ATAI - Earnings call transcript Q1 2022

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Greg Weaver

Hi everyone, I’m Greg Weaver, CFO of atai Life Sciences. And I’m pleased to welcome you to our First Quarter 2022 Earnings Management Interview. I’m joined today by my colleagues, CEO, Florian Brand; and CSO, Srini Rao. We thought we do things a bit differently this time by hosting a conversation with two of our analysts, Charles Duncan from Cantor, and Ritu Baral from Cowen and we’re super excited to have them here with us today.

Over the next 30 minutes Ritu and Charles will be asking us a series of questions on our Q1 activities and progress made in our pipeline developments.

actual discussion and include to performance, uncertainties may our atai’s statements risks reminder, that results differ. future which cause a today forward-looking may about and As to results are subject does only of speak undertake statements, as obligation update today. to atai such not which any

Before moving earnings QX to release. I’d interview, briefly first our today’s on to reported and cash in the quarter operating like comment expenses as

operating on The expenses, in Our use R&D next reach over in of G&A Charles with our like I’ll clinical off first the milestones cash, years hand two runway XXXX. reiterate quarter our $XX generally expectations. key use that, $XXX guidance hand to we expenses continued quarter over ended the into with of line call cash I’d to cash total of emphasize with multiple the discipline and total the of of were strength with million for that the and And with the and to our million cash With cash. conversation. we QX management Charles? kick resources. liquidity to position

Charles Duncan

Greg. with recent hi and this the co-host opportunity on Hi Q&A team you, everyone. to and So Florian the progress. for congratulations Ritu Thank

so And opportunity perhaps as is a cash your you guess in Just turbulent this like COMPASS more the about strategy year. new assets for forces just the I’m a prices are ownership to companies biotech invested been see low, for starting navigating this acquire runway? wondering careful you to an already equity prospective Pathways or I with of thinking or a perhaps builder your which this be frankly prices that headwind, increase or challenge the you’ve Florian, with if Florian. about atai to markets. It’s

Florian Brand

Charles, your or And ago also biotech new hosting to index, if we new look And XBI answer and And all turbulent facing were that across where has Ritu. are Charles joining and all we basically we first we or areas, over yes, years my are those we yes, years format at many of times. five across the cash side, from were question approach we for in this the five years thanks of Yes. XXXX, where companies, are now at trading ago or this despite those value therapeutic that been May below generated five cash. below companies

biotech my we broadly, So great in opportunity perspective it’s it’s broadly. very that in – fair I think say to a a statement invest to to investors

the this As current a prices of seeing we basically that that, and are result undervalued sector.

this we look you last we or me an in we number even decades the the mental past in are innovation sadly. recent why. approximately that time, explain billion space. we’ve and the you active at believe specifically, know, in greater are little suffering over coming making to investors. just neuropsych the – further have discussed studies If neuropsychiatry, I already in And before and we area even – particular, seen that people one to from out as health at that learning very, Number for atai very pandemic At you very COVID and X let there’s through – as the we’ve in disorders therapeutic opportunity are that are we’ve are likely grow the globally same

in met So being been drugs has unfortunately the of progress lot not with need of unmet approved. a terms

acquire on execute to very development has this puts cash valuations position assets us BDI a on having in with new rigorous And through And in asset have since model drugs and we the space de-risking million, always very aware only an look remain you we a that and started neuropsychiatry as compared approved of in Greg a our mentioned, new space. oncology. very look, multiple much around close been very complimentary those market. a fortunate also been in business active – have unique with the as position we to at as If that PD about to diverse And basically way. are our pipeline drugs potential screening XXXX you’re and shots will to opportunities, very close look XXX you goal. very yes, XX pipeline a And level, and yes, a strong opportunities a continued model mentioned at to the well very $XXX atai with pipeline that

Charles Duncan

bad good, news. news, Very good

any Ritu, thoughts? So

Ritu Baral

unique for far further? new is digital aspect this does Florian, to as which on cash On calculate that given therapeutics, and that, as XX% emerging would in therapy. thanks you go strategy – as But including care. psychiatric I how a an little position you that it that As of How out and given technologies Could has, digital complements therapeutics flexibility me format. have? guess in that runway as offset atai that a drug your much deemphasize initiative of have emerging digital field, digital services you the of neuropsych runway? sort as well

