- Earnings call transcript Q3 2022

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Stephen Bardin

Hi, everyone and welcome to the Atai Life Sciences Third Quarter Earnings Call. I am Stephen Bardin, CFO of Atai and I am very pleased to have you with us. I am joined by our CEO and Co-Founder, Florian Brand as well as our CSO and Co-Founder, Srini Rao. Today, we will be speaking with two of our long-term analysts; Andrew Tsai from Jefferies and Ritu Baral from Cowen.

Over the next 30 minutes, Andrew and Ritu will be asking us about recent progress across the pipeline and upcoming catalysts. may standard about our performance, Atai’s risks uncertainties the include today subject for to and statements results forward-looking future that now reminder discussion that may to differ. And actual cause results and Atai statements speak does only such which today. not obligation of update any undertake to as

comment the financial the takeaways included kicking off on release. Before in interview, I’ll key today’s earnings

line QX with was was $XX our million cash operating there. of so expectations, in use no surprises First, and

an our previously $XXX I debt to mid-August, want everyone of cash access capital runway cash we into We QX ended to Next, Hercules, balance reiterate XXXX. with position. up when facility, cash. provides million. announced which extending plus initial down the the remind gives million. facility This strong in in drew Hercules We we to closed a Back with our $XXX $XX facility million us

mic to Let’s hand interview Ritu the I’ll Ritu? to started. Cowen start section. us over from our get

Ritu Baral

there has of Stephen. as news Thanks, late. company our been of Florian, around flow lot a

familiar to get ones high your it, we of summary and it, recent brief be please Atai? provide progress level not too milestones might with most for could who upcoming the a you with Before

Florian Brand

clinically and patients. you and both health have achieve to format. Great Ritu. sustained Absolutely, this mental of Ritu, you, behavioral in earnings as recap, meaningful back, Atai our to at is Andrew a on change Quickly interview call ultimate goal

all we X also with to have target complementary X of X be today, we programs And that neuropsychiatric major the indications, programs X and As development deem programs. those those indications. several have of in clinics, enabling technologies drug we very

we COMPXXX, be for proof efficacy that already these And efficacy to have programs X Atai. are case in these the datasets value upcoming path to data of all inflection a have going the either years. of next really achieved expect or concept, over addition, In of points

have and very KUR-XXX, we addition encouraging initial to announced compounds. GRX-XXX, compound of briefly, mitragynine course, very, development drive Phase positive that initiations, deuterated multiple with completed Looking X showed PCN-XXX. clinical study. with of further. of trial but quarter, least, we and this in us our our to them enrollment very etifoxine results encourage announced And two at have PK/PD then those not we last We Both in the intriguing very deuterated our last programs results

the trial of to study that’s forward out in and with are coming the end proof-of-concept Phase Xa TRD around R-ketamine, this we much very data year. this the So of looking

Ritu Baral

can drug? the PCN-XXX, profile more planned of about clinical of share speaking you details Florian, target that So

Florian Brand

Sure.

So we two treatments our effect, within plan course, targeting dosing are treatment-resistant so with PCN-XXX, per of times from dimensions depression differentiated XX And very R-ketamine, approximately we be looking anticipating are or developing week. not following the or much elements, an rapid TRD. at we’re administration; but onset is at-home really so and looking unsupervised compound to focused in of depression, MDD hours; on regimen, on other intermittent dosing this

Ritu Baral

a for to see forces choose, biggest more aim or the unmet that and far profile stronger one choose, you current is you the than forces would that need options? therapy the biggest to if PK/PD you opportunity? you do treatment has the How And efficacy tolerable

Florian Brand

of or to we to basically so that sedation program at-home this why Yes, without the to supervision. profile that’s data like And and key this PCN-XXX compound also sedation for is at allows – that demonstrating that dissociation allows use. home really administer demonstrate happen,

within the prominent of other product terms kind our in looking, we’re internal other is as to esketamine comparable efficacy, of be ketamine. goal, depression treatments, terms to enantiomer approved in While such of

Ritu Baral

practically that previously do of and X, and X Exactly ratio I math think what what’s reach you disclosed does mean the And that it. dissociation. analysis? target sedation ratio risk Got that, if the safety behind of risk

Srini Rao

Yes.

