Earnings call transcript Q2 2023

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Operator

Good morning, and welcome to BioXcel Therapeutics' Second Quarter 2023 Financial Results Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] After the speakers’ 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. materially anticipated differ statements. these could results from in those forward-looking Actual

quarter XXXX, XX, factors results www.bioxceltheapeutics.com, updated on its quarter annual the future may or the Form XX-Q for quarterly March detailed for Risk which affect in company's on are www.sec.gov, that will found can which be in XXXX. and the XX-Q report June ended at Form XX, be ended report on

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

Vimal Mehta, Commercial Joining Executive today's Risinger, us Officer are Dr. Therapeutics; Dr. Officer; Dr. Chief on Steinhart, of Richard Wiley, Chief Neuroscience; and Financial R&D Frank Officer; Chief Chief O'Neill, of call Officer; Rob Chief Yocca, Vince OnkosXcel Officer. Medical Chief Matt Officer Dr. Scientific

my Dr. to over of pleasure and Founder call the Mehta, Therapeutics. CEO now Please ahead. to BioXcel turn It go the is

Vimal Mehta

everyone for Thank thank you, our and operator. call today. Welcome, you joining

say frustrated had certain changes company that This entire I we we our the TRANQUILITY II we not was want summer of make to plan discovery and that to business recent trial. has and to progressed dismayed investigator during structure. our our as Before first anticipated occurred begin, significant misconduct by

and to position I'm continue back Therapeutics I'm core than accomplish While drug mission. candidates deeply its more a determined put to developing disappointed, ever BioXcel our in

position Now I success for us going to how will forward. designed start by is covering and our strategic it reprioritization

with approval and have to AI can agitation. transformative and fulfilled of mission launch about using clear programs bring BioXcel In this the addition, Six with a model of with in founded our status I medicines biopharmaceutical we Alzheimer's as IGALMI build uniquely late-stage patients. I ago, Therapeutics the as to share clinical TRANQUILITY information We years disruptive program to will of believe, our much we the in development. associated mission a approaches

across and the necessary strategy. are taking strengthen land our steps expense ability to the advance to We business now our

actions decisive clear, well-defined are we in and three Specifically, taking areas.

our institutional First, IGALMI's landed in discuss reprioritization. commercial We with approval the let's setting.

our difficult originally aspect in setting is post-COVID a expand potentially We however, we we are to to proved we of the now strategy largely more shifting anticipated, outpatient what setting. into Despite is and the be fact that (ph) retail the committed IGALMI market patients than particularly these hospital more environment. pharmacy promising This shift due institutional resources a available to in to penetrate remain setting. challenging to making to the believe challenges,

pleased our a with systems systems. health have and began been increased contracting it and customers achieve demand integrated some success, initial reprioritization effort hospitals, large to care prior network health and existing We large see to deploying delivery hospital for with

QX revenues largely will due we our fact, In broadly from Therefore, this it. contracting adopt now QX to doubled strategy.

commercial approximately total a from operations, access, XXX be the part reduce from IGALMI, As XX we months. sales member next to of expansions over commercial plan this our help trade workforce market we the core to action, functions. to to support label build reductions and towards several will in and us XX potential organization majority will employees maintain team The of these

company. difficult and market our our variety a to who all business This our factors. extremely necessitated grateful was workforce of reduce decision many for but by team made to Board, management the of to contributions was I'm and the employees

they as committed to We the to are transition support from providing company. those impacted

and this We firmly medical focus business address and for unmet our potential believe on involves transformation high part opportunities development disorders, the a schizophrenia agitation significant and has to Alzheimer's shifting second to of patients impact market dementia. need. in our drug have bipolar The BXCLXXX potential caregivers a positive

episodes agitation the in U.S. setting. at-home annually million XX occur bipolar schizophrenia-related the example, For of in

in year In episodes agitation related the Alzheimer's addition, every occur million XXX U.S.

an in agitation more than Importantly, are than of episode total setting these here volume. represent half episode more and of the XX% patients