Florian Brand

approved the and having clinical think to that sustaining sustained that allow very therapeutic effectively open window change the on agents mental novel is behavioral neuroplastic durable behavioral digital through plasticity that a in and with side strong effect therapeutics that your then very disorders side a differentiated point or for them and health one combining we becoming How on a pharmacological very, basically – way. achieving treating effects Yes. that meaningful mental about patients and health in sustained

and integral are with them part funding especially it’s to those the we about to assisted and fully psychedelic also trials. essential through disorders think therapies unit digital clinical treating as we how committed the the an it’s bring So

cash In and disciplined. of Greg much are we that very terms management mentioned

of likelihood our model the character that’s spacing are that of terms part reviewing in decisions, continuously also new success come effective capital the also data and and comes basically basis updating and shift capital and own are once continue our most way. out course of especially assumptions make We along allocation of portfolio – we

sufficient today, communicated, $XXX those in capital hit the here catalysts are the millions R&D again we stand development. all have we including we As that digital have therapeutics that to

Ritu Baral

Great.

Charles Duncan

I say, guess risk can drugs with –sorry, on. high, one thing I’ll one was as going associated the I just higher is I relatively of or thing know to that add particularly early Ritu. both you are

with but new know So we sense, digital beneficial. adapted being are widely So the have using therapeutic that right? is I actually used, less, approaches a say, they’re they’re much associated right? would been the psychotherapeutic technologies that we’re [indiscernible] in approaches – risk therapeutics format, to this These

multiple overall, risk So on respect those say, associated risk with the But course less drugs. the drugs significantly I associated the to is we with would have than of with goals shots the themselves.

Ritu Baral

Good point.

you the Perception about dive you start was as the you in SPRAVATO. into commercial of That expectations guys questions has and launch opportunity? the profile lessons the uptake? lessons That what ongoing, mistakes at Let’s some for What with for and the missed but think with underperformed as product the biggest PCN-XXX. vastly And PCN-XXX think are do landscape, learned now. trial the on maybe with look and prep pipeline commercial really you modest

Florian Brand

and level hand give me it a Srini. over then perspective high let Yes, Sure.

use. SPRAVATO, Rketamine that esketamine, I target our we to with you also developing clinic, are differentiated a our be are program. – it’s lot differentiated that having DMT profile instance, for at from administered to of is the product said therapies course important have That for home our thought So commercial this, of profile, mentioned esketamine think emphasize are from in that and we

has SPRAVATO meanwhile clinics, build entails we think in what I administer to observing have a a upon learn we SPRAVATO. clinics so with things emphasize J&J it’s lot that over from. the of done important can actually very And U.S. in also that that the thousand licensed and But can

and the patients I effect or actually and of rollout J&J for great the think that’s neatly a SPRAVATO. serve are starting that our it established into as with we into for basis the build into or the rollout our great as therapeutic it to that paradigm designing window a will duration news has slot as can point for

So first our learn the mover, good been first for basically has the what this actually first thing, not us, the by advantage. use but a to mover and in case, out it’s from mover built to be

on some So these And one? high further are level this perspectives. comment want you Srini, to maybe

Srini Rao

No, I hit regards main you’ve as think the Yes. commercial. all points

So that’s always always – has efficacy front as Florian mentioned, this question duration of center. and been

use, So this in can right. when can Why utilize of sort build we you infrastructure. fact

do that’s essentially to our what programs. we’re with several trying So of

Florian A certainly the So DMT mentioned. and program Salvinorin that

Florian Brand

the educate of educate landscape. to I on engage patient groups, is And and early proactive be key and groups to takeaways ultimately, physicians, stakeholders, on early payers, awareness with raise very and efficacy think, one the whole

SPRAVATO, As to in course, – paradigm the on built only the the in we was I really clinic think we was the of but building capacity being emphasize. build done important that’s out, here, that this is as this with also infrastructure, are a shift And that cannot – infrastructure is on also psychiatry past.

Ritu Baral

about endpoints, then you program ideal potentially compare clinical How to Phase in X and PCN-XXX think Phase design it. as trial Phase multiple And X about was that SPRAVATO what Got think the you as the done into Phase program? X, populations, Phase you would your into X especially contrast Xs.

