BTAI - Earnings call transcript Q4 2020 | BioXcel Therapeutics, Inc.

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Operator

Good morning and welcome to the BioXcel Therapeutics Fourth Quarter and Full Year 2020 Financial Results Conference Call. [Operator Instructions] Just to remind everyone, certain matters discussed in today’s conference call and/or answers that maybe given to questions asked are forward-looking statements that are subject to risks and uncertainties relating 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. The risk factors that may affect results are detailed in the company’s most recent filings with the U.S. Securities and Exchange Commission, including its quarterly report on Form 10-Q for the quarterly period ended September 30, 2020 as will be updated by its Annual Report on Form 10-K for the year ended December 31, 2020, which can be found on its website, www.bioxceltherapeutics.com or on www.sec.gov. follow presentation. will session question-and-answer the formal A

go As is the now this call BioXcel. call recorded. It is being Please of my CEO to Mehta, a sir. Vimal reminder, over the ahead, pleasure to turn

Vimal Mehta

everyone’s thank and Thank our for XXXX. full Therapeutics’ results year conference everyone for highlights appreciate BioXcel joining and discuss of you business you, time to the morning, operator. financial Good and and attention. call fourth We quarter

that have our approval. discovery from approved hard AI-derived Financial call FDA the Vince like Joining Development to Kane, proud are important Officer; treatment leadership today AI-based Officer; we me transformation to new Chief strategic Yocca, schizophrenia NDA of submission received to to X Officer; Will NDA a by submission We we if to Today, Commercial BioXcel transition accomplish I Steinhart, Javier Scientific pleased Rodriguez we and of agitation. the to commercial bipolar first speed BioXcel. welcome supported our in of is believe warm as milestones work O’Neill, to the June team’s trials Frank can to impressive Officer; would first-in-human were company. announce on over board historic for with a our Officer. and And support Chief FDA we experience first Chief development and in team powerful and and Richard schedule. disorder-related time and Bray platform. the our to completing is drug achievement of Medical years, be neuroscience-focused and strengthening management the extend Reina This significant Chief just This acute Benabou, on to application preparing for are are bringing our have am we the team, Chief to this drug completed the our these able

to readiness steps are to potentially have undergoes launch review, a and application FDA’s NDA begin our commercial initiative. the stage we taken our As we advancing organization transition actively

our establishing including seasoned to design our are force. with addition and infrastructure, of and commercial sales building structure commercial teams the medical we In professionals, our

expansion, as across its been which Our been a unique report opioid franchise will treatment day. well would commercialization year’s and the of medical confident month. accepted innovative approval of XXX, of disorder-related agitation currently and be Psychiatric delirium-related exchange I team XXX’s our and is multiple are agitation potential the symptoms agitation, scientific begin end Due dementia-related completing neuroscience presentation withdrawal in specifically in in way XXX to early Association schizophrenia X investigating science mechanism for team that SERENITY by unique action, candidate This establishing we interactions The as of two an follow-on spectrum hired the I to the our indications: for neuropsychiatric this three SERENITY training. and prepared has on this American recently also liaison agitation. am KOL if be to for XXX-focused this important the X in new abstracts disorders. treatment address broad highlighted an May. pleased will at and potential pave Meeting help Annual have am we approved U.S. bipolar will that

adverse to XX supplemental TRANQUILITY cohort events, with initiated range We Phase this well-tolerated PEC, from randomization. scales. development multi-center, with reductions XX with setting agitation X from X positive to in measured cohorts the will come. Phase Xb/X our build in announced of To half a our stress-related and to with the agitation XX-microgram our progress recap and neuropsychiatric significant past agitation patients symptoms. at-home across of meeting We end TRANQUILITY trial, scheduled was with long-term from of PS Rapid believe syncope lasting program centers or care with recently XXXX. results to care achieved second have dose has reductions initiate millions clinical FDA the additional second fall. XX of modified goal to the we as hours. by inform agitation. expansion with of Furthermore, providing other BXCLXXX placebo-controlled We XXX, To CMI to the dementia-related study, our X-to-X the of help strategy indications Over we suffering the and study, with supplemental both NDAs full with such this in plan if targeting been pivotal in the of efficacy the as and serious the reductions comprehensive these or microgram on data programs were submit development quarter seen months, TRANQUILITY agitation for year, microgram were Phase the meaningful plans results, XX up for this in to endpoints of acute of dementia the dose, all treatment X from approved, X cohort follow-on made a durable care. have XX-patient investigating tremendous cohort the BXCLXXX the and the at post no trial Statistically for clinically severe hours years significant

treatment patients patients for debilitating month, side agitation. of helping of of overcome Phase to symptom, Last delirium-related PLACIDITY to BXCLXXX thereby the Xb/X Turning to initiated their month alleviate of our the of we BXCLXXX’s line track this top addiction. potential the trial withdrawal, later opioid with BXCLXXX withdrawal for a RELEASE trial remain on treatment ICU further report trial, we effects explore the the results Phase study, X to

ICU, quarter which results in the including occurs in of wards, top treatment hospital patients this surgical trial in U.S. extending delirium wards experience We XXXX. occurs first and million complicating line hospital the expect from departments. patient X to approximately hospital annually, care estimate report overall stays. agitation, often Most patients and numerous settings, we Delirium emergency

hospital of our delirium these first this highly all in currently making commercial with indication evaluate support in hospital-based to are settings, across we medical patients NDA. synergistic the infrastructure building is and thus strategy Our XXX

its collaborators, the suffering Lastly, for potential PTSD from grant patients System U.S. of a are as Healthcare investigating substance University Yale and Department the chronic time at-home Medical School, under in treatment the setting to alcohol BioXcel Connecticut a for first related XXX from disorders and an VA abuse and the Defense.

