BTAI - Earnings call transcript Q4 2019 | BioXcel Therapeutics, Inc.

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Operator

Good morning, and welcome to BioXcel Therapeutics' Fourth Quarter and Full-Year 2019 Earnings Conference Call and audio webcast.

Before we start, I would like to inform that this conference is being recorded and that all participants are in a listen-only mode. At the request of the company, we will open up the conference for questions-and-answers after the presentation. [Operator Instructions]

Just to remind everyone, certain matters discussed in today's conference call or answers that may be given to questions asked are forward-looking statements that are subject to risks and uncertainties relating to future events and/or the future financial performance of the company. materially anticipated differ statements. these could results from in those forward-looking Actual risk results public most U.S. affect that filings detailed the The may company's are factors in the with recent XX-K its XXXX, XX, can on be Web report including www.sec.gov. ended the which Commission, on www.bioxceltherapeutics.com Exchange fiscal year and on Securities Form site for found the December annual or

Therapeutics. I Chief Executive Mehta, over to Please ahead. would go Vimal now like to turn of call BioXcel the Officer

Vimal Mehta

our and for today. Thank to appreciate conference to and you, joining morning, a you experienced results call highlights and everyone, knowledgeable XXXX BioXcel business thank full-year to thanks be Operator. our and the pivotal financial Therapeutics' attention We proven everyone's time discuss for for Good year Therapeutics, team. has quarter of and XXXX. fourth BioXcel

development significant reach well company with beyond. strides positioning clinical in and our to BXCLXXX, and programs, XXXX made have We BXCLXXX the multiple milestones important two

would and year I far start, the like last XXXX. neuroscience and our the lead have over we on To achievements in focus program, accomplished discuss BXCLXXX, thus to clinical key

is proprietary As BXCLXXX or of acute our the reminder, thin-film agitation. dexmedetomidine, formulation Dex, a for of treatment

and designed without so to candidate have easily a calming be action, We onset rapid excessive of it administered a this produce can have effect sedation.

who either data patients micrograms, in receiving the two disorder. up to agitation X of assess Phase studies Building arm schizophrenia trial with BXCLXXX in for Phase SERENITY XXX program, acute at trials initiation each of with positive our treatment The on December the separately the and Xb the of from the XXX studies, BXCLXXX XXX XXXX, both to we studies will of announced patient the This bipolar one initiation BXCLXXX effective have the to Please the step us already placebo. option with the a individuals needed closer of clinical from the quantity note use. these to agitation neuropsychiatric of have suffer manufactured associated SERENITY millions treatment the brings for of to films disorders. micrograms, program providing delivered sites we complete and non-invasive or

Since patient pivotal we these submitting first mid-XXXX. to It results in we the relatively NDA these of and plan duration track, line report on in on enrollment top of is are our Artificial completion the submitted advancing filing this clearance expect studies, to a important short Furthermore, understand NDA for files improved the the BXCLXXX. the which has showcase Intelligence following to that identifying IND, for helps the years approach short and of potential therapies. to our after of efficiency be few is only

momentum clinical candidate Phase we acute the does there. stop agitation of of to beyond utility BXCLXXX for current indication geriatric an this neuropsychiatric month product not potential disorders. the The expanding with Last initiated Xb/X dementia, a and the treatment TRANQUILITY, trial

of this results therapy patients this there and mid-XXXX. report high experiencing sedation. effects study effective expect from does is an We as undesired side With to treat FDA result agitation, such no to dementia unmet symptom, XX% in need excessive not in for medical approved that a therapies

plans the elderly, dementia, including Moreover, lay the market we in disease, to foundation BXCLXXX agitation agitation trial dementia-related treatment easy-to-administer the patients. physicians the for BXCLXXX expanding treat that a who candidate. future off-label since therapy TRANQUILITY geriatric believe caregivers provides this in potential the across have of struggled for for continuously of a agitation warning and will our treatments investigate have is Additionally, spectrum Alzheimer's blackbox to fast-acting option significantly

may help initial physiological caregivers severe signal in heart with also us allow associated could time BXCLXXX. response with February to that changes be only as this to adequate hyperarousal in linked agitation, we will in assess this This of feel to not to deliver justify these experience their and turn three year, agitation. can schizophrenia University to to an X that EEG agitation. study at patients effect, ongoing trials, determine but researchers of rate before trial announced further initiated provide patients calming a to Yale used We including have addition In BXCLXXX's BXCLXXX Phase and biomarkers

