BTAI - Earnings call transcript Q2 2022 | BioXcel Therapeutics, Inc.

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Operator

Good morning and welcome to the BioXcel Therapeutics Second Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] After the presentation, there will be a question-and-answer session. [Operator Instructions] Just to remind everyone, certain matters discussed in today's conference call and/or answers that may be given to questions asked are forward-looking statements 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 be Form XX, XX, which may company's in ended updated that or XXXX. the XXXX report www.BioXceltherapeutics.com quarter report quarterly XX-Q can XX-Q in factors its future which on detailed results the March on quarterly Risk www.sec.gov, at Form will for found for June the ended

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

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

Vimal Mehta

everyone XXXX. have for discuss highlights Thank thank updates have of quarter BioXcel you, we been months. been rewarding And -- to financial we exciting few our to for performance Therapeutics and operator. morning. and business a busy this It call second today review but many Welcome you has the joining

As company Intelligence to and utilizing transformative a are approaches neuroscience you immuno-oncology. medicines Artificial in we develop know, biopharmaceutical

our five ambitious continues You our this driven of neuroscience become to across progress quarter to year have company bring closer goal. from discuss business heard the me our parts all and to us vision premier AI this past

our highlighting by begin across organization. me achievements Let the notable

II in associated with mild, our or agitation We successful I into treatment FDA or have entry IGALMI, market approved the the acute disorder moderate adults. laid for for a schizophrenia foundation severe or bipolar for

in are to professionals awareness field been in for We delivering option commercial and two and trade early eventual adoption. to and hospital create July, Our our launch system, remains swing treatment patients. this key full priority over sales new team in months drive the has activities healthcare

feedback from and the will Wiley detail shortly. commercial field Officer, Commercial Chief more discuss Our in early progress Matt

heavy launch our the important pillars franchise. expansion IGALMI our portfolio milestone on focus marked continue the we While three for for trade an XXX program, strategy

Let me summarize quarter. progress last our since

study Type the III trials with to further for of can single evaluate for schizophrenia consist at for double-blinded XX where this pillar, broadening a II in and will FDA, associated which controlled is the Following be or microgram we BXCLXXX to use. pivotal executed meeting with settings bipolar medical front, is our strategic placebo first and offered. home This announce XXX agitation I successful have excited dose disorder our I'm SERENITY our On strategy B parts. two designed

the our approval SERENITY first is setting. designed The institutional and for primary safety total trials, at earlier is in schizophrenia compared part an in to similar efficacy and and IGALMI acutely I and is which II two patients agitated this in II, were fact, year, basis change a endpoint bipolar to I efficacy to III score and SERENITY assess SERENITY Like placebo. from hours baseline, our

at administered is of placebo following is may derisked the SERENITY SERENITY be designed III for compared to safety when We home. The to second assess it believe part III reasons.

utilize First, clinical II. will I SERENITY it and of investigators sites the same as many and

in the unclaimed large of XX, patients episodes observed schizophrenia already data XXX agitation we for XX million in showing the in significant IGALMI. Phase dependent medical safety home related bipolar which Coupled efficacy that is this of study in and already number have at research doses. X/Xb episodes clearly dose and market a additive the the claim one-third defined together, demonstrated institutional and outside occur setting. the is a opportunity Recent have research responses of and need bipolar shows untreated setting. we This Second, XXX our XX, market and identified to microgram newly

approved. the in which eventual psychiatrists a gain use will strong bridge experience if effort current to help community build institutions Additionally, the with the commercial will

in We expect III to SERENITY half the initiate second of XXXX.

strides clinical our programs XXX. Next, as we development integration of expansion part our strategy, for have in strategy, made

for Alzheimer's disease with treatment program acute advancing of agitation the in TRANQUILITY Our patients well. is

pivotal II and III, second expected TRANQUILITY still the second this program. for trial enrolling with enrollment Our initiating data anticipate is half first line half of of in top trial pivotal year the our in the XXXX now we TRANQUILITY in

TRANQUILITY the significantly approval been With de-risked. a the level, we strong of recent initial IGALMI program and believe has

