BTAI - Earnings call 3 2023 | BioXcel Therapeutics, Inc.

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Operator

Good morning, and welcome to the BioXcel Therapeutics Conference Call, which will cover its alignment with the FDA on its TRANQUILITY program, provide an update on strategic financing, and review its financial results for the Third Quarter of 2023. 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 that are subject to risks and uncertainties related to future events and/or the future financial or business performance of the company. Actual results could differ materially from those anticipated in these forward-looking statements. be affect on are quarter will Form XX, September which may company's in ended XXXX. be that or XX, for XXXX, report www.bioxceltherapeutics.com the quarterly quarterly XX-Q can Form updated factors in future and report detailed results the June on its Risk www.sec.gov, at on which XX-Q found for ended the quarter

and Mehta, Richard Presenting reminder, Chief on being today's Chief today's Executive Dr. are a Officer; As Officer. recorded. Vimal Steinhart, Financial conference call is

Joining participation to my Chief Frank Dr. Dr. of for to pleasure Mehta. Officer Risinger, in them Officer are the call and now Neuroscience; Matt Commercial Chief Yocca, turn the Q&A Chief Wiley, Vince of Dr. Rob R&D Therapeutics; session O'Neill, Scientific Chief Officer; over Officer. Dr. OnkosXcel is Medical It

Vimal Mehta

you, morning, Thank TRANQUILITY anticipated with Today, for clinical for I and joining on program with you our our us. thank highly several recent SERENITY development III. exciting late-stage updates Good begin and X and operator. BXCLXXX,

In and then cover results updates Investment with Qatar the about Capital news I Oaktree Rich will Therapeutics. commercial important our financial third and terms After economic activities touch our financing briefly Management for this, will cover on the OnkosXcel will Authority. quarter. I for addition,

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development III additional and pivotal recommendation trial third-party setting our important for the the more in audit month. path into TRANQUILITY our this positive June. in we just Going II in with October potential an completed independent TRANQUILITY submission. follows as the are minute at-home detail, results study regarding sNDA This receipt aligned of TRANQUILITY a Phase FDA's TRANQUILITY meeting in FDA an the II trial to The

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are We base program. resources now summary, we and cost-effectively. the poised for us trial expect will and we on this advance the TRANQUILITY efficiently focus at-home believe recently let program In the to redeploy agreed

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to identified moving We and study look that forward our this were data findings finalizing no impact forward. protocol addition, In integrity.

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patent with been X extended new to Additionally, patents. XXXX Book-listed Orange has U.S. IGALMI protection

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recent reported In castrate-resistant with and cancer cancer. addition, cell in open-label the in for BXCLXXX prostate metastatic survival we patients Phase small were data with our with positive pleased neuroendocrine prostate II trial patients in

their focusing to our various their With hand, with dedication bringing like options will these quarter review for drives I to Rich, turn of Rich? financial in over who our to that OnkosXcel. are colleagues call data ultimately to on mission medicines patients, will thanking end results. by our all of our now third is it tireless work transformative success. we the strategic for I

Richard Steinhart

million XX, indeed was the was for pleased review quarter and same time expenses same compared and approximately The and third Thank primarily or totaled our equivalents a estimates for financing cash the The $XX.X not any to additional trials. you, primarily the runway the our Net available XXXX. potential for to $XX.X transformative equivalents development onetime the and professional TRANQUILITY expenses III OnkosXcel to to $XX.X in million XXXX BXCLXXX loss in the company revenue for administrative million costs that an as to public increase expenses a and cash $XX.X legal third operating $XX financial quarter results SERENITY from This related current associated financing fees, the compared of the may the XXXX the amendments offering capital same BioXcel $XXX,XXX activities quarter $XX.X $XX.X cash for of associated Vimal. The of XXXX. general XXXX. reprioritization. become clinical in costs for net mid-XXXX. Selling, September net to IGALMI that agreements of Cash million I'm does through quarter to personnel of of for with prior quarter. as of to quarter well were include cash of under company, undertake. quarter. in third States attributable loss increased costs XXXX. XXXX quarter The in with in IGALMI third for the we were potential The million compared in will strategic period million approximately support a had resulting were cash company the $XX.X commercialization used as its and third last potential may a for period and II XXXX. expenses that and estimated million the of Therapeutics Research million attributable decrease the decreased to in the United were during

