BTAI - Earnings call transcript Q4 2021 | BioXcel Therapeutics, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good morning and welcome to BioXcel Therapeutics' Fourth Quarter and Full Year 2022 [ph] Financial Results Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] After the presentation, there will be a question-and-answer session. [Operator Instructions] Just to remind everyone, certain matters discussed in today's conference call and/or answers that may be given to questions asked are forward-looking statements subject to risks and uncertainties related to future events and/or the future financial performance of the company. Actual results could differ materially from those anticipated in these forward-looking statements. affect filings detailed with may most the that public recent the factors results in are company's Risk U.S. XXXX, period Securities quarterly and on bioxceltherapeutics.com XX, September Form quarterly ended the annual found at XXXX report it's be sec.gov. XX, ended December on Form XX-K or by Exchange XX-Q for report Commission, it's as will including which year be updated for the on can

being is recorded. conference today's reminder, a As

BioXcel President is Steinhart, Please Chief Joining Yocca, and Chief Richard us Rob now Vice call on Executive go Chief Matt It O'Neill, to pleasure Dr. Commercial call of turn Chief Dr. Frank the Officer. Mehta, Officer; Development; Therapeutics. Clinical Mehta, Vimal my Financial Dr. Medical over today's ahead. are Officer; Risinger, Dr. Wiley, of Vince to Chief Senior Dr. Officer; CEO the Officer; Scientific

Vimal Mehta

for BioXcel the to Thank performance and everyone call you, operator. Welcome, highlights today fourth thank you our XXXX. Therapeutics' financial year joining of the for quarter discuss and business full and

We discuss year get as monumental on potentially so a company, the for into to a it. right lot we embark have let's

As you company develop artificial immuno-oncology. biopharmaceutical medicines a know, is to and approaches Therapeutics in neuroscience clinical-stage transformative intelligence utilizing BioXcel

with in II. three schizophrenia in date with capped achievements As review the Starting like from journey FDA just bipolar an company asset, under to currently acute submission and year trials. across of years having associated near is significance landmark franchises. the We regulatory for under XXXX, reflect first-in-human and which treatment neuroscience agitation disorders immuno-oncology BXCLXXX of April I for with unprecedented we numerous X BXCLXXX, our the PDUFA for on lead and our I would XXXX, a

validation efficiently of and any the we and AI-driven timeline as our this are have. as milestone development AI company not as R&D discovery view for We capabilities. that of impressive platform has achieved this We drug aware other

the as XXX vision, support approval Matt readiness joining development as an activities which drug. launch sales month our of the strategy our than Commercial national of build-out Since away less commercial our is led of now and from as one are commercial our has long-term including first integrated We Officer, potential force near- Chief progressing marketed and potential Wiley to planned.

on representatives market extensive finalizing focused sales are with and strategies. and our are We and hiring experience materials pricing access marketing

disrupt medical medical managed actively care and their are on health science paradigm schizophrenia for from payers educating patients and and bipolar to liaison care agitation. the teams Our unmet market providers treatment needs suffering

neuropsychiatric in emergency around in participated the and a XXXX, more with country of ahead. number conferences medicine the in Our planned team months events

positive If current widespread nearly encouraged therapy patients benefit approved, approved. be was including for caregivers. of first display broadly This treatments. other prescribing and we recognition these by standard and a it's the broad if after We a they their in would market for prescribe have of of that had reflects message health patients and also brand In care bipolar a marketing XXX for and reviewing positive benzodiazepines, atypical it's of and XXX to providers, reaction new BXCLXXX for intent shown schizophrenia to story XX% recent BXCLXXX proposed our blinded study enthusiasm research are and over potential of typical XX% seen decade indications our in BXCLXXX prescription antipsychotics care material platform. impression stated would the and

is offered. three committed portfolio indication pillar Beyond includes strategy approval where and XXX medical growing of which geographical extending our XXX, to we the setting our expansion potential remain expansion, reach

and of ability Alzheimer's million patients residential Phase December, higher growth an XXX estimated address initiated associated agitation opportunities. - expansion This XXX we this strategy, look II a indication for our in facilities; mark the pipeline significant Alzheimer's need a regarding of With with the to III has would and we and product This two within living treatment approved. advancing first homes. indication in new in or the disease. approved these potential XXX with year, indications the for nursing to of medical program trials: the patients high representing in represents program forward consists for a episodes acute of we are pursuing option III unmet patients. past therapy treatment We evaluating Alzheimer's growing TRANQUILITY U.S. this believe First, actively future every in TRANQUILITY XXX population novel assisted if for agitation patients