TRANQUILITY agitation forward supplemental continued NDA remains positive pivotal Alzheimer's. Alzheimer's breakthrough and efficacy, along area XXX related designation unmet a in for data tolerability in disease We growing FDA to safety of the significant with and confidence progressing us look agitation need patients clinical to generated with date, Additionally, the provides program. sought the Further therapy an a an agitation. from towards major FDA potential per providing the XXX indication depressive by as expansion potential after Alzheimer's therapies. for treatment estimated disorder. XXX in XXX strategy, million the year episodes of U.S. play in and the to much excited we're We're of no adjunctive a associated key solution in approved role investigating our a utility to with

controlled slow action depression XX limited and and first trial multiple study supportive dose is is each consisting our More anti-depression dose seven in broadly, volunteers. Data dose microgram dosing study programs healthy XX daily is volunteers responses. onset includes The of proof-of-concept underway. encouraging dose escalation style the quite leading for treatments currently our Our studies. U.S. million healthy XX incomplete ascending this annually is readout and future microgram progressing inform are microgram Over half dose cohorts the will prescriptions XXXX the over This XXX volunteers filled of at a in XX daily complete. our and double-blinded of are the current for for multiple of home portion in days expected in selection X well use. Phase with XX placebo cohorts, by and dosing for

MDD, near-term the company developing pillar third XXX by geographic given available final adjunctive the and in strategy U.S. have choice and II to ex-U.S. the made we the growing the opportunities, prioritize for strategy, over schizophrenia XXX U.S. for expansion for as Moving market home our has to bipolar setting I on significant footprint, and patients on strategy resources and in execute treatment to an

not opportune file timed we a at time, to at an have MAA the well As we expansion to chosen a and geographic this result, fully most intend appropriate pursue time.

a build beyond Moving technology proven are out leveraging XXX, R&D we pipeline. AI our to sustainable

and of immuno-oncology out other we neuropsychiatric build As the expected treatment operational fully financial neuroscience our to our including This of Shifting be expansion clinical subsidiary phenotype. options, maximum which trial We're either advance franchise, seeking dementia small Patient to KEYTRUDA oncology candidate work to strategic have established to a X Phase with ultimately is immuno-oncology to of us in OnkosXcel resistant of mechanism combination the neuroendocrine optimization castrate franchise, our for our adenocarcinoma of this clinical in completed second being agitation flexibility provide of SCNC position patients for development cohort treatment progress a OnkosXcel, cancer or third-party the sustained investments cell the conditions. enrollment carcinoma plus we're for actively of in half and and the demonstrates BXCLXXX, part unlock the efforts therapy formulation chronic franchise. of developed value XXX significant metastatic to differentiated prostate year. and to our for for cancer. prostate leading continue we action focus on OnkosXcel, forms and strategic related and novel of includes BXCLXXX our advance franchise. Under advancing aggressive

KEYTRUDA In later combination enrollment adenocarcinoma to addition, trial is XXX value for providing we its therapy, look forward subsidiary maximize evaluating shareholder advancing year. on additional plans expansion, updates for this oncology our our XXX our randomised to monotherapy to

welcomed Board front, of have we Miller and industry On Directors Michael BioXcel our family. the veteran, corporate the to

commercial exciting available pleased his We strategic time BioXcel. and experience his leadership are very for have growth to during

fortify Lastly, summary, continuing with business across of two new of property landscape have that. great cell formulations and conditions. made this we In aspects our work we quarter, our patents to the to IGALMI's and transform methods our containing department related are all and agitation using continue to neuropsychiatric dexmedetomidine progress other agitation treating intellectual

continuing horizon leading forward the catalysts exciting We to becoming towards have journey on enabled company. many the neuroscience our AI and look

like would who to will an I turn the on Matt? Matt Wiley, update launch, IGALMI to call the Now, give over

Matt Wiley

progress Thank you, Vimal three fronts I'm our morning. pleased on this and good report to morning, everyone.

schedule. Our strategy commercial access initial from on momentum, our and execution. learnings activities are our early access market efforts key well field are and and market progressing very The force

various in GPOs GPOs of with timeframe of our encouraged contracting organizations our group to three nine each. the with hospitals. the early we are And over X,XXX or have and on that engagement. been targeted and average, discussions take can represent we months purchasing There While are by XX% beds negotiations national six stages

the relationships are our finalize we'll to these We few months complete. progress expect over process and next the when with contracting you share

national In IGALMI. delivery GPOs, adoption further engaged downstream to of integrated drive addition to hospitals network or with we've IDNs