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

Vimal Mehta

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

Operator

your of come question. Greg question-and-answer now We will Instructions] session. the Please proceed America. a with Bank [Operator Our from with of Harrison line conducting first questions be

Greg Harrison

With of more XXX-patient the broad TRANQUILITY this on trial what success strategy going would for criteria can trial, respect are in color to what the give the you positive initially? like? and label some trial, for a development look a And then us

Vimal Mehta

Vimal. conduct setting to recommendation a We home is that FDA pleased were have This the we alignment from very on trial.

of observed home were Alzheimer's a number like in were nature. home in more patients III, episodes after you in development very of know, that in As most TRANQUILITY setting the the live setting. we or required was do important This chronic that

So conduct need anymore. don't to III TRANQUILITY we

this broadest and provide circumstances, possible population. this is to the this drug best patient scenario our under case So to to move access medication

the of trial program, Rob So will this that's entail. to in exciting. terms it I to clinical what on will program very And pass describe

right the the FDA, process of protocol clinical are we in now. minutes developing Just just received the Rob? remember, the from we meeting and

Robert Risinger

Sure.

caregivers. agree excited double-blind, safety that So to will clinical protocol. proposed we design. or now expect And placebo-controlled actually assessed really that to family as back let We're get with just working that about you further highlight facts protocol. primarily me study, we're includes benefit describing with by that the the be and we a on This FDA's

Greg Harrison

package? selected you're you use all of can the sNDA for part II And it. TRANQUILITY Got as of your clarify data able whether to

Vimal Mehta

will to receiving in believes information we Company after that use able all be announced II have data independent we the we TRANQUILITY the that audit our June. and

Operator

Please come Ram Our H.C. the from questions. of with Wainright. next your questions with line proceed Selvaraju

Raghuram Selvaraju

something forward first agitation time only we that you to would all, I on approval of if acute expect and additional this being you us you look as within about target be chronic ultimate was context in agitation. what path in could and once have and expect Alzheimer's this, clarity some label you XXX for of if provide with the you to an associated be pursue line to thinking the wondering, what should

Richard Steinhart

That's FDA, III, episodes. question, multiple When considering many of with TRANQUILITY there times had dose we did those episodes, and the Ram. are agitation number XXX great we so treat the conversation a to

chronic a possibility would be discussion a be as that was may be or could there could there So or useful a treatment. that treat developed XXX

know, program, done you have volunteers and for treat have data, chronic right data we that can chronic but We our dosing, no as MDD the in agitation. it now have healthy we

work with path. use our setting of of agency drug the We path agitation our or explore treatment can so that laser to on develop a related we acute the Alzheimer's focus expand will a home agitation. this in is in Currently,

exists to focus deploy all we point But have that and the a home this So to of strategy for will in resources opportunity and explore. completion at be path time, in trial us, in setting. the will

Raghuram Selvaraju

XXX how approved? have secondly, provide if then opportunity, of you respect give size us and any to use potentially be maybe expect to opioid us you potential disorder do of market And with were can the additional it would you to information be regarding this deployed a indication, Okay. to sense the

Vimal Mehta

in you are as we investigators program what to forward It's by on and Upon is emerging pass provide of working, they Phase like outcome II trial. he Matt area, huge, on funded will there know, know And investigators is a this threat. this are But So will trial, an the national in trial ongoing the NIDA. world-renowned opportunity, the Ram, we can market if of be. any will color I that terms path this. it huge

Matthew Wiley

It's threat. but get know we as readout, phenomenon that an the xylazine data we do fentanyl additional give to closer data growing. We'll is plus emerging Sure.

great certain yet We certainly White cities state significant Philadelphia like epidemiology problems so of or [indiscernible]. and for attention this Connecticut, it's not there's on the with and have gotten And others the that emerging of House instance, do the know really threat it.