and numerous with valuable you As potential goal indications neuroscience exploring we neuropsychiatric are distinct highly can disorders, five see, advancing BXCLXXX creating actively of a the ventures. across neurodegenerative

trials to has Our disorders underlying various at broad robust strategy and treatment XXX well-tolerated a is for the a in demonstrated clinical market multiple effect shown have diagnosis. ranges, helping support that dose

reinforce additional passionate that potentially populations hallmarked for therapy. that of the lack agitation. identifying developments BXCLXXX, We about the and millions if treatment and These continue the symptoms. treatment become approved, this significant care tolerable the are power to stress-related our by has novel of to We are bringing potentially in explore AI standard of we potential effective platform of the believe that patient to best-in-class patients developing and options

pipeline to drug and expand We continue our evolving neuroscience addition model programs new develop to leverage XXX. this to identify to in innovation

to the to like Society KEYTRUDA Annual stimulate candidate, Back trial Cancer we clinical conversation ongoing combination I presented Now, designed Immunotherapy our turn and immunooncology immunomodulator in Meeting. systems. oral BXCLXXX, data would of immune and XXX at to of from safety November, in acquired efficacy both for our the innate the the

tumors top from aggressive to the of Anderson-led Xb/X both We targeting inhibitor, tumors, with to Additionally, Xb/X both forward last prostate like we aggressive believe potential on cancer seen results trial forms in and tumors. our advance encouraging provided combined to look trial XXX the forms I cancer XXX’s enhance at we line continuing the would the prostate difficult-to-treat cold GU basket Richard the trial immunity update on Based in mid-XXXX. call Steinhart. maybe of to CFO, an to in that, in advanced when turn ongoing these innate to in effective and Phase at With hot over and has Richard? ASCO action, Phase checkpoint mechanism of MD plans a solid activities month. with anti-tumor provide

Richard Steinhart

a same We in for of XXXX fourth of a of Vimal. net $XX.X loss the loss you, period Thank compared $X.X XXXX. to the for net reported million quarter million

million to year, and quarter professional fourth the costs. BioXcel higher The in of personnel launch $X.X growth million $XX XXXX XXXX in compensation-related in of million million full compared legal $X.X in development related higher the for along for attendant fourth and for related period The same review. the increases administrative generally to We the growth Research quarter increase an for R&D There to in approximately and The for XXXX. compared activity period year fourth million compensation in General of $X.X costs and administrative for period insurance clinical compared financial million had a year in trials million the increase year full same December relations the general Research XXXX. XXXX XXXX. trials. premiums the million fees. to in due million were research costs costs generally for loss rise and compared and our XX, and with cash totaled approximately same to research expenses the were full patent and for were million for of about the were the expenses and insurance $XX.X $XXX.X to same our concludes the to in the services, to net perform related company’s costs. quarter necessary compared $X.X $XX.X BXCLXXX and and as cash of increased expenses net professional BXCLXXX. in General That and XXXX. expenses due full and clinical million XXXX. for consisted XXXX full to the increase a the investor equivalents of preparation to period The was expenses legal $XX.X increase higher $XX fees For of trial of market compensation loss quarter $XX.X and the costs year was and professional reported as primarily as development and administrative potential trial fourth XXXX was also for for fees of XXXX. expenses expenses

to comments. Vimal? would the turn any back further for call I Now, Vimal to like

Vimal Mehta

would We to now open call Richard. Thanks, questions. to like Operator? the

Operator

with Meacham line with Geoff your first Bank question Thank question. you. of Instructions] [Operator the from proceed comes Please America. of Our

Geoff Meacham

Hey, that pivotal starting just two pivotal to the the quick when XXX, would include how guys. mostly and role you talked is plans? then for that XXX, question guys seems the down on and curious a from I impact your about data And have agitation Would XX-microgram what a you you very me congrats It you clinical delay have in just on NDA base broad could the TRANQUILITY. there where a and could explore ones, neuroscience second any progress. broad it guys all road? indication for indications am are Thanks development the have question that? pretty across a have guys to I field. would cohort obviously, you. you the the other like plays Thank beyond plan be

Vimal Mehta

rates our with Vimal. don’t are expect already doses, have statistically initiation any good have seen the and response we Geoff your doses. both question. question data thanks both Phase expect the dose will significant we this for because the is as delay To in trial, X and XX-microgram XX microgram about answer we We readout XX sometime two of cohort, had your microgram, you This year.

in X meeting very second our initiate with we this plan the development the trial trial to clinical the initiate our your well question, FDA, on Phase to on year. the we Phase to after half X dose, Phase plan endpoint. will our design with other begin and expect have the after on agreement as trial X a we and the yes, strategy. Coming meeting, them we of as do So, back broad getting Once, trial

have platform and indications we We our and withdrawal explore addition working disorders this to in already ongoing committed, sometime three of done to trials XXX. five month. we is have we The the dementia them using like bipolar schizophrenia, continue our and experts of indications: in expand to proof-of-concept in have data with upcoming, AI all expected potential opioid

some patient were patient Our we next good are have indication that where our depressed responses. patients depression-related in evidence of agitation, because bipolar we some looking is saw and population we robust the and

exploring are that. we So

able to an IP our and PTSD our areas where believe have XXX other at of looking position up ongoing relevant. with we are the lot of SNDAs considering be this We the is is new these first mechanism is IP to We to bring patent, some of marketplace. to exercise. And life XXXX that

Geoff Meacham

Okay. Thank you, Vimal.