- XX data million slow suggests With these BXCLXXX filled responses, over could as treatments, these action in limitation new treatment We prescriptions as clinical and that depression disorder. to a are annually. incomplete an with common There MDD believe XXX XXX into the cases XXX of have in remains major onset expanding for IND antidepressant our we an million year. effective the for of U.S. patients. are and treatment approximately such option depressive also potential own most a indications filed XX adjunctive recently type be

Moving to our expansion. pillar, second geographic

could of first We Application and the in submit for more to we working are our U.S., Authorization Marketing from a to to product. the Agency expect novel opportunity year reach BXCLXXX. the grow half similar diligently this Medicines patients European With benefit footprint a potential with sizable our who market

partner strategy, to are potentially actively this a of part commercialize As XXX. we seeking

to strategy, like and new evaluate land-and-expand into XXX Our future care ultimately pursue expansion regardless we indications. strategy, patients and for continue to setting. growth our our be accessible to settings of in treatment opportunities third current pillar of both we strategic Rounding want

BXCLXXX have is candidate, pipeline our We AI part As signaling antagonist cortex, we of initiated and be mechanism. newest BXCLXXX. for formulation a patients. sustainable for for novel our of a treatment a serotonergic product and for the target cerebral strategy our in with and our designed pipeline agitation chronic GPCR R&D expanded using platform, differentiated affecting a potent the selective to XXX dementia in

the XXX tremendous program. advancing turn Let me progress we immuno-oncology to where our continue to now franchise make

BXCLXXX the developed at an mCRPC, cancer, advanced reminder, presented we of both in plus aggressive response Together, support hard-to-treat February, and systemic cancer as for tumors. XXX treatment administered, ASCO composite results adenocarcinoma XX% In prostate activator approach [ph] forms patients patient and patients of a possibly patients. As extend cancers. to for is a XX% XXX KEYTRUDA differentiated solid cohorts metastatic immunity and prostate the data encouraging inhibitor orally sell into mCRPC castrate-resistant of GU. rates for potential demonstrated SCNC innate therapy positive for checkpoint being of

MD also solid drive and encouraged critical our journal, two franchises. first be successes. is continue busy on lead milestones tumors up efficacy way such Starting XXXX Phase AI we of neuro the a JAMA Anderson-led XXXX basket promising our a year was as exciting of our shown many prestigious both Therapeutics of with to product hit to II second and our and innovation. platform potential for for product to candidates, as results as approval. the XXXX towards and the for we be JITC the XXX on oncology recent many trial data we future and BioXcel our including and be couldn't through more advanced year by XXX. potential look shaping excited expect development, KEYTRUDA the half summarize, To We open-label of in our additional publication continues from have in clinical to key build

will Now, a give I Richard turn call financial like to update. would the to who Richard? over

Richard Steinhart

increased million as and the professional of administrative the results. and to commercial the our $X.X attributable increased to BXCLXXX trial year fees fourth and quarter the million expenses million period as $XX.X the increased launch XXXX, $XX.X potential BXCLXXX million decrease well $XX.X related decreased for compensation, noncash quarter primarily full in $XX.X million headcount insurance Vimal. to the were which expenses XXXX ended fourth as XX, increased was will States and increased primarily full same compared headcount costs, for to in XXXX. including December Research XX, compared and for the related was United costs XXXX development compared now legal The trials. in headcount compensation. related compared for for stock-based primarily General I increased expenses year was $XX.X and to review year trial development and you, year XXXX, and related XXXX $XX higher expenses were period as attributable related attributable of million for due Research in same XXXX. were and of were partially to fourth the XXXX. increase the by the costs. to of expenses period period The the to month costs, and ended quarter full offset December to administrative the same stock-based Thank increase primarily million year XXXX million costs were were during period to clinical $XX.X expenses clinical financial for for to for XXXX. XXXX. the associated three expenses General The BXCLXXX and The same increased marketing in for as XXXX including