While solely patients hyperarousal, experiences disorder this lead we indications with believe BXCLXXX the trial schizophrenia, and are post-traumatic we performing may symptoms. that study this stress withdrawal also to other of alcohol-related exploration similar on in including

for the of caused the are and to More epidemic, to be symptoms. needed United overdose are we opioid elevate to main are combat effective by our treatment continuous that opioid and and FDA reason has received potential usage. withdrawal due age national potency its application number for options believe a under we for BXCLXXX opioid have the intrinsic withdrawal this symptoms pleased individuals action. for symptoms mechanism are of the years, to States to of one of Opioid its XX the death is treatment Lastly, distressing in IND reported clearance of BXCLXXX cause the withdrawal drug specific

the on After study [Ph], [attacks] symptoms. we reviewing showed results intervene withdrawal promising investigating reducing

a differentiated experiencing that trial indication. of withdrawal, We year, current we to program patient past neuroscience the a built in are treatment care. This in initiate to population, from expanding an symptoms BXCLXXX the and out standard highly we fourth opioid is preparing our into option the therapeutic of provide hopes alternative of patients broader release opportunity believe have of reaching truly

our Schizophrenia. treating trials, With we're patients in ongoing gaining disease beyond with in conditions BXCLXXX experience

associated product candidate Thus, we're broaden value the various the indications of this continuous franchise. with regimen with commercial creating this to exploration In an potential feel of portfolio has the as BXCLXXX hyperarousal. to numerous treatment our is candidate neuroscience an advanced to we efficient be strategy addition, dedicated for disorders

This to tumors. candidate is treatment would Center open-label tumors Cancer solid solid when is expanding our to a and of combination that with immune-oncology trial clinical we We're numerous will of innate help with BXCLXXX announced Back conversation systemic that actions. I clinical leading at to in turn over activator, Phase of or evaluation the U.S. we're like BXCLXXX, trials. cancer used orally into evaluating mechanism dual to Keytruda range our a program of expansion BXCLXXX responses Now, the designed basket X place refractory the immunity Keytruda December, accelerating taking advanced therapy. wider advanced into with Checkpoint are patients combination the extend Anderson, this to who in naive to either hopeful in MD in

explore Symposium February first at enrolling to American of dosing conducting we neuroendocrine the We're of twice the Society presented year, readout, our from we're treatment-emergent double from BXCLXXX of expansion currently following safety the this of tNEPC. the to potential of cohort move and we Cancer XB San and X the Clinical in Francisco. Oncology of and the for tolerability Additionally, the Phase cohort trial. cancer the combination study Xb/X prostate efficacy In portion results plan Phase second benefit day or data expect Keytruda in a to trial first XXXX half of an the Phase portion and currently report to Genitourinary

The of trial. the Nektar combination start in following and from Merck BXCLXXX study of and Avelumab avelumab outcome of safety and KGaA and Pfizer pancreatic run-in the of and Nektar Pfizer's Bempeg from that Bempeg trial completion cancer will

key this into net XXXX. proceeds public past milestones current provide significantly our month, regulatory enough offering, and well cash results, cash sheet, of $XX together clinical, operation balance we this in BioXcel million to with our Importantly, securing strengthened fund a runway

With call to Richard? Steinhart. CFO, that, like turn over the to our I Richard would

Richard Steinhart

Thanks, you and this for welcome Vimal. all joining to Once shareholders. again thank us our morning

the quarter for net fourth loss quarter fourth the loss million of a XXXX. recorded For to compared of of we $X.X a XXXX, net $X.X million, of

$X and salary in related for for million costs, and in development related totaled costs, approximately was costs XXXX. the by increase primarily the and research professional million payroll to due in manufacturing period same Research expenses quarter, expenses. compared The clinical decrease to trial increase in project offset part an $X.X fourth

approximately in for related $X.X General of costs increase fourth the of and was and professional to fourth expenses salary due were administrative million increases to and $X.X fees. quarter in about The payroll the million XXXX. compared quarter primarily XXXX

$XX.X $XX.X million XXXX. for a With reported million loss million Research million for full-year regard $XX for expenses full-year same $XX.X as the and million administrative expenses million as the the for same we the and in $X.X $X.X General to the to to compared XXXX. XXXX XXXX. full-year XXXX of to period loss year XXXX, were were compared for compared of the a development period

include and and cash cash XXXX. XX, million equivalents net had of XXXX full-year financing, note million not in proceeds. recent secured as that We which quarter Please our of December cash fourth do $XX.X concludes numbers review. our the December $XX financial That

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

Vimal Mehta

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

Operator

your with question first At session. question. you. Robyn [Operator Karnauskas with this question-and-answer time, Thank Please will conduct SunTrust. proceed Our we comes from a Instructions]

