ATAI - Earnings call transcript Q3 2021

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Operator

Good morning. And welcome the ATAI Life Sciences Third Quarter 2021 Financial Results and Corporate Update Conference Call. Currently all participants are in listen-only mode. This call is being webcast live via the News & Events section of the company's website at www.atai.life and is being recorded.

For opening remarks I would like to introduce Chad Messer, Vice President of Investor Relations and Strategic Finance of ATAI Life Sciences. ahead. go Please

Chad Messer

section to September corporate Welcome our quarter ATAI with on & XXXX results and SEC. at Thank quarterly the XXXX our conference our will call. Sciences report Media Investors the update available XX-Q reporting our The Life website is www.atai.life ended you. Form in third of XX press financial today release file

Scientific our Officer; and today Greg Chief our Executive co-Founder are and Srinivas Dr. me Chief Chief Joining our co-Founder Rao, and Weaver, Financial Florian Officer. Brand, Officer.

are certain XXXX. During of to today's be Safe Private will by call, the Harbor Act Reform covered we forward Securities making looking provisions Litigation of statements that be the intended

performance risks as to from today, are statements subject uncertainties differ results results and of management's While of these projections and represent ATAI’s many could expectations expectations. materially to current cause that those actual about results, future

this additional on our statements with our In of highlighted these Exchange Commission, SEC filed are addition final in XXXX. described XX call, are including prospectus to during with subject filings Securities that and the risks any September the to made risks

over except of caution November looking statements would like update such as these management's ATAI's change. to XX if place Florian views forward to law, call Your speak CEO to required I only now XXXX any undue on which by be obligation to not reliance as Brand, turn and Florian. applicable disclaims may today, ATAI statements, the even

Florian Brand

have disorders life. underpinning live and that June, And joining will IPO by strategy address and co-Founder can our will of a reports a call NASDAQ pipeline, To important I review today. CSO, unmet all our Srini the on my in Good health. to provide diversified on mental highlights needs to drug everywhere CFO innovative our quarterly more Q&A. our morning. heal pipeline. everyone earnings to And comments development the on introductory begin momentum advance patient thank our our fulfilled continued and health vision XXXX provide and will quarter Then followed successful for we the so third you focused from Greg few approaches Building finally, now, financial mental differentiated the reiterate

anticipate the approach. drug in population, and development pipeline digital approach set heterogeneous patient to diverse by plan we our and individual needs growing buy supported technologies from remain developments. of we to active further patient and robust addition, mental through In health therapeutics tailor by using In enabling our will to response and highly business biomarkers multimodal data insights treatments our a build

RL-XXX for anticipate data given no entering study progress encouraged the this lack in we We Just It rapid we week, first important line your quarter, through Impairment therapeutic potential results will were further data full with our biomarker positive CIAS. of with Cognitive last another funded investigated have are very company come developing of of in treatments. earlier eagerly COMPASS’s clinical demonstrated strong approved anticipating ability of a readout the proprietary see details this treatments of we and we CIAS, the trial and from still treatment to Xb formulation Xa of effects this research that excited readout the these results. XX. COMPASS were This resistant in Pathways, minutes the top Phase Phase depression. provide Later on Srini In Associated study we psychedelics. or psilocybin Schizophrenia, onset data year, few to by

individual study health with deriving earlier discovery stage to indications. this better tailored quarter, of mechanisms more of precision we launch our assets, patient PsyProtix associated a symptoms meet treatments for on goal announced PsyProtix, metabolic needs. will with therapeutics developing the for psychiatry depression focused mental As company

XXXX. in We expect clinical launch trials to

progress great technologies. seen also on have our enabling We

proof Introspect this example, which brain recently our our developing apps study. anticipate various the from a launched patients gel-based user to digital transport a company nose preclinical technology directly accepting technology principle InnarisBio, In drug depression, pipeline. completed to compounds the a with ketamine For of therapeutic is cell effectively acceptability We across September, study of our in candidates undergoing treatment in resistant applying therapy.

In experience. reality to device clinic BCI a based company soon begin virtual in Neurofeedback of addition, our Cyber the patient concept testing will [ph] support and proof

of and currently and are ahead in Revixia IB. of Viridia, optimizing We trials Bio Revixia inclusion the the device clinical COMPASS

We Srini of now our goal broad milestones. Srini. will to of us a updates, tailored key mental patient over of therapies are making needs. our take towards to and pipeline to progress hand health I great pipeline novel some transformative through upcoming

Srinivas Rao

of The comparing week Depression the for TRD. MADRS with baseline of to a response XX XX the to of Last receptor resulted in potentially trial The offer a of symptomatology. COMPASS array milestones. an positive top-line as milligram X broad in Xb or hours term proprietary and ladder in treatment durability When treatment own the also with trial will Florian. significant the or widely results, met and was endpoint reduction from synthetic X the candidate statistically XX.X% measured acting formulation response at used Pathways randomized, demonstrated blind the have XX arms. stake The upcoming statistically efficacy On points Scale dose we to I treatment or this exciting Montgomery-Åsberg the COMPXXX. a XHTXA depression summary, X.X as its rates start COMPASS huge Further of rapid programs like post-dose. we on a the clinic. COMPXX I'll COMPXXX patients assays study a strategic being psilocybin, controlled, which nearing with and XXX primary to Phase near focus with MADRS, noted visibility We'd of significant measure changes weeks. remission highlight congratulations team. development is a Rating in of resistant of Thanks rapid double In and week depressive found, a agonist COMPXXX antidepressant. as of by with most its oral developed call, dose results a from a

