ATAI - Earnings call transcript Q2 2022

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Greg Weaver

Hi, everyone. Welcome and thanks for joining us for the Atai Second Quarter Earnings Call. I’m Greg Weaver, CFO of Atai Life Sciences.

We’re very pleased to have you join us. I’m joined by our CSO, Srini Rao; our CEO, Florian Brand; and Stephen Bardin, our Deputy CFO, who joined our team last month and was most recently from BridgeBio. earnings Atai’s last my is call CFO. as Today to the CFO very pleased over handing confident and I’m range be to Stephen. on of the He’ll I’ll of taking the of as be tomorrow, the remain year. one through the company to advisor the end role and want do you do introduction? jump to Stephen, and in an

Stephen Bardin

incredible. of so Atai course. honored Back as selected huge to to you, you And I’m of Atai. first field keep at much, And CFO month My of mental been be in impact can’t Yes, fantastic thank this to I’ll has be And the Greg. health. the team. a And wait joining brief. incredibly thrilled next I’m make to this Greg. I

Greg Weaver

today, our format two Frommer Stephen. led by analysts, be long-term from the interview Jefferies Thanks, to Credit board. great It’s and of will Tsai have Andrew from you Judah Suisse. But on

Over activities, update. the a Andrew questions us minutes, of on Judah and asking be pipeline and will next XX our a QX series business

So and does forgive forward-looking to financial release. future to cause Atai of bit, Atai’s today’s for update kicking results reminder, any in a way undertake risks about key statements may that as results discussion actual but and today comment subject the uncertainties statements, off briefly our reported today. that just include to differ. quarter and we may me obligation not earnings the speak such takeaways performance, only for out which this the as on before with as And of the interview, I’ll

with and use was our $XX line was operating million QX First, expectations. of cash in

there. surprise no So

added this from importantly that up announced where the addition, $XXX facility let in me Second, debt Hercules we to your attention million. morning our to of other release press Atai draw we’ve

debt with billion. that $XXX Third addition the in of and combination is of really the critical it’s million facility, approaching total point cash the the and $X.X

thoughtful cost and a the guidance And a of runway forecast cash earlier use tightening, That’s macro this the of strong and pipeline combination challenging XXXX. takeaway we exercise environment. extending beyond some which runway, important with in year very to into disciplined here. now continue an have We prioritization full in we as a

let’s the Judah with Credit introduce I’ll himself Suisse hand over So kick Judah? into section mic interview move the here. from and that, us off. to to

Judah Frommer

to Great. team it’s been me the Thanks well. and me working endeavors. of to as welcome inviting great future with participate. Atai and in luck team having for best your you Stephen, Greg,

work to excited We’re with you.

last an financial and your question. of time clinic. a you So maybe maybe ideal with And capital. been outside broad reasonable have in biotechs news, recent not This be of for off just mid-cap light a has in already kicking to the few raising pipeline runway days

over And capital priorities XX months? so does So allocation the factor or think your for how how we about this? current runway should next into

Florian Brand

on clinical the believe we are focused and those POC very a Judah, us of the Hercules clinical – the non-dilutive seven year that sit to actually data readouts deliver and focused a POC in that we this will I funding need position confident pipeline, thoughtful really up very the $XXX not with strategic an anticipate a be meaningful now combined don’t very, to appreciated of combination important intentional focus the going that and programs XXXX Greg in puts and our takeaway the reprioritizing way in into debt on to measures taken investors. facility execute that’s of because think additional any for And believe we investors that of to the and million, way into we on by forward. all eight inflections one runway, that financing, are we as mentioned, programs very we’ve extend soon

Judah Frommer

should should then as expense continue business platform? further And an activities? of helpful. building ones a on to the inclination Or the programs, we or really focus development potentially neuropsych we earlier as broader That’s to read further of at think later-stage that Okay. Atai process in of

Florian Brand

we into to with go point, us those trials. more call BD effective like the And the going into last in that – we clinical in on over strong when compounds. emphasize programs and BD but years, together position current pipeline have very great very programs, we the And many will a also very the focused enabling efficient on already very, on Yes, execute clinical side, for those and in a I focus sure. further comes a with to programs built have can been to very, your basis or that the very little our this platform continue And is those develop M&A bit in DNA. – to would we that we in many have, technologies clinical forward, to strong our proven perspective a puts a and and it

to complementing near-term and lookout through We built tie technologies can accelerate that or seeing, basically those very especially companies, we can programs for have adding depressed complementary aggressive assets, we and BD. very, are very value active M&A the points. be pipeline continue that with are and And valuations existing in a our – be by inflection pipeline on or existing the

near-term we are in focus definitely what future, active programs. in So the with clinical a on is that

Srini Rao

something to I was just that going said. Florian reiterate

data this the prioritized by all of all years. to So clinical product generate be selected meaningful and some will two are the these proof-of-concept that end going programs of the we year. And in type within results,

way So over to prioritization next... that’s the of the the terms of in think model kind here been That’s about it. really

Judah Frommer

Perfect.