We in XXXX million for BioXcel a the same $XX.X period BXCLXXX. of Therapeutics of reported XXXX. in U.S. loss of also costs for a incurred net of significant a preparation launch quarter loss million commercial the potential for $XX.X net compared fourth to

For period the of year, loss million to in million same BioXcel compared net full XXXX. for $XXX.X reported loss the of net a $XX.X a

$XXX XXXX, of equivalents totaled XX, As approximately December cash cash and million.

Vimal. call Now, I'd like the to to turn back

Vimal Mehta

Operator? questions. like We would Richard. the for call to you, Thank now open

Operator

first Instructions] from Our of today America. question is Bank [Operator of Harrison Greg

Greg Harrison

now in are far? discussions the label currently? right So And them around you you so how is the that XXX corner, characterize PDUFA would

Vimal Mehta

and review the PDUFA our our by the response Greg, under FDA date. NDA of continue expect remains by to we April NDA the X

GregHarrison

then could What attributes any the future partners And in Got of in a to you EU? is for with looking a what the it. XXX partner? if commercialize on And topic. different are status discussions hit I

Vimal Mehta

can approval the strategic only MDD. And schizophrenia bipolar Alzheimer's terms of we partner we point year. also our are just on we that unless to submit are MAA attributes and getting to mentioned partners. also will submitting not looking we we have and in in as in that So of got a unless from with which very sNDAs our first FDA. in this the is a is a holding That two our the our discussions we partner first a ready indications upcoming who get we're - for are where And be half at but MAA facilitate

have partner franchise they will So in a and partner. be capabilities, attributes key if are a those kind of the a has we seeking those neuropsychiatric

Operator

is of question next from Jefferies. The Howerton Chris

Chris Howerton

about excited have just PDUFA month super I'm away. to the a

actually the be there amount package my - pivotal just So acceptable evaluated from the was - for what data guess current that extensive European an the recollection have the do were would you EMA for in I I EU, the with I would indication submission? the patients respect to question have a that there that of was study.

maybe is terms the But you'll have you're some that about and allow moving to us that. So it's programs a second on the the work. sneak on a expected then, little XXX? I have? process me what And the the the early what just expecting to formulation clarity you I of think decision-making - expanding forward in, final encouraging you're is that in it of obviously, question, dosage for question tell just you in XXX, if said third then be XXX. quickie, would capital Could versus form for And deploying towards those would results timelines

Vimal Mehta

you, try to through them all will I on have noted I by three one Thank go questions. one. Chris.

AI that we package comfortable the what U.S., to on currently and MAA And and patients had submit and agency our were Coming European all already have And date company, neuroscience presented current the neuroscience in But we leading data not way we for a MAA, Europe. - have is most in the first the outlined we and all Coming within to pipeline have close question MAA. from made. the just advanced PDUFA Primarily, which We go continue have the be we second the to to III that the aligned, a focus the And five trials that. Regarding to submit be that's extensive And package the a the Phase package have second is that BioXcel is SERENITY using that year our two discussions product Alzheimer's it's the presented very program. from in a yes, authorities, I package Europe, authorities. product pivotal ahead? in our deploy they question with indications II required to clarify FDA your vision MDD to were your we want sufficient have, to the and with the to we for regarding to space. neuroscience And we the then our will commercialization program we the we from XXX, Therapeutics. then shortly. NDA resources initiating commitment in will company. AI-enabled

has So been already that commitment made.

In proof of XXX, we the have a hard-to-treat terms tumors. concept of now clinical in

a So mechanism It to like explore we proven potentially following believe options could co-development. JV think spinout. be the in of We could have we'll things. XXX continue a partnering. could It include be truly we strategic a and and/or which

it We have is can combined demonstrated that and with It safe tolerable. KEYTRUDA. be

have demonstrated We clinical activity.

the in have We published mechanism JITC.