Operator

Our next with the question. Suvannavejh your of line Please Graig from with Sachs. question is Goldman proceed

Graig Suvannavejh

on Thanks question. for my taking the on filing. Congrats morning. good the progress Hey,

have the of trying and for to activities NDA, as a product I your primarily pre-commercialization how now continued you One, build questions. awareness think you with just couple physicians. Just can am the filed about around

of so everything you my current what upcoming is your awareness is, need How going think you is APA your question are do And do? product? of the much is education virtual. probably to sense to

just an should ramp up, the just especially commercialization on the So on how quarter-by-quarter or activities think of secondly, up you are about you of sense are operating I expenses, in get first we of CMC I maybe could share ahead model could any on lastly, give assume sense about So, should us build your boxes all making filing then the how if think kind SG&A? And sorts. comments in the to then about intend the just particularly just your trying manufacturing update perhaps you XXXX, my there? that’s a we And thinking try directionally of and a as how physicians? be am a mine Thanks. of you to given where with sure question we checked launch, give to basis

Vimal Mehta

our Thanks, build Vimal. answer colleagues, involve Will will of trial. have Graig. use a X We strategy. for the will CMC a batches precommercialization CMC, I process. question I to our to that we and Phase This Reina, my your and automated as take question like awareness part then is

the We up process projection scalable you a beyond, And throughput, and you have automated can several to years then have is shift, like By up the increase next and XXXX our can capacity increasing increase we scaled whatever add and forecast the for or CMC. can the another you it’s throughput. process.

it in we that, and scale Will address I we perspective are your perspective, Reina to and a a believe, on shape CMC good will from from So, a to up capacity pass With perspective. commercialization question. to

Will Kane

Sure. Graig. is This Thanks, Vimal Good and morning, Will.

we who of bar, this a of and research, marketplace great see patients in as of So, on as market our of opportunity an who Therapeutics you relative treatment is it obviously, there one, raising high on of and potential awareness development will, obviously with clinicians can neuropsychiatric also fronts: about a the awareness therapy. and impact and awareness, BioXcel also treat establishing In two a the drug conditions. reputation is agitation, health innovator also a to the on level and experience associated if them. introducing mental there their limitations patients the to on some raising high that There have the current therapy the agitation

XXX emerged has that profile the on So, well is received.

and we twofold the medical plan from starting over is month the team liaison science deploy next our weeks when clinical several both a perspective So, actually payer this perspective. a

regarding medical planning is of campaign, scientific about those Awareness obviously to helpful we we begin raise educational month able meeting, questions then which in the its potential the and of are also May, to be a so program, to advancing an be on the to a and treatment to in process to Health begin patients. respond XXX month APA medical and to why also will as And educate the to of are secondly, launch the to for agitation development Mental which patients lay to could the they And exchange foundation of launch and way impact clinicians awareness etcetera. begin

solid have they starting are and plans to we So rollout.

Vimal Mehta

Reina?

Reina Benabou

The medical build team. virtual and two our posters mentioned, Vimal And Will. scientific from all at and of working poster to they poster with would venues as sessions closely association X May June have virtual-in-virtual APA with going information actually X details, are we exchange this holes MSLs we are still to we to don’t accepted be we very have you, those presentations the XX and posters. but Thank medical approximately got

Vimal Mehta

Graig?

Graig Suvannavejh

to the think modeling throughout the on just year? questions SG&A And on maybe then how Yes. about

Vimal Mehta

we pre-commercialization because and plans specific terms getting So provided in up. are haven’t formed guidance specific yet, evolving that guidance, our of and commercialization

as is key and laid into December XXXX. today million we seen position XX. well good execute that cash of This position out as have $XXX XXXX is on cash milestones you to Our have in

as will So as more along, our form move we we plans guidance up. provide

Graig Suvannavejh

questions. for you Thank Okay. taking my

Operator

Please is Howerton line The Jefferies. with your from next question the with proceed Chris question. of

Chris Howerton

Great. questions. Thanks so quick much for the taking just ones I two from me. guess

is expect terms of coming First, data the the to if in the so just months might understand to And can guess throughout communications what Thanks should kind we I help acceptance with the our be we then and frame kind in just respect the us XXX kind year in our the should two line” question much. what of NDA for with of the interactions the results what have the be with expectations FDA to relative of there? we submission, year, already of this or respect middle that middle “top the maybe expectations what know? any

Vimal Mehta

Chris. This is Thanks, Vimal.

of terms In the we NDA. submitted our communication, just

We will NDA of process rest review XX-day will until go accepted it’s then approval. is go then through the get then process from like process the which it the filed will will through the and which

we what expect. So that’s

will We QX of launch process standard be priority to preparing which and internally a the a case ready is for XX-month in are launch review, this on we product review commercial get then a year. we in

medical teams team, for the team, preparing are affairs scenarios. commercial medical our So, liaison both

is question prostate trials, what And CRPC form MD with is to scenario standard have and and to the case aggressive Both XXX, to which review. NEPC of then is coming which related Our basket your cancer the the base back trial expect? Anderson. we

further signs seeing in the seen KEYTRUDA patient will data tumors are more cold what data basket activities is that that we which and our that and activity or will patients. naïve hot KEYTRUDA whatever is have of tumors we the will build in refractory the come mature confidence expect trial which primarily a initial We

So or it next in terms the clarity provides a which in direction move path program of be approvability terms us step stage will more want we data the a mature as to which late trial. of

the these like completed. been data have So those reach from to once trials this decisions two are we

Chris Howerton

very Okay. much. That’s Thanks great.