XXX to patients. these are needs develop to We the address of motivated

plan that pleased TRANQUILITY with to a at Alzheimer's-associated our a were demonstrating reduction score have baseline team, our line agitation data requiring TRANQUILITY mobilization an significant for We statistically In uniquely agitation. we our a from top comprehensive the This program complex developed of with that in XX-megagram PEC showed hours. X positive June, from in trial II. clinical was endpoint placebo We primary greater dose, met top-line XXX episode compared whenever we data occurred. announced XX%

X duration. micro well score tolerated, met at adverse events also in significant a dose. trial statistically drug with secondary agitation from over with by key reduction versus with change (ph) endpoint XX no related gram We measured a PEC symptoms hour baseline as was placebo, XXX serious

in disclosed we unacceptable investigator related conduct were to at by side. II principal was there an TRANQUILITY a a issues PI X-K and unfortunate. As clinical They filing, extremely this

issue the PI's investigating and, of an the example, an data for the from are side. clinical We initiated independent third-party audited have already by

of the audit to the an support the end a program. both with entire the to FDA we FDA including dementia that the trials, program, approval of have the be mild XXX for and moderate may include TRANQUILITY acute an data addition, meeting TRANQUILITY the audit treatment We seeking in the meeting patients package on have submission with agitation Alzheimer's II, and sNDA our hope year. will clinical In requested of probable III data of disease. This TRANQUILITY TRANQUILITY discuss to required to by update

better as acute a frequency our on focus we trial than developing background expected. suited patient episode is treatment XXX showed Regarding this data TRANQUILITY higher enrollment treatment early paused much It for while may appears chronic agitation, that agitation. of Alzheimer's III, a originally of of agitation after population be

treatment agitation reminder, breakthrough designation the with of therapy we have a for acute As associated dementia.

associated XX-microgram top monitored In the from medical acute parallel, is bipolar half reported We SERENITY I SERENITY in are approved efficacy same the we which endpoint secondary In disorders BXCLXXX, patients using lowest or dose the Part X a of in the assessed Part The agitation IGALMI I. of setting as results [indiscernible]. setting. our trial advancing schizophrenia. surrogates with we program for dose as for safety the treatment and May, of in at-home the line primary of SERENITY at-home evaluated and of

the potential micro of in with suggests for to dose, monitored change in we believe did score mean gram endpoint X effective medical the we settling meet While primary data a XXX at XX be not PEC hours. the

potential results, favorable We microgram believe to II, However, approved and was at-home observed use. compared which the XX these safety tolerated events and micro the the safety results proportionately adverse well fewer gram SERENITY doses. or dose during I those XXX evaluated demonstrated microgram XXX including for support

X. identify of of schizophrenia now Part further XX-week study and optimal XX that suggested XX an of SERENITY experience population, to we during an use dose dose with conducting potentially patients It dose could previous modeling Ib provide XX Phase a agitation. is pharmacodynamic the trial microgram with in and dose. dose III our To performed that the BXCLXXX at-home microgram supported dose with balance. by pharmacokinetic our in of is BXCLXXX, a the the balance evaluate between this microgram to a clinical optional an are of efficacy an provide microgram believe safety evaluation We We this XX safety

part the III meet emergent the adverse assessments. emergent primary to efficacy incidence describe serious adverse and of endpoints is of a events treatment events number adverse compared endpoint the and of secondary a events, comparison to as treatment primary to amendment Part objective microgram placebo protocol study. is of the and the The X with dose ongoing discuss II XX to a FDA to We SERENITY plan the include

Phase Ib Turning to our in positive depressive major results May. ascending from multiple dose trial program, we reported disorder top the line

As Head O’Neill, is play of effort, we development R&D a part serving of as role our pause development. reprioritization augment this clinical program. for OnkosXcel our our Dr. team, broader currently in will Vince neuroscience who To will