Andrew Tsai

stage is guys a for the Maybe space more more in pioneering COMPASS, focusing little bit a are on technically industry holistic speaking like portion. so the question instance, And a clinical as my about, is think of you sense. we they peers, question

knows dose a placebo in footsteps example, X, follow if of a in did COMPASS’ pursue So later-stage comparator, follow but for who expect do we a to of kind Phase as they you you they sense? X, as footsteps could you Phase studies, should their kind ranging,

Srini Rao

many actually following their in ways, we’re footsteps in already Yes, I say would right. that

study know required. of a doses that really handle of that we’re It’s So their meet said, we’re our to for and in you efficacy, idea with dose a basically And study, the – and We And ranging. good I what can Perception. single know single-dose dose was of going But that Perception trial ranging. well, doing on doses, efficacy. magnitude as right. Clinics, multiple to multiple duration it’s administration definitively Ketamine first both first it course, is right, was, are get exactly of who very say was the

very And going to take trial. I that’s we’re next the that is forward data And COMPASS again, so and doing that something to help that similar. imagine design

Andrew Tsai

I board for as that support. before plus could to incorporate early FDA it And learned on It’s Judah, Understood. you are tools – they is as dynamics we psychological technically leveraging some instance. studies apparent turn with over Phase X Phase in X, these digital this, even neuro within

Srini Rao

we’ve digital technologies a while right. been working Well, for now, on

So years we ago, of one over actually the two announced Introspect, within which two areas company, the ago. is years focus

type technologies now so trials, point digital matured testing where got acceptability in Clinics. clinical So user really but more the our in Ketamine they’re to have

help we content, data we’re So the and really to getting right. need all that

soon as and with Phase EmpathBio. both content we’re testing in X our And Viridia to these actually we’re So very well. trial deploying going be

So healthy they but dosing. work. support prep still Phase still of some these volunteers, are require course, they X post require – And

used So Xs. digital there. course, the of will Phase be in subsequent roll then, we’ll technologies And them on

Florian Brand

investors quickly to you remind jump like important. I are therapeutics digital actually would in, Judah Before think we why

that our meaningful behavioral rapid-acting to strategy. of we elements digital that through So on is multiple really effects if we you clinically the through remember, leverage durable our want and therapy really help change content habits And such then behavioral interventions new exactly believe are achieving be pursue induce about through therapeutics through One focus other patients this elements we those differentiated in effectively company delivered neuroplastic to we means. and behavioral and digital this to health that strong all mental window Introspect plasticity believe are that have really can as change. we more foster pharmacological achieve behavioral three-pillar intending

the support to phenotyping population. very harness the to for example, us to way, biological of be here data use Pillar or more collecting but harvest a that given going move patient strategy. thinking is by digital precision then our ongoing – elements along of and also approach psychotherapeutic we’re psychiatry potentially the in this that And biomarkers looking this of patients two So at treating heterogeneous about nature

actually So the with see very, first in DMT the clinical excited very technologies program. now to study our applied first

Andrew Tsai

tools? months could some get early technically over the we we the with digital So see coming data

Florian Brand

correct. That’s correct. Judah? That’s

Judah Frommer

get we’ll Great. It COMPASS, the for I And their latest. around design maybe a X of is here. like with trial Phase a October, sounds detail second think, sticking just

carry So beyond what you’re could Atai? in looking for digital would a that at say you read pipeline design of programs for across maybe components terms the trial