Florian Brand

Phase X, the right. right now, know, as midst you Well, in we’re of still

informed trials be regards longer the lot with I ones Phase the had through of three. In So of there there’s by unique with – one shorter yes, particularly that – redosing as were the that X their in the going general, Johnson results trial of to designs and to is well Janssen X Phase with transforms trial, things that program nature. obviously program mean, a

use, for so that compound recently have home can the for been compounds at model developing at are other We approved certainly on home use, based we right.

program, an will mean, the again, like about some the get there’s of the therapy, trials I to XX the or we endpoints, to think looking duration, at That matters some Sage primary but the at have made et that – to whether the be atai for you going part, to cetera, probably longer would once home most weeks. key – So today it’s be results. X easiest for decisions

Ritu Baral

Great. turn With back to I’ll that, it Charles.

Charles Duncan

Ritu. Super. Thanks,

But program in of investment resistant also, about about. theme So sticking for have depression you’ve that really just with frankly, been and an the jump here you’ve innovation thinking this to I talking patients and that made. treatment

for on from forward X of wanted key I saw Xb. takeaways its So pretty their rigorously the with the COMPXXX disclosure what your you ask Phase agency. COMPASS to with data its plans from Phase end you following conducted despite that meeting waiting were

to X probability Phase in talk their you of terms next steps success would really being for that about of As see program? to they in terms like well of as gauge ask you what able when

Florian Brand

course, of really with effects, was was calls, most previous for in because results onset. of not important of whole course, rapidity is of rapidity intervening in administration key give the The class of about That premise the thing the the with one of was of quite talked most certainly we of in onset. Well, this essentially the side effect compound this a Yes. period. long-term absence of the demonstrations robust single me. really efficacy. of drug the And drug you’re taking compounds Durability

So trial there demonstrated. appeal, that of was in That quite was results results other course study this those safety. words, always long the replicated. duration were good this And also of showing the In efficacy academic robustly. was was replicated

our these that’s stake So really increase to were course what motivated exciting, things all in COMPASS. of us

learned what of forward we’ve to forward. going lot course I a to lot to repeat clearance like the they Xb we have we’d are things are take program. they’ll of those just learned with imagine and for and programs Now, this TBD. Phase terms couple see the that in Phase obviously move details learn I’m clearly dosing. from that a X mean, their I like is our of from sure Perception study, relate A

details something not but So I the insight I’m imagine sure. the what same, their dosing. DMT we’re do of that – any doing we program anticipated, have their incorporating don’t always they’re of repeat the we plan. course I That’s in.

Charles Duncan

It’s it. on Florian Greg helpful got that I before anything on? Yeah, or very Srini, else move

Florian Brand

biomarkers think right to to how we I also someone. when our using it more it’s No, think also to ties digital flexible assessing about the it when therapeutics re-dose forward and time, into be comes approach, going

than in And our heterogeneous on is very not but we treatment takes really kind precision way patient our holistic of that really key that that account. working driven So the approaches of that developing for this into very areas our population our static, paradigm. hope compounds integrate given biomarker a is it and we’ll this to that basically one

Charles Duncan

Got it patients. differentiate really super, paradigm for very depression interesting

that its the on progress for had move RL-XXX, evaluated me to Recognify impairment schizophrenia. cognitive is Let little with with being recent associated which candidate and you’ve quickly most

as are about a So to are of in standard of to as class affected for treatment know, terms know you general add a screening for dysfunction unfortunately with and the this anti-psychedelics you there schizophrenia that one decrease core also deviations are patient population. function. patients in And cognitive of targeted functions range the pharmacological the cognitive two fortunate compared schizophrenia, there’s one to population they

atai obviously cholinergic, and Recognify investing modulator. So glutamatergic CIAS, in receptor is a and RL-XXX for GABA-B with it’s

question going clinical be you work? think that in of these patients? the do for activity Why to benefit is my is translating receptors really can So why these modulating that to useful

Srini Rao

Yeah, that’s a good question.