Raghuram Selvaraju

basis, for separate of OnkosXcel data it a on some on consummate there's give can either XXX extent to for the us this easier you pretty comment of strategic availability of out some you identify recent to clinical make qualitative the a spin if obviously, lastly, positive data you sense -- looks And been that entity? partnership kind OnkosXcel. Can or of, what a maybe might for indeed

Vimal Mehta

the very saw With from do trials, the about Vince, data in think want that you XXX hand, and take I potential. question? data to the reinforcing that's X you the

Vincent O'Neill

add Yes, have, work including to as also package exactly we potential just but see really would I to would data that, that assessment. and biomarker an the need the want form said, complete partners to is data you survival, really

now in I actively So you hand, we that conversations. have are having those tell can that we

Operator

come with Please Canaccord proceed the from Kulkarni question. with Genuity. Our next questions of line your Sumant

Sumant Kulkarni

So the of with not way, specifically in the Asked to still sNDA on ability further patients? time, with initially alone? agency the another at more file is on a older the alignment not some the trial safety I did because a need your did why about ask profile that you guess, FDA, go you the label to company your limited or TRANQUILITY choose expand with basis to establish the potential II possible to

Vimal Mehta

Sumant, TRANQUILITY what conversation allow an to we met, we us the around program, all sNDA. file II when agency had with the will the

of this setting, terms our of live In home home to the a ALF. have is to know which want access strategy, and to the drug We patients this we patients. XX% strategy, the we broadest in adopted

to get We working data caregivers. the collect demonstrate a for and also to optimal the to setting, in efficacy have and by company, that will on home broader the to presentation, this was in choice needed agency and to the patient we a the data allow ALF able be with that and safety the access the

homes, is the for reasons One patient to to these you to patients in a Alzheimer's go nursing home ALF from or as biggest know, of agitation.

So of population, are agitation. drugs scenario there know, home no no knowledge, this are our drugs possible the in also best -- that for and a you development setting get a the patient we whereas we this is thought case treatment we best conduct can and label under study approved, there to in acute

position. So a have very we unique

Sumant Kulkarni

then specific trial to new to AD X-week end new And acute you And you limit how confident is treatment? not considered of number it. acute but episodes a that that at-home period TRANQUILITY Got up is where the the this agitation trial for there will can not III-like are really treat in be chronic? a in an outcome

Vimal Mehta

have if you be up question, and will if protocol, FDA, we XX episode, Those this an there clear Y are But inclusion what not information, on not definition We or said, are discussing chronic. episodes, of acute number it's we And is and any is we after have path defines will our your the as where a with acute XX you he treatment. what set one. number are have literature criteria aware guidelines episodes guidelines be will that is working it's more episodic details considered of that migraine, no like be be chronic. it's and providing of acute or the to you paths developing episodic. answer and will you and Rob about a a there's the that which acute But of X as the for

Sumant Kulkarni

given and before us my microgram I on the in And led give with SERENITY you then what you what the are last contemplated allowed dose. on the that queue to with jump that to program, it's you past? is question around back than some XXX just the go now III FDA a home in had color Could the discussions higher

Vimal Mehta

for meeting multiple had SERENITY choices program, III the on we the doses. we When had

and at higher generated, that is microgram And estimate that well XXX. setting. the is XXX should doses has least now a approved provides And people, of IGALMI. home as given than confidence which company know, evaluate data we more for dose you there XXX to could XX,XXX to already it As dose which been as through the the lot a agency is this a be in company

already lot had and XX-microgram we had could a you have know chosen understand dose. on and exists. that a done episode will also based we where modeling choosing We of is dose, reason on data we and PK-PD to home XXX we our flexibility Those a capture to XX are evaluate in safety setting The XXX. XX-microgram the about setting, in allow home XX extended in the the beyond that a already hospital. and safety need that's to million episodes the XX that established, primarily evaluate us happen Efficacy choice million

it if home So in can it go setting, always like was setting, that's very if any hospital the a they get dose synergistic given and hospital. in patients XXX home a more medication, setting can need in a in same

the very very, setting. for part XXX home and synergistic, a of it's we in chosen that's reason evaluating So have

