo XX-milligram with

Elemer Piros

the to be just clarified, sure understand just would those you not I want make retreated. think I And even that to responding but have who I well that are Okay. option

Kabir Nath

Correct.

Elemer Piros

really it's who remission not remission. out and of So went into those fell

Kabir Nath

Correct.

Elemer Piros

single retreatment, this is And a Kabir?

Kabir Nath

Yes, yes.

Elemer Piros

Okay.

I establish potentially in effort code, to their to are working activities? a the think together with harmonize MAPS And your endeavor got I in that. you

Kabir Nath

are. we Yes,

working As we with we've said yes are before, MAPS.

Elemer Piros

And one you internal be agents? other to your provide able please. Okay. last question programs an would When R&D on into psychoactive update

Kabir Nath

don't know. back we'll I did We say that question. Markets good course. that very that landed and Day, you. actually on as at haven't due we -- We'll mentioned but come you a take do That's to we Capital in would internally

Elemer Piros

Okay. much for the so update. Thank you

Kabir Nath

Elemer. you, Thank

Operator

Thank next our Neena with question. moment question And from for next you. Bitritto-Garg our One is Citi.

is line Your open.

Neena Bitritto-Garg

Hi guys. Thanks questions. for taking my

So, I just have two.

So just first time at clarify Part the to just Part studies. XXX retreatment or earlier XXX could going during the Part and is possibly be in you in XX it B back can and in Can one go C or a only session, third the retreated C six-month point and Part B second, C? this Part dosing then XX through patients week and week that patient so

sheet. just of second quarters you're a on my is cash. question balance then maybe And couple this going end to It the cash with looks like year of and

planning how runway? So, curious with on cash Thanks. the just dealing you're

Kabir Nath

Thanks Neena.

is and this sorry, yes, So hard. all I doing know verbally

would be to a B, to be eligible have in that failure So expect would C clear XX dose. we Part and retreatment in option pretty Part the be C, COMPXXX Part then to are between to for who on chose respond. depending patients early and And six or in relapse those for week

of the after be XX-week would section. the open-label soon that So final start

Mike Falvey

yeah, runway. it moves operating we front we're our and And then runway, on financing that could the also the from make at looking to so a perspectives, couple of lengthen

market difficult it X a the said last having very have had Markets a from really from environment sophisticated Day And investors serious our remains it's Phase a Capital since that, front, But financing financing of biotech we the we announced On for attention interest lot at investors. fall. biotech.

So investors. those the I right offering still as do circumstances, opportunity but mentioned it's an challenging could that there's environment interested equity we with an a under

Secondly, we do ATM place. have in an

take lastly I to opportunity want up to there's were then a an us debt. cash. that's for to investor new way a raise equity and And think potentially a there's, if So issue position with

that little be forms market bit think Now think kinds of stated stage considering past, have in the to to environments early do be we're in of we've we we a these but flexible. debt, I

right another So way runway would to financing. the that continue the of under circumstances, to be the lengthen

XXXX and we've And disciplined we sure to we've start company long really that investments on focused to on then balance the X all in have way Phase and execute we strong our end the advanced just Phase at runway. on results further continue the really to well been Phase prepare sheet of grown have as lastly, able and and making being the as announced side, a X really operating programs on the the since very dated the have X two

we've do pretty key that's And in way done balance And think important create that's us going to while successfully. sheet as strategic a that asset want potential And those for shareholders. an breakthrough going we've it for to a value I to-date pursue to And our these always going said, efforts so be will we therapies, forward. and continue. view want we our we strong to

Neena Bitritto-Garg

you. Thank helpful. it. It's Got

Operator

our our have we next Bert for Thank question. you. from moment with One Hazlett BTIG. next question And

Your line is open.

Bert Hazlett

my taking you you. Thank for Thank question.

I'll on You intellectual COMPXXX. covered lot call. property, think on might on of And ground if I a I this ask just

material number XXXX. pending of were with your expire Thanks. applications. for IP that Has other any importance? about evolution regard or COMPXXX there that to been a patents of are elements There protection talked that and You've to

Kabir Nath

Bert. Thanks

our was no, also appeal So, patents recall another was note, that rejected appealed. They organization. to And except you'll new by in one February. that three challenged challenge disclose here, of That rejected. nothing were

the that's update. So actually only

of be XXXX. to that a state out continue have to We confident robust protection we

Bert Hazlett

for on you Thank you. Thank the retreatment, helpful. very clarity Thanks. additional the

Kabir Nath

Thanks Bert.