executed CMS of respectively. sales and expressing To-date, review. Multiple majority and phase in progress and unlock out successfully formulary have state for engaged the our our indicated VA in of have hospitals and completed personnel their target P&T is IDNs hospitals, our product the federal interest highest discussions. force to targets. We made and build systems access field the has the schedule submissions and completed to contract priority also the hospital review supply their deployment the intent first to We've commercial of

expenses. since a committees early activity, with a the understanding concept our strengthen. worrisome agitation of challenges there year, precedent has metrics. response intramuscular of a starkly to lot hospitals, of these provide agitated surpasses weeks surrounding staff. meetings $X,XXX a typically IGALMI. As reimbursement. for costly IGALMI is work can creates to that care. like IGALMI which patient increasingly review of market commercial half schizophrenia continues injections to caregiver unsafe the which still ago. loss one favorable patient institutional and the is while COVID P&T and result environments. dynamic We've an discussions is for patients, revealed driven risks the resource The transfers, target of second this be been approximately may limiting market of Consequently, no these and use injuries, leads The can we which may sales messaging, at staff opportunity more IGALMI issues, in is increase within novel to intensive to has many of solution which often and patient, stakeholders their and exist lawsuits, the The and launched physical outburst specific inject a restraint scheduled option and places our treatment administration with and Physical to will at effective IGALMI during to agitated XX restraint update potentially the and tremendous time, per pressure becoming hospitals expenses required safety an positive, learned markets. generally value field address both staffing offer stakeholders and associated Through the Furthermore, bipolar proposition work environment in to awareness

to to institutions As ways use for and decrease of staff. look restraints reduce the injury

We of use invasive consistent are the oral with guidelines. managing desire to for agitation increase less consensus observing a medications

market to HCP of response increasingly content market deploy phase IGALMI favorable a XX our advantage and over positive to providers in to treat market the are healthcare educate access Turning and the on core next to we're amplify with we significantly drive IGALMI significant sales months. XXX,XXX now our to IGALMI, will in of just To of promotion full Based This digital time. several marketing, efforts short to awareness formulary two and period of website now of peer volumes adoption team tactics have territories The program. our to available support promotional campaign, benefits on the programs position puts and excited These personal recently take our the fully team ramp the garnered deployed next speaker patients. achieved the meaningful with and engagement our deploying successfully begin has sales us also opportunity we over of quarters second visits launched process dynamics, to interest peer across the IGALMI. over which up to a has demand. strong

I'll will give Now, over Richard update. the a Rich? turn financial call to who

Richard Steinhart

and in administrative increase the The to clinical the a TRANQUILITY to $XX.X personnel financial million to for million of BioXcel XXXX expenses XXXX Therapeutics to and $XX.X XXXX. primarily period the million R&D million quarter the Thank development related quarter The loss net you, loss second million includes prepaid same second were of $XXX,XXX net the for SG&A XXXX. expenses quarter quarter in of general program. to $XX.X U.S. clinical increase costs attributable in of the Research XXXX. which in second costs in $XX.X Matt. will I a $XX.X of and XXXX were quarter of now reported review same expenses were was primarily related for compared in million launch the compared fees. our compared period in for second period results. Selling, due were company's IGALMI XXXX in expenses burn to the approximately trial and the $XX approximately costs same inventory Cash $XX.X in million, for $X.X the to million for

milestones To-date As of received in million. and has This $XXX the million cash million and contributions $XX $XXX agreement. June that April. million cash $XXX.X company financing announced of the from XX, equivalents approximately XXXX. excludes strategic met from totaled has the

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

Vimal Mehta

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

Operator

gentlemen, ladies be conducting we Thank you. this session. Instructions]. At will our time, question-and-answer and [Operator

Our coming Bank with with line of Please first from of question. the proceed is Harrison Greg America. question your

Greg Harrison

for behind and Hey, the out, provide decision discussions questions. to talk you've guys. would could had with you potential little a on the Maybe how some color morning, partners? just the good that you Thanks Maybe the characterize drivers the taking ex-U.S. strategy. about bit more start

Vimal Mehta

a been SERENITY that Regarding we completion recent where the evolving program III file U.S. already attractive And program opportunity it Alzheimer's that progressing, to can of in so it trials. really approved has ready short program fast. announcement program will ex-U.S. strategy, in is after setting. is the be two evolving to our the our drug IGALMI, of is with run our SNDA pivotal is and go home considering