- we So of lot public had these selected we just a we as company achieved to when remind XXXX, XXX. became BXCLXXX have two everyone, XXX. and a March with And in assets,

to and very is has close of them approval cleaner another one of concept. demonstrated One proof

now have the our assets will the both go for And portfolio. excited for super are we formulation. I we XXX So in

in recently several months. has last work begun Formulation

So we need have getting therapy. what And we out, we in timelines do, that that that is to all will enter our an timeline developing clarity are of to what XXXX. - position and it provide to in be test the to and timelines a provide point be are, will But on once clinic. worked to going we our oral we we'll

Operator

from Robyn question next is The Securities. of Karnauskas Truist

Robyn Karnauskas

questions Two you. for

I on you you time thought same disclose have planning And you on and a reading data? then the So are the I that as through you are reading how how and follow-up. out might TRANQUILITY II,

Vimal Mehta

you initiated know, program alignment program, point at initiated almost in in And time, Robyn. We the this got FDA, December. Sure. Great the the that question, with Omicron was at peak. as - we

to So situation, when centers. some elderly sites because clinical limiting the or we access started COVID care opening our there is sometimes Omicron can be

we very So need. good forward a have clarity sites that going many we now how

not we know, a it's ask. in XXX have trial, patients you so As big each

and these determining how are to need going many how we're So we just programs. sites we two stagger

TRANQUILITY in followed elderly will of some the centers from - have as we in will conducted the and nursing the these So imagine, one residential are readout, home trials II that But the III. be facilities these both places, TRANQUILITY readout the data data can facilities same first you are care and all by and building.

be will staggered out program. staggered readout data a So will these trials and TRANQUILITY for fashion come the in

Robyn Karnauskas

should nursing your are population for that not living about about any indication. you're seeing? center, like And be people But that the differences the in the patients there. in a of sets you than homes follow-up we'll And there the in that other? label and there's obviously, mild more type those are discussions same for dealing when I guess, be asked thinking with, So think one differences the we initial data like that facility versus

Vimal Mehta

these the Let are me what he what Alzheimer's pass question populations and to so this kind can Rob, describe of are patients in centers. patient two

Robert Risinger

day their it of has ability to someone we who a XX/X life, who of difference someone activities in Yes, monitoring the supervision do daily live patient to the as complete themselves sort between fundamental can call and medicine. by minimal requires with - with

not we that of substantial believe in difference do the terms efficacy. any is So there

of efficacy become However, entire the we want with demonstrate dementia care for agitated. who to across patients spectrum

Operator

The next question of Sumant from Canaccord. Kulkarni comes

Sumant Kulkarni

primary on have I'll saw as three. trials had that a XX and doses TRANQUILITY trial. yesterday for date XX has of Could with I on and a confirm of Phase completion start you one posted the the ClinicalTrials.gov of XXXX III an over the reflect latest behind December first update weeks. it one given seems of posted maximum Omicron We 'XX of Omicron just of what in number your doses update that completion now more the date my might your does we which than That's And light the expectations that yesterday to be us? be? December comments, be appears thought maximum question. to study was

Vimal Mehta

and So on I first question. of Sumant, about to other pass question will take portions the it will the the I Rob

sure to as number will pieces. testing the as the enrollment And are there complete year a see big over agitation. repaid I We and be two data effect can not patient said, sufficient guidance patients, is then, enrollment the from be. it's just We that want dose [ph] have readout a we perspective. up open. a we that we are We But One only to key acute have period, to so trial sure want that sites the not when that there have - is - no can you be like three Like of first XX XXX to doses trial. what indicated earlier provided is.

know, Alzheimer's, multiple patients in have you As episodes. these

capture when to not we has to we chronic So out, broader intermittent our trying that we sNDA capture a episodes only go they multiple the the when trying acute, are are have so level.

background, pass on So will to with I Rob. it that Rob?