tolerated current different with with mental Finally, effect belief well health of more administration, our confirm highly bode COMPASS’s emergent help only mild We that options. actions rapid of disorders drugs severity. not patients lives these COMPXXX durable are durations the or difficult of and a by both while we care. improving results routes with anti-depressive generally events moderate was and XX% but improve of pharmacology of this for serious in treat a continued of adverse treatment program, treatment the progress pipeline encouraged limited data In than with summary, in of well showing psychedelic can to our population standard the on believe

developing double glutamatergic TRD. controlled IV modulator testing at enrolled from is subcutaneous September to the TRD. anticipate that parallel, patients XXXX. through treatment diagnosed This in bridge we late running blind our comparative support home to of PCN-XXX we study Phase conducted study Next IV trial on with of and the Perception to PCN-XXX. PCN-XXXone sites In to for will initiated We U.S., an the Europe bioavailability formulation Phase placebo of be of Neuroscience, X the intend randomized a conclude the formulation XX In formulation use. a will believe we multiple academy Xa which of trial across

models, PCN-XXX a recently completed induced builds in Recognify Xa RL-XXX, trial. Impairment modulator subjects study XXX R-ketamine at both spectral XX were particularly the safety potential Associated Schizophrenia of at had with and The we before, previously we've memory quantitative available patient in analysis in and IV. shifts scopolamine these on CIAS. trial and excited XX scalability which aspect of cholinergic Phase treated what XXXX, involving Of from shifts encouraging. of in or a about note Phase strong the trials data doses are and commercial a in of a These perspective and positive announced from results trial XX a In home. of first to were This XXXX, up clinical cohort XX that our Phase for is preclinical extensive a in potential tested contrast milligrams results product patients and restored the to were differentiation, In this has R-Ketamine GABA of receptor partially proof April observed Xa previous compared support doses potential no academy tolerability electroencephalogram, for the at qEEG additional delivered In or a or of mechanism qEEG in late-September. demonstrating healthy An there verbal build Xa challenge preclinical potency, effects that S- are qEEG associated glutamate minimal in higher the RL-XXX Ketamine. initiated sub-dissociated the qualitatively we're power demonstrated February were summary, by are S-ketamine. for of In Cognitive scopolamine. tolerability evaluate mentioned made being perception similar to data the the improve the measures to trial. And Phase the upon treatment effects on the details doses study and doses As the spectral at designed biomarkers preliminary of cognition. found this interim for the safety, eight X based greater viewed respectively. challenge as qEEG and milligram We the scopolamine that durability abuse hypothesis and that RL-XXX volunteers, that efficacious quantitatively may be the demonstrated lower seen

result, payment, this of a placebo a on that battery. cognitive the X of the concept focusing traditional ATAI As study initiation proof accelerate more to Phase including be advance a as portion a aiming subsets endpoints, we a double subsequent milestone blind Broadly, anticipate METRICS trial. controlled will future of

qEEG results reviewing top-line information including of of clinical a us can year. decision you spectral trial confluence We measurements as will And so cognition changes to stroke a candidate. to the Phase end potential the shifts we support advancement evoked of be the the it expect a on and help Xa of and use announce before data

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We now and our programs will to for this an turn on other provide over will a early highlights. financial more enter Greg milestones overview detailed as and update associated I next call of year. we the stage

Greg Weaver

the you, XX, net $X.X in ATAI of expenses was driven million IPO our XXXX, prior costs XXXX. X related The its of equivalents of and offset operating Srini. $XX.X maintain cash as $XXX.X from in by of net position, compared consistent cash September $XXX.X notes Thank of to million convertible to cash investments to quarter. million payment fund excellent continues expected totaling with XX, our and $XX.X in as And months as cash guidance, proceeds with of net million use platform in operations conversion runway is XXXX. companies by into cash and million the June

were as $XX.X million to in of to decrease based compensation by million in million was compared driven compared total $XX.X $XX.X QX. Third QX. $XX.X primarily of total operating OpEx XXXX decrease stock The quarter million a non-cash the as in expenses

a current growth D&O to $XX.X operating ATAI QX in the benefits, a and was related comment to a $XX.X brief based going based $XX to public comp In advancements in increase million excluding looking our of million comp one $X.X of QX acquired in increase addition, initial $X expenses, million the we to in in QX were by we again, the due Florian. QX personnel the related our in our personnel QX, total offset Neuronasal. programs. qX, X.X I'll million million stock in run-rate consolidation The neuro $X.X And all million an decreases compensation X.X vesting from to stock normal of costs call compensation recorded R&D process of based excluding as the in of and in time and as represents expense million conditions added based These in R&D expenses in from clinical regarding G&A insurance, decrease in R&D back company. $X.X and forward. building back hand that was in G&A Thanks stock stock to of from of

Florian Brand

thank Greg Thank we've well the their and Srini. achieved this as team, I like investors entire ATAI our as to you, would for supportive all contributions to quarter.

model bringing is believe in we profit to of solutions While X the fastest new the patients way need.