So U.S. really large. opportunity is in

we us. deployment, In continue pursuing shall U.S. resource to addition, it's or MDD, outside on we and strategic are on a both in focus focus choice U.S.

be in rather than And deployment look we partner we ex-U.S. originally for will our we to strategy thinking geographies were partner cover outside So have a just start will Europe. captured U.S., once in opportunity who then like for looking can a of of goal multiple single

Alzheimer's we Now Japan positions. related agitation, the are is a very considering IP attractive market very strong and

So resource strategic in outside is attractive a choices addition making deployment to Otherwise, we from opportunity U.S., U.S. very are perspective. just

Greg Harrison

sense. when start to update on launch? the makes seen then Okay, in one And an Have you just month IGALMI expect since trade that And the maybe you if so maybe on early any adopters launch. board? not, would the come more, first or to

Vimal Mehta

process, With Greg. the

the The First takes process to average thanks six of get months the all, the on question. just XX for to hospitals. formulary approval in

been driving so that adoption completed. process And has typically happens after

So operational typical adoption that the that this P&T that how drive happens, proceed. that within to interest, identify swifter Once been steps the and last we've see those process now working get just over in but And begin taking the facts. we're set is It's hospitals. is weeks to formulary uptake, hospital stakeholders launches taking an we'll of we're XX fact.

Greg Harrison

it. Got

congrats Okay. Well, progress. on And the again. thanks

Vimal Mehta

Greg. you, Thank

Operator

you. Thank

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

Robyn Karnauskas

on good progress. And for thanks again, taking my the work Hi, question.

-- SERENITY why would what on I you first the repeat percentage a dose? And Can XX have higher follow-up. exclude not So why milligrams. might question, a my just population need That's III, that of then that those?

Vimal Mehta

starting relevant with great effective. they XX, that's as XX, a XX in Robyn. drop. study, like, in outpatient chose microgram XXX we have were outline you our XXX, a That's we We setting why previous and question, dose that dose XX, dose microgram, saw all know escalation because Rob I'll most XX an

Robert Risinger

Sure.

has actually a from schizophrenia. study two patients Vimal is from XX, pointed say, who separated It on chose so micrograms number proportion placebo dose the to the might, in data because respond at as we as dose large that of hours. another we our very have out, So It ranging XX need XX let's small.

will bipolar designed, II. that is we're design, identical it it's schizophrenia be efficacy, the the almost of a very disorder. trial frankly and sites and an completed demonstrating I combination It slick at very So SERENITY population, same a, done will and be the

And a the of So use. allow which two we we're from for you baseline an the at expand agreement in expect us safety at that purposes total testing we've at hours. results identical disorder, PEC terms received is and FDA then will to score same home, from improvement with label bipolar agitation the pivotal associated indication, home this for or schizophrenia and if will but this trial it

Robyn Karnauskas

in home? for second And portion is then just so the just portion can second the be those clear, hospital to more first portion all is just at safety? is home at the repeat Or it and you and and

Robert Risinger

II, in The an it agitated identical acutely will done present SERENITY state. who and agitated what acutely in first we've I portion is to be patients

We will XX portion the the demonstrate at And dose second testing to the then home. microgram be efficacious. safety is the able study as of

Robyn Karnauskas

setting? portion in first the So a is hospital

Robert Risinger

Yes.

Robyn Karnauskas

Just be want to clear.

Vimal Mehta

is And Robyn score. we it's experts, And a the there lot split convenient a to that's at what by setting. home some are And than rather PEC their score phases. because more reason we reason rated a it, two have for using the PEC

Robert Risinger

PEC the already demonstrated. we've score Ridges, what was

Robyn Karnauskas

of then sell going Medicare going what Medicare if I by thought guess United you law? how That look to be bill, drugs second I about Medicare? about. the population. that and health in large obviously, makes is your we we it's reform that And for the top be, question split And rather exclusion you now Alzheimer's, it should first States? Okay. Have is could to within criteria. estimate model thought for it's the would out, about in I you how XX in after should that's think like are And given nine significantly, launch, question regarding the a care sense. the impact you drug have small years of this you if mean, biotech be the outside But Alzheimer's

Robert Risinger

the So focused drugs bill med D really the CMS dollars. in provision on already are billions those costing in is that graph of

to going -- happen a that our We total opportunity as portion expect the of so modeling. to the answer your would of third down opportunity in Alzheimer's address we potential that the where So the approval, we for seen issues fact ratified Medicare that's been roughly that yet first. not to we The market. line bill get the little communicated we've is these we've about negotiations to got are instance, has would that, in a to go question And and way we're FDA thinking is long want about a how pricing approach downstream particular to this a we've past that is, and premature. thinking flexibility

Robyn Karnauskas

great. Okay, Thank you.