Operator

with The line Sumant the next proceed Canaccord. of from Please question is with Kulkarni your questions. coming

Sumant Kulkarni

Thanks I a have for couple. questions. taking my

opportunity setting. theme your regular at product event, like that So, be a used your key least initially, At an consistent was use to will real recent be at-home leader seemed opinion XXX it the seems that there setting. for in

what take to That’s you specifically, a So from able needs? regulatory steps you approval need do perspective? commercial to question. How indication change soon home And would first the in might bring achieve that goal? to product your meaningfully infrastructure be that first the after the

XXX one second in the the to or basis? sub-chronic specific potential use given the developments with psychosis episodic setting an on The either space, is, in have do DRP dementia-related of you recent respect any plans the

Vimal Mehta

questions, great Two Sumant.

let question more. me to try to I So, will address add invite and first the Will

then with saw Once and to home is to conversations, our we FDA if on thinking institutional and building in know setting, evidence an get that, do based the in once label, trial the involve what has, will institutional providing home are work will this safety remind want separating. to conducted institutional take terms into for setting. because Xb/X that we schizophrenia, from not XX, doses with restriction, we even additional Phase and need it trial setting, that based was commercial know microgram, that that it the we And And I the numerically our than that our and that our XX there setting. in of care we a do for FDA our of XXX, experts will on we require a NDA internal would drug. label even a were FDA. plan, that lower our get infrastructure label tolerability initially, what just the to In we the our we is everyone agreement first

this dementia, dose microgram very Will are a strategy we our response lot clear this the good done market how dose care we design So, centers the quite divided cohort, and us to well flexibility XX because as it’s home thinking we now setting. is team, very initiated drug the take long-term dementia in long-term. we in the XX:XX has Partly of And gives have center. bit and his as into that care at-home market. assessment a in of of almost

trial, are initiate for higher gives with XX how So, additional in have much X it XX think started do and conversations us levels XX a good dosing explore a us significance be since setting, Phase to we there the PK/PD seeing, lot exposure a where terms to in we Phase we doses home X dementia build lower flexibility statistical setting optionality doses, two with long-term is optionality seeing and when our patient, our gives and care we very of care able have the we have trial to and XXX reason observed modeling, clear do we which with that FDA. in and the because we why when of are

So, around into how have? little bit to our overall setting. of it home the that’s take thinking do you care the you about a market will add insights Will, we want kind

Will Kane

Sure. Sumant. Good morning,

treatment don’t patients the for it agitation disorder, through want treatment delirium, to is to because institutional in characterize minimize me dementia, this I have lots many, experiencing. the they settings multiple in There of opportunity are many schizophrenia, XXX. that in get whether symptoms help setting, let importance bipolar that with order of channel So, they way. the etcetera,

pointed institutional as at bipolar out, initial is least setting frequency place and Vimal treatment. high episodes of the a of look the across So, agitation dementia, as and three, schizophrenia, we

least based volume to the one a reasons, And though, which label population. there in in that with there. Longer nursing adoption. either living gate homes, we next rate setting an not community obviously will rapidly term achieve good is over product obviously, So, community etcetera, get of the a patients to be at why is us take to that our is dementia setting are couple the context of literally out going start grow of in the plan as high in we number patient we outlined home the important to believe years. Alzheimer’s increases or XX able can a there, The for enables the the the that’s of one is how on of that Vimal

so initial And hospital and where additional in the build think hospital you living home how kind on in eventually decide how setting obviously, to we of the co-promotion will help. sequentially terms for to home. label we commercial do our to we if we loan will, go of expansion, best our infrastructure, approach label of in based allows can nursing at about have commercially land-and-expand from on we the land, then bring and as can the point, the we or to to assisted setting when then whether that terms we get that And we

Vimal Mehta

our in is of dementia your and works PANSS, PEC, part That’s psychosis. XXX spectrum. XXX and in use psychosis about have agitation. a of which where we agitation all clear. a psychosis, answer subset That’s which of And are for agitation, we it’s proven the efficacy question patients we second know measure a the the measurement drug the very To the

possibilities outside are So, there other are will outside XXX focused to what program, the we see on Currently, an eye in evolve like be will what psychosis we with assess have we as laser and can for then we our a continue agitation agitation. position to XXX indications. into impact to into expansion on and discuss agitation continue

Sumant Kulkarni

thanks. Well,

Operator

line with Our from question Robyn your of next Karnauskas is Please with questions. proceed Truist. the