in So ratio of that and both is let compare risk summary you to calculating X. So XX% patients you abnormal are percentages normal very right? basically percentage. – course, or that’s you ratio them So MOAA/S ranges have ratio, way that’s the can obviously, you and you what point. if you arm and similar then the for for placebo right? normal arm, across a we and approval. can how risk jump break of into Essentially, there are their each in SPRAVATO it’s can risk the XX a abnormal arm, me arms. is basis take in – and on Basically, drug a generate now – a and gives was those And risk that And were it’s just sedated, used of with example, CADSS, those that essentially ratio

Ritu Baral

on population So basis. on individual rather basis, than an more of it’s pioneering a a analysis

Srini Rao

And the right. more also agency looked abnormal incidents. severe exactly That’s versus and at looked at normal they

example, for that also they sedation, look something was So severe at.

reason that define we’ll taking. of we the that’s comparable say to to of idea, we criteria general is placebo. it’s ratios Florian the at-home targeting a the tack And is is be essentially risk use. ways this So the that as really And that mentioned, course, That’s argument. in are many X

that Eszopiclone data hallucinations there is there and is prominent. but dissociation sedation, than higher fantastic less that’s drugs So quite sedating, data fact, Lunesta. can we around of is know that many-fold quite a se, per plenty in there example, be that are are sedating certainly There placebo. for out around

X% X% the hallucinations So, pretty used, drug. on [indiscernible], hallucinations widely for it’s placebo,

risk see can effects ratio I mean side some prominent of you how these of So a you be. from sense get how – prominent perspective, a

number, in are So put markedly placebo and comparable fine, markedly than get better forward a SPRAVATO regard. saying, a to better, let’s best let’s get ratio our foot okay, we that’s that

Ritu Baral

like need? accepted? are And at-home comp And there unmet that at-home you far comp? practical that, so that for profiles good of Maybe that other Lunesta, a what’s than drug that represent what’s can best what’s push other good will a the need, profile How address that? a would

Srini Rao

an interesting that’s question. Yes,

in So approval SPRAVATO the little I that of think did a something is the unusual. FDA

adverse So normally are two – In dissociation right? sedation on events, event, spontaneous sedation, when about were cetera, case a and about are the those adverse these talk event, adverse et any of thinking just specifically So right? the that instruments about outcomes, was particular SPRAVATO, focus to you you talk normally there or dissociation. designed measure

a they something. the Adverse So sedation, the dissociation, to was and as they event logic There use – that. rates certain MOAA/S that can was our of that trained CADSS. point use is on basis everything. change get doctors And

tough term, certain and can using patient complicated, to that terms map get I – CADSS, a metrics, is to up patient that right? I’m using So or does report little doctor the using of term bit pick you that’s What So a on. a that dissociated, the MOAA/S what does the kind issue. when dissociation one to onto is I a entire mean? have mean, prefer

that in regard. did the to I the out that the It we is And reason the regard. CADSS either MOAA/S of have Nidra exploration best turns So don’t fair in we analog the bring our knowledge. or States a amount in United of the in has up the that an exact label

and one, or rates So things more we interesting again, is BELVIQ hallucination lorcaserin interesting BELVIQ is back an to, It’s around an nature. of went Certainly, analog. that multiples.

dose of an ways. therapeutic that because get know – we’re kind is interesting creates we’re kind many multiple to hallucinating of trying or That’s drug pronounced to So hallucinations. of a product to right? we in get the here, that’s multiples to trying are quite what very a and therapeutic Dissociation, in at dissociations that index but to analogous get results trying

Ritu Baral

Andrew? Thanks.

Andrew Tsai

Ritu. Thanks, Sure.

So guys. like guys because for I be we – you to but touched big could data a want on PCN-XXX you I on safety think enough, do readout stay it

your framework why to X let’s X, why calculus? to placebo bar? did you What efficacy the that at maybe went hour on shift Why not X, So X? How be points not versus XX then. decide into

Srini Rao

Florian mentioned, change cetera. of X the X could on MADRS we’re as for our studies, weeks, is final endpoint, the X pivotal based points the Well, be looking at et order weeks, label, on ultimately in what which

not – that don’t yet. clearly – just got guided that have haven’t a have we of have that We good sense we on

we’re So that’s what looking for ultimately.