Vimal Mehta

Robyn. Thanks,

Operator

Thank you.

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

Sumant Kulkarni

question. my taking for Thanks

any sorry And couple. noise. have for background a I

The the three, one to the first is metrics exactly on plan you What use atom uncertainty terms aspect. for in do component? of safety collect

Robert Risinger

Rob any be the of time metrics as Risinger. It's example, be Sumant. you the for adverse adverse in collect patients trial, There at adverse dosing. Thanks, events The for events, events collected would will collecting maybe will will the to whomever they'll family be to reliable a report report son, daughter, informants a maybe maybe will and be events investigators. member, these caregiver a or spouse, adverse also there say

is So the investigator events and Patient events this says, you outpatient. other what to This comes records the study is office into adverse trials identically as adverse that. and and felt collected I how are happens. how might an

Sumant Kulkarni

with Is there? And anything to today a as a physician Right. that restrict patient currently that from IGALMI setting. follow-up of not is my precludes there sending home the then a does specific use given label

Vimal Mehta

great a supervision. as label question, you said that's the focuses on Sumant, under

in use and experience, million So that of just supervision focusing we of available, market. develop next wherever it, hospital We're to setting It's very two-thirds focused approach, physicians in comes all the will months. used. to out be IGALMI well how will there hospital they six unfold XX patient is episode once of believe defined a can because the the a XX

Sumant Kulkarni

you. Thank

Vimal Mehta

Sumant. you, Thank

Operator

Thank you.

with next coming from of line Jefferies. the Our question is Please proceed question. [indiscernible] with your

Unidentified Analyst

indication, you use Commis interpretation for Hi, agitation of that the is and second Chris. SERENTITY this bring meaningfulness regarding and What's III, the Alzheimer's anticipate your for drivers what as do then MDD was psychosis, in trial, team, clinically in and endpoint are significance outpatient lastly interim a completely for clinical on that? you selection confidence meaningful there what for your is and -- gives for dose

Vimal Mehta

on will I the Thank with MDD. your you for as to program it follow-up pass answer TRANQUILLITY well Rob to as then questions, both

Robert Risinger

acute disorder. the Sure, let so indication it's same or associated in III, episodes bipolar with agitation be me clear, is schizophrenia SERENITY this

And using but in a that a the just episodes directly clinic. the for front running or so hospitalization the or at potentially even requiring emergency prevent to home, IGALMI this provider, take we patient patient from aren't the they're in believe just to that agitated of going hospital care to when or could health room enabling

and escalation indication, sort that around And second it's a and prevent from in but is patient value the a So the up occurring. because patient the is same to the there's why the to piece exactly tremendous people agitation end moderate, it emergency then an the patient room, severe, escalates. of mild, spectrum,

these are in the very patients go emergency to need room. than to agitation you when home, preventing not the if it's at stages early will of So different stages it's mild

I between choice, patient think no dynamics there end treatment have it's home. or options a reason a because the at institution, up the don't they So

IGALMI when patients back could scores institution. the end with available, selected. So compared to the they're we patient room, the have two-thirds lower and these is the emergency that's when they why are of dose they treat up in And up in if you end

Unidentified Analyst

escalating dose, the example, escalating both and to doses example. a and of depression dose doses, for respect and dividing course doses with the day So of an dosing evening and a than at tolerability safety once for testing major individual more morning selection, we're

a tolerability the for so prior testing study is really this depression. to And important in proof-of-concept

continue biomarkers simple far thus it escalate issues, dose, we there safety to well any enable that is Are those sort us to tolerated? the a how would select patients. So very are of and

Operator

your question, of proceed We'll the coming next move question. to on line Thank is from our with you. Please Yatin Suneja which Guggenheim. with

Unidentified Analyst

questions. Yatin. is the morning. progress. Eddie Good This our all for Thanks taking on for Congrats on

what happen reason in SERENITY would X III would a or patient have for does be at-home administration? bar safety move to to the limit to proceed some program, ensure rapid regulators have a of for the company experts program a need and wouldn't efficacy expansion why at-home time number of to Part in can then dosing patient the then patient earliest you safely there you MDD see spoken And would Part at-home or for the For are to points the a antidepressant given agitation, be And a a would to expect onset efficacy? take looking and for can you're action onset doses in saw rapid of what the X you this what study?