We that X solved alone. by be mental understand health will models the not crisis also profit

with the must The proceeds to I'm be Impact. tackle in and of X% ATAI initially health the The program will program With as We and report our gross solidify philanthropic shareholders shoulder from contributions mental disorders. launch broad an of to share October, So shoulder continue that we drug entities funded mental will we equity Impact developer that from sheet non-profit within portfolio, non-profits strong program health. of founders. announced proud ATAI’s support institutions and that balance stand to commercial leadership crisis. vision and our global healing by position believe new IPO this and innovative our our to and ATAI collaborate

company our that milestone-based allocation. humans, Most with across the the our expect development, we happy for evidence pipeline. pharma drive By questions. With take QX the data the in drug forward validated further look we elements to been updates of notably, the Xa progress by value has to We're model on and forward business compounds differentiated combination XXXX. Phase our are partnerships Recognify’s large success designing in our top-line in is we XXXX, focus unique followed driving to academic progress developing that early prior forward. institutions. as our to and approach data and of and of X by continue end providing probability portfolio the Phase maximize catalysts We look GABA to to capital the X by with with in pleased approach, Our structured the

Operator

be your the with question Thank time, Charles conducting [Operator Our line of Cantor question-and-answer Please session. proceed this question. Duncan you. At first in with comes a Instructions] Fitzgerald. we'll

Charles Duncan

Xb Good quick since to sounds on and good progress team. question upcoming of half our if cohort. be saw? Xb? Have the the that's ask some Phase Florian out taking And it you congratulations can -- a question imagine second X win like a spectrum wondering have about a the color I'm the on morning, -- in and terms a -- like in And color a specifically of the then coming Any have any in Phase on Phase to And you recently. for of And quarter nice can of patients Thanks first in Xa. need shifts information public the RL-XXX. could to you further provide what not designing really you in of being terms XXXX? I'd that observation that

Srinivas Rao

Yeah. Thanks, Charles.

Basically, on Phase So, for of I've in Xa. as previously. discussed things looking were we're that a the there couple

of first to X of and trial. observed The similar the you that, will tier The challenge were if in sort qualitatively the what spectral next quantitatively there was shifts Phase from evoked down were tier potential. was previously scopolamine quantitative-EEG

PXXXs sustained So on are focusing attention. specifically also tier we at with And the the an sort looked mismatch oddball memory really assessments, and in cognitive negativity, verbal PXXX, final of task. but

cognitive top. correlation for, up I marker. looking power some really for adequate are compound. of impact will say, wasn't -- in of of This right terms there So set or What the the sort truly three designed is to cognitive size -- tiers some other assess sort off those of with we're really the robustly to the trial

These next totality the cohorts quantitative-EEG X of spectral course, decision a were up running And about quarter. advancement trial we power looking of the did what data patients of get trial. go to us results. are be all milestone at found Obviously, portion a making that next comparable show we on So the the the saw earlier. primary no and And bit sooner to save what to and led before what go from X hopefully encouraging. the shifts that's, little that of that's we'll the first

haven't ahead. on go guided We yeah, --

Charles Duncan

I'm No, sorry.

the address were I to question. think that you going timing

Srinivas Rao

on that But haven't we up, with trial be broadly guided Yeah, be said once another this wraps that we'll mean, really we to I you. honest starting trial.

Charles Duncan

one you X any in back think and or hop your that about I efficacy programs durability. Any color that impact trial? And versus in then saw I resistant I'm guess wondering impressions COMPXXX the Okay. the further regarding the you or if your recently And have and that I'll paradigm week least primary X additional of assumptions from I'm endpoint for way, or timing, X in other further question, And on the control what and studies sizing maybe, treatment wondering depression. at on is the depression. in know queue, data COMPXXX. here I results guess

Florian Brand

Yep. Thanks, Charles.

I maybe COMPASS Before me team congratulate the readout. hand data it again, back the to entire take Srini, to quickly let philosophiques opportunity

really that quick moment us. for was So a

in very we have as perceive the that this in first know, you for greatly psychedelic company your to was other And assisted therapy. point, COMPASS for therapies also psilocybin But funded space. assisted we development. we this their As validating the that

the but the comment on little So And for psychedelic further Srini, in mental that, details. a you data, approaches maybe with COMPXXX was bit large. it to encouraging health for all want on greatly with week, last

Srinivas Rao

Yeah.

at psilocybin effect that design. that's shorter. we'll it of Charles, impact that much are mean psychedelic something very we're we're what question course, I -- what are and And more with did. point mean, some is into long your differences around is of of compounds So psychedelic be this durability these this point. how duration fundamental been that duration looking detail. doing course, There things I are certainly some designing versus open addressing all COMPASS first of effects

element, want to always help Our going approach to to trials is I going And to use be decisions an -- therapeutics speak some there's we're were flexibility. so think redosing figure important how ultimately digital guide this. conference I we redosing. obviously to that's that configured for can't those

we I changed. So of big learning design pick say the be fundamentally this. But would through lot in terms obviously, a the of hasn't picture, there'll detailed as

data us. pick available we and more becomes data As this to

that least really that really of mean X shorter of terms S-ketamine, known X.X point, the term week were had it you're that on familiar I at II the weekend X honest X II the again, III. approval a TRANSFORM was think short actually it as when in terms a basis of TRANSFORM trials now trials was endpoint. And I for I, the S-ketamine pretty the of that be and squares endpoint. data, and efficacy comparing some ours. package failed with II Particularly much week let's approval X change you COMPASS In term start of X compared the reasonable TRANSFORM looked trial and to they smaller, really MADRS as to was one in the