a there, to is a how is different single this can and a right? regard, this formulation, X a it’s of it got experiment it’s you our like that’s should backtrack we trial, in considering essence, Phase backtrack from study, this we dose triangulate number. got look in this we what So kind how on X. So first that’s Also,

signs, ketamine range. of are esketamine look and similar patients have XX the X that your X you in to numbers per at X, order range, on kind somewhere of arm, in of other the if that So trials

we two different these again, triangulate of So the on number. data use that to are the points sort

Andrew Tsai

see. I see. I

tempted tends at report Street across data, when the SPRAVATO compare to Wall shows what naturally, might they so And compare XX. maybe And be trials. you to hour

would or fair that if So it why guess? I be guess not, directly, fair compare not to I why is

Srini Rao

It the study, studies unreasonable are terms in of the types depending XXXX, is larger size. on right? the not [indiscernible] the So potentially of studies those

are I magnitude on some that – first think where There IV may some have you’re that J&J efficacy Xa trial that exaggerated trial are very esketamine. there focusing that the the of conducted with headed things of is form there. Phase of features that with

it’s study, a small right? It’s XX of all, only First per group.

only was X.X the X group mpk fact, In subjects.

over had many sites. course. – issue. of sites, So are had XX that we and X, It’s that’s well They those – know recruiting, one we they fewer certainly actively so do actually – many how don’t of and

mpk The So CADSS, if esketamine placebo numbers however, number really that trial, small. factor. that may be either functionally for quite So high. X.X quite that mpk were at is most in X.X you unwinding The or for CADSS factor, right? the another CADSS look important very was were the

occurring doses a So trial Obviously, well very results. unwinding there with was in chose we the trial. was our is that Xa something very we’re anticipating that that that definition, sway that that in Phase functional the pronounced could by not

Andrew Tsai

Makes sense.

scenario And maybe so we shouldn’t you go bigger would is would or cause you a efficacy which like Xb that? something like What see safety? on What picture, forward? the in or reassess to moving you Phase into say what

Florian Brand

efficacy, you I On before. think it mentioned

So right, single dose of really this study, a is PCN-XXX.

While foresees the doses earlier. per discussed as actually we TPP multiple week

guided potential to we very all – greater approved what of really course, therapeutic I also And clinical regarding index considered and to testing is is internally as study a data any important reassessing we compared preclinical lead trial below that is plan that that that, into remember it’s R-ketamine disclosed me current clinically to depression. dose be I in what emphasize this have this studying objective in won’t on, in very that first the certainly other thresholds, third to options. let remain based single achieve that but specific the whether you But a terms existing confident to can Day objectives of about So we R&D all and Srini we parties development treatment for would mentioned, Xa. clinical have specifics, tell of meaningful treatment-resistant us discussed efficacy the from go whether our on Phase

Andrew Tsai

Ritu, back Okay. Alright. I’ll Thanks. And I’ll – to you. it give hand

Ritu Baral

Andrew. Thanks,

how you two select consider did profiles, to you doses bringing two versus this again, safety would guys the And trial? question for Phase X? that different So forward doses into going two efficacy back with

Srini Rao

Yes.

based So stop. full the selection on was our X dose Phase

dissociative, around consistent ago So XX were what range a is milligrams, and XXX XX, and that the one dose doses then trial of index. with other one milligrams essentially I we one our the and XX, is sub and picked – dissociative now, at between. of course. – or years XX we by looked And other XX to was conducted of that threshold doses hypothesis And that’s that milligrams. And X essentially mean up that that therapeutic we picked we’ve

by allows index, properly So X from have hypothesis to results the study. will our healthy therapeutic much that definition, based a this volunteer we our on Phase us test pretty

there the go the love mean is to on a Doctors second multiple results that forward as question in whether may doses. the of rich And them. physician’s sort be vis-à-vis important, of at general that flexibility. front a different yes, trials. about I subsequent bringing history it depends in to potentially, tolerability Now particular that’s again, mean a of well of have as patient exactly right, we course, doses additional different perspective with may that mean, sitting balance forward But be study I your of from doses, I of there and two efficacy very

Ritu Baral

what total bridging So feature is I confer you of study, the exposure? as effect Is subcu to your a anti PK/PD mean, this you guess, Is I through think it important the do depressive replicate AUC, what mechanism? you are about it think perspective from that the trying peak? IV? to most from PD