Vimal Mehta

So thank you.

first SERENITY dosed Part be X, So or in patients independent are the at-home. the in those dose, the with the XX III, gateway. will the testing Part not X patients of portion It's either dose placebo a is patients microgram

that question think with to to start use is doing. Part that it realized I your and patient you we're X implies that's a continue not So going at-home, what

it present with treating of agitated, they The acutely dose. who is and trial the XX agitation, patients we're part are first with the microgram

will, if efficacy, if room. you a deed, as So situation, be everything tightly well where as in just we'll accurate monitored, have were very in can you on controlled safety the emergency as

The the of is at-home patients. a in entirely different set of whole second part study

data, at-home. consider have for that So a enough indication the again, this FDA they we pivotal said has will trial will the

Robert Risinger

use I the and SERENITY for at-home, time the so were to and of robustness using that reasons at-home II, scale or safety setting, data package in for expansion safety able I and can this first the portion we about no at we SNDA. concerns, having we mentioned the in the do demonstrate label as not another any a it to there that previously, it's that could or and So the become used all were have same

Unidentified Analyst

on And efficacy? Got helpful. you, that's then

Vimal Mehta

again that say please. Sorry,

Unidentified Analyst

The are MDD to see time whether what you'd if and the that about look what efficacy you points antidepressant similar would for earliest at be study, could agitation? talk to going for

Vimal Mehta

response. seen, hours, be to or expect looking not like Maybe the just work remains work who for greater we're proportion week, of first for proportion antidepressant are at MDD, than we'll the at looking in large, but know MDD to early very also XX%. and But cetera efficacy we're patients they be not end all weeks, for likely SSRIs second In don't greatly at example, to not the testing that a we're two of the at this improve We're and and we'd looking acceleration everyone. we the improve, days a et antidepressants week, be that. see looking one within we large all

So we're response acceleration when treated looking and both or BXCLXXX. overall, with at responders

Unidentified Analyst

or this And to study like right that have treatment? is four going weeks something

Vimal Mehta

over a four weeks. period dosing Daily of

Operator

of question, the we'll with move you, on which question. our your next is to Please from Thank coming Bristow line Colin UBS. with proceed

Colin Bristow

recognized behind let's Hey, or for and when So give two us to revenue, guess from anything received? I question other details moving can the sorry TRANQUILITY year any you're curious May, report as you where orders that's the questions. just be shipped question subsequent terms are just about taking good if ended of rationale one, made, that? but morning. quarters that Thanks what's to give can will details is assets you this think going we first us any around revenue in to slipped of II I've or half and this Thanks. this say little timing into missed on a the how

Richard Steinhart

This going that's final hospital, sales to sold the actually we through sales. when the the recognize Richard, customer on where recognize sales to it's is we're will

Colin Bristow

great. Okay,

Vimal Mehta

Fall what sometimes months these in don't we And know sites, we and TRANQUILITY for patients several ALS, disruptions reside and COVID and elderly setting, happen elderly in CRO And that in residential the conducting could this to the observed program, regarding trial center. the COVID. have in access where go the restricts we in are into the next with

guidance just of there could we cautious the data So are providing be those that readout slip on a reasons. being because and

of of so younger will operational SERENITY are These more terms of not those aspects, that get in screen are frail, number patients terms patients. it trial, are in any In get and that patients, they there. because bit you are elderly issues are failures, we do seeing you little

reasons nothing the the very they specific patients So they and other can may delay, are COVID you associated and because get say or complication, those screen related are frail I would excluded. failures have get some can medical more except

Colin Bristow

Thank you. great. Okay,

Vimal Mehta

was had MDD to it or you just question, want third And the related to our, clarify? I

Colin Bristow

other stealthy of on under Just for forward? -- somewhat in do we more when information terms moving the the assets your get

Vimal Mehta

Sure.