Srini Rao

think one, want they validated digital we that perspective and Well, characterize hit I think how be course, and will on seeing interesting. And what is of really that that. have their test, on I

guidelines, are that’d precedents dose that very issue. very that? they would imagine upon for other How the repeat looking – But see like for is want et looking that long-term these be the obviously And questions placebo do the piece they both. work terms an earlier, testing, of the in looking approximate There I stuff of I there? year. ICH What for and for that there’s potentially really that to they What dosing, sort are to interesting They mean, control. comp are end agency it’ll of the for the right. will XXX repeat are – are studies. so things And other be at of the subjects our imagine cetera, of impact they repeated that’s over versus meaning can’t be tox would what The implications for that be other Are lots controversial us within data? the right. dosing time. much Or does ones interesting. dosing. our very obviously the impactful one be would I are can’t alluded

Judah Frommer

quick a CEO? with Okay. nervosa you gone That’s And couple indication? minority just And have anorexia in on helpful. the have any new your given changes then there, the on on interacted thoughts that of way stake significant guys COMPASS a a hitting

Florian Brand

Yes.

I have had call, great fact, – a choice. ago it’s believe In Kabir. we with X.X weeks We we a believe, actually

that COMPASS So decision. I applaud the board for

to he’s has also set the through how I and hopefully, and right then to commercialize effectively company has right the the of and also definitely think requisite experience skill now move to approval that drugs. person X Phase

great staying it. And for as spearheading forward him that setup is also So I success Chairman. a George, with board believe very going COMPASS for on

we And really, COMPASS. we believe going unmet plot solution This also very, I So have for need is very a really nervosa. psychiatry. a anorexia them strong significant for here after in

COMPXXX on So drug that very potential signals early no the from saw worthwhile there open-label this trial and approved see perspective. and their we great believe is pursue our here is given that to we for based a

Andrew Tsai

one guys any you the Xb follow-up. was think as pivotal have if their but small study deems asking potentially? hard curious Phase say, guess, just maybe to a you Just thoughts. it’s I just FDA if I

Srini Rao

I for mean, Phase data, using right. there’s data X precedence supportive clearly,

much marginal. I more So a emphasize It’s did Will least precedents one follow-up don’t though accept whether including Phase trials X truly the as COMPASS I – they or call, clearly, pivotal? know. they we’re two Phase also accept is or obvious one, X the not robust. where Xstudy. a is will the study. Phase There’s if at mean, agency long-term a during not than earnings been of sort it certainly of more certainly

course have more skeptical the bit. the So clarity but of the next I’m data a that, we’ll get we’ll personally soon. over little little of

just So let’s wait.

Judah Frommer

we inbounds to if most Certainly, Maybe lately. on program right. could. All switching we PCN-XXX, the gears the get

the the how So bar couple this clinical end Phase with design, expected into time gone bridging you of readouts subcu Xa us lines of can the has expansion drug-drug U.S. in for much a success study. study and with year, interaction along of the the remind for

lot a unpack So to there.

Srini Rao

That to a unpack. is lot

is with to I this [indiscernible] administration level footsteps Janssen. the placebo-controlled as set in Phase the the footsteps IV, following everybody, the with So Single following is at X study case, yes, again just mentioned, Compass.

That’s R-ketamine. other dissociated. and sub-dissociative, two one each in and course, in it’s looking next measure subjects XX outcome placebo. XX over we And is of is doses of primary days. one So looked is those matters also threshold hours arms, at XX of XX XX course, of at seven is the One respectively. basically sort arm the third of milligrams XX milligrams are days

the that’s really the well. recruitment of outline So trial, is going

the that. for a – by So completely end this very this track will on readout And excited about of trial year. we’re

did announce as an – year. U.S. of this IND of we expansion, earlier terms you In course

well. can You look really going on actually clinicaltrials.gov. It’s

that And so and are others XX the recruiting sites in in up coming there’s that of three there’s process are the far United States online. currently

really So again, well. going

– mentioned here is back what threshold and what look important premise Now, premise at-home you to use. is, terms in like? what also that And of does It’s our to what right? go success our

there pretty thoughts required our So efficacy. that’s hope is dissociated well straightforward. that realm, more versus at that if placebo regard, that’s element FDA XX support MSD, is tolerability, hope process we see aware, we differences specifically very be efficacy not, know We dissociation. a hours. at an at-home within in that doses for really to to lower factor on in But much the probably important the for important And at that guys the the regarding use. the MAD us you mean, and two, the SPRAVATO going making are normal I what good decision are obviously be as other to minimum quite to clinically versus the than

of for. kind of picture big terms in what looking are the there that’s So we

Judah Frommer

Okay. uses And the is other Yeah. subcu. piece of at-home

Srini Rao

Yeah.