different that involved, systems. many neurotransmitter certainly investigated is but cognition So have there’s right? neurotransmitter complicated, systems people So are

a glutamate, they’ve of that single So the molecules now of course, play there’s in That that’s and on et is that’s development with complicated, modulating gentle it’s a of cholinergic, a of feature more the of So a effect. think are taken again, But ones do optimum fashion. a cetera balance is what right? drug receptor these, associated is some system. drug, this basically with this and unique focus we in sort all cognitive

different about these a a perhaps don’t may mood different of how effect. certainly This systems. having a impairments. lot deficits more know. that’s means vis-a-vis heterogeneous systems, of a broad cognitive but Again, could heterogeneity there’s think I this generally We heterogeneous, patients it’s of the not be disorder, we mean, All of in as compound. as have

Charles Duncan

Okay, so to and effective, durable I good. And that, perhaps more looking forward guess.

clinical being gives move really, RL-XXX, to steward are compound? tell about quantitative it, of think EEG benefit for data concept key forward terms therapeutic study confidence that data there you previous proof at X In could into you is looking that what if with your may candidate. of what Florian, and Phase a that work a that this In particular, this translate that is activity of potential capital, from you about the it with know, you into the

Florian Brand

happy us the excited observed what’s And Phase months address to also then effect, data volunteers combination I’m compound. to to biomarker with was convinced saw in I was of that a that. that for No, study. Yep. yeah, XX relevant very more XX he’s pro-cognitive we then Srini reported we on basically doses and very, this us really that pro-cognitive And first were really move and our proof study clinical X most think very consistent full ago. details qEEG healthy effect milligram would comment to the invite reassuring supportive to qEEG in several And meaningful drive forward the maybe forward that this in into based on technical that out why and clinical the move also about milligram further concept

Charles Duncan

consistency, that big picture, just terms think I inverted I in anticipated reason what is right? right, of for we U-shaped we complex. curve cognition I the mean, So Yeah. outlined saw was

lot anticipated forward. of seeing that to same that We studies, we pattern saw respect curve was to and and curve nice the There a quantitative data internally we faith saw U-shaped this with it. previous an was cognition us We to So these the on consistent, I saw gives that inverted important. in that’s think respect EEG. move based with

Srini Rao

response. okay Yeah. the for complex. I’m Yeah. that’s dose It two. But with opportunity inverted U-shape is

Florian Brand

right. exactly That’s

Ritu Baral

Thanks.

mechanisms you that or the anxiety for we’re drug positive bringing seeing So and this disorders. guys to these around your days, around other allosteric the mechanism program, differential GABA, clinic talk the numerous disorders? GABAergic benzos GRX-XXX MDD for especially mechanism to let’s modulators move in GABAergic that candidate to your to Can of anxiety

Srini Rao

Yeah, absolutely.

all pretty action the So So this an GABA It’s GRX-XXX This The how they presence They those have blunt unique modulators because a over of the that definitely by anxiolysis. and right? they allosteric channel. direct all. of So right? basically really at is that drug. agonists endogenous the an are require are selectivity, suppress a improve giving instrument, benzodiazepines they’re etifoxine your pretty and different. anything very positive compound activity The you activate receptors ligand, of GABA, extensions to on neurons that’s do brain.

of endogenous actually increasing they’re which So neurosteroids. the the ligand, production are

of is allopregnanolone. One which

in for was that course, Of approved XXXX depression. postpartum

So profile this gives our you a safety better that’s thought in certainly at data. what is. And least reflected etifoxine the that’s

I with are seen pump you really an So of the but sedating, that’s get basically can etifoxine. that’s mean, anesthetic, allopregnanolone, the allopregnanolone. it downside – been PAMs you not right. And even if quite frankly, you some

in unique body’s about TSPO The how allopregnanolone, you’re the out like that not you cutting The control I you right. to way matter protein. no think going there. because much it’s still is very the so crank crank manner it are brakes, – So how the to only systems hard on

Ritu Baral

Based on sedation for preclinical do up versus GABA versus how and The the Do competitive data, the your somnolence? data what you do you’ve seen like that far? – mentioned, stack and you issues big things benzos preclinical PAMs? they expectations how so the

Srini Rao

Yes.

a So is lots mean, came out. with, out drug is compound So right? came obviously time Etifoxine ago XXXX. that long this I a again, in history use of that here, a there’s

we EEG there nothing AE didn’t this, parameters. of look really that there. was. significant no lots with to at [indiscernible] We wanted etifoxine we’ve there know tables with, find really that is didn’t We been event see quantitative sedation prominent we’ve either. with PK adverse Yes, those because We don’t what seen etifoxine. data it’s particularly the of or our tables like other experience ran – the or experience, made any So seen those of own like compound so sedation trial We example, public certainly a and not clinical for have there’s any was and set sedation benzo

the see So the in X different pharmacologically we our of anticipation won’t trial way sedation. that much with mechanistically XXX is compounds. those probably certainly two nothing between Phase with There’s