Robyn Karnauskas

Hi, taking question. guys, thanks for my

of mentioned to questions So, positive can you're do lot delay some how as second this just to And the that need you and to like get do, do reimbursed you trials, what these you a you saying cetera? have much occur? then, capacity is how of be code, trials, anything? for prior us talk much to can manufacturing happen as on enough to for And up far launch, first you about ramp-up to you needs manufacturing, how then I the to a to reimbursement, people more will get that question a hospital, submission have et the could about through to

Thanks. ease about us to talk reimbursement. Just of

Vimal Mehta

Vimal Robyn. This you, Mehta. Thank Sure. is

mentioned is completed our batches All up readiness Regarding CMC SERENITY all We've the complete have U.S. to scaling pivotal for been manufacturing, preparing we that X. the SERENITY two like, as needed trials, for X commercial and in we CMC. done are and

preparing delays see of in So, for we any don't the terms launch.

of good readiness will the that So, XXXX launch end we the feel we the material up to towards commercial for or to required position be early prepare that scale are continue and XXXX. in

key the Then this pharmacoeconomic developing like up, two centers a will pricing. our Coming regarding care less pricing? pricing in a there visits, or you we're ER withdrawal maybe will centers to are X symptoms understand then will and treatment strategy with be system which a benefit the discussions living is and the our dementia long-term as right that that are. to pricing know, the and be be and reimbursability, the type for assisted what currently in as waiting initiate value are the will these show we that and these will complete more whole providing we're there hospital for regimen could back be homes opioid the and well patients what that, what be At SERENITY a what high-level, studies, for pricing when pricing, claims nursing for like, payers we expect patients, reimbursability, of for the our proposition, question to X, your we

this progress. work think I is in So,

come on indicated, we a As soon, Chief the and can we we a Officer, have where have and the is pricing process to then board to the hiring able strategy session of reimbursability are expected be for Commercial our that will we product. outline in

Robyn Karnauskas

you. thank Great,

Operator

question next proceed from Sumant Genuity. the Canaccord Please with comes question. with Kulkarni Our

Sumant Kulkarni

Good for my morning. Thanks taking questions.

XXX know that logistics We First, of themselves. from we've able questions investors on were in the your place trials, the received some of all the the patients in placement the X to sublingually. film actual film side, Phase

you any So, terms ongoing experiences program? of in far talk in of SERENITY the film about of so could the the that placement had you've

Vimal Mehta

case, and not As we observed so be Phase otherwise. far, has SERENITY study, our have in both X the to we our we heard that experience know continues X, anything the far as been what Xb program, with what

Sumant Kulkarni

the side, there that potential used withdrawal the some are Correct. around for generic off-label. opioid be in Clonidine questions And setting to on

us could there're be some there. might you know know on going exactly how are different? selectivity We let Dex that things So,

on please So, expound that? could you

Vimal Mehta

Sure.

develop this can program, will have and I Dex fundamental outline outline our who we decided of Risinger, BXCLXXX for the is he Dr. why Research to for VP rationale So, we that. Clinical Rob that,

Rob Risinger

between Dexmedetomidine the upcoming This We'll withdrawal. long the for Clonidine, our as exploring Dexmedetomidine plasma The and our and half-life. opioid in well in in has good Dr. Risinger. morning. formulation Hi, differences the very pharmacokinetics as be a principal hands, the example, is trial range for dose

because a believe and there's there's United Although generic complex used a a has be we adjusted use there'll then differentiating would BXCLXXX, from for certain the be day, dose opioid a for advantage, be and in to we clear that that ease example, Clonidine a titrated, demonstrate to and for -- times is example, Clonidine up factor for We of fairly or Clonidine. dosed regimen down. multiple believe that States hope withdrawal, is certain

Sumant Kulkarni

is because on XXX out your that do And of talk timeline it. that for Got could you think side, that? the it's of trial portion could what interest plus safety given Thanks. Avelumab, my about last the Bempeg in be you your run-in question study on to partner's the hands,

Vimal Mehta

data the will we study our data, to like get Currently, have will conversation they or They XXX. in and Then position expect QX that that a either with be our QX we initiate this the is ongoing. timeframe. in in partners, then will completed

you said, partners working to are but is control, program of our and forward. as out move So, we that little are bit the very committed, diligently

Sumant Kulkarni

Got it. you. Thank

Operator

question Please proceed next BMO Capital. from Kim with Our question. your comes Do with

Do Kim

Thanks good question. taking for my morning. Hi,

manic I on just First to the bipolar behave XXX you clinicaltrials.gov a able will there episode and you Do in would differentiate patients XXX, between started to that patients? wanted calm, hasn't XXX agitation? that be and that any been study, differently confirm in yet, bipolar reason updated say, dosing that is let's think

Vimal Mehta

So, Do, Vimal. this is

I pass and patients will the bipolar, part second why on the in the of it be drug your answer shortly. will we that Risingerto behave schizophrenia. Rob updated dosing will similarly started question Rob? like We have think about clinicaltrials.gov to again bipolar,

Rob Risinger

So, dosing. dosed patients a some reduction agitation a we large robust number have patients. in in We've of with seeing disorder trial. the X initiated SERENITY We're and bipolar

is and continues trial blinded. the course, Of

data as it is That one-third placebo. and patients of the we're monitoring fact. a in, receiving are So, comes

So, that we're is seeing data consistent.