Robert Risinger

Yes.

the depend think XXX ability to I upon patient subjects. the enroll our entirely will completion trial date

Now why it predicting seems precisely until forward that's final and to predicted not the waves Greek patient the dosed it down before on Omicron moving have enrollment who a the when that potential we dates letter of knows trial. numbers we we people have readout pandemic accrual no slow that bead and next given will our has solid and in yet is. have one the and the for But be what and began. And have difficulty data

increasing. great have After initiated we we confidence. was So the all, as trial Omicron

And to information. and be and soon, we'll accrual able enrollment report better rates much

Sumant Kulkarni

use saw a XX% participants delivery in participants prescribing, key seem And which the on And a XX% what on being full that have is What the research impediments XXX. positive not a my product? the to response cited a that was their you setting to those of is second the little points did survey it. the of not bit on assumed? were I bit little focus the question, to conducted. - survey Got that you market that want glass

Vimal Mehta

Sumant, question. So for take this Matt you question. thank will the

Matthew Wiley

Yes.

This survey the So we part was the on XX% found feedback the survey a there had not where reaction. just positive qualitative or is XX%. of quantitative a

So something dig in find qualitatively we time. but that's on not the we'll over did XX% remaining

Sumant Kulkarni

which question, the activity? then setting? single-agent prescribing ask last are latest And too is about your my How ascertain to what I'll plans XXX,

Matthew Wiley

hospital the we at So setting. in case expect our prescribing on focus building and base relation setting, we're type to the out the institution That's to sales launch. team where in would

Vimal Mehta

like Matt our Vince? what the care from has So to would few a a of like Vince. case activity weeks this clarity. base our back said, say for Sumant, as have been look I that health the But are we question we understanding me will label will pass away a XXX, to let supervision and single-agent provider. under Coming

Vincent O'Neill

Sumant, the - single step, part previously plan, or need the that's Vimal. logical of develop to would Thanks, test agent. As next we development we've yes, exactly right? said, as

the at into XXXX So that will a GU we adenocarcinoma. randomization portion presentation, ASCO announce did for proceed we

next the is step. that So

Operator

The Yatin Guggenheim next Partners. comes question from of Suneja

Unidentified Analyst

It's progress. on Eddie Yatin. the [ph] all on Congrats for

metrics few Just from the perspective? year a us. And April, think revenue first for in you approval launch trajectory? you'll script of Maybe from both of quarters you providing can about what that sort and be see help a how number Matt, should a gating assuming we do what in And factor the about for talk us the the key launch? track first few to as

Matthew Wiley

a number that tracking identified have to we performance internally. we're key going of So indicators be

that of communications is, we with those And some investors, future are so provide will what relevant. in do

Unidentified Analyst

is you a in drug these to can administered, for episodes used? like be And number there's what how the where often care then just often this agitation of for patients XXX patients? terms how the about a sort center talk do And of you. those chance of episode be bring would Got to average

Vimal Mehta

home. episodes these emergency done, have is And they basically rooms So in it for get of the every been patients million patients end and treated tends And be patients research X/X as the there at an options of That's the episodes the X/X Eddie, treatment no up on reason indicated, have about dozen year average. rooms. in at that the of emergency is that home. a end get kind can to take XX market dynamic a out we that current that the case. and up we

they is go the there episode their they in could room in have goal for period vision if we room, the of this up much a with are escalates, neuropsychiatric they whenever medical of XXX is they go go the it And change treated these strategic not So have over to move, program. therapeutic even the of they available a dynamics with how and send will our because and critical care end in When always option. I plan XXX. to to - any or be we terms to emergency as they said them And emergency setting they get the coming centers, time. expand physician emergency the or to room

and As setting this care the hospital the will to and community at change dynamics of the we treated move these many setting, are into how home patient go home. how many

it So today a much of bipolar is X there that of patients. for know and XX lot what million million episodes, that's schizophrenia episodes, are pretty about about we

Operator

The next comes Sachs. of Corinne Jenkins Goldman from question

Unidentified Analyst

is Corrine. Maddie for [ph] on This

The any to the on second, most with launch Alzheimer's the you off-table first in focused is XXX. setting? in one use currently preparation expect And do respect