Operator

Our with your come from questions UBS. of questions. Bristow the Colin with next line Please proceed

Colin Bristow

point clarification a on path just of education. the forward in Alzheimer's Maybe

the specifically I study, be submissibility from to the think And it sort remain looking or then of of cash XXXX say II like a the data company a say going Secondly, believes additional this the will what heard the feels the But can used. studies, -- timelines readout? I can review you issue? we're still on TRANQUILITY FDA this of just runway. is to be you did on prior the data, -- about

because really the detail it you've get will the language. agreement said you your mid-â€˜XX, last finalized? QX, updated cash cash maintained in your isn't to would Is On Just â€“ you helpful. that that runway, be simply more

Vimal Mehta

Vimal. -- specifically this to the Sure. your Colin, the data. Coming II about back about is TRANQUILITY question

have to is not no that usable. not tells reason data we TRANQUILITY have believe or which We any discussion,

any for once FDA assessment, sNDA. submission will know, that and does case his the your to sNDA, you you be of As continue do

as have as usable said, that audit was on to of data we that. based assessment independent believes concluded. our as company this on recently terms is And our In the own reason well no believe discussion, we

was additional about question second readout the studies be Your will what when the there.

a XXX As have study that patients home we setting. you to it's in notice about conduct,

the We protocol. are developing

to how be a lot sites thing I required can than more conducting the TRANQUILITY a is in in have easy helicopter assessment III. will trial for The like mention is here be you conduct that going home II setting a We designing efficacy. many a the X III, to for is CRO trial II in and conducting are that study. TRANQUILITY Only and this the to reason make

collect safety, to and to we mentioned, the caregiver we evaluate as Here, continue efficacy. the are assessment we'll of trying

these but we easier be home are done not a trials, setting, have relatively trial in expect we going that setting. to So a in

and program.Third with and when a concluding are long very completed working So protocol, we there CRO, the be related value point first inflection the inflection be it and trial diligently value to recruitment able will are when agitation say, very be the question the the catalysts take term on we the will with be binding Authority. protocol. soon, back Oaktree to we the Investment Recently, Qatar getting Oaktree. our the to defining plan alignment and patient will we for when Alzheimer's-related will is come how dose, when will initiate -- And sheet

setting efforts organization, terms needed for and for commercial recent Alzheimer's-related we a We agreement drug believe our with to SERENITY grateful program, III that of this in both are -- for in They we and the having IGALMI very be now And very reprioritization BXCLXXX they clear are path based home us, believed in agitation amended. like and supportive. a also have path like or on the and expanding it. our very label

sheet, was for on We soon. binding report term have today, can are needed. will the be outline is very the organization why Richard And under so will upon they the and this very he it I pleased to pass been value what agreed documented that which to

Richard Steinhart

Sure Richard. Colin. It's

couple started here, have for make attractive the So we've a year. a covenants to to cash flow that revenue it impact things us. Colin, our out done year of We moved next that early about would

us been new revenue and Vimal as new cash deal. that the align required budgets. with the under So covenants original that and our And our significant targets have saves payments said, may new the really some reprioritization

the in to down over flexibility more lot take us, tranches a terms for the us gives next operation us that and it allow we of may months. capital additional few renegotiated So

Operator

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

Robyn Karnauskas

starting one. with I the guess first

for to for about before you kind for the think the for XX conversations you XX I half is the TRANQUILITY? at-home, So using what of trials, said micrograms FDA dose the like study and at-home can -- these have cut milligram Second the likes living did at-home question in you thinking the then on now assisted setting, are number going doses us we setting have a like episodes you're the about? the for follow-up. or and on is market your that at-home hospital what that now I in be or And potential thoughts of number that should update in

Vimal Mehta

trying your just to I'm question. So understand, Robin, first

the is question agitation home a sure dose just want XX-microgram being about understood... used first to setting. in I I Alzheimer's-related Your that in the make

Robyn Karnauskas

And before what talked a [ Yes. lower. living. which high confidence it [indiscernible] how I using with that's the you your trial you're go the you've in for about that what mean was they cut dose the think you is SERENITY, that at-home, and did I to SCOs little when assisted XX-microgram you gives dose ] wants did