-- XXX the Risinger, Vince and approval for with role trials oncology Dr. I in Vince extensive Medical clinical been IPO resulted our experience. instrumental Rob with development been since that and proof-of-concept played along successful the in human an SERENITY IGALMI has pharmaceutical the Officer, in and has our of Chief II in program. XXXX, trials, company the has

clinical potential includes commercialization Kostic, INVEGA, of Affairs Head decades such in an more as two development than experience in and XXX will Dusan leading medical and commercialization to Abilify, our any has Abilify industry clinical developing and role This Rexulti. neuroscience. He important of pharmaceutical support of drugs, indications. of Medical Maintena play strategies of

also have a initiated our strengthen of Directors to We search Board expertise. to clinical expand development

talent. involves of third clinical The to prioritizing strengthen our our AI-driven part neuroscience business innovation transformation

commercialization data robust of expertise pipeline. integration powerful and unique science and building competitive a advantage us gives in distinct clinical Our R&D a

BXCLXXX. are candidates, excited initiatives our clinical We about pipeline and including truly

later host forward event look we to R&D highlighting We developments at to these this year. an plan

reinnovating and to plan XXX. capabilities AI and also late-stage BXCLXXX candidates next-generation identify spotlight and introduce our drug to platform We

for challenging our this company. period summary, yet In a is transformative

the are for decisive taking in the steps with and best company We swift possible the of position future goal success. putting

interest have potential We received corporate partners. from

it know transaction could However, if far take. form any such too early a what is to

We to shareholders. and long-term to are goals passionate about remain value our delivering committed

to financial turn results. discuss quarter over the will I second call Now, will who Rich, our

Richard Steinhart

you, Thank Vimal.

II. Our to for are million and period were the was quarter. $XX.X XXXX trial XXXX. for compared III approximately attributable expenses same for follows. in development SERENITY results were second Research $XXX,XXX increased revenue as quarter for expenses clinical The to TRANQUILITY and second $XX XXXX the primarily financial expenses million Net of quarter IGALMI the of increased

administrative a commercialization included for primarily second related XXXX. The same general million non-cash compensation. of million a in personnel and $X.X an million $XX.X for of million were compared stock-based support compared and period IGALMI. the loss XXXX increased the $XX.X the expenses $XX.X of expenses loss had quarter attributable of period The loss the XXXX. to in the same to Selling, in $XX.X Therapeutics net second XXXX BioXcel quarter million the in increase for to approximately for for costs to were quarter

and $XXX.X as of million equivalents XXXX. Cash June XX, cash totaled

the the otherwise, agreements absence In the additional company or its estimates undertaking includes strategic available, in noted, which a reprioritization equivalents company significantly. that expenses reduction that strategic reduce last workforce to capital cash is is a will more of mid-XXXX. the the under than cash becoming current the expected of company and XX%, As financing through

is is company's its multiple ways extend access its not a agreements. of million events, modification these partners runway already be cash company's is and the of to with $XXX The agreements full of capital recent position strategic The the under could the agreements disclosed strategic on cash additional agreements. company its runway. extend the Based with and in discussions in to Successful exploring Fund utilization the required the amend the Oaktree runway financing to company financing to Qatar to Authority. milestones likely Investment financing previously cash assumed Administration meet projection

Finally, with regards including alternatives, examining to OnkosXcel, we partnerships currently strategic financing. are or strategic

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

Vimal Mehta

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

Operator

we your Please first this a be session. from At conducting Instructions] question-and-answer proceed Greg Harrison [Operator of question. of time, with will Our comes today question America. Bank

Gregory Harrison

How story morning. at point? Thanks you the the this Good you company for taking about think the think investors the question. are outlook restructuring should thinking for Hey. and do how with this about

Vimal Mehta

Good business. morning, for Vimal. I'm about outlook the Greg. excited This very our is

earlier, opportunities As I for focused BXCLXXX. shared at-home we the on laser are

and resources institutional two schizophrenia a associated Alzheimer's to setting outpatient more We are for and we the IGALMI for in drivers program Specifically, agitation. now retail for TRANQUILITY and potentially value pharmacy shifting into promising the setting. landed agitation XXX our SERENITY program expand are bipolar and

the end pipeline by forward BXCLXXX R&D of highlighting look with our to also update We year. Day this at

Gregory Harrison

more, one And helpful. the decision us color can. you more to you institutional some made medical That's the at-home setting? shift it. why I and from focus away to give if on Could Got setting