Vimal Mehta

you question. Thank for your

full what launch be of we health like are. our supervision trial a the label provide able have indicated, is, have our are label, have approval. what a understanding a the for Once we our said, our provider. conducted - as care under to we we that But about in will settings As we waiting then was

the if to And So settings expand launch. of we to your and Did additional answer I explore XXX. question? as are we continue potential that's condition, the will prepared go we

Unidentified Analyst

things the focused right you're in wanted Yes. preparation, now? on of to most launch are one I also that ask terms what

Vimal Mehta

launch launch we fact, are, were And better product now. PDUFA for in I to we January original to ready prepared in our the think date.

sales been access, recruitment materials are provisions like and force, to So and force that market having terms of sales all for strategies, that a the pricing in have of build-out go. that ready national built needed marketing the

this good we have we the to pieces confident product. feel that launch all place very in So and

Operator

comes question Colin next The of Bristow UBS. from

Colin Bristow

I guys something. wanted to push you on

yet like in launch label guidance? about think wondering, sort of So has post-approval And so, set you just the if will when not expectation secondly, it metrics reasonable of And have FDA was some we is specifically do an us? it what arrive? to a setting, just this then anticipate sounds label you as do expect hand. I giving

Vimal Mehta

Thank matter you, time your answer I commenting per FDA. questions. we reiterated are of your subject company the and potential on Colin, for first ongoing the To already question, not that policy, ongoing this with conversation at

We continue to to X FDA the NDA by date. expect with regards from the April PDUFA a response our

And share will a track what Matt, we would in see January. to of have has you the is So your we question launch regarding all position label, joined performance And Matt that's to first answering the in of be the metrics, those metrics. once launch the kind to building approval, launch. about us metrics recently where add to the are. He he anything? like

Matthew Wiley

we get that right. relevant. as I that's key market, indicators we'll mean the into are performance Yes, share

Operator

The is Ram from question next H.C. Wainwright. Selvaraju of

Ram Selvaraju

ones, Three straightforward relatively hopefully.

I to the exploring any if other partnering respect but be you your timeline on MAA with that XXX. for you emphasis comment strategy time to European outlook on U.S. particular your ex filing ask regions at of with this could Firstly, wanted also given stated may the

Vimal Mehta

patients equal outside or Ram. critical U.S. question, of great So patients are for amount lot expansion is of Geographical our there growth BXCLXXX part that's program of you. a a than because Thank

And have MAA on of we in we our will clarity the from to of to file So this half the I European said, wanted as strategy, once first year. in file approval that we ready FDA. be terms

about our approval gives window months time us MAA, then for As the and launch. basically that we of file XX

business partner. And actively a our partners - we also. initiate will we by look to effort by So obviously for also, approached get development the

follow two who focus bipolar follow-on that first of and be sNDAs. have So they to attributes, our only we be our kind process partner for continue indications in a not capability but has and for the able right that have schizophrenia to will on will our

terms I a is other In regions, of territory. Japan very say would important

patient a you unmet Alzheimer's, pool that As know, in big there medical a it's is big, particularly large need. very and

be So options. those considering we will

and we after product, will I So BXCLXXX Europe partnering opportunities for be think commercialization both perspective. a get our Japan first very from of viable approval

Ram Selvaraju

Great.

about Secondly, specifically disorder treatment setting. your the depressive what you envision I as and major wanted if in to ask could plans you clarify optimum

You're what of how specific and talking treatment-resistant in as and talking adjunctive to optimum anticipate And therapy here you in patients Are you subgroup competitive is MDD MDD? within to within being we could comment classified? quantified adjunctive if being about depression? how nature As this the landscape but of the about well what this positioning on obtain or able indication.

Robert Risinger

Sure, Ram.

don't with SNRI. So anticipate an an we that is patients major into be take SNRI. intend Rob SS would plan simple Risinger or again. this specify We to depression We We studying do this to major depression. that as adjunct to SS or

this treatment get for terms targeting for We to accelerant, depression. treatments major depression depression, the landscape who a them of not the outpatient sort this setting is an of as patients adjunctive changing as sort patients specifically refractory or used and of treat on more rapidly feet. point. order in TRD, would be We're So in have at their know that in

Ram Selvaraju

development context then with part And clinical XXX, could sleep integral patient lastly, and of Okay. on respect you if chronic the And was little potential of about in the if outcome areas of to XXX. I disease an include evaluation unique to you efficacy-related as particular, talk plans Alzheimer's monitoring in wondering effort measures bit a have more dementia.