XX% the over the That's in size single whereas the S-ketamine ours well. response. X administration, magnitude a were the of on trials as is is week. And administration's configured based how per of So increase course,

improve really stance Congrats on COMPXXX and Thanks this S-katamine. study versus for the color. for logistics the the So added progress. for

Srinivas Rao

you. Thank

Operator

the Neena Bitritto-Garg question question? comes line with next with Citi. Please from of your proceed Our

Neena Bitritto-Garg

thanks taking Hey, question. for my guys,

the see on planning a bridging from that about Thanks. that for when study the data dose? Can talk the bit And just So little Perception more conducting Neuroscience subcutaneous could update. on you study? you're we

Srinivas Rao

Yeah.

initial The was trial So formulation. formulation the an using aware, IV R-ketamine. based current comparable trial IV to an is on of their S-ketamine This is Jansen you're very how conducted really as program.

subcutaneous profile, mentioned IV bioavailability closely mean, fundamentally the XX-minute limits IV the the as looking broadly sort we infusion of idea, speaking. I is formulation, versus is as PK And this parallel, the try is of and at PK possible which Of are of course, -- in doing in the that infusion that I match study bioequivalence that formulations now. as are course a within development the were to

make it's pickiness, on So safety we sure cetera, efficacy. could et that both want not that seeing and you're more to markedly impact that shorter,

terms roughly It's results. the -- when those when Phase of contemporaneous In anticipated. those results Xa with endpoints are

Neena Bitritto-Garg

perfect. you. Okay, Thank

Operator

Thank you.

with Our proceed your & question Baral the Please from Company. Ritu with Cowen question. next comes line of

Ritu Baral

everyone. Thanks my morning, for Good taking least got I've questions. X. at

following the Just And on I up on question guess Neena’s PK. XXX.

the First, could I and scale the impacting starting as profile? of bring could you there sort side form what's would we as versus going potential down disassociated subcue to be Like from one be Srini, you about peak of Phase what -- you the dissociative want talk effects that efficacy? reasons disassociation? guess the if with that the But improve [Indiscernible] how and and X, PK that a should of as is then its that's see, separation magnitude scale thinking be from sort looking the effect we area And at competition? about [ph] far curve? looking And best then the this pharmaceutical what two peaks from that that PK separate you that should to contributes to be there should be How we under efficacy? of XXX curve provider at less fear

Srinivas Rao

a great that's Yeah, question.

going at of scales, in terms be the we're course, [indiscernible]. to So the of looking

a scale lot choice seems to trials. these of for be the So of it

is with of its kets. in what S-ketamine mean, label. course used of [indiscernible] some the the number Of challenges are resolution the I course, not There great. ketamine it's well studies in the as and a was as in

and So we're at also like [indiscernible] looking the BPRS. things the

are So I that that -- those really other focusing instruments that other the are thing are mean, we're trials the on.

anticipate That's for far with In tolerability. efficacy is peak in little higher AUC to is that cetera. deviating hoping our possible, match really PK to see next priority. plan initial But rather as the would result this really assuming that profile. goal than that I bit one. really et the difficult probably decrease terms Again, is assess from closely a mean, we're really increase would and how of peak versus as around question One good it. too this a our in as a closely that impacts more as that possible trial, try current efficacy or match we

Ritu Baral

Got up it? my follow And etifoxine XXX. on is deuterated

that You other dose for, for? Should spectral And threshold dose what that talk single to be be the band single from been the has Can we GABA-ergic ascending qEEG shift would see band. XXXX. looking that ascending Or think beta mentioned early would mentioned able you're you're shift drugs? in looking multiple available data portion? I beta you What's percentage that the be dose? the in seen again, the from in you the the to it

Srinivas Rao

Yeah.

the changes the don't on So we've magnitude ascertain, first robust really the spectral we're the SAD of looking a are data? of MAD at to for bit up. coming in shifts fact, the of trial of when sample both much think of are -- going SAD which the moment. wrapped component elements SAD not the And MAD the the in we're The in I releasing I as mean, detail from we lot terms point, a be quantitative-EEG we're as SAD Yes, for really will a data. data data forms and be shifts. there. giving element. replication spectral saying And is mean, I that's basically

I think these into end of for waiting any on both results. before going detail up kind we'll probably

Ritu Baral

questions. I'll the taking back the queue. it. Thanks hop for in Got

Operator

Thank you.

Credit Our from Judah with Suisse. question. next question Frommer Please proceed your with comes

Judah Frommer

Yeah. Hi, taking my questions. for thanks

terms a We've steps just endpoints questions, a the little in you once I of when of that? Xb? think cognitive designed the Xa about Xa should decision that hoping And plan. on unpacking a the up we be just the an maybe is maybe that back within you'll of versus how looking got point, design we're XXX. First, bit can trial? kind is few you the next Phase was Kind at kind making talk we Or always -- of about incremental get those of,

Srinivas Rao

Yeah.

I think let's last question take -- the first. that first

with terms that's you. terms decision -- question. in be Xb Xb, again, still the we're still Well, didn't understand I meeting Clearly, the trial else an be These like, working considerations the it, that honest pretty the looks of that still we're trying endpoints. Xb to efficacy of interpret of METRICS now. durability what through maybe that the considerations and duration next something be Xa consensus way under course of are on So be the some of figure entire There the could important battery where versus of quite of we're just thing, I where will of using Phase end it. focusing kind lies. is our some it supportive working the design are making first of to on or consideration. in we're some still parts And we parts of may battery,

Judah Frommer

the next portion? do you and placebo of active in arms Okay, have size and the

Srinivas Rao

We placebo. Yes. will have

Judah Frommer

Okay. are? you how many Do know patients

Srinivas Rao

It's yet, the to no. design? depend entirely on Not going

Judah Frommer

got Yeah, it.