Vimal Mehta

significant XX I the tolerated, And clear you and know, also, II for tested and safety assisted XX-microgram well the micrograms. profile XX we data we we statistically TRANQUILITY have it micrograms X and in XX As was had was living in program, micrograms. a doses, very TRANQUILITY established. our

clearly in established that's it efficacy the through So Rob, the and X home like the add setting because on? to you anything dose profile test do trials. want safety to a we

Robert Risinger

with being therefore, in No, microgram And efficacy XX as at-home. was that's dosed to II. TRANQUILITY at-home. FDA able The be demonstrated profile felt to the dose the XX that of test consistent safety had

trial the study. TRANQUILITY believe in safety we've be consistent at-home demonstrating And successful we what a II with will so shown

Vimal Mehta

no of the continue because episodes, number we is approved. terms In there of drug

the -- leaders are of in acute one Alzheimer's-related we treatment believe We in agitation. of agitation

what Matt little work on number episodes. color the of understand to understanding of lot opportunity. I provide internally a do our will to continue invite we to is So a the

Matthew Wiley

Sure.

at-home better to are This of an earlier, population the patients typically are not this an the As setting. potentially are benzodiazepines optimal unmet the Alzheimer's need choice. effects than dementia Vimal where not due side greatest.Antipsychotics in with is is in said and XX% used

these what's type technique some is used -- typically, of are for ineffective. So relatively these soothing patients and

What market is And average, seen our that at-home research the patients so in tremendous. for believe is on number episodes we we've that the the per of is month in setting X. opportunity these

the So opportunity tremendous. there pretty is out

Robyn Karnauskas

little Would you they -- kinds final lot are completely on are thinking get the that? TRANQUILITY other like the assumed reasons financing have would a cash get minutes monetizing XXX. Vimal, you about How that thinking opportunity development release you that that prioritizing your bit to diagnosed are other how about talk in, press to And seemed in for like patients say, back then position. be Like, a you SERENITY question, you're about of not I future that dementia, guess, patients the maybe one maybe reads might upside have prioritize Alzheimer's, have your versus once something versus, Alzheimer's but be given of to

Vimal Mehta

have the Regarding is I meeting. full programs we FDA from clarity recent and news both think our X prioritization, on that good

we setting. sense that had back Coming multiple more TRANQUILITY about meeting the both protocol have this into We to that steps drug makes considering we options And TRANQUILITY our that blessed for the and development we So at bring taking to opportunity, we are large in the very October, like we a is program. related our your are and question disposal have TRANQUILITY options it to in home prioritize believe financing. the forward program. financing. advanced next with

revise In financial with build strategic addition our we to equity to terms financing, partner were flexibility. to our recently able

XXX have we to partner program. be to addition, opportunity able In

Alzheimer's clarity on U.S. because ex now, Now opportunity, for programs. explode right waiting we that agitation full we not have a these X have in are we clarity

mentioned are In also addition, and monetization we mentioned, on OnkosXcel. you as focusing of that Vince

clinical the can need, the -- and clinical program these TRANQUILITY leverage program. the one of our followed for So cash milestones extend to meaningful on depending get options the business us by to we SERENITY to runway

Matthew Wiley

confirmed in Alzheimer's the label will is I'll this how reaction about things Robyn, take will that for market course, prior market to see to potential way. what on dementia. That's your payers is that in of test otherwise we Matt. But on just a saw research one. episodes. prior a presumed might my authorization who Number authorization question our we might are a leverage diagnosis number these to be them. is market And initial have that in to due react the able not two that the

One was X did number per that things the we prior the dementia of the of of Alzheimer's definitive month and month. episodes collect to diagnosis is per

agitation do and definitive lead we diagnosis. So that know to exists prior may actually to the

Operator

with next the line Suneja with come proceed of questions. Our questions Yatin from Guggenheim. Please your

Unknown

This ] Velma Yatin. is [ for

that TRANQUILITY clinical what issues? clarify where you you â€“ which long-term please use the you submission could to program? So are for safety saw in planning next site, the study, TRANQUILITY misconduct are requirements for the And then

Vimal Mehta

as that, topic FDA. a outlined long-term safety, that Regarding to -- the be have of discussion a is we with continue will

what of Our episodic continue. episodic agitation. in is It's on acute will chronic. treatment what is and is drug discussions acute depending and Those nature,

we topic agency. that of our a based we will discuss agitation, So with the frequency it's on

the site, In that And as mentioned site, specifically a setting. we planning of the with terms are that which at-home now to mentioned, forward not you for we was use site moving we setting. an are that and designed ALF

So the new we'll using be sites.