Robert Risinger

let me We - think.

me There potential dementia. that's are a I part. Let additional with the I'll potential There first which it we're other pejorative, suppose, take indications simply dimension are rather but agitation exploring. than call simply - associated indications

Frank Yocca

So let me you help out.

Robert Risinger

yes. Yes,

Frank Yocca

Frank, Ram. This is

fit us. agitation profile similar with mechanism dealing have what - approach approach good the XXX. points the really it how and because with very to. of into a agitation. We're that molecule But it with we're a different behaves we we for our gives fit a be action. see data the did chronic molecule, preclinical chronic that it and So We'll on initial to will approaching will now different us directions to look But it be go at

Operator

comes from next question The Anita of Berenberg. Dushyanth

Anita Dushyanth

a just I of on them already some answered. have that follow-up you

Alzheimer's, to with Phase might how think in patients number study should the respect on settings? different that of we benefit the the III two So between from actually two like you provide about the studies, the higher some dose could clarity

Vimal Mehta

our in response. our as well Anita, lower as dose, dose it's as higher you a know, TRANQUILITY trial, dose-dependent

be what don't see we each will from that So doses. like differences the

to response it XXX. like, doses bipolar, looks schizophrenia see and II are the SERENITY in two rate and like We our what and for testing we trials the benefit how and exactly XXX patient will did I

So that's Rob, will we once add we the those purpose. dose things forward? data, of are Phase will our we we like the know come else? anything forward take now, doses So take do the do program. out to And III or single both you have like

Robert Risinger

who label, factors, No, as benefit in typically is registration, we dose may that particularly it's helps done, simply from - dose. those we to the characterize dosing. for if And put a guide lower find higher we'll a versus

Anita Dushyanth

this XX actually million there on the was Yes, the a MDD of specific I might that wondering, subset benefit definitely. from cases And then program. a population adjunct question treatment? from like is

Robert Risinger

necessarily clinical is development don't like about mice humans. in way. predict along discover Rats the we and things everything I What

or effects those development that with another And as suggesting, the may may you're in so depression. that in of it well direction. find subpopulations, population general If we pathway steer we intend characterize us be to the

Vimal Mehta

accelerate four antidepressants me color. little six targeting, these of general, - what are add more these some In don't a agents. of weeks. work So put that's first the we And in effect to how to Anita, let

So we targeting. are need that's the unmet

Operator

Rx Samir Securities. Devani comes The next of from question

Samir Devani

the comment Can on JAMA. one in the author the But that on on paper important article. represents Obviously, just in change phrase one a the clearly very me? and I where no that discusses phrase for one. that's just clinically minimally PEC It's or you score comment it's published data in consensus positive - just was the the by difference. caught Congrats getting

Vimal Mehta

Samir, me to this pass so let Rob. question

Robert Risinger

discussion a intricacies of delve into I could of that. important but wish there's a clinical I "minimally the difference" lot defining over

bit that XX%, a change clinical is we over It's a is greater The publication the was any by difference The is have PEC response pedantic. XX%, XX%. in quite minimal percent than what shows one far We high. minimal who simply no respond a score manuscript almost the what irrefutable. a think that in robust and I almost criteria showed argues. arguing

and So for significant hour I'll happy minimal clinical an greater we a showed we professor to be difference. far play can than talk but

Operator

There for this Dr. turn Vimal to questions to back remarks. are like I'd the Mehta no time. additional closing call at

Vimal Mehta

the everyone, updating and coming us connecting many day. forward progress. a look today. in Thank you, joining you our I weeks Have you with of for on continued to great

Operator

today's conference. concludes This

You Thank may lines your disconnect at this for participation. you time. your

BioXcel Therapeutics (BTAI) 10 Mar 222021 Q4 Earnings call transcript