So of understanding this mean, basically relative be initiation of dose point. have towards administration, different we’re IV, we’ll what for subcu routes you moving now two looking forward – the planning that’s that But at formulation there. need levels, I subcu testing, that it’s a basically yeah, comparability bioavailability what still for these we right been

Judah Frommer

it. Got

Srini Rao

be would for we much imagine that That’s course, forward subsequent trials. what Of suitable you as dosing. take in can more repeat

Judah Frommer

Sure.

Srini Rao

well. as And you study mentioned DDI the

on study TCXX So those focused inhibitors and is XAX compounds of at and R-ketamine. PK of the the DDI on the looking really impact

is is at – all point. that phase this clinical completed dosing so the everything trial clinical And – the and

of analysis – before end So, now the expecting this line top it’s under again, end and the by certainly year.

Judah Frommer

Great.

Andrew Tsai

points top curious, Street the about of guess, or as placebo? is think line that Is maybe Delta two I’m market prefers more we to And approvable something S-ketamine about I S-ketamine shows. fundamental, terms a data But in the sense. the the fair drug to where technically versus delta similar traditionally think the in

Srini Rao

I Yes. a think valid very I point. mean, it’s

the and mean, then trials three package S-ketamine it for just that S-ketamine the Really bit. was, So, this they X, the what kind positive was I and of long they And right? X thinking truly a basically, was a that’s through approvability X, four the think TRANSFORM-X, trial had only had I had term XX TRANSFORM-X TRANSFORM-X, X point matters. was day. delta – on

but the rapid minimum into you that two lot bar not clinic, can right? differentiates that’s of that every there efficacy me, going So course efficacy, you’re get week for weeks. certainly of S-ketamine, would bar, the four bar XX the but completely right? a that’s a good months great, So you if win, a was hours, right? SSRIs minimum SSRI. So a but from And it’s not same of there plus, a be weeks, going with get going in that a an – or you’re month are if for twice to level onset,

at-home, I commute, You’re travel. going obviate once and think do It’s a of four the a a time week this we a of That’s there if lot can lot So for all of right? lot weeks. we that. subsequent

a strong compound. remains very that mean, I So, for this win

Andrew Tsai

done I’m want dataset it inpatient setting, or go be at-home. – reliable whereas, successful? presuming how my eventually was an “reliable” you do assuming And to think you – translatable Because this in it’s under would

any around about think around this? color So you how that do have – you

Srini Rao

that. two to elements there’s Yeah. I mean, well,

the changing is PK there there’s So piece, the of So on right? be will route an a impact so the PK. administration, first

So protocol, we’re continuous is obviously generating minutes which administration data XX with our current infusion.

the X. here to course to need the So some that we right? want is. of the things we’ve there, to course you the by of And that’ll want – So got be look subcutaneous where And match see Phase what all that’s that driven PK at. parameters we understand are we of CMAX formulation

of I some your going sort placebo drive it’s will mean, It response. up but clinic a to to up impact So have efficacy. impact a on effect. you’re on your have drive going going generally placebo is in-house right, that should drugs, different And similarly, course, may response, to of

So we on may we’re better actually signal have ratio a at-home see we’ll plays out. the purely if speculation, noise to this how have

Andrew Tsai

study I the question next within is, And release maybe the bridging the complete press few more one in quarters. could noticed

study gating subsequent X. So technically the next Phase that this before a steps as to step we afterwards, the after think move you is about

Srini Rao

of there’s in some the also are the talks, process. Well, also some things that additional

there support one those certainly. of to that come to are them yes, results have But trial. of a So obviously together few next need the pieces that we course, is

Andrew Tsai

Great. Thanks.

Srini Rao

course. Of

Judah Frommer

CIAS. over Okay. If us move I could and to RL-XXX

So, there that those be have chemistry some CIAS of literally to even XXX. In that or much can pathways compounds compounds similar in attributed target of design? been of view, have dozens how failed trial your to with versus selection