Do Kim

And in [indiscernible]? case of

Frank Yocca

of agitation is this We high. tends we Frank, a events is lot the of to these bipolar in behind that to So, know Norepinephrine that Do, is to and quite patients. role know add just the science drive which mania, Norepinephrine occur and this, there

approach for these of targeted types that So, a we very down, have we patients. really here knocking believe that

Do Kim

Great, for with trials, infrastructure the side, when program operating we and could should about or expenses that's commercial you be a -- do how thinking multiple have And helpful. financial provide XXX? ramp meaningful You building on the about clinical start the for you XXXX? XXX thinking in

Vimal Mehta

question. great a that's Do, So,

month. X already as SERENITY [Ph] February you As TRANQUILITY in X trial both we SERENITY dementia well our remember and before last as that [raise] trial, the funded were did

So, the Xb/X our with is Phase pre-commercialization Commercial additional forward move capital and forward if allows the to trial, the push will allow the of us Officer, do activity. hiring withdrawal from Chief trial, and start us do late-stage dementia opiate positive, to data also

symptoms it that additional forward in allows gives long able be this that I the and and to the So, flexibility, expect say provide this that's cash And withdrawal Richard where of of we us can opioid did, how kind move NDA us with way a -- terms we recently would outline capital… more operational, in faster. can us

Richard Steinhart

Sure, Vimal.

said things So, what we accelerate said, what and Vimal is right, allow us should programs, into to do we've and well take additional cash that is us and XXXX.

Do Kim

Great. for taking my Thank you questions.

Richard Steinhart

welcome. You

Operator

next question. with with H.C. Selvaraju from Please Raghuram Wainwright. comes your Our proceed question

Raghuram Selvaraju

Can Thank you questions. taking my hear much for you so me?

Vimal Mehta

Yes.

Raghuram Selvaraju

and you to expect Okay. Very if of sense sequence you us X quickly, what could wondering was to just I data give SERENITY with potential the respect versus the release a X be of studies. TRANQUILITY

if or has going, you the for accomplished specific timeframe Yale expect to SERENITY, Biomarker in provide what first, with you to of both likely and around and us also enrollment sequence with If which, And on you the example, able also, a of of updates been is tell enrollment mature Study provide if could in please? kind readout completion you those have be be SERENITY would TRANQUILITY might sense of ahead studies? the us which how to of us the

Vimal Mehta

Thank question. Great Sure. you, Ram.

we patients XX, as both by In that schizophrenia Xb enrollment, study. what X. and immediately in our as study like, had expected, in of could on been announced we in terms first, both we phase as of followed have The has we multiple Phase have, indicated, that enrollment Phase And observe of terms in the well initiated December have or Rob SERENITY X. patients -- SERENITY X study SERENITY we those then started patient. SERENITY the going

acute which conducting that are in TRANQUILITY first I we a think care dementia in for conducted anybody trial, is environment, is setting in trial, the setting. a has for this agitation dementia-related which time. patients in of don't treatment long-term

January well is for Enrollment So, as we've X. some or trial we we well. been very as but far progressing it into as announced XX on learning, so, had that with days it

team data is so as and have X need trial, that of database our once take and for is we enrollment a the you the In readouts discuss treat to then how TRANQUILITY it happen, various be step, discussing the line for what regimented, study, to doses, Phase announce In with data. and we can that dose, position dementia data those to we that the top pivotal itself terms and data it good necessary to handle test can next continue sequence lock, the imagine we you us. and the ending on which have is trial may all a will we -- dose has from hard the FDA the in more will when determine the the can the says trial,

So, the the that when goal? goal do that's achieve we study, of

small indication In better it's Trial will Biomarker finished biomarker supports of expect that a we literally data window be fast, which XX mechanism study support kind with we we about to us and In terms time future the the get of our into that is Yale course handle once a that current are or and have of into. Study, gives so. patients due a data if a ongoing. the and ongoing, is trial we can what data, expand other

next mechanism the X with dementia that and move will the to SERENITY develop focal of focus, that the will stage. be allow biomarkers, BXCLXXX. that the to the say would and or understanding continues deeper it X be us generate to look data, the sequence without And I the with continues where that's drug into like. major to So, company's

Raghuram Selvaraju

TRANQUILITY, setting you to possible moving just specifically this to it logistically feasible? assuming the then, from is dementia the get into Is context year? that pivotal results before And end with XXX, of positive envisage the clarify, you're in Okay.