Vimal Mehta

IGALMI in continue institutional to to factors focus particularly business and post-COVID originally targeted through our than that is the a our The from the customers shifting hospital setting in market are call. and core we small note due team. It more contracting setting will difficult retail/at-home make hospital important available to we challenging effort to a to our more market anticipated, We environment. to was shared penetrate the

for and committed families to current are IGALMI indications. their future We and for current bringing and new indication to patients

Gregory Harrison

the you question. Thank taking for

Operator

question Bristow with Please question. your proceed next is UBS. The from of Colin

Colin Bristow

Good on wanted reprioritization. this just morning. you. well Thank And to pass I on done

maybe that a And we back made from but how just the focus see you the be at-home question of opportunity of kind opportunity tough that pigging You And you should I now problems, they and IGALMI of view? shifting about how for outline could market done. decisions, think setting? you're to market point had to off the think first specifically

timing is secondly, on the first of getting order. I question And think the then the most external this is common from we're just updates investors

said when just regarding are expect this is the this that be interactions with you second the this sort heard process end on you any timing any around by you. and you've I a And great. part I color you of in know of but feedback you think from but more give then you would requested I FDA. the occur year, where can do meeting, feedback data Thank have had to issue? or of

Vimal Mehta

Good morning, Colin.

question about have in expect my that audit have I stated TRANQUILITY progress. remarks the hope update, update is your we as to update the in Regarding to year. by end the of Independent the program or earlier

have provide We a would to we clarity the an meeting, the file have time on have TRANQUILITY an a requested what sNDA data and update the we package will a meeting. program. Once good to be is required

so back can come that asked first I just that had to you your would can you that. we question address appreciate, if

Matt Wiley

How It's you? Colin. are morning, Matt. Good

Colin Bristow

Yeah.

are [Multiple as you So Speakers] checking,

Matt Wiley

Yeah. I did.

So hospital at-home the setting million Keep XX that at-home from setting. opportunity the setting. the to question in about there the episodes switching mind the are market in

And would need unmet XX% they It's in but use the value patients quite for the BXCLXXX things the profile see market department their the capture setting setting well. models the recognize underrecognized up they that many of that we we've of we this given the in underdiagnosed, in wind and the emergency in patients accounted conducted. One at-home here. research of that for is home the caregivers well that certainly their both that And would is as We in episodes. as product indicated significant. and our

So we at-home the we to the favorable look feel forward setting quite and to patients. drug conditions market the for is bringing that those

Colin Bristow

Great. you. Thank

Operator

question. next Sumant your The of question Kulkarni from Please with is Canaccord. proceed

Sumant Kulkarni

for taking questions. morning. Good Thanks my

lines, instances a film factors. is therapy for because breakthrough terms FDA month? of your in for or of you how usage convenience the per the Along of per of status, exactly think episodes appropriate two at-home asking misstep number of film So on pricing the do those designation defined of I'm agitation treatment does current of use? acute $XXX strategic

a chronic even roughly basis, there well. XXX pricing a much hit pricing enjoy on one per a of higher that higher the using would caps market translate values agitation films First, year, to patient or specialty were of significantly gross year as assumptions and to of tier treatments for $XX,XXX buyout annual but makers

Matt Wiley

number -- So question let address episodes. price of I'll me the the and

price we price in see there episodes. ALF either for we more market recognize become XXX the episodes was month other the from that that can First Certainly, also and volume mild used what breakthrough foremost, roughly the schizophrenia episodic or in treatment escalate episodic and volume setting But also established as appetite over setting in both launch the we is the episodes And is they dementia we in patients we in three at-home is of and further did bipolar conduct for at-home to And Alzheimer's a as research at-home our when the ADA. locations doesn't in XX% what of that that (ph) represent point. an found is [indiscernible] that being ADA agitation are of moderate. well. XX% breakthrough total setting, one setting, and of an preclude in good which in

Sumant Kulkarni

not have then redo on does be include FDA currently? And will what says file in to just you runway II case the it. potential your the TRANQUILITY cash Got to new you able

Vimal Mehta

Sumant, we are not speculating on that.

and on an then the and to will want we with are it. feedback, audit the be comment We able doing to meet we FDA get

Sumant Kulkarni

Thanks.