Srinivas Rao

of course, of terms handle sizes a of part really getting it some trial. And in of the what of effect good seeing this is on we're

some give decisions. at some expect around that us So color can will least that's what obviously we going empowering drives and

Judah Frommer

by way? in on XXXX. about terms may I just of X, Phase housekeeping now X expecting Phase you a anything Did data talked XXXX, Okay, any perfect. change but then item, in timelines be And or think impacted made COVID GABA. in This recruiting had early

Srinivas Rao

you nail head on on one. Well hit Yeah. the that the

lot a folks that depend depend that students were also these the through we think these was of they if about of Australia, travelling both anticipated for way curtailed I some we heavily trials. all slower had. kind you -- are on recruitment they on lockdowns of during So do did than They through the mean, the trial.

at of definitely things a site moment. bit clearing down, the of there's a bit of backlog occurring did at So slow the that's a

we and in just guidance the pushing sooner. side decided So, be cohorts get to a bit. hard we're But, makes to that push on conservative little the out very sense our it obviously

Judah Frommer

Got it.

last of cash on prioritization think And programs about one, runway Okay. the various just kind cash a you How should that tied we programs. I guess have. to towards pipeline of

today? amongst -- far get there to to runway. further of way programs is as But you they highlighted programs want cash any you've presumably get that that are get talk about these the as are end along that You'll the prioritization as toward can

Greg Weaver

Weaver? I in drive good details XXXX cash in our sheet. reason of laying say ‘XX give we We've runway now priorities. we're No going right question. Greg around ‘XX. balance Keep $XXX Judah. going think safe QX, planning now And to like most for But mind, deprioritizing a thought to continue it's to anything. fronts. million, and at thanks, to think we're stages lot we'll be very a allocation the a have strong companies through that the the to It's forward. in got debt all out We Yeah, right of on

to along company, as going to Phase several on push the X we're for be with BD will well. area of think on in earlier, to the into trend XXXX moving Phase to continue that programs, an as focus continue X mentioned I continues push Florian

the to words, So in my the pedals metal.

Judah Frommer

Thank you. Got it.

Operator

you. Thank

Our next question question. comes from Andrew Please Tsai proceed your with with Jefferies.

Andrew Tsai

Thanks. Thanks. And good morning.

So on unquote like just, also quote XXX question sounds one data. signal a ERP biomarker is there's more promising on

So maybe PXXX. PXXX

you're for assume for the or thanks. is trend question Just would other would PXXX be is, say it helpful, instance, kind seeing some how benefit give that some perhaps secondly around, context first So, reduction? benefit, do shows to some drugs PXXX I cognition framework schizophrenia? And be, us fair much even guess the of

Srinivas Rao

Yeah, the don't -- to in again cohort details. only of it's we're There's seeing And, to subjects. little little X get into -- what this I I mentioned. at the a really the moment, oversell terms early first a want it's from as

the on we're from spectral results As trial. of focused previous I replication mentioned, the and really shifts,

what really that's we focus So goal. the first on

We've at you at it, giving point. of and proceed a seeing mismatch changes how us [Indiscernible] entirety we'll really we're got We sets that magnitude data both test. the to color compared to as give for some advisory will across the of compounds as on really the how of good the look the potentials, and [indiscernible] other part PXXX negativity that the as of well PXXX the

data. to think again, into have and the we're once I So, about we just don't in yet, really position get results the details

Andrew Tsai

Thanks. sense. Make

Fair expect response? about how at the end data, cohort cohorts And dose looked And should then are to interim just look? can lowest Thanks. of assume dose I some and you we of thinking your data kind guess dose you we many the confirm getting? so

Srinivas Rao

is for interested. Clinicaltrials.gov Yeah, actually there's that But are those so on here. up X this cohorts essentially,

models far the really associated the humans, in heard, -- animal with at more I'm analgesia. are were doses whereas And that because primarily animal precognitive some may both we're really have data looking are focused you in in -- the of and so on really effects, doses, lower lower ones [indiscernible] or higher the doses

a of ascending of linear very what We well-known profile didn't because XX, that's of sequence, XX safety just looking XX. some the of XX, compound. we're So sort typical this follow details and and at

dose we're if we backfill the and So did higher the doses. with first to lower going look

seeing that be definitely doing results going of are But really We at and data, don't correlation -- of yet then talk about have course we once those kind looking to go on. to some again it. are

Andrew Tsai

Thanks All for right, all thank you. the color

Operator

you. Thank

Esther with with proceed question. next comes Berenberg. Our from Hong Please your question

Esther Hong

taking ranging this the questions. our intranasal trial NAC looking you. study? Good expected this I on also there are for morning. the just -- biomarkers you're Thank trial biomarkers, you That is the before What of to focus data end looking for dose at? And year. want I Phase Thank is mTBI. expectations which believe are for at X your or or

Srinivas Rao

Esther. Thanks,

pushed important get couple time. So that trial most out in of for the reasons There's is a did that, biomarker.