Operator

Greg Our from the questions. of Savanavij with next questions line with your Mizuho. proceed Please come

Graig Suvannavejh

I if could. couple, A

I'm study, wondering if sNDA what current the support current then setting. I expectation in of AD-agitation order in a safety thinking I to long-term safety that X-week you you'll Just there question, What with an beyond is support to the requirements. a could. additional around around guess, the is will sNDA? in question respect your comments is long-term the just need? XXX-patient And need an And follow-up

were think it and of in and first expecting could we given half wondering the I'm fourth just the than OpEx, next current significantly to quarter I came evolve on Just year. the the we burn. current OpEx higher in how anticipate

Vimal Mehta

of as been topic the is trial long-term mentioned, Alzheimer's which the meeting. as and initiating It a that There when a are regarding not as nature. there's in setting home I continued is like episodic drug discussion. -- well in has between this agitation now the pre-NDA Greg, for safety, at be treatment will a acute approved, we happen will not is

that we'll the focused setting, that those are update the the continue with at-home Currently, agency, with on study So discussed like we will for discussions. package we are agency. the and have where be pivotal on we trial agreed to

rate, burn guidance I color In what terms is. cash our to of provide the pass to will on Richard it on

Richard Steinhart

Sure.

the begin So to quarter Graig, will fourth the year. results then impact reprioritization next certainly into of the and

decrease. our to see rates we'll So burn start

In addition, this that of be were a onetime repeated will forward. moving quarter there charges couple in

rate then overall, So into next we and to the next year. expect burn continue quarter decrease

Graig Suvannavejh

Great. trajectory I The ask might we one And how impact should maybe if the how expect that sales? of J-Code, follow-on. just could like,

Vimal Mehta

So with Graig, pleased will might very concerns providing to a neutralize permanent J-Code. this in or the issue clinics were that putting CMS' or We use hospitals formulary within have on clinic. first of broader and all, either decision economic believe do IGALMI we hospital any that

with. that feedback director our we this they've as team at look corporate positive been So hospitals contact getting a Certainly, either key has in or from systems account been positive.

of So about one the and do this alleviates that it feel very increased to we good think barriers development use.

Operator

the Goldman Sachs. Our from with proceed line Please with Jenkins Corinne your come questions. next questions of

Corinne Jenkins

patients these be do for one I trial enroll going will need primary on that determine new prior that it that the then to the protocols you're you'll sites but you on TRANQUILITY based these from guided, answers, couple able When the be that to anticipate you like you've out? TRANQUILITY? XXX and evaluating. think, us. initiate study of study, your endpoint And at-home point, got a be all finalize guess sounds And you in I for to to

did how up determine that So the acquired could as protocol? evolve with and you the come it you for erosions guidance

Vimal Mehta

in the it's a We So protocol, of month. development. FDA the last meeting terms with had under

progress. confirm minutes understanding, protocol were we but expecting our So meeting in the to is

able you know, we we a time protocol protocol submit exports all the after submitted, finalizing initiate be been to are our We the FDA. trial. position within And will after we then input at be that will as a that or board, in short has to to protocol from once the had

So to we efficacy I the many think it what recruitment the when designed XXX will and we sites is process of Also, the Coming and to provide saw, we initiated patient collect back as will be trial you will the that are data. we and safety about be on how finding can look first like. rate open the in your guidance and dosed. number, that will trial question will, for when was,

be to that add will So FDA that, have in data current XXX to sufficient set in patient number with our that and dearly we us felt population.