Operator

comes from Wainwright. proceed question Please Selvaraju of question. H.C. The Ram your next with

Raghuram Selvaraju

in reprioritization context previously to have the ask I announced the to in all the previously we different pursuing also that could along context. to so back to activities able wins that comment already if in revert on And affected, you you all, in Thanks that extent and into capitalize to setting you engaged formulary much at institutional trajectory? wanted you at-home versus happened could expect were wins taking for To potentially your what Thank that formulary setting. the if be the at-home wanted expect you the to and question. just Hi. promotional how institutional you. had my on the institutional is how here what by at setting be

Matt Wiley

Sure.

all, we We're of [indiscernible] date. a first to wins out over had still XXX reported we over those So wins, that at wins of rate formulary accumulating win XX%.

fact, In wins on three we had Friday.

that are affairs And still they through them scheduled drug process. reach with activities, expect so hospitals, would we that will distribution support that utilize vote out accrue to of assuming will hospitals medical contracting and we And to and access or certainly that continue continue XXX market trade these we the to and so to access the activities, it. them through can that ensure

them the is medical you so obviously how patients because helping well. in protocols pathways, support in different is and at little bit market to for educating The develop as at-home the and important really are be The will physicians affairs planning activities a time. promotional determine same that place

PBMs have patients As to the be drugs, part prescription are accomplished would even can market plan well, to as ask And a you that are activities those be these the know, FDA sampling may with that contracting drug PBMs. so on prior state for with and activities today. be and that Medicaid, approval, contract the and then considering of we motivated through

to are in So on activities get potential planning the of that come. to market and actual months come entry ahead to approval strategy out that those we're more

Raghuram Selvaraju

you. Thank

Operator

question proceed is Partners. your of next The with question. Guggenheim from Yatin Please Suneja

Yatin Suneja

FDA of the like is you just this? get and of an of from for is Alzheimer's ICS feedback enough stopping guidelines is try II. talk What question. sort I taking for me, what II about you disease approval. and TRANQUILITY exposure, is a generally the indication regulatory TRANQUILITY an It's I. agitation. get for first millions a with the perspective if I meet on you you like on Thank sort were question and you guys. their that people? will affects combined clear Because duration exposure Can Maybe to Hey, II of for needed understand to my not seems it can disease TRANQUILITY to still

Basically agitation understand Alzheimer's forward So help for me one. disease just the as understand. you path that's

the on bit The XXX. seems the talk a you're going like it is, about R&D second to day, little

a runway, us can Thanks. Just curious, we you cost? that's how it help exactly the if sales terms the maybe highlight these questions. are still cash three forward? understand cutting should then maybe model of you're you in And have? bit little So rep of going to there. How going many Where

Vimal Mehta

Yatin. you, Thank

First will what program, the question answer regarding plans are. like TRANQUILITY Rob our

Robert Risinger

Yeah.

our let we FDA better may our breakthrough with TRANQUILITY because for that population So early episodic indicated chronic the for focus is suited that patient opposed treatment. trial the And on you therapy. line episodic designation the paused therapy know, me in treatment episodic III be as be clear the data in as to by

guidance package. of to for discuss year the the have able we'll necessary more point, provide auditing FDA And that the we'll in regard II be end be at that We be provide filing this sNDA results. discuss with meeting order more on to upcoming issue and an will TRANQUILITY at and guidance both able meeting decided meeting at an do the occurs. to pause expect to what trial with We at once the to the to that that

Vimal Mehta

on pass pass will to Rob I -- question, XXX. it it second for to your Frank on regarding Yatin,

Frank Yocca

forward especially This discuss progress we'll development I'm R&D an but indications this are interest. We where really candidates, to upcoming molecule, present looking Day Hi, is its also BXCLXXX. pipeline emerging our Yocca. particularly development, some Frank unique of with excited about our Yatin.

pipeline the And did been have ago, and also for BXCLXXX considerably. next-generation opportunities. platform. discuss our AI R&D years has as identifying we two late-stage are Day evolved XXX. discuss will we and entries, capabilities such the This Secondly, candidates some our first time From for -- enhanced additional reinnovating we'll

So it interesting will a be very day.