MRS, looking within we acetyl looking at levels within are Resonance Spectroscopy. we in So levels are brain. the alterations and And Magnetic cysteine for glutathione

kind and this switching Zealand specialized along. back is to ultimately -- of to United are in the board, of and specialized were takes looked up within we that countries, a trial delay bring ultimately this specialists imaging this on bringing the can someone most a ATAI -- comfortable deal lot different that's we helped help States several to end, the and IND. this States particular. with this run -- concluding us who Australia this also trial sites a turns and at including takes really ended that to it The out, we very experience pull And New on personnel decided just equipment, it hence teams an do under great to of United really in the As it In did a the we it do adequately.

Esther Hong

much answer. your so for you Thank

Srinivas Rao

problem. No

Operator

next proceed question Please comes Capital Our your Brian RBC from with Markets. question. Abrahams with

Brian Abrahams

than to the follow been day with impact dosing PK, form XXX dosing. nice, -- up curious deuteration’s might you future have get If whether confidence on there's Thanks taking to the realize on Thanks. dose etifoxine. seeing morning. with but or better that's that the seen frequency? on thus I study. able of with then doses -- And seeing do ascending off couple that's far on Were ups? be deuterated what regard days, a for obviously non-deuterated a What could respect your you And a sense from with early, then I or following to it's Maybe to not I single you you're on get or guess questions. even expand of was allopregnanolone? what Hi, maybe non-deuterated? X the on still times on multiple again Ritu’s with of what's to a seeing you're place if relative potential any wondering my there. starting it's early can the kind learnings or you're to the equivalent, database. based Realized a large you X And Good have safety little but quantitative-EEG. on question you bit safety

Srinivas Rao

lot at pieces And that expectation go as in the again, over Certainly, there's exposure allopregnanolone, like particular course, color. be together we'll push to direct all any very And on we're itself. results, certainly also a the that to on analyzing we're higher. that data. all the a to to And, got together. mean, I able quantitative-EEG able maybe be is all put will well We're really We we sharing an that element increase but into seen it I this coherent not is MAD with because with signals moment. you that Yeah. still really SAD higher, those a approaching the what into awaiting of story. etifoxine we see which that, data may we provide see is have agonist haven't

Brian Abrahams

Okay.

for compare the non- guess versus Now, form? does how that's I fair half-life deuterated And the enough. deuterated

Srinivas Rao

Again, we all don't data have yet. of in the hand

don't anything have really to we and it want that in I provide Sorry, totality. speak can to until

Brian Abrahams

it. Got

of sort about if of Okay. And was platforms very the technologies, lot see spent product? along envision doing going business little do the in about to bit that of maybe could expansions? next wondering lines forward. Will on that a enabling you've you you then, remain deals and expectation types dollars of the development. Where terms being these active I the in you front a be talked talk more

Florian Brand

one, Brian. Sure. this Yeah. take to Happy

you So, in we very remain areas of that we active mentioned the are of and and to active anticipate some those. all

the in complimentary of believe truly of we the benefit therapeutics. So potential digital

approach. in remains perspective interest -- of So which more This precision we also data therapies to more patient the be to anticipate more moving to tailor that in area, and needs, to us. a the is towards to high psychiatry which needed is invest will with do much our ultimately area clearly be linked to or will

side, we add see the to on approaches. potential complementary more In enabling also technology addition, there

discussions size all So there's believe and having that truly mental we no And drug and solution we and existing believe add also need a tools array great see our truly very, to We treatments to great interesting a that fits here. of very development we will area. this ultimately, treatments health. in therapies potential further one pipeline. Hence,

Brian Abrahams

helpful. Got financials if it. guess for could. one really That's on me more I the a Greg. for Maybe I question

rate mix normalized the clinical guess we're R&D also, will, SG&A run an decline may think run-rate continues about relative the company think that quarter matures? And to relative You sort we talked how should this base relative was going and to absolute for should also we SG&A compensation. how this SG&A trials those things. the end the of run-rate Or at as Because components in OpEx OpEx we to the evolve I run talked and -- on about that proportion should more magnitude this And kind spend? stock-based a grow, the but best relative where company the -- rate grows a along the as now to I relative I about wondering, spend. last advance. of the the of of you to guess, Thanks. And then, lines, forward? base be about peers? higher Is of as overall does look be bit thinking about a

Greg Weaver

Thanks, Brian. unpack. there couple things to The

take last the Let me one first.

in If you spike -- recall, non-cash stock me. a in IPO in investing back had We our excuse comp. to related QX

it's quarter-to-quarter guidance forward. So that QX benchmark so a what the in much stock for anticipating a Not lumpy more we'll significantly but $XX going while basis, going is percentage dropped comp. I'm of number. on forward non-cash million as see that so indicative

quarters in R&D In we'll a the ahead, OpEx see in I of think of the normalization R&D over and G&A. actual terms increase a I G&A, of more an and think

to build this a reflect of we increase of year, consider. employees. year And you back we to that started G&A. R&D, on maybe concepts So and couple just XX anticipating if XXXX is, One that capabilities both the to this out we've our headcount, doubled XX on that'll couple there as focus continue with internally

that'll be weighted in more while forward. as go on the G&A, heavily think initially -- balance more I we I it’s So think

And guidance so, as But out the for a that now. game building XXXX plan of right be hopefully stop helpful. we're would specific short

Brian Abrahams

That's my super questions. helpful. Thanks again for taking

Operator

Thank you.