Srini Rao

a the to it’s discussion how of know seems some is, esketamine. don’t have sense the on in what a there a mean, where the I that this. to lot data There be is Cmax-driven It’s question really esketamine. concept I but that ketamine Is coalescence seems around efficacy driving it that strong with a it and fascinating effect AUC? the to. be come Cmax? that people is of Is

However, if is you compound more NMDA think antagonism, has about seems to AUC. another that [indiscernible], it which glutamatergic be

dextromethorphan, And is – around quite content the so buprenorphine far is long. of when as the half-life really

So it’s just there. sitting around kind of

course X, a of so X over days. level up first – building the You’re or the days X

case, that AUC. in it’s being It’s Cmax. So probably by not driven probably

most that’s a need total the important a or most on of is to One not handle And assess anticipates to discordant. any kind really is that will points a data important time. any then, is effect we two the subcu end, – thing course, the get the to the XXX%. But for from closely that right? more should want In nonetheless, likely these duration perspective have be the we one, Cmax. true we first. to I XXX%, really of likely bioavailability. is at bioavailability there local thing mean are we to Overall be look another So bit not There metabolism, of example. that close be

pick you for – basically look you on let’s lineup depending do the example, may be into. what some like, I the say So doses. against just you numbers – effective do will And effective. all looked may you all factors Then a right? things these these bracketing XX do those dose, mean, is may So

actually pick that different that the then the Cmax. another actually on replicates AUC little one a You but be dose replicates a and might may AUC

much So did this is pretty what in their J&J development.

that they So they ranging again. to trial around went, as but IV an intranasal, once the dose from do intranasal we’ve discussed, did

Ritu Baral

Got it. Andrew?

Andrew Tsai

efficacy than Great. to I Is placebo-adjusted Well, of something what sedation, ideally And end dissociation, the of day, then at to something safety, significantly X just on want fair here. kind is comparable that you is takeaway? placebo less hallucination, the it’s on see. of a think what provided

Srini Rao

yes. summary, Perfect

Andrew Tsai

Alright. Very good.

my Phase different. can plans. notes, And a we recently X Compass announced placebo so is maybe And actually to shift it’s their actually. They pretty in One controlled.

repeat believe. a Another one is dose, I

after are So, meeting obviously different FDA. – different with the studies there two

they So option X view in doing is types flexible view, the FDA studies? FDA your both them the to sponsors with that either your Phase to as or is do wants move of it

Srini Rao

the broadly, it’s don’t for on We answer is don’t right? provided sorts the that We the I the – is say the drug Compass controls What to have information us. short mean depending interesting different know depending an indication. question. on with can is sure, we more however, I comfortable that of and FDA

is MAPS kind fundamentally of the dose and on control It and dose with is Compass doing are is Why XXX% says placebo not okay only. the So placebo-controlled dose okay zero, a right? settled control, one that’s Really, guidance. other they one dose-controlled is certain. that. EXX So placebo-controlled? there obviously ICH is

On hand, to as interesting. is the programs. It’s other own it forward we helpful move our

that next something as will those advisement we obviously, design So trials. under we take

Andrew Tsai

as well now adding is Phase maybe integration they in X. using digital And even Compass as more on are one support

you or your is view terms I or how guess? ahead this go there view, way the to that to the about guess. psychedelic a important what is is serve these I talk think, tools these in – augment of the and it Just maximizing outcome, of your you, to in – tools Is use quantify

Srini Rao

formed you XXXX, us Yes. for itself significant time. is something in an certainly, came IntroSpect recall. about and IntroSpect focus been have that and was is I behind for of quite This area mean, this I guys time. us, a XXXX with for original together early concept The some long really late talked as in we’ve

really scalability hearts. reproducibility, of for offer allowing The is something potential therapeutics or to is dear also a been of but and therapy. for that’s digital you this will, near if that our standardization means So reason that

a vision, in allow strategic then right? change, another can SSRI, more behavior This able right? is to So have with kind behavioral effect that change setting want it’s where that something, well, course, our mean to something for to there a prep to very And that. think thing behavioral to be a are or And work this change one intention, that behavioral suggestion this There one motif strong compounds. improved concept actually that is right? what Compass it’s Psychedelic should it experience. to disconcerting. the change to setting a psychedelic very of patient central of about plasticity the there And do take is things It’s concept, maybe – period you’re if just therapeutics. more some whether that’s really be that expectations, that’s And unique. exercise response, certainly, durable expect, maybe to Telling to all a I thing has of also if critical is important, of But what experience indicated. advantage prior our or and behavior is for unique behavioral is example, you also do uninitiated, the So can that that is very plasticity improved more occurs really fantastic That’s digital we malleability that. of interesting of harnessing socialization these really habits, administration symptom. after these changes. there flexibility, effect. to