Robyn Karnauskas

will them Hi, guys. I Thanks progress. for question have and I read to on my slowly. three. congratulations try the

there your guess effects PLACIDITY, data curious if a say, on did you in on your I FDA dementia if age-related you see that because over proactively, the sense give ways, that, you in on might want TRANQUILITY, asking the And say I am including will a on filing, you has to going think been get not a behaving to in to of And just hey, know are RELEASE you first just chance, one little increased I to Street data may may how trying is patients we the a be manage one question is label. that in from filing, exposure. one different. I there that’s filing, and so Wall the or XX So, of see the side

dementia is on set on in COWS and getting the all just a the RELEASE, you of SOWS will what given if bar different what trial. we waiting are data the some and more the good for question from – patients classic seeing you confirm trial different again a first you obviously, population you are is And like get all doses? that a at PLACIDITY, while the are until all be able of over-XX of or you do then versus dementia And is dose point the few of seeing expect for happened we and are only saying XXXX, that the question looking doses way is might the you upcoming got early sort the you in of planning stop again, at half are be on data you at are doses you Could to the in the also that quarter that older that you are more Second if little point trial group bit five data that patients. more a can sensitive dose. dose data coming

are those. questions. my I Those happy rephrase So to three am

Vimal Mehta

down. have jotted them Robyn. I you, Thank

one colleagues. also to will one address I So, by and invite my try

the conversation NDA dementia. the have an up coming FDA So, first Phase to and a submitted related part have end of have meeting Whatever don’t we data, of your with additional NDA agreed, We needed any that just question submission. and any providing a we our we pre-NDA any provided had needed was with as FDA. or we inclination X meeting for is the once that data NDA whatever the and the additional was any

it’s analysis, And older those are right, patients. patients, we seen schizophrenia bipolar bipolar have and any were patients, trial. done patients versus there younger they are difference haven’t very XX and the You interesting analysis, we which and our much in subset that whenever and schizophrenia are in

XX So, we tolerability? trial, day dementia for time, our the we well this these a for we the being in days, in is, question are as to the specific very dosed the about trial patient, and back bar to two address drug what is maybe first to for apart. are Because the questions the be safety first. or will patients important X these that your is trying in XX what as patients. seeing Coming That’s most times hours RELEASE elderly

almost it’s dosing. sub-chronic a So

want said, that. understand from are X you cohorts. we we dose So testing you And get cohorts, data and will the as dose to all

Second, the like in is drug on patients get very, important benchmark will retained long efficacy keeping of because a them these program important. the within very how terms retention is

the based So of a retention that been similar approved, and with have non-opioid one some there other drugs is important only is and mechanism.

we and So them to data a so trying look And efficacy? and COWS So important. doses SOWS kind are at that’s retention third seeing of and those is what is what the second will start about the are piece this be the reduction – things, achieve FDA will the the the we can steps say, what conversation next would that take I trial next like. we and with have to and

right. you the PLACIDITY, are Regarding

haloperidol, or what in We doses have required proof-of-concept patients designed on were treat agitation, understanding, them. delirium-related who is to there our based were the on that to refractory trial based on that haloperidol

data. indications we experience our up with use We or come to use all multiple that the doses. So

for we we we further and delirium ICU safety, make patients doses in go do the the and a need patients in test efficacy, see that at will we tolerability agitation. to assessing As point, decision,

are ascending these We make dose. move adaptive trials. – decisions These along. as will we it So are

data the done out but recruitment early? have our currently, It we do, our on possible, the XXXX. QX is the can – doses need So work all and to guidance of what terms come based we is of rate in

Robyn Karnauskas

guess, and is quick something COWS meaningful And SOWS? looking just is retention so going And we’re a clinically I follow-up, for what at. be to just,

are is that other any side to patients, I back those see to – all effects you’re guess the an the these are I’m based after that can familiar drug? X drug X r opioid endpoints go the that then up... days. when these that for Because for And patients? days for are looking with? your for them opioid-based they looking sort following coming It’s occur any you’re also, during you what they expectation Sorry on X What So of are on enough number? the if with stay days you’re is Is off to patients, the they questions. not less And there watching XX days drug?

Vimal Mehta

questions. are phase. good to little invite will symptom happens. very withdrawal happens trying patients Frank? them post are What these I Frank on we perspective what what a to to their And provide for Those and achieve

Frank Yocca

Right.

thing from is these care really important on. they So Robyn, of things, But what think the them profile, some are about patients the lot think relief most I making are a not they and in in a we stay okay? others of most some effect sure and study. and sure experiencing side the different is that study, that I stay getting so that I’m from

COWS, it’s placebo. just versus at it SOWS basically relating and of looking terms In

process. You’re these handle, going the to of – withdrawal variability okay, lot in the of get patients these a because you way get studies

probably So thing that’s to XXX or they we’re onto with these to process to treatment the the withdrawal important. gain could them the and that, naltrexone important get begin at rehab. achieve also is through treatment. here of this and day, very like That, can that what to me end trying where get we like most is things a But us, patients

Vimal Mehta

back in we did to dementia, in schizophrenia, coming parameter things doing impacts what bipolar the the because and Robyn, to terms doses, XX-hour we of the kind – XX are cardiovascular are other safety, parameters, are for watching of on your and days. will apart X similar like And two question we

of symptoms. more say, a a of dosing sub-chronic withdrawal it’s or for validation more So opioid less, range

Robyn Karnauskas

Great. Thank you all.

Operator

from Wainwright. Our of Please the Ram next your proceed question is questions. with line Selvaraju with H.C.