Operator

Thank you. for next our our One moment question And from Qian with is CGS. next Kyle question.

Your open. is line

Kyle Qian

not an I'm a thought is open-label reaching Thanks. Kulkarni. as-needed Maybe has -- development This been maybe for Hello. from implemented. an company speaking basis us, process the why has a few retreatment, Kyle to in paradigm duration? Sumant for doing of curious, longer for the longer-term on on And that a retreatment that the

Kabir Nath

Kyle. proposing clarify as-needed No. when retreatments, multiple Thank just you you, to you're on And yes. say an,

Kyle Qian

Yeah.

more like and a over than example, year one retreatment? duration For potentially

Kabir Nath

program terms X is the reality No. as yes, we not is a of I of design we out. all in all fair considered well. question. a to how however, and it it, we variety payers, regulators, is extend And to And answer It's on designs those Phase know answer going so our of clinicians questions think, the that we the satisfaction of this

as expect antidepressants at that. two doses without we per XXX arrived allow single we and getting protocol to to something what as with terms Ultimately, also clarity recognizing or that you'd on did you a the or durability trade-off was point, retreatment in because potentially go on in of that one happens sustain of dose back on IIb have to ethically some patients to cannot in you expect at

So, ultimately, is actually if on SSRI the multiple they're interpretability to background challenging. doses already of going be

again as interesting is clinicians impact background the in on case on of I single label the the that with therapy. open the perspective about think of data a that from in to and so the this re-dose

This we there designs -- of stakeholders. balancing it's needs different of in the acknowledge I no, different have gone for also think choice. right could the and are we was terms the But interpretability

Kyle Qian

Got In have as And you bipolar incidents the it. of many nervosa ideation be? of And suicidal percent observed of studies as non-TRD MDD all maybe to-date? how would anorexia that more. such what total in Thanks, one or

Kabir Nath

back don't get MDD to So, particularly cover. you this. anything have would to finding, actually have I'm Zurich which study from aware with will I of but in we to specific not I come to with the I'll back need you data. that any

patients. saw examples I we in those that is among the There were of I investor that me these study, as mentioned -- Steve remember none. no bipolar in XX are I And of presentation. As some reminding our think

Operator

Brisebois And you. question we Oppenheimer. a have follow-up Thank Frank with from

Your open. line is

François Brisebois

Hi, thank you.

here. one quick a Just

just is You amendments. mentioned trying of to out the Is would disclose expectations waiting you'll March for this that XXth terms from maybe should feedback on be that or something of XXX, this in that getting you in just accordingly, -- the or -- FDA feedback of hear and I'm adjust date. terms what something we figure your

Kabir Nath

Yes.

you and of have typically as actually and to not lot company I know as on. the would the fro a to disclosed So, amendments mean FDA for we correspondence fro have any we including because and our with of you expect protocol Phase so III

the a terms what said XXX the ultimately that in power this analysis decision around That data we We and first though believe recognize on that that's and we both the significant treatment in sizing based of XXX flag was follow-up that believe sponsor of difference. we sufficiently the terms long-term integration of wanted of our of it. and to

that's with long-term FDA. design principles the for worked through And follow-up aligned had that the with we clearly the

but So, they comments changes significance the that date to not I clearing that us acknowledge wanted as making back particular if think with there in to which we will any. see the event, of said a we is we're a also given they get do

François Brisebois

Perfect. Thank you.

Operator

no questions back like for closing time. management this conference now to to I would showing further And I'm turn at the remarks.

Steven Schultz

Thank you, Amy.

Thanks Thank your today. And many us happy much more. find take always thanks to to as the know questions. and always you So, for where for very we're everyone. you participation

thanks great So, a everyone. day. Have

Operator

concludes this And participating. conference call. Thank for you today's

You may disconnect. now

COMPASS Pathways (CMPS) 28 Feb 232022 Q4 Earnings call transcript