Please Partners. with Our next Capital question your comes question. proceed ROTH from Elemer with Piros

Elemer Piros

Thank morning. my good you questions. for taking Yes,

week, get I you psilocybin how they used you But Srini, already R-ketamine. X was could, complement how With you be three last about the if other tell us differentially? talking if your would god based depression programs on and focus could elaborate all further if might forbid COMPXXX, started would approved, wondering perhaps therapies

Srinivas Rao

of of pharmacology the DMT compounds these certainly or are than Well, that different of psilocybin. several

glutamatergic or Salvinorin based A nature, is cap-opioid has mechanism opioid-based in the mechanism. R-ketamine So

And able is obviously element. TRG an that's a important and on this And up anticipate anticipate subsets pharmacology. to -- hypothesis pick we being but so we population the using different

home R-ketamine discussed, the is assay intended for we've As at use.

The used anticipate other an would -- how on without assays we being inclining basis.

being in sense, many in differentiation are designed to infrastructure The well. slot So internal is some of of the into S-ketamine compound currently. that's DMT as there ways deployed for that kind points

in we're a -- anticipate also half-life. we compound duration shorter the much we of a it logistics simplify more administration to Obviously, a we both opioid with compound context. cost has therapeutics, it's And shorter developing the are the software are sorry psilocybin. dosing -- simpler I hardware So with intend the little to when digital psychedelic this mean, of and support in bit the really based to and compared of our site physician cost combination

Elemer Piros

envision administration compounds Do same patient? a Okay. in you combination the or subsequent these of various

Srinivas Rao

a Yeah, interesting really that's question.

also there's course, patients, think certainly maintenance Of some different type but approach and for induction points of these. there's different the an in journey. can patient's of One

But which for hump again, individual or whether For And biological benefit. in they're example, could the R-ketamine? products as biomarker to suited best by suited from given best compounds this is data biomarkers strategies. at over then you things did compound on journey. are for at shorter for to imagine DMT and announce perhaps patient including really that anticipate patient using real that very the be we metabolomic can first regard. scope. acting patient, these biomarkers, looking get were, The also the And when hopefully looking will compounds, it how for such, profiling, together example, psilocybin a patient all digital and patient's help we world, is program. they inform the which Certainly, a again based complex Will or be that's probably I totally that to tends would not developed development within be put in

Elemer Piros

much so Srini. Thanks

Operator

you. Thank

comes Sumant Canaccord Kulkarni Genuity. question. next question with your Our Please from with proceed

Sumant Kulkarni

have morning. ones strategy. specific couple questions. X product on Good and a one for of I my taking Thanks

you to for the Or my the comfort of use? PCN-XXX, that on have approval more and around at first until at of potential That's is thing? the First kind home a watch do more point question. what expect products wait

Srinivas Rao

occur really will Phase once from that data that Xa. think the I these have we

either see healthy a with tend minimally the have completely was bit So the We you that that milligram were look what taken provide patients. dissociative and Obviously and quite than were doses non-dissociative see as those, to you mentioned in or little S-ketamine. different XX I we different volunteer things can in population, forward. those did on call, in color XX that the

going we're those to trial help decisions. some that that's data to really So drive forward looking in

Sumant Kulkarni

Got it.

Srinivas Rao

XX surprising about Least is if the compound. milligram know dose what given however, profoundly dissociative, the we

Sumant Kulkarni

X/Xa success safety XXXX. of would early we DMX-XXXX, Understood. Phase results ibogaine? already What as qualify what study your you know to are due relative On in especially the that with profile about

Srinivas Rao

closely very a in We in parameters Yeah, making with normal for intoxicant characterizing trials, the a things. robust of at that, what literature there's -- Obviously, EKGs time trials changes lot and ECGs understand understanding that that's each There's rigorous stuff sure we're know the cardiovascular of we'll we're in occurs doing so that the resolution around about obviously looking resolution. And tolerability course that signal all all in to been of talked very there's the the that's and obviously these trial, instances. what be seeing of safety a or sort example, important a few the this those magnitude viability. there.

taken of Phase will ibogaine be to trial. X help factors for decisions All these together the dosing guide

Sumant Kulkarni

Phase in the but set of the last is secondary fresh, looking partnering? COMPXXX impact to have see the my from space still strategy. question And of tone discussions on assays that know, any prices be We Xb might data and it's or you still quite for began

Srinivas Rao

heard don't know if I anything. seen It’s or early days Florian, yet. you've

Florian Brand

impact was Did -- on that -- understood of I any you that to could I you what currently the you whether If prices assays? question? said? Yeah. say ensure of Is there repeat

Sumant Kulkarni

Yes.

data the your you this with we given hand. tone the on psychedelic have price in of partners in the COMPXXX know potential about what we that of Have discussions themselves, changes any set seen Now assays data?

Florian Brand

early. I Srini’s that's To Yeah. reiterate very point, think

so So there also highly our I Yeah. we add holds to are far. Again, we think And for that compounds complementary for evaluating it's and was that the discussion doing. true other us, what platform. in validating to no we highly encouraging, for realized technologies direct that impact

Sumant Kulkarni

Thank you.