Vimal Mehta

think I most and where specific that next would ready to discussion but say is a that be, that not with the any with as have of data as are related to what fast to in our FDA, to so guidance once will we provide is I important and our FDA, have trial. our stage data and that I going go are possible conversations a as be we where will company to that not dementia to collect and we FDA sufficient amount with interaction leave question have start hand, goal the

Raghuram Selvaraju

Okay.

different We potential profile words, other activity what would from studying? be the haven't the really outcome wondering typically talked are context you would the medication the might assess are currently to measures that the drugs distinct impact context parameters delirium on if care trial other outcome much would design about XXX. in acute that was you contexts are within In Frank acute you these you of too delirium, or which on but particular in in agitation apply to to assess use comment to of delirium acute that efficacy measures I these

Frank Yocca

on Ram, what throw trying and who asking. agitated. achieve to So, freely, the is question focusing these remember you're really are we're that we term that, delirium good around it's that a delirium patients we're Remember quite

at what So the That's on is we in delirium, total focusing it's somewhere to this first. hyperactive really XX% patients. XX% around which are of

at done IV the ability a which the were we Dexmedetomidine where our Carrasco to to a in basically study was calm were they Haloperidol, very of scale used in when they given used back patients, Now, that there who study. IV looking scale, refractory simple was and Spain,

Richard Steinhart

was That scale, a right… rare

Frank Yocca

in potentially the well. it looking apply very similar that as portion the just think think focus asking hyperactive were measures we question very questions dementia of on a simply see, They to more have could you're to I to It's different it. to I Exactly. we is with

that Okay, for forward are study. So, are with things it's as that looking want to something reduce? you behaviors? the have this we to what that deal What are with question. the the we What move factors? a It's will great you're

Vimal Mehta

withdrawal in withdrawal progress. considering stage. planning bandwidth to one And Delirium Phase trial just ongoing, of trial all we of the ongoing, in Xb, Ram, direct, two and currently be more starting have delirium is opiate opiate is work So this soon. Phase organization is X the trials

is withdrawal opiate -- starting trial dementia So, soon.

with are we So, delirium. stage the the in planning

market will to and works the know in We but have in, in hyperactive we where company's the general drug that a it and delirium we trying Xb/X say measure, trial refractory once studies come prior look Phase delirium the agitation, Even are to already been has as the in back results we understand the what from patient. like, most dose. will find zoomed will what important parameters to We strategy haloperidol patients worked. use first

to to to to move have find time. pivotal we the able So, the dose be

we currently. So, are trial a that's delirium with where

Raghuram Selvaraju

use Okay. trial this if with And whether on in was just testing envisage just I very XXX, or you shifting agonist? combination triple future juncture a thinking then XXX different about wondering in Bempegaldesleukin to potentially you quickly are X continuing combo at regiments, to

Vimal Mehta

we committed that and combination. to look that, to the Vince? XXX I that's in Vince for continue I let mentioned will work progress, combination in because So, and approaches at already relationship think to are other continue we use we

Vincent O'Neill

Ram. morning, Good sure. Yes,

and you on there said, we of and the call. probably -- that Nektar, in previous they're we're as targets out but this the as touched ongoing and on town. spin-offs said, our three think approaches, or list know, that four pegylated have there, maybe are I Vimal potential mean only I not with I on list combination collaboration committed the are to we've ILX could IL-X several

discussions. having So, we are those

Raghuram Selvaraju

you. Thank

Operator

call management you. this closing comments. time, would to to Thank turn like At I for the back

Vimal Mehta

substantial filled XXXX. year for the transformative clinical to look growth tremendous Thank progress, with share us updates forward We you, ahead. Operator. year throughout to positioning and XXXX was continuing

Conferences. to look questions. reach again in are the As any us months, updates coming many day, you a Have you forward please Investor pivotal for you upcoming including expecting, readout. Thank at additional and have Thank joining we if you. out our today, of Healthcare to and we great the data clinical key call seeing

Operator

Thank you. concludes and webcast. This teleconference audio does today's

time lines great a your disconnect this and may have You at day.

BioXcel Therapeutics (BTAI) 9 Mar 202019 Q4 Earnings call transcript