Ram Selvaraju

taking for my much question. thank so Hi, you

kind technical ones few of here. a just So,

to of going that’s R&D if a separate clinical ask would XX-microgram I wanted of into But to right had that we XXX whether trend relative you a to being provide sense as know on with And could First that of Because are to time being if you you dose Will. putting were higher in a and that regard directly you sense clarify what if in line commentary And you’re outlook spending directionality if a into spun in XXXX? is to Thanks. preponderance evidence far concerned. to in you profiles offer or possibility with as R&D, to you us this your spending, Also comment on I just from place? with of wanted speaking, entity. run timing in a XXXX? wanted dementia? contemplate when that? see XXXX, XXX but is out running likely now is generally basis? take trials contingent in clinical a to not? the XXXX with to you to Second previously, R&D to for for order on actual relative strategy make whether anticipate profiles the XXXX going about need would be expect salespeople you on trials get on then was so, to get the XXXX what wanted of question results if the How speculated some that to are I the is the are in bit just with that of different determination that, you in the what bringing to I a on pursue a could XXX that? to wondering position is, strategy And going would contemplate translate of

Vimal Mehta

take Will. Ram, will well question then to back the on XXX it I as dose as XX-microgram question I pass can and

the Regarding will due XX-microgram when dose provide this announced data And will sometime dose. we data we XX-microgram course timing the year. expect the in question, will from be

We melanoma. is in refracted that rates by a line. activity has can to Regarding before already tumors which to has or KEYTRUDA had activity. in question these encouraging previous It has cold single-agent previous drug convert your very of XXX are good hot company the we treatment XXX-patient or this to evidence the the some response the increase tumor, anti-tumor that acquired. data XXX, was done a related It work next from which

next question, is would we key best in to decision to focus tumor we’re be that what the to us types will that allow time, data on we will At we development have So choice our point develop this partnering. once plan will will XXX. in hand, make addressing a going we build approvability and be what a where want path for

options, like that will Board. some strategic mentioned, you and we best is work we shareholders, with As our in for option. explore our Whatever will

One have to way So we a as company in an progress. update we the a it’s development build neuroscience a are, about and as will integrated and as data have work discovery, we we clear we Stay focused drug and commercialization. strategy. is that the learn now provide get ourselves company, we AI, thing to tuned, from all made becoming our

build to commercialize we to on capability we want So drug so one have the with that and come to to unique roof capability. to a continue very be under up able be able

pass question on on address so will the commercial with Will, So can that, it I he to your side.

Will Kane

Ram. Vimal. Thanks, Hello, Sure.

is strategy place. force-built sales Our in

this build we is assumption a representatives. our design, project As about be XXX XX informed to as sales that XXX but we force, size previously, sales will with ongoing talked hospital-based number point. to force own structure and to certainly reasonable That complete to we’ve the intend at XX

over Then successful has if of year, the That the there. been the Day starting the only filing we’ll obviously, our know to We continue with if accepted, know, build will obviously track will letter. but the course we’ll the NDA support not XX we’re review PDUFA.

building the are today. commercial infrastructure We

then receive then for hiring reps. of would be to do need the lever the the a pulled is that sales We will the have event that ready we just September, in priority And review.

a then, We will track we’re it to at. move fourth that review to if just have to launch hire to goal meeting, be force monitor in have case But we base priority that. QX get or and quarter we’ll is review. the have to that to earlier mid-cycle our under where the We’ll etcetera, just ready on positive assumption, trained our sales news in ready them

Ram Selvaraju

Okay.

clarificatory saying clarify you when quick you that that. two are are draft get wanted I kind points would of point sales to to Just review when discussions you just accelerate labeling force the you with or activities mid-cycle meaningfully in there, FDA? the the

Will Kane

have complete quarter so mean, the obviously, and Sure. trained which the except, track. you No our we’ll we’ll can recruit plan training and approved. just then, And for and will label, in that everything sales fourth It drug complete if would at be approval. I come training. thank is the we’ll then the hire product clarification. our then launch the No, organization to is its the

I yes, just So no, to was referring progress. tracking

know at very end. You know don’t you until the

I any the It’s represent will questions want to guarantee. etcetera. just So us any that didn’t track from it give the way FDA, other mid-cycle we’ll

Ram Selvaraju

a reasonable to there talent as Is assumption? that when pool likely hiring that make a and to you you’re looking decisions? from rich anticipate And be those choose to is

Will Kane

That is my reasonable assumption.

So yes.

Ram Selvaraju

thinking Okay. spending should relative that? we And to of be to directionality in then just on how XXXX R&D back XXXX, about the wanted circle

Vimal Mehta

if initiating SERENITY even trial but our Those Ram, the dementia trials, that trials be the X at we’ll bigger those that quite – was trial R&D trial. was X our have we our complete limited Phase and XXX patients, is which look spend X, major in X X with to Phase trials. the spend,

of our Phase per dementia will cost in So I patient something patient that cost. be for would say trial order $XX,XXX can spend of X per to terms be that $XX,XXX

will withdrawal late-stage is, our data on ‘XX. in our opioid that the use the end release add it So up with assumptions. plan And we we after planning depending to and XXXX, that where comes basically building for our what

think all XXXX. point achieve is milestones our cash into our in So in that and at not these guidance overall providing to are is well get – but it’s this and in position good granular we I time, any a XXXX guidance,

Ram Selvaraju

And consider to the just you you X-point minor was administration, time the was good How are on other you would you the could endpoint the the at the of kind a relationship wondering endpoint then In primary the primary be secondary thinking that you of the about classified as primary look clarify, is when between question real XXX is And Thanks. secondary earliest Okay. importance technical only and at words, secondary? I explain the can PLACIDITY secondary the if RASS outcome wasn’t and on after the endpoint? which relationship secondary what in which a seen met? endpoint drop between one endpoint, trial, as endpoint?