Srini Rao

currently focus let’s of for to pharmacology, on the some reductionist general, this the much got GABAB-mediated Trying that’s pharmacology good with of RL-XXX moment. but development, some so indications. other work polypharmacology, true compared very is the [indiscernible] things for over SSRIs really reality that The several Certainly better to also decades these the is absolutely little it a the bit has are also thing its focused. is activity, are the degree. that which But has to differentiation last right? a in nice and drugs in activity, tend find concept it. more point a it example, that or of on GABA-mediated Well, about interesting a driving with that to that’s chemistry of make a the clean being but is dirty efficacy the In atypical bit most been drugs piece antipsychotics thing

that’s interesting angle. So think an I

it’s we consistent with different albeit pre have our groups. in course, Of model, We right? – clinical existing have data,

probably general as right? they they So That neuropathic in peripheral some has subclinical have a compromise have central why pain, that neuropathic in diabetic vascular diabetic have we peripheral degree that’s one vasculature population impairment, pain. we path, Our well. is presume some of cognitive

saw mechanism So cognitive there. on sort vis-à-vis We hypothesis signal which in proof saw EEG of We some so again, We the in consistent healthy signal We well, effects. it was we volunteers. a as was saw that inverted our a with trial. our saw U-shaped hypothesis. normal type saw curve, that quantitative an of with mirroring consistent change

favor walk we our compound, that a away the all. to got lot of at going a disputing not not that indication, it’s in trying with So, things this challenging fact from

In question. design, terms clinical an it’s the interesting of trial

this been recognition MCCB lot thing, there’s industry involved extended right? a this, medical endpoints So long is of very academics the for time development with this need FDA the partners with entire this a on of has this been time. this unmet over It’s all an right? indication, been for period Other for have broad of been The involved. have

there’s evolution some that more the of – the in on on being should endpoints of we has a on been have a little So, There like. focused nice bit what consensus endpoints. battery been look terms

that our that’s that’s So been something ongoing. subsets that’s – been

subsets do endpoints. particularly and the ability now overall of degree with focus those So the to I it’s around some lot a to the though, pharmacology endpoints probably on think to

Judah Frommer

a on end lot Phase Xb stand to And decision what the then prefer of could go Phase sense. Phase of next makes there? do an latest whether Xa? additional And and endpoint about steps profile or dosing an X on terms of in pursue potentially selection for the it we touched the what’s improving you and just where That do meeting on

Srini Rao

Well, Okay. me bit last that first. take let

a the we Xb are point endpoint at the and So Phase indeed going prepping to be this for is MCCB.

MCCB. very recall very has Simple So in may last the coding was we simple coding, saw positive that study correlation the trial. good in you with overall which

take comfort of that proof some in degree So, we of terms concept. in of

with so happy of it’ll an that. part results. fact and the meeting positive to we’ve The will In end that’s is robust coding decided course, X of trial be MCCB, why move Phase support certainly simple assuming forward of

this good this an dosing posology, of we’d – that could angles There TID. there. make made one patient Now, course you We use area be make We’ve in to technology particularly where QDM, some is be formulation can Right it terms of that argument great, in keeping love on. we’re this BID. it is of improve to to in would now, got population. is that course a mind

We bridge to only that’s we’re looking a So later point. thing that at. that could the at

Judah Frommer

That’s helpful. Thanks.

Florian Brand

And with unfortunately, that, out of we are already time.

Judah for this Thank also like inquisitive thank And So of so asking to for express would I today. with found to you, much drive gratitude these and servers passion. Andrew I CFO to dialing and our very like Greg would in so I interactive. insightful as my to questions for mission really today. forward much very, your you and Atai

So I’m for really, service. really thankful your

also very You an handing part And here. and the month leadership of instrumental of our have have to year to you thrilled Stephen when transition stay another you Stephen. the couple CFO you’re – to the of a day job over I’m really end that smooth end ensure your been team, grateful until of

expertise You bring pursuing. we of that a with experience and are with lot you model that

more decentralized have couldn’t way of on you happy be developing this So to board. and drugs

reemphasize, So guess, ultimately forward to investors. to the with looking much a forward. would you our work welcome warm I my I to and from key like very for And you takeaways going perspective

value over very, taken believe, measures runway. thoughtful to XXXX, has proof by lot the there’s our to the concept end our year. have on this points And puts data sitting really eight our very key to inflection the up of a to position because decision right I in perspective, intentional our now, the out depth By wish financing strategic and non-dilutive into right very the year been to out reprioritization in in in you. programs. And of of pipeline, everyone clinic two us by of report of have intend Thank the We in into this and to we a we years. next in thoughtful And adding one day. and eight there $XXX we very with thank million extend and assume of strong focus great are seven dial that that everyone this a clinic

Atai Life Sciences (ATAI) 15 Aug 222022 Q2 Earnings call transcript