home the of So what be what will add relevant in those success up decisions anything? ended number were be profile. demonstrating you'd terms and needs patient making safety what the a shown setting, like will criteria in Rob, choices to we and to the be

Robert Risinger

primary the in trial, aim pivotal and recognize and patients, really development dose that but or generation. XXX are being placebo. with as only to focused is XX-microgram needed I the and a safety Just on this feasible the is they treated about is protocol described both rapid

at-home. generate designed potential review placebo-controlled with to including FDA safety these labeling data the on it's a adverse So for events in respect to to

to able So will we're results when available. not say be the

we'll the share expect begins. is finalized. enrollment we'll And course, protocol when more the that once of we However, facts announce

Corinne Jenkins

market? as with on equity And [ agreement a about how extended and QIA, capital about you through this versus think you way seeking the ] think debt Oaktree do taking additional Okay. then

Vimal Mehta

on delicate have based equity partnering, is the have disposal. position, your we for Good agitation always, current that well to, it's at options and both business is previously, your balance I U.S. the you in as news think be a cash the Alzheimer's-related mentioned because can it's outside in as U.S. opportunity which addition debt outside really potential I as option need, large.

that now we mentioned what as started addition, concerted In OnkosXcel. efforts more have we

for to develop So create financing we leverage value our these shareholders. that is strategy assets our best

Operator

questions. your Our next Sumant with proceed Kulkarni Canaccord questions come Genuity. from the of with line Please

Sumant Kulkarni

up. have X. Thanks the follow I for

the feedback and events based be patient So be more the will trial? greater in the III to CRO. mentioned you the in company easier new relative the ensuring on in a it's at-home safety think But lack would of monitored real burden you older trial to because term conduct how not time in the of, safety-based used a at-home I Phase setting of to helicopter

Vimal Mehta

TRANQUILITY a you nonmedical as So know, we and ALF setting where conducted is II. setting, I have

to reason in So II, now setting. and to like home the we efficacy, measure the in patients we be is safety and will helicopter have TRANQUILITY and the evaluating you profile CRO a in only in PEC measurement now have I elderly

home more will come the the the safety the now for drug an as -- drug So we patient design how because there agitation in whether in setting. terms up have is any are a other if primarily will efficacy, developing that and of and a being and be access then to approved. safety with we caregiver, is data, But setting it patient that And to by this like ALF, a established that expand given be will that. more measured was collecting to we efficacy come to we will get the the XX-microgram efficacy was the home reason tested in measure patient protocol the population in

Sumant Kulkarni

trials? understand But an And the be you FDA won't specifically in II submit opine TRANQUILITY would a data part as did have you or with this of then the we that agency more additional that required that review. could say on require hand one only trial to the only efficacy sNDA,

Vimal Mehta

because of design trial collecting well a and safety setting I efficacy using a that think as recommendation and the possible the is setting. alignment executable efficacy home best the is that this caregiver is patient as the XXX with assessment is in home collecting this FDA a it our the assessment

there believes will have today trial that's required So the potential that clear a be of be that submission understanding one will our for we more company outlined and sNDA.

Sumant Kulkarni

And last to Part SERENITY going X one, X, and I'll trial one a III? like Is squeeze this Part in. have

Vimal Mehta

as then and No. confirmed and believe, in further will X you microgram has I X not we in trial. been XX have TRANQUILITY established, Part because, know, efficacy This has Part II our TRANQUILITY

was see no need we it the there determine SERENITY, study. X-part a of dose dose and in So X-part TRANQUILITY, reason to In approved a to a study. trying That's designed will safe. was design than be to trying were as it efficacious the part that and as lower

Sumant Kulkarni

Thanks for the clarification.

Operator

Thank you.

turn Mehta our of like closing floor to the We back for remarks. have question-and-answer reached end over to Dr. I would session. the now

Vimal Mehta

Thank a Therapeutics. you, everyone, for joining us in today Have and interest day. great for your BioXcel continued

Operator

you. teleconference. conclude Thank We today's This appreciate your participation. does

You at of may the disconnect day. your your this time. rest Enjoy lines

BioXcel Therapeutics (BTAI) 14 Nov 232023 Q3 Earnings call transcript