Ritu Baral

I’ll next Charles program. it. to the for turn Got it

Charles Duncan

Yes.

don’t So know trying of of the this just patients ask with left, but I are that importance I’m because intrigued time think lot experience about to wanted having. question we a really have if I the a to you

for psychedelics short which considering that and and treatment coming experience really transmucosal how you therapeutic of resistant wondering investment, the the I to driving versus about landscape wondering that importance think about thinking DMT contains and kind back – really guess relative other Atai VLS-XX your film, guess program, treatment the good long-acting I as companies of there. So I’m out Viridia is emerging for I’m buccal benefit and to some depression, Compass with it TRD,

Florian Brand

Yes.

they’re think I well here and as scientific address as in in considerations very them commercial this to factor considerations some already. we interesting of

DMT in side, are commercial therapies. the way a those basically part into way to programs believe designing On pragmatism and [indiscernible] good commercialization this again, accelerate is with of Viridia a good we we to our is those fit and this

on duration is in a a [indiscernible] be little data, label we’re it the effect. durable rapid broadly. And very, best the we And And with think, I has short But to well do course And gentle of good discussed like the window depression a like more duration scientific case, rapid of so taken DMT or a on believe. has we been very of of to is course promising here program optimize is seen think out there’s, Compass that grain you we XX-minute salt. that PK of what the open treatment and then where starting very before the data probably effect that of what’s effect window onset TRD more for we’ve data roundabout or very that’s of that of shows in discussion So compared the the to start in terms onset that’s duration. we’ve I side as interesting have why commercial hour-ish bit very, a coming psychedelic an side, point. this very, effect,

a we needed, also ultimately effect. the but give like see four So with – or is the hour not that we think Compass to LSD XX-hour therapeutic might XX-minute don’t ideal six

And to to so Srini this is the you I add do want high want – know if level to that? you don’t assessment.

Srini Rao

you No, did I with a job that. great think

the effect. anticipate always some was amount redosing, So part shorter we’re consideration of we psychedelic that looking fact So and of right? for in of that

So Florian’s a need to of as you much efficacy important how the amount I both Phase VLS-XX as forward with with the our That’s we point, we That’s what don’t question. Xa program affect for to or know of well psychedelic resolve durability as x response. hope asset. move that Revixia really

Florian Brand

from these the the generation looking also what’s no based benefit and starting our one think we’re And with well I there compound decouple for for drive then the the neuroplastic that’s Yes. course at the are the experience effect discovery drug instance, is you [indiscernible] basically compounds, compound here? our most and psychedelic compounds generation second that’s reasonable psychedelic with strong the a of also, to a And there complementary data, EntheogeniX – it with looking engines. on of at we driver So neuroplastic Is can fashion? Is that third in all point. generation third forward effect? then effect basically as

Charles Duncan

color. the Thanks for

Florian Brand

housekeeping apologies. as knew from very, by a would. My I we and in Charles. might gone jump just minutes perspective it very Thanks, has quickly XX

couple markets just from turbulent quick these very, my are of sit rough middle a of we and the as I It’s I financial really here very together. conversation QX it you here thank might as perspective, leave a great takeaways minutes Ritu, with enjoyed in Charles, These the think you thoughts times. XXXX. we are been wrap first great and very here thank just XX questions. investors up Might for

to a strong those here We’ve years XX, – XX, ago, on reflect from in weather back and a position. seen XX This can that before. have this got and were think treasury. we’re the dips this got resources I these company’s storm. good We’ve

to you’ve discipline milestones these them to today. with the We’re about reach programs move heard that going to fund forward

on future, markets We’re in you again and very long the term, focused quarter clinical sweet spot much. next see and listening thank with patients development, a here our day. in term near and very that, optimistic have near again, you the and focused and And need both both in about Thanks term. very despite great for we’ll the

Atai Life Sciences (ATAI) 16 May 222022 Q1 Earnings call transcript