Vimal Mehta

to Yatin, related answer. your the will runway, So third cash question, Richard regarding

Richard Steinhart

Yatin. Sure,

by on extend that the the our various reprioritization now burn other significantly. includes cash we're to strategic our reducing So partner. working extend which And runway also options cash will working on the with we're working runway,

said, go-forward that's we about to the is $XX As what burn million the and annualized goal an company towards. we're working rate to get

through access terms team of market to the market, that In sector. group market will commercial we'll access of be core reduce the a teams work

Operator

of your proceed question with Securities. next Graig Suvannavejh Mizuho question. from The is Please

Unidentified Participant

for Good Graig morning. from This is on Mizuho. Suvannavejh Richard

do SG&A focus So you just a two and be at-home IGALMI and just up between that sales, moving Thank you. following opportunity then go-forward how the setting? expect two, we on primary should from One, the on questions split the that forward? me. how from And going cash is R&D for basis now your question,

Richard Steinhart

dozen commercialization, team the of terms a people. be in to about core So it's going small of a

our expenses reduce pretty will that forward. dramatically So SG&A moving

R&D should implemented the Remember, III expenses caused what go half of year, XXXX. the and had in of in Our that's and SERENITY fully we expenses half first TRANQUILITY in first down. the II increase the

Matt Wiley

your sales. second provided We've Richard, on on And guidance regarding question modeling. never IGALMI

think about think headcount our ability in commercial it in X,XXX reducing out way limits so to had to our go way to and we And the hospitals. that the prospect targeting the this is XX, I by

distribution approve that the choose our will through However, customers online and we those and them and come to way. will through support continue existing IGALMI and to efforts contracting same formulary, we on support both trade in through

you, but help may beyond I that can't that. give So guidance

Operator

is of Please The Karnauskas proceed Securities. question. next Robyn Truist question from your with

Unidentified Participant

us Alex approximate for market the what for between the Robyn. factors uptake is, facility remind are nursing is to on setting and This the what living IGALMI Hi. home opportunity assisted gating the Can living breakdown you versus facility? assisted on dementia

Matt Wiley

for price XX% can the have with dimension, something setting this an those breakdown ALF we've specific us XX% to that drug I So be million the market call, can feel don't total, certainly communicate opposed the I are as I Alzheimer's either that, as or as are get in And And later of in at-home earlier we in as patients in than episodes a setting. the mentioned certainly I settings. the episodic the disclosure. with to think pricing setting. drug any as episodes here, entry drug allows XXX Better a episodically the chronic about it previously you to an we and communicated of but closer used

think we that TAM at So holds episodes. the million still XXX

Operator

from Goldman Jenkins proceed question. of with your Corinne Sachs. is question Please next The

Unidentified Participant

This [indiscernible] Hi. on for is Jenkins. Corinne

So have view the -- same your will mid-XXXX? first, further what additional do TRANQUILITY requires population you same the as to they beyond then And trial question runway if of extend starting study, the the best second is, in where FDA II? options an we have kind with

Vimal Mehta

This Hi. is Vimal.

has expense, cash our on. Regarding of be cash clinical what we runway predicated obviously XXXX. runway our And as outlined, Richard executing will trials already in mid on that's

our of Richard terms outlined, runway, interest corporate extend by strategic our financing has opportunities. is which an these One have multiple to that are working other partners. cash with partners. partner, There our is already we In in options who developing programs

runway. some monetize that can to capitalize addition, into in looking we assets core And have we our are and cash We extend that.

that good So and opportunities is achieve have multiple news runway meaningful our milestones. clinical cash we to extend

Robert Risinger

that upon the point, to another at would terms that certainly again, be So or that let update the study if premature to But another FDA in later with study at-home, consultation we'll just this year. of study, ALF me is whether and decision has providing handle this be FDA, required. do discuss it's make we whether

Vimal Mehta

of treat medication top are developing on a I pioneer said, Rob we agitation. think to to what add just in like episodic I'd

We signs, the we from episodes the expected clinical the outcomes learning the data, so never nursing in are that from or from setting. FDA will observed homes have many that never are We observing. we

and make as are makes that that probable I'd the home option? we to evaluate information acute to what believe a Alzheimer's on and program to sense sense. designing home designation put whatever disease what a as mild-to-moderate ALF in make have is so for is far Therapy Breakthrough and most go we And of to Does one agitation treatment setting have Because an like is it would we it the a later nursing remind relevant back package. our back to and episodic taking observed. FDA everyone in population chronic more So sense needed together

Unidentified Participant

you. Thank Okay.