Vimal Mehta

will Reina invite for I So this.

Reina Benabou

Thank you question. for the

to the the which experts, according the all is very how of X goes. quick is So yes, patient where primary significant, of drop not the endpoint a is it RASS And endpoint, is somnolent. secondary

saw talked X may you to patient an the we good. that possible. and experts. that we because we with And so soon about our with significant And as a want appropriately as So statistically results we will SERENITY calming also all minutes, XX X of calm make excellent sure understand, be as ICU, in this with very period

doses, the and to of the we then we’re that that why escalation but be with have would triangulate – intend also done, is So the duration our the if, your second point, can course, effect. also of we all soon with endpoint, going meet primary to that and of how we to

Ram Selvaraju

Yes.

is should about designed it’s a way very the X-point could in endpoint see earlier basically, secondary to be RASS thinking possible drop right? that significantly X what than we capture, hours, that’s this you the So is and the

Reina Benabou

have correct. is and X we the precedence is correct. from And this TRANQUILITY. X – even That That’s in is and SERENITY this That correct.

Ram Selvaraju

Thank you.

Reina Benabou

You are welcome.

Operator

is line with proceed questions. with Guggenheim from question Hickman next Our the of your Eddie Securities. Please

Eddie Hickman

Hey, for for I’m on taking Thanks guys. morning. this questions. my Yatin

the recent worry getting on lack regulatory there the from the clarity are from FDA Acadia, by investors is So on the given some the front. of setback companies that increasing

give give scope just dementia you and proposition the baseline your the size needed on update that be any bipolar, So give down the studies how many line? schizophrenia, study you if and what you for now the us us success sense can comfort us you and of like that will then pricing see with of NDA? sort on a will could filed And the you

Vimal Mehta

question. Vimal. and is will first address the this Eddie, question your about This the Acadia Thanks, for FDA. I

tolerability. a our safety size and very from acute, it are dementia-related our you indication, TRANQUILITY, agitation a seeing has endpoint, different with is look at is our patients, data Even we dose-dependent responses, of smaller it’s very large. X-hour – and also, So like number effect situation. if And our efficacy, in

So propose with hand design on but Phase data, FDA, at least our we not what end Phase is the that the and interaction addressed the Those questions safety have or a SERENITY, of FDA, expanded. something develop dementia trial be All in FDA plan this, as on as we’ll trial we a in based of we in That’s X be QX. endpoints, get multiple of the Once X purpose trials would such be strong the data on – could will if Phase to I trial, the anything efficacy will needed and X TRANQUILITY will the to needs number trials also the agreement which than like initiate and the be and we our meeting. need endpoint, a thinking will of trial. end if that we to design, think with get on trial of one or – in then we our conversation be position of the meeting those trial Phase additional doses X with that database a are for is sufficient a a one more two will it’s required sNDA through single our patient. And in order well have or sufficient

there has these that been drug not decades, approved As helping new or – you have almost, come been patients. a two last know, in

So, the with is unmet very high. We’ve all encouraged FDA. very interaction been need with our

imagine, can you have these we X around interactions multiple As indications.

plan. we So stage will the productive we with the interactions, conversations the very our have treatment we so the develop and with from pleased we confident very then agitation the with of FDA are next data all are of to have acute TRANQUILITY trial, far strong for

address that? second Your you Will, want question, to do

Will Kane

Sure.

indication? your on the was So for Eddie, initial launch question pricing

Eddie Hickman

Yes.

Will Kane

involves case, course and, pharmacists gaining the P&T we be payers until insights over an of in So our obviously, a because and the members. announce price process work pricing will ongoing hospital, this get year. from approval, We committee wouldn’t

We’ve is are recognized say that that well begun profile unmet certainly the is We members. received. need process. committee XXX I’ll individuals. P&T of those And the by

the And so gain we’ll market. to insights from continue

believe, will conversations in the they’ll deployed more we for the value Our shortly, insight initially But payer that MSL setting. and a emergency potential talked opportunity team to in hospital but so be the get and about begin the setting. hospital proposition, pharmacists, and efficiently the more will clinical exist opportunities reaction have be be the can And into in may the XXX other even if etcetera, this data. department strong patients recognize context, one, also, we’ve the treated given

to put that so solid be together something proposition. And the exploring a will value be we’ll continues process as

Eddie Hickman

is hours? it Do multiple be Or will as believe in a you setting, that single doses film? priced that of reason to can be the think like is there priced a needing we over course several

Will Kane

would current is one more so a used thinking, our than needed per priced be a not be film is film So Each that If is thinking obviously if a unlikely, patient which built they film, could single it basis needed separately. current would on could it context. be that happen. it in the film,

Eddie Hickman

on and that perfect. dose of one then of And timing Okay, can any sort on us the just PTSD, color give quickly size, you study?