So going formulations. is the that asset now through

which complete. the all of where mentioned very that explore Initially, additional what the work that dementia. continue that once then But we disclose and indication ready preclinical agitation will the will have treatment indications one we expect done mechanism is clinic, lay the We to like and is we in XXXX. to in we And fit have to of workup we choosing. take options out are asset and to we we the where it will chronic in plan well agitation like fits chronic in are

Colin Bristow

guys. you thank Great,

Vimal Mehta

you, Thank Colin.

Operator

Thank you.

is Please question next with Suvannavejh Graig Mizuho. the Our with question. proceed coming from your of line

Richard Allen

Good morning. And great is having be a who name. for I to Richard it's be on best. to This his fantastic Allen day. hope back everyone's Suvannavejh Graig tend is

part the state? do the enrolling you outside a peak think the patients how of third do expect occur goes first revenues to assume what of what increase was when a Can you plan. increase on episodes III institutional SERENITY my you. company's of with expect do or Thank settings? to to How study incremental since revenue to many be we that large is my question of XX% And So you and goals them. second by that a

Vimal Mehta

for III. Richard, the around SERENITY questions you, those Thank

to he's will But to on it Rob short. I can be we First outline number on so and question, of this pass patients expect trial agreeing everything. pretty he

study everyone, months remind completed three and to were both in XXX XXX we the our two so. II we each. And about and enrollment there testing SERENITY arm And patients, placebo. I doses a had Just trials or five

So power fast And of Rob. sure to will doing to are studies terms pass these in to the very powering terms is trial we because the the of patients, of I number currently on it timing. he make in Rob, study

Robert Risinger

in II. the portion So second was I will and be I, first the SERENITY -- believe each well of study SERENITY patients XXX under half XXX in the

independent we way these studies, are know patients independent will they're that relatively because a in enroll So quickly. essentially

In was II with mixing the similar. with common. exclusion, II, in the bipolar an both we able addition, even that regardless can even enroll patients We're expect disorder this because I our study, very faster humans, has SERENITY of in same disorders. midst were and with effects the the the is COVID this I schizophrenia and recruitment agitation Humans part and we SERENITY so SERENITY is I rapidly, and test are don't underlying enrollment. at unlike SERENITY the patients agreed any problems schizophrenia. this with there's same major bipolar was to time of and FDA what patients anticipate And relatively that We of the in are thus the both II for we illness pandemic. no

Vimal Mehta

or guidance roll but provide will we provide is when a on So certainly be expected, pivotal will second XXXX, granular once half Richard, out -- guidance we the first more that we'll plan, it the half. and readout plan in data

Matt Wiley

to take your Richard, Matt, just the setting. So, for community revenues question this on is

math specifically are majority community that we've episodes there recent that of roughly agitation, data. claims approximately in the you're XX things agitation the research captured calculating that of bipolar the But are the episodes the the setting. is a correct in in here represents is not market the third that in which population, one we in that learned see So, of additional

And they're with roughly patients. was. typically episodes. is episodes the when a it not seeing thought in increase the These this compliant what we would community setting their agitation So schizophrenia in suppress previously anti-psychotics, opportunity we're XX% the

identical sense, bipolar claims. alcohol. exercise, illicit meditation, XXX We get that that drug believe opportunities the should saw what So through But are episodes XX makes well for we for being in those called in are it use those shadow managed to indication. we approval

Richard Allen

thank Great, you.

So shifting? comfortable then? and value proposition. their like see also uptake that for curve a you you where IGALMI should then, that IGALMI Or exceeded you currently? expectations do think look is with do What consensus the in you mentioned Are

Matt Wiley

we as to with that said, there's value deal a hospitals. still there's or process. and have an to -- I uptake operational the mechanical in unlock process And So

early see in However, interest very have very drug a signs And the positive in very things encouraging. we the direction. been the encouraging, moving is

unlocking uptake that once potential patients. of opportunity see near But lot and for wouldn't the curves just on helping see and the because term the I us, a formulary a of getting So big I of behind drug mechanics demand. impacting that's

Vimal Mehta

And to a of face lot continue we to see meeting. face

of face getting Our to a or Matt feedback, all are COVID teams face any other lot sales positive very very It's time, despite said. the encouraging. they're reason. And getting as

marketplace thinking weeks. for this will potential being in the In fact, be drug XX whatever now were we

We excited about. are more even

Richard Allen

you Great, thank much. so

Vimal Mehta

Thank Richard. you,

Operator

is the your Ram proceed Thank of H.C. from question The Wainwright. you. question. Selvaraju coming next with with Pleased line