Operator

question is proceed question. next Devani Rx Please Samir with from The Securities. your of

Samir Devani

is Yeah. I've the directly already, guys questions. to it realistic Hi, that for more -- the reduce me a And been of deal the setting? generalist the at-home question Isn't market just guess of around It a I got for really my have for address taking very And many the that but III seeing it burn? Thanks thought really much. is you interest, just doing question home for big in episodes TRANQUILITY you have then second about out the you must guess cash partnership IGALMI I the Thanks in big and to how physicians guys. agitation setting? nursing to domain asked couple. is pharma? were

Matt Wiley

Good morning. question. I'll the first take

when bipolar the that are roughly schizophrenia, to psychiatrists at-home setting X,XXX for diagnose either treatments or X,XXX and about patients. therapeutic for those manage the we think So there actively

be positioned very that well to So market. would feel we we that access

physicians Alzheimer's of by in are are of to XX,XXX line the additionally about the interest those these Those treatment States, managed to XX,XXX dementia relates it these As from about perspective making be a patients. us. top diagnosis United and XX,XXX would evaluation agitation, patients for

Now permutations three pharmaceutical somewhere generalist larger primary have the of or are all a of that interest. there you opportunity as to a either with with to would specialists potential the a we or X,XXX those. partnership care CSO, opportunity, company partner of are But between of X,XXX those, described,

I this that but time. guess, not potential so has defined, at entry yet And opportunities, we’re market problems strategy clearly working those through or those

Vimal Mehta

let Samir, we how answer many So Rob that. I regarding episodes observed. will

Robert Risinger

at continue trial the in continuing patients are there to So have point they episodes. this and

is to hard It's accruing. given day. on So the it a say number

the is way an describe I And be exactly we reported year. would II is at it's that why on episodes individual acute we TRANQUILITY we'll it forward our of so for to what greater in a we than that the are discussing it to treatment And results. clear think with guidance So say of basis the and episodic it the have have end best path this regular. FDA

Samir Devani

Thanks very much.

Operator

of from The Jefferies. question. question with is next Please your Yazdi proceed Kambiz

Kambiz Yazdi

team. protocol Part What to amendment your and And features access your going that morning, you then assessments secondary Good SERENITY to [indiscernible] financing X? earlier credit proposed agreement that What you. are will partners? enable partnerships, III are for be the attractive or efficacy in [indiscernible] capital on and kind Thank valuable? to modifications are your of the what the key be would be the maybe

Robert Risinger

amended that protocol. we finalizing So are

call The And different, the describe the secondary will measures them with easier be the once it much and meeting have efficacy. to on details. perspectives do entire study I we to with we'll variety a have the FDA, of think

Vimal Mehta

Kambiz, Because So we modifying based FDA expecting. XX are initiate your on our question? dose selected now, the will micrograms to be as modeling answer study. And protocol and then we of we now what we is matter it a it's the have a were position in did pharmacokinetic/pharmacodynamic submitting saying to

As is period. as a Robert primary measure XX-week said, trends then the over safety we and efficacy

So outcome that looking be will we from that's be the what time. will

Kambiz Yazdi

Vimal. Yeah. Thank you,

Vimal Mehta

question, your on the agreement. Regarding next modification credit

make we that an are progress, active we'll mentioned And provide has discussions. in Richard As as update. we

Kambiz Yazdi

you Thank it. much. Appreciate very

Operator

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

Vimal Mehta

everyone today. for joining you, Thank us

strategic are our reprioritization on and a excited continued have for through interest in to updates BioXcel Thank Therapeutics day. forward this our your about path look forward great We and you sharing progress.

Operator

conference. today's concludes This

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

BioXcel Therapeutics (BTAI) 14 Aug 232023 Q2 Earnings call transcript