The develop was – digital combination a our working not is is in non-factorial Compass – our – The again, they have a – are therapies, term approaching It us. very that fascinating it’s Day. I’ll of love vision, put design. and of these not in have So guidance indicating it. viewing we specific something therapies, Compass there it’s a That’s art, R&D we we on they their products inseparable or together, provided to as yes, that in how – these towards, that important and caveat, our right? Do obviously course, that right? device, and been these drug that we are therapy has to So caveat highlighted being would combination really label. was that’s how

Andrew Tsai

Makes Thanks. about back on to pipeline. turn I’ll sense. Ritu, you questions the other it

Ritu Baral

Andrew. Thanks,

XXX. to I to move So want

to trial As trial, in endpoint? you look the the endpoint, endpoint scale be does you choose next And trial? would how the MCCB it did that RLXXX secondary Phase for endpoint, VRFCAT, And assess? Xa for an then the that that pivotal CIAS, efficacy primary approvable this what

Florian Brand

it while was cognition, function simulating is, has fact or been, changes past an in input – in in cognition living. by while or impact been – So of have assesses the there in it the for by they as approval was involved FDA’s the MCCB endpoint developed And activities supported – and – the fact, actually, been the of – CIAS. FDA MCCB and basically with daily the assesses VRFCAT broadly the has

also So endpoints around decision, course, of that specific this trial. went basically into the for

Ritu Baral

choose this And XX-milligram the XX-milligram study? the and doses how for did you

Florian Brand

on to of forward effects, And based doses go study the we those this was that the we year. patients year. So essentially still both larger the also anticipate with read biomarker basically And the doses initiate study the both doses this selected them. in XX-milligram, Phase clinically meaningful where Xb showed in XX-milligram basis that pro-cognitive to where data we then data earlier the or published out were our

Ritu Baral

Andrew? Great.

Andrew Tsai

on any if are year. maybe actually And following CIAS initial all? know this more Does their asset, Presumably, at I changes kind you guess. Thanks. their of confidence believe Biogen had Do sailed your they in with biomarker that one topic, shake I datasets? that that asset you

Srini Rao

We are following that asset.

of cost this no is challenging of here. the course, about of huge placed. unmet is to course, There This of the patients is personal The of these that. and, society they is following there indication. That, obviously certainly a aspects doubt the is very, cost We’re medical path need that high. indication. part appeal Obviously, very of a

changes daily small in that’s ultimately VRFCAT, activities the as going of even key. in and So actual reflected cognition in living, natural of pretty example, course, to for be and

– So on in that of biomarker don’t published anything will personally. recall terms I I data, seeing

better So read the of granular sense it a to more they that get will be even had. or results interesting get that on a

Florian Brand

with joined of and you grateful top us the the thank you much, Ritu, Andrew so unfortunately, XX hitting really being Already minutes, so again. today, for that

Ritu Baral

you. Thank

Florian Brand

And lot innovation believe, that of in is breadth we this we of I the that, programs speaks to covered in and – personally happening that session Atai. a

entire my Looking we’ve in pipeline. at quarter, the last view, across meaningful progress, our made

for standards Srini we And eagerly We we specific have dataset own a also to treatment-resistant programs. the an cannot course. as met anticipate end have Phase for around of as that wait potentially, at-home looking of ourselves Xa R-ketamine, This line targeting highest Atai that the – event we’re for delivered Andrew anticipated set be X depression. ahead, results share and top of the in can we for Phase year. And results our therapy significant mentioned, that of this be the

a sheet had strong XXXX. we’ve into runway and So balance

positioned anticipate makes quarters us across come our milestones programs. and we R-ketamine, that We the And excited, are, years. very additional our over all a other in very perspective, more and achieve to of to well beyond next lot

me thank let have that, today, you with great a for everyone, and listening week. So in

Atai Life Sciences (ATAI) 11 Nov 222022 Q3 Earnings call transcript