Operator

Patrick line you. from Instructions] with [Operator Please of proceed the Trucchio Thank comes question. Our next Wainwright. with question H.C. your

Unidentified Analyst

trial other further Can many compounds CIAS? I what a how of And for is potential is little it Patrick. you RL-XXX. differentiates the bit this other Phase from Hi, then the X kind thank being Jason RL-XXX? one validated question. is action you. discuss the differentiation? to of have And you thank more This Thank you. for on mechanism for And developed the about related can speaking taking question of for just my is

Srinivas Rao

a question. Yeah, that's good

pharmacology the It doesn't bind So complex. sites traditional compounds. thing compound other on as the quite is

it's difficult receptors. efficacy against understand binding to to in do So binding these vitro experiments potency and the

been So the this has studies. done today, way is antagonists using

you're I As mentioned, no GABA-B in doses, a at analgesic higher animal effects effect models, lower antagonists. tropic seeing doses of

GABA-B so of no Yeah, as the the antagonists. the actually it’s antagonists think compounds. some cholinergic effects mitigate tropic some do of I

So, were be benefit. existing again to to receptor GABA of pronounced pretty pronounced provide do in have the That most be side pretty reasons to it -- have effects. its multiple clinical systems aggressively case That's seem seems Conversely, doesn't agents the the hitting trials. one pushed here. pretty a doses

are glutamatergic glut are compounds. those lot how glycine does of agents, these or So compare? a compounds, this Well,

So little ultimately of going they're terms a complementary their being of is bit is to a in pharmacology. be to up to lot different this would going another. suspect I one end --

more quite Phase X of makes through than So the one I'm these I hope encouraged. it and gauntlet compounds pretty X trials of Phase frankly.

class be think could very very than I and compound patient, in need different in to within putting going is be patients more with a same one there's together the beneficial. even that, piecing with the of huge useful, terms medical different dosing it compounds

Unidentified Analyst

you. Thank great. right, All

Operator

with question. with Our Capital. next Nathan your question from comes Aegis Weinstein proceed Please

Nathan Weinstein

confirmed Question that versus Xb. a Good the onset was team. highlight Seems for example. benefit on morning, psilocybin ATAI Phase of COMPXXX. The SSRIs of rapidity to in

one you health mental trouble in can acute So day emergency that of terms care or what patients use might I an mean in opine to setting? for

Srinivas Rao

a good that's question. Yeah,

a of this So got was of motivators that's that the one with could their onset presumably certainly like anticipate why is rapidity label. the ultimately compound. something That of suicidal for motivators. in the One indication certainly one S-ketamine happening

in actually in one day It's it of So doing the a be But not use to maybe some population. at great use to stabilization, in this. you do time certainly and have best deal or sense make after someone clinic in this the initial a compound the probably this does a trial such patient morning. walks certainly

Nathan Weinstein

much. so thanks Great,

Operator

Our from Cowen Company. question. proceed Baral is with your a & with next up question follow Please Ritu

Ritu Baral

quick. a clinical digital therapeutics the you Florian, FDA Thanks. I'll them -- building Can Hi, programs guys. and these therapeutics European on can into relatively or with programs authorities keep incorporation? up. talk Thanks for on speak discussions either the about development the and early digital to it spoke around you of receptivity basis. follow bringing their regulatory you

Florian Brand

Yeah, if you want Srini, jump to in. you can

Srinivas Rao

Okay.

So various have elements through process. here already regulatory the been the

to respect is [Indiscernible] with believe So kind combination a reset of, of XXX(k) reset. But off sort functionally I of product.

that combination digital there. the the hardware drug, and basically products, is there. the -- with a So combination Obviously, combo out cost and already the out other thing -- is concept drug, the therapeutic general concept where

regulatory So I process. have through the the elements been overall, think the already

do some immediately bit general not seems regulatory process. the have had we with we so through again, already a We doesn't this, impact be a a of our to as think FDA go EMA us IND however, But, the been specific assays. through will validated concepts little discussion from have behind process I go around we those further as the The perspective. on with the

about noted Of a way. And FDA should little chance also it's process, bit being thinking go different. general a there. the [indiscernible] compliance did are through certainly concepts hardware rather along get like educate it other the course, element a management. of there's is to be digital is more that a the digital companies nonetheless, site concept was But drug My And course, out a approval therapeutic of with It really that sense, this. that in partially it based. paired traditional hardware, wasn't this we

are So question? your pieces all out that the Does already. answer

Ritu Baral

Thank the for Yes. you, follow. thanks

Operator

now end we reached for and call to the the session. closing Brand Ladies you. answer question turn over I and gentlemen, Thank of on. the will have Florian

Florian Brand

share pleasure everyone It And our joining us you, today. you, to thank Thank highlights latest a operator. been for has much so interaction. and

and the As the broader we've a highly as importance whole. psychedelics and as its mental data including health COMPXXX encouraging always, of potential discussed, for

And technologies. size it are our continue patient we does not comes active a to treatments array momentum, mental all. also in broad enabling also and diverse one of health, array Understanding when a supported novel business development fit positive across we discussed progressing insights that highly and our today. population very facing heterogeneous discuss onward in treatments data We that we digital remain of therapeutics will addition by could our

treatment are today mental great approach much and driving for a patient-centric So we week. With you vision have to very focus we with as advance very a health. our I heal that. in dialing all thank

Operator

disconnect Thank lines you you. concludes And at for And conference. you This your your this may today's day. have Thank a participation. wonderful time.

Atai Life Sciences (ATAI) 15 Nov 212021 Q3 Earnings call transcript