Ram Selvaraju

taking for much questions. very Thanks my

wanted you indication capture for regarding to regulatory the within Just could if what degree. statement information certain the IGALMI are of ask context this of for submit to here with you trying the process user the

to clinical any SERENITY any anxiety III thinking to we intent on Thank should about disorder, work comment respect if what period. proved to respect be you And with a if doing positive, you. your also if [indiscernible] with side could view generalized on exploratory So regulatory any? in

Vimal Mehta

Thank you, Ram.

you… Rob So

Robert Risinger

we on which request the fast robust could we doses. or anticipate microgram and basis Ram, for to application together rapidly findings, expect within with fully of And even timeline NDA example, trial XXX package efficacy few for we on able than we XXX FDA, put complete and safety the have track course, approved so, will the of review been would better the supplemental And be is a a should months. to what very depend a once have similar several

data you an we'll if outline a to relatively all And planning you comers really indications update anxiety for acute a autism, so at stress and generalized in discussion, studying We've but of future enrolling need studies excuse at then with, we me, get investors we or can anxiety had disorder, indications can look in schizophrenia are at this could will bipolar more have additional water a We regard anxiety fact, the future. will, look like lot with indications, any in the in developmental toes data. process, in such quickly, and clarity we because the example. variety our we're aren't have of well, disorder that might who if why and regulatory we for disorder, to provide even generalized With putting believe certainly as potential disorder, disorders. this -- look disorder, we you said, to panic, PTSD discussions

demonstrate they're take And there's just where a so of we are a have they're plans certain are you of sort to you directionality do and These basket signal and continues if to open major small they has These in our development. focus at next with the IGALMI. home disorder. next agitation primarily expansion to out associated the steps for or they And label determine and fast. tend patients studies, for been efficacy and and But depressive will if numbers me to to give Alzheimer's to disease be on to preliminary, that and be Alzheimer's cheap, point not, be us way studies utility you let studies. will the a safety and use

Ram Selvaraju

you. Thank

Operator

Thank you.

proceed next question. the your Please with is Corinne Jenkins of from coming line question Sachs. Our Goldman with

Corinne Jenkins

for Thank pricing needed we should or potential to dosing economy? you. indication of include as about think strategy how Hi, your expansion chronic

Robert Risinger

so. Yes

in in how about of think flexibility downstream think those we indications, further might have we pricing to we settings. As continue

the closely. monitor nature, legislation watch have made to question best dynamics we'll institutional going into. we'll setting, the may We'll previous future We strategy now And indications. still actually per to fit downstream market, the and continue say a things that fit we're any around yet. on make haven't determinations market of very pricing the that we and a smart Surprise pricing markets that in the to that decision

monitor if get those while we'll for markets. continue indications? at decision approval that to entered those And as the So we make should and that time we

Corinne Jenkins

expecting III two doses could are part how And receive evaluating the for also patients? trial? long And IGALMI Sure, of you you you this SERENITY will of many to thanks. patients please confirm in how be

Robert Risinger

be at will of have the using home when Patients an episode agitation. BXCLXXX they acute

giving so film the of over monitoring and we're period months. And them a

will a to from alcohol frequency as attempt Patients or principally, very dose, the will take, is able a if at thing. use meditation. that because it's that we to single they're feeling that you the lot pick their controlled BXCLXXX placebo patient and that possibility of the for effect but to an happens or patients dose to obviously take additional the and home of XX rescue dose, would dose initial So medications -- individual treat take marijuana, do what but to are not they we're There's a testing to there be much medication, when something calming. also up anxiety. will things microgram of have and that that They additional Patients up try take film. the be whether the they an

Corinne Jenkins

Sure. Thank you.

Operator

time. It you. appears no questions additional have Thank at we this

for So to any Dr. I'd back remarks. pass like the concluding to floor additional over Mehta

Vimal Mehta

you and hosting forward and the the for a chat. will coming to meetings with Thank participating Matt at a where Have be you Canaccord fireside today. day. in of everyone Growth I joining look in many great us We Conference, including connecting weeks,

Operator

and at webcast. Once conclude gentlemen, this and we and lines participation does you disconnect may teleconference this today's Ladies your for time. again, thank you your

BioXcel Therapeutics (BTAI) 9 Aug 222022 Q2 Earnings call transcript