Vimal Mehta

done, like IST like that. say, pursuing is Let’s Yale

home efficiently XXX setting. those on care test comment that But like potential in can are to these don’t to designed whether we things. So we trials explore a

Eddie Hickman

you. thank Okay,

Operator

question the with your with Our UBS. question. of Colin Please from next Bristow is line proceed

Unidentified Analyst

A questions guys. Rich Colin. in of is couple calling from This for Hey, us.

to get in that included only at-home if now of dementia, trial setting. XX difference that some you’re the for at-home the that sort separate would the to a regarding Phase So to And pivotal Would the able setting dose mcg more or I get population schizophrenia of study be how especially – dose to be future? in X clarity want in patients a at the any level into then relates that usage some the get terms the just I warning from expected another is that? for idea Thank would the XX-year-older or and there question there be on regarding the scenario want that. us is What be bipolar that Yes. disorder. that frequency? you. or regarding for label Would

Vimal Mehta

have just the submitted we NDA. So

have have haven’t patient and analysis trial hand optionality dose, to will We hand. XX-microgram in we the that we FDA. now. – label any we be for with initiating TRANQUILITY done, on the very elderly being and that back with we bipolar. focus will younger had the different doses have about we our the in conversation positive schizophrenia in it’s data your the any patient Coming don’t in that question subgroup data is Phase a our multiple built and expect had had once data X the the But or data ALF be Currently, the where focus, setting is we our laser

on time, care in using the which setting, clear, or Colin, home not hand, the have for will is we’re and community it’s XX. be the the So what is focused may we your restriction answer as once on to to going X a label home plan What be expand to that. we if then setting on is, with And XX; trial we can design super are optionality the wide that stay question? we and our our almost considered then to that meeting then a is understanding X Phase we home the care and to will And are and X setting. smart HX and able end we are, what in the in expand choices from any preparing trials, very FDA, or nursing FDA have decisions, care in anything prove what that whether a setting, setting, label having and deploy; we position retail. learned an else, need the the in need after initiating will XX did Phase meeting, trial a that of point hour X ALF it and home at we had make requirements we we

Unidentified Analyst

Yes.

how to that, of I to three on just follow-up going to come may be Phase XX add you doing in or to on? want kind going are including doses two Are and those Phase how your after that of timing the data are what the you mcg going do influence the X? XX like going is you initiation to your just another see so X. later So, be maybe that

Vimal Mehta

safe ALS two is Current doses They are their setting profile. difference the thinking that Both in XX. good There effective. with are tolerable. XX is in and and are PK sufficient

trial, any So X which if, no and dose. XX in to insights home a need that, dose a is particularly care add for there future, be any then need to lower we involving help determine we will us additional could setting. a could design mid-dose, use

So a that. X optionality. that builds patients also to in for for And need terms any doses, already We present FDA. is hand don’t number our the we who plan just the up and we have what to have the don’t of data see specific of it in

Unidentified Analyst

Got it. Thank you.

Operator

next the your Securities. question. Please Devani with with of Our Rx question is Samir from line proceed

Samir Devani

have is I cohort just dose got micrograms? the else. One completion the Congrats XX wondering as extra of the question chose the then micrograms questions. my why actually. point interest, which anything on the than I’ve to And taking couple of is trial. filing. just was would opposed for more RELEASE as midpoint, really But Thanks second you a been XX a on

Thanks need go assuming you we would or data, positive Phase trial? Assuming that will Xb a to it see we much. X very are a Phase

Vimal Mehta

what do our and information. Phase some FDA. do RELEASE choice look inform data can address may the the to X we that and the this convince what should Once X then unless But X for program any the have should we the decision So we present at data, go bridging If FDA able we’ll the to need to we make study. then a do Phase FDA be me cohort to from what question, to and time, let as we gap, we some in trial. see asks point need a like

have XX, we the are effective that. know we on the PK/PD question and modeling XX the I of our like based be would and with terms think costs and In effective also XX prediction, package about been will effective are efficacious. also and all where is XX they and XX

flexibility, dose more – in as care exactly that like has saying, is thinking the been it us gives that’s setting for it separated have doses because and that XX efficacy. a the it chose is lower a lower XX, with home we So I and what enough

no our more market XX both we reason provide expand in would as other dementia. will XX, flexibility it be or There So is effective.

the made So that’s very modeling. PK/PD doing choice detailed why after

Samir Devani

Thanks very much.

Operator

Thank you.

Canaccord. Our next the Kulkarni question Sumant line your question. with is from proceed Please with of

Sumant Kulkarni

Thanks follow-up. for the

month dosing agitation different of versus acute an treat per are or to know expanding doses closer So for something some franchise agitation, on. of per of tachyphylaxis any and/or that potential worked IV Dex is number you chronic as as basis? Dex, the go to your are limiting you ballgame as XXX a episodes Dex about you gets the you closer and settings, on very But think of maximum thinking and aware tolerance into while market, how of about and we especially the year spin

Vimal Mehta

we at we any So you need that have alpha-X And been of used, aware of the are but of agonists that if – most aware not that. chronically. have look we limitation, to been are the some they know used

we don’t with we demonstrate XXX, chronic that. to will then So will eye question that going good we If that, keep it’s a it. to expect an be are an for agitation but issue, on need

Sumant Kulkarni

you. Thank

Operator

we’ve over At question-and-answer remarks. the reached end session. the back call I Mehta you. Thank of turn for the to closing now this time, will Vimal

Vimal Mehta

great I conclude, want thank XXXX to a everybody year for us we today. for joining BioXcel. was Before

BXCLXXX year pipeline, questions. exciting us on across proprietary to value us an reach of milestones to the as continue you additional expand we platform commercial execute potential have our our this momentum program, we to out if neuroscience plan positions for employing to create for grow and our Please AI our any As ahead shareholders. long-term

Operator

you. This today’s Thank concludes conference.

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

BioXcel Therapeutics (BTAI) 11 Mar 212020 Q